Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices 49777 

C. Federal Reserve Bank of San 

Francisco (Gerald C. Tsai, Director, 

Applications and Enforcement) 101 

Market Street, San Francisco, California 

94105–1579: 

1. Seacoast Commerce Bank Holdings, 

San Diego, California; to become a bank 

holding company by acquiring 100 

percent of the voting shares of Seacoast 

Commerce Bank, San Diego, California. 

Board of Governors of the Federal Reserve 

System, August 19, 2014. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2014–19933 Filed 8–21–14; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3303–PN] 

Medicare and Medicaid Programs; 

Application From the Accreditation 

Commission for Health Care, Inc., for 

Continued Approval of Its Home Health 

Agency Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from 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. Section 

1865(b)(3)(A) of the Social Security Act 

(the Act) requires that within 60 days of 

receipt of an organization’s complete 

application, CMS publish a notice that 

identifies the national accrediting body 

making the request, describes the nature 

of the request, and provides at least a 

30-day public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on September 22, 2014. 

ADDRESSES: In commenting, please refer 

to file code CMS–3303–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. You may submit 

comments in one of four ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3303–PN, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3303–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written ONLY to the following 

addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–7195. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310, 

Monda Shaver, (410) 786–3410, or 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a home health agency 

(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 an HHA. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. The regulations 

at 42 CFR part 484 specify the minimum 

conditions that an HHA must meet to 

participate in the Medicare program. 

Generally, to enter into an agreement, 

an HHA must first be certified by a state 

survey agency as complying with the 

conditions or requirements set forth in 

part 484 of our Medicare regulations. 

Thereafter, the HHA is subject to regular 

surveys by a state survey agency to 

determine whether it continues to meet 

these requirements. There is an 

alternative, however, to surveys by state 

agencies. 

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

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 


tkelley on DSK3SPTVN1PROD with NOTICES
49778 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices 

CMS with reasonable assurance that the 

accrediting organization requires the 

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 

accrediting organizations to reapply for 

continued approval of its accreditation 

program every 6 years or sooner as 

determined by us. 

ACHC’s current term of approval for 

their HHA accreditation program 

expires February 24, 2015. 

II. Approval of Deeming Organizations 

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

regulations at § 488.8(a) require that our 

findings concerning review and 

approval of a national accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide CMS with the 

necessary data for validation. 

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

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of ACHC’s 

request for continued approval of its 

HHA accreditation program. This notice 

also solicits public comment on whether 

ACHC’s requirements meet or exceed 

the Medicare conditions of participation 

(CoPs) for HHAs. 

III. Evaluation of Deeming Authority 

Request 

ACHC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its HHA 

accreditation program. This application 

was determined to be complete on June 

27, 2014. Under section 1865(a)(2) of the 

Act and our regulations at § 488.8 

(Federal review of accrediting 

organizations), our review and 

evaluation of ACHC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of ACHC’s 

standards for HHAs as compared with 

Medicare’s HHA CoPs. 

• ACHC’s survey process to 

determine the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of ACHC’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ ACHC’s processes and procedures 

for monitoring a HHA found out of 

compliance with ACHC’s program 

requirements. These monitoring 

procedures are used only when ACHC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state survey agency 

monitors corrections as specified at 

§ 488.7(d). 

++ ACHC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ ACHC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of ACHC’s staff and 

other resources, and its financial 

viability. 

++ ACHC’s capacity to adequately 

fund required surveys. 

++ ACHC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ ACHC’s agreement to provide 

CMS with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as CMS may require (including 

corrective action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

V. Response to Public Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

Dated: August 12, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–19697 Filed 8–21–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0084] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Channels of Trade 

Policy for Commodities With Residues 

of Pesticide Chemicals, for Which 

Tolerances Have Been Revoked, 

Suspended, or Modified by the 

Environmental Protection Agency 

Pursuant to Dietary Risk 

Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

22, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0562. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002 PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 


tkelley on DSK3SPTVN1PROD with NOTICES