49834 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

As reflected in table 1, we estimate 

two manufacturers will submit two 

requests annually for tier-one DR, and 

that there will be one appeal of these 

requests to the DR panel (tier-two DR). 

We estimate also that it will take 

manufacturers approximately 30 hours 

to prepare and submit each request for 

a tier-one DR, and approximately 8 

hours to prepare and submit each 

request for a tier-two DR. Based on our 

experience with this collection we have 

not changed our estimate since our last 

request for OMB approval. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23444 Filed 10–26–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–3710] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Evaluation of the 

Food and Drug Administration’s 

Education at the Point of Sale 

Campaign 

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 

27, 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—NEW and 

title ‘‘Evaluation of FDA’s Education at 

the Point of Sale Campaign.’’ Also, 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Evaluation of FDA’s Education at the 

Point of Sale Campaign OMB Control 

Number 0910—NEW 

The 2009 Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) amends 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) to grant FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health and to 

reduce tobacco use by minors. Section 

1003(d)(2)(D) of the FD&C Act (21 

U.S.C. 393(d)(2)(D)) supports the 

development and implementation of 

FDA public education campaigns 

related to tobacco use. Accordingly, 

FDA is currently developing and 

implementing a tobacco education 

intervention at the point of sale to 

reduce the public health burden of 

tobacco use. The campaign features 

advertisements intended to encourage 

future quit attempts among current 

smokers in stores that sell tobacco 

products. 

In support of the provisions of the 

Tobacco Control Act that require FDA to 

protect the public health, FDA requests 

OMB approval to collect information to 

evaluate the effectiveness of the point of 

sale tobacco education campaign. Data 

from this outcome evaluation study will 

be used to examine statistical 

associations between exposure to the 

campaign and specific outcomes of 

interest, which include awareness of the 

campaign and its messaging, tobaccorelated attitudes, beliefs and risk 

perceptions, and motivation to quit 

smoking. 

Evaluation is an essential 

organizational practice in public health 

and a systematic way to account for and 

improve public health actions. 

Comprehensive evaluation of FDA’s 

public education campaigns will be 

used to document whether the intended 

audience is aware of and understands 

campaign messages, and whether 

campaign exposure influences tobaccorelated attitudes, beliefs and risk 

perceptions, intentions to use tobacco, 

and motivation to quit smoking. 

Participation in the outcome evaluation 

study will be voluntary. All of the 

information collected is integral to that 

evaluation. 

Evaluation of the Point of Sale 

Campaign. This outcome evaluation 

study will consist of four longitudinal 

data collection periods over 24 months 

(approximately every 7 months), with 

the first survey (Wave 1) occurring 

approximately 3 months after campaign 

launch. A fourth wave of data collection 

has been added to the three proposed in 

the 60-day notice because the campaign 

has been extended from 18 to 24 

months. The additional wave of data 

collection is necessary to continue to 

assess the impact of the campaign. To 

reduce the number of participants 

needed to detect the effects of the 

campaign on outcomes of interest, the 

design of the campaign was changed 

from two treatment groups and one 

control group to one treatment group 

and one control group. The respondent 

numbers and burden hours below have 

been revised to reflect the four data 

collection waves and the change in the 

number of treatment groups. 

Information will be collected from 

adult cigarette smokers, ages 25 to 54, 

about awareness of and exposure to 

campaign advertisements, tobacco use, 

and knowledge, attitudes, and beliefs 

related to tobacco use. Information will 

be collected on demographic variables 

including age, sex, race/ethnicity, and 

primary language. Participants will also 

be offered the option to download a 

smartphone application that will track 

their exposure to the campaign, and that 

will ask them to respond to a brief 

survey about every 6 months over 18 

months. 

FDA’s media contractor identified 37 

potential counties for the campaign. 

From this list, FDA’s evaluation 

contractor has selected 30 counties to be 

included in the evaluation. Of these, 15 

counties will receive the intervention 

(treatment counties), and 15 counties 

will not receive it (control counties). 

The number of counties has changed 

since the 60-day notice because we 

changed the experimental design to 

have one treatment group instead of 

two, which resulted in needing fewer 

counties. 

Data will be collected from a 

longitudinal cohort that will consist of 

an entirely new sample of adult 

cigarette smokers. Addresses will be 

randomly selected from postal carrier 

routes in the 30 selected U.S. counties 

to identify households that contain one 

or more adult smokers between the ages 

of 25 and 54. Pre-paid pre-addressed 

paper screening surveys will be mailed 

to approximately 104,541 households. 

We estimate that 27,651 (9,217 

annualized respondents) households 

will return the 10-minute screener they 

received by mail, and 26,258 (8,753 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49835 

annualized respondents) households 

will complete a 10-minute in-person 

field screener conducted by trained field 

interviewers. Field interviewers will 

attempt to conduct field screeners for all 

households that return the mail screener 

and appear to have one or more eligible 

participants in the household, and a 

subsample of the households that do not 

return the screener. At 10 minutes per 

screening, the potential burden hours 

for the mail screener are 4,701 hours 

(1,567 annualized). At 10 minutes per 

screening, the potential burden hours 

for the field screener are 4,464 hours 

(1,488). The process for locating and 

screening participants has been updated 

since the 60-day notice to better reflect 

the study design. 

Accounting for nonresponse, we 

estimate that the mail and field 

screenings will result in 4,282 (1,427 

annualized) adults who meet criteria for 

participation and complete the full 

Wave 1 questionnaire. The Wave 1 

questionnaire will be completed during 

an in-person visit to the home, 

immediately after the field screening is 

completed, assuming the selected 

participant is available to complete the 

questionnaire at that time. If the 

participant is not available at that time, 

the interviewer will schedule a time to 

return to the household and complete 

the evaluation questionnaire in person. 

We estimate that the Wave 1 

questionnaire will take 40 minutes to 

complete, resulting in 2,869 (956 

annualized) burden hours. Adjusting for 

loss to follow-up between waves, we 

anticipate that 3,426 (1,142 annualized) 

participants will complete the Wave 2 

questionnaire, which will take 40 

minutes and result in 2,295 (765 

annualized) burden hours, that 2,912 

(971 annualized) participants will 

complete the Wave 3 questionnaire, 

which will take 40 minutes and result 

in 1,951 (650 annualized) burden hours, 

and that 2,475 (825 annualized) 

participants will complete the Wave 4 

questionnaire, which will take 40 

minutes and result in 1,658 (553 

annualized) burden hours. The Waves 2, 

3, and 4 questionnaires will be 

completed online or in person by 

trained interviewers, depending on 

participant preference. The total burden 

hours for Waves 2 to 4 evaluation 

questionnaires will be 5,904 (1,968 

annualized). 

We anticipate that approximately 54 

percent of the participants (2,308 people 

(769 annualized)) who complete the 

Wave 1 questionnaire will download a 

smartphone application that will deliver 

brief app-based questionnaires to them 

in between the four waves of evaluation 

data collection. These participants will 

complete three questionnaires lasting 5 

minutes each (every 6 months over the 

course of 18 months), resulting in 554 

(185 annualized) burden hours. The app 

will also use geolocation technology to 

record participants’ visits to 

convenience stores as a measure of 

passive campaign exposure. 

In addition, over the course of the 

study, telephone verification 

questionnaires will be conducted with a 

small portion of participants. The 

purpose of these questionnaires is to 

ensure that information obtained by 

field interviewers is correct, to evaluate 

the performance of field interviewers, to 

avoid fraud, and to ensure that all 

relevant incentives were delivered. 

Trained staff will administer a 5-minute 

verification questionnaire to a random 

sample of 10 percent of participants 

who completed the in-person screening 

but not the Wave 1 questionnaire (2,198 

individuals (733 annualized)), and a 

random sample of 10 percent of 

participants who completed the Waves 

1 to 4 questionnaires (1,308 individuals 

(436 annualized)). At 5 minutes per 

verification questionnaire, this results in 

177 burden hours (59 annualized) for 

the field screener telephone 

verifications and 105 burden hours (35 

annualized) for the four evaluation 

questionnaire telephone verifications. 

Some telephone verification 

questionnaires may be administered in 

person if it is not possible to reach the 

individual by phone. This verification 

process has been added to the 

information collection request since the 

60-day notice to prevent fraudulent data 

entry by interviewers. 

In addition to the telephone 

verification survey, we will also audio 

record (with participants’ consent) 

interviews with a random sample of 

approximately 10 percent of 

respondents to the Wave 1 

questionnaire and a random 10 percent 

of the Waves 2, 3, and 4 respondents 

who complete the questionnaire in 

person as an additional quality control 

measure. These recordings will be used 

to measure interviewer compliance with 

study procedures and will be destroyed 

after they are reviewed. This procedure 

does not affect participant burden. 

The total burden hours for the mail 

and field screeners, four outcome 

evaluation questionnaires, three appbased questionnaires, and four 

telephone verification questionnaires is 

18,773 (6,258 annualized). 

In the Federal Register of November 

15, 2016 (81 FR 80075), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Two comments were 

received; however, only one was PRArelated. 

Comment: One comment stated that 

requiring or compelling retailers to 

display ‘‘anti-smoking or anti-tobacco 

advocacy’’ is prohibited under the First 

Amendment. If the campaign is deemed 

unconstitutional, then there is no need 

for the information collection. 

Response: The comment 

misunderstands how FDA intends to 

carry out this public education 

campaign. FDA intends to purchase 

advertising space from retailers on a 

voluntary basis and will not require that 

retailers participate in the campaign. 

Therefore, the comment raises an issue 

that is outside the scope of this 

proposed information collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Households (adults 18 and up) ...... Mail screener ................................................ 9,217 1 9,217 0.17 (10 minutes) ...... 1,567 

Field screener .............................................. 8,753 1 8,753 0.17 (10 minutes) ...... 1,488 

Telephone verification, field screener .......... 733 1 733 0.08 (5 minutes) ........ 59 

Adult smokers, ages 25 to 54 ........ Wave 1 questionnaire .................................. 1,427 1 1,427 0.67 (40 minutes) ...... 956 

Wave 2–4 questionnaires ............................ 2,938 1 2,938 0.67 (40 minutes) ...... 1,968 

Telephone verification, questionnaires 1–4 436 1 436 0.08 (5 minutes) ........ 35 

Study participants (opt in) .............. App-based questionnaire ............................. 769 3 2,308 0.08 (5 minutes) ........ 185 

Total ........................................ ....................................................................... .................... .................... .................... .................................... 6,258 

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


asabaliauskas on DSKBBXCHB2PROD with NOTICES
49836 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23450 Filed 10–26–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6145] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Dispute Resolution 

Procedures for Science-Based 

Decisions on Products Regulated by 

the Center for Veterinary Medicine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of the dispute 

resolution procedures for science-based 

decisions on products regulated by the 

Center for Veterinary Medicine (CVM). 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 26, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 26, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 26, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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–N–6145 for ‘‘Dispute Resolution 

Procedures for Science-Based Decisions 

on Products Regulated by the Center for 

Veterinary Medicine.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 


asabaliauskas on DSKBBXCHB2PROD with NOTICES