Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs, 55482-55484 [06-8023]
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55482
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
Meeting Date: October 17, 2006
from 9 a.m. to 3:30 p.m., e.d.t.
Deadline for Meeting Registration,
Presentations, and Written Comments:
October 10, 2006, 12 noon, e.d.t.
ADDRESSES: Meeting Location: Marriott
Metro Center Hotel, 775 12th Street,
NW., Washington, DC 20005, (202) 737–
2200.
Meeting Registration, Presentations,
and Written Comments: Lynne Johnson,
Health Insurance Specialist, Division of
Partnership Development, Office of
External Affairs, Centers for Medicare &
Medicaid Services, 7500 Security
Boulevard, Mail stop S1–05–06,
Baltimore, MD 21244–1850 or contact
Ms. Johnson via e-mail at
Lynne.Johnson@cms.hhs.gov.
Meeting Registration: The meeting is
open to the public, but attendance is
limited to the space available. Persons
wishing to attend this meeting must
register by contacting Lynne Johnson at
the address listed in the ADDRESSES
section of this notice or by telephone at
(410) 786–0090, by 12 noon, e.d.t., on
October 10, 2006.
FOR FURTHER INFORMATION CONTACT:
Lynne Johnson, (410) 786–0090. Please
refer to the CMS Advisory Committees’
Information Line (1–877–449–5659 toll
free)/(410–786–9379 local) or the
Internet (https://www.cms.hhs.gov/
FACA/04_APME.asp) for additional
information and updates on committee
activities. Press inquiries are handled
through the CMS Press Office at (202)
690–6145.
SUPPLEMENTARY INFORMATION: Section
222 of the Public Health Service Act (42
U.S.C. 217a), as amended, grants to the
Secretary the authority to establish an
advisory panel if the Secretary finds the
panel necessary and in the public
interest. The Secretary signed the
charter establishing this Panel on
January 21, 1999 and approved the
renewal of the charter on January 14,
2005. The establishment of the charter
and renewal of the charter were
announced in the February 17, 1999
Federal Register (64 FR 7899), and the
January 28, 2005 Federal Register (70
FR 4129), respectively. The Panel
advises and makes recommendations to
the Secretary and the Administrator of
the Centers for Medicare & Medicaid
Services (CMS) on opportunities to
enhance the effectiveness of consumer
education strategies concerning the
Medicare program.
The goals of the Panel are as follows:
• To develop and implement a
national Medicare education program
that describes the options for selecting
a health plan under Medicare.
sroberts on PROD1PC70 with NOTICES
DATES:
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• To enhance the Federal
government’s effectiveness in informing
the Medicare consumer, including the
appropriate use of public-private
partnerships.
• To expand outreach to vulnerable
and underserved communities,
including racial and ethnic minorities,
in the context of a national Medicare
education program.
• To assemble an information base of
best practices for helping consumers
evaluate health plan options and build
a community infrastructure for
information, counseling, and assistance.
The current members of the Panel are:
Anita B. Boles, Executive Director,
Partnership for Clear Health
Communications; Gwendolyn T.
Bronson, SHINE/SHIP Counselor,
Massachusetts SHINE Program; Dr.
Yanira Cruz, President and Chief
Executive Officer, National Hispanic
Council on Aging; Clayton Fong,
President and Chief Executive Officer,
National Asian Pacific Center on Aging;
Nan Kirsten-Forte, Executive Vice
President, Consumer Services, WebMD;
Dr. Jessie C. Gruman, President and
Chief Executive Officer, Center for the
Advancement of Health; Betty L.
Kennard, Vice President, Government
Programs and Compliance, Health First
Health Plans; Dr. David Lansky,
Director, Health Program, Markle
Foundation; Dr. Daniel Lyons, Senior
Vice President, Government Programs,
Independence Blue Cross; Dr. Frank B.
McArdle, Manager, Hewitt Research
Office, Hewitt Associates; Traci
McClellan, J.D., Executive Director,
National Indian Council on Aging; Dr.
Keith Mueller, Professor and Section
Head, Health Services Research and
Rural Health Policy, University of
Nebraska; Lee Partridge, Senior Health
Policy Advisor, National Partnership for
Women and Families; Myisha M.
Patterson, National Health Coordinator,
National Association for the
Advancement of Colored People; Susan
O. Raetzman, Associate Director, Public
Policy Institute, American Association
of Retired Persons; Rebecca Snead,
Administrative Manager, National
Alliance of State Pharmacy Association;
William A. Steel, President, The
National Grange; Marvin Tuttle, Jr.,
CAE, Executive Director and Chief
Executive Officer, Financial Planning
Association; Catherine Valenti,
Chairperson and Chief Executive
Officer, Caring Voice Coalition; and
Grant Wedner, Manager, Business
Development Team, Cosmix
Corporation.
The agenda for the October 17, 2006
meeting will include the following:
PO 00000
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• Recap of the previous (May 25,
2006) meeting.
• Centers for Medicare & Medicaid
Services Update.
• Medicare Preventive Benefits.
• Medicare Prescription Drug Benefit
Update.
• Public Comment.
• Listening Session with CMS
Leadership.
• Next Steps.
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to Lynne
Johnson at the address listed in the
ADDRESSES section of this notice no later
than 12 noon, e.d.t., on October 10,
2006. The number of oral presentations
may be limited by the time available.
Individuals not wishing to make a
presentation may submit written
comments to Ms. Johnson at the address
listed in the ADDRESSES section of this
notice by 12 noon, e.d.t., on October 10,
2006.
Special Accommodation: Individuals
requiring sign language interpretation or
other special accommodations should
contact Ms. Johnson at the address
listed in the ADDRESSES section of this
notice at least 15 days before the
meeting.
Authority: Sec. 222 of the Public Health
Service Act (42 U.S.C. 217a) and sec. 10(a)
of Public Law 92–463 (5 U.S.C. App. 2, sec.
10(a) and 41 CFR 102–3).
(Catalog of Federal Domestic Assistance
Program No. 93.733, Medicare—Hospital
Insurance Program; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 7, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 06–7884 Filed 9–21–06; 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; Submission for Office of
Management and Budget Review;
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
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55483
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
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 October 23,
2006.
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:
202–395–6974.
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: 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—21 CFR 518.80—(OMB
Control No. 0910–0284)—Extension
Implementation of section 512(l) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360b(l)) and § 514.80 (21
CFR 514.80) requires applicants of
approved new animal drug applications
(NADAs) and abbreviated new animal
drug applications (ANADAs) 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 (CVM). The total annual
responses are also based on the
submission of reports to the Division of
Surveillance, CVM. The annual
frequency of response was calculated as
the total annual responses divided by
the number of respondents.
In the Federal Register of May 19,
2006 (71 FR 29157), FDA published a
60-day notice requesting public
comment on the information collection
provisions. In response to this notice,
FDA received seven comments, four of
which required a response by CVM that
are addressed as follows: One comment
stated that FDA’s estimate for the
burden of the proposed collection of
information seems unrealistic and
inaccurate. The comment proposed 16
hours of response time for Drug
Experience Reports (DER), and 49 hours
for recordkeeping for each DER. FDA
agrees that 16 hours is a reasonable
response time required to make a DER
report. In view of increased reporting
requirements under § 514.80 (b)(4),
CVM has increased the ‘‘Hours per
Response’’ under this citation in ‘‘Table
1—Estimated Annual Reporting
Burden,’’ from 11 to 16 hours thereby
increasing the total burden hours to
19,616. The comment also proposed 49
hours response time per record for each
DER. However, based on CVM’s
experience and previous surveys of
industry, the 49 hours of response per
record for each DER is excessive. In
view of increased requirements, under
§ 514.80(e)3, CVM has increased the
‘‘Hours per Record’’ under this citation
in ‘‘Table 2—Estimated Annual
Recordkeeping Burden,’’ from 10.35 to
14 hours, thereby increasing the total
burden hours to 33,320.
Another comment suggested that the
burden collections may be potentially
reduced by: (1) Reducing submission
requirements with established safety
and (2) by automating the information
collection system. FDA agrees with the
comment regarding both suggestions.
Under § 514.80(b)(4), it states for yearly
periodic DER reports, an applicant may
petition FDA to change the anniversary
date and/or change the frequency of
reporting. Regarding the comment
suggesting automation of the
information collection system, future
burden estimates for collections of
information will be considered when
automated reporting requirements are
implemented by FDA.
Another comment wanted to know
the purpose for submitting a periodic
report for a known event for a product
with an established record. As
previously stated, under § 514.80(b)(4),
an applicant may petition FDA to
change the anniversary date and/or
change the frequency of reporting.
The respondents to this collection of
information are applicants of approved
NADAs and ANADAs.
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
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)
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514.80(b)(1)
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
Voluntary reporting
FDA Form 1932a
for public
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20:37 Sep 21, 2006
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22SEN1
55484
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
FDA Form
No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
514.80(b)(4)
2301
190
6.45
1,226
16
19,616
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
1There
40,957
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
0.5
14
Total Hours
9,693
33,320
43,013
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), and (b)(3); Form FDA 1932.
estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.
2Recordkeeping
3Recordkeeping
The reporting and recordkeeping
burden estimates for this collection of
information are based on the submission
of reports to the Division of
Surveillance, CVM. The total annual
response numbers are also based on the
submission of reports to the Division of
Surveillance, CVM. The annual
frequency of response was calculated as
the total annual responses divided by
the number of respondents.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–8023 Filed 9–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0105]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 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.
VerDate Aug<31>2005
20:37 Sep 21, 2006
Jkt 208001
Fax written comments on the
collection of information by October 23,
2006.
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:
202–395–6974.
FOR FURTHER INFORMATION CONTACT: Liz
Berbakos, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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.
DATES:
Environmental Impact
Considerations—(OMB Control Number
0910–0322)—Extension
FDA is requesting OMB approval for
the reporting requirements contained in
the FDA regulation ‘‘Environmental
Impact Considerations.’’
The National Environmental Policy
Act (NEPA) (42 U.S.C. 4321–4347),
states national environmental objectives
and imposes upon each Federal agency
the duty to consider the environmental
effects of its actions. Section 102(2)(C)
of NEPA requires the preparation of an
environmental impact statement (EIS)
for every major Federal action that will
significantly affect the quality of the
human environment.
The FDA NEPA regulations are in part
25 (21 CFR part 25). All applications or
PO 00000
Frm 00069
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petitions requesting agency action
require the submission of a claim for a
categorical exclusion or an
environmental assessment (EA). A
categorical exclusion applies to certain
classes of FDA-regulated actions that
usually have little or no potential to
cause significant environmental effects
and are excluded from the requirements
to prepare an EA or EIS. Section
25.15(a) and (d) specifies the procedures
for submitting to FDA a claim for a
categorical exclusion. Extraordinary
circumstances (§ 25.21), which may
result in significant environmental
impacts, may exist for some actions that
are usually categorically excluded. An
EA provides information that is used to
determine whether an FDA action could
result in a significant environmental
impact. Section 25.40(a) and (c)
specifies the content requirements for
EAs for nonexcluded actions.
This collection of information is used
by FDA to assess the environmental
impact of agency actions and to ensure
that the public is informed of
environmental analyses. Firms wishing
to manufacture and market substances
regulated under statutes for which FDA
is responsible must, in most instances,
submit applications requesting
approval. Environmental information
must be included in such applications
for the purpose of determining whether
the proposed action may have a
significant impact on the environment.
Where significant adverse effects cannot
be avoided, the agency uses the
submitted information as the basis for
preparing and circulating to the public
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55482-55484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0180]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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
[[Page 55483]]
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 October
23, 2006.
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: 202-395-6974.
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: 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--21 CFR 518.80--(OMB Control No. 0910-0284)--Extension
Implementation of section 512(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(l)) and Sec. 514.80 (21 CFR 514.80)
requires applicants of approved new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) 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 semi-annually 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 (CVM). The total annual responses are also based on
the submission of reports to the Division of Surveillance, CVM. The
annual frequency of response was calculated as the total annual
responses divided by the number of respondents.
In the Federal Register of May 19, 2006 (71 FR 29157), FDA
published a 60-day notice requesting public comment on the information
collection provisions. In response to this notice, FDA received seven
comments, four of which required a response by CVM that are addressed
as follows: One comment stated that FDA's estimate for the burden of
the proposed collection of information seems unrealistic and
inaccurate. The comment proposed 16 hours of response time for Drug
Experience Reports (DER), and 49 hours for recordkeeping for each DER.
FDA agrees that 16 hours is a reasonable response time required to make
a DER report. In view of increased reporting requirements under Sec.
514.80 (b)(4), CVM has increased the ``Hours per Response'' under this
citation in ``Table 1--Estimated Annual Reporting Burden,'' from 11 to
16 hours thereby increasing the total burden hours to 19,616. The
comment also proposed 49 hours response time per record for each DER.
However, based on CVM's experience and previous surveys of industry,
the 49 hours of response per record for each DER is excessive. In view
of increased requirements, under Sec. 514.80(e)\3\, CVM has increased
the ``Hours per Record'' under this citation in ``Table 2--Estimated
Annual Recordkeeping Burden,'' from 10.35 to 14 hours, thereby
increasing the total burden hours to 33,320.
Another comment suggested that the burden collections may be
potentially reduced by: (1) Reducing submission requirements with
established safety and (2) by automating the information collection
system. FDA agrees with the comment regarding both suggestions. Under
Sec. 514.80(b)(4), it states for yearly periodic DER reports, an
applicant may petition FDA to change the anniversary date and/or change
the frequency of reporting. Regarding the comment suggesting automation
of the information collection system, future burden estimates for
collections of information will be considered when automated reporting
requirements are implemented by FDA.
Another comment wanted to know the purpose for submitting a
periodic report for a known event for a product with an established
record. As previously stated, under Sec. 514.80(b)(4), an applicant
may petition FDA to change the anniversary date and/or change the
frequency of reporting.
The respondents to this collection of information are applicants of
approved NADAs and ANADAs.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 55484]]
514.80(b)(4) 2301 190 6.45 1,226 16 19,616
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 ........... ................. ................. ................. ................. 40,957
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--ESTIMATED ANNUAL RECORDKEEPING BURDEN1
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 14 33,320
Total ................. .................... .................... .................... 43,013
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Recordkeeping estimates for Sec. 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.
\3\Recordkeeping estimates for Sec. 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.
The reporting and recordkeeping burden estimates for this
collection of information are based on the submission of reports to the
Division of Surveillance, CVM. The total annual response numbers are
also based on the submission of reports to the Division of
Surveillance, CVM. The annual frequency of response was calculated as
the total annual responses divided by the number of respondents.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8023 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S
