Agency Information Collection Request; 30-Day Public Comment Request, 78361-78362 [E8-30274]
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78361
Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
and is designed to establish a fixed but
reasonable time for implementing this
policy change. This phase-in period will
provide agencies with time to comply
with their obligations under the Federal
Service Labor-Management Relations
Act, as amended, 5 U.S.C. Ch. 71, LaborManagement Relations, in those
circumstances where there is an
exclusive union representative for the
employees.
b. The only exceptions to the general
policy against smoking as described in
EO 13058 and this bulletin are:
(1) Residential accommodations for
persons voluntarily or involuntarily
residing, on a temporary or long-term
basis, in a building owned, leased or
rented by the Federal Government;
(2) Portions of federally owned
buildings leased, rented or otherwise
provided in their entirety to non-federal
parties; and
(3) Places of employment in the
private sector or in other non-Federal
Governmental units that serve as the
permanent or intermittent duty station
of one or more federal employees.
c. The exception in the Federal
Management Regulation (FMR) for
designated smoking areas, 41 CFR 102–
74.320(a), is being eliminated.
Accordingly, all designated interior
smoking areas will be closed [insert date
6 months after publication of FMR
amendment on smoking, FMR Case
2008–102–3]. This date provides a sixmonth phase-in period and is designed
to establish a fixed but reasonable time
for implementing this policy change.
This phase-in period will provide
agencies with time to comply with their
obligations under the Federal Service
Labor-Management Relations Act, as
amended, 5 U.S.C. Ch. 71, LaborManagement Relations, in those
circumstances where there is an
exclusive union representative for the
employees.
d. Executive agency heads may
establish limited and narrow exceptions
that are necessary to accomplish agency
missions. Such exceptions must be in
writing, approved by the agency head
and, to the fullest extent possible,
provide protection of non-smokers from
exposure to environmental tobacco
smoke. Authority to establish such
exceptions may not be delegated.
e. The heads of executive agencies are
encouraged to use existing authority to
establish programs designed to help
employees stop smoking. Cessation
program materials for agencies
interested in establishing a smoking
cessation program for their employees
are available from the Department of
Health and Human Services, Centers for
Disease Control and Prevention, Web
site at https://www.cdc.gov/tobacco/
quit_smoking/index.htm. This Web site
also identifies several How to Quit
resources for individuals interested in
smoking cessation.
f. The heads of executive agencies are
responsible for ensuring compliance
with the requirements of this bulletin.
[FR Doc. E8–30377 Filed 12–19–08; 8:45 am]
BILLING CODE 6820–RH–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services (HHS), is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden. To obtain copies of
the supporting statement and any
related forms for the proposed
paperwork collections referenced above,
e-mail your request, including your
address, phone number, OMB number,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
AGENCY:
690–5683. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 30
days.
Proposed Project: Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation—OMB
No. 0990–0260—Office for Human
Research Protections.
Abstract: Section 491(a) of Public Law
99–158 states that the Secretary of HHS
shall by regulation require that each
entity applying for HHS support (e.g., a
grant, contract, or cooperative
agreement) to conduct research
involving human subjects submit to
HHS assurances satisfactory to the
Secretary that it has established an
institutional review board (IRB) to
review the research in order to ensure
protection of the rights and welfare of
the human research subjects. IRBs are
boards, committees, or groups formally
designated by an entity to review,
approve, and have continuing oversight
of research involving human subjects.
Pursuant to the requirement of the
Public Law 99–158, HHS promulgated
regulations at 45 CFR part 46, subpart A,
the basic HHS Policy for the Protection
of Human Subjects. The June 18, 1991
adoption of the common Federal Policy
(56 FR 28003) by 15 departments and
agencies implements a recommendation
of the President’s Commission for the
Study of Ethical Problems in Medicine
and Biomedical and Behavioral
Research which was established on
November 9, 1974, by Pub. L. 95–622.
The Common Rule is based on HHS
regulations at 45 CFR part 46, subpart A,
the basic HHS Policy for the Protection
of Human Subjects.
The respondents for this collection
are institutions engaged in such
research. Institutional adherence to the
Common Rules also is required by other
federal departments and agencies that
have codified or follow the Common
Rule which is identical to 45 CFR part
46, subpart A. The information being
requested related to the Common Rule
should be readily available to the
institution or organization that registers
the IRB.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Title
.103(b)(4), .109(d) IRB Actions, .116 and .117 Informed Consent ...............
VerDate Aug<31>2005
19:07 Dec 19, 2008
Jkt 217001
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
6,000
E:\FR\FM\22DEN1.SGM
39.33
22DEN1
Average
burden per
response (in
hours)
Total burden
hours
1
235,980
78362
Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS—Continued
Number of
respondents
Title
.115(a) IRB Recordkeeping ...........................................................................
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ..
6,000
6,000
Total ........................................................................................................
........................
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–30274 Filed 12–19–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration Under the Public
Readiness and Emergency
Preparedness Act
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
mstockstill on PROD1PC66 with NOTICES
Number of
responses per
respondent
SUMMARY: Declaration pursuant to
section 319F–3 of the Public Health
Service Act (42 U.S.C. 247d–6d) to
provide targeted liability protections for
pandemic influenza diagnostics,
personal respiratory protection devices,
and respiratory support devices based
on a credible risk that an avian
influenza virus spreads and evolves into
a strain capable of causing a pandemic
of human influenza.
DATES: This notice and the attached
declaration are effective as of the date of
signature of the declaration.
FOR FURTHER INFORMATION CONTACT:
RADM W.C. Vanderwagen, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION: Highly
pathogenic avian influenza A H5N1
viruses have been spread by infected
migratory birds and exports of poultry
or poultry products from Asia through
Europe and Africa since 2003, and
could spread into North America in
2008 or later, and have caused disease
in humans, with over 60% of infected
people dying from H5N1. In addition to
H5N1, other animal influenza A viruses
have also caused disease in humans,
including H2N2, H7N7, H7N2, and
VerDate Aug<31>2005
19:07 Dec 19, 2008
Jkt 217001
15
0.5
..........................
H9N2 influenza A viruses, and also pose
a pandemic threat. Section 319F–3 of
the Public Health Service Act (42 U.S.C.
247d–6d), which was enacted by the
Public Readiness and Emergency
Preparedness Act, is intended to
alleviate certain liability concerns
associated with pandemic
countermeasures, and, therefore, ensure
that the countermeasures are available
and can be administered in the event an
avian influenza virus spreads and
evolves into a strain capable of causing
a pandemic of human influenza.
HHS Secretary’s Declaration for the Use
of the Public Readiness and Emergency
Preparedness Act for Pandemic
Influenza Diagnostics, Personal
Respiratory Protection Devices, and
Respiratory Support Devices
Whereas highly pathogenic avian
H5N1 influenza A viruses have spread,
through various mechanisms, from Asia
through Europe and Africa since 2003
and have caused disease in humans
with an associated high case fatality.
The real possibility that these viruses
could be spread into North America
exists as well as the possibility that
these H5N1 viruses could participate
directly or indirectly in development of
a human pandemic strain;
Whereas other animal influenza
viruses such as H2N2, H7N2, H7N7 and
H9N2 viruses have also caused illness
among humans and pose a pandemic
threat;
Whereas avian H5N1 or other
influenza A viruses might evolve into
strains capable of causing a pandemic of
human influenza;
Whereas there are countermeasures to
identify, reduce exposure to, or support
patients infected by highly pathogenic
avian H5N1 influenza A viruses, other
animal influenza viruses that pose a
pandemic threat, or pandemic influenza
in humans;
Whereas such countermeasures that
currently exist or may be the subject of
research and development include
diagnostics to identify avian or other
animal influenza A viruses that pose a
pandemic threat, or to otherwise aid in
the diagnosis of pandemic influenza;
personal respiratory protection devices
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Average
burden per
response (in
hours)
Total burden
hours
10
45/60
900,000
2,250
........................
1,138,230
to reduce exposure to avian or other
animal influenza A viruses; and
respiratory support devices to support
patients infected by avian or other
animal influenza A viruses;
Whereas such countermeasures may
be used and administered in accordance
with Federal contracts, cooperative
agreements, grants, interagency
agreements, and memoranda of
understanding, and may also be used
and administered at the Regional, State,
and local level in accordance with the
public health and medical response of
the Authority Having Jurisdiction;
Whereas, the possibility of
governmental program planners
obtaining stockpiles from private sector
entities except through voluntary means
such as commercial sale, donation, or
deployment would undermine national
preparedness efforts and should be
discouraged as provided for in section
319F–3(b)(2)(E) of the Public Health
Service Act (42 U.S.C. 247d-6d(b)) (‘‘the
Act’’);
Whereas, immunity under section
319F–3(a) of the Act should be available
to governmental program planners for
distributions of Covered
Countermeasures obtained voluntarily,
such as by (1) Donation; (2) commercial
sale; (3) deployment of Covered
Countermeasures from Federal
stockpiles; or (4) deployment of
donated, purchased, or otherwise
voluntarily obtained Covered
Countermeasures from State, local, or
private stockpiles;
Whereas, the extent of immunity
under section 319F–3(a) of the Act
afforded to a governmental program
planner that obtains Covered
Countermeasures except through
voluntary means is not intended to
affect the extent of immunity afforded
other covered persons with respect to
such Covered Countermeasures;
Whereas, in accordance with section
319F–3(b)(6) of the Act, I have
considered the desirability of
encouraging the design, development,
clinical testing or investigation,
manufacturing, labeling, distribution,
formulation, packaging, marketing,
promotion, sale, purchase, donation,
dispensing, prescribing, administration,
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78361-78362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30274]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services (HHS), is publishing the
following summary of a proposed information collection request for
public comment. Interested persons are invited to send comments
regarding this burden estimate or any other aspect of this collection
of information, including any of the following subjects: (1) The
necessity and utility of the proposed information collection for the
proper performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden. To obtain copies of the
supporting statement and any related forms for the proposed paperwork
collections referenced above, e-mail your request, including your
address, phone number, OMB number, and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on
(202) 690-5683. Written comments and recommendations for the proposed
information collections must be directed to the OS Paperwork Clearance
Officer at the above e-mail address within 30 days.
Proposed Project: Protection of Human Subjects: Assurance of
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed
Consent/Consent Documentation--OMB No. 0990-0260--Office for Human
Research Protections.
Abstract: Section 491(a) of Public Law 99-158 states that the
Secretary of HHS shall by regulation require that each entity applying
for HHS support (e.g., a grant, contract, or cooperative agreement) to
conduct research involving human subjects submit to HHS assurances
satisfactory to the Secretary that it has established an institutional
review board (IRB) to review the research in order to ensure protection
of the rights and welfare of the human research subjects. IRBs are
boards, committees, or groups formally designated by an entity to
review, approve, and have continuing oversight of research involving
human subjects.
Pursuant to the requirement of the Public Law 99-158, HHS
promulgated regulations at 45 CFR part 46, subpart A, the basic HHS
Policy for the Protection of Human Subjects. The June 18, 1991 adoption
of the common Federal Policy (56 FR 28003) by 15 departments and
agencies implements a recommendation of the President's Commission for
the Study of Ethical Problems in Medicine and Biomedical and Behavioral
Research which was established on November 9, 1974, by Pub. L. 95-622.
The Common Rule is based on HHS regulations at 45 CFR part 46, subpart
A, the basic HHS Policy for the Protection of Human Subjects.
The respondents for this collection are institutions engaged in
such research. Institutional adherence to the Common Rules also is
required by other federal departments and agencies that have codified
or follow the Common Rule which is identical to 45 CFR part 46, subpart
A. The information being requested related to the Common Rule should be
readily available to the institution or organization that registers the
IRB.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Title respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d) IRB Actions, .116 and .117 6,000 39.33 1 235,980
Informed Consent...............................
[[Page 78362]]
.115(a) IRB Recordkeeping....................... 6,000 15 10 900,000
.103(b)(5) Incident Reporting, .113 Suspension 6,000 0.5 45/60 2,250
or Termination Reporting.......................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,138,230
----------------------------------------------------------------------------------------------------------------
Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. E8-30274 Filed 12-19-08; 8:45 am]
BILLING CODE 4150-36-P
