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, 51034-51035 [2011-20958]

Download as PDF 51034 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices Background 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 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. AGENCY: The NTP announces the availability of the Draft NTP Monograph on Potential Developmental Effects of Cancer Chemotherapy During Pregnancy (available at https://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 whiteld@niehs.nih.gov. 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: whiteld@niehs.nih.gov. 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, whiteld@niehs.nih.gov. Emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:13 Aug 16, 2011 Jkt 223001 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 (https://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 (https:// ntp.niehs.nih.gov/go/36639) by October 12, 2011, to facilitate access to the NIEHS campus. A photo ID is required PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 to access the NIEHS campus. The NTP is making plans to webcast the meeting at https://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 inperson 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 https://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 preregistered 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, E:\FR\FM\17AUN1.SGM 17AUN1 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 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-thescience evaluations to address issues of importance in environmental health sciences. OHAT assessments are published as NTP Monographs. Information about OHAT is found https://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 Emcdonald on DSK2BSOYB1PROD with NOTICES Designation of a Class of Employees for Addition to the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS). AGENCY: Notice. VerDate Mar<15>2010 18:13 Aug 16, 2011 All employees of the Department of Energy, its predecessor agencies, and its contractors and subcontractors who worked in any area at the Sandia National Laboratories in Albuquerque, New Mexico, from January 1, 1949 through December 31, 1962, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort. This designation will become effective on September 9, 2011, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC. FOR FURTHER INFORMATION CONTACT: Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health (NIOSH), 4676 Columbia Parkway, MS C–46, Cincinnati, OH 45226, Telephone 877– 222–7570. Information requests can also be submitted by e-mail to DCAS@CDC.GOV. John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2011–20925 Filed 8–16–11; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: HHS gives notice of a decision to designate a class of employees from Sandia National Laboratories in Albuquerque, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 29, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC: SUMMARY: Jkt 223001 [60Day–11–08AJ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 51035 summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 or send comments to CDC Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns (OMB No. 0920–0800, exp. 1/31/2012)— Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The mission of the CDC’s Division of Cancer Prevention and Control (DCPC) is to reduce the burden of cancer in the United States through cancer prevention, reduction of risk, early detection, better treatment, and improved quality of life for cancer survivors. Toward this end, the DCPC supports the scientific development, implementation, and evaluation of various health communication campaigns with an emphasis on specific cancer burdens. This process requires testing of messages, concepts, and materials prior to their final development and dissemination, as described in the second step of the health communication process, a scientific model developed by the U.S. Department of Health and Human Services’ National Cancer Institute to guide sound campaign development. CDC is currently approved to collect information for these purposes (OMB No. 0920–0800, exp. 1/31/2012). A three-year extension of the existing generic approval is requested. The communication literature supports various data collection methods to conduct credible formative, E:\FR\FM\17AUN1.SGM 17AUN1

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



[[Page 51034]]

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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.

-----------------------------------------------------------------------

SUMMARY: The NTP announces the availability of the Draft NTP Monograph 
on Potential Developmental Effects of Cancer Chemotherapy During 
Pregnancy (available at https://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 
whiteld@niehs.nih.gov. 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: whiteld@niehs.nih.gov. 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, whiteld@niehs.nih.gov.

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 (https://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 (https://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 https://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 https://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,

[[Page 51035]]

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 https://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
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