Federal Register / Vol. 74, No. 75 / Tuesday, April 21, 2009 / Notices 18241 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: April 16, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–9106 Filed 4–20–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0031] (formerly 

Docket No. 2007D–0233) 

Guidance for Industry on Integrated 

Summaries of Effectiveness and 

Safety: Location Within the Common 

Technical Document; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Integrated Summaries of 

Effectiveness and Safety: Location 

Within the Common Technical 

Document.’’ Since FDA began accepting 

new drug application (NDA) and 

biologics license application (BLA) 

submissions in the common technical 

document (CTD) format, there has been 

confusion regarding where within the 

CTD to include an integrated summary 

of effectiveness (ISE) and integrated 

summary of safety (ISS), both of which 

are required components of an NDA 

submission and recommended 

components of a BLA submission. This 

guidance informs applicants where to 

place the ISE and ISS in the CTD, 

addresses specific FDA requirements 

not discussed in the ICH guidance for 

industry ‘‘M4E: The CTD—Efficacy,’’ 

and is intended to improve application 

quality and consistency. This guidance 

finalizes the draft guidance of the same 

title published in the Federal Register 

of July 3, 2007 (72 FR 36471). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this 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, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 301–827–1800. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 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 to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

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 Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Integrated Summaries of Effectiveness 

and Safety: Location Within the 

Common Technical Document.’’ This 

guidance is intended for applicants 

submitting an NDA or BLA in the CTD 

or electronic common technical 

document (eCTD) format. Since FDA 

adopted the CTD, a standard way to 

organize a marketing or licensing 

application, there has been confusion 

regarding where to place an ISE and ISS 

within the CTD. The ISE and ISS are 

unique requirements of the United 

States and are not addressed fully by 

ICH M4E. 

FDA considers the ISE and ISS critical 

components of the clinical efficacy and 

safety portions of a marketing or 

licensing application. Therefore, the ISE 

and ISS are required in NDA 

applications submitted to FDA in 

accordance with the regulations in 21 

CFR 314.50(d)(5)(v) and (d)(5)(vi)(a). 

Although there are no corresponding 

regulations requiring an ISE or ISS for 

BLAs, applicants are encouraged to 

provide these analyses. 

A common problem with the way 

many of the CTD-formatted applications 

are submitted is that applicants 

incorrectly assume that the clinical 

summaries in Module 2 satisfy the 

regulatory requirements for the ISE and 

ISS. This assumption can result in a 

determination by FDA that an 

application is incomplete. Despite their 

names, the ISE and ISS are detailed 

integrated analyses of all relevant data 

from the clinical study reports, not 

summaries. This guidance focuses on 

where to place ISE and ISS documents 

within the structure of the CTD or 

eCTD. 

This guidance updates the part of 

sections II.G. and H. of the guidance on 

the ‘‘Format and Content of the Clinical 

and Statistical Sections of an 

Application’’ that relates to placement 

of the ISE and ISS. This guidance 

finalizes the draft guidance of the same 

title that published in the Federal 

Register of July 3, 2007 (72 FR 36471). 

No public comments were received 

regarding the draft guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the location for an 

ISE and ISS within the CTD. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

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

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

guidelines.htm, or http:// 

www.regulations.gov. 

Dated: April 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–9051 Filed 4–20–09; 8:45 am] 

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