Advisory Committee; Blood Products Advisory Committee; Renewal, 31642-31643 [2016-11774]
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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices
demographic and service utilization
data, performance measurement, and
continuous quality improvement, and
participating in or conducting rigorous
evaluation activities. Grantees are
expected to submit the implementation
plan by the end of Year 1 of the grant,
with draft submission milestones
throughout the first year. As part of the
non-competing continuation application
for Years 3–5 of the grant, Tribal
MIECHV grantees will update their
implementation plans as necessary to
ensure that the plan accurately reflects
activities to be completed throughout
the remainder of the grant.
Following each year that Tribal
MIECHV grantees implement home
visiting services, they must also submit
Form 1: Demographic and Service
Utilization Data.
Respondents: Tribal Maternal, Infant,
and Early Childhood Home Visiting
Program Grantees. (The information
collection does not include direct
interaction with individuals or families
that receive the services).
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Tribal Maternal, Infant, and Early Childhood Home Visiting Implementation
Plan Guidance ..............................................................................................
Tribal MIECHV Form 1 Demographic & Service Utilization Data & Service
Data ..............................................................................................................
25
1
1000
25,000
25
1
500
12,500
Estimated Annual Burden Hours: .............................................................
........................
........................
........................
37,500
Estimated Total Annual Burden
Hours: 37,500.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
ACTION:
Robert Sargis,
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–11791 Filed 5–18–16; 8:45 am]
BILLING CODE 4184–01–P
mstockstill on DSK3G9T082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Blood Products
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:47 May 18, 2016
Jkt 238001
Notice; renewal of advisory
committee.
The Food and Drug
Administration (FDA) is announcing the
renewal of the Blood Products 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
Blood Products Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until May 13, 2018.
DATES: Authority for the Blood Products
Advisory Committee will expire on May
13, 2016, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Bryan Emery, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10993
New Hampshire Ave., Bldg. 71, Rm.
6132, Silver Spring, MD 20993–0002,
240–402–8054, Bryan.emery@
fda.hhs.gov.
SUMMARY:
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
Blood Products Advisory Committee.
The committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Blood Products 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
FDA has regulatory responsibility.
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The Committee shall consist of a core
of 17 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of clinical
and administrative medicine,
hematology, immunology, blood
banking, surgery, internal medicine,
biochemistry, engineering, biological
and physical sciences, biotechnology,
computer technology, statistics,
epidemiology, sociology/ethics, and
other related professions. Members will
be invited to serve for overlapping terms
of up to 4 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.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
BloodVaccinesandOtherBiologics/
BloodProductsAdvisoryCommittee/
ucm121602.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: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11774 Filed 5–18–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Diabetes Outcome Measures Beyond
Hemoglobin A1c: CDER Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER), is
sponsoring a public workshop entitled
‘‘Diabetes Outcome Measures Beyond
Hemoglobin A1c (HbA1c).’’ The
purpose of this public workshop is to
have a forum for dialogue with the
public, patients, patient advocacy
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SUMMARY:
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18:47 May 18, 2016
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groups and industry to gain greater
appreciation on the extent to which the
current regulatory paradigm for
antidiabetic drug therapies addresses
the needs of patients with diabetes and
to identify additional outcomes, beyond
HbA1c, that are of direct relevance and
importance to patients living with the
disease.
DATES: The public workshop will be
held on August 29, 2016, from 9 a.m. to
5 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak campus,
10903 New Hampshire Ave., Building
31 (The Great Room B, and C), Silver
Spring, MD 20993. Entrance for the
public workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Francis Kalush, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, DIABHbA1c-CDER@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop entitled
‘‘Diabetes Outcome Measures Beyond
Hemoglobin A1c.’’ This public
workshop is intended to gain greater
appreciation on the extent to which the
current regulatory paradigm for drugs to
treat diabetes addresses the needs of
patients with diabetes, to identify what
the most urgent unmet patient needs are
and to identify measures beyond HbA1c
that would reliably capture outcomes
important to the health or quality of life
of patients living with diabetes. The
ultimate purpose of identifying and
qualifying these outcomes for regulatory
purposes would be to continue to
support the development of novel
therapies that directly address the needs
of patients living with the disease.
There will be an opportunity for
questions and answers following each
presentation.
Registration: There is no registration
fee to attend the public workshop. Early
registration is recommended because
seating is limited, and registration will
be on a first-come, first-served basis.
There will be no onsite registration.
Persons interested in attending this
workshop must register online at https://
www.fda.gov/Drugs/NewsEvents/
ucm499281.htm by July 29, 2016. For
those without Internet access, please
contact Francis Kalush (see FOR FURTHER
INFORMATION CONTACT) to register.
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31643
If you need special accommodations
due to a disability, please contact
Francis Kalush (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Transcripts: A transcript of the
workshop will be available for review at
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and on the
Internet at https://www.regulations.gov
approximately 30 days after the
workshop. Transcripts will also be
available in either hard copy or on CD–
ROM, after submission of a Freedom of
Information request. The Freedom of
Information office address is available
on the Agency’s Web site at https://
www.fda.gov.
Dated: May 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–11846 Filed 5–18–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Peripheral and
Central Nervous System Drugs
Advisory Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Peripheral and Central
Nervous System 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
Peripheral and Central Nervous System
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until June 4, 2018.
DATES: Authority for the Peripheral and
Central Nervous System Drugs Advisory
Committee will expire on June 4, 2016,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31642-31643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Blood Products 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 Blood Products 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 Blood Products Advisory
Committee for an additional 2 years beyond the charter expiration date.
The new charter will be in effect until May 13, 2018.
DATES: Authority for the Blood Products Advisory Committee will expire
on May 13, 2016, unless the Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm.
6132, Silver Spring, MD 20993-0002, 240-402-8054,
Bryan.emery@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 Blood Products Advisory Committee. The committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner.
The Blood Products 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 FDA has regulatory responsibility.
The Committee shall consist of a core of 17 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of clinical and administrative medicine, hematology, immunology,
blood banking, surgery, internal medicine, biochemistry, engineering,
biological and physical sciences, biotechnology, computer technology,
statistics, epidemiology, sociology/ethics, and other related
professions. Members will be invited to serve for overlapping terms of
up to 4 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.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) Expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum
[[Page 31643]]
when, because of unforeseen circumstances, a quorum is or will be
lacking. Because of the size of the Committee and the variety in the
types of issues that it will consider, FDA may, in connection with a
particular committee meeting, specify a quorum that is less than a
majority of the current voting members. The Agency's regulations (21
CFR 14.22(d)) authorize a committee charter to specify quorum
requirements.
If functioning as a medical device panel, a non-voting
representative of consumer interests and a non-voting representative of
industry interests will be included in addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm121602.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: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11774 Filed 5-18-16; 8:45 am]
BILLING CODE 4164-01-P
