40208 Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 

(National Institutes of Health), Center for 

Biologics, Evaluation and Research (Food 

and Drug Administration), a discussion on 

causation, and an update from the IOM on 

the project to review adverse effects of 

vaccines. Agenda items are subject to change 

as priorities dictate. 

Public Comments: Persons interested in 

providing an oral presentation should submit 

a written request, along with a copy of their 

presentation to: Kay Cook, DVIC, Healthcare 

Systems Bureau (HSB), Health Resources and 

Services Administration (HRSA), Room 11C– 

26, 5600 Fishers Lane, Rockville, Maryland 

20857 or e-mail: kcook@hrsa.gov. Requests 

should contain the name, address, telephone 

number, and any business or professional 

affiliation of the person desiring to make an 

oral presentation. Groups having similar 

interests are requested to combine their 

comments and present them through a single 

representative. The allocation of time may be 

adjusted to accommodate the level of 

expressed interest. DVIC will notify each 

presenter by mail or telephone of their 

assigned presentation time. Persons who do 

not file an advance request for a presentation, 

but desire to make an oral statement, may 

announce it at the time of the comment 

period. These persons will be allocated time 

as it permits. 

FOR FURTHER INFORMATION CONTACT: 

Anyone requiring information regarding 

the ACCV should contact Kay Cook, 

DVIC, HSB, HRSA, Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857; 

telephone (301) 443–6593 or e-mail: 

kcook@hrsa.gov. 

Dated: August 4, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–19109 Filed 8–10–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Meeting; National 

Commission on Children and Disasters 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice of meeting. 

DATES: The meeting will be held on 

Tuesday, September 15, 2009, from 9:30 

a.m. to 3:30 p.m. 

ADDRESSES: The meeting will be held at 

the Administration for Children and 

Families, 901 D Street, SW., 

Washington, DC 20024. To attend either 

in person or via teleconference, please 

register by 5 p.m., Eastern Time, 

September 11, 2009. To register, please 

e-mail capelt@acf.hhs.gov with 

‘‘Meeting Registration’’ in the subject 

line, or call (202) 205–9560. Registration 

must include your name, affiliation, and 

phone number. If you require a signlanguage interpreter or other special 

assistance, please call Carol Apelt at 

(202) 205–4618 as soon as possible and 

no later than 5 p.m., Eastern Time, 

September 1, 2009. 

Agenda: The Commission will hear 

reports from four subcommittees: (1) 

Pediatric Medical Care Subcommittee; 

(2) Education, Child Welfare, and 

Juvenile Justice Subcommittee; (3) 

Evacuation, Transportation and Housing 

Subcommittee; and (4) Human Services 

Recovery Subcommittee. The 

Commission will also deliberate and 

vote on its Interim Report to the 

President and Congress. 

Written comments may be submitted 

electronically to 

roberta.lavin@acf.hhs.gov with ‘‘Public 

Comment’’ in the subject line. The 

Commission recommends that you 

include your name, mailing address and 

an email address or other contact 

information in the body of your 

comment. This ensures that you can be 

identified as the submitter of the 

comment, and it allows the Commission 

to contact you if further information on 

the substance of your comment is 

needed or if your comment cannot be 

read due to technical difficulties. The 

Commission’s policy is that the 

Commission will not edit your 

comment, and any identifying or contact 

information provided in the body of a 

comment will be included as part of the 

comment placed in the official record. 

The Commission will provide an 

opportunity for public comments during 

the public meeting on September 15, 

2009. Those wishing to speak will be 

limited to three minutes each; speakers 

are encouraged to submit their remarks 

in writing in advance to ensure their 

comment is received in case there is 

inadequate time for all comments to be 

heard on September 15, 2009. 

Additional Information: Contact 

Roberta Lavin, Office of Human Services 

Emergency Preparedness and Response, 

e-mail roberta.lavin@acf.hhs.gov or 

phone (202) 401–9306. 

SUPPLEMENTARY INFORMATION: The 

National Commission on Children and 

Disasters is an independent Commission 

that shall conduct a comprehensive 

study to examine and assess the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, building upon the evaluations 

of other entities and avoiding 

unnecessary duplication by reviewing 

the findings, conclusions, and 

recommendations of these entities. The 

Commission shall then submit a report 

to the President and Congress on the 

Commission’s independent and specific 

findings, conclusions, and 

recommendations to address the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, including major disasters and 

emergencies. 

Dated: August 3, 2009. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. E9–19157 Filed 8–10–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Council on Blood Stem 

Cell Transplantation. 

Date and Times: September 21, 2009, 8:30 

a.m. to 4:30 p.m. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, Bethesda, Maryland 

20814. 

Status: The meeting will be open to the 

public. 

Purpose: Pursuant to Public Law 109–129, 

42 U.S.C. 274k (section 379 of the Public 

Health Service Act, as amended) the 

Advisory Council on Blood Stem Cell 

Transplantation (ACBSCT) advises the 

Secretary of HHS and the Administrator, 

HRSA, on matters related to the activities of 

the C.W. Bill Young Cell Transplantation 

Program (Program) and the National Cord 

Blood Inventory (NCBI) Program. 

Agenda: 

The Council will hear reports from three 

ACBSCT Work Groups: Informed Consent, 

Access to Transplantation, and Cord Blood 

Collections. The Council also will hear 

presentations and discussions on the 

following topics: Induced pluripotent stem 

cells and adult stem cells, National Marrow 

Donor Program Infrastructure Summit, 

Radiation Injury Treatment Network, and 

trends in post-transplant survival. Agenda 

items are subject to change as priorities 

indicate. 

After the presentations and Council 

discussions, members of the public will have 

an opportunity to provide comments. 

Because of the Council’s full agenda and the 

timeframe in which to cover the agenda 

topics, public comment will be limited. All 

public comments will be included in the 

record of the ACBSCT meeting. Meeting 

summary notes will be made available on the 

HRSA’s Program Web site at http://bloodcell.

transplant.hrsa.gov/ABOUT/Advisory_

Council/index.html. 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40209 

The draft meeting agenda and a registration 

form will be available on or about August 21, 

2009, on the HRSA’s Program Web site at 

http://bloodcell.transplant.hrsa.gov/ABOUT/ 

Advisory_Council/index.html. 

The completed registration form should be 

submitted by facsimile to Professional and 

Scientific Associates (PSA), the logistical 

support contractor for the meeting, at fax 

number (703) 234–1701 ATTN: Rebecca 

Pascoe. Registration can also be completed 

electronically at https://www.team-psa.com/ 

dot/fall2009/acbsct. Individuals without 

access to the Internet who wish to register 

may call Rebecca Pascoe with PSA at (703) 

234–1747. 

FOR FURTHER INFORMATION CONTACT: 

Remy Aronoff, Executive Secretary, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

5600 Fishers Lane, Room 12–105, 

Rockville, Maryland 20857; telephone 

(301) 443–3264. 

Dated: August 4, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–19110 Filed 8–10–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Oncologic Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 1, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Nicole Vesely, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane, (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

the following topics: (1) Supplemental 

new drug application (sNDA) 021– 

673/S–009, CLOLAR (clofarabine) 

Injection for intravenous use, Genzyme 

Corp., proposed indication for the 

treatment of previously untreated adults 

aged 60 years or older with acute 

myeloid leukemia with at least one 

unfavorable baseline prognostic factor 

and (2) new drug application (NDA) 

022–489, proposed trade name 

ONRIGIN (laromustine) Injection, Vion 

Pharmaceuticals, Inc., proposed 

indication for remission induction 

therapy for patients 60 years or older 

with de novo poor-risk acute myeloid 

leukemia (AML). 

CLOLAR (clofarabine) Injection for 

intravenous use has a new proposed 

indication for treatment of AML in 

previously untreated adults aged 60 

years or older with at least one medical 

or health factor that increases the risk of 

an unfavorable outcome. Laromustine 

Injection, with the proposed trade name 

ONRIGIN, has a proposed use for 

‘‘remission induction therapy’’ for AML. 

This is an initial approach to AML 

treatment designed to induce, or bring 

about, remission (reduction or 

disappearance) of leukemia in patients 

60 years or older with de novo, or first 

occurrence, AML designated as ‘‘poorrisk,’’ or more likely to have a poor 

outcome. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 25, 2009. 

Oral presentations from the public will 

be scheduled between approximately 

10:45 a.m. and 11:15 a.m. and between 

approximately 3:30 p.m. and 4 p.m. 

Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before August 

25, 2009. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 26, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 

Vesely at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 3, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–19108 Filed 8–10–09; 8:45 am] 

BILLING CODE 4160–01–S 


sroberts on DSKD5P82C1PROD with NOTICES