Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting, 68802 [2010-28188]
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68802
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices
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Donald M. Berwick,
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Dated: October 29, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–28251 Filed 11–4–10; 2:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children; Notice of Meeting
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children.
Dates and Times: January 27, 2011, 8:30
a.m. to 5 p.m. January 28, 2011, 8:30 a.m. to
3:30 p.m.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue, NW., Washington, DC 20037.
Status: The meeting will be open to the
public with attendance limited to space
availability. Participants are asked to register
for the meeting by going to the registration
Web site at https://altarum.cvent.com/event/
SACHDNC012011. The registration deadline
is Tuesday, January 25, 2011. Individuals
who need special assistance, such as sign
language interpretation or other reasonable
accommodations should indicate their needs
on the registration Web site. The deadline for
special accommodation requests is Friday,
January 21, 2011. If there are technical
problems gaining access to the Web site,
please contact Maureen Ball, Meetings
Coordinator at conferences@altarum.org.
Purpose: The Secretary’s Advisory
Committee on Heritable Disorders in
VerDate Mar<15>2010
15:18 Nov 08, 2010
Jkt 223001
Newborns and Children (Advisory
Committee) was established to advise and
guide the Secretary regarding the most
appropriate application of universal newborn
screening tests, technologies, policies,
guidelines and programs for effectively
reducing morbidity and mortality in
newborns and children having or at risk for
heritable disorders. The Advisory Committee
also provides advice and recommendations
concerning the grants and projects authorized
under the Public Health Service Act, 42
U.S.C. 300b–10, (Heritable Disorders
Program) as amended in the Newborn
Screening Saves Lives Act of 2008.
Agenda: The meeting will include: (1)
Presentations from the following Advisory
Committee workgroups: Communications,
Health Information Technology, and
Evidence Review; (2) a report from a National
Survey of Recent and Prospective Mothers
about Newborn Screening; and (3)
presentations on the continued work and
reports of the Advisory Committee’s
subcommittees on laboratory standards and
procedures, follow-up and treatment, and
education and training. Proposed Agenda
items are subject to change as priorities
dictate. You can locate the Agenda,
Committee Roster and Charter, presentations,
and meeting materials at the home page of
the Advisory Committee’s Web site at
https://www.hrsa.gov/
heritabledisorderscommittee/.
Public Comments: Members of the public
can present oral comments during the public
comment periods of the meeting, which are
scheduled for both days of the meeting.
Those individuals who want to make a
comment are requested to register online by
Tuesday, January 25, 2011, at https://
altarum.cvent.com/event/SACHDNC012011.
Requests will contain the name, address,
telephone number, and any professional or
business affiliation of the person desiring to
make an oral presentation. Groups having
similar interests are requested to combine
their comments and present them through a
single representative. The list of public
comment participants will be posted on the
Web site. Written comments should be emailed via e-mail no later than Tuesday,
January 25, 2011, for consideration.
Comments should be submitted to Maureen
Ball, Meetings Coordinator, Conference and
Meetings Management, Altarum Institute,
1200 18th Street, NW., Suite 700,
Washington, DC 20036, telephone: 202 828–
5100; fax: 202 785–3083, or e-mail:
conferences@altarum.org.
Contact Person: Anyone interested in
obtaining other relevant information should
write or contact Alaina M. Harris, Maternal
and Child Health Bureau, Health Resources
and Services Administration, Room 18A–19,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857, Telephone (301)
443–0721, aharris@hrsa.gov. More
information on the Advisory Committee is
available at https://mchb.hrsa.gov/
heritabledisorderscommittee.
PO 00000
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Dated: November 2, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–28188 Filed 11–8–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0369]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
Under the Food and Drug
Administration Modernization Act of
1997 (Modernization Act), the Food and
Drug Administration (FDA) is required
to report annually in the Federal
Register on the status of postmarketing
requirements and commitments
required of, or agreed upon by, holders
of approved drug and biological
products. This notice is the Agency’s
report on the status of the studies and
clinical trials that applicants have
agreed to or are required to conduct.
FOR FURTHER INFORMATION CONTACT:
Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6464,
Silver Spring, MD 20993–0002, 301–
796–0700; or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1400
Rockville Pike, Rockville, MD 20852,
301–827–0373.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
A. The Modernization Act
Section 130(a) of the Modernization
Act (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new
provision requiring reports of certain
postmarketing studies, including
clinical trials, for human drug and
biological products (section 506B of the
FD&C Act (21 U.S.C. 356b)). Section
506B of the FD&C Act provides FDA
with additional authority to monitor the
progress of a postmarketing study or
clinical trial that an applicant has been
required to or has agreed to conduct by
requiring the applicant to submit a
report annually providing information
E:\FR\FM\09NON1.SGM
09NON1
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[Federal Register Volume 75, Number 216 (Tuesday, November 9, 2010)]
[Notices]
[Page 68802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28188]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Secretary's Advisory Committee on Heritable Disorders in Newborns
and Children; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Secretary's Advisory Committee on Heritable Disorders in
Newborns and Children.
Dates and Times: January 27, 2011, 8:30 a.m. to 5 p.m. January
28, 2011, 8:30 a.m. to 3:30 p.m.
Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New
Hampshire Avenue, NW., Washington, DC 20037.
Status: The meeting will be open to the public with attendance
limited to space availability. Participants are asked to register
for the meeting by going to the registration Web site at https://altarum.cvent.com/event/SACHDNC012011. The registration deadline is
Tuesday, January 25, 2011. Individuals who need special assistance,
such as sign language interpretation or other reasonable
accommodations should indicate their needs on the registration Web
site. The deadline for special accommodation requests is Friday,
January 21, 2011. If there are technical problems gaining access to
the Web site, please contact Maureen Ball, Meetings Coordinator at
conferences@altarum.org.
Purpose: The Secretary's Advisory Committee on Heritable
Disorders in Newborns and Children (Advisory Committee) was
established to advise and guide the Secretary regarding the most
appropriate application of universal newborn screening tests,
technologies, policies, guidelines and programs for effectively
reducing morbidity and mortality in newborns and children having or
at risk for heritable disorders. The Advisory Committee also
provides advice and recommendations concerning the grants and
projects authorized under the Public Health Service Act, 42 U.S.C.
300b-10, (Heritable Disorders Program) as amended in the Newborn
Screening Saves Lives Act of 2008.
Agenda: The meeting will include: (1) Presentations from the
following Advisory Committee workgroups: Communications, Health
Information Technology, and Evidence Review; (2) a report from a
National Survey of Recent and Prospective Mothers about Newborn
Screening; and (3) presentations on the continued work and reports
of the Advisory Committee's subcommittees on laboratory standards
and procedures, follow-up and treatment, and education and training.
Proposed Agenda items are subject to change as priorities dictate.
You can locate the Agenda, Committee Roster and Charter,
presentations, and meeting materials at the home page of the
Advisory Committee's Web site at https://www.hrsa.gov/heritabledisorderscommittee/.
Public Comments: Members of the public can present oral comments
during the public comment periods of the meeting, which are
scheduled for both days of the meeting. Those individuals who want
to make a comment are requested to register online by Tuesday,
January 25, 2011, at https://altarum.cvent.com/event/SACHDNC012011.
Requests will contain the name, address, telephone number, and any
professional or business affiliation of the person desiring to make
an oral presentation. Groups having similar interests are requested
to combine their comments and present them through a single
representative. The list of public comment participants will be
posted on the Web site. Written comments should be e-mailed via e-
mail no later than Tuesday, January 25, 2011, for consideration.
Comments should be submitted to Maureen Ball, Meetings Coordinator,
Conference and Meetings Management, Altarum Institute, 1200 18th
Street, NW., Suite 700, Washington, DC 20036, telephone: 202 828-
5100; fax: 202 785-3083, or e-mail: conferences@altarum.org.
Contact Person: Anyone interested in obtaining other relevant
information should write or contact Alaina M. Harris, Maternal and
Child Health Bureau, Health Resources and Services Administration,
Room 18A-19, Parklawn Building, 5600 Fishers Lane, Rockville,
Maryland 20857, Telephone (301) 443-0721, aharris@hrsa.gov. More
information on the Advisory Committee is available at https://mchb.hrsa.gov/heritabledisorderscommittee.
Dated: November 2, 2010.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-28188 Filed 11-8-10; 8:45 am]
BILLING CODE 4165-15-P