Notice: International Conference on Harmonisation; Guidance on S9 
Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability

Federal Register: March 8, 2010 (Volume 75, Number 44)             
                  Page 10487-10488

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``S9 Nonclinical Evaluation for 
Anticancer Pharmaceuticals.'' 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 provides recommendations for nonclinical studies for the 
development of pharmaceuticals, including both drugs and biotechnology 
derived products, intended to treat patients with advanced cancer. The 
recommendations describe the type and timing of nonclinical studies to 
support an investigational new drug application (IND) and the 
submission of a new drug application (NDA) or biologics license 
application (BLA). The guidance is intended to provide information on 
internationally accepted recommendations for nonclinical studies to 
facilitate the development of anticancer pharmaceuticals.

DATES:  Submit written or electronic comments on agency guidance 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 two self-addressed adhesive labels 
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.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John K. 
Leighton, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave, Bldg. 22, rm. 2204, Silver 
Spring, MD 20993-0002, 301-796-2330; or Mercedes Serabian, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 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 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 February 17, 2009 (74 FR 7445), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' 
The notice gave interested persons an opportunity to submit comments by 
April 20, 2009.
    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 October, 2009.
    The guidance provides guidance on recommendations for nonclinical 
studies for the development of pharmaceuticals, including both drugs 
and biotechnology derived products, intended to treat patients with 
advanced cancer. The recommendations describe the type and timing of 
nonclinical studies to support an IND and the submission of an NDA or 
BLA.
    In response to comments received on the draft guidance, the 
guidance was revised to provide clarification of the following topics: 
(1) The intended patient population covered by the guidance, (2) 
inclusion of recovery groups for general toxicology studies, (3) 
additional nonclinical studies to support clinical dosing schedule 
changes, and (4) when impurities should be qualified. The guidance was 
revised to address the following additional topics: (1) Inclusion of 
electrocardiographic measurements as part of general toxicology 
studies, (2) the study design for reproduction toxicology assessment 
for biopharmaceuticals, (3) assessment of the safety of pharmaceutical 
combinations, and (4) photosafety assessments.
    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 on the guidance. 
Submit a

[[Page 10488]]

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: March 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4841 Filed 3-5-10; 8:45 am]
BILLING CODE 4160-01-S