[Federal Register: November 18, 1998 (Volume 63, Number 222)]
[Notices]
[Page 64090-64091]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no98-98]

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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 Burden<SUP>1
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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 Burden<SUP>1
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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