Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability, 9583-9584 [2011-3679]

Download as PDF Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices Estimated Total Annual Burden Hours: 476,351. Additional Information Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–3664 Filed 2–17–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0082] Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.’’ The draft guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome could affect the clinical pharmacology WReier-Aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 13:57 Feb 17, 2011 Jkt 223001 properties and clinical responses of drugs. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2011. 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 the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), 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 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: Lawrence J. Lesko, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3178, Silver Spring, MD 20993–0002, 301– 796–1565; or Shiew-Mei Huang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3188, Silver Spring, MD 20993–0002, 301– 796–1541; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM–17), 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 entitled ‘‘Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.’’ Pharmacogenomics (PGx) broadly refers to the study of variations of DNA and RNA characteristics and their relation to drug exposure and/or response. Drug exposure refers to either the administered dose or levels in a body tissue or fluid (e.g., blood, plasma, cerebrospinal fluid). Drug response PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 9583 results from the interplay of pharmacokinetics (e.g., drug absorption, metabolism, and excretion), and pharmacodynamics (i.e., all of the effects of the drug on various physiologic and pathologic processes, including effectiveness and adverse effects). Genetic variations can also influence the exposure-response (E/R) relationship of drugs. PGx studies can enhance the understanding of interindividual differences in the efficacy and safety of investigational drugs. Drug development is commonly described as going through ‘‘phases’’ (21 CFR 312.21). The first two phases collect information about safety and dosing, so that the larger, later (phase 3) studies (the adequate and wellcontrolled studies needed to support marketing approval) can gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Much of the genomic information collected and assessed during the early phases is often described as ‘‘exploratory.’’ Phase 2 studies that suggest genomic influences can lead to phase 3 trials that incorporate findings into prespecified hypotheses, such as enriching the study with genomically defined individuals, determining dose based on demonstrated variability in earlier studies, and defining a priori hypothesis testing of a primary endpoint in a genomic subset. PGx information obtained from genomic investigations during the course of drug development (and from postmarketing studies) can improve the effectiveness and safety of drugs by identifying patients at high risk for a serious adverse event or absence of benefit; improving the benefit/risk relationship of drugs by using genomic tests to identify patients most likely to respond, or unable to respond to a drug; and by helping to select optimal doses based on genotype-driven differences in PK (pharmacodynamics) and/or PD (pharmacodynamics) of a drug. An important prerequisite to successful use of genetic information in drug development is appropriate collection and storage of DNA samples from all clinical trials, both exploratory and the adequate and well-controlled studies intended to support effectiveness and safety. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agency’s current thinking on conducting pharmacogenomic studies in E:\FR\FM\18FEN1.SGM 18FEN1 9584 Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices early phase clinical studies. 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 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 201.57 have been approved under OMB control number 0910–0572. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. 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.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances, or https:// www.regulations.gov. Dated: February 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–3679 Filed 2–17–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration WReier-Aviles on DSKGBLS3C1PROD with NOTICES [Docket No. FDA–2010–N–0528] Unapproved Animal Drugs; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. the notice that appeared in the Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA requested comments on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit electronic or written comments by April 19, 2011. ADDRESSES: You may submit comments, identified by Docket No. FDA–2010–N– 0528 by any of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • FAX: 301–827–6870. • Mail/Hand delivery/Courier (for paper, disk, or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2010–N–0528. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Request for Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or 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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tracey H. Forfa, Center for Veterinary Medicine (HFV–1), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9000, e-mail: Tracey.Forfa@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Request for comments; extension of comment period. I. Background The Food and Drug Administration (FDA) is extending to April 19, 2011, the comment period for In the Federal Register of December 20, 2010 (75 FR 79383), FDA published a notice with a 60-day comment period ACTION: SUMMARY: VerDate Mar<15>2010 13:57 Feb 17, 2011 Jkt 223001 PO 00000 Frm 00051 Fmt 4703 to request comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The notice expressed FDA’s interest in receiving comments on strategies that utilize FDA’s existing regulatory framework for addressing this issue as well as on novel strategies not currently employed by the Agency. The Agency has received requests for a 60-day extension of the comment period. The requests conveyed concern that the current 60-day comment period does not allow respondents sufficient time to address fully the many important issues FDA raised in the notice. FDA has considered the requests and is extending the comment period for the notice for 60 days, until April 19, 2011. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying the Agency’s consideration of these important issues. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. Dated: February 15, 2011. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2011–3712 Filed 2–17–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Health Resources and Services Administration, HHS. ACTION: Correction of Burden Table. AGENCY: The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of SUMMARY: Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1

Agencies

[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Pages 9583-9584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3679]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0082]


Draft Guidance for Industry on Clinical Pharmacogenomics: 
Premarketing Evaluation in Early Phase Clinical Studies; 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 ``Clinical 
Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical 
Studies.'' The draft guidance is intended to assist the pharmaceutical 
industry and other investigators engaged in new drug development in 
evaluating how variations in the human genome could affect the clinical 
pharmacology properties and clinical responses of drugs.

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 April 19, 2011.

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 the 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), 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 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:

Lawrence J. Lesko, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3178, 
Silver Spring, MD 20993-0002, 301-796-1565; or
Shiew-Mei Huang, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3188, Silver 
Spring, MD 20993-0002, 301-796-1541; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration (HFM-17), 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 entitled 
``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase 
Clinical Studies.'' Pharmacogenomics (PGx) broadly refers to the study 
of variations of DNA and RNA characteristics and their relation to drug 
exposure and/or response. Drug exposure refers to either the 
administered dose or levels in a body tissue or fluid (e.g., blood, 
plasma, cerebrospinal fluid). Drug response results from the interplay 
of pharmacokinetics (e.g., drug absorption, metabolism, and excretion), 
and pharmacodynamics (i.e., all of the effects of the drug on various 
physiologic and pathologic processes, including effectiveness and 
adverse effects). Genetic variations can also influence the exposure-
response (E/R) relationship of drugs. PGx studies can enhance the 
understanding of interindividual differences in the efficacy and safety 
of investigational drugs.
    Drug development is commonly described as going through ``phases'' 
(21 CFR 312.21). The first two phases collect information about safety 
and dosing, so that the larger, later (phase 3) studies (the adequate 
and well-controlled studies needed to support marketing approval) can 
gather the additional information about effectiveness and safety that 
is needed to evaluate the overall benefit-risk relationship of the drug 
and to provide an adequate basis for physician labeling. Much of the 
genomic information collected and assessed during the early phases is 
often described as ``exploratory.'' Phase 2 studies that suggest 
genomic influences can lead to phase 3 trials that incorporate findings 
into prespecified hypotheses, such as enriching the study with 
genomically defined individuals, determining dose based on demonstrated 
variability in earlier studies, and defining a priori hypothesis 
testing of a primary endpoint in a genomic subset.
    PGx information obtained from genomic investigations during the 
course of drug development (and from postmarketing studies) can improve 
the effectiveness and safety of drugs by identifying patients at high 
risk for a serious adverse event or absence of benefit; improving the 
benefit/risk relationship of drugs by using genomic tests to identify 
patients most likely to respond, or unable to respond to a drug; and by 
helping to select optimal doses based on genotype-driven differences in 
PK (pharmacodynamics) and/or PD (pharmacodynamics) of a drug. An 
important prerequisite to successful use of genetic information in drug 
development is appropriate collection and storage of DNA samples from 
all clinical trials, both exploratory and the adequate and well-
controlled studies intended to support effectiveness and safety.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the Agency's current thinking on conducting pharmacogenomic 
studies in

[[Page 9584]]

early phase clinical studies. 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 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 201.57 have been 
approved under OMB control number 0910-0572.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances, or https://www.regulations.gov.

    Dated: February 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3679 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P
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