National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, 56988 [E6-15949]
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Federal Register / Vol. 71, No. 188 / Thursday, September 28, 2006 / Notices
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of research grant applications in
response to Development and Testing of a
Coal Mine Safehouse, Program
Announcement PA 04–038.
For More Information Contact: George
Bokosh, Designated Federal Official, 626
Cochrans Mill Road, Pittsburgh, PA 15236,
telephone (412) 386–6465.
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 CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: September 21, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–15957 Filed 9–27–06; 8:45 am]
BILLING CODE 4163–18–P
Subcommittee. Items are subject to change as
priorities dictate.
Supplementary Information: This
teleconference meeting is scheduled to begin
at 1 p.m. Eastern Standard Time. To
participate during the Public Comment
period (2–2:10 p.m. Eastern Standard Time),
dial (877) 315–6535 and enter conference
code 383520.
For More Information Contact: Individuals
interested in attending the meeting, please
contact Shirley D. Little, Committee
Management Specialist, NCEH/ATSDR, 1600
Clifton Road, Mail Stop E–28, Atlanta, GA
30303; telephone (404) 498–0003, fax (404)
498–0059; E-mail: slittle@cdc.gov.
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 CDC and the National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
Dated: September 21, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–15949 Filed 9–27–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on PROD1PC70 with NOTICES
The Health Department Subcommittee
of the Board of Scientific Counselors
(BSC), Centers for Disease Control and
Prevention (CDC), National Center for
Environmental Health (NCEH)/Agency
for Toxic Substances and Disease
Registry (ATSDR): Teleconference
Meeting.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), The Centers for
Disease Control and Prevention, NCEH/
ATSDR announces the following
subcommittee teleconference meeting:
Name: Health Department Subcommittee
(HDS).
Time and Date: 1 p.m.–2:30 p.m., October
16, 2006.
Place: Century Center, 1825 Century
Boulevard, Atlanta, Georgia 30345.
Status: Open to the public, teleconference
access limited only by availability of
telephone ports.
Purpose: Under the charge of the Board of
Scientific Counselors, NCEH/ATSDR the
Health Department Subcommittee will
provide the BSC, NCEH/ATSDR with advice
and recommendations on local and state
health department issues and concerns that
pertain to the mandates and mission of
NCEH/ATSDR.
Matters To Be Discussed:
The meeting agenda will include a followup on Workforce Recommendations; a
selection of FY 2007/2008 Environmental
Public Health Program Priorities; and the
next steps for the Health Department
VerDate Aug<31>2005
20:16 Sep 27, 2006
Jkt 208001
Food and Drug Administration
[Docket No. 2006N–0378]
Review of Agreements, Guidances,
and Practices Specific to Assignment
of Combination Products in
Compliance With the Medical Device
User Fee and Modernization Act of
2002; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Federal Food, Drug, and
Cosmetic Act (the act) requires the Food
and Drug Administration (FDA) to
review each agreement, guidance, or
practice that is specific to the
assignment of combination products to
agency centers and to determine
whether the agreement, guidance, or
practice is consistent with the
requirements of the act. In carrying out
the review, the agency is to consult with
stakeholders and directors of the agency
centers, and then determine whether to
continue in effect, modify, revise, or
eliminate such an agreement, guidance,
or practice. The agency has completed
its initial review of relevant agreements,
guidances, and practices, and has
consulted with directors of the agency
centers. This document provides the
preliminary results of the agency’s
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
review and requests stakeholder
comments to fulfill the act’s
requirement for stakeholder
consultation prior to the agency’s final
determination whether to continue the
agreements, guidance, or practices in
effect, or to modify, revise, or eliminate
them.
DATES: Submit written or electronic
comments by November 27, 2006.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Suzanne O’Shea, Office of Combination
Products (HFG–3), Food and Drug
Administration, 15800 Crabbs Branch
Way, suite 200, Rockville, MD 20855,
301–427–1934, FAX: 301–427–1935, email: suzanne.oshea@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In October 2002, the Medical Device
User Fee and Modernization Act
(MDUFMA) added section 503(g)(4)(F)
(21 U.S.C. 353(g)(4)(F)) to the act. This
new provision requires the Secretary of
the Department of Health and Human
Services (the Secretary), acting through
the Office of Combination Products
(OCP), to review each agreement,
guidance, or practice of the Secretary
that is specific to the assignment of
combination products to agency centers
and to determine whether the
agreement, guidance, or practice is
consistent with the requirements of
section 503(g) of the act. In carrying out
such a review, OCP is to consult with
stakeholders and the directors of the
agency centers. After such consultation,
OCP is to determine whether to
continue in effect, modify, revise, or
eliminate such agreement, guidance, or
practice, and publish in the Federal
Register a notice of the availability of
any modified or revised agreement,
guidance, or practice.
This notice provides the preliminary
results of OCP’s review of agreements,
guidances, and practices that were in
effect at the time section 503(g)(4)(F) of
the act was enacted for their consistency
with the act’s requirement for the
prompt assignment of combination
products to agency centers on the basis
of the products’ primary mode of action
(PMOA).1 The directors of relevant
1 Section 503(g)(1) of the act requires that
combination products be assigned to an agency
center for regulation and review on the basis of the
product’s PMOA. In addition, section 503(g)(4)(B)
of the act directs OCP to ensure the prompt
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28SEN1
]]>Agencies
[Federal Register Volume 71, Number 188 (Thursday, September 28, 2006)]
[Notices]
[Page 56988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15949]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Environmental Health/Agency for Toxic
Substances and Disease Registry
The Health Department Subcommittee of the Board of Scientific
Counselors (BSC), Centers for Disease Control and Prevention (CDC),
National Center for Environmental Health (NCEH)/Agency for Toxic
Substances and Disease Registry (ATSDR): Teleconference Meeting.
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), The Centers for Disease Control and
Prevention, NCEH/ATSDR announces the following subcommittee
teleconference meeting:
Name: Health Department Subcommittee (HDS).
Time and Date: 1 p.m.-2:30 p.m., October 16, 2006.
Place: Century Center, 1825 Century Boulevard, Atlanta, Georgia
30345.
Status: Open to the public, teleconference access limited only
by availability of telephone ports.
Purpose: Under the charge of the Board of Scientific Counselors,
NCEH/ATSDR the Health Department Subcommittee will provide the BSC,
NCEH/ATSDR with advice and recommendations on local and state health
department issues and concerns that pertain to the mandates and
mission of NCEH/ATSDR.
Matters To Be Discussed:
The meeting agenda will include a follow-up on Workforce
Recommendations; a selection of FY 2007/2008 Environmental Public
Health Program Priorities; and the next steps for the Health
Department Subcommittee. Items are subject to change as priorities
dictate.
Supplementary Information: This teleconference meeting is
scheduled to begin at 1 p.m. Eastern Standard Time. To participate
during the Public Comment period (2-2:10 p.m. Eastern Standard
Time), dial (877) 315-6535 and enter conference code 383520.
For More Information Contact: Individuals interested in
attending the meeting, please contact Shirley D. Little, Committee
Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-
28, Atlanta, GA 30303; telephone (404) 498-0003, fax (404) 498-0059;
E-mail: slittle@cdc.gov.
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 CDC and the National Center for Environmental
Health/Agency for Toxic Substances and Disease Registry.
Dated: September 21, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E6-15949 Filed 9-27-06; 8:45 am]
BILLING CODE 4163-18-P
