2432 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices 

1See the Drugged Driving Web page on the Office 

of National Drug Control Policy Web site at 

http://www.whitehouse.gov/ondcp/drugged-driving. 

(Pub. L. 113–86) which reauthorized the 

CCDF program and made some changes 

to ACF–801 reporting requirements. 

Owing to the need to consult with CCDF 

administrators and other interested 

parties on these changes, and a limited 

amount of time before the current ACF– 

801 form expires, ACF is not proposing 

changes to the ACF–801 at this time. We 

request to extend the ACF–801 without 

changes in order to ensure the form does 

not expire. In the near future, ACF plans 

to initiate a new clearance process 

under the Paperwork Reduction Act to 

implement the data reporting changes in 

the newly-reauthorized law. 

Respondents: States, the District of 

Columbia, and Territories including 

Puerto Rico, Guam, the Virgin Islands, 

American Samoa, and the Northern 

Marianna Islands. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

ACF–801 .......................................................................................................... 56 4 25 5,600 

Estimated Total Annual Burden 

Hours: 5,600. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 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. Email 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, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–00560 Filed 1–15–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2300] 

Evaluating Drug Effects on the Ability 

To Operate a Motor Vehicle; Draft 

Guidance for Industry; 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 ‘‘Evaluating Drug 

Effects on the Ability to Operate a Motor 

Vehicle.’’ The purpose of this guidance 

is to assist sponsors in the evaluation of 

the effects of psychoactive drugs on the 

ability to operate a motor vehicle. 

Driving is a complex activity involving 

a wide range of cognitive, perceptual, 

and motor activities. Reducing the 

incidence of motor vehicle accidents 

(MVAs) that occur because of drugimpaired driving is a public health 

priority. This draft guidance 

recommends using a systematic effort to 

identify drugs that increase the risk of 

MVAs as a critical component of 

assessing drug risk and designing 

strategies to reduce this risk. 

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 March 17, 

2015. 

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, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft 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: 

Aaron Sherman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 4339, 

Silver Spring, MD 20993–0002, 240– 

402–0493. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Evaluating Drug Effects on the Ability 

to Operate a Motor Vehicle.’’ The 

purpose of this guidance is to assist 

sponsors in the evaluation of the effects 

of psychoactive drugs on the ability to 

operate a motor vehicle. 

Driving is a complex activity 

involving a wide range of cognitive, 

perceptual, and motor activities that can 

be adversely affected by therapeutic 

drugs. Reducing the incidence of MVAs 

that occur because of drug-impaired 

driving is a public health priority.1

Drugs that impair driving ability may 

also impair the ability to judge the 

extent of one’s own impairment. This 

increases the need for objective 

evaluation of the presence and degree of 

driving impairment, with risk mitigation 

strategies based on that information. 

This guidance recommends a systematic 

effort to identify drugs for which 

evaluation of effects on driving abilities 

may be needed, and the types of studies 

that such an evaluation entails. 

This draft guidance is being 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 evaluating drug effects on the ability 

to operate a motor vehicle. 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 requirements of the 

applicable statutes and regulations. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices 2433 

II. The Paperwork Reduction Act of 

1995 

This 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 parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collection of 

information for prescription drug 

product labeling is approved under 

OMB control number 0910–0572. 

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 

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/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: January 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00596 Filed 1–15–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group Child Psychopathology and 

Developmental Disabilities Study Section. 

Date: February 12–13, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco, 700 F Street NW., 

Washington, DC 20001. 

Contact Person: Jane A DoussardRoosevelt, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 3184, MSC 7848, Bethesda, MD 20892, 

(301) 435–4445, doussarj@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group 

Cancer Etiology Study Section. 

Date: February 12–13, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Long Beach and Executive 

Center, 701 West Ocean Boulevard, Long 

Beach, CA 90831. 

Contact Person: Svetlana Kotliarova, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

Bethesda, MD 20892, 301–594–7945, 

kotliars@mail.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group Macromolecular Structure and 

Function B Study Section. 

Date: February 12–13, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda 

(Formerly Holiday Inn Select), 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: C. L. Albert Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4146, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1016, wangca@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group Macromolecular Structure and 

Function D Study Section. 

Date: February 12, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Mayflower Hotel, 1127 

Connecticut Avenue NW., Washington, DC 

20036. 

Contact Person: James W Mack, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4154, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

2037, mackj2@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group Cardiovascular Differentiation and 

Development Study Section. 

Date: February 12, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Seattle Hotel, 515 

Madison Street, Seattle, WA 98104. 

Contact Person: Sara Ahlgren, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Rm. 4136, 

Bethesda, MD 20817–7814, 301–435–0904, 

sara.ahlgren@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel PAR13–132: 

Understanding and Promoting Health 

Literacy. 

Date: February 13, 2015. 

Time: 11:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Mayflower Park Hotel, 405 Olive 

Way, Seattle, WA 98101. 

Contact Person: Rebecca Henry, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3158, 

MSC 7770, Bethesda, MD 20892, 301–435– 

1717, henryrr@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel PAR13–213: 

Outcome Measures for Use in Treatment 

Trials for Individuals with Intellectual and 

Developmental Disabilities (R01). 

Date: February 13, 2015. 

Time: 2:00 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monaco, 700 F Street NW., 

Washington, DC 20001. 

Contact Person: Jane A. DoussardRoosevelt, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 3184, MSC 7848, Bethesda, MD 20892, 

(301) 435–4445, doussarj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Oral, Dental, 

and Craniofacial Sciences SBIR/STTR. 

Date: February 17–18, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Yi-Hsin Liu, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1781, liuyh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Fellowships: 

Synthetic and Biological Chemistry. 

Date: February 17–18, 2015. 

Time: 8:30 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Michael Eissenstat, Ph.D., 

Scientific Review Officer, BCMB IRG, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4166, 

MSC 7806, Bethesda, MD 20892, 301–435– 

1722, eissenstatma@csr.nih.gov. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES