Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 20218-20221 [2024-05986]
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20218
Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
February 22, 2024
Tara Viviani, RAC
Senior Director, Molecular Regulatory Affairs
Luminex Corporation
12212 Technology Blvd.
Austin, TX 78727
Re: Revocation of EUA.201881
Dear Tara Viviani:
'I11is letter is in response to the request from Luminex Corporation, in a letter dated February 19,
2024, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for the xMAP
SARS-CoV-2 Multi-Antigen IgG Assay issued on July 16, 2020, and amended on September 23,
2021, and March 9, 2022. Luminex Corporation indicated that they have discontinued
manufacture of the authorized product and requested that the EUA be withdrawn. FDA
understands that as ofthe date of this letter there are no viable xMAP SARS-CoV-2 MultiAntigen IgG Assayreagents remaining in distribution in the United States.
The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) 1nay, pursuant to section 564(g)(2) of the. Act,
be revoked when .circmustances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because Lmninex Corporation has requested that FDA
withdraw the EUAfor the xMAP SARS-Co V 2 Multi-Antigen lgG Assay, FDA has determined
that it is appropriate to ptotect the public health or safety to revoke this authorization.
Accordingly, FDA hereby revokes EUA201881 for the xMAP SARS-Co V-2 Multi-Antigen IgG
Assay, pursuant to section 564(g)(2)(C) of the Act As of the date of this letter, the xMAP
SARS-CoV-2 Multi-Antigen IgG Assay is no longer authorized for emergency use by FDA
0
Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1)
oftheAct
Sincerely,
/Isl!
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Cc: Jennifer Svoboda, Manager, Regulatory Affairs, Lum.inex Corporation
[FR Doc. 2024–05980 Filed 3–20–24; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–C
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.
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ACTION:
Notice.
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
SUMMARY:
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EN21MR24.005</GPH>
Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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
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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-201509-18/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
PO 00000
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20219
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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
§ 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
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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-fdaguidance-documents/cvm-gfi-233veterinary-feed-directive-commonformat-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. 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
Number of
respondents
21 CFR part/activity
Number of
responses per
respondent
Total annual
responses
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.
558.6(c)(6) requires a distributor to notify FDA within 30 days of any change in ownership, business name, or business address.
112
1
112
0.12 (7 minutes)
13
239
1
239
0.12 (7 minutes)
29
Total .......................................................................................................................
351
........................
........................
...........................
42
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
Veterinarians, and Clients (Food Animal
Producers).
Description of Respondents: VFD
Feed Distributors, Food Animal
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part/activity
558.6(a)(4) and (c)(3), (4), and (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.
lotter on DSK11XQN23PROD with NOTICES1
1 There
Number of
records per
recordkeeper
30,800
219.03
Total
annual
records
6,746,096
Average
burden per
recordkeeping
Total
hours
0.02 (1 minute) ..
134,922
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-fdaguidance-documents/cvm-gfi-213-newanimal-drugs-and-new-animal-drugcombination-products-administered-ormedicated-feed) describes a voluntary
process wherein sponsors of new animal
drugs used in and on animal feed and
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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
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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
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Federal Register / Vol. 89, No. 56 / Thursday, March 21, 2024 / Notices
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 BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR part/activity
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 ..................
5,278
2,422
40
5
211,120
12,110
Total ...........................................................................................................................
7,700
......................
......................
1 There
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
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 and
recordkeeping requirements of our
regulations implementing the Federal
Import Milk Act (FIMA).
Either electronic or written
comments on the collection of
information must be submitted by May
20, 2024.
DATES:
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.
ADDRESSES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0972]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Average
burden per
disclosure
Total
hours
0.12 (7 minutes)
0.12 (7 minutes)
25,334
1,453
...........................
26,787
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 thirdparty 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.
lotter on DSK11XQN23PROD with NOTICES1
Total
annual
disclosures
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
SUMMARY:
VerDate Sep<11>2014
16:53 Mar 20, 2024
Jkt 262001
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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–0972 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Regulations Under the Federal Import
Milk Act.’’ 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
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR part/activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden per Total
21 CFR part/activity respondents per disclosures disclosure hours
respondent
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
