Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 62445 

premises. You may be subject to a fine 

or imprisonment under 18 U.S.C. 1001 

for any false statements you make in 

your request to enter the Board’s 

premises. 

Matters To Be Considered 

Discussion Agenda: 

1. Final Credit Risk Retention Rule 

under Section 941 of the Dodd-Frank 

Wall Street Reform and Consumer 

Protection Act. 

Notes: 1. The staff memo to the Board 

will be made available to the public on 

the day of the meeting in paper and the 

background material will be made 

available on a compact disc (CD). If you 

require a paper copy of the entire 

document, please call Penelope Beattie 

on 202–452–3982. The documentation 

will not be available until about 20 

minutes before the start of the meeting. 

2. This meeting will be recorded for 

the benefit of those unable to attend. 

The Web cast recording and a transcript 

of the meeting will be available after the 

meeting on the Board’s public Web site 

http://www.federalreserve.gov/about

thefed/boardmeetings/ or if you prefer, 

a CD recording of the meeting will be 

available for listening in the Board’s 

Freedom of Information Office, and 

copies can be ordered for $4 per disc by 

calling 202–452–3684 or by writing to: 

Freedom of Information Office, 

Board of Governors of the Federal 

Reserve System, 

Washington, DC 20551. 

For more information please contact: 

Michelle Smith, Director, Office of 

Board Members at 202–452–2955. 

SUPPLEMENTARY INFORMATION: You may 

access the Board’s public Web site at 

www.federalreserve.gov for an electronic 

announcement. (The Web site also 

includes procedural and other 

information about the open meeting.) 

Dated: October 15, 2014. 

Margaret M. Shanks, 

Deputy Secretary of the Board. 

[FR Doc. 2014–24874 Filed 10–15–14; 4:15 pm] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1630–N] 

Medicare Program; The Advisory Panel 

on Hospital Outpatient Payment (HOP 

Panel) Spring Meeting, March 9–10, 

2015 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

spring meeting of the Advisory Panel on 

Hospital Outpatient Payment (the Panel) 

for 2015. The purpose of the Panel is to 

advise the Secretary of the Department 

of Health and Human Services (DHHS) 

(the Secretary) and the Administrator of 

the Centers for Medicare & Medicaid 

Services (CMS) (the Administrator) on 

the clinical integrity of the Ambulatory 

Payment Classification (APC) groups 

and their associated weights, and 

hospital outpatient therapeutic services 

supervision issues. 

DATES: Meeting Dates: The first semiannual meeting in 2015 is scheduled for 

the following dates and times. The times 

listed in this notice are Eastern Time 

(ET) and are approximate times; 

consequently, the meetings may be 

shorter than or last longer than the times 

listed in this notice, but will not begin 

before the posted times: 

• Monday, March 9, 2015, 9 a.m. to 5 

p.m. ET 

• Tuesday, March 10, 2014, 9 a.m. to 5 

p.m. ET 

Meeting Information Updates 

The actual meeting hours and days 

will be posted in the agenda. As 

information and updates regarding the 

onsite, webcast, and teleconference 

meeting, and agenda become available, 

they will be posted to the CMS Web site 

at: http://cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonAmbulatoryPayment

ClassificationGroups.html 

Deadlines 

Deadline for Presentations and 

Comments 

Presentations and Comments can be 

submitted by email only. Presentations 

or comments and form CMS–20017 

must be in the Designated Federal 

Official’s (DFO’s) email inbox 

(APCPanel@cms.hhs.gov) by 5 p.m. ET, 

Friday, February 6, 2015. Presentations 

and comments that are not received by 

the due date will be considered late and 

will not be included on the agenda. (See 

below for submission instructions for 

electronic submissions.) 

Meeting Registration Timeframe: 

Monday, January 19, 2015 through 

Friday, February 20, 2015 at 5 p.m. ET. 

Participants planning to attend this 

meeting in person must register online, 

during the above specified timeframe at: 

https://www.cms.gov/apps/events/

default.asp. On this Web page, double 

click the ‘‘Upcoming Events’’ hyperlink, 

and then double click the ‘‘HOP Panel’’ 

event title link and enter the required 

information. Include any requests for 

special accommodations. 

Note: Participants who do not plan to 

attend this meeting in person should not 

register. No registration is required for 

participants who plan to view the meeting 

via webcast. 

In commenting, please refer to file 

code CMS–1630–N. Because of staff and 

resource limitations, we cannot accept 

comments and presentations by 

facsimile (FAX) transmission or hard 

copy. 

Meeting Location, Webcast, and 

Teleconference 

The meeting will be held in the 

Auditorium, CMS Central Office, 7500 

Security Boulevard, Woodlawn, 

Maryland 21244–1850. Alternately, the 

public may either view this meeting via 

a webcast or listen by teleconference. 

During the scheduled meeting, 

webcasting is accessible online at: 

http://cms.gov/live. Teleconference dialin information will appear on the final 

meeting agenda, which will be posted 

on the CMS Web site when available at: 

http://cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonAmbulatoryPayment

ClassificationGroups.html 

FOR FURTHER INFORMATION CONTACT: 

Designated Federal Official (DFO): 

Carol Schwartz, DFO, 7500 Security 

Boulevard, Mail Stop: C4–04–25, 

Woodlawn, MD 21244–1850. 

Phone: (410) 786–3985. 

Email: APCPanel@cms.hhs.gov. 

Send email copies to the following 

address: 

Email: APCPanel@cms.hhs.gov. 

News Media: Representatives must 

contact our Public Affairs Office at (202) 

690–6145. 

Advisory Committees’ Information 

Lines: The phone number for the CMS 

Federal Advisory Committee Hotline is 

(410) 786–3985. 

Web Sites 

For additional information on the 

Panel and updates to the Panel’s 

mstockstill on DSK4VPTVN1PROD with NOTICES

62446 Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 

activities, we refer readers to view our 

Web site at: http://www.cms.gov/

Regulations-and-Guidance/Guidance/

FACA/AdvisoryPanelonAmbulatory

PaymentClassificationGroups.html. 

Information about the Panel and its 

membership in the Federal Advisory 

Committee Act (FACA) database are also 

located at: http://facadatabase.gov/. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary of the Department of 

Health and Human Services (DHHS) 

(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 the Advisory 

Panel on Hospital Outpatient Payment 

(the Panel) regarding the clinical 

integrity of the Ambulatory Payment 

Classification (APC) groups and relative 

payment weights. The Panel is governed 

by the provisions of the Federal 

Advisory Committee Act (Pub. L. 92– 

463), as amended (5 U.S.C. Appendix 2), 

to set forth standards for the formation 

and use of advisory panels. 

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 outpatient 

prospective payment system (OPPS). 

II. Agenda 

The agenda for the March 9, 2015 

through March 10, 2015 meeting will 

provide for discussion and comment on 

the following topics as designated in the 

Panel’s Charter: 

• Addressing whether procedures 

within an APC group are similar both 

clinically and in terms of resource use. 

• Evaluating APC group weights. 

• Reviewing the packaging of OPPS 

services and costs, including the 

methodology and the impact on APC 

groups and payment. 

• Removing procedures from the 

inpatient-only list for payment under 

the OPPS. 

• Using single and multiple 

procedure claims data for CMS’ 

determination of APC group weights. 

• Addressing other technical issues 

concerning APC group structure. 

• Recommending the appropriate 

supervision level (general, direct, or 

personal) for individual hospital 

outpatient therapeutic services. 

The Agenda will be posted on the 

Centers for Medicare & Medicaid 

Services (CMS) Web site approximately 

one week before the meeting. 

III. Presentations 

The presentation subject matter must 

be within the scope of the Panel 

designated in the Charter. Any 

presentations outside of the scope of 

this Panel will be returned or requested 

for amendment. Unrelated topics 

include, but are not limited to, the 

conversion factor, charge compression, 

revisions to the cost report, passthrough payments, correct coding, new 

technology applications (including 

supporting information/documentation), 

provider payment adjustments, 

supervision of hospital outpatient 

diagnostic services and the types of 

practitioners that are permitted to 

supervise hospital outpatient services. 

The Panel may not recommend that 

services be designated as nonsurgical 

extended duration therapeutic services. 

The Panel may use data collected or 

developed by entities and organizations, 

other than DHHS and CMS in 

conducting its review. We recommend 

organizations submit data for CMS staff 

and the Panel’s review. 

All presentations are limited to 5 

minutes, regardless of the number of 

individuals or organizations represented 

by a single presentation. Presenters may 

use their 5 minutes to represent either 

one or more agenda items. 

All presentations will be shared with 

the public. Presentations may not 

contain any pictures, illustrations, or 

personally identifiable information. 

In order to consider presentations 

and/or comments, we will need to 

receive the following information by 

email only. We cannot accept hardcopy 

submittals. 

1. An email copy of the presentation 

sent to the DFO mailbox, APCPanel@

cms.hhs.gov 

2. Form CMS–20017 with complete 

contact information that includes name, 

address, phone number, and email 

addresses for all presenters and a 

contact person that can answer any 

questions and or provide revisions that 

are requested for the presentation. 

• Presenters must clearly explain the 

actions that they are requesting CMS to 

take in the appropriate section of the 

form. A presenter’s relationship with 

the organization that they represent 

must also be clearly listed. 

• The form is now available through 

the CMS Forms Web site. The Uniform 

Resource Locator (URL) for linking to 

this form is as follows: http://www.cms.

hhs.gov/cmsforms/downloads/

cms20017.pdf. 

IV. Oral Comments 

In addition to formal oral 

presentations, which are limited to 5 

minutes total per presentation, there 

will be an opportunity during the 

meeting for public oral comments, 

which will be limited to 1 minute for 

each individual and a total of 3 minutes 

per organization. 

V. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Priority will be given to those 

who pre-register, and attendance may be 

limited based on the number of 

registrants and the space available. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must register by following the 

instructions in the ‘‘Meeting 

Registration Timeframe’’ section of this 

notice. A confirmation email will be 

sent to the registrants shortly after 

completing the registration process. 

VI. Security, Building, and Parking 

Guidelines 

The following are the security, 

building, and parking guidelines: 

• Persons attending the meeting, 

including presenters, must be preregistered and on the attendance list by 

the prescribed date. 

• Individuals who are not preregistered in advance may not be 

permitted to enter the building and may 

be unable to attend the meeting. 

• Attendees must present a 

government issued photo identification 

to the Federal Protective Service or 

Guard Service personnel before entering 

the building. Without a current, valid 

photo identification, persons may not be 

permitted entry to the building. 

• Security measures include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. 

• All persons entering the building 

must pass through a metal detector. 

• All items brought into CMS 

including personal items, for example, 

laptops and cell phones are subject to 

physical inspection. 

• The public may enter the building 

30 to 45 minutes before the meeting 

convenes each day. 

• All visitors must be escorted in 

areas other than the lower and first-floor 

levels in the Central Building. 

• The main-entrance guards will 

issue parking permits and instructions 

upon arrival at the building. 

• Foreign nationals visiting any CMS 

facility require prior approval. If you are 

a foreign national and wish to attend the 

meeting onsite, in addition to registering 

for the meeting, you must also send a 

separate email to APCPanel@

cms.hhs.gov prior to the close of 

registration to request authorization to 

attend as a foreign national. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 201 / Friday, October 17, 2014 / Notices 62447 

VII. Special Accommodations 

Individuals requiring special 

accommodations must include the 

request for these services during 

registration. 

VIII. Panel Recommendations and 

Discussions 

The Panel’s recommendations at any 

Panel meeting generally are not final 

until they have been reviewed and 

approved by the Panel on the last day 

of the meeting, before the final 

adjournment. These recommendations 

will be posted to our Web site after the 

meeting. 

IX. 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. 

Dated: October 7, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–24755 Filed 10–16–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

037 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (‘‘FDA Recognized 

Consensus Standards’’). This 

publication, entitled ‘‘Modifications to 

the List of Recognized Standards, 

Recognition List Number: 037’’ 

(‘‘Recognition List Number: 037’’), will 

assist manufacturers who elect to 

declare conformity with consensus 

standards to meet certain requirements 

for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

for the effective date of the recognition 

of standards announced in this 

document. 

ADDRESSES: An electronic copy of 

Recognition List Number: 037 is 

available on the Internet at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI for electronic access to the searchable 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 037 

modifications and other standards 

related information. 

Submit written requests for single 

copies of the document entitled 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

037’’ to the Division of Industry and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 301–847–8149. 

Submit electronic comments on this 

document 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: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3632, Silver Spring, 

MD 20993, 301–796–6287, standards@

cdrh.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) amended section 

514 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d). Amended section 514 allows 

FDA to recognize consensus standards 

developed by international and national 

organizations for use in satisfying 

portions of device premarket review 

submissions or other requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how we would 

implement our standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, can be accessed at 

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

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

Agency maintains HTML and PDF 

versions of the list of FDA Recognized 

Consensus Standards. Both versions are 

publicly accessible at the Agency’s 

Internet site. See section VI of this 

document for electronic access 

information. Interested persons should 

review the supplementary information 

sheet for the standard to understand 

fully the extent to which FDA 

recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 037 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the Agency 

will recognize for use in premarket 

submissions and other requirements for 

devices. We will incorporate these 

modifications in the list of FDA 

Recognized Consensus Standards in the 

Agency’s searchable database. We will 

use the term ‘‘Recognition List Number: 

037’’ to identify these current 

modifications. 

In Table 1, we describe the following 

modifications: (1) The withdrawal of 

standards and their replacement by 

others, if applicable, (2) the correction 

of errors made by FDA in listing 

previously recognized standards, and (3) 

the changes to the supplementary 

information sheets of recognized 

standards that describe revisions to the 

applicability of the standards. 

mstockstill on DSK4VPTVN1PROD with NOTICES