Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52051 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Health Department Workers (Control Restaurants) Visit 3.Restaurant Environment Observation Form .. 54 1 30/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–24416 Filed 11–8–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Prenatal Alcohol and Other 

Drug Exposures in Child Welfare 

(PAODE–CW) Study. 

OMB No.: New Collection. 

Description: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS) is proposing a data 

collection activity as part of the Prenatal 

Alcohol and Other Drug Exposures in 

Child Welfare (PAODE–CW) Study. The 

study examines the current state of 

child welfare practice regarding the 

identification and provision of services 

for children with prenatal substance 

exposures, including alcohol and other 

drugs. 

The descriptive study will document 

the policies and practices of child 

welfare agencies and related 

organizations to identify, assess, and 

refer to services children who may have 

been exposed to prenatal substances 

and/or diagnosed with a resulting 

condition such as fetal alcohol spectrum 

disorders (FASD). The study will 

document procedures as well as 

challenges faced and lessons learned to 

inform the field of practice as well as 

policy makers, program administrators, 

and funders at various levels. 

The proposed information collection 

activities consist of semi-structured 

interviews and surveys conducted at 28 

child welfare agency sites. Focus groups 

conducted at 8 of the 28 sites will gather 

information on needs, challenges, and 

strategies to support children with 

prenatal substance exposures and their 

families within the child welfare 

system. 

Respondents: State and child welfare 

agency directors, child welfare staff and 

supervisors; agency partners and service 

providers; and family members and 

caregivers of children who have been 

prenatally exposed to substances. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Local Agency Staff Interview Protocol—Frontline Only ................................... 27.5 1 1 27.5 

Local Agency Staff Interview Protocol—Ongoing Only ................................... 27.5 1 1 27.5 

Local Agency Staff Interview Protocol—Frontline and Ongoing ..................... 15 1 1.25 18.75 

Local Agency Medical Staff Interview Protocol ............................................... 14 1 1 14 

Local Agency Director Interview Protocol ........................................................ 14 1 1 14 

Focus Group of Caregivers ............................................................................. 32 1 1.5 48 

Local Agency Staff Survey .............................................................................. 280 1 .33 92.4 

Service Provider Survey .................................................................................. 12 1 .33 3.96 

Local Agency Data Staff Interview Protocol .................................................... 6 1 1.5 9 

Estimated Total Annual Burden 

Hours: 255.11. 

In compliance with the requirements 

of the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. Chap 35) 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW., 

Washington, DC 20201. Attn: ACF 

Reports Clearance Officer. Email 

address: infocollection@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–24420 Filed 11–8–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5994] 

Tobacco Products Scientific Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 


sradovich on DSK3GMQ082PROD with NOTICES
52052 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Tobacco Products 

Scientific Advisory Committee. The 

general function of the committee is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

DATES: The meeting will be held on 

January 24, 2018, from 8:30 a.m. to 5 

p.m. and January 25, 2018, from 8 a.m. 

to 3 p.m. 

ADDRESSES: FDA White Oak Conference 

Center, Building 31, the Great Room 

(Rm. 1503), 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Caryn Cohen, Office of Science, Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 1–877–287–1373, email: 

TPSAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On January 24 and 25, 2018, 

the committee will discuss modified 

risk tobacco product applications, 

submitted by Philip Morris Products 

S.A. for IQOS system with Marlboro 

Heatsticks, IQOS system with Marlboro 

Smooth Menthol Heatsticks, and IQOS 

system with Marlboro Fresh Menthol 

Heatsticks. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before January 4, 2018. 

Oral presentations from the public will 

be scheduled between approximately 8 

a.m. and 9 a.m. on January 25, 2018. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before December 27, 2017. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

December 28, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Caryn Cohen 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 31, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24379 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–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; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

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 

guidance finalizes the draft guidance 

issued on January 16, 2015, of the same 

name. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 9, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: https:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 


sradovich on DSK3GMQ082PROD with NOTICES