Attachment 120 -- 60 Day Federal Register Notice

20952

Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices

30 minutes. The self-administered
questionnaire will be completed by the
focus group participants and the
adolescent participants of the semistructured interviews, and will take

about 6 minutes to complete. The total
burden for all participants is estimated
to be 134 hours.
Exhibit 2 shows the estimated
annualized cost burden for the

respondent’s time to participate in the
project. The total cost is estimated to be
$2,001.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Data collection mode

Number of
responses
per respondent

Hours per
response

Total burden
hours

Screening form ................................................................................................
Self-administered questionnaire ......................................................................
Focus group with parents of children o´8 years of age (4 groups of 8 participants) ...........................................................................................................
Focus group with adults (4 groups of 8 participants) ......................................
Semi-structured interviews with adolescents (13 to 20 years of age) ............
Semi-structured interview with primary care physicians .................................
Semi-structured interviews with pharmacists ..................................................

124
84

1
1

3/60
6/60

6
8

32
32
20
20
20

1
1
1
1
1

1.5
1.5
30/60
20/60
20/60

48
48
10
7
7

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

332

........................

........................

134

Average hourly wage rate*

Total cost burden

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents

Data collection mode

Total burden
hours

Screening form ................................................................................................
Self-administered questionnaire ......................................................................
Focus groups with parents of children o´8 years of age (4 groups of 8 participants) .......................................................................................................
Focus groups with adults (4 groups of 8 participants) ....................................
Semi-structured interviews with adolescents (13 to 20 years of age) ............
Semi-structured interviews with primary care physicians ................................
Semi-structured interviews with pharmacists ..................................................

124
84

6
8

$10.30
10.30

$62
82

32
32
20
20
20

48
48
10
7
7

10.30
10.30
10.30
61.10
48.22

494
494
103
428
338

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

332

134

........................

2,001

* Patient average hourly wage based on the average per capita income of $21,435 (computed into an hourly wage rate of $10.30) in Harris
County, Texas where the study will take place. Provider hourly wage based on the following estimates from National Compensation Survey: Occupational wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics: primary care physician = $61.10/hour; pharmacist = $48.22/hour.

Estimates of Annualized Cost to the
Government
Exhibit 3 shows the estimated cost to
the Federal government for this sixmonth project. The total cost is
$164,440. This amount includes all
direct and indirect costs of the design,
data collection, analysis, and reporting
phase of the study.

EXHIBIT 3—ESTIMATED COST

mstockstill on PROD1PC66 with NOTICES

Cost component

Total cost

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

$13,250
61,699
14,080
750
17,000
57,661

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

164,440

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information

VerDate Nov<24>2008

18:36 May 05, 2009

Jkt 217001

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.

PO 00000

Frm 00054

Fmt 4703

Sfmt 4703

Dated: April 23, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–10407 Filed 5–5–09; 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: 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: ‘‘Medical

E:\FR\FM\06MYN1.SGM

06MYN1

Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices

Proposed Project

MEPS–HC is a sample of households
participating in the National Health
Interview Survey (NHIS) in the prior
calendar year that are interviewed 5
times over a 21⁄2 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.
MEPS–MPC collects information from
medical and financial records
maintained by hospitals, physicians,
pharmacies, health care institutions,
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.
This request is for the MEPS–HC and
MEPS–MPC only.

’’Medical Expenditure Panel Survey
(MEPS) Household Component and the
MEPS Medical Provider Component
Through 2012’’
AHRQ seeks to renew the Medical
Expenditure Panel Survey Household
Component (MEPS–HC) and the MEPS
Medical Provider Component (MEPS–
MPC) through the year 2012. For over
thirty years, the results of 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.
AHRQ is authorized to conduct the
MEPS pursuant to 42 U.S.C. 299b–2.
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 current MEPS design, unlike
the previous periodic surveys, 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 surveys’ analytic capacity
by providing another data point for
comparisons over time.
The MEPS–HC and MEPS–MPC are
two of three components of the MEPS:

Method of Collection
The MEPS is designed to meet the
need for information to estimate health
expenses, insurance coverage, access,
use and quality. Households selected for
participation in the MEPS 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.
After a preliminary mail contact
containing an advance letter,
households will be mailed MEPS record
keeping materials (a calendar) and a
DVD and brochure. After the advance
contact, households will be contacted
for the first of five in-person interviews.
The interviews are conducted as a
computer assisted personal interview
(CAPI). The CAPI instrument is
organized as a core instrument that will
repeat unchanged in each of the rounds.
Additional sections are asked only once
a year and provide greater depth.
Dependent interviewing methods in
which respondents are asked to confirm
or revise data provided in earlier
interviews will be used to update
information such as employment and
health insurance data after the round in
which such data are usually collected.
The main data collection modules for
the MEPS–HC are as follows:
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

mstockstill on PROD1PC66 with NOTICES

Expenditure Panel Survey (MEPS)
Household Component and the MEPS
Medical Provider Component Through
2012.’’ In accordance with the
Paperwork Reduction Act of 1995,
Public Law 104–13 (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 July 6, 2009.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at [email protected].
SUPPLEMENTARY INFORMATION:

VerDate Nov<24>2008

18:36 May 05, 2009

Jkt 217001

PO 00000

Frm 00055

Fmt 4703

Sfmt 4703

20953

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,
priority conditions, income, assets,
satisfaction with health plans and
providers, childrens health, adult
preventive care. 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.
Adult Self Administered
Questionnaire. A brief self-administered
questionnaire (SAQ), administered once
a year in rounds 2 and 4, will be used
to collect self-reported (rather than
through household proxy) information
on health status, health opinions and
satisfaction with health care for adults
18 and older.
Diabetes Care SAQ. A brief self
administered questionnaire on the
quality of diabetes care is administered
once a year in rounds 3 and 5 to persons
identified as having diabetes.
Permission forms for the MEPS–MPC.
As in previous panels of the MEPS, we
will ask respondents for permission to
obtain supplemental information from
their medical providers (hospitals,
physicians, health care institutions,
home health agencies and pharmacies).
MEPS–MPC Instruments
The main objective of the MEPS–MPC
is a collection of data from medical
providers that will serve as an
imputation source of medical
expenditure and source of payment data
reported by household respondents.
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. The questionnaires
used in the MEPS–MPC vary according
to type of provider. The data collection
instruments are as follows:
Home Care for Health Care Providers
Questionnaire. 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.
Home Care Provider Questionnaire for
Non-Health Care Providers. This 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.

E:\FR\FM\06MYN1.SGM

06MYN1

20954

Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices

Office-based Providers Questionnaire.
This questionnaire is for the officebased physician sample, including
doctors of medicine (MD5) and
osteopathy (DOs), as well as providers
practicing under the direction or
supervision of an MO 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.
Separately Billing Doctors
Questionnaire. Information from
physicians identified by hospitals as
providing care to sampled persons
during the course of inpatient stays,
outpatient department or emergency
room care, but who bill separately from
the hospital, is collected in this
questionnaire.
Hospitals 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 itself.

Institutions Questionnaire. This
questionnaire is used to collect data
from health care institutions providing
care to sampled persons and includes
nursing homes, assisted living facilities,
rehabilitation facilities, as well as any
other health care facilities providing
health care to a sampled person.
Pharmacies Questionnaire. This
questionnaire requests the prescription
name, NDC code, date prescription was
filled, payments by source, prescription
strength, form and quantity, and person
for whom the prescription was filled.
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.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
MEPS–HC and MEPS–MPC. The MEPS–
HC Core Interview will be completed by
15,000 ‘‘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 1

and Y2 hours to administer. The Adult
SAQ will be completed once a year by
each person in the RU that is 18 years
old and older, an estimated 21,000
persons. The Adult SAQ requires an
average of 7 minutes to complete. The
Diabetes care SAQ will be completed
once a year by each person in the RU
identified as having diabetes, an
estimated 1,800 persons and takes about
3 minutes to complete. Permission
forms for the MEPS–MPC will be
completed once for each medical
provider seen by any RU member. Each
of the 15,000 RUs in the MEPS–HC will
complete an average of 5.2 forms, which
require about 3 minutes each to
complete. The total annual burden
hours for the MEPS–HC is estimated to
be 62,690 hours.
The MEPS–MPC uses 7 different
questionnaires; 6 for medical providers
and 1 for pharmacies. Each
questionnaire is relatively short and
requires 3 to 5 minutes to complete. The
total annual burden hours for the
MEPS–HC and MPC is estimated to be
82,767 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 $1,226,216; the annual cost burden
for the MEPS–MPC is estimated to be
$285,965.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Number of respondents

Number of responses per
respondent

15,000
21,000
1,800
15,000

2.5
1
1
5.2

1.5
7/60
3/60
3/60

56,250
2,450
90
3,900

mstockstill on PROD1PC66 with NOTICES

MEPS–HC:
MEPS–HC Core Interview ........................................................................
Adult SAQ .................................................................................................
Diabetes care SAQ ...................................................................................
Permission forms for the MEPS–MPC .....................................................

Hours per response

Total burden
hours

Subtotal for the MEPS–HC ...............................................................
MEPS–MPC:
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 ........................................................................

52,800

na

na

62,690

441
23
13,665
12,450
5,402
72
7,760

6.5
6.6
5.8
2
6.5
1.5
23.3

5/60
5/60
5/60
3/60
5/60
5/60
3/60

239
13
6,605
1,245
2,926
9
9,040

Subtotal for the MEPS–MPC .............................................................

39,813

na

ia

20,077

Grand Total ................................................................................

92,613

na

ia

82,767

Average hourly wage rate *

Total cost burden

$19.56

$1,100,250

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents

Form mode
MEPS–HC:
MEPS–HC Core Interview ........................................................................

VerDate Nov<24>2008

18:36 May 05, 2009

Jkt 217001

PO 00000

Frm 00056

Fmt 4703

Sfmt 4703

15,000

Total burden
hours
56,250

E:\FR\FM\06MYN1.SGM

06MYN1

20955

Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of respondents

Form mode

Total burden
hours

Average hourly wage rate *

Total cost burden

Adult SAQ .................................................................................................
Diabetes care SAQ ...................................................................................
Permission forms for the MEPS–MPC .....................................................

21,000
1,800
15,000

2,450
90
3,900

19.56
19.56
19.56

47,922
1,760
76,284

Subtotal for the MEPS–HC ...............................................................
MEPS–MPC:
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 ........................................................................
Subtotal for the MEPS–MPC .............................................................

52,800

62,690

na

1,226,216

441
23
13,665
12,450
5,402
72
7,760
39,813

239
13
6,605
1,245
2,926
9
9,040
20,077

14.24
19.56
14.24
14.24
14.24
14.24
14.24
na

3,403
254
94,055
17,729
41,666
128
128,730
285,965

Grand Total ................................................................................

92,613

82,767

na

1,512,181

* Based upon the mean of the average wages for Healthcare Support Workers, All Other (31–9099) and All Occupations (00–0000), Occupational Employment Statistics, May 2007 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the total and
annualized cost of this information

collection. The cost associated with the
design and data collection of the MEPS–
HC and MEPS–MPC is estimated to be

$47.6 million in each of the next three
fiscal years.

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Total cost
(in million)

Cost component
Sampling Activities ...............................................................................................................................................
Interviewer Recruitment and Training .................................................................................................................
Data Collection Activities .....................................................................................................................................
Data Processing ..................................................................................................................................................
Production of Public Use Data Files ...................................................................................................................
Project Management ............................................................................................................................................

$2.79
8.52
86.7
21.39
19.53
3.93

mstockstill on PROD1PC66 with NOTICES

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

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
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

VerDate Nov<24>2008

18:36 May 05, 2009

Jkt 217001

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: April 27, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–10406 Filed 5–5–09; 8:45 am]
BILLING CODE 4160–90–M

PO 00000

Annualized cost
(in million)

142.8

$0.93
2.84
28.9
7.13
6.51
1.31
47.6

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0487] (formerly
Docket No. 2007D–0260)

Compliance Policy Guide; ‘‘Sec.
110.310 Prior Notice of Imported Food
Under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002;’’ Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a Compliance Policy
Guide (CPG) entitled ‘‘Sec. 110.310
Prior Notice of Imported Food Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002.’’ The CPG
provides written guidance to FDA’s and

Frm 00057

Fmt 4703

Sfmt 4703

E:\FR\FM\06MYN1.SGM

06MYN1