NIH Electronic Request for Proposal (RFP) Directory

STREAMLINED RFP REFERENCES
OPTIONAL RFP INSTRUCTIONS AND PROVISIONS


 

Updated through FAC 97-16
Last updated on 04/04/00

If any items contained in this section are applicable to a specific RFP, they will be identified in the "Applicable RFP REFERENCES" section of that RFP.

  1. Notice: This Requirement is Not Set-Aside for Small Business
  2. Notice of Small Business Set-Aside
  3. Notice of 8(a) Competitive Set-Aside
  4. Concept Review
  5. Late Proposals, Modifications of Proposal, and Withdrawals of Proposals,
    PHS 352.215-10
  6. Human Subjects
  7. Care of Live Vertebrate Animals
  8. Small Business Subcontracting Plan (JAN 1999)
  9. ALTERNATE II of the Small Business Subcontracting Plan (JAN 1999)
  10. Inclusion of Women and Minorities in Research Involving Human Subjects
  11. Total Compensation Plan - Instructions
  12. Total Compensation Plan - Evaluation
  13. Past Performance Information
  14. Facilities Capital Cost of Money
  15. "JUST IN TIME"
  16. ALTERNATE II of FAR CLAUSE 52.215-1, Instructions to Offerors-- Competitive Acquisition
  17. IT Systems Security
  18. Inclusion of Children in Research Involving Human Subjects

  1. NOTICE: 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. The SIC Code and corresponding size standard will be set forth in the specific RFP.

  2. NOTICE OF SMALL BUSINESS SET-ASIDE

    1. General. Bids or proposals under this procurement are solicited only from small business concerns. The procurement is to be awarded only to one or more such concerns, organizations, or individuals. This action is based on a determination by the Contracting Officer, alone or in conjunction with a representative of the Small Business Administration, that it is in the interest of maintaining or mobilizing the Nation's full productive capacity, or in the interest of war or national defense programs, or in the interest of assuring that a fair proportion of Government procurement is placed with small business concerns. Bids or proposals received from others will be considered non-responsive.

    2. Definitions. The term "small business concern" means a concern, including its affiliates, which is independently owned and operated, is not dominant in the field of operation in which it is bidding on Government contracts, and can further qualify under the criteria set forth in the regulations of the Small Business Administration (13 CFR 121.3-8). In addition to meeting these criteria, a manufacturer or a regular dealer submitting bids or proposals in his own name must agree to furnish in the performance of the contract end items manufactured or produced in the United States, its territories and possessions, Commonwealth of Puerto Rico, the Trust Territory of the Pacific Islands, and the District of Columbia, by small business concerns. Provided, that this additional requirement does not apply in connection with construction or service contracts.

  3. NOTICE OF 8(a) COMPETITIVE SET-ASIDE

    Offers are solicited only from small business concerns expressly certified by the Small Business Administration (SBA) for participation in the SBA's 8(a) Program. Bids or proposals received from others will be considered non-responsive.

  4. CONCEPT REVIEW

    This project has not been given concept review. Such review will occur prior to technical evaluation. Thus potential offerors are cautioned that cancellation of this RFP due to disapproval by the Board of Scientific Counselors/IC Advisory Council, or equivalent, is a possibility.

  5. LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS OF PROPOSALS, PHS 352.215-10

    Notwithstanding the procedures contained in the provision of this solicitation entitled Late Submissions, Modifications, and Withdrawals of Proposals, 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 working days after the exact time specified for receipt, whichever is earlier.

  6. HUMAN SUBJECTS

    Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (SEPTEMBER 1985)

    1. Copies of the Department of Health and Human Services (Department) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office for Protection from Research Risks (OPRR), National Institutes of Health, Bethesda, Maryland 20892. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the Department.

    2. The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information. The regulations extend to the use of human organs, tissue and body fluids from individually identifiable human subjects as well as to graphic, written or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR, Part 46.

    3. Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage.

    4. Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The Public Health Service will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, prior consultation with OPRR, (telephone: 301-496-7041), is recommended.

    5. In accordance with 45 CFR, Part 46, prospective Contractors being considered for award shall be required to file with OPRR an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall assure that the rights and welfare of the human subjects involved are adequately protected, that the risks to the subjects are reasonable in relation to the potential benefits, if any, to the subjects and the importance of the knowledge to be gained, and that informed consent will be obtained by methods that are adequate and appropriate. Prospective Contractors proposing research that involves human subjects shall be contacted by OPRR and given detailed instructions for establishing an institutional review board and filing an Assurance of Compliance.

    6. It is recommended that OPRR be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects.


  7. CARE OF LIVE VERTEBRATE ANIMALS

    Notice to Offerors of requirement for adequate assurance of protection of vertebrate animal subjects - (SEPTEMBER 1985)

    The Public Health Service (PHS) Policy on Human Care and Use of Laboratory Animals by Awardee Institutions establishes a number of requirements for research activities involving animals. Before a PHS award may be made to an applicant organization, the organization shall file, with the Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH), PHS, a written Animal Welfare Assurance which commits the organization to comply with the provisions of the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources. In accordance with the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions, applicant organizations must establish a committee, qualified through the experience and expertise of its members, to oversee the institution's animal program, facilities and procedures. No PHS award involving the use of animals shall be made unless the Animal Welfare Assurance has been approved by OPRR. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects that involve live vertebrate animals that an Animal Welfare Assurance is required. The Contracting Officer will request that OPRR negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, OPRR may be contacted at 6100 Executive Boulevard, Suite 3B01, MSC 7507, Rockville, Maryland 20892-7507 (301-496-7163, ext. 234). Copies of the PHS Policy are available on the Internet at http://www.nih.gov:80/grants/oprr.htm.

  8. SMALL BUSINESS SUBCONTRACTING PLAN

    If the proposed contract exceeds a total estimated cost of $500,000 for the entire period of performance, the 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.

    1. THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.

    2. The term "subcontract" means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

    3. The offeror understands that:

    1. No contract will be awarded unless and until an acceptable plan is negotiated with the Contracting Officer which plan will be incorporated into the contract, as a material part thereof.
    2. An acceptable plan must, in the determination of the Contracting Officer, provide the maximum practicable opportunity for small business concerns and small business concerns owned and controlled by socially and economically disadvantaged persons to participate in the performance of the contract.
    3. If a subcontracting plan acceptable to the Contracting Officer is not negotiated within the time limits prescribed by the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the offeror, the offeror shall be ineligible for an award. The Contracting Officer shall notify the Contractor in writing of the reasons for determining a subcontracting plan unacceptable early enough in the negotiation process to allow the Contractor to modify the plan within the time limits prescribed.
    4. Prior compliance of the offeror with other such subcontracting plans under previous contracts will be considered by the Contracting Officer in determining the responsibility of the offeror for award of the contract.
    5. It is the offeror's responsibility to develop a satisfactory subcontracting plan with respect to small business concerns, small business concerns owned and controlled by socially and economically disadvantaged individuals, and women-owned small business concerns and that each such aspect of the offeror's plan will be judged independent of the other.
    6. The offeror will submit, as required by the Contracting Officer, subcontracting reports in accordance with the instructions thereon, and as further directed by the Contracting Officer. Subcontractors will also submit these reports to the Government's Contracting Officer or as otherwise directed, with a copy to the prime Contractor's designated small and disadvantaged business liaison.

    4. Each plan must contain the following:

    1. Goals, expressed in terms of percentages of total planned subcontracting dollars, for the use of Small, small disadvantaged, and women-owned small business concerns as subcontractors.
    2. A statement of total dollars planned to be subcontracted. A statement of total dollars to be subcontracted to each of the following type of small business concerns: Small, Small Disadvantaged, and Women-Owned Small Businesses.
    3. A description of the principal types of supplies and services to be subcontracted with an identification of which supplies and services are expected to be subcontracted to small, small disadvantaged, and/or women-owned small business concerns.
    4. A description of the method used to develop the subcontracting goals.
    5. A description of the method used to identify potential sources for solicitation purposes.
    6. A statement as to whether or not indirect costs were included in establishing subcontracting goals. If they were, a description of the method used to determine the proportionate share of indirect costs to be incurred with small, small disadvantaged and women-owned small business concerns.
    7. The name of the individual employed by the offeror who will administer the offeror's subcontracting program and a description of his/her duties.
    8. A description of the efforts the offeror will make to assure that small, small disadvantaged and women-owned small business concerns have an equitable chance to compete for subcontracts.
    9. Assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns" Assure that all subcontractors, other than small businesses, in excess of $500,000 adopt a plan similar to the plan agreed upon by the offeror.
    10. Assurances that the offeror (and any required subcontractors) will cooperate in studies or surveys as required and submit required reports (SF 294 and SF 295) to the Government.
    11. List the types of records the offeror will maintain to demonstrate procedures that have been adopted to comply with the requirement and goals in the plan, including establishing source lists. Also, the offeror shall describe its efforts to locate small, small disadvantaged, and women-owned small business concerns and award subcontracts to them.

    For additional information about each of the above elements required to be contained the subcontracting plan, see FAR Clause 52.219-9 (JAN 1999), Small Business Subcontracting Plan, and the Sample Subcontracting Plan which is included in the FORMS, FORMATS AND ATTACHMENTS. 

  9. ALTERNATE II (JAN 1999) of FAR Clause 52.219-9, Small Business Subcontracting Plan (OCT 1999) applies to this RFP.


  10. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

    It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies.

    All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research" which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), [(this was reprinted to correct typesetting errors from Federal Register dated March 9, 1994 (FR 59 11146-11151)], and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. A copy of this document is available in the FORMS, FORMATS AND ATTACHMENTS directory. Unless otherwise specified in the specific RFP,the Government has determined that the work set forth herein does not involve a gender specific study or a single or limited number of minority population groups. Therefore, the Government believes that the inclusion of women and minority populations is appropriate for this project. (See the Technical Evaluation Criteria of the specific RFP for more information about evaluation factors for award.) The format for the Annual Technical Progress Report also found in the FORMS directory shall be used in proposal preparation.


  11. TOTAL COMPENSATION PLAN - INSTRUCTIONS

    1. Total compensation (salary and fringe benefits) of professional employees under service contracts may, in some cases, be lowered by recompetition of these contracts. Lowering of compensation can be detrimental in obtaining the necessary quality of professional services needed for adequate performance of service contracts. It is, therefore, in the best interest of the Government that professional employees, as defined in 29 CFR Part 541, be properly compensated in these contracts. As a part of their business proposals, offerors will submit a "Total Compensation Plan" (salaries and fringe benefits) for these professional employees for evaluation purposes.

    2. The Government will evaluate the Total Compensation Plan to ensure that this compensation reflects a sound management approach and an understanding of the requirements to be performed. It will include an assessment of the offeror's ability to provide uninterrupted work of high quality. The total compensation proposed will be evaluated in terms of enhancing recruitment and retention of personnel and its realism and consistency with a total plan for compensation (both salaries and fringe benefits).

    3. Evaluation for award, therefore, will include an assessment of the Total Compensation Plan submitted by each offeror.


  12. TOTAL COMPENSATION PLAN - EVALUATION

    1. Total Compensation Plan (Professional Employees)

      In establishing compensation levels for professional employees, the total compensation (both salaries and fringe benefits) proposed shall reflect a clear understanding of the requirements of the work to be accomplished and the suitability of the proposed compensation structure to obtain and retain qualified personnel to meet mission objectives. The salary rates or ranges must recognize the distinct differences in professional skills and the complexity of varied disciplines as well as job difficulty. Proposals offering total compensation levels less than currently being paid by the predecessor Contractor for the same work will be evaluated, in addition to the above, on the basis of maintaining program continuity, uninterrupted work of high quality, and availability of required competent professional employees. Offerors are cautioned that instances of lowered compensation for essentially the same professional work may be considered a lack of sound management judgment in addition to indicating a lack of understanding of the requirement.

    2. Cost (Professional Compensation)

      Proposals which are unrealistically low or do not reflect a reasonable relationship of compensation to the professional job categories so as to impair the Contractor's ability to recruit and retain competent professional employees, may be viewed as reflecting a failure to comprehend the complexity of the contract requirements. The Government is concerned with the quality and stability of the work force to be employed on this contract. The compensation data required will be used in evaluation of the offeror's understanding of the contract requirements.

    3. Other (Labor Relations)

      An assessment of the potential for adverse effect upon performance and maintenance of the required number of professional employees with requisite skills resulting from an unrealistically low compensation structure will also be made.

    4. Federal Acquisition Regulation Clauses incorporated by Reference 52.222-46, Evaluation of Compensation for Professional Employees (February 1993)


  13. PAST PERFORMANCE INFORMATION


    1. Offerors shall submit the following information as part of their business proposals (for both the offeror and proposed major subcontractors): A list of the contracts completed during the past three years and all contracts currently in progress for products or services similar to the solicitation workscope. Contracts listed may include those entered into with the Federal Government, agencies of state and local governments and commercial customers. Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Include the following information for each contract or subcontract:

      1. Name of Contracting Organization
      2. Contract Number (for subcontracts, provide the prime contract number and subcontract number)
      3. Contract Type
      4. Total Contract Value
      5. Description of Requirement
      6. Contracting Officer's Name and Telephone Number
      7. Project Officer's Name and Telephone Number


    2. Each offeror will be evaluated on their performance under existing and prior contracts for similar products or services. Performance information will be used for both responsibility determinations and as an evaluation factor against which offerors' relative rankings will be compared to assure the greatest value to the Government. The Government will focus on information that demonstrates quality of performance relative to the size and complexity of the acquisition under consideration. The Government is not required to contact all references provided by the offeror, 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 an offeror's past performance.


  14. FAR 32.215-16, FACILITIES CAPITAL COST OF MONEY (October 1997)

    (This is applicable if you are a commercial organization.)

    1. Facilities capital cost of money [see FAR 15.408(h)] will be an allowable cost under the contemplated contract, if the criteria for allowability in subparagraph 31.205-10(a)(2) of the Federal Acquisition Regulations are met. One of the allowability criteria requires the prospective Contractor to propose facilities capital cost of money in its offer.

    2. If the prospective Contractor does not propose this cost, the resulting contract will include the clause Waiver of Facilities Capital Cost of Money.

    (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.

  15. "JUST IN TIME"

    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 needed during the initial evaluation of proposals. Certain documents will not 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. Applicable items, if any, are identified in the appropriate section of each specific RFP.

    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 best and final offer.

    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 best and final offer.

    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 best and final offer.

    Subcontracting Plan. The offeror's Small, Small Disadvantaged, and Women-Owned Small Business Subcontracting Plan shall not be submitted with the initial business proposal. Only those offerors included in the competitive range will be required to submit an acceptable subcontracting plan.

    OR

    Subcontracting Plan. The offeror's Small, Small Disadvantaged, and Women-Owned 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 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.

  16. ALTERNATE II (OCTOBER 1997) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition (OCTOBER 1997) applies to this RFP.

    As perscribed in 15.209(a)(2), the following paragraph, (c)(9), is added to the basic FAR Clause 52.215-1:

    (C)(9) Offerors may submit proposals that depart from stated requirements. Such proposals shall clearly identify why the acceptance of the proposal would be advantageous to the Government. Any deviations from the terms and conditions of the solicitation, as well as the comparative advantage to the Government, shall be clearly identified and explicitly defined. The Government reserves the right to amend the solicitation to allow all offerors an opportunity to submit revised proposals based on the revised requirements.

  17. IT SYSTEMS SECURITY

    If this project involves IT, the proposal must present a detailed outline of its proposed IT systems security program which complies with the requirements of the Statement of Work, the Computer Security Act of 1987 Office of Management and Budget (OMB) Circular A-130, Appendix III, "Security of Federal Automated Information Systems," and the DHHS Automated Information Systems Security Program Handbook (Release 2.0, dated May, 1994). The proposal will also need to include similar information for any subcontract proposed.

    NOTE: OMB A-130 is accessible via web site: http://www.whitehouse.gov/WH/EOP/OMB/html/circular.html

  18. INCLUSION OF CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS

    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 scientific or ethical reasons not to include them. 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.

    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 exempt 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. In the technical proposal, the offeror should create a section titled "Participation of Children." This section 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. The RFP will contain a review criterion addressing the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification of exclusion.

    All investigators 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 may also obtain copies from the contact person listed in the RFP.



Top | RFP References

NIH Home | NIH RFP Directory Home | OCM Home


This page was last updated on April 04, 2000.