RFP-NIH-NIAID-DMID-99-20

Request for Proposal No.:	NIH-NIAID-DMID-99-20
Issue Date:	June 15, 1998
Issued By:	Carl R. Henn Contracting Officer, NIH, NIAID Contract Management Branch Solar Building, Room 3C07 6003 Executive Boulevard, MSC 7610 Bethesda, Maryland 20892-7610
Point of Contact:	Carl R. Henn, Contracting Officer
Purchase Authority:	Public Law 92-218 as amended
Small Business Set-Aside:	No, SIC Code 8733
Just In Time:	No
Offer Expiration Date:	Offers will be valid for 120 days unless a different period is specified by the Offeror on the form entitled "Proposal Summary and Data Record, NIH 2043".
Proposal Due Date:	October 29, 1998, 4:30 P.M EST

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the requirements of this RFP NIH-NIAID-DMID-99-20 entitled "Tuberculosis Research Unit". The Government anticipates that one (1) cost reimbursement contract will be awarded for a period of seven (7) years as a result of this RFP.

The documents included with this electronic RFP package are as follows:

Attachments:

1. Introduction, Background and Work Statement, dated June 15, 1998
2. Reporting Requirements and Deliverables, dated June 15, 1998
3. Evaluation Factors for Award, dated June 15, 1998
4. Specific RFP Instructions and Provisions, dated June 15, 1998
5. Applicable RFP References, dated June 15, 1998

In addition to the information provided in this document (i.e., The Streamlined RFP), there are five (5) other referenced documents in the Streamlined RFP References that must be retrieved, in whole or in part, in order to submit a proposal. The applicable portions of these referenced documents are explained in Attachment E, Applicable RFP References of this RFP.

If you are unable to download any of the applicable documents, please contact Carl Henn, Contract Specialist, by phone/fax/Internet (see contact numbers/addresses below).

The information contained in this electronic RFP represents all the necessary information required for the submission of a proposal for this acquisition. Following proposal submission and review, additional information will be requested by the Contracting Officer during discussions (if applicable).

Although sufficient information for you or your organization to submit a proposal is provided, if you intend to submit a proposal in response to this RFP, it is essential that you immediately notify Carl Henn at the internet address listed below. If you fail to notify the Contracting Office of your interest, you will not receive notice of amendments which may be issued for this RFP, and this could impact your proposal preparation. However, please note that all amendments will be posted on the NIH RFP home page and the NIAID Contract Management Branch (CMB) home page.

The Business and Technical proposals must be separate from one another in the proposal package as the peer review panel will only receive the Technical Proposal. The Business Proposal must be signed by an authorized official of your organization, and must contain a detailed breakdown of costs by year for each cost category/element. The basis for all costs must be explained and supporting documentation must be submitted with the proposal. (See "STANDARD RFP INSTRUCTIONS AND PROVISIONS," in the NIH RFP home page, for more detail on the Business Proposal requirement.)

Within this Web based RFP we have included a template cost spreadsheet in Microsoft Excel. Offerors are requested to complete this spreadsheet and include it with their business proposal. This spreadsheet can replace the cost sheets that you ordinarily provide. It is our hope that this spreadsheet will provide you with a useful tool, allow us to more easily understand your cost proposal, and eliminate our need to recreate your spreadsheets. This spreadsheet template is a new approach, and we would appreciate any feedback you could give us about it.

The original and twenty (15) copies of your Technical Proposal and the original and five (5) copies of your Business Proposal must be received by this office no later than October 29, 1998, at 4:30 p.m. local time at the address listed in Attachment D.

Your attention is further directed to the "Proposal Intent Response Sheet" contained in Attachment D of this document. Please complete this form and return it to this office on or before September 24, 1998. This will allow us to expedite preparations for the peer review of proposals.

The "Technical Proposal Cover Sheet" must be completed in full detail and used as the cover sheet for each copy of your Technical Proposal. It is important that you list all professional personnel and organizations named in the proposal who have any role in the proposed work, including: staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. Organizational affiliation(s) must be indicated for every person named. You may use additional sheets, as needed, following the format shown in the Technical Proposal Cover Sheet. This information will be used to ensure that there will be no conflict of interest when selecting review committee members.

Finally, your technical proposal must be organized and submitted in accordance with the "Technical Proposal Table of Contents" contained in Attachment D of this document.

Questions concerning any areas of uncertainty which, in your opinion, require clarification or correction, must be furnished in writing to Carl Henn at the Internet electronic mail address ch24v@nih.gov, or by fax at 301/480-5253. Mr. Henn can be reached at 301/496-0993. Collect calls will NOT be accepted.

Sincerely,

/s/

Rosemary McCabe Hamill
Chief, Infectious and Allergic Diseases Contract Section
Contract Management Branch
National Institute of Allergy and Infectious Diseases

Attachments: A - E

The National Institute of Allergy and Infectious Diseases (NIAID) established the Tuberculosis Research Unit (TBRU) via contract NO1-AI-45244; Principal Investigator – Jerrold Ellner, Case Western University in 1994, to create a multidisciplinary, international team dedicated to identifying and validating surrogate markers of human tuberculosis disease progression and correlates of the human protective immune response to Mycobacterium tuberculosis (M. tuberculosis) infection. This Request for Proposals represents a recompetition of the original TBRU award for a seven-year contract period.

In response to the increased tuberculosis epidemic in the United States in the late 1980s and early 1990s, NIAID increased its funding for tuberculosis research approximately ten fold. These new resources were devoted largely to building a solid basic research foundation in the molecular biology and physiology of M. tuberculosis, and the host immune response to mycobacterial infection, to the development of new epidemiologic tools, and to efforts to develop improved drugs, diagnostics and vaccines. The TBRU was designed to support translational research in tuberculosis – i.e., translating basic research findings into useful tools in the clinical tuberculosis arena. NIAID intends during the next project period for the TBRU to continue this effort through a multidisciplinary, collaborative approach to validating surrogate markers of disease progression and protection, and by using these new tools to advantage in the conduct of Phase 1, 2 and 3 studies of potential tuberculosis therapeutic, diagnostic and intervention strategies. The emphasis is intended to shift somewhat during the new contract period towards preparation for expanded Phase 2 and Phase 3 trials of potential new drugs and vaccines. NIAID encourages the involvement of multiple geographic sites, in order to accomplish the overall task in an efficient and timely manner. The primary offeror is encouraged to coordinate, through the use of subcontracts, its response with other laboratories and clinical centers in which access to specific populations under investigation, or demonstrated ability in a particular area of research, would complement the abilities and populations available to the primary offeror. Both foreign and domestic clinical trial sites may be appropriate. The offeror is encouraged to include multi-disciplinary components in the proposal, drawn from academic, non-profit, or for-profit institutions. NIAID encourages flexibility throughout the contract period regarding use of collaborators and choice of projects in order to continually incorporate projects of the highest scientific merit.

There were 19,855 new cases of tuberculosis in the United States in 1997 ¹ and tuberculosis is currently responsible for approximately 18.5% of adult deaths in the developing world. ² Recent data demonstrate that multidrug resistant strains of M. tuberculosis are spreading through virtually all regions of the world. Although highly effective when properly implemented, current control strategies for tuberculosis are expensive, labor-intensive and difficult to implement in many of the most highly endemic regions of the world.³ New York State, alone, spent approximately $750 million dollars from 1993 to 1996 to control its tuberculosis epidemic.⁴ A recent projection⁵ predicts that even with intense efforts to implement current tools, at least 70 million people worldwide will die of tuberculosis in the next thirty years. This situation demands that better therapeutic and intervention strategies be developed for controlling the tuberculosis epidemic. NIAID intends that the TBRU will contribute significantly to this effort by helping to develop and improve the capability to conduct fruitful clinical trials of novel therapeutic, diagnostic and vaccination regimens. Offerors are encouraged to use human studies to the greatest extent possible.

1. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 1996. July 1997.
2. Raviglione M, Dye C, Schmidt S, Kochi A. Assessment of worldwide tuberculosis control. Lancet 1997;350:624-629.
3. WHO/IUATLD 1998.
4. Dr. Paula Fujiwara, New York State Dept. of Health, personal communication.
5. Dr. Christopher Murray, Harvard School of Public Health Burden of Disease Unit, personal communication.

Independently and not as an agent of the Government, the Contractor shall exert its best effort to furnish all necessary services, qualified professional and technical personnel, volunteer populations, materials, equipment, and facilities, not otherwise provided by the Government under the terms of this contract as needed to conduct the basic and applied research studies as set out below and as approved by the Project Officer.

1. Develop and implement a systematic approach towards furthering scientific understanding of the epidemiology of tuberculosis in populations with a high prevalence of disease. In doing so, the Contractor shall:
   
   1. Implement studies for assessment of the critical host factors associated with primary infections, re-infections, re-activation of persistent infection, and progression of clinical disease.
   2. Implement incidence/prevalence surveys in the populations proposed for study so as to provide the necessary background information to conduct Phase 2 and 3 vaccine and/or therapeutic trials.
   3. Implement capability to identify and track individual strains of M. tuberculosis.

INSTRUCTIONS TO OFFEROR:

2. Conduct coordinated, multi-disciplinary investigations of human host immunologic response mechanisms to M. tuberculosis in order to identify and validate surrogate markers for clinical use. To be most useful in vaccine trials, these markers should ideally be specific to M. tuberculosis infection, distinguishing it from exposure to or infection with BCG and atypical mycobacteria. In this, the Contractor shall:

INSTRUCTIONS TO OFFEROR:

3. Conduct an investigation of the microbial factors expressed during various stages of M. tuberculosis infection and illness in order to identify surrogate markers. These markers shall be used to assess the effect of interventions on human disease progression, and distinguish between infection with M. tuberculosis versus infection with or exposure to BCG and atypical mycobacteria. The types of studies shall include, but not be limited to:

INSTRUCTIONS TO OFFEROR:

4. Conduct human studies of potential interventions such as new vaccines, prophylactic or therapeutic regimens, using developed surrogate markers of M. tuberculosis infection, tuberculosis progression and/or host protection to validate the usefulness of these markers in clinical trials and evaluate safety and efficacy of new regimens. Toward this, the Contractor shall:

5. Establish and/or maintain a repository of clinical samples, including, but not limited to, sera and sputa from patients involved in all clinical trials supported by this contract, and human tissue samples such as autopsy, surgical and aspirate specimens from well-characterized tuberculosis patients and controls, where possible, and distribute these specimens to qualified investigators, with the approval of the Project Officer.
6. Organize and administer the basic research and clinical activities of the contract. The prime contractor shall manage and coordinate all contract sites and activities.
   1. Plan, conduct, and report on approved clinical studies and associated research studies. This shall include developing the specifics of experimental design, receiving and shipping of reagents and samples, coding of patients, reagents, and samples, and coordinating all subcontractor activities (if applicable). This shall also include conducting all clinical studies in compliance with DMID/NIAID policy and in coordination with the Clinical and Regulatory Affairs Branch, DMID/NIAID.
   2. Manage the information generated, including transmission, storage, confidentiality, retrieval, validation, and statistical analysis.
   3. Coordinate the preparation of all manuscripts and presentations involving studies performed under this contract. Establish and implement a publication policy for results of all contract-supported studies. All publications and presentations shall acknowledge NIAID support. The Government, through the Project Officer, shall have access to all data generated with the support of this contract.
   4. Organize and attend meetings for the purposes of future planning, protocol and study development and/or evaluation, data discussion between co-investigators and other essential personnel, and meeting with NIAID staff and FDA staff, and convening of Data Safety and Monitoring Boards (DSMB). These meetings shall be arranged at the direction of the Project Officer and shall include scientific advisors at the direction of the Project Officer.

The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to technical inspection and requests for clarification by the Project Officer. These shall be brief and factual and prepared in accordance with the following format:

A. Technical Reports

 In addition to those reports required by SECTION I and other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below:

(1) Semi-Annual Technical Progress Reports - 15 working days following the end of each six month period, the Contractor shall submit four (4) copies of a semi-annual Technical Progress Report, comprising three (3) copies to the Project Officer and one (1) copy to the Contracting Officer. Such reports shall include the following specific information:

Semi-annual Technical Progress Reports are not due for periods in which an annual or final report is due.

(2) Annual Reports - 15 working days following the anniversary date of the contract, the Contractor shall submit four (4) copies of an Annual Technical Progress Report, as above, comprising three (3) copies to the Project Officer and one (1) copy to the Contracting Officer. Such reports shall detail, document, and summarize the results of the entire contract work for the period covered. These reports shall be in sufficient detail to explain comprehensively the results achieved. Also to be included in the report is a summary of work proposed for the next reporting period. A one- page summary of each ongoing and completed protocol shall be submitted at this time. An annual report will not be required for the period when the final report is due. Preprints and reprints of papers and abstracts not submitted in the semi-annual report shall be submitted.

To be included in the Annual Technical Progress Report is the reporting of the ethnic and gender breakdown of subjects enrolled in studies. This information is to be reported by study and in the following format:

(3) Transition Plan – 90 days prior to expiration (unless called for sooner ), the Contractor shall submit a transition plan for review and approval by the PO. The plan shall be prepared in accordance with Task 7 of the contract.

(4) Final Report - By the expiration date of the contract, the Contractor shall submit four (4) copies of a comprehensive Final Report, as above, comprising three (3) copies to the Project Officer and one (1) copy to the Contracting Officer. This final report shall detail, document and summarize the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. Preprints and reprints not included previously shall be submitted.

(5) Summary of Salient Results - With the final report, the Contractor shall submit a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

(6) Other Reports - The Contractor shall submit four (4) copies of: a) a one page summary of each ongoing and completed protocol one year and thirty days after an individual IND goes into effect and b) yearly IRB approvals and supporting documents (Optional Form 310).

B. If the Contractor believes it will be unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays with reasons, therefore.

C. Technical Report Distribution

Copies of the technical reports shall be submitted as follows:

Type of report	No. Copies	Addressee	Due Dates
Semi-Annual Progress	3	Project Officer (P.O.) DMID/NIAID/NIH Solar Building 6003 Executive Blvd. MSC 7630 Bethesda, MD 20892-7630	Specific dates will be listed in the contract document
Semi-Annual Progress	1	Contracting Officer (C.O.) CMB/NIAID/NIH Solar Building, Room 3C07 6003 Executive Blvd. MSC 7610 Bethesda, MD 20892-7610	Same as above
Annual Progress	3	Project Officer (P.O.) DMID/NIAID/NIH Solar Building 6003 Executive Blvd. MSC 7630 Bethesda, MD 20892-7630	Specific dates will be listed in the contract document
Annual Progress	1	Contracting Officer (C.O.) CMB/NIAID/NIH Solar Building, Room 3C07 6003 Executive Blvd. MSC 7610 Bethesda, MD 20892-7610	Same as above
Transition Plan	2	Same as P.O. above	90 days prior to expiration of contract
Transition Plan	1	Same as C.O. above	Same as above
OF 310	1	Same as C.O. above	Annually
Final	3	Same as P.O. above	Completion date
Final	1	Same as C.O. above	Same as above

1. General
   

   Selection of an offeror for contract award will be based on an evaluation of proposals against two factors. The factors in order of importance are: technical and cost. Although technical factors are of paramount consideration in the award of the contract, cost/price also is important to the overall contract award decision.

   Offers are advised that award will be made to that offeror whose proposal provides the best overall value to the Government.

   The estimated cost of an offer must be reasonable for the tasks to be performed and, in accordance with FAR 15.305, will be subject to a cost realism analysis by the Government.

   The evaluation will be based on the demonstrated capabilities of the prospective Contractors 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 criteria listed below.

2. Mandatory Qualification Criteria
   

   The following mandatory qualification criteria establish conditions that MUST be met by the time of source selection in order for the proposal to be considered for award.

   The Contractor must have available all facilities necessary to perform the tasks set forth in the Statement of Work including, but not limited to, access to: 1) facilities of sufficient capacity for all laboratory procedures and assays involving virulent strains of M. tuberculosis, 2) AAALAC-accredited (or equivalent) animal facility and the capacity for testing the safety and immunogenicity of manufactured products, and for performing low-dose aerosol challenge experiments of small animals with virulent M. tuberculosis and 3) clinical facilities.

3. Technical Evaluation Criteria
   

   Proposals submitted in response to this RFP will be evaluated based on the following factors, which are listed and weighted in order of their relative importance. Proposals will be judged solely on the written material provided by the offerors.

	Criterion Element	Weight
	1. Technical Approach Documented technical adequacy and feasibility of the proposed methods and approaches for: Studies of the epidemiology of pulmonary tuberculosis in endemic populations, as evidenced by sample protocol(s) for incidence/prevalence surveys, evaluating primary infection, re-infection, re-activation, and relapse, and proposed plans to evaluate treatment regimens and compliance; Studies to evaluate host immunological responses to and microbiological factors expressed during various stages of M. tuberculosis infection and illness as a means to identify surrogate markers for clinical use, including the relevance and significance of the proposed: animal model system(s); immune and microbial factors selected for detailed evaluation; and development of in vitro assays to assess these potential surrogate markers; Conducting Phase 1, 2 and 3 studies of new therapeutic, diagnostic and intervention strategies, including plans for recruitment and retention of appropriate population(s) to conduct the requested number of studies, and methods and approaches planned for evaluating and validating surrogate marker of disease progression and/or protection; and Operating a tuberculosis repository for cataloguing, maintaining and distributing clinical samples derived from trial subjects and controls.	60     (15)     (15)     (20)     (10)
	2. Personnel Documented adequacy and relevance of expertise, experience, education, and availability staff for performing the work statement: The Principal Investigator should have documented expertise in studying M. tuberculosis infections; and the team of professional personnel should have composite expertise in infectious diseases, immunology, clinical trials, vaccinology, diagnostics, surveillance, biostatistics, epidemiology, microbiology, and molecular biology. The technical personnel should have documented training and experience to perform the laboratory procedures. The support staff should possess the requisite experience to perform their clerical and administrative duties.	30
	3. Administration  Adequacy and feasibility of proposed plans to coordinate the multidisciplinary aspects of the proposed contract as evidenced by: The proposed integration of staff, plans, and materials to accomplish the work statement; The chain of authority and responsibility for the project and its components; and procedures which will be implemented to ensure communication and coordination of activities and achievements in near real time at each project site including, but not limited to, remote data entry, exchange analysis and manipulation of data.	10
	Total Possible Points	100

SPECIFIC RFP INSTRUCTIONS AND PROVISIONS

NOTICE TO OFFERORS: This attachment contains proposal instructions and information that are specifically related to this acquisition. The information provided below is only a portion of the instructions and notices required for the submission of a proposal. References to additional, more general information, and forms regarding proposal preparation are contained in Attachment E, "Applicable RFP References."

1. NUMBER AND TYPE OF AWARD(S)

It is anticipated that one (1) award will be made from this solicitation and that the award will be made on/about September 30, 1999.

It is anticipated that the award from this solicitation will be a cost reimbursement contract with a 7 year performance period, and that incremental funding will be used.

2. ESTIMATE OF EFFORT

It is expected that one contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the seven year total effort to be approximately 20,650%, (2,950% per year). This estimate includes both prime contract and subcontract labor effort. This estimate is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

As further assistance, it is estimated that the above total labor effort is constituted as follows:

Labor Category	Annual Effort
Principal Investigator	50%
Co-Investigators	100%
Technical	600%
Administrative	250%
Subcontract labor
Principle Investigators	150%
Co Investigators	300%
Technical	1,200%
Administrative	300%
TOTAL	2,950%

These percentages are based on a 12 month calendar year.



3. SIC CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS (FEB 1998), FAR 52.219-1:

1. The standard industrial classification (SIC) code for this acquisition is 8733.

(1) The small business size standard is $5M.

(2) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is $5M.

2. 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 Standard Industrial Classification (SIC) Code and corresponding size standard which best describes the nature of the requirement in the solicitation.
4. SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2
1. Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the General Accounting Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Hand-Carried Address:

Carl Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

Mailing address (U.S.) Postal Service

Carl Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

2. The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.
5. PACKAGING AND DELIVERY OF THE PROPOSAL

Your proposal shall be organized in accordance with the guidance provided in "Standard RFP Instructions and Provisions". 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. NIH-NIAID-DMID-99-20
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES

The number of copies required of each part of your proposal are as specified below.

TECHNICAL PROPOSAL: ORIGINAL AND 15 COPIES

BUSINESS PROPOSAL: ORIGINAL AND 5 COPIES

NOTE: The original proposal must be readily accessible for date stamping.

COPIES TO

If hand-delivered or delivery service

Carl Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

If using U.S. Postal Service

Carl Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE: All material sent to this office by Federal Express should be sent to the Hand Carried Address.

NOTE: The U.S. Postal Service's "Express Mail" does not deliver to the Rockville, Maryland address. Any package sent to the Rockville address via this service will be held at a local post office for pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A LOCAL POST OFFICE. If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal," in accordance with PHSAR 352.215-10, Late Proposals, Modifications of Proposals and Withdrawals of Proposals (NOV 1986).

6. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS TECHNICAL PROPOSAL.

"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 also 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 paragraph 315.608-72."

(For information regarding authorized restrictive notices, offerors should refer to the "Confidentiality of Proposals" section, Item F.6., of the STANDARD RFP INSTRUCTIONS AND PROVISIONS, General Instructions.)

7. PRIVACY ACT SYSTEM OF RECORDS

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 Notice that applies to this RFP was published in Federal Register Vol. 62, No. 66, Pages 16596-16602. This notice will be incorporated into any contract resulting from this RFP. If you would like a copy, please contact the Contracting Officer identified in the cover letter to this RFP.

8. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUG 1997)

(a)  To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration, and other agencies at the Federal, State, and local levels (Federal, State, and local regulatory/enforcement agencies).

(b)  Further, the Contractor shall take or cause to be taken such additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officers, determines to be reasonably necessary. If compliance with such additional safety measures results in an increase or decrease in the cost or time required of performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause as set forth in the contract.  

(c)  The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contact and all violations for which the Contractor has been cited by any Federal, State, or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.  

(d)  If the Contractor fails or refuses to comply promptly with the Federal, State, or local regulatory/enforcement agency's directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any such stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

(e)  The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

9. PROPOSAL INTENT RESPONSE SHEET

APPLICABLE RFP REFERENCES

This section identifies the items found in the RFP Web directory entitled RFP REFERENCES that are applicable to this RFP.

1. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as otherwise may be modified by the inclusion of an item from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS".
2. The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS":
• LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS OF PROPOSALS, PHS 352.215-10
• CARE OF LIVE VERTEBRATE ANIMALS
• SMALL BUSINESS AND SMALL DISADVANTAGED AND WOMEN OWNED SMALL BUSINESS SUBCONTRACTING PLAN (does not apply to small business or to work performed in foreign countries)

Note: A Subcontracting Plan is not due with the initial proposal. The Contracting Officer will notify offerors if a plan becomes due.

3. The following items/files are applicable from the subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS":

Applicable to Technical Proposal

• Technical Proposal Cover Sheet
• Technical Proposal Cost Information
• Summary of Current and Proposed Activities

Applicable to Business Proposal

• Proposal Summary and Data Record, NIH-2043
• Business Proposal Cost Information
• Disclosure of Lobbying Activities, OMB Form SF-LLL
• Excel cost spreadsheet (Template provided)

To Become Contract Attachments

• Invoice/Financing Requests Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-1, May 1997
• Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin 81-16), Apr. 1984
• Research Patient Care Costs, NIH(RC)-11
• Protection of Human Subjects Assurance/Identification/Certification/Declaration, OF 310
• Annual Technical Progress Report Forma for Each Study
• Form NIH 2706 (Financial Report) and Instructions for Completing Form NIH 2706 Note: Financial reports are not always required. This will be discussed during negotiations.

Other-to be submitted as directed by Contracting Officer

• Certificate of Current Cost or Pricing Data, NIH-1397
4. The "Representations and Certifications" are applicable.
5. The "Sample Contract Format-General" is applicable.

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