Draft Guidance for Industry on Bioanalytical Method Validation; Availability, 56718-56719 [2013-22309]

Download as PDF 56718 Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1020] Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Bioanalytical Method Validation.’’ The draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic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 This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and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. SUMMARY: 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 12, 2013. ADDRESSES: Submit written requests for single copies of the revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 selfaddressed adhesive label to assist that office in processing your requests. See tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 19:46 Sep 12, 2013 Jkt 229001 the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the draft guidance to https:// 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\13SEN1.SGM 13SEN1 Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices 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 https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances or https://www.regulations.gov. Dated: September 7, 2013. Leslie Kux, Assistant Commissioner for Policy. to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4160–01–P Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1639. DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: [FR Doc. 2013–22309 Filed 9–12–13; 8:45 am] [Docket No. FDA–2012–D–0322] Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry entitled ‘‘Arsenic in Apple Juice: Action Level’’ that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes FDA’s intended sampling and enforcement approach. In the notice, we requested comments on the draft guidance. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the draft guidance. Submit either electronic or written comments by November 12, 2013. ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:23 Sep 12, 2013 Jkt 229001 Frm 00074 Fmt 4703 II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. Dated: September 10, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P In the Federal Register of July 15, 2013 (78 FR 42086), we published a notice announcing the availability of three documents, a draft guidance for industry entitled ‘‘Arsenic in Apple Juice: Action Level,’’ a draft supporting document entitled ‘‘Supporting Document for Action Level for Arsenic in Apple Juice,’’ and a risk assessment document entitled ‘‘A Quantitative Assessment of Inorganic Arsenic in Apple Juice.’’ The draft guidance identifies an action level for inorganic arsenic in apple juice of 10 micrograms/ kilogram (mg/kg) or 10 parts per billion (ppb), and identifies FDA’s intended sampling and enforcement approach. The draft supporting document reviews data on arsenic levels, health effects, and achievability, and explains FDA’s rationale for identifying an action level for inorganic arsenic in apple juice of 10 mg/kg. The risk assessment document provides estimates of arsenic exposure and risk to humans at different hypothetical limits for inorganic arsenic in apple juice. The notice invited comments on the draft guidance by September 13, 2013. As of August 28, 2013, we have received two requests for an extension of the comment period. The requests, from the Arsenic Science Task Force and the Juice Products Association, explained that they needed more time to complete their analyses of the supporting documents. We have considered the request and are extending the comment period for the notice for 60 days, until November 12, 2013. We believe that a 60-day extension allows adequate time for interested persons to submit comments PO 00000 without significantly delaying further FDA action on this guidance. [FR Doc. 2013–22313 Filed 9–12–13; 8:45 am] I. Background Food and Drug Administration 56719 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation.’’ FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. Dates and Times: The public workshop will be held on October 17, 2013, from 8:30 a.m. to 5 p.m. and October 18, 2013, from 8:30 a.m. to 12:15 p.m. Location: The public workshop will be held at the Grand Hyatt Washington, E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[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]



[[Page 56718]]

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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.

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

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 https://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 https://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

[[Page 56719]]

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 https://www.regulations.gov.

IV. Electronic Access

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