[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36471-36472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0233]


Draft Guidance for Industry on Integrated Summaries of 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Integrated 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 much 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 on 
where to place the ISE and ISS in the CTD. This guidance addresses 
specific FDA requirements not discussed in the ICH guidance for 
industry M4E: The CTD--Efficacy. This guidance is intended to improve 
application quality and consistency.

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this draft guidance before it begins work on the

[[Page 36472]]

final version of the guidance, submit written or electronic comments on 
the draft guidance by September 4, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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. 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft 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 Leonard Wilson, Center for Biologics Evaluation and 
Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 
much 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.
    The pertinent Federal regulations that require an ISE and an ISS 
for NDAs are Sec. Sec.  314.50(d)(5)(v) and 314.50(d)(5)(vi)(a), 
respectively (21 CFR 314.50(d)(5)(v) and 314.50(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 the applicants incorrectly assume 
that the clinical summaries in Module 2 satisfy the regulatory 
requirement for the ISE and ISS. This assumption can result in a 
determination by FDA that an application is incomplete. The ISE and ISS 
are detailed integrated analyses of all relevant data from the clinical 
study reports, not summaries, despite their names. 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 applications submitted to the FDA in accordance 
with the regulations (Sec. Sec.  314.50(d)(5)(v) and 
314.50(d)(5)(vi)(a)). This guidance focuses on where to place ISE and 
ISS documents within the structure of the CTD or eCTD.
    When finalized, this guidance will update, in the guidance on the 
format and content of the clinical and statistical sections of an 
application, the part of sections II.G and H that relates to placement 
of the ISE and ISS.
    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 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.fda.gov/ohrms/dockets/default.htm.

    Dated: June 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12792 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S