[Federal Register: April 20, 2005 (Volume 70, Number 75)]
[Notices]               
[Page 20570-20571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap05-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0470]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information 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: Fax written comments on the collection of information by May 20, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 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)--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

[[Page 20571]]

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.
    In the Federal Register of November 10, 2004 (69 FR 65198), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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
----------------------------------------------------------------------------------------------------------------
511.1(b)(4)                     190               4.09                 778                  8              6,224
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511.1(b)(5)                     190               0.58                 110                140             15,400
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511.1(b)(6)                     190                .01                  20                  1                 20
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511.1(b)(8)(ii)                 190                .005                  1                 20                 20
----------------------------------------------------------------------------------------------------------------
511.1(b)(9)                     190                .10                  20                  8                160
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Total                                                                                                     21,824
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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 Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers        per Record          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
511.1(a)(3)                      190               2.11                400                  9              3,600
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511.1(b)(3)                      190               4.20                798                  1                798
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511.1(b)(7)(ii)                  400               3.00              1,200                3.5              4,200
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511.1(b)(8)(i)                   190               6.38              1,200                3.5              4,200
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Total                                                                                                     12,798
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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: April 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7823 Filed 4-19-05; 8:45 am]

BILLING CODE 4160-01-S