The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of Offers remains unchanged: March 20, 2001 at 3:00 p.m. EST. 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 Sharon A. Miller)
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. Proposals submitted in response to this Announcement shall not require any cost information or cost-related information. No "technical cost proposal" or "business proposal" shall be submitted. All references in the subject Master Agreement Announcement to cost information is hereby deleted.
2. Section J, List of Attachments, the requirement for submission of "Summary of Related Activities" is hereby deleted.
3. Section K, Representations, Certifications, and Other Statements of Offerors, the requirement for submission of the Representations and Certifications is hereby deleted.
4. SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS,subparagraph (10) Human Subjects is deleted and replaced as follows:
(10) Protection of Human Subjects from Research Risks
It is anticipated that research projects associated with this Master Agreement will involve human subjects. The offeror's proposal must address the involvement of human subjects and protections from research risk relating to their participation, or provide sufficient information on the research subjects to allow a determination by NCI that a designated exemption is appropriate.
For subsequent Master Agreement Orders (MAOs), if concerns are identified and you are included in the competitive range, you will be afforded the opportunity to further discuss and/or clarify your position during discussions and in your Final Proposal Revision (FPR). If, after discussions, concerns still exist, your proposal may not be considered further for award.
5. SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS, (14) Inclusion of Women and Minorities in Research Involving Human Subjects, and (15) Inclusion of Children in Research Involving Human Subjects, are deleted and replaced as reflected below. Additional information is located on NIH websites: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html for women and minorities and http://grants.nih.gov/grants/guide/notice-files/not98-024.html for children.
(14) Inclusion of Women and Minorities In Research Involving Human Subjects
Women and members of minority groups and their subpopulations must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. In addition, for Phase III clinical trials, it is required that all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, unless the Government has specified in the Statement of Work that this solicitation involves a sex/gender specific study or a single or limited number of minority population groups.
Where the offeror determines that inclusion of women and minority populations is not feasible, a detailed rationale and justification for exclusion of one or both groups from the study population must be submitted with the technical proposal. The NCI will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research.
If the rationale is not considered acceptable by the Government and you are included in the competitive range for subsequent Master Agreement Orders(MAOs), you will be afforded the opportunity to further discuss, clarify, or modify your plan for inclusion in your Final Proposal Revision (FPR). If your exclusion position is still considered unacceptable by the Government after discussions, your proposal may not be considered further for award.
(15) Inclusion of Children in Research Involving Human Subjects
Children (i.e. individuals under the age of 21) must be included in all human subject research unless there are scientific and ethical reasons not to include them.
The offeror's proposal must include a description of plans for including children. If children will be excluded from the research, the proposal must present an acceptable justification for the exclusion. If the offeror determines that exclusion of a specific age range of child is appropriate, the proposal must also address the rationale for such exclusion.
If the information about the inclusion of children is absent or considered inadequate and you are included in the competitive range for subsequent Master Agreement Orders (MAOs), you will be afforded the opportunity to further discuss, clarify or modify your plan for inclusion in your Final Proposal Revision (FPR). If your exclusion position is still considered unacceptable by the Government after discussions, your proposal may not be considered further for award.
6. PART I - THE SCHEDULE (Sample Master Agreement Order provisions), SECTION H, ARTICLE H.2. HUMAN SUBJECTS is hereby deleted due to recent changes in NIH policy concerning protection of human subjects. Any Master Agreement Orders which contain human subjects will include the appropriate provisions current at the time of the Master Agreement Order award.