[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48995-48997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft National Toxicology Program (NTP) Monograph on 
Developmental Effects and Pregnancy Outcomes Associated With Cancer 
Chemotherapy Use During Pregnancy; Request for Comments; Peer Review 
Panel Meeting

AGENCY: Division of the National Toxicology Program (DNTP), National

[[Page 48996]]

Institute of Environmental Health Sciences (NIEHS), National Institutes 
of Health.

ACTION: Notice.

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DATES: The peer review meeting will take place October 1, 2012, 1:00 to 
5:00 p.m. Eastern Daylight Time (EDT) and October 2, 2012, from 8:30 
a.m. until adjournment, approximately 5 p.m. Two days are set aside for 
the meeting; however, it may adjourn sooner if the panel completes its 
peer review of the draft monograph.
    Topic: Peer review of the draft NTP Monograph on Developmental 
Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use 
during Pregnancy (available by August 14, 2012, at http://ntp.niehs.nih.gov/go/36639).
    Place: Rodbell Auditorium, Rall Building, NIEHS, 111 T.W. Alexander 
Drive, Research Triangle Park, NC 27709. The meeting is open to the 
public with attendance limited only by the space available. Webcast of 
the meeting will be available at http://www.niehs.nih.gov/news/video/index.cfm.
    Contact Person: Dr. Mary S. Wolfe, NTP Designated Federal Official, 
Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD 
K2-03, Research Triangle Park, NC 27709, Phone: (919) 541-7539, Fax: 
(919) 541-0295, or [email protected]. Courier address: 530 Davis 
Drive, Room 2142, Morrisville, NC 27560.
    Request for Comments and Registration: The meeting is open to the 
public with time scheduled for oral public comment. The NTP also 
invites written comments on the draft monograph, submission deadline is 
September 14, 2012, and the deadline for pre-registration to attend the 
meeting and/or provide oral comments is September 24, 2012, online 
registration is available at http://ntp.niehs.nih.gov/go/36639. Visitor 
and security information is available at http://www.niehs.nih.gov/about/visiting/index.cfm. Public comments and any other correspondence 
on the draft monograph should be sent to the Contact Person. 
Individuals with disabilities who need accommodation to participate in 
this event should contact Danica Andrews at phone: (919) 541-2595 or 
email: [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.

SUPPLEMENTARY INFORMATION:

Background

    The panel will peer review the Draft NTP Monograph on Developmental 
Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use 
during Pregnancy, prepared by the Office of Health Assessment and 
Translation (OHAT), DNTP. Cancer diagnosed during pregnancy affects 
approximately 1/6000 to 1/1000 women. Treatment for cancer frequently 
involves chemotherapy, and nearly all chemotherapeutic agents are known 
developmental toxicants in laboratory animals. OHAT has prepared a 
comprehensive draft NTP Monograph that summarizes the effects on 
development and pregnancy outcomes of gestational exposure to 52 cancer 
chemotherapeutic agents, individually and/or in combination therapy as 
reported in the peer-reviewed literature. The draft monograph also 
provides information on seven frequently diagnosed cancers in pregnant 
women and on mechanism of action, placental and breast milk transport, 
and laboratory animal developmental toxicology for the more frequently 
used chemotherapeutic agents. The overall goal of the monograph is to 
serve as a resource for the medical communities and their patients.

Preliminary Topic and Availability of Meeting Materials

    The preliminary agenda and draft monograph should be posted on the 
NTP Web site (http://ntp.niehs.nih.gov/go/36639) by August 14, 2012. 
Additional information, when available, will be posted on the NTP Web 
site or may be requested in hardcopy from the Contact Person. Following 
the meeting, a report of the peer review will be prepared and made 
available on the NTP Web site. 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 September 14, 2012, to enable review by the peer 
review 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 1-5 p.m. EDT on October 1 
and from 8:30 until adjournment on October 2, although oral comments 
will be received only during the formal public comment period 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 register 
online at http://ntp.niehs.nih.gov/go/36639 by September 24, 2012, 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/DNTP 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. 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 at 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

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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 the Contact Person. 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, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-20044 Filed 8-14-12; 8:45 am]
BILLING CODE 4140-01-P