Tribal Consultation Meetings, 18627-18628 [2015-07958]
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18627
Federal Register / Vol. 80, No. 66 / Tuesday, April 7, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
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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
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.
AGENCY:
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.
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
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Number of
respondents
Form name
Online surveys ..................................
Discussion Groups ............................
Focus groups ....................................
Website/app usability testing ............
Interviews ..........................................
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
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Number of
responses per
respondent
2,500
150
700
250
100
Avgerage
burden per
response
1
1
1
1
1
30/60
120/60
120/60
45/60
90/60
for the FACA database is https://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
Office of Head Start (OHS),
Administration for Children and
Families, HHS.
ACTION: Notice of meetings.
AGENCY:
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
SUMMARY:
E:\FR\FM\07APN1.SGM
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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 https://eclkc.
ohs.acf.hhs.gov/hslc/hs/calendar/
tc2015.
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.
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SUPPLEMENTARY INFORMATION:
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17:46 Apr 06, 2015
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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 https://
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.
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
SUMMARY:
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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 https://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 https://
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.
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.
SUMMARY:
E:\FR\FM\07APN1.SGM
07APN1
Agencies
[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18627-18628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07958]
-----------------------------------------------------------------------
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
[[Page 18628]]
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 https://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 https://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