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Evaluation of the Potential Developmental Effects of Cancer Chemotherapy During Pregnancy: Call for Information and Nomination of Scientific Experts

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Information about this document as published in the Federal Register.

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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 (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 howdeshellkl@niehs.nih.gov (email). Courier address: NIEHS, 530 Davis Drive, Room K2161, Morrisville, NC 27560.

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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 Start Printed Page 21369environmental 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).

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Dated: April 7, 2011.

John R. Bucher,

Associate Director, National Toxicology Program.

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[FR Doc. 2011-9182 Filed 4-14-11; 8:45 am]

BILLING CODE 4140-01-P