Document ID: FDA-2018-N-1857-0011
Agency: fda
Document Type: Notice
Title: 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 Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Posted Date: 2021-09-03T04:00Z

[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49543-49546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19116]

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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 Human Food, and 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, Agency, 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: Submit written comments (including recommendations) on the 
collection of information by October 4, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0751. Also include the FDA docket 
number found in brackets in the heading of this document.

[[Page 49544]]

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: 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 Human Food--21 CFR Part 117; Current Good 
Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals--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. 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 food 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 
for animal food is dependent upon whether a facility is required to 
register, while the applicability of the current good manufacturing 
practice requirements for human food 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 A 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.
    In the Federal Register of March 16, 2021 (86 FR 14436), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 per response      Total hours
                                                  respondents         respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(c); qualified facility as reported on             37,134            \2\ 0.5             18,567  0.5 (30 minutes)................           9,284
 Form FDA 3942a.
507.7(c); qualified facility as reported on                1,120                0.5                560  0.5 (30 minutes)................             280
 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of      Number of records     Total annual
           21 CFR section; activity              recordkeepers     per recordkeeper       records       Average burden per recordkeeping    Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan               46,685                  1             46,685  110.............................       5,135,350
 and reanalysis.
117.136; assurance records...................             16,285                  1             16,285  0.25 (15 minutes)...............           4,071
117.145(c); monitoring records...............              8,143                730          5,944,390  0.05 (3 minutes)................         297,220

[[Page 49545]]

 
117.150(d); corrective actions and                        16,285                  2             32,570  1...............................          32,570
 corrections records.
117.155(b); verification records.............              8,143                244          1,986,892  0.05 (3 minutes)................          99,345
117.160; validation records..................              3,677                  6             22,062  0.25 (15 minutes)...............           5,515
117.475(c)(7)-(9); supplier records..........             16,285                 10            162,850  4...............................         651,400
117.180(d); training records for preventive               46,685                  1             46,685  0.25 (15 minutes)...............          11,671
 controls 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.

                                             Table 3--Estimated Annual Recordkeeping Burden: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of      Number of records     Total annual                                        Total hours
           21 CFR section; activity              recordkeepers     per recordkeeper       records       Average burden per recordkeeping        \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Subpart A--General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.4(d); documentation of animal food safety              7,469               0.75              5,579  0.05 (3 minutes)................             279
 and hygiene training.
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                                              Subpart C--Hazard Analysis and Risk-Based Preventive Controls
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food safety plan--                  7,469                519          3,876,411  0.1 (6 minutes).................         387,641
 including hazard analysis, preventive
 controls, and procedures for monitoring,
 corrective actions, verification, recall
 plan, validation, reanalysis, modifications,
 and implementation records.
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                                                             Subpart E--Supply Chain Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.105 through 507.175; written supply-chain              7,469                519          3,876,411  0.1 (6 minutes).................         387,641
 program--including records documenting
 program.
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                                   Subpart F--Requirements Applying to Records That Must Be Established and Maintained
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                              ----------------------------------------------------------------------------------------------------------
    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.

[[Page 49546]]

                                        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 per disclosure    Total hours
                                                 respondents         respondent          disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food                          37,134                   1              37,134   0.25 (15 minutes).............           9,284
 manufacturing facility 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: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
           21 CFR section; activity                Number of       disclosures per      Total annual      Average burden per disclosure     Total hours
                                                  respondents         respondent        disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal food                      330                 10              3,300  0.25 (15 minutes)...............             825
 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 products with                1,120                  4              4,480  1...............................           4,480
 labels.
507.7(e)(2); change address on labeling                      974                  1                974  1...............................             974
 (sales documents) for qualified facilities.
507.25(a)(2); animal food, including raw                     373                312            116,376  0.01 (36 seconds)...............        1,163.76
 materials, other ingredients, and rework, is
 accurately identified.
507.28(b); holding and distribution of human              40,798                  2             81,596  0.25 (15 minutes)...............          20,399
 food byproducts for use as animal food.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  .................  .................  .................  ................................       27,841.76
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\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 food. 
In this submission we provide a cumulative estimate for related 
disclosure activities that we had previously accounted for separately.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19116 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P