Agency Information Collection Activities: Proposed Collection; Comment Request, 2550-2551 [06-349]
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Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / Notices
your organization must register with the
Central Contractor Registry (CCR),
which requires a Data Universal
Number System (DUNS) number. A
DUNS number is a unique number that
identifies an organization and has been
adopted by the Federal Government.
The CCR is the central government
repository for organizations working
with the Federal government. The CCR
collects, validates, stores and
disseminates data in support of agency
acquisitions. For grants, CCR stores an
applicant’s information, allowing
Grants.gov to verify an organization’s
identity and identify key business
contacts for the organization. An
organization will be required to provide
a DUNS number, an E-Business pointof-contact (POC) and a Marketing
Partner ID Number (MPIN) when
registering with CCR. Please note that
CCR recently began validating the tax
identification number with IRS/
Department of Treasury, which delays
the activation of the registration by
approximately 24–48 hours. Active CCR
registrations and changes to registration
information are passed to Grants.gov on
a daily basis. A yearly validation of the
CCR information is required to maintain
an active registration.
• CCR Registration Assistance: 1–
888–227–2423 (https://www.ccr.gov).
2. Register as an Authorized
Organization Representative (AOR). An
AOR is a person named by an
organization to submit an application
for funding consideration on behalf of
the organization. In order to safeguard
the security of your electronic
information and to submit a Federal
grant application via Grants.gov, an
AOR must first obtain a Username and
Password from Grants.gov. The
organizational DUNS number will be
needed to access the registration form,
https://grants.gov/Register1. Completion
of the registration form will provide a
Grants.gov Username and Password.
The AOR’s must then register the
Username and Password with
Grants.gov, https://grants.gov/Register2.
3. Organization Authorizes Submitter
(AOR). Grants.gov will send the
organization’s CCR E-Business point-ofcontact (POC) an e-mail notifying them
that someone from their organization
has registered with Grants.gov and
needs to be authorized as an AOR. The
E-Business POC must log into
Grants.gov, using their organization
DUNS # and MPIN and authorize the
AOR to submit an application via
Grants.gov. The registration process is
complete once the AOR has been
authorized.
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15:57 Jan 13, 2006
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III. Time Allotted for Registration
Based on Grants.gov applicant
feedback, it usually takes 3–5 days to
complete registration with Grants.gov.
Registrants should be aware that
portions of the Grants.gov registration
process leverage other governmentwide
databases such as CCR. Some
organizations have found it can take up
to 2 weeks to complete the registration
process when unexpected delays are
encountered during the CCR registration
process.
FOR FURTHER INFORMATION CONTACT: The
Grants.gov Web site provides detailed
registration checklists that guide users
through the registration process. The
checklists are available through the ‘‘Get
Started’’ link on the Grants.gov Web site
(https://www.grants.gov). Questions may
also be referred to the Grants.gov
Contact Center at 1–800–518–4726 or by
e-mail at support@Grants.gov. A
Webcast has been scheduled for the end
of January 2006 specifically to cover the
Grants.gov registration process.
Interested organizations may sign-up for
the Webcast at the Grants.gov Web site
(https://www.grants.gov).
Dated: January 10, 2006.
Charles E. Johnson,
Assistant Secretary for Budget, Technology
and Finance.
[FR Doc. E6–396 Filed 1–13–06; 8:45 am]
BILLING CODE 4150–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
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.
This proposed information collection
was previously published in the Federal
Register on November 2, 2005 and
allowed 60 Days for public comment.
No public comments were received. The
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purpose of this notice is to allow an
additional 30 Days for public comment.
DATES: Comments on this notice must be
received by February 16, 2006.
ADDRESSES: Written comments should
be submitted to: John Kraemer, at the
Office of Information and Regulatory
Affairs, OMB at the following e-mail
address: John_Kraemer@omb.eop.gov
and the fax number is (202) 395–6974.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ 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
place, 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
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Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / Notices
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 data will be collected using a
telephone survey. The contractor will
contact each health 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
Number of
respondents
Type of survey
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 time
per respondent in minutes
Estimated total
burden hours
Estimated
annual cost
to the
respondents
60
45
45
$4500
Total ..........................................................................................................
sroberts on PROD1PC69 with NOTICES
Telephone interviews .......................................................................................
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.
Dated: January 6, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–349 Filed 1–13–06; 8:45 am]
BILLING CODE 4160–90–M
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Jkt 208001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0122]
Guidance for Industry on Exploratory
Investigational New Drug Studies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Exploratory IND Studies.’’
This guidance describes the preclinical
and clinical issues as well as chemistry,
manufacturing, and controls
information that should be considered
when planning exploratory studies,
including studies of closely related
drugs or biologics, under an
investigational new drug (IND)
application.
Submit written or electronic
comments on agency guidances at any
time.
DATES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
David Jacobson-Kram, Center for Drug
Evaluation and Research (HFD–24),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–443–5346.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Exploratory IND Studies.’’ In its March
E:\FR\FM\17JAN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 10 (Tuesday, January 17, 2006)]
[Notices]
[Pages 2550-2551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-349]
-----------------------------------------------------------------------
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.
This proposed information collection was previously published in
the Federal Register on November 2, 2005 and allowed 60 Days for public
comment. No public comments were received. The purpose of this notice
is to allow an additional 30 Days for public comment.
DATES: Comments on this notice must be received by February 16, 2006.
ADDRESSES: Written comments should be submitted to: John Kraemer, at
the Office of Information and Regulatory Affairs, OMB at the following
e-mail address: John--Kraemer@omb.eop.gov and the fax number is (202)
395-6974.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ 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 place, 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
[[Page 2551]]
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 data will be collected using a telephone survey. The contractor
will contact each health 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
Type of survey respondents per respondent total burden to 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.
Dated: January 6, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-349 Filed 1-13-06; 8:45 am]
BILLING CODE 4160-90-M
