80 FR 17057 - Development and Submission of Near Infrared Analytical Procedures; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Development and Submission of Near Infrared Analytical Procedures.'' This draft guidance provides recommendations to applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals. This draft guidance only pertains to the development and validation of NIR analytical procedures and does not provide recommendations concerning the set up and qualification of NIR instruments or their maintenance and calibration.

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17057-17058]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07266]


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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Procedures; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Development 
and Submission of Near Infrared Analytical Procedures.'' This draft 
guidance provides recommendations to applicants of new drug 
applications (NDAs) and abbreviated new drug applications (ANDAs) 
regarding the development and submission of near infrared (NIR) 
analytical procedures used during the manufacture and analysis of 
pharmaceuticals. This draft guidance only pertains to the development 
and validation of NIR analytical procedures and does not provide 
recommendations concerning the set up and qualification of NIR 
instruments or their maintenance and calibration.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 1, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
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 draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John L. Smith, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1757.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Development and Submission of Near Infrared Analytical 
Procedures.'' This draft guidance provides recommendations to 
applicants of NDAs and ANDAs regarding the development and submission 
of NIR analytical procedures used during the manufacture and analysis 
of pharmaceuticals (including raw materials, in-process materials and 
intermediates, and finished products). It also provides recommendations 
regarding how the concepts described in the International Conference on 
Harmonisation (ICH) guidance for industry, ``Q2(R1) Validation of 
Analytical Procedures: Text and Methodology'' (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm265700.htm) 
and ``PAT--A Framework for Innovative Pharmaceutical Development, 
Manufacturing, and Quality Assurance'' (http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf) can be applied to the development, 
validation,

[[Page 17058]]

and submission of NIR analytical procedures.
    This draft guidance only pertains to the development and validation 
of NIR analytical procedures and does not provide recommendations 
concerning the set up and qualification of NIR instruments or their 
maintenance and calibration.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the submission 
and development 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 for NDAs, 
ANDAs, supplements to applications, and annual reports have been 
approved under OMB control number 0910-0001.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07266 Filed 3-30-15; 8:45 am]
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