Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting, 48438-48439 [2013-19138]
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48438
Federal Register / Vol. 78, No. 153 / Thursday, August 8, 2013 / Notices
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2013–19137 Filed 8–7–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Board of Scientific Counselors,
National Center for Health Statistics
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC), National
Center for Health Statistics (NCHS)
announces the following meeting of the
aforementioned committee:
Times and Dates:
11:00 a.m.–5:30 p.m., September 19,
2013
8:30 a.m.–1:00 p.m., September 20, 2013
Place: NCHS Headquarters, 3311
Toledo Road, Hyattsville, Maryland
20782.
Status: This meeting is open to the
public; however, visitors must be
processed in accordance with
established federal policies and
procedures. For foreign nationals or
non-US citizens, pre-approval is
required (please contact Gwen Mustaf,
301–458–4500, glm4@cdc.gov or
Virginia Cain, vcain@cdc.gov at least 10
days in advance for requirements). All
visitors are required to present a valid
form of picture identification issued by
a state, federal or international
government. As required by the Federal
Property Management Regulations, Title
41, Code of Federal Regulation, Subpart
101–20.301, all persons entering in or
on Federal controlled property and their
packages, briefcases, and other
containers in their immediate
possession are subject to being x-rayed
and inspected. Federal law prohibits the
knowing possession or the causing to be
present of firearms, explosives and other
dangerous weapons and illegal
substances. The meeting room
accommodates approximately 100
people.
Purpose: This committee is charged
with providing advice and making
recommendations to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NCHS, regarding the scientific
and technical program goals and
objectives, strategies, and priorities of
NCHS.
Matters to be Discussed: The agenda
will include welcome remarks by the
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Acting Director, NCHS; Demo of the
NHIS Online Analytic Real-time System
(OARS); initiation of Office of Analysis
and Epidemiology review.
Requests to make oral presentations
should be submitted in writing to the
contact person listed below. All requests
must contain the name, address,
telephone number, and organizational
affiliation of the presenter.
Written comments should not exceed
five single-spaced typed pages in length
and must be received by September 4,
2013.
The agenda items are subject to
change as priorities dictate.
Contact Person for more Information:
Virginia S. Cain, Ph.D., Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7208, Hyattsville,
Maryland 20782, telephone (301) 458–
4500, fax (301) 458–4020.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both Centers
for Disease Control and Prevention and
the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker,
Management Analysis and Services Office,
Centers for Disease Control and Prevention.
[FR Doc. 2013–19156 Filed 8–7–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a subcommittee of a public
advisory committee of the Food and
Drug Administration (FDA). The
meeting will be open to the public.
Name of Subcommittee: Pediatric
Ethics Subcommittee of the Pediatric
Advisory Committee.
General Function of the
Subcommittee: To advise and make
recommendations to the Pediatric
Advisory Committee on pediatric
ethical issues.
Date and Time: The meeting will be
held on September 9, 2013, from 8 a.m.
to 5:30 p.m. and September 10, 2013,
from 8 a.m. to 3 p.m.
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Location: Doubletree Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD
20910, 301–589–5200 or visit the hotel’s
Web site at https://
doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelwashington-dc-silver-spring-DCASSDT/
index.html.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301–796–
0885, email
walter.ellenberg@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 subcommittee 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: On September 9 and 10,
2013, the Pediatric Ethics Subcommittee
of the Pediatric Advisory Committee
will meet to discuss ethical issues in
pediatric product development,
including medical counter measures,
focusing on the concepts of minimal
risk, disorder or condition, and
exposure of pediatric subjects to risks
under 21 CFR 50.54.
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 subcommittee 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 September 9, 2013.
Oral presentations from the public will
be scheduled between approximately 2
p.m. and 3 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
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Federal Register / Vol. 78, No. 153 / Thursday, August 8, 2013 / Notices
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 August
30, 2013. 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 September 3, 2013.
Persons attending FDA’s
subcommittee meetings are advised that
the Agency is not responsible for
providing access to electrical outlets.
FDA welcomes the attendance of the
public at this meeting and will make
every effort to accommodate persons
with physical disabilities or special
needs. If you require special
accommodations due to a disability,
please contact Walter Ellenberg at 301–
796–0885, email
walter.ellenberg@fda.hhs.gov, 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: August 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19138 Filed 8–7–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Analyzing Title V Programs in the
Context of the Affordable Care Act
OMB No.: 0915–xxxx—New
Abstract: The Affordable Care Act
(ACA) will make affordable health
coverage available to all legal U.S.
residents, as well as guide
transformation in the delivery of
medicine and public health services.
For children, expanded coverage has
come about gradually over the past two
decades and implementation of major
coverage provisions of the ACA in 2014
will result in some shifts in child health
coverage.
The Title V Maternal and Child
Health (MCH) Block Grant,
administered by the Health Resources
and Services Administration’s Maternal
SUMMARY:
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and Child Health Bureau, provides the
foundation for ensuring the health of the
nation’s mothers, women, children, and
youth, including children and youth
with special health care needs and their
families. Many ACA provisions, like
state Medicaid expansions and
mandatory health insurance, will
change the face of health insurance
demand and services provided. In
response, State Title V programs will
focus on increasing access, equality, and
health equity.
A proposed data collection form has
been developed to collect health care
services budget information from Title V
MCH Block Grant recipients to better
understand the types of direct services
currently provided by Title V MCH
programs. This form will request
information on expenditures for medical
services in addition to data on the
individuals served.
Need and Proposed Use of the
Information: As children shift between
coverage categories as a result of
implementation of the ACA, HRSA
would like to quantify the impact of
these shifts on the federal investment in
Title V funding specifically through the
federal funds provided via the Title V
MCH Block Grant. To do this, HRSA
will need to survey states to collect
information on whether they use federal
Title V MCH Block Grant funds to
reimburse health care practitioners who
provide services to children and
pregnant women.
Likely Respondents: The respondents
to the survey will be the Title V Program
Directors in the states, the District of
Columbia, and Puerto Rico.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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Agencies
[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Notices]
[Pages 48438-48439]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19138]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Pediatric Ethics Subcommittee of the Pediatric Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a subcommittee of a
public advisory committee of the Food and Drug Administration (FDA).
The meeting will be open to the public.
Name of Subcommittee: Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee.
General Function of the Subcommittee: To advise and make
recommendations to the Pediatric Advisory Committee on pediatric
ethical issues.
Date and Time: The meeting will be held on September 9, 2013, from
8 a.m. to 5:30 p.m. and September 10, 2013, from 8 a.m. to 3 p.m.
Location: Doubletree Hilton Hotel, 8727 Colesville Rd., Silver
Spring, MD 20910, 301-589-5200 or visit the hotel's Web site at https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/.
Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993, 301-796-0885, email
walter.ellenberg@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 subcommittee 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: On September 9 and 10, 2013, the Pediatric Ethics
Subcommittee of the Pediatric Advisory Committee will meet to discuss
ethical issues in pediatric product development, including medical
counter measures, focusing on the concepts of minimal risk, disorder or
condition, and exposure of pediatric subjects to risks under 21 CFR
50.54.
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 subcommittee 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
September 9, 2013. Oral presentations from the public will be scheduled
between approximately 2 p.m. and 3 p.m. Those individuals interested in
making formal oral presentations should notify the contact
[[Page 48439]]
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 August 30, 2013. 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 September 3, 2013.
Persons attending FDA's subcommittee meetings are advised that the
Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at this meeting and will
make every effort to accommodate persons with physical disabilities or
special needs. If you require special accommodations due to a
disability, please contact Walter Ellenberg at 301-796-0885, email
walter.ellenberg@fda.hhs.gov, 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: August 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19138 Filed 8-7-13; 8:45 am]
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