Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 51351-51352 [2024-13299]
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51351
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0802]
Veterinary Feed Directive
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Veterinary Feed
Directive
AGENCY:
OMB Control Number 0910–0363—
Extension
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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 July 17,
2024.
SUMMARY:
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 0910–0363. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
This information collection helps
support implementation of FDA
statutory and regulatory requirements.
Section 504 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
354) establishes a regulatory category for
certain new animal drugs called
veterinary feed directive (VFD) drugs.
Our VFD regulation is set forth at
§ 558.6 (21 CFR 558.6). VFD drugs are
new animal drugs, intended for use in
or on animal feed, which are limited to
use under the professional supervision
of a licensed veterinarian in the course
of the veterinarian’s professional
practice. An animal feed containing a
VFD drug or a combination VFD drug
may be fed to animals only by or upon
a lawful VFD issued by a licensed
veterinarian.
Distributors of medicated feed
containing VFD drugs must notify FDA
of their intent to distribute such feed via
U.S. Postal mail, email, or fax and must
maintain records of the receipt and
distribution of all medicated feeds
containing VFD drugs. Veterinarians
issue three copies of the VFD: one for
their own records, one for their client,
and one to the client’s VFD feed
distributor. For third-party disclosures,
FDA regulation requires that
veterinarians include specific
information on the VFD. A distributor
may only distribute a VFD feed to
another distributor for further
distribution if the originating distributor
(consignor) first obtains a written
acknowledgment letter from the
receiving distributor (consignee) before
the feed is shipped.
We developed the guidance document
‘‘Guidance for Industry (GFI) #233
Veterinary Feed Directive Common
Format Questions and Answers’’
(September 2016) (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/cvm-gfi-233veterinary-feed-directive-commonformat-questions-and-answers) to
provide guidance concerning the
elements that must be included on the
VFD and the elements that may be
included on the VFD as described in
§ 558.6. The guidance also provides
examples that illustrate how a common
VFD format might appear. Agency
guidance documents are issued in
accordance with our good guidance
practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
The VFD regulation ensures the
protection of public health while
enabling animal producers to obtain and
use needed drugs as efficiently and cost
effectively as possible. We will use the
information collected to assess
compliance with the VFD regulation.
The required reporting, recordkeeping,
and third-party disclosures provide
assurance that the medicated feeds will
be safe and effective for their labeled
conditions of use and that edible
products from treated animals will be
free of unsafe drug residues.
In the Federal Register of March 21,
2024 (89 FR 20218), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
A. Reporting Requirements
Description of Respondents: VFD
Feed Distributors.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR part/activity
558.6(c)(5) requires a distributor to notify FDA prior to the first time it distributes
a VFD feed.
558.6(c)(6) requires a distributor to notify FDA within 30 days of any change in
ownership, business name, or business address.
khammond on DSKJM1Z7X2PROD with NOTICES
Total ..................................................................................................................
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total
hours
112
1
112
0.12 (7 minutes) .....
13
239
1
239
0.12 (7 minutes) .....
29
351
........................
........................
.................................
42
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Totals may not sum due to rounding.
The number of respondents is based
on the average number of notifications
we have received over the past 3 years.
Additional reporting burdens for current
VFD drug sponsors are approved under
VerDate Sep<11>2014
17:00 Jun 14, 2024
Jkt 262001
OMB control numbers 0910–0032 (New
Animal Drug Applications) and 0910–
0669 (Abbreviated New Animal Drug
Applications).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
B. Recordkeeping Requirements
Description of Respondents: VFD
Feed Distributors, Food Animal
Veterinarians, and Clients (Food Animal
Producers).
E:\FR\FM\17JNN1.SGM
17JNN1
51352
Federal Register / Vol. 89, No. 117 / Monday, June 17, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR part/activity
558.6(a)(4) and (c)(3), (4), and (8); requires recordkeeping by veterinarians, producers, and distributors to maintain their copy of the VFD
Order, their receipt and distribution records, and their manufacturing
records and acknowledgement letters, if applicable, for 2 years.
1 There
2 Totals
Number of
records per
recordkeeper
30,800
Total annual
records
219.03
6,746,096
Average burden
per recordkeeping
0.02 (1 minute) ...........
Total
hours
134,922
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
FDA’s guidance document, ‘‘GFI #
213 New Animal Drugs and New
Animal Drug Combination Products
Administered in or on Medicated Feed
or Drinking Water of Food-Producing
Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning
Product Use Conditions with GFI #209,’’
(December 2013) (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/cvm-gfi-213-newanimal-drugs-and-new-animal-drugcombination-products-administered-ormedicated-feed) describes a voluntary
process wherein sponsors of new animal
drugs used in and on animal feed and
in water changed the marketing status of
these drugs from over-the-counter to
VFD. As a result of this voluntary
process, which occurred in January
elements and averaged among
respondents.
In addition to the recordkeeping
requirement under § 558.6(c)(3), if a
distributor manufactures the VFD feed,
the distributor must also keep VFD
manufacturing records for 1 year in
accordance with 21 CFR part 225 and
such records must be made available for
inspection and copying by FDA upon
request (§ 558.6(c)(4)). These record
requirements are currently approved
under OMB control number 0910–0152,
‘‘Current Good Manufacturing Practice
Regulations for Medicated Feed.’’
2017, the number of establishments
distributing feeds containing VFD drugs
increased, as well as the number of
veterinarians issuing VFDs, and the
number of food animal producers using
VFD medicated feed. Thus, based on the
current number of mixed practice
veterinarians and the number of food
animal veterinarians listed on the
American Veterinary Medical
Association’s website, we have
increased the number of recordkeepers
for veterinarians and producers.
Additionally, based on our program
experience, we have decreased the
number of records per recordkeeper, as
we believe the previous numbers were
too high. The burden we attribute to
recordkeeping activities is assumed to
be distributed among the individual
C. Third-Party Disclosure Requirements
Description of Respondents: Food
Animal Veterinarians, VFD Feed
Distributors, and Clients.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
respondents
21 CFR part/activity
Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure
Total
hours
558.6(b)(3)(v) and (b)(7)(ix); requires veterinarians to disclose information
on a VFD.
558.6(c)(8); requires acknowledgment letter from one distributor to another
5,278
40
211,120
0.12 (7 minutes) .....
25,334
2,422
5
12,110
0.12 (7 minutes) .....
1,453
Total ........................................................................................................
7,700
..............................
........................
.................................
26,787
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Totals may not sum due to rounding.
Based on program experience, we
believe the original number of thirdparty disclosures estimate was too high
and have decreased the number of
disclosures per respondent. The VFD
regulation also contains several labeling
provisions. These labeling statements
are a ‘‘public disclosure of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public’’ (5
CFR 1320.3(c)(2)) and, therefore, do not
constitute a ‘‘collection of information’’
under the PRA (44 U.S.C. 3501, et seq.).
After a review of the information
collection since our last request for
OMB approval, we have adjusted our
estimates based on our experience with
the VFD regulations and updated data.
As a result, the total burden for the
information collection has decreased
39,387 hours since the last OMB
approval.
VerDate Sep<11>2014
17:00 Jun 14, 2024
Jkt 262001
Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13299 Filed 6–14–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–0784]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:
Reproduction Testing (Revision 1);
Draft Guidance for Industry; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA or Agency) is
correcting a notice that appeared in the
Federal Register on May 23, 2024. The
SUMMARY:
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\17JNN1.SGM
17JNN1
]]>Agencies
[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51351-51352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13299]
[[Page 51351]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0802]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Veterinary Feed
Directive
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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 July 17, 2024.
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 0910-0363. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
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.
Veterinary Feed Directive
OMB Control Number 0910-0363--Extension
This information collection helps support implementation of FDA
statutory and regulatory requirements. Section 504 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 354) establishes a
regulatory category for certain new animal drugs called veterinary feed
directive (VFD) drugs. Our VFD regulation is set forth at Sec. 558.6
(21 CFR 558.6). VFD drugs are new animal drugs, intended for use in or
on animal feed, which are limited to use under the professional
supervision of a licensed veterinarian in the course of the
veterinarian's professional practice. An animal feed containing a VFD
drug or a combination VFD drug may be fed to animals only by or upon a
lawful VFD issued by a licensed veterinarian.
Distributors of medicated feed containing VFD drugs must notify FDA
of their intent to distribute such feed via U.S. Postal mail, email, or
fax and must maintain records of the receipt and distribution of all
medicated feeds containing VFD drugs. Veterinarians issue three copies
of the VFD: one for their own records, one for their client, and one to
the client's VFD feed distributor. For third-party disclosures, FDA
regulation requires that veterinarians include specific information on
the VFD. A distributor may only distribute a VFD feed to another
distributor for further distribution if the originating distributor
(consignor) first obtains a written acknowledgment letter from the
receiving distributor (consignee) before the feed is shipped.
We developed the guidance document ``Guidance for Industry (GFI)
#233 Veterinary Feed Directive Common Format Questions and Answers''
(September 2016) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-233-veterinary-feed-directive-common-format-questions-and-answers) to provide guidance concerning the
elements that must be included on the VFD and the elements that may be
included on the VFD as described in Sec. 558.6. The guidance also
provides examples that illustrate how a common VFD format might appear.
Agency guidance documents are issued in accordance with our good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
The VFD regulation ensures the protection of public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost effectively as possible. We will use the information collected
to assess compliance with the VFD regulation. The required reporting,
recordkeeping, and third-party disclosures provide assurance that the
medicated feeds will be safe and effective for their labeled conditions
of use and that edible products from treated animals will be free of
unsafe drug residues.
In the Federal Register of March 21, 2024 (89 FR 20218), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
A. Reporting Requirements
Description of Respondents: VFD Feed Distributors.
Table 1--Estimated Annual Reporting Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part/activity Number of responses per Total annual Average burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
558.6(c)(5) requires a 112 1 112 0.12 (7 minutes)....... 13
distributor to notify FDA
prior to the first time it
distributes a VFD feed.
558.6(c)(6) requires a 239 1 239 0.12 (7 minutes)....... 29
distributor to notify FDA
within 30 days of any change
in ownership, business name,
or business address.
---------------------------------------------------------------------------------
Total..................... 351 .............. .............. ....................... 42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Totals may not sum due to rounding.
The number of respondents is based on the average number of
notifications we have received over the past 3 years. Additional
reporting burdens for current VFD drug sponsors are approved under OMB
control numbers 0910-0032 (New Animal Drug Applications) and 0910-0669
(Abbreviated New Animal Drug Applications).
B. Recordkeeping Requirements
Description of Respondents: VFD Feed Distributors, Food Animal
Veterinarians, and Clients (Food Animal Producers).
[[Page 51352]]
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part/activity Number of records per Total annual Average burden per recordkeeping Total
recordkeepers recordkeeper records hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(4) and (c)(3), (4), and (8); requires 30,800 219.03 6,746,096 0.02 (1 minute)............................ 134,922
recordkeeping by veterinarians, producers, and
distributors to maintain their copy of the VFD
Order, their receipt and distribution records,
and their manufacturing records and
acknowledgement letters, if applicable, for 2
years.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
FDA's guidance document, ``GFI # 213 New Animal Drugs and New
Animal Drug Combination Products Administered in or on Medicated Feed
or Drinking Water of Food-Producing Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209,'' (December 2013) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed)
describes a voluntary process wherein sponsors of new animal drugs used
in and on animal feed and in water changed the marketing status of
these drugs from over-the-counter to VFD. As a result of this voluntary
process, which occurred in January 2017, the number of establishments
distributing feeds containing VFD drugs increased, as well as the
number of veterinarians issuing VFDs, and the number of food animal
producers using VFD medicated feed. Thus, based on the current number
of mixed practice veterinarians and the number of food animal
veterinarians listed on the American Veterinary Medical Association's
website, we have increased the number of recordkeepers for
veterinarians and producers.
Additionally, based on our program experience, we have decreased
the number of records per recordkeeper, as we believe the previous
numbers were too high. The burden we attribute to recordkeeping
activities is assumed to be distributed among the individual elements
and averaged among respondents.
In addition to the recordkeeping requirement under Sec.
558.6(c)(3), if a distributor manufactures the VFD feed, the
distributor must also keep VFD manufacturing records for 1 year in
accordance with 21 CFR part 225 and such records must be made available
for inspection and copying by FDA upon request (Sec. 558.6(c)(4)).
These record requirements are currently approved under OMB control
number 0910-0152, ``Current Good Manufacturing Practice Regulations for
Medicated Feed.''
C. Third-Party Disclosure Requirements
Description of Respondents: Food Animal Veterinarians, VFD Feed
Distributors, and Clients.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part/activity Number of disclosures per Total annual Average burden per disclosure Total
respondents respondent disclosures hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(b)(3)(v) and (b)(7)(ix); requires 5,278 40 211,120 0.12 (7 minutes)........................ 25,334
veterinarians to disclose information on a VFD.
558.6(c)(8); requires acknowledgment letter from 2,422 5 12,110 0.12 (7 minutes)........................ 1,453
one distributor to another.
-------------------------------------------------------------------------------------------------------
Total....................................... 7,700 ................. .............. ........................................ 26,787
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
Based on program experience, we believe the original number of
third-party disclosures estimate was too high and have decreased the
number of disclosures per respondent. The VFD regulation also contains
several labeling provisions. These labeling statements are a ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)) and, therefore, do not constitute a ``collection of
information'' under the PRA (44 U.S.C. 3501, et seq.).
After a review of the information collection since our last request
for OMB approval, we have adjusted our estimates based on our
experience with the VFD regulations and updated data. As a result, the
total burden for the information collection has decreased 39,387 hours
since the last OMB approval.
Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13299 Filed 6-14-24; 8:45 am]
BILLING CODE 4164-01-P
