Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices 9583 

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Draft Guidance for Industry on Clinical 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. 

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availability of a draft guidance for 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 The draft guidance is intended 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on the draft guidance by April 19, 2011.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single copies of the draft guidance to the 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 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: 

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 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 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

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 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances, or 

http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances, or http:// 

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 

[Docket No. FDA–2010–N–0528] 

Unapproved Animal Drugs; Extension 

of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

April 19, 2011, the comment period for 

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: http:// 

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 http:// 

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 http:// 

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: 

I. Background 

In the Federal Register of December 

20, 2010 (75 FR 79383), FDA published 

a notice with a 60-day comment period 

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 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Correction of Burden Table. 

SUMMARY: The Health Resources and 

Services Administration published an 

Agency Information Collection 

document in the Federal Register of 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES