Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 72183 

ensure continuity of supply of a critical 

input, the Order requires that the parties 

supply Spectranetics with PTA balloon 

catheters for up to three years while 

Spectranetics transitions to independent 

manufacturing. This provision ensures 

that drug-coated balloon catheters will 

continue to be available for ongoing 

clinical trials while Spectranetics works 

to obtain FDA approval to manufacture 

the PTA balloon catheters 

independently. 

To ensure that the divestiture is 

successful, the Order requires the 

parties to enter into a transitional 

services agreement with Spectranetics to 

assist the company in establishing its 

manufacturing capabilities and securing 

all necessary FDA approvals. Further, 

the Order requires that the parties 

transfer all confidential business 

information to Spectranetics, as well as 

provide access to employees who 

possess or are able to identify such 

information. Spectranetics also will 

have the right to interview and offer 

employment to employees associated 

with Covidien’s drug-coated balloon 

catheter business. 

The parties must accomplish the 

divestiture no later than ten days after 

the consummation of the Proposed 

Acquisition. If the Commission 

determines that Spectranetics is not an 

acceptable acquirer, or that the manner 

of the divestiture is not acceptable, the 

Order requires the parties to unwind the 

sale and accomplish the divestiture 

within 180 days of the date the Order 

becomes final to another Commissionapproved acquirer. 

To ensure compliance with the Order, 

the Commission has agreed to appoint 

an Interim Monitor to ensure that 

Medtronic and Covidien comply with 

all of their obligations pursuant to the 

Consent Agreement and to keep the 

Commission informed about the status 

of the transfer of the rights and assets to 

Spectranetics. Further, the Order allows 

the Commission to appoint a Divestiture 

Trustee to accomplish the divestiture 

should the parties fail to comply with 

their divestiture obligations. Lastly, the 

Order terminates after ten years. 

The purpose of this analysis is to 

facilitate public comment on the 

Consent Agreement, and it is not 

intended to constitute an official 

interpretation of the proposed Decision 

and Order or to modify its terms in any 

way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2014–28609 Filed 12–4–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6056–N] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Provider 

Enrollment Application Fee Amount for 

Calendar Year 2015 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces a 

$553.00 calendar year (CY) 2015 

application fee for institutional 

providers that are initially enrolling in 

the Medicare or Medicaid program or 

the Children’s Health Insurance 

Program (CHIP); revalidating their 

Medicare, Medicaid, or CHIP 

enrollment; or adding a new Medicare 

practice location. This fee is required 

with any enrollment application 

submitted on or after January 1, 2015 

and on or before December 31, 2015. 

DATES: This notice is effective on 

January 1, 2015. 

FOR FURTHER INFORMATION: Frank 

Whelan, (410) 786–1302 for Medicare 

enrollment issues. Alvin Anderson, 

(410) 786–2188 for Medicaid and CHIP 

enrollment issues. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the February 2, 2011 Federal 

Register (76 FR 5862), we published a 

final rule with comment period titled 

‘‘Medicare, Medicaid, and Children’s 

Health Insurance Programs; Additional 

Screening Requirements, Application 

Fees, Temporary Enrollment Moratoria, 

Payment Suspensions and Compliance 

Plans for Providers and Suppliers.’’ This 

rule finalized, among other things, 

provisions related to the submission of 

application fees as part of the Medicare, 

Medicaid, and CHIP provider 

enrollment processes. As provided in 

section 1866(j)(2)(C)(i) of the Social 

Security Act (as amended by section 

6401 of the Affordable Care Act) and in 

42 CFR 424.514, ‘‘institutional 

providers’’ that are initially enrolling in 

the Medicare, Medicaid, or CHIP 

program, revalidating their enrollment, 

or adding a new Medicare practice 

location are required to submit a fee 

with their enrollment application. An 

‘‘institutional provider’’ for purposes of 

Medicare is defined at § 424.502 as 

‘‘(a)ny provider or supplier that submits 

a paper Medicare enrollment 

application using the CMS–855A, CMS– 

855B (not including physician and nonphysician practitioner organizations), 

CMS–855S, or associated Internet-based 

PECOS enrollment application.’’ As we 

explained in the February 2, 2011 final 

rule (76 FR 5914), in addition to the 

providers and suppliers subject to the 

application fee under Medicare, 

Medicaid-only, and CHIP-only 

institutional providers would include 

nursing facilities, intermediate care 

facilities for persons with mental 

retardation (ICF/MR), psychiatric 

residential treatment facilities, and may 

include other institutional provider 

types designated by a state in 

accordance with their approved state 

plan. 

As indicated in §§ 424.514 and 

455.460, the application fee is not 

required for either of the following: 

• A Medicare physician or nonphysician practitioner submitting a 

CMS–855I. 

• A prospective or revalidating 

Medicaid or CHIP provider— 

++ Who is an individual physician or 

non-physician practitioner; or 

++ That is enrolled in Title XVIII of 

the Act or another state’s Title XIX or 

XXI plan and has paid the application 

fee to a Medicare contractor or another 

state. 

II. Provisions of the Notice 

A. CY 2014 Fee Amount 

In the December 2, 2013 Federal 

Register (78 FR 72089), we published a 

notice announcing a fee amount for the 

period of January 1, 2014 through 

December 31, 2014 of $542.00. This 

figure was calculated as follows: 

• Section 1866(j)(2)(C)(i)(I) of the Act 

established a $500 application fee for 

institutional providers in CY 2010. 

• Consistent with section 

1866(j)(2)(C)(i)(II) of the Act, 

§ 424.514(d)(2) states that for CY 2011 

and subsequent years, the preceding 

year’s fee will be adjusted by the 

percentage change in the consumer 

price index (CPI) for all urban 

consumers (all items; United States city 

average, CPI–U) for the 12-month period 

ending on June 30 of the previous year. 

• The CPI–U increase for CY 2011 

was 1.0 percent, based on data obtained 

from the Bureau of Labor Statistics 

(BLS). This resulted in an application 

fee amount for CY 2011 of $505 (or $500 

× 1.01). 

• The CPI–U increase for the period 

of July 1, 2010 through June 30, 2011 

was 3.54 percent, based on BLS data. 

This resulted in an application fee 

amount for CY 2012 of $522.87 (or $505 

× 1.0354). In the aforementioned 

February 2, 2011 final rule, we stated 


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72184 Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 

that if the adjustment sets the fee at an 

uneven dollar amount, we would round 

the fee to the nearest whole dollar 

amount. Accordingly, the application 

fee amount for CY 2012 was rounded to 

the nearest whole dollar amount, or 

$523.00. 

• The CPI–U increase for the period 

of July 1, 2011 through June 30, 2012 

was 1.664 percent, based on BLS data. 

This resulted in an application fee 

amount for CY 2013 of $531.70 ($523 × 

1.01664). Rounding this figure to the 

nearest whole dollar amount resulted in 

a CY 2013 application fee amount of 

$532.00. 

• The CPI–U increase for the period 

of July 1, 2012 through June 30, 2013 

was 1.8 percent, based on BLS data. 

This resulted in an application fee 

amount for CY 2014 of $541.576 ($532 

× 1.018). Rounding this figure to the 

nearest whole dollar amount resulted in 

a CY 2014 application fee amount of 

$542.00. 

B. CY 2015 Fee Amount 

Using BLS data, the CPI–U increase 

for the period of July 1, 2013 through 

June 30, 2014 was 2.1 percent. This 

results in a CY 2015 application fee 

amount of $553.382 ($542 × 1.021). As 

we must round this to the nearest whole 

dollar amount, the resultant application 

fee amount for CY 2015 is $553.00. This 

represents a $6.00 difference from the 

$547 application fee amount that we 

had originally projected for CY 2015 in 

the February 2, 2011 final rule. 

III. 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. 

However, it does reference previously 

approved information collections. The 

forms CMS–855A, CMS–855B, and 

CMS–855I are approved under OMB 

control number 0938–0685; the CMS– 

855S is approved under OMB control 

number 0938–1056. 

IV. Regulatory Impact Statement 

A. Background 

We have examined the impact of this 

notice as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits, 

including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and equity. 

A regulatory impact analysis (RIA) must 

be prepared for major rules with 

economically significant effects ($100 

million or more in any 1 year). As 

explained in this section of the notice, 

we estimate that the total cost of the 

increase in the application fee will not 

exceed $100 million. Therefore, this 

notice does not reach the $100 million 

economic threshold and is not 

considered a major notice. 

B. Costs 

The costs associated with this notice 

involve the increase in the application 

fee amount that certain providers and 

suppliers must pay in CY 2015. 

1. Initial Estimates in February 2011 

Final Rule 

In the RIA for the February 2, 2011 

final rule, as indicated earlier, we 

estimated the total amount of 

application fees for CYs 2011 through 

2015. For CY 2015, and based on a 

projected $547 application fee amount, 

we estimated in Tables 11 and 12 (76 FR 

5955 and 5956) a total cost in fees of 

$63,465,675 ($17,066,400 + 

$46,399,275) for 116,025 affected 

Medicare institutional providers (31,200 

newly enrolling + 84,825 revalidating). 

We also projected in Tables 13 and 14 

(76 FR 5957 and 5958) a total cost in CY 

2015 application fees of $13,748,298 

($4,615,586 + $9,132,712) for 25,134 

affected Medicaid and CHIP providers 

(8,438 newly enrolling + 16,696 

revalidating). 

2. Estimates of Number of Affected 

Institutional Providers in December 2, 

2013 Fee Notice 

In the December 2, 2013 application 

fee notice, we estimated that— 

• 4,800 newly enrolling Medicare 

institutional providers would be subject 

to an application fee in CY 2014. This 

was based on CMS statistics for the final 

quarter of CY 2012 and represented a 

substantial decrease from our estimate 

in the February 2, 2011 final rule of 

31,200 affected, newly enrolling 

institutional providers for CY 2014. 

• 580,000 Medicare providers and 

suppliers would be subject to 

revalidation in CY 2014, of which 

116,000 would be institutional 

providers required to pay a fee. 

• 27,859 Medicaid and CHIP 

providers (8,438 newly enrolling + 

19,421 revalidating) would be subject to 

an application fee in CY 2014. 

3. CY 2015 Estimates 

a. Medicare 

Based on CMS data, we estimate that 

in CY 2015 approximately— 

• 10,000 newly enrolling institutional 

providers will pay an application fee; 

and 

• 35,000 institutional providers will 

be subject to revalidation and will pay 

an application fee. 

Using a figure of 45,000 (10,000 newly 

enrolling + 35,000 revalidating) 

institutional providers, we estimate an 

increase in the cost of the Medicare 

application fee requirement in CY 2015 

of $270,000 (or 45,000 x $6.00) from the 

CY 2015 projections we had made in the 

February 2, 2011 final rule. 

b. Medicaid and CHIP 

As we did for CY 2014, we continue 

to estimate that 27,859 (8,438 newly 

enrolling + 19,421 revalidating) 

Medicaid and CHIP providers would be 

subject to an application fee in CY 2015. 

Using this figure, we project an increase 

in the cost of the Medicaid and CHIP 

application fee requirement in CY 2015 

of $167,154 (27,859 x $6.00) from the 

CY 2014 projections we had made in the 

February 2, 2011 final rule. 

c. Total 

Based on the foregoing, we estimate 

the total increase in the cost of the 

application fee requirement for 

Medicare, Medicaid, and CHIP 

providers and suppliers in CY 2015 to 

be $437,154 ($270,000 + $167,154) from 

the CY 2015 projections we had made 

in the February 2, 2011 final rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of less than $7.5 million to $38.5 

million in any 1 year. Individuals and 

states are not included in the definition 

of a small entity. As we stated in the 

RIA for the February 2, 2011 final rule 

with comment period (76 FR 5952), we 

do not believe that the application fee 


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Federal Register / Vol. 79, No. 234 / Friday, December 5, 2014 / Notices 72185 

1Section 505–1 of the FD&C Act applies to any 

application for approval of a prescription drug 

submitted under section 505(b) or (j) of the FD&C 

Act (including both NDAs submitted under section 

505(b)(2) and ANDAs submitted under section 

505(j)), as well as applications submitted under 

section 351 of the Public Health Service Act (42 

U.S.C. 262). 

will have a significant impact on small 

entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area for 

Medicare payment regulations and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined, 

and the Secretary certifies, that this 

notice would not have a significant 

impact on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule whose mandates 

require spending in any 1 year of $100 

million in 1995 dollars, updated 

annually for inflation. In 2014, that 

threshold is approximately $141 

million. The Agency has determined 

that there will be minimal impact from 

the costs of this notice, as the threshold 

is not met under the UMRA. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has federalism implications. 

Since this notice does not impose 

substantial direct costs on state or local 

governments, the requirements of 

Executive Order 13132 are not 

applicable. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

Dated: October 22, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–28503 Filed 12–2–14; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1891] 

How To Obtain a Letter From the Food 

and Drug Administration Stating That 

Bioequivalence Study Protocols 

Contain Safety Protections 

Comparable to Applicable Risk 

Evaluation and Mitigation Strategies 

for Reference Listed Drugs; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘How to Obtain a 

Letter from FDA Stating that 

Bioequivalence Study Protocols Contain 

Safety Protections Comparable to 

Applicable REMS for RLD.’’ This draft 

guidance describes how a prospective 

abbreviated new drug application 

(ANDA) applicant may request a letter 

stating that FDA has determined the 

following: The potential applicant’s 

bioequivalence (BE) study protocol 

contains safety protections comparable 

to those in the risk evaluation and 

mitigation strategy (REMS) with 

elements to assure safe use (ETASU) 

applicable to the reference listed drug 

(RLD) and FDA will not consider it a 

violation of the REMS for the RLD 

sponsor to provide a sufficient quantity 

of the RLD to the interested generic firm 

or its agent to allow the firm to perform 

the testing necessary to support its 

ANDA. 

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 on 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 February 3, 

2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance 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. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Giaquinto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993, 240–402– 

7930, Elizabeth.Giaquinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘How to Obtain a Letter from FDA 

Stating that Bioequivalence Study 

Protocols Contain Safety Protections 

Comparable to Applicable REMS for 

RLD.’’ Section 505–1(a)(1) of the FD&C 

Act authorizes FDA to require 

applicants to submit a proposed REMS 

as a part of the relevant application 1 if 

FDA determines that a REMS is 

necessary to ensure that the benefits of 

a drug outweigh its risks (21 U.S.C. 355– 

1(a)(1)). A REMS is a required risk 

management plan that uses tools beyond 

routine professional labeling (such as a 

medication guide, a patient package 

insert, and/or a communication plan) to 

ensure that the benefits of a drug 

outweigh its risks (section 505–1(f) of 

the FD&C Act). In addition, FDA may 

require ETASU in some circumstances 

when such elements are necessary to 

mitigate the risks associated with the 

drug. ETASU may include, for example, 

requirements that health care providers 

who prescribe or administer the drug 

have particular training or certification; 

that patients using the drug be 

monitored and/or enrolled in a registry; 

or that pharmacies, practitioners, or 

health care settings that dispense the 

drug be specially certified. 

FDA is aware of instances in which an 

RLD sponsor has refused to sell drug 

products to a prospective ANDA 

applicant seeking to conduct the testing 

needed to obtain approval, and the RLD 

sponsor has cited the REMS ETASU as 

justification. In the interest of 

facilitating prospective generic 

applicants’ access to RLD products to 

conduct the testing necessary to support 

ANDA approval, FDA has, on request, 

reviewed the BE study protocols 

proposed by a prospective ANDA 


wreier-aviles on DSK5TPTVN1PROD with NOTICES