Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Meeting, 28946 [05-9987]
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28946
Federal Register / Vol. 70, No. 96 / Thursday, May 19, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–0263]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Office of the Secretary.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of
proposed collections for public
comment. Interested persons are invited
to send comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
#1 Type of Information Collection
Request: Extension of Currently
Approved Collection;
Title of Information Collection:
Protection of Human Subjects
Assurance Identification/ Institutional
Review Board (IRB) Certification/
Declaration of Exemption;
Form/OMB No.: OS–0990–0263;
Use: The Federal Policy for the
Protection of Human Subjects, known as
the Common Rule, requires that before
engaging in non-exempt human subjects
research that is conducted or supported
by a Common Rule department or
agency, each institution must: (1) Hold
an applicable assurance of compliance
[Section 103(a)]; and (2) certify to the
awarding department or agency that the
application or proposal for research has
been reviewed and approved by an IRB
designated in the assurance [Sections
103(b) and (f)].
Frequency: Reporting on occasion;
Affected Public: Federal, State, local,
or tribal governments, business or other
for-profit, not-for-profit institutions and
individuals or households;
Annual Number of Respondents:
5,000; Total Annual Responses: 166,667;
Average Burden per Response: 0.25
hours;
Total Annual Hours: 41,667;
To obtain copies of the supporting
statement and any related forms for the
AGENCY:
VerDate jul<14>2003
22:14 May 18, 2005
Jkt 205001
proposed paperwork collections
referenced above, access the HHS Web
site address at https://www.hhs.gov/
oirm/infocollect/pending/ or e-mail your
request, including your address, phone
number, OMB number, and OS
document identifier, to
naomi.cook@hhs.gov, or call the Reports
Clearance Office on (202) 690–6162.
Written comments and
recommendations for the proposed
information collections must be mailed
within 60 days of this notice directly to
the OS Paperwork Clearance Officer
designated at the following address:
Department of Health and Human
Services, Office of the Secretary,
Assistant Secretary for Budget,
Technology, and Finance, Office of
Information and Resource Management,
Attention: Naomi Cook (0990–0263),
Room 531–H, 200 Independence
Avenue, SW., Washington, DC 20201.
Dated: May 11, 2005.
Robert E. Polson,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 05–10004 Filed 5–18–05; 8:45 am]
BILLING CODE 4168–17–P
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): 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 (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Antimalarial Drug Resistance
and Prevention of Malaria During Pregnancy
CI05–061, Linkage of International
Collaboration and Research Programs for
Prevention and Control of Malaria, CI–05–
062 and Comparisons of Community with
Facility Management of Malaria and
Pneumonia in Rural Tanzania, CI05–064.
Times and Dates: 1 p.m.–3:30 p.m., June
15, 2005 (Closed).
Place: Teleconference.
Status: Portions of the meeting will be
closed to the public in accordance with
provisions set forth in 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 Pub. L. 92–
463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to: Preventing Maternal and
Neonatal Bacterial Infections in Developing
Frm 00046
Fmt 4703
Dated: May 12, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–9987 Filed 5–18–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Settings with a High Prevalence of HIV:
Antimalarial Drug Resistance and Prevention
of Malaria During Pregnancy CI05–061,
Linkage of International Collaboration and
Research Programs for Prevention and
Control of Malaria, CI–05–062 and
Comparisons of Community with Facility
Management of Malaria and Pneumonia in
Rural Tanzania, CI05–064.
FOR FURTHER INFORMATION
CONTACT: Trudy Messmer, Ph.D., Scientific
Review Administrator, National Center for
Infectious Diseases, CDC, 1600 Clifton Road
NE., Mailstop C19, Atlanta, GA 30333,
Telephone (404) 639–3770.
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.
Sfmt 4703
Food and Drug Administration
[Docket No. 2002D–0389] (formerly 02D–
0389)
Guidance for Industry on Nonclinical
Studies for the Safety Evaluation of
Pharmaceutical Excipients; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Nonclinical Studies for the
Safety Evaluation of Pharmaceutical
Excipients.’’ This document is intended
to provide guidance on the types of
toxicity information that FDA
recommends be provided to the agency
to support the use of new excipients in
drug products. Previously, such
information was not available to drug
sponsors in a written document. This
information should allow drug sponsors
to determine if a potential new
excipient is safe to use in drug products.
DATES: Submit written or electronic
comments on agency guidances at any
time.
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
ADDRESSES:
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 70, Number 96 (Thursday, May 19, 2005)]
[Notices]
[Page 28946]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9987]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): 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 (CDC) announces the following meeting:
Name: Disease, Disability, and Injury Prevention and Control
Special Emphasis Panel (SEP): Antimalarial Drug Resistance and
Prevention of Malaria During Pregnancy CI05-061, Linkage of
International Collaboration and Research Programs for Prevention and
Control of Malaria, CI-05-062 and Comparisons of Community with
Facility Management of Malaria and Pneumonia in Rural Tanzania,
CI05-064.
Times and Dates: 1 p.m.-3:30 p.m., June 15, 2005 (Closed).
Place: Teleconference.
Status: Portions of the meeting will be closed to the public in
accordance with provisions set forth in 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 Pub. L. 92-463.
Matters To Be Discussed: The meeting will include the review,
discussion, and evaluation of applications received in response to:
Preventing Maternal and Neonatal Bacterial Infections in Developing
Settings with a High Prevalence of HIV: Antimalarial Drug Resistance
and Prevention of Malaria During Pregnancy CI05-061, Linkage of
International Collaboration and Research Programs for Prevention and
Control of Malaria, CI-05-062 and Comparisons of Community with
Facility Management of Malaria and Pneumonia in Rural Tanzania,
CI05-064.
FOR FURTHER INFORMATION CONTACT: Trudy Messmer, Ph.D.,
Scientific Review Administrator, National Center for Infectious
Diseases, CDC, 1600 Clifton Road NE., Mailstop C19, Atlanta, GA
30333, Telephone (404) 639-3770.
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: May 12, 2005.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 05-9987 Filed 5-18-05; 8:45 am]
BILLING CODE 4163-18-P
