Federal Register / Vol. 73, No. 168 / Thursday, August 28, 2008 / Notices 50825 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Centers for 

Birth Defects Research and 

Prevention, Funding Opportunity 

Announcement (FOA) DD09–001 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting. 

Time and Date: 9 a.m.–2 p.m., October 7, 

2008 (Closed). 

Place: Centers for Disease Control and 

Prevention, Global Communications Center, 

1600 Clifton Road, NE., Atlanta, GA 30333, 

404–639–3138. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications received in 

response to ‘‘Centers for Birth Defects 

Research and Prevention, FOA DD09–001.’’

Contact Person for More Information: 

Susan Stanton, D.D.S., Scientific Review 

Officer, Office of the Chief Science Officer, 

CDC, 1600 Clifton Road, NE., Mailstop D74, 

Atlanta, GA 30333, Telephone 404–639–

4640. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 22, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–19946 Filed 8–27–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0449] 

Draft Guidance for Industry on 

Integrated Summary of Effectiveness; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Integrated Summary 

of Effectiveness.’’ This draft guidance 

describes how an integrated summary of 

effectiveness (ISE) should be prepared 

by industry for new drug applications 

(NDAs) and biologics license 

applications (BLAs). This guidance, 

when final, will supersede section G, 

Integrated Summary of Effectiveness 

Data, of the 1988 guidance on ‘‘Format 

and Content of the Clinical and 

Statistical Sections of an Application’’

(Clin-Stat guidance). This guidance also 

incorporates the conceptual framework 

of section 2.7.3, Summary of Clinical 

Efficacy, from the International 

Conference on Harmonisation (ICH) 

guidance for industry ‘‘M4E The CTD 

—Efficacy.’’ This guidance is intended 

to improve the quality of product 

applications by describing what efficacy 

information should be submitted so that 

FDA can make a regulatory decision on 

an application. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by October 27, 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; or the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, 1401 Rockville Pike, 

Rockville, MD 20852–1448. The 

guidance may also be obtained from the 

Center for Biologics Evaluation and 

Research by mail by calling 1–800–835–

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 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. 

FOR FURTHER INFORMATION CONTACT: 

Howard Chazin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6470, 

Silver Spring, MD 20993–0002, 

301–796–0700; or 

Leonard Wilson, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, suite 576N, 

Rockville, MD 20852, 301–827–

1053. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Integrated Summary of Effectiveness.’’

This draft guidance describes how an 

ISE should be prepared by industry for 

NDAs and BLAs. The ISE has been 

required as part of an NDA submission 

(21 CFR 314.50(d)(5)(v)) since 1985, but 

the regulation does not describe the 

specific components of the ISE. The 

Clin-Stat guidance provides a 

description of what FDA recommends 

be included in an ISE. However, since 

the Clin-Stat guidance was published, 

several International Conference on 

Harmonisation guidances, including the 

ICH guidances for industry ‘‘E3 

Structure and Content of Clinical Study 

Reports,’’ ‘‘E10 Choice of Control Group 

and Related Issues in Clinical Trials,’’

and ‘‘M4E The CTD—Efficacy,’’ have 

provided further recommendations for 

describing individual trials and 

providing results of efficacy analyses. 

This guidance, when final, will 

supersede section G of the Clin-Stat 

guidance to reflect FDA’s current 

thinking regarding the format and 

content of the ISE to provide a truly 

integrated analysis, rather than a 

summary of efficacy results from 

individual clinical trials, and to satisfy 

FDA regulatory requirements. Although 

there are no corresponding regulations 

requiring an ISE for BLA submissions, 

applicants are encouraged to provide 

these analyses. 

Regarding the common technical 

document, the ISE is often confused 

with the document included in Module 

2, section 2.7.3, Summary of Clinical 

Efficacy. Although one of the goals of 

the ISE is to summarize the available 

effectiveness data, the ISE primarily is 

intended to be an integrated analysis of 

these data, going beyond a simple 

summary. The focus of the ISE is not on 

the detailed results of the individual 

studies, which are described in 

individual study reports, but a 

comprehensive, detailed, in-depth 

analysis that goes beyond individual 

study results to examine the basis for 

the entire approach taken. 

This draft guidance is being issued 

consistent with FDA’s good guidance 


jlentini on PROD1PC65 with NOTICES
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