[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51034-51035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20958]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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.

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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: (919) 541-0295, or 
[email protected]. 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: 919-541-9834 or e-mail: [email protected]. 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, (919) 541-9834, [email protected].

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,

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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.
[FR Doc. 2011-20958 Filed 8-16-11; 8:45 am]
BILLING CODE 4140-01-P