Document ID: FDA-2012-N-0021-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Substances
Generally Recognized as Safe: Notification Procedure
Posted Date: 2016-02-18T05:00Z

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8206-8207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03330]

[[Page 8206]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
21, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0495. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
generally recognized as safe (GRAS) by qualified experts. In the 
Federal Register of April 17, 1997 (62 FR 18938) (the 1997 proposed 
rule), 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 that 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 (GRAS) 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.
    In the Federal Register of September 17, 2015 (80 FR 55857), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received a number of comments in support 
of the information collection generally. We also received one comment 
suggesting that the names, credentials, and affiliations of ``qualified 
experts'' associated with GRAS determinations be included on the form. 
We received a second comment suggesting that information submitted by 
manufacturers be reviewed by independent scientists. We appreciate this 
input. As discussed previously, rulemaking is underway that will 
necessitate a revision to the information collection provisions 
associated with our GRAS program and we continue to consider all 
comments.
    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 Section                         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)............................  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.

[[Page 8207]]

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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.

    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: February 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03330 Filed 2-17-16; 8:45 am]
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