Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal, 60359-60360 [2016-21040]
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Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
enough to provide timely notice.
Therefore, you should always check the
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www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Agenda: On October 5, 2016, during
session I, the topic to be addressed will
be reclassification of quantitative
Cytomegalovirus (CMV) viral load
devices from class III (Premarket
approval) to class II (510(k)). A nucleic
acid-based in vitro diagnostic device for
the quantitation of CMV viral load,
within the context of transplant patient
management, is a post-amendment
device classified into class III under
section 513(f)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360c(f)(1)). To date, the following
product code has been established for
CMV viral load devices: PAB
(Cytomegalovirus (CMV) DNA
Quantitative Assay). During session II,
the topics to be addressed include
appropriate initial classification for
qualitative or quantitative viral load
devices for Epstein-Barr virus (EBV), BK
virus (BK), JC virus (JCV), Human
Herpesvirus 6 (HHV6), and Adenovirus
infections. FDA is seeking expert
recommendations to assess the potential
risks and benefits of these devices when
used in patients following solid-organ or
stem cell transplantation.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
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present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
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person on or before September 29, 2016.
Oral presentations from the public will
be scheduled on October 5, 2016,
between approximately 1 p.m. and 2
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
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brief statement of the general nature of
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public comment on this document. The
docket number is FDA–2016–N–1660.
The docket will close on November 9,
2016. Comments received on or before
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If you require accommodations due to a
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ucm111462.htm for procedures on
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committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21045 Filed 8–31–16; 8:45 am]
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60359
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Endocrinologic
and Metabolic 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 Endocrinologic and
Metabolic 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 Endocrinologic
and Metabolic Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until
August 27, 2018.
DATES: Authority for the Endocrinologic
and Metabolic Drugs Advisory
Committee will expire on August 27,
2016, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, EMDAC@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
Endocrinologic and Metabolic Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The
Endocrinologic and Metabolic Drugs
Advisory 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
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of endocrine and
metabolic disorders, and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
SUMMARY:
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60360
Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
endocrinology, metabolism,
epidemiology or statistics, 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
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/
EndocrinologicandMetabolicDrugs
AdvisoryCommittee/ucm100261.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 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21040 Filed 8–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Indian Health Service
Office of Public Health Support;
Division of Planning, Evaluation &
Research; National Native Health
Research Training Initiative
Announcement Type: New.
Funding Announcement Number:
HHS–2017–IHS–DPER–001.
Catalog of Federal Domestic
Assistance Number: 93.933.
Key Dates:
Application Deadline Date: October
30, 2016.
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17:14 Aug 31, 2016
Jkt 238001
Approximate Review Date: November
2–4, 2016.
Earliest Anticipated Start Date:
November 15, 2016.
Proof of Non-Profit Status Due Date:
October 30, 2016.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Office of Public Health Support (OPHS),
Division of Planning, Evaluation and
Research (DPER), is accepting
applications for one new cooperative
agreement for the National Native
Health Research Training Initiative.
This initiative will help build capacity
and disseminate new and best practices
for American Indian and Alaska Native
(AI/AN) health research and promote
Tribally-driven research activity
through a variety of educational and
training opportunities. Focus will be on
the promotion of health research and
related opportunities for AI/AN
students, highlighting promising
practices and practice-based approaches
to improving the health of AI/AN
people, and culture-based approaches to
reducing health disparities between AI/
AN people and the U.S. population.
Other areas will focus on resilience and
protective factors and their role in AI/
AN health outcomes, innovative and
culturally-based approaches to
improving the health of AI/AN youth,
and dissemination of study findings in
AI/AN health science research to
investigators and providers working in
or with Tribal communities as well as
Tribal leaders and health officials.
Activities will include the planning,
coordination, and hosting of research
meetings and conferences, webinars,
hosting of a Web site/Web page for
dissemination of AI/AN health science
research information, and other
activities to be determined. This IHS
activity is authorized under the Snyder
Act, codified at 25 U.S.C. 13; the
Transfer Act, codified at 42 U.S.C. 2001;
the Consolidated Appropriations Act,
2012, Public Law 112–74 and the
Continuing Appropriations Resolution,
2013, Public Law 112–175. This
program is described in the Catalog of
Federal Domestic Assistance under
93.933.
Background
The AI/AN populations have long
experienced poorer health status
compared to other Americans. Although
major gains in reducing health
disparities were made during the last
half of the twentieth century, most gains
stopped by the mid-1980s (Trends in
Indian Health 1998–99) and a few
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diseases, e.g., diabetes, worsened. ‘‘All
Indian’’ rates contain marked variation
among the ‘‘IHS Areas’’ or regions
(Regional Differences in Indian Health
2002–2003); variation by Tribe exists
within Areas as well. The Trends and
Regional Differences reference can be
found on the IHS Web site at https://
www.ihs.gov/dps/publications/. The
daunting task confronting Tribes,
research scientists, and health programs
is to reduce the disparities among and
within areas and Tribes. Factors known
to contribute to health status and
disparities are complex, and include
underlying biology, physiology, and
epigenetics, as well as ethnicity, culture,
socioeconomic status, gender/sex, age,
geographical access to care, and levels
of insurance.
Additional factors known to
contribute to health status and
disparities include:
1. Family, home, and work
environments;
2. general or culturally specific health
practices;
3. social support systems;
4. lack of access to culturallyappropriate health care; and
5. attitudes and beliefs about health.
Health disparities of AI/ANs may also
reflect a lack of in depth research
relevant to improving their health
status. Many AI/ANs also distrust
research for historical reasons. One
approach that combats this distrust is to
ensure that Tribes are managing
partners in training and research that
involves them, as for example in
community-based participatory research
(CBPR) (i.e., a collaborative research
process between researchers and
community representatives). This
approach is especially helpful to design
both training relevant to researchers
from Tribal communities and research
relevant to health needs of the
communities. Another approach is
increasing the number of AI/AN
scientists and growing the intellectual
community of researchers working with
AIAN health research issues.
DPER has the responsibility of
promoting health research to help
improve the health status of AI/ANs.
The development of AI/AN scientists
and scientist-practitioners and
enhancing the ability of Tribes to
participate in and initiate their own
research projects is a key part of
improving quality and delivery of health
services. Scientific meetings,
conferences, and other training
opportunities will support AI/AN
faculty and student development and
promote participatory collaboration
between Tribes and the academic
community. Such meetings and other
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[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60359-60360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Endocrinologic and Metabolic 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 Endocrinologic and Metabolic 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
Endocrinologic and Metabolic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until August 27, 2018.
DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory
Committee will expire on August 27, 2016, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, EMDAC@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 Endocrinologic and Metabolic Drugs Advisory Committee.
The committee is a discretionary Federal advisory committee established
to provide advice to the Commissioner. The Endocrinologic and Metabolic
Drugs Advisory 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 data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders, and makes
appropriate recommendations to the Commissioner of Food and Drugs.
[[Page 60360]]
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of endocrinology, metabolism, epidemiology or statistics, 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 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/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.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 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21040 Filed 8-31-16; 8:45 am]
BILLING CODE 4164-01-P
