[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20218-20221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0802]


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an

[[Page 20219]]

existing collection of information, and to allow 60 days for public 
comment in response to the notice. This notice solicits comments on the 
reporting, recordkeeping, and third-party disclosure burden associated 
with the veterinary feed directive regulations.

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 20, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-N-0802 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Veterinary Feed Directive.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Veterinary Feed Directive--21 CFR 558.6

OMB Control Number 0910-0363--Revision

    This information collection helps support implementation of FDA 
statutory and regulatory requirements. Section 504 of the Federal Food, 
Drug, and Cosmetic Act (FD&C) (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

[[Page 20220]]

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 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. 
We plan to revise the information collection to incorporate this 
guidance document as an instrument. 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.
A. Reporting Requirements
    Description of Respondents: VFD Feed Distributors.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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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.

    The number of respondents is based on the average number of 
notifications we have received over the past 3 years.
B. Recordkeeping Requirements
    Description of Respondents: VFD Feed Distributors, Food Animal 
Veterinarians, and Clients (Food Animal Producers).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                      Number of       Total
       21 CFR part/activity           Number of      records per      annual      Average burden per      Total
                                    recordkeepers   recordkeeper     records         recordkeeping        hours
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558.6(a)(4) and (c)(3), (4), and           30,800          219.03    6,746,096  0.02 (1 minute).......   134,922
 (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.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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

[[Page 20221]]

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\
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                                                      Number of
                                       Number of     disclosures  Total annual     Average burden per     Total
       21 CFR part/activity           respondents        per       disclosures         disclosure         hours
                                                     respondent
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558.6(b)(3)(v) and (b)(7)(ix);               5,278            40       211,120  0.12 (7 minutes).......   25,334
 requires veterinarians to
 disclose information on a VFD.
558.6(c)(8); requires                        2,422             5        12,110  0.12 (7 minutes).......    1,453
 acknowledgment letter from 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.

    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: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05986 Filed 3-20-24; 8:45 am]
BILLING CODE 4164-01-P