National Center for Research Services; Submission for OMB Review; Comment Request, 2175-2177 [05-587]
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2175
Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
reactions, and cautions for specific
populations, with a focus on why the
particular product requires a Medication
Guide. These regulations are intended to
improve the public health by providing
information necessary for patients to use
certain medication safely and
effectively.
The regulations contain the following
reporting requirements that are subject
to the PRA, and the estimates for the
burden hours imposed by the following
regulations are listed in table 1 of this
document:
21 CFR 208.20—Applicants must
submit draft Medication Guides for FDA
approval according to the prescribed
content and format.
21 CFR 314.70(b)(3)(ii) and 21 CFR
601.12(f)—Application holders must
submit changes to Medication Guides to
FDA for prior approval as supplements
to their applications.
21 CFR 208.24(e)—Each authorized
dispenser of a prescription drug product
for which a Medication Guide is
required, when dispensing the product
to a patient or to a patient’s agent, must
provide a Medication Guide directly to
each patient unless an exemption
applies under 21 CFR 208.26.
21 CFR 208.26 (a)—Requests may be
submitted for exemption or deferral
from particular Medication Guide
content or format requirements.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
208.20
Annual frequency
per response
Total Annual
Responses
Hours Per
Response
Total Hours
35
1.34
47
242
11,374
3
1
3
24
72
208.24(e)
55,000
20
1,100,000
.0014
1540
208.26(a)
1
1
1
4
4
314.70(b)(3)(ii) 601.12(f)
Total
1 There
12,990
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–659 Filed 1–11–05; 3:26 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research Services;
Submission for OMB Review;
Comment Request
Request for generic clearance to
collect public comments on the
proposed standards of care for
chimpanzees in the federally supported
chimpanzee sanctuary system.
SUMMARY: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Center for Research Services, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval the information collection
listed below. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1, 1995
unless it displays a currently valid OMB
control number.
Proposed Collection: Title: Request for
Generic Clearance to collect public
comments on the Proposed Standards of
Care Regulations covering chimpanzees
in the federally supported Chimpanzee
Sanctuary System. Type of Information
Collection Request: New. Need and Use
of Information Collection: The
Chimpanzee Health Improvement,
Maintenance, and Protection Act of
2000 (Public Law 106–551) requires the
Secretary of the Department of Health
and Human Services to develop
Standards of Care Regulations for
chimpanzees in the Sanctuary System.
The Act further requires the Secretary to
publish the proposed standards in the
Federal Register to provide a 60 day
period for public comment on the
proposed standards. Following receipt
of public comments, NCRR/NIH will
consider these comments in preparing
the final regulations for the sanctuary
system. The public includes members of
the general population, interested
communities (local, regional, and
national organizations), and non-profit
business entities. Input from the public
will allow the NCRR/NIH staff to receive
critical review of the standards from
different stakeholders, provide a review
and analyses of the burden estimated by
the government, and help assure that
the proposed standards are necessary
and current. Frequency of Response:
One time event. Affected Public: Nonprofit entities serving as a contractor to
the government to operate and maintain
the federally supported Chimpanzee
Sanctuary System. Type of Respondents:
Non-profit businesses that possess
qualified staff and resources needed to
develop, operate, and maintain several
hundred chimpanzees. Estimated
number of respondents: 1–3. Number
Respondents per Response: 1–3.
Average Burden Hours Per Response:
15.4. Burden Hours Requested: 186.95.
Total annualized cost to respondents is
estimated at $8412.75. There is no
capital, operating, and/or maintenance
costs to report.
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Annual number of respondents*
Reporting:
§ 9.3(a)(7)(v)(C ) .......................................................................................
§ 9.6(c)(6) ..................................................................................................
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Annual frequency
1–3
1–3
E:\FR\FM\12JAN1.SGM
Average burden hours
2
3
12JAN1
6
2
Annual burden
hours per response
12
6
2176
Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued
Annual number of respondents*
§ 9.6(d) ......................................................................................................
§ 9.8(a)(4) .................................................................................................
§ 9.11(a) ....................................................................................................
§ 9.11(b)(1) (iii) .........................................................................................
§ 9.12(b) ...........................................................................................................
Annual frequency
1–3
1–3
**1–3
**1–3
1–3
Average burden hours
2
4
1
6
1
Subtotal .................................................................................................
0.5
5
1
2
6
20
Annual burden
hours per response
1
20
12
12
6
69
* Presently, there is only one (1) respondent, the Contractor for the federally supported Chimpanzee Sanctuary System. The estimates are
based upon a maximum of three (3) respondents in the future.
** See also § 9.5(c) & 9.5(e).
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Annual number of Respondents*
Recordkeeping:
§ 9.3(a)(7)(v)(c) .........................................................................................
§ 9.3(a)(10) ...............................................................................................
§ 9.3(a)(11) ...............................................................................................
§ 9.4(d)(1) .................................................................................................
§ 9.4(d)(3) .................................................................................................
§ 9.4(c) ......................................................................................................
§ 9.5(c)(4) ..................................................................................................
§ 9.5 (e) .....................................................................................................
§ 9.6(c)(8) ..................................................................................................
§ 9.6(c)(10) ................................................................................................
§ 9.8(a)(1–4) .............................................................................................
§ 9.8(b) ......................................................................................................
§ 9.9(a)(3) .................................................................................................
§ 9.10(a)(1) ...............................................................................................
§ 9.10(a)(2) ...............................................................................................
§ 9.10(b)(1) ...............................................................................................
§ 9.11(a) ....................................................................................................
§ 9.12(b)(1) .......................................................................................................
Annual
frequency
1–3
Average burden hours
2
1
1
1
1
3
1
1
5
4
10
5
12
12
4
3
6
1
**1–3
**1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
***1–3
***1–3
Subtotal .................................................................................................
2
8
8
1
6
8
2
4
0.05
0.1
0.5
2
0.2
0.2
3
1.5
1
3
69
Annual burden
hours per response
4
8
8
1
6
24
2
4
0.25
0.4
5
10
2.4
2.4
12
4.5
6
3
102.55
** See
§ 9.5(c) & 9.5(e) also.
*** The reporting requirements for these sections vary because it is estimated that chimpanzees will be shipped 6 times per year. This requires
6 notifications of shipment to the Project Officer. It is estimated that approximately 1 of these shipments might require reporting because of undesirable conditions.
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Annual number of respondents
Disclosure:
§ 9.3(a)(10) ** ............................................................................................
§ 9.3(a)(11) ** ............................................................................................
§ 9.3(a)(13) ...............................................................................................
§ 9.4(c) ......................................................................................................
§ 9.4(d)(2) .................................................................................................
§ 9.5(e) ......................................................................................................
§ 9.5(f)(2) ..................................................................................................
§ 9.6(c)(10) ................................................................................................
§ 9.9(a)(3) .................................................................................................
§ 9.10(a)(1) ...............................................................................................
§ 9.10(b)(1) ...............................................................................................
§ 9.11(a) ....................................................................................................
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
Annual
frequency
6
1
1
1
1
1 x event
<1/5
4
10
10
1
2
Subtotal .................................................................................................
Total ......................................................................................................
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0.5
0.5
1
0.1
0.1
2
8
0.1
0.2
0.2
0.2
1
Annual burden
hours per response
3
1
1
0.1
0.1
2
1.6
0.4
2
2
0.2
2
38.02
1–3
15.4
127.02
186.95
** See 9.5(c) & 9.5(e) also.
VerDate jul<14>2003
Average burden hours
E:\FR\FM\12JAN1.SGM
12JAN1
Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
2177
*** The reporting requirements for these sections vary because it is estimated that chimpanzees will be shipped 6 times per year. This requires
6 notifications of shipment to the Project Officer. It is estimated that approximately 1 of these shipments might require reporting because of undesirable conditions such as inadequate food or water, unexpected death or illness, or any conditions affecting animal welfare.
Request for Comments: Written
comments from the public and affected
entities are invited on one or more of
the following points: (1) Whether the
proposed collection of information is
necessary for the proper monitoring and
oversight of the care, welfare, and
maintenance of the chimpanzees, (2) the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, (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 the information on those
who are to respond, including the use
of automated, electronic, mechanical,
and other technological collection
techniques or other forms of information
technology.
Direct comments to OMB: Written
comments and/or suggestions regarding
items contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the Office of
Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
William Watson, NCRR, 6701
Democracy Boulevard, Room 954,
Bethesda, MD 20892–4874, telephone
(301) 345–0747 (not a toll-free number),
or e-mail; watsonwm@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having full effect if
received within 30 days of the date of
this publication.
Dated: January 11, 2005.
Patricia Newman,
National Center for Research Services Project
Clearance Liaison, National Institutes of
Health.
[FR Doc. 05–587 Filed 1–11–05; 8:45 am]
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
will be closed to the public in
accordance with the provisions set forth
in section 552b(c)(6), title 5 U.S.C., as
amended for discussion of personal
qualifications and performance, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: January 31, 2005.
Open: 2 p.m. to 4 p.m.
Agenda: To review the Clinical Center
operating plan, ABCR workgroups and
Budget update.
Place: National Institutes of Health,
Building 10, 10 Center Drive, 4–2551, CRC
Medical Board Room, Bethesda, MD 20892.
Closed: 4 p.m. to 5 p.m.
Agenda: For discussion of personal
qualifications and performance the
disclosure of which constitute a clearly
unwarranted invasion of personal privacy.
Place: National Institutes of Health,
Building 10, 10 Center Drive, 4–2551, CRC
Medical Board Room, Bethesda, MD 20892.
Contact Person: Maureen E. Gormley,
Executive Secretary, Warren Grant Magnuson
Clinical Center, National Institutes of Health,
Building 10, Room 6–1610, Bethesda, MD
20892, (301) 496–2897,
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Dated: January 6, 2005.
Laverne Y, Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–632 Filed 1–11–05; 8:45 am]
BILLING CODE 4140–01–M
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Naitonal Institutes of Health
National Institutes of Health
Clinical Center; Notice of Meeting
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
President’s Cancer Panel.
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The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(9)(B), Title 5 U.S.C., as
amended, because the premature
disclosure of information and the
discussions would likely to significantly
frustrate implementation of
recommendations.
Name of Committee: President’s Cancer
Panel.
Date: January 18, 2005.
Time: 3 p.m. to 5 p.m.
Agenda: The Panel will discuss the future
focuses of the Panel with direction bearing
on prepublication manuscripts on
Translating Research into Clinical Practice.
These manuscripts have been provided by
their authors with the understanding that the
Panel will not break prepublicaiton embargo
conditions.
Place: National Cancer Institute, National
Institutes of Health, 31 Center Drive,
Building 31, Room 3A18, Bethesda, MD
20892, (Teleconference).
Contact Person: Maureen O. Wilson, PhD,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 31
Center Drive, Building 31, Room 3A18,
Bethesda, MD 20892, 301/496–1148.
This meeting is being published less than
15 days prior to the meeting due to
scheduling conflicts.
Any interested person may file written
comments with the committee by forwarding
the comments to the Contact Person listed on
this notice. The comments should include
the name, address, telephone number and,
when applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.deainfo.nic.nih.gov/advisory/pcp/
pcp.htm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research manpower; 93.399,
cancer Control, National Institutes of Health,
HHS.)
Dated: January 5, 2005.
Anna P. Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–584 Filed 1–11–05; 8:45 am]
BILLING CODE 4140–01–M
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[Federal Register Volume 70, Number 8 (Wednesday, January 12, 2005)]
[Notices]
[Pages 2175-2177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-587]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Research Services; Submission for OMB Review;
Comment Request
Request for generic clearance to collect public comments on the
proposed standards of care for chimpanzees in the federally supported
chimpanzee sanctuary system.
SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Center for Research Services, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval the
information collection listed below. The National Institutes of Health
may not conduct or sponsor, and the respondent is not required to
respond to, an information collection that has been extended, revised,
or implemented on or after October 1, 1995 unless it displays a
currently valid OMB control number.
Proposed Collection: Title: Request for Generic Clearance to
collect public comments on the Proposed Standards of Care Regulations
covering chimpanzees in the federally supported Chimpanzee Sanctuary
System. Type of Information Collection Request: New. Need and Use of
Information Collection: The Chimpanzee Health Improvement, Maintenance,
and Protection Act of 2000 (Public Law 106-551) requires the Secretary
of the Department of Health and Human Services to develop Standards of
Care Regulations for chimpanzees in the Sanctuary System. The Act
further requires the Secretary to publish the proposed standards in the
Federal Register to provide a 60 day period for public comment on the
proposed standards. Following receipt of public comments, NCRR/NIH will
consider these comments in preparing the final regulations for the
sanctuary system. The public includes members of the general
population, interested communities (local, regional, and national
organizations), and non-profit business entities. Input from the public
will allow the NCRR/NIH staff to receive critical review of the
standards from different stakeholders, provide a review and analyses of
the burden estimated by the government, and help assure that the
proposed standards are necessary and current. Frequency of Response:
One time event. Affected Public: Non-profit entities serving as a
contractor to the government to operate and maintain the federally
supported Chimpanzee Sanctuary System. Type of Respondents: Non-profit
businesses that possess qualified staff and resources needed to
develop, operate, and maintain several hundred chimpanzees. Estimated
number of respondents: 1-3. Number Respondents per Response: 1-3.
Average Burden Hours Per Response: 15.4. Burden Hours Requested:
186.95. Total annualized cost to respondents is estimated at $8412.75.
There is no capital, operating, and/or maintenance costs to report.
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual number Annual burden
of Annual Average hours per
respondents\*\ frequency burden hours response
----------------------------------------------------------------------------------------------------------------
Reporting:
Sec. 9.3(a)(7)(v)(C )...................... 1-3 2 6 12
Sec. 9.6(c)(6)............................. 1-3 3 2 6
[[Page 2176]]
Sec. 9.6(d)................................ 1-3 2 0.5 1
Sec. 9.8(a)(4)............................. 1-3 4 5 20
Sec. 9.11(a)............................... \**\1-3 1 1 12
Sec. 9.11(b)(1) (iii)...................... \**\1-3 6 2 12
Sec. 9.12(b)................................... 1-3 1 6 6
-----------------
Subtotal................................... .............. 20 ............. 69
----------------------------------------------------------------------------------------------------------------
\*\ Presently, there is only one (1) respondent, the Contractor for the federally supported Chimpanzee Sanctuary
System. The estimates are based upon a maximum of three (3) respondents in the future.
\**\ See also Sec. 9.5(c) & 9.5(e).
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual number Annual burden
of Annual Average hours per
Respondents\*\ frequency burden hours response
----------------------------------------------------------------------------------------------------------------
Recordkeeping:
Sec. 9.3(a)(7)(v)(c)........................ 1-3 2 2 4
Sec. 9.3(a)(10)............................. \**\1-3 1 8 8
Sec. 9.3(a)(11)............................. \**\1-3 1 8 8
Sec. 9.4(d)(1).............................. 1-3 1 1 1
Sec. 9.4(d)(3).............................. 1-3 1 6 6
Sec. 9.4(c)................................. 1-3 3 8 24
Sec. 9.5(c)(4).............................. 1-3 1 2 2
Sec. 9.5 (e)................................ 1-3 1 4 4
Sec. 9.6(c)(8).............................. 1-3 5 0.05 0.25
Sec. 9.6(c)(10)............................. 1-3 4 0.1 0.4
Sec. 9.8(a)(1-4)............................ 1-3 10 0.5 5
Sec. 9.8(b)................................. 1-3 5 2 10
Sec. 9.9(a)(3).............................. 1-3 12 0.2 2.4
Sec. 9.10(a)(1)............................. 1-3 12 0.2 2.4
Sec. 9.10(a)(2)............................. 1-3 4 3 12
Sec. 9.10(b)(1)............................. 1-3 3 1.5 4.5
Sec. 9.11(a)................................ \***\1-3 6 1 6
Sec. 9.12(b)(1)................................. \***\1-3 1 3 3
-----------------
Subtotal.................................... .............. 69 ............. 102.55
----------------------------------------------------------------------------------------------------------------
\**\ See Sec. 9.5(c) & 9.5(e) also.
\***\ The reporting requirements for these sections vary because it is estimated that chimpanzees will be
shipped 6 times per year. This requires 6 notifications of shipment to the Project Officer. It is estimated
that approximately 1 of these shipments might require reporting because of undesirable conditions.
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual burden
Annual number Annual Average hours per
of respondents frequency burden hours response
----------------------------------------------------------------------------------------------------------------
Disclosure:
Sec. 9.3(a)(10) **........................... 1-3 6 0.5 3
Sec. 9.3(a)(11) **........................... 1-3 1 0.5 1
Sec. 9.3(a)(13).............................. 1-3 1 1 1
Sec. 9.4(c).................................. 1-3 1 0.1 0.1
Sec. 9.4(d)(2)............................... 1-3 1 0.1 0.1
Sec. 9.5(e).................................. 1-3 1 x event 2 2
Sec. 9.5(f)(2)............................... 1-3 <1/5 8 1.6
Sec. 9.6(c)(10).............................. 1-3 4 0.1 0.4
Sec. 9.9(a)(3)............................... 1-3 10 0.2 2
Sec. 9.10(a)(1).............................. 1-3 10 0.2 2
Sec. 9.10(b)(1).............................. 1-3 1 0.2 0.2
Sec. 9.11(a)................................. 1-3 2 1 2
-----------------
Subtotal..................................... .............. 38.02 ............. 15.4
=================
Total........................................ 1-3 127.02 ............. 186.95
----------------------------------------------------------------------------------------------------------------
** See 9.5(c) & 9.5(e) also.
[[Page 2177]]
*** The reporting requirements for these sections vary because it is estimated that chimpanzees will be shipped
6 times per year. This requires 6 notifications of shipment to the Project Officer. It is estimated that
approximately 1 of these shipments might require reporting because of undesirable conditions such as
inadequate food or water, unexpected death or illness, or any conditions affecting animal welfare.
Request for Comments: Written comments from the public and affected
entities are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper monitoring and oversight of the care, welfare, and maintenance
of the chimpanzees, (2) the accuracy of the agency's estimate of the
burden of the proposed collection of information, (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 the
information on those who are to respond, including the use of
automated, electronic, mechanical, and other technological collection
techniques or other forms of information technology.
Direct comments to OMB: Written comments and/or suggestions
regarding items contained in this notice, especially regarding the
estimated public burden and associated response time, should be
directed to the Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. William Watson, NCRR, 6701 Democracy
Boulevard, Room 954, Bethesda, MD 20892-4874, telephone (301) 345-0747
(not a toll-free number), or e-mail; watsonwm@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having full effect if received within 30 days of
the date of this publication.
Dated: January 11, 2005.
Patricia Newman,
National Center for Research Services Project Clearance Liaison,
National Institutes of Health.
[FR Doc. 05-587 Filed 1-11-05; 8:45 am]
BILLING CODE 4140-01-P
