80_FR_53482 80 FR 53311 - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal

80 FR 53311 - Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 171 (September 3, 2015)

Page Range53311-53312
FR Document2015-21914

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.

Federal Register, Volume 80 Issue 171 (Thursday, September 3, 2015) 
[Federal Register Volume 80, Number 171 (Thursday, September 3, 2015)]
[Notices]
[Pages 53311-53312]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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, [email protected].

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

Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices 53311 nonbanking company complies with the Liquid and Gaseous Oxygen’’ (CPG DATES: Authority for the standards in section 4 of the BHC Act 7132a.16). Subsequently, the Agency’s Nonprescription Drugs Advisory (12 U.S.C. 1843). Unless otherwise Manual of Compliance Policy Guides Committee will expire on August 27, noted, nonbanking activities will be was reorganized and this material 2017, unless the Commissioner formally conducted throughout the United States. became Section 435.100. The CPG determines that renewal is in the public Unless otherwise noted, comments provided guidance to FDA district interest. regarding each of these applications offices for issuing warning letters to FOR FURTHER INFORMATION CONTACT: must be received at the Reserve Bank firms that are engaged in filling Moon Hee V. Choi, Division of Advisory indicated or the offices of the Board of cylinders with gas(es) for medical use Committee and Consultant Governors not later than September 28, that are not operating in conformance Management, Food and Drug 2015. with the adulteration, misbranding, Administration, 10903 New Hampshire A. Federal Reserve Bank of Dallas and/or new drug provisions of the Ave., Bldg. 31, Rm. 2417, Silver Spring, (Robert L. Triplett III, Senior Vice Federal Food, Drug, and Cosmetic Act. MD 20993–0002, 301–796–9001, President) 2200 North Pearl Street, On March 15, 2015, FDA NDAC@fda.hhs.gov. Dallas, Texas 75201–2272: implemented the revised Compliance SUPPLEMENTARY INFORMATION: Pursuant 1. Independent Bank Group, Inc., Program Guidance Manual (CPGM) to 41 CFR 102–3.65 and approval by the McKinney, Texas; to acquire 100 7356.002E, entitled ‘‘Compressed Department of Health and Human percent of the voting shares of Grand Medical Gases,’’ available at http:// Services pursuant to 45 CFR part 11 and Bank, Dallas, Texas. www.fda.gov/downloads/ICECI/ by the General Services Administration, Board of Governors of the Federal Reserve ComplianceManuals/ FDA is announcing the renewal of the System, August 31, 2015. ComplianceProgramManual/ Nonprescription Drugs Advisory Michael J. Lewandowski, UCM125417.pdf. CPGM 7356.002E Committee. The Committee is a Associate Secretary of the Board. instructs FDA staff regarding a range of discretionary Federal advisory [FR Doc. 2015–21897 Filed 9–2–15; 8:45 am] subjects, including, but not limited to, committee established to provide advice BILLING CODE 6210–01–P the inspections and investigations, to the Commissioner. The Committee regulatory and/or administrative action, advises the Commissioner or designee and the issuance of warning letters in discharging responsibilities as they related to compressed medical gases. As relate to helping to ensure safe and DEPARTMENT OF HEALTH AND the CPGM 7356.002E articulates FDA’s effective drugs for human use and, as HUMAN SERVICES current thinking on issuing warning required, any other product for which Food and Drug Administration letters related to compressed medical FDA has regulatory responsibility. gases, CPG Section 435.100 is The Committee reviews and evaluates [Docket No. FDA–2015–N–3043] withdrawn. available data concerning the safety and Compressed Medical Gases-Warning Dated: August 28, 2015. effectiveness of over-the-counter Letters for Specific Violations Steven Solomon, (nonprescription) human drug products, Covering Liquid and Gaseous Oxygen; Deputy Associate Commissioner for or any other FDA-regulated product, for Withdrawal of Compliance Policy Regulatory Affairs. use in the treatment of a broad spectrum Guide [FR Doc. 2015–21874 Filed 9–2–15; 8:45 am] of human symptoms and diseases and BILLING CODE 4164–01–P advises the Commissioner either on the AGENCY: Food and Drug Administration, promulgation of monographs HHS. establishing conditions under which ACTION: Notice; withdrawal. DEPARTMENT OF HEALTH AND these drugs are generally recognized as HUMAN SERVICES safe, effective, not misbranded, and on SUMMARY: The Food and Drug the approval of new drug applications. Administration (FDA) is announcing the Food and Drug Administration The Committee serves as a forum for the withdrawal of Compliance Policy Guide exchange of views regarding the (CPG) Section 435.100, entitled [Docket No. FDA–2015–N–3137] prescription and nonprescription status, ‘‘Compressed Medical Gases—Warning including switches from one status to Letters for Specific Violations Covering Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal another. The Committee may also Liquid and Gaseous Oxygen.’’ conduct peer review of Agency DATES: The withdrawal is effective AGENCY: Food and Drug Administration, sponsored intramural and extramural September 3, 2015. HHS. scientific biomedical programs in FOR FURTHER INFORMATION CONTACT: support of FDA’s mission and regulatory ACTION:Notice; renewal of advisory Mary E. Kennelly, Office of Regulatory committee. responsibilities. Affairs, 10903 New Hampshire Ave., The Committee shall consist of a core Bldg. 32, Rm. 4338, Silver Spring, MD SUMMARY: The Food and Drug of 10 voting members including the 20993, 240–402–9577. Administration (FDA) is announcing the Chair. Members and the Chair are SUPPLEMENTARY INFORMATION: A renewal of the Nonprescription Drugs selected by the Commissioner or Compliance Policy Guide (CPG) on Advisory Committee by the designee from among authorities medical gases was originally issued on Commissioner of Food and Drugs (the knowledgeable in the fields of internal November 5, 1987, in the Agency’s Commissioner). The Commissioner has medicine, family practice, clinical tkelley on DSK3SPTVN1PROD with NOTICES Manual of Compliance Policy Guides. In determined that it is in the public toxicology, clinical pharmacology, a notice published in the Federal interest to renew the Nonprescription pharmacy, dentistry, and related Register of September 16, 1992 (57 FR Drugs Advisory Committee for an specialties. Members will be invited to 42757), FDA announced the availability additional 2 years beyond the charter serve for overlapping terms of up to 4 of a revised CPG on this topic entitled expiration date. The new charter will be years. Almost all non-Federal members ‘‘Compressed Medical Gases—Warning in effect until the August 27, 2015, of this committee serve as Special Letters for Specific Violations Covering expiration date. Government Employees. The core of VerDate Sep<11>2014 14:42 Sep 02, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\03SEN1.SGM 03SEN1

53312 Federal Register / Vol. 80, No. 171 / Thursday, September 3, 2015 / Notices voting members may include one youth) with special health care needs The purpose of the NCFPP technically qualified member, selected (CSHCN) and their families. Strategies cooperative agreement, as stated in the by the Commissioner or designee, who may include: (1) Family-centered care, funding opportunity announcement, is is identified with consumer interests (2) cultural and linguistic competence, to improve the health delivery system and is recommended by either a and (3) shared decision-making for and quality of life for CSHCN and their consortium of consumer-oriented families of CSHCN at all levels of families. Strategies may include: (1) organizations or other interested decision-making (individual, peer, Family-centered care, (2) cultural and persons. In addition to the voting community, etc.). Family/Professional linguistic competence, and (3) shared members, the Committee may include Partnership program activities are decision-making for families of CSHCN one non-voting member who is primarily carried out through federal at all levels of decision-making identified with industry interests. leadership strategies, the NCFPP (individual, peer, community, etc.). Further information regarding the cooperative agreement and state Family/Professional Partnership most recent charter and other implementation grants in the form of program activities are primarily carried information can be found at http:// Family-to-Family Health Information out through federal leadership www.fda.gov/AdvisoryCommittees/ Centers. The purpose of this notice is to strategies, the NCFPP cooperative CommitteesMeetingMaterials/Drugs/ award supplemental funds to coordinate agreement and state implementation Nonprescription among leadership trainings for families grants in the form of Family-to-Family DrugsAdvisoryCommittee/default.htm partnering on state and national level Health Information Centers. In 2013, or by contacting the Designated Federal system and service improvements by following objective review of its Officer (see FOR FURTHER INFORMATION Family Voices, the cooperative application, HRSA awarded Family CONTACT). In light of the fact that no agreement awardee who serves as the Voices cooperative agreement funding change has been made to the committee NCFPP, during the budget period of 6/ for the NCFPP. If approved, this would name or description of duties, no 1/2015– 5/31/2016. be the first project expansion amendment will be made to 21 CFR SUPPLEMENTARY INFORMATION: supplement for this project. 14.100. This document is issued under Intended Recipient of the Award: For over two decades Family Voices the Federal Advisory Committee Act (5 Family Voices, Inc. has brought the voice of families of U.S.C. app.). For general information Amount of the Non-Competitive CSHCN to the healthcare arena and related to FDA advisory committees, Award: $118,700. demonstrated the value of family please visit us at http://www.fda.gov/ Period of Supplemental Funding: 6/1/ perspectives in shaping healthcare AdvisoryCommittees/default.htm. 2015–5/31/2016. systems and services to maximize CFDA Number: 93.110. outcomes for families and their Dated: August 28, 2015. Authority: Social Security Act, Title children. Its infrastructure is based on a Jill Hartzler Warner, V, Section 501(a)(1)(D), (42 U.S.C. network of family-led organizations at Associate Commissioner for Special Medical 701(a)(1)(D)). the national, state, and local levels Programs. including the Family-to-Family Health Justification [FR Doc. 2015–21914 Filed 9–2–15; 8:45 am] Information Centers and Family Voices BILLING CODE 4164–01–P The Institute of Medicine Report State Affiliate Organizations. It Crossing the Quality Chasm: A New facilitates the work of a community of Health System for the 21st Century family leaders through peer mentoring, DEPARTMENT OF HEALTH AND established shared decision-making and training, and technical assistance. It HUMAN SERVICES patient/family centered care as key partners with key MCHB programs and elements of a quality health care system. stakeholders including State Title V Health Resources and Services National quality indicators of family/ agencies. Administration professional partnership, shared- Results were recently released from a decision-making, and patient/family- survey of state Title V organizations’ National Center for Family/ centered care show that children (and progress in engaging families and Professional Partnerships Cooperative youth) with special health care needs consumers. From this information, Agreement (CSHCN) benefit from family/patient- Family Voices recognized a need for AGENCY: Health Resources and Services centered care by improved transition ongoing development of a continually Administration (HRSA), Department of from pediatric to adult health care renewed pipeline of family leaders from Health and Human Services (HHS). systems, fewer unmet needs and fewer diverse racial and cultural communities ACTION: Notice of Single-Case Deviation problems accessing needed referrals. and from populations served across all from Competition Requirement for Several MCHB programs rely on MCHB programs. Thus, they submitted Program Expansion for the National families as key partners in the a proposal requesting to supplement the Center for Family/Professional improvement of overall systems and NCFPP cooperative agreement with Partnerships Cooperative Agreement at services, based on their personal activities to meet this need. Family Voices, Grant Number experiences and their work with other The proposed project aligns with U40MC00149. families. There is a need for NCFPP’s current project plan in its coordination among leadership efforts to increase the capacity of SUMMARY: HRSA announces its intent to trainings, including ongoing mentoring families, Title V and other providers to award a program expansion supplement and technical assistance, for families strengthen the primary care workforce in the amount of $118,700 for the partnering on state and national level through family/professional partnership tkelley on DSK3SPTVN1PROD with NOTICES National Center for Family/Professional system and service improvements. learning opportunities (Goal 2). Family Partnerships (NCFPP) cooperative Meeting these needs would support a Voices, working with MCHB, would agreement. The purpose of the NCFPP sustainable approach to leadership coordinate with other MCHB-funded cooperative agreement, as stated in the development that can be maintained by initiatives to identify needs and develop funding opportunity announcement, is both individuals and organizations, a framework for an evidence-based/ to improve the health delivery system linking together key MCHB investments informed family leadership training and quality of life for children (and by supporting State Title V agencies. aimed at supporting family leaders VerDate Sep<11>2014 14:42 Sep 02, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\03SEN1.SGM 03SEN1


Document Created: 2015-12-15 09:57:05
Document Modified: 2015-12-15 09:57:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; renewal of advisory committee.
DatesAuthority for the Nonprescription Drugs Advisory Committee will expire on August 27, 2017, unless the Commissioner formally determines that renewal is in the public interest.
ContactMoon 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, [email protected]
FR Citation80 FR 53311 
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