The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of Offers remains unchanged: March 20, 2002, 3:00 p.m. Eastern Standard Time. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by one of the following methods:
1. By requesting a copy of the Standard Form 30 for this amendment and completing the information requested in items 8 and 15, and returning 1 copy of the amendment; (a hard copy of this amendment, including the Standard Form 30 may be requested from Kim L. Hall)
2. By acknowledging receipt of this amendment on each copy of the offer submitted; or
3. By separate letter, telegram, or Electronic Mail which includes a reference to the solicitation and amendment numbers.
FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.
This amendment revises the RFP as stated below.
1. The proposal submission address is changed in Attachment #5, Packaging and Delivery of Proposal, to the following:
TECHNICAL PROPOSAL ONLY
ORIGINAL AND 3 COPIES TO:
If hand-delivered or delivery service |
If using U.S. Postal Service |
Kim L. Hall |
Kim L. Hall |
Contract Specialist |
Contract Specialist |
Research Contracts Branch |
Research Contracts Branch |
National Cancer Institute |
National Cancer Institute |
Executive Plaza North, Room 313 |
Executive Plaza North, Room 313 |
6130 Executive Boulevard |
6130 Executive Boulevard MSC 7224 |
Rockville, Maryland 20852 |
Bethesda, Maryland 20892-7224 |
The 15 COPIES to the Special Review Referral and Resources Branch remains the same.
2. SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS, Subparagraph (10) Human Subjects is deleted and replaced as follows:
(10) Human Subjects
The following notice is applicable when contract performance is expected to involve risk to human subjects:
Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (JANUARY 2001)
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 for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS). 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 OHRP, (telephone: 301-496-7005), is recommended.
e) In accordance with 45 CFR, Part 46, prospective Contractors being considered for award shall be required to file with OHRP 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 OHRP and given detailed instructions for establishing an institutional review board and filing an Assurance ofCompliance.
f) It is recommended that OHRP be consulted for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects. (End of Clause) For more information, the OHRP website may be accessed at http://ohrp.osophs.dhhs.gov/
3. SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS, Subparagraphs (21) Required Education in the Protection of Human Research Participants, and (22) Obtaining and Disseminating Biomedical Research Resources, are hereby incorporated and reads as follows:
(21) 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/. This site may be downloaded at no cost and modified for use by the offeror, if desired. In addition, the University of Rochester has made available its training program for individual investigators, and 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 has already developed educational programs on the protection of research participants, completion of these programs will also 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 following written information to the contracting officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.
(22) Obtaining and Disseminating Biomedical Research Resources
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 andsponsored 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