Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19673 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 part 801 have been approved 

under OMB control number 0910–0485; 

the collections of information in 21 CFR 

part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 822 have been approved under 

OMB control number 0910–0449; the 

collection of information in 21 CFR part 

860, subpart C have been approved 

under OMB control number 0910–0138; 

and the collections of information in the 

guidance document regarding requests 

for feedback on medical device 

submission have been approved under 

OMB control number 0910–0756. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08363 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2294] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Evaluation of the 

Food and Drug Administration’s ‘Fresh 

Empire’ Multicultural Youth Tobacco 

Prevention 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 May 13, 

2015. 

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 the Food and Drug 

Administration’s ‘Fresh Empire’ 

Multicultural Youth Tobacco Prevention 

Campaign.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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 the Food and Drug 

Administration’s ‘Fresh Empire’ 

Multicultural Youth Tobacco 

Prevention Campaign (OMB Control 

Number 0910–NEW) 

The 2009 Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) amended 

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 youth-targeted public 

education campaign (‘Fresh Empire’) to 

help prevent tobacco use among 

multicultural youth and thereby reduce 

the public health burden of tobacco. The 

campaign will feature events, 

advertisements on television and radio 

and in print, digital communications 

including social media, and other forms 

of media. 

In support of the provisions of the 

Tobacco Control Act that require FDA to 

protect the public health and to reduce 

tobacco use by minors, FDA requests 

OMB approval to collect information 

needed to evaluate FDA’s ‘Fresh 

Empire’ multicultural youth tobacco 

prevention campaign. Comprehensive 

evaluation of FDA’s public education 

campaigns is needed to ensure 

campaign messages are effectively 

received, understood, and accepted by 

those for whom they are intended. 

Evaluation is an essential organizational 

practice in public health and a 

systematic way to account for and 

improve public health actions. 

FDA plans to evaluate the 

effectiveness of its multicultural youth 

tobacco prevention campaign through 

an outcome evaluation study that will 

be designed to follow the multiple, 

discrete waves of media advertising 

planned for the campaign. 

The outcome evaluation study 

consists of a pre-test survey of 

multicultural youth aged 12 to 17 before 

campaign launch. The pre-test survey 

will be followed by ongoing crosssectional surveys of the target audience 

of youth beginning approximately 3 

months following campaign launch. 

Information will be collected about 

youth awareness of and exposure to 

campaign events and advertisements 

and about tobacco-related knowledge, 

attitudes, beliefs, intentions, and use. 

Information will also be collected on 

demographic variables including age, 

sex, race/ethnicity, grade level, and 

primary language. 

All information will be collected 

through in-person and Web-based 

questionnaires. Youth respondents will 

be recruited from two sources: (1) A 

sample drawn from 30 U.S. media 

markets gathered using an addressbased postal mail sampling of U.S. 

households for the outcome evaluation 

studies and (2) targeted social media 

mstockstill on DSK4VPTVN1PROD with NOTICES

19674 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 

(e.g., Facebook). Participation in the 

study is voluntary. 

The information collected is 

necessary to inform FDA’s efforts and 

measure the effectiveness and public 

health impact of the campaign. Data will 

be used to estimate awareness of and 

exposure to the campaign among youth 

in target markets where the campaign is 

active. Data will also be used to examine 

statistical associations between 

exposure to the campaign and 

subsequent changes in specific 

outcomes of interest, which will include 

knowledge, attitudes, and beliefs, 

related to tobacco use. 

FDA’s burden estimate is based on 

prior experience with in-person and 

Internet panel studies similar to the 

Agency’s plan presented in this 

document. Since the 60-day notice 

published, FDA has revised the 

estimated burden. The original burden 

estimate accounted for evaluation of 

more than one FDA multicultural 

campaign. The current burden estimate 

accounts for the evaluation of one 

campaign, FDA’s ‘Fresh Empire’ Youth 

Tobacco Prevention Campaign. 

A mail-based screener will be one of 

the methods used to identify eligible 

youth. Parents or guardians will be 

asked to provide consent and their 

contact information on this form. For 

the pre-launch survey, the 5-minute 

screener will be completed by 13,816 

households for a total of 1,151 burden 

hours for youth and an additional 230 

hours for the parents or guardians. For 

the pre-test survey, 2,100 youth will 

complete a questionnaire with an 

estimated burden of 30 minutes per 

respondent, for an annualized total of 

1,050 hours. For the post-test screening 

survey, the estimated burden is 3,453 

hours for youth and 691 hours for 

adults. For the post-test surveys, the 

estimated burden is 45 minutes per 

respondent, for a total of 4,725 burden 

hours. 

We will also recruit youth through 

social media (e.g., Facebook, Twitter) as 

a secondary strategy to recruit youth 13 

to 17. An online version of the screener 

described above will be used to identify 

eligible youth (included in Attachment 

3). Eligible youth will be asked to 

provide their parents’ or guardians’ 

contact information. The screener will 

take 5 minutes and will be completed by 

2,500 youth for the pre-test survey for a 

total of 208 burden hours. Of these, 500 

will be eligible and complete the pretest survey for a total of 250 burden 

hours. For the post-test survey, 10,500 

youth will complete the 5-minute 

screener, for 875 burden hours. Of these, 

2,100 will be eligible and complete the 

post-test survey online (up to 45 

minutes), for a total of 1,575 burden 

hours. 

The target number of completed 

campaign questionnaires for all 

respondents is 134,528, and the 

annualized response burden is 

estimated at 14,208 hours. 

In the Federal Register of January 5, 

2015 (80 FR 230), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Two comments were 

received, however, only one was PRA 

related. 

Comment: One comment stated that 

the media tracking survey and the 

outcome evaluation study proposed by 

FDA are critical to FDA’s efforts to 

develop and implement an effective 

multicultural youth tobacco prevention 

campaign. 

Response: FDA agrees that this 

collection of information is necessary to 

the Agency’s efforts to promote and 

improve public health. 

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 

Youth aged 12 to 17 in the 

United States.

Screener and Consent 

Process—Pre-test outcome survey.

13,816 1 13,816 0.0833 (5 min.) ..... 1,151 

Adults 18 and older in the 

United States.

Screener and Consent 

Process—Pre-test outcome survey.

13,816 1 13,816 0.0166 (1 min.) ..... 230 

Youth aged 12 to 17 in the 

United States.

Screener and Consent 

Process—post-test outcome survey.

41,448 1 41,448 0.0833 (5 min.) ..... 3,453 

Adults 18 and older in the 

United States.

Screener and Consent 

Process—post-test outcome survey.

41,448 1 41,448 0.01666 (1 min.) ... 691 

Multicultural Youth aged 

12–17 in select media 

markets.

Pre-test outcome evaluation 

survey.

2,100 1 2,100 0.5 (30 min.) ......... 1,050 

Post-test evaluation survey 6,300 1 6,300 0.75 (45 min.) ....... 4,725 

Multicultural youth aged 13– 

17 in the select media 

markets recruiting through 

social media.

Pre-test online screener ..... 2,500 1 2,500 0.0833 (5 min.) ..... 208 

Pre-test online survey ......... 500 1 500 0.5 (30 min.) ......... 250 

Post-test online screener .... 10,500 1 10,500 0.0833 (5 min.) ..... 875 

Post-test online survey ....... 2,100 1 2,100 0.75 (45 min.) ....... 1,575 

Total ............................. ............................................. 134,528 ........................ ........................ ............................... 14,208 

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

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 19675 

Dated: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08466 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–0990–0391– 

30D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, has submitted an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB) for 

review and approval. The ICR is for 

reinstatement of a previously-approved 

information collection assigned OMB 

control number 0990–0391, which 

expired on March 31, 2015. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public on this ICR during the review 

and approval period. 

DATES: Comments on the ICR must be 

received on or before May 13, 2015. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.Collection

Clearance@hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

document identifier HHS–OS–0990– 

0391–30D for reference. 

Information Collection Request Title: 

The Hospital Preparedness Program 

OMB No.: 0990–0391. 

Abstract: The Science Healthcare 

Preparedness Evaluation and Research 

(SHARPER), part of the Department of 

Health and Human Services (HHS), 

Assistant Secretary for Preparedness 

and Response (ASPR), Office of 

Emergency Management (OEM), 

Division of National Healthcare 

Preparedness Programs (NHPP), in 

conjunction with the Hospital 

Preparedness Program (HPP) is seeking 

a reinstatement with change on a 

currently approved clearance by the 

Office of Management of Budget (OMB) 

for a Generic Data Collection Form to 

serve as the cornerstone of its effort to 

assess awardee program under the HPP 

Cooperative Agreement (CA) Program. 

Program data are gathered from 

awardees as part of their Ad-hoc and 

End-of-Year Progress Reports and other 

similar information collections (ICs) 

which have the same general purpose, 

account for awardee spending and 

program on all activities conducted in 

pursuit of achieving the HPP Grant 

goals. 

This data collection effort is crucial to 

HPP’s decision-making process 

regarding the continued existence, 

design and funding levels of this 

program. Results from these data 

analyses enable HPP to monitor 

healthcare emergency preparedness and 

progress towards national preparedness 

goals. HPP supports priorities outlined 

by the National Preparedness Goal (the 

Goal) established by the Department of 

Homeland Security (DHS) in 2005. The 

Goal guides entities at all levels of 

government in the development and 

maintenance of capabilities to prevent, 

protect against, respond to and recover 

from major events. Additionally, the 

Goal will assist entities at all levels of 

government in the development and 

maintenance of the capabilities to 

identify, prioritize and protect critical 

infrastructure. 

Likely Respondents: Hospital 

Preparedness Program Awardees. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Data collection activity Number of 

respondents 

Number of 

responses 

Response time 

(hours) 

Total annual burden 

hours 

(for all awardees) 

3-Year total 

(for all awardees) 

Generic and Future Program Data Information Collection(s) ................................ 62 1 58 3,596 ....................................

Total .................................................... ........................ ........................ .......................... 3,596 10,788 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2015–08298 Filed 4–10–15; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are 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) ways to enhance 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. 

Proposed Project: Primary and 

Behavioral Health Care Integration 

Program (OMB No. 0930–0340)— 

Revision 

The Substance Abuse and Mental 

Health Services Administration’s 

(SAMHSA) Center for Mental Health 

Services, (CMHS) is requesting a 

revision from the Office of Management 

and Budget (OMB) for data collection 

activities associated with their Primary 

and Behavioral Health Care Integration 

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