[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52784-52786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18516]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1503]


Q2(R2) Validation of Analytical Procedures and Q14 Analytical 
Procedure Development; International Council for Harmonisation; Draft 
Guidances 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 two draft guidances for industry entitled ``Q2(R2) 
Validation of Analytical Procedures'' and ``Q14 Analytical Procedure 
Development.'' These draft guidances were prepared under the auspices 
of the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH), formerly the 
International Conference on Harmonisation. These draft guidances 
harmonize scientific approaches for analytical procedure development 
and include validation of a wider range of analytical techniques. The 
draft guidances are intended to facilitate regulatory evaluations and 
facilitate potential flexibility in postapproval change management of 
analytical procedures. The draft Q2(R2) guidance revises the ICH 
guidance for industry ``Q2(R1) Validation of Analytical Procedures: 
Text and Methodology'' published in November 2005.

DATES: Submit either electronic or written comments on the draft 
guidance by September 28, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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.

[[Page 52785]]

     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-2022-D-1503 for ``Q2(R2) Validation of Analytical Procedures'' and 
``Q14 Analytical Procedure Development.'' 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 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 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. Send 
one self-addressed adhesive label to assist that 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: 
    Regarding the guidance: David Keire, Center for Drug Evaluation and 
Research, Food and Drug Administration, 645 S Newstead Ave., Rm. 2008, 
St. Louis, MO 63110-1116, [email protected].
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6364, Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of two draft guidances for 
industry entitled ``Q2(R2) Validation of Analytical Procedures'' and 
``Q14 Analytical Procedure Development.'' The draft guidances were 
prepared under the auspices of ICH. ICH has the mission of achieving 
greater regulatory harmonization worldwide to ensure that safe, 
effective, high-quality medicines are developed, registered, and 
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the 
world, ICH guidelines have substantially reduced duplicative clinical 
studies, prevented unnecessary animal studies, standardized the 
reporting of important safety information, standardized marketing 
application submissions, and made many other improvements in the 
quality of global drug development and manufacturing and the products 
available to patients.
    The six Founding Members of the ICH are the FDA; the Pharmaceutical 
Research and Manufacturers of America; the European Commission; the 
European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; and the Japanese 
Pharmaceutical Manufacturers Association. The Standing Members of the 
ICH Association include Health Canada and Swissmedic. Additionally, the 
Membership of ICH has expanded to include other regulatory authorities 
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and 
industry parties in detailed technical harmonization work and the 
application of a science-based approach to harmonization through a 
consensus-driven process that results in the development of ICH 
guidelines. The regulators around the world are committed to 
consistently adopting these consensus-based guidelines, realizing the 
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in 
the development of each of the ICH guidelines, which FDA then adopts 
and issues as guidance for industry. FDA's guidance documents do not 
establish legally enforceable responsibilities. Instead, they describe 
the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited.
    In March 2022, the ICH Assembly endorsed the draft guidelines 
entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14 
Analytical Procedure Development'' and agreed that the guidelines 
should be made available for public comment. The draft guidelines are 
the product of the Quality Expert Working Group of the ICH. Comments 
about these draft guidances will be considered by FDA and the Quality 
Expert Working Group.
    The draft Q2(R2) guideline revises the Q2(R1) guideline published 
in 2005 to cover a broader range of analytical

[[Page 52786]]

procedures, including those used for process control and that apply to 
multivariate methods. The draft Q14 guideline harmonizes scientific 
approaches for analytical procedure development and describes 
principles to facilitate more efficient and science-based and risk-
based postapproval change management. The two guidelines are intended 
to facilitate regulatory evaluations and facilitate potential 
flexibility in postapproval change management of analytical procedures 
where scientifically justified.
    These draft guidances have been left in the original ICH format. 
The final guidances will be reformatted and edited to conform with 
FDA's good guidance practices regulation (21 CFR 10.115) and style 
before publication. The draft guidances, when finalized, will represent 
the current thinking of FDA on the topics they address. They do not 
establish any rights for any person and are 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 investigational new drug applications have been 
approved under OMB control number 0910-0014; the collections of 
information for review of new drug applications have been approved 
under OMB control number 0910-0001; and the collections of information 
for review of biologics license applications have been approved under 
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidances 
at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18516 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P