[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Notices]
[Pages 31788-31789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0308]


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 obligating holders of approved new animal drug 
applications (NADA's) and abbreviated new animal drug applications to 
submit information on adverse drug reactions, lack of effectiveness and 
product defects.

DATES: Submit written comments on the collection of information by 
August 10, 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. 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 collection of information, including 
each proposed reinstatement of an existing collection, 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.

Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product 
Defect Report--21 CFR Part 510--(OMB Control Number 0910-0012--
Reinstatement)

    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(l)), 21 CFR 510.300, 510.301, and 510.302 require that 
applicants of approved NADA's submit within 15 working days of receipt, 
complete records of reports of certain adverse drug reactions and 
unusual failure of new animal drugs. Other reporting requirements of 
adverse reactions to these drugs must be reported annually or 
semiannually in a specific format.
    This continuous monitoring of approved new animal drugs, affords 
the primary means by which FDA obtains information regarding potential 
problems in safety and effectiveness of marketed animal drugs and 
potential manufacturing problems. Data already on file with FDA is not 
adequate because animal drug effects can change over time and less 
apparent effects may take years to manifest themselves. Reports are 
reviewed along with those previously submitted for a particular drug to 
determine if any change is needed in the product or labeling, such as 
package insert changes, dosage changes, additional warnings or 
contraindications, or product reformulation.
    Adverse reaction reports are required to be submitted by the drug 
manufacturer on FDA Forms 1932 or 1932a (voluntary reporting form), 
following complaints from animal owners or veterinarians. Also, product 
defects and lack of effectiveness complaints are submitted to FDA by 
the drug manufacturer following their own

[[Page 31789]]

detection of a problem or complaints from product users or their 
veterinarians using forms FDA Forms 1932 and 1932a. Form FDA 2301 is 
available for the required transmittal of periodic reports and 
promotional material for new animal drugs. Respondents to this 
collection of information are applicants of approved NADA's.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
      Form        21 CFR Section      No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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FDA 2301              510.302(a)      190              19.74        3,750               0.5          1875       
FDA 1932              510.302(b)      190              15.26        2,900               1.0           290       
FDA 1932a                                                                                                       
 (voluntary)          510.302(b)      100               1.0           100               1.0           100       
Total Burden                                                                                                    
 Hours                                                                                              4,875       
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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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510.300(a) and 510.301(a)             190              15.26        3,750              10.35       38,812       
510.300(b) and 510.301(b)             190              19.74        2,900               0.50        1,450       
Total Burden Hours                                                                                 40,262       
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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 times required for record preparation and 
maintenance is based on agency communication with industry. Other 
information needed to calculate the total burden hours (i.e., adverse 
drug reaction, lack of effectiveness, and product defect reports) are 
derived from agency records and experience.

    Dated: June 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15485 Filed 6-9-98; 8:45 am]
BILLING CODE 4160-01-F