Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 54351 

will determine the amount of time 

allotted to each presenter and the 

approximate time that each oral 

presentation is scheduled to begin. Prior 

to the meeting, presenters will be 

notified of their allotted time and the 

approximate scheduled time of their 

remarks. An agenda of the public 

meeting, including the oral presentation 

schedule, will be available 

approximately 3 days before the public 

meeting at the Division of Dockets 

Management (Docket No. FDA–2009–D– 

0007) and on the Internet at http:// 

www.regulations.gov. 

Pre-registered participants will 

receive additional information on 

parking and public transportation with 

their e-mail registration confirmation. 

IV. Comments on the Draft Guidance 

Regardless of attendance at the public 

meeting, interested persons may submit 

either electronic or written comments 

regarding the Draft Guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

FDA–2009–D–0007. Although you can 

comment on any guidance at any time 

(see 21 CFR 10.115(g)(5)), to ensure that 

the agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance, 

submit either electronic or written 

comments on Draft Guidance by January 

5, 2011. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

V. Transcripts 

Transcripts of the meeting will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 45 days after the 

meeting. A transcript will also be 

available in either hardcopy or on CD– 

ROM, after submission of a Freedom of 

Information request. Written requests 

are to be sent to Division of Freedom of 

Information (HFI–35), Office of 

Management Programs, Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857. 

Dated: September 1, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22198 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Cell and Gene Therapy Clinical Trials 

in Pediatric Populations; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Center for Biologics Evaluation 

and Research (CBER) is announcing a 

public workshop entitled ‘‘Cell and 

Gene Therapy Clinical Trials in 

Pediatric Populations.’’ The purpose of 

the workshop is to gather information 

from Institutional Review Boards (IRBs), 

gene and cellular therapy clinical 

researchers, and other stakeholders 

regarding best practices related to cell 

and gene therapy clinical trials in 

pediatric populations, as well as 

challenges and considerations in the 

review of these clinical trials. 

Date and Time: The public workshop 

will be held on November 2, 2010, from 

8 a.m. to 5:30 p.m. 

Location: The public workshop will 

be held at the Bethesda North Marriott 

Hotel and Conference Center, 5701 

Marinelli Rd., North Bethesda, MD 

20852. 

Contact Person: Bernadette Kawaley, 

Center for Biologics Evaluation and 

Research (HFM–43), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–2000, FAX 301–827–3079; 

email: CBERTraining@fda.hhs.gov 

(Subject line: Pediatrics Ethics 

Workshop). 

Registration: Email, mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person by October 1, 2010. 

There is no registration fee for the 

public workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 7:30 

a.m. 

If you need special accommodations 

due to a disability, please contact 

Bernadette Kawaley (see Contact 

Person) at least 7 days in advance. 

SUPPLEMENTARY INFORMATION: The 

workshop will include presentations on 

cell and gene therapy clinical trials in 

pediatric populations. The workshop 

will include panel discussions regarding 

best practices related to cell and gene 

therapy clinical trials in pediatric 

populations including those related to: 

(1) Evaluating these novel therapeutic 

products prior to initiating pediatric 

clinical studies; (2) identifying and 

minimizing risks associated with the 

administration of cell and gene therapy 

products in pediatric populations; (3) 

obtaining informed consent and assent; 

and (4) conducting continuing review of 

cell and gene therapy products in 

pediatric populations. The workshop 

also will include panel discussions 

addressing the challenges and 

considerations in the review of cell and 

gene therapy clinical trials in pediatric 

populations and the role of IRBs. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. A 

transcript of the public workshop will 

be available on the Internet at http:// 

www.fda.gov/BiologicsBloodVaccines/ 

NewsEvents/WorkshopsMeetings

Conferences/TranscriptsMinutes/ 

default.htm. 

Dated: August 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22168 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 75 FR 45134–45142, 

dated August 2, 2010) is amended to 

reflect the reorganization of the Office of 

Health and Safety, Office of the Chief 

Operating Officer, Office of the Director, 

Centers for Disease Control and 

Prevention. 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
54352 Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the title and 

functional statements for the Office of 

Health and Safety (CAJP), and insert the 

following: 

Office of Safety, Health, and 

Environment (CAJP). The mission of the 

Office of Safety, Health, and 

Environment (OSHE) of the Centers for 

Disease Control and Prevention (CDC) is 

to help workers protect themselves as 

they carry out their public health 

mission. By helping staff create a safe, 

healthful workplace environment, by 

assisting in the prevention of workrelated injury and illness, and by 

promoting safe work practices, the 

Office improves worker morale, 

increases efficiency and contributes to 

the creation of sound public health 

science. In carrying out its mission, 

OSHE: (1) Provides leadership and 

service for the CDC Health and Safety 

Program to proactively ensure safe and 

healthy workplaces at CDC worksites for 

CDC employees, contractors, and 

visitors (including deployed personnel), 

and to protect the environment and 

communities adjacent to CDC-owned 

and leased facilities; (2) promotes 

healthy and safe work practices to 

prevent injury and illness, and provides 

occupational medical, employee 

assistance, and worksite health 

promotion/lifestyle services; (3) 

provides advice and counsel to the CDC 

Director and other senior OD and 

Centers/Institute/Offices (ClO) staff on 

health, safety, and environment-related 

matters, and to individuals and 

organizations nationally and 

internationally, as requested; (4) 

provides advice, counsel, and direct 

support services to supervisors and 

employees on health, safety, and 

environment-related matters; (5) assures 

compliance with applicable federal, 

state, and local health, safety, and 

environmental (HSE) laws and 

regulations; (6) provides liaison with 

both CDC safety officers and staff, and 

other partners such as Health and 

Human Services (HHS) health and 

safety officials, Occupational Safety and 

Health Administration (OSHA), 

Environmental Protection Agency 

(EPA), Nuclear Regulatory Commission 

(NRC), and other governmental and nongovernmental organizations on HSE 

issues; (7) coproduces the CDC/NIH 

Biosafety in Microbiological and 

Biomedical Laboratories; (8) serves as a 

World Health Organization 

Collaborating Center for Applied 

Biosafety Programs and Training; (9) 

serves as a significant resource of 

subject matter expertise for the national 

and international community in the 

field of biosafety; and, (10) works with 

key partners, such as the World Health 

Organization, on critical health and 

safety issues around the globe. 

Office of the Director (CAJP1). (1) 

Serves as the principal advisor to the 

Director, CDC, with responsibility for 

the CDC Health and Safety Program; (2) 

plans, identifies, and requests required 

resources; directs, manages, and 

evaluates the operations and programs 

of OSHE; (3) assures coordination and 

cooperation among OSHE staff; (4) 

provides advice and counsel to the CDC 

Director, the Chief Operating Officer, 

and other senior OD and CIO officials 

on workplace HSE matters; (5) assures 

compliance with applicable federal, 

state, and local HSE laws, regulations, 

and policies; (6) develops and 

implements new HSE injury/illness 

prevention programs indicated by 

surveys, incident investigations, reports 

of unsafe/unhealthful working 

conditions and other means; (7) assures 

cross-cutting, collaborative team 

functionality in building and 

maintaining a successful safety program; 

(8) assures OSHE coordination with the 

Office of Security and Emergency 

Preparedness, the Building and 

Facilities Office, and other staff and staff 

service offices on HSE matters; (9) 

provides liaison with both CDC safety 

officers and staff, and other partners 

such as HHS, OSHA, EPA, NRC, and 

other governmental and nongovernmental organizations on HSE 

issues; (10) when asked, consults with 

individuals and organizations nationally 

and internationally on issues such as 

laboratory safety, biosafety, 

occupational health issues in the 

biomedical laboratory and animal care 

setting, and deployment health and 

safety; (11) maintains oversight and 

support for the CDC safety committees 

in operational components with 

representation, attendance, interaction 

and collaboration, and collaboration 

with non-Atlanta health and safety 

officers and staff and (12) provides an 

annual report on the CDC HSE and other 

4 reports required or requested by CDC 

management officials, HHS, and 

regulatory agencies. 

Dated: August 22, 2010. 

William P. Nichols, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–21764 Filed 9–3–10; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Free Trade Agreements 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 60-Day Notice and request for 

comments; Extension of an existing 

collection of information: 1651–0117. 

SUMMARY: As part of its continuing effort 

to reduce paperwork and respondent 

burden, CBP invites the general public 

and other Federal agencies to comment 

on an information collection 

requirement concerning: Free Trade 

Agreements. This request for comment 

is being made pursuant to the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13; 44 U.S.C. 3505(c)(2)). 

DATES: Written comments should be 

received on or before November 8, 2010, 

to be assured of consideration. 

ADDRESSES: Direct all written comments 

to U.S. Customs and Border Protection, 

Attn: Tracey Denning, Regulations and 

Rulings, Office of International Trade, 

799 9th Street, NW., 7th Floor, 

Washington, DC 20229–1177. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Regulations and Rulings, Office of 

International Trade, 799 9th Street, 

NW., 7th Floor, Washington, DC 20229– 

1177, at 202–325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

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 estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) the 

annual costs burden to respondents or 

record keepers from the collection of 

information (a total capital/startup costs 

and operations and maintenance costs). 

The comments that are submitted will 

be summarized and included in the CBP 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1