19672 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Notices 

petitions. 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. If you submit a written 

petition, two copies are required. A 

petition submitted electronically must 

be submitted to http://

www.regulations.gov, Docket No. FDA– 

2013–S–0610. Comments and petitions 

that have not been made publicly 

available on http://www.regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08362 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–D–0090] 

Balancing Premarket and Postmarket 

Data Collection for Devices Subject to 

Premarket Approval; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Balancing Premarket and Postmarket 

Data Collection for Devices Subject to 

Premarket Approval.’’ This guidance 

clarifies FDA’s current policy on 

balancing premarket and postmarket 

data collection during the Agency’s 

review of premarket approval 

applications (PMA). Specifically, this 

guidance outlines how FDA considers 

the role of postmarket information in 

determining the appropriate type and 

amount of data that should be collected 

in the premarket setting to support 

premarket approval, while still meeting 

the statutory standard of safety and 

effectiveness. FDA believes this 

guidance will improve patient access to 

safe and effective medical devices that 

are important to public health by 

improving the predictability, 

consistency, transparency, and 

efficiency of the premarket process. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Balancing 

Premarket and Postmarket Data 

Collection for Devices Subject to 

Premarket Approval’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Josephson, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5449, Silver Spring, 

MD 20993–0002, 301–796–5178; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has long applied postmarket 

controls as a way to reduce premarket 

data collection, where appropriate, 

while assuring that the statutory 

standard for approval of reasonable 

assurance of safety and effectiveness is 

still met. The right balance of premarket 

and postmarket data collection 

facilitates timely patient access to 

important new technology without 

undermining patient safety. 

In this guidance, FDA describes 

existing statutory requirements under 

the Federal Food, Drug, and Cosmetic 

Act, its implementing regulations, and 

FDA policies that support the policy on 

balancing premarket and postmarket 

data collection during review of PMAs. 

In addition, FDA clarifies how the 

Agency considers postmarket data as 

part of the benefit-risk framework 

described in FDA’s guidance ‘‘Factors to 

Consider When Making Benefit-Risk 

Determinations in Medical Device 

Premarket Approval and De Novo 

Classifications,’’ issued on March 28, 

2012. This guidance provides a resource 

for industry and FDA staff on how FDA 

determines when it is appropriate for a 

sponsor of a PMA to collect some data 

(clinical or non-clinical) in the 

postmarket setting, rather than 

premarket. 

A draft of this guidance was made 

available in the Federal Register on 

April 23, 2014, and the comment period 

closed July 22, 2014. Changes between 

the draft and final versions of this 

guidance include an increased focus on 

patient outcomes and additional 

examples to help industry better 

understand when it may be appropriate 

to shift data collection from the 

premarket to postmarket setting. The 

final guidance also recognizes the 

potential for use of registry data to 

satisfy post-approval study 

requirements. 

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 Agency’s 

current thinking on balancing premarket 

and postmarket data collection for 

devices subject to premarket approval. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or from 

CBER at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Persons unable to download an 

electronic copy of ‘‘Balancing Premarket 

and Postmarket Data Collection for 

Devices Subject to Premarket Approval’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1833 to 

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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 

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