[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56392-56393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15003]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2484]


Purpose and Content of Use-Related Risk Analyses for Drugs, 
Biological Products and Combination Products; Draft Guidance for 
Industry and Food and Drug Administration Staff; 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the availability of a draft guidance for industry and FDA staff 
entitled ``Purpose and Content of Use-Related Risk Analyses for Drugs, 
Biological Products, and Combination Products.'' This document provides 
guidance to industry and FDA staff on the purpose and content of a use-
related risk analysis (URRA) and how a URRA, along with other 
information, can be used to determine human factors (HF) data needs 
during product development and to support a marketing application.

DATES: Submit either electronic or written comments on the draft 
guidance by September 9, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2024-D-2484 for ``Purpose and Content of Use-Related Risk Analyses 
for Drugs, Biological Products and Combination Products.'' 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 this 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; the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; 
or the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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: Jason Flint, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 22, Rm. 4488, Silver Spring, MD 20993-0002, 240-
402-6293, [email protected]; Tania Reina, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2502, Silver Spring, MD 20993-0002, 301-221-7499; 
John Barlow Weiner, Office of Combination Products, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver 
Spring, MD 20993-0002, 301-796-8930, [email protected]; or James 
Myers, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7226, Silver 
Spring, MD 20993-0002, 240-402-5923.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Purpose and Content of Use-Related Risk 
Analyses for Drugs, Biological Products, and Combination

[[Page 56393]]

Products.'' This guidance provides recommendations to industry and FDA 
staff on the purpose and content of a URRA and how a URRA, along with 
other information, can be used to determine HF data needs during 
product development and to support a marketing application. This 
guidance applies to drug- and biologic-led combination products that 
are the subject of an investigational new drug application (IND), a new 
drug application (NDA), or a biologics license application (BLA) and 
supplements to these applications. This guidance also applies to human 
prescription drug products, including biological products, that are the 
subject of an IND, NDA, or BLA and supplements to these applications, 
and to human nonprescription drug products that are the subject of an 
IND or NDA and supplements to these applications. This guidance does 
not describe the methods used to design, conduct, or analyze human 
factors studies (for example, human factors validation studies or 
comparative use human factors studies).
    The URRA is a risk management tool that supports the entire human 
factors engineering process and should be considered as part of an 
overall risk management framework. The URRA can be used in all phases 
of the medical product lifecycle. As part of evaluating the products as 
described above, FDA will evaluate human factors data submitted by 
sponsors to support the product user interface when submission of such 
data is warranted. The URRA can be used as one data element to help 
determine whether submission of human factors data is warranted.
    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 ``Purpose and 
Content of Use-Related Risk Analyses for Drugs, Biological Products and 
Combination Products.'' 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR part 312 pertaining to the submission of INDs have been 
approved under OMB control number 0910-0014. The collections of 
information in 21 CFR part 314 pertaining to the submission of NDAs and 
supplements to NDAs have been approved under 0910-0001. The collections 
of information in 21 CFR part 601 pertaining to the submissions of BLAs 
and supplements to BLAs have been approved under OMB control number 
0910-0338.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: July 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15003 Filed 7-8-24; 8:45 am]
BILLING CODE 4164-01-P