Agency Information Collection Activities: Proposed Collection; Comment Request, 66438-66440 [05-21866]
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66438
Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices
statement on the form so that it precedes
the signature and date block.
Second, OGE proposes modifying the
Privacy Act Statement summary of the
OGE Form 201. In 2003, OGE updated
the OGE/GOVT–1 system of records
notice (covering Executive Branch
Personnel Public Financial Disclosure
Reports and Other Name-Retrieved
Ethics Program Records, and in which
completed OGE Form 201s are
maintained). See 68 FR 3097–3109, at
3100 (January 22, 2003). As a result,
OGE is modifying the sixth routine use
listed in the Privacy Act Statement
summary in part II of the form. Finally,
OGE proposes updating the edition date
on pages one and two of the form.
Reporting Burden
OGE estimates that an average of 374
OGE Form 201s will be filed throughout
the executive branch each year by
members of the public (primarily by
news media, public interest groups and
private citizens) for the next three years.
This figure is based on the number of
OGE Form 201s filed at OGE by
members of the public (221 for 2003 and
143 for 2004) and responses to OGE’s
annual agency ethics program
questionnaire (244 for 2003 and 140 for
2004) for a total of 748. That number is
then divided by two to give the
projected annual average of 374.
The estimated average amount of time
to complete the form, including review
of the instructions, remains at ten
minutes. Thus, the estimated annual
public burden for the OGE Form 201
(throughout the executive branch) is 63
hours (374 form × 10 minutes per form
¥number rounded up). This is an
increase from the current burden of 37
hours. The current burden accounts for
filers whose OGE Form 201s were filed
each year only with OGE. The proposed
estimate of burden hours includes OGE
Form 201s or equivalent access forms
filed by the public with departments
and agencies throughout the executive
branch (including OGE).
Web Site Distribution of Blank Forms
The OGE Form 201 as modified will
continue to be made available free-ofcharge as a downloadable and fillable
Portable Document Format (PDF) file to
the public as well as departments and
agencies on OGE’s Internet Web site at
https://www.usoge.gov.
OGE will continue to permit
departments and agencies to use the
copy of the OGE Form 201 available on
OGE’s Web site or to develop and utilize
their own, electronic versions of the
OGE form, provided that they precisely
duplicate the original to the extent
possible. Agencies can also develop
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20:22 Nov 01, 2005
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their own access forms, provided all the
information required by the Ethics Act
and OGE regulations is placed on such
forms, along with the appropriate
Privacy Act and paperwork notices with
any attendant clearances being obtained
by the agencies therefor.
For now, OGE itself accepts filing of
a completed OGE Form 201 by mail, fax,
or in person, but does not permit E-mail
or Internet online transmission.
Similarly, requested copies of reports or
other covered records are supplied by
OGE as hard (paper) copies.
Consideration of Comments
Public comment is invited on each
aspect of the proposed modified OGE
Form 201 as set forth in this notice,
including specifically views on the need
for and practical utility of this
information collection; the accuracy of
OGE’s burden estimate; the
enhancement of quality, utility and
clarity of the information collected; and
the minimization of burden (including
the use of information technology).
Comments received in response to
this notice will be summarized for, and
may be included with, the OGE request
for OMB paperwork approval for this
proposed modified information
collection. The comments will also
become a matter of public record.
public health community, and other
stakeholders.
Contact Person for More Information:
Substantive program information as
well as summaries of meetings and a
roster of Committee members may be
obtained from Anna Poker, Lead Staff
Person for the NCVHS Subcommittee on
Special Populations, Working Group on
Quality, Agency for Healthcare Research
and Quality, Center for Quality
Improvement and Patient Safety, 540
Gaither Road, Room #3331, Rockville,
MD 20850, Phone: 301–427–1802; or
Marjorie S. Greenberg, Executive
Secretary, NCVHS, NCHS, CDC, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4245.
Information also is available on the
NCVHS home page of the HHS Web site:
https://aspe.os.dhhs.gov/ncvhs, where an
agenda for the meeting will be posted
when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (301) 458–4EEO (4336)
as soon as possible.
Dated: October 20, 2005.
James Scanlon,
Deputy Assistant Secretary for Science and
Data Policy, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 05–21806 Filed 11–1–05; 8:45 am]
Approved: October 27, 2005.
Marilyn L. Glynn,
General Counsel, Office of Government
Ethics.
[FR Doc. 05–21834 Filed 11–1–05; 8:45 am]
BILLING CODE 4151–05–M
BILLING CODE 6345–02–P
Agency for Healthcare Research and
Quality
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request
National Committee on Vital and Health
Statistics: Meeting
AGENCY:
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services announces
the following advisory committee
meeting:
Name: National Committee on Vital
and Health Statistics (NCVHS),
Subcommittee on Populations—
Working Group on Quality.
Time and Date: 8:30 a.m.–5 p.m.,
November 18, 2005.
Place: Hubert H. Humphrey Building,
200 Independence Avenue SW., Room
705A, Washington, DC 20201.
Status: Open.
Purpose: At this meeting the Working
Group on Quality will study the
expected impact of the electronic health
record on health measurement and
quality, hearing views from patients, the
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) allow the proposed
information collection project: ‘‘Security
Checkpoints and Patients With
Radiopharmaceuticals.’’ In accordance
with the Paperwork Reduction Act of
1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be
received by January 3, 2006.
ADDRESSES: Written comments should
be submitted to: Cynthia D. McMichael,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Suite 5022, Rockville, MD
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
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Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices
20850. Copies of the proposed
collection plan, data collection
instrument, and specific details on the
estimated burden can be obtained from
AHRQ’s Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Cynthia D. McMichael, AHRQ, Reports
Clearance Officer, (301) 427–1651.
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Security Checkpoints and Patients
With Radiopharmaceuticals’’
Patients receiving radioactive
therapeutic or diagnostic compounds
(called ‘‘radiopharmaceuticals’’) can
emit radiation at the time when they are
released from a hospital facility and
present danger to their families and the
public. In addition, these individuals
might activate radiation detectors at
airports, stadiums, and other public
places, and will be stopped for
questioning by law enforcement
personnel. It is very important that
hospitals provide patients with
educational materials that explain the
unique problems patients may face as a
result of receiving this treatment, as
well as provide guidance about how to
respond to situations where law
enforcement questions and other
concerns may arise.
The goal of the study is to determine
what procedures are followed by
hospitals when releasing patients
treated with radioactive compounds.
The study will involve interviewing
60 health care providers who are
directly involved in the release of
patients treated with radioactive
compounds.
Specifically, the interview protocol
will be centered on the following topics:
Methods of Collection
(1) How health care providers
determine when patients receiving
radiopharmaceuticals can be released
from care.
(2) What type of information is
provided to patients to ensure safety to
their families and the public.
(3) How this information is
communicated to patients.
(4) What information is (or can be)
provided to patients who may activate
radiation detectors at security
checkpoints so that their processing is
facilitated should questions regarding
their medical procedures arise.
Best practices identified through the
analyses of interview data could lead to
the development of standardized
procedures to: (a) reduce secondary
exposure to radiation by members of the
patient’s family and by the public; and
(b) ensure that patients who activate
radiation detectors at security
checkpoints understand why they emit
radiation and carry the appropriate
documentation to validate their
statements. The study findings will be
disseminated to the health care
community through a scholarly
publication journal article (title is to be
determined).
The date will be collected using a
telephone survey. The contractor will
contact each health care provider
through appropriate management offices
explaining this survey and ask to be
directed to the appropriate,
knowledgeable staff in their facility. The
interviews will be conducted by
telephone. If requested, the contractor
will provide a copy of the interview
questions in advance so that the
hospital staff has time to obtain
pertinent information. The contractor
will also request copies of educational
materials provided to patients, any
specific tools used to calculate radiation
dose to members of the public as well
as other pertinent material. The
contractor will obtain and evaluate the
referenced educational materials
qualitatively, describing the content and
detail of such materials and reviewing
them for clarity. In addition, the
contractor will analyze the responses to
the interview questions quantitatively
and qualitatively as appropriate.
To recruit the appropriate
interviewees, we will first contact the
Chief of Medicine’s office and ask the
staff to refer us to the Head of the
Department of Radiology/Radiation
Oncology/Nuclear Medicine. (Based on
our experience surveying health care
providers, for smaller hospitals it is
sometimes more effective to start with
the Hospital Administrator’s office.) We
will introduce ourselves, explain the
goals of the study, and volunteer to
provide a cover letter describing the
study and any letters of endorsement.
We will then contact the Department
Heads and request that they refer us to
the appropriate, knowledgeable staff in
their departments.
Data Confidentiality Provisions
Data collected by the contractor and
the contractor’s draft analyses will be
retained for one year after final
acceptance of all contract deliverables,
unless, longer retention is requested by
the agency for audit purposes.
All agency documents pertaining to
the contract will be archived after the
contract is completed and retained in
accordance with a Federal Records Act
of 1950 retention schedule.
ESTIMATED ANNUAL RESPONDENT BURDEN
Number of
respondents
Type of survey
Estimated time
per respondent in minutes
Estimated total
burden hours
Estimated
annual cost to
the
respondents
Telephone Interviews .......................................................................................
60
45
45
$4500
Total ..........................................................................................................
60
45
45
4500
Request for Comments
In accordance with the above cited
legislation, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of functions of AHRQ,
including whether the information will
have practical utility; (b) the accuracy of
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17:22 Nov 01, 2005
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AHRQ’s estimate of burden (including
hours and cost) of the proposed
collection of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
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Fmt 4703
Sfmt 4703
Comments submitted in response to
this notice will be summarized and
included in the request for OMB
approval of the proposed information
collection. All comments will become a
matter of public record.
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66440
Federal Register / Vol. 70, No. 211 / Wednesday, November 2, 2005 / Notices
Dated: October 25, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05–21866 Filed 11–1–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–90–M
[Docket No. 2003N–0502]
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study to Measure
the Compliance of Prescribers With the
Contraindication of the Use of Triptans
in Migraine Headache Patients With
Vascular Disease
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration on Aging
2005 White House Conference on
Aging
Administration on Aging, HHS.
Notice of conference call.
AGENCY:
AGENCY:
ACTION:
HHS.
Pursuant to section 10(a) of
the Federal Advisory Committee Act as
amended (5 U.S.C. Appendix 2), notice
is hereby given that the Policy
Committee of the 2005 White House
Conference on Aging will vote on the
Annotated Agenda for the WHCoA and
may discuss other items related to
finalizing the 2005 WHCoA during a
conference call. The conference call will
be open to the public to listen, with callins limited to the number of telephone
lines available. Individuals who plan to
call in and need special assistance, such
as TTY, should inform the contact
person listed below in advance of the
conference call. This Notice is being
published less than 15 days prior to the
conference call due to scheduling
problems.
SUMMARY:
The conference call will be held
on Thursday, November 3, 2005, at 5
p.m., eastern standard time.
ADDRESSES: The conference call may be
accessed by dialing, U.S. toll-free, 1–
800–857–0419, passcode: 6045175, on
the date and time indicated above.
FOR FURTHER INFORMATION CONTACT: Kim
Butcher, (301) 443–2887, or e-mail at
Kim.Butcher@whcoa.gov. Registration is
not required. Call in is on a first come,
first-served basis.
SUPPLEMENTARY INFORMATION: Pursuant
to the Older Americans Act
Amendments of 2000 (Pub. L. 106–501,
November 2000), the Policy Committee
will hold a meeting by conference call
to vote on the Annotated Agenda for the
2005 White House Conference on Aging.
The public is invited to listen by dialing
the telephone number and using the
passcode listed above under the
Address section.
DATES:
Dated: October 28, 2005.
Edwin L. Walker,
Deputy Assistant Secretary for Policy and
Programs.
[FR Doc. 05–21823 Filed 11–1–05; 8:45 am]
BILLING CODE 4154–01–P
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ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
2, 2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, 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.
Study to Measure the Compliance of
Prescribers With the Contraindication
of the Use of Triptans in Migraine
Headache Patients With Vascular
Disease
Migraine headache affects about 20
million Americans. Over the last
decade, numerous drugs in a category
referred to as ‘‘triptans’’ have been
shown to be efficacious in treating
migraine headache and have been
approved for this condition. Triptan
drugs have been prescribed to millions
of patients. However, triptans are
routinely contraindicated in patients
with vascular diseases due to associated
rare occurrence of myocardial
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Frm 00094
Fmt 4703
Sfmt 4703
infarction, stroke, and other ischemic
events. In view of the wide use of this
class of drugs and the potential impact
on public health as a result of this
contraindication, FDA believes it would
be significantly helpful to better
understand the prescribing practices for
these drugs.
FDA plans to examine the feasibility
of using the Internet to recruit triptanuser migraine headache patients to
determine whether prescribers follow
the labeling recommendation by not
prescribing this class of drugs to
patients with pre-existing
cardiovascular, cerebrovascular, or
peripheral vascular syndromes or with
cardiac risk factors.
FDA intends to solicit patients over
the Internet to identify a group of triptan
users. FDA will then ask these patients
to complete a questionnaire about their
medical history with a focus on vascular
diseases. Following that, FDA will
request medical records from a sample
of the patients and review the submitted
records to verify the medical history and
the presence, if any, of cardiovascular,
cerebrovascular, or peripheral vascular
ischemic diseases. FDA will also collect
information about patients’
demographics, route of administration
(oral, injection, intranasal), and duration
of exposure to triptans.
In the Federal Register of November
17, 2003 (68 FR 64902), FDA published
a notice requesting comment on this
information collection. Three comments
were received in response to the notice,
each raising several issues, as follows:
(1) One comment contended that the
agency has not put forth an adequate
foundation for conducting the study.
The comment said that no data or other
information has been described to
justify the expenditure of government
resources and the imposition of
information collection burdens on the
industry. The comment said that the
only rationale consists of speculation
that ‘‘it would be of great use to better
understand the prescribing practices as
a result of this contraindication [use of
triptans in patients with vascular
diseases].’’ The comment contended
that this is an insufficient predicate for
conducting publicly-funded research
that casts a cloud of suspicion over a
class of currently marketed drug
products that provide great clinical
benefit to patients who suffer from
migraine headaches. The comment said
that the Federal Register notice
provides no information about FDA’s
view of the relative role of data derived
from the survey in relation to data from
controlled clinical studies,
epidemiology studies, and spontaneous
medical event reports.
E:\FR\FM\02NON1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 211 (Wednesday, November 2, 2005)]
[Notices]
[Pages 66438-66440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21866]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) allow the proposed information collection
project: ``Security Checkpoints and Patients With
Radiopharmaceuticals.'' In accordance with the Paperwork Reduction Act
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be received by January 3, 2006.
ADDRESSES: Written comments should be submitted to: Cynthia D.
McMichael, Reports Clearance Officer, AHRQ, 540 Gaither Road, Suite
5022, Rockville, MD
[[Page 66439]]
20850. Copies of the proposed collection plan, data collection
instrument, and specific details on the estimated burden can be
obtained from AHRQ's Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ, Reports
Clearance Officer, (301) 427-1651.
SUPPLEMENTARY INFORMATION:
Proposed Project
``Security Checkpoints and Patients With Radiopharmaceuticals''
Patients receiving radioactive therapeutic or diagnostic compounds
(called ``radiopharmaceuticals'') can emit radiation at the time when
they are released from a hospital facility and present danger to their
families and the public. In addition, these individuals might activate
radiation detectors at airports, stadiums, and other public places, and
will be stopped for questioning by law enforcement personnel. It is
very important that hospitals provide patients with educational
materials that explain the unique problems patients may face as a
result of receiving this treatment, as well as provide guidance about
how to respond to situations where law enforcement questions and other
concerns may arise.
The goal of the study is to determine what procedures are followed
by hospitals when releasing patients treated with radioactive
compounds.
The study will involve interviewing 60 health care providers who
are directly involved in the release of patients treated with
radioactive compounds.
Specifically, the interview protocol will be centered on the
following topics:
(1) How health care providers determine when patients receiving
radiopharmaceuticals can be released from care.
(2) What type of information is provided to patients to ensure
safety to their families and the public.
(3) How this information is communicated to patients.
(4) What information is (or can be) provided to patients who may
activate radiation detectors at security checkpoints so that their
processing is facilitated should questions regarding their medical
procedures arise.
Best practices identified through the analyses of interview data
could lead to the development of standardized procedures to: (a) reduce
secondary exposure to radiation by members of the patient's family and
by the public; and (b) ensure that patients who activate radiation
detectors at security checkpoints understand why they emit radiation
and carry the appropriate documentation to validate their statements.
The study findings will be disseminated to the health care community
through a scholarly publication journal article (title is to be
determined).
Data Confidentiality Provisions
Data collected by the contractor and the contractor's draft
analyses will be retained for one year after final acceptance of all
contract deliverables, unless, longer retention is requested by the
agency for audit purposes.
All agency documents pertaining to the contract will be archived
after the contract is completed and retained in accordance with a
Federal Records Act of 1950 retention schedule.
Methods of Collection
The date will be collected using a telephone survey. The contractor
will contact each health care provider through appropriate management
offices explaining this survey and ask to be directed to the
appropriate, knowledgeable staff in their facility. The interviews will
be conducted by telephone. If requested, the contractor will provide a
copy of the interview questions in advance so that the hospital staff
has time to obtain pertinent information. The contractor will also
request copies of educational materials provided to patients, any
specific tools used to calculate radiation dose to members of the
public as well as other pertinent material. The contractor will obtain
and evaluate the referenced educational materials qualitatively,
describing the content and detail of such materials and reviewing them
for clarity. In addition, the contractor will analyze the responses to
the interview questions quantitatively and qualitatively as
appropriate.
To recruit the appropriate interviewees, we will first contact the
Chief of Medicine's office and ask the staff to refer us to the Head of
the Department of Radiology/Radiation Oncology/Nuclear Medicine. (Based
on our experience surveying health care providers, for smaller
hospitals it is sometimes more effective to start with the Hospital
Administrator's office.) We will introduce ourselves, explain the goals
of the study, and volunteer to provide a cover letter describing the
study and any letters of endorsement. We will then contact the
Department Heads and request that they refer us to the appropriate,
knowledgeable staff in their departments.
Estimated Annual Respondent Burden
----------------------------------------------------------------------------------------------------------------
Estimated
Number of Estimated time Estimated annual cost to
Type of survey respondents per respondent total burden the
in minutes hours respondents
----------------------------------------------------------------------------------------------------------------
Telephone Interviews............................ 60 45 45 $4500
-----------------
Total....................................... 60 45 45 4500
----------------------------------------------------------------------------------------------------------------
Request for Comments
In accordance with the above cited legislation, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of functions of AHRQ, including
whether the information will have practical utility; (b) the accuracy
of AHRQ's estimate of burden (including hours and cost) of the proposed
collection of information; (c) ways to enhance the quality, utility and
clarity of the information to be collected; and (d) ways to minimize
the burden of the collection of information upon the respondents,
including the use of automated collection techniques or other forms of
information technology.
Comments submitted in response to this notice will be summarized
and included in the request for OMB approval of the proposed
information collection. All comments will become a matter of public
record.
[[Page 66440]]
Dated: October 25, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-21866 Filed 11-1-05; 8:45 am]
BILLING CODE 4160-90-M
