[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Notices]
[Pages 66980-66981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0573]


International Conference on Harmonisation; Draft Guidance on 
Addendum to International Conference on Harmonisation S6; Preclinical 
Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1); 
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availability of a draft guidance entitled ``Addendum to ICH S6: 
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 
S6(R1).'' The draft guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance 
provides recommendations on nonclinical studies to support the safety 
of clinical trials and marketing applications for biotechnology-derived 
pharmaceuticals. The draft guidance is intended to clarify and provide 
greater detail to the nonclinical recommendations in the ICH guidance 
entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived 
Pharmaceuticals'' (ICH S6) published in the Federal Register of 
November 18, 1997 (62 FR 61515).

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this draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by February 1, 2010.

ADDRESSES:  Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 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Submit written requests for single copies of the draft guidance to the 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, 
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 two self-addressed 
adhesive labels to assist the office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Anne M. Pilaro, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, rm. 2324, Silver Spring, MD 20993-0002, 301-796-2320; or 
Mercedes A. Serabian, Center for Biologics Evaluation and Research 
(HFM-760), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-5377.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

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

[[Page 66981]]

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 October 2009, the ICH Steering Committee agreed that a draft 
guidance entitled ``Addendum to ICH S6: Preclinical Safety Evaluation 
of Biotechnology-Derived Pharmaceuticals S6(R1)'' should be made 
available for public comment. The draft guidance is the product of the 
Safety (S6) Expert Working Group of the ICH. Comments about this draft 
will be considered by FDA and the ICH S6 Safety Expert Working Group.
    The draft document provides guidance on nonclinical studies to 
support the safety of clinical trials and marketing applications for 
biotechnology-derived pharmaceuticals. Biotechnology-derived 
pharmaceuticals include protein therapeutic, diagnostic, and 
prophylactic products derived from cell-culture systems such as 
bacteria, yeast, and eukaryotic cells, including organisms produced by 
recombinant DNA technology. The draft guidance specifically provides 
clarification of and greater detail to the nonclinical recommendations 
in ICH S6 regarding the topics of species selection, study design, and 
recommendations for immunogenicity, carcinogenicity, and reproductive 
and developmental toxicity testing of biotechnology-derived 
pharmaceuticals. ICH S6 was published more than 10 years ago and much 
knowledge relevant to the safety evaluation of biopharmaceuticals has 
been gained since that original publication. This draft guidance seeks 
to incorporate this new knowledge within the established framework of 
ICH S6 and is intended to enable the development of safe and effective 
biopharmaceuticals. In addition, this draft guidance harmonizes 
approaches given in both ICH S6 and the ICH guidance ``M3(R2) 
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and 
Marketing Authorization for Pharmaceuticals.''
    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 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) electronic or written comments on the draft guidance. 
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.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: December 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29991 Filed 12-16-09; 8:45 am]
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