[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29141-29142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13298]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0231]
Agency Information Collection Activities; Proposed Collection;
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 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 extension 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 (NADAs) and abbreviated new animal drug applications
(ANADAs) to submit information on adverse drug reactions, lack of
effectiveness, and product defects.
DATES: Submit written or electronic comments on the collection of
information by July 30, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. 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 set forth in this document.
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 No. 0910-0012)--
Extension
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 NADAs 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. FDA form 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 NADAs.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\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 510.302(a) 190 13.16 2,500 0.5 1,250
Form FDA 1932 510.302(b) 190 94.74 18,000 1.0 18,000
[[Page 29142]]
Form FDA 1932a (voluntary) 510.302(b) 100 1.0 100 1.0 100
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Total burden hours 19,350
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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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Total Annual
21 CFR No. of Annual Frequency Response per Hours per Total Hours
Section Recordkeepers per Recordkeeping Recordkeeper Recordkeeper
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510.300(a) 190 13.16 2,500 10.35 25,875
and
510.301(a)
510.300(b) 190 94.74 2,900 0.50 9,000
and
510.301(b)
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Total 34,875
burden
hours
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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: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13298 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S