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
10494 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 

Monday through Friday, and will be 

posted to the docket at http://

www.regulations.gov. 

Transcripts: As soon as a transcript is 

available, FDA will post it at http://

wwww.fda.gov/NewsEvents/

MeetingsConferencesWorkshops/

ucm433552.htm. 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03974 Filed 2–25–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Organ 

Transplantation; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Organ 

Transplantation (ACOT). 

Date and Time: March 12, from 8:30 

a.m. to 4:30 p.m. Eastern Standard 

Time. March 13, from 8:30 a.m. to 12:30 

p.m. Eastern Standard Time. 

Place: Health Resources and Services 

Administration, 5600 Fishers Lane, 

Room 05W11, Rockville, MD 20857. 

Status: The meeting will be open to 

the public. 

Purpose: Under the authority of 42 

U.S.C. Section 217a, Section 222 of the 

Public Health Service Act, as amended, 

and 42 CFR 121.12 (2000), ACOT was 

established to assist the Secretary in 

enhancing organ donation, ensuring that 

the system of organ transplantation is 

grounded in the best available medical 

science, and assuring the public that the 

system is as effective and equitable as 

possible, thereby increasing public 

confidence in the integrity and 

effectiveness of the transplantation 

system. ACOT is composed of up to 25 

members including the Chair. Members 

serve as Special Government Employees 

and have diverse backgrounds in fields 

such as organ donation, health care 

public policy, transplantation medicine 

and surgery, critical care medicine, and 

other medical specialties involved in 

the identification and referral of donors, 

non-physician transplant professions, 

nursing, epidemiology, immunology, 

law and bioethics, behavioral sciences, 

economics and statistics, as well as 

representatives of transplant candidates, 

transplant recipients, organ donors, and 

family members. 

Agenda: The Committee will hear 

presentations, including those on the 

following topics: Kidney Paired 

Donation; Vascularized Composite 

Allografts; Donor Management 

Research; Living Donation; and the 

Affordable Care Act and 

Transplantation. Agenda items are 

subject to change as priorities indicate. 

After Committee discussions, 

members of the public will have an 

opportunity to comment. Because of the 

Committee’s full agenda and timeframe 

in which to cover the agenda topics, 

public comment will be limited. All 

public comments will be included in 

the record of the ACOT meeting. 

Meeting summary notes will be posted 

on the Department’s organ donation 

Web site at http://www.organdonor.gov/ 

legislation/advisory.html#meetings. 

The draft meeting agenda will be 

posted on www.blsmeetings.net/ACOT. 

Those participating on this meeting 

should pre-register by visiting 

www.blsmeetings.net/ACOT. The 

deadline to pre-register for this meeting 

is Wednesday, March 11, 2015. 

Registration will be confirmed on site. 

For all logistical questions and 

concerns, please contact Anita Allen, 

Seamon Corporation at 301–658–3442 

or send an email to aallen@

seamoncorporation.com. 

Public Comment: It is preferred that 

persons interested in providing an oral 

presentation email a written request, 

along with a copy of their presentation, 

to Patricia Stroup, MBA, MPA, 

Executive Secretary, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, at pstroup@hrsa.gov. 

Requests should contain the name, 

address, telephone number, email 

address, and any business or 

professional affiliation of the person 

desiring to make an oral presentation. 

Groups having similar interests are 

requested to combine their comments 

and present them through a single 

representative. 

The allocation of time may be 

adjusted to accommodate the level of 

expressed interest. Persons who do not 

file an advance request for a 

presentation, but desire to make an oral 

statement, may request it during the 

public comment period. Public 

participation and ability to comment 

will be limited to time as it permits. FOR

FURTHER INFORMATION CONTACT: Patricia 

Stroup, MBA, MPA, Executive 

Secretary, Healthcare Systems Bureau, 

Health Resources and Services 

Administration, 5600 Fishers Lane, 

Room 17W65, Rockville, MD 20857; 

telephone (301) 443–1127. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–03929 Filed 2–25–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Emergency Clearance Request Human 

Influenza Surveillance of Health Care 

Centers in the United States and 

Taiwan 

SUMMARY: In accordance with Section 

3507(j) of the Paperwork Reduction Act 

of 1995, the National Institute of Allergy 

and Infectious Diseases (NIAID), the 

National Institutes of Health (NIH), has 

submitted to the Office of Management 

and Budget (OMB) a request for 

emergency review and processing of this 

information collection by March 7, 

2015. NIAID is requesting emergency 

processing of this information 

collection, pursuant to 5 CFR 1320.13, 

because NIAID cannot reasonably 

comply with the normal clearance 

procedures which would cause a delay 

and likely prevent or substantially 

disrupt the collection of information. A 

delay in starting the information 

collection would hinder the agency in 

accomplishing its mission to the 

detriment of the public good. Public 

harm could result through the loss of 

critically needed information to 

understand the causes of severity of 

influenza and associated morbidity and 

mortality during the Northern 

hemisphere 2014–15 influenza season. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. Written comments and/or 

suggestions from the public and affected 

agencies are invited on one or more of 

the following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 


rmajette on DSK2VPTVN1PROD with NOTICES