[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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