Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47535 

FOR FURTHER INFORMATION CONTACT: Paul 

Hart or Samantha Loh Collado, Center 

for Tobacco Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Document Control Center, Bldg. 

71, Rm. G335, Silver Spring, MD 20993– 

0002, 877–287–1373, email: 

CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘The 

Prohibition of Distributing Free Samples 

of Tobacco Products.’’ Title 21 of the 

CFR 1140.16(d)(1) prohibits, with a 

limited exception, tobacco product 

manufacturers, distributors, and 

retailers from distributing or causing to 

be distributed any free samples of 

cigarettes, smokeless tobacco, or other 

tobacco products. This guidance 

finalizes the draft guidance of the same 

title, which was made available for 

public comment as noted in the Federal 

Register of January 18, 2017 (82 FR 

5583), and describes, among other 

things, FDA’s current thinking on how 

the prohibition of distributing free 

samples of tobacco products applies to 

non-monetary exchanges, coupons and 

discounts, membership and rewards 

programs, contests and games of chance, 

and the business-to-business exchange 

of free samples. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the prohibition of 

distributing free samples of tobacco 

products. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at either https://

www.regulations.gov or https://

www.fda.gov/TobaccoProducts/ 

Labeling/RulesRegulationsGuidance/ 

default.htm. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22045 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5960] 

Respiratory Syncytial Virus Infection: 

Developing Antiviral Drugs for 

Prophylaxis and Treatment; Draft 

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 draft 

guidance for industry entitled 

‘‘Respiratory Syncytial Virus Infection: 

Developing Antiviral Drugs for 

Prophylaxis and Treatment.’’ The 

purpose of this draft guidance is to 

assist sponsors in all phases of antiviral 

drug development for prophylaxis and 

treatment of disease caused by 

respiratory syncytial virus (RSV) 

infection. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 11, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–5960 for ‘‘Respiratory Syncytial 

Virus Infection: Developing Antiviral 

Drugs for Prophylaxis and Treatment; 

Draft Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov

/fdsys/pkg/FR-2015-09-18/pdf/2015-

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47536 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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– 

0002. 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. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Murray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6360, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Respiratory Syncytial Virus Infection: 

Developing Antiviral Drugs for 

Prophylaxis and Treatment.’’ This draft 

guidance addresses FDA’s current 

thinking regarding the overall drug 

development program for an indication 

for treatment and prevention of disease 

caused by RSV infection including 

nonclinical development, early phases 

of clinical development, and phase 3 

trial designs. This draft guidance 

focuses primarily on pediatric antiviral 

drug development for RSV but also 

discusses drug development for other 

populations. 

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 current thinking of FDA 

on ‘‘Respiratory Syncytial Virus 

Infection: Developing Antiviral Drugs 

for Prophylaxis and Treatment.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. The 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 

parts 312 and 314 have been approved 

under OMB control numbers 0910–0014 

and 0910–0001, respectively. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 5, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22051 Filed 10–11–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier OS–0990–new] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before December 11, 

2017. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990-New-60D 

and project title for reference, to 

Sherrette.funn@hhs.gov, or call the 

Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: I Can Do It, 

You Can Do It! Program Evaluation. 

Type of Collection: New. 

OMB No. 0990–NEW–Office within 

OS—Office of the President’s Council 

on Fitness, Sports & Nutrition 

(OPCFSN), Office of the Assistant 

Secretary for Health. 

Abstract: Initiated by the former HHS 

Office on Disability, supported by the 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development and the former Division of 

Nutrition Research Coordination at the 

National Institutes of Health, and 

adopted by OPCFSN in 2011, the I Can 

Do It, You Can Do It! health promotion 

program is designed to provide access 

and opportunities for children and 

adults with a wide range of physical and 

cognitive disabilities to lead healthy, 

active lives. Approximately 56 million 

children and adults living in the United 

States have some level of disability. 

Despite physical activity and good 

nutrition being the cornerstones of 

evidence-based health promotion 

interventions for reducing the risk of 

comorbidities (e.g., diabetes, heart 

disease, stroke), many people with a 

disability or caregivers who have a child 

with a disability experience substantial 

difficulty accessing these programs. The 

program partners with K–12 schools and 

school districts, colleges and 

universities, and other communitybased entities that implement the 

program using a mentoring approach 

that has been well-documented in the 

research literature as efficacious in 

changing the attitudes, knowledge, and 

health behaviors of individuals with 

and without a disability. 

The information collected for the I 

Can Do It, You Can Do It! Program 

Evaluation will allow the OPCFSN and 

partners to assess the impact of the 

program and gather critical information 

for improvement. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES