[Federal Register: November 10, 2004 (Volume 69, Number 217)]
[Notices]               
[Page 65198-65200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no04-117]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0470]

 
Agency Information Collection Activities: Proposed Collection; 
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 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 extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting and 
recordkeeping requirements for ``New Animal Drugs for Investigational 
Use.''

DATES: Submit written or electronic comments on the collection of 
information by January 10, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(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: Denver Presley, Office of Management 
Programs (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

[[Page 65199]]

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 extension 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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)--Extension
    FDA has the responsibility under the Federal Food, Drug, and 
Cosmetic Act (the act), for approval of new animal drugs. Section 
512(j) of the act (21 U.S.C. 360b(j)), authorizes FDA to issue 
regulations relating to the investigational use of new animal drugs. 
The regulations setting forth the conditions for investigational use of 
new animal drugs have been codified at part 511 (21 CFR part 511). A 
sponsor must submit to FDA a Notice of Claimed Investigational 
Exemption (INAD), before shipping the new animal drug for clinical 
tests in animals. The INAD 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, (4) name and address of each 
clinical investigator, (5) the approximate number of animals to be 
treated or amount of new animal drug(s) to be shipped, and (6) 
information regarding the use of edible tissues from investigational 
animals. 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, and that distribution is 
controlled to prevent potential abuse. The agency utilizes these 
required records under its Bio-Research Monitoring Program to monitor 
the validity of the studies submitted to FDA to support new animal drug 
approval and to assure that proper use of the drug is maintained by the 
investigator.
    Investigational new animal drugs are used 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 the persons who use new animal drugs 
investigationally.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents       per  Response        Responses           Response         Total Hours
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511.1(b)(4)                      190               4.09                778                  8              6,224
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Total Burden                  21,824
 Hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                    Estimated Annual Recordkeeping Burden\1\
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                                                                       Annual
                                                        No. of     Frequency per   Total     Hours per    Total
                  21 CFR Section                    Recordkeepers                  Annual  Recordkeeper   Hours
                                                                   Recordkeeping  Records
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511.1(a)(3)                                                190           2.11         400           9      3,600
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Total Burden Hours                                      12,798
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 65200]]

    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: November 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24991 Filed 11-9-04; 8:45 am]

BILLING CODE 4160-01-S