[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28016-28018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10030]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0168]


Benefit-Risk Considerations for Product Quality Assessments; 
Draft Guidance for Industry; Availability

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the availability of a draft guidance for industry entitled ``Benefit-
Risk Considerations for Product Quality Assessments.'' This guidance 
describes the benefit-risk principles applied by FDA when conducting 
product quality-related assessments of chemistry, manufacturing, and 
controls (CMC) information submitted for FDA assessment as part of 
original new drug applications (NDAs), original biologics license 
applications (BLAs), or supplements to such applications, in addition 
to other information (e.g., inspectional findings) available to FDA 
during its assessment. This guidance discusses how FDA assesses risks, 
sources of uncertainty, and possible mitigation strategies for a 
product quality-related issue and how those considerations inform FDA's 
understanding of the potential effect on a product. This guidance also 
discusses how unresolved product quality issues may be addressed in the 
context of regulatory decision making. The guidance notes that product 
quality assessments are also done for abbreviated new drug applications 
(ANDAs), and it discusses how, in certain rare circumstances, 
unresolved product quality issues may be addressed when there is an 
urgent clinical need for

[[Page 28017]]

an ANDA (e.g., a public health emergency or a pervasive drug shortage).

DATES: Submit either electronic or written comments on the draft 
guidance by July 11, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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-2022-D-0168 for ``Benefit-Risk Considerations for Product Quality 
Assessments.'' 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.
    <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 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: Natalia Comella, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Benefit-Risk Considerations for Product Quality 
Assessments.'' This guidance describes the benefit-risk principles 
applied by FDA when conducting product quality-related assessments of 
CMC information submitted for FDA assessment as part of original NDAs 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), original BLAs under section 351 of the Public Health 
Service Act (42 U.S.C. 262), or supplements to such applications, in 
addition to other information (e.g., inspectional findings) available 
to FDA during its assessment. This guidance discusses how FDA assesses 
risks, sources of uncertainty, and possible mitigation strategies for a 
product quality-related issue and how those considerations inform FDA's 
understanding of the potential effect on a product. The outcome of the 
product quality assessment results in a determination as to whether an 
applicant has developed a drug product, manufacturing process, and 
control strategy that will consistently result in a product of 
acceptable quality when manufactured at the facilities named in the 
application.
    When a regulatory decision regarding the approval of an NDA or BLA 
is made, FDA considers the overall benefit(s) and risks identified for 
the product. This can include any residual risk related to unresolved 
product quality issues if they directly affect the assessment. This 
guidance also discusses how unresolved product quality issues may be 
addressed in the context of regulatory decision making. The guidance 
notes that product quality assessments are also done for ANDAs, and it 
discusses how, in certain rare circumstances, unresolved product 
quality issues may be addressed when there is an urgent clinical need 
for an ANDA (e.g., a public health emergency or a pervasive drug 
shortage).
    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 ``Benefit-Risk 
Considerations for Product Quality Assessments.'' 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

[[Page 28018]]

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 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR parts 601 and 610 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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: May 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10030 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P