Attachment A -- Federal Register Notice -- HCUP Online Application Form

Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:

HHS gives notice of a
determination concerning a petition to
add a class of employees from Titanium
Alloys Manufacturing in Niagara Falls,
New York, to the Special Exposure
Cohort (SEC) under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7384q. On August
23, 2012, the Secretary of HHS
determined that the following class of
employees does not meet the statutory
criteria for addition to the SEC as
authorized under EEOICPA:

SUMMARY:

All employees who worked in any area or
building at Titanium Alloys Manufacturing
from January 1, 1955, through December 31,
1956.
FOR FURTHER INFORMATION CONTACT:

Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 1–
877–222–7570. Information requests can
also be submitted by email to
[email protected].
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2012–23276 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Secretary’s Advisory Committee on
Human Research Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
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AGENCY:

Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
twenty-ninth meeting. The meeting will
be open to the public. Information about

SUMMARY:

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SACHRP and the full meeting agenda
will be posted on the SACHRP Web site
at: http://www.hhs.gov/ohrp/sachrp/
mtgings/index.html.
DATES: The meeting will be held on
Tuesday, October 9, 2012 from 8:30 a.m.
until 5:00 p.m. and Wednesday, October
10, 2012 from 8:30 a.m. until 4:30 p.m.
ADDRESSES: U.S. Department of Health
and Human Services, 200 Independence
Avenue SW., Room 705A, Washington,
DC 20201.
FOR FURTHER INFORMATION CONTACT: Jerry
Menikoff, M.D., J.D., Director, Office for
Human Research Protections (OHRP), or
Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; email address:
[email protected].
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
The meeting will open Tuesday,
October 9, with remarks from SACHRP
Chair Dr. Barbara Bierer and OHRP
Director Dr. Jerry Menikoff, followed by
a report from the Subpart A
Subcommittee (SAS). SAS will discuss
their recent work, including
considerations for revisions to the
expedited review list, principal
investigator responsibilities, and
informed consent waiver criteria. SAS is
charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment; this
subcommittee was established by
SACHRP in October 2006. Tuesday
afternoon will be a discussion of
informed consent issues in cluster
randomized trials, featuring Dr. Andrew
McRae, Research Director of the
Division of Emergency Medicine,
University of Calgary.
On the morning of October 10, the
Subcommittee on Harmonization (SOH)
will give a report and discuss their
recent work, including local context
guidance recommendations. SOH was
established by SACHRP at its July 2009
meeting, and is charged with identifying
and prioritizing areas in which
regulations and/or guidelines for human
subjects research adopted by various
agencies or offices within HHS would

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benefit from harmonization,
consistency, clarity, simplification and/
or coordination. Wednesday afternoon
SACHRP will discuss a revised
document on the issue of the use of the
Internet in human subjects research,
drafted by Drs. Elizabeth Buchanan and
Dean Gallant. Public Comment will be
heard on both days.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
materials to the Executive Director,
SACHRP, prior to the close of business
October 1, 2012.
Dated: September 13, 2012.
Jerry Menikoff,
Director, Office for Human Research
Protections, Executive Secretary, Secretary’s
Advisory Committee on Human Research
Protections.
[FR Doc. 2012–23143 Filed 9–19–12; 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 for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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: ‘‘Online
Application Order Form for Products
from the Healthcare Cost and Utilization
Project (HCUP).’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on June 27th, 2012 and allowed
60 days for public comment. Several
comments were received. The purpose

SUMMARY:

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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices

of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by October 22, 2012.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
[email protected]
(attention: AHRQ’s desk officer).
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
email at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project

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Online Application Order Form for
Products From the Healthcare Cost and
Utilization Project (HCUP)
The Healthcare Cost and Utilization
Project (HCUP, pronounced ‘‘H-Cup’’) is
a vital resource helping AHRQ achieve
its research agenda, thereby furthering
its goal of improving the delivery of
health care in the United States. HCUP
is a family of health care databases and
related software tools and products
developed through a Federal-StateIndustry partnership and sponsored by
AHRQ. HCUP includes the largest
collection of longitudinal hospital care
data in the United States, with all-payer,
encounter-level information beginning
in 1988. The HCUP databases are annual
files that contain anonymous
information from hospital discharge
records for inpatient care and certain
components of outpatient care, such as
emergency care and ambulatory
surgeries. The project currently releases
a variety of databases created for
research use on a broad range of health
issues, including cost and quality of
health services, medical practice
patterns, access to health care programs,
and outcomes of treatments at the
national, State, and local market levels.
HCUP also produces a large number of
software tools to enhance the use of
administrative health care data for
research and public health use. Software
tools use information available from a
variety of sources to create new data
elements, often through sophisticated
algorithms, for use with the HCUP
databases.
HCUP’s objectives are to:
• Create and enhance a powerful
source of national, state, and all-payer
health care data.

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• Produce a broad set of software
tools and products to facilitate the use
of HCUP and other administrative data.
• Enrich a collaborative partnership
with statewide data organizations (that
voluntarily participate in the project)
aimed at increasing the quality and use
of health care data.
• Conduct and translate research to
inform decision making and improve
health care delivery.
The HCUP releases six types of
databases for public research use:
(1) The Nationwide Inpatient Sample
(NIS) is the largest all-payer inpatient
care database in the United States,
containing data from approximately 8
million hospital stays from roughly
1,000 hospitals; this approximates a 20percent stratified sample of U.S.
community hospitals. NIS data releases
are available for purchase from the
HCUP Central Distributor for data years
beginning in 1988.
(2) The Kids’ Inpatient Database (KID)
is the only all-payer inpatient care
database for children in the United
States. The KID was specifically
designed to permit researchers to study
a broad range of conditions and
procedures related to child health
issues. The KID contains a sample of
over 3 million discharges for children
age 20 and younger from more than
3,500 U.S. community hospitals.
(3) The Nationwide Emergency
Department Sample (NEDS) is the
largest all-payer ED database in the
United States. It is constructed to
capture information both on ED visits
that do not result in an admission and
on ED visits that result in an admission
to the same hospital. The NEDS
contains more than 25 million
unweighted records for ED visits at
about 1,000 U.S. community hospitals
and approximates a 20-percent stratified
sample of U.S. hospital-based EDs. Files
are available beginning with data year
2006.
(4) The State Inpatient Databases (SID)
contain the universe of inpatient
discharge abstracts from data
organizations in 46 States that currently
participate in the SID. Together, the SID
encompasses approximately 97 percent
of all U.S. community hospital
discharges. Most States that participate
in the SID make their data available for
purchase through the HCUP Central
Distributor. Files are available beginning
with data year 1990.
(5) The State Ambulatory Surgery
Databases (SASD) contain data from
ambulatory care encounters in hospitalaffiliated (and sometimes freestanding)
ambulatory surgery sites. Currently, 29
States participate in the SASD. Files are
available beginning with data year 1997.

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(6) The State Emergency Department
Databases (SEDD) contain data from
hospital-affiliated emergency
department (ED) abstracts for visits that
do not result in a hospitalization.
Currently, 29 States participate in the
SEDD. Files are available beginning
with data year 1999.
To support AHRQ’s mission to
improve health care through scientific
research, HCUP databases and software
tools are disseminated to users outside
of the Agency through a mechanism
known as the HCUP Central Distributor.
The HCUP Central Distributor assists
qualified researchers to access uniform
research data across multiple states with
the use of one application process. The
HCUP databases disseminated through
the Central distributor are referred to as
‘‘restricted access public release files;’’
that is, they are publicly available, but
only under restricted conditions.
HCUP databases are released to
researchers outside of AHRQ after the
completion of required training and
submission of an application that
includes a signed FICUP Data Use
Agreement (DUA). In addition, before
restricted access public release statelevel databases are released, the user is
asked for a brief description of their
research to ensure that the planned use
is consistent with HCUP policies and
with the FICUP data use requirements.
Fees are set for databases released
through the HCUP Central Distributor
depending on the type of database. The
fee for sale of state-level data is
determined by each participating
Statewide Data Organization and
reimbursed to those organizations. This
project is being conducted by AHRQ
through its contractor and
subcontractor, Thomson Reuters and
Social & Scientific Systems, Inc.,
pursuant to AHRQ’s statutory authority
to conduct and support research on
healthcare and on systems for the
delivery of such care, including
activities with respect to the outcomes,
cost, cost-effectiveness, and use of
health care services and access to such
services. (42 U.S.C. 299a(a)(3).)
Method of Collection
This information collection request is
for the activities associated with
completing an online application form
to request HCUP data, not the collection
of health care data for HCUP databases.
The activities associated with the HCUP
online application include:
(1) HCUP Application Form. All
persons wanting access to the HCUP
databases must complete an application
package. Each unique database has a
unique application package. All
application packages are available for

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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
downloading at http://www.hcupus.ahrq.gov/tech_assist/centdist.jsp.
(2) HCUP Data Use Agreement
Training. All persons wanting access to
the HCUP databases must complete this
online training course. The purpose of
the training is to emphasize the
importance of data protection, reduce
the risk of inadvertent violations, and
describe the individual’s responsibility
when using HCUP data. The training
course can be accessed and completed
online at http://www.hcup-us.ahrq.gov/
tech_assist/dua.jsp.
(3) HCUP Data Use Agreement (DUA).
All persons wanting access to the HCUP
databases must sign a data use
agreement. Each database has a unique
DUA; an example DUA for the
Nationwide Inpatient Sample database
is available at http://www.hcupus.ahrq.gov/team/NISDUA.jsp.

Information collected in the HCUP
Application Order Form will be used for
two purposes only:
1. Business Transaction: HCUP
databases and software are currently
delivered on disk and shipped to users
who have completed the application
process. Contact information is used for
shipping the data on disk (or any other
media used in the future). AHRQ policy
and current agreements with Statewide
Data Organizations contributing data to
HCUP prohibit providing access to the
data via the Internet or email.
2. Enforcement of the HCUP Data Use
Agreement (DUA): The HCUP DUA
contains several restrictions on use of
the data. Most of these restrictions have
been put in place to safeguard the
privacy of individuals and
establishments represented in the data.
For example, data users can only use the
data for research, analysis, and aggregate

statistical reporting and are prohibited
from attempting to identify any persons
in the data. Contact information on
HCUP Data Use Agreements is retained
in the event that a violation of the DUA
takes place.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden associated with the
applicants’ time to order any of the
HCUP databases. An estimated 1,200
persons will order HCUP data annually.
Each of these persons will complete an
application (10 minutes), the DUA
training (15 minutes) and a DUA (5
minutes). The total burden is estimated
to be 600 hours annually.
Exhibit 2 shows the estimated
annualized cost burden associated with
the applicants’ time to order HCUP data.
The total cost burden is estimated to be
$21,408 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total burden
hours

HCUP Application Form ..................................................................................
HCUP DUA Training ........................................................................................
HCUP DUA ......................................................................................................

1,200
1,200
1,200

1
1
1

10/60
15/60
5/60

200
300
100

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

3,600

na

na

600

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly wage rate *

Total cost
burden

HCUP Application Form ..................................................................................
HCUP DUA Training ........................................................................................
HCUP DUA ......................................................................................................

1,200
1,200
1,200

200
300
100

$35.68
35.68
35.68

$7,136
10,704
3,568

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

3,600

600

na

21,408

* Based upon the mean of the average wages for Life Scientists, All Other (19–1099), National Compensation Survey: Occupational wages in
the United States May 2011, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to process HCUP

database applications and maintain the
ordering system over the 3 years
covered by this information collection
request. It is estimated to cost $17,237

annually to operate and maintain the
ordering system.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

Annualized
cost

Order Review ...........................................................................................................................................................
Monthly Updates—Product Catalog ........................................................................................................................
System Maintenance ...............................................................................................................................................
Customer Inquiries ...................................................................................................................................................
Management/Troubleshooting .................................................................................................................................

$14,493
1,857
13,820
4,483
17,058

$4,831
619
4,607
1,495
5,689

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

51,711

17,237

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Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices

Request for Comments
In accordance with the Paperwork
Reduction Act, 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 healthcare
research and healthcare 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 13, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–23165 Filed 9–19–12; 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.
ACTION: Notice.
AGENCY:

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: ‘‘Medical
Expenditure Panel Survey (MEPS)
Household Component and the MEPS
Medical Provider Component.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on June 13th, 2012 and allowed
60 days for public comment. One
comment was received. The purpose of

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this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be
received by October 22, 2012.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
[email protected]
(attention: AHRQ’s desk officer).
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
email at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Medical Expenditure Panel Survey
(MEPS) Household Component and the
MEPS Medical Provider Component
For over thirty years, results from the
MEPS and its predecessor surveys (the
1977 National Medical Care
Expenditure Survey, the 1980 National
Medical Care Utilization and
Expenditure Survey and the 1987
National Medical Expenditure Survey)
have been used by OMB, DHHS,
Congress and a wide number of health
services researchers to analyze health
care use, expenses, and health policy.
Major changes continue to take place
in the health care delivery system. The
MEPS is needed to provide information
about the current state of the health care
system as well as to track changes over
time. The MEPS permits annual
estimates of use of health care and
expenditures and sources of payment
for that health care. It also permits
tracking individual change in
employment, income, health insurance
and health status over two years. The
use of the National Health Interview
Survey (NHIS) as a sampling frame
expands the MEPS analytic capacity by
providing another data point for
comparisons over time.
Households selected for participation
in the MEPS Household Component
(MEPS–HC) are interviewed five times
in person. These rounds of interviewing
are spaced about 5 months apart. The
interview will take place with a family
respondent who will report for him/
herself and for other family members.
The MEPS–HC has the following goal:
• To provide nationally
representative estimates for the U.S.
civilian noninstitutionalized population
for health care use, expenditures,

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sources of payment and health
insurance coverage.
The MEPS Medical Provider
Component (MEPS–MPC) will contact
medical providers (hospitals,
physicians, home health agencies and
institutions) identified by household
respondents in the MEPS–HC as sources
of medical care for the time period
covered by the interview, and all
pharmacies providing prescription
drugs to household members during the
covered time period. The MEPS–MPC is
not designed to yield national estimates.
The sample is designed to target the
types of individuals and providers for
whom household reported expenditure
data was expected to be insufficient. For
example, households with one or more
Medicaid enrollees are targeted for
inclusion in the MEPSMPC because this
group is expected to have limited
information about payments for their
medical care.
The MEPS–MPC has the following
goal:
• To serve as an imputation source
for and to supplement/replace
household reported expenditure and
source of payment information. This
data will supplement, replace and verify
information provided by household
respondents about the charges,
payments, and sources of payment
associated with specific health care
encounters.
This study is being conducted by
AHRQ through its contractors, Westat
and RTI International, pursuant to
AHRQ’s statutory authority to conduct
and support research on healthcare and
on systems for the delivery of such care,
including activities with respect to the
cost and use of health care services and
with respect to health statistics and
surveys. 42 U.S.C. 299a(a)(3) and (8); 42
U.S.C. 299b–2.
Method of Collection
To achieve the goals of the MEPS–HC
the following data collections are
implemented:
1. Household Component Core
Instrument. The core instrument
collects data about persons in sample
households. Topical areas asked in each
round of interviewing include condition
enumeration, health status, health care
utilization including prescribed
medicines, expense and payment,
employment, and health insurance.
Other topical areas that are asked only
once a year include access to care,
income, assets, satisfaction with health
plans and providers, children’s health,
and adult preventive care. While many
of the questions are asked about the
entire reporting unit (RU), which is

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