Attachment H -- 60 Day FR Notice

Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Notices
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: June 22, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–15086 Filed 6–29–09; 8:45 am]
BILLING CODE 4160–90–P

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: ‘‘Health
IT Community Tracking Study 2009.’’ 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 August 31, 2009.

Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at [email protected].
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.
sroberts on PROD1PC70 with NOTICES6

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:

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19:55 Jun 29, 2009

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Proposed Project
Health IT Community Tracking Study
2009
Electronic prescribing (e-prescribing)
is a central focus of efforts to promote
health information technology (IT) and
is of particular interest to AHRQ
because of its potential to improve
patient safety by reducing medication
errors. Despite many public- and
private-sector initiatives to support eprescribing, to date, physician adoption
and use has been limited (Friedman,
Schueth and Bell 2009). Recently,
section 132 of the Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA), Public
Law 110–275, authorized a new
incentive program for eligible
individual providers who are successful
e-prescribers. In addition, section 4101
of the American Recovery and
Reinvestment Act of 2009 (ARRA),
Public Law 111–5, provides incentives
for meaningful use of electronic health
record technology, which includes the
use of e-prescribing.
The potential gains from e-prescribing
assume that prescribers and pharmacists
have access to the required features and
use them. Limited research on the topic
suggests, however, that not all eprescribing systems currently have the
full range of e-prescribing features
required under MIPPA; that even when
the features are available, physician
practices face barriers to implementing
them effectively; and even when they
are implemented at the practice level,
physicians may not use them. For
example, in a small, exploratory
qualitative study by Grossman, et al.
(2005), physicians did not routinely
have access to patient medication
histories or formulary data for a
significant portion of their patients and
when they did, physicians often did not
use the information, instead continuing
to rely on patients for medication
history and pharmacists to identify
formulary issues. Several studies have
identified that IT system limitations,
workflow and training issues, and real
or perceived regulatory barriers present
obstacles in both the physician and
pharmacy settings to electronic
transmission of prescriptions (Grossman
et al. 2007; NORC 2007; Rupp and
Warholak 2008; Warholak and Rupp
2009).
AHRQ proposes to conduct a
qualitative research study designed to
help build knowledge on how the eprescribing features required under
MIPPA are actually being implemented
and used by physicians and pharmacies
in 12 nationally representative
communities. These communities have

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been studied longitudinally since the
mid-1990s as part of the Center for
Studying Health System Change (HSC)
Community Tracking Study (CTS)
(Center for Studying Health System
Change 2007). This qualitative study
will collect data from physician
practices and pharmacies that are using
electronic transmission of prescriptions
to allow a focus on both the facilitators
of and barriers to this critical aspect of
e-prescribing. The study will be the first
to ask questions of physician practices
and pharmacies in the same
communities on the same topics,
providing a much more complete
picture of e-prescribing implementation.
For example, in addition to gaining
physician and pharmacy perspectives
on electronic transmission, the study
will explore how physician practices
use patient formulary data and how
pharmacies perceive changes in the
communication with physician
practices around formulary issues with
e-prescribing.
Information collected by this study
will inform strategies to promote the
adoption and effective use of eprescribing being developed by AHRQ
and other Department of Health and
Human Services agencies, including the
Centers for Medicare & Medicaid
Services (CMS) and the Office of the
National Coordinator for Health IT, as
well as State and local governments and
private health care organizations. In
particular, while physician adoption has
been the focus of most policy efforts,
findings from the study can help
identify and shape strategies to promote
more effective implementation of eprescribing in retail and mail-order
pharmacies. This work will be
conducted by AHRQ’s contractor, the
Center for Studying Health System
Change (HSC), under contract number
290–05–0007–03. This study is being
conducted pursuant to AHRQ’s
statutory authority to conduct and
support research on health care and
systems for the delivery of such care,
including activities with respect to
health care technologies, facilities and
equipment, 42 U.S.C. 299a(a)(5).
Method of Collection
The study will use qualitative
methods, including telephone
interviews with physician practices and
pharmacies, as well as State pharmacy
associations, IT vendors and other eprescribing experts. Using semistructured interview protocols, the
following specific research questions
will be addressed to provide an in-depth
look at unexplored barriers to effective
e-prescribing use in physician practices
and pharmacies, including:

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Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Notices

• How are physicians using thirdparty information in making prescribing
decisions, including patient medication
history, generic drug information, and
patient-specific formulary data?
• How are physician practices and
retail and mail-order pharmacies using
e-prescribing systems to communicate
electronically with each other?
• What are the most common reasons
that physician practices and pharmacies
communicate about prescriptions
generated by physician e-prescribing
systems (regardless of how they were
sent)?
• What are the facilitators of and
challenges to implementing eprescribing features that support
physician access to third-party
information in making prescribing
decisions and features that support
electronic communication between
physician practices and pharmacies?

• What are the perceived effects of
having access to e-prescribing features
that support physician access to thirdparty information in making prescribing
decisions and features that support
electronic communication between
physician practices and pharmacies on
physician practice and pharmacy
operations, physician prescribing
behavior and patient outcomes?
• What are the implications for policy
efforts to promote e-prescribing?
Estimated Annual Respondent Burden
Interviews will be conducted at a total
of 110 organizations over the two years
of this project. Within each of the 24
participating physician practices (12
annually), two interviews will be
conducted: one with the medical
director or physician-user best able to
describe practice processes for eprescribing, who will provide a clinical

perspective (Interview Protocol 2), and
a second with an IT administrator or
office manager, who can provide a
technical and operational perspective
(Interview Protocol 1). The other 86
organizations will each have only one
interview, for a total of 43 additional
interviews annually. Eight different
organization-specific interview
protocols have been developed, with
response times ranging from 30 minutes
to 1 hour.
Exhibit 1 shows the estimated annual
burden hours for each organization’s
time to participate in this research. The
total annual burden is estimated to be
57 hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
organizations’ time to participate in this
research. The total annual burden is
estimated to be $3,004.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
organization

Number of
organizations*

Form name
Interview Protocol 1—Physician Practice IT Administrator or Office Manager ................................................................................
Interview Protocol 2—Physician Practice Medical Director or Physician User ...................................................................................
Interview Protocol 3—Pharmacy Pharmacist-In-Charge .................
Interview Protocol 4—State Pharmacy Association Representative
Interview Protocol 5—Pharmacy IT Vendor Representative ...........
Interview Protocol 6—E-prescribing System Vendor Representative ................................................................................................
Interview Protocol 7—E-prescribing Connectivity and Content
Vendor Representatives ...............................................................
Interview Protocol 8—Other E-prescribing Experts .........................
Total ..........................................................................................

Hours per
response

Total burden
hours

12

1

30/60

6

12
28
6
1

1
1
1
1

45/60
1
1
1

9
28
6
1

3

1

1

3

3
2

1
1

1
30/60

3
1

67

NA

NA

57

The estimated total number of unique organizations participating in each year of the study is 55 since Interview Protocols 1 and 2 will both be
administered to respondents in physician practices.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
organizations*

Form name

sroberts on PROD1PC70 with NOTICES6

Interview Protocol 1—Physician Practice IT Administrator or Office Manager ..............................................................................
Interview Protocol 2—Physician Practice Medical Director or
Physician User ...........................................................................
Interview Protocol 3—Pharmacy Pharmacist-In-Charge ...............
Interview Protocol 4—State Pharmacy Association Representative ..............................................................................................
Interview Protocol 5—Pharmacy IT Vendor Representative .........
Interview Protocol 6—E-prescribing System Vendor Representative ..............................................................................................
Interview Protocol 7—E-prescribing Connectivity and Content
Vendor Representatives .............................................................
Interview Protocol 8—Other E-prescribing Experts .......................
Total ........................................................................................

Total burden
hours

Average hourly
wage rate**

Total cost burden

12

6

32.62

$196

12
28

9
28

80.42
48.09

724
1,347

6
1

6
1

49.89
54.75

299
55

3

3

54.75

164

3
2

3
1

54.75
54.75

164
55

67

57

NA

3,004

* The estimated total number of unique organizations participating in each year of the study is 55 since Interview Protocols 1 and 2 will both be
administered to respondents in physician practices.
** Wage rates were calculated using the mean hourly wage from the U.S. Department of Labor, Bureau of Labor Statistics, May 2007 National
Occupational Employment and Wage Estimates for the United States, Occupational Employment Statistics (OES), Washington, DC (Feb. 2009),
http://www.bls.gov/oes/2007/may/oes_nat.htm (accessed April 2009). Wage rate for Interview Protocol 3—Pharmacy Pharmacist-In-Charge reflects the weighted average for retail and mail order pharmacists ($47.58 per hour) and pharmacy chain representatives ($54.75 per hour).

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Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Notices
Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
Government for this project is $374,635

over a two-year period from February 2,
2009 to February 1, 2010. The estimated
average annual cost is $187,318. Exhibit
3 provides a breakdown of the estimated

total and average annual costs by
category.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUAL COST* TO THE FEDERAL GOVERNMENT
Cost component

Total cost

Annualized cost

Project Development and Project Management ..............................................................................................
Data Collection Activities .................................................................................................................................
Data Analysis ...................................................................................................................................................
Publication and Dissemination of Results .......................................................................................................

$87,783
141,048
55,884
89,920

$43,892
70,524
27,942
44,960

Total ..........................................................................................................................................................

374,635

187,318

* Costs are fully loaded including overhead and G&A.

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: June 22, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–15089 Filed 6–29–09; 8:45 am]
BILLING CODE 4160–90–P

sroberts on PROD1PC70 with NOTICES6

Breast Cancer and Environmental
Research Act of 2008; Delegation of
Authority
Notice is hereby given that I have
delegated to the Director, National
Institutes of Health (NIH), the
authorities under Section 2 of the Breast
Cancer and Environmental Research Act

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BILLING CODE 4140–01–M

SUMMARY: In accordance with section
10(a) of the Federal Advisory Committee
Act, 5 U.S.C. App. 2, this notice
announces a meeting of the National
Advisory Council for Healthcare
Research and Quality Subcommittee on
Quality Measures for Children’s
Healthcare in Medicaid and Children’s
Health Insurance Programs (CHIP).
DATES: The meeting will be held on
Wednesday, July 22, 2009, from 10 a.m.
to 5 p.m. and Thursday, July 23, 2009
from 9 a.m. to 5 p.m.
ADDRESSES: Holiday Inn Capitol, 550 C
Street, SW., Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT:
Padmini Jagadish, Public Health Analyst
at the Agency for Healthcare Research
and Quality, 540 Gaither Road,
Rockville, Maryland 20850, (301) 427–
1927. For press-related information,
please contact Karen Migdail at (301)
427–1855.
If sign language interpretation or other
reasonable accommodation for a
disability is needed, please contact Mr.
Michael Chew, Director, Office of Equal
Employment Opportunity Program,
Program Support Center, on (301) 443–
1144, no later than July 3, 2009.
SUPPLEMENTARY INFORMATION:

I. Purpose
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Meeting of the National Advisory
Council for Healthcare Research and
Quality Subcommittee on Quality
Measures for Children’s Healthcare in
Medicaid and Children’s Health
Insurance Programs (CHIP)

National Institutes of Health

19:55 Jun 29, 2009

Dated: June 23, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9–15439 Filed 6–29–09; 8:45 am]

Agency for Healthcare Research and
Quality

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

VerDate Nov<24>2008

of 2008, Public Law 110–354, as
amended, which amends Subpart 1 of
Part C of Title IV of the Public Health
Service Act by adding Section 417F,
authorizing the establishment of the
Interagency Breast Cancer and
Environmental Research Coordinating
Committee. I am also delegating the
authority under Section 417F of the
Public Health Service Act, as amended,
to select both voting and nonvoting
members of the Committee and to
review the necessity of the Committee
in the year 2011 and, thereafter, at least
once every two years.
This delegation shall be exercised in
accordance with the Department’s
applicable policies, procedures,
guidelines, and regulations.
In addition, I ratified and affirmed
any actions taken by the NIH Director or
his subordinates which involved the
exercise of the authorities delegated
herein prior to the effective date of this
delegation.
This delegation is effective upon date
of signature.

AGENCY: Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services.
ACTION: Notice of public meeting.

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The National Advisory Council for
Healthcare Research and Quality was
established in accordance with section
921 (now section 931) of the Public
Health Service Act, 42 U.S.C. 299c. In
accordance with its statutory mandate,
the Council is to advise the Secretary of
the Department of Health and Human
Services and the Director, Agency for
Healthcare Research and Quality
(AHRQ), on matters related to actions of
AHRQ to enhance the quality, and
improve the outcomes of health care
services; improve access to such
services through scientific research; and
promote improvements in clinical
practice and in the organization,

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