9582 Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

On-line Survey of SCF Grantees ..................................................................... 84 1 0.25 21 

Telephone Interview of SCF Grantees ............................................................ 84 1 1.5 126 

On-line Survey of Faith-based and Community Organizations (FBCOs) ....... 1,000 1 0.5 500 

Estimated Total Annual Burden 

Hours: 647. 

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. 2011–3745 Filed 2–17–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Income Withholding for 

Support (IWO). 

OMB No.: 0970–0154. 

Description 

Use of the OMB-approved Income 

Withholding for Support form falls 

under the authority of section 466 of the 

Act, 42 U.S.C. 666. Section 

466(b)(6)(A)(ii) of the Act requires that 

the notice given to the employer for 

income withholding in IV–D cases shall 

be in a standard format prescribed by 

the Secretary, and contain only such 

information as may be necessary for the 

employer to comply with the 

withholding order for all IV–D cases. 

Section 466(a)(8)(B)(iii) of the Act 

requires that section 466(b)(6)(A)(ii) of 

the Act be applicable also to non-IV–D 

income withholding orders. These 

provisions clearly require all 

individuals and entities to use a form 

developed by the Secretary of HHS to 

notify employers of the income 

withholding order for child support in 

all IV–D and non-IV–D cases. 

OCSE requires States’ automated 

systems to be able to automatically 

generate and download data to the OMB 

approved income withholding form. If 

child support orders are established by 

the child support agency, necessary 

information is already contained within 

the automated system for downloading 

into income withholding orders. If a 

court or other tribunal has issued a 

child support order, then agency staff 

enter the terms of the order into the 

automated system for use in issuing 

income withholding orders. Copies of 

the income withholding order are made 

for all necessary parties, and copies are 

transmitted to the employer/income 

withholder by mail or through the OCSE 

electronic income withholding order (eIWO) portal. 

The Income Withholding for Support 

form and instructions were updated for 

consistency and clarity in light of 

numerous comments suggesting 

changes, based on comments received 

during the 60-day comment period of 

the 1st Federal Register Notice 

publication. 

Respondents: Non-IV–D Custodial 

Parties and Employers. 

Previous iterations of the IWO 

omitted employers and non-IV–D CPs or 

their representatives, including 

attorneys or other entities issuing IWOs 

on behalf of CPs, as respondents; 

however, upon further review it has 

been determined that the impact on 

employers and non-IV–D CPs should be 

included in this information collection. 

This is based on the requirement that 

employers complete the ‘‘Notification of 

Termination/Income Status’’ section of 

the IWO and that non-IV–D CPs or their 

representative issuing IWOs do not have 

the information required to complete 

the IWO contained in an automated 

system and therefore are required to 

manually issue IWOs to employers/ 

income withholders. The annual burden 

estimates for employers and CPs is 

captured in number 12. 

ANNUAL BURDEN ESTIMATES

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

(min) 

Total burden 

hours 

Employers ........................................................................................................ 1,232,622 8 2 312,264 

Non-IV–D CPs ................................................................................................. 1,969,044 1 5 164,087 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

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