4164-01-P
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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
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, 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.
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 § 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-233veterinary-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 § 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.
21 CFR Part/Activity

1
Table 1.--Estimated Annual Reporting Burden1, 2
No. of
No. of
Total Annual
Respondents
Responses
Responses
per
Respondent

Average
Burden per
Response

Total
Hours

558.6(c)(5) requires a distributor to
notify FDA prior to the first time it
distributes a VFD feed

1

0.12
(7 minutes)

558.6(c)(6) requires a distributor to
notify FDA within 30 days of any
change in ownership, business name, or
business address

1

0.12
(7 minutes)

Total

There are no capital costs or operating and maintenance costs associated with this collection of information.
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 09100669 (Abbreviated New Animal Drug Applications).
B. Recordkeeping Requirements

Description of Respondents: VFD Feed Distributors, Food Animal Veterinarians, and
Clients (Food Animal Producers).
Table 2.--Estimated Annual Recordkeeping Burden1, 2
21 CFR Part/Activity
No. of
No. of
Total
Recordkeepers
Records per
Annual
Recordkeeper
Records

Average
Burden per
Recordkeeping

Total
Hours

558.6(a)(4) and (c)(3), (4), and (8);
30,800
219.03 6,746,096
0.02
134,922
requires recordkeeping by
(1 minute)
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 FoodProducing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use
Conditions with GFI #209,” (December 2013) (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animaldrug-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 § 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.”
C. Third-Party Disclosure Requirements
Description of Respondents: Food Animal Veterinarians, VFD Feed Distributors, and
Clients.
Table 3.--Estimated Annual Third-Party Disclosure Burden1, 2
21 CFR Part/Activity
No. of
No. of
Total
Average
Respondents Disclosures per
Annual
Burden per
Respondent
Disclosures
Disclosure
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
Total
1
Total Hours

5,278

211,120

0.12
(7 minutes)

25,334

2,422

12,110

0.12
(7 minutes)

1,453

7,700

26,787

There are no capital costs or operating and maintenance costs associated with this collection of information.
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: 6/14/2024 8:45 am; Publication Date: 6/17/2024]