[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43555-43557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16930]


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

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.

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

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guidance finalizes the draft guidance of the same title issued on March 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:
     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 43556]]

     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-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 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. 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'' (https://www.fda.gov/media/71012/download) and the International Council for 
Harmonisation guidance for industry entitled ``Q2(R1) Validation of 
Analytical Procedures: Text and Methodology'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology) 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.

[[Page 43557]]

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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    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