Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 18627 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avgerage 

burden per 

response 

Customer or Stakeholder ............................................. Online surveys .................................. 2,500 1 30/60 

Customer or Stakeholder ............................................. Discussion Groups ............................ 150 1 120/60 

Customer or Stakeholder ............................................. Focus groups .................................... 700 1 120/60 

Customer or Stakeholder ............................................. Website/app usability testing ............ 250 1 45/60 

Customer or Stakeholder ............................................. Interviews .......................................... 100 1 90/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–07840 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Health Resources and Services 

Administration 

Advisory Committee on the Maternal, 

Infant and Early Childhood Home 

Visiting Program Evaluation 

AGENCY: Administration for Children 

and Families (ACF), HHS; Health 

Resources and Services Administration 

(HRSA), HHS. 

ACTION: Notice to announce the renewal 

of the Advisory Committee on the 

Maternal, Infant and Early Childhood 

Home Visiting Program Evaluation. 

Authority: Sec. 511(g)(1) of Title V of the 

Social Security Act (42 U.S.C. 711, et seq.). 

The Committee is governed by provisions of 

Public Law 92–463, as amended, (5 U.S.C. 

App. 2), which sets forth standards for the 

formation and use of advisory committees. 

SUMMARY: ACF and HRSA announce the 

renewal of the Advisory Committee on 

the Maternal, Infant and Early 

Childhood Home Visiting Program 

Evaluation to provide advice to the 

Secretary of Health and Human Services 

(‘‘the Secretary’’) on the design, plan, 

progress, and findings of the evaluation 

required under the Act. 

FOR FURTHER INFORMATION CONTACT: 

T’Pring Westbrook, Administration for 

Children and Families; 

tpring.westbrook@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: Sec. 

511(g)(1) of Title V of the Social 

Security Act mandates an Advisory 

Committee to review, and make 

recommendations on, the design and 

plan for the evaluation required under 

the Act. To comply with the authorizing 

directive and guidelines under the 

Federal Advisory Committee Act 

(FACA), a charter has been filed with 

the Committee Management Secretariat 

in the General Services Administration 

(GSA), the appropriate committees in 

the Senate and U.S. House of 

Representatives, and the Library of 

Congress to establish the Advisory 

Board as a non-discretionary federal 

advisory committee. The charter was 

filed on January 27, 2015. 

Objectives and Scope of Activitie 

The purpose of the Committee is to 

provide advice and make 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary, ACF, and the 

Administrator, HRSA, with respect to 

the design, plan, progress, and results of 

the evaluation. 

Membership and Designation 

The Committee shall consist of up to 

25 members appointed by the Secretary. 

Members shall be experts in the areas of 

program evaluation and research, 

education, and early childhood 

development. Members shall be 

appointed as Special Government 

Employees. The committee shall also 

include ex-officio members representing 

ACF, HRSA, and other agencies of the 

federal government designated by the 

Secretary as ex-officio members. The 

ACF Assistant Secretary and HRSA 

Administrator each shall recommend 

nominees for Co-Chairs of the 

Committee. 

Members shall be invited to a 3-year 

term; such terms are contingent upon 

the renewal of the Committee by 

appropriate action prior to its 

termination. 

Administrative Management and 

Support 

Coordination, management, and 

operational services shall be provided 

by ACF, with assistance from HRSA. 

A copy of the Committee charter can 

be obtained from the designated contact 

or by accessing the FACA database that 

is maintained by the GSA Committee 

Management Secretariat. The Web site 

for the FACA database is http://fido.gov/ 

facadatabase/. 

Dated: March 25, 2015. 

Mary K. Wakefield, 

Administrator, HRSA. 

Mark H. Greenberg, 

Acting Assistant Secretary, ACF. 

[FR Doc. 2015–07978 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meetings 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families, HHS. 

ACTION: Notice of meetings. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, Public Law 110–134, notice is 

hereby given of three 1-day Tribal 

Consultation Sessions to be held 

between the Department of Health and 

Human Services, Administration for 

Children and Families, OHS leadership 

and the leadership of Tribal 

Governments operating Head Start 

(including Early Head Start) programs. 

The purpose of these Consultation 

Sessions is to discuss ways to better 

meet the needs of American Indian and 

Alaska Native children and their 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations [42 U.S.C. 9835, 

Section 640(l)(4)]. 

DATES: 

June 16, 2015, from 1:00 p.m. to 5:00 

p.m.; 

July 30, 2015, from 1:00 p.m. to 5:00 

p.m.; 

August 17, 2015, from 1:00 p.m. to 

5:00 p.m. 

Locations: 

• June 16, 2015—National Indian Head 

Start Directors Association, Hyatt 

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18628 Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices 

Regency, 1209 L Street, Sacramento, 

California 95814 

• July 30, 2015—Oklahoma Indian Head 

Start Coalition Conference, 

DoubleTree at Warren Place, 6110 

South Yale Avenue, Tulsa, Oklahoma 

74136 

• August 17, 2015—Northwest Indian 

Head Start Association Conference, 

Holiday Inn Grand Montana, 5500 

Midland Road, Billings, Montana 

59101 

FOR FURTHER INFORMATION CONTACT: 

Robert Bialas, Regional Program 

Manager, Region XI, Office of Head 

Start, email Robert.Bialas@acf.hhs.gov 

or phone (202) 205–9497. Additional 

information and online meeting 

registration is available at http://eclkc.

ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces OHS Tribal 

Consultations for leaders of Tribal 

Governments operating Head Start and 

Early Head Start programs. 

The agenda for the scheduled OHS 

Tribal Consultations in Sacramento, 

California, Tulsa, Oklahoma, and 

Billings, Montana, will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of American Indian/ 

Alaska Native children and families, 

taking into consideration funding 

allocations, distribution formulas, and 

other issues affecting the delivery of 

Head Start services in their geographic 

locations. In addition, OHS will share 

actions taken and in progress to address 

the issues and concerns raised in 2014 

OHS Tribal Consultations. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 U.S.C. 

9835, Section 640(l)(4)(A)]. Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe prior to the 

Consultation Sessions. Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of the Consultation 

Sessions will be prepared and made 

available within 45 days of the 

Consultation Sessions to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Robert Bialas at 

Robert.Bialas@acf.hhs.gov either prior 

to the Consultation Sessions or within 

30 days after the meeting. 

OHS will summarize oral testimony 

and comments from each Consultation 

Session in the report without 

attribution, along with topics of concern 

and recommendations. OHS has sent 

hotel and logistical information for the 

California, Oklahoma, and Montana 

Consultation Sessions to tribal leaders 

via email and posted information on the 

Early Childhood Learning and 

Knowledge Center Web site at http://

eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/

tc2015. 

Dated: March 26, 2015. 

Ann Linehan, 

Acting Director, Office of Head Start. 

[FR Doc. 2015–07958 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0229] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that CHOLBAM 

(cholic acid), manufactured by 

Asklepion Pharmaceuticals, LLC, meets 

the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Larry Bauer, Rare Diseases Program, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Silver Spring, MD 20993–0002, 

301–796–4842, FAX: 301–796–9858, 

email: larry.bauer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of a rare 

pediatric disease product application. 

Under section 529 of the FD&C Act (21 

U.S.C. 360ff), added by FDASIA, FDA 

will award priority review vouchers to 

sponsors of rare pediatric disease 

product applications that meet certain 

criteria. FDA has determined that 

CHOLBAM (cholic acid), manufactured 

by Asklepion Pharmaceuticals, LLC, 

meets the criteria for a priority review 

voucher. CHOLBAM (cholic acid) is a 

bile acid indicated for the treatment of 

bile acid synthesis disorders due to 

single enzyme defects and as adjunctive 

treatment of peroxisomal disorders, 

including Zellweger spectrum disorders 

in patients who exhibit manifestations 

of liver disease or steatorrhea or 

complications from decreased fat 

soluble vitamin absorption. Bile acid 

synthesis disorders is a group of rare 

congenital disorders caused by the 

absence or malfunction of an enzyme 

involved in an important metabolic 

pathway, leading to a failure to produce 

normal bile acids. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/

DevelopingProductsforRare

DiseasesConditions/RarePediatric

DiseasePriorityVoucherProgram/

default.htm. 

For further information about 

CHOLBAM (cholic acid), go to the 

Drugs@FDA Web site at http://

www.accessdata.fda.gov/scripts/cder/

drugsatfda/index.cfm. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08016 Filed 4–6–15; 8:45 am] 

BILLING CODE CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0229] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

as amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that UNITUXIN 

(dinutuximab), manufactured by United 

Therapeutics Corporation, meets the 

criteria for a priority review voucher. 

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