[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4828-4829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02596]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 we) 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, 2019.

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 0910-0546. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

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 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.
    Regarding 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.
    In the Federal Register of August 3, 2018 (83 FR 38149), 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 
follows:

[[Page 4829]]



                                 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: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02596 Filed 2-15-19; 8:45 am]
BILLING CODE 4164-01-P