[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36921-36922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18145]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0363]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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,
including each proposed reinstatement of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting and recordkeeping
requirements for new animal drugs for investigational use.
DATES: Submit written comments on the collection of information by
September 8, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: 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.
[[Page 36922]]
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 reinstatement of an existing 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 listed below.
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.
New Animal Drugs for Investigational Use (21 CFR Part 511) (OMB
Control Number 0910-0117--Reinstatement)
FDA has the responsibility under the Federal Food, Drug, and
Cosmetic Act (the act), for 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 a ``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 amount of new animal drug(s) to be
shipped. Part 511 also requires that records be established and
maintained to document the distribution and use of the investigational
drug to assure 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
assure 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 for 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 estimate of the 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.
Dated: June 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18145 Filed 7-7-98; 8:45 am]
BILLING CODE 4160-01-F