[Federal Register Volume 70, Number 235 (Thursday, December 8, 2005)]
[Notices]
[Pages 73009-73010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0457]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Notice of a Claim for Generally Recognized as Safe 
Exemption Based on a Generally Recognized as Safe Determination

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 procedures used for 
submitting a Generally Recognized as Safe (GRAS) notice stating that a 
particular use of a substance is not subject to the premarket approval 
requirements of the Federal Food, Drug, and Cosmetic Act (the act).

DATES: Submit written or electronic comments on the collection of 
information by February 6, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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.

Notice of a Claim for GRAS Exemption Based on a GRAS Determination--21 
CFR 170.36 and 570.36 (OMB Control Number 0910-0342)--Extension

    Section 409 of 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(s)) provides an exemption from the definition of ``food 
additive'' and thus from the premarket approval requirement, for uses 
of substances that are GRAS by qualified experts. FDA is proposing a 
voluntary procedure whereby members of the food industry who determine 
that use of a substance satisfies the statutory exemption may notify 
FDA of that determination. 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 GRAS claim, 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.

[[Page 73010]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     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                                                         50                      1                     50              150                  7,500
570.36                                                         10                      1                     10              150                  1,500
Total                                              ...............  .....................  .....................  ...............                 9,000
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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                            Hours per
                  21 CFR Section                    Recordkeepers       Recordkeeping       Total Annual Records    Recordkeeper        Total Hours
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170.36(c)(v)                                                   50                      1                     50               15                    750
570.36(c)(v)                                                   10                      1                     10               15                    150
Total                                              ...............  .....................  .....................  ...............                   900
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting requirement is for a proposed rule that has not yet 
been issued as a final rule. In developing the proposed rule, FDA 
solicited input from representatives of the food industry on the 
reporting requirements, but could not fully discuss with those 
representatives the details of the proposed notification procedure. FDA 
received no comments on the agency's estimate of the hourly reporting 
requirements, and thus has no basis to revise that estimate at this 
time. In 1998, FDA began receiving notices that were submitted under 
the terms of the proposed rule. Since it began receiving notices, FDA 
has received 12 in 1998, 23 in 1999, 30 in 2000, 28 in 2001, 26 in 
2002, 23 in 2003, 20 in 2004, and 22 to date in 2005, notices annually. 
To date, the number of annual notices is less than FDA's estimate; 
however, the number of annual notices could increase when the proposed 
rule becomes final. FDA received 23 notices in 1999, 30 notices in 
2000, 28 notices in 2001, 26 notices in 2002, 23 notices in 2003, and 
20 notices in 2004.

    Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23747 Filed 12-7-05; 8:45 am]
BILLING CODE 4160-01-S