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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Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices 21745 

Pregnancy Prevention (TPP) Program 

and the ACF/FYSB Personal 

Responsibility Education Program 

Innovative Strategies (PREIS). These 

data will allow OAH and FYSB to 

monitor the progress of program 

grantees, and to report to Congress on 

the performance of the programs. 

Likely Respondents: The 106 TPP and 

PREIS grantees and approximately 2000 

PREIS youth participants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. 

The total annual burden hours 

estimated for this ICR are summarized 

in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Forms 

(if necessary) 

Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Measures for all grantees ................. Grantee program staff—all ............... 106 1 7 742 

Participant-level measures ............... Grantee program staff—Tier 1 C/D, 

Tier 2, and PREIS.

45 1 1 45 

Perceived impact questions .............. Youth participants—PREIS .............. 2,000 1 5/60 167 

Perceived impact measures ............. Grantee program staff—PREIS ........ 11 1 3 33 

Total ........................................... ........................................................... ........................ ........................ ........................ 987 

Terry S. Clark, 

Asst Information Collection Clearance 

Officer. 

[FR Doc. 2015–08960 Filed 4–17–15; 8:45 am] 

BILLING CODE 4168–11–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: HHS–0990–0260–30D] 

Agency Information Collection 

Activities; Proposed Collection; Public 

Comment Request 

AGENCY: Office of the Assistant 

Secretary for Health, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

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

Reduction Act of 1995, the Office of the 

Secretary, Department of Health and 

Human Services (HHS), announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). The ICR is for extending 

the use of the approved information 

collection assigned OMB control 

number 0990–0260, which expires on 

April 30, 2015. Prior to submitting that 

ICR to OMB, OS seeks comments from 

the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on the ICR must be 

received on or before May 20, 2015. 

ADDRESSES: Submit your comments to 

Information.CollectionClearance

@hhs.gov or by calling (202) 690–6162. 

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 

document identifier 0990–0260 for 

reference. 

Information Collection Request Title: 

Protection of Human Subjects: 

Assurance of Compliance with Federal 

Policy/IRB Review/IRB Recordkeeping/

Informed Consent/Consent 

Documentation—Extension OMB No. 

0990–0260, Assistant Secretary for 

Health, Office for Human Research 

Protections. 

OMB No.: 0990–0260. 

Abstract: The information collected 

through the Protection of Human 

Subjects: Assurance. 

Identification/IRB Certification/

Declaration of Exemption Form 

Protection of Human Subjects: 

Assurance of Compliance with Federal 

Policy/IRB Review/IRB Recordkeeping/

Informed Consent/Consent 

Documentation collection requirement 

is the minimum necessary to satisfy the 

assurance, certification, reporting, 

disclosure, documentation and 

recordkeeping requirements of Section 

491(a) of the Public Health Service Act 

and HHS Regulations for the protection 

of human subjects at 45 CFR part 46. 

Likely Respondents: Research 

institutions engaged in HHS-conducted 

or -supported research involving human 

subjects. Institutional use of the form is 

also relied upon by other federal 

departments and agencies that have 

codified or follow the Federal Policy for 

the Protection of Human Subjects 

(Common Rule). 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Title Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent .................. 6,000 39.33 1 235,980 

.115(a) IRB Recordkeeping ............................................................................. 6,000 15 10 900,000 

.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting .... 6,000 0.5 45/60 2,250 

Total .......................................................................................................... ........................ ........................ ........................ 1,138,230 

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