[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29665-29666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


International Conference on Harmonisation; Addendum to 
International Conference on Harmonisation Guidance on S6 Preclinical 
Safety Evaluation of Biotechnology-Derived Pharmaceuticals; 
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 ``S6 Addendum to Preclinical Safety 
Evaluation of Biotechnology-Derived Pharmaceuticals'' (S6 addendum). 
The S6 addendum was prepared under the auspices of the International 
Conference on Harmonisation of Technical Requirements for Registration 
of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to 
incorporate new knowledge and experience gained since the 
implementation of the ICH guidance

[[Page 29666]]

entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived 
Pharmaceuticals'' (ICH S6) and to clarify and provide greater detail to 
enable the development of safe and effective biopharmaceuticals.

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 (CBER), 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 CBER 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. 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: 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, 301-827-4119. 
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, 301-796-4600.

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 December 17, 2009 (74 FR 66980), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Addendum to ICH S6: Preclinical Safety Evaluation of 
Biotechnology-Derived Pharmaceuticals (S6)(R1).'' The notice gave 
interested persons an opportunity to submit comments by February 1, 
2010.
    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 June 2011.
    The S6 addendum provides recommendations 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 S6 addendum incorporates new knowledge 
and experience gained since the implementation of the ICH S6 guidance 
in 1997 and provides clarification of and greater detail to the 
nonclinical recommendations in ICH S6 to enable the development of safe 
and effective biopharmaceuticals. The S6 addendum is intended to be 
used in conjunction with the original ICH S6 guidance. In general, the 
S6 addendum is complementary to ICH S6, and where the S6 addendum 
differs from ICH S6, the guidance in the S6 addendum prevails. In 
addition, the S6 addendum 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 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. 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: May 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12039 Filed 5-17-12; 8:45 am]
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