NIDCR-BAA-DR-02-08
| Broad Agency Announcement: |
NIDCR-BAA-DR-02-08 |
| Issue Date: |
February 20, 2002 |
| Issued By: |
Kristiane E. Cooper, Contracting Officer NIH/NHLBI Contracts Operations Branch 6701 ROCKLEDGE DR MSC 7902 BETHESDA MD 20892-7902 |
| Telephone Number: |
(301) 402-6462 |
| FAX Number: |
(301) 480-3432 |
| E-Mail: |
kc116y@nih.gov |
| Purchase Authority: |
42USC201, Public Health Service Act |
| Small Business Set-Aside: |
No; NAICS 541710 |
| Proposal Intent Due Date: |
March 20, 2002 |
| Proposal Due Date: |
April 05, 2002, 4:30 PM (Eastern Time) |
COMBINED SOLICITATION FORM AND COVER LETTER
Ladies and Gentlemen:
The National Heart, Lung, and Blood Institute (NHLBI) is issuing this Request for Proposal (RFP) for a Broad Agency Announcement (BAA) on behalf of the National Institute for Dental and Craniofacial Research (NIDCR). Offerors are invited to submit a proposal in accordance with the requirements of this BAA entitled "Research Registries and Repository for the Evaluation of Temporomandibular Joint Implants."
The Broad Agency Announcement is authorized by Federal Acquisition Regulation (FAR) 6.102. BAA's are used by agencies to fulfill their requirements for scientific study and experimentation directed toward advancing the state of the art or increasing knowledge or understanding rather than focusing on a specific system or hardware solution. Proposals received as a result of this BAA will be evaluated in accordance with the evaluation criteria specified herein through a peer review process. Proposals will not be evaluated against a specific Government requirement, as in the case of a conventional RFP, as they are not submitted in accordance with a common work statement.
The Government anticipates that it will make two to three awards based on this announcement. It is expected that these awards will be multi-year, cost-reimbursement, completion type contracts. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The NIDCR estimates that awards under this solicitation will be for five (5) years. The amount of each contract will vary depending on the scope and capacity of the technical objectives of the award. The total estimated costs for all contract awards combined under this solicitation is estimated to be $10,000,000. Awards are expected to be made on or about September 30, 2002. Award documents will be tailored to the final negotiations with the selected offerors and modified, as necessary, for the type of organization, cost or price arrangements, and other elements as negotiated prior to award.
This BAA includes this combined solicitation form and cover letter (PART A), and three additional components as follows:
B. Background/Research and Technical Objectives/Additional Technical Proposal Instructions
C. Reporting Requirements/Deliverables
D. Evaluation Factors for Award with Technical Evaluation Criteria
These components contain the technical information required for the submission of a proposal for this acquisition. In addition, there are two other sections in this specific RFP. Section I entitled "Specific RFP Instructions and Provisions" contains, for example, the address for delivery of your proposal. Section II entitled "Applicable RFP References" lists those items in the STREAMLINED RFP REFERENCES directory that apply to this RFP, including forms for submission of the proposal. The Streamlined RFP References directory is located at URL: http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm
The information contained in this streamlined 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 these documents contain sufficient information for you or your organization to submit a proposal, if you intend to submit a proposal in response to this RFP, IT IS ESSENTIAL THAT YOU IMMEDIATELY NOTIFY KRISTIANE E. COOPER, CONTRACTING OFFICER, AT THE FOLLOWING INTERNET ADDRESS: kc116y@nih.gov
IF YOU DO NOT NOTIFY THE CONTRACTING OFFICE 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 original and fifteen (15) copies of your technical proposal and the original and six (6) copies of your business proposal must be received by the Contracting Office no later than April 5, 2002, 4:30 P.M. (Eastern Standard Time) at the address listed in the item entitled "Packaging and Delivery of Proposals". 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" (PDF format; MS Word format) also located at the site for FORMS, FORMATS, AND ATTACHMENTS.
Also, please complete the form entitled "Proposal Intent Response Sheet" and send it to the address indicated therein on or before March 20, 2002. This will allow us to expedite preparations for the review of proposals.
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 details on the Business Proposal requirements. As part of this electronic RFP, we have included a template cost spreadsheet in Microsoft Excel. Information relevant to the cost spreadsheet is located in this RFP, under Specific RFP Instructions, "Other Provisions," Item K. Offerors are requested to complete this spreadsheet and include it with their business proposal.
You are reminded that the "Technical Proposal Cover Sheet" (also available in MS Word format) must be completed in full detail and used as the cover sheet for each copy of your technical proposal. It is very important that you list all professional personnel and organizations named in the proposal that have any role in the proposed work, including staff of the primary organization (offeror), subcontractors, collaborating organizations, and consultants. This information will be used to ensure that there is no conflict of interest when selecting review committee members. BE ADVISED THAT YOUR TECHNICAL PROPOSAL IS SUBJECT TO PAGE LIMITATIONS. The format and content of your technical proposal along with page limitation information is detailed in the Technical Proposal Table of Contents/Format under Specific RFP Instructions, item G.
Please note that one copy of the Representations and Certifications (PDF format; WordPerfect format; MS Word format) must be submitted with the offerors proposal.
NOTE: IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR DESIGNEE AT THE PLACE AND TIME SPECIFIED, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR 352.215-70, see Section II of this RFP, Applicable RFP References, Item 1.E, "Late Proposals, HHSAR 352.215-70."
If you have any additional questions regarding this RFP, please contact Ms. Kristiane E. Cooper through the Internet using the electronic mail address kc116y@nih.gov, or by phone (301) 402-6462, or FAX (301) 480-3432. Collect calls will not be accepted.
SUBMISSION OF PROPOSALS USING FACSIMILE OR E-MAIL IS NOT AUTHORIZED.
NOTE: DIRECTIONS FOR ACCESSING THE "STREAMLINED RFP REFERENCES" REFERRED TO THROUGHOUT THIS RFP ARE AS FOLLOWS:
After reviewing this Request For Proposal, type in URL: "http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm". In this directory, entitled "NIH Request For Proposals Directory", following the list of NIH Institutes by name, is the section entitled "STREAMLINED RFP REFERENCES". Select (click on) each section you wish to review:
"STANDARD RFP INSTRUCTIONS AND PROVISIONS" for proposal preparation instructions and other standard provisions,
"OPTIONAL RFP INSTRUCTIONS AND PROVISIONS" for the special provisions identified in this specific RFP,
"FORM, FORMATS, AND ATTACHMENTS" to download the forms listed in this specific RFP that you will need to submit a proposal, and
"SAMPLE CONTRACT FORMAT-GENERAL" to view some of the clauses that are typical for inclusion in a Research and Development type contract issued by NIH.
Sincerely,
/s/
Ms. Kristiane E. Cooper
Contracting Officer
B. BACKGROUND, RESEARCH AND TECHNICAL OBJECTIVES, ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS
This section presents the background for this solicitation and the technical objectives that the Government seeks to achieve through this BAA. Proposals should explain how the offeror will contribute to these overall objectives. Contracts awarded as a result of this BAA will incorporate the statement of work proposed by the offeror and negotiated and accepted by the Government.
The NIDCR supports and encourages research aimed at discovering the etiology and pathogenesis of Temporomandibular disorders (TMDs), and developing new tissue engineering strategies for the repair and regeneration of Temporomandibular joint (TMJ) structures.
Temporomandibular disorders (TMDs) refer to a collection of medical and dental conditions affecting the temporomandibular joint (TMJ) and or the muscles of mastication, as well as contiguous tissue structures. As a group, these conditions have no common etiology or biological explanation and comprise a heterogeneous group of health problems whose signs and symptoms are overlapping but not necessarily identical. Given the variation among the problems labeled TMDs, it is not surprising that a variety of therapeutic approaches have evolved for the relief of TMD symptoms. Implants have been used primarily to replace the articular disc of the joint and the condylar head of the mandible. Therefore, a number of individuals suffering with TMDs, have received more than one TMJ implant and others are in need of such devices, particularly in situations where TMD disorders are not responsive to other modalities of treatment; in situations where tissue grafts have failed or implants such as teflon-proplast or silastic have failed. Therefore, for a number of TMD patients, treatment with TMJ implants is required. However, long-term success and functioning of these implants remains a major problem. Among the reasons for implant failure are lack of understanding of the etiology and pathogenesis of the TMDs, and the evolution of the disorder and lack of sufficient information (e.g., genetic immunological profile) regarding patients about to receive implants. Additional factors contributing to the failure of TMJ devices are the choice of the design and materials of the implant, and the production of wear particles that can trigger a cascade of events that ultimately may result in the damage to TMJ structures (e. g., disappearance of bone around the implant). Surgery to replace these failures is more difficult to perform, more costly, and has a poorer outcome than the original joint replacement surgery.
The NIDCR realizes that there is a need to better the understanding of the success and failure of TMJ implants. To meet this objective, the proposed contract(s) will support the collection of medical information from health care provider records and interviews; the collection of clinical and laboratory data on the genotypic immunological profile (e.g., MHC, cytokines) of the enrollees; the establishment and maintenance of a registry and repository of TMJ retrieved implants and a registry of biological materials. The information gained by the registries and the repository will provide insight into the strengths and weaknesses of the design of TMJ implants, and enable improvements to future implant design.
RESEARCH AND TECHNICAL OBJECTIVES
The NIDCR is interested in providing researchers and clinicians with high-quality data on patients' medical and clinical history (e.g., genetic immunological profile of the registry enrollees) that have received TMJ implant(s) or are about to receive such implants as well as data on TMJ implant performance. These objectives will be achieved by supporting one or more registries for a sufficiently large number of TMD patients and a repository of retrieved implants for analysis and storage. It is expected that the registry(s) and repository will promote and facilitate future substantive hypothesis and design driven research projects, including clinical trials.
[NOTE TO OFFERORS: Offerors must submit one proposal that addresses both Technical Objectives. Proposals that address only one Technical Objective will not be considered].
A. To design and implement a research registry of clinical information and biological specimens on TMD patients receiving implants.
Implant success or failure in general, is thought to depend on the evolution (state) of a disease/disorder, the genetic immunological profile of the host and the implant itself. TMDs comprise a heterogeneous group of health problems whose signs and symptoms are overlapping but not necessarily identical. Among the manifestations of the disorder are TMJ structure (bone, articular cartilage) degradation that leads to pain and destructive changes in the joint. TMJ implants have been used to treat these conditions. However, to date there are not well-developed criteria as to what type of implant is best for a particular patient. As a result, while some patients can adapt to implant treatment, others do not. The purpose of this part of the registry is to collect background information on individuals who have had failed or successful implants or are currently considering a partial or total TMJ implant (e.g., for the replacement of the articular disc of the joint and/or the condylar head of the mandible). The successful contractor should be able to address questions such as: What diagnostic criteria are used to treat patients with implants? Are there data on patients' responses to TMJ implants? Are there any genetically based factors (e.g., MHC, cytokines) that can modulate the host response (local and systemic) to different implant materials and designs, as well as to fragmented and wear particles of implant materials? What are the cellular and biochemical mechanisms involved in local and systemic response to implantable materials? The contractor shall collect medical information on the participants from health care professionals (medical and/or dental surgeons, healthcare personnel and other professionals whose practice is likely to include a high proportion of individuals with TMDs), collect clinical data on the genotypic and immunological profile of the participants, create storage facilities for specimen maintenance, and develop computing programs for data collection, and for achieving large data sets.
NIDCR expects that the registry will provide high-quality data (medical, clinical, epidemiological) to help health care providers make informed treatment decisions in providing better patient care. The registry will also serve as a resource of well-characterized and analyzed biological specimens, the availability of which is expected to promote and facilitate substantive research projects in understanding the underlying etiology and pathogenesis of TMJ structures and their repair and regeneration. The offeror shall present a plan for developing a process to maintain and make available all materials to biomedical researchers as well as a plan for future long-term support of the program through additional sources other than the Government.
B. To design and implement a research registry and repository on TMJ retrieved implants.
Despite short-term success of TMJ implants, these devices usually break down with devastating effects (pain, dysfunction of the jaw, local and systemic effects and other disabilities) to the patient. Often the implant has to be removed and replaced with a similar device. To date, other than sporadic reports on TMJ implant performance, there is not a systematic long-term study of retrieved TMJ implant analysis that will provide information of the success or failure of an implant. The NIDCR realizes that implant retrieval and analysis is of great importance in the processes of improving implant design, fabrication and material, and wishes to establish a registry and repository to collect retrieved TMJ implant materials and analyze them. The research activities in the registry/repository will focus on: the collection and storage of removed implants, the analysis of the implant, the molecular and cellular responses of local tissues to different types of implant materials, the health status of the patient before and after implant removal, and the incidence and prevalence of implant failure in regard to the type and implantation site.
It is expected that the contractor will initiate and maintain collaborations with health care professionals (medical and/or dental surgeons, healthcare personnel and other professionals whose practice is likely to include a high proportion of individuals with TMDs) and those that may maintain collections of archived retrieved TMJ implants. The successful contractor will also operate a repository of retrieved implants, tissues and cells. The offeror shall present a plan for developing a process to maintain and make available all biopsy materials and TMJ retrieved implants to biomedical researchers as well as a plan for future long-term support of the program through additional sources other than the Government.
ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS
In addition to addressing the technical objectives above, each proposal should include the following:
1. A discussion of the need, significance, and potential impact that the establishment of the proposed registry and repository would have in facilitating patient diagnosis, choice of treatment in regard to TMJ implants, and future basic and clinical research on TMDs. The proposal should include a list of specific objectives that the registry and repository plans to accomplish as well as broad research areas that the existence of a registry and repository could facilitate.2. A description of future research projects that would become feasible because of the availability of the proposed research registry and repository. The offeror should detail the significance of such projects in advancing the understanding and/or the treatment of TMDs. The actual research projects are not part of the scope of this solicitation and, thus, will not be funded as part of any contract award resulting from this BAA.
3. A detailed description of the facilities and staff necessary to establish and maintain a repository of retrieved implants, tissue, blood, and synovial fluid of enrollees. A copy of the proposed consent form that addresses use of tissue, blood or other biological samples should be included.
4. A detailed description of the plan for patient recruitment as well as information regarding the expertise and experiences of the offeror and the personnel in recruiting and maintaining patient populations.
5. A detailed description of the proposed criteria for inclusion in each registry. Include a discussion of the acceptability of those criteria to the medical/scientific community, the advantages and limitations of the proposed criteria, and a description of plans to update or modify the criteria in response to relevant medical or scientific advances.
6. A discussion of a plan for monitoring and storage of data collected on patients with successful or failed TMJ implants.
7. A detailed description of the methods and procedures for the acquisition of relevant clinical information that ensure that entry criteria are met, the methods and intervals for updating the information, and the quality control measures proposed.
8. A description of the plans to make the registry information and specimens available to the scientific community as well as a plan for working with other NIDCR supported investigators in similar research fields. The proposal should include a description of the process and personnel involved in the review and approval of requests including the role of the Principal Investigator and the NIDCR Project Officer in arriving at final decisions on requests.
9. A discussion of collaborations between basic research scientists and health care professionals (medical and/or dental surgeons, healthcare personnel and other professionals whose practice is likely to include a high proportion of individuals with TMDs).
10. A description of the plans for the identification and inclusion of women, minorities and, if appropriate, children to the greatest extent possible in the registry.
11. A description of the plan to establish an internal advisory group for the purpose of periodic evaluation of the progress of the contract. This group will be comprised of the Principal Investigator of each awarded BAA contract, 2-3 extramural scientists and the Project Officer. The advisory group will meet annually. The Chair of the Advisory Group will be appointed by the NIDCR. The purpose of this committee will be to strengthen collaborations among the Contractors, identify impediments to the progress of the contract and suggest strategies to surmount them.
C. REPORTING REQUIREMENTS/DELIVERABLES
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 contracts resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting periods. For proposal preparation purposes only, it is estimated that reports will be required as follows:
1. Program Plan—A program plan shall be submitted 60 days after contract award for review and approval. The plan shall identify critical decision points and technical risks that are expected to result, and include a one page graphic that reflects, task-by-task, when the key milestones of the registries will be met. Any revisions to the approved plan shall be submitted to the NIDCR Project Officer for review and approval.
2. Annual Technical Reports—This report shall document and summarize all work results for the period covered. Specifically, the report shall include:
a. Face page to include contract number, title, period of performance being reported, Contractor's name and address, telephone and facsimile numbers, and date of submission.b. An executive summary, to include:
1. A full description of data pertaining to:
a) The work performed during the reporting period;2. A summary of activities planned for the next reporting period;
b) The materials and methods pertaining to the work;
c) The relationship between the accomplishments made relative to the goals, objectives, and milestones of the Statement of Work;
d) A brief overview of any problems (technical or financial) that occurred during the current reporting period and their resolution or status.3. 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 resulting from this work must cite the support received from this contract.
The initial report shall be submitted for the first full twelve months of performance including any fractional part of the initial month. Annual reports thereafter shall be submitted at 12 month intervals. An annual report is not required for the period when the final report is due.
3. Final Technical Report—This report shall cover the entire period of contract performance and 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.
4. Annual Technical Progress Report for Clinical Research Study Populations—The contractor shall submit information about the inclusion of women, and members of minority groups and their subpopulations for each registry contract being performed under this requirement.
5. Abstracts and Manuscripts—Abstracts and manuscripts in progress and proposed for publication shall be provided to the NIDCR for review and comment 30 days prior to submission for publication.
6. Other Reports as required by the contract.
Copies of reports shall be sent to the following addresses
| Item |
Description |
Quantity |
Delivery Schedule |
|---|---|---|---|
| 1 |
Program Plan |
3 |
60 days after contract start |
| 2 |
Annual Technical Reports |
3 |
Annually |
| 3 |
Final Report |
3 |
Contract expiration date |
| 4 |
Annual Technical Progress Report for Clinical Research Study Populations |
2 |
Annually |
| 5 |
Abstracts and Manuscripts |
1 |
As required in the contract |
| 6 |
Other Reports |
TBD |
As required in the contract |
| 7 |
Subcontracting Report for Individual Contracts (294) |
1 |
April 30 and October 31 annually |
| 8 |
Summary Contracting Report (295) |
1 |
October 31 annually |
| 9 |
Human Subject Assurances OF-310 |
1 |
Annually |
| 10 | Data and Specimens Collected | TBD | To be specified |
The items above shall be delivered to the following addresses:
| Addressee |
Deliverable Item # |
Quantity |
|---|---|---|
| Contracting Officer Contracts Operations Branch, DEA, NHLBI Two Rockledge Center, Room 6136 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902 |
1,2,3,4,6,7,9 |
1 |
| Project Officer National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4an18a Bethesda, MD 20892-6401 |
1,2,3,4,5,6,10 | 2 |
D. EVALUATION FACTORS FOR AWARD WITH TECHNICAL EVALUATION CRITERIA
The Government will make awards to the responsible offeror(s) whose proposals provide the best value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective offerors in relation to the evaluation criteria as set forth herein. Each proposal must document the feasibility of successful implementation of the requirements of the BAA. 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.
All technical proposals will undergo evaluation by a peer review group also known as the Technical Evaluation Panel (TEP). The merits of each proposal will be evaluated carefully against the technical evaluation criteria below. Proposals will not be evaluated against each other since they are not submitted in accordance with a common work statement.
Subsequent awards will depend on scientific priority, program balance, and the availability of funds which the NIDCR determines to exist at the time of award selection. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price.
It is anticipated that technical discussions will be held with all offerors whose proposals remain under consideration after the TEP evaluation. Cost negotiations may be necessary as well.
The NIDCR reserves the right to make awards for only certain portions of proposed work.
Past performance is not an evaluation factor but will be considered in determining the offerors responsibility in accordance with FAR 9.104-3(b) (Reference Applicable RFP References, Optional RFP Instructions and Provisions).
The offeror's Small Disadvantaged Business (SDB) Participation Plan (see Section I, Specific RFP Instructions and Provisions, Item K.) will be evaluated after the initial technical evaluation. Only those offerors being considered further for award, will be evaluated.
The technical evaluation criteria below are to be used by the Technical Evaluation Panel when reviewing technical proposals. The criteria below are listed in order of relative importance with weights assigned for evaluation purposes.
| 1. | Scientific and Technical Merit | 40 Points |
|---|---|---|
| Adequacy, feasibility and technical merit of the proposed methods and approaches to collect the appropriate information from patients, including access to patient populations, ability to establish and maintain a registry and repository, and methods of quality assurance and updating data. |
||
| 2. | Staff Experience | 40 Points |
| Demonstrated expertise and experience of the proposed Principal Investigator and other staff related to patient recruitment case ascertainment, information dissemination, diagnosis, and follow-up for the proposed registry/repository. Demonstrated expertise and capability to compile information/data for the proposed registry and the ability to interact with the research community interested in the evaluation of treatment TMJ. Documented experience with managing projects with similar complexity. Demonstrated familiarity with the basic science that relates to the disease. Sufficient knowledge of the disease and of the available treatment(s) of TMDs in order to promptly and appropriately handle those questions concerning all medical/scientific aspects of the registry and repository operation, in particular, those situations in which the diagnosis of individual cases may be questionable. |
||
| 3. | Ability to Interact with Researchers | 10 Points |
| The capability of the proposed offeror to stimulate advances in the understanding of treatment choices, design and fabrication of future TMJ implants, by demonstrated ability to interact effectively and collaborate with researchers in the same and/or similar scientific areas. |
||
| 4. | Facilities/Equipment/Resources | 10 Points |
| Availability of adequate facilities, equipment and resources necessary to support the technical objectives. Adequacy of computer systems for the input and maintenance of data files and of proposed measures taken to assure security of the data. |
||
| TOTAL: | 100 Points | |
THE REMAINDER OF THIS RFP CONSISTS OF THE FOLLOWING SECTIONS:
I. Specific RFP Instructions and Provisions, and
II. Applicable RFP References
SECTION I. SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
NOTICE TO OFFEROR: This section contains proposal instructions and information which 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 under Section II, Applicable RFP References.
The following specific RFP instructions and provisions apply to this Request For Proposal:
A. Proposal Intent Response Sheet
B. Government Notice for Handling Proposals
C. Packaging and Delivery of Proposal
D. NAICS Code and Small Business Size Standard
E. Number and Type of Award
F. Service of Protest
G. Technical Proposal Table of Contents
H. Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns
I. Privacy Act
J. Safety and Health
K. Other Provisions
A. PROPOSAL INTENT RESPONSE SHEET
RFP No. BAA-DR-02-08
TITLE OF BAA/RFP: Research Registries and Repository for the Evaluation of Temporomandibular Joint Implants
FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY March 20, 2002. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT WILL ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.
I INTEND TO SUBMIT A PROPOSAL
B. GOVERNMENT NOTICE FOR HANDLING PROPOSALS
NOTE: This Notice is for the Technical Evaluation Review Group who 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.
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 paragraph 315.608-72.
(2) Written agreement must be obtained from the evaluator that the information (data) contained in the proposal will be used only for evaluation purposes and will not be further disclosed;
(3) Any authorized restrictive legends placed on the proposal by the prospective Contractor or subcontractor or by the Government shall be applied to any reproduction or abstracted information made by the evaluator;
(4) Upon completing the evaluation, all copies of the proposal, as well as any abstracts thereof, shall be returned to the Government office which initially furnished them for evaluation; and
(5) All determinations to release the proposal outside the Government take into consideration requirements for avoiding organizational conflicts of interest and the competitive relationship, if any, between the prospective Contractor or subcontractor and the prospective outside evaluator.
(f) If authorized in agency implementing regulations, agencies may release proposals outside the Government for evaluation, consistent with the following:
C. PACKAGING AND DELIVERY OF THE PROPOSAL
(1) Decisions to release proposals outside the Government for evaluation purposes shall be made by the agency head or designee;
(g) The submitter of any proposal shall be provided notice adequate to afford an opportunity to take appropriate action before release of any information (data) contained therein pursuant to a request under the Freedom of Information Act (5 USC 552); and, time permitting, the submitter should be consulted to obtain assistance in determining the eligibility of the information (data) in question as an exemption under the Act. (See also Subpart 24.2, Freedom of Information Act.)
Your proposal shall be organized in accordance with the guidelines provided in "Standard RFP Instructions and Provisions." Shipment and marking shall be as follows:
EXTERNAL PACKAGE MARKING
In addition to the address cited below, mark each package as follows:
"RFP/BAA NO. NIDCR-BAA-DR-02-08
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
The number of copies required of each part of your proposal are:
TECHNICAL PROPOSAL: ORIGINAL* AND Fifteen (15) COPIES
BUSINESS PROPOSAL: ORIGINAL* AND Six (6) COPIES
*DELIVER PROPOSAL TO:
If courier delivery service:
Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge Building, Room 7091
6701 ROCKLEDGE DRIVE MSC 7924
BETHESDA, MD 20817-7924
*(Note: Proposals delivered in person will not be accepted)
If using U.S. Postal Service:
Review Branch, Division of Extramural Affairs
National Institutes of Health
National Heart, Lung, and Blood Institute
6701 ROCKLEDGE DRIVE MSC 7924
BETHESDA, MD 20892-7924
*THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE STAMPING.
D. NAICS CODE AND SIZE STANDARD
THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the FAR requires in every solicitation (except for foreign acquisitions) the inclusion of the code and corresponding size standard which best describes the nature of the requirement in the solicitation.
NOTE: The following information is to be used by the offeror in preparing its Representations and Certifications, specifically in completing the provisions entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS, FAR 52.219-1:
The North American Industry Classification System (NAICS) code for this acquisition is 541710.
The small business size standard is 500 employees.
It is anticipated that two to three awards will be made from this solicitation and that the awards will be made on or about September 30, 2002.
It is anticipated that the awards made from this solicitation will be multiple-year cost reimbursement, completion type contracts with a period of performance of five years, and that incremental funding will be used.
In accordance with FAR 52.233-2 SERVICE OF PROTEST (AUG 1996):
(a) 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:
Mr. Robert Best
Chief, Contracting Operations Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7902
Bethesda, MD 20892-7902
The copy of any protest shall be received in the office designated above within one day of filing a protest with GAO.
G. TECHNICAL PROPOSAL TABLE OF CONTENTS
Please number each page of text. The technical proposal, excluding resumes, biosketches and appendices, is limited to 50 pages. Type density and size must be 10-12 points If constant spacing is used, there should be no more than 15 cpi, 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. The technical proposal should be organized as follows:
1. TECHNICAL PROPOSAL COVER SHEET (also available in MS Word (Form is located in the Streamlined RFP References under "FORMS, FORMATS, ATTACHMENTS")—Page 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS—Page 2
3. ABSTRACT—Page 3
State the proposal's broad, long-term objectives and specific aims. Briefly and concisely describe the research design and methods for achieving these goals. DO NOT EXCEED one page in providing the abstract. Identify the RFP Number, Institution and Principal Investigator on the abstract.
4. TECHNICAL PLAN Refer to Technical Proposal Instructions located in the Standard RFP Instructions and Provisions under Streamlined RFP References for more detail.
a. Statement of Work5. OTHER SUPPORT—Page #
1. Objectives—Page #
2. Approach—Page #
3. Methods—Page #
4. Schedule—Page #b. PERSONNEL
List of all Personnel in the project including Subcontractors, Consultants/Collaborators, by name, title, department and organizationPROVIDE NARRATIVE FOR:
1. Principal Investigator/Project Director
2. Other Investigators
3. Professional Personnel
4. Support Staff
[NOTE: For all personnel except support staff, include a two-page biosketch under APPENDICES below.]c. FACILITIES, EQUIPMENT AND OTHER RESOURCES—Page #
List/describe all facilities, equipment and other resources available for this project.d. OTHER CONSIDERATIONS—Page #
(Use specifically titled subparagraphs, as applicable.)
6. TECHNICAL PROPOSAL COST INFORMATION—Page #
(Form located in the Streamlined RFP References under "FORMS, FORMATS, & ATTACHMENTS.")
7. LITERATURE CITED—Page #
8. APPENDICESPage #
List each Appendix and identify the number of pages for each one. Appendices must be clear and legible, and easily located. Include biosketches here. Provide in appendices, letters of commitment for proposed consultants.
9. Human Subjects and Minority Gender issues not otherwise addressed (if applicable)—Page #
H. NOTICE OF 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, 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.I. 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 applicable to this project is Number 09-25-0200, Clinical, Epidemiology and Biometric Studies of the NIH. The notice was published in the Federal Register, Volume 64, number 229 on November 30, 1999 (http://www.access.gpo.gov/su_docs/aces/PrivacyAct.shtml).
J. SAFETY AND HEALTH DEVIATION PHS 352.223-70 (AUGUST 1997)
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 this 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).
Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the project or other appropriate officer, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable "Changes" Clause set forth in this contract.
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 contract 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.
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 stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor. The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.
1. COST/PRICING INFORMATION
The offeror's business proposal shall include the basic cost/pricing information specified in the Standard RFP Instructions and Provisions, under the Streamlined RFP References Directory referenced in this RFP. Please include information to substantiate the proposed costs or prices. including payroll documentation, vendor quotes, invoice prices, and/or any other information relevant to aid the Government in evaluating the reasonableness of the price or to determine cost realism. Before award, submission and certification of cost or pricing data may be required. The cost spreadsheets should be in Microsoft Excel using the format located at http://ocm.od.nih.gov/contracts/rfps/buscost.htm. A diskette or CD ROM containing the Microsoft Excel spreadsheets should be attached to the original proposal. As an alternative to submitting the file on diskette, you may send the Microsoft file by electronic mail to kc116y@nih.gov.
2. Uniform Resource Locators (URLs) in Contract Proposals
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.
3. Small Disadvantaged Business Participation Plan
Evaluation of Small Disadvantaged Business (SDB) Participation Plans will be made based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance. The Government is seeking to determine whether the offeror has demonstrated their commitment and capability to use SDB concerns for the work that it intends to perform as the prime contractor.
a. Evaluation of the Plan will be performed only on those offerors being considered for award. 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. The SDB Participation Plan should address 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 plan:
a. The extent of an offerors commitment to use SDB concerns. Commitment should be as specific as possible, e.g., are subcontract arrangements already in place; are letters of commitment in place. Enforceable commitments will be weighted more heavily than non-enforceable ones;b. Specifically identify the SDB concerns with point of contact and telephone number;
c. The complexity and variety of the work SDB concerns are to perform;
d. Realism for the use of SDB in the proposal;
e. Past performance of the offeror in complying with subcontracting plans for SDB concerns;
f. Targets expressed as dollars and percentage of total contract value, in each of the applicable authorized SIC Major Group(s). A total target for SDB participation by the prime contractor that includes any joint ventures and team members* shall be provided, as well as a total target for SDB participation by subcontractors. Targets may be incorporated into and become part of any resulting contract; and
g. The extent of participation of SDB concerns in terms of the value of the total acquisition.
NOTE: The SDB Participation Plan is a separate requirement from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan.
SECTION II. APPLICABLE RFP REFERENCES
This section identifies the items located in the Streamlined RFP References that are applicable to this Request For Proposal (RFP). The files identified below must be retrieved, in whole or in part, in order to submit a proposal in response to this RFP. The entire file entitled "STANDARD RFP INSTRUCTIONS AND PROVISIONS" is applicable to this RFP, except as modified by the inclusion of items from the "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS" below. Note: all references to "competitive range"contained in the standard RFP instructions are hereby deleted because this is a BAA and not a conventional RFP.
1. The following items are applicable from the file entitled "OPTIONAL RFP INSTRUCTIONS AND PROVISIONS". The full text of the provisions is available in the file.
List of optional provisions which apply to this specific RFP:
A. Notice: This requirement is Not Set-Aside for Small Business2. The following items are applicable to this specific RFP and are located in the file entitled "FORMS, FORMATS, AND ATTACHMENTS", under Streamlined RFP References:
E. Late Proposals, HHSAR 352.215-70
F. Human Subjects
J. Inclusion of Women and Minorities in Research Involving Human Subjects
N. Facilities Capital Cost of Money
Q. IT Systems Security
R. Inclusion of Children in Research Involving Human Subjects
SUBMIT WITH TECHNICAL PROPOSAL (with original and every copy of technical proposal)
1. Technical Proposal Cover Sheet (also available in MS Word)
2. Government Notice for Handling Proposals (See Section I of this RFP, Specific RFP Instructions and Provisions, Item B)
3. Summary of Current and Proposed Activities (also available in MS Word format)
4. Technical Proposal Cost Information
SUBMIT WITH BUSINESS PROPOSAL:
1. Proposal Summary and Data Record, NIH-2043 (PDF format; MS Word format), with every copy of business proposal.
2. Disclosure of Lobbying Activities (PDF format), OMB SF-LLL, only one completed and signed original. This form is not required if there are no lobbying activities to disclose.
3. Representations and Certifications (PDF format; WordPerfect format; MS Word format), only one completed and signed original.
4. Electronic Business Proposal Spread Sheet located at:
http://ocm.od.nih.gov/contracts/rfps/buscost.htm.
5. Supporting documentation for staff salaries, consultants, subcontracts, supplies and equipment.
6. Small Disadvantaged Business (SDB) Participation Plan (see Section I, Specific RFP Instructions and Provisions, Item K.) (This plan is different from the Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan).
OTHER—TO BE SUBMITTED WITH THE FINAL PROPOSAL REVISION:
1. Certificate of Current Cost or Pricing Data, NIH-1397, to be submitted with Final Proposal Revision.
2. Small, Small Disadvantaged and Women-Owned Small Business Subcontracting Plan, only one completed and signed original.
ANTICIPATED TO BE INCLUDED AS CONTRACT ATTACHMENTS:
1. Invoice/Financing Request Instructions for NIH Cost-Reimbursement Type Contracts (PDF format), NIH(RC)-1
2. NIH 2706, Financial Report for Individual Project/Contract Instructions
3. NIH 2706, Financial Report for Individual Project/Contract Form (PDF format)
4. Procurement of Certain Equipment, NIH(RC)-7
The "SAMPLE CONTRACT FORMAT-GENERAL" under the Streamlined RFP References is applicable to this RFP. Selected clauses, applicable to this acquisition, will be included in the contract.
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