[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43204-43205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-12230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information (RFI): Change in Grant Appendix Materials

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) and the Agency for 
Healthcare Research and Quality (AHRQ) are evaluating guidelines for 
grant application appendixes in an effort to streamline the application 
and review processes. This RFI requests input from interested 
applicants, reviewers and other members of the research community 
regarding the way appendix materials should be used in the grant 
submission, review and management process. Comments will be considered 
in the development of new policies on appendix materials for various 
grant programs.

DATES: Reponses must be received by September 14, 2006 in order to 
ensure that NIH and AHRQ will be able to consider the comments in 
developing new policies on appendix materials for various grant 
programs.

FOR FURTHER INFORMATION CONTACT: E-mail inquiries will be accepted at 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The goal of changing the guidelines for grant application appendix 
materials is to encourage applications to be as concise as possible 
while containing the information needed for expert scientific review. 
These changes should make application preparation and handling easier 
for both applicants and reviewers.
    Current NIH and AHRQ policy indicates that the Appendix may not be 
used to circumvent the page limitations of the Research Plan. Appended 
publications may not be used to provide further details of 
methodologies or preliminary data described in the Research Plan. All 
applications and proposals for NIH and AHRQ funding must be self-
contained. NIH application guide instructions note that the Appendix is 
sent only to those members of the Scientific Review Group (SRG) 
assigned as primary reviewers of the application. Currently, unless 
otherwise stated in the solicitation, the following materials may be 
included in a grant application Appendix:
     Up to 10 publications or manuscripts accepted for 
publication, using URL links to publicly accessible journal articles.
     Surveys, questionnaires, data collection instruments, 
clinical protocols, and informed consent documents.
     Photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included 
within the 25-page limit of Items a-d of the research plan. No 
photographs or color images may be included in the Appendix that are 
not also represented within the Research Plan.
    Investigators spend much time and energy developing applications to 
Federal Agencies. It is unclear whether appendix material which may or 
may not be read by members of the SRG improves current applications. 
Submission of unnecessary materials with grant applications wastes the 
time, energy and resources of investigators, applicant institutions, 
reviewers, and the NIH and AHRQ.

Proposed Changes

    The following changes are being considered for implementation 
concurrent with NIH/AHRQ's transition to the electronic grant 
application process and the SF-424 (R&R):
     Submission of photographs or color images of gels, 
micrographs, etc., will not be allowed in the Appendix. Use of the SF-
424 (R&R) electronic grant application will permit insertion into the 
body of the Research Plan high resolution images of the same quality 
found in scientific publications.
     Materials currently submitted in the Appendix which are 
essential to the review of the application will be submitted as part of 
the grant application itself. For example, documents such as clinical 
protocols, informed consent forms, key questionnaires, surveys, and 
similar items which are needed by the SRG to adequately assess human 
subjects issues will be submitted as part of the 'Protection of Human 
Subjects' section of the grant application.
     Reprints or preprints of publications or their PDFs will 
no longer be allowed as part of the Appendix. Links (URLs) to PubMed 
Central or publicly available on-line journals will be permitted in the 
Biographical Sketches, Bibliography & References Cited, and the 
Research Plan sections of the grant application. Critical information 
and detail should be included within the Research Plan and cited in the 
Bibliography & References Cited section and/or figure or table 
legend(s) to indicate publication status.
     Materials specifically designated in the Funding 
Opportunity Announcement may be included in the Appendix, within 
identified page limits. It is anticipated that most FOAs will not 
permit materials to be included in the Appendix.
     All members of the SRG will receive copies of the full 
application including any permitted Appendix materials thereby 
increasing the equity of the review.

Information Requested

    Information in the following areas will assist the NIH and AHRQ in 
developing new policies regarding submission of appendix materials. 
Respondents will be asked to indicate what perspective(s) they 
represent, i.e. reviewer and/or applicant, institutional official, etc.
    1. Is there a need to reduce the material submitted in the 
Appendix? If yes, please provide specific types of material that could 
be eliminated.
    2. Is there information essential to the application's review that 
cannot be included in the body of a grant application as proposed? If 
yes, please describe the material and identify applicable grant 
program(s).

[[Page 43205]]

    3. Is it necessary to include reprint and preprint PDFs as appendix 
material? If yes, please explain.
    4. Do you have concerns about discontinuing the submission of 
photographs or color images in the Appendix of electronic grant 
applications? If yes, please explain.
    5. Will the proposed changes favor or disfavor any specific group 
of investigators? If yes, please explain.

Responses

    Responses must be submitted electronically at http://grants.nih.gov/grants/guide/rfi_files/rfi_appendix_add.htm. The 
responses for each item should be limited to 500 words. Acknowledgement 
of receipt of responses will not be made, nor will respondents be 
notified of the Government's assessment of the information received. No 
basis for claims against the Government shall arise as a result of a 
response to this request for information or the Government's use of 
such information as either part of our evaluation process or in 
developing specifications for any subsequent announcement. Individual 
responses will be confidential. Any proprietary information should be 
so marked.

    Dated: July 24, 2006.
Norka Ruiz Bravo,
Deputy Director for Extramural Research, National Institutes of Health.
 [FR Doc. E6-12230 Filed 7-28-06; 8:45 am]
BILLING CODE 4140-01-P