10492 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 

II. Public Meeting: NIOSH will hold a 

public meeting to allow for comments 

on future directions for surveillance of 

injuries within the agricultural 

production industry. The meeting is 

open to the public, limited only by the 

capacity of 100 connections to the Web 

based conference. 

Confirm your attendance to this 

meeting by sending an email to 

mgoldcamp@cdc.gov by March 16, 

2015. An email confirming registration 

will be sent from NIOSH and will 

include details needed to participate. 

Requests to make presentations at the 

public meeting should be emailed to 

mgoldcamp@cdc.gov by March 16, 

2015. All requests to present should 

contain the name, address, telephone 

number, and relevant business 

affiliations of the presenter. Presenters 

will be assigned a 10-minute slot on the 

agenda. Presenters who wish to use 

slides must email an electronic file in 

Microsoft PowerPoint format to 

mgoldcamp@cdc.gov by March 16, 

2015. An email confirming the 

presentation request will be sent from 

NIOSH and will include details needed 

to present and an approximate start time 

for the presentation. 

If a presenter is not in attendance 

when his/her presentation is scheduled 

to begin, the remaining presenters will 

be heard in order. After the last 

scheduled presenter is heard, those who 

missed their opportunity may be 

allowed to present, limited by time 

available. 

Attendees who wish to speak, but did 

not submit a request for the opportunity 

to make a presentation, may be given 

this opportunity after the scheduled 

presenters are heard, at the discretion of 

the presiding officer and limited by time 

available. 

The public meeting, including all 

presentations and slides, will be 

recorded, transcribed, and posted 

without change to http://

www.regulations.gov, including any 

personal information provided. 

III. Written Comments: You may 

submit comments, identified by CDC– 

2015–0005 and Docket Number NIOSH– 

281, by either of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov Follow the 

instructions for submitting comments. 

• Mail: National Institute for 

Occupational Safety and Health, NIOSH 

Docket Office, 1090 Tusculum Avenue 

MS C–34, Cincinnati, Ohio 45226–1998. 

All information received in response 

to this notice must include the agency 

name and docket number [CDC–2015– 

0005; NIOSH–281]. All relevant 

comments received will be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. All 

electronic comments should be 

formatted as Microsoft Word. All 

information received in response to this 

notice will also be available for public 

examination and copying at the NIOSH 

Docket Office, 1150 Tusculum Avenue, 

Room 155, Cincinnati, Ohio 45226– 

1998. 

Dated: February 18, 2015. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2015–03949 Filed 2–25–15; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Title: Youth Education and 

Relationship Services (YEARS) 

Descriptive Study. 

OMB No.: New Collection. 

Description: Since 2006, Congress has 

authorized dedicated funding (currently 

at the level of $75 million annually) to 

support programs promoting healthy 

marriage and relationship education 

(HMRE). In order to better understand 

the services that federally-funded HMRE 

programs are providing to youth and the 

populations the programs are reaching, 

The Office of Planning, Research and 

Evaluation (OPRE), within ACF/HHS is 

proposing data collection activity as 

part of the Youth Education and 

Relationship Services (YEARS) 

Descriptive Study. The data that ACF 

proposes to collect includes information 

on funding spent serving youth, the 

number of youth being served, youth 

demographic characteristics, 

characteristics of the organizations or 

programs serving youth, information on 

program curricula and contents, and 

program implementation information. 

This data is to be collected through a 

web-based survey that is to be 

completed by HMRE grantee program 

staff. This information will be critical to 

informing future efforts to improve 

HMRE programs serving youth. 

Respondents: Healthy marriage and 

relationship education (HMRE) grantee 

program staff. 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Web-based survey ............................................................... 176 88 1 0.5 44 

Estimated Total Annual Burden 

Hours: 44 

In compliance with the requirements 

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

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: OPRE Reports Clearance Officer. 

Email address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. The Department specifically 

requests comments on (a) whether the 

proposed collection of information is 

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) 

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. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Reference 

[1] http://www.ssa.gov/OP_Home/ssact/


rmajette on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 10493 

title04/0403.htm. 

Karl Koerper, 

Reports Clearance Officer. 

[FR Doc. 2015–03924 Filed 2–25–15; 8:45 am] 

BILLING CODE 4184–73–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–20115–N–0456] 

Pediatric Stakeholder Meeting; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Office of 

Pediatric Therapeutics (OPT), the Center 

for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research (CBER) are 

announcing a public meeting seeking 

input from patient groups, consumer 

groups, regulated industry, academia 

and other interested parties to obtain 

any recommendations or information 

relevant to the report to Congress that 

FDA is required to submit concerning 

pediatrics, as outlined in section 508 of 

the Food and Drug Administration 

Safety and Innovation Act (FDASIA) 

(see the SUPPLEMENTARY INFORMATION

section for additional background 

information). 

DATES: The public meeting will be held 

on March 25, 2015, from 9 a.m. to 5 p.m. 

Registration to attend the meeting 

should be received by March 20, 2015 

(see the SUPPLEMENTARY INFORMATION

section for instructions). 

ADDRESSES: The meeting will be held at 

FDA’s White Oak Campus, 10903 New 

Hampshire Ave., Building 31 

Conference Center, the Great Room 

(1503–B & C), Silver Spring, MD 20993– 

0002. Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For information on parking 

and security procedures, please refer to 

http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740. 

Submit either electronic or written 

comments by April 24, 2015. Submit 

electronic comments 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. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FDA will post the agenda 

approximately 5 days before the meeting 

at: http://wwww.fda.gov/NewsEvents/

MeetingsConferencesWorkshops/

ucm433552.htm. 

FOR FURTHER INFORMATION CONTACT: 

Terrie L. Crescenzi, Office of Pediatric 

Therapeutics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

terrie.crescenzi@fda.hhs.gov or Betsy 

Sanford, Office of Pediatric 

Therapeutics, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

elizabeth.sanford@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the President signed 

into law the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144). 

Section 508 of FDASIA directs the 

Secretary of HHS to submit a report to 

Congress on the implementation of the 

Best Pharmaceuticals for Children Act 

(BPCA) and Pediatric Research Equity 

Act (PREA). The first report must be 

submitted to Congress by July 9, 2016, 

and every 5 years thereafter. FDASIA 

also requires FDA to obtain, at least 180 

days prior to submission of the report, 

stakeholder input from patient groups, 

consumer groups, regulated industry, 

academia, and any other interested 

parties to obtain any recommendations 

or information relevant to the report 

including suggestions for modifications 

that would improve pediatric drug 

research and pediatric labeling of drugs 

and biological products. 

The basic content of the report will 

include: An assessment of the 

effectiveness of BPCA (section 505A) 

and PREA (section 505B) in improving 

information about pediatric uses for 

approved drugs and biological products, 

including the number and type of 

labeling changes made since the 

enactment of FDASIA and the 

importance of such uses in the 

improvement of the health of children; 

various statistics related to both PREA 

and BPCA, including the Written 

Request referral process with the 

National Institutes of Health; an 

assessment of the timeliness and 

effectiveness of pediatric study plans; 

an assessment of studying biologics; 

efforts made to increase the number of 

studies conducted in the neonatal 

population; the number and importance 

of drugs and biologics studied in 

children with cancer and any 

recommendations for modification to 

the programs that would improve 

pediatric drug research and increase 

labeling of drugs and biologics; an 

assessment of the successes of and 

limitations to studying drugs for rare 

diseases; an assessment of the efforts to 

address the suggestions and options 

described in any prior report issued by 

the Comptroller General, Institute of 

Medicine, or the Secretary, and any 

stakeholder recommendations or 

modifications that would improve 

pediatric drug research and pediatric 

labeling of drugs and biological 

products. 

The specific topics to be discussed at 

the meeting will include, but not be 

limited to, pediatric labeling changes, 

waivers and deferrals, Written Requests, 

pediatric study plans, programmatic 

activities with the NIH Written Request 

referral process, activities concerning 

neonates, pediatric cancers and rare 

diseases, and transparency. 

II. Meeting Attendance and 

Participation 

If you wish to attend this meeting, 

visit http://

stakeholderinput.eventbrite.com. Please 

register by March 20, 2015. Those who 

are unable to attend the meeting in 

person can register to view a live 

Webcast of the meeting. You will be 

asked to indicate in your registration if 

you plan to attend in person or via the 

Webcast. Your registration will also 

contain your complete contact 

information, including name, title, 

affiliation, address, email address, and 

phone number. Seating will be limited 

so early registration is recommended. 

Registration is free and will be on a firstcome, first-served basis. Onsite 

registration on the day of the meeting 

will be based on space availability. If 

you need special accommodations due 

to a disability, please contact Betsy 

Sanford (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance. 

Persons attending the meeting are 

advised that FDA is not responsible for 

providing access to electrical outlets. 

Persons interested in presenting 

comments at the meeting will be asked 

to indicate this in their registration. 

FDA will try to accommodate all 

participant requests to speak, however 

the duration of comments may be 

limited by time constraints. 

Comments: Regardless of attendance 

at the public meeting, you can submit 

electronic or written comments to the 

public docket (see ADDRESSES) by April 

24, 2015. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 


rmajette on DSK2VPTVN1PROD with NOTICES