Notice2025-07578
Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
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Published
May 1, 2025
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 recordkeeping provisions set forth in Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk Substances.
Full Text
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18665-18667]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0082]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Compounding Animal Drugs From Bulk Drug Substances
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 existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the recordkeeping provisions set forth in
Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk
Substances.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2025.
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 June 30, 2025. 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.
[[Page 18666]]
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-2025-N-0082 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Compounding Animal Drugs from
Bulk Drug Substances.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#9dcdcfdccee9fcfbfbddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="8bdbd9cad8ffeaededcbedefeaa5e3e3f8a5ece4fd">[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.
Compounding Animal Drugs From Bulk Substances
OMB Control Number 0910-0904--Extension
This information collection helps support recommendations discussed
in FDA guidance. Animal drugs compounded from bulk drug substances by
pharmacists and veterinarians do not meet certain important
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). To
be legally marketed in accordance with animal drug approval
requirements of the FD&C Act, an approval, conditional approval, or
listing on the Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species \1\ is required, and compounded drugs do not go
through any of these pre-market review processes. (Information
collection associated with new animal drug applications is approved
under OMB control no. 0910-0032; information collection pertaining to
index of legally marketed unapproved new animal drugs for minor species
is approved under OMB control no. 0910-0605.) Further, all animal drugs
are required to, among other things, be made in accordance with current
good manufacturing practice (CGMP) requirements and have adequate
directions for use, requirements not met by compounded drugs.\2\ Thus,
drugs compounded from bulk drug substances violate the FD&C Act because
they are not approved or indexed, are not made according to CGMP, and
cannot satisfy the FD&C Act's adequate directions for use provision
(which requires, among other things, that a prescription drug have FDA-
approved labeling). However, FDA has generally refrained from taking
enforcement action against animal drugs
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compounded from bulk drug substances under certain circumstances when
no other medically appropriate treatment options exist.
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\1\ Sections 512, 571, and 572 of the FD&C Act (21 U.S.C. 360b,
360ccc, 360ccc-1).
\2\ Section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)), 21 CFR parts 210 and 211, and section 502(f)(1) of
the FD&C Act (21 U.S.C. 352(f)(1)).
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To assist respondents in understanding FDA's current thinking about
animal drug compounding from bulk substances, our Center for Veterinary
Medicine developed GFI #256 entitled ``Compounding Animal Drugs from
Bulk Drug Substances'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances</a>). The guidance describes circumstances under which
FDA generally does not intend to take enforcement action against
pharmacists and veterinarians who compound animal drugs from bulk drug
substances.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
Activity Number of responses per annual per response Total hours
respondents respondent responses (1 minute)
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Documenting rationales by licensed 7,500 1,134 8,505,000 0.017 144,585
veterinarian/pharmacist compounders in
state-licensed pharmacies or Federal
facilities.............................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimates on our experience with the regulation of
compounded animal drugs. Based on a review of the information
collection since our last request for OMB approval, we have made no
adjustments to our burden estimate.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07578 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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