| Request for Proposal No.: | NHLBI-HB-03-07 |
| Issue Date: | January 03, 2003 |
| Issued By: | Joanna Magginas, Contracting Officer NIH/NHLBI Contracts Operations Branch 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902 |
| Telephone Number: | (301) 435-0360 |
| FAX Number: | (301) 480-3432 |
| E-Mail: | magginaj@nhlbi.nih.gov |
| Purchase Authority: | 42USC201, Public Health Service Act of 1944, as amended |
| Just In Time: | Yes; See Part IV Section L |
| Small Business Set-Aside: | No; NAICS 541710 |
| Proposal Intent Due Date: | February 03, 2003 |
| Proposal Due Date: | March 03, 2003 4:00 PM (Eastern Time) |
The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals under the subject Request for Proposals (RFP). This RFP is prepared in accordance with the Uniform Contract Format as prescribed by the Federal Acquisition Regulations.
The NHLBI recognizes that scientific and technical staff of potential offerors may want to read portions of an RFP first. The RFP has four parts as follows:
Part I Contract Schedule
Part II Contract Clauses
Part III List of Documents, Exhibits, and other Attachments
Part IV Representations and Instructions
Attention is directed to Part I, Section C and, Part III, Section J, for the Statement of Work (general description of the required objectives and desired results, background information, detailed description of the technical requirements, and technical/cost information specific to this RFP). Attention also is directed to Part IV, Section L, which contains instructions for preparing technical and cost proposals. In Section L.1., please note paragraphs f., g., h., and i. which provide information specifically for this RFP. Finally, staff is referred to Part IV, Section M, for the Evaluation Factors for Award. These parts need to be integrated with the rest of the RFP since all portions must be considered when preparing a proposal.
To assist us in expediting preparations for review of proposals, completion and submittal of the Proposal Intent Response Sheet is extremely important and is due by February 3, 2003. See Section J, Attachment 15. If you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Joanna Magginas, Contracting Officer, at the following internet address:
If you do not notify the Contracting Officer of your intent to submit a proposal, you will not receive an individual notice of any amendments to the RFP, if any are issued. However, all amendments will be posted on the NIH web site.
The due date for submittal of proposals is March 3, 2003, 4:00 p.m. (local time). The address for submittal of proposals and packaging instructions is sent forth in Part III, Section J, Attachment 1.
/s/
Joanna Magginas
Contracting Officer
Contract Operations Branch
National Heart, Lung, and Blood Institute
The contract schedule set forth in SECTIONS B through H, below, is NOT an exact representation of the contract that will result from this RFP. Rather, it is a sample that provides general information pertinent to many of the contracts awarded and should be reviewed as such. Specific contractual provisions pertinent to the offeror's organizational structure (e.g. Non-Profit, Commercial, Educational) and specific cost authorizations unique to the offeror's proposal will be discussed in the negotiation process and included in the resultant contract. This sample contract is meant to provide the offeror with an overview of the elements of a typical contract.
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
This project is designed to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science to animal studies to proof-of-principle and eventually human trials. The somatic cell processing facilities are charged with implementing the rapid, safe, and equable transition of basic research ideas to clinical practice as well as supplying clinical grade products produced in a manner that is compliant with all regulatory requirements. The somatic cell administrative center will serve as the monitor and coordinator for organizational and regulatory aspects of the program.
ARTICLE B.2. PRICES/COSTS
The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.
ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer for: 1) Acquisition, by purchase or lease, of any interest in real property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 4) Travel Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs; 8) Accountable Government Property; and 9) Research Funding.
ARTICLE B.4. ADVANCE UNDERSTANDINGS
Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.
SECTION C—DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, SECTION J, ATTACHMENT 2, dated [to be inserted at time of contract award] , attached hereto and made a part of this Solicitation.
NOTE TO OFFERORS: Section J, Attachment 2 outlines the following three items:
General Description of the Required Objectives and Desired Results
Background Information
Detailed Description of the Technical Requirements
ARTICLE C.2. REPORTING REQUIREMENTS
In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. For proposal preparation purposes only, it is anticipated that reports will be required as follows:
Quarterly Progress Reports: This report shall document and summarize all work results for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. The report shall be in letter form (2-3 pages) and include progress for the quarter, problems encountered during the quarter, goals met or missed, customer satisfaction surveys, a summary of activities planned for the next quarter, manuscripts in progress, submitted or published.
The first reporting period consists of the first full three months of performance and any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. A quarterly progress report is not required for the periods in which an annual or final report is due.
Abstracts and Manuscripts: Copies of manuscripts (published or unpublished) derived from research under the contract and copies of all abstracts, manuscripts, preprints and publications that resulted from work conducted or any protocol or method developed specifically under this contract during the performance period. Manuscripts and publications will only be judged as resulting from this work if they cite the support received from this contract.
Abstracts and manuscripts in progress and proposed for publication shall be provided to the NHLBI for review and comment 30 days prior to submission for publication.
Manual of Procedures: The MOP shall begin as a general document describing the operation of the SCAC and the cell processing facilities. The document shall be completed and approved by the NHLBI before any requests for products can be accepted. The MOP shall be updated continually as new protocols arise from product requests.
Steering Committee and External Review Panel Minutes: Complete and accurate minutes of all Steering Committee Meetings and the open portion of the External Review Panel Meetings. Minutes shall be delivered to the NHLBI within 30 days of the meeting.
Site Visit Reports: Reports for all site visits taken shall be provided within 2 weeks after each site visit.
Annual Technical Reports: This report shall document and summarize all work results for the period covered. Specifically, the report shall include:
External Review Panel Reports: This report shall be submitted two weeks prior to the External Review Panel meetings. The report shall be an update to and same format as the Annual Technical Report. The Project Officer may request, on an as needed basis, additional information not included in the Annual Technical Report or External Review Panel Minutes.
Final Technical Report: This report shall consist of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The final report shall be submitted on or before the last day of the contract performance period.
The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.
All reports and documentation required by FAR Clause 52.227-11 including, but not limited to, the invention disclosure report, the confirmatory license, and the government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of the annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer at the address listed below. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the contract to the Contracting Officer, whose address will be identified in the resultant contract.
Contracting OfficerTo assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.
National Institutes of Health
National Heart, Lung, and Blood Institute
Rockledge Building (RKL2)
6701 Rockledge Drive MSC 7902
Bethesda, Maryland 20892-7902
SECTION D—PACKAGING, MARKING AND SHIPPING
All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.
SECTION E—INSPECTION AND ACCEPTANCE
Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.
FAR Clause No. 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APRIL 1984).
SECTION F—DELIVERIES OR PERFORMANCE
ARTICLE F.1. DELIVERIES
Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in Article C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:
| Item | Description | Quantity | Delivery Schedule |
|---|---|---|---|
| (a) | Manual of Procedures | 5 | Six months after contract award |
| (b) | Steering Committee Meeting Minutes | 5 | Within 30 days following each meeting |
| (c) | External Review Panel Minutes (Open Session) | 5 | Within 30 days following each meeting |
| (d) | Site Visit Reports | 5 | Within 2 weeks after the site visit |
| (e) | Quarterly Progress Reports | 5 | Quarterly |
| (f) | Annual Technical Reports | 5 | Annually |
| (g) | External Review Panel Reports | 10 | Two weeks prior to External Review Panel meeting |
| (h) | Final Technical Report | 5 | Expiration of Contract |
| (i) | Public Use Data set | in accordance with NHLBI policy | per Public Use Data Clause |
[The specific information will be included in the resultant contract]
| Addressee | Deliverable Item No. | Quantity |
|---|---|---|
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
SECTION G—CONTRACT ADMINISTRATION DATA
Any contract awarded from this RFP will contain the following:
ARTICLE G.1. PROJECT OFFICER
The following Project Officer(s) will represent the Government for the purpose of this contract:
[To be specified prior to award]
The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
The Government may unilaterally change its Project Officer designation.
ARTICLE G.2. KEY PERSONNEL
Pursuant to the Key Personnel clause incorporated in this contract, the following individual(s) is/are considered to be essential
to the work being performed hereunder:
| NAME | TITLE |
|---|---|
| [To be specified prior to award]] | |
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST
An original and one copy to the following designated billing office:
Contracting Officer
Contracts Operations Branch
National Heart, Lung, and Blood Institute, NIH
Rockledge Building (RKL2)
6701 Rockledge Drive MSC 7902
BETHESDA MD 20892-7902
ARTICLE G.4. CONTRACT FINANCIAL REPORT
| Expenditure Category | ||
| Direct Labor | ||
| Principal Investigator | ||
| Co-Principal Investigator | ||
| Key Personnel | ||
| Other Professional Personnel | ||
| Personnel—Other | ||
| Fringe Benefits | ||
| Accountable Personal Property | ||
| Materials/Supplies | ||
| Travel | ||
| Consultant Costs | ||
| Computer Costs | ||
| Subcontract Costs | ||
| Other Direct Costs | ||
| Indirect Costs | ||
| G&A Expense | ||
| Total Cost | ||
| Fee | ||
| Total Cost Plus Fixed Fee | ||
ARTICLE G.5. INDIRECT COST RATES
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7(d)(2), "Allowable Cost and Payment" incorporated by reference in this contract in Part II, Section I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:
Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6100 Building, Room 6B05
6100 EXECUTIVE BLVD MSC 7540
BETHESDA MD 20892-7540
These rates are hereby incorporated without further action of the Contracting Officer.
ARTICLE G.6. GOVERNMENT PROPERTY
If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the DHHS Publication (OS) 686, entitled, Contractor's Guide for Control of Government Property, (1990) which can be found at http://knownet.hhs.gov/log/contractorsguide.htm
ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work.
Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.
Copies of the evaluations, contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.
Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:
http://ocm.od.nih.gov/cdmp/cps_contractor.htm
The registration process requires the contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.
SECTION H—SPECIAL CONTRACT REQUIREMENTS
ARTICLE H.1. HUMAN SUBJECTS
As part of the work to be conducted under this contract, the contractor will assist investigators in developing and designing protocols for products to be used in clinical trials as well as developing, obtaining, and maintaining any INDs required for manufacture cellular therapies. For the performance of work related to clinical trials, research involving human subjects shall not be conducted under this contract until each protocol developed has been approved, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed Optional Form 310 (PDF format) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor's self designated form, provided that it contains the information required by the Optional Form 310.
ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. The information below is a summary of the NIH Policy Announcement:
The contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.
Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.
ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.
[Applicable information to be included at award]
[Applicable information to be included at award]
ARTICLE H.5. PRIVACY ACT
This procurement action requires the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties. The Privacy Act System of Records applicable to this project is Number [to be included in contract]. This document
is incorporated into this contract as an Attachment in SECTION J of the contract .
ARTICLE H.6. SUBCONTRACTING PROVISIONS
April 30th
October 30th
The Report shall be sent to the Contracting Officer at following address:
Contracting Officer
Contracts Operations Branch
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive MSC 7902
BETHESDA MD 20892-7902
October 30th
The first Report shall be submitted after the first full year of this contract in addition to any fractional part of the year in which this contract became effective.
One copy of this report shall be sent to the Contracting Officer at the address above. One copy of this Report shall be mailed to the Office of Small and Disadvantaged Business Utilization, DHHS at the following addresses:
Office of Small and Disadvantaged Business Utilization
Department of Health and Human Services
Hubert H. Humphrey Bldg., Room 517-D
200 Independence Avenue, S.W.
Washington, D.C. 20201
ARTICLE H.7. SALARY RATE LIMITATION LEGISLATION PROVISIONS
| b. | Public Law No. | Fiscal Year | Dollar Amount of Salary Limitation* |
| [pending passage of legislation*] | |||
* For contract expenditures using FY-03 funds, the period 10/1/02—12/31/02 the Executive Level rate is $ . Effective 1/1/03,for contract expenditures using FY-03 funds, the Executive Level rate may be increased by $ and will remain at that level until such time as it is determined to raise the Executive Schedule annual rates. See the web site listed below for Executive Schedule rates of pay.
LINK to EXECUTIVE LEVEL SALARIES: http://www.opm.gov/oca/PAYRATES/index.htm
(Click on "Executive Schedule" for the current Fiscal Year's salary rate or scroll down to the "General Schedule Salary Tables from Previous Years" to locate the Executive Level salary rates from previous years.)
ARTICLE H.8. PUBLICATION AND PUBLICITY
The contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, under Contract No. .
[Applicable information to be included at award]
ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
[Applicable information to be included at award]
ARTICLE H.12. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
Unique research resources arising from NIH-funded research are to be shared with the scientific research community. NIH provides guidance, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate terms for disseminating and acquiring these research resources. This guidance, found at : http://ott.od.nih.gov/NewPages/64FR72090.pdf (PDF format) is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.
Note: For the purposes of this Article, the terms, "research tools," "research materials," and "research resources" are used interchangeably and have the same meaning.
PART II—CONTRACT CLAUSES
SECTION I—CONTRACT CLAUSES
THE FOLLOWING PAGES CONTAIN A LISTING(S) OF GENERAL CLAUSES WHICH WILL BE APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS RFP. HOWEVER, THE ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSES LISTING TO BE CONTAINED IN THE CONTRACT(S) AWARDED FROM THIS RFP.
This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.
| FAR CLAUSE NO. |
DATE | TITLE |
|---|---|---|
| 52.202-1 | Dec 2001 | Definitions |
| 52.203-3 | Apr 1984 | Gratuities (Over $100,000) |
| 52.203-5 | Apr 1984 | Covenant Against Contingent Fees (Over $100,000) |
| 52.203-6 | Jul 1995 | Restrictions on Subcontractor Sales to the Government (Over $100,000) |
| 52.203-7 | Jul 1995 | Anti-Kickback Procedures(Over $100,000) |
| 52.203-8 | Jan 1997 | Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000) |
| 52.203-10 | Jan 1997 | Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000) |
| 52.203-12 | Jun 1997 | Limitation on Payments to Influence Certain Federal Transactions (Over $100,000) |
| 52.204-4 | Aug 2000 | Printed or Copied Double-Sided on Recycled Paper (Over $100,000) |
| 52.209-6 | Jul 1995 | Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000) |
| 52.215-2 | Jun 1999 | Audit and Records—Negotiation (Over $100,000) |
| 52.215-8 | Oct 1997 | Order of Precedence—Uniform Contract Format |
| 52.215-10 | Oct 1997 | Price Reduction for Defective Cost or Pricing Data |
| 52.215-12 | Oct 1997 | Subcontractor Cost or Pricing Data (Over $500,000) |
| 52.215-14 | Oct 1997 | Integrity of Unit Prices (Over $100,000) |
| 52.215-15 | Dec 1998 | Pension Adjustments and Asset Reversions |
| 52.215-18 | Oct 1997 | Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions |
| 52.215-19 | Oct 1997 | Notification of Ownership Changes |
| 52.215-21 | Oct 1997 | Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data—Modifications |
| 52.216-7 | Feb 2002 | Allowable Cost and Payment |
| 52.216-8 | Mar 1997 | Fixed Fee |
| 52.219-8 | Oct 2000 | Utilization of Small Business Concerns (Over $100,000) |
| 52.219-9 | Jan 2002 | Small Business Subcontracting Plan (Over $500,000) |
| 52.219-16 | Jan 1999 | Liquidated Damages—Subcontracting Plan (Over $500,000) |
| 52.222-2 | Jul 1990 | Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.) |
| 52.222-3 | Aug 1996 | Convict Labor |
| 52.222-26 | Apr 2002 | Equal Opportunity |
| 52.222-35 | Dec 2001 | Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans |
| 52.222-36 | Jun 1998 | Affirmative Action for Workers with Disabilities |
| 52.222-37 | Dec 2001 | Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans |
| 52.223-6 | May 2001 | Drug-Free Workplace |
| 52.223-14 | Oct 2000 | Toxic Chemical Release Reporting |
| 52.225-1 | May 2002 | Buy American Act—Supplies |
| 52.225-13 | Jul 2000 | Restrictions on Certain Foreign Purchases |
| 52.227-1 | Jul 1995 | Authorization and Consent, Alternate I (Apr 1984) |
| 52.227-2 | Aug 1996 | Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000) |
| 52.227-11 | Jun 1997 | Patent Rights—Retention by the Contractor (Short Form) (Note: In accordance with FAR 27.303(a)(2), paragraph (f) is modified to include the requirements in FAR 27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is annual. |
| 52.227-14 | Jun 1987 | Rights in Data—General |
| 52.232-9 | Apr 1984 | Limitation on Withholding of Payments |
| 52.232-17 | Jun 1996 | Interest (Over $100,000) |
| 52.232-20 | Apr 1984 | Limitation of Cost |
| 52.232-23 | Jan 1986 | Assignment of Claims |
| 52.232-25 | Feb 2002 | Prompt Payment |
| 52.232-34 | May 1999 | Payment by Electronic Funds Transfer—Other Than Central Contractor Registration |
| 52.233-1 | Jul 2002 | Disputes |
| 52.233-3 | Aug 1996 | Protest After Award, Alternate I (Jun 1985) |
| 52.242-1 | Apr 1984 | Notice of Intent to Disallow Costs |
| 52.242-3 | May 2001 | Penalties for Unallowable Costs (Over $500,000) |
| 52.242-4 | Jan 1997 | Certification of Final Indirect Costs |
| 52.242-13 | Jul 1995 | Bankruptcy (Over $100,000) |
| 52.243-2 | Aug 1987 | Changes—Cost Reimbursement, Alternate V (Apr 1984) |
| 52.244-2 | Aug 1998 | Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required, the identified subcontracts are listed in ARTICLE B, Advance Understandings. |
| 52.244-5 | Dec 1996 | Competition in Subcontracting (Over $100,000) |
| 52.245-5 | Jan 1986 | Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract) |
| 52.246-23 | Feb 1997 | Limitation of Liability (Over $100,000) |
| 52.249-6 | Sep 1996 | Termination (Cost-Reimbursement) |
| 52.249-14 | Apr 1984 | Excusable Delays |
| 52.253-1 | Jan 1991 | Computer Generated Forms |
| HHSAR CLAUSE NO. |
DATE | TITLE |
|---|---|---|
| 352.202-1 | Jan 2001 | Definitions—with Alternate paragraph (h) (Jan 2001) |
| 352.216-72 | Oct 1990 | Additional Cost Principles |
| 352.228-7 | Dec 1991 | Insurance—Liability to Third Persons |
| 352.232-9 | Apr 1984 | Withholding of Contract Payments |
| 352.233-70 | Apr 1984 | Litigation and Claims |
| 352.242-71 | Apr 1984 | Final Decisions on Audit Findings |
| 352.270-5 | Apr 1984 | Key Personnel |
| 352.270-6 | Jul 1991 | Publications and Publicity |
| 352.270-7 | Jan 2001 | Paperwork Reduction Act |
[ End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - Rev. 9/2002].
ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES
Any authorized substitutions and/or modifications other than the General Clauses which will be based on the type of contract/Contractor will be determined during negotiations.
It is expected that the following clauses will be made part of the resultant contract:
FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor. Note: When this contract is fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will become applicable.
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during
negotiations. Any contract awarded from this solicitation will contain the following:
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
"(c) Waiver of evaluation preference....[ ] Offeror elects to waive the evaluation preference."
"(b) Evaluation adjustment. (1) The Contracting Officer will evaluate offers by adding a factor of 10 percent to the price of all offers, except ..."
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
Additional clause other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following:
This contract incorporates the following clause in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:
| (a) | Definitions. As used in this clause— Commercial item, has the meaning contained in the clause at 52.202-1, Definitions. Subcontract, includes a transfer of commercial items between divisions, subsidiaries, or affiliates of the Contractor or subcontractor at any tier. |
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| (b) | To the maximum extent practicable, the Contractor shall incorporate, and require its subcontractors at all tiers to incorporate, commercial items or nondevelopmental items as components of items to be supplied under this contract. |
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| (c) | (1) | The Contractor shall insert the following clauses in subcontracts for commercial items: | ||
| (i) | 52.219-8, Utilization of Small Business Concerns (OCT 2000) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. | |||
| (ii) | 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246). | |||
| (iii) | 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)). | |||
| (iv) | 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793). | |||
| (v) | 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (JUN 2000) (46 U.S.C. Appx 1241) (flowdown not required for subcontracts awarded beginning May 1, 1996). |
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| (2) | While not required, the Contractor may flow down to subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. |
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| (d) | The Contractor shall include the terms of this clause, including this paragraph (d), in subcontracts awarded under this contract. | |||
PART III—LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
Footnotes:
PART IV—REPRESENTATIONS AND INSTRUCTIONS
SECTION K—REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS
Representations, Certifications, and Other Statements of Offerors or Quoters (Negotiated).
1. REPRESENTATIONS AND CERTIFICATIONS
The Representations and Certifications required by this particular acquisition can be accessed electronically from the INTERNET at the following URL:
http://rcb.nci.nih.gov/forms/rcneg.pdf (PDF format)
If you are unable to access this document electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.
IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST COMPLETE THE REPRESENTATIONS AND CERTIFICATIONS AND SUBMIT THEM AS PART OF YOUR BUSINESS PROPOSAL.
SECTION L—INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS
1. GENERAL INFORMATION
| (a) | Definitions. As used in this provision— |
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| Discussions are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal. |
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| "In writing", "writing", or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information. |
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| "Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award. |
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| "Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations. |
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| "Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day. |
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| (b) | Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s). |
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| (c) | Submission, modification, revision, and withdrawal of proposals. (1) Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision. |
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| (2) | The first page of the proposal must show— | ||||
| (i) | The solicitation number; | ||||
| (ii) | The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available); | ||||
| (iii) | A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item; | ||||
| (iv) | Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and | ||||
| (v) | Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office. |
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| (3) | Submission, modification, revision, and withdrawal of proposals. (i) Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due. | ||||
| (ii) | (A) | Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and— | |||
| (1) | If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of proposals; or | ||||
| (2) | There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or | ||||
| (3) | It is the only proposal received. |
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| (B) | However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted. |
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| (iii) | Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel. |
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| (iv) | If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. |
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| (v) | Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award. |
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| (4) | Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items. |
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| (5) | Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign Currency Offers, is included in the solicitation. |
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| (6) | Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award. |
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| (7) | Offerors may submit revised proposals only if requested or allowed by the Contracting Officer. |
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| (8) | Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer. |
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| (d) | Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror). |
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| (e) | Restriction on disclosure and use of data. (1) The proposal submitted in response to this request may contain data (trade secrets; business data, e.g., commercial information, financial information, and cost and pricing data; and technical data) which the offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror marks the cover sheet of the proposal with the following legend, specifying the particular portions of the proposal which are to be restricted in accordance with the conditions of the legend. The Government's determination to withhold or disclose a record will be based upon the particular circumstances involving the record in question and whether the record may be exempted from disclosure under the Freedom of Information
Act. The legend reads:
Unless disclosure is required by the Freedom of Information Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of Information (FOI) officials of the Department of Health and Human Services, data contained in the portions of this proposal which have been specifically identified by page number, paragraph, etc. by the offeror as containing restricted information shall not be used or disclosed except for evaluation purposes. |
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| (2) | In addition, the offeror should mark each page of data it wishes to restrict with the following statement:
"Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal or quotation." |
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| (3) | Offerors are cautioned that proposals submitted with restrictive legends or statements differing in substance from the above legend may not be considered for award. The Government reserves the right to reject any proposal submitted with a nonconforming legend. |
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| (f) | Contract award. (1) The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation. |
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| (2) | The Government may reject any or all proposals if such action is in the Government's interest. |
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| (3) | The Government may waive informalities and minor irregularities in proposals received. |
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| (4) | The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror's initial proposal should contain the offeror's best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. |
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| (5) | The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the offeror specifies otherwise in the proposal. |
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| (6) | The Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so. |
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| (7) | Exchanges with offerors after receipt of a proposal do not constitute a rejection or counteroffer by the Government. |
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| (8) | The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques. A proposal may be rejected if the Contracting Officer determines that the lack of balance poses an unacceptable risk to the Government. |
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| (9) | If a cost realism analysis is performed, cost realism may be considered by the source selection authority in evaluating performance or schedule risk. |
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| (10) | A written award or acceptance of proposal mailed or otherwise furnished to the successful offeror within the time specified in the proposal shall result in a binding contract without further action by either party. |
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| (11) | The Government may disclose the following information in postaward debriefings to other offerors: |
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| (i) | The overall evaluated cost or price and technical rating of the successful offeror; | ||||
| (ii) | The overall ranking of all offerors, when any ranking was developed by the agency during source selection; | ||||
| (iii) | A summary of the rationale for award; and | ||||
| (iv) | For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror. |
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| Alternate I (October 1997). As prescribed in 15.209(a)(1), substitute the following paragraph (f)(4) for paragraph (f)(4) of the basic provision: |
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| (f) | (4) | The Government intends to evaluate proposals and award a contract after conducting discussions with offerors whose proposals have been determined to be within the competitive range. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. Therefore, the offeror's initial proposal should contain the offeror's best terms from a price and technical standpoint. | |||
This RFP contains special procedures for the submission of business management proposals. These special procedures are designed to reduce the administrative burden on offerors without compromising the information during the initial evaluation of proposals. Certain documents will no longer be required to be submitted with initial proposals, but will be requested at a later stage in the competitive process. Specifically, the travel policy, the annual financial statement, the total compensation plan, the subcontracting plan, and certain types of cost/pricing information will only be required to be submitted from those offerors included in the competitive range or the apparent successful offeror. The special procedures for submission of this documentation are set forth in detail below:
Travel Policy. The offeror's (and any proposed subcontractor's) written travel policy shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required to submit a travel policy as a part of their final proposal revision.
Annual Report. The offeror's most recent annual report shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required submit a copy of their most recent annual report as a part of their final proposal revision.
Total Compensation Plan. The offeror's total compensation plan shall not be submitted with the initial business proposal. All offerors included in the competitive range will be required submit a total compensation plan as a part of their final proposal revision.
Subcontracting Plan. The offeror's Small Business Subcontracting Plan shall not be submitted with the initial business proposal. Only the apparent successful offeror will be required to submit an acceptable subcontracting plan.
Cost/Pricing Information. The offeror's business proposal shall include the basic cost/pricing information specified in Section L.2.c.1 of this RFP. In addition, the Government may require offerors included in the competitive range to submit additional information substantiating their proposed costs or prices. This additional cost/pricing information will be requested after establishment of the competitive range, and potentially includes payroll documentation, vendor quotes, invoice prices, and/or any other information deemed necessary by the contracting officer to evaluate the reasonableness of the price or to determine cost realism. The information may also include submission and certification of cost or pricing data.
Note: The following information is to be used by the offeror in preparing its Representations and Certifications (See Section K of this RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM FAR Clause 52.219-1.
THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in EVERY solicitation, (except for foreign acquisitions) the inclusion of the North American Industry Classification (NAICS) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.
In accordance with FAR Clause 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, incorporated in Section I.3., offerors will be evaluated by adding a factor of 10 percent to the price of all offers, except offers from small disadvantaged business concerns that have not waived the adjustment. (Note: A listing of other offerors who are excepted and will not have this evaluation factor added to their offer may be found in subparagraph (b) of FAR Clause 52.219-23.
A small disadvantaged business concern may elect to waive the adjustment, in which case the factor will be added to its offer for evaluation purposes. The agreements in paragraph (d) of FAR Clause 52.219-23 do not apply to offerors that waive the adjustment.
AN OFFEROR WHO ELECTS TO WAIVE THIS EVALUATION ADJUSTMENT MUST SPECIFICALLY INDICATE WITH A STATEMENT TO THIS EFFECT ON THE COVER PAGE OF ITS BUSINESS PROPOSAL.
It is anticipated that one award will be made from this solicitation and that the award will be made on/about September 30, 2003. It is anticipated that the award from this solicitation will be a multiple-year cost reimbursement completion type performance-based contract with a period of performance of five years and that incremental funding will be used [see Section L.2.c. Business Proposal Instructions].
It is expected that a completion type contract will be awarded as a result of this RFP. The level of effort devoted to the project must be compatible with the scientific and technical approach proposed to cover the activities in the Statement of Work. Professional, technical, and support staff should have experience pertinent to the operation of an administrative center for a project related to cell processing or transfusion medicine. Expertise is required in data collection and management, monitoring, FDA regulations and guidelines, biostatistics, and preparation of scientific manuscripts and reports. If a consultant is used, a letter of commitment must be provided. The following staffing patterns are broad guidelines which may be useful to offerors. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.
| Percent of Effort* | |||
|---|---|---|---|
| 6 MOS. Phase I |
54 MOS. Phase II |
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| Principal Investigator | 10% | 25% | |
| Project Director | 100% | 100% | |
| Statistician (Ph.D.) | 10% | 50% | |
| Regulatory Specialist | 10% | 100% | |
| Data Manager | 0% | 50% | |
| Administrative Assistant |
100% |
100% |
|
| *Phase I is ½ year; Phase II is 4½ years. | |||
RFP NHLBI-HB-03-06; "Somatic Cell Therapy Processing Facilities"
This project involves research on human subjects. It is expected that final products from the cell processing facilities will be used in clinical trials. Therefore, the facilities will bear the responsibility of producing the clinical grade reagent and assuring compliance with all regulatory requirements. They will also assist the investigator in designing studies to test the efficacy and safety of the reagent. Applicable clauses will be incorporated into any resultant contract. Human subject assurance certification by the institution's IRB must be obtained prior to participant contact.
Offerors should provide examples of previous experience in monitoring multicenter studies related to cell processing or transfusion medicine. These examples should include a description of the process for evaluation of requests and associated cost information. Offerors should also provide examples of regulatory submissions developed for the FDA and/or specific experience of personnel who can provide guidance to the cell processing facilities in this area.
The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid.
Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this RFP. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.
Contract selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, and to all offerors following award.
The relative importance of the evaluation factors are specified in SECTION M of this solicitation.
This RFP does not commit the Government to pay for the preparation and submission of a proposal.
Robert Best
Chief, Contracts Operations Branch
National Heart, Lung, and Blood Institute
Rockledge Building (RKL2)
6701 Rockledge Drive MSC 7902 (Room 6100)
Bethesda, Maryland 20892—7902
(End of Provision)
Notwithstanding the procedures contained in FAR 52.215-1(c)(3) of the provision of this solicitation entitled Instructions to Offerors-Competitive Acquisition, a proposal received after the date specified for receipt may be considered if it offers significant cost or technical advantages to the Government; and it was received before proposals were distributed for evaluation, or within five calendar days after the exact time specified for receipt, whichever is earlier.
(End of provision)
2. INSTRUCTIONS TO OFFERORS
INTRODUCTION
The following instructions will establish the acceptable minimum requirements for the format and contents of proposals. Special attention is directed to the requirements for technical and business proposals to be submitted in accordance with these instructions.
It is anticipated that a cost-reimbursement completion type performance-based contract will be awarded. (See General Information) Any resultant contract shall include the clauses applicable to the selected offeror's organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.
It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the Technical Proposal Instructions and as specified in SECTION J, List of Attachments.
It is recommended that the business proposal consist of a cover page, a table of contents, and the information requested in the Business Proposal Instructions and as specified in SECTION J, List of Attachments.
The offeror must complete the Form NIH-2043 (PDF format, MS Word format), attached, with particular attention to the length of time the proposal is firm and the designation of those personnel authorized to conduct negotiations. (See Section J, Attachment entitled, PROPOSAL SUMMARY AND DATA RECORD.)
The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., and associated costs so that the offeror's understanding of the project may be evaluated (See Attachment entitled, TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR AND DIRECT COSTS [HTML format, MS Word format]). However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions.
You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this RFP, shall be clearly identified.
The Government will evaluate technical proposals in accordance with the criteria set forth in Part IV, Section M of this RFP.
The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary.
It is the policy of the Department of Health and Human Services to support the Federal transition to the metric system and to use the metric system of measurement in all procurement, grants, and other business related activities unless such use is impracticable or is likely to cause significant inefficiencies.
The offeror is encouraged to prepare their proposal using either "Hard Metric," "Soft Metric," or "Dual Systems" of measurement. The following definitions are provided for your information:
Hard Metric—The replacement of a standard inch-pound size with an accepted metric size for a particular purpose. An example of size substitution might be: selling or packaging liquids by the liter instead of by the pint or quart (as for soft drinks), or instead of by the gallon (as for gasoline).Soft Metric—The result of a mathematical conversion of inch-pound measurements to metric equivalents for a particular purpose. The physical characteristics are not changed.
Dual Systems—The use of both inch-pound and metric systems. For example, an item is designed, produced, and described in inch-pound values with soft metric values also shown for information or comparison purposes.
IMPORTANT NOTE TO OFFERORS: The following 6 paragraphs [(9) through (14)] address HUMAN SUBJECTS issues. While it is understood that much of the language DOES NOT apply for proposal purposes, some of the information contained in the following paragraphs may apply, after contract award, to those manufactured products which will be used in clinical trials. Attachments/tables need NOT be completed at this time.
The following notice is applicable when contract performance is expected to involve risk to human subjects:
Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (JANUARY 2001)
*Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH) wherever it appears in this provision. The phone number to reach this office is 301-496-7005. For more information, the OHRP website may be accessed at http://ohrp.osophs.dhhs.gov/. Copies of the DHHS Regulations for the Protection of Human Subjects, 45 CFR Part 46, are also available on line at http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html.
Offerors must address the following human subjects protections issues if this contract will be for research involving human subjects (note: under each of the following points below, the offeror should indicate whether the information provided relates to the primary research site, or to a collaborating performance site(s), or to all sites:
Human Subjects Involvement and Characteristics:
Sources of Materials:
Potential Risks:
Recruitment and Informed Consent:
Protection Against Risk:
Note: If a test article (investigational new drug, device, or biologic) is involved, name the test article and state whether the 30-day interval between submission of offeror's certification to the Food and Drug Administration (FDA) and its response has elapsed or has been waived and/or whether the FDA has withheld or restricted use of the test article.
Collaborating Site(s)
When research involving human subjects will take place at collaborating site(s) or other performance site(s), the offeror must provide in this section of its proposal a list of the collaborating sites and their assurance numbers. Further, if you are awarded a contract, you must obtain in writing, and keep on file, an assurance from each site that the previous points have been adequately addressed at a level of attention that is at least as high as that documented at your organization. Site(s) added after an award is made must also adhere to the above requirements.
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for contracts for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Offerors should review the policy announcement prior to submission of their offers. The following is a summary of the Policy Announcement:
For any solicitation for research involving human subjects, the offeror shall provide in its technical proposal the following information: (1) a list of the names of the principal investigator and any other individuals proposed under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program completed (or to be completed prior to the award of the contract) for each named personnel; (3) a one sentence description of the program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.
Curricula that are readily available and meet the educational requirement include the NIH on-line tutorial, titled "Protection of Human Research Subjects: Computer-Based Training for Researchers," available at http://ohsr.od.nih.gov/cbt/. You may download the information at this site at no cost and modify it, if desired. In addition, the University of Rochester has made its training program available for individual investigators. Completion of this program will also satisfy the educational requirement. The University of Rochester manual can be obtained through Centerwatch, Inc. at http://www.centerwatch.com/order/pubs_profs_protect.html. If an institution already has developed educational programs on the protection of research participants, completion of these programs also will satisfy the educational requirement.
In addition, prior to the substitution of the principal investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the contractor shall provide the contracting officer with the title of the education program and a one sentence description of the program that the replacement has completed.
It is NIH policy that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an Institute/Center Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43), and applies to research subjects of all ages.
All investigators proposing research involving human subjects should read the UPDATED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 at the following web site:
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
These guidelines contain a definition of clinical research adopted in June 2001, as: "(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research" (http://www.nih.gov/news/crp/97report/execsum.htm).
Information Required for ALL Clinical Research Proposals
This solicitation contains a review criterion addressing the adequacy of (1) the offeror's plans for inclusion of women and minorities in the research proposed; or (2) the offeror's justification(s) for exclusion of one or both groups from the research proposed.
Provide information on the composition of the proposed study population in terms of sex/gender and racial/ethnic groups and provide a rationale for selection of such subjects in response to the requirements of the solicitation. The description may include (but is not limited to) information on the population characteristics of the disease or condition being studied in the planned research, and/or described in the statement of work, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned research.
The proposal must include the following information:
NOTE 1: For all proposals, use the ethnic and racial categories and complete the "Targeted/Planned Enrollment Table in accordance with the Office of Management and Budget (OMB) Directive No. 15, which may be found at: http://www.whitehouse.gov/OMB/fedreg/ombdir15.html.
NOTE 2: If this is an Indefinite Delivery, Indefinite Quantity (IDIQ) or Requirements contract as defined in FAR 16.5, the proposal should describe in general terms how it will comply with each bulleted item above for each task order. When the Government issues a task order request for proposal, each of the bulleted information items must be fully and specifically addressed in the proposal.
Standards for Collecting Data. When you, as a contractor, are planning data collection items on race and ethnicity, you shall use, at a minimum, the categories identified in OMB Directive No. 15. The collection of greater detail is encouraged. However, you should design any additional, more detailed items so that they can be aggregated into these required categories. Self-reporting or self-identification using two separate questions is the preferred method for collecting data on race and ethnicity. When you collect race and ethnicity separately, you must collect ethnicity first. You shall offer respondents the option of selecting one or more racial designations. When you collect data on race and ethnicity separately, you shall also make provisions to report the number of respondents in each racial category who are Hispanic or Latino. When you present aggregate data, you shall provide the number of respondents who selected only one category, for each of the five racial categories. If you collapse data on multiple responses, you shall make available, at a minimum, the total number of respondents reporting "more than one race." Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.
In addition to the above requirements, solicitations for NIH defined Phase III clinical trials (See NIH Guide http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm for the Definition of an "NIH-Defined Phase III clinical trial) require that: a) all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect (see NIH Guide:
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm, Definitions—Significant Difference),by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable; and b) all contractors to report annually cumulative subject accrual, and progress in conducting analyses for sex/gender and race/ethnicity differences.
Offerors may obtain copies of the Updated Guidelines from the sources above or from the contact person listed in the solicitation.
Also, the proposal must include one of the following plans:
Use the form in Section J, Attachments, entitled, "Targeted/Planned Enrollment Table," when preparing your response to the solicitation requirements for inclusion of women and minorities.
Unless otherwise specified in this solicitation, the Government has determined that the work required by this solicitation does not involve a sex/gender specific study or a single or limited number of minority population groups. Therefore, the NIH believes that the inclusion of women and minority populations is appropriate for this project. (See Section M of this RFP for more information about evaluation factors for award.)
Use the format for the Annual Technical Progress Report for Clinical Research Study Populations (See Section J—List of Documents, Exhibits and Other Attachments of the RFP) entitled, "Inclusion Enrollment Report," for reporting in the resultant contract.
It is NIH policy that children (defined below) must be included in all human subjects research, including, but not limited to, clinical trials, conducted under a contract funded by the NIH, unless there are clear and compelling reasons not to include them. (See examples of Justifications for Exclusion of Children below). For the purposes of this policy, contracts involving human subjects include categories that would otherwise be exempt from the DHHS Policy for Protection of Human Research Subjects (sections 101(b) and 401(b) of 45 CFR 46), such as surveys, evaluation of educational interventions, and studies of existing data or specimens that should include children as participants. This policy applies to both domestic and foreign research contracts.
For purposes of this policy, a child is defined as an individual under the age of 21 years.
All offerors proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" which was published in the NIH Guide for Grants and Contracts on March 6, 1998 and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html
Offerors also may obtain copies from the contact person listed in the RFP.
Inclusion of children as participants in research must be in compliance with all applicable subparts of 45 CFR 46 as well as other pertinent laws and regulations whether or not such research is otherwise exempted from 45 CFR 46. Therefore, any proposals must include a description of plans for including children, unless the offeror presents clear and convincing justification for an exclusion. The "Human Subjects" section of your technical proposal should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. This solicitation contains a review criterion addressing the adequacy of: (1) the plans for including children as appropriate for the scientific goals of the research; and/or (2) the justification of exclusion of children or exclusion of a specific age range of children.
When children are included, the plan also must include a description of: (1) the expertise of the investigative team for dealing with children at the ages included; (2) the appropriateness of the available facilities to accommodate the children; and, (3) the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose/objective of the solicitation.
Justifications for Exclusion of Children
It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:
Definition of a Child
For the purpose of this solicitation, a child is defined as an individual under the age of 21 years. The definition of child described above will pertain to this solicitation (notwithstanding the FDA definition of a child as an individual from infancy to 16 years of age, and varying definitions employed by some states). Generally, State laws define what constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address when a child can consent to participate in research. Federal Regulations (45 CFR 46, subpart D, Sec.401-409) address DHHS protections for children who participate in research, and rely on State definitions of "child" for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
All offerors are directed to the full text of the NIH Policies regarding Data and Safety Monitoring and Reporting of Adverse Events that are found in the NIH Guide for Grants and Contracts Announcements at the following web sites:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
All offerors receiving an award under this solicitation must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this solicitation.
The following is a brief summary of the Data and Safety Monitoring and Adverse Event Reporting Requirements:
Data and Safety Monitoring is required for every clinical trial. Monitoring must be performed on a regular basis and the conclusions of the monitoring reported to the Project Officer.
The type of data and safety monitoring required will vary based on the type of clinical trial and the potential risks, complexity and nature of the trial. A plan for data and safety monitoring is required for all clinical trials. A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for the monitoring, and the policies and procedures for adverse event reporting. Phase III clinical trials generally require the establishment of a Data Safety Monitoring Board (DSMB). The establishment of a DSMB is optional for Phase I and Phase II clinical trials.
The DSMB/Plan is established at the time the protocol is developed and must be approved by both the Institutional Review Board (IRB) and the Government and in place before the trial begins. If the protocol will be developed under the contract awarded from this solicitation, a general description of the data and safety monitoring plan must be submitted as part of the proposal and will be reviewed by the scientific review group (Technical Evaluation Panel, (TEP)) convened to evaluate the proposal. If the protocol is developed and is included as part of the submitted proposal, a complete and specific data and safety monitoring plan must be submitted as part of the proposal.
Monitoring Plans, at a minimum, must include the prompt reporting of adverse events to the IRB, the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA). Also, in the plan you should describe the frequency of reporting of the conclusions of the monitoring activities. The overall elements of each plan may vary depending on the size and complexity of the trial. The NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/notice-files/not98-084.html describes examples of monitoring activities to be considered.
The frequency of monitoring will depend upon potential risks, complexity, and the nature of the trial; therefore a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a:
For multi-site Phase I and Phase II trials, a central reporting entity that will be responsible for preparing timely summary reports of adverse events for distribution among sites and IRBs should be considered.
Organizations with a large number of clinical trials may develop standard monitoring plans for Phase I and Phase II trials. In this case, such organizations may include the IRB-approved monitoring plan as part of the proposal submission.
As a public sponsor of biomedical research, the National Institutes of Health (NIH) has a dual interest in accelerating scientific discovery and facilitating product development. Intellectual property restrictions can stifle the broad dissemination of new discoveries and limit future avenues of research and product development. At the same time, reasonable restrictions on the dissemination of research tools are sometimes necessary to protect legitimate proprietary interests and to preserve incentives for commercial development. To assist NIH contractors achieve an appropriate balance, the NIH has provided guidance in the form of a two-part document, consisting of Principles setting forth the fundamental concepts and Guidelines that provide specific information to patent and license professionals and sponsored research administrators for implementation.
The purpose of these Principles and Guidelines is to assist NIH funding recipients in determining: 1) Reasonable terms and conditions for making NIH-funded research resources available to scientists in other institutions in the public and private sectors (disseminating research tools); and 2) Restrictions to accept as a conditions of receiving access to research tools for use in NIH-funded research (acquiring research tools). The intent is to help recipients ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.
This policy, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090] will be included in any contract awarded from this solicitation. It can be found at the following website: http://ott.od.nih.gov/NewPages/64FR72090.pdf (PDF format).
The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency advise each individual whom it asks to supply information, the authority which authorizes the solicitation, whether disclosure is voluntary or mandatory, the principal purpose or purposes for which the information is intended to be used, the uses outside the agency which may be made of the information, and the effects on the individual, if any, of not providing all or any part of the requested information.
The NIH is requesting the information called for in this RFP pursuant to the authority provided by Sec. 301(a)(7) of the Public Health Service Act, as amended, and P.L. 92-218, as amended.
Providing the information requested is entirely voluntary. The collection of this information is for the purpose of conducting an accurate, fair, and adequate review prior to a discussion as to whether to award a contract.
Failure to provide any or all of the requested information may result in a less than adequate review.
In addition, the Privacy Act of 1974 (P.L. 93-579, Section 7) requires that the following information be provided when individuals are requested to disclose their social security number.
Provision of the social security number is voluntary. Social security numbers are requested for the purpose of accurate and efficient identification, referral, review and management of NIH contracting programs. Authority for requesting this information is provided by Section 301 and Title IV of the PHS Act, as amended.
The information provided by you may be routinely disclosed for the following purposes:
Such communications shall not be used to cure proposal deficiencies or omissions that alter the technical or cost elements of the proposal, and/or otherwise revise the proposal, but may be considered in rating proposals for the purpose of establishing the competitive range.
While it is NHLBI's policy to conduct discussions with all offerors in the competitive range, NHLBI reserves the right, in special circumstances, to limit the number of proposals included in the competitive range to the greatest number that will permit an efficient competition. All aspects of the proposals are subject to discussions, including cost, technical approach, past performance, and contractual terms and conditions. At the conclusion of discussions, each offeror still in the competitive range shall be given an opportunity to submit a written Final Proposal Revision (FPR) with the reservation of the right to conduct finalization of details with the selected source in accordance with HHSAR 315.370.
**** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****
If the proposed contract exceeds a total estimated cost of $500,000 for the entire period of performance, the apparent successful offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No.52.219-9, incorporated herein by reference in the Solicitation, Attachment 7 (PDF format) to this RFP is an example of such a plan.
For additional information about each of the above elements required to be contained the subcontracting plan, see FAR Clause 52.219-9, Small Business Subcontracting Plan, and the Sample Subcontracting Plan (PDF format) which is provided as an attachment to this RFP in SECTION J.
HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFP are as follows:
.0083% for Small Business; 0% for Small Disadvantaged Business; 0%for Women-Owned Small Business; 0% for HubZone Small Business; and 0% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.
Small Business offerors located in underutilized business zones, called "HUBZones," will be evaluated in accordance with FAR Clause 52.219-4, NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS, which is incorporated by reference in ARTICLE I.3. of this solicitation. Qualified HUBZone firms are identified in the Small Business Administration website at http://www.sba.gov/hubzone.
In accordance with FAR part 15.304(c)(4), the extent of participation of Small Disadvantaged Business (SDB) concerns in performance of the contract in the authorized SIC Major Groups will be evaluated in unrestricted competitive acquisitions expected to exceed $500,000 ($1,000,000 for construction) subject to certain limitations (see FAR 19.1202-1 and 19.1202-2(b). The dollar amounts cited above include any option years/option quantities that may be included in this solicitation. The definition of a "small disadvantaged business" is cited in FAR 19.001.
NOTE: The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan described elsewhere in this solicitation, if applicable. Offerors shall submit a Small Disadvantaged Business Participation Plan which includes the following information in one clearly marked section of their business proposal:
A plan on the extent of participation of SDB concerns in performance of the contract. Participation in performance of the contract includes the work expected to be performed by SDB concern(s). This can include SDB (as prime contractor), joint ventures, teaming arrangements, and subcontracts. Include the following information in your SDB participation plans:
*NOTE: FAR Subpart 9.6 defines "Contractor team arrangements" to include two or more companies forming a partnership or joint venture to act as a potential prime contractor, or a potential prime contractor who agrees with one or more companies to have them act as its subcontractors on a specific contract or acquisition program. For purposes of evaluation of the SDB participation factor, FAR 19.1202-4 requires that SDB joint ventures and teaming arrangements at the prime level be presented separately from SDB participation by subcontractors.
SDB participation information furnished in the plan described above will be used as an evaluation factor (see Section M. Evaluation Criteria, Small Disadvantaged Business Participation Factor.) The Government will focus on information that demonstrates realistic commitments to use SDB concerns relative to the size and complexity of the acquisition under consideration. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror's commitment to SDB participation.
The Government is seeking to determine whether the offeror has demonstrated a commitment to use SDB concerns for the work that it intends to perform as the prime contractor. The assessment of the offeror's SDB Participation Plan will be used as a means of evaluating the relative capability and commitment of the offeror and the other competitors, e.g., an offeror with an exceptional record of participation with SDB concerns may receive a more favorable evaluation than another whose record of participation with SDB concerns is acceptable, even though both may have acceptable technical proposals.
NOTE: Offers to rely on SDB concerns merely for such activities as provision of supplies and basic services such as travel arrangements, unless such supplies and arrangements are of significant value and are an integral part of contract performance, will be considered of negligible value for the purposes of evaluating the SDB participation plan.
The primary purpose of the Public Health Service (PHS) is to support and advance independent research within the scientific community. This support is provided in the form of contracts and grants totaling approximately 7 billion dollars annually. PHS has established effective, time tested and well recognized and accepted procedures for stimulating and supporting this independent research by selecting from multitudes of proposals those research projects most worthy of support within the constraints of its appropriations. The reimbursement of independent research and development costs not incidental to product improvement, through the indirect cost mechanism, would circumvent this competitive process.
To ensure that all research and development projects receive similar and equal consideration, all offerors may compete for direct funding for independent research and development projects they consider worthy of support by submitting those projects to the appropriate Public Health Service grant and/or contract office for review. Since these projects may be submitted for direct funding, the successful offeror agrees that no costs for any independent research and development project, including applicable indirect costs, will be claimed under any contract resulting from this solicitation.
Offerors are advised that pursuant to P.L. *, no NIH Fiscal Year 2003 (October 1, 2002—September 30, 2003) funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level I* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the contractor.
This does not preclude the offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level I*. The salary rate limitation set by P.L. * applies only to Fiscal Year 2002 funds, however, salary rate ceilings for subsequent years may be included in future DHHS appropriation acts. Multi-year contracts awarded pursuant to this solicitation may be subject to unilateral modifications by the Government if an individual's annual salary exceeds any salary rate ceiling established in future appropriations acts. The Executive Schedule, Level I* annual salary rate limit also applies to individuals proposed under subcontracts, however it does not apply to consultants. P.L. * states in pertinent part:
"None of the funds appropriated in this Act for the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Substance Abuse, and Mental Health Services Administration shall be used to pay the salary of an individual through a grant or extramural mechanism at a rate in excess of Executive Level I."
Link to Executive Schedule Salaries: http://www.opm.gov/oca/PAYRATES/index.htm
* pending passage of FY-2003 legislation
EACH INSTITUTION MUST:
Institutional Management of Conflicting Interests
Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interests include, but are not limited to:
This Solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):
All proposals must be self-contained within the specific page limitations cited elsewhere in this solicitation. Unless otherwise specified, URLs/Internet addresses shall not be used to provide information necessary to the review because reviewers are under no obligation to review the Internet sites.
The Technical Plan (objectives, approach, methods and procedures, and schedule) of the Technical Proposal shall not exceed 30 single-sided pages or 15 double-sided pages. This page limitation does not apply to the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, other support, cost information, and literature cited. Appendices shall be limited to 100 single-sided pages or 50 double-sided pages. Pages in excess of this will be deleted and will be neither read nor evaluated. Each page of the Technical Proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the Technical Proposal, inclusive of appendices, attachments, etc. Note that although no page limit has been placed on the Business Proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.
Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be set to one inch around.
A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks.
The technical discussion included in the technical proposal should respond to the items set forth below:
The offeror shall insert a completed NIH Form 1688-1, Project Objective (PDF format), as provided in Section J, Attachments, behind the Title Page of each copy of the proposal, along with the "Government Notice for Handling Proposals." The NIH Form 1688-1 is to be completed as follows:
The information required under the "Summary of Objectives" portion of the form MUST meet the requirements set forth in the section of the form entitled, "INSTRUCTIONS:"
State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.
Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.
Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.
Provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments, as applicable, as well as for the overall program. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer. Unless the request for proposal indicates that the stipulated schedules are mandatory, they shall be treated as desired or recommended schedules. In this event, proposals based upon the offeror's best alternative schedule, involving no overtime, extra shift or other premium, will be accepted for consideration.
Describe the experience and qualifications of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.
OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE TIME COMMITMENT.
List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.
List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.
List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:
Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.
Proposals will be technically evaluated in accordance with the factors, weights, and order of relative importance as described in the Technical Evaluation Criteria (Section M., hereof).
Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:
The business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit.
**** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****
Depending on your system, you must provide breakdowns for the following basic cost elements, as applicable:
The detailed breakdown shall be in the format as shown on the form Breakdown of Proposed Estimated Cost (plus fee) and Labor Hours (Section J, List of Attachments). For each separate cost estimate, the offeror must furnish a breakdown by cost element as indicated above. In addition, summary total amounts shall be furnished. In the event the RFP cites specific line items, by number, a cost breakdown for each line item must be furnished.
To assist in the preparation of future cost estimates, the Projected Consumer Price Index may be accessed at: http://rcb.nci.nih.gov/forms/cpi.htm
**** (Please note that data substantiating the costs or prices proposed (i.e. payroll documentation, vendor quotes, invoice price, etc.) shall not be submitted with the initial proposal. This information will be requested from the offeror during the negotiation process. The initial proposal need only indicate from what source the proposed costs and prices are substantiated.) ****
(End of provision)
Alternate I (October 1997). As prescribed in 15.408(l), substitute the following paragraph (b)(1) for paragraph (b)(1) of the basic provision:
(b)(1) The offeror shall submit cost or pricing data and supporting attachments in the following format:
The format specified in Formats for Submission of Line Item Summaries above shall be used for the submission cost information. Submission of all other cost or pricing data shall be in accordance with Table 15-2 in FAR 15.408.
You are requested to submit a summary of your "General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts."
General experience is defined as general background, experience and qualifications of the offeror. A discussion of proposed facilities which can be devoted to the project may be appropriate.
Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP.
Performance history is defined as meeting contract objectives within delivery and cost schedules on efforts, either past or on-going, which is comparable or related to the effort required by this RFP.
Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process. The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted.
List grants supported by the Government that involved similar or related work to that called for in this RFP. Include the grant number, involved agency, names of the grant specialist and the Science Administrator, identification of the work, and when performed.
You are cautioned that omission or an inadequate or inaccurate response to this very important RFP requirement could have a negative effect on the overall selection process.
The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration.
The offeror shall indicate if it has the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source.
An incrementally funded cost-reimbursement contract is a contract in which the total work effort is to be performed over a multiple year period and funds are allotted, as they become available, to cover discernible phases or increments of performance. The incremental funding technique allows for contracts to be awarded for periods in excess of one year even though the total estimated amount of funds expected to be obligated for the contract are not available at the time of the contract award. If this requirement is specified elsewhere in this RFP, the offeror shall submit a cost proposal for each year. In addition, the following provisions are applicable:
HHSAR 352.232-75, Incremental Funding (January 2001)
(End of provision)
(This is applicable if you are a commercial organization.)
(End of Provision)
If the offeror elects to claim this cost, the offeror shall specifically identify or propose it in the cost proposal for the contract by checking the appropriate box below.
[ ] The prospective Contractor has specifically identified or proposed facilities capital cost of money in its cost proposal and elects to claim this cost as an allowable cost under the contract. Submit Form CASB-CMF (see FAR 31.205-10).[ ] The prospective Contractor has not specifically identified or proposed facilities capital cost of money in its proposal and elects not to claim it as an allowable cost under the contract.
If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:
Note: Organizations that plan to enter into a subcontract with an educational concern under a contract awarded under this RFP should refer to the following Web Site for a listing of clauses that are required to be incorporated in Research & Development (R&D) subcontracts with educational institutions:
http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm
**** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****
All offerors included in the competitive range will be required to submit a copy of the organization's most recent annual financial report.
One copy of the Representations and Certifications attached as Section K shall be completed and be signed by an official authorized to bind your organization. Additionally, a completed copy of the Representations and Certifications shall be submitted from any proposed subcontractor.
Costs for lodging, meals, and incidental expenses incurred by Contractor personnel shall be considered to be reasonable and allowable to the extent they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulations, General Services Administration (GSA). Therefore, if travel costs are applicable and proposed by offerors, please be advised that they shall be calculated using the per diem rate schedule as established by GSA. Reimbursement of travel costs under any contract awarded from this RFP shall be in accordance with FAR 31.205-46.
**** This document is INCLUDED in the "Just In Time" procedures. Specific instructions for the submission of this document are outlined in SECTION L.1.b. of this RFP. ****
All offerors included within the competitive range will be required to submit one copy of their written travel policy. A written travel policy for any proposed subcontractors shall also be submitted at that time. If an offeror (or any proposed subcontractor) does not have a written travel policy, the offeror shall so state.
SECTION M—EVALUATION FACTORS FOR AWARD
GENERAL
Selection of an offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: technical, cost/price, and small disadvantaged business (SDB) participation. Past performance is NOT an evaluation factor but will be considered in determining an offeror's responsibility in accordance with FAR 9.104-3(b). (Reference Section L.) All evaluation factors other than cost/price, when combined, are significantly more important than cost/price. The trade-off process described in FAR 15.101-1 will be employed. This process permits tradeoffs among cost/price and non-cost factors and allows the Government to consider award to other than the lowest priced or highest technically rated offeror. In any event, the Government reserves the right to make an award to that offeror whose proposal provides the best value to the Government.
The evaluation will be based on the demonstrated capabilities of offerors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed evaluation criteria/factors listed below.
The technical evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Price analysis will be used to verify that the overall price offered is fair and reasonable. Cost/price analysis will be used to evaluate the reasonableness of individual cost elements when cost or pricing data are required. Cost analysis may be used to evaluate information other than cost or pricing data to determine cost reasonableness or cost realism.
TECHNICAL EVALUATION CRITERIA
| TECHNICAL APPROACH | 40 Points | |
| Adequacy of plans for fulfilling the Administrative Center functions, including methods for coordination, monitoring, and central management of all activities required for collaborative development of cell processing protocols. These activities include, but are not limited to, plans for the preparation and updating the manual of procedures, oversight of facilities operations and communication, assistance to facilities in developing regulatory submissions for the FDA, and assistance in archiving samples for repository placement. | ||
| PERSONNEL | 25 Points | |
| Qualifications and availability of proposed personnel, with experience pertinent to the operation of an administrative center for a multicenter program including expertise in preparing regulatory submissions to the FDA, data collection and analysis, monitoring, standardization, quality assurance, quality control, preparation of scientific reports and manuscripts. | ||
| INSTITUTIONAL EXPERIENCE AND FACILITIES | 20 Points | |
| Adequacy of the organizational and administrative structure of the proposed program and institutional commitment to the program. Prior successful participation by the institution in multicenter studies related to cell processing or transfusion medicine, both in the collection of data from multiple clinical and laboratory sites, as well as experience in monitoring and quality and timeliness of such data. Availability and adequacy of proposed facilities, equipment, and space. | ||
| ADMINISTRATIVE AND SCIENTIFIC LEADERSHIP | 15 Points | |
| Demonstrated experience in administrative and scientific leadership and coordination necessary for soliciting cooperation from the cell processing facilities and exercising appropriate leadership in matters of data acquisition, management, and analysis. | ||
Price Evaluation Adjustment for Small Disadvantaged Business Concerns
In accordance with FAR Clause 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns, offerors will be evaluated by adding a factor of 10 percent to the price of all offers, except offers from small disadvantaged business (SDB) concerns that have not waived the price evaluation adjustment. In addition, offerors that satisfy the exception requirements under subparagraph (b) of FAR Clause 52.219-23 will not have the price evaluation adjustment factor added to their offers.
A SDB concern may elect to waive the price evaluation adjustment, in which case the factor will be added to its offer for evaluation purposes. (The agreements in paragraph (d) of FAR Clause 52.219-23 do not apply to offerors that waive the price evaluation adjustment.) If the SDB concern elects to waive the price evaluation adjustment, it will be evaluated under the Small Disadvantaged Business Participation Factor cited in Section M, and participation in performance of the resultant contract shall include the work expected to be performed by SDB concerns at the prime contract level. Small businesses, other than SDB concerns, will also be evaluated under this factor. Any targets will be incorporated into and become part of the resulting contract.
Credit under the small disadvantaged business participation factor is not available to small disadvantaged business concerns that receive a price evaluation adjustment.
Small Disadvantaged Business Participation Factor
In accordance with FAR part 15.304(c)(4), the extent of participation of Small Disadvantaged Business (SDB) concerns in performance of the contract will be evaluated; however, the evaluation may take place after establishment of the competitive range. This evaluation will not be conducted on any offeror whose proposal would not be selected for award based on the results of the evaluation of factors other than SDB participation.
The evaluation will be based on information obtained from the Small Disadvantaged Business Participation Plan provided by the offeror (Reference Section L.), other relevant information obtained from named SDB concerns, any information supplied by the offeror concerning problems encountered in SDB participation, and other references available to the Government. Evaluation of the SDB Participation Plan will be based on consideration of all relevant facts and circumstances; it will not be based on absolute standards of acceptable performance.
SDB participation will not be scored, but the Government's conclusions about overall commitment and realism of the offeror's SDB Participation Plan will be considered in determining the relative merits of the offeror's proposal and in selecting the offeror whose proposal is considered to offer the best value to the Government.
The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan.
PACKAGING AND DELIVERY OF THE PROPOSAL Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors"—General Instructions. Shipment and marking shall be as indicated below.
EXTERNAL PACKAGE MARKING
In addition to the address cited below, mark each package as follows:
"RFP NO. NHLBI-HB-03-07
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
PLEASE READ THE FOLLOWING INFORMATION CAREFULLY:
NUMBER OF COPIES
TECHNICAL PROPOSAL: ORIGINAL* AND 25 COPIES TO:
BUSINESS PROPOSAL: ORIGINAL* AND 6 COPIES TO:
| If hand-delivered or delivery service |
If using U.S. Postal Service |
|---|---|
| Review Branch Division of Extramural Affairs National Institutes of Health National Heart, Lung, and Blood Institute 6701 Rockledge Dr., MSC 7924 (Room 7091) Bethesda, Maryland 20892-7924 |
Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Rockledge Building, Room 7091 6701 Rockledge Dr., MSC 7924 Bethesda, Maryland 20817-7924 |
*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.
Note to Offerors: To ensure that data analysis is conducted independently of data acquisition, the same institution may submit proposals for both a cell processing facility and the administrative center, but each proposal must not have the same investigators.
The project is designed to develop novel somatic cellular therapies that will aid investigators by providing support in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials. The somatic cell processing facilities are charged with implementing the rapid, safe, and equable transition of basic research ideas to clinical practice as well as supplying clinical grade products produced in a manner that is compliant with all regulatory requirements. The somatic cell administrative center will serve as the monitor and coordinator for organizational and regulatory aspects of the program. It is anticipated that up to three somatic cell processing facilities will be awarded under separate contracts.
The use of cells as more than replacement therapy has become a reality over the course of the last several years. While basic and clinical scientists are developing many new and promising strategies to improve immune reconstitution and transplant outcome, they are dependent on many others to implement these new therapies. Blood collection centers must collect the lymphocytes, hematopoietic progenitors, or other components. Clinical cell processing laboratories must scale up the processes developed in the research laboratory using reagents approved for use in humans and using good manufacturing practices (GMP). Immunology laboratories must establish techniques to monitor the outcome of the immune therapy. All of these processes must comply with local, state, national, and in some cases international regulations and standards. Implementation of procedures that were successful in the laboratory can be expensive and difficult to put through a scale-up process.
To cope with these issues, many institutions have established specialized cell processing centers. However, a specialized cell processing lab and specially trained laboratory staff do not resolve all the problems associated with scaling a new procedure for a clinical trial. In some cases, equivalent reagents and processes suitable for clinical work are not available. Therefore, the establishment of cellular processing facilities is proposed as a method to combine the consulting, manufacturing, and regulatory duties that are necessary for the development of novel cellular therapies. It is envisioned that cell processing facilities will provide the actual product desired by an investigator along with the assurance that it is clinical grade and produced in a manner that is compliant with all regulatory requirements.
As translational research becomes a major focus in cellular therapies, cellular processing facilities can assume the responsibility of bridging the gap between basic and clinical research. Some of the preclinical tasks of a cell processing facility include the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, and the provision of controlled GMP infrastructure. As a therapy moves from preclinical testing to clinical studies, a dialogue with the Food and Drug Administration (FDA) is necessary, and cell processing facilities are in a position to coordinate the assembly of an Investigational New Drug (IND) application.
This purpose of this somatic cell project is to find a way whereby a focus is placed on translational work involving immunomodulation research and to address the lack of assistance in transporting cellular therapies from the bench to the bedside. For example, space and facilities to perform such work could be centralized and made readily available to many investigators, rather than having each one creating his or her own GMP-level, quality assurance facility.
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below. The contractor shall deliver the items specified in ARTICLE F.1. to the destinations indicated.
The study schedule is estimated to be as follows:
Phase I—6 months (September 30, 2003—March 31, 2004)
Phase II—54 months (April 1, 2004—September 29, 2008)
Specifically, the Contractor shall serve as the Somatic Cell Administrative Center (SCAC) and perform the following project requirements:
Complete the following and return with the BUSINESS PROPOSAL.
Name, Title and Address* of Business Representative with whom daily contact is required.
| _____________________________________________ | ___________________________________ | |
| Name |
Telephone Number |
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| _____________________________________________ | ___________________________________ | |
| Institutional Title |
FAX Number |
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| _____________________________________________ | ___________________________________ | |
| Institutional Office |
E-Mail Address |
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| ________________________________________________________________________________ | ||
| Institution Name |
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| ________________________________________________________________________________ | ||
| **Street Address |
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| ___________________________________ | __________ | ___________________________________ | City |
State |
ZIP Code |
Name, Institutional Title and Address of Proposed Principal Investigator |
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| _____________________________________________ | ___________________________________ | |
| Name |
Telephone Number |
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| _____________________________________________ | ___________________________________ | |
| Institutional Title |
FAX Number |
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| _____________________________________________ | ___________________________________ | |
| Institutional Office |
E-Mail Address |
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| ________________________________________________________________________________ | ||
| Institution Name |
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| ________________________________________________________________________________ | ||
| **Street Address |
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| ___________________________________ | __________ | ___________________________________ | City |
State |
ZIP Code |
These exact addresses are necessary to ensure that contact can be made with the proper individual(s) in the most expeditious manner.
* May not necessarily be same as legal address of offeror.
**Please use actual street address, not P.O. Box.
PROPOSAL INTENT RESPONSE SHEET
RFP No. NHLBI-HB-03-07
PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST PRACTICABLE DATE. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.
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DO INTEND TO SUBMIT A PROPOSAL
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DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
COMPANY/INSTITUTION NAME:
AUTHORIZED SIGNATURE:
TYPED NAME AND TITLE:
DATE:
RETURN TO:
National Institutes of Health
National Heart, Lung, and Blood Institute
Attention: Joanna Magginas
Fax: (301)480-3432
NOTE: This notice is for the Technical Evaluation Committee which will be reviewing the proposals submitted in response to this RFP. THE OFFEROR SHALL PLACE A COPY OF THIS NOTICE BEHIND THE TITLE PAGE OF EACH COPY OF THE TECHNICAL PROPOSAL.
GOVERNMENT NOTICE FOR HANDLING PROPOSALS
This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR 352.215-1.
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