Agency Information Collection Activities: Proposed Collection; Comment Request, 2596-2598 [E9-537]
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Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices
SUMMARY: The Department of Health and
Human Services (HHS) is soliciting
ideas and information relating to ways
in which HHS could continue to
improve its use of resources and
authorities in encouraging the
development and use of new medical
technologies, consistent with the goals
of (a) maintaining and improving the
quality of care, (b) controlling overall
healthcare costs, and (c) using timely
and practical administrative procedures.
This Request for Information is now
available on the HHS Web site at
https://aspe.hhs.gov/sp/
medtechinnovation/rfi.
DATES: Responses should be submitted
to the U.S. Department of Health and
Human Services on or before 5 p.m.,
EDT, April 16, 2009.
ADDRESSES:
Instructions for Submitting
Comments: Electronic responses are
preferred and should be addressed to
medtechinnovation@hhs.gov. Written
responses should be addressed to the
U.S. Department of Health and Human
Services, Room 434E, 200 Independence
Ave, SW., Washington, DC 20201.
Attention: Medical Technology
Innovation RFI. A copy of this RFI is
available on the Web site of the
Assistant Secretary for Planning and
Evaluation at https://aspe.hhs.gov/sp/
medtechinnovation/rfi.
The submission of comments in
response to this notice should not
exceed 25 pages, not including
appendices and supplemental
documents. Any information you
submit will be made public.
Consequently, please do not send any
proprietary, commercial, financial,
business confidential, trade secret, or
personal information that you do not
wish to be made public.
Public Access: Responses to this RFI
will be available to the public in the
Policy Information Center, 200
Independence Avenue, SW.,
Washington, DC, 20201. Please call
(202) 690–6445 between 9 a.m. and 5
p.m. to arrange access.
jlentini on PROD1PC65 with NOTICES
FOR FURTHER INFORMATION CONTACT:
Medical Technology Innovation Desk,
Office of the Assistant Secretary for
Planning and Evaluation, (202) 690–
7858.
Dated: January 12, 2009.
Mary M. McGeein,
Principal Deputy Assistant Secretary for
Planning and Evaluation.
[FR Doc. E9–807 Filed 1–14–09; 8:45 am]
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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:
‘‘Improving Patient Flow and Reducing
Emergency Department Crowding.’’ 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 March 16, 2009.
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.
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Improving Patient Flow and Reducing
Emergency Department Crowding’’
AHRQ proposes to study
implementation of strategies from the
Urgent Matters (UM) Toolkit for
improving patient flow in emergency
departments (ED). UM, a Robert Wood
Johnson Foundation (RWJF) funded
initiative, began as a collaborative of 10
urban, safety net hospitals that
experimented with a variety of strategies
(now included in the ‘‘UM Toolkit’’)
designed to relieve ED crowding. The
first phase of this initiative
demonstrated that reductions in ED
crowding were achievable without
investment of significant financial
resources. However, implementation of
these strategies has not been
widespread, and questions remain about
how readily the strategies could be
implemented in a more diverse group of
hospitals, and the associated costs and
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
outcomes of implementation. This study
is funded by a grant from RWJF to
AHRQ.
Six diverse hospitals have been
selected for this study of the
implementation of strategies from the
UM Toolkit for improving ED patient
flow. This study poses a common
outcome goal across all six sites of
improving patient flow and reducing ED
crowding, but requires each hospital to
select strategies that fit its own needs
amid context. This approach rests on
innovation research showing that
organizational innovations are more
successful when they are aligned with
features of the adopting hospital.
Participating hospitals will select
strategies from the UM Toolkit that they
believe will work best to address the
particular problems they face. The six
hospitals have agreed to participate in a
collaborative run by the UM National
Program Office (NPO) over the course of
this study to facilitate the sharing of
data and experiences while the project
is under way.
This study will document the
experiences of a diverse set of hospital
EDs as they identify and implement ED
patient flow improvement strategies.
The six case study hospitals were
selected to reflect diversity of size,
ownership, teaching status, safety net
status, and types of challenges with ED
crowding.
Research methods will include
observational site visits, in-person and
telephone interviews, and the analysis
of cost data. AHRQ’s contractor for this
study, Health Research & Educational
Trust (HRET), will perform analysis of
secondary data on ED performance
measures; this secondary data will be
provided to HRET by the Urgent Matters
NPO. These qualitative and quantitative
methods will be used to:
• Study the processes through which
hospitals decide upon and adopt patient
flow improvement strategies;
• Identify facilitators and barriers to
the implementation and maintenance of
these strategies;
• Document changes in patient flow,
patient satisfaction, and staff
satisfaction associated with the
implementation of strategies and
processes;
• Generate estimates of the costs of
adopting the strategies;
• Identify issues associated with the
reporting of ED performance measures,
and
• Develop lessons for hospitals
considering the adoption of patient flow
improvement strategies.
The study will not be used to answer
questions about causality or degrees of
effectiveness (e.g to what degree did a
E:\FR\FM\15JAN1.SGM
15JAN1
2597
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices
given intervention cause an
improvement in patient flow?). Rather,
the study seeks to enhance
understanding of factors affecting
decision-making and adoption processes
that facilitate or hinder implementation.
Insights and lessons learned about
organizational, technical and resource
challenges arising from these
improvement activities may be of
interest or benefit to others seeking to
identify and adopt strategies to address
similar problems in their EDs.
This study is being conducted
pursuant to AHRQ’s statutory authority
to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to: The quality,
effectiveness, efficiency,
appropriateness and value of health care
services; quality measurement and
improvement; and health care costs,
productivity, organization, and market
forces. 42 U.S.C. 299a(a)(1), (2), and (6).
Method of Collection
AHRQ seeks approval for the
following data collection activities:
• In-person interviews will be
conducted within two months of the
implementation with up to 12
individuals at each of the 6 sites during
two-day site visits to each of the
hospitals.
• Telephone interviews will be
conducted approximately 6 months after
implementation with 12 individuals
from each of the six hospitals (most or
all of whom will be the same
individuals interviewed in person).
• Each of the six hospitals will
submit information on the costs
associated with the planning,
implementation, and maintenance of the
patient flow improvement strategies on
a monthly basis. One study team
member at each site will record costs on
an assessment instrument specifically
designed for this purpose and tailored to
each hospital’s own organizational
structure and patient flow strategies.
This assessment instrument will
collect information on staff time
devoted to the patient flow
improvement initiatives as well as the
costs of items or resources purchased to
support the initiatives.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
hospitalst time to participate in this
study. In-person interviews will be
conducted within two months of
implementation with 12 administrative
and clinical personnel from each of the
six participating hospitals and will
require about one hour. Telephone
interviews will be conducted
approximately six months thereafter
with 12 individuals (administrative and
clinical) from each hospital and will
take about 45 minutes. Monthly cost
assessment data will be collected from
each participating hospital each month
and will require about one hour. The
total estimated burden for participation
in this study is 198 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents’ time to provide the
requested data. The total cost burden is
approximately $6,536.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Data collection
Hours per
response
Total burden
hours
In-person interviews .........................................................................................
Telephone interviews .......................................................................................
Cost Assessment .............................................................................................
6
6
6
12
12
12
1
45/60
1
72
54
72
Total ..........................................................................................................
18
na
na
198
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Data collection
Total burden
hours
Average
hourly wage
rate*
Total cost
burden
In-person interviews .........................................................................................
Telephone interviews .......................................................................................
Cost Assessment .............................................................................................
6
6
6
72
54
72
$35.07
35.07
28.15
$2,525
1,984
2,027
Total ..........................................................................................................
18
198
na
6,536
* For the interviews, the hourly rate of $35.07 is an average of the administrative personnel hourly wage of $14.53, the physician rate of
$62.52, and the registered nurse rate of $28.15. For cost assessment, the hourly rate of $28.15 is the hourly rate for registered nurses. National
Compensation Survey: Occupational Wages in the United States 2005, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost to the government for
this eighteen-month study.
jlentini on PROD1PC65 with NOTICES
EXHIBIT 3—ESTIMATED COST
Cost component
Total cost
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
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15JAN1
$52,446
90,298
Annualized
cost
$34,964
60,199
2598
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices
EXHIBIT 3—ESTIMATED COST—Continued
Cost component
Total cost
Annualized
cost
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................
70,569
41,420
68,908
76,320
47,046
27,613
45,939
50,880
Total ..................................................................................................................................................................
399,961
266,641
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’s 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
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: December 30, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E9–537 Filed 1–14–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on PROD1PC65 with NOTICES
[Docket No. FDA–2008–N–0543]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Waiver of In Vivo
Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A
Medicated Articles
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
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18:58 Jan 14, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr.,Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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.
Waiver of In Vivo Demonstration of
Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form
Products and Type A Medicated
Articles—21 CFR Part 514 (OMB
Control Number 0910–0575)—Extension
BILLING CODE 4160–90–M
HHS.
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 February
17, 2009.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submissions@OMB.eop.gov. All
comments should be identified with the
OMB control number 0910–0575. Also
include the FDA docket number found
in brackets in the heading of this
document.
The Center for Veterinary Medicine
has written this guidance to address a
perceived need for agency guidance in
its work with the animal health
industry. This guidance describes the
procedures that the agency recommends
for the review of requests for waiver of
in vivo demonstration of bioequivalence
for generic soluble powder oral dosage
form products and Type A medicated
articles.
The Generic Animal Drug and Patent
Term Registration Act of 1988 permitted
the generic drug manufacturers to copy
those pioneer drug products that were
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no longer subject to patent or other
marketing exclusivity protection. The
approval for marketing these generic
products is based, in part, upon a
demonstration of bioequivalence
between the generic product and the
pioneer product. This guidance clarifies
circumstances under which FDA
believes the demonstration of
bioequivalence required by the statute
does not need to be established on the
basis of in vivo studies for soluble
powder oral dosage form products and
Type A medicated articles. The data
submitted in support of the waiver
request are necessary to validate the
waiver decision.
The requirement to establish
bioequivalence through in vivo studies
(blood level bioequivalence or clinical
endpoint bioequivalence) may be
waived for soluble powder oral dosage
form products or Type A medicated
articles in either of two alternative
ways. A biowaiver may be granted if it
can be shown that the generic soluble
powder oral dosage form product or
Type A medicated article contains the
same active and inactive ingredient(s)
and is produced using the same
manufacturing processes as the
approved comparator product or article.
Alternatively, a biowaiver may be
granted without direct comparison to
the pioneer product’s formulation and
manufacturing process if it can be
shown that the active pharmaceutical
ingredient(s) (API) is the same as the
pioneer product, is soluble, and that
there are no ingredients in the
formulation likely to cause adverse
pharmacologic effects. For the purpose
of evaluating soluble powder oral
dosage form products and Type A
medicated articles, solubility can be
demonstrated in one of two ways: (1)
‘‘USP definition’’ approach or (2)
‘‘Dosage adjusted’’ approach.
In the Federal Register of October 29,
2008 (73 FR 64338), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2596-2598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-537]
-----------------------------------------------------------------------
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: ``Improving Patient Flow and Reducing Emergency Department
Crowding.'' 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 March 16, 2009.
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.
SUPPLEMENTARY INFORMATION:
Proposed Project
``Improving Patient Flow and Reducing Emergency Department Crowding''
AHRQ proposes to study implementation of strategies from the Urgent
Matters (UM) Toolkit for improving patient flow in emergency
departments (ED). UM, a Robert Wood Johnson Foundation (RWJF) funded
initiative, began as a collaborative of 10 urban, safety net hospitals
that experimented with a variety of strategies (now included in the
``UM Toolkit'') designed to relieve ED crowding. The first phase of
this initiative demonstrated that reductions in ED crowding were
achievable without investment of significant financial resources.
However, implementation of these strategies has not been widespread,
and questions remain about how readily the strategies could be
implemented in a more diverse group of hospitals, and the associated
costs and outcomes of implementation. This study is funded by a grant
from RWJF to AHRQ.
Six diverse hospitals have been selected for this study of the
implementation of strategies from the UM Toolkit for improving ED
patient flow. This study poses a common outcome goal across all six
sites of improving patient flow and reducing ED crowding, but requires
each hospital to select strategies that fit its own needs amid context.
This approach rests on innovation research showing that organizational
innovations are more successful when they are aligned with features of
the adopting hospital. Participating hospitals will select strategies
from the UM Toolkit that they believe will work best to address the
particular problems they face. The six hospitals have agreed to
participate in a collaborative run by the UM National Program Office
(NPO) over the course of this study to facilitate the sharing of data
and experiences while the project is under way.
This study will document the experiences of a diverse set of
hospital EDs as they identify and implement ED patient flow improvement
strategies. The six case study hospitals were selected to reflect
diversity of size, ownership, teaching status, safety net status, and
types of challenges with ED crowding.
Research methods will include observational site visits, in-person
and telephone interviews, and the analysis of cost data. AHRQ's
contractor for this study, Health Research & Educational Trust (HRET),
will perform analysis of secondary data on ED performance measures;
this secondary data will be provided to HRET by the Urgent Matters NPO.
These qualitative and quantitative methods will be used to:
Study the processes through which hospitals decide upon
and adopt patient flow improvement strategies;
Identify facilitators and barriers to the implementation
and maintenance of these strategies;
Document changes in patient flow, patient satisfaction,
and staff satisfaction associated with the implementation of strategies
and processes;
Generate estimates of the costs of adopting the
strategies;
Identify issues associated with the reporting of ED
performance measures, and
Develop lessons for hospitals considering the adoption of
patient flow improvement strategies.
The study will not be used to answer questions about causality or
degrees of effectiveness (e.g to what degree did a
[[Page 2597]]
given intervention cause an improvement in patient flow?). Rather, the
study seeks to enhance understanding of factors affecting decision-
making and adoption processes that facilitate or hinder implementation.
Insights and lessons learned about organizational, technical and
resource challenges arising from these improvement activities may be of
interest or benefit to others seeking to identify and adopt strategies
to address similar problems in their EDs.
This study is being conducted pursuant to AHRQ's statutory
authority to conduct and support research on health care and on systems
for the delivery of such care, including activities with respect to:
The quality, effectiveness, efficiency, appropriateness and value of
health care services; quality measurement and improvement; and health
care costs, productivity, organization, and market forces. 42 U.S.C.
299a(a)(1), (2), and (6).
Method of Collection
AHRQ seeks approval for the following data collection activities:
In-person interviews will be conducted within two months
of the implementation with up to 12 individuals at each of the 6 sites
during two-day site visits to each of the hospitals.
Telephone interviews will be conducted approximately 6
months after implementation with 12 individuals from each of the six
hospitals (most or all of whom will be the same individuals interviewed
in person).
Each of the six hospitals will submit information on the
costs associated with the planning, implementation, and maintenance of
the patient flow improvement strategies on a monthly basis. One study
team member at each site will record costs on an assessment instrument
specifically designed for this purpose and tailored to each hospital's
own organizational structure and patient flow strategies.
This assessment instrument will collect information on staff time
devoted to the patient flow improvement initiatives as well as the
costs of items or resources purchased to support the initiatives.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
hospitalst time to participate in this study. In-person interviews will
be conducted within two months of implementation with 12 administrative
and clinical personnel from each of the six participating hospitals and
will require about one hour. Telephone interviews will be conducted
approximately six months thereafter with 12 individuals (administrative
and clinical) from each hospital and will take about 45 minutes.
Monthly cost assessment data will be collected from each participating
hospital each month and will require about one hour. The total
estimated burden for participation in this study is 198 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents' time to provide the requested data. The total cost burden
is approximately $6,536.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
In-person interviews............................ 6 12 1 72
Telephone interviews............................ 6 12 45/60 54
Cost Assessment................................. 6 12 1 72
---------------------------------------------------------------
Total....................................... 18 na na 198
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Data collection Number of Total burden hourly wage Total cost
respondents hours rate* burden
----------------------------------------------------------------------------------------------------------------
In-person interviews............................ 6 72 $35.07 $2,525
Telephone interviews............................ 6 54 35.07 1,984
Cost Assessment................................. 6 72 28.15 2,027
---------------------------------------------------------------
Total....................................... 18 198 na 6,536
----------------------------------------------------------------------------------------------------------------
* For the interviews, the hourly rate of $35.07 is an average of the administrative personnel hourly wage of
$14.53, the physician rate of $62.52, and the registered nurse rate of $28.15. For cost assessment, the hourly
rate of $28.15 is the hourly rate for registered nurses. National Compensation Survey: Occupational Wages in
the United States 2005, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the total and annualized cost to the government for
this eighteen-month study.
Exhibit 3--Estimated Cost
------------------------------------------------------------------------
Annualized
Cost component Total cost cost
------------------------------------------------------------------------
Project Development..................... $52,446 $34,964
Data Collection Activities.............. 90,298 60,199
[[Page 2598]]
Data Processing and Analysis............ 70,569 47,046
Publication of Results.................. 41,420 27,613
Project Management...................... 68,908 45,939
Overhead................................ 76,320 50,880
-------------------------------
Total............................... 399,961 266,641
------------------------------------------------------------------------
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's 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 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: December 30, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E9-537 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-90-M
