Attachment I: 60 Day Federal Register Notice

Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
FEDERAL MARITIME COMMISSION

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Notice of Agreements Filed
The Commission hereby gives notice
of the filing of the following agreements
under the Shipping Act of 1984.
Interested parties may submit comments
on the agreements to the Secretary,
Federal Maritime Commission,
Washington, DC 20573, within twelve
days of the date this notice appears in
the Federal Register. Copies of the
agreements are available through the
Commission’s Web site (www.fmc.gov)
or by contacting the Office of
Agreements at (202)–523–5793 or
tradeanalysis@fmc.gov.
Agreement No.: 012339–001.
Title: Sealand/APL West Coast of
Central America Slot Charter
Agreement.
Parties: APL Co. Pte Ltd; and
American President Lines, Ltd.
(collectively ‘‘APL’’); Maersk Line A/S
dba Sealand.
Filing Party: Wayne R. Rohde, Esq.;
Cozen O’Conner; 1627 I Street NW.,
Suite 1100; Washington, DC 20006–
4007.
Synopsis: The amendment would add
ports on the Pacific Coast of Guatemala,
El Salvador, and Nicaragua to the
agreement.
Agreement No.: 012429.
Title: CMA CGM/APL Panama—USEC
Space Charter Agreement.
Parties:. APL Co. Pte Ltd; and
American President Lines, Ltd.
(collectively ‘‘APL’’); CMA CGM, S.A.
Filing Party: Draughn B. Arbona, Esq;
CMA CGM (America) LLC; 5701 Lake
Wright Drive; Norfolk, VA 23502.
Synopsis: The agreement authorizes
APL to charter space to CMA CGM in
the trade between Panama and the U.S.
East Coast.
Agreement No.: 012430.
Title: CMA CGM/APL Colombia/
Panama-USEC Space Charter
Agreement.
Parties: APL Co. Pte Ltd; and
American President Lines, Ltd.
(collectively ‘‘APL’’)
Filing Party: Draughn B. Arbona, Esq;
CMA CGM (America) LLC; 5701 Lake
Wright Drive; Norfolk, VA 23502.
Synopsis: The agreement authorizes
APL to charter space to CMA CGM in
the trade between Colombia and
Panama on the one hand, and the U.S.
East Coast on the other hand.
Agreement No.: 0123431.
Title: HSDG/Zim Asia US East Coast
Slot Charter Agreement.
Parties: Hamburg Sud Amerikanische
Dampfschifffahrts-Gesellschaft KG and
Zim Integrated Shipping Services, Ltd.

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Filing Party: Mark E. Newcomb; ZIM
American Integrated Shipping Services
Co., LLC; 5801 Lake Wright Dr.; Norfolk,
VA 23508.
Synopsis: The Agreement would
authorize Zim to charter space to
Hamburg Sud in the trade between
China and Korea on one hand, and
Panama, Jamaica and the U.S. East Coast
on the other hand. The parties have
requested Expedited Review.
Agreement No.: 012432.
Title: APL/ANL Asia—USWC Space
Charter Agreement.
Parties: APL Co. Pte Ltd; and
American President Lines, Ltd.
(collectively ‘‘APL’’); and ANL
Singapore Pte Ltd.
Filing Party: Draughn B. Arbona, Esq;
CMA CGM (America) LLC; 5701 Lake
Wright Drive; Norfolk, VA 23502.
Synopsis: The Agreement authorizes
APL to charter space to ANL in the trade
between Asia and the U.S. West Coast.
Agreement No.: 012433.
Title: HLAG/MOL Slot Charter
Agreement.
Parties: Hapag-Lloyd AG and Mitsui
O.S.K. Lines, Ltd.
Filing Party: Wayne Rohde, Esq.;
Cozen O’Connor; 1200 Nineteenth Street
NW; Washington, DC 20036.
Synopsis: The Agreement authorizes
Hapag-Lloyd to charter space to MOL in
the trade between Puerto Rico, the
Dominican Republic, and Panama.
By Order of the Federal Maritime
Commission.
Dated: July 29, 2016.
Rachel E. Dickon,
Assistant Secretary.
[FR Doc. 2016–18388 Filed 8–2–16; 8:45 am]
BILLING CODE 6731–AA–P

FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices

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51199

of the Board of Governors. Comments
must be received not later than August
18, 2016.
A. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Theresa Dawley, Richfield,
Minnesota, Kathryn Appold, Burnsville,
Minnesota, and Delbert Dawley,
Shakopee, Minnesota, as a group acting
in concert, to retain shares of Munich
Bancshares, Inc., Munich, North Dakota,
and thereby indirectly retain shares of
Horizon Financial Bank, both in
Munich, North Dakota.
Board of Governors of the Federal Reserve
System, July 29, 2016.
Michele T. Fennell,
Assistant Secretary of the Board.
[FR Doc. 2016–18380 Filed 8–2–16; 8:45 am]
BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘The
Patient-Centered Medical Home (PCMH)
Items Demonstration Study.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be
received by October 3, 2016.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

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Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices

Proposed Project

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The Patient-Centered Medical Home
(PCMH) Items Demonstration Study
This study is being conducted by
AHRQ through its contractor, RAND,
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 and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
The patient-centered medical home
(PCMH) is a model for delivering
primary care that is patient-centered,
comprehensive, coordinated, accessible,
and continuously improved through a
systems-based approach to quality and
safety.
As primary care practices across the
United States seek National Committee
for Quality Assurance (NCQA)
recognition as patient-centered medical
homes (PCMH), they can choose to
administer the Consumer Assessment of
Healthcare Providers and Systems
(CAHPS®) Clinician and Group (CG–
CAHPS) survey with or without the
PCMH supplemental item set (AHRQ,
2010; Hays et al., 2014; Ng et al., 2016;
Scholle et al., 2012). NCQA offers a
special patient experience distinction to
practices that opt to use the PCMH
CAHPS items set in their CG–CAHPS
survey tool. While over 11,000
practices, representing an estimated 15–
18% of primary care physicians, are
currently recognized for PCMH by
NCQA (NCQA, 2015), fewer than 3% of
them submit patient experience surveys
to NCQA when applying for recognition
under NCQA’s PCMH recognition
program.
Despite the rapid movement toward
PCMH primary care transformation and
the increasing use of PCMH CAHPS
items, little is known about the ways in
which practices are using these CAHPS
data and the PCMH supplemental item
information (about access,
comprehensiveness, self-management,
shared decision making, coordination of
care, and information about care and
appointments) to understand and
improve their patients’ experiences
during PCMH transformation. The
PCMH Items Demonstration Study will
investigate:
• How practices across the U.S. use
CAHPS and the PCMH item set during
PCMH transformation,
• How practices assemble and select
items for inclusion in their patient

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experience surveys (e.g. core, PCMH,
supplemental, and custom items),
• Primary care practice leaders’
perspectives on NCQA PCMH
Recognition and CAHPS Patient
Experience Distinction,
• Effects of changes made during
PCMH transformation on patient
experiences reported on CAHPS surveys
and any PCMH items, and
• Associations between PCMH
transformation and patient experience
scores.
To achieve the goals of this project the
following data collections will be
implemented:
(1) Office Manager Questions
administered via phone about the
participating practice’s characteristics to
describe the type of practices in the
study and to understand how practice
characteristics influence PCMH
transformation and patient experience.
(2) Physician Interviews administered
via phone with the lead PCMH clinical
expert about the details, decisions and
processes of PCMH transformation,
NCQA PCMH Recognition and CAHPS
Patient Experience Distinction and their
use of patient experience data during
the transformation process.
(3) PCMH–A Assessment Tool to be
completed by the lead PCMH clinical
expert (before or after the interview on
the standardized form via fax or email)
to collect validated metrics on the
‘‘PCMH-ness’’ of the practice.
(4) CAHPS Patient Experience Data
Files, which are patient-level, deidentified CAHPS patient experience
data covering the period of PCMH
transformation for the participating
practice. These data are collected
independently of this study by the
practice (or network) via its current
vendor. We will work with the PCMH
clinical expert, or a designated person
who handles data, in each of the
participating practices to submit these
CAHPS data files securely to RAND to
understand CAHPS patient experience
trends and associations with PCMH
implementation during the practice’s
PCMH journey.
Characterizing the use of CAHPS and
PCMH items by primary care practices
will provide important insight into the
activities practices conduct during
PCMH transformation to improve
patient experience scores. This
information may be useful in supporting
practices that lag behind their peers,
learning from practices with
outstanding records of patient
experience, and providing
recommendations that may be used to
refine the content of the CAHPS survey
items.

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Estimated Annual Respondent Burden
Table 1 shows the estimated
annualized burden and cost for the
respondents’ time to participate in this
data collection. These burden estimates
are based on tests of data collection
conducted on nine or fewer entities. As
indicated below, the annual total
burden hours are estimated to be 179
hours. The annual total cost associated
with the annual total burden hours is
estimated to be $16,899.
The PCMH Items Demonstration
Study will recruit 150 practices
including the participating practices’
office managers and one physician/lead
PCMH clinical expert. We will recruit
and administer the Office Manager
Questions by phone to 150 office
managers, recruit all sampled
physicians by sending them a
recruitment packet that includes a cover
letter, an AHRQ endorsement letter and
an information sheet, and then
administer the Physician Interview
protocol questions by phone to 150
physicians, and 150 physicians will
self-administer the PCMH–A
Assessment Tool.
We have calculated our burden
estimate for Office Manager Questions
asked during physician recruitment
using an estimate of 3–5 questions a
minute as the Office Manager Questions
are closed-ended survey questions. The
Office Manager Questions contains 17
questions and is estimated to require an
average of 5 minutes; this estimate is
supported by the information gathered
during a pilot of these questions. For the
Physician Interview, we have calculated
the burden estimate to require an
average of 40 minutes per interview. For
the PCMH–A Assessment Tool, we
calculated our burden using a
conservative estimate of 4.5 items per
minute. Prior work suggests that 3–5
items on an assessment tool can
typically be completed per minute,
depending on item complexity and
respondent characteristics (Berry, 2009;
Hays & Reeve, 2010). The PCMH–A
Assessment tool contains 36 items and
is estimated to require an average
completion time of 8–10 minutes.
Participating practices will be asked
to submit any available CAHPS Patient
Experience data files (e.g. submission of
de-identified data including a data
dictionary via encrypted transfer) for the
period of time covering their NCQA
PCMH Recognition history. Each
practice will have an average estimate of
3 CAHPS Patient Experience data files
to submit per one submission, which we
based on the average number of years of
PCMH history of the sample. In
addition, we conservatively estimate

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Federal Register / Vol. 81, No. 149 / Wednesday, August 3, 2016 / Notices
that half of the control practices (25/50)
administer CG–CAHPS data, as this
percentage is unknown; while 90% of

the participating current and past
CAHPS practices (90/100) will submit
CAHPS data, yielding 115 submissions

of CAHPS patient experience data files.
As indicated below, the annual total
burden is estimated to be 179 hours.

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

Hours per
response

Total burden
hours

Data collection task

Number of respondents

Office Manager Questions .........................................
Physician Interview ....................................................
PCMH–A Assessment Tool .......................................

1 .........................................
1 .........................................
1 (same person as above)

5/60
40/60
15/60

12.5
100
37.5

CAHPS Patient Experience Data Files .....................

150 ...................................
150 ...................................
150 (same physicians as
above).
115 ...................................

1 per practice .....................

15/60

28.75

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

415 ...................................

1 .........................................

75/60

178.75

+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
requests

Data collection task
Office Manager Questions ...............................................................................
Physician Interview ..........................................................................................
PCMH–A Assessment Tool .............................................................................
CAHPS Patient Experience Data Files ............................................................
Total ..........................................................................................................

150
150
150
115
300

Average
hourly wage
rate *

Total burden
hours

a $57.44

12.5
100
37.5
28.75
178.75

b 97.33
b 97.33
b 97.33

55.48

Total cost
burden
$718.00
9,733.00
3,649.88
2,798.24
16,899.12

+ The same respondent completes the Physician Interview and PCMH–A Assessment Tool and submits the CAHPS Patient Experience Data
Files.
* Occupational Employment Statistics, May 2015 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.
a Based on the mean wages for General and Operations Managers, 11–1021 within Healthcare Support Occupations, the occupational group
most likely tasked with completing the Office Manager Questions.
b Based on the mean wages for Physicians and Surgeons, 29–1060, the occupational group most likely tasked with completing the Physician
Interview, PCMH–A Assessment Tool, and submitting the CAHPS Patient Experience Data Files.

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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 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

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comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016–18392 Filed 8–2–16; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2049]

Medical X-Ray Imaging Devices
Conformance With International
Electrotechnical Commission
Standards; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Medical X-Ray
Imaging Devices Conformance With IEC
Standards.’’ This draft guidance

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ADDRESSES:

You may submit comments

as follows:

Notice of availability.

SUMMARY:

describes FDA’s policy regarding the
regulation of medical x-ray imaging
equipment that are subject to
requirements in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) and
FDA’s regulations that apply to medical
devices and electronic products. The
draft guidance also provides
recommendations to industry on how to
comply with the applicable
requirements. This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 1,
2016.

Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.

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