Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs, 29157-29158 [E6-7616]
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Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
proposed costs. In addition, the
business proposal format will
standardize the cost proposing and
pricing process among all QIOs. With
well-defined cost centers and line items,
proposals can be compared among QIOs
for reasonableness and appropriateness;
Form Number: CMS–718BP, 719BP,
720BP, 721BP, SUM, STAFFING, SC1
and SC2 (OMB#: 0938–0579);
Frequency: Reporting—Triennially;
Affected Public: Not-for-profit
institutions, Business or other for-profit;
Number of Respondents: 20; Total
Annual Responses: 20; Total Annual
Hours: 455.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503. Fax Number:
(202) 395–6974.
Dated: May 9, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–7511 Filed 5–18–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0180]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experience With
Approved New Animal Drugs
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
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
VerDate Aug<31>2005
17:37 May 18, 2006
Jkt 208001
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
requirements for recordkeeping and
reports concerning experience with
approved new animal drugs. The
information contained in the reports
required by this regulation enables FDA
to monitor the use of new animal drugs
after approval and to ensure their
continued safety and efficacy.
DATES: Submit written or electronic
comments on the collection of
information by July 18, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (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 Management
Programs (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 extension of an
existing collection of information,
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 these topics: (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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
29157
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.
Records and Reports Concerning
Experience With Approved New
Animal Drugs—21 CFR 514.80—(OMB
Control Number 0910–0284)—Extension
Implementation of section 512(l) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b) and 21 CFR 514.80
requires applicants of approved new
animal drug applications and
abbreviated new animal drug
applications (NADAs) to submit
product/manufacturing defects, initial
and followup reports for adverse drug
experiences and lack of effectiveness of
new animal drugs, increased frequency
15-day alert reports, periodic drug
experience reports (annually or
semiannually in a specific format), and
other reports (special drug experience
reports, advertisement and promotional
material submissions, and distributor
statements.)
This continuous monitoring of
approved NADAs affords the primary
means by which FDA obtains
information regarding potential
problems in safety and effectiveness of
marketed animal drugs and potential
manufacturing problems. Current data
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.
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. Also, 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
using FDA Forms 1932 and 1932a. Form
FDA 2301 is used to submit the required
transmittal of periodic reports and
promotional material for new animal
drugs. The reporting and recordkeeping
burden estimates are based on the
submission of reports to the Division of
Surveillance, Center for Veterinary
Medicine. The total annual responses
are also based on the submission of
reports to the Division of Surveillance,
Center for Veterinary Medicine. The
E:\FR\FM\19MYN1.SGM
19MYN1
29158
Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
annual frequency of response 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
FDA Form
No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
514.80(b)(1)
1932
190
0.50
95
1
95
514.80(b)(2)(i)
1932
190
64.65
12,283
1
12,283
514.80(b)(2)(ii)
1932
190
31.62
6,007
1
6,007
514.80(b)(3)
1932
340
2.94
1,000
1
1,000
1923a
250
1
250
1
250
514.80(b)(4)
2301
190
6.45
1,226
11
13,486
514.80(b)(5)(i)
2301
190
0.13
25
2
50
514.80(b)(5)(ii)
2301
190
4.06
772
2
1544
514.80(b)(5)(iii)
2301
530
0.11
56
2
112
Voluntary reporting FDA
Form 1932a for public
Total Hours
1There
34827
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
514.80(e)2
514.80(e)3
Total
1There
Annual Frequency
per Recordkeeping
530
530
Total Annual Records
36.58
4.49
Hours per Record
19,385
2,379
Total Hours
0.5
10.35
9,693
24,623
34,316
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates for 514.80(b)(1), (b)(2)(i), (b)(2)(ii), (b)(3), and Form FDA 1932.
estimates for 514.80(b)(2)(iii), (b)(4), (c), (b)(5), and Form FDA 2301.
2Recordkeeping
3Recordkeeping
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7616 Filed 5–18–06; 8:45 am]
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
guidance on informed consent for in
vitro diagnostic device studies using
leftover human specimens that are not
individually identifiable.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0185]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That are
Not Individually Identifiable
wwhite on PROD1PC61 with NOTICES
AGENCY:
Submit written or electronic
comments on the collection of
information by July 18, 2006.
DATES:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
VerDate Aug<31>2005
17:37 May 18, 2006
Jkt 208001
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
ADDRESSES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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 Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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 extension of an
existing collection of information,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 71, Number 97 (Friday, May 19, 2006)]
[Notices]
[Pages 29157-29158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7616]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0180]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Records and Reports Concerning Experience With
Approved New Animal Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 requirements for recordkeeping
and reports concerning experience with approved new animal drugs. The
information contained in the reports required by this regulation
enables FDA to monitor the use of new animal drugs after approval and
to ensure their continued safety and efficacy.
DATES: Submit written or electronic comments on the collection of
information by July 18, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(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 Management
Programs (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 extension of an existing collection of information,
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 these topics: (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.
Records and Reports Concerning Experience With Approved New Animal
Drugs--21 CFR 514.80--(OMB Control Number 0910-0284)--Extension
Implementation of section 512(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b) and 21 CFR 514.80 requires applicants of
approved new animal drug applications and abbreviated new animal drug
applications (NADAs) to submit product/manufacturing defects, initial
and followup reports for adverse drug experiences and lack of
effectiveness of new animal drugs, increased frequency 15-day alert
reports, periodic drug experience reports (annually or semiannually in
a specific format), and other reports (special drug experience reports,
advertisement and promotional material submissions, and distributor
statements.)
This continuous monitoring of approved NADAs affords the primary
means by which FDA obtains information regarding potential problems in
safety and effectiveness of marketed animal drugs and potential
manufacturing problems. Current data 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.
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. Also, 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 using FDA Forms
1932 and 1932a. Form FDA 2301 is used to submit the required
transmittal of periodic reports and promotional material for new animal
drugs. The reporting and recordkeeping burden estimates are based on
the submission of reports to the Division of Surveillance, Center for
Veterinary Medicine. The total annual responses are also based on the
submission of reports to the Division of Surveillance, Center for
Veterinary Medicine. The
[[Page 29158]]
annual frequency of response 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form No. of Annual Frequency Total Annual Hours per
21 CFR Section No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(1) 1932 190 0.50 95 1 95
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(2)(i) 1932 190 64.65 12,283 1 12,283
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(2)(ii) 1932 190 31.62 6,007 1 6,007
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(3) 1932 340 2.94 1,000 1 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary reporting FDA Form 1932a for 1923a 250 1 250 1 250
public
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(4) 2301 190 6.45 1,226 11 13,486
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(i) 2301 190 0.13 25 2 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(ii) 2301 190 4.06 772 2 1544
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(b)(5)(iii) 2301 530 0.11 56 2 112
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours ........... ................. ................. ................. ................. 34827
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping BURDEN\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency
21 CFR Section Recordkeepers per Recordkeeping Total Annual Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.80(e)\2\ 530 36.58 19,385 0.5 9,693
514.80(e)\3\ 530 4.49 2,379 10.35 24,623
Total ................. .................... .................... .................... 34,316
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Recordkeeping estimates for 514.80(b)(1), (b)(2)(i), (b)(2)(ii), (b)(3), and Form FDA 1932.
\3\Recordkeeping estimates for 514.80(b)(2)(iii), (b)(4), (c), (b)(5), and Form FDA 2301.
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7616 Filed 5-18-06; 8:45 am]
BILLING CODE 4160-01-S
