Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC), 61134-61135 [E8-24499]
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
bear the docket control number ATSDR–
214. This material is available for public
inspection at the Division of Toxicology
and Environmental Medicine, Agency
for Toxic Substances and Disease
Registry, 4700 Buford Highway,
Building 106, Second Floor, Chamblee,
Georgia 30341 between 8 a.m. and 4:30
p.m., Monday through Friday, except
legal holidays.
Availability
This notice announces the availability
of the final toxicological profile for
perchlorates, which completes the
nineteenth set prepared by ATSDR. The
following toxicological profile is now
available at https://www.atsdr.cdc.gov/
toxpro2.html or through the U.S.
Department of Commerce, National
Technical Information Service (NTIS),
5285 Port Royal Road, Springfield,
Virginia 22161, telephone 1–800–553–
6847. This profile is available for a fee
as determined by NTIS.
Toxicological
profile
Perchlorates
NTIS Order
No.
PB2009–
100006.
CAS No.
10034–81–8
007778–81–8
007790–74–7
007601–89–0
007791–03–9
Dated: October 9, 2008.
Ken Rose,
Director, Office of Policy Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. E8–24388 Filed 10–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
jlentini on PROD1PC65 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel, Department of Health
and Human Services, has been renewed
for a 2-year period through September
18, 2010.
For information, contact Elaine Baker,
Executive Secretary, Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel, Department of
Health and Human Services, 57
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Executive Park Drive, 4th Floor,
Mailstop E72, Atlanta, Georgia 30329,
telephone (770) 498–0090; fax (770)
498–0011.
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 the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: October 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–24409 Filed 10–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Childhood
Lead Poisoning Prevention (ACCLPP)
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)
announces the following meeting of the
aforementioned committee:
Times and Dates: 12:30 p.m.–5 p.m.,
October 29, 2008. 8:30 a.m.–5 p.m.,
October 30, 2008.
Place: The Westin San Diego, 400
West Broadway, San Diego, California
92101, Telephone: (619) 338–3613, Fax:
(619) 239–4527.
Status: Open to the public, limited
only by the space available. The meeting
room accommodates approximately 125
people.
Purpose: The committee provides
advice and guidance to the Secretary;
the Assistant Secretary for Health; and
the CDC Director regarding new
scientific knowledge and technologic
developments and their practical
implications for childhood lead
poisoning prevention efforts. The
committee also reviews and reports
regularly on childhood lead poisoning
prevention practices and recommends
improvements in national childhood
lead poisoning prevention efforts.
Matters to be Discussed: Agenda items
are subject to change as priorities
dictate; however, the current agenda
includes
• Discussion on the potential
approaches to strengthen existing
strategies to achieve the Healthy People
2010 goal of eliminating elevated blood
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lead levels (BLLs) as a public health
problem in the United States by 2010;
• Update on school performance and
concurrent BLLs;
• Discussion on study designs related
to adverse effects from BLLs <10 µg/dL;
and
• Discussion on the development of a
prevention-based research agenda.
Opportunities will be provided during
the meeting for oral comments.
Depending on the time available and the
number of requests, it may be necessary
to limit the time for each presenter.
FOR FURTHER INFORMATION CONTACT:
Claudine Johnson, Program Operations
Assistant, Telephone: (770) 488–3629;
Barry Brooks, Administrative Team
Leader, Telephone: 770–488–3841; Lead
Poisoning Prevention Branch, Division
of Environmental Emergency Health
Services, National Center for
Environmental Health, CDC, 4770
Buford Hwy., NE., Mailstop F60,
Atlanta, Georgia 30341.
(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: October 7, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–24394 Filed 10–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director,
Centers for Disease Control and
Prevention (CDC)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned committee:
Time and Date: 8 a.m.–3:30 p.m., October
30, 2008.
Place: CDC, Tom Harkin Global
Communications Center, Auditorium B, 1600
Clifton Road, NE., Atlanta, GA 30333.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 150 people.
Purpose: The committee will provide
advice to the CDC Director on strategic and
other broad issues facing CDC.
Matters To Be Discussed: Agenda items
will include discussions on budget
challenges for Fiscal Year 2009 and beyond;
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
reports from the Ethics Subcommittee and
National Biosurveillance Advisory
Subcommittee; progress report on Healthiest
Nation; and discussions on globalization.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Brad
Perkins, M.D., M.B.A., Executive Officer,
Advisory Committee to the Director, CDC,
1600 Clifton Road, NE., M/S D–14, Atlanta,
Georgia 30333. Telephone 404/639–7000.
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 the CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: October 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–24499 Filed 10–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0523]
FDA–Regulated Products that Contain
Bisphenol-A; Request for Information
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice; request for information.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
assistance in the identification of types
of FDA-regulated products that contain
Bisphenol A (BPA), whether as a
component of the product or its
packaging, and any information relating
to the leaching of BPA from the
packaging to the product and/or from
the product from the product following
human administration.
DATES: Submit written or electronic
comments and information by December
29, 2008.
ADDRESSES: Submit written comments
and information to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments and
information to https://
www.regulations.gov. Information
submitted will be reviewed by the FDA
BPA Task Force.
FOR FURTHER INFORMATION CONTACT:
Norris Alderson, Office of Science and
Health Coordination (HF–32), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
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3340, FAX 301–827–3042, e-mail:
norris.alderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
BPA is a chemical commodity used
primarily in the production of
polycarbonate plastics and epoxy resins.
Such plastics and resins have many
applications including as components of
packaging for food and drink, and as
components of certain medical products
and their packaging. Consequently, low
levels of residual BPA may be present
in such products. On April 14, 2008, the
National Toxicology Program (NTP)
released a draft brief on BPA for public
comment and peer review. The NTP
draft brief raises concerns that exposure
to BPA could be linked to
developmental problems of the
endocrine system in infants and young
children. The NTP draft brief also
contains an exposure estimate to BPA
for infants and young children due to
leaching of BPA to food from plastic
baby bottles and the linings of certain
baby food containers. NTP has
subsequently released a final report on
BPA on September 3, 2008.
In response to the NTP draft brief,
Commissioner von Eschenbach has
convened an agency-wide task force to
facilitate cross-agency review of current
research and new information on BPA
for all FDA-regulated products. The
review will include the NTP brief and
all other available information on the
exposure of US consumers to BPA from
FDA-regulated products.
During the course of this process the
task force has been making an inventory
of all FDA-regulated products that are
known to contain BPA. The task force
has already completed a thorough
assessment of the potential exposure to
BPA due to leaching from food-contact
materials and is now interested in
additional information on other types of
products, specifically medical devices,
biological products (including blood,
blood products, vaccines, and cell and
gene therapies, and drugs.
To ensure that we have current
information to support our review of
issues related to BPA risks, we are
requesting information on the presence
and levels of BPA for products with
either direct or indirect patient contact.
This would include situations where the
BPA is a component of the product or
its packaging. Information relating to the
leaching of BPA from the packaging to
the product and/or from the product to
patients is also of interest.
At this time, exposure to BPA from
the use of the following BPA-related
materials provides an initial basis for
the agency’s query:
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∑ Polycarbonate.
∑ Polyether sulfone.
∑ Polycarbonate/siloxane co-polymer.
∑ Biostable polyurethanes.
∑ Epoxy resin.
The agency’s query also extends to
products that contain certain bisphenol
acrylic oligomers, such as the following:
∑ Bisphenol A diglycidylether
methacrylate (BIS-GMA).
∑ Bisphenol A diglycidylether
(BADGE).
∑ Bisphenol A dimethacrylate (BISDMA).
∑ Ethoxylated bisphenol A diacrylates.
II. Information Requested for FDARegulated Products
A. Medical Devices and Articles Used in
Product Manufacturing
Direct contact devices would include,
but not be limited to, those with direct
contact with tissue, blood, other fluids,
such as cerebrospinal fluid, and skin.
Implants, catheters, and most dental
devices are additional examples of
devices with direct patient contact.
Indirect patient contact or external
communicating devices would include,
but are not limited to the following:
∑ Components of blood pathway
circuits, (e.g., hemodialysis,
apheresis, and cardiopulmonary
bypass).
∑ Respiratory tubing circuits.
∑ Blood and parenteral solution
administration sets.
∑ Apheresis instrument harnesses
including separation bowls and
break away closures.
∑ Hard casing for leukocyte reduction
filters.
∑ Platelet rich plasma preparation
devices including tubes for
centrifugation of blood.
∑ Tops for vials or other container
closures.
∑ Large volume containers used in
preparation of raw materials for
biological products production
when lined with epoxy material
that contains BPA.
∑ Materials used for preparation of
cell/tissue/gene therapies,
including: T-flasks, roller bottles,
cell factories, cell culture beads,
hard conical tubes, and disposable
plastic pipettes.
In submitting your comments, we ask
you to provide information with respect
to any Class I, Class II, and Class III
medical device that has direct or
indirect patient contact. Whenever
possible, include a description of the
analytical method used to develop the
submitted data and information.
If the device contains polycarbonate
or BPA, we request the submission of
data concerning the following:
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]]>Agencies
[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61134-61135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24499]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Advisory Committee to the Director, Centers for Disease Control
and Prevention (CDC)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the CDC announces the following meeting
of the aforementioned committee:
Time and Date: 8 a.m.-3:30 p.m., October 30, 2008.
Place: CDC, Tom Harkin Global Communications Center, Auditorium
B, 1600 Clifton Road, NE., Atlanta, GA 30333.
Status: Open to the public, limited only by the space available.
The meeting room accommodates approximately 150 people.
Purpose: The committee will provide advice to the CDC Director
on strategic and other broad issues facing CDC.
Matters To Be Discussed: Agenda items will include discussions
on budget challenges for Fiscal Year 2009 and beyond;
[[Page 61135]]
reports from the Ethics Subcommittee and National Biosurveillance
Advisory Subcommittee; progress report on Healthiest Nation; and
discussions on globalization. Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Brad Perkins, M.D., M.B.A.,
Executive Officer, Advisory Committee to the Director, CDC, 1600
Clifton Road, NE., M/S D-14, Atlanta, Georgia 30333. Telephone 404/
639-7000.
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 the CDC and the Agency for Toxic Substances and
Disease Registry.
Dated: October 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E8-24499 Filed 10-14-08; 8:45 am]
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