Notice2021-13392
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability
Primary source
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Published
June 24, 2021
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 final guidance document entitled "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products." The guidance is intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). The guidance describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes. The guidance announced in this notice finalizes the draft guidance, "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products," dated December 2017 and supersedes the document entitled "Guidance for Industry: Changes to an Approved Application: Biological Products," dated July 1997 (July 1997 guidance).
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33310-33312]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13392]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1995-D-0288 (Formerly Docket No. 95D-0052)]
Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Guidance for Industry;
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 final guidance document entitled ``Chemistry,
Manufacturing, and Controls Changes to an Approved Application: Certain
Biological Products.'' The guidance is intended to assist applicants
and manufacturers of certain licensed biological products in
determining which reporting category is appropriate for a change in
chemistry, manufacturing, and controls (CMC) information to an approved
biologics license application (BLA). The guidance describes general and
administrative information on evaluating and reporting changes and
recommendations for reporting categories based on a tiered-reporting
system for specific changes. The guidance announced in this notice
finalizes the draft guidance, ``Chemistry, Manufacturing, and Controls
Changes to an Approved Application: Certain Biological Products,''
dated December 2017 and supersedes the document entitled ``Guidance for
Industry: Changes to an Approved Application: Biological Products,''
dated July 1997 (July 1997 guidance).
DATES: The announcement of the guidance is published in the Federal
Register on June 24, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
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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-1995-D-0288 (Formerly Docket No. 95D-0052) for ``Chemistry,
Manufacturing, and Controls Changes to an Approved Application: Certain
Biological 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 the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
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 the office in processing your
requests. The guidance may also be obtained by mail by calling CBER at
1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance document
entitled ``Chemistry, Manufacturing, and Controls Changes to an
Approved Application: Certain Biological Products.'' The guidance
document is intended to assist applicants and manufacturers of licensed
biological products in determining which reporting category is
appropriate for a change in CMC to an approved BLA as specified in
Sec. 601.12 (21 CFR 601.12). The guidance document provides applicants
and manufacturers general and administrative information on evaluating
and reporting changes and recommendations for reporting categories
based on a tiered-reporting system for specific changes under Sec.
601.12.
FDA issued the July 1997 guidance (62 FR 39904; July 24, 1997) to
assist applicants in determining which reporting mechanism is
appropriate for reporting a change to an approved application to reduce
the burden on manufacturers when reporting changes and to facilitate
the approval process of the change being made. FDA is updating the July
1997 guidance to accommodate advances in manufacturing and testing
technology and to clarify FDA's current thinking on assessing
reportable changes. The updated guidance applies to certain biological
products licensed under section 351(a) of the Public Health Service Act
(PHS Act) (42 U.S.C. 262(a)). The guidance applies to all manufacturing
locations, including contract locations. The following biological
products are not within the scope of this guidance: (1) Whole blood,
blood components (including source plasma), and source leukocytes; (2)
specified biotechnology products described in Sec. 601.2(a); and (3)
biosimilar and interchangeable products subject to licensure under
section 351(k) of the PHS Act. The guidance also does not apply to
human cells, tissues, and cellular and tissue-based products regulated
solely under section 361 of the PHS Act (42 U.S.C. 264) and the
regulations in 21 CFR part 1271.
In the Federal Register of December 22, 2017 (82 FR 60750), FDA
announced the availability of the draft guidance of the same title
dated December 2017. FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized. The guidance was updated to reflect the ICH Harmonised
Guideline: Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management: Q12, which was issued after publication
of the draft guidance on November 11, 2019. In addition, editorial
changes were made to improve clarity. The guidance announced in this
notice finalizes the draft guidance dated December 2017. The guidance
also supersedes the July 1997 guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current
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thinking of FDA on ``Chemistry, Manufacturing, and Controls Changes to
an Approved Application: Certain Biological 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. 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 210 and 21 CFR part 211 have been
approved under OMB control number 0910-0139; the collections of
information in 21 CFR 601.12 have been approved under OMB control
numbers 0910-0338, and the collections of information in 21 CFR part
820 have been approved under OMB control number 0910-0073.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <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/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: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13392 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P
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