[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52667-52668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21447]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0386]


International Conference on Harmonisation; Guidance on E2F 
Development Safety Update Report; 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 guidance entitled ``E2F Development Safety Update 
Report.'' The guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The guidance 
describes the format, content, and timing of a development safety 
update report (DSUR) for an investigational drug. The DSUR will serve 
as a common standard for periodic reporting on drugs under development 
(including marketed drugs that are under further study) among the ICH 
regions. The DSUR can be submitted in the United States in place of an 
annual report for an investigational new drug application (IND). The 
harmonized DSUR is intended to promote a consistent approach to annual 
clinical safety reporting among the ICH regions and enhance efficiency 
by reducing the number of reports generated for submission to the 
regulatory authorities.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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, Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist the office in processing your requests. The guidance may also 
be obtained by mail by calling the Center for Biologics Evaluation and 
Research at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov.

[[Page 52668]]

Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Ellis F. 
Unger, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4208, Silver 
Spring, MD 20993-0002, 301-796-2270; or Peter F. Bross, Center for 
Biologics Evaluation and Research (HFM-755), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5102.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 3506, Silver Spring, MD 20993, 301-796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote 
international harmonization of regulatory requirements. FDA has 
participated in many meetings designed to enhance harmonization and is 
committed to seeking scientifically based harmonized technical 
procedures for pharmaceutical development. One of the goals of 
harmonization is to identify and then reduce differences in technical 
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission; the European Federation of Pharmaceutical Industries 
Associations; the Japanese Ministry of Health, Labour, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of 
the ICH sponsors and the IFPMA, as well as observers from the World 
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of August 5, 2008 (73 FR 45462), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``E2F Development Safety Update Report.'' The notice gave 
interested persons an opportunity to submit comments by November 3, 
2008.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in August 2010.
    The guidance describes the format, content, and timing of a DSUR 
for an investigational drug. The DSUR will serve as a common standard 
for periodic reporting on drugs under development (including marketed 
drugs that are under further study) among the ICH regions. The DSUR is 
patterned after the periodic safety update report (used for safety 
reporting in the postmarketing environment) and can be submitted in the 
United States in place of an annual report for an IND. The harmonized 
DSUR is intended to promote a consistent approach to annual clinical 
safety reporting among the ICH regions and enhance efficiency by 
reducing the number of reports generated for submission to the 
regulatory authorities.
    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 this topic. 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) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: August 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21447 Filed 8-22-11; 8:45 am]
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