Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14145 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Pathologist ...................................................... Pathology Report—No standard form ............ 5 1 5/60 

Next-of-kin for deceased miner ...................... 2.6 .................................................................. 5 1 15/60 

Leroy A. 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. 2015–06160 Filed 3–17–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Hearing: Reconsideration of 

Disapproval Louisiana Medicaid State 

Plan Amendment (SPA) 12–66–B 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of hearing: 

Reconsideration of disapproval. 

SUMMARY: This notice announces an 

administrative hearing to be held on 

April 30, 2015, at the Department of 

Health and Human Services, Centers for 

Medicare and Medicaid Services, 

Division of Medicaid & Children’s 

Health, Dallas Regional Office, 1301 

Young Street, Room 730, Dallas, TX 

75202, to reconsider CMS’ decision to 

disapprove Louisiana’s Medicaid SPA 

12–66–B. 

Closing Date: Requests to participate 

in the hearing as a party must be 

received by the presiding officer by 

April 2, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin R. Cohen, Presiding Officer, 

CMS, 2520 Lord Baltimore Drive, Suite 

L, Baltimore, Maryland 21244, 

Telephone: (410) 786–3169. 

SUPPLEMENTARY INFORMATION: This 

notice announces an administrative 

hearing to reconsider CMS’ decision to 

disapprove Louisiana’s Medicaid SPA 

12–66B which was submitted to the 

Centers for Medicare and Medicaid 

Services (CMS) on December 20, 2012 

and disapproved on December 11, 2014. 

In part, this SPA requested CMS 

approval to revise the current pharmacy 

reimbursement methodology for 

estimated acquisition cost (EAC) which 

is currently calculated as average 

acquisition cost (AAC) of the drug 

dispensed to a new calculation of AAC 

adjusted by a multiplier of 1.1 for 

multiple source drugs and 1.01 for 

single source drugs. In addition, 

propose a reimbursement methodology 

of wholesale acquisition cost (WAC) 

adjusted by a multiplier of 1.05 for statedefined specialty therapeutic classes of 

drugs. 

The issues to be considered at the 

hearing are: 

• Whether the state’s proposed 

increased payment methodology under 

Louisiana Medicaid SPA 12–66–B 

complies with the requirements of 

section 1902(a)(30)(A) of the Act which 

requires, in part, that states have 

methods and procedures to assure that 

payment rates are consistent with 

efficiency, economy, and quality of care. 

• Whether the state demonstrated that 

the proposed payment increases are 

consistent with the aggregate upper 

payment limits set in implementing 

regulations at 42 CFR 447.512 which 

provide that payments for drugs are to 

be based on the lower of: (1) The 

ingredient EAC of the drug and a 

reasonable dispensing fee; or (2) the 

provider’s usual and customary charges 

to the general public. 

• Whether the proposed calculation 

of EAC used in calculating upper 

payment limits (based on a multiple of 

the AAC) is consistent with the 

definition of EAC in 42 CFR 447.502, 

which defines EAC as ‘‘the agency’s best 

estimate of the price generally and 

currently paid by providers for a drug 

marketed or sold by a particular 

manufacturer or labeler in the package 

size of drug most frequently purchased 

by providers.’’ 

Section 1116 of the Act and federal 

regulations at 42 CFR part 430, establish 

Department procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

state plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a state Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to Louisiana announcing 

an administrative hearing to reconsider 

the disapproval of its SPA reads as 

follows: 

J. Ruth Kennedy 

State Medicaid Director 

Louisiana Department of Health and 

Hospitals 

628 N. 4th Street 

P.O. Box 91030 

Baton Rouge, LA 70821 

Dear Ms. Kennedy: 

I am responding to your request for 

reconsideration of the decision to disapprove 

Louisiana’s Medicaid state plan amendment 

(SPA) 12–66B, which was submitted to the 

Centers for Medicare and Medicaid Services 

(CMS) on December 20, 2012, and 

disapproved on December 11, 2014. I am 

scheduling a hearing on your request for 

reconsideration to be held on April 30, 2015, 

at the Department of Health and Human 

Services, Centers for Medicare and Medicaid 

Services, Division of Medicaid & Children’s 

Health, Dallas Regional Office, 1301 Young 

Street, Room 730, Dallas, TX 75202. 

I am designating Mr. Benjamin R. Cohen as 

the presiding officer. If these arrangements 

present any problems, please contact Mr. 

Cohen at (410) 786–3169. In order to 

facilitate any communication that may be 

necessary between the parties prior to the 

hearing, please notify the presiding officer to 

indicate acceptability of the hearing date that 

has been scheduled and provide names of the 

individuals who will represent the state at 

the hearing. If the hearing date is not 

acceptable, Mr. Cohen can set another date 

mutually agreeable to the parties. The 

hearing will be governed by the procedures 

prescribed by federal regulations at 42 CFR 

part 430. 

In part, this SPA would revise the current 

pharmacy reimbursement methodology for 

estimated acquisition cost (EAC) which is 

currently calculated as average acquisition 

cost (AAC) of the drug dispensed to a new 

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14146 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 

calculation of AAC adjusted by a multiplier 

of 1.1 for multiple source drugs and 1.01 for 

single source drugs. In addition, this SPA 

would apply a reimbursement methodology 

of wholesale acquisition cost (WAC) adjusted 

by a multiplier of 1.05 for state-defined 

specialty therapeutic classes of drugs. 

The issues to be considered at the hearing 

are: 

• Whether the state’s proposed increased 

payment methodology under Louisiana 

Medicaid SPA 12–66–B complies with the 

requirements of section 1902(a)(30)(A) of the 

Act which requires, in part, that states have 

methods and procedures to assure that 

payment rates are consistent with efficiency, 

economy, and quality of care. 

• Whether the state demonstrated that the 

proposed payment increases are consistent 

with the aggregate upper payment limits set 

in implementing regulations at 42 CFR 

447.512 which provide that payments for 

drugs are to be based on the lower of: 1) the 

ingredient EAC of the drug and a reasonable 

dispensing fee; or 2) the provider’s usual and 

customary charges to the general public. 

• Whether the proposed calculation of 

EAC used in calculating upper payment 

limits (based on a multiple of the AAC) is 

consistent with the definition of EAC in 42 

CFR 447.502, which defines EAC as ‘‘the 

agency’s best estimate of the price generally 

and currently paid by providers for a drug 

marketed or sold by a particular 

manufacturer or labeler in the package size 

of drug most frequently purchased by 

providers.’’ 

In the event that CMS and the state come 

to agreement on resolution of the issues 

which formed the basis for disapproval, this 

SPA may be moved to approval prior to the 

scheduled hearing. 

Sincerely, 

Andrew M. Slavitt 

Section 1116 of the Social Security Act (42 

U.S.C. 1316; 42 CFR 430.18) (Catalog of 

Federal Domestic Assistance program No. 

13.714. Medicaid Assistance Program.) 

Dated: March 13, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–06226 Filed 3–17–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0684] 

Identification of Alternative In Vitro 

Bioequivalence Pathways Which Can 

Reliably Ensure In Vivo Bioequivalence 

of Product Performance and Quality of 

Non-Systemically Absorbed Drug 

Products for Animals; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Identification of Alternative In 

Vitro Bioequivalence Pathways Which 

Can Reliably Ensure In Vivo 

Bioequivalence of Product Performance 

and Quality of Non-Systemically 

Absorbed Drug Products for Animals’’. 

The purpose of the public meeting is to 

discuss the use of in vitro methods as 

a mechanism for assessing the in vivo 

product bioequivalence (BE) of nonsystemically absorbed drug products 

intended for use in veterinary species. 

FDA is seeking additional public 

comment to the docket, and is 

requesting that any written comments 

be submitted by May 18, 2015. 

Date and Time: The public meeting 

will be held on April 16, 2015, from 9 

a.m. to 4 p.m. 

Location: The public meeting will be 

held at the Center for Veterinary 

Medicine (CVM), Food and Drug 

Administration, 7519 Standish Pl., 3rd 

Floor, Conference Room A, Rockville, 

MD 20855. Parking is free. 

Contact Person: Aleta Sindelar, CVM, 

Food and Drug Administration, 7519 

Standish Pl., Rm. 144, Rockville, MD 

20855, 240–276–9230, FAX: 240–276– 

9241, email: BioequivalencePublic

MeetingRegistration@fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in requesting 

an opportunity to speak during the open 

public comment period must register by 

April 8, 2015, and must include a brief 

summary of comments with their 

registration. Those individuals will be 

contacted prior to the meeting regarding 

their participation. Persons interested in 

attending this meeting who are not 

requesting an opportunity to speak at 

the meeting must register by April 14, 

2015. For general questions about the 

meeting, for assistance registering for 

the meeting, to request an opportunity 

to make an oral presentation, or to 

request special accommodations due to 

a disability, contact Aleta Sindelar (see 

Contact Person). Please include your 

name, organization, and contact 

information. Early registration for the 

meeting is encouraged due to limited 

time and space. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Given the imprecision and logistic 

challenges associated with clinical 

endpoint BE studies, FDA is exploring 

alternative pathways that can be applied 

to help ensure the equivalence of 

product performance and quality for 

those products that are non-systemically 

absorbed (locally acting). 

The assessment of in vivo BE of nonsystemically absorbed drug products has 

been a longstanding challenge facing 

drug manufacturers and regulators of 

human and animal health products. 

Although blood level BE trials remain 

the standard for comparing drug 

products that are systemically absorbed 

and that act at a target site reached via 

the blood (systemic circulation), such 

studies cannot confirm product in vivo 

BE when a drug is either not 

systemically absorbed or when it is 

associated with therapeutic effects 

occurring proximal to the site of 

absorption. To date, unless the active 

pharmaceutical ingredient met the 

criteria for highly soluble, as defined in 

CVM Guidance #171 entitled ‘‘Waivers 

of In Vivo Demonstration of 

Bioequivalence of Animal Drugs in 

Soluble Powder Oral Dosage Form 

Products and Type A Medicated 

Articles,’’ clinical endpoint BE trials 

have provided the only option for 

generating inter-product comparisons. 

FDA is exploring whether an alternative 

in vitro BE approach may be considered 

when blood level BE studies are either 

not feasible or not appropriate, and 

when products do not meet the criteria 

for applying a Guidance #171-based 

biowaiver. 

The assumption underlying the 

application of the in vitro BE approach 

is that equivalence in product 

physicochemical attributes and in vitro 

product performance translates to 

equivalence in product in vivo behavior. 

For sponsors with a right of reference to 

underlying safety and effectiveness data, 

the criteria for similarity of 

physicochemical attributes would be 

defined on the basis of the underlying 

dataset to confirm the comparability of 

the original formulation and pre- and 

post-approval changes in formulation or 

method of product manufacture. In the 

case of generic products, a more rigid 

approach to sameness would be used in 

terms of product composition and 

physicochemical characteristics. In both 

situations, physicochemical 

comparisons would be based upon a 

battery of in vitro test procedures, 

including a comparison of in vitro 

dissolution behavior under a range of 

physiologically-relevant conditions. 

Examples of the kinds of products 

where in vitro bioequivalence concepts 

can potentially be applied include some 

orally administered products (e.g., Type 

A medicated articles), solutions, 

emulsions, ointments, creams, 

suspensions, transdermal products, and 

intra-mammary formulations. Due to 

unique issues raised by products 

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