Agency Information Collection Activities: Proposed Collection; Comment Request, 33069-33073 [2019-14770]
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depository institution, was charged with
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10042 .................
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Dated at Washington, DC, on July 8, 2019.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2019–14746 Filed 7–10–19; 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
changes to the currently approved
information collection project: ‘‘Medical
Expenditure Panel Survey (MEPS)
Household Component and the MEPS
Medical Provider Component.’’
This proposed information collection
was previously published in the Federal
Register on May 1, 2019 and allowed 60
days for public comment. AHRQ
received no substantive comments. The
purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by 30 days after date of
publication.
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 OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
This request is for an update to the
previously submitted and OMBapproved clearance for the data
collections of the Household and
Medical Provider Components of the
MEPS. The previous OMB clearance
request for the MEPS was approved
November, 2018 with an expiration date
of November 30, 2021. We propose
updating the MEPS–HC by (1) adding a
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Termination
date
7/1/2019
section to the 2020 self-administered
questionnaire (SAQ, Male/Female) that
will include questions on mental health,
(2) collecting a health insurance costsharing document and (3) implementing
a pilot study to evaluate the potential
effectiveness of including a sample of
National Health Interview Survey
(NHIS) nonrespondents in future MEPS
panels as a strategy to improve the
overall MEPS response rate.
MEPS Household Component and the
MEPS Medical Provider Component
• Household Component: A sample of
households participating in the NHIS in
the prior calendar year are interviewed
5 times over a 2 and one half (2.5) year
period. These 5 interviews yield two
years of information on use of, and
expenditures for, health care, sources of
payment for that health care, insurance
status, employment, health status and
health care quality.
• Medical Provider Component: The
MEPS–MPC collects information from
medical and financial records
maintained by hospitals, physicians,
pharmacies and home health agencies
named as sources of care by household
respondents.
• Insurance Component (MEPS–IC):
The MEPS–IC collects information on
establishment characteristics, insurance
offerings and premiums from
employers. The MEPS–IC is conducted
by the Census Bureau for AHRQ and is
cleared separately.
The MEPS is a multi-purpose survey.
In addition to collecting data to yield
annual estimates for a variety of
measures related to health care use and
expenditures, MEPS also provides
estimates of measures related to health
status, consumer assessment of health
care, health insurance coverage,
demographic characteristics,
employment and access to health care
indicators.
Estimates can be provided for
individuals, families and population
subgroups of interest. Data obtained in
this study are used to provide, among
others, the following national estimates:
• Annual estimates of health care use
and expenditures for persons and
families
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• annual estimates of sources of
payment for health care utilizations,
including public programs such as
Medicare and Medicaid, private
insurance, and out of pocket payments
• annual estimates of health care use,
expenditures and sources of payment of
persons and families by type of
utilization including inpatient stay,
ambulatory care, home health, dental
care and prescribed medications
• the number and characteristics of
the population eligible for public
programs including the use of services
and expenditures of the population(s)
eligible for benefits under Medicare and
Medicaid
• the number, characteristics, and use
of services and expenditures of persons
and families with various forms of
insurance
• annual estimates of consumer
satisfaction with health care, and
indicators of health care quality for key
conditions
• annual estimates to track disparities
in health care use and access
In addition to national estimates, data
collected in this ongoing longitudinal
study are used to study the
determinants of the use of services and
expenditures, and changes in the access
to and the provision of health care in
relation to:
• Socio-economic and demographic
factors such as employment or income
• the health status and satisfaction
with health care of individuals and
families
• the health needs and circumstances
of specific subpopulation groups such
as the elderly and children
To meet the need for national data on
health care use, access, cost and quality,
MEPS-Household Component (MEPS–
HC) collects information on:
• Access to care and barriers to
receiving needed care
• satisfaction with usual providers
• health status and limitations in
activities
• medical conditions for which
health care was used
• use, expense and payment (as well
as insurance status of person receiving
care) for health services
Given the twin problems of
nonresponse and response error of some
household reported data, information is
collected directly from medical
providers in the MEPS–MPC to improve
the accuracy of expenditure estimates
derived from the MEPS–HC. Because of
their greater level of precision and
detail, we also use MEPS–MPC data as
the main source of imputations of
missing expenditure data. Thus, the
MEPS–MPC is designed to satisfy the
following analytical objectives:
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• Serve as source data for household
reported events with missing
expenditure information
• Serve as an imputation source to
reduce the level of bias in survey
estimates of medical expenditures due
to item nonresponse and less complete
and less accurate household data
• Serve as the primary data source for
expenditure estimates of medical care
provided by separately billing doctors in
hospitals, emergency rooms, and
outpatient departments, Medicaid
recipients and expenditure estimates for
pharmacies
• Allow for an examination of the
level of agreement in reported
expenditures from household
respondents and medical providers
Data from the MEPS, both the HC and
MPC components, are intended for a
number of annual reports produced by
AHRQ, including the National
Healthcare Quality and Disparities
Report.
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 priority
condition enumeration, health status,
health care utilization including
prescribed medicines, expenses and
payments, employment, and health
insurance. Other topical areas that are
asked only once a year include access to
care, income, assets, satisfaction with
providers, and children’s health. While
many of the questions are asked about
the entire reporting unit (RU), which is
typically a family, only one person
normally provides this information. All
sections of the current core instrument
are available on the AHRQ website at
https://meps.ahrq.gov/mepsweb/survey_
comp/survey_questionnaires.jsp .
2. Adult Self-Administered
Questionnaire. A brief self-administered
questionnaire (SAQ) is used to collect
self-reported (rather than through
household proxy) health opinions and
satisfaction with health care, and
information on health status, preventive
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care and health care quality measures
for adults 18 and older.
3. Diabetes Care SAQ. A brief selfadministered paper-and-pencil
questionnaire on the quality of diabetes
care is administered once a year (during
rounds 3 and 5) to persons identified as
having diabetes. Included are questions
about the number of times the
respondent reported having a
hemoglobin A1c blood test, whether the
respondent reported having his or her
feet checked for sores or irritations,
whether the respondent reported having
an eye exam in which the pupils were
dilated, the last time the respondent had
his or her blood cholesterol checked and
whether the diabetes has caused kidney
or eye problems. Respondents are also
asked if their diabetes is being treated
with diet, oral medications or insulin.
4. Authorization forms for the MEPS–
MPC Provider and Pharmacy Survey.
We ask respondents for authorization to
obtain supplemental information from
their medical providers (hospitals,
physicians, home health agencies and
institutions) and pharmacies.
5. MEPS Validation Interview. Each
interviewer is required to have at least
15 percent of his/her caseload validated
to insure that the computer assisted
personal interview (CAPI) questionnaire
content was asked appropriately and
procedures followed, for example, the
use of show cards. Validation flags are
set programmatically for cases preselected by data processing staff before
each round of interviewing. Home office
and field management may also request
that other cases be validated throughout
the field period. When an interviewer
fails a validation their work is subject to
100 percent validation. Additionally,
any case completed in less than 30
minutes is validated. A validation
abstract form containing selected data
collected in the CAPI interview is
generated and used by the validator to
guide the validation interview.
6. Mental Health Questions. Added to
SAQ (Male/Female). MEPS will include
questions addressing issues in regards to
an individual’s mental health and
mental health treatment including
mental health status, access to care,
barriers to care, experiences with care,
and use of peer support and other
services to the SAQ for administration
during the summer of 2020 with data
collection targeting the adult (age 18
and over) population. AHRQ worked
with several experts in the mental
health field to develop these questions
and used their expertise to take
advantage of already tested and widely
accepted measures.
7. Health Insurance Cost Sharing
Collection. AHRQ is seeking to enhance
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data collection practices in the 2020
fielding of the MEPS–HC to collect more
detailed health insurance cost-sharing
information from respondents with
current private insurance, Medicare
Advantage, or Medicare Part D
Prescription Drug plans. Specifically,
we will ask respondents to provide a
document for themselves and family
members that includes information on
plan deductibles, out-of-pocket
maximums and other cost sharing
details for specific services. An example
of the type of document we are
proposing to collect is the Summary of
Benefits and Coverage. AHRQ worked
with experts on a feasibility study to
identify the best methods for collecting
these types of documents in a way that
would minimize respondent burden
(OMB approval 0935–0124). AHRQ
proposes to provide informational
materials to respondents to help them
identify the documents and also
proposes to provide respondents with a
$30 per plan, post-collection incentive
to facilitate response and mitigate
perceived additional burden.
8. Pilot Test on Sampling NHIS
Nonrespondents. This test will be
conducted on 400 sampled addresses in
6–8 selected MEPS primary sampling
units (PSUs) in the 2020 spring data
collection cycle. The sample households
for this test will be drawn from
nonrespondents to the 2019 NHIS
(which are not currently part of the
MEPS frame), and only the MEPS
Round 1 interview will be administered.
The purpose of the test is to evaluate the
potential effectiveness of including a
sample of NHIS nonrespondents in
future MEPS panels to mitigate the
impact of declining NHIS response rates
on the overall MEPS response rate. The
general trend of declining response rates
for household surveys is problematic
and this evaluation is designed to
explore an avenue to stop further
declines and potentially improve the
overall MEPS response rate.
To achieve the goal of the MEPS–MPC
the following data collections are
implemented. No updates to the MEPS–
MPC are being requested:
1. MPC Contact Guide/Screening Call.
An initial screening call is placed to
determine the type of facility, whether
the practice or facility is in scope for the
MEPS–MPC, the appropriate MEPS–
MPC respondent and some details about
the organization and availability of
medical records and billing at the
practice/facility. All hospitals,
physician offices, home health agencies,
institutions and pharmacies are
screened by telephone. A unique
screening instrument is used for each of
these seven provider types in the
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MEPS–MPC, except for the two home
care provider types which use the same
screening form.
2. Home Care Provider Questionnaire
for Health Care Providers. This
questionnaire is used to collect data
from home health care agencies which
provide medical care services to
household respondents. Information
collected includes type of personnel
providing care, hours or visits provided
per month, and the charges and
payments for services received. Some
HMOs may be included in this provider
type.
3. Home Care Provider Questionnaire
for Non-Health Care Providers. This
questionnaire is used to collect
information about services provided in
the home by non-health care workers to
household respondents because of a
medical condition; for example,
cleaning or yard work, transportation,
shopping, or child care.
4. Medical Event Questionnaire for
Office-Based Providers. This
questionnaire is for office-based
physicians, including doctors of
medicine (MDs) and osteopathy (DOs),
as well as providers practicing under
the direction or supervision of an MD or
DO (e.g., physician assistants and nurse
practitioners working in clinics).
Providers of care in private offices as
well as staff model HMOs are included.
5. Medical Event Questionnaire for
Separately Billing Doctors. This
questionnaire collects information from
physicians identified by hospitals
(during the Hospital Event data
collection) as providing care to sampled
persons during the course of inpatient,
outpatient department or emergency
room care, but who bill separately from
the hospital.
6. Hospital Event Questionnaire. This
questionnaire is used to collect
information about hospital events,
including inpatient stays, outpatient
department, and emergency room visits.
Hospital data are collected not only
from the billing department, but from
medical records and administrative
records departments as well. Medical
records departments are contacted to
determine the names of all the doctors
who treated the patient during a stay or
visit. In many cases, the hospital
administrative office also has to be
contacted to determine whether the
doctors identified by medical records
billed separately from the hospital;
doctors that do bill separately from the
hospital will be contacted as part of the
Medical Event Questionnaire for
Separately Billing Doctors. HMOs are
included in this provider type.
7. Institutions Event Questionnaire.
This questionnaire is used to collect
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information about institution events,
including nursing homes, rehabilitation
facilities and skilled nursing facilities.
Institution data are collected not only
from the billing department, but from
medical records and administrative
records departments as well. Medical
records departments are contacted to
determine the names of all the doctors
who treated the patient during a stay. In
many cases, the institution’s
administrative office also has to be
contacted to determine whether the
doctors identified by medical records
billed separately from the institution
itself. Some HMOs may be included in
this provider type.
8. Pharmacy Data Collection
Questionnaire. This questionnaire
requests the National Drug Code (NDC)
and when that is not available the
prescription name, strength and form as
well as the date prescription was filled,
payments by source, the quantity, and
person for whom the prescription was
filled. When the NDC is available, we do
not ask for prescription name, strength
or form because that information is
embedded in the NDC; this reduces
burden on the respondent. Most
pharmacies have the requested
information available in electronic
format and respond by providing a
computer generated printout of the
patient’s prescription information. If the
computerized form is unavailable, the
pharmacy can report their data to a
telephone interviewer. Pharmacies are
also able to provide a CD–ROM with the
requested information if that is
preferred. HMOs are included in this
provider type.
Dentists, optometrists, psychologists,
podiatrists, chiropractors, and others
not providing care under the
supervision of a MD or DO are
considered out of scope for the MEPS–
MPC.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
MEPS–HC and the MEPS–MPC.
The MEPS–HC Core Interview will be
completed by 13,338 * (see note below
Exhibit 1) ‘‘family level’’ respondents,
also referred to as RU respondents.
Since the MEPS–HC consists of 5
rounds of interviewing covering a full
two years of data, the annual average
number of responses per respondent is
2.5 responses per year. The MEPS–HC
core requires an average response time
of 92 minutes to administer. The Adult
Female SAQ (PSAQ) and Adult SAQ
(SAQ) will be completed once a year by
each female person in the RU that is 18
years old and older, an estimated 12,984
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persons. The Adult Male SAQ (PSAQ)
and Adult SAQ (SAQ) will be
completed once a year by each male
person in the RU that is 18 years old
and older, an estimated 11,985 persons.
The Adult SAQs each require an average
of 7 minutes to complete. The Mental
Health Questions in the Adult SAQ
(Male/Female) will be completed during
Round 2, Panel 25; Round 4, Panel 24
by each person in the RU that is 18
years old and older, an estimated 20,476
persons, and takes about 3.5 minutes to
complete. The Diabetes Care SAQ will
be completed once a year by each adult
person in the RU identified as having
diabetes, an estimated 2,072 persons,
and takes about 3 minutes to complete.
The 12,804 RUs in the MEPS–HC will
complete an average of 5.4 forms, which
require about 3 minutes each to
complete. The authorization form for
the MEPS–MPC Pharmacy Survey will
be completed once for each pharmacy
for any RU member who has obtained a
prescription medication. RUs will
complete an average of 3.1 forms, which
take about 3 minutes to complete. The
Health Insurance Cost Sharing
collection will be completed during
Round 1, Panel 25 and Round 3, Panel
24 by each RU with a current private
health insurance plan, a Medicare
Advantage plan, or a Medicare Part D
plan. An estimated 6,258 respondents
will locate and provide cost-sharing
documentation for an average of 1.3
plans per eligible RU. This activity will
require 45 minutes to complete for each
plan. About one third of all interviewed
RUs will complete a validation
interview as part of the MEPS–HC
quality control, which takes an average
of 5 minutes to complete. The Pilot Test
Sampling NHIS Nonrespondents will be
completed by 200 * (see note below
Exhibit 1) ‘‘family level’’ respondents,
also referred to as RU respondents. The
Pilot MEPS–HC core requires an average
response time of 92 minutes to
administer. The total annual burden
hours for the MEPS–HC are estimated to
be 67,542 hours.
All medical providers and pharmacies
included in the MEPS–MPC will receive
a screening call and the MEPS–MPC
uses 7 different questionnaires; 6 for
medical providers and 1 for pharmacies.
Each questionnaire is relatively short
and requires 2 to 13 minutes to
complete. The total annual burden
hours for the MEPS–MPC are estimated
to be 17,388 hours. The total annual
burden for the MEPS–HC and MPC is
estimated to be 86,160 hours.
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in this
information collection. The annual cost
burden for the MEPS–HC is estimated to
be $1,673,909; the annual cost burden
for the MEPS–MPC is estimated to be
$298,580. The total annual cost burden
for the MEPS–HC and MPC is estimated
to be $1,972,489.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
MEPS–HC
MEPS–HC Core Interview ...............................................................................
Adult Female SAQ (PSAQ)—Years 2019 and 2021; Adult SAQ (SAQ)—
Year 2020 .....................................................................................................
Adult Male SAQ (PSAQ)—Years 2019 and 2021; Adult SAQ (SAQ)—Year
2020 .............................................................................................................
Diabetes care SAQ ..........................................................................................
Mental Health Questions Included in Adult SAQ (Male/Female)—Year 2020
Authorization form for the MEPS–MPC Provider Survey ................................
Authorization form for the MEPS–MPC Pharmacy Survey .............................
Health Insurance Cost Sharing Collection—2020 ...........................................
MEPS–HC Validation Interview .......................................................................
Pilot Test on Sampling NHIS Nonrespondents—2020 ....................................
* 13,338
2.5
92/60
51,129
12,984
1
7/60
1,515
11,985
2,072
20,476
12,804
12,804
6,258
4,225
200
1
1
1
5.4
3.1
1.3
1
1
7/60
3/60
3.5/60
3/60
3/60
45/60
5/60
92/60
1,398
104
1,194
3,457
1,985
6,101
352
307
Subtotal for the MEPS–HC .......................................................................
102,366
na
na
67,542
MPC Contact Guide/Screening Call ** .............................................................
Home care for health care providers questionnaire ........................................
Home care for non-health care providers questionnaire .................................
Office-based providers questionnaire ..............................................................
Separately billing doctors questionnaire ..........................................................
Hospitals questionnaire ...................................................................................
Institutions (non-hospital) questionnaire ..........................................................
Pharmacies questionnaire ...............................................................................
36,598
635
11
11,210
12,397
5,310
116
6,919
1
1.53
1
1.65
3.46
3.26
2.05
2.92
2/60
9/60
11/60
10/60
13/60
9/60
9/60
3/60
1,220
146
2
3,083
9,294
2,597
36
1,010
Subtotal for the MEPS–MPC ....................................................................
73,196
na
na
17,388
Grand Total .......................................................................................
175, 562
na
na
84,930
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MEPS–MPC
* While the expected number of responding units for the annual estimates is 12,804, it is necessary to adjust for survey attrition of initial respondents by a factor of 0.96 (13,338 = 12,804/0.96).
** There are 6 different contact guides; one for office based, separately billing doctor, hospital, institution, and pharmacy provider types, and
the two home care provider types, which use the same contact guide.
The total estimated annual burden
hours for the MEPS has increased from
77,666 hours in the previous clearance
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to 84,930 hours in this clearance
request, a difference of 7,264 hours. The
addition of 1,194 hours due to the
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addition of Mental Health questions to
the Adult SAQ (Male/Female), 6,101
additional hours due to the health
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insurance cost sharing collection, and
307 additional hours due to the pilot
test on sampling NHIS nonrespondents
account for the difference. While the
burden associated with these added
tasks totals 7,602 hours, reductions in
other burden estimates leave a net
difference of 7,264 hours overall.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate
Total cost
burden
MEPS–HC
MEPS–HC Core Interview ...............................................................................
Adult Female SAQ (PSAQ)–Years 2019 and 2021; Adult SAQ (SAQ)—Year
2020 .............................................................................................................
Adult Male SAQ (PSAQ)—Years 2019 and 2021; Adult SAQ (SAQ) -Year
2020 .............................................................................................................
Diabetes care SAQ ..........................................................................................
Mental Health Questions Included in Adult SAQ (Male/Female)—Year 2020
Authorization forms for the MEPS–MPC Provider Survey ..............................
Authorization form for the MEPS–MPC Pharmacy Survey .............................
Health Insurance Cost Sharing Collection—2020 ...........................................
MEPS–HC Validation Interview .......................................................................
Pilot Test on Sampling NHIS Nonrespondents—2020 ....................................
* 13,338
51,129
* $24.34
$1,244,479
12,984
1,515
* 24.34
36,875
11,985
2,072
20,476
12,804
12,804
6,258
4,225
200
1,398
104
1,194
3,457
1,985
6,101
352
307
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
34,027
2,531
29,062
84,143
48,314
148,498
8,567
7,472
Subtotal for the MEPS–HC .......................................................................
102,366
67,542
na
1,643,968
MPC Contact Guide/Screening Call ................................................................
Home care for health care providers questionnaire ........................................
Home care for non-health care providers questionnaire .................................
Office-based providers questionnaire ..............................................................
Separately billing doctors questionnaire ..........................................................
Hospitals questionnaire ...................................................................................
Institutions (non-hospital) questionnaire ..........................................................
Pharmacies questionnaire ...............................................................................
36,598
635
11
11,210
12,397
5,310
116
6,919
1,220
146
2
3,083
9,294
2,597
36
1,010
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
*** 15.90
21,045
2,519
35
53,182
160,322
44,798
621
16,059
Subtotal for the MEPS–MPC ....................................................................
73,196
17,388
na
298,580
Grand Total .......................................................................................
175,562
na
na
1,942,548
MEPS–MPC
* Mean hourly wage for All Occupations (00–0000).
** Mean hourly wage for Medical Secretaries (43–6013).
*** Mean hourly wage for Pharmacy Technicians (29–2052).
jspears on DSK30JT082PROD with NOTICES
Occupational Employment Statistics,
May 2017 National Occupational
Employment and Wage Estimates
United States, U.S. Department of Labor,
Bureau of Labor Statistics.
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
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
VerDate Sep<11>2014
17:26 Jul 10, 2019
Jkt 247001
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: July 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–14770 Filed 7–10–19; 8:45 am]
BILLING CODE 4160–90–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–1768]
Harmonizing Compendial Standards
With Drug Application Approval Using
the United States Pharmacopeial
Convention Pending Monograph
Process; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Harmonizing Compendial Standards
with Drug Application Approval Using
the USP Pending Monograph Process.’’
This guidance assists applicants (or
drug substance master file (MF) holders
referenced in an application) in the
SUMMARY:
Frm 00023
Fmt 4703
Sfmt 4703
E:\FR\FM\11JYN1.SGM
11JYN1
Agencies
[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33069-33073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14770]
=======================================================================
-----------------------------------------------------------------------
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 changes to the
currently approved information collection project: ``Medical
Expenditure Panel Survey (MEPS) Household Component and the MEPS
Medical Provider Component.''
This proposed information collection was previously published in
the Federal Register on May 1, 2019 and allowed 60 days for public
comment. AHRQ received no substantive comments. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by 30 days after date
of publication.
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).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
This request is for an update to the previously submitted and OMB-
approved clearance for the data collections of the Household and
Medical Provider Components of the MEPS. The previous OMB clearance
request for the MEPS was approved November, 2018 with an expiration
date of November 30, 2021. We propose updating the MEPS-HC by (1)
adding a section to the 2020 self-administered questionnaire (SAQ,
Male/Female) that will include questions on mental health, (2)
collecting a health insurance cost-sharing document and (3)
implementing a pilot study to evaluate the potential effectiveness of
including a sample of National Health Interview Survey (NHIS)
nonrespondents in future MEPS panels as a strategy to improve the
overall MEPS response rate.
MEPS Household Component and the MEPS Medical Provider Component
Household Component: A sample of households participating
in the NHIS in the prior calendar year are interviewed 5 times over a 2
and one half (2.5) year period. These 5 interviews yield two years of
information on use of, and expenditures for, health care, sources of
payment for that health care, insurance status, employment, health
status and health care quality.
Medical Provider Component: The MEPS-MPC collects
information from medical and financial records maintained by hospitals,
physicians, pharmacies and home health agencies named as sources of
care by household respondents.
Insurance Component (MEPS-IC): The MEPS-IC collects
information on establishment characteristics, insurance offerings and
premiums from employers. The MEPS-IC is conducted by the Census Bureau
for AHRQ and is cleared separately.
The MEPS is a multi-purpose survey. In addition to collecting data
to yield annual estimates for a variety of measures related to health
care use and expenditures, MEPS also provides estimates of measures
related to health status, consumer assessment of health care, health
insurance coverage, demographic characteristics, employment and access
to health care indicators.
Estimates can be provided for individuals, families and population
subgroups of interest. Data obtained in this study are used to provide,
among others, the following national estimates:
Annual estimates of health care use and expenditures for
persons and families
[[Page 33070]]
annual estimates of sources of payment for health care
utilizations, including public programs such as Medicare and Medicaid,
private insurance, and out of pocket payments
annual estimates of health care use, expenditures and
sources of payment of persons and families by type of utilization
including inpatient stay, ambulatory care, home health, dental care and
prescribed medications
the number and characteristics of the population eligible
for public programs including the use of services and expenditures of
the population(s) eligible for benefits under Medicare and Medicaid
the number, characteristics, and use of services and
expenditures of persons and families with various forms of insurance
annual estimates of consumer satisfaction with health
care, and indicators of health care quality for key conditions
annual estimates to track disparities in health care use
and access
In addition to national estimates, data collected in this ongoing
longitudinal study are used to study the determinants of the use of
services and expenditures, and changes in the access to and the
provision of health care in relation to:
Socio-economic and demographic factors such as employment
or income
the health status and satisfaction with health care of
individuals and families
the health needs and circumstances of specific
subpopulation groups such as the elderly and children
To meet the need for national data on health care use, access, cost
and quality, MEPS-Household Component (MEPS-HC) collects information
on:
Access to care and barriers to receiving needed care
satisfaction with usual providers
health status and limitations in activities
medical conditions for which health care was used
use, expense and payment (as well as insurance status of
person receiving care) for health services
Given the twin problems of nonresponse and response error of some
household reported data, information is collected directly from medical
providers in the MEPS-MPC to improve the accuracy of expenditure
estimates derived from the MEPS-HC. Because of their greater level of
precision and detail, we also use MEPS-MPC data as the main source of
imputations of missing expenditure data. Thus, the MEPS-MPC is designed
to satisfy the following analytical objectives:
Serve as source data for household reported events with
missing expenditure information
Serve as an imputation source to reduce the level of bias
in survey estimates of medical expenditures due to item nonresponse and
less complete and less accurate household data
Serve as the primary data source for expenditure estimates
of medical care provided by separately billing doctors in hospitals,
emergency rooms, and outpatient departments, Medicaid recipients and
expenditure estimates for pharmacies
Allow for an examination of the level of agreement in
reported expenditures from household respondents and medical providers
Data from the MEPS, both the HC and MPC components, are intended
for a number of annual reports produced by AHRQ, including the National
Healthcare Quality and Disparities Report.
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 priority condition enumeration,
health status, health care utilization including prescribed medicines,
expenses and payments, employment, and health insurance. Other topical
areas that are asked only once a year include access to care, income,
assets, satisfaction with providers, and children's health. While many
of the questions are asked about the entire reporting unit (RU), which
is typically a family, only one person normally provides this
information. All sections of the current core instrument are available
on the AHRQ website at https://meps.ahrq.gov/mepsweb/survey_comp/survey_questionnaires.jsp .
2. Adult Self-Administered Questionnaire. A brief self-administered
questionnaire (SAQ) is used to collect self-reported (rather than
through household proxy) health opinions and satisfaction with health
care, and information on health status, preventive care and health care
quality measures for adults 18 and older.
3. Diabetes Care SAQ. A brief self-administered paper-and-pencil
questionnaire on the quality of diabetes care is administered once a
year (during rounds 3 and 5) to persons identified as having diabetes.
Included are questions about the number of times the respondent
reported having a hemoglobin A1c blood test, whether the respondent
reported having his or her feet checked for sores or irritations,
whether the respondent reported having an eye exam in which the pupils
were dilated, the last time the respondent had his or her blood
cholesterol checked and whether the diabetes has caused kidney or eye
problems. Respondents are also asked if their diabetes is being treated
with diet, oral medications or insulin.
4. Authorization forms for the MEPS-MPC Provider and Pharmacy
Survey. We ask respondents for authorization to obtain supplemental
information from their medical providers (hospitals, physicians, home
health agencies and institutions) and pharmacies.
5. MEPS Validation Interview. Each interviewer is required to have
at least 15 percent of his/her caseload validated to insure that the
computer assisted personal interview (CAPI) questionnaire content was
asked appropriately and procedures followed, for example, the use of
show cards. Validation flags are set programmatically for cases pre-
selected by data processing staff before each round of interviewing.
Home office and field management may also request that other cases be
validated throughout the field period. When an interviewer fails a
validation their work is subject to 100 percent validation.
Additionally, any case completed in less than 30 minutes is validated.
A validation abstract form containing selected data collected in the
CAPI interview is generated and used by the validator to guide the
validation interview.
6. Mental Health Questions. Added to SAQ (Male/Female). MEPS will
include questions addressing issues in regards to an individual's
mental health and mental health treatment including mental health
status, access to care, barriers to care, experiences with care, and
use of peer support and other services to the SAQ for administration
during the summer of 2020 with data collection targeting the adult (age
18 and over) population. AHRQ worked with several experts in the mental
health field to develop these questions and used their expertise to
take advantage of already tested and widely accepted measures.
7. Health Insurance Cost Sharing Collection. AHRQ is seeking to
enhance
[[Page 33071]]
data collection practices in the 2020 fielding of the MEPS-HC to
collect more detailed health insurance cost-sharing information from
respondents with current private insurance, Medicare Advantage, or
Medicare Part D Prescription Drug plans. Specifically, we will ask
respondents to provide a document for themselves and family members
that includes information on plan deductibles, out-of-pocket maximums
and other cost sharing details for specific services. An example of the
type of document we are proposing to collect is the Summary of Benefits
and Coverage. AHRQ worked with experts on a feasibility study to
identify the best methods for collecting these types of documents in a
way that would minimize respondent burden (OMB approval 0935-0124).
AHRQ proposes to provide informational materials to respondents to help
them identify the documents and also proposes to provide respondents
with a $30 per plan, post-collection incentive to facilitate response
and mitigate perceived additional burden.
8. Pilot Test on Sampling NHIS Nonrespondents. This test will be
conducted on 400 sampled addresses in 6-8 selected MEPS primary
sampling units (PSUs) in the 2020 spring data collection cycle. The
sample households for this test will be drawn from nonrespondents to
the 2019 NHIS (which are not currently part of the MEPS frame), and
only the MEPS Round 1 interview will be administered. The purpose of
the test is to evaluate the potential effectiveness of including a
sample of NHIS nonrespondents in future MEPS panels to mitigate the
impact of declining NHIS response rates on the overall MEPS response
rate. The general trend of declining response rates for household
surveys is problematic and this evaluation is designed to explore an
avenue to stop further declines and potentially improve the overall
MEPS response rate.
To achieve the goal of the MEPS-MPC the following data collections
are implemented. No updates to the MEPS-MPC are being requested:
1. MPC Contact Guide/Screening Call. An initial screening call is
placed to determine the type of facility, whether the practice or
facility is in scope for the MEPS-MPC, the appropriate MEPS-MPC
respondent and some details about the organization and availability of
medical records and billing at the practice/facility. All hospitals,
physician offices, home health agencies, institutions and pharmacies
are screened by telephone. A unique screening instrument is used for
each of these seven provider types in the MEPS-MPC, except for the two
home care provider types which use the same screening form.
2. Home Care Provider Questionnaire for Health Care Providers. This
questionnaire is used to collect data from home health care agencies
which provide medical care services to household respondents.
Information collected includes type of personnel providing care, hours
or visits provided per month, and the charges and payments for services
received. Some HMOs may be included in this provider type.
3. Home Care Provider Questionnaire for Non-Health Care Providers.
This questionnaire is used to collect information about services
provided in the home by non-health care workers to household
respondents because of a medical condition; for example, cleaning or
yard work, transportation, shopping, or child care.
4. Medical Event Questionnaire for Office-Based Providers. This
questionnaire is for office-based physicians, including doctors of
medicine (MDs) and osteopathy (DOs), as well as providers practicing
under the direction or supervision of an MD or DO (e.g., physician
assistants and nurse practitioners working in clinics). Providers of
care in private offices as well as staff model HMOs are included.
5. Medical Event Questionnaire for Separately Billing Doctors. This
questionnaire collects information from physicians identified by
hospitals (during the Hospital Event data collection) as providing care
to sampled persons during the course of inpatient, outpatient
department or emergency room care, but who bill separately from the
hospital.
6. Hospital Event Questionnaire. This questionnaire is used to
collect information about hospital events, including inpatient stays,
outpatient department, and emergency room visits. Hospital data are
collected not only from the billing department, but from medical
records and administrative records departments as well. Medical records
departments are contacted to determine the names of all the doctors who
treated the patient during a stay or visit. In many cases, the hospital
administrative office also has to be contacted to determine whether the
doctors identified by medical records billed separately from the
hospital; doctors that do bill separately from the hospital will be
contacted as part of the Medical Event Questionnaire for Separately
Billing Doctors. HMOs are included in this provider type.
7. Institutions Event Questionnaire. This questionnaire is used to
collect information about institution events, including nursing homes,
rehabilitation facilities and skilled nursing facilities. Institution
data are collected not only from the billing department, but from
medical records and administrative records departments as well. Medical
records departments are contacted to determine the names of all the
doctors who treated the patient during a stay. In many cases, the
institution's administrative office also has to be contacted to
determine whether the doctors identified by medical records billed
separately from the institution itself. Some HMOs may be included in
this provider type.
8. Pharmacy Data Collection Questionnaire. This questionnaire
requests the National Drug Code (NDC) and when that is not available
the prescription name, strength and form as well as the date
prescription was filled, payments by source, the quantity, and person
for whom the prescription was filled. When the NDC is available, we do
not ask for prescription name, strength or form because that
information is embedded in the NDC; this reduces burden on the
respondent. Most pharmacies have the requested information available in
electronic format and respond by providing a computer generated
printout of the patient's prescription information. If the computerized
form is unavailable, the pharmacy can report their data to a telephone
interviewer. Pharmacies are also able to provide a CD-ROM with the
requested information if that is preferred. HMOs are included in this
provider type.
Dentists, optometrists, psychologists, podiatrists, chiropractors,
and others not providing care under the supervision of a MD or DO are
considered out of scope for the MEPS-MPC.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in the MEPS-HC and the MEPS-MPC.
The MEPS-HC Core Interview will be completed by 13,338 * (see note
below Exhibit 1) ``family level'' respondents, also referred to as RU
respondents. Since the MEPS-HC consists of 5 rounds of interviewing
covering a full two years of data, the annual average number of
responses per respondent is 2.5 responses per year. The MEPS-HC core
requires an average response time of 92 minutes to administer. The
Adult Female SAQ (PSAQ) and Adult SAQ (SAQ) will be completed once a
year by each female person in the RU that is 18 years old and older, an
estimated 12,984
[[Page 33072]]
persons. The Adult Male SAQ (PSAQ) and Adult SAQ (SAQ) will be
completed once a year by each male person in the RU that is 18 years
old and older, an estimated 11,985 persons. The Adult SAQs each require
an average of 7 minutes to complete. The Mental Health Questions in the
Adult SAQ (Male/Female) will be completed during Round 2, Panel 25;
Round 4, Panel 24 by each person in the RU that is 18 years old and
older, an estimated 20,476 persons, and takes about 3.5 minutes to
complete. The Diabetes Care SAQ will be completed once a year by each
adult person in the RU identified as having diabetes, an estimated
2,072 persons, and takes about 3 minutes to complete. The 12,804 RUs in
the MEPS-HC will complete an average of 5.4 forms, which require about
3 minutes each to complete. The authorization form for the MEPS-MPC
Pharmacy Survey will be completed once for each pharmacy for any RU
member who has obtained a prescription medication. RUs will complete an
average of 3.1 forms, which take about 3 minutes to complete. The
Health Insurance Cost Sharing collection will be completed during Round
1, Panel 25 and Round 3, Panel 24 by each RU with a current private
health insurance plan, a Medicare Advantage plan, or a Medicare Part D
plan. An estimated 6,258 respondents will locate and provide cost-
sharing documentation for an average of 1.3 plans per eligible RU. This
activity will require 45 minutes to complete for each plan. About one
third of all interviewed RUs will complete a validation interview as
part of the MEPS-HC quality control, which takes an average of 5
minutes to complete. The Pilot Test Sampling NHIS Nonrespondents will
be completed by 200 * (see note below Exhibit 1) ``family level''
respondents, also referred to as RU respondents. The Pilot MEPS-HC core
requires an average response time of 92 minutes to administer. The
total annual burden hours for the MEPS-HC are estimated to be 67,542
hours.
All medical providers and pharmacies included in the MEPS-MPC will
receive a screening call and the MEPS-MPC uses 7 different
questionnaires; 6 for medical providers and 1 for pharmacies. Each
questionnaire is relatively short and requires 2 to 13 minutes to
complete. The total annual burden hours for the MEPS-MPC are estimated
to be 17,388 hours. The total annual burden for the MEPS-HC and MPC is
estimated to be 86,160 hours.
Exhibit 2 shows the estimated annual cost burden associated with
the respondents' time to participate in this information collection.
The annual cost burden for the MEPS-HC is estimated to be $1,673,909;
the annual cost burden for the MEPS-MPC is estimated to be $298,580.
The total annual cost burden for the MEPS-HC and MPC is estimated to be
$1,972,489.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
MEPS-HC
----------------------------------------------------------------------------------------------------------------
MEPS-HC Core Interview.......................... * 13,338 2.5 92/60 51,129
Adult Female SAQ (PSAQ)--Years 2019 and 2021; 12,984 1 7/60 1,515
Adult SAQ (SAQ)--Year 2020.....................
Adult Male SAQ (PSAQ)--Years 2019 and 2021; 11,985 1 7/60 1,398
Adult SAQ (SAQ)--Year 2020.....................
Diabetes care SAQ............................... 2,072 1 3/60 104
Mental Health Questions Included in Adult SAQ 20,476 1 3.5/60 1,194
(Male/Female)--Year 2020.......................
Authorization form for the MEPS-MPC Provider 12,804 5.4 3/60 3,457
Survey.........................................
Authorization form for the MEPS-MPC Pharmacy 12,804 3.1 3/60 1,985
Survey.........................................
Health Insurance Cost Sharing Collection--2020.. 6,258 1.3 45/60 6,101
MEPS-HC Validation Interview.................... 4,225 1 5/60 352
Pilot Test on Sampling NHIS Nonrespondents--2020 200 1 92/60 307
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Subtotal for the MEPS-HC.................... 102,366 na na 67,542
----------------------------------------------------------------------------------------------------------------
MEPS-MPC
----------------------------------------------------------------------------------------------------------------
MPC Contact Guide/Screening Call **............. 36,598 1 2/60 1,220
Home care for health care providers 635 1.53 9/60 146
questionnaire..................................
Home care for non[dash]health care providers 11 1 11/60 2
questionnaire..................................
Office[dash]based providers questionnaire....... 11,210 1.65 10/60 3,083
Separately billing doctors questionnaire........ 12,397 3.46 13/60 9,294
Hospitals questionnaire......................... 5,310 3.26 9/60 2,597
Institutions (non-hospital) questionnaire....... 116 2.05 9/60 36
Pharmacies questionnaire........................ 6,919 2.92 3/60 1,010
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Subtotal for the MEPS-MPC................... 73,196 na na 17,388
---------------------------------------------------------------
Grand Total............................. 175, 562 na na 84,930
----------------------------------------------------------------------------------------------------------------
* While the expected number of responding units for the annual estimates is 12,804, it is necessary to adjust
for survey attrition of initial respondents by a factor of 0.96 (13,338 = 12,804/0.96).
** There are 6 different contact guides; one for office based, separately billing doctor, hospital, institution,
and pharmacy provider types, and the two home care provider types, which use the same contact guide.
The total estimated annual burden hours for the MEPS has increased
from 77,666 hours in the previous clearance to 84,930 hours in this
clearance request, a difference of 7,264 hours. The addition of 1,194
hours due to the addition of Mental Health questions to the Adult SAQ
(Male/Female), 6,101 additional hours due to the health
[[Page 33073]]
insurance cost sharing collection, and 307 additional hours due to the
pilot test on sampling NHIS nonrespondents account for the difference.
While the burden associated with these added tasks totals 7,602 hours,
reductions in other burden estimates leave a net difference of 7,264
hours overall.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate burden
----------------------------------------------------------------------------------------------------------------
MEPS-HC
----------------------------------------------------------------------------------------------------------------
MEPS-HC Core Interview.......................... * 13,338 51,129 * $24.34 $1,244,479
Adult Female SAQ (PSAQ)-Years 2019 and 2021; 12,984 1,515 * 24.34 36,875
Adult SAQ (SAQ)--Year 2020.....................
Adult Male SAQ (PSAQ)--Years 2019 and 2021; 11,985 1,398 * 24.34 34,027
Adult SAQ (SAQ) -Year 2020.....................
Diabetes care SAQ............................... 2,072 104 * 24.34 2,531
Mental Health Questions Included in Adult SAQ 20,476 1,194 * 24.34 29,062
(Male/Female)--Year 2020.......................
Authorization forms for the MEPS-MPC Provider 12,804 3,457 * 24.34 84,143
Survey.........................................
Authorization form for the MEPS-MPC Pharmacy 12,804 1,985 * 24.34 48,314
Survey.........................................
Health Insurance Cost Sharing Collection--2020.. 6,258 6,101 * 24.34 148,498
MEPS-HC Validation Interview.................... 4,225 352 * 24.34 8,567
Pilot Test on Sampling NHIS Nonrespondents--2020 200 307 * 24.34 7,472
---------------------------------------------------------------
Subtotal for the MEPS-HC.................... 102,366 67,542 na 1,643,968
----------------------------------------------------------------------------------------------------------------
MEPS-MPC
----------------------------------------------------------------------------------------------------------------
MPC Contact Guide/Screening Call................ 36,598 1,220 ** 17.25 21,045
Home care for health care providers 635 146 ** 17.25 2,519
questionnaire..................................
Home care for non[dash]health care providers 11 2 ** 17.25 35
questionnaire..................................
Office[dash]based providers questionnaire....... 11,210 3,083 ** 17.25 53,182
Separately billing doctors questionnaire........ 12,397 9,294 ** 17.25 160,322
Hospitals questionnaire......................... 5,310 2,597 ** 17.25 44,798
Institutions (non-hospital) questionnaire....... 116 36 ** 17.25 621
Pharmacies questionnaire........................ 6,919 1,010 *** 15.90 16,059
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Subtotal for the MEPS-MPC................... 73,196 17,388 na 298,580
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Grand Total............................. 175,562 na na 1,942,548
----------------------------------------------------------------------------------------------------------------
* Mean hourly wage for All Occupations (00-0000).
** Mean hourly wage for Medical Secretaries (43-6013).
*** Mean hourly wage for Pharmacy Technicians (29-2052).
Occupational Employment Statistics, May 2017 National Occupational
Employment and Wage Estimates United States, U.S. Department of Labor,
Bureau of Labor Statistics.
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, 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: July 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-14770 Filed 7-10-19; 8:45 am]
BILLING CODE 4160-90-P