Agency Information Collection Activities; Submission for OMB Review; Comment Request; Salmonella Discovery System Pilot Study

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by July 15, 2002.

ADDRESSES:

Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Salmonella Discovery System Pilot Study

FDA's Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Informatics and Computational Safety Analysis Staff intends to conduct a Salmonella Discovery System Pilot Study (the pilot study). The primary goal of the pilot study is to construct and execute a mutually beneficial process by which FDA and pharmaceutical companies can share information based on their proprietary toxicology study data and thereby expand their own knowledge databases. This process will be designed and conducted using procedures that do not compromise the identity and chemical structures of the individual collaborator's proprietary chemicals.

The three major objectives of the pilot study are to:

• Build a joint and comprehensive FDA/pharmaceutical industry database for compounds tested in the Salmonella typhimurium reverse mutagenicity assay;
• Use these data to construct a new enhanced Salmonella t. mutagenicity assay database module for the MultiCASE quantitative structure activity relationship software program; and
• Employ the recently developed MultiCASE expert system (MCASE-ES) to predict the mutagenic response, mutagenic potency, and mechanism of mutagenesis of test chemicals in Salmonella t.

The pilot study will be a joint venture designed to maximize the benefits and minimize the risks to all collaborators. FDA intends to send letters to companies that have purchased either MultiCASE or CASETOXII software programs to invite them to become a collaborator in the project.

FDA intends to request that each collaborator submit the following data electronically: (1) Test compound chemical structures; and (2) assay data, identifying the type of Salmonella mutagenicity assay used in the studies, the source and concentration of any exogenous activation system used, and the average number of revertants/plate for the negative control, positive control, and each of the test compound treatment groups. Although there is no minimum requirement for the number of test compounds to be submitted to FDA, the agency would expect to receive at least 200 compounds from each collaborator. Each company will be able to identify its own compounds in the resulting discovery system, and the more data submitted, the greater the coverage will be for each company's molecular universe.

FDA intends to act as the broker for the pilot study and will be responsible for the confidentiality and integrity of each collaborator's proprietary data. The number of compounds in the database module will depend upon the number of collaborators and the size of the data sets they contribute to the pilot study. After the enhanced Salmonella discovery system has been constructed and tested, FDA intends to custom prepare individual discovery systems for each collaborator.

The anticipated benefits to collaborators include:

• Receipt of a new expanded Salmonella in silico discovery tool at no cost;
• Access to proprietary molecular fragment data derived from Salmonella t. mutagenicity studies from FDA and other collaborator archives;
• Comprehensive lists of molecular structural alerts correlated with mutagenicity in Salmonella t., including previously uncharacterized alerts derived from heretofore inaccessible undeveloped lead pharmaceutical test data; and
• A Salmonella discovery system which should provide high coverage and high predictive performance for organic chemicals in each company's combinatorial and lead chemical data sets.

The Salmonella discovery system provided by FDA will be compatible with each company's current MCASE software program currently v. 3.46 and will supplement current Salmonella modules purchased from MultiCASE, Inc.

Participation in this pilot study will be voluntary. FDA estimates that approximately 12 companies will participate, and that it will take each company approximately 8 hours to compile the information from electronic archives and submit the requested data and information.

FDA estimates the burden of this collection of information as follows:

In the Federal Register of January 28, 2002 (67 FR 3902), the agency requested comments on the proposed collections of information. No comments were received.