Proposed Collection; Comment Request; Web Based Training for Pain Management Providers, 6208-6209 [2010-2694]
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Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
operation or use of other person finder
systems. NLM would also use the data
to evaluate the functioning and utility of
the lost person finder and guide future
enhancements to the system. Frequency
of Response: The NLM Lost People
Finder would be activated only during
disasters or emergencies in which U.S.
government agencies are called to
contribute to relief efforts. It would
operate until cessation of relief efforts.
During this period of time, information
on found persons would be submitted
by first-responders, medical, and other
relief personnel on an ad-hoc basis,
possibly several times per day.
Information about missing persons
would be submitted voluntarily by
members of the public (i.e., those who
are seeking family members friends, and
other loved ones) on hoc basis, once or
twice during the disaster. Affected
Public: Individuals or households. Type
of Respondents: Emergency Care FirstResponders, Physicians, and Other
Health Care Providers who have found
(recovered) people, and family members
seeking a missing person. Estimate of
burden: The annual reporting burden is
as follows: The estimated burden
consists of the burden to emergency
responders (care providers, relief
workers) of voluntarily entering data
into the system about found people and
of family members voluntarily entering
data to list a missing person and/or
search for possible matches. The burden
may vary significantly from one disaster
to another, depending upon the number
of people affected. Using the 2010
earthquake in Haiti as a model, we
estimate that some 500 emergency
responders might use the system during
the course of the relief effort and that
each might submit information on 100
people. Submission of information,
Estimated
number of
respondents
Types of respondents
especially through the iPhone
application, is very fast and is estimated
to average not more than 5 minutes per
entry. The number of family members
entering information about a missing
person could be much higher. Based on
use of the Google Person Finder system
during the Haiti earthquake (which
contained information on 50,000 people
after two weeks of operation), we
estimate that some 50,000 family
members might use the system twice
during a disaster. Data entry would
average no more than 5 minutes. Based
on these estimates, the total hour
burden is calculated to be 12,000 hours.
All use of the system is voluntary.
Improved estimates of the burden, in
particular the number of respondents
and frequency of response, could be
provided after the initial use of the
system in Haiti.
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated total
annual burden
hours
requested
500
50,000
100
2
0.08
0.08
4,000
8,000
Total ..........................................................................................................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Emergency Care First-Responders, Physicians, Other Health Care Providers ............................................................................................................
Family members seeking a missing person ....................................................
50,500
........................
........................
12,000
The annualized cost to respondents
for each year of the clearance is
estimated to be $293,120.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
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11:51 Feb 05, 2010
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the data collection plans and
instruments, contact: David Sharlip,
National Library of Medicine, Building
38A, Room B2N12, 8600 Rockville Pike,
Bethesda, MD 20894, or call non-toll
free number 301–402–9680 or e-mail
your request to sharlipd@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: February 2, 2009.
Betsy L. Humphreys,
Deputy Director, National Library of
Medicine, National Institutes of Health.
[FR Doc. 2010–2691 Filed 2–5–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Web Based Training for Pain
Management Providers
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
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Institute on Drug Abuse, the National
Institutes of Health has submitted to the
Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
The purpose of this notice is to allow 60
days for public comment.
Proposed Collection
Title: Web Based Training for Pain
Management Providers.
Type of Information Collection
Request: New.
Need and Use of Information
Collection: This research will evaluate
the effectiveness of the Web Based
Training for Pain Management
Providers, via the Web site
PainAndAddictionTreatment.com, to
positively impact the knowledge,
attitudes, intended behaviors and
clinical skills of health care providers in
the U.S. who treat pain. The Web Based
Training for Pain Management Providers
is a new program developed with
funding from the National Institute on
Drug Abuse. The primary goal is to
assess the impact of the training
program on knowledge, attitude,
intended behavior, and clinical skills. A
secondary goal is to assess learner
satisfaction with the program. If the
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Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices
program is a success, there will be a
new, proven resource available to health
care providers to improve their ability to
treat pain and addiction co-occurring in
the provider’s patients. In order to
evaluate the effectives of the program,
information will be collected from
health care providers before exposure to
the web based materials (pre-test), after
exposure to the web based materials
(post-test), and 4–6 weeks after the
program has been completed (followup).
Frequency of Response: On occasion.
Affected Public: Volunteer health care
providers who treat patients with pain.
Type of Respondents: Physicians,
nurse practitioners, and physician
assistants.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
80.
Estimated
number of respondents
Type of respondents
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated annual burden
hours
requested
60
20
3
3
0.75
0.75
135
45
Physicians ........................................................................................................
Other primary care providers (e.g., nurse practitioners, physician assistants)
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (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 information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Scudder Quandra,
Project Officer, NIH/NIDA/CCTN, Room
3105, MSC 9557, 6001 Executive
Boulevard, Bethesda, MD 20892–9557
or e-mail your request, including your
address to scudderq@nida.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: January 25, 2010.
Mary Affeldt,
Executive Officer (OM Director), NIDA.
[FR Doc. 2010–2694 Filed 2–5–10; 8:45 am]
BILLING CODE 4140–01–P
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Estimated Number of Responses per
Respondent: 3.
Average Burden Hours per Response:
0.75.
Estimated Total Annual Burden
Hours Requested: 180.
The annualized cost to respondents is
estimated at: $11,925. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–D–0410] (formerly
Docket No. 2006D–0191)
Guidance for Industry and Food and
Drug Administration; Guidance for the
Use of Bayesian Statistics in Medical
Device Clinical Trials; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Guidance for the Use of Bayesian
Statistics in Medical Device Clinical
Trials.’’ This guidance summarizes
FDA’s current thoughts on the
appropriate use of Bayesian statistical
methods in the design and analysis of
medical device clinical trials.
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Guidance for the Use of
Bayesian Statistics in Medical Device
Clinical Trials’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
Bldg. 66, rm. 4617, 10903 New
Hampshire Ave., Silver Spring, MD
20993 or to the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. Send one self-addressed
adhesive label to assist that office in
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processing your request, or fax to CDRH
at 301–847–8149. The guidance may
also be obtained by mail by calling
CBER at 1–800–835–4709 or 301–827–
1800. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document. Submit written comments
concerning this guidance to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Greg Campbell, Center for Devices
and Radiological Health, Bldg. 66,
rm. 2110, Food and Drug
Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–5750; or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301–827–
6210.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance outlines FDA’s current
thinking on the use of Bayesian
statistical methods in medical device
clinical trials. Bayesian statistical
methods are currently used in a variety
of medical device applications to FDA.
This guidance includes a general
description of Bayesian methods,
discussions on design and analysis of
Bayesian medical device clinical trials,
the benefits and difficulties with the
Bayesian approach, and comparisons
with standard (frequentist) statistical
methods. Additionally, some ideas on
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]]>Agencies
[Federal Register Volume 75, Number 25 (Monday, February 8, 2010)]
[Notices]
[Pages 6208-6209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2694]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Web Based Training for Pain
Management Providers
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse, the
National Institutes of Health has submitted to the Office of Management
and Budget (OMB) a request to review and approve the information
collection listed below. The purpose of this notice is to allow 60 days
for public comment.
Proposed Collection
Title: Web Based Training for Pain Management Providers.
Type of Information Collection Request: New.
Need and Use of Information Collection: This research will evaluate
the effectiveness of the Web Based Training for Pain Management
Providers, via the Web site PainAndAddictionTreatment.com, to
positively impact the knowledge, attitudes, intended behaviors and
clinical skills of health care providers in the U.S. who treat pain.
The Web Based Training for Pain Management Providers is a new program
developed with funding from the National Institute on Drug Abuse. The
primary goal is to assess the impact of the training program on
knowledge, attitude, intended behavior, and clinical skills. A
secondary goal is to assess learner satisfaction with the program. If
the
[[Page 6209]]
program is a success, there will be a new, proven resource available to
health care providers to improve their ability to treat pain and
addiction co-occurring in the provider's patients. In order to evaluate
the effectives of the program, information will be collected from
health care providers before exposure to the web based materials (pre-
test), after exposure to the web based materials (post-test), and 4-6
weeks after the program has been completed (follow-up).
Frequency of Response: On occasion.
Affected Public: Volunteer health care providers who treat patients
with pain.
Type of Respondents: Physicians, nurse practitioners, and physician
assistants.
The annual reporting burden is as follows:
Estimated Number of Respondents: 80.
Estimated Number of Responses per Respondent: 3.
Average Burden Hours per Response: 0.75.
Estimated Total Annual Burden Hours Requested: 180.
The annualized cost to respondents is estimated at: $11,925. There
are no Capital Costs, Operating Costs, and/or Maintenance Costs to
report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden annual burden
Type of respondents number of responses per hours per hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Physicians...................................... 60 3 0.75 135
Other primary care providers (e.g., nurse 20 3 0.75 45
practitioners, physician assistants)...........
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (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 information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Scudder Quandra, Project Officer, NIH/NIDA/CCTN,
Room 3105, MSC 9557, 6001 Executive Boulevard, Bethesda, MD 20892-9557
or e-mail your request, including your address to
scudderq@nida.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: January 25, 2010.
Mary Affeldt,
Executive Officer (OM Director), NIDA.
[FR Doc. 2010-2694 Filed 2-5-10; 8:45 am]
BILLING CODE 4140-01-P
