Last updated on 09/29/2003
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.
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.
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.
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.
As prescribed in
HHSAR 315.208, the following provision may be included in the solicitation:
Late Proposals and Revisions (Nov. 1986)
Notwithstanding the procedures contained in FAR 52.215-1(c)(3) of the provision of this solicitation entitled Instructions to Offerors-Competitive Acquisition, a proposal received after the date specified for receipt may be considered if it offers significant cost or technical advantages to the
Government; and it was received before proposals were distributed for evaluation, or within five calendar days after the exact time specified for receipt, whichever is earlier.
(End of provision)
Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (JANUARY 2001)
Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption Form (JAN 2003) (click here)
a) 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 of Protection from Research Risks (OPRR), National Institutes of Health (NIH), 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.
b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or 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.
c) 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.
d) 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 National Institutes of Health 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 consideration with OPRR*, (telephone: 301-496-7014*), is recommended.
e) 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.
f) It is recommended that OPRR* be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. (End of Provision)
*Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH) wherever it appears in this provision. The phone number to reach this office is 301-496-7005. For more information, the OHRP website may be accessed at http://ohrp.osophs.dhhs.gov/. Copies of the DHHS Regulations for the Protection of Human Subjects, 45 CFR Part 46, are also available on line at http://www.access.gpo.gov/nara/cfr/waisidx_01/45cfr46_01.html.
(10) Instructions to Offerors Regarding Protection of Human Subjects
Note: The requirements in this paragraph (10), may be supplemented when necessary, based on the specific requirements of the solicitation. Offerors must address the following human subjects protections issues if this contract will be for research involving human subjects (note: under each of the following points below, the offeror should indicate whether the information provided relates to the primary research site, or to a collaborating performance site(s), or to all sites:
(a) Risks to the subjects
Human Subjects Involvement and Characteristics:
- Describe the proposed involvement of human subjects in response to the solicitation.
- Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
- Identify the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special classes of subjects, such as fetuses, pregnant women, children, prisoners, institutionalized individuals, or others who are likely to be vulnerable populations.
Sources of Materials:
- Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data.
- Describe the potential risks to subjects (physical, psychological, social, legal, or other) and assess their likelihood and seriousness to the subjects.
- Describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures, to participants in the proposed research, where appropriate.
(b) Adequacy of Protection Against Risks
Recruitment and Informed Consent:
- Describe plans for the recruitment of subjects and the procedures for obtaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. The informed consent document for the contractor and any collaborating sites should be submitted only if requested elsewhere in the solicitation. Be aware that an IRB-approved informed consent document for the contractor and any participating collaborative sites must be provided to the Government prior to patient accrual or participant enrollment.
Protection Against Risk:
- Describe the procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.
- Discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects where appropriate.
- In studies that involve interventions, describe the provisions for data and safety monitoring of the research to ensure the safety of subjects.
(c) Potential Benefits of the Proposed Research to the Subjects and Others
- Discuss the potential benefits of the research to the subjects and others.
- Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.
- Describe treatments and procedures that are alternatives to those provided to the participants by the proposed research, where appropriate.
(d) Importance of the Knowledge to be Gained
- Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.
- Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that may reasonably be expected to result.
Note: If a test article (investigational new drug, device, or biologic) is involved, name the test article and state whether the 30-day interval between submission of offeror’s certification to the Food and Drug Administration (FDA) and its response has elapsed or has been waived and/or whether the FDA has withheld or restricted use of the test article.
When research involving human subjects will take place at collaborating site(s) or other performance site(s), the offeror must provide in this section of its proposal a list of the collaborating sites and their assurance numbers. Further, if you are awarded a contract, you must obtain in writing, and keep on file, an assurance from each site that the previous points have been adequately addressed at a level of attention that is at least as high as that documented at your organization. Site(s) added after an award is made must also adhere to the above requirements.
(11) Required Education in the Protection of Human Research Participants
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for contracts for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Offerors should review the policy announcement prior to submission of their offers. The following is a summary of the Policy Announcement:
For any solicitation for research involving human subjects, the offeror shall provide in its technical proposal the following information: (1) a list of the names of the principal investigator and any other individuals proposed under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program completed (or to be completed prior to the award of the contract) for each named personnel; (3) a one sentence description of the program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.
Curricula that are readily available and meet the educational requirement include the NIH on-line tutorial, titled "Protection of Human Research Subjects: Computer-Based Training for Researchers," available at http://ohsr.od.nih.gov/cbt/. You may download the information at this site at no cost and modify it, if desired. In addition, the University of Rochester has made its training program available for individual investigators. Completion of this program will also satisfy the educational requirement. The University of Rochester manual can be obtained through Centerwatch, Inc. at http://www.centerwatch.com/order/pubs_profs_protect.html. If an institution already has developed educational programs on the protection of research participants, completion of these programs also will satisfy the educational requirement.
In addition, prior to the substitution of the principal investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the contractor shall provide the contracting officer with the title of the education program and a one sentence description of the program that the replacement has completed.
It is NIH policy that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The Director, NIH, may determine that exclusion under other circumstances is acceptable, upon the recommendation of an Institute/Center Director, based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43), and applies to research subjects of all ages.
All investigators proposing research involving human subjects should read the UPDATED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 at the following web site: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm . These guidelines contain a definition of clinical research adopted in June 2001, as: "(1) Patientoriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research" (http://www.nih.gov/news/crp/97report/execsum.htm).
Information Required for ALL Clinical Research Proposals
This solicitation contains a review criterion addressing the adequacy of: (1) the offeror’s plans for inclusion of women and minorities in the research proposed; or (2) the offeror’s justification(s) for exclusion of one or both groups from the research proposed.
Provide information on the composition of the proposed study population in terms of sex/gender and racial/ethnic groups and provide a rationale for selection of such subjects in response to the requirements of the solicitation. The description may include (but is not limited to) information on the population characteristics of the disease or condition being studied in the planned research, and/or described in the statement of work, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned research.
The proposal must include the following information:
- A description of the subject selection criteria
- The proposed dates of enrollment (beginning and end)
- A description of the proposed outreach programs for recruiting women and minorities as subjects
- A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group
- The proposed sample composition using the "Targeted/Planned Enrollment Table" (see Section J, Attachments)
NOTE 1: For all proposals, use the ethnic and racial categories and complete the "Targeted/Planned Enrollment Table in accordance with the Office of Management and Budget (OMB) Directive No. 15, which may be found at: http://www.whitehouse.gov/OMB/fedreg/ombdir15.html.
NOTE 2: If this is an Indefinite Delivery, Indefinite Quantity (IDIQ) or Requirements contract as defined in FAR 16.5, the proposal should describe in general terms how it will comply with each bulleted item above for each task order. When the Government issues a task order request for proposal, each of the bulleted information items must be fully and specifically addressed in the proposal.
Standards for Collecting Data. When you, as a contractor, are planning data collection items on race and ethnicity, you shall use, at a minimum, the categories identified in OMB Directive No. 15. The collection of greater detail is encouraged. However, you should design any additional, more detailed items so that they can be aggregated into these required categories. Self-reporting or self-identification using two separate questions is the preferred method for collecting data on race and ethnicity. When you collect race and ethnicity separately, you must collect ethnicity first. You shall offer respondents the option of selecting one or more racial designations. When you collect data on race and ethnicity separately, you shall also make provisions to report the number of respondents in each racial category who are Hispanic or Latino. When you present aggregate data, you shall provide the number of respondents who selected only one category, for each of the five racial categories. If you collapse data on multiple responses, you shall make available, at a minimum, the total number of respondents reporting "more than one race." Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.
In addition to the above requirements, solicitations for NIH defined Phase III clinical trials1 require that: a) all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect (see NIH Guide: http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm , Definitions - Significant Difference), by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable; and b) all contractors to report annually cumulative subject accrual, and progress in conducting analyses for sex/gender and race/ethnicity differences.
Offerors may obtain copies of the Updated Guidelines from the sources above or from the contact person listed in the solicitation.
Also, the proposal must include one of the following plans:
- Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR
- Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups, OR
- Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups. Use the form in Section J, Attachments, entitled, "Targeted/Planned Enrollment Table," when preparing your response to the solicitation requirements for inclusion of women and minorities. Unless otherwise specified in this solicitation, the Government has determined that the work required by this solicitation does not involve a sex/gender specific study or a single or limited number of minority population groups. Therefore, the NIH believes that the inclusion of women and minority populations is appropriate for this project. (See Section M of this RFP for more information about evaluation factors for award.) Use the format for the Annual Technical Progress Report for Clinical Research Study Populations (See Section J - List of Documents, Exhibits and Other Attachments of the RFP) entitled, "Inclusion Enrollment Report," for reporting in the resultant contract. See NIH Guide http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm , for the Definition of an "NIH-Defined Phase III clinical trial.
It is NIH policy that children (defined below) must be included in all human subjects research, including, but not limited to, clinical trials, conducted under a contract funded by the NIH, unless there are clear and compelling reasons not to include them. (See examples of Justifications for Exclusion of Children below). For the purposes of this policy, contracts involving human subjects include categories that would otherwise be exempt from the DHHS Policy for Protection of Human Research Subjects (sections 101(b) and 401(b) of 45 CFR 46), such as surveys, evaluation of educational interventions, and studies of existing data or specimens that should include children as participants. This policy applies to both domestic and foreign research contracts.
For purposes of this policy, a child is defined as an individual under the age of 21 years. All offerors proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" which was published in the NIH Guide for Grants and Contracts on March 6, 1998 and is available at the following URL address:
Offerors also may obtain copies from the contact person listed in the RFP. Inclusion of children as participants in research must be in compliance with all applicable subparts of 45 CFR 46 as well as other pertinent laws and regulations whether or not such research is otherwise exempted from 45 CFR 46. Therefore, any proposals must include a description of plans for including children, unless the offeror presents clear and convincing justification for an exclusion.
The "Human Subjects" section of your technical proposal should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. This solicitation contains a review criterion addressing the adequacy of: (1) the plans for including children as appropriate for the scientific goals of the research; and/or (2) the justification of exclusion of children or exclusion of a specific age range of children. When children are included, the plan also must include a description of: (1) the expertise of the investigative team for dealing with children at the ages included; (2) the appropriateness of the available facilities to accommodate the children; and, (3) the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose/objective of the solicitation.
Justifications for Exclusion of Children
It is expected that children will be included in all research involving human subjects unless one or more of the following exclusionary circumstances can be fully justified:
- The objective of the solicitation is not relevant to children.
- There are laws or regulations barring the inclusion of children in the research to be conducted under the solicitation.
- The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be redundant. You should provide documentation of other studies justifying the exclusion.
- A separate, age-specific study in children is warranted and preferable. Examples include:
- The relative rarity of the condition in children, as compared with adults (in that extraordinary effort would be needed to include children); or
- The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; or
- Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages of different age-related metabolic processes); or
- Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). While children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis; or
- Study designs aimed at collecting additional data on pre-enrolled adult study subjects (e.g., longitudinal follow-up studies that did not include data on children);
- Other special cases justified by the offeror and found acceptable to the review group and the Institute Director
Definition of a Child
For the purpose of this solicitation, a child is defined as an individual under the age of 21 years. The definition of child described above will pertain to this solicitation (notwithstanding the FDA definition of a child as an individual from infancy to 16 years of age, and varying definitions employed by some states). Generally, State laws define what constitutes a "child," and such definitions dictate whether or not a person can legally consent to participate in a research study. However, State laws vary, and many do not address when a child can consent to participate in research. Federal Regulations (45 CFR 46, subpart D, Sec.401-409) address DHHS protections for children who participate in research, and rely on State definitions of "child" for consent purposes. Consequently, the children included in this policy (persons under the age of 21) may differ in the age at which their own consent is required and sufficient to participate in research under State law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
Note: The following language may be modified to incorporate an IC's alternate and comparable approach to expressing the NIH policy regarding Data and Safety Monitoring in Clinical Trials.
All offerors are directed to the full text of the NIH Policies regarding Data and Safety Monitoring and Reporting of Adverse Events that are found in the NIH Guide for Grants and Contracts Announcements at the following web sites:
All offerors receiving an award under this solicitation must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this solicitation.
The following is a brief summary of the Data and Safety Monitoring and Adverse Event Reporting Requirements:
Data and Safety Monitoring is required for every clinical trial. Monitoring must be performed on a regular basis and the conclusions of the monitoring reported to the Project Officer. The type of data and safety monitoring required will vary based on the type of clinical trial and the potential risks, complexity and nature of the trial. A plan for data and safety monitoring is required for all clinical trials. A general description of a monitoring plan establishes the overall framework for data and safety monitoring. It should describe the entity that will be responsible for the monitoring, and the policies and procedures for adverse event reporting. Phase III clinical trials generally require the establishment of a Data Safety Monitoring Board (DSMB). The establishment of a DSMB is optional for Phase I and Phase II clinical trials.
The DSMB/Plan is established at the time the protocol is developed and must be approved by both the Institutional Review Board (IRB) and the Government and in place before the trial begins. If the protocol will be developed under the contract awarded from this solicitation, a general description of the data and safety monitoring plan must be submitted as part of the proposal and will be reviewed by the scientific review group (Technical Evaluation Panel, (TEP)) convened to evaluate the proposal. If the protocol is developed and is included as part of the submitted proposal, a complete and specific data and safety monitoring plan must be submitted as part of the proposal.
Monitoring Plans, at a minimum, must include the prompt reporting of adverse events to the IRB, the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA). Also, in the plan you should describe the frequency of reporting of the conclusions of the monitoring activities. The overall elements of each plan may vary depending on the size and complexity of the trial. The NIH Policy for Data and Safety Monitoring at http://grants.nih.gov/grants/guide/noticefiles/ not98-084.html describes examples of monitoring activities to be considered.
The frequency of monitoring will depend upon potential risks, complexity, and the nature of the trial; therefore a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a:
- Principal Investigator (required)
- Independent individual /Safety Officer
- Designated medical monitor
- Internal Committee or Board with explicit guidelines
- Data and Safety Monitoring Board (DSMB - required for multisite trials)
- Institutional Review Board (IRB - required)
For multi-site Phase I and Phase II trials, a central reporting entity that will be responsible for preparing timely summary reports of adverse events for distribution among sites and IRBs should be considered.
Organizations with a large number of clinical trials may develop standard monitoring plans for Phase I and Phase II trials. In this case, such organizations may include the IRB-approved monitoring plan as part of the proposal submission.
Item 26: The following item is applicable when animals will be involved in the RFP.
1. The following notice is applicable when contract performance is expected to involve 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 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 of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), 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 OER. 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 OER, OLAW negotiate an acceptable Animal Welfare Assurance with those Contractor(s). For further information, OER, OLAW, may be contacted at Rockledge Center I - Suite 1050, 6705 Rockledge Drive, Bethesda, MD 20817, (301) 496-7163, ext 234. FAX copies are of the PHS Policy are available at (301) 402-2803.
This policy is also available on the internet at http://www.grants.nih.gov/grants/olaw/olaw.htm .
2. If an Animal Assurance is already in place, the offeror's proposal shall include:
-The Animal Welfare Assurance number.
-The date last certified by OLAW. (i.e. assurance letter from OLAW)
-Evidence of recent AAALAC Accreditation.
Item 27: This item is applicable to all Research and Development RFPs.
As a public sponsor of biomedical research, the National Institutes of Health (NIH) has a dual interest in accelerating scientific discovery and facilitating product development. Intellectual property restrictions can stifle the broad dissemination of new discoveries and limit future avenues of research and product development. At the same time, reasonable restrictions on the dissemination of research tools are sometimes necessary to protect legitimate proprietary interests and to preserve incentives for commercial development. To assist NIH contractors achieve an appropriate balance, the NIH has provided guidance in the form of a two-part document, consisting of Principles setting forth the fundamental concepts and Guidelines that provide specific information to patent and license professionals and sponsored research administrators for implementation.
The purpose of these Principles and Guidelines is to assist NIH funding recipients in determining:
1) Reasonable terms and conditions for making NIH-funded research resources available to scientists in other institutions in the public and private sectors (disseminating research tools); and
2) restrictions to accept as a conditions of receiving access to research tools for use in NIH-funded research (acquiring research tools). The intent is to help recipients ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy. This policy, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090] will be included in any contract awarded from this solicitation. It can be found at the following website: http://ott.od.nih.gov/NewPages/64FR72090.pdf .
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:
4. Each plan must contain the following:
For additional information about each of the above elements required to be contained
the subcontracting plan, see FAR Clause 52.219-9 (JAN 2002), Small Business Subcontracting
Plan, and the Sample Subcontracting Plan which is included in the FORMS,
FORMATS AND ATTACHMENTS.
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.
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.
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.
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.
(This is applicable if you are a commercial organization.)
(End of Provision)
If the offeror elects to claim this cost, the offeror shall specifically identify or
propose it in the cost proposal for the contract by checking the appropriate box below.
___ The prospective Contractor has specifically identified or proposed facilities
capital cost of money in its cost proposal and elects to claim this cost as an allowable
cost under the contract. Submit Form CASB-CMF (see FAR 31.205-10).
___ The prospective Contractor has not specifically identified or proposed facilities
capital cost of money in its proposal and elects not to claim it as an allowable cost
under the contract.
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
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.
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
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.
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.
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
NOTE: OMB A-130 is accessible via web site: http://www.whitehouse.gov/omb/circulars/index.html
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
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:
Offerors may also obtain copies from the contact person listed in the RFP.
PROCUREMENT OF ELECTRONIC AND INFORMATION TECHNOLOGY (EIT)
Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by P.L.105-220 under Title IV (Rehabilitation Act Amendments of 1998) and the Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards (36 CFR part 1194) require that all EIT acquired by the Government must ensure that:
1. Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities; and
2. Members of the public with disabilities seeking information or services from an agency have access to and use of information and data that is comparable to the access to and use of information and data by members of the public who are not individuals with disabilities.
This requirement includes the development, procurement, maintenance, and/or use of EIT products/services, therefore, any proposal submitted in response to this solicitation must demonstrate compliance with the established EIT Accessibility Standards. Further information about Section 508 is available via the Internet at http://508.nih.gov/ or http://www.section508.gov .
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