[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21368-21369]
From the Federal Register Online via the Government Publishing 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.
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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 (http://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
[email protected] (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 http://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 (http://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