47948 Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices 

mechanisms of action. The draft 

guidance applies to therapeutic cancer 

vaccines intended to be administered to 

patients with an existing cancer for the 

purpose of treatment. It does not apply 

to products intended to be administered 

to patients to prevent or decrease the 

incidence of cancer. Also, it does not 

apply to adoptive immunotherapeutic 

products such as T cell or NK cell 

products. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; and the collections 

of information in 21 CFR part 50 on 

informed consent have been approved 

under OMB control number 0910–0130. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

http://www.regulations.gov. 

Dated: September 15, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22531 Filed 9–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0431] 

Preparation for International 

Conference on Hamonization: Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in St. Louis, Missouri’’ to 

provide information and receive 

comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in St. 

Louis, MO. The topics to be discussed 

are the topics for discussion at the 

forthcoming ICH Steering Committee 

Meeting. The purpose of the public 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in St. 

Louis, MO, October 24 to 29, 2009, at 

which discussion of the topics 

underway and the future of ICH will 

continue. 

Date and Time: The public meeting 

will be held on Wednesday, October 14, 

2009, from 2:30 p.m. to 4:30 p.m. 

Location: The public meeting will be 

held at the Washington Room at the 

Hilton Rockville, 1750 Rockville Pike, 

Rockville, MD 20852. 

Contact Person: Mary Morrison, 

Office of the Commissioner, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, by e-mail: 

Mary.morrison@fda.hhs.gov, or FAX: 

301–827–0003. 

Registration and Requests for Oral 

Presentations: Mail or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers), written 

material and requests to make oral 

presentations, to Mary Morrison (see 

Contact Person) by October 9, 2009. 

If you need special accommodations 

due to a disability, please contact Mary 

Morrison (see Contact Person) at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan, and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission, the European 

Federation of Pharmaceutical Industries 

Associations, the Japanese Ministry of 

Health, Labor and Welfare, the Japanese 

Pharmaceutical Manufactures 

Association, the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA, and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Public oral presentations will 

be scheduled between approximately 

2:30 p.m. and 4:30 p.m. Time allotted 

for oral presentations may be limited to 

10 minutes. Those desiring to make oral 

presentations should notify the contact 

person by October 9, 2009, and submit 

a brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices 47949 

telephone number, fax, and e-mail of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

at http://www.fda.gov/Drugs/News

Events/ucm181849.htm. 

Transcripts: Please be advised that as 

soon as a transcript is available, it can 

be obtained 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 11, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22445 Filed 9–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. 

Transdisciplinary Cancer Genomics 

Research: Post-Genome Wide Association 

(Post-GWA) Initiative. 

Date: October 27–28, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Old Town, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Marvin L. Salin, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Boulevard, Room 7073, 

Bethesda, MD 20892–8329. 301–496–0694. 

msalin@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer 

Biology Research; 93.397, Cancer Centers 

Support; 93.398, Cancer Research 

Manpower; 93.399, Cancer Control, 

National Institutes of Health, HHS) 

Dated: September 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22568 Filed 9–17–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Statement of Organization, Functions, 

and Delegations of Authority 

Notice is hereby given that I have 

delegated to the Regional Program 

Managers, American Indian Alaska 

Native Program Branch Chief, and 

Migrant and Seasonal Program Branch 

Chief the following authority vested in 

me by the Director, Office of Head Start 

in the memorandum dated August 27, 

2009. 

(a) Authority Delegated: 

Authority to approve or disapprove 

requests for non-Federal share waivers 

under 42 U.S.C. 9835(b) for 

expenditures funded by the American 

Recovery & Reinvestment Act of 2009, 

Public Law 111–5 (Feb. 17, 2009). 

(b) Limitations: 

1. This delegation shall be exercised 

under financial and administrative 

requirements applicable to all 

Administration for Children and 

Families authorities. 

2. These authorities may not be 

redelegated. 

(c) Effective Date: 

This redelegation is effective on the 

date of signature. 

(d) Effect on Existing Delegations: 

This redelegation of authority 

supplements the previous delegations 

from the Director, Division of Program 

Operations by the memorandum dated 

April 26, 2007. 

I hereby affirm and ratify any actions 

taken by any Regional Program 

Manager, the American Indian Alaska 

Native Program Branch Chief or the 

Migrant and Seasonal Program Branch 

Chief that involved the exercise of this 

authority prior to the effective date of 

this redelegation. 

Dated: August 28, 2009. 

Renee Perthuis, 

Director, Division of Program Operations. 

[FR Doc. E9–22572 Filed 9–17–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2009–0846] 

Information Collection Request to 

Office of Management and Budget; 

OMB Control Number: 1625–0100 

AGENCY: Coast Guard, DHS. 

ACTION: Sixty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to submit 

Information Collection Request (ICR) 

and Analysis to the Office of 

Management and Budget (OMB) 

requesting an extension of its approval 

for the following collection of 

information: 1625–0100, Advanced 

Notice of Vessel Arrival. Before 

submitting this ICR to OMB, the Coast 

Guard is inviting comments as 

described below. 

DATES: Comments must reach the Coast 

Guard on or before November 17, 2009. 

ADDRESSES: To avoid duplicate 

submissions to the docket [USCG–2009– 

0846], please use only one of the 

following means: 

(1) Online: http:// 

www.regulations.gov. 

(2) Mail: Docket Management Facility 

(DMF) (M–30), U.S. Department of 

Transportation (DOT), West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue, SE., Washington, 

DC 20590–0001. 

(3) Hand deliver: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

(4) Fax: 202–493–2251. 

The DMF maintains the public docket 

for this Notice. Comments and material 

received from the public, as well as 

documents mentioned in this Notice as 

being available in the docket, will 

become part of the docket and will be 

available for inspection or copying at 

room W12–140 on the West Building 

Ground Floor, 1200 New Jersey Avenue, 

SE., Washington, DC, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find the docket on the Internet at 

http://www.regulations.gov. 


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