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Notice

Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability

A Notice by the Food and Drug Administration on 04/20/2023

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Published Document: 2023-08331 (88 FR 24427)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2023-D-1146]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.” The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation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 ( printed page 24428) 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Submit either electronic or written comments on the draft guidance by July 19, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 onhttps://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 ( printed 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

Published Document: 2023-08331 (88 FR 24427)