Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 46435 

FDA is issuing this guidance as level 

1 guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The guidance represents the 

agency’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 alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that 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 

this guidance were approved under 

OMB Control Nos. 0910–0643 and 

0910–0645. This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collection of information in 21 CFR 

7.46 has been approved under OMB 

Control No. 0910–0249. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. Received 

comments may be seen 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 guidance at http:// 

www.fda.gov/Food/Guidance

ComplianceRegulatoryInformation/ 

GuidanceDocuments/default.htm or 

http://www.regulations.gov. 

Dated: September 3, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21713 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Oncologic Drugs Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of a meeting of the Oncologic 

Drugs Advisory Committee. This 

meeting was announced in the Federal 

Register of August 25, 2009 (74 FR 

42907). The amendment is being made 

to reflect a change in the Agenda 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 25, 2009, 

FDA announced that a meeting of the 

Oncologic Drugs Advisory Committee 

would be held on October 6, 2009. On 

page 42907, in the second column, the 

Agenda portion of the document is 

changed to read as follows: 

Agenda: The committee will discuss 

new drug application (NDA) 021–825, 

with the proposed trade name 

FERRIPROX (deferiprone) film-coated 

tablets, manufactured by ApoPharma 

Inc. This product is an iron chelating 

agent, which is a drug that binds with 

iron in the body and helps to make 

elimination of iron easier, reducing iron 

build-up. There are two specific 

proposed indications (uses) of 

FERRIPROX: (1) For the treatment of 

iron overload, or build-up in patients 

with transfusion-dependent 

thalassemia, an inherited blood disorder 

that necessitates frequent transfusion of 

normal blood which can lead to iron 

build-up due to the iron content in the 

blood a patient receives; and (2) for the 

treatment of iron overload in patients 

with other transfusion-dependent 

anemias (other blood disorders that 

require frequent transfusions) for whom 

the use of other iron chelating agents 

has been considered inappropriate. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: September 2, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21556 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Cellular, Tissue and Gene Therapies 

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: Cellular, Tissue 

and Gene Therapies 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 October 9, 2009, from 8:30 a.m. 

to approximately 4:30 p.m. 

Location: Bethesda Marriott, 5151 

Pooks Hill Rd., Bethesda, MD. 

Contact Person: Gail Dapolito or 

Danielle Cubbage, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20853, 

301–827–1289, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512389. 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: On October 9, 2009, in open 

session, the Committee will discuss 

ISOLAGEN THERAPY, BLA 125348, 

Isolagen Technologies, Inc., for 

moderate to severe nasolabial fold 

wrinkles. Nasolabial fold wrinkles are 

the two skin folds that run from each 

side of the nose to the corners of the 

mouth. 

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 


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