[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Pages 38638-38640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15811]



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.


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 July 
30, 2012.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0342. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, [email protected].

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)--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, 
    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 Electronic Submissions Gateway 
(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 
    FDA's Center for Veterinary Medicine (CVM) continues to comply with 
the GRAS Pilot Program procedures announced on June 4, 2010 (75 FR 

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:

[[Page 38639]]

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 

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 
     Method of manufacture;
     Specifications for food-grade material;
     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
    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.
    In the Federal Register of January 18, 2012 (77 FR 2552), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                             Number of
             21 CFR Section                      FDA Form No. \2\            Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
170.36 (CFSAN).........................  FDA 3667 \3\...................              40               1              40             150           6,000
570.36 (CVM)...........................  N/A............................              20               1              20             150           3,000
    Total..............................  ...............................  ..............  ..............  ..............  ..............           9,000
\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\
                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
170.36(c)(v) (CFSAN)............              40               1              40              15             600
570.36(c)(v) (CVM)..............              20               1              20              15             300
    Total.......................  ..............  ..............  ..............  ..............             900
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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

[[Page 38640]]

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 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: June 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-15811 Filed 6-27-12; 8:45 am]