[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