Announcement of Solicitation of Written Comments on Modifications of Healthy People 2020 Objectives, 62077-62078 [2015-26244]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 199 / Thursday, October 15, 2015 / Notices
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Philip Bautista,
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, FAX:
301–847–8533, PCNS@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 206031,
drisapersen solution for injection,
sponsored by BioMarin Pharmaceutical
Inc., for the treatment of patients with
Duchenne muscular dystrophy with
mutations in the dystrophin gene that
are amenable to treatment with exon 51
skipping as determined by genetic
testing.
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.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 9, 2015.
Oral presentations from the public will
VerDate Sep<11>2014
17:19 Oct 14, 2015
Jkt 238001
be scheduled between approximately
12:40 p.m. and 2:40 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 30, 2015. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 2, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Philip Bautista
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 8, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–26162 Filed 10–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERIVCES
Announcement of Solicitation of
Written Comments on Modifications of
Healthy People 2020 Objectives
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
62077
The U.S. Department of
Health and Human Services solicits
written comments regarding new
objectives proposed to be added to
Healthy People 2020 since the fall 2014
public comment period, as well as
written comments proposing new
objectives to be included within existing
Healthy People 2020 topic areas. Public
participation helps shape Healthy
People 2020, its framework, objectives,
organization, and targets. Healthy
People 2020 will provide opportunities
for public input periodically throughout
the decade to ensure that Healthy
People 2020 reflects current public
health priorities and public input. The
updated set of Healthy People 2020
objectives will be incorporated on
www.HealthyPeople.gov. This set will
reflect further review and deliberation
by the topic area workgroups, Federal
Interagency Workgroup on Healthy
People 2020, and other Healthy People
2020 stakeholders.
DATES: Written comments will be
accepted until 5:00 p.m. ET on
November 16, 2015.
ADDRESSES: Written comments will be
accepted via an online public comment
database at https://
www.healthypeople.gov/2020/about/
history-development/Public-Comment;
by mail at the Office of Disease
Prevention and Health Promotion, U.S.
Department of Health and Human
Services, Attn: Public Comment, 1101
Wootton Parkway, Room LL–100,
Rockville, MD 20852; fax—(240) 453–
8281; or email—HP2020@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Caitie Blood, MPH, Office of Disease
Prevention and Health Promotion, U.S.
Department of Health and Human
Services, 1101 Wootton Parkway, Room
LL–100, Rockville, MD 20852,
Caitlin.Blood@HHS.gov (email), (240)
453–8265 (telephone), (240) 453–8281
(fax).
SUPPLEMENTARY INFORMATION: For three
decades, Healthy People has provided a
comprehensive set of national 10-year
health promotion and disease
prevention objectives aimed at
improving the health of all Americans.
Healthy People 2020 objectives provide
a framework by presenting a
comprehensive picture of the nation’s
health at the beginning of the decade,
establishing national goals and targets to
be achieved by the year 2020, and
monitoring progress over time. The U.S.
Department of Health and Human
Services is soliciting the submission of
written comments regarding new
objectives proposed to be added to
Healthy People 2020 since the fall 2014
public comment period.
SUMMARY:
E:\FR\FM\15OCN1.SGM
15OCN1
62078
Federal Register / Vol. 80, No. 199 / Thursday, October 15, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Healthy People 2020 is the product of
an extensive collaborative process that
relies on input from a diverse array of
individuals and organizations, both
within and outside the federal
government, with a common interest in
improving the nation’s health. Public
comments were a cornerstone of
Healthy People 2020’s development.
During the first phase of planning for
Healthy People 2020, HHS asked for the
public’s comments on the vision,
mission, and implementation of Healthy
People 2020. Those comments helped
set the framework for Healthy People
2020. The public was also invited to
submit comments on proposed Healthy
People 2020 objectives, which helped
shape the final set of Healthy People
2020 objectives.
The public is now invited to comment
on new objectives proposed to be added
to Healthy People 2020. These new
objectives were developed by topic area
workgroups led by various agencies
within the federal government. They
have been reviewed by the Federal
Interagency Workgroup on Healthy
People 2020 and are presented now for
the public’s review and comment. The
public is also invited to suggest
additional objectives for consideration
that address critical public health issues
within existing Healthy People 2020
topic areas. Any proposed new objective
must meet all of the objective selection
criteria (see below).
Written comments will be accepted at
https://www.healthypeople.gov/2020/
about/history-development/PublicComment during a 30-day public
comment period beginning in October
2015. The public will also be able to
submit written comments via mail, fax,
and email (see contact information
above). Comments received in response
to this notice will be reviewed and
considered by the appropriate topic area
workgroup, Federal Interagency
Workgroup on Healthy People 2020, and
other Healthy People 2020 stakeholders.
Objective Selection Criteria
The following nine criteria should be
taken into consideration when
commenting on the proposed new
objectives or suggesting additional
objectives.
1. The result to be achieved should be
important and understandable to a
broad audience and support the Healthy
People 2020 goals.
2. Objectives should be prevention
oriented and should address health
improvements that can be achieved
through population-based and
individual actions, and systems-based,
environmental, health-service, or policy
interventions.
VerDate Sep<11>2014
17:19 Oct 14, 2015
Jkt 238001
3. Objectives should drive actions that
will work toward the achievement of the
proposed targets (defined as quantitative
values to be achieved by the year 2020).
4. Objectives should be useful and
reflect issues of national importance.
Federal agencies, states, localities, nongovernmental organizations, and the
public and private sectors should be
able to use objectives to target efforts in
schools, communities, work sites, health
practices, and other environments.
5. Objectives should be measurable
and should address a range of issues,
such as: Behavior and health outcomes;
availability of, access to, and content of
behavioral and health service
interventions; socio-environmental
conditions; and community capacity—
directed toward improving health
outcomes and quality of life across the
life span. (Community capacity is
defined as the ability of a community to
plan, implement, and evaluate health
strategies.)
6. Continuity and comparability of
measured phenomena from year to year
are important, thus, when appropriate,
retention of objectives from previous
Healthy People iterations is encouraged.
However, in instances where objectives
and/or measures have proven ill-suited
to the purpose or are inadequate, new
improved objectives should be
developed. Whether or not an objective
has met its target in a previous Healthy
People iteration should not be the sole
basis for retaining or archiving an
objective.
7. The objectives should be supported
by the best available scientific evidence.
The objective selection and review
processes should be flexible enough to
allow revisions to objectives in order to
reflect major updates or new knowledge.
8. Objectives should address
population disparities. These include
populations categorized by race/
ethnicity, socioeconomic status, gender,
disability status, sexual orientation, and
geographic location. For particular
health issues, additional special
populations should be addressed, based
on an examination of the available
evidence on vulnerability, health status,
and disparate care.
9. Healthy People 2020, like past
versions, is heavily data driven. Valid,
reliable, nationally representative data
and data systems should be used for
Healthy People 2020 objectives. Each
objective must have (1) a data source, or
potential data source, identified, (2)
baseline data and (3) assurance of at
least one additional data point
throughout the decade.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Dated: October 9, 2015.
Don Wright,
Deputy Assistant Secretary for Health, Office
of Disease Prevention and Health Promotion.
[FR Doc. 2015–26244 Filed 10–14–15; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
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 materials,
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: National Institute on
Drug Abuse Special Emphasis Panel—
Harnessing Genome Editing Technologies to
Functionally Validate Genetic Variants in
Substance Use Disorders (R21/R33).
Date: November 6, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Jagadeesh S. Rao, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, National Institutes of Health,
DHHS, 6001 Executive Boulevard, Room
4234, MSC 9550, Bethesda, MD 02892, 301–
443–9511, jrao@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel—Phase
II In-person Interview: NIDA Avant-Garde
Award Program for HIV/AIDS Research
(DP1).
Date: December 1, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Hiromi Ono, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, National Institutes of Health,
DHHS, 6001 Executive Boulevard, Room
4238, MSC 9550, Bethesda, MD 20892, 301–
402–6020, hiromi.ono@nih.gov.
Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
E:\FR\FM\15OCN1.SGM
15OCN1
]]>Agencies
[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Notices]
[Pages 62077-62078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26244]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERIVCES
Announcement of Solicitation of Written Comments on Modifications
of Healthy People 2020 Objectives
AGENCY: Office of Disease Prevention and Health Promotion, Office of
the Assistant Secretary for Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Health and Human Services solicits
written comments regarding new objectives proposed to be added to
Healthy People 2020 since the fall 2014 public comment period, as well
as written comments proposing new objectives to be included within
existing Healthy People 2020 topic areas. Public participation helps
shape Healthy People 2020, its framework, objectives, organization, and
targets. Healthy People 2020 will provide opportunities for public
input periodically throughout the decade to ensure that Healthy People
2020 reflects current public health priorities and public input. The
updated set of Healthy People 2020 objectives will be incorporated on
www.HealthyPeople.gov. This set will reflect further review and
deliberation by the topic area workgroups, Federal Interagency
Workgroup on Healthy People 2020, and other Healthy People 2020
stakeholders.
DATES: Written comments will be accepted until 5:00 p.m. ET on November
16, 2015.
ADDRESSES: Written comments will be accepted via an online public
comment database at https://www.healthypeople.gov/2020/about/history-development/Public-Comment; by mail at the Office of Disease Prevention
and Health Promotion, U.S. Department of Health and Human Services,
Attn: Public Comment, 1101 Wootton Parkway, Room LL-100, Rockville, MD
20852; fax--(240) 453-8281; or email_HP2020@hhs.gov.
FOR FURTHER INFORMATION CONTACT: Caitie Blood, MPH, Office of Disease
Prevention and Health Promotion, U.S. Department of Health and Human
Services, 1101 Wootton Parkway, Room LL-100, Rockville, MD 20852,
Caitlin.Blood@HHS.gov (email), (240) 453-8265 (telephone), (240) 453-
8281 (fax).
SUPPLEMENTARY INFORMATION: For three decades, Healthy People has
provided a comprehensive set of national 10-year health promotion and
disease prevention objectives aimed at improving the health of all
Americans. Healthy People 2020 objectives provide a framework by
presenting a comprehensive picture of the nation's health at the
beginning of the decade, establishing national goals and targets to be
achieved by the year 2020, and monitoring progress over time. The U.S.
Department of Health and Human Services is soliciting the submission of
written comments regarding new objectives proposed to be added to
Healthy People 2020 since the fall 2014 public comment period.
[[Page 62078]]
Healthy People 2020 is the product of an extensive collaborative
process that relies on input from a diverse array of individuals and
organizations, both within and outside the federal government, with a
common interest in improving the nation's health. Public comments were
a cornerstone of Healthy People 2020's development. During the first
phase of planning for Healthy People 2020, HHS asked for the public's
comments on the vision, mission, and implementation of Healthy People
2020. Those comments helped set the framework for Healthy People 2020.
The public was also invited to submit comments on proposed Healthy
People 2020 objectives, which helped shape the final set of Healthy
People 2020 objectives.
The public is now invited to comment on new objectives proposed to
be added to Healthy People 2020. These new objectives were developed by
topic area workgroups led by various agencies within the federal
government. They have been reviewed by the Federal Interagency
Workgroup on Healthy People 2020 and are presented now for the public's
review and comment. The public is also invited to suggest additional
objectives for consideration that address critical public health issues
within existing Healthy People 2020 topic areas. Any proposed new
objective must meet all of the objective selection criteria (see
below).
Written comments will be accepted at https://www.healthypeople.gov/2020/about/history-development/Public-Comment during a 30-day public
comment period beginning in October 2015. The public will also be able
to submit written comments via mail, fax, and email (see contact
information above). Comments received in response to this notice will
be reviewed and considered by the appropriate topic area workgroup,
Federal Interagency Workgroup on Healthy People 2020, and other Healthy
People 2020 stakeholders.
Objective Selection Criteria
The following nine criteria should be taken into consideration when
commenting on the proposed new objectives or suggesting additional
objectives.
1. The result to be achieved should be important and understandable
to a broad audience and support the Healthy People 2020 goals.
2. Objectives should be prevention oriented and should address
health improvements that can be achieved through population-based and
individual actions, and systems-based, environmental, health-service,
or policy interventions.
3. Objectives should drive actions that will work toward the
achievement of the proposed targets (defined as quantitative values to
be achieved by the year 2020).
4. Objectives should be useful and reflect issues of national
importance. Federal agencies, states, localities, non-governmental
organizations, and the public and private sectors should be able to use
objectives to target efforts in schools, communities, work sites,
health practices, and other environments.
5. Objectives should be measurable and should address a range of
issues, such as: Behavior and health outcomes; availability of, access
to, and content of behavioral and health service interventions; socio-
environmental conditions; and community capacity--directed toward
improving health outcomes and quality of life across the life span.
(Community capacity is defined as the ability of a community to plan,
implement, and evaluate health strategies.)
6. Continuity and comparability of measured phenomena from year to
year are important, thus, when appropriate, retention of objectives
from previous Healthy People iterations is encouraged. However, in
instances where objectives and/or measures have proven ill-suited to
the purpose or are inadequate, new improved objectives should be
developed. Whether or not an objective has met its target in a previous
Healthy People iteration should not be the sole basis for retaining or
archiving an objective.
7. The objectives should be supported by the best available
scientific evidence. The objective selection and review processes
should be flexible enough to allow revisions to objectives in order to
reflect major updates or new knowledge.
8. Objectives should address population disparities. These include
populations categorized by race/ethnicity, socioeconomic status,
gender, disability status, sexual orientation, and geographic location.
For particular health issues, additional special populations should be
addressed, based on an examination of the available evidence on
vulnerability, health status, and disparate care.
9. Healthy People 2020, like past versions, is heavily data driven.
Valid, reliable, nationally representative data and data systems should
be used for Healthy People 2020 objectives. Each objective must have
(1) a data source, or potential data source, identified, (2) baseline
data and (3) assurance of at least one additional data point throughout
the decade.
Dated: October 9, 2015.
Don Wright,
Deputy Assistant Secretary for Health, Office of Disease Prevention and
Health Promotion.
[FR Doc. 2015-26244 Filed 10-14-15; 8:45 am]
BILLING CODE 4150-32-P
