Notice2024-05986
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
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Published
March 21, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
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<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
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[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20218-20221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.
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) (<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.
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) (<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
[[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.
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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.
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
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