2011-20958. Availability of Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy; Request for Comments; Announcement of a Panel Meeting To Peer Review Draft Monograph

AGENCY:

Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health.

ACTION:

Availability of Draft Monograph; Request for Comments; Announcement of a Peer Review Panel Meeting.

SUMMARY:

The NTP announces the availability of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy (available at http://ntp.niehs.nih.gov/​go/​36639) that will be peer reviewed by an NTP Peer Review Panel at a meeting on October 19-20, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft monograph (see Request for Comments below).

DATES:

The meeting to peer review the draft NTP monograph will be held on October 19-20, 2011. The draft NTP monograph should be available for public comment by September 9, 2011. The deadline to submit written comments is October 5, 2011, and the deadline for pre-registration to attend the meeting and/or provide oral comments is October 12, 2011.

ADDRESSES:

The meeting will be held at the Rodbell Auditorium, Rall Building, NIEHS, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709. Public comments and any other correspondence on the draft monograph should be sent to Dr. Lori White, NIEHS, P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709, Fax: [phone], or [e-mail]. Courier address: 530 Davis Drive, Room 2136, Morrisville, NC 27560. Individuals with disabilities who need accommodation to participate in this event should contact Dr. White at voice telephone: [phone] or e-mail: [e-mail]. TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at least five business days in advance of the event.

FOR FURTHER INFORMATION CONTACT:

Dr. Lori White, NTP Designated Federal Officer, [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The panel will peer review the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy, which has been prepared by the NTP Office of Health Assessment and Translation (OHAT, formerly the Center for the Evaluation of Risks to Human Reproduction [CERHR]). Cancer during pregnancy affects 1/1000 to 1/6000 women per year and treatment for cancer frequently involves chemotherapy. The majority of the reviews of pregnancy outcomes in the medical literature have focused on a specific cancer type or a particular agent. Therefore, OHAT has prepared a comprehensive survey of the literature that reviews pregnancy outcomes and follow-up evaluations, when available, of conceptuses exposed to cancer chemotherapy in utero. The main body of this document includes the published human data for over 40 different cancer chemotherapy drugs in tables, and it presents a summary of the human developmental effects as well as background information on mechanism of action, placental and breast milk transport, and laboratory animal developmental toxicology for the more frequently used agents in accompanying text. This 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.

Preliminary Agenda and Availability of Meeting Materials

The preliminary agenda and draft monograph should be posted on the NTP Web site by September 9, 2011. Any additional information, when available, will be posted on the NTP Web site (http://ntp.niehs.nih.gov/​go/​36639) or may be requested in hardcopy from the Designated Federal Officer (see ADDRESSES above). Following the meeting, a report of the peer review will be prepared and made available on the NTP Web site.

Attendance and Registration

The meeting is scheduled for October 19, from 8:30 a.m. Eastern Daylight Time to 5 p.m., and October 20, from 8:30 a.m. until adjournment. The meeting is open to the public with attendance limited only by the space available. Individuals who plan to attend are encouraged to register online at the NTP Web site (http://ntp.niehs.nih.gov/​go/​36639) by October 12, 2011, to facilitate access to the NIEHS campus. A photo ID is required to access the NIEHS campus. The NTP is making plans to webcast the meeting at http://www.niehs.nih.gov/​news/​video/​live. Registered attendees are encouraged to access the meeting page to stay abreast of the most current information regarding the meeting.

Request for Comments

The NTP invites written comments on the draft monograph, which should be received by October 5, 2011, to enable review by the panel and NTP staff prior to the meeting. Persons submitting written comments should include their name, affiliation, mailing address, phone, email, and sponsoring organization (if any) with the document. Written comments received in response to this notice will be posted on the NTP Web site, and the submitter will be identified by name, affiliation, and/or sponsoring organization.

Public input at this meeting is also invited, and time is set aside for the presentation of oral comments on the draft monograph. In addition to in-person oral comments at the meeting at the NIEHS, public comments can be presented by teleconference line. There will be 50 lines for this call; availability will be on a first-come, first-served basis. The available lines will be open from 8:30 a.m. until 5 p.m. on October 19 and from 8:30 until adjournment on October 20, although public comments will be received only during the formal public comment periods indicated on the preliminary agenda. Each organization is allowed one time slot. At least 7 minutes will be allotted to each speaker, and if time permits, may be extended to 10 minutes at the discretion of the chair. Persons wishing to make an oral presentation are asked to notify Dr. Lori White via online registration at http://ntp.niehs.nih.gov/​go/​36639, phone, or email (see ADDRESSES above) by October 12, 2011, and if possible, to send a copy of their slides and/or statement or talking points at that time. Written statements can supplement and may expand the oral presentation. Registration for oral comments will also be available at the meeting, although time allowed for presentation by on-site registrants may be less than that for pre-registered speakers and will be determined by the number of persons who register on-site.

Background Information on OHAT and NTP Peer Review Panels

The NIEHS/NTP established OHAT to serve as an environmental health resource to the public and to regulatory and health agencies. This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as “substances”) cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels. Assessments of potential adverse effects of environmental substances on reproduction or development carried out by CERHR from 1998-2010 are now conducted by OHAT. OHAT also organizes workshops or state-of-the-science evaluations to address issues of importance in environmental health sciences. OHAT assessments are published as NTP Monographs. Information about OHAT is found http://ntp.niehs.nih.gov/​go/​ohat.

NTP panels are technical, scientific advisory bodies established on an “as needed” basis to provide independent scientific peer review and advise the NTP on agents of public health concern, new/revised toxicological test methods, or other issues. These panels help ensure transparent, unbiased, and scientifically rigorous input to the program for its use in making credible decisions about human hazard, setting research and testing priorities, and providing information to regulatory agencies about alternative methods for toxicity screening. The NTP welcomes nominations of scientific experts for upcoming panels. Scientists interested in serving on an NTP panel should provide a current curriculum vitae to Dr. Lori White (see ADDRESSES). The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service (PHS) Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

Dated: August 8, 2011.

John R. Bucher,

Associate Director, National Toxicology Program.