[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Notices]
[Pages 24427-24429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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the availability of a draft guidance for industry entitled ``Acute 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The purpose of this draft guidance is to provide information and 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DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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.
    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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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


