[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24124-24127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1857]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Food for Animals

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 24125]]

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 
requirements associated with current good manufacturing practice, 
hazard analysis, and risk-based preventive controls for animal food.

DATES: Submit either electronic or written comments on the collection 
of information by July 23, 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 July 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 23, 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-2018-N-1857 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals.'' 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based 
Preventive Controls for Food for Animals--21 CFR Part 507 OMB Control 
Number 0910-0789--Extension

    The information collection supports FDA regulations. As amended by 
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) enables the Agency 
to better protect the public health by helping to ensure the safety and 
security of the food supply. It enables FDA to focus

[[Page 24126]]

more on preventing food safety problems rather than relying primarily 
on reacting to problems after they occur. FSMA recognizes the important 
role industry plays in ensuring the safety of the food supply, 
including the adoption of modern systems of preventive controls in food 
production. Specifically, section 418 (21 U.S.C. 350g) of the FD&C Act 
sets forth requirements for hazard analysis and risk-based preventive 
controls for facilities that produce food for animals. To implement 
these provisions, regulations were codified under 21 CFR part 507--
Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based 
Preventive Controls For Food For Animals. The regulations establish 
requirements for a written food safety plan; hazard analysis preventive 
controls; monitoring; corrective actions and corrections; verification; 
supply-chain program; recall plan; and associated records and became 
effective November 16, 2015. Currently, we continue to evaluate burden 
associated with the information collection requirements however, for 
purposes of extending the information collection we retain the 
currently approved figures as shown below.
    We estimate our burden of the information collection as follows:

                  Table 1--Estimated Annual Reporting Burden for OMB Control No. 0910-0789 \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
      21 CFR section; activity        respondents      per         annual           response         Total hours
                                                    respondent   responses
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507.7 exemption: Submit attestation         1,120          0.5          560  0.5 (30 minutes)......          280
 of preventive controls or
 compliance with State and local
 laws (non-federal).
507.67, 507.69, and 507.71;                     1            1            1  4.....................            4
 submission of an appeal, including
 submission of a request for an
 informal hearing.
507.85(b); requests for                         1            1            1  2.....................            2
 reinstatement of exemption.
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    Total...........................  ...........  ...........  ...........  ......................          286
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
      21 CFR section; activity        respondents      per         annual           response         Total hours
                                                    respondent   responses
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                                          Subpart A--General Provisions
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507.7(e); records attesting that the        1,120          0.5          560  0.1 (6 minutes).......           56
 facility is a ``qualified''
 facility.
507.4(d); documentation of animal           7,469         0.75        5,579  0.05 (3 minutes)......          279
 food safety and hygiene training.
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                          Subpart C--Hazard Analysis and Risk-Based Preventive Controls
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507.31 through 507.55; food safety          7,469          519    3,876,411  0.1 (6 minutes).......      387,641
 plan--including hazard analysis,
 preventive controls, monitoring,
 corrective actions, verification,
 validation reanalysis,
 modifications, and implementation
 records.
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                                         Subpart E--Supply-Chain Program
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507.105 through 507.175; written            7,469          519    3,876,411  0.1 (6 minutes).......      387,641
 supply-chain program--including
 records documenting program.
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                                   Subpart F--Requirements Applying to Records
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507.200 through 507.215; general            7,469          519    3,876,411  0.1 (6 minutes).......      387,641
 requirements, additional
 requirements applying to food
 safety plan, requirements for
 record retention, use of existing
 records, and special requirements
 applicable to written assurance.
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    Totals..........................  ...........  ...........   11,635,372  ......................    1,163,258
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of
                                       Number of    responses      Total       Average burden per
      21 CFR section; activity        respondents      per         annual           response         Total hours
                                                    respondent   responses
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507.27(b); labeling for the animal            330           10        3,300  0.25 (15 minutes).....          825
 food product contains the specific
 information and instructions needed
 so the food can be safely used for
 the intended animal species.

[[Page 24127]]

 
507.7(e)(1); change labels on               1,526            4        6,104  1.....................        6,104
 products with labels.
507.7(e)(2); change address on              1,329            1        1,329  1.....................        1,329
 labeling (sales documents) for
 qualified facilities.
507.25(a)(2); animal food, including          330          312      102,960  0.01 (36 seconds).....        1,030
 raw materials, other ingredients,
 and rework, is accurately
 identified.
507.28(b); holding and distribution        40,798            2       81,596  0.25 (15 minutes).....       20,399
 of human food byproducts for use as
 animal food.
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    Total...........................  ...........  ...........  ...........  ......................       29,687
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    These figures are based on our regulatory impact analysis in 
support of the final rule on Preventive Controls for Food for Animals, 
which published in the Federal Register of September 17, 2015 (80 FR 
56170). Using Agency data we estimated the number of animal food 
facilities that we believe are subject to the regulations. We base our 
estimate of the time necessary for the individual reporting, 
recordkeeping, and third-party disclosure activities on our experience 
with similar information collections.

    Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11114 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


