Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal, 53311-53312 [2015-21914]
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Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than September 28,
2015.
A. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. Independent Bank Group, Inc.,
McKinney, Texas; to acquire 100
percent of the voting shares of Grand
Bank, Dallas, Texas.
Board of Governors of the Federal Reserve
System, August 31, 2015.
Michael J. Lewandowski,
Associate Secretary of the Board.
[FR Doc. 2015–21897 Filed 9–2–15; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3043]
Compressed Medical Gases-Warning
Letters for Specific Violations
Covering Liquid and Gaseous Oxygen;
Withdrawal of Compliance Policy
Guide
AGENCY:
Food and Drug Administration,
Liquid and Gaseous Oxygen’’ (CPG
7132a.16). Subsequently, the Agency’s
Manual of Compliance Policy Guides
was reorganized and this material
became Section 435.100. The CPG
provided guidance to FDA district
offices for issuing warning letters to
firms that are engaged in filling
cylinders with gas(es) for medical use
that are not operating in conformance
with the adulteration, misbranding,
and/or new drug provisions of the
Federal Food, Drug, and Cosmetic Act.
On March 15, 2015, FDA
implemented the revised Compliance
Program Guidance Manual (CPGM)
7356.002E, entitled ‘‘Compressed
Medical Gases,’’ available at https://
www.fda.gov/downloads/ICECI/
ComplianceManuals/
ComplianceProgramManual/
UCM125417.pdf. CPGM 7356.002E
instructs FDA staff regarding a range of
subjects, including, but not limited to,
the inspections and investigations,
regulatory and/or administrative action,
and the issuance of warning letters
related to compressed medical gases. As
the CPGM 7356.002E articulates FDA’s
current thinking on issuing warning
letters related to compressed medical
gases, CPG Section 435.100 is
withdrawn.
Dated: August 28, 2015.
Steven Solomon,
Deputy Associate Commissioner for
Regulatory Affairs.
[FR Doc. 2015–21874 Filed 9–2–15; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide
(CPG) Section 435.100, entitled
‘‘Compressed Medical Gases—Warning
Letters for Specific Violations Covering
Liquid and Gaseous Oxygen.’’
DATES: The withdrawal is effective
September 3, 2015.
FOR FURTHER INFORMATION CONTACT:
Mary E. Kennelly, Office of Regulatory
Affairs, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 4338, Silver Spring, MD
20993, 240–402–9577.
SUPPLEMENTARY INFORMATION: A
Compliance Policy Guide (CPG) on
medical gases was originally issued on
November 5, 1987, in the Agency’s
Manual of Compliance Policy Guides. In
a notice published in the Federal
Register of September 16, 1992 (57 FR
42757), FDA announced the availability
of a revised CPG on this topic entitled
‘‘Compressed Medical Gases—Warning
Letters for Specific Violations Covering
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SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3137]
Advisory Committee; Nonprescription
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 Nonprescription 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 Nonprescription
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the August 27, 2015,
expiration date.
SUMMARY:
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53311
Authority for the
Nonprescription Drugs Advisory
Committee will expire on August 27,
2017, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Moon Hee V. Choi, Division of Advisory
Committee and Consultant
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
NDAC@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
Nonprescription Drugs Advisory
Committee. The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The 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 reviews and evaluates
available data concerning the safety and
effectiveness of over-the-counter
(nonprescription) human drug products,
or any other FDA-regulated product, for
use in the treatment of a broad spectrum
of human symptoms and diseases and
advises the Commissioner either on the
promulgation of monographs
establishing conditions under which
these drugs are generally recognized as
safe, effective, not misbranded, and on
the approval of new drug applications.
The Committee serves as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another. The Committee may also
conduct peer review of Agency
sponsored intramural and extramural
scientific biomedical programs in
support of FDA’s mission and regulatory
responsibilities.
The Committee shall consist of a core
of 10 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of internal
medicine, family practice, clinical
toxicology, clinical pharmacology,
pharmacy, dentistry, and related
specialties. 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
DATES:
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Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices
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/
Nonprescription
DrugsAdvisoryCommittee/default.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 28, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–21914 Filed 9–2–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Center for Family/
Professional Partnerships Cooperative
Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of Single-Case Deviation
from Competition Requirement for
Program Expansion for the National
Center for Family/Professional
Partnerships Cooperative Agreement at
Family Voices, Grant Number
U40MC00149.
AGENCY:
HRSA announces its intent to
award a program expansion supplement
in the amount of $118,700 for the
National Center for Family/Professional
Partnerships (NCFPP) cooperative
agreement. The purpose of the NCFPP
cooperative agreement, as stated in the
funding opportunity announcement, is
to improve the health delivery system
and quality of life for children (and
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SUMMARY:
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youth) with special health care needs
(CSHCN) and their families. Strategies
may include: (1) Family-centered care,
(2) cultural and linguistic competence,
and (3) shared decision-making for
families of CSHCN at all levels of
decision-making (individual, peer,
community, etc.). Family/Professional
Partnership program activities are
primarily carried out through federal
leadership strategies, the NCFPP
cooperative agreement and state
implementation grants in the form of
Family-to-Family Health Information
Centers. The purpose of this notice is to
award supplemental funds to coordinate
among leadership trainings for families
partnering on state and national level
system and service improvements by
Family Voices, the cooperative
agreement awardee who serves as the
NCFPP, during the budget period of 6/
1/2015– 5/31/2016.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Family Voices, Inc.
Amount of the Non-Competitive
Award: $118,700.
Period of Supplemental Funding: 6/1/
2015–5/31/2016.
CFDA Number: 93.110.
Authority: Social Security Act, Title
V, Section 501(a)(1)(D), (42 U.S.C.
701(a)(1)(D)).
Justification
The Institute of Medicine Report
Crossing the Quality Chasm: A New
Health System for the 21st Century
established shared decision-making and
patient/family centered care as key
elements of a quality health care system.
National quality indicators of family/
professional partnership, shareddecision-making, and patient/familycentered care show that children (and
youth) with special health care needs
(CSHCN) benefit from family/patientcentered care by improved transition
from pediatric to adult health care
systems, fewer unmet needs and fewer
problems accessing needed referrals.
Several MCHB programs rely on
families as key partners in the
improvement of overall systems and
services, based on their personal
experiences and their work with other
families. There is a need for
coordination among leadership
trainings, including ongoing mentoring
and technical assistance, for families
partnering on state and national level
system and service improvements.
Meeting these needs would support a
sustainable approach to leadership
development that can be maintained by
both individuals and organizations,
linking together key MCHB investments
by supporting State Title V agencies.
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The purpose of the NCFPP
cooperative agreement, as stated in the
funding opportunity announcement, is
to improve the health delivery system
and quality of life for CSHCN and their
families. Strategies may include: (1)
Family-centered care, (2) cultural and
linguistic competence, and (3) shared
decision-making for families of CSHCN
at all levels of decision-making
(individual, peer, community, etc.).
Family/Professional Partnership
program activities are primarily carried
out through federal leadership
strategies, the NCFPP cooperative
agreement and state implementation
grants in the form of Family-to-Family
Health Information Centers. In 2013,
following objective review of its
application, HRSA awarded Family
Voices cooperative agreement funding
for the NCFPP. If approved, this would
be the first project expansion
supplement for this project.
For over two decades Family Voices
has brought the voice of families of
CSHCN to the healthcare arena and
demonstrated the value of family
perspectives in shaping healthcare
systems and services to maximize
outcomes for families and their
children. Its infrastructure is based on a
network of family-led organizations at
the national, state, and local levels
including the Family-to-Family Health
Information Centers and Family Voices
State Affiliate Organizations. It
facilitates the work of a community of
family leaders through peer mentoring,
training, and technical assistance. It
partners with key MCHB programs and
stakeholders including State Title V
agencies.
Results were recently released from a
survey of state Title V organizations’
progress in engaging families and
consumers. From this information,
Family Voices recognized a need for
ongoing development of a continually
renewed pipeline of family leaders from
diverse racial and cultural communities
and from populations served across all
MCHB programs. Thus, they submitted
a proposal requesting to supplement the
NCFPP cooperative agreement with
activities to meet this need.
The proposed project aligns with
NCFPP’s current project plan in its
efforts to increase the capacity of
families, Title V and other providers to
strengthen the primary care workforce
through family/professional partnership
learning opportunities (Goal 2). Family
Voices, working with MCHB, would
coordinate with other MCHB-funded
initiatives to identify needs and develop
a framework for an evidence-based/
informed family leadership training
aimed at supporting family leaders
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]]>Agencies
[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Notices]
[Pages 53311-53312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21914]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3137]
Advisory Committee; Nonprescription 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 Nonprescription 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
Nonprescription Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the August 27, 2015, expiration date.
DATES: Authority for the Nonprescription Drugs Advisory Committee will
expire on August 27, 2017, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Division of Advisory
Committee and Consultant Management, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-
0002, 301-796-9001, NDAC@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 Nonprescription Drugs Advisory Committee. The Committee
is a discretionary Federal advisory committee established to provide
advice to the Commissioner. The 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 reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as safe, effective, not misbranded, and on the approval of
new drug applications. The Committee serves as a forum for the exchange
of views regarding the prescription and nonprescription status,
including switches from one status to another. The Committee may also
conduct peer review of Agency sponsored intramural and extramural
scientific biomedical programs in support of FDA's mission and
regulatory responsibilities.
The Committee shall consist of a core of 10 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of internal medicine, family practice, clinical toxicology,
clinical pharmacology, pharmacy, dentistry, and related specialties.
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
[[Page 53312]]
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/NonprescriptionDrugsAdvisoryCommittee/default.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 28, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-21914 Filed 9-2-15; 8:45 am]
BILLING CODE 4164-01-P
