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, 2865-2866 [2010-782]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
Vaccines and Related Biological
Products Advisory Committee,
Center for Drug Evaluation and
Research:
Anesthetic and Life Support Drugs
Advisory Committee,
Antiviral Drugs Advisory Committee,
Endocrinologic and Metabolic Drugs
Advisory Committee,
Center for Devices and Radiological
Health:
Medical Devices Advisory Committee
(consisting of report for Circulatory
System Devices Panel).
Annual reports are available for
public inspections between 9 a.m. and
4 p.m., Monday through Friday at the
following locations:
1. The Library of Congress, Madison
Bldg., Newspaper and Current
Periodical Reading Room, 101
Independence Ave. SE., rm. 133,
Washington, DC; and
2. The Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Dated: January 13, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–807 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
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
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
2865
The electronic versions of Forms FDA
1932 and 1932a have been incorporated
into the agency-wide information
collection (MedWatchPlusPortal and
Rational Questionnaire) that was
announced for public comment in the
Federal Register on October 23, 2008
(73 FR 63153). MedWatchPlus Portal and
Rational Questionnaire is part of a new
electronic system for collecting,
FOR FURTHER INFORMATION CONTACT:
submitting, and processing adverse
Denver Presley, Jr. Office of Information event reports and other safety
Management (HFA–710), Food and Drug information for all FDA-regulated
Administration, 5600 Fishers Lane,
products. In the Federal Register of May
Rockville, MD 20857, 301–796–3793.
20, 2009 (74 FR 23721), FDA announced
the submission for OMB review and
SUPPLEMENTARY INFORMATION: In
clearance of the electronic data
compliance with 44 U.S.C. 3507, FDA
collection using MedWatchPlus Portal
has submitted the following proposed
and Rational Questionnaire.
collection of information to OMB for
Burden hours for the electronic
review and clearance.
versions of these forms were included as
Records and Reports Concerning
part of the MedWatchPlus Portal and
Experience With Approved New
Rationale Questionnaire information
Animal Drugs; Adverse Event Reports
collection approved under OMB control
on Forms FDA 1932, 1932a, and 2301
number 0910–0645. It is estimated that,
(OMB Control Number 0910–0284)—
during the first 3 years that the
Extension
MedWatchPlus Portal is in use, half of
the reports will be submitted in paper
Section 512(l) of the Federal Food,
format and half will be submitted
Drug, and Cosmetic Act (the act) (21
electronically. In order to avoid double
U.S.C. 360b(l) and § 514.80 (21 CFR
counting, an estimated 50 percent of
514.80) of FDA regulations require
applicants of approved new animal drug total annual responses for FDA Form
1932 (404) and FDA Form 1932a (81.5)
applications (NADAs) and abbreviated
are counted here as part of OMB Control
new animal drug applications
No. 0910–0284 for the paper versions of
(ANADAs) to report adverse drug
experiences and product/manufacturing Forms FDA 1932 and 1932a, and an
estimated 50 percent of the total annual
defects (see § 514.80(b)).
responses (404) and (81.5) for Form FDA
This continuous monitoring of
1932 and FDA Form 1932a respectively,
approved NADAs and ANADAs affords
are counted as part of OMB Control No.
the primary means by which FDA
0910–0645 for the electronic reporting
obtains information regarding potential
of these adverse reports using the
problems with the safety and efficacy of
MedWatchPlus Portal.
marketed approved new animal drugs as
In the Federal Register of October 15,
well as potential product/manufacturing 2009 (74 FR 52967), FDA published a
problems. Post-approval marketing
60-day notice requesting public
surveillance is important because data
comment on the proposed collection of
previously submitted to FDA may not be information. No comments were
adequate, as animal drug effects can
received.
change over time and less apparent
In a separate 30-day notice, FDA
effects may take years to manifest.
requested public comment on data
Under § 514.80(d), an applicant must
elements associated with revisions to
report adverse drug experiences and
Forms FDA 1932 and 1932a (both paper
product/manufacturing defects on Form and electronic) under revised OMB
FDA 1932, ‘‘Veterinary Adverse Drug
Control No. 0910–0645 (November 20,
Reaction, Lack of Effectiveness, Product 2009, 74 FR 60265). The agency plans
Defect Report.’’ Periodic drug experience to give companies time to accommodate
reports and special drug experience
the revisions since the proposed
reports must be accompanied by a
revisions may require changes to
completed Form FDA 2301,
validated databases. The agency plans to
‘‘Transmittal of Periodic Reports and
provide a transition period for
Promotional Material for New Animal
respondents until September 30, 2010,
Drugs’’ (see § 514.80(d)). Form FDA
during which the current FDA Form
1932a, ‘‘Veterinary Adverse Drug
1932 (version dated 01/2007— approved
Reaction, Lack of Effectiveness or
under this OMB Control No. 0910–0284)
Product Defect Report’’ allows for
will be accepted as well as the revised
voluntary reporting of adverse drug
FDA Form 1932 approved under revised
experiences or product/manufacturing
OMB Control No. 0910–0645. After the
defects.
transition period, Form FDA 2301 will
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. 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
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
E:\FR\FM\19JAN1.SGM
19JAN1
2866
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
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 BURDEN1
21 CFR Section or Section
of the Act
No. of
Respondents
FDA Form No.
514.80(b)(1), (b)(2)(i),
(b)(2)(ii), and (b)(3)
19322
Voluntary reporting FDA
Form 1932a for the public
Annual Frequency
per Response
404
1932a2
44.26
81.5
514.80(b)(4)
2301
2301
84
514.80(b)(5)(ii)
2301
514.80(b)(5)(iii)
2301
Hours per
Response
17,881
1
84
514.80(b)(5)(i)
Total Annual
Responses
1
81.5
17.0
Total Hours
17,881
13
81.5
1,428
16
22,848
0.31
26
2
52
84
33.92
2,849
2
5,698
646
0.08
2
103
51.68
Total hours
46,663.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours were determined as explained previously.
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 MedWatchPlus Portal information collection (see 74 FR 23721 at 23727).
2 Burden
3 The
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
514.80(e)2
Annual Frequency
per Recordkeeping
646
Total Annual
Records
7.20
Hours per
Record
4,651
Total Hours
14
65,116.8
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0483]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
User Fee Cover Sheet—Form FDA 3601
AGENCY:
Food and Drug Administration,
jlentini on DSKJ8SOYB1PROD with NOTICES
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
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
(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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0511. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Medical Device User Fee Cover Sheet—
Form FDA 3601—OMB Control Number
0910–0511—Extension
The Federal Food, Drug, and Cosmetic
Act, as amended by the Medical Device
User Fee and Modernization Act of 2002
(Public Law 107–250), and the Medical
Device User Fee Amendments of 2007
(Title II of the Food and Drug
Administration Amendments Act of
2007), authorizes FDA to collect user
fees for certain medical device
applications. Under this authority,
companies pay a fee for certain new
medical device applications or
supplements submitted to the agency for
review. Because the submission of user
fees concurrently with applications and
supplements is required, the review of
an application cannot begin until the fee
is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2865-2866]
From the Federal Register Online via the Government Printing 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 oira_submission@omb.eop.gov. 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
