Notice2021-26734
Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry; Availability
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Published
December 10, 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 for industry entitled "CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports." This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. The guidance finalizes the draft guidance of the same title dated August 2017.
Full Text
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<title>Federal Register, Volume 86 Issue 235 (Friday, December 10, 2021)</title>
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[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70508-70509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26734]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-2802]
Chemistry, Manufacturing, and Controls Postapproval Manufacturing
Changes for Specified Biological Products To Be Documented in Annual
Reports; 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 for industry entitled ``CMC
Postapproval Manufacturing Changes for Specified Biological Products to
Be Documented in Annual Reports.'' This guidance provides
recommendations to holders of biologics license applications (BLAs) for
specified biological products regarding the types of changes to be
documented in annual reports. Specifically, the guidance describes
chemistry, manufacturing, and controls (CMC) postapproval manufacturing
changes that FDA generally considers to have a minimal potential to
have an adverse effect on the identity, strength, quality, purity, or
potency of the product as they may relate to the safety or
effectiveness of the product. Under FDA regulations, such minor changes
in the product, production process, quality controls, equipment,
facilities, or responsible personnel must be documented by applicants
in an annual report. The guidance finalizes the draft guidance of the
same title dated August 2017.
DATES: The announcement of the guidance is published in the Federal
Register on December 10, 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 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-2017-D-2802 for ``CMC Postapproval Manufacturing Changes for
Specified Biological Products To Be Documented in Annual Reports.''
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
[[Page 70509]]
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 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; or to 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. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Michail Alterman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4245, Silver Spring, MD 20993, 240-402-
9355, or Stephen Ripley, 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 guidance for industry
entitled ``CMC Postapproval Manufacturing Changes for Specified
Biological Products To Be Documented in Annual Reports.'' Applicants
must notify FDA of a change to an approved BLA in accordance with all
statutory and regulatory requirements--including section 506A of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356a) and
Sec. 601.12 (21 CFR 601.12). Section 506A of the FD&C Act provides
requirements for making and reporting manufacturing changes to an
approved application or license and for distributing a drug made with
such changes. Under Sec. 601.12, each postapproval change in the
product, production process, quality controls, equipment, facilities,
or responsible personnel established in an approved BLA is categorized
into one of three reporting categories:
<bullet> Major change: Applicants must submit and receive FDA
approval of a supplement to the BLA before the product produced with
the manufacturing change is distributed.
<bullet> Moderate change: Applicants must submit a supplement at
least 30 days before the product is distributed or, in some cases, the
product may be distributed immediately upon FDA's receipt of the
supplement.
<bullet> Minor change: Applicants may proceed with the change but
must notify FDA of the change in an annual report.
This guidance provides recommendations for reporting certain
changes in an annual report. It discusses the contents of an annual
report notification and lists examples of postapproval manufacturing
changes for BLAs that FDA generally considers to have a minimal
potential to have an adverse effect on the identity, strength, quality,
purity, or potency of the product as they may relate to the safety or
effectiveness of the product.
This guidance finalizes the draft guidance of the same title issued
on August 9, 2017 (82 FR 37232) in the Federal Register. FDA considered
comments received on the draft guidance as the guidance was finalized.
Based on comments received, FDA updated the guidance with additional
manufacturing examples and made editorial changes to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``CMC Postapproval Manufacturing Changes for
Specified Biological Products To Be Documented in Annual Reports.'' 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 601.12 have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR parts
210 and 211 have been approved under OMB control number 0910-0139.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <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/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: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26734 Filed 12-9-21; 8:45 am]
BILLING CODE 4164-01-P
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