Agency Information Collection Activities: Proposed Collection; Comment Request, 54403-54405 [E8-21824]
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54403
Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices
and the intended use(s) of survey data.
Individuals and organizations contacted
will be assured of the confidentiality of
their replies under 42 U.S.C. 924(c).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated burden
hours for the medical offices’ time to
participate in this one-time data
collection. It is anticipated that an
average of 20 persons (about 6
physicians and 14 staff) in each of the
350 medical offices will respond to the
survey, resulting in 7000 responses
(approximately 2,000 physicians and
5,000 staff). The Survey on Patient
Safety and the Post-Survey Evaluation
will be completed by both physicians
and staff, while the Office
Characteristics Survey will be
completed by the office manager at each
of the 350 participating medical offices.
Each survey will require approximately
15 minutes to complete. The total
annualized burden for the medical
offices to participate in this project is
estimated to be 3,588 hours.
Exhibit 2 shows the estimated cost
burden to participate in this project. The
total annualized cost burden, based on
the burden hours and hourly rates of the
physicians and staff, is estimated at
$99,368.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Survey name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Survey on Patient Safety (SOPS) ...................................................................
Office Characteristics Survey ..........................................................................
Post-Survey Evaluation ...................................................................................
350
350
350
20
1
20
15/60
15/60
15/60
1,750
88
1,750
Total ..........................................................................................................
1,050
na
na
3,588
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Survey name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Survey on Patient Safety (SOPS) ...................................................................
Office Characteristics Survey ..........................................................................
Post-Survey Evaluation ...................................................................................
350
350
350
1,750
88
1,750
$27.44
37.82
27.44
$48,020
3,328
48,020
Total ..........................................................................................................
1,050
3,588
na
99,368
* For the SOPS and Post-Survey Evaluation the wage rate is the national average wage for ‘‘healthcare practitioner and technical occupations.’’ For the Office Characteristics Survey the hourly wage is the national average wage for ‘‘medical and health services managers.’’ National
Compensation Survey: Occupational Wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
The total cost to the Government for
conducting this research will be
approximately $340,000. This estimate
includes the costs of medical office
identification and recruitment; data
collection and aggregation; shipping,
inputting and cleaning of data; analysis
and report writing.
jlentini on PROD1PC65 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act 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
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) 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
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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 Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 9, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–21822 Filed 9–18–08; 8:45 am]
BILLING CODE 4160–90–M
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.
AGENCY:
PO 00000
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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) approve the proposed
information collection project:
‘‘Conducting Measurement Activities in
Support of the AHRQ Health IT
Initiative.’’ 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 November 18, 2008.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov.
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:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.lefkowitz@ahrq.hhs.gov.
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54404
Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices
SUPPLEMENTARY INFORMATION:
Proposed Project
Conducting Measurement Activities in
Support of the AHRQ Health IT
Initiative
Over the past 35 years, AHRQ and its
predecessor agencies have made
adoption of health information
technology (IT) an agency priority. In
addition, AHRQ-supported research has
helped to demonstrate the potential of
health IT to enhance health care quality
and patient safety. As the lead federal
research agency on the quality, safety,
efficiency, and effectiveness of health
care in America, AHRQ plays a central
role in efforts to increase the adoption
of health IT.
Consistent with its mission, AHRQ
proposes to develop measures of four
indicators of performance of its health
IT portfolio, namely:
1. Reduction in medication errors due
to adoption of electronic prescribing
systems;
2. The number of persons who can
access their medication information
online;
3. The number of clinicians who can
electronically access evidence-based
prevention or treatment information;
and
4. The number of clinician
organizations who have adopted
evidence-based decision support
technologies.
While secondary data are available to
calculate measures 1, 3 and 4 described
above, no national data exist for
measure #2. Thus, this proposed
information collection relates to
measure #2: The number of persons who
can access their medication information
online.
This project is being conducted
pursuant to AHRQ’s statutory mandates
to conduct and support research,
evaluations and initiatives to advance
information systems for health care
improvement (42 U.S.C. 299b–3) and to
promote innovations in evidence-based
health care practices and technologies
by conducting and supporting research
on the development, diffusion, and use
of health care technology (42 U.S.C.
299b–5(a)(1)).
Method of Collection
The data will be collected using a
random-digit-dial (RDD) telephone
survey of the U.S. adult population. To
ensure a representative geographic
distribution of the sample, the total
sample will be allocated to each Census
region in proportion to the total number
of adults in each region. The survey will
be administered in both English and
Spanish.
Estimated Annual Respondent Burden
Exhibit 1 presents the estimated
annualized burden hours for the
respondents’ time to participate in this
project. The telephone survey will be
completed by 1,000 respondents and is
expected to require 12 minutes to
complete. The cognitive pretest
interviews, which are used to refine and
validate the survey instrument, will be
completed by 18 respondents (9
English-speaking and 9 Spanishspeaking) and are expected to last one
hour. The total burden hours are
estimated to be 218 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents’ time to participate in this
project. The total cost burden is
estimated to be $4,205.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Number of responses per
respondent
Hours per response
Telephone Survey ............................................................................................
Cognitive Pretest Interview ..............................................................................
1000
18
1
1
12/60
1
200
18
Total ..........................................................................................................
1018
na
na
218
Average hourly wage rate *
Total cost burden
Data collection
Total burden
hours
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents
Data collection
Total burden
hours
Telephone Survey ............................................................................................
Cognitive Pretest Interview ..............................................................................
1000
18
200
18
$19.29
19.29
$3,858
347
Total ..........................................................................................................
1018
218
na
4,205
* Based upon the mean of the average wages, National Compensation Survey: Occupational Wages in the United States 2006, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Estimated Annual Costs to the Federal
Government
We are requesting approval for a onetime, one year, data collection effort.
The estimated cost of this data
collection is $310,067, which includes
the cost of developing, administering
and analyzing the survey. Exhibit 3
details labor hours, operational
expenses (such as equipment, overhead,
printing, and support staff), and any
other expenses that would not have
been incurred without this collection of
information.
jlentini on PROD1PC65 with NOTICES
EXHIBIT 3. ANNUAL COSTS FOR THE ESTIMATE OF THE NUMBER OF PERSONS WHO CAN ACCESS THEIR MEDICATION
INFORMATION ONLINE
Annual cost
Labor:
1,514 hours plus 42% fringe ........................................................................................................................................................
Data collection:
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$123,998
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Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Notices
EXHIBIT 3. ANNUAL COSTS FOR THE ESTIMATE OF THE NUMBER OF PERSONS WHO CAN ACCESS THEIR MEDICATION
INFORMATION ONLINE—Continued
Annual cost
Interviewer training, sample purchase, survey administration, data entry, toll calls ...................................................................
Other direct costs:
Computer charge, telephone/fax/teleconference, printing and duplication, travel .......................................................................
Indirect costs:
Regular overhead, 46.5%; G&A ...................................................................................................................................................
Contract Fee ........................................................................................................................................................................................
101,775
25,602
Total ..............................................................................................................................................................................................
$310,067
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act 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
AHRQ health care research, quality
improvement and information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) 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 Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 9, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–21824 Filed 9–18–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–8003]
jlentini on PROD1PC65 with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
AGENCY:
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Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections 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 function;
(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.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Home and
Community Based Waiver Requests and
Supporting Regulations in 42 CFR
440.180 and 441.300–310; Use: Under a
Secretarial waiver, States may offer a
wide array of home and communitybased services to individuals who
would otherwise require
institutionalization. States requesting a
waiver must provide certain assurances,
documentation and cost and utilization
estimates which are reviewed, approved
and maintained for the purpose of
identifying/verifying States’ compliance
with such statutory and regulatory
requirements. Form Number: CMS–8003
(OMB# 0938–0449); Frequency:
Occasionally; Affected Public: State,
Local or Tribal Governments; Number of
Respondents: 50; Total Annual
Responses: 136; Total Annual Hours:
8,010.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
30,274
28,418
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on October 20, 2008.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington,
DC 20503, Fax Number: (202) 395–
6974.
Dated: September 11, 2008.
Michelle Shortt,
Director, Regulations Development Group.
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–21906 Filed 9–18–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Structured Product Labeling Content
of Labeling and Electronic Drug
Establishment Registration and Drug
Listing for the Biologics Industry;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Structured Product Labeling
(SPL) Content of Labeling and
Electronic Drug Establishment
Registration and Drug Listing for the
Biologics Industry.’’ The purpose of the
public workshop is to provide the
biologics industry with guidance on
submitting to FDA content of labeling in
SPL format, present an overview of
FDA’s voluntary pilot program for
electronic submission of drug
establishment registration and drug
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]]>Agencies
[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
[Notices]
[Pages 54403-54405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21824]
-----------------------------------------------------------------------
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) approve the proposed information collection
project: ``Conducting Measurement Activities in Support of the AHRQ
Health IT Initiative.'' 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 November 18, 2008.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@ahrq.hhs.gov.
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: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
doris.lefkowitz@ahrq.hhs.gov.
[[Page 54404]]
SUPPLEMENTARY INFORMATION:
Proposed Project
Conducting Measurement Activities in Support of the AHRQ Health IT
Initiative
Over the past 35 years, AHRQ and its predecessor agencies have made
adoption of health information technology (IT) an agency priority. In
addition, AHRQ-supported research has helped to demonstrate the
potential of health IT to enhance health care quality and patient
safety. As the lead federal research agency on the quality, safety,
efficiency, and effectiveness of health care in America, AHRQ plays a
central role in efforts to increase the adoption of health IT.
Consistent with its mission, AHRQ proposes to develop measures of
four indicators of performance of its health IT portfolio, namely:
1. Reduction in medication errors due to adoption of electronic
prescribing systems;
2. The number of persons who can access their medication
information online;
3. The number of clinicians who can electronically access evidence-
based prevention or treatment information; and
4. The number of clinician organizations who have adopted evidence-
based decision support technologies.
While secondary data are available to calculate measures 1, 3 and 4
described above, no national data exist for measure 2. Thus,
this proposed information collection relates to measure 2: The
number of persons who can access their medication information online.
This project is being conducted pursuant to AHRQ's statutory
mandates to conduct and support research, evaluations and initiatives
to advance information systems for health care improvement (42 U.S.C.
299b-3) and to promote innovations in evidence-based health care
practices and technologies by conducting and supporting research on the
development, diffusion, and use of health care technology (42 U.S.C.
299b-5(a)(1)).
Method of Collection
The data will be collected using a random-digit-dial (RDD)
telephone survey of the U.S. adult population. To ensure a
representative geographic distribution of the sample, the total sample
will be allocated to each Census region in proportion to the total
number of adults in each region. The survey will be administered in
both English and Spanish.
Estimated Annual Respondent Burden
Exhibit 1 presents the estimated annualized burden hours for the
respondents' time to participate in this project. The telephone survey
will be completed by 1,000 respondents and is expected to require 12
minutes to complete. The cognitive pretest interviews, which are used
to refine and validate the survey instrument, will be completed by 18
respondents (9 English-speaking and 9 Spanish-speaking) and are
expected to last one hour. The total burden hours are estimated to be
218 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents' time to participate in this project. The total cost burden
is estimated to be $4,205.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Telephone Survey................................ 1000 1 12/60 200
Cognitive Pretest Interview..................... 18 1 1 18
---------------------------------------------------------------
Total....................................... 1018 na na 218
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Data collection respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Telephone Survey................................ 1000 200 $19.29 $3,858
Cognitive Pretest Interview..................... 18 18 19.29 347
---------------------------------------------------------------
Total....................................... 1018 218 na 4,205
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the average wages, National Compensation Survey: Occupational Wages in the United
States 2006, ``U.S. Department of Labor, Bureau of Labor Statistics.''
Estimated Annual Costs to the Federal Government
We are requesting approval for a one-time, one year, data
collection effort. The estimated cost of this data collection is
$310,067, which includes the cost of developing, administering and
analyzing the survey. Exhibit 3 details labor hours, operational
expenses (such as equipment, overhead, printing, and support staff),
and any other expenses that would not have been incurred without this
collection of information.
Exhibit 3. Annual Costs for the Estimate of the Number of Persons Who
Can Access Their Medication Information Online
------------------------------------------------------------------------
Annual cost
------------------------------------------------------------------------
Labor:
1,514 hours plus 42% fringe......................... $123,998
Data collection:
[[Page 54405]]
Interviewer training, sample purchase, survey 30,274
administration, data entry, toll calls.............
Other direct costs:
Computer charge, telephone/fax/teleconference, 28,418
printing and duplication, travel...................
Indirect costs:
Regular overhead, 46.5%; G&A........................ 101,775
Contract Fee............................................ 25,602
---------------
Total............................................... $310,067
------------------------------------------------------------------------
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
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
AHRQ health care research, quality improvement and information
dissemination functions, including whether the information will have
practical utility; (b) the accuracy of AHRQ's estimate of burden
(including hours and costs) of the proposed collection(s) 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 Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: September 9, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8-21824 Filed 9-18-08; 8:45 am]
BILLING CODE 4160-90-M
