[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2865-2866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0488]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Records and Reports
Concerning Experience With Approved New Animal Drugs; Adverse Event
Reports on Forms FDA 1932, 1932a, and 2301
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 18, 2010.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0284.
Also include the FDA docket number found in brackets in the heading of
this document
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr. Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Records and Reports Concerning Experience With Approved New Animal
Drugs; Adverse Event Reports on Forms FDA 1932, 1932a, and 2301 (OMB
Control Number 0910-0284)--Extension
Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360b(l) and Sec. 514.80 (21 CFR 514.80) of FDA
regulations require applicants of approved new animal drug applications
(NADAs) and abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects (see Sec.
514.80(b)).
This continuous monitoring of approved NADAs and ANADAs affords the
primary means by which FDA obtains information regarding potential
problems with the safety and efficacy of marketed approved new animal
drugs as well as potential product/manufacturing problems. Post-
approval marketing surveillance is important because data previously
submitted to FDA may not be adequate, as animal drug effects can change
over time and less apparent effects may take years to manifest.
Under Sec. 514.80(d), an applicant must report adverse drug
experiences and product/manufacturing defects on Form FDA 1932,
``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product
Defect Report.'' Periodic drug experience reports and special drug
experience reports must be accompanied by a completed Form FDA 2301,
``Transmittal of Periodic Reports and Promotional Material for New
Animal Drugs'' (see Sec. 514.80(d)). Form FDA 1932a, ``Veterinary
Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report''
allows for voluntary reporting of adverse drug experiences or product/
manufacturing defects.
The electronic versions of Forms FDA 1932 and 1932a have been
incorporated into the agency-wide information collection
(MedWatch\Plus\Portal and Rational Questionnaire) that was announced
for public comment in the Federal Register on October 23, 2008 (73 FR
63153). MedWatch\Plus\ Portal and Rational Questionnaire is part of a
new electronic system for collecting, submitting, and processing
adverse event reports and other safety information for all FDA-
regulated products. In the Federal Register of May 20, 2009 (74 FR
23721), FDA announced the submission for OMB review and clearance of
the electronic data collection using MedWatch\Plus\ Portal and Rational
Questionnaire.
Burden hours for the electronic versions of these forms were
included as part of the MedWatch\Plus\ Portal and Rationale
Questionnaire information collection approved under OMB control number
0910-0645. It is estimated that, during the first 3 years that the
MedWatch\Plus\ Portal is in use, half of the reports will be submitted
in paper format and half will be submitted electronically. In order to
avoid double counting, an estimated 50 percent of total annual
responses for FDA Form 1932 (404) and FDA Form 1932a (81.5) are counted
here as part of OMB Control No. 0910-0284 for the paper versions of
Forms FDA 1932 and 1932a, and an estimated 50 percent of the total
annual responses (404) and (81.5) for Form FDA 1932 and FDA Form 1932a
respectively, are counted as part of OMB Control No. 0910-0645 for the
electronic reporting of these adverse reports using the MedWatch\Plus\
Portal.
In the Federal Register of October 15, 2009 (74 FR 52967), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
In a separate 30-day notice, FDA requested public comment on data
elements associated with revisions to Forms FDA 1932 and 1932a (both
paper and electronic) under revised OMB Control No. 0910-0645 (November
20, 2009, 74 FR 60265). The agency plans to give companies time to
accommodate the revisions since the proposed revisions may require
changes to validated databases. The agency plans to provide a
transition period for respondents until September 30, 2010, during
which the current FDA Form 1932 (version dated 01/2007-- approved under
this OMB Control No. 0910-0284) will be accepted as well as the revised
FDA Form 1932 approved under revised OMB Control No. 0910-0645. After
the transition period, Form FDA 2301 will
[[Page 2866]]
continue to be counted as part of OMB Control No. 0910-0284.
The reporting and recordkeeping burden estimates, including the
total number of annual responses, are based on the submission of
reports to the Division of Surveillance, Center for Veterinary
Medicine. The annual frequency of responses was calculated as the total
annual responses divided by the number of respondents.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section or Section of the Act FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3) 1932\2\ 404 44.26 17,881 1 17,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary reporting FDA Form 1932a for the 1932a\2\ 81.5 1 81.5 1\3\ 81.5
public
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(4) 2301 84 17.0 1,428 16 22,848
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(i) 2301 84 0.31 26 2 52
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(ii) 2301 84 33.92 2,849 2 5,698
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(iii) 2301 646 0.08 51.68 2 103
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total hours 46,663.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden hours were determined as explained previously.
\3\ The hours per response for paper versions of Forms FDA 1932 and 1932a are assumed to be 1 hour. The hours per response for the electronic version of
Form FDA 1932 is assumed to be 1 hour, while the electronic version of Form FDA 1932a is assumed to take .6 hours to complete the form and gather the
required information as part of the MedWatch\Plus\ Portal information collection (see 74 FR 23721 at 23727).
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency
Section Recordkeepers per Recordkeeping Total Annual Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
514.80( 646 7.20 4,651 14 65,116.8
e)\2\
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Section 514.80(e) covers all recordkeeping hours for all adverse event reporting.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-782 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S