[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6894-6895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0031]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Substances Generally Recognized as Safe: Notification 
Procedure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the Notification Procedure for Substances Generally 
Recognized as Safe.

DATES: Submit written or electronic comments on the collection of 
information by April 13, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Substances Generally Recognized as Safe: Notification Procedure--21 CFR 
170.36 and 570.36 (OMB Control Number 0910-0342)--Extension

    Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 348) establishes a premarket approval requirement for ``food 
additives;'' section 201(s) of the act (21 U.S.C. 321) provides an 
exemption from the definition of ``food additive'' and thus from the 
premarket approval requirement, for uses of substances that are 
Generally Recognized as Safe (GRAS) by qualified experts. In April 
1997, FDA proposed a voluntary procedure whereby manufacturers would 
notify FDA about a view that a particular use (or uses) of a substance 
is not subject to the statutory premarket approval requirements based 
on a determination that such use is GRAS (62 FR 18938, April 17, 1997). 
Proposed Sec. Sec.  170.36 and 570.36 provide a standard format for the 
voluntary submission of a notice. The notice would include a detailed 
summary of the data and information that support the GRAS 
determination, and the notifier would maintain a record of such data 
and information. FDA would make the information describing the subject 
of the GRAS notice, and the agency's response to the notice, available 
in a publicly accessible file; the entire GRAS notice would be publicly 
available consistent with the Freedom of Information Act and other 
Federal disclosure statutes.
    Description of Respondents: Manufacturers of Substances Used in 
Food and Feed.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 6895]]



                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                           No. of        Annual Frequency  per      Total Annual        Hours Per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
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170.36                                                              25                        1                 25                150              3,750
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570.36                                                               5                        1                  5                150                750
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Total                                                .................  .......................  .................  .................              4,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    Table 2--Estimated Annual Recordkeeping Burden\1\
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                                                           No. of        Annual Frequency  per      Total Annual
                   21 CFR Section                      Recordkeepers         Recordkeeping            Records       Hours Per  Record     Total Hours
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170.36(c)(v)                                                        25                        1                 25                 15                375
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570.36(c)(v)                                                         5                        1                  5                 15                 75
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Total                                                .................  .......................  .................  .................                450
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the proposed rule, FDA estimated that the Center for Food Safety 
and Applied Nutrition (CFSAN) would receive approximately 50 GRAS 
notices per year and that the Center for Veterinary Medicine (CVM) 
would receive approximately 10 GRAS notices per year. Although FDA 
requested comment on this estimate, the comments did not provide useful 
information regarding this issue. Therefore, FDA evaluated the number 
of notices received by CFSAN to date. CFSAN received 274 GRAS notices 
during the 11-year period from 1998 through 2008, for an average of 
approximately 25 GRAS notices per year. Based on this experience, FDA 
is revising its estimate of the annual number of GRAS notices submitted 
to CFSAN to be 25 or less. FDA also is revising its estimate of the 
annual number of GRAS notices submitted to CVM to be 5 or less.

    Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2861 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S