Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47533 

submitting requests for reconsideration, 

including details on the content and 

format of the submission. Respondents 

to the collection of information are 

applicants of ANDAs. Based on 

available data with regard to similar 

information collections, FDA’s Center 

for Drug Evaluation and Research will 

receive approximately 150 requests for 

reconsideration annually from 75 

respondents. Because we estimate it will 

take 5 hours to prepare a request for 

reconsideration, we estimate it will take 

an average of 750 total hours annually 

for respondents to prepare and submit 

requests for reconsideration. The burden 

of the information collection, therefore, 

is estimated as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance recommendation Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

Section IV: Procedures for Submitting and Responding to 

a Request for Reconsideration ........................................ 75 2 150 5 750 

1There are no capital or operating and maintenance costs associated with the collection of information. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

GuidanceCompliance

RegulatoryInformation/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. 2017–22049 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–2011–N–0424] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Temporary 

Marketing Permit Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

13, 2017. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0133. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10–12M, 11601 Landsdown 

St., North Bethesda, MD 20852, 301– 

796–7729, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Temporary Marketing Permit 

Applications—21 CFR 130.17(c) and (i) 

OMB Control Number 0910–0133— 

Extension 

This information collection supports 

Agency regulations. Specifically, section 

401 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

341) directs FDA to issue regulations 

establishing definitions and standards of 

identity for food ‘‘whenever . . . such 

action will promote honesty and fair 

dealing in the interest of consumers 

. . . .’’ Under section 403(g) of the 

FD&C Act (21 U.S.C. 343(g)), a food that 

is subject to a definition and standard of 

identity prescribed by regulation is 

misbranded if it does not conform to 

such definition and standard of identity. 

Section 130.17 (21 CFR 130.17) provides 

for the issuance by FDA of temporary 

marketing permits that enable the food 

industry to test consumer acceptance 

and measure the technological and 

commercial feasibility in interstate 

commerce of experimental packs of food 

that deviate from applicable definitions 

and standards of identity. Section 

130.17(c) enables the Agency to monitor 

the manufacture, labeling, and 

distribution of experimental packs of 

food that deviate from applicable 

definitions and standards of identity. 

The information so obtained can be 

used in support of a petition to establish 

or amend the applicable definition or 

standard of identity to provide for the 

variations. Section 130.17(i) specifies 

the information that a firm must submit 

to FDA to obtain an extension of a 

temporary marketing permit. 

In the Federal Register of June 15, 

2017 (82 FR 27489), we published a 60- 

day notice requesting public comment 

on the proposed extension of this 

collection of information. No comments 

were received. 

We therefore estimate the burden of 

this collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

130.17(c)—Request for temporary marketing permit .......... 13 2 26 25 650 

130.17(i)—Request to extend marketing permit .................. 1 2 2 2 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 654 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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