[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Notices]
[Pages 42427-42428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20851]



[[Page 42427]]

Food and Drug Administration
[Docket No. 96N-0225]


Submission Requirements for All Grant and/or Cooperative 
Agreement Applications Submitted to the Food and Drug Administration 
for Funding Consideration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing changes 
to its grant and/or cooperative agreement noncompeting continuation 
application submission requirements for fiscal year (FY) 1997. The 
Streamlined Noncompeting Award Process (SNAP) was originally 
implemented by the National Institutes of Health (NIH) in FY 1994, in 
an effort to simplify the process for submission of information 
necessary for grantees to receive a noncompeting grant award. By 
incorporating SNAP into FDA's processes, effective in FY 1997, FDA will 
be consistent with NIH requirements for the submission and processing 
of noncompeting continuations.

FOR FURTHER INFORMATION CONTACT: Robert L. Robins, Grants Management 
Officer, Food and Drug Administration (HFA-520), Park Bldg., rm. 3-40, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-6170.

SUPPLEMENTARY INFORMATION:

I. Eligibility

    All grantees covered by the Expanded Authorities are eligible for 
SNAP. Any grantee excluded from the Expanded Authorities, e.g., those 
grantees designated as ``Exceptional'' and foreign grantees, would 
routinely be excluded from SNAP. Additional examples of grantees that 
would be excluded from SNAP include (but are not limited to) the 
following: (1) Grantees that require close project monitoring or 
technical assistance (e.g., first time grantees); (2) grantees that 
have a consistent pattern of failure to adhere to appropriate reporting 
deadlines; and (3) any activity that is excluded from SNAP at the 
discretion of the awarding agency. Applicants applying for FDA's Small 
Scientific Conference Grant Program or those applying for cooperative 
agreements are not eligible for SNAP regardless of whether or not they 
are covered by the Expanded Authorities authorized under other grant 
programs.

II. Snap Procedures

    For a new competitive application received in FY 1997, the 
applicant must address all years of funding support requested in the 
Scope of Work or Research Plan, and provide sufficient information 
needed for evaluation of the entire project, independent of any other 
documentation. As the funding for the project will be negotiated for 
all years at the time of the initial competitive segment, the budgets 
for all years of requested support must be fully justified.
    New grantees who receive competitive awards in FY 1997, for which 
there is a noncompetitive segment, will be required to use the SNAP for 
future years of support utilizing the instructions listed below in 
conjunction with the instructions in the PHS 2590 (Rev. 5/95) 
application kit. Elements in the PHS 2590 that remain the same, e.g., a 
biographical sketch page for new key personnel and when additional 
information is required, should use the appropriate pages from the PHS 
2590 application.
    Instructions:
    1. Complete the face page (form page 1), the Progress Report 
Summary (form page 6), the personnel and study subjects page (form page 
7), the checklist page (form page 8), and provide a brief, two page 
progress report (tables and/or figures that summarize key 
accomplishments may be in addition to the two pages). It is not 
necessary to complete the indirect cost portion of the checklist page 
unless there is a change in the performance site.
    2. Answers to the following questions should be inserted before the 
progress report:
    a. Has there been a change in other support of key personnel since 
the last reporting period? Specific information is to be provided only 
if active support has changed. If a previously active grant has 
terminated and/or if a previously pending grant is now active, the 
change in support is to be reported. Submission of other support 
information is not necessary if support is pending or for changes in 
the level of effort for active support reported previously. Other 
support information should be submitted only for the principal 
investigator and for those individuals who are considered by the 
principal investigator to be key to the project. A key person is 
defined as an individual who contributes in a substantive way to the 
scientific development or execution of the project, whether or not a 
salary is requested. Key personnel are defined on page 11 of the PHS 
398 grant application kit (Rev. 5/95).
    b. Will there be, in the next budget period, significant 
rebudgeting of funds and/or changes in level of effort for key 
personnel from what was approved in the current year's budget for this 
project? Significant rebudgeting occurs when expenditures in a single 
direct cost budget category deviate (increase or decrease) from the 
categorical commitment level established at the time of the competing 
award by more than 25 percent of the total amount awarded, or $250,000, 
whichever is less. The basis for determining significant rebudgeting 
excludes the effects of carryover of prior year unobligated balances, 
but includes competing or administrative supplements. This 
implementation redefines significant rebudgeting contained in the 
current PHS Grants Policy Statement (Rev. 4/1/91), pages 8-1 and 8-7.
    c. Will there be, in the next budget period, a change in the level 
of effort for key personnel? A significant change in the level of 
effort is defined in the Federal regulations (45 CFR 74.25(c)(3)) as a 
25 percent reduction in time/effort devoted to the project. For 
example, if a key person on the project is expected to reduce his/her 
effort from 40 percent to 30 percent, which represents a 25 percent 
reduction in the level of effort, the detailed budget page (form page 
2) and the budget justification page (form page 3) are to be submitted 
in the noncompeting continuation. This requirement applies regardless 
of whether or not the key person is compensated from the grant.
    3. Explain any estimated unobligated balance (including prior year 
carryover) that is greater than 25 percent of the current year's total 
budget or more than $250,000. An estimated unobligated balance that 
meets this criterion is to be reported on the Progress Report Summary 
page (form page 5). An explanation of why there is a significant 
balance and how it will be spent if carried forward into the next 
budget period is to be provided.
    The questions regarding other support and significant rebudgeting 
and/or change in level of effort must be answered by stating that no 
change has occurred or is planned. If a change has occurred or is 
planned, the appropriate form and/or justification is to be submitted 
in the noncompeting continuation application. Information regarding 
unobligated balances must be provided when it is anticipated that there 
will be an unobligated balance (including prior year carryover) of 25 
percent of the current year's total budget, or more than $250,000.
    The Progress Report Summary (form page 5) is to be used to provide 
the requested information, which should be provided before beginning 
the progress report. The progress report instructions

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contained on pages 7 through 9 of the PHS 2590 (Rev. 5/95) form should 
be followed for reporting on research progress. Supplemental reporting 
instructions may be required depending on different FDA grant program 
requirements. After reviewing the noncompeting continuation 
application, the FDA program and/or grants management staff may require 
additional information to evaluate the project for continued funding. 
Failure to provide this information in a timely manner may result in a 
delayed award.
    FDA grants are funded under the legislative authority of section 
301 of the Public Health Service Act (24 U.S.C. 241).

    Dated: August 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-20851 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F