Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices 21743 

by expert panels to be of high quality 

and to advance the field. 

• The average number of publications 

per award based on NIDILRR-funded 

research and development activities in 

refereed journals. 

• The percentage of new NIDILRR 

grants that assess the effectiveness of 

interventions, programs, and devices 

using rigorous methods. 

NIDILRR uses information submitted 

by grantees as part of their Annual 

Performance Reports for these reviews. 

5. Continuation Awards: In making a 

continuation award, the Administrator 

of the Administration for Community 

Living may consider, under 45 CFR part 

75, the extent to which a grantee has 

made ‘‘substantial progress toward 

meeting the objectives in its approved 

application.’’ This consideration 

includes the review of a grantee’s 

progress in meeting the targets and 

projected outcomes in its approved 

application, and whether the grantee 

has expended funds in a manner that is 

consistent with its approved application 

and budget. In making a continuation 

grant, the Administrator also considers 

whether the grantee is operating in 

compliance with the assurances in its 

approved application, including those 

applicable to Federal civil rights laws 

that prohibit discrimination in programs 

or activities receiving Federal financial 

assistance from the Department. 

Continuation funding is also subject to 

availability of funds. 

VII. Agency Contact 

FOR FURTHER INFORMATION CONTACT: 

Patricia Barrett, U.S. Department of 

Health and Human Services, 400 

Maryland Avenue SW., room 5142, PCP, 

Washington, DC 20202–2700. 

Telephone: (202) 245–6211 or by email: 

patricia.barrett@acl.hhs.gov. 

If you use a TDD or a TTY, call the 

Federal Relay Service (FRS), toll free, at 

1–800–877–8339. 

VIII. Other Information 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF you must 

have Adobe Acrobat Reader, which is 

available free at the site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at: www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: April 14, 2015. 

John Tschida, 

Director, National Institute on Disability, 

Independent Living, and Rehabilitation 

Research. 

[FR Doc. 2015–09013 Filed 4–17–15; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–1037] 

Pilot Program for Center for Devices 

and Radiological Health Electronic 

Submission for Home Use Device 

Labeling 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for 

Devices and Radiological Health (CDRH) 

is announcing the availability of a 

CDRH electronic submissions Pilot 

Program database to house labeling for 

home use devices. Participation in the 

pilot is open to applicants who label 

their device(s) for home use. 

Participation in the pilot project is 

voluntary. Participants will be asked to 

navigate through the electronic 

submissions system and practice 

submitting labels and package inserts. 

The pilot project is intended to provide 

industry and CDRH staff the 

opportunity to evaluate the submissions 

process and system and to receive 

comments from industry participants. 

DATES: FDA will accept applications for 

participation in the voluntary electronic 

submissions CDRH Home Use Device 

Labeling Pilot Program from May 1, 

2015, through May 31, 2015. See the 

‘‘Participation’’ section for instructions 

on how to submit a request to 

participate. The pilot project will occur 

July 1, 2015, through December 31, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Mary Weick-Brady, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66 Rm. 5426, Silver Spring 

MD 20993, 301–796–6089, Mary.Brady@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring that 

medical devices are safe and effective 

when used for their intended purpose. 

Risks are inherent in all CDRH-regulated 

medical devices, and the Center plays a 

critical role in preventing injuries and 

deaths related to product use. CDRH 

minimizes risk through regulation, 

enforcement, and education. Risk 

minimization is accomplished, in part, 

through clear communication on the 

benefits and risks of the medical devices 

regulated by the Center, including 

communications by CDRH, product 

manufacturers, and product distributors. 

These communications include medical 

device labeling produced by 

manufacturers and distributors. 

Medical device labeling provides 

safety information, instructions for use, 

and/or other necessary information to 

the user. This labeling can be essential 

for home-use devices, which are much 

more likely to be used by lay users, who 

frequently have not been trained to use 

such medical devices and who are 

especially reliant on the instructions for 

use and other information provided by 

the device label and package insert. 

When used in an environment where a 

healthcare professional is not available 

to provide supervision and assistance, 

these devices can present unique 

concerns and challenges. When a homeuse device is used over a period of 

years, it becomes increasingly more 

likely that it may be separated from its 

original labeling or that its original 

labeling will not include current safety 

information or instructions for use. In 

contrast with use in professional 

healthcare settings, a patient or 

caregiver using a home-use device in a 

setting without professional oversight 

may not have extensive experience in 

the use of a device and may not have 

ready access to the original packaging or 

to alternative sources of information 

about a device. 

Home-use devices have significant 

public health importance to patients, 

caregivers, and healthcare professionals. 

Therefore, it is necessary to ensure that 

users are able to access necessary 

information for use, including safety 

information and instructions for use. 

Although many manufacturers have 

Internet sites that provide information 

concerning the devices they currently 

market, those sites typically focus on 

newer products and often do not 

provide any information on devices that 

they no longer actively market. Web 

sites also vary considerably in the types 

of information provided and may lack 

important details concerning their 

devices. Although some manufacturers’ 

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21744 Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices 

Web sites provide some labeling, FDA 

believes that most do not provide the 

label and package insert for all of their 

home-use devices listed with FDA. 

II. CDRH Home Use Device Labeling 

Pilot 

CDRH is developing an electronic 

submissions database, accessible to the 

public through FDA’s Web site, of labels 

and package inserts for listed home-use 

devices. This database would fill an 

important gap in the information 

available to patients, caregivers, and the 

healthcare community concerning 

home-use devices. The database would 

allow both broad searches to identify 

legally marketed home-use devices that 

may fill a particular need and focused 

searches to obtain information 

concerning the use of a specific homeuse device. 

This electronic submissions database 

will be evaluated for usability through 

the CDRH Home Use Device Labeling 

Pilot Project. This pilot project will 

proceed for 6 months. Participation in 

the pilot is open to applicants who label 

their device(s) for home use. 

Participants will be asked to navigate 

through the electronic submissions 

system and practice submitting labels 

and package inserts. The pilot project is 

intended to provide industry and CDRH 

staff the opportunity to evaluate the 

submissions process and system and to 

receive comments from industry 

participants. Comments received during 

the pilot project will be used to evaluate 

the usability of the database. FDA will 

not review the content of any labeling 

submitted to the pilot database for a 

regulatory purpose. The submitted 

labeling and the database will only be 

available to pilot participants. 

A. Participation 

Volunteers interested in participating 

in the pilot project should contact pilot 

staff by email at Mary.Brady@

fda.hhs.gov. The following information 

should be included in the request: 

Contact name, contact phone number, 

and contact email address. FDA will 

contact interested applicants to discuss 

the pilot project. FDA is seeking a 

limited number of participants (no more 

than nine) to participate in this pilot 

project. 

B. Procedures 

By following a series of prompts and 

instructions, pilot participants will 

submit a PDF version of their device 

labeling to the pilot database. The 

content of the submissions will not be 

reviewed by FDA for any regulatory 

purpose, nor will the pilot database be 

available to the public during this pilot 

project. During the pilot, CDRH staff 

will be available to answer any 

questions or concerns that may arise. 

Pilot project participants will be asked 

to comment on and discuss their 

experiences with the pilot submissions 

process. Their comments and 

discussions will assist CDRH in its 

development of this electronic 

submissions database. 

III. Duration of the Home Use Device 

Labeling Pilot 

FDA intends to accept requests for 

participation in the Home Use Device 

Labeling Pilot from May 1, 2015, 

through May 31, 2015. The pilot will 

proceed for 6 months, from July 1, 2015, 

through December 31, 2015. This pilot 

program may be extended as resources 

and needs allow. 

IV. Paperwork Reduction Act of 1995 

This notice 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 parts 801 and 809 have been 

approved under OMB control number 

0910–0485. 

V. Comments 

Interested persons may submit 

electronic comments regarding the 

Home Use Device Labeling Pilot to 

http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 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 14, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08957 Filed 4–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–0990–0392– 

30–D] 

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 

renewal of the approved information 

collection assigned OMB control 

number 0990–0392, scheduled to expire 

on May 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 20, 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.CollectionClearance@

hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the OMB 

control number 0990–0392 and 

document identifier HHS–OS0990– 

0392–30D for reference. 

Information Collection Request Title: 

Office of Adolescent Health and 

Administration for Children, Youth and 

Families Teen Pregnancy Prevention 

Performance Measure Collection. 

Abstract: The Office of Adolescent 

Health (OAH), U.S. Department of 

Health and Human Services (HHS) is 

requesting an extension without change 

of a currently approved information 

collection request by OMB. The purpose 

of the extension is to complete the 

ongoing data collection for the Office of 

Adolescent Health and Administration 

for Children, Youth and Families Teen 

Pregnancy Prevention Performance 

Measures. 

Need and Proposed Use of the 

Information: To collect performance 

measure data on the OAH Teen 

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