[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Notices]
[Pages 66548-66549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32021]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0363]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; New Animal Drugs for Investigational Use
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 (the PRA).
DATES: Submit written comments on the collection of information by
January 4, 1999.
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:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
New Animal Drugs for Investigational Use ( 21 CFR Part 511) (OMB
Control Number 0910-0117)
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is
responsible for the approval of new animal drugs for investigational
use. Section 512(j) of the act (21 U.S.C. 360b(j)) requires that a
sponsor submit to FDA ``Notice of Claimed Investigational Exemption''
(INAD), prior to shipment of the new animal drug for clinical tests in
animals. The regulations implementing statutory requirements for INAD
approval have been codified under part 511 (21 CFR part 511). The INAD
application must contain, among other things, the following specific
information: (1) Identity of the new animal drug, (2) labeling, (3)
statement of compliance of any nonclinical laboratory studies with good
laboratory practices, and (4) name and address of each clinical
investigator and the approximate number of animals to be treated or the
amount of new animal drugs to be shipped. Part 511 also requires that
records be established and maintained to document the distribution and
use of the investigational drug to ensure that its use is safe, that
distribution is controlled to prevent potential abuse, and that edible
products of treated animals will not be distributed for food without
proper authorization from FDA. The agency utilizes these required
records under its ``Bio-Research Monitoring Program'' to monitor the
validity of the studies and to ensure that proper use of the drug is
maintained by the investigator.
Investigational new animal drugs are sponsored primarily by drug
industry firms, academic institutions, and the Government.
Investigators may include individuals from these entities as well as
research firms and members of the medical profession. Respondents to
this collection of information are both sponsors and investigators.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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511.1(b)(4) 190 6 1,147 8 9,176
511.1(b)(5) 190 1.5 287 140 40,180
511.1(b)(6) 190 .005 1 250 250
511.1(b)(8)(ii) 190 .005 1 20 20
511.1(b)(9) 190 .16 30 8 240
Total Burden Hours 49,866
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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511.1(a)(3) 190 7.5 1,434 9 12,906
511.1(b)(3) 190 10 1,912 1 1,912
511.1(b)(7)(ii) 190 2 956 3.5 3,346
511.1(b)(8)(i) 190 4 956 3.5 3,346
Total Burden Hours 21,510
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated time required for reporting requirements, record
preparation, and maintenance for this collection of information is
based on agency communication with industry. Additional information
needed to make a final calculation of the total burden hours (i.e., the
number of respondents, the number of recordkeepers, the number of INAD
applications received, etc.) is derived from agency records.
[[Page 66549]]
Dated: November 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32021 Filed 12-1-98; 8:45 am]
BILLING CODE 4160-01-F