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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
respondents through an online survey,
paper form or telephone administration.
Information that will be collected
includes demographic information,
specialty, number of years the physician
has provided direct patient care,
training related to cultural competency
and the National CLAS Standards,
provision of CLAS to patients,
organizational characteristics that
helped or prevented provision of CLAS,
and awareness of the National CLAS
Standards.
The target universe of the CLAS
survey includes non-federally employed
physicians who were classified by the
American Medical Association or the
American Osteopathic Association as
providing ‘‘office-based, patient care.’’
The target universe excludes physicians
in the specialties of anesthesiology,
radiology, and pathology. The survey
sample of 2,400 physicians will be used
as the basis to provide regional and
national estimates. Participation in the
CLAS survey is voluntary. There will be
no financial incentive to participate.
The CLAS survey will be a self-
administered online questionnaire, with
paper form and telephone
administration as follow-up alternatives
for non-respondents. A three-year
approval will be requested.
There is no cost to the respondents
other than their time.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondent
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Office-based physicians ....................
NAMCS CLAS Survey .....................
800
1
30/60
400
Total
...........................................
...........................................................
........................
........................
........................
400
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21343 Filed 8–27–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15BEB; Docket No. CDC–2015–
0071]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
AGENCY
:
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION
:
Notice with comment period.
SUMMARY
:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collect project entitled Balance After
Baby Intervention: Phase 2 (BABI2.) A
three-year clearance is requested to
conduct a randomized controlled trial of
a Web site-based lifestyle program with
a racially diverse population of
postpartum women who had recent
Gestational diabetes mellitus (GDM).
DATES
:
Written comments must be
received on or before October 27, 2015.
ADDRESSES
:
You may submit comments,
identified by Docket No. CDC–2015–
0071 by any of the following methods:
Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT
:
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION
:
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Balance After Baby Intervention:
Phase 2 (BABI2)—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC Division of Reproductive
Health (DRH) is focused on
understanding and preventing
complications due to pregnancy and the
development of chronic diseases in
reproductive age women. Similarly, the
CDC established the National Diabetes
Prevention Program (NDPP),
administered through the Division of
Diabetes Translation (DDT), to make
strategies for preventing type 2 diabetes
broadly available to individuals at high
risk of developing diabetes. Gestational
diabetes mellitus (GDM) is one of the
most common pregnancy complications
in the US, affecting approximately 3–
13% of pregnancies, or approximately
200,000 cases annually. As defined by
the American Diabetes Association
(2003), GDM is glucose intolerance that
first presents during pregnancy after the
first trimester. Women with a history of
GDM have a substantially increased risk
of developing type 2 diabetes mellitus
(T2DM) within 5 to 16 years after their
index pregnancy. It has also been shown
that many women with a history of
GDM gain weight after pregnancy,
increasing their risk for obesity, which
itself is a strong risk factor for repeat
GDM and T2DM. Because of this, as US
obesity prevalence continues to
increase, there is a concurrent rise in the
incidence and prevalence of GDM and
T2DM, resulting in a large disease
burden on individuals, families, and
society. To assist in reducing this
national disease burden, it is critical to
develop and implement successful
interventions that reduce the annual
number of newly diagnosed T2DM
cases, especially in increased risk
populations, such as women with a
history of GDM. As part of this Healthy
People 2020 objective, the Diabetes
Prevention Program (DPP) demonstrated
that an intensive lifestyle intervention
(16 face-to-face sessions over a 24-week
period) promoting physical activity,
healthy eating, and weight reduction
significantly decreased T2DM incidence
by 58% in high risk patients. However,
the DPP included predominantly older
individuals whose ability to attend
group meetings and adopt healthy
lifestyle changes is different than
younger postpartum women. For this
reason, successful adaptations of the
DPP that address barriers in postpartum
women with recent GDM, such as
limited time and resources, fatigue, and
childcare demands, must be identified
and tested.
This BABI2 data collection request
aims to address these barriers through
the conduct of a randomized, controlled
intervention trial of a Web site-based
lifestyle program, Balance after Baby
(BAB) that is adapted from the DPP and
tailored specifically for postpartum
women with recent GDM.
The project aims to screen 293 (98
annualized over 3 years) women with a
recent GDM pregnancy for enrollment
into the study, followed by assessments
at the following five post-partum time
points: 6-weeks, 6-months, 12-months,
18-months, and 24-months. Of the
estimated 190 (63 annualized) women
who will meet eligibility requirements
and attend the first study visit,
approximately half will be assigned to
the control group and will receive
standard postpartum follow-up, while
those assigned to the intervention group
will have access to the BAB
informational Web site and a lifestyle
coach. For all participants, the BABI2
study visits will involve the completion
of visit-specific questionnaires,
laboratory testing, and the collection of
physical measurements such as height
and weight. Collected data will be used
by CDC and BABI2 investigators to
assess the impact and effectiveness of
the BABI2 intervention as a potential
public health weight loss tool for
women at increased T2DM risk.
For the calculation of the estimated
burden hours per study visit detailed in
the table below, a constant 5% rate of
exclusion and attrition was applied
between visits. The burden table
provides a participant estimate, which
will be evenly distributed across control
and intervention groups for each
information collection step, annualized
over a 3-year collection period.
Therefore, of the 190 women (63
annualized) who attend the 6-week
visit, the estimated number of
participants returning for the 6-month
visit is reduced to 180 (60 annualized),
followed by 172 (57 annualized), 162
(54 annualized), and 154 (51
annualized) for the 12-, 18-, and 24-
month visits respectively. The average
burden per questionnaire ranges from 8
minutes for the BABI2 Screener
Questionnaire up to 36 minutes for the
BABI2 6-month Questionnaire.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondents
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
Women with a recent history GDM ...
BABI2 Screener Questionnaire .......
98
1
8/60
13
Women with a recent history GDM ...
BABI2 6-Week Questionnaire ..........
63
1
35/60
37
Women with a recent history GDM ...
BABI2 6-Month Questionnaire .........
60
1
36/60
36
Women with a recent history GDM ...
BABI2 12-Month Questionnaire .......
57
1
32/60
31
Women with a recent history GDM ...
BABI2 18-Month Questionnaire .......
54
1
32/60
29
Women with a recent history GDM ...
BABI2 24-Month Questionnaire .......
51
1
33/60
28
Total
...........................................
..........................................................
........................
........................
........................
174
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52294
Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21344 Filed 8–27–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1643–N]
Medicare Program; Solicitation of
Nominations to the Advisory Panel on
Hospital Outpatient Payment
AGENCY
:
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION
:
Notice.
SUMMARY
:
This notice solicits
nominations for up to seven new
members to the Advisory Panel on
Hospital Outpatient Payment (HOP, the
Panel). There will be vacancies on the
Panel for four-year terms that begin
during Calendar Year 2016.
The purpose of the Panel is to advise
the Secretary of the Department of
Health and Human Services (Secretary)
and the Administrator of the Centers for
Medicare & Medicaid Services on the
clinical integrity of the Ambulatory
Payment Classification groups and their
associated weights, and supervision of
hospital outpatient therapeutic services.
The Secretary re-chartered the Panel
in 2014 for a 2-year period effective
through November 6, 2016.
DATES
:
Submission of Nominations: We
will consider nominations if they are
received no later than 5 p.m. Eastern
Standard Time (E.S.T) October 27, 2015.
ADDRESSES
:
Please submit nominations
electronically to the following email
address: [email protected].
Web site: For additional information
on the Panel and updates to the Panel’s
activities, we refer readers to our Web
site at the following address: http://
www.cms.gov/Regulations-and-
Guidance/Guidance/FACA/Advisory
PanelonAmbulatoryPayment
ClassificationGroups.html.
FOR FURTHER INFORMATION CONTACT
:
Persons wishing to nominate
individuals to serve on the Panel or to
obtain further information may contact
Carol Schwartz at the following email
address: [email protected] or call
(410) 786–3985.
News Media: Representatives should
contact the CMS Press Office at (202)
690–6145.
SUPPLEMENTARY INFORMATION
:
I. Background
The Secretary of the Department of
Health and Human Services (the
Secretary) is required by section
1833(t)(9)(A) of the Social Security Act
(the Act), and section 222 of the Public
Health Service Act (PHS Act) to consult
with an expert outside advisory panel
regarding the clinical integrity of the
Ambulatory Payment Classification
(APC) groups and relative payment
weights that are components of the
Medicare Hospital Outpatient
Prospective Payment System (OPPS),
and the appropriate supervision level
for hospital therapeutic outpatient
services. The Advisory Panel on
Hospital Outpatient Payment (HOP, the
Panel) is governed by the provisions of
the Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory panels. The Panel may
consider data collected or developed by
entities and organizations (other than
the Department of Health and Human
Services) as part of their deliberations.
The Charter provides that the Panel
shall meet up to 3 times annually. We
consider the technical advice provided
by the Panel as we prepare the proposed
and final rules to update the OPPS for
the following Calendar Year (CY).
The Panel shall consist of a chair and
up to 15 members who are full-time
employees of hospitals, hospital
systems, or other Medicare providers
that are subject to the OPPS. For
supervision deliberations, the Panel
shall also include members that
represent the interests of Critical Access
Hospitals (CAHs), who advise the
Centers for Medicare & Medicaid
Services (CMS) only regarding the level
of supervision for hospital outpatient
therapeutic services. (For purposes of
the Panel, consultants or independent
contractors are not considered to be full-
time employees in these organizations.)
The current Panel members are as
follows:
(Note: The asterisk [*] indicates the
Panel members whose terms end during
CY 2016, along with the month that the
term ends.)
•
E.L. Hambrick, M.D., J.D., Chair, a
CMS Medical Officer.
•
Karen Borman, M.D., F.A.C.S.*
(July 2016)
•
Dawn L. Francis, M.D., M.H.S.
•
Ruth Lande
•
Jim Nelson, M.B.A., C.P.A.,
F.H.F.M.A.* (January 2016)
•
Leah Osbahr, M.A., M.P.H.*
(January 2016)
•
Jacqueline Phillips* (February
2016)
•
Johnathan Pregler, M.D.
•
Traci Rabine* (January 2016)
•
Michael Rabovsky, M.D.
•
Wendy Resnick, F.H.F.M.A.
•
Michael K. Schroyer, R.N.
•
Marianna V. Spanaki-Varelas M.D.,
Ph.D., M.B.A.* (February 2016)
•
Norman Thomson, III, M.D.
•
Gale Walker* (January 2016)
•
Kris Zimmer
Panel members serve on a voluntary
basis, without compensation, according
to an advance written agreement;
however, for the meetings, CMS
reimburses travel, meals, lodging, and
related expenses in accordance with
standard Government travel regulations.
CMS has a special interest in ensuring,
while taking into account the nominee
pool, that the Panel is diverse in all
respects of the following: Geography;
rural or urban practice; race, ethnicity,
sex, and disability; medical or technical
specialty; and type of hospital, hospital
health system, or other Medicare
provider subject to the OPPS.
Based upon either self-nominations or
nominations submitted by providers or
interested organizations, the Secretary,
or her designee, appoints new members
to the Panel from among those
candidates determined to have the
required expertise. New appointments
are made in a manner that ensures a
balanced membership under the FACA
guidelines. For 2016, we anticipate
doing one solicitation for nominees. Our
appointment schedule will assure that
we have the full complement of
members for each Panel meeting.
Current members’ terms expire at
different times throughout the year;
therefore, we will add new members
throughout the year as terms expire.
II. Criteria for Nominees
The Panel must be fairly balanced in
its membership in terms of the points of
view represented and the functions to
be performed. Each panel member must
be employed full-time by a hospital,
hospital system, or other Medicare
provider subject to payment under the
OPPS (except for the CAH members,
since CAHs are not paid under the
OPPS). All members must have
technical expertise to enable them to
participate fully in the Panel’s work.
Such expertise encompasses hospital
payment systems; hospital medical care
delivery systems; provider billing
systems; APC groups; Current
Procedural Terminology codes; and
alpha-numeric Health Care Common
Procedure Coding System codes; and
the use of, and payment for, drugs,
medical devices, and other services in
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| File Type | application/pdf |
| File Modified | 0000-00-00 |
| File Created | 2021-01-21 |