Notice2024-15003
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
July 9, 2024
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products."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.
Full Text
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<title>Federal Register, Volume 89 Issue 131 (Tuesday, July 9, 2024)</title>
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[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56392-56393]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15003]
[[Page 56392]]
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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Biological Products and Combination Products; Draft Guidance for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the availability of a draft guidance for industry and FDA staff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DATES: Submit either electronic or written comments on the draft
guidance by September 9, 2024 to ensure that the Agency considers your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:
<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-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 <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 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, <a href="/cdn-cgi/l/email-protection#f6b9a5b3d8a6bbbda2a4b3b1a5b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="ffb0acbad1afb2b4abadbab8acbf999b9ed197978cd1989089">[email protected]</span></a>; 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, <a href="/cdn-cgi/l/email-protection#63000c0e010a0d02170a0c0d230507024d040c15"><span class="__cf_email__" data-cfemail="1c7f73717e75727d687573725c7a787d327b736a">[email protected]</span></a>; 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 <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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</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: 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
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