National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Hydroxyurea Expert Panel Report; Request for Public Comment, 8384-8385 [E7-3151]
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8384
Federal Register / Vol. 72, No. 37 / Monday, February 26, 2007 / Notices
Form/OMB No.: 0990–
Use: The ‘‘Understanding Barriers and
Successful Strategies for Faith-Based
Organizations in Accessing Grants’’
study aims to complement internal
Health and Human Services (HHS)
efforts to provide equal access to federal
discretionary grants for faith-based
organizations by collecting information
directly from such organizations on
their experiences applying for federal
grants.
Frequency: Single time.
Affected Public: Not-for-profit
institutions.
Annual Number of Respondents: 290.
Total Annual Responses: 290.
Average Burden per Response: 35.3
minutes.
Total Annual Hours: 170.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be
received with 60 days, and directed to
the OS Paperwork Clearance Officer at
the following address: Department of
Health and Human Services, Office of
the Secretary, Assistant Secretary for
Resources and Technology, Office of
Resources Management, Attention:
Sherrette Funn-Coleman (0990–NEW),
Room 537–H, 200 Independence
Avenue, SW., Washington, DC 20201.
Dated: February 15, 2007.
Alice Bettencourt,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E7–3175 Filed 2–23–07; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–0243] [60day notice]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Office of the Secretary, HHS.
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 a
proposed collection for public
ycherry on PROD1PC64 with NOTICES
AGENCY:
VerDate Aug<31>2005
16:03 Feb 23, 2007
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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.
Type of Information Collection
Request: Extension.
Title of Information Collection: OCR
Pre-grant Data Request Form.
Form/OMB No.: 0990–0243.
Use: The form is designed to collect
data from health care providers who
have requested certification to
participate in the Medicare program.
This civil rights compliance
determination is an essential component
of HHS’ decision to grant or deny
certification and must be made prior to
the Department’s final notification of its
decision to the provider.
Frequency: Recordkeeping single
time.
Affected Public: Business or other forprofit.
Annual Number of Respondents:
3,500.
Total Annual Responses: 3,500.
Average Burden per Response: 15
hours.
Total Annual Hours: 52,500.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be
received with 60-days, and directed to
the OS Paperwork Clearance Officer at
the following address: Department of
Health and Human Services, Office of
the Secretary, Assistant Secretary for
Resources and Technology, Office of
Resources Management, Attention:
Sherrette Funn-Coleman (0990–0243),
Room 537–H, 200 Independence
Avenue, SW., Washington DC 20201.
Dated: February 15, 2007.
Alice Bettencourt,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E7–3177 Filed 2–23–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Announcement of the Availability of
the Hydroxyurea Expert Panel Report;
Request for Public Comment
National Institute of
Environmental Health Sciences;
National Institutes of Health, HHS.
ACTION: Request for comment.
AGENCY:
SUMMARY: CERHR announces
availability of the hydroxyurea expert
panel report by March 5, 2007 on the
CERHR Web site (https://
cerhr.niehs.nih.gov) or in print from
CERHR (see ‘‘ADDRESSES’’ below). This
expert panel report is an evaluation of
the reproductive and developmental
toxicity of hydroxyurea conducted by a
13-member expert panel composed of
scientists from the Federal Government,
universities, and private organizations.
CERHR invites the submission of public
comments on this expert panel report.
DATES: The final hydroxyurea expert
panel report will be available by March
5, 2007, and written public comments
on this report should be received by
April 18, 2007.
ADDRESSES: Public comments and any
other correspondence should be sent to
Dr. Michael D. Shelby, CERHR Director,
NIEHS, P.O. Box 12233, MD EC–32,
Research Triangle Park, NC 27709
(mail), (919) 316–4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander
Drive, Building 4401, Room 103,
Research Triangle Park, NC 27709.
SUPPLEMENTARY INFORMATION:
Background
Hydroxyurea is used in the treatment
of cancer, sickle cell disease, and
thalassemia. It is the only treatment for
sickle cell disease used in children
aside from blood transfusion.
Hydroxyurea may be used in the
treatment of children and adults with
sickle cell disease for an extended
period of time or for repeated cycles of
therapy. Treatment with hydroxyurea
may be associated with cytotoxic and
myelosuppressive effects and
hydroxyurea is mutagenic. Hydroxyurea
is FDA-approved for reducing the
frequency of painful crises and the need
for blood transfusions in adults with
sickle cell anemia who experience
recurrent moderate to severe crises.
CERHR selected hydroxyurea for expert
panel evaluation because of (1)
increasing use in the treatment of sickle
cell disease in children and adults, (2)
E:\FR\FM\26FEN1.SGM
26FEN1
Federal Register / Vol. 72, No. 37 / Monday, February 26, 2007 / Notices
knowledge that it inhibits DNA
synthesis and is cytotoxic, and (3)
published evidence of reproductive and
developmental toxicity in rodents.
The CERHR convened an expert panel
on January 24–26, 2007, to review and
revise the draft expert panel report and
reach conclusions regarding whether
exposure to hydroxyurea is a hazard to
human development or reproduction.
The expert panel also identified data
gaps and research needs. Prior to the
meeting, CERHR solicited public
comment on the draft expert panel
report (Federal Register Vol. 71, No. 199
pp. 60746–60748).
Following receipt of public comments
on the hydroxyurea expert panel report,
CERHR staff will prepare the NTP–
CERHR monograph. NTP–CERHR
monographs are divided into four major
sections: (1) The NTP Brief which
provides the NTP’s interpretation of the
potential for the chemical to cause
adverse reproductive and/or
developmental effects in exposed
humans, (2) a roster of expert panel
members, (3) the final expert panel
report, and (4) public comments
received on that report. The NTP Brief
is based on the expert panel report,
public comments on that report, public
and peer review comments on the draft
NTP Brief, and any new information
that became available after the expert
panel meeting.
ycherry on PROD1PC64 with NOTICES
Request for Comments
CERHR invites written public
comments on the hydroxyurea expert
panel report. Written comments should
be sent to Dr. Michael Shelby at the
address provided above. Persons
submitting written comments are asked
to include their name and contact
information (affiliation, mailing address,
telephone and facsimile numbers, email, and sponsoring organization, if
any). All comments received will be
posted on the CERHR website and will
be included in the NTP–CERHR
monograph on hydroxyurea. The NTP
will consider all public comments
during preparation of the NTP Brief.
Background Information on CERHR
The NTP established CERHR in June
1998 [Federal Register, December 14,
1998 (Vol. 63, No. 239, pp. 68782)].
CERHR is a publicly accessible resource
for information about adverse
reproductive and/or developmental
health effects associated with exposure
to environmental and/or occupational
exposures. Expert panels conduct
scientific evaluations of agents selected
by CERHR in public forums.
CERHR invites the nomination of
agents for review or scientists for its
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16:03 Feb 23, 2007
Jkt 211001
expert registry. Information about
CERHR and the nomination process can
be obtained from its Web site (https://
cerhr.niehs.nih.gov) or by contacting Dr.
Shelby (see ADDRESSES above). CERHR
selects chemicals for evaluation based
upon several factors including
production volume, potential for human
exposure from use and occurrence in
the environment, extent of public
concern, and extent of data from
reproductive and developmental
toxicity studies.
CERHR follows a formal, multi-step
process for review and evaluation of
selected chemicals. The formal
evaluation process was published in the
Federal Register notice July 16, 2001
(Vol. 66, No. 136, pp 37047–37048) and
is available on the CERHR Web site
under ‘‘About CERHR’’ or in printed
copy from CERHR.
Dated: February 12, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–3151 Filed 2–23–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–07–0274]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Joan Karr, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
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8385
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
CDC Model Performance Evaluation
Program (MPEP) (0920–0274)—
Revision—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (proposed)
(NCPDCID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is requesting OMB approval of a
revision to its data collection, the CDC
Model Performance Evaluation Program
(MPEP). CDC originally implemented
MPEP in 1986 to evaluate the
performance of laboratories conducting
testing to detect human
immunodeficiency virus type 1 (HIV–1)
antibody (Ab). CDC is requesting a 3year approval for this data collection.
In this program, respondents receive 2
shipments of specimens per year.
Respondents test the specimens in their
laboratory/testing site and report their
results either using a report booklet or
on-line. CDC provides the respondent
with a report containing the analysis of
the laboratory test results reported to
CDC. Participation in this program is
voluntary and provides the respondents
an opportunity to (1) assure accurate
tests are being provided by the
laboratory/testing site through external
quality assessment; (2) improve testing
quality through self-evaluation in a
nonregulatory environment; (3) test well
characterized samples from a source
outside the test kit manufacturer; (4)
discover potential testing problems so
that procedures can be adjusted to
eliminate them; (5) compare of testing
results with others at a national and
international level; and (6) consult with
CDC staff to discuss testing issues.
In this request, CDC proposes to make
the following revisions to the currently
approved data collection:
• Addition of a Name and Address
change form to report changes for the
MPEP manager and coordinator at the
respondent laboratory;
• Inclusion of additional test kit
manufacturers approved by the FDA
since previous OMB approval; and
• Elimination of reporting HIV–1
RNA Viral Load and CD4+ T-cell
determinations.
All respondents are MPEP affiliated
laboratories.
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]]>Agencies
[Federal Register Volume 72, Number 37 (Monday, February 26, 2007)]
[Notices]
[Pages 8384-8385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Announcement of the Availability
of the Hydroxyurea Expert Panel Report; Request for Public Comment
AGENCY: National Institute of Environmental Health Sciences; National
Institutes of Health, HHS.
ACTION: Request for comment.
-----------------------------------------------------------------------
SUMMARY: CERHR announces availability of the hydroxyurea expert panel
report by March 5, 2007 on the CERHR Web site (https://
cerhr.niehs.nih.gov) or in print from CERHR (see ``ADDRESSES'' below).
This expert panel report is an evaluation of the reproductive and
developmental toxicity of hydroxyurea conducted by a 13-member expert
panel composed of scientists from the Federal Government, universities,
and private organizations. CERHR invites the submission of public
comments on this expert panel report.
DATES: The final hydroxyurea expert panel report will be available by
March 5, 2007, and written public comments on this report should be
received by April 18, 2007.
ADDRESSES: Public comments and any other correspondence should be sent
to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-
32, Research Triangle Park, NC 27709 (mail), (919) 316-4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W.
Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
Hydroxyurea is used in the treatment of cancer, sickle cell
disease, and thalassemia. It is the only treatment for sickle cell
disease used in children aside from blood transfusion. Hydroxyurea may
be used in the treatment of children and adults with sickle cell
disease for an extended period of time or for repeated cycles of
therapy. Treatment with hydroxyurea may be associated with cytotoxic
and myelosuppressive effects and hydroxyurea is mutagenic. Hydroxyurea
is FDA-approved for reducing the frequency of painful crises and the
need for blood transfusions in adults with sickle cell anemia who
experience recurrent moderate to severe crises. CERHR selected
hydroxyurea for expert panel evaluation because of (1) increasing use
in the treatment of sickle cell disease in children and adults, (2)
[[Page 8385]]
knowledge that it inhibits DNA synthesis and is cytotoxic, and (3)
published evidence of reproductive and developmental toxicity in
rodents.
The CERHR convened an expert panel on January 24-26, 2007, to
review and revise the draft expert panel report and reach conclusions
regarding whether exposure to hydroxyurea is a hazard to human
development or reproduction. The expert panel also identified data gaps
and research needs. Prior to the meeting, CERHR solicited public
comment on the draft expert panel report (Federal Register Vol. 71, No.
199 pp. 60746-60748).
Following receipt of public comments on the hydroxyurea expert
panel report, CERHR staff will prepare the NTP-CERHR monograph. NTP-
CERHR monographs are divided into four major sections: (1) The NTP
Brief which provides the NTP's interpretation of the potential for the
chemical to cause adverse reproductive and/or developmental effects in
exposed humans, (2) a roster of expert panel members, (3) the final
expert panel report, and (4) public comments received on that report.
The NTP Brief is based on the expert panel report, public comments on
that report, public and peer review comments on the draft NTP Brief,
and any new information that became available after the expert panel
meeting.
Request for Comments
CERHR invites written public comments on the hydroxyurea expert
panel report. Written comments should be sent to Dr. Michael Shelby at
the address provided above. Persons submitting written comments are
asked to include their name and contact information (affiliation,
mailing address, telephone and facsimile numbers, e-mail, and
sponsoring organization, if any). All comments received will be posted
on the CERHR website and will be included in the NTP-CERHR monograph on
hydroxyurea. The NTP will consider all public comments during
preparation of the NTP Brief.
Background Information on CERHR
The NTP established CERHR in June 1998 [Federal Register, December
14, 1998 (Vol. 63, No. 239, pp. 68782)]. CERHR is a publicly accessible
resource for information about adverse reproductive and/or
developmental health effects associated with exposure to environmental
and/or occupational exposures. Expert panels conduct scientific
evaluations of agents selected by CERHR in public forums.
CERHR invites the nomination of agents for review or scientists for
its expert registry. Information about CERHR and the nomination process
can be obtained from its Web site (https://cerhr.niehs.nih.gov) or by
contacting Dr. Shelby (see ADDRESSES above). CERHR selects chemicals
for evaluation based upon several factors including production volume,
potential for human exposure from use and occurrence in the
environment, extent of public concern, and extent of data from
reproductive and developmental toxicity studies.
CERHR follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process was
published in the Federal Register notice July 16, 2001 (Vol. 66, No.
136, pp 37047-37048) and is available on the CERHR Web site under
``About CERHR'' or in printed copy from CERHR.
Dated: February 12, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-3151 Filed 2-23-07; 8:45 am]
BILLING CODE 4140-01-P
