Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 28629-28630 [2015-12104]

Download as PDF Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES The draft guidance indicates in section III.C.10 that, to meet the conditions of the guidance, outsourcing facilities compounding animal drug from bulk drug substances for office use in veterinary practices include on the label of any compounded drug these four statements: • ‘‘Not for resale.’’ • ‘‘For use only in [fill in species and any associated condition or limitation listed in Appendix A].’’ • ‘‘Compounded by [name of outsourcing facility].’’ • ‘‘Adverse events associated with this compounded drug should be reported to FDA on a Form FDA 1932a.’’ We tentatively conclude that these four label statements are ‘‘public disclosures of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public’’ (5 CFR 1320.3(c)(2)) and are therefore not subject to review by OMB under the PRA. Thus, the time it would take to provide this information is not included in the burden estimate reported in table 2. This draft guidance also refers to previously approved collections of information. A condition set forth in sections III.A.7., III.B.6, and III.C.5 is that any bulk drug substance used is manufactured by an establishment that is registered under section 510 of the FD&C Act (including a foreign establishment that is registered under section 360(i) of the FD&C Act) and is accompanied by a valid certificate of analysis. The information collection related to the disclosure of the certificate of analysis is approved under OMB control number 0910–0139. Before the proposed information collection provisions contained in this draft guidance become effective, we will publish a notice in the Federal Register announcing OMB’s decision to approve, modify, or disapprove the proposed information collection provisions. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VI. Comments Interested persons may submit either electronic comments regarding this draft guidance to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with Docket No. FDA–2015–D–1176. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday VerDate Sep<11>2014 16:53 May 18, 2015 Jkt 235001 through Friday, and will be posted to the docket at https:// www.regulations.gov. VII. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/ucm042450.htm or https://www.regulations.gov. Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11982 Filed 5–18–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics: Meeting Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. Name: National Committee on Vital and Health Statistics (NCVHS) Review Committee, pursuant to Section 1104(i) of the Patient Protection and Affordable Care Act (ACA). Time and Date: June 16, 2015, 9:00 a.m.– 5:00 p.m. EST; June 17, 2015, 8:00 a.m.–5:15 p.m. EST. Place: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, 3311 Toledo Road, Auditorium B and C, Hyattsville, Maryland 20782, (301) 458–4524. Status: Open. Purpose: The purpose of this hearing is to obtain information from the health care industry on the currently adopted standards, operating rules, code sets and identifiers used in administrative simplification transactions. The objectives of this hearing are as follows: (1) Review currently adopted standards, operating rules, code sets and identifiers used in each of the HIPAA-named administrative simplification transactions and evaluate the degree to which they meet current industry business needs; and (2) Identify transactions, standards, operating rules, code sets and identifiers used in administrative simplification that require changes, deletions or new versions in order to meet industry needs. We invite the public to prepare and submit written testimony on any and all areas covered by this hearing. We also invite testifiers to prepare and submit more extensive written testimony, in addition to the oral testimony they will be providing during the hearing. Written testimonies should be sent to Marietta Squire, Committee Management Specialist, Centers for Disease Control and Prevention, National Center for Health Statistics, email msquire@cdc.gov. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 28629 Background on the Review Committee, including the Review Committee’s Charter can be accessed at https://www.ncvhs.hhs.gov/ subcommittees-work-groups/subcommitteeon-standards/review-committee/. Contact Person for More Information: Debbie M. Jackson, Acting Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2339, Hyattsville, Maryland 20782, telephone (301) 458–4614 or Terri Deutsch, Centers for Medicare and Medicaid Services, Office of EHealth Standards and Services, 7500 Security Boulevard, Baltimore, Maryland 21244, telephone (410) 786–9462. Program information as well as summaries of meetings and a roster of committee members are available on the NCVHS home page of the HHS Web site: https://ncvhs.us/, where further information including an agenda will be posted when available. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (301) 458–4EEO (4336) as soon as possible. Dated: May 13, 2015. James Scanlon, Deputy Assistant Secretary for Planning and Evaluation Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2015–12106 Filed 5–18–15; 8:45 am] BILLING CODE 4151–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health Office of the Surgeon General of the United States Public Health Service, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92–463, as amended (5 U.S.C. App.), notice is hereby given that two meetings are scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ‘‘Advisory Group’’). The meetings will be open to the public. Information about the Advisory Group and the agendas for these meetings can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/initiatives/ prevention/advisorygrp/. DATES: The first meeting will be held on June 11, 2015, from 11:30 a.m. to 2:30 p.m. EST. The second meeting will be held on August 31 from 9:00 a.m. to SUMMARY: E:\FR\FM\19MYN1.SGM 19MYN1 tkelley on DSK3SPTVN1PROD with NOTICES 28630 Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices 5:00 p.m. EST—September 1, 2015, from 9:00 a.m. to 1:00 p.m. EST. ADDRESSES: The first meeting on June 11, 2015, will be held via teleconference. The second meeting on August 31—September 1, 2015, will be held in Washington, DC Teleconference and meeting location information will be published closer to the meeting dates at: https://www.surgeongeneral.gov/ initiatives/prevention/advisorygrp/ index.html. FOR FURTHER INFORMATION CONTACT: Office of the Surgeon General, 200 Independence Ave. SW.; Washington, DC 20201; 202–205–9517; prevention.council@hhs.gov. SUPPLEMENTARY INFORMATION: The Advisory Group is a non-discretionary federal advisory committee that was initially established under Executive Order 13544, dated June 10, 2010, to comply with the statutes under Section 4001 of the Patient Protection and Affordable Care Act, Public Law 111– 148. The Advisory Group was established to assist in carrying out the mission of the National Prevention, Health Promotion, and Public Health Council (the Council). The Advisory Group provides recommendations and advice to the Council. The Advisory Group was terminated on September 30, 2012, by Executive Order 13591, dated November 23, 2011. Authority for the Advisory Group to be re-established was given under Executive Order 13631, dated December 7, 2012. Authority for the Advisory Group to continue to operate until September 30, 2015, was given under Executive Order 13652, dated September 30, 2013. It is authorized for the Advisory Group to consist of no more than 25 non-federal members. The Advisory Group currently has 21 members who were appointed by the President. The membership includes a diverse group of licensed health professionals, including integrative health practitioners who have expertise in (1) worksite health promotion; (2) community services, including community health centers; (3) preventive medicine; (4) health coaching; (5) public health education; (6) geriatrics; and (7) rehabilitation medicine. Meeting descriptions and relevant materials will be published closer to the meeting dates at: https:// www.surgeongeneral.gov/initiatives/ prevention/advisorygrp/. Members of the public have the opportunity to participate in each meeting and/or provide comments to the Advisory Group. Public comment will be limited to 3 minutes per speaker. VerDate Sep<11>2014 16:53 May 18, 2015 Jkt 235001 Individuals who wish to participate in the meetings and/or provide comments must register by 12:00 p.m. EST on June 4, 2015, for the meeting on June 11, 2015, and by 12:00 p.m. EST on August 24, 2015, for the meeting on August 31– September 1, 2015. In order to register, individuals must send their full name and affiliation via email to prevention.council@hhs.gov. Individuals who need special assistance and/or accommodations, i.e., sign language interpretation or other reasonable accommodations, should indicate so when they register. Members of the public who wish to have materials distributed to the Advisory Group members at these scheduled meetings should submit those materials by June 4, 2015, for the June meeting and by August 24, 2015, for the August/ September meeting. Dated: May 6, 2015. Corinne M. Graffunder, Designated Federal Officer, Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, Office of the Surgeon General. [FR Doc. 2015–12104 Filed 5–18–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Pathogenic Eukaryotes Study Section. Date: June 4–5, 2015. Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Marriott Wardman Park, Washington DC Hotel, 2660 Woodley Road, NW., Washington, DC 20008. Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review National Institutes of PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, 301–435– 2306, boundst@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Host Interactions with Bacterial Pathogens Study Section. Date: June 5, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications Place: Warwick Seattle Hotel, 401 Lenora Street, Seattle, WA 98121. Contact Person: Fouad A El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7808, Bethesda, MD 20892, (301) 435– 1149, elzaataf@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section. Date: June 10, 2015. Time: 8:30 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: George Washington University Inn, 824 New Hampshire Ave., NW., Washington, DC 20037. Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–402– 5671, zhengli@csr.nih.gov. Name of Committee: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Biomedical Imaging Technology A Study Section. Date: June 11–12, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Ruth Grossman, DDS, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5215, Bethesda, MD 20892, (301) 435–2409, grossmanrs@mail.nih.gov. Name of Committee: Interdisciplinary Molecular Sciences and Training Integrated Review Group; Enabling Bioanalytical and Imaging Technologies Study Section. Date: June 11–12, 2015. Time: 8:00 a.m. to 10:00 p.m. Agenda: To review and evaluate grant applications. Place: Washington Marriott Georgetown, 1221 22nd Street NW., Washington, DC 20037. Contact Person: Kenneth Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3218, MSC 7717, Bethesda, MD 20892, 301–435– 0229, kenneth.ryan@nih.hhs.gov. Name of Committee: Oncology 1-Basic Translational Integrated Review Group, Tumor Microenvironment Study Section. Date: June 15–16, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28629-28630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12104]


-----------------------------------------------------------------------

 DEPARTMENT OF HEALTH AND HUMAN SERVICES


 Meetings of the Advisory Group on Prevention, Health Promotion, 
and Integrative and Public Health

AGENCY: Office of the Surgeon General of the United States Public 
Health Service, Office of the Assistant Secretary for Health, Office of 
the Secretary, Department of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with Section 10(a) of the Federal Advisory 
Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is 
hereby given that two meetings are scheduled for the Advisory Group on 
Prevention, Health Promotion, and Integrative and Public Health (the 
``Advisory Group''). The meetings will be open to the public. 
Information about the Advisory Group and the agendas for these meetings 
can be obtained by accessing the following Web site: https://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/.

DATES: The first meeting will be held on June 11, 2015, from 11:30 a.m. 
to 2:30 p.m. EST. The second meeting will be held on August 31 from 
9:00 a.m. to

[[Page 28630]]

5:00 p.m. EST--September 1, 2015, from 9:00 a.m. to 1:00 p.m. EST.

ADDRESSES: The first meeting on June 11, 2015, will be held via 
teleconference. The second meeting on August 31--September 1, 2015, 
will be held in Washington, DC Teleconference and meeting location 
information will be published closer to the meeting dates at: https://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/.

FOR FURTHER INFORMATION CONTACT: Office of the Surgeon General, 200 
Independence Ave. SW.; Washington, DC 20201; 202-205-9517; 
prevention.council@hhs.gov.

SUPPLEMENTARY INFORMATION: The Advisory Group is a non-discretionary 
federal advisory committee that was initially established under 
Executive Order 13544, dated June 10, 2010, to comply with the statutes 
under Section 4001 of the Patient Protection and Affordable Care Act, 
Public Law 111-148. The Advisory Group was established to assist in 
carrying out the mission of the National Prevention, Health Promotion, 
and Public Health Council (the Council). The Advisory Group provides 
recommendations and advice to the Council.
    The Advisory Group was terminated on September 30, 2012, by 
Executive Order 13591, dated November 23, 2011. Authority for the 
Advisory Group to be re-established was given under Executive Order 
13631, dated December 7, 2012. Authority for the Advisory Group to 
continue to operate until September 30, 2015, was given under Executive 
Order 13652, dated September 30, 2013.
    It is authorized for the Advisory Group to consist of no more than 
25 non-federal members. The Advisory Group currently has 21 members who 
were appointed by the President. The membership includes a diverse 
group of licensed health professionals, including integrative health 
practitioners who have expertise in (1) worksite health promotion; (2) 
community services, including community health centers; (3) preventive 
medicine; (4) health coaching; (5) public health education; (6) 
geriatrics; and (7) rehabilitation medicine.
    Meeting descriptions and relevant materials will be published 
closer to the meeting dates at: https://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/.
    Members of the public have the opportunity to participate in each 
meeting and/or provide comments to the Advisory Group. Public comment 
will be limited to 3 minutes per speaker. Individuals who wish to 
participate in the meetings and/or provide comments must register by 
12:00 p.m. EST on June 4, 2015, for the meeting on June 11, 2015, and 
by 12:00 p.m. EST on August 24, 2015, for the meeting on August 31-
September 1, 2015. In order to register, individuals must send their 
full name and affiliation via email to prevention.council@hhs.gov. 
Individuals who need special assistance and/or accommodations, i.e., 
sign language interpretation or other reasonable accommodations, should 
indicate so when they register. Members of the public who wish to have 
materials distributed to the Advisory Group members at these scheduled 
meetings should submit those materials by June 4, 2015, for the June 
meeting and by August 24, 2015, for the August/September meeting.

    Dated: May 6, 2015.
Corinne M. Graffunder,
Designated Federal Officer, Advisory Group on Prevention, Health 
Promotion, and Integrative and Public Health, Office of the Surgeon 
General.
[FR Doc. 2015-12104 Filed 5-18-15; 8:45 am]
 BILLING CODE 4163-18-P
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