Notice2025-06047
Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Reopening of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing the availability of a draft guidance for industry (GFI) that appeared in the Federal Register of January 7, 2025. In that notice, FDA requested comments on draft GFI #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments before the agency begins work on the final version of the guidance.
Full Text
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<title>Federal Register, Volume 90 Issue 67 (Wednesday, April 9, 2025)</title>
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[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Page 15248]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06047]
[[Page 15248]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-5376]
Type VII Veterinary Master File for Research and Development and
Risk Reviews; Draft Guidance for Industry; Reopening of the Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice announcing the availability
of a draft guidance for industry (GFI) that appeared in the Federal
Register of January 7, 2025. In that notice, FDA requested comments on
draft GFI #260 entitled ``Type VII Veterinary Master File for Research
and Development and Risk Reviews.'' The Agency is taking this action in
response to a request for an extension to allow interested persons
additional time to submit comments before the agency begins work on the
final version of the guidance.
DATES: FDA is reopening the comment period on the notice of
availability published January 7, 2025 (90 FR 1143). Submit either
electronic or written comments by June 9, 2025 to ensure that the
Agency considers your comments on this draft guidance before it begins
work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-D-5376 for ``Type VII Veterinary Master File for Research and
Development and Risk Reviews.'' Received comments 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: Lynne Boxer, Center for Veterinary
Medicine, Food and Drug, Food and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240-402-0611, <a href="/cdn-cgi/l/email-protection#85e9fcebebe0abe7eafde0f7c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="84e8fdeaeae1aae6ebfce1f6c4e2e0e5aaececf7aae3ebf2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 7, 2025,
FDA published a notice announcing the availability of a draft GFI
entitled ``Type VII Veterinary Master File for Research and Development
and Risk Reviews.'' Interested persons were originally given until
March 10, 2025, to comment on the draft guidance.
The Agency received a request for a 60-day extension of the comment
period for the draft guidance. The requestor indicated they needed more
time to complete development of comments to submit in response to the
draft guidance. FDA has considered the request and is reopening the
comment period for the draft guidance for 60 days until June 9, 2025.
The Agency believes that a 60-day reopening of the comment period
allows adequate time for interested persons to submit comments to
ensure that the agency can consider the comments on this draft guidance
before it begins work on the final version of the guidance.
Dated: March 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06047 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P
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