Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal, 53311-53312 [2015-21914]

Download as PDF 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 http:// 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FDA’s current thinking on issuing warning letters related to compressed medical gases, CPG Section 435.100 is withdrawn.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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:42 Sep 02, 2015 Jkt 235001 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: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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: E:\FR\FM\03SEN1.SGM 03SEN1 53312 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 http:// 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 http://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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:42 Sep 02, 2015 Jkt 235001 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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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 E:\FR\FM\03SEN1.SGM 03SEN1

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]


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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.

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 http://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 http://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