55852 Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 

written or electronic comments on the 

draft guidance by November 25, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert Powell, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4526, 

Silver Spring, MD 20993–0002, 301– 

796–1589 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘End-of-Phase 2A Meetings.’’ This draft 

guidance will meet one of the 

performance goals agreed to under the 

September 27, 2007, reauthorization of 

the Prescription Drug User Fee Act 

(PDUFA IV). Under section XI of the 

PDUFA IV Performance Goals, 

Expediting Drug Development, FDA 

agreed to publish by the end of fiscal 

year 2008 a draft guidance on end-ofphase 2A meetings (see section XI.A.4 at 

http://www.fda.gov/oc/pdufa4/ 

pdufa4goals.html). This draft guidance 

is intended to facilitate early meetings 

(referred to as end-of-phase 2A meetings 

or EOP2A meetings) between FDA and 

sponsors who seek interaction or 

guidance related to the use of 

quantitative drug development methods 

(i.e., exposure-response, 

pharmacokinetic/pharmacodynamic 

(PK/PD) modeling, drug-disease 

modeling, genomic analysis) to inform 

drug development and regulatory 

decisions. The draft guidance provides 

recommendations to IND sponsors on 

the following topics: 

• Objectives of an EOP2A meeting, 

• Possible topics for discussion at 

EOP2A meetings, 

• Useful information for an EOP2A 

meeting package, and 

• Timing of EOP2A meetings. 

This draft guidance is being issued 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 end-of-phase 2A meetings. 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. 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. 

III. Paperwork Reduction Act of 1995 

This 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 and 

the guidance on ‘‘Formal Meetings With 

Sponsors and Applicants for PDUFA 

Products’’ have been approved under 

OMB control numbers 0910–0014 and 

0910–0429, respectively. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 22, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22669 Filed 9–25–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2008–M–0207, FDA– 

2008–M–0243, FDA–2008–M–0244, FDA– 

2008–M–0283, FDA–2008–M–0335, FDA– 

2008–M–0311, FDA–2008–M–0342, FDA– 

2008–M–0378] 

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: 

Nicole Wolanski, Center for Devices and 

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4010. 

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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Notices 55853 

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 April 1, 2008, through 

June 30, 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 APRIL 1, 

2008, THROUGH JUNE 30, 2008 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P050020 

FDA–2008–M–0207 

Abbott Diabetes Care, Inc. FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE 

MONITORING SYSTEM 

March 12, 2008 

P010012 (S037) 

FDA–2008–M–0243 

Guidant Corp. Contak Renewal 3 AVT system & contak reviewal 3AVT 

HE System 

March 13, 2008 

P070027 

FDA–2008–M–0244 

Medtronic Vascular The talent abdominal stent graft system April 15, 2008 

P060040 

FDA–2008–M–0283 

Thoratec Corp. Thoratec Heartmate II Left ventricular assist April 21, 2008 

P070008 

FDA–2008–M–0335 

Biotronik, Inc. Stratos LV CRT–P & stratos LV–T CRT–P, corox OTW 

BP lead & corox OTW-s bp lead 

May 12, 2008 

P070016 

FDA–2008–M–0311 

Cook, Inc. Zenith TX2 Thoracic TAA endovascular graft with the 

H&LB One-shot introduction system 

May 21, 2008 

P070007 

FDA–2008–M–0342 

Medtronic Vascular Talent Thoracic Stent Graft System June 5, 2008 

H070003 

FDA–2008–M–0378 

Synapse Biomedical, Inc. NeuRx RA/4 June 17, 2008 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

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

Dated: September 12, 2008. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E8–22668 Filed 9–25–08; 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. 

Methods for Preparing Bacillus 

anthracis Protective Antigen for Use 

in Vaccines 

Description of Technology: This 

invention relates to improved methods 

of preparing Bacillus anthracis 

protective antigen (PA) from a cell or 

organism, particularly a recombinant 

cell or microorganism, for use in 

vaccines. Production and purification 

methods of modified PA from a nonsporogenic strain of Bacillus anthracis 

are described. Specifically, a scalable 

fermentation and purification process is 

claimed that is suitable for vaccine 

development, and that produces almost 

three times more product than earlierreported processes. This is 

accomplished using a biologically 

inactive protease-resistant PA variant in 

a protease-deficient non-sporogenic 

avirulent strain of B. anthracis (BH445). 

One of the PA variants described in the 

patent application lacks the furin and 

chymotrypsin cleavage sites. 

Advantages: Bacillus anthracis 

protective antigen is a major component 

of the currently licensed human vaccine 

(Anthrax Vaccine Adsorbed, AVA). 

Although the current human vaccine 

has been shown to be effective against 

cutaneous anthrax infection in animals 

and humans and against inhalation 

anthrax in rhesus monkeys, the licensed 

vaccine has several limitations: (1) AVA 


jlentini on PROD1PC65 with NOTICES