
[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Pages 9467-9468]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0103]


Draft Guidance for Industry on Analytical Procedures and Methods 
Validation for Drugs and Biologics; 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availability of a draft guidance for industry entitled ``Analytical 
Procedures and Methods Validation for Drugs and Biologics.'' This 
revised draft guidance supersedes the 2000 draft guidance for industry 
on ``Analytical Procedures and Methods Validation'' and, when 
finalized, will also replace the 1987 FDA guidance for industry on 
``Submitting Samples and Analytical Data for Methods Validation.'' This 
draft guidance discusses how to submit analytical procedures and 
methods validation data to support the documentation of the identity, 
strength, quality, purity, and potency of drug substances and drug 
products.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 20, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://

[[Page 9468]]

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: Lucinda Buhse, Center for Drug 
Evaluation and Research, Food and Drug Administration, 1114 Market St., 
Suite 1002, St. Louis, MO 63101, 314-539-2134; or Stephen Ripley, 
Center for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Analytical Procedures and Methods Validation for Drugs and 
Biologics.'' This revised draft guidance supersedes the 2000 draft 
guidance for industry on ``Analytical Procedures and Methods 
Validation'' and, when finalized, will also replace the 1987 FDA 
guidance for industry on ``Submitting Samples and Analytical Data for 
Methods Validation.'' It discusses how to submit analytical procedures 
and methods validation data to support the documentation of the 
identity, strength, quality, purity, and potency of drug substances and 
drug products and how to assemble information and present data to 
support analytical methodologies. The recommendations in this guidance 
apply to new drug applications, abbreviated new drug applications, 
biologics license applications, and supplements to these applications. 
The principles in this revised draft guidance also apply to Type II 
drug master files. This draft guidance does not address investigational 
new drug application (IND) methods validation specifically, but the 
principles being discussed may be helpful to sponsors preparing INDs.
    This draft guidance complements the International Conference on 
Harmonisation guidance ``Q2(R1) Validation of Analytical Procedures: 
Text and Methodology.''
    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 Agency's current thinking on analytical 
procedures and methods validation. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach 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 211, 21 CFR part 
314, and 21 CFR part 601 have been approved under OMB control numbers 
0910-0139, 0910-0001, and 0910-0338.

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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03580 Filed 2-18-14; 8:45 am]
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