Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee, Renewal, 60356-60357 [2016-21041]
Download as PDF
<![CDATA[
60356
Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2016–21039 Filed 8–31–16; 8:45 am]
BILLING CODE 4163–18–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, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
Pursuant to the Improving
Head Start for School Readiness Act of
2007, Public Law 110–134, notice is
hereby given of a 1-day Tribal
Consultation Session to be held between
the Department of Health and Human
Services (HHS), 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: October 19, 2016, from 8:00 a.m.
to 1:00 p.m.
LOCATION: ThrivAlaska Head Start
Center at 1949 Gilliam Way, Fairbanks,
Alaska 99701.
FOR FURTHER INFORMATION CONTACT:
Angie Godfrey, Regional Program
Manager, Region XI AI/AN, OHS, email
Angie.Godfrey@acf.hhs.gov, or phone
(202) 205–5811. Additional information
and online meeting registration is
available at: https://
eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/
tc2016.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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 Fairbanks,
Alaska, will be organized around the
statutory purposes of Head Start Tribal
Consultations related to meeting the
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:14 Aug 31, 2016
Jkt 238001
needs of American Indian and Alaska
Native children and families, taking into
consideration funding allocations,
distribution formulas, and other issues
affecting the delivery of Head Start
services in that geographic location. In
addition, OHS will share actions taken
and in progress to address the issues
and concerns raised in the 2016 OHS
Tribal Consultation.
The Consultation Session 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. Tribal Governments
must submit the designee letter at least
3 days in advance of the Consultation
Session to Angie Godfrey at
Angie.Godfrey@acf.hhs.gov. Other
representatives of tribal organizations
and Native nonprofit organizations are
welcome to attend as observers.
A detailed report of the Consultation
Session will be prepared and made
available within 45 days of the
Consultation Session 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 Angie Godfrey at
Angie.Godfrey@acf.hhs.gov either prior
to the Consultation Session or within 30
days after the meeting. OHS will
summarize oral testimony and
comments from the Consultation
Session in a report without attribution,
along with topics of concern and
recommendations.
Dated: August 26, 2016.
Blanca E. Enriquez,
Director, Office of Head Start.
announcement of the award of 13
single-source grants for a total of
$35,513,938 under the W–F Alternative
Program. The document contained an
incorrect address and telephone
number.
FOR FURTHER INFORMATION CONTACT:
Colleen Mahar-Piersma, Program
Analyst, Office of Refugee Resettlement,
Mary E. Switzer Building, 330 C Street
SW., Washington, DC 20201. Telephone:
202–205–5266; Email: colleen.maharpiersma@acf.hhs.gov.
Correction
In the Federal Register of August 22,
2016, in FR Doc. 2016–19923, on page
56655, in the third column, correct the
FOR FURTHER INFORMATION CONTACT
caption to read: Colleen Mahar-Piersma,
Program Analyst, Office of Refugee
Resettlement, Mary E. Switzer Building,
330 C Street SW., Washington, DC
20201. Telephone: 202–205–5266;
Email: colleen.mahar-piersma@
acf.hhs.gov.
Mary M. Wayland,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2016–21038 Filed 8–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Cardiovascular
and Renal Drugs Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
[FR Doc. 2016–21047 Filed 8–31–16; 8:45 am]
BILLING CODE 4184–40–P
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal
Drugs Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Cardiovascular and
Renal Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until August 27, 2018.
DATES: Authority for the Cardiovascular
and Renal Drugs Advisory Committee
will expire on August 27, 2016, unless
the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Announcement of the Award of SingleSource Grants Under the Wilson-Fish
Alternative Program (W–F); Correction;
CFDA Number: 93.583
Office of Refugee Resettlement,
ACF, HHS.
ACTION: Notice; correction.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), published
a document in the Federal Register of
August 22, 2016, concerning the
SUMMARY:
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
E:\FR\FM\01SEN1.SGM
01SEN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: CRDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Cardiovascular and Renal Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The
Cardiovascular and Renal Drugs
Advisory Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
cardiology, hypertension, arrhythmia,
angina, congestive heart failure,
diuresis, and biostatistics. Members will
be invited to serve for overlapping terms
of up to four years. Almost all nonFederal members of this committee
serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
CardiovascularandRenalDrugs
AdvisoryCommittee/ucm094743.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
VerDate Sep<11>2014
17:14 Aug 31, 2016
Jkt 238001
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21041 Filed 8–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
Program; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘The Sentinel
Post-Licensure Rapid Immunization
Safety Monitoring (PRISM) Program.’’
The purpose of the workshop is to
describe the Sentinel Initiative and
PRISM program, illustrate how PRISM
is used by FDA for regulatory
responsibilities (including how it has
been integrated into FDA’s regulatory
review process and case examples), and
discuss the future direction of PRISM in
terms of expansion and further
integration into the regulatory review
process.
SUMMARY:
The public workshop will be
held on December 7, 2016, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the National Institutes of
Health, 8600 Rockville Pike, Lister Hill
Center Auditorium, Building 38A,
Bethesda, MD 20894.
FOR FURTHER INFORMATION CONTACT:
Chris Nguyen, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124,
Silver Spring, MD 20993–0002; or
Cynthia Whitmarsh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993–0002: For
questions, email: CBERPublicEvents@
DATES:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
60357
fda.hhs.gov (Subject Line: Sentinel
PRISM Workshop).
SUPPLEMENTARY INFORMATION: The
Sentinel Initiative is FDA’s national
electronic surveillance system for the
post-market safety monitoring of
medical products. The Sentinel System
was implemented as an Active PostMarket Risk Identification and Analysis
program in response to section 905 of
the Food and Drug Administration
Amendments Act of 2007. PRISM was
initiated in 2009 as one of several
national vaccine safety surveillance
systems deployed during the H1N1
influenza pandemic. PRISM was
integrated into the FDA Sentinel
Initiative in September 2010. PRISM has
been used on multiple occasions to
evaluate for vaccine-adverse events,
such as the risk of intussusception
following rotavirus vaccination, and the
risk of febrile seizure among children
receiving the trivalent inactivated
influenza vaccine.
The PRISM distributed database
covers more than 171 million
individuals in a number of data partner
organizations. The database is enhanced
by linkages to State-wide registries and
birth registries. PRISM is being used to
develop broad-based signal detection
tools that can be used to further evaluate
vaccine safety. There are currently
several active vaccine protocol-based
assessments underway. More
information can be found at: https://
www.mini-sentinel.org/assessments/
medical_events/default.aspx.
The workshop will bring together
other government agencies, academia,
industry, and other stakeholder
participants involved in vaccine
development and safety. The goal of the
workshop is to present and discuss the
current capabilities of PRISM. Topics
include: (1) The available data
infrastructure, (2) methods, and (3)
tools. In addition, a few representative
examples of PRISM studies will be
presented to demonstrate the program’s
success in safety signal refinement and
evaluation and informing the regulatory
process. There will also be a discussion
of possible future directions for PRISM.
Registration: Please visit the following
Web site to register for the workshop by
November 23, 2016, midnight Eastern
Standard Time: https://
www.eventbrite.com/e/the-sentinel-postlicensure-rapid-immunization-safetymonitoring-prism-system-publicworkshop-tickets-22494636062. There is
no registration fee for the public
workshop. Early registration is
recommended because seating is
limited. Registrants will receive
confirmation once they have been
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60356-60357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21041]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Cardiovascular and Renal Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until August 27, 2018.
DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2016, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and
[[Page 60357]]
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993-0002, 301-796-9001, email: CRDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Cardiovascular and Renal Drugs
Advisory Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which the
Food and Drug Administration has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics. Members will be invited to
serve for overlapping terms of up to four years. Almost all non-Federal
members of this committee serve as Special Government Employees. The
core of voting members may include one technically qualified member,
selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one non-
voting member who is identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm094743.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21041 Filed 8-31-16; 8:45 am]
BILLING CODE 4164-01-P
