[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38149-38151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1093]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Additive Petitions and Investigational Food 
Additive Exemptions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information,

[[Page 38150]]

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 our regulations regarding Food Additive Petitions and 
Investigational Food Additive Exemptions.

DATES: Submit either electronic or written comments on the collection 
of information by October 2, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 2, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-1093 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Additive Petitions and 
Investigational Food Additive Exemptions.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Food Additive Petitions and Investigational Food Additive Exemptions--
21 CFR 570.17, 571.1, and 571.6

OMB Control Number 0910-0546--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe unless its use is permitted by a regulation which 
prescribes the condition(s) under which it may safely be used, or 
unless it is exempted by

[[Page 38151]]

regulation for investigational use. Section 409(b) of the FD&C Act (21 
U.S.C. 348(b)) specifies the information that must be submitted by a 
petitioner to establish the safety of a food additive and to secure the 
issuance of a regulation permitting its use.
    To implement the provisions of Sec.  409 of the FD&C Act, we issued 
procedural regulations under 21 CFR part 571. These procedural 
regulations are designed to specify more thoroughly the information 
that must be submitted to meet the requirement set down in broader 
terms by the FD&C Act. The regulations add no substantive requirements 
to those indicated in the FD&C Act, but attempt to explain these 
requirements and provide a standard format for submission to speed 
processing of the petition. Labeling requirements for food additives 
intended for animal consumption are also set forth in various 
regulations contained in 21 CFR parts 501, 573, and 579. The labeling 
regulations are considered by FDA to be cross-referenced to Sec.  
571.1, which is the subject of this same OMB clearance for food 
additive petitions.
    With regard to the investigational use of food additives, Sec.  
409(j) of the FD&C Act (Sec.  409(j)) (21 U.S.C. 348(j)) provides that 
any food additive, or any food bearing or containing such an additive, 
may be exempted from the requirements of this section if intended 
solely for investigational use by qualified experts. Investigational 
use of a food additive is typically to address the safety and/or 
intended physical or technical effect of the additive.
    To implement the provisions of Sec.  409(j), we issued regulations 
under 21 CFR 570.17. These regulations are designed to specify more 
thoroughly the information that must be submitted to meet the 
requirement set down in broad terms by the FD&C Act. Labeling 
requirements for investigational food additives are also set forth in 
various regulations contained in 21 CFR 501. The labeling regulations 
are considered by FDA to be cross-referenced to Sec.  570.17, which is 
the subject of this same OMB clearance for investigational food 
additive files.
    The information collected is necessary to protect the public 
health. We use the information submitted by food manufacturers or food 
additive manufacturers to ascertain whether the data establish the 
identity of the substance, justify its intended effect in/on the food, 
and establish that its intended use in/on food is safe.
    Description of Respondents: Respondents to this collection of 
information are food manufacturers or food additive manufacturers.
    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              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Food Additive Petitions:
    571.1(c) Moderate Category..              12               1              12           3,000          36,000
    571.1(c) Complex Category...              12               1              12          10,000         120,000
    571.6 Amendment of Petition.               2               1               2           1,300           2,600
Investigational Food Additive
 Files:
    570.17 Moderate Category....               4               1               4           1,500           6,000
    570.17 Complex Category.....               5               1               5           5,000          25,000
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        Total Hours.............  ..............  ..............  ..............  ..............         189,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of the total annual responses on submissions 
received during fiscal years 2016 and 2017. We base our estimate of the 
hours per response upon our experience with the petition and filing 
processes.
    Sec.  571.1(c) Moderate Category: For a food additive petition 
without complex chemistry, manufacturing, efficacy or safety issues, 
the estimated time requirement per petition is approximately 3,000 
hours. We estimate that, annually, 12 respondents will each submit 1 
such petition, for a total of 36,000 hours.
    Sec.  571.1(c) Complex Category: For a food additive petition with 
complex chemistry, manufacturing, efficacy and/or safety issues, the 
estimated time requirement per petition is approximately 10,000 hours. 
We estimate that, annually, 12 respondents will each submit 1 such 
petition, for a total of 120,000 hours.
    Sec.  571.6: For a food additive petition amendment, the estimated 
time requirement per petition is approximately 1,300 hours. We estimate 
that, annually, two respondents will each submit one such amendment, 
for a total of 2,600 hours.
    Sec.  570.17 Moderate Category: For an investigational food 
additive file without complex chemistry, manufacturing, efficacy, or 
safety issues, the estimated time requirement per file is approximately 
1,500 hours. We estimate that, annually, four respondents will each 
submit one such file, for a total of 6,000 hours.
    Sec.  570.17 Complex Category: For an investigational food additive 
file with complex chemistry, manufacturing, efficacy, and/or safety 
issues, the estimated time requirement per file is approximately 5,000 
hours. We estimate that, annually, five respondents will each submit 
one such file, for a total of 25,000 hours.
    The burden for this information collected has not changed since the 
last OMB approval.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16616 Filed 8-2-18; 8:45 am]
 BILLING CODE 4164-01-P


