46434 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 

address HPV devices that are intended 

to be used independent of a cervical 

cytology result. 

The one product code established for 

this HPV DNA detection device is code 

MAQ, class III. The recommendations in 

this guidance apply to HPV diagnostic 

devices that detect HPV nucleic acid 

(not only HPV DNA, but HPV RNA, as 

well). Many of the recommendations 

will also apply to HPV detection devices 

that utilize targets other than HPV 

nucleic acid (such as HPV protein). This 

guidance therefore may encompass 

future HPV product codes beyond the 

one listed. Because HPV diagnostic 

devices are postamendment devices, 

they are automatically classified as class 

III under section 513(f)(1) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360c(f)(1)). 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on establishing the performance 

characteristics of in vitro diagnostic 

devices for the detection or detection 

and differentiation of human 

papillomaviruses. 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 statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Establishing 

the Performance Characteristics of In 

Vitro Diagnostic Devices for the 

Detection or Detection and 

Differentiation of Human 

Papillomaviruses,’’ you may either send 

an e-mail request to dsmica@fda.hhs.gov 

to receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number 1699 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations 

and guidance documents. 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 814 have been approved 

under OMB Control No. 0910–0231; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB Control No. 0910–0078; and the 

collections of information in 21 CFR 

809.10 have been approved under OMB 

Control No. 0910–0485. 

V. 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. 

Dated: August 26, 2009. 

Catherine M. Cook, 

Associate Director for Regulations and Policy. 

[FR Doc. E9–21725 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–D–0260] 

Guidance for Industry: Questions and 

Answers Regarding the Reportable 

Food Registry as Established by the 

Food and Drug Administration 

Amendments Act of 2007; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Questions and Answers 

Regarding the Reportable Food Registry 

as Established by the Food and Drug 

Administration Amendments Act of 

2007.’’ The document provides 

guidance to the industry in complying 

with the Reportable Food Registry 

requirements prescribed by the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA). 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Food Defense, Communication 

and Emergency Response (HFS–005), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Faye 

Feldstein, Center for Food Safety and 

Applied Nutrition (HFS–005), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 1–888– 

SAFEFOOD. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2009 (74 FR 27803), FDA announced the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Reportable Food Registry as Established 

by the Food and Drug Administration 

Amendments Act of 2007’’ and gave 

interested parties an opportunity to 

submit comments by July 27, 2009. The 

agency reviewed and evaluated these 

comments and has modified the 

guidance where appropriate. 

The guidance contains questions and 

answers intended to assist those parties 

responsible for complying with the 

Reportable Food Registry requirements 

prescribed by the Food and Drug 

Administration Amendments Act of 

2007 (Public Law 110–085), including: 

(1) How, when, and where to submit 

reports to FDA; (2) who is required to 

submit reports to FDA; (3) what is 

required to be submitted to FDA; and (4) 

what may be required when providing 

notifications to other persons in the 

supply chain of an article of food. 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
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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