47534 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 

The estimated number of temporary 

marketing permit applications and 

hours per response is an average based 

on our experience with applications 

received for the past 3 years, and 

information from firms that have 

submitted recent requests for temporary 

marketing permits. Based on this 

information, we estimate that there will 

be, on average, approximately 13 firms 

submitting requests for 2 temporary 

marketing permits per year over the next 

3 years. 

Thus, we estimate that 13 respondents 

will submit 2 requests for temporary 

marketing permits annually pursuant to 

§ 130.17(c). The estimated number of 

respondents for § 130.17(i) is minimal 

because this section is seldom used by 

the respondents; therefore, the Agency 

estimates that there will be one or fewer 

respondents annually with two or fewer 

requests for extension of the marketing 

permit under § 130.17(i). The estimated 

number of hours per response is an 

average based on the Agency’s 

experience and information from firms 

that have submitted recent requests for 

temporary marketing permits. We 

estimate that 13 respondents each will 

submit 2 requests for temporary 

marketing permits under § 130.17(c) and 

that it will take a respondent 25 hours 

per request to comply with the 

requirements of that section, for a total 

of 650 hours. We estimate that one 

respondent will submit two requests for 

extension of its temporary marketing 

permits under § 130.17(i) and that it will 

take a respondent 2 hours per request to 

comply with the requirements of that 

section, for a total of 4 hours. 

Dated: October 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22053 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–0113] 

The Prohibition of Distributing Free 

Samples of Tobacco Products; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘The Prohibition of Distributing 

Free Samples of Tobacco Products.’’ The 

guidance provides information intended 

to assist tobacco product manufacturers, 

distributors, and retailers in complying 

with the regulations prohibiting the 

distribution of free samples of tobacco 

products. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 12, 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 

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–0113 for ‘‘The Prohibition of 

Distributing Free Samples of Tobacco 

Products; 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 

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. 

Submit written requests for single 

copies of this guidance to the Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

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

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a fax 

number to which the guidance 

document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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