[Federal Register Volume 67, Number 115 (Friday, June 14, 2002)]
[Notices]
[Pages 40946-40947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0590]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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:

[[Page 40947]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                       Annual Frequency     Total Annual        Hours per
         No. of Respondents              Per Response        Responses           Response         Total Hours
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12                                                    1                 12                  8                 96
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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.

    Dated: June 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15002 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S