Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 52533 

the meeting. Members of the public will 

have the opportunity to provide 

comments at the meeting. Public 

comment will be limited to five minutes 

per speaker. Individuals who would like 

to submit written statements should 

e-mail or fax their comments to the 

National Vaccine Program Office at least 

five business days prior to the meeting. 

Those wishing to register to attend the 

meeting may do so by sending an e-mail 

to nvpo@hhs.gov or by calling 202–690– 

5566 and providing name, e-mail 

address and organization. 

Dated: August 23, 2010. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office. 

[FR Doc. 2010–21263 Filed 8–25–10; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Meeting of the Presidential 

Commission for the Study of 

Bioethical Issues 

AGENCY: Department of Health and 

Human Services, Office of Public Health 

and Science, The Presidential 

Commission for the Study of Bioethical 

Issues. 

ACTION: Notice of meeting. 

SUMMARY: The Presidential Commission 

for the Study of Bioethical Issues will 

conduct a meeting in September. At this 

meeting, the Commission will continue 

discussing the emerging science of 

synthetic biology, including its potential 

benefits and risks, and appropriate 

ethical boundaries and principles. 

DATES: The meeting will take place 

Monday, September 13, 2010, from 8:50 

a.m. to approximately 4:15 p.m., and 

Tuesday, September 14, 2010, from 9 

a.m. to approximately noon. 

ADDRESSES: Monday, September 13, The 

Inn at Penn, 3600 Sansom Street, 

Philadelphia, PA 19104. Phone 215– 

222–0200. Tuesday, September 14, The 

Annenberg Public Policy Center, 202 

South 36th Street, Philadelphia, PA 

19104. Phone 215–898–9400. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Diane M. Gianelli, Director of 

Communications, The Presidential 

Commission for the Study of Bioethical 

Issues, 1425 New York Avenue, NW., 

Suite C–100, Washington, DC 20005. 

Telephone: 202/233–3960. E-mail: 

info@bioethics.gov. Additional 

information may be obtained by viewing 

the Web site: http://www.bioethics.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the Federal Advisory Committee Act, 

Public Law 92–463, 5 U.S.C. App., 

notice is hereby given that the 

Presidential Commission for the Study 

of Bioethical Issues (PCSBI) will be 

conducting a meeting. The meeting will 

be held from 8:50 a.m. to approximately 

4:15 p.m. on Monday, September 13, 

2010, at the Inn at Penn, 3600 Sansom 

Street, Philadelphia, PA 19104, and 

from 9 a.m. to approximately noon on 

Tuesday, September 14, 2010, at The 

Annenberg Public Policy Center, 202 

South 36th Street, Philadelphia, PA 

19104. The meeting will be open to the 

public with attendance limited to space 

available. The meeting will also be Web 

cast. 

Under authority of Executive Order 

13521, dated November 24, 2009, the 

President established the 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 items for 

this meeting involve further discussion 

of the opportunities and benefits to the 

public of the emerging science of 

synthetic biology, the challenges and 

risks, and the ethical boundaries that 

may be important to formulation of 

public policy with regard to this 

advancing science. The Commission 

also will hear more from the perspective 

of faith communities and others. The 

draft meeting agenda and other 

information about PCSBI, including 

information about access to the Web 

cast, will be available at http:// 

www.bioethics.gov. 

The Commission welcomes input 

from anyone wishing to provide public 

comment on any issue before it. 

Individuals who would like to provide 

public comment at the meeting should 

notify Ms. Diane Gianelli, Director of 

Communications, by telephone at 202– 

233–3960, or e-mail at 

diane.gianelli@bioethics.gov. Anyone 

planning to attend the meeting who 

needs special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

also notify Ms. Gianelli in advance of 

the meeting. The Commission will make 

every effort to accommodate persons 

who need special assistance. 

Written comments will also be 

accepted in accord with the 

Commission’s existing request for 

public comment on the issues before the 

Commission. Please address written 

comments by e-mail to 

info@bioethics.gov, or by mail to the 

following address: Public Commentary, 

The 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: August 17, 2010. 

Valerie H. Bonham, 

Executive Director, The Presidential 

Commission for the Study of Bioethical Issues. 

[FR Doc. 2010–21267 Filed 8–25–10; 8:45 am] 

BILLING CODE 4154–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

52534 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

Proposed Project: Sickle Cell Disease 

and Other Hemoglobinopathies 

Program Evaluation—[NEW] 

Background: In response to the 

growing need for resources devoted to 

sickle cell disease and other 

hemoglobinopathies, Congress, under 

Section 501(a)2 of the Social Security 

Act (2000), authorized the appropriation 

of funds for enabling the Secretary to 

provide for special projects of regional 

and national significance, research and 

training with respect to maternal and 

child health and children with special 

health care needs the following: Genetic 

disease testing, counseling and 

information development and 

dissemination programs, for grants 

relating to hemophilia without regard to 

age, and for the screening of newborns 

for sickle cell anemia and other genetic 

disorders, and follow-up services. As 

stated in House Report No. 107–229 

regarding the Department of Labor, 

Health and Human Services, and 

Education, and Related Agencies 

Appropriation Bill 2002, the purpose of 

the Sickle Cell Disease and Newborn 

Screening Program (SCDNBSP) is ‘‘to 

enhance the sickle cell disease newborn 

screening program and its locally based 

outreach and counseling efforts.’’ In 

addition, the American Jobs Creation 

Act of 2004, Public Law 108–357, states 

that ‘‘* * * the Bureau of Primary 

Health Care and the Maternal and Child 

Health Bureau, shall conduct a 

demonstration program by making 

grants for up to 40 eligible entities, for 

each fiscal year in which the program is 

conducted under this section, for the 

purpose of developing and establishing 

systemic mechanisms to improve the 

prevention and treatment of Sickle Cell 

Disease.’’ (See 42 U.S.C. 300b–1). 

Purpose: HRSA’s activities under the 

legislative authorities relative to the 

Sickle Cell Disease and Newborn 

Screening Program (SCDNBSP) have 

been delegated to the Maternal and 

Child Health Bureau (MCHB), Genetic 

Services Branch (GSB). The MCHB’s 

GSB supports seventeen community 

based organizations and the National 

Coordinating and Evaluation Center for 

the Sickle Cell Disease and Newborn 

Screening Program (SCDNBS) in 

addition to nine cooperative agreements 

and a National Coordinating Center for 

the Sickle Cell Disease Treatment 

Demonstration Program (SCDTDP). An 

evaluation will be conducted to assess 

the service delivery processes and 

quality of the system of care delivered 

by grantees under the Newborn 

Screening Program to individuals 

affected by Sickle Cell disease who 

present at their sites for care. The 

Centers for Disease Control and 

Prevention defines Hemoglobinopathies 

as ‘‘a group of disorders affecting red 

blood cells. SCD and Thalassemia are 

included in this group.’’ (See http:// 

www.cdc.gov/ncbddd/sicklecell/ 

RuSH_FAQs.html). The information 

from the evaluation will be used to 

evaluate the grantees’ performance in 

achieving the objectives of the 

hemoglobinopathies program during the 

grant period, assess the breadth of 

grantees’ outreach to emerging 

populations affected by 

hemoglobinopathies and the needs of 

those populations attempting to access 

services. Data collection tools for which 

OMB approval is being requested are as 

follows: (1) The Minimum Database 

Project Sickle Cell Disease (MDP SCD) 

Questionnaire, (2) the Minimum 

Database Project Sickle Cell Trait/ 

Carrier (MDP SCT) Questionnaire, and 

(3) the MDP Hemoglobinopathies 

Emerging Populations Questionnaire. 

Respondents: The MDP SCD and the 

MDP SCT Questionnaires will be 

administered by grantees to clients or 

caregivers when they present for 

services. At the time of enrollment, 

SCDNBSP participants will be informed 

about the data collection and clients 

will be asked to participate in either the 

SCD questionnaire or the SCT 

questionnaire depending on their 

disease or carrier status. The program 

will enroll participants on a rolling 

basis such that new patients will be 

added to the program as they present for 

services and provide consent. Data will 

be collected at two points annually for 

the SCD Questionnaire, the first, when 

clients and caregivers are enrolled into 

the SCDNBS Program and the second, at 

follow-up after enrollment. Data will be 

collected once annually for the SCT 

Questionnaire. The Hemoglobinopathies 

Emerging Populations Form serves as a 

stand alone form for the other HRSA 

hemoglobinopathies programs, with its 

content. These questions are also 

embedded in the MDT SCD and MDP 

SCT questionnaires. The HRSA 

hemoglobinopathies programs also plan 

to use this questionnaire in developing 

educational materials, prioritizing 

outreach activities and informing 

decisions for future funding requests. 

The annual estimate of burden is as 

follows: 

Questionnaires Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average hours 

per response 

Total hour 

burden Wage rate Total hour cost 

MDP SCD Questionnaire ......... 140 2 280 .45 126 $20.90 $2,633.40 

MDP SCT Questionnaire ......... 1,400 1 1,400 .30 420 20.90 8,778.00 

Hemoglobinopathies Emerging 

Populations Form ................. *1,125 2 *2,250 .20 450 20.90 9,405.00 

Total .................................. 2,665 ........................ 3,930 ........................ 996 .................... 20,816.40 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: August 19, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–21220 Filed 8–25–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0213] 

Su Van Ho: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

mstockstill on DSKH9S0YB1PROD with NOTICES