21368 Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 

Board of Governors of the Federal Reserve 

System, April 12, 2011. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2011–9165 Filed 4–14–11; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Evaluation of the Potential 

Developmental Effects of Cancer 

Chemotherapy During Pregnancy: Call 

for Information and Nomination of 

Scientific Experts 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS); National Toxicology Program; 

National Institutes of Health (NIH), 

HHS. 

ACTION: Call for information and 

nomination of scientific experts. 

SUMMARY: CERHR is evaluating the 

scientific evidence regarding the 

potential developmental effects of 

cancer chemotherapy during pregnancy. 

CERHR invites the submission of 

information about ongoing studies or 

upcoming publications on the 

pregnancy outcomes and long-term 

health of offspring exposed to cancer 

chemotherapy agents during pregnancy 

and associated topics that might be 

considered for inclusion in the 

evaluation. CERHR also invites the 

nomination of scientific experts to 

potentially serve as technical advisors 

in conducting the evaluation or as 

members of an ad hoc expert panel to 

be convened to peer review the draft 

Monograph on Cancer Chemotherapy 

during Pregnancy (see SUPPLEMENTARY

INFORMATION). The peer review meeting 

is tentatively scheduled for August 29– 

30, 2011 at the NIEHS. When set, the 

date and location of the meeting will be 

announced in the Federal Register and 

posted on the CERHR Website (http:// 

cerhr.niehs.nih.gov). The peer review 

meeting will be open to the public with 

time scheduled for oral public 

comment. 

DATES: All information and nominations 

should be received by May 16, 2011. 

ADDRESSES: Information and 

nominations may be submitted to Dr. 

Kembra Howdeshell, CERHR, NTP, 

NIEHS, P.O. Box 12233, MD K2–04, 

Research Triangle Park, NC 27709 

(mail), 919–316–4708 (telephone), or 

howdeshellkl@niehs.nih.gov (email). 

Courier address: NIEHS, 530 Davis 

Drive, Room K2161, Morrisville, NC 

27560. 

SUPPLEMENTARY INFORMATION: 

Background 

A significant number of pregnant 

women are diagnosed with cancer each 

year. The frequency of such diagnoses is 

difficult to determine, but has been 

estimated to be between 1 in 1000 to 1 

in 6000 pregnancies. Treatment for 

cancer most often involves some form of 

chemotherapy. The United States Food 

and Drug Administration has 

categorized nearly all chemotherapy 

agents as Pregnancy Category D, i.e., 

investigational or post-marketing data 

show risk to the fetus. The evidence for 

risk for health effects from exposure to 

the chemotherapeutic agents usually 

comes from studies in laboratory 

animals. The general medical opinion 

on chemotherapy use during pregnancy 

is that it should be avoided in the first 

trimester and that treatment during the 

second and third trimesters, with the 

exception of a few chemotherapy agents, 

presents minimal risk to the fetus. 

While some reviews have been 

published in the medical literature on 

pregnancy outcomes following 

chemotherapy during pregnancy, the 

majority of these reviews focus on 

specific cancer types or specific 

chemotherapeutic agents. Thus, CERHR 

proposes to conduct a comprehensive 

survey of the literature and 

systematically evaluate the scientific 

evidence regarding the developmental 

toxicity of cancer chemotherapy during 

pregnancy in humans for the six most 

frequently diagnosed cancers in 

pregnant women, i.e., lymphoma, 

leukemia, and cancers of the breast, 

ovary, skin, and cervix. This review will 

evaluate a large literature, including 

more than 700 papers and 

approximately 40 chemotherapeutic 

agents, available on pregnancy 

outcomes in humans following 

chemotherapy. The CERHR evaluation 

will include studies of individual, as 

well as combinations of, chemotherapy 

agents and the period of gestation in 

which they are administered. The 

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. While CERHR recognizes 

that some chemotherapeutic agents are 

also used to treat non-cancer health 

conditions of pregnant women, the 

focus of the proposed evaluation is on 

cancer chemotherapy. The NTP Board of 

Scientific Counselors (BSC) discussed 

the CERHR evaluation of developmental 

effects of cancer chemotherapy on June 

21, 2010 (75 FR 21003). BSC meeting 

minutes are available at http:// 

ntp.niehs.nih.gov/go/9741. 

Request for Information 

CERHR invites the public and other 

interested parties to submit information 

on cancer chemotherapy during 

pregnancy, including data on pregnancy 

outcomes, long-term health reports of 

human offspring, and laboratory animal 

toxicology information from completed, 

ongoing, or planned studies. This 

information will be considered in 

evaluating the potential developmental 

effects of exposure to cancer 

chemotherapy during pregnancy. 

Information should be submitted to 

CERHR (see ADDRESSES). 

Request for Nomination of Scientific 

Experts 

CERHR invites nominations of 

qualified scientists (i.e., basic scientists, 

clinicians, and toxicologists) to serve as 

technical advisors and/or as members of 

an ad hoc expert panel to peer review 

the draft NTP Monograph on Cancer 

Chemotherapy during Pregnancy. 

Scientists serving as technical advisors 

or on the peer review panel should 

represent a wide range of expertise 

including, but not limited to: 

developmental biology, developmental 

toxicology, epidemiology, medicine 

(e.g., obstetrics, oncology, and 

pediatrics), neurotoxicology, 

pharmacokinetics, reproductive 

toxicology, renal toxicology, and 

biostatistics. Technical advisors and 

expert panel members should meet 

criteria to serve as an expert including, 

but not limited to, formal academic 

training and experience in a relevant 

scientific field, publications in peerreviewed journals, and membership in 

relevant professional societies. 

Nomination should include contact 

information and current curriculum 

vitae (if possible) and be forwarded to 

CERHR (see ADDRESSES). Final selection 

of individuals to serve on the peer 

review panel will be made in 

accordance with the Federal Advisory 

Committee Act and Department of 

Health and Human Services 

implementing regulations. All technical 

advisors and panel members serve as 

individual experts and not as 

representatives of their employers or 

other organizations. 

Background Information on CERHR 

The NTP established CERHR in 1998 

(63 FR 68782). CERHR is a publicly 

accessible resource for information 

about adverse reproductive and/or 

developmental health effects associated 

with exposure to environmental and/or 

occupational exposures. CERHR 

publishes monographs that assess the 

evidence regarding whether 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices 21369 

environmental chemicals, physical 

substances, or mixtures (collectively 

referred to as ‘‘substances’’) cause 

adverse effects on reproduction and/or 

development and provide opinion on 

whether these substances are hazardous 

for humans. Information about CERHR 

can be obtained from its homepage 

(http://cerhr.niehs.nih.gov). 

Dated: April 7, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–9182 Filed 4–14–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Meeting of the Presidential 

Commission for the Study of 

Bioethical Issues 

AGENCY: Presidential Commission for 

the Study of Bioethical Issues, Office of 

the Assistant Secretary for Health, 

Department of Health and Human 

Services. 

ACTION: Notice of meeting. 

SUMMARY: The Presidential Commission 

for the Study of Bioethical Issues will 

conduct its fifth meeting in May. At this 

meeting, the Commission will discuss 

the topic of Federal standards regarding 

human subjects protection in Federally 

funded scientific studies. 

DATES: The meeting will take place 

Wednesday, May 18, 2011, from 9 a.m. 

to approximately 4:45 p.m., and 

Thursday, May 19, 2011, from 9 a.m. to 

approximately 1:15 p.m. 

ADDRESSES: The Warwick New York 

Hotel, 65 West 54th Street, New York, 

NY 10019. Phone 212–247–2700. 

FOR FURTHER INFORMATION CONTACT: 

Hillary Wicai Viers, Communications 

Director, Presidential Commission for 

the Study of Bioethical Issues, 1425 

New York Avenue, NW., Suite C–100, 

Washington, DC 20005. Telephone: 

202–233–3963. E-mail: 

Hillary.Viers@bioethics.gov. Additional 

information may be obtained at http:// 

www.bioethics.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the Federal Advisory Committee Act 

of 1972, Public Law 92–463, 5 U.S.C. 

app. 2, notice is hereby given of the fifth 

meeting of the Presidential Commission 

for the Study of Bioethical Issues 

(PCSBI). The meeting will be held from 

9 a.m. to approximately 4:45 p.m. on 

Wednesday, May 18, 2011, and from 9 

a.m. to approximately 1:15 p.m. on 

Thursday, May 19, 2011, at the Warwick 

New York Hotel, New York, NY. The 

meeting will be open to the public with 

attendance limited to space available. 

The meeting will also be webcast at 

http://www.bioethics.gov. 

Under authority of Executive Order 

13521, dated November 24, 2009, the 

President established PCSBI to serve as 

a public forum and advise him on 

bioethical issues generated by novel and 

emerging research in biomedicine and 

related areas of science and technology. 

The Commission is charged to identify 

and promote policies and practices that 

assure ethically responsible conduct of 

scientific research, healthcare delivery, 

and technological innovation. In 

undertaking these duties, the 

Commission will examine specific 

bioethical, legal, and social issues 

related to potential scientific and 

technological advances; examine 

diverse perspectives and possibilities 

for useful international collaboration on 

these issues; and recommend legal, 

regulatory, or policy actions as 

appropriate. 

The main agenda item for this fifth 

meeting is to review Federal as well as 

transnational standards of human 

subjects protections in scientific studies 

supported by the Federal government as 

requested by President Obama on 

November 24, 2010. 

The draft meeting agenda and other 

information about PCSBI, including 

information about access to the webcast, 

will be available at http:// 

www.bioethics.gov. 

The Commission welcomes input 

from anyone wishing to provide public 

comment on any issue before it. There 

will be a public comment session in the 

afternoon on May 18, 2011. Individuals 

who would like to provide public 

comment at that time should notify 

Esther Yoo by telephone at 202–233– 

3960, or e-mail at 

Esther.Yoo@bioethics.gov before May 9, 

2011. To accommodate as many 

speakers as possible the time for each 

individual to speak may be limited. If 

the number of individuals wishing to 

speak is greater than can reasonably be 

accommodated during the scheduled 

meeting, the Commission may randomly 

select speakers from among those who 

register to speak. 

Anyone planning to attend the 

meeting who needs special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should also notify Esther Yoo (contact 

information above) in advance of the 

meeting. The Commission will make 

every effort to accommodate persons 

who need special assistance. 

Written comments will also be 

accepted and are especially welcome. 

Please address written comments by email to info@bioethics.gov, or by mail to 

the following address: Public 

Commentary, Presidential Commission 

for the Study of Bioethical Issues, 1425 

New York Ave., NW, Suite C–100, 

Washington, DC 20005. Comments will 

be publicly available, including any 

personally identifiable or confidential 

business information that they contain. 

Trade secrets should not be submitted. 

Dated: April 6, 2011. 

Valerie H. Bonham, 

Executive Director, Presidential Commission 

for the Study of Bioethical Issues. 

[FR Doc. 2011–9123 Filed 4–14–11; 8:45 am] 

BILLING CODE 4154–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10369] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Solicitation for 

Applications: Community-based Care 

Transitions Program; Use: The 

Community-based Care Transitions 

Program (CCTP) described in Section 

3026 of the Affordable Care Act will run 

for 5 years with a mandated start date 

of January 1, 2011. This program 

provides funding to community-based 

organizations in partnership with acute 

care hospitals for the provision of care 

transition services delivered to high risk 


srobinson on DSKHWCL6B1PROD with NOTICES