National Center for Injury Prevention and Control Initial Review Group, 24855-24856 [E6-6349]
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Notices
rmajette on PROD1PC67 with NOTICES
positions on the Committee membership
that will become vacant on January 3,
2007.
DATES: Nominations for membership on
the Committee must be received no later
than May 30, 2006.
ADDRESSES: Nominations should be
mailed or delivered to: Dr. Bernard
Schwetz, Director, Office for Human
Research Protections, Department of
Health and Human Services, 1101
Wootton Parkway, Suite 200; Rockville,
MD 20852. Nominations will not be
accepted by e-mail or by facsimile.
FOR FURTHER INFORMATION CONTACT: Ms.
Catherine Slatinshek, Executive
Director, SACHRP, Office for Human
Research Protections, 1101 Wootton
Parkway, Suite 200, Rockville, MD
20852, telephone: 1–240–453–6900. A
copy of the Committee charter and list
of the current membership can be
obtained by contacting Ms. Slatinshek
or by accessing the SACHRP Web site at
https://www.hhs.gov/ohrp/sachrp, or
requesting via e-mail at
sachrp@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION: The
Committee shall advise on matters
pertaining to the continuance and
improvement of functions within the
authority of HHS directed toward
protections for human subjects in
research. Specifically, the Committee
will provide advice relating to the
responsible conduct of research
involving human subjects with
particular emphasis on: Special
populations, such as neonates and
children, prisoners, and the decisionally
impaired; pregnant women, embryos,
and fetuses; individuals and
populations in international studies;
populations in which there are
individually identifiable samples, data,
or information; and investigator
conflicts of interest.
In addition, the Committee is
responsible for reviewing selected
ongoing work and planned activities of
the OHRP and other offices/agencies
within HHS responsible for human
subjects protection. These evaluations
may include, but are not limited to, a
review of assurance systems, the
application of minimal research risk
standards, the granting of waivers,
education programs sponsored by
OHRP, and the ongoing monitoring and
oversight of institutional review boards
and the institutions that sponsor
research.
Nominations
The Office for Human Research
Protections is requesting nominations to
fill four positions for voting members of
SACHRP. The positions will become
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vacant on January 3, 2007. Nominations
of potential candidates for consideration
are being sought from a wide array of
fields, including, but not limited to
public health and medicine, behavioral
and social sciences, health
administration, and biomedical ethics.
To qualify for consideration of
appointment to the Committee, an
individual must possess demonstrated
experience and expertise in any of the
several disciplines and fields pertinent
to human subjects protection and/or
clinical research.
The individuals selected for
appointment to the Committee will
serve as voting members. The
individuals selected for appointment to
the Committee can be invited to serve a
term of up to four years. Committee
members receive a stipend and, when
applicable, reimbursement for per diem
and any travel expenses incurred, for
attending Committee meetings and
conducting other business in the
interest of the Committee.
Nominations should be typewritten.
The following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
nominator’s name, address, and daytime
telephone number, and the home and/
or work address, telephone number, and
e-mail address of the individual being
nominated; and (3) a current copy of the
nominee’s curriculum vitae. The names
of Federal employees should not be
nominated for consideration of
appointment to this Committee.
The Department makes every effort to
ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made to ensure
that a broad representation of
geographic areas, females, ethnic and
minority groups, and the disabled are
given consideration for membership on
HHS Federal advisory committees.
Appointment to this Committee shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and
cultural, religious, or socioeconomic
status.
Nominations must state that the
nominee is willing to serve as a member
of SACHRP and appears to have no
conflict of interest that would preclude
membership. Potential candidates are
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24855
required to provide detailed information
concerning such matters as financial
holdings, consultancies, and research
grants or contracts to permit evaluation
of possible sources of conflict of
interest.
Dated: April 21, 2006.
Bernard A. Schwetz,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. E6–6311 Filed 4–26–06; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Center for Injury Prevention
and Control Initial Review Group
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) announce
the following meeting:
Name: National Center for Injury
Prevention and Control (NCIPC) Initial
Review Group (IRG)
Times and Dates: 10 a.m.–10:30 p.m., May
23, 2006. 8 a.m.–6:30 p.m., May 24, 2006.
8:30 a.m.–6 p.m., May 25, 2006.
Place: Doubletree Club Atlanta Airport,
3400 Norman Berry Drive, Atlanta, GA
30344.
Status: Open: 10 a.m.–11 a.m., May 23,
2006, Closed: 11 a.m.–10:30 p.m., May 23,
2006, Closed: 8 a.m.–6:30 p.m., May 24,
2006, Closed: 8:30 a.m.–6 p.m., May 25,
2006.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services and the Director, CDC, concerning
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
injury research that focuses on prevention
and control.
Matters to be Discussed: Agenda items
include an overview of the injury program,
discussion of the review process and
panelists’ responsibilities, and the review of
and vote on applications. Beginning at 11
a.m., May 23, through 6 p.m., May 25, the
Group will review individual research grant
and cooperative agreement applications
submitted in response to two Fiscal Year
2006 Requests for Applications related to the
following individual research
announcements: #06008, Urban Partnership
Academic Center of Excellent and #06006,
Parenting Programs in the Prevention of
Child Maltreatment. This portion of the
meeting will be closed to the public in
accordance with provisions set forth in
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Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Notices
section 552b(c)(4) and (6), Title 5, U.S.C., and
the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to section 10(d) of Public Law
92–463.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact:
Gwendolyn H. Cattledge, Ph.D., M.S.E.H.,
Executive Secretary, NCIPC IRG, CDC, 4770
Buford Highway, NE., M/S K02, Atlanta,
Georgia 30341–3724, telephone (770) 488–
1430.
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: April 20, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–6349 Filed 4–26–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006F–0059]
Danisco USA, Inc.; Filing of Food
Additive Petition; Amendment
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
filing notice for a food additive petition
filed by Danisco USA, Inc., to indicate
that the petition proposes to amend the
food additive regulations at 21 CFR
172.841 by incorporating by reference
the specifications for polydextrose in
the 5th edition of the Food Chemicals
Codex (FCC), 2003.
ADDRESSES: Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
C. DeLeo, Center for Food Safety and
Applied Nutrition (HFS–265), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–1302.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
February 15, 2006 (71 FR 7975), FDA
announced that a food additive petition
(FAP 6A4763) had been filed by Danisco
USA, Inc., 440 Saw Mill River Rd.,
Ardsley, NY 10502–2605. The petition
proposed to amend the food additive
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regulations in § 172.841 Polydextrose
(21 CFR 172.841) to provide for the safe
use of polydextrose as a bulking agent,
formulation aid, humectant, and
texturizer in all foods, except meat and
poultry. After publication of the filing
notice, FDA learned that the petition
also proposed to update § 172.841 by
incorporating by reference the
specifications for polydextrose in the
FCC, 5th ed., 2003. Currently, § 172.841
incorporates by reference the
specifications of FCC, 4th ed., 1996.
The agency compared specifications
in the monograph for polydextrose in
the 4th and 5th editions of the FCC and
found that the 5th edition retains the
lead limit of 0.5 milligram(mg)/
kilogram(kg), but no longer lists a
specification limit of 5 mg/kg for heavy
metals as lead. The 5th edition of the
FCC eliminated the heavy metals as lead
test from most monographs in favor of
including individual specifications for
relevant heavy metals. In addition, the
5th edition added a nickel specification
of 2 mg/kg for hydrogenated
polydextrose, as well as modified the
pH specification of a 10 percent solution
of untreated polydextrose from ‘‘not less
than 2.5’’ (4th edition) to ‘‘between 2.5
and 7.0’’ (5th edition). The name of the
specification for 5–
Hydroxymethylfurfural has also
changed from ‘‘5–
Hydroxymethylfurfural’’ (4th edition) to
‘‘5–Hydroxymethylfurfural and Related
Compounds’’ (5th edition), although the
test and equation used to determine the
level have remained the same. The
agency has placed copies of the
polydextrose monograph in the 4th and
5th editions of the FCC on public
display at the Division of Dockets
Management (see ADDRESSES) for public
review.
Dated: March 30, 2006.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E6–6370 Filed 4–26–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0202]
Food and Drug Administration,
HHS.
ACTION:
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Submit written or electronic
comments on agency guidances at any
time.
DATES:
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit written comments on the
guidance 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. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
For
products regulated by the Center for
Drug Evaluation and Research: Valerie
L. Whipp, Center for Drug Evaluation
and Research (HFD–310), Food and
Drug Administration, 11919 Rockville
Pike, Rockville, MD 20852, 301–827–
8963. For products regulated by the
Center for Biologics Evaluation and
Research: Elizabeth Callaghan, Center
for Biologics Evaluation and Research
(HFM–370), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–8963.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
Guidance for Industry on Bar Code
Label Requirements—Questions and
Answers; Availability
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Bar Code Label
Requirements—Questions and
Answers.’’ FDA regulations require
certain human drug and biological
products to have on their labels a linear
bar code that identifies the drug’s
National Drug Code (NDC) number. We
have received several inquiries about
how the requirements apply to specific
products or circumstances. The purpose
of the guidance is to respond to the
questions.
FDA is announcing the availability of
a guidance for industry entitled ‘‘Bar
Code Label Requirements—Questions
and Answers.’’ In the Federal Register
of February 26, 2004 (69 FR 9120), FDA
issued a final rule that requires certain
human drug and biological product
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Agencies
[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Notices]
[Pages 24855-24856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Injury Prevention and Control Initial Review
Group
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) announce the following meeting:
Name: National Center for Injury Prevention and Control (NCIPC)
Initial Review Group (IRG)
Times and Dates: 10 a.m.-10:30 p.m., May 23, 2006. 8 a.m.-6:30
p.m., May 24, 2006. 8:30 a.m.-6 p.m., May 25, 2006.
Place: Doubletree Club Atlanta Airport, 3400 Norman Berry Drive,
Atlanta, GA 30344.
Status: Open: 10 a.m.-11 a.m., May 23, 2006, Closed: 11 a.m.-
10:30 p.m., May 23, 2006, Closed: 8 a.m.-6:30 p.m., May 24, 2006,
Closed: 8:30 a.m.-6 p.m., May 25, 2006.
Purpose: This group is charged with providing advice and
guidance to the Secretary, Department of Health and Human Services
and the Director, CDC, concerning the scientific and technical merit
of grant and cooperative agreement applications received from
academic institutions and other public and private profit and
nonprofit organizations, including State and local government
agencies, to conduct specific injury research that focuses on
prevention and control.
Matters to be Discussed: Agenda items include an overview of the
injury program, discussion of the review process and panelists'
responsibilities, and the review of and vote on applications.
Beginning at 11 a.m., May 23, through 6 p.m., May 25, the Group will
review individual research grant and cooperative agreement
applications submitted in response to two Fiscal Year 2006 Requests
for Applications related to the following individual research
announcements: 06008, Urban Partnership Academic Center of
Excellent and 06006, Parenting Programs in the Prevention
of Child Maltreatment. This portion of the meeting will be closed to
the public in accordance with provisions set forth in
[[Page 24856]]
section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination
of the Director, Management Analysis and Services Office, CDC,
pursuant to section 10(d) of Public Law 92-463.
Agenda items are subject to change as priorities dictate.
For Further Information Contact: Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Executive Secretary, NCIPC IRG, CDC, 4770 Buford Highway,
NE., M/S K02, Atlanta, Georgia 30341-3724, telephone (770) 488-1430.
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: April 20, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E6-6349 Filed 4-26-06; 8:45 am]
BILLING CODE 4163-18-P