[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33310-33312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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finalizes the draft guidance, ``Chemistry, Manufacturing, and Controls 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:
     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

[[Page 33311]]

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-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 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 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 https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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