Document ID: FDA-2012-N-0021-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Generally Recognized as Safe:
Notification Procedure
Posted Date: 2015-09-17T04:00Z

[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55857-55859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0021]

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 or we) 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 (GRAS).

DATES: Submit either electronic or written comments on the collection 
of information by November 16, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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

[[Page 55858]]

requirement, we are publishing this notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
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 our 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 (FD&C Act) 
(21 U.S.C. 348) establishes a premarket approval requirement for ``food 
additives''; section 201(s) of the FD&C Act (21 U.S.C. 321(s)) provides 
an exclusion to the definition of ``food additive'' and thus from the 
premarket approval requirement, for uses of substances that are GRAS by 
qualified experts. In the Federal Register of April 17, 1997 (62 FR 
18938), we published a proposed rule that would establish a voluntary 
procedure whereby manufacturers would notify us about a view of 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. Under an interim policy announced in the proposed rule, we 
invited manufacturers to submit notices of their independent 
determinations for review under the framework of the proposed rule 
during the period between issuance of the proposal and any final rule 
based on the proposal. The proposed regulations (proposed 21 CFR 170.36 
and 21 CFR 570.36) provide a standard format for the voluntary 
submission of a notice.
    To assist respondents in submissions to our Center for Food Safety 
and Applied Nutrition (CFSAN), we developed Form FDA 3667 entitled 
``Generally Recognized as Safe Notice.'' The form, and elements 
prepared as attachments to the form, may be submitted in electronic 
format via the Electronic Submission Gateway (ESG), or may be submitted 
in paper format, or as electronic files on physical media with paper 
signature page. While we do not expect Form FDA 3667 to reduce 
reporting time for respondents, use of the form helps to expedite our 
review of the information being submitted. For submissions to our 
Center for Veterinary Medicine (CVM), respondents may continue to send 
GRAS notices in letter format to the Agency, as instructed in our 
Federal Register notice of June 4, 2010 (75 FR 31800).
    Presently, we have committed to issuing a final rule regarding 
``Substances Generally Recognized as Safe'' in 2016, as part of a 
settlement agreement with the Center for Food Safety, which filed a 
lawsuit in 2014 seeking to vacate our 1997 proposed rule.
    Description of Respondents: The respondents to this collection of 
information are manufacturers of substances used in food and feed.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                21 CFR part                        FDA Form No.\2\           Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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170.36 (CFSAN)............................  FDA 3667 \3\................              40               1              40             150           6,000
570.36 (CVM)..............................  N/A.........................              20               1              20             150           3,000
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    Total.................................  ............................  ..............  ..............  ..............  ..............           9,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Only CFSAN uses Form FDA 3667.
\3\ Form FDA 3667 may be submitted electronically via the ESG.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of      Number of records     Total annual      Average burden
                       21 CFR part                           recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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170.36(c)(v) (CFSAN).....................................                 40                  1                 40                 15                600
570.36(c)(v) (CVM).......................................                 20                  1                 20                 15                300
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    Total................................................  .................  .................  .................  .................                900
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 55859]]

    For purposes of this extension request, we are retaining our 2012 
estimates. The PRA analysis for the GRAS final rule will take into 
account any changes to the GRAS notification procedure as set forth in 
the final rule and we will revise the collection accordingly.

    Dated: September 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23334 Filed 9-16-15; 8:45 am]
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