60 Day Federal Register Notice

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Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs

Form name

Number of
responses per
POC

Hours per
response

Total burden
hours

Registration Form ............................................................................................
Hospital Information Form ...............................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................

300
300
300
2

1
1
1
150

5/60
5/60
3/60
1

25
25
15
300

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

902

NA

NA

365

Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to complete one

submission process. The cost burden is
estimated to be $16,722 annually.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Registration Form ............................................................................................
Hospital Information Form ...............................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................

300
300
300
2

25
25
15
300

53.69a
a53.69
b94.25
c 42.08

$1,342
1,342
1,414
12,624

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

902

365

NA

16,722

* National Compensation Survey: Occupational wages in the United States May 2017, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
(a) Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
(b) Based on the mean hourly wage for Chief Executives (11–1011).
(c) Based on the mean hourly wages for Computer Programmer (15–1131).

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’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.
Gopal Khanna,
Director.
[FR Doc. 2019–05144 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

Proposed Project

Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.

Consumer Assessment of Healthcare
Providers and Systems (CAHPS®) Home
and Community Based Services (HCBS)
Survey Database

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
‘‘Consumer Assessment of Healthcare
Providers and Systems (CAHPS) Home
and Community Based Services (HCBS)
Survey Database.’’
DATES: Comments on this notice must be
received by May 20, 2019.
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.

In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
The CAHPS Home and CommunityBased Services Survey is the first crossdisability survey of home and
community-based service beneficiaries’
experience receiving long-term services
and supports. It is designed to facilitate
comparisons across state Medicaid
HCBS programs throughout the country
that target adults with disabilities, e.g.,
including frail elderly, individuals with
physical disabilities, persons with
developmental or intellectual
disabilities, those with acquired brain
injury and persons with severe mental
illness.
The HCBS CAHPS Survey was
developed by the Centers for Medicare
& Medicaid Services (CMS) for

AGENCY:

SUMMARY:

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Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices

voluntary use by state Medicaid
programs, including both fee-for-service
HCBS programs as well as managed
long-term services and supports
(MLTSS) programs. States with
adequate sample sizes may consider
using survey metrics in value-based
purchasing initiatives.
The HCBS–CAHPS Database will
serve as a primary source of data
available to states, agency programs and
researchers to help answer important
questions related to beneficiary
experiences. AHRQ, through its
contractor, will collect and make
available de-identified survey data,
enabling HCBS programs to identify
areas where quality can be improved.
Rationale for the information
collection. Aggregated HCBS–CAHPS
Database results will be made publicly
available on AHRQ’s CAHPS website.
Technical assistance will be provided
by AHRQ, through its contractor, at no
charge to programs to facilitate the
access and use of these materials for
quality improvement and research.
Technical assistance will also be
provided to support HCBS–CAHPS data
submission.
The HCBS–CAHPS Database will
support AHRQ’s goals of promoting
improvements in the quality and
patient-centeredness of health care in
home or community-based care settings.
This research has the following goals:
1. Improve care provided by
individual providers and state
programs.
2. Offer several products and services,
including providing survey results
presented through an Online Reporting
System, summary chartbooks, custom
analyses, private reports and data for
research purposes.
3. Provide information to help
identify strengths and areas with
potential for improvement in patient
care.

This study is being conducted by
AHRQ through its contractor, Westat,
pursuant to AHRQ’s statutory authority
to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of health care
services; quality measurement and
improvement; and health surveys and
database development 42 U.S.C.
299a(a)(1) and (2), and (8).
Method of Collection
The development and operation of the
HCBS–CAHPS Database will include the
following major components undertaken
by AHRQ through its contractor. To
achieve the goals of this project, the
following activities and data collections
that constitute information collection
under the Paperwork Reduction Act
(PRA) will be implemented:
• Registration with the site to obtain
an account with a secure username and
password: The point-of-contact (POC)
completes an online registration form,
providing contact and organizational
information required to initiate the
registration process.
• Submission of signed Data Use
Agreements (DUAs) and survey
questionnaires: The data use agreement
completed by the participating
organization provides confidentiality
assurances and states how the data
submitted will be used.
• Submission of program information
form: The POC completes an online
information form to describe
organizational characteristics of the
program.
• Submission of de-identified survey
data files: POCs upload data files in the
format specified in the data file
specifications to ensure data submitted
is standardized and consistently named
and coded.
• Follow-up with submitters in the
event of a rejected file, to assist in

making corrections and resubmitting the
file.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated burden
hours for the respondents to participate
in the database. The 51 POCs in Exhibit
1 represent the 51 states or agencies that
will administer the Adult HCBS survey.
An estimated 13 survey vendors will
assist them.
Each state or agency will register
online for submission. The online
Registration form will require about 5
minutes to complete. Each submitter
will also complete a program
information form of information about
each program such as the name of the
program, program size, state, etc. The
online program information form takes
on average 5 minutes to complete. The
data use agreement will be completed
by each of the 51 participating States.
Survey vendors do not sign or submit
DUAs. The DUA requires about 3
minutes to sign and return by fax or
mail. Each submitter, which in most
cases will be the survey vendor
performing the data collection, will
provide a copy of their questionnaire
and the survey data file in the required
file format. Survey data files must
conform to the data file layout
specifications provided by the HCBS–
CAHPS Database. Since the unit of
analysis is at the program level,
submitters will upload one data file per
program. Once a data file is uploaded
the file will be automatically checked to
ensure it conforms to the specifications
and a data file status report will be
produced and made available to the
submitter. Submitters will review each
report and will be expected to correct
any errors in their data file and resubmit
if necessary. It will take about one hour
to submit the data for each program. The
total burden is estimated to be 63 hours
annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs

Form name

Number of
responses
per POC

Hours per
response

Total burden
hours

Registration Form ............................................................................................
Program Information Form ..............................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................

51
51
51
13

1
1
1
4

5/60
5/60
3/60
1

4.25
4.25
2.5
52

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

166

NA

NA

63

Exhibit 2 shows the estimated
annualized cost burden based on the

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submission process. The cost burden is
estimated to be $2,880 annually.

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Federal Register / Vol. 84, No. 53 / Tuesday, March 19, 2019 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Registration Form ............................................................................................
Program Information Form ..............................................................................
Data Use Agreement .......................................................................................
Data Files Submission .....................................................................................

51
51
51
13

4.25
4.25
2.5
52

a 53.69

c 42.08

$228
228
236
2,188

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

** 166

63

NA

2,880

a 53.69
b 94.25

* National Compensation Survey: Occupational wages in the United States May 2017, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean hourly wage for Medical and Health Services Managers (11–9111).
b Based on the mean hourly wage for Chief Executives (11–1011).
c Based on the mean hourly wages for Computer Programmer (15–1131).
** The 51 POCs listed for the registration form, program information form and the data use agreement are the estimated POCs from the estimated participating programs.

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’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.
Gopal Khanna,
Director.
[FR Doc. 2019–05141 Filed 3–18–19; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Noninvasive
Nonpharmacologic Treatment for
Chronic Pain
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:

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The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Noninvasive Nonpharmacologic
Treatment for Chronic Pain, which is
currently being conducted by the
AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before April 18, 2019.
ADDRESSES:
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Noninvasive
Nonpharmacologic Treatment for
Chronic Pain. AHRQ is conducting this
systematic review pursuant to Section
902(a) of the Public Health Service Act,
42 U.S.C. 299a(a).
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
SUMMARY:

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are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Noninvasive
Nonpharmacologic Treatment for
Chronic Pain, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
topics/noninvasive-nonpharm-painupdate/protocol.
This is to notify the public that the
EPC Program would find the following
information on Noninvasive
Nonpharmacologic Treatment for
Chronic Pain helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov,
please provide a summary, including
the following elements: Study number,
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your

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