[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27437-27438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10611]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0166]


International Council for Harmonisation Q12: Implementation 
Considerations for Food and Drug Administration-Regulated Products; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``ICH Q12: 
Implementation Considerations for FDA-Regulated Products.'' The 
International Council for Harmonisation (ICH) guidance for industry 
entitled ``Q12 Technical and Regulatory Considerations for 
Pharmaceutical Product Lifecycle Management'' and its Annexes (ICH Q12, 
May 2021) provide a framework to facilitate the management of 
postapproval chemistry, manufacturing, and controls (CMC) changes in a 
more predictable and efficient manner. ICH Q12 includes regulatory 
tools and enablers with associated guiding principles that should 
enhance industry's ability to manage postapproval changes and increase 
transparency between industry and regulatory authorities, supporting 
innovation and continual improvement. This guidance complements ICH Q12 
by clarifying how its tools and enablers can be implemented within the 
U.S. regulatory system. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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.
     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-2021-D-0166 for ``ICH Q12: Implementation Considerations for FDA-
Regulated 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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), Food and Drug Administration, 10001 New Hampshire 
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; 
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 
Office of Policy, Center for Devices and Radiological Health (CDRH), 
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: Ashley Boam, CDER, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver 
Spring, MD 20993-0002, 301-796-6341; Stephen Ripley, CBER, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911; or Andrew Yeatts, CDRH, 
Food and Drug Administration, 10903 New Hampshire

[[Page 27438]]

Ave., Bldg. 66, Rm. 5510, Silver Spring, MD 20993-0002, 301-796-4539.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ICH Q12: Implementation Considerations for FDA-Regulated 
Products.'' ICH Q12 provides a framework to facilitate the management 
of postapproval CMC changes in a more predictable and efficient manner. 
It includes regulatory tools and enablers with associated guiding 
principles that should enhance industry's ability to manage 
postapproval changes and increase transparency between industry and 
regulatory authorities, supporting innovation and continual 
improvement.
    This guidance should be read in conjunction with ICH Q12, which 
this guidance complements by clarifying how the ICH Q12 tools and 
enablers can be implemented within the U.S. regulatory system. These 
guidances apply to drug substances and drug products that are the 
subject of new drug applications (NDAs), biologics license applications 
(BLAs), abbreviated new drug applications (ANDAs), and supplements to 
these applications regulated by CDER and CBER. They also apply to 
combination products with device constituent parts that are the subject 
of NDAs, BLAs, ANDAs, and supplements to these applications regulated 
by CDER and CBER. This guidance provides considerations for 
implementation of ICH Q12 tools, such as established conditions, 
postapproval change management protocols, and the product lifecycle 
management document. The considerations provided follow the order of 
the sections in ICH Q12 and are specific to FDA's implementation.
    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 ``ICH Q12: 
Implementation Considerations for FDA-Regulated 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 for the submission of NDAs and ANDAs in 21 CFR 314.50, 
314.70, 314.71, 314.94, and 314.97, including supplements, have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR parts 210 and 211 have been approved under OMB 
control number 0910-0139. The collections of information for the 
submission of BLAs under 21 CFR 601.2 and 601.12 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10611 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P