[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14436-14440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05332]


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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 Human Food, and Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Animal Food

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, 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,

[[Page 14437]]

hazard analysis, and risk-based preventive controls for human and 
animal food.

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2021.

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 May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 17, 2021. 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 Human 
Food, and Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Animal Food.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 Human Food--21 CFR Part 117; Current Good 
Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive 
Controls for Animal Food--21 CFR Part 507

OMB Control Number 0910-0751--Revision

    This information collection supports FDA regulations setting forth 
criteria and definitions applicable to human food and to animal food, 
as established under the FDA Food Safety and Modernization Act (FSMA) 
(Pub. L.

[[Page 14438]]

111-353). Congress enacted FSMA in response to dramatic changes in the 
global food system and in our understanding of foodborne illness and 
its consequences, including the realization that preventable foodborne 
illness is both a significant public health problem and a threat to the 
economic well-being of the food system. The purpose of the regulations 
is to prevent the introduction of adulterated and/or misbranded 
products into the marketplace and ensure the safety of both human foods 
and animal foods in accordance with sections 402 and 403 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342 and 343). 
Generally, domestic and foreign food facilities that are required to 
register in accordance with section 415 of the FD&C Act (21 U.S.C. 
350d) must comply with these requirements, unless an exemption applies. 
It is important to note, however, that applicability of the current 
good manufacturing practice requirements is not dependent upon whether 
a facility is required to register. Regulations governing human food 
are set forth in part 117 (21 CFR part 117), while regulations 
governing animal food are found in part 507 (21 CFR part 507). 
Respondents to the information collection are those who manufacture, 
prepare, pack, or hold food intended for humans or animals.
    The regulations include recordkeeping necessary to demonstrate 
compliance with the requirements; however, respondents that meet the 
definition of a ``qualified facility,'' under 21 CFR 117.3 and 507.3, 
are subject to reporting. To be subject to the modified requirements 
set forth in part 117, subpart D and part 507, subpart D for human food 
and animal food, respectively, respondents must attest to their status. 
To assist respondents in this regard, we have developed Forms FDA 3942a 
(Quality Facility Attestation: Human Food) and 3942b (Quality Facility 
Attestation: Animal Food), available for downloading from our website 
at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation.
    Section 418(l)(2)(B)(ii) of the FD&C Act (21 U.S.C. 
350g(l)(2)(B)(ii)) directs us to issue guidance on documentation 
required to determine status as a qualified facility. Accordingly, we 
issued a guidance for industry entitled ``Determination of Status as a 
Qualified Facility Under Part 117: Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food and 
Part 507: Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Food for Animals,'' also available 
for downloading from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility. The guidance discusses the 
content, format, frequency, and timing of submissions. For efficiency 
of Agency operations, we are now accounting for burden we attribute to 
reporting associated with Forms FDA 3942a and 3942b, currently approved 
under OMB control number 0910-0854, with this information collection.
    We estimate 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; reporting       Number of     responses per    Total annual    Average burden     Total hours
                                 respondents      respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
117.201(c); qualified                  37,134          \2\ 0.5          18,567  0.5 (30 minutes)           9,284
 facility as reported on Form
 FDA 3942a.
507.7(c); qualified facility            1,120              0.5             560  0.5 (30 minutes)             280
 as reported on Form FDA
 3942b.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ...............  ..............  ................           9,564
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Reporting occurs biennially.


                         Table 2--Estimated Annual Recordkeeping Burden: Human Foods \1\
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                                                   Number of                     Average burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d);              46,685               1          46,685  110.............       5,135,350
 food safety plan and
 reanalysis.
117.136; assurance records....          16,285               1          16,285  0.25 (15                   4,071
                                                                                 minutes).
117.145(c); monitoring records           8,143             730       5,944,390  0.05 (3 minutes)         297,220
117.150(d); corrective actions          16,285               2          32,570  1...............          32,570
 and corrections records.
117.155(b); verification                 8,143             244       1,986,892  0.05 (3 minutes)          99,345
 records.
117.160; validation records...           3,677               6          22,062  0.25 (15                   5,515
                                                                                 minutes).
117.475(c)(7)-(9); supplier             16,285              10         162,850  4...............         651,400
 records.
117.180(d); training records            46,685               1          46,685  0.25 (15                  11,671
 for preventive controls                                                         minutes).
 qualified individual.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................       6,237,142
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 14439]]


                        Table 3--Estimated Annual Recordkeeping Burden: Animal Foods \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping         \2\
----------------------------------------------------------------------------------------------------------------
                                          Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
507.4(d); documentation of               7,469            0.75           5,579  0.05 (3 minutes)             279
 animal food safety and
 hygiene training.
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                          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, and procedures for
 monitoring, corrective
 actions, verification, recall
 plan, 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 That Must Be Established and Maintained
----------------------------------------------------------------------------------------------------------------
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.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............      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.
\2\ Total hours have been rounded.


                    Table 4--Estimated Annual Third-Party Disclosure Burden: Human Foods \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
   21 CFR section; activity       Number of    disclosures per   Total annual    Average burden     Total hours
                                 respondents      respondent      disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of              37,134                1          37,134  0.25 (15                   9,284
 food manufacturing facility                                                     minutes).
 address.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 5--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
   21 CFR section; activity       Number of    disclosures per   Total annual    Average burden     Total hours
                                 respondents      respondent      disclosures    per  disclosure
----------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the               330               10           3,300  0.25 (15                     825
 animal food product contains                                                    minutes).
 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           1,120                4           4,480  1...............           4,480
 products with labels.
507.7(e)(2); change address               974                1             974  1...............             974
 on labeling (sales
 documents) for qualified
 facilities.
507.25(a)(2); animal food,                373              312         116,376  0.01 (36                1,163.76
 including raw materials,                                                        seconds).
 other ingredients, and
 rework, is accurately
 identified.
507.28(b); holding and                 40,798                2          81,596  0.25 (15                  20,399
 distribution of human food                                                      minutes).
 byproducts for use as animal
 food.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ...............  ..............  ................       27,841.76
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made slight adjustments to reflect a 
decrease in third-party disclosure burden associated with animal foods. 
In this submission we provide a cumulative estimate for related 
disclosure activities that we had previously accounted for separately.


[[Page 14440]]


    Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05332 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


