Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 24255 

V. Response to 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. Upon 

completion of our evaluation, including 

evaluation of comments received as a 

result of this notice, we will publish a 

notice in the Federal Register 

announcing the result of our evaluation. 

Dated: April 21, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–10171 Filed 4–29–15; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10336] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by June 1, 2015. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR, Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

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. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of the currently 

approved collection; Reinstatement with 

change of a previously approved 

collection; Title of Information 

Collection: Medicare and Medicaid 

Programs: Electronic Health Record 

Incentive Program; Use: The American 

Recovery and Reinvestment Act of 2009 

(Recovery Act) (Pub. L. 111–5) was 

enacted on February 17, 2009. The 

Recovery Act includes many measures 

to modernize our nation’s infrastructure, 

and improve affordable health care. 

Expanded use of health information 

technology (HIT) and certified 

electronic health record (EHR) 

technology will improve the quality and 

value of America’s health care. Title IV 

of Division B of the Recovery Act 

amends Titles XVIII and XIX of the 

Social Security Act (the Act) by 

establishing incentive payments to 

eligible professionals (EPs), eligible 

hospitals and critical access hospitals 

(CAHs), and Medicare Advantage (MA) 

organizations participating in the 

Medicare and Medicaid programs that 

adopt and successfully demonstrate 

meaningful use of certified EHR 

technology. These Recovery Act 

provisions, together with Title XIII of 

Division A of the Recovery Act, may be 

cited as the ‘‘Health Information 

Technology for Economic and Clinical 

Health Act’’ or the ‘‘HITECH Act.’’ 

The HITECH Act creates incentive 

programs for EPs and eligible hospitals, 

including CAHs, in the Medicare Feefor-Service (FFS), MA, and Medicaid 

programs that successfully demonstrate 

meaningful use of certified EHR 

technology. In their first payment year, 

Medicaid EPs and eligible hospitals may 

adopt, implement or upgrade to certified 

EHR technology. It also, provides for 

payment adjustments in the Medicare 

FFS and MA programs starting in FY 

2015 for EPs and eligible hospitals 

participating in Medicare that are not 

meaningful users of certified EHR 

technology. These payment adjustments 

do not pertain to Medicaid providers. 

The first final rule for the Medicare 

and Medicaid EHR Incentive Program, 

which was published in the Federal 

Register on July 28, 2010 (CMS–0033– 

F), specified the initial criteria EPs, 

eligible hospitals and CAHs, and MA 

organizations must meet in order to 

qualify for incentive payments; 

calculation of incentive payment 

amounts; payment adjustments under 

Medicare for covered professional 

services and inpatient hospital services 

provided by EPs, eligible hospitals and 

CAHs failing to demonstrate meaningful 

use of certified EHR technology 

beginning in 2015; and other program 

participation requirements. On the same 

date, the Office of the National 

Coordinator of Health Information 

Technology (ONC) issued a closely 

related final rule (45 CFR part 170, RIN 

0991–AB58) that specified the initial set 

of standards, implementation 

specifications, and certification criteria 

for certified EHR technology. ONC has 

also issued a separate final rule on the 

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24256 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 

establishment of certification programs 

for health information technology (HIT) 

(45 CFR part 170, RIN 0991–AB59). The 

functionality of certified EHR 

technology should facilitate the 

implementation of meaningful use. 

Subsequently, final rules have been 

issued by CMS (77 FR 53968) and ONC 

(77 FR 72985) to create a Stage 2 of 

meaningful use criteria and other 

changes to the CMS EHR Incentive 

Programs and the 2014 Edition 

Certification Criteria for EHR 

technology. 

The information collection 

requirements contained in this 

information collection request are 

needed to implement the HITECH Act. 

In order to avoid duplicate payments, 

all EPs are enumerated through their 

National Provider Identifier (NPI), while 

all eligible hospitals and CAHs are 

enumerated through their CMS 

Certification Number (CCN). State 

Medicaid agencies and CMS use the 

provider’s tax identification number and 

NPI or CCN combination in order to 

make payment, validate payment 

eligibility and detect and prevent 

duplicate payments for EPs, eligible 

hospitals and CAHs. Form Number: 

CMS–10336 (OMB control number: 

0938–1158); Frequency: Occasionally; 

Affected Public: Private sector; Number 

of Respondents: 214,694; Total Annual 

Responses: 214,694; Total Annual 

Hours: 2,034,740. (For policy questions 

regarding this collection contact 

Elisabeth Myers at 410–786–4751.) 

Dated: April 28, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–10197 Filed 4–29–15; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 9, 2015, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Grand Ballroom, 

620 Perry Parkway, Gaithersburg, MD 

20877. The hotel telephone number is 

301–977–8900. 

Contact Person: Philip Bautista, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, Fax: 

301–847–8533, EMDAC@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area). A notice in 

the Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http:// 

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

the safety and efficacy of biologics 

license application 125559, proposed 

trade name PRALUENT (established 

name: Alirocumab) for injection, 

submitted by Sanofi Aventis, U.S., as an 

adjunct to diet, for long-term treatment 

of adult patients with primary 

hypercholesterolemia (non-familial and 

heterozygous familial) or mixed 

dyslipidemia including patients with 

type 2 diabetes mellitus, to reduce lowdensity lipoprotein cholesterol, total 

cholesterol, non-high-density 

lipoprotein cholesterol, apolipoprotein 

B, tryglyceride, and lipoprotein A, and 

to increase high-density lipoprotein 

cholesterol and apolipoprotein A–1 

either in combination with a statin or as 

monotherapy including in patients who 

cannot tolerate statins. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 26, 2015. Oral 

presentations from the public will be 

scheduled between approximately 1:15 

p.m. to 2:15 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before May 15, 

2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by May 18, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Philip 

Bautista at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 24, 2015. 

Peter Lurie, 

Associate Commissioner for Public Health 

Strategy and Analysis. 

[FR Doc. 2015–10023 Filed 4–29–15; 8:45 am] 

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