Académique Documents
Professionnel Documents
Culture Documents
Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 300
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19074 Federal Register / Vol. 73, No. 68 / Tuesday, April 8, 2008 / Notices
of any non-clinical laboratory studies investigational drug to assure that its industry, academic institutions, and the
with good laboratory practices; (4) the use is safe and that the distribution is government. Investigators may include
name and address of each clinical controlled to prevent potential abuse. individuals from these entities as well
investigator; (5) the approximate The agency uses these required records as research firms and members of the
number of animals to be treated or under its Bio-Research Monitoring medical professional. Respondents for
amount of new animal drug(s) to be Program to monitor the validity of the this collection of information are
shipped; and (6) information regarding studies submitted to FDA to support investigators who use new animal drugs
the use of edible tissues from new animal drug approval and to assure for investigational purposes.
investigational animals. Part 511 also that proper use of the drug is
requires that records be established and maintained by the investigator. FDA estimates the burden for this
maintained to document the Investigational new animal drugs are collection of information as follows:
distribution and use of the used primarily by the pharmaceutical
Total 12,178
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Total 11,627
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for reporting Please note that on January 15, 2008, DEPARTMENT OF HEALTH AND
requirements, record preparation, and the FDA Division of Dockets HUMAN SERVICES
maintenance for this collection of Management Web site transitioned to
information are based on agency the Federal Dockets Management Food and Drug Administration
communication with industry and System (FDMS). FDMS is a [Docket No. FDA–2008–D–0199] (formerly
agency records. Based on the number of Government-wide, electronic docket Docket No. 2006D–0526)
sponsors subject to animal drug user management system. Electronic
fees, FDA estimates there are 134 comments or submissions will be International Conference on
respondents. This estimate is used accepted by FDA through FDMS only. Harmonisation; Guidance on E15
consistently throughout the burden Pharmacogenomics Definitions and
Dated: March 31, 2008. Sample Coding; Availability
tables and for example, the ‘‘annual
Jeffrey Shuren,
frequency per respondent’’ was AGENCY: Food and Drug Administration,
Associate Commissioner for Policy and
calculated by dividing the total annual HHS.
Planning.
responses by the number of ACTION: Notice.
[FR Doc. E8–7255 Filed 4–7–08; 8:45 am]
respondents. Additional information
needed to make final calculations for BILLING CODE 4160–01–S SUMMARY: The Food and Drug
the total burden estimates in tables 1 Administration (FDA) is announcing the
pwalker on PROD1PC71 with NOTICES
and 2 of this document, i.e., the hours availability of a guidance entitled ‘‘E15
per response, the hours per record, the Definitions for Genomic Biomarkers,
number of NCIEs received, etc., was Pharmacogenomics, Pharmacogenetics,
derived from agency records. Genomic Data and Sample Coding
Categories.’’ The guidance was prepared
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