Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Draft Guidance for Industry; Availability, 2432-2433 [2015-00596]

Download as PDF 2432 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices (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 asabaliauskas on DSK5VPTVN1PROD with NOTICES [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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for SUMMARY: VerDate Sep<11>2014 17:36 Jan 15, 2015 Jkt 235001 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. 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 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: Aaron Sherman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4339, ADDRESSES: PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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. 1 See the Drugged Driving Web page on the Office of National Drug Control Policy Web site at https://www.whitehouse.gov/ondcp/drugged-driving. E:\FR\FM\16JAN1.SGM 16JAN1 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Notices 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 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 17:36 Jan 15, 2015 Jkt 235001 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. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 2433 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. E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 80, Number 11 (Friday, January 16, 2015)]
[Notices]
[Pages 2432-2433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00596]

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

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 drug-impaired 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 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: 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\
---------------------------------------------------------------------------

\1\ See the Drugged Driving Web page on the Office of National
Drug Control Policy Web site at https://www.whitehouse.gov/ondcp/drugged-driving.
---------------------------------------------------------------------------

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.

[[Page 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 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.

IV. Electronic Access

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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.