[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