Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices 26763 

LeRoy 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. 2014–10617 Filed 5–8–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[CDC–2013–0024; Docket Number NIOSH– 

270] 

Issuance of Final Publication 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of issuance of final 

publication. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

announces the availability of the 

following publication: ‘‘NIOSH Center 

for Motor Vehicle Safety: Strategic Plan 

for Research and Prevention, 2014– 

2018’’ [2014–122]. 

ADDRESSES: This document may be 

obtained at the following link: http:// 

www.cdc.gov/niosh/docs/2014-122/. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Pratt, NIOSH Division of 

Safety Research, 1095 Willowdale Road, 

Mail Stop H–1808, Morgantown, WV 

26505. (304) 285–5992 (not a toll free 

number). 

Dated: May 2, 2014. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2014–10666 Filed 5–8–14; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1467–N] 

Medicare Program; The Advisory Panel 

on Hospital Outpatient Payment (HOP 

Panel) Summer Meeting, August 25–26, 

2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

summer meeting of the Advisory Panel 

on Hospital Outpatient Payment (the 

Panel) for 2014. 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 second semiannual meeting in 2014 is scheduled for 

the following dates and times. The times 

listed in this notice are Eastern Daylight 

Time (EDT) and are approximate times; 

consequently, the meetings may last 

longer than the times listed in this 

notice, but will not begin before the 

posted times: 

• Monday, August 25, 2014, 9 a.m. to 5 

p.m. EDT 

• Tuesday, August 26, 2014, 9 a.m. to 

5 p.m. EDT 

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 (APC

Panel@cms.hhs.gov) by 5 p.m. EDT, 

Friday, July, 25, 2014. 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, June 30, 2014 through Friday, 

August 01, 2014 at 5 p.m. EDT. 

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–1467–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://www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory

PanelonAmbulatoryPayment

ClassificationGroups.html. 

FOR FURTHER INFORMATION CONTACT: 

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 

activities, we refer readers to view our 

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

Regulations-and-Guidance/Guidance/

FACA/AdvisoryPanelonAmbulatory

PaymentClassificationGroups.html. 


ehiers on DSK2VPTVN1PROD with NOTICES
26764 Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices 

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 August 25, 2014 

through August 26, 2014 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 ID, 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. 

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 


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Federal Register / Vol. 79, No. 90 / Friday, May 9, 2014 / Notices 26765 

will be posted to our Web site after the 

meeting. 

IX. Collection of Information 

Requirements 

This document does not impose 

information collection and 

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: May 2, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–10688 Filed 5–8–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0086] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Potential Tobacco 

Product Violations Reporting Form 

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 June 9, 

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 0910–0716. 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, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Potential Tobacco Product Violations 

Reporting Form—(OMB Control 

Number 0910–0716)—Extension 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended 

section 201 et seq. of the Federal Food, 

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

(21 U.S.C. 321 et seq.) by adding a new 

chapter granting FDA important new 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. FDA is requesting an extension 

of OMB approval for the collection of 

information to accept consumer and 

other stakeholder feedback and 

notification of potential violations of the 

FD&C Act, as amended by the Tobacco 

Control Act. 

FDA created a Tobacco Call Center 

(with a toll-free number: 1–877–CTP– 

1373). Callers are able to report 

potential violations of the Tobacco 

Control Act, and FDA will conduct 

targeted followup investigations based 

on information received. When callers 

report a violation, the caller will be 

asked to provide as much certain 

information as they can recall, 

including: The date the potential 

violation occurred; product type (e.g., 

cigarette, smokeless, roll-your-own); 

tobacco brand; potential violation type; 

type of potentially violative promotional 

materials; who potentially violated; and 

the name, address, phone number, and 

email address of the potential violator. 

The caller will also be asked to list the 

potential violator’s Web site (if 

available), describe the potential 

violation, and provide any additional 

files or information pertinent to the 

potential violation. 

FDA currently provides a form that 

may be used to solicit this information 

from the caller (Form FDA 3779, 

Potential Tobacco Product Violations 

Report), and seeks renewal of Form FDA 

3779. This form is posted on FDA’s Web 

site. The public and interested 

stakeholders are also able to report 

information regarding possible 

violations of the Tobacco Control Act 

through the following methods: Calling 

the Tobacco Call Center using the 

Center for Tobacco Products’ (CTP) tollfree number; using a fillable Form FDA 

3779 found on FDA’s Web site; 

downloading a PDF version of the form 

to send via email or mail to FDA; 

requesting a copy of Form FDA 3779 by 

contacting CTP and sending by mail to 

FDA; and sending a letter to FDA’s CTP. 

The public and interested stakeholders 

will also be able to report information 

regarding possible violations of the 

Tobacco Control Act in the future using 

FDA’s tobacco violation reporting 

smartphone application. 

In the Federal Register of February 

18, 2014 (79 FR 9216), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity and Form FDA 3779 Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Reporting violations of the FD&C Act, as amended by the 

Tobacco Control Act, by telephone, Internet form, mail, 

smartphone application, or email ..................................... 400 2 800 2 0.25 200 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 15 minutes. 

FDA estimates that submitting the 

information (by telephone, Internet, 

mail, smartphone application, or email) 

will take 0.25 hours (i.e., 15 minutes) 

per response. FDA estimates the number 

of annual respondents to this collection 

of information will be 400, who will 

each submit 2 reports by telephone, 

Internet, mail, smartphone application, 

or email. This estimate is based on the 

rate of reporting through Form FDA 

3779, reports received from FDA’s tollVerDate Mar<15>2010 14:53 May 08, 2014 Jkt 232001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\09MYN1.SGM 09MYN1

ehiers on DSK2VPTVN1PROD with NOTICES