Notice2021-16930
Development and Submission of Near Infrared Analytical Procedures; Guidance for Industry; Availability
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Published
August 9, 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 "Development and Submission of Near Infrared Analytical Procedures." This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. This guidance finalizes the draft guidance of the same title issued on March 31, 2015.
Full Text
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<title>Federal Register, Volume 86 Issue 150 (Monday, August 9, 2021)</title>
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[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43555-43557]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16930]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0868]
Development and Submission of Near Infrared Analytical
Procedures; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (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
``Development and Submission of Near Infrared Analytical Procedures.''
This guidance provides recommendations to applicants to aid the
development, validation, and use of near infrared (NIR)-based
analytical procedures in evaluating the identity, strength, quality,
purity, and potency of drug substances and drug products. The
recommendations apply to new drug applications (NDAs), abbreviated new
drug applications (ANDAs), and supplemental NDAs and ANDAs for small
molecule drugs. The principles in this guidance also apply to drug
substances and drug products covered in Type II drug master files. This
guidance finalizes the draft guidance of the same title issued on March
31, 2015.
DATES: The announcement of the guidance is published in the Federal
Register on August 9, 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>.
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<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-2015-D-0868 for ``Development and Submission of Near Infrared
Analytical Procedures.'' 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 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. 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: Eugenia Nashed, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4154, Silver Spring, MD 20993-0002, 301-
796-1723.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Development and Submission of Near Infrared Analytical
Procedures.'' This guidance provides recommendations to applicants to
aid the development, validation, and use of NIR-based analytical
procedures in evaluating the identity, strength, quality, purity, and
potency of drug substances and drug products. The recommendations apply
to NDAs, ANDAs, and supplemental NDAs and ANDAs for small molecule
drugs. The principles in this guidance also apply to drug substances
and drug products covered in Type II drug master files. FDA intends to
issue recommendations specific to NIR methods used for biological
products under biologics license applications in a future revision to
this guidance. Specifically, this guidance, among other things, (1)
addresses the development and submission of NIR analytical procedures
used during and for the manufacture and analysis of pharmaceuticals
(including raw materials, in-process materials and intermediates, drug
substances, and finished products); (2) provides recommendations to
manufacturers for applying the concepts described in the guidance for
industry entitled ``PAT--A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance'' (<a href="https://www.fda.gov/media/71012/download">https://www.fda.gov/media/71012/download</a>) and the International Council for
Harmonisation guidance for industry entitled ``Q2(R1) Validation of
Analytical Procedures: Text and Methodology'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology</a>) to NIR analytical
procedures that use chemometric models; and (3) describes the type of
information that should be submitted about NIR analytical procedures in
applications.
This guidance pertains only to the development and validation of
NIR analytical procedures and does not provide recommendations
concerning the setup, qualification, maintenance, or calibration of NIR
instruments. Although this guidance specifically addresses NIR
spectroscopy, this guidance's concepts of validation can be applied to
other multivariate analytical technics, including, for example, Raman.
This guidance finalizes the draft guidance entitled ``Development
and Submission of Near Infrared Analytical Procedures'' issued on March
31, 2015 (80 FR 17057). FDA considered comments received on the draft
guidance as the guidance was finalized. Changes from the draft to the
final guidance include updates to reflect Agency regulatory experience
and technological advancements in the industry, as well as management
of NIR procedures over the life cycle of the products.
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 the development and submission of NIR
analytical procedures. 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.
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The previously approved collections of information are subject to
review by OMB under the PRA. The collections of information in 21 CFR
part 314 for NDAs and in 21 CFR parts 314 and 601 for annual reports,
ANDAs, and supplements to applications have been approved under OMB
control numbers 0910-0001 and 0910-0338, respectively. The collections
of information in 21 CFR part 211 for current good manufacturing
practices for finished pharmaceuticals and medical gases 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> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16930 Filed 8-6-21; 8:45 am]
BILLING CODE 4164-01-P
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