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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
lotter on DSK11XQN23PROD with NOTICES1

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 HFA305, 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
2015D0868 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, 2404027500.
Confidential SubmissionsTo 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 FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https

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www.govinfo.gov/content/pkg/FR-201509-18/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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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 209930002, 301
7961723.
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
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recommendations to manufacturers for applying the concepts described in the guidance for industry entitled PATA
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 Q2R1 Validation of Analytical Procedures: Text and Methodology https www.fda.gov/
regulatory-information/search-fdaguidance-documents/q2-r1-validationanalytical-procedures-text-andmethodology 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 guidances 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 FDAs 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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