[Federal Register Volume 89, Number 46 (Thursday, March 7, 2024)]
[Notices]
[Pages 16582-16584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04834]
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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;
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 final guidances for industry entitled ``Q2(R2)
Validation of Analytical Procedures'' and ``Q14 Analytical Procedure
Development.'' The guidances were prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH). The guidance entitled ``Q2(R2)
Validation of Analytical Procedures'' provides a general framework for
the principles of analytical procedure validation, including validation
principles that cover the analytical use of spectroscopic data. The
guidance entitled ``Q14 Analytical Procedure Development'' provides
harmonized guidance on scientific approaches for analytical procedure
development and describes principles to facilitate more efficient,
science-based, and risk-based postapproval change management. The
guidances are intended to facilitate regulatory evaluations and
potential flexibility in postapproval change management of analytical
procedures when scientifically justified. The guidances replace the
draft guidances ``Q2(R2) Validation of Analytical Procedures'' and''
Q14 Analytical Procedure Development'' issued on August 29, 2022.
DATES: The announcement of the guidances is published in the Federal
Register on March 7, 2024.
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
[[Page 16583]]
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-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]; or James Myers,
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.
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, 301-796-5259,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the guidances for industry
entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14
Analytical Procedure Development.'' The guidances were prepared under
the auspices of ICH. ICH seeks to achieve 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 enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
The six Founding Members of the ICH are 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. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and 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.
[[Page 16584]]
In the Federal Register of August 29, 2022 (87 FR 52784), FDA
published a notice announcing the availability of the draft guidances
entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14
Analytical Procedure Development.'' The notice gave interested persons
an opportunity to submit comments by September 28, 2022.
After consideration of the comments received and revisions to the
guideline, final drafts of the guidelines were submitted to the ICH
Assembly and endorsed by the regulatory agencies in November 2023.
These guidances finalize the draft guidances issued on August 29,
2022. The final ``Q2(R2) Validation of Analytical Procedures'' guidance
resolves issues on range, response, reference material, biologics,
replicates, and dissolution. In addition, guidance on data requirements
for accuracy, precision, and the combined approach (e.g., confidence
intervals) were refined. The final ``Q14 Analytical Procedure
Development'' guidance includes further clarification of concepts like
minimum versus enhanced approach, the definition and description of the
analytical targeting profile, and established conditions.
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Q2(R2) Validation of Analytical
Procedures'' and ``Q14 Analytical Procedure Development.'' These
guidances 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). 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 guidance at
https://www.regulations.gov, 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, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Dated: March 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04834 Filed 3-6-24; 8:45 am]
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