Notice2021-19116
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 169 (Friday, September 3, 2021)</title>
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[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49543-49546]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa">[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 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: <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation</a>.
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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility</a>. 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
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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.
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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 Number of records Total annual
21 CFR section; activity recordkeepers per recordkeeper records Average burden per recordkeeping Total hours
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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.
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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\
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Number of Number of records Total annual Total hours
21 CFR section; activity recordkeepers per recordkeeper records Average burden per recordkeeping \2\
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Subpart A--General Provisions
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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
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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
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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
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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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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\
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Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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117.201(e); disclosure of food 37,134 1 37,134 0.25 (15 minutes)............. 9,284
manufacturing facility address.
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\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\
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Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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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.
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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
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