Notice2023-08331
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability
Primary source
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Published
April 20, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment." The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.
Full Text
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<title>Federal Register, Volume 88 Issue 76 (Thursday, April 20, 2023)</title>
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[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24427-24429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1146]
Acute Radiation Syndrome: Developing Drugs for Prevention and
Treatment; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Acute
Radiation Syndrome: Developing Drugs for Prevention and Treatment.''
The purpose of this draft guidance is to provide information and
recommendations to assist sponsors and other interested parties in the
development of drugs to prevent or treat acute radiation syndrome (ARS)
caused by exposure to ionizing radiation from accidental or deliberate
events. Generally, drugs developed for such indications will require
approval under
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the regulations commonly referred to as the Animal Rule.
DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2023 to ensure that the Agency considers your
comment 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-2023-D-1146 for ``Acute Radiation Syndrome: Developing Drugs for
Prevention and Treatment.'' 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ronald Honchel, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5426, Silver Spring, MD 20993, 301-796-
0915.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Acute Radiation Syndrome: Developing Drugs for Prevention
and Treatment.'' ARS is the term applied to a variety of clinical
subsyndromes resulting from the exposure of humans to high doses of
radiation. The predominance of expression of these clinical
subsyndromes is highly dependent on the magnitude and extent of
radiation exposure and the time following exposure. This draft
guidance, when finalized, will help sponsors efficiently develop drugs
to prevent or treat ARS. Generally, drugs developed for such
indications will require approval under the regulations commonly
referred to as the Animal Rule.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Acute
Radiation Syndrome: Developing Drugs for Prevention and Treatment.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 for investigational new drug
applications have been approved under OMB control number 0910-0014. The
collections of information pertaining to expanded access to
investigational drugs for treatment use have been approved under OMB
control number 0910-0814. The collections of information in 21 CFR part
314 for new drug applications have been approved under OMB control
number 0910-0001. The collections of information pertaining to
prescription drug user fee program have been approved under OMB control
number 0910-0297. The collections of
[[Page 24429]]
information in 21 CFR part 58 pertaining to good laboratory practices
have been approved under OMB control number 0910-0119. The collections
of information for general records and postmarket adverse experience
reporting pertaining to biological products have been approved under
OMB control number 0910-0308. The collections of information pertaining
to postmarketing adverse drug experience reporting have been approved
under OMB control number 0910-0230. The collections of information
resulting from special protocol assessments have been approved under
OMB control number 0910-0470. The collection of information pertaining
to current good manufacturing practices have been approved under OMB
control number 0910-0139. The collections of information in 21 CFR part
601 pertaining to biologics license applications have been approved
under OMB control number 0910-0338. The collections of information in
FDA's guidance entitled ``Emergency Use Authorization of Medical
Products and Related Authorities'' have been approved under OMB control
number 0910-0595. The collections of information pertaining to
expedited review programs for serious conditions and under section 506
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) (as amended
by the Food and Drug Administration Safety and Innovation Act) have
been approved under OMB control number 0910-0765. The collections of
information for the content and format of prescription drug labeling in
21 CFR 201.56 and 201.57 have been approved under OMB control number
0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: April 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08331 Filed 4-19-23; 8:45 am]
BILLING CODE 4164-01-P
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