67592 Federal Register / Vol. 69, No. 222 / Thursday, November 18, 2004 / Notices 

Appendix VI—Researcher Affidavit of 

Confidentiality 

I certify that no confidential data or 

information viewed or otherwise obtained 

while I am a researcher in the National 

Center for Health Statistics (NCHS) Research 

Data Center (RDC) will be removed from 

NCHS. Further, I understand that NCHS will 

perform a disclosure review and must 

provide approval to me before I remove any 

data from the RDC, whether they are in 

electronic or paper form. I acknowledge 

NCHS Confidentiality Statute, Sec. 308(d) of 

the Public Health Service Act (42 U.S.C. 

242m) stated below and fully understand my 

legal obligations to NCHS to protect all 

confidential data. Further, I understand that 

any violation may be punishable by fine or 

imprisonment for up to 5 years or both under 

Title 18 U.S.C. 1001. 

NCHS Confidentiality Statute—No 

information, if an establishment or person 

supplying the information or described in it 

is identifiable, obtained in the course of 

activities undertaken or supported under 

section 304, 306, or 307 may be used for any 

purpose other than the purpose for which it 

was supplied unless such establishment or 

person has consented (as determined under 

regulations of the Secretary) to its use for 

such other purpose and in the case of 

information obtained in the course of health 

statistical or epidemiological activities under 

section 304 or 306, such information may not 

be published or released in other form if the 

particular establishment or person supplying 

the information or described in it is 

identifiable unless such establishment or 

person has consented (as determined under 

regulations of the Secretary) to its publication 

or release in other form. 

Title 18 U.S.C. 1001—Deliberately making 

a false statement in any matter within the 

jurisdiction of any Department or Agency of 

the Federal Government violates Title 18 

U.S.C. 1001 and is punishable by a fine or 

up to 5 years in prison or both.

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Researcher’s Signature

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Date

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NCHS Witness

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Date

Dated: November 9, 2004. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention.

[FR Doc. 04–25537 Filed 11–17–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

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 December 1, 2004, from 8 a.m. 

to 5 p.m.

Location: Holiday Inn, Kennedy/

Adams Ballroom, 8777 Georgia Ave., 

Silver Spring, MD.

Contact Person: Johanna M. Clifford, 

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–

7001, Fax: 301–827–6776, e-mail: 

cliffordj@cder.fda.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.

Agenda: The committee will discuss 

these items: (1) New drug application 

(NDA) 21–673, proposed trade name 

CLOLAR (clofarabine) Ilex Products, 

Inc., proposed indication for the 

treatment of pediatric patients 1 to 21 

years old with refractory or relapsed 

acute leukemias, and (2) NDA 21–600, 

proposed trade name MARQIBO 

(vincristine sulfate liposome injection) 

Inex Pharmaceuticals Corp., proposed 

indication for the treatment of patients 

with aggressive non-Hodgkin’s 

lymphoma previously treated with at 

least two combination chemotherapy 

regimens.

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 by November 23, 2004. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11 a.m., and between 

approximately 2:30 p.m. and 3 p.m. 

Time allotted for each presentation may 

be limited. Those desiring to make 

formal oral presentations should notify 

the contact person before November 23, 

2004, 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.

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 Trevelin 

Prysock at 301–827–7001 at least 7 days 

in advance of the meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: November 9, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–25530 Filed 11–17–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

Advisory Committee to the Director, 

National Institutes of Health (NIH). 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

A portion of the meeting will be 

closed to the public in accordance with 

the provisions set forth in the 

Government in the Sunshine Act, 

sections 552b(c)(6) and 552b(c)(9)(B), 

Title 5 U.S.C., as amended, because the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal property and the premature 

disclosure of information and the 

discussions are likely to significantly