[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56718-56719]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22309]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1020]


Draft Guidance for Industry on Bioanalytical Method Validation; 
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availability of a draft guidance for industry entitled ``Bioanalytical 
Method Validation.'' The draft guidance is intended to provide 
recommendations regarding analytical method development and validation 
for the measurement of drugs and/or metabolites, therapeutic biologics, 
and biomarkers for sponsors of investigational new drug applications 
(INDs), new drug applications (NDAs), abbreviated new drug applications 
(ANDAs), and biologics license applications (BLAs) for therapeutic 
biologics regulated by the Center for Drug Evaluation and Research. 
This draft guidance may apply to some studies related to the veterinary 
drug approval process (Investigational New Animal Drugs (INADs), New 
Animal Drug Applications (NADAs), and Abbreviated New Animal Drug 
Applications (ANADAs)) regulated by the Center for Veterinary Medicine. 
This guidance was originally issued in 2001. FDA is revising the 
guidance to reflect advancements in the science and technology of 
bioanalytical method validation.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 12, 2013.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information, Center for Drug 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 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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.
    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: Brian Booth, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993-0002, 301-
796-1508; or John Kadavil, Center for Veterinary Medicine (HFV-151), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
240-276-9589.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Bioanalytical Method Validation.'' The measurement of drug 
and/or metabolite, therapeutic biological product, or biomarker 
concentrations in in vivo studies provides critical support for many 
types of drug and therapeutic biologic development studies. The 
accuracy and the reliability of these data are of critical importance 
to the interpretation of the study outcomes. The draft guidance 
reflects the Agency's view that the reliability of these data is, in 
part, assured by adequate method development and validation prior to 
study conduct. The method validation should provide assurance that the 
samples are unaffected by handling conditions, and that the 
measurements are accurate and can be repeated without significant 
change.
    The draft guidance provides recommendations for sponsors of INDs, 
NDAs, ANDAs, and BLAs regarding measurement of drug, therapeutic 
biological product, and biomarker concentrations in nonclinical and 
clinical study samples. The guidance provides recommendations for 
sponsors of INADs, NADAs, and ANADAs regarding measurement of drug 
concentrations in some bioavailability, bioequivalence, and 
pharmacokinetic studies. The guidance lists the recommendations for 
sample handling and stability; method acceptance criteria for accuracy 
and precision; and reproducibility. The guidance also addresses the 
fit-for-purpose concept, biomarkers, and novel technologies.
    On May 23, 2001 (66 FR 28526), FDA issued the first version of this 
guidance. Since then, substantial scientific and technical advancements 
have taken place related to the validation of bioanalytical methods. 
FDA revised the guidance to reflect these advancements and is issuing 
the revised guidance in draft to solicit public input. The revised 
draft guidance contains a number of new sections, including sections on 
endogenous compounds, incurred sample reanalysis, biomarker assays, use 
of diagnostic kits and new technologies, system suitability, and 
examples of report formats for tabular data listings. In addition, FDA 
has updated sections where needed, such as the sections on 
chromatography and ligand-binding assays. The changes and additions are 
intended to reflect the many advances in the field during the last 
decade.
    This revised draft guidance is 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 
Bioanalytical Method 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 requirement of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This revised draft 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 58 
have been approved under OMB control number 0910-0119; the collections 
of information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; the collections 
of information in 21 CFR part 514 have been approved under OMB control 
number 0910-0032; the collections of information in 21 CFR part 511 
have been approved under OMB control number 0910-0117; and the 
collections of information in section 360b(n)(1) (21 U.S.C 512(n)(1)) 
of the Federal Food, Drug and Cosmetic Act have been approved in OMB 
control number 0910-0669.

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

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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 or http://www.regulations.gov.

    Dated: September 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22309 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P