Evaluation of the Potential Developmental Effects of Cancer Chemotherapy During Pregnancy: Call for Information and Nomination of Scientific Experts, 21368-21369 [2011-9182]
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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
Board of Governors of the Federal Reserve
System, April 12, 2011.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2011–9165 Filed 4–14–11; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Evaluation of the Potential
Developmental Effects of Cancer
Chemotherapy During Pregnancy: Call
for Information and Nomination of
Scientific Experts
National Institute of
Environmental Health Sciences
(NIEHS); National Toxicology Program;
National Institutes of Health (NIH),
HHS.
ACTION: Call for information and
nomination of scientific experts.
AGENCY:
CERHR is evaluating the
scientific evidence regarding the
potential developmental effects of
cancer chemotherapy during pregnancy.
CERHR invites the submission of
information about ongoing studies or
upcoming publications on the
pregnancy outcomes and long-term
health of offspring exposed to cancer
chemotherapy agents during pregnancy
and associated topics that might be
considered for inclusion in the
evaluation. CERHR also invites the
nomination of scientific experts to
potentially serve as technical advisors
in conducting the evaluation or as
members of an ad hoc expert panel to
be convened to peer review the draft
Monograph on Cancer Chemotherapy
during Pregnancy (see SUPPLEMENTARY
INFORMATION). The peer review meeting
is tentatively scheduled for August 29–
30, 2011 at the NIEHS. When set, the
date and location of the meeting will be
announced in the Federal Register and
posted on the CERHR Website (https://
cerhr.niehs.nih.gov). The peer review
meeting will be open to the public with
time scheduled for oral public
comment.
DATES: All information and nominations
should be received by May 16, 2011.
ADDRESSES: Information and
nominations may be submitted to Dr.
Kembra Howdeshell, CERHR, NTP,
NIEHS, P.O. Box 12233, MD K2–04,
Research Triangle Park, NC 27709
(mail), 919–316–4708 (telephone), or
howdeshellkl@niehs.nih.gov (email).
Courier address: NIEHS, 530 Davis
Drive, Room K2161, Morrisville, NC
27560.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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Background
A significant number of pregnant
women are diagnosed with cancer each
year. The frequency of such diagnoses is
difficult to determine, but has been
estimated to be between 1 in 1000 to 1
in 6000 pregnancies. Treatment for
cancer most often involves some form of
chemotherapy. The United States Food
and Drug Administration has
categorized nearly all chemotherapy
agents as Pregnancy Category D, i.e.,
investigational or post-marketing data
show risk to the fetus. The evidence for
risk for health effects from exposure to
the chemotherapeutic agents usually
comes from studies in laboratory
animals. The general medical opinion
on chemotherapy use during pregnancy
is that it should be avoided in the first
trimester and that treatment during the
second and third trimesters, with the
exception of a few chemotherapy agents,
presents minimal risk to the fetus.
While some reviews have been
published in the medical literature on
pregnancy outcomes following
chemotherapy during pregnancy, the
majority of these reviews focus on
specific cancer types or specific
chemotherapeutic agents. Thus, CERHR
proposes to conduct a comprehensive
survey of the literature and
systematically evaluate the scientific
evidence regarding the developmental
toxicity of cancer chemotherapy during
pregnancy in humans for the six most
frequently diagnosed cancers in
pregnant women, i.e., lymphoma,
leukemia, and cancers of the breast,
ovary, skin, and cervix. This review will
evaluate a large literature, including
more than 700 papers and
approximately 40 chemotherapeutic
agents, available on pregnancy
outcomes in humans following
chemotherapy. The CERHR evaluation
will include studies of individual, as
well as combinations of, chemotherapy
agents and the period of gestation in
which they are administered. The
document should provide clinicians,
patients, and researchers with a
comprehensive review of the incidence
and types of adverse effects observed in
humans exposed in utero to cancer
chemotherapy. While CERHR recognizes
that some chemotherapeutic agents are
also used to treat non-cancer health
conditions of pregnant women, the
focus of the proposed evaluation is on
cancer chemotherapy. The NTP Board of
Scientific Counselors (BSC) discussed
the CERHR evaluation of developmental
effects of cancer chemotherapy on June
21, 2010 (75 FR 21003). BSC meeting
minutes are available at https://
ntp.niehs.nih.gov/go/9741.
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Frm 00051
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Request for Information
CERHR invites the public and other
interested parties to submit information
on cancer chemotherapy during
pregnancy, including data on pregnancy
outcomes, long-term health reports of
human offspring, and laboratory animal
toxicology information from completed,
ongoing, or planned studies. This
information will be considered in
evaluating the potential developmental
effects of exposure to cancer
chemotherapy during pregnancy.
Information should be submitted to
CERHR (see ADDRESSES).
Request for Nomination of Scientific
Experts
CERHR invites nominations of
qualified scientists (i.e., basic scientists,
clinicians, and toxicologists) to serve as
technical advisors and/or as members of
an ad hoc expert panel to peer review
the draft NTP Monograph on Cancer
Chemotherapy during Pregnancy.
Scientists serving as technical advisors
or on the peer review panel should
represent a wide range of expertise
including, but not limited to:
developmental biology, developmental
toxicology, epidemiology, medicine
(e.g., obstetrics, oncology, and
pediatrics), neurotoxicology,
pharmacokinetics, reproductive
toxicology, renal toxicology, and
biostatistics. Technical advisors and
expert panel members should meet
criteria to serve as an expert including,
but not limited to, formal academic
training and experience in a relevant
scientific field, publications in peerreviewed journals, and membership in
relevant professional societies.
Nomination should include contact
information and current curriculum
vitae (if possible) and be forwarded to
CERHR (see ADDRESSES). Final selection
of individuals to serve on the peer
review panel will be made in
accordance with the Federal Advisory
Committee Act and Department of
Health and Human Services
implementing regulations. All technical
advisors and panel members serve as
individual experts and not as
representatives of their employers or
other organizations.
Background Information on CERHR
The NTP established CERHR in 1998
(63 FR 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. CERHR
publishes monographs that assess the
evidence regarding whether
E:\FR\FM\15APN1.SGM
15APN1
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
environmental chemicals, physical
substances, or mixtures (collectively
referred to as ‘‘substances’’) cause
adverse effects on reproduction and/or
development and provide opinion on
whether these substances are hazardous
for humans. Information about CERHR
can be obtained from its homepage
(https://cerhr.niehs.nih.gov).
Dated: April 7, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–9182 Filed 4–14–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues will
conduct its fifth meeting in May. At this
meeting, the Commission will discuss
the topic of Federal standards regarding
human subjects protection in Federally
funded scientific studies.
DATES: The meeting will take place
Wednesday, May 18, 2011, from 9 a.m.
to approximately 4:45 p.m., and
Thursday, May 19, 2011, from 9 a.m. to
approximately 1:15 p.m.
ADDRESSES: The Warwick New York
Hotel, 65 West 54th Street, New York,
NY 10019. Phone 212–247–2700.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues, 1425
New York Avenue, NW., Suite C–100,
Washington, DC 20005. Telephone:
202–233–3963. E-mail:
Hillary.Viers@bioethics.gov. Additional
information may be obtained at https://
www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given of the fifth
meeting of the Presidential Commission
for the Study of Bioethical Issues
(PCSBI). The meeting will be held from
9 a.m. to approximately 4:45 p.m. on
Wednesday, May 18, 2011, and from 9
a.m. to approximately 1:15 p.m. on
Thursday, May 19, 2011, at the Warwick
New York Hotel, New York, NY. The
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SUMMARY:
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meeting will be open to the public with
attendance limited to space available.
The meeting will also be webcast at
https://www.bioethics.gov.
Under authority of Executive Order
13521, dated November 24, 2009, the
President established PCSBI to serve as
a public forum and advise him on
bioethical issues generated by novel and
emerging research in biomedicine and
related areas of science and technology.
The Commission is charged to identify
and promote policies and practices that
assure ethically responsible conduct of
scientific research, healthcare delivery,
and technological innovation. In
undertaking these duties, the
Commission will examine specific
bioethical, legal, and social issues
related to potential scientific and
technological advances; examine
diverse perspectives and possibilities
for useful international collaboration on
these issues; and recommend legal,
regulatory, or policy actions as
appropriate.
The main agenda item for this fifth
meeting is to review Federal as well as
transnational standards of human
subjects protections in scientific studies
supported by the Federal government as
requested by President Obama on
November 24, 2010.
The draft meeting agenda and other
information about PCSBI, including
information about access to the webcast,
will be available at https://
www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it. There
will be a public comment session in the
afternoon on May 18, 2011. Individuals
who would like to provide public
comment at that time should notify
Esther Yoo by telephone at 202–233–
3960, or e-mail at
Esther.Yoo@bioethics.gov before May 9,
2011. To accommodate as many
speakers as possible the time for each
individual to speak may be limited. If
the number of individuals wishing to
speak is greater than can reasonably be
accommodated during the scheduled
meeting, the Commission may randomly
select speakers from among those who
register to speak.
Anyone planning to attend the
meeting who needs special assistance,
such as sign language interpretation or
other reasonable accommodations,
should also notify Esther Yoo (contact
information above) in advance of the
meeting. The Commission will make
every effort to accommodate persons
who need special assistance.
Written comments will also be
accepted and are especially welcome.
Please address written comments by e-
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21369
mail to info@bioethics.gov, or by mail to
the following address: Public
Commentary, Presidential Commission
for the Study of Bioethical Issues, 1425
New York Ave., NW, Suite C–100,
Washington, DC 20005. Comments will
be publicly available, including any
personally identifiable or confidential
business information that they contain.
Trade secrets should not be submitted.
Dated: April 6, 2011.
Valerie H. Bonham,
Executive Director, Presidential Commission
for the Study of Bioethical Issues.
[FR Doc. 2011–9123 Filed 4–14–11; 8:45 am]
BILLING CODE 4154–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10369]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) 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: New collection; Title of
Information Collection: Solicitation for
Applications: Community-based Care
Transitions Program; Use: The
Community-based Care Transitions
Program (CCTP) described in Section
3026 of the Affordable Care Act will run
for 5 years with a mandated start date
of January 1, 2011. This program
provides funding to community-based
organizations in partnership with acute
care hospitals for the provision of care
transition services delivered to high risk
AGENCY:
E:\FR\FM\15APN1.SGM
15APN1
]]>Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21368-21369]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9182]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Evaluation of the Potential Developmental Effects of Cancer
Chemotherapy During Pregnancy: Call for Information and Nomination of
Scientific Experts
AGENCY: National Institute of Environmental Health Sciences (NIEHS);
National Toxicology Program; National Institutes of Health (NIH), HHS.
ACTION: Call for information and nomination of scientific experts.
-----------------------------------------------------------------------
SUMMARY: CERHR is evaluating the scientific evidence regarding the
potential developmental effects of cancer chemotherapy during
pregnancy. CERHR invites the submission of information about ongoing
studies or upcoming publications on the pregnancy outcomes and long-
term health of offspring exposed to cancer chemotherapy agents during
pregnancy and associated topics that might be considered for inclusion
in the evaluation. CERHR also invites the nomination of scientific
experts to potentially serve as technical advisors in conducting the
evaluation or as members of an ad hoc expert panel to be convened to
peer review the draft Monograph on Cancer Chemotherapy during Pregnancy
(see SUPPLEMENTARY INFORMATION). The peer review meeting is tentatively
scheduled for August 29-30, 2011 at the NIEHS. When set, the date and
location of the meeting will be announced in the Federal Register and
posted on the CERHR Website (https://cerhr.niehs.nih.gov). The peer
review meeting will be open to the public with time scheduled for oral
public comment.
DATES: All information and nominations should be received by May 16,
2011.
ADDRESSES: Information and nominations may be submitted to Dr. Kembra
Howdeshell, CERHR, NTP, NIEHS, P.O. Box 12233, MD K2-04, Research
Triangle Park, NC 27709 (mail), 919-316-4708 (telephone), or
howdeshellkl@niehs.nih.gov (email). Courier address: NIEHS, 530 Davis
Drive, Room K2161, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
A significant number of pregnant women are diagnosed with cancer
each year. The frequency of such diagnoses is difficult to determine,
but has been estimated to be between 1 in 1000 to 1 in 6000
pregnancies. Treatment for cancer most often involves some form of
chemotherapy. The United States Food and Drug Administration has
categorized nearly all chemotherapy agents as Pregnancy Category D,
i.e., investigational or post-marketing data show risk to the fetus.
The evidence for risk for health effects from exposure to the
chemotherapeutic agents usually comes from studies in laboratory
animals. The general medical opinion on chemotherapy use during
pregnancy is that it should be avoided in the first trimester and that
treatment during the second and third trimesters, with the exception of
a few chemotherapy agents, presents minimal risk to the fetus.
While some reviews have been published in the medical literature on
pregnancy outcomes following chemotherapy during pregnancy, the
majority of these reviews focus on specific cancer types or specific
chemotherapeutic agents. Thus, CERHR proposes to conduct a
comprehensive survey of the literature and systematically evaluate the
scientific evidence regarding the developmental toxicity of cancer
chemotherapy during pregnancy in humans for the six most frequently
diagnosed cancers in pregnant women, i.e., lymphoma, leukemia, and
cancers of the breast, ovary, skin, and cervix. This review will
evaluate a large literature, including more than 700 papers and
approximately 40 chemotherapeutic agents, available on pregnancy
outcomes in humans following chemotherapy. The CERHR evaluation will
include studies of individual, as well as combinations of, chemotherapy
agents and the period of gestation in which they are administered. The
document should provide clinicians, patients, and researchers with a
comprehensive review of the incidence and types of adverse effects
observed in humans exposed in utero to cancer chemotherapy. While CERHR
recognizes that some chemotherapeutic agents are also used to treat
non-cancer health conditions of pregnant women, the focus of the
proposed evaluation is on cancer chemotherapy. The NTP Board of
Scientific Counselors (BSC) discussed the CERHR evaluation of
developmental effects of cancer chemotherapy on June 21, 2010 (75 FR
21003). BSC meeting minutes are available at https://ntp.niehs.nih.gov/go/9741.
Request for Information
CERHR invites the public and other interested parties to submit
information on cancer chemotherapy during pregnancy, including data on
pregnancy outcomes, long-term health reports of human offspring, and
laboratory animal toxicology information from completed, ongoing, or
planned studies. This information will be considered in evaluating the
potential developmental effects of exposure to cancer chemotherapy
during pregnancy. Information should be submitted to CERHR (see
ADDRESSES).
Request for Nomination of Scientific Experts
CERHR invites nominations of qualified scientists (i.e., basic
scientists, clinicians, and toxicologists) to serve as technical
advisors and/or as members of an ad hoc expert panel to peer review the
draft NTP Monograph on Cancer Chemotherapy during Pregnancy. Scientists
serving as technical advisors or on the peer review panel should
represent a wide range of expertise including, but not limited to:
developmental biology, developmental toxicology, epidemiology, medicine
(e.g., obstetrics, oncology, and pediatrics), neurotoxicology,
pharmacokinetics, reproductive toxicology, renal toxicology, and
biostatistics. Technical advisors and expert panel members should meet
criteria to serve as an expert including, but not limited to, formal
academic training and experience in a relevant scientific field,
publications in peer-reviewed journals, and membership in relevant
professional societies. Nomination should include contact information
and current curriculum vitae (if possible) and be forwarded to CERHR
(see ADDRESSES). Final selection of individuals to serve on the peer
review panel will be made in accordance with the Federal Advisory
Committee Act and Department of Health and Human Services implementing
regulations. All technical advisors and panel members serve as
individual experts and not as representatives of their employers or
other organizations.
Background Information on CERHR
The NTP established CERHR in 1998 (63 FR 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. CERHR publishes monographs
that assess the evidence regarding whether
[[Page 21369]]
environmental chemicals, physical substances, or mixtures (collectively
referred to as ``substances'') cause adverse effects on reproduction
and/or development and provide opinion on whether these substances are
hazardous for humans. Information about CERHR can be obtained from its
homepage (https://cerhr.niehs.nih.gov).
Dated: April 7, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-9182 Filed 4-14-11; 8:45 am]
BILLING CODE 4140-01-P
