[Federal Register Volume 67, Number 18 (Monday, January 28, 2002)]
[Notices]
[Pages 3902-3903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0590]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on FDA's burden estimates to construct and 
utilize a database from which FDA and pharmaceutical companies can 
share information based on their proprietary toxicology study data to 
predict the mutagenic response, mutagenic potency, and mechanism of 
mutagenesis of test chemicals in Salmonella typhimurium.

DATES: Submit written or electronic comments on the collection of 
information by March 29, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    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 t. reverse 
mutagenicity assay;
     Use these data to construct a new enhanced Salmonella t. 
mutagenicity assay database module for the Mu1tiCASE quantitative 
structure activity relationship software program; and
     Employ the recently developed Mu1tiCASE 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

[[Page 3903]]

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 that 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 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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                   Annual Frequency per    Total Annual
       No. of Respondents                Response            Responses      Hours per 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.


    Dated: January 17, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-1989 Filed 1-25-02; 8:45 am]
BILLING CODE 4160-01-S