[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46496-46497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 October 
15, 2018.

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 <a href="/cdn-cgi/l/email-protection#7d12140f1c220e081f10140e0e1412133d12101f5318120d531a120b"><span class="__cf_email__" data-cfemail="7f10160d1e200c0a1d12160c0c1610113f10121d511a100f51181009">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0789. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#0a5a584b597e6b6c6c4a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="fdadafbcae899c9b9bbd9b999cd395958ed39a928b">[email protected]</span></a>.

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.

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 (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 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 in the following tables.
    In the Federal Register of May 24, 2018 (83 FR 24124), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received three comments, however none 
pertained to the information collection or underlying regulations.
    We estimate our burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                              Number of
                                 Number of    responses      Total
   21 CFR section; activity     respondents      per         annual     Average burden per response  Total hours
                                              respondent   responses
----------------------------------------------------------------------------------------------------------------
507.7 exemption: submit               1,120          0.5          560  0.5 (30 minutes)............          280
 attestation of preventive
 controls or compliance with
 State and local laws (non-
 federal).

[[Page 46497]]

 
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.
                               ---------------------------------------------------------------------------------
    Total.....................  ...........  ...........  ...........  ............................          286
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                Number of      Total
   21 CFR section; activity      Number of     records per     annual        Average burden per      Total hours
                               recordkeepers  recordkeeper    records           recordkeeping
----------------------------------------------------------------------------------------------------------------
                                          Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.7(e); records attesting           1,120            0.5          560  0.1 (6 minutes)...........           56
 that the facility is a
 ``qualified'' facility.
507.4(d); documentation of            7,469           0.75        5,579  0.05 (3 minutes)..........          279
 animal food safety and
 hygiene training.
----------------------------------------------------------------------------------------------------------------
                          Subpart C--Hazard Analysis and Risk-Based Preventive Controls
----------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food           7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 safety plan--including
 hazard analysis, preventive
 controls, monitoring,
 corrective actions,
 verification, validation
 reanalysis, modifications,
 and implementation records.
----------------------------------------------------------------------------------------------------------------
                                         Subpart E--Supply-Chain Program
----------------------------------------------------------------------------------------------------------------
507.105 through 507.175;              7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 written supply-chain
 program--including records
 documenting program.
----------------------------------------------------------------------------------------------------------------
                                   Subpart F--Requirements Applying to Records
----------------------------------------------------------------------------------------------------------------
507.200 through 507.215;              7,469            519    3,876,411  0.1 (6 minutes)...........      387,641
 general requirements,
 additional requirements
 applying to food safety
 plan, requirements for
 record retention, use of
 existing records, and
 special requirements
 applicable to written
 assurance.
                              ----------------------------------------------------------------------------------
    Totals...................  .............  ............   11,635,372  ..........................    1,163,258
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                              Number of
                                 Number of   disclosures     Total          Average burden per
   21 CFR section; activity     respondents      per         annual             disclosure           Total hours
                                              respondent  disclosures
----------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the             330           10        3,300  0.25 (15 minutes)...........          825
 animal food product contains
 the specific information and
 instructions needed so the
 food can be safely used for
 the intended animal species.
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,              330          312      102,960  0.01 (36 seconds)...........        1,030
 including raw materials,
 other ingredients, and
 rework, is accurately
 identified.
507.28(b); holding and               40,798            2       81,596  0.25 (15 minutes)...........       20,399
 distribution of human food
 byproducts for use as animal
 food.
                               ---------------------------------------------------------------------------------
    Total.....................  ...........  ...........  ...........  ............................       29,687
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As previously stated, we retain the currently approved burden 
estimate for the information collection. 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19909 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


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