83 FR 46496 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 178 (September 13, 2018)

Page Range		46496-46497
FR Document		2018-19909

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.

Federal Register, Volume 83 Issue 178 (Thursday, September 13, 2018)

[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46496-46497]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-19909]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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,
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 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

46496 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices

responses. We calculate a reporting Dated: September 7, 2018. Current Good Manufacturing Practice
burden of 120 hours per response, for a Leslie Kux, and Hazard Analysis and Risk-Based
total burden of 1,440 hours. We estimate Associate Commissioner for Policy. Preventive Controls for Food for
42 respondents will submit 2 Category [FR Doc. 2018–19898 Filed 9–12–18; 8:45 am] Animals—21 CFR Part 507
D submissions annually, for a total of 84 BILLING CODE 4164–01–P
responses. We calculate a reporting OMB Control Number 0910–0789—
burden of 150 hours per response, for a Extension
total burden of 12,600 hours. We DEPARTMENT OF HEALTH AND The information collection supports
estimate 38 respondents will submit 1 HUMAN SERVICES FDA regulations. As amended by the
Category E submission annually, for a FDA Food Safety Modernization Act
total of 38 responses. We calculate a Food and Drug Administration
(FSMA) (Pub. L. 111–353), the Federal
reporting burden of 150 hours per [Docket No. FDA–2018–N–1857] Food, Drug, and Cosmetic Act (FD&C
response, for a total burden of 5,700
Act) enables the Agency to better protect
hours. Agency Information Collection
In row 6, we estimate 190 respondents the public health by helping to ensure
Activities; Submission for Office of
will submit information to a pre- the safety and security of the food
Management and Budget Review;
notification consultation or a master file supply. It enables FDA to focus more on
Comment Request; Current Good
in support of FCN submission using Manufacturing Practice, Hazard preventing food safety problems rather
Form FDA 3480. We calculate a Analysis, and Risk-Based Preventive than relying primarily on reacting to
reporting burden of 0.5 hours per Controls for Food for Animals problems after they occur. FSMA
response, for a total burden of 95 hours. recognizes the important role industry
In row 7 we estimate 100 respondents AGENCY: Food and Drug Administration, plays in ensuring the safety of the food
will submit an amendment (Form FDA HHS. supply, including the adoption of
3480A) to a substantive or non- ACTION: Notice. modern systems of preventive controls
substantive request of additional in food production. Specifically, section
SUMMARY: The Food and Drug
information to an incomplete FCN 418 (21 U.S.C. 350g) of the FD&C Act
Administration (FDA) is announcing
submission, an amendment to a pre- sets forth requirements for hazard
that a proposed collection of
notification consultation, or an analysis and risk-based preventive
information has been submitted to the
amendment to a master file in support Office of Management and Budget controls for facilities that produce food
of an FCN. We calculate a reporting (OMB) for review and clearance under for animals. To implement these
burden of 0.5 hours per response, for a the Paperwork Reduction Act of 1995. provisions, regulations were codified
total burden of 50 hours. under 21 CFR part 507—Current Good
DATES: Fax written comments on the
In row 8, we estimate one respondent Manufacturing Practice, Hazard
collection of information by October 15,
will submit one indirect food additive 2018. Analysis, And Risk-Based Preventive
petition under § 171.1, for a total of one Controls For Food For Animals. The
ADDRESSES: To ensure that comments on
response. We calculate a reporting regulations establish requirements for a
the information collection are received,
burden of 10,995 hours per response, for written food safety plan; hazard analysis
OMB recommends that written
a total burden of 10,995 hours. preventive controls; monitoring;
In row 9, we estimate 10 respondents comments be faxed to the Office of
corrective actions and corrections;
will utilize the recommendations in the Information and Regulatory Affairs,
verification; supply-chain program;
guidance document entitled, ‘‘Use of OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_ recall plan; and associated records and
Recycled Plastics in Food Packaging: became effective November 16, 2015.
Chemistry Considerations,’’ to develop submission@omb.eop.gov. All
comments should be identified with the Currently, we continue to evaluate
the additional information for one such burden associated with the information
OMB control number 0910–0789. Also
submission annually, for a total of 10 collection requirements however, for
include the FDA docket number found
responses. We calculate a reporting purposes of extending the information
in brackets in the heading of this
burden of 25 hours per response, for a collection we retain the currently
document.
total burden of 250 hours. approved figures as shown in the
Finally, in row 10, we estimate 2 FOR FURTHER INFORMATION CONTACT:
following tables.
respondents will utilize the JonnaLynn Capezzuto, Office of
recommendations in the draft guidance, Operations, Food and Drug In the Federal Register of May 24,
once finalized, entitled, ‘‘Preparation of Administration, Three White Flint 2018 (83 FR 24124), FDA published a
Food Contact Notifications for Food North, 10A–12M, 11601 Landsdown St., 60-day notice requesting public
Contact Substances in Contact with North Bethesda, MD 20852, 301–796– comment on the proposed collection of
Infant Formula and/or Human Milk,’’ to 3794, PRAStaff@fda.hhs.gov. information. We received three
develop the additional information for SUPPLEMENTARY INFORMATION: In comments, however none pertained to
one such submission annually, for a compliance with 44 U.S.C. 3507, FDA the information collection or underlying
total of 2 responses. We calculate a has submitted the following proposed regulations.
reporting burden of 5 hours per collection of information to OMB for We estimate our burden of the
response, for a total burden of 10 hours. review and clearance. information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
daltland on DSKBBV9HB2PROD with NOTICES

Number of
Number of responses Total annual Average
21 CFR section; activity Total hours
respondents per responses burden per response
respondent

507.7 exemption: submit attestation of preventive controls or compliance with 1,120 0.5 560 0.5 (30 minutes) ............. 280
State and local laws (non-federal).

VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1

Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46497

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of responses Total annual Average
21 CFR section; activity Total hours
respondents per responses burden per response
respondent

507.67, 507.69, and 507.71; submission of an appeal, including submission of 1 1 1 4 ...................................... 4
a request for an informal hearing.
507.85(b); requests for reinstatement of exemption ........................................... 1 1 1 2 ...................................... 2

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
Number of Average
records per Total annual
21 CFR section; activity record- burden per Total hours
record- records
keepers recordkeeping
keeper

Subpart A—General Provisions

507.7(e); records attesting that the facility is a ‘‘qualified’’ facility ...................... 1,120 0.5 560 0.1 (6 minutes) ............... 56
507.4(d); documentation of animal food safety and hygiene training ................. 7,469 0.75 5,579 0.05 (3 minutes) ............. 279

Subpart C—Hazard Analysis and Risk-Based Preventive Controls

507.31 through 507.55; food safety plan—including hazard analysis, preven- 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641
tive controls, monitoring, corrective actions, verification, validation reanaly-
sis, modifications, and implementation records.

Subpart E—Supply-Chain Program

507.105 through 507.175; written supply-chain program—including records 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641
documenting program.

Subpart F—Requirements Applying to Records

507.200 through 507.215; general requirements, additional requirements ap- 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641
plying 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 annual Average
21 CFR section; activity Total hours
respondents per disclosures burden per disclosure
respondent

507.27(b); labeling for the animal food product contains the specific informa- 330 10 3,300 0.25 (15 minutes) ........... 825
tion and instructions needed so the food can be safely used for the intended
animal species.
507.7(e)(1); change labels on products with labels ............................................ 1,526 4 6,104 1 ...................................... 6,104
507.7(e)(2); change address on labeling (sales documents) for qualified facili- 1,329 1 1,329 1 ...................................... 1,329
ties.
507.25(a)(2); animal food, including raw materials, other ingredients, and re- 330 312 102,960 0.01 (36 seconds) .......... 1,030
work, is accurately identified.
507.28(b); holding and distribution of human food byproducts for use as ani- 40,798 2 81,596 0.25 (15 minutes) ........... 20,399
mal 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 the time necessary for the individual DEPARTMENT OF HEALTH AND
currently approved burden estimate for reporting, recordkeeping, and third- HUMAN SERVICES
the information collection. These figures party disclosure activities on our
are based on our regulatory impact experience with similar information Food and Drug Administration
analysis in support of the final rule on collections.
daltland on DSKBBV9HB2PROD with NOTICES

Preventive Controls for Food for [Docket No. FDA–2018–N–3381]
Dated: September 7, 2018.
Animals, which published in the
Leslie Kux, Science Board to the Food and Drug
Federal Register of September 17, 2015
Associate Commissioner for Policy. Administration Advisory Committee;
(80 FR 56170). Using Agency data, we
[FR Doc. 2018–19909 Filed 9–12–18; 8:45 am] Notice of Meeting
estimated the number of animal food
facilities that we believe are subject to BILLING CODE 4164–01–P AGENCY: Food and Drug Administration,
the regulations. We base our estimate of HHS.

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Document Created: 2018-09-13 01:01:27
Document Modified: 2018-09-13 01:01:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by October 15, 2018.
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, [email protected]
FR Citation		83 FR 46496

83 FR 46496 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 178 (September 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration