2708 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 

• the revised version of ‘‘Asb2 

regulates the activity of SCF E3 

ubiquitin ligases by antagonizing 

CAND1-mediated exchange of F-box 

proteins,’’ submitted to Molecular Cell 

on September 29, 2014; hereafter 

referred to as the ‘‘revised Molecular 

Cell manuscript 

• grant application CA189216–01 

submitted to the National Cancer 

Institute (NCI), NIH; hereafter referred to 

as the ‘‘original NCI grant application’’ 

• grant application CA189216–01A1 

submitted to NCI, NIH; hereafter 

referred to as the ‘‘revised NCI grant 

application’’ 

ORI found that Respondent 

knowingly falsified and/or fabricated 

Western blot gel images by duplication, 

reuse and relabeling, and/or alteration 

through contrast, rotation, and/or scale 

of the images. 

Specifically, Respondent included 

falsified images in all of the figures 

(Figures 1–6 and S1–5) in the original 

Molecular Cell manuscript, all of the 

figures (Figures 1–6 and S1–7) in the 

revised 

Molecular Cell manuscript, Figures 2– 

4, 9, and 11 in the original NCI grant 

application, and Figures 3–5, 10, and 11 

in the revised NCI grant application. 

Dr. Kang has entered into a Voluntary 

Settlement Agreement (Agreement) and 

has voluntarily agreed for a period of 

three (3) years, beginning on December 

23, 2014: 

(1) To have his research supervised; 

Respondent agreed to ensure that prior 

to the submission of an application for 

U.S. Public Health Service (PHS) 

support for a research project on which 

the Respondent’s participation is 

proposed and prior to Respondent’s 

participation in any capacity on PHSsupported research, the institution 

employing him must submit a plan for 

supervision of his duties to ORI for 

approval; the plan for supervision must 

be designed to ensure the scientific 

integrity of Respondent’s research 

contribution; Respondent agreed that he 

will not participate in any PHSsupported research until such a 

supervision plan is submitted to and 

approved by ORI; Respondent agreed to 

maintain responsibility for compliance 

with the agreed upon plan for 

supervision; 

(2) that any institution employing him 

must submit, in conjunction with each 

application for PHS funds, or report, 

manuscript, or abstract involving PHSsupported research in which 

Respondent is involved, a certification 

to ORI that the data provided by 

Respondent are based on actual 

experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract; and 

(3) to exclude himself voluntarily 

from serving in any advisory capacity to 

PHS including, but not limited to, 

service on any PHS advisory committee, 

board, and/or peer review committee, or 

as a consultant. 

FOR FURTHER INFORMATION CONTACT: 

Acting Director, Office of Research 

Integrity, 1101 Wootton Parkway, Suite 

750, Rockville, MD 20852, (240) 453– 

8200. 

Donald Wright, 

Acting Director, Office of Research Integrity. 

[FR Doc. 2015–00802 Filed 1–16–15; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary; Office of 

Medicare Hearings and Appeals; 

Statement of Organization, Functions, 

and Delegations of Authority 

Part A, Office of the Secretary, 

Statement of Organization, Functions, 

and Delegations of Authority for the 

Department of Health and Human 

Services, is being amended at Chapter 

AK, Office of Medicare Hearings and 

Appeals (OMHA), as last amended at 70 

FR 36386–36387, dated June 23, 2005, 

and most recently at 76 FR 19995 (Apr. 

11, 2011) as follows: 

I. Under Section AK.10, Organization, 

delete the bullets and sub-bullets 

after the phrase, ‘‘OMHA consists of 

the following components,’’ and 

replace with the following: 

• Medicare Hearings and Appeals 

Chief Judge’s Office (CJO) (Headquarters 

Office) 

— Office of Operations 

— Office of Programs 

• Medicare Hearings and Appeals 

Field Offices 

II. Under Section AK.20, Functions, 

Paragraph B, replace ‘‘Medicare 

Hearings and Appeals Field Offices 

(AKB1–4)’’ with ‘‘Medicare 

Hearings and Appeals Field 

Offices.’’ 

III. Under Section AK.20, Functions, 

Paragraph B, ‘‘Medicare Hearings 

and Appeals Field Offices,’’ replace 

all references to the ‘‘Managing 

Administrative Law Judge (MALJ)’’ 

with ‘‘Associate Chief 

Administrative Law Judge 

(ACALJ).’’ 

Dated: January 13, 2015. 

E.J. Holland, Jr., 

Assistant Secretary for Administration (ASA). 

[FR Doc. 2015–00743 Filed 1–16–15; 8:45 am] 

BILLING CODE 4150–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3303–FN] 

Medicare and Medicaid Programs; 

Continued Approval of the 

Accreditation Commission for Health 

Care, Inc.; Home Health Agency 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the 

Accreditation Commission for Health 

Care, Inc., (ACHC) for continued 

recognition as a national accrediting 

organization for home health agencies 

(HHAs) that wish to participate in the 

Medicare or Medicaid programs. An 

HHA that participates in Medicaid must 

also meet the Medicare conditions for 

participation (CoPs) as required under 

42 CFR 488.6(b). 

DATES: This final notice is effective 

February 24, 2015 through February 24, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310, or 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A healthcare provider may enter into 

an agreement with Medicare to 

participate in the program as a HHA 

provided certain requirements are met. 

Sections 1861(o) and 1891 of the Social 

Security Act (the Act), establish distinct 

criteria for facilities seeking designation 

as a HHA. Regulations concerning 

Medicare provider agreements in 

general are at 42 CFR part 489 and those 

pertaining to the survey and 

certification for Medicare participation 

of providers and certain types of 

suppliers are at part 488. The 

regulations at part 484 specify the 

specific conditions that a provider must 

meet to participate in the Medicare 

program as an HHA. 

Generally, to enter into a Medicare 

provider agreement, a facility must first 

be certified as complying with the 

conditions set forth in part 484 and 

recommended to us for participation by 


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Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 2709 

a state survey agency. Thereafter, the 

HHA is subject to periodic surveys by a 

state survey agency to determine 

whether it continues to meet these 

conditions. However, there is an 

alternative to certification surveys by 

state agencies. Accreditation by a 

nationally recognized Medicare 

accreditation program approved by us 

may substitute for both initial and 

ongoing state review. 

Section 1865(a)(1) of the Act provides 

that, if the Secretary of the Department 

of Health and Human Services, (the 

Secretary) finds that accreditation of a 

provider entity by an approved national 

accrediting organization meets or 

exceeds all applicable Medicare 

conditions, we may treat the provider 

entity as having met those conditions, 

that is, we may ‘‘deem’’ the provider 

entity to be in compliance. 

Accreditation by an accrediting 

organization is voluntary and is not 

required for Medicare participation. 

Part 488, subpart A, implements the 

provisions of section 1865 and requires 

that a national accrediting organization 

applying for approval of its Medicare 

accreditation program must provide us 

with reasonable assurance that the 

accrediting organization requires its 

accredited provider entities to meet 

requirements that are at least as 

stringent as the Medicare conditions. 

Our regulations concerning the approval 

of accrediting organizations are set forth 

at § 488.4 and § 488.8(d)(3). The 

regulations at § 488.8(d)(3) require an 

accrediting organization to reapply for 

continued approval of its Medicare 

accreditation program every 6 years or 

sooner as determined by us. ACHC’s 

current term of approval as a recognized 

Medicare accreditation program for 

HHAs expires February 24, 2015. 

II. Application Approval Process 

Section 1865(a)(3)(A) of the Act 

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us with 210 days after the date 

of receipt of a complete application, 

with any documentation necessary to 

make the determination, to complete 

our survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

In the August 22, 2014 Federal 

Register (79 FR 49777), we published a 

proposed notice announcing ACHC’s 

request for continued approval of its 

Medicare HHA accreditation program. 

In that notice, we detailed our 

evaluation criteria. Under section 

1865(a)(2) of the Act and in our 

regulations at § 488.4 and § 488.8, we 

conducted a review of ACHC’s Medicare 

HHA accreditation application in 

accordance with the criteria specified by 

our regulations, which include, but are 

not limited to the following: 

• An onsite administrative review of 

ACHC’s: (1) Corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its HHA surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited HHAs; and, (5) survey review 

and decision-making process for 

accreditation. 

• The comparison of ACHC’s 

Medicare accreditation program 

standards to our current Medicare HHA 

CoPs. 

• A documentation review of ACHC’s 

survey process to: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and ACHC’s ability to provide 

continuing surveyor training. 

++ Compare ACHC’s processes to 

those we require of state survey 

agencies, including periodic resurvey 

and the ability to investigate and 

respond appropriately to complaints 

against accredited HHAs. 

++ Evaluate ACHC’s procedures for 

monitoring HHAs it has found to be out 

of compliance with ACHC’s program 

requirements. (This pertains only to 

monitoring procedures when ACHC 

identifies non-compliance. If 

noncompliance is identified by a state 

survey agency through a validation 

survey, the state survey agency monitors 

corrections as specified at § 488.7(d).) 

++ Assess ACHC’s ability to report 

deficiencies to the surveyed HHA and 

respond to the HHA’s plan of correction 

in a timely manner. 

++ Establish ACHC’s ability to 

provide us with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ Determine the adequacy of 

ACHC’s staff and other resources. 

++ Confirm ACHC’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm ACHC’s policies with 

respect to surveys being unannounced. 

++ Obtain ACHC’s agreement to 

provide us with a copy of the most 

current accreditation survey together 

with any other information related to 

the survey as we may require, including 

corrective action plans. 

In accordance with section 

1865(a)(3)(A) of the Act, the August 22, 

2014 proposed notice also solicited 

public comments regarding whether 

ACHC’s requirements met or exceeded 

the Medicare CoPs for HHAs. No 

comments were received in response to 

our proposed notice. 

IV. Provisions of the Final Notice 

A. Differences Between ACHC’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements 

We compared ACHC’s HHA 

accreditation requirements and survey 

process with the Medicare CoPs of 42 

CFR part 484, and the survey and 

certification process requirements of 

parts 488 and 489. Our review and 

evaluation of ACHC’s HHA application, 

which were conducted as described in 

section III of this final notice, yielded 

the following areas where, as of the date 

of this notice, ACHC has completed 

revising its standards and certification 

processes to meet the requirements at: 

• Section 1891(c)(2)(A) of the Act, to 

ensure all renewal surveys are 

conducted within 36 months of the last 

survey end date. 

• § 484.10(c)(2), to address the 

patient’s right to participate in the 

planning of care. 

• § 484.14(e), to ensure personnel 

records include qualifications and 

current licensure. 

• § 488.8(a)(2)(v), to ensure data 

submitted in CMS’ Accrediting 

Organization System for Storing User 

Recorded Experiences (ASSURE) 

database is complete and accurate. 

• § 489.3, to ensure situations that 

rise to the level of immediate jeopardy 

(IJ) are cited at the condition level. 

B. Term of Approval 

Based on our review and observations 

described in section IV of this final 

notice, we have determined that the 

ACHC accreditation program 

requirements meet or exceed our 

requirements. Therefore, we approve the 

ACHC as a national accreditation 

organization for HHAs that request 

participation in the Medicare program, 

effective February 24, 2015 through 

February 24, 2021. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 


rljohnson on DSK3VPTVN1PROD with NOTICES
2710 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

Dated: January 9, 2015. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2015–00699 Filed 1–16–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0025] 

Medical Device Accessories: Defining 

Accessories and Classification 

Pathway for New Accessory Types; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Medical Device Accessories: 

Defining Accessories and Classification 

Pathway for New Accessory Types.’’ 

This draft document provides proposed 

guidance to industry and FDA staff 

about the regulation of accessories in 

medical devices. The guidance explains 

what FDA considers to be an 

‘‘accessory,’’ outlines how the riskbased framework for the classification of 

devices applies to accessories, and 

describes the use of the de novo 

classification process for the 

classification of new types of 

accessories. 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 of 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 April 20, 2015. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by March 23, 

2015. See section IV of this document, 

the ‘‘Paperwork Reduction Act of 1995.’’ 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Medical Device 

Accessories: Defining Accessories and 

Classification Pathway for New 

Accessory Types’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

Submit electronic comments on the 

draft guidance or the information 

collection to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Sugato De, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5435, 

Silver Spring, MD 20993–0002, 301– 

796–6270 or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 7301, Silver Spring, MD 20993– 

0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document is 

intended to provide guidance to 

industry and FDA staff about the 

regulation of accessories to other 

medical devices. In doing so, this 

guidance document explains what FDA 

considers to be an ‘‘accessory’’ and 

outlines how the risk-based framework 

for the classification of devices applies 

to accessories. In addition, this guidance 

describes use of the de novo 

classification process to classify new 

types of accessory devices under 

Section 513(f)(2) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c(f)(2)) based on risk and 

the ability of general and special 

controls to assure safety and 

effectiveness. 

For the purposes of this guidance 

document, FDA considers an 

‘‘accessory’’ as a medical device that is 

intended to support, supplement, and/

or augment the performance of one or 

more medical devices. In practice, the 

distinctions among devices that support, 

supplement, and/or augment parent 

devices are subtle and many devices 

that we would consider to be an 

accessory may do more than one of 

these things. Thus, if the device is 

intended to support, supplement, and/

or augment the performance of one or 

more parent devices, we intend to 

consider the device as an accessory. 

Once a specific article has been 

determined to be an accessory, the 

guidance document describes how the 

accessory is classified based on its risks 

when used as intended with the 

intended parent device(s). In practice, 

FDA may classify individual accessories 

either by inclusion in the classification 

regulation of the parent device (either 

via a premarket submission or via 

express inclusion in the language of the 

regulation or order) or via development 

of a unique, separate classification 

regulation or order for the accessory. 

For accessories of a new type, the 

guidance outlines the use of the de novo 

process for classification. This process 

provides a pathway to class I or class II 

classification for accessory devices for 

which general controls, or general and 

special controls, provide a reasonable 

assurance of safety and effectiveness, 

but for which there are no legally 

marketed predicate device. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the regulation of medical device 

accessories. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Medical Device Accessories: 

Defining Accessories and Classification 

Pathway for New Accessory Types’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1770 to 

identify the guidance you are 

requesting. 


rljohnson on DSK3VPTVN1PROD with NOTICES