Meetings of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health, 28629-28630 [2015-12104]
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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The draft guidance indicates in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This draft guidance also refers to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draft guidance become effective, we will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electronic comments regarding this draft
guidance to https://www.regulations.gov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
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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]
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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.
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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]
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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:
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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.
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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]
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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
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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.
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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]
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