50826 Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the content and format of the ISE. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 314 have 

been approved under 0910–0001. The 

collections of information for 

submission of data in a BLA under 21 

CFR 601.2 have been approved under 

0910–0338. 

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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm 

or http://www.fda.gov/cber/ 

guidelines.htm or http:// 

www.regulations.gov. 

Dated: August 19, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19906 Filed 8–27–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2008–M–0084, FDA–

2008–M–0100 (formerly 2008M–0013), FDA–

2008–M–0182, FDA–2008–M–0109, FDA–

2008–M–0207] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in Table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Samie Allen, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4013. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from January 1, 2008, through 

March 31, 2008. There were no denial 

actions during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the approval date. 

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 

2008, THROUGH MARCH 31, 2008 

PMA No. 

Docket No. Applicant TRADE NAME Approval Date 

P040021 (S004) 

FDA–2008–M–0084 

St. Jude Medical, Inc. SJM EPIC VALVE AND SJM SUPRA VALVE November 15, 2007 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 50827 

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 

2008, THROUGH MARCH 31, 2008—Continued 

PMA No. 

Docket No. Applicant TRADE NAME Approval Date 

P070001 

FDA–2008–M–0100 (formerly 

2008M–0013) 

Synthes Spine, Inc. PRODISC–C TOTAL DISC PEPLACEMENT December 17, 2007 

P050045 

FDA–2008–M–0182 

Dako Denmark a/s DAKO TOP2A FISH PHARM DX KIT January 11, 2008 

P060033 

FDA–2008–M–0109 

Medtronic Vascular ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY 

STENT ON THE OVER THE WIRE (OTW), RAPID 

EXCHANGE (RX), OR MULTI-EXHANGE II (MX2) 

STENT DELIVERY SYSTEM 

February 1, 2008 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: August 14, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–19907 Filed 8–27–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Identification and Characterization of 

Folliculin-Interacting Protein 2, FNIP2 

Description of Technology: The 

invention describes the identification 

and characterization of a FNIP1 

homolog, folliculin-interacting protein 2 

(FNIP2), that interacts with folliculin, 

the protein encoded by the FLCN gene, 

which is responsible for the Birt-HoggDube’ (BHD) syndrome. BHD is a 

dermatologic disorder associated with 

an increased risk for developing renal 

cancer, spontaneous pneumothorax and 

lung cysts. FNIP2 binds to the 

C-terminus of folliculin and to AMPK. 

Importantly, FNIP2 expression was 

elevated in renal tumors seen in BDH 

patients. This finding suggests that 

FNIP2 may serve as a biomarker for 

BHD. 

Applications: Research tool; 

Diagnostic applications. 

Advantages: Could facilitate the 

development of therapeutic drugs to 

treat the skin lesions and renal tumors 

that develop in BHD patients. 

Development Status: Early stage of 

development. 

Market: Dermatologic products; 

Diagnostic applications. 

Inventors: Laura S. Schmidt et al. 

(NCI). 

Relevant Publication: H Hasumi et al. 

Identification and characterization of a 

novel folliculin-interacting protein 

FNIP2. (2008) Gene, in press. 

Patent Status: HHS Reference No. E–

213–2008/0—Research Tool. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

biological materials licensing only. 

Licensing Contact: John Stansberry, 

Ph.D.; 301–435–5236; 

stansbej@mail.nih.gov. 

Collaborative Research Opportunity: 

The Urologic Oncology Branch at the 

National Cancer Institute is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize detection methods 

specific for FNIP2 to be used to screen 

FNIP2 as a biomarker for renal cancer. 

This may include development of an 

efficient FNIP2 antibody which does not 

cross react with FNIP1 for 

immunhistochemical screening of renal 

tumors for FNIP2 expression. Please 

contact John D. Hewes, Ph.D. at 301–

435–3121 or hewesj@mail.nih.gov for 

more information. 

Immunotoxins Made With Modified 

Cholix Toxin and Uses Thereof 

Description of Technology: 

Immunotoxins are chimeric molecules 

comprising an antibody targeting moiety 

and a toxin domain capable of killing a 

cell. Immunotoxins represent an 

important therapeutic tool for the 

treatment of cancer because they are 

able to specifically target cancer cells 

while ignoring healthy cells. The major 

drawback to immunotoxins is the 

development of neutralizing antibodies 

against the toxin portion of the 

immunotoxin. Many patients treated 

with Pseudomonas exotoxin A (PE) 

based immunotoxins develop 

neutralizing antibodies after the first 

administration. As a result, only one 

effective administration of a PE-based 

immunotoxin is often possible. 

NIH inventors have created a novel 

immunotoxin, where the toxin portion 

is a truncated Cholera exotoxin (cholix 

toxin). Although cholix toxin retains 

strong functional and structural 

similarity to PE, neutralizing antibodies 

to PE do not affect the truncated cholix 

toxin. As a result, cholix toxin-based 

immunotoxins are of potential utility 

after a patient has developed 

neutralizing antibodies to PE. The 

ability to deliver two rounds of 

immunotoxins to a patient will increase 

the successful treatment of various 

diseases, including cancer. 

Application: 


jlentini on PROD1PC65 with NOTICES