Attachment 1_42 U.S.C. 241

Attachment 1_42 U.S.C. 241.docx

Balance After Baby Intervention

Attachment 1_42 U.S.C. 241

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52292

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: omb@cdc.gov.

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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52293

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: APCPanel@cms.hhs.gov.

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: APCPanel@cms.hhs.gov 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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