51034 Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 

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 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 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 (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 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 

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 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, 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices 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-thescience 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Designation of a Class of Employees 

for Addition to the Special Exposure 

Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: 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: 

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 

[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 

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, 


Emcdonald on DSK2BSOYB1PROD with NOTICES