[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Pages 64090-64091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of 
Effectiveness, Product Defect Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below 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: Submit written comments on the collection of information by 
December 18, 1998.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk 
Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

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

    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 new animal drug applications (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. Product 
defects and lack of effectiveness complaints are submitted to FDA by 
the drug manufacturer following their own detection of a problem or 
complaints from product users or their veterinarians also using FDA 
Forms 1932 and 1932a. Form FDA 2301 is used 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.
    In the Federal Register of June 10, 1998 (63 FR 31788), the agency 
requested comments on the proposed collection of information using the 
reporting forms cited previously. In response, FDA received one comment 
to the docket. The comment expressed favor in submitting adverse drug 
reactions, lack of effectiveness and product defect reports (data), 
electronically and suggested that Form FDA 1932 be formatted in 
industry standard format (Microsoft Word or Word Perfect), so that 
these data can be submitted electronically. The Center for Veterinary 
Medicine (CVM), is developing procedures for electronic submission of 
adverse drug reactions, lack of effectiveness and product defects. 
Currently, CVM is not able to accept electronic submission of this 
specific data until the electronic submission data standards are in 
place and the hardware/software technology is set up. In the meantime, 
the current regulations do allow for acceptance of computerized reports 
under 21 CFR 510.302(c)(1), in lieu of Form FDA 1932. The information 
contained in a computerized report and the sequence in which it is 
presented must be equivalent to that required in the hard copy of Form 
FDA 1932 and should include the valid OMB control number identified 
with Form FDA 1932, i.e., 0910-0012. The computerized report must be 
submitted in duplicate to CVM for approval prior to initial use. 
Further, once the forms are approved and disseminated for use, CVM will 
post electronic copies via the Worldwide

[[Page 64091]]

Web (WWW). Both the computerized report and forms available via the WWW 
must be submitted via paper.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
    Form No.      21 CFR Section      No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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Form FDA 2301         510.302a        190              19.74        3,750               0.5         1,875       
Form FDA 1932         510.302b        190              15.25        2,900               1.0         2,900       
Form FDA 1932a                                                                                                  
 (voluntary)          510.302b        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       Total Annual                                 
         21 CFR Section               No. of       Frequency per   Response per      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping   Recordkeeper    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: November 10, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30752 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F