[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]]

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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 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\
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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
----------------------------------------------------------------------------------------------------------------
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
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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).

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                                                 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) (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\
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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.
                                                 -------------------------------------------------------------------------------------------------------
    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