Notice2024-13299
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
Primary source
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Published
June 17, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 117 (Monday, June 17, 2024)</title>
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[Federal Register Volume 89, Number 117 (Monday, June 17, 2024)]
[Notices]
[Pages 51351-51352]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13299]
[[Page 51351]]
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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.
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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 <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 0910-0363. 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,
<a href="/cdn-cgi/l/email-protection#b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="3f6f6d7e6c4b5e59597f595b5e1157574c11585049">[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.
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) (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-233-veterinary-feed-directive-common-format-questions-and-answers">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-233-veterinary-feed-directive-common-format-questions-and-answers</a>) 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\
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Number of
21 CFR part/activity Number of responses per Total annual Average burden per Total
respondents respondent responses response hours
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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.
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Total..................... 351 .............. .............. ....................... 42
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\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\
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Number of
21 CFR part/activity Number of records per Total annual Average burden per recordkeeping Total
recordkeepers recordkeeper records hours
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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.
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\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) (<a href="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">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</a>)
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\
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Number of
21 CFR part/activity Number of disclosures per Total annual Average burden per disclosure Total
respondents respondent disclosures hours
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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.
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Total....................................... 7,700 ................. .............. ........................................ 26,787
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\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
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