
[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Pages 2552-2555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-783]


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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) 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) and new Form FDA 3667, which may be submitted 
electronically via the Electronic Submission Gateway (ESG).

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2012.

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

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docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, (301) 796-3793.

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)--Revision

I. Background

    Section 409 of the Federal Food, Drug, and Cosmetic Act (the 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) 
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. In the Federal Register of April 17, 
1997 (62 FR 18938) (the 1997 proposed rule), FDA published a proposed 
rule that would establish 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. The 
proposed regulations (proposed 21 CFR 170.36 and 21 CFR 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. In the Federal 
Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA 
announced the reopening of the comment period for the 1997 proposed 
rule. The Agency requested that comments be submitted by March 28, 
2011.
    FDA's Center for Food Safety and Applied Nutrition (CFSAN) has 
recently developed a form that prompts a notifier to include certain 
elements of a GRAS notice in a standard format. New Form FDA 3667 is 
entitled ``Generally Recognized as Safe (GRAS) Notice.'' The form, and 
elements that would be prepared as attachments to the form, may be 
submitted in electronic format via the ESG, or may be submitted in 
paper format, or as electronic files on physical media with paper 
signature page. CFSAN expects that most if not all businesses filing 
GRAS notices in the next 3 years will choose to take advantage of the 
option of electronically submitting their GRAS notice. Thus, the burden 
estimate in table 1, line 1 is based on the expectation of 100 percent 
participation in the electronic submission process.
    FDA's Center for Veterinary Medicine (CVM) continues to comply with 
the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR 
31800).

II. GRAS Information on Form FDA 3667

    The GRAS notice submitted to CFSAN includes the following 
information on Form FDA 3667 and in attachments to the form:
A. Introductory Information About the Submission
     Whether the GRAS notice submission is a new GRAS notice, 
or an amendment or supplement to a previously transmitted GRAS notice;
     Whether the notifier has determined that all files 
provided in an electronic transmission are free of computer viruses;
     The date of the notifier's most recent meeting with FDA 
before transmitting a new GRAS notice; and
     The date of any correspondence, sent to the notifier by 
FDA, relevant to an amendment or supplement the notifier is 
transmitting.
B. Information About the Notifier
     The name of and contact information for the notifier, 
including the identity of the contact person and the company name (if 
applicable); and
     The name of and contact information for any agent or 
attorney who is authorized to act on behalf of the notifier.
C. General Administrative Information
     The name of the substance that is the subject of the GRAS 
notice submission;
     The format of the submission (i.e., paper, electronic, or 
electronic with a paper signature page);
     The mode of transmission of any electronic submission 
(i.e., ESG or transmission on physical media such as CD-ROM or DVD);
     Whether the notifier is referring us to information 
already in our files;
     The statutory basis for the notifier's determination of 
GRAS status;
     Whether the notifier has designated in its submission any 
information as trade secret or as confidential commercial or financial 
information; and
     Whether the notifier has attached a redacted copy of some 
or all of the submission.
D. Intended Use
     The intended conditions of use of the notified substance.
E. Identity
     Information that identifies the notified substance. For 
example, there may be a chemical name and formula and a standardized 
registry number.
F. Checklist of Other Elements Not Completed Directly on Form FDA 3667
     Any additional information about identity not previously 
covered;
     Method of manufacture;
     Specifications for food-grade material;

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     Dietary exposure;
     Self-limiting levels of use;
     Common use in food before 1958 (if applicable);
     Comprehensive discussion of the basis for the 
determination of GRAS status; and
     Bibliography.
Form FDA 3667 also requires the signature of a responsible official (or 
agent or attorney) and a list of attachments.
    The information is used by FDA to evaluate whether the notice 
provides a sufficient basis for a conclusion of GRAS status and whether 
information in the notice or otherwise available to FDA raises issues 
of public health significance that lead the Agency to question whether 
use of the substance is GRAS.

III. Description of Respondents

    The respondents to this collection of information are manufacturers 
of substances used in food and feed.
    FDA estimates 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                       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. CVM continues to comply with the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR 31800).
\3\ Form FDA 3667 may be submitted electronically via the ESG.


                                                   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
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................               900
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    As noted, CFSAN estimates that all of the future Form FDA 3667 
submissions will be made electronically via the ESG. While FDA does not 
charge for the use of the ESG, FDA requires respondents to obtain a 
public key infrastructure certificate in order to set up the account. 
This can be obtained in-house or outsourced by purchasing a public key 
certificate that is valid for 1 year to 3 years. The certificate 
typically costs from $20-$30.
    Both CFSAN and CVM receive submissions that are intended by the 
submitter to be GRAS notices. Not all of the submissions received 
contain sufficient information to be filed by the Agency as GRAS 
notices. In the December 28, 2010, GRAS reopener, FDA requested comment 
on its GRAS submission filing decision process and described its 
current preliminary review process of GRAS submissions (75 FR 81536, at 
81543). Therefore, the Agency is basing the following estimates on the 
number of GRAS notices that have been filed by the relevant Center.
    In the 1997 proposed rule, FDA estimated that CFSAN would file 
approximately 50 GRAS notices per year and that CVM would file 
approximately 10 GRAS notices per year. Approval for the GRAS 
notification program was granted by OMB on June 16, 1997, under OMB 
control number 0910-0342. In 2009, FDA's estimate of the annual number 
of GRAS notices that will be filed by CFSAN and CVM was revised 
downward from the original PRA approval, based on the actual number of 
GRAS notices filed by CFSAN from 1998 to 2008. In 2009, FDA sought and 
OMB approved an estimate that CFSAN would file 25 GRAS notices and CVM 
would file 5 GRAS notices. On June 4, 2010 CVM announced the beginning 
of a GRAS Pilot Program (75 FR 31800). This notice stated that the 
revised estimate in the 2009 PRA approval reflected FDA's best judgment 
at the time as to the number of notices CVM will file annually through 
this pilot program.
    For purposes of this extension request, CFSAN and CVM are re-
evaluating their estimates of the annual number of GRAS notices that 
will be received by CFSAN and CVM in the next 3 years, 2012 through 
2015. CFSAN filed 365 GRAS notices during the 13-year period from 1998 
through 2010, for an average of approximately 28 GRAS notices per year. 
However, recent years have seen an increase in the number of GRAS 
notices filed, with 36 notices filed in both 2008 and 2009 and 55 
notices in 2010. Based on an approximate average from the last 3 years, 
FDA is revising its estimate of the annual number of GRAS notices filed 
by CFSAN to be 40 or less. CFSAN expects that most if not all 
businesses filing GRAS notices in the next 3 years will choose to take 
advantage of the option of electronically submitting their GRAS notice. 
We expect participation to be 100 percent; thus the estimate in Table 1 
is based on the burden of that experience. FDA also is revising its 
estimate of the annual number of GRAS notices submitted to CVM. As 
noted, on June 4, 2010, CVM announced the beginning of a GRAS Pilot 
Program. From June 2010 to October 2011, CVM filed 13 GRAS notices. 
Based on this experience, FDA is revising its estimate of the annual 
number of GRAS notices filed by CVM to be 20 or less.
    In the 1997 proposed rule, FDA estimated that the notification 
procedures would require 150 hours per response for the reporting 
burdens and 15 hours per response for the recordkeeping burdens for 
both proposed sections (Sec. Sec.  170.36 and 570.36). FDA is retaining 
these

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estimates for this request. The availability of the form, and the 
opportunity to provide the information in electronic format, could 
reduce this estimate. However, as a conservative approach for the 
purpose of this analysis, FDA is assuming that the availability of the 
form and the opportunity to submit the information in electronic format 
will have no effect on the average time to prepare a GRAS notification.

    Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-783 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P


