Federal Register / Vol. 78, No. 210 / Wednesday, October 30, 2013 / Notices 64953 

waive notice and comment rulemaking 

when notice and public comment 

thereon are unnecessary. On this basis, 

we waive publication of a proposed 

notice and a solicitation of public 

comments. 

VI. 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). 

VII. Regulatory Impact Analysis 

A. Statement of Need 

Section 1818(d) of the Act requires 

the Secretary of the Department of 

Health and Human Services (the 

Secretary) during September of each 

year to determine and publish the 

amount to be paid, on an average per 

capita basis, from the Federal Hospital 

Insurance Trust Fund for services 

incurred in the impending calendar year 

(CY) (including the associated 

administrative costs) on behalf of 

individuals aged 65 and over who will 

be entitled to benefits under Medicare 

Part A. 

B. Overall Impact 

We have examined the impacts of this 

rule 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., Part I, Ch. 8). 

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 

notices with economically significant 

effects ($100 million or more in any 1 

year). As stated in section IV of this 

notice, we estimate that the overall 

effect of the changes in the Part A 

premium will be a savings to voluntary 

enrollees (section 1818 and section 

1818A of the Act) of about $119 million. 

As a result, this notice is economically 

significant under section 3(f)(1) of 

Executive Order 12866 and thus, a 

major action under the Congressional 

Review Act. In accordance with the 

provisions of Executive Order 12866, 

this notice was reviewed by the Office 

of Management and Budget. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. 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 $7.0 million to $35.5 

million in any 1 year (for details, see the 

Small Business Administration’s Web 

site at http://www.sba.gov/sites/default/ 

files/files/Size_Standards_Table.pdf). 

Individuals and states are not 

included in the definition of a small 

entity. As discussed above, this annual 

notice announces Medicare’s Hospital 

Insurance (Part A) premium for 

uninsured enrollees in calendar year 

(CY) 2014. As a result, we are not 

preparing an analysis for the RFA 

because the Secretary has determined 

that this notice will not have a 

significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the 

Social Security 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. As discussed above, we are not 

preparing an analysis for section 1102(b) 

of the Act, because the Secretary has 

determined that this notice will 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 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 2013, that threshold is approximately 

$141 million. This notice does not 

impose mandates that will have a 

consequential effect of $141 million or 

more on state, local, or tribal 

governments or on the private sector. 

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 any 

costs on state or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 20, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: October 18, 2013. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2013–25591 Filed 10–28–13; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–8053–N] 

RIN 0938–AR59 

Medicare Program; Inpatient Hospital 

Deductible and Hospital and Extended 

Care Services Coinsurance Amounts 

for CY 2014 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

inpatient hospital deductible and the 

hospital and extended care services 

coinsurance amounts for services 

furnished in calendar year (CY) 2014 

under Medicare’s Hospital Insurance 

Program (Medicare Part A). The 

Medicare statute specifies the formulae 

used to determine these amounts. For 

CY 2014, the inpatient hospital 

deductible will be $1,216. The daily 

coinsurance amounts for CY 2014 will 

be: $304 for the 61st through 90th day 

of hospitalization in a benefit period; 

$608 for lifetime reserve days; and $152 

for the 21st through 100th day of 

extended care services in a skilled 

nursing facility in a benefit period. 

DATES: Effective Date: This notice is 

effective on January 1, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Clare McFarland, (410) 786–6390 for 


emcdonald on DSK67QTVN1PROD with NOTICES
64954 Federal Register / Vol. 78, No. 210 / Wednesday, October 30, 2013 / Notices 

general information. Gregory J. Savord, 

(410) 786–1521 for case-mix analysis. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1813 of the Social Security 

Act (the Act) provides for an inpatient 

hospital deductible to be subtracted 

from the amount payable by Medicare 

for inpatient hospital services furnished 

to a beneficiary. It also provides for 

certain coinsurance amounts to be 

subtracted from the amounts payable by 

Medicare for inpatient hospital and 

extended care services. Section 

1813(b)(2) of the Act requires us to 

determine and publish each year the 

amount of the inpatient hospital 

deductible and the hospital and 

extended care services coinsurance 

amounts applicable for services 

furnished in the following calendar year 

(CY). 

II. Computing the Inpatient Hospital 

Deductible for CY 2014 

Section 1813(b) of the Act prescribes 

the method for computing the amount of 

the inpatient hospital deductible. The 

inpatient hospital deductible is an 

amount equal to the inpatient hospital 

deductible for the preceding CY, 

adjusted by our best estimate of the 

payment-weighted average of the 

applicable percentage increases (as 

defined in section 1886(b)(3)(B) of the 

Act) used for updating the payment 

rates to hospitals for discharges in the 

fiscal year (FY) that begins on October 

1 of the same preceding CY, and 

adjusted to reflect changes in real casemix. The adjustment to reflect real casemix is determined on the basis of the 

most recent case-mix data available. The 

amount determined under this formula 

is rounded to the nearest multiple of $4 

(or, if midway between two multiples of 

$4, to the next higher multiple of $4). 

Under section 1886(b)(3)(B)(i)(XX) of 

the Act, the percentage increase used to 

update the payment rates for FY 2014 

for hospitals paid under the inpatient 

prospective payment system is the 

market basket percentage increase, 

otherwise known as the market basket 

update, reduced by 0.3 percentage 

points (see section 1886(b)(3)(B)(xii)(II) 

of the Act), and an adjustment based on 

changes in the economy-wide 

productivity (the multifactor 

productivity (MFP) adjustment (see 

section 1886(b)(3)(B)(xi)(II) of the Act). 

Under section 1886(b)(3)(B)(viii) of the 

Act, hospitals will receive this update 

only if they submit quality data as 

specified by the Secretary of the 

Department of Health and Services (the 

Secretary). The update for hospitals that 

do not submit this data is reduced by 

2.0 percentage points. We are estimating 

that after accounting for those hospitals 

receiving the lower market basket 

update in the payment-weighted average 

update, the calculated deductible will 

remain the same, as the majority of 

hospitals submit quality data and 

receive the full market basket update. 

Under section 1886(b)(3)(B)(ii)(VIII) of 

the Act, the percentage increase used to 

update the payment rates for FY 2014 

for hospitals excluded from the 

inpatient prospective payment system is 

as follows: 

• For FY 2014, the percentage 

increase for long term care hospitals is 

the market basket percentage increase 

reduced by 0.3 percentage points and 

the MFP adjustment (see sections 

1886(m)(3)(A) and 1886(m)(4)(C) of the 

Act). 

• For FY 2014, the percentage 

increase for inpatient rehabilitation 

facilities is the market basket percentage 

increase reduced by 0.3 percentage 

points and the MFP adjustment (see 

sections 1886(j)(3)(C) and 

1886(j)(3)(D)(ii) of the Act). 

• For FY 2014, the percentage 

increase used to update the payment 

rate for psychiatric hospitals is the 

market basket percentage increase 

reduced by 0.1 percentage points and 

the MFP adjustment (see sections 

1886(s)(2)(A)(ii) and 1886(s)(3)(B) of the 

Act). 

The Inpatient Prospective Payment 

System market basket percentage 

increase for 2014 is 2.5 percent and the 

MFP adjustment is 0.5 percent, as 

announced in the final rule with 

comment period published in the 

Federal Register on August 19, 2013 

entitled, ‘‘Medicare Program; Hospital 

Inpatient Prospective Payment Systems 

for Acute Care Hospitals and the LongTerm Care Hospital Prospective 

Payment System and Fiscal Year 2014 

Rates; Quality Reporting Requirements 

for Specific Providers; Hospital 

Conditions of Participation; Payment 

Policies Related to Patient Status ’’ (78 

FR 50608). Therefore, the percentage 

increase for hospitals paid under the 

inpatient prospective payment system is 

1.7 percent. The average payment 

percentage increase for hospitals 

excluded from the inpatient prospective 

payment system is 1.94 percent. 

Weighting these percentages in 

accordance with payment volume, our 

best estimate of the payment-weighted 

average of the increases in the payment 

rates for FY 2014 is 1.73 percent. 

To develop the adjustment to reflect 

changes in real case-mix, we first 

calculated an average case-mix for each 

hospital that reflects the relative 

costliness of that hospital’s mix of cases 

compared to those of other hospitals. 

We then computed the change in 

average case-mix for hospitals paid 

under the Medicare prospective 

payment system in FY 2013 compared 

to FY 2012. (We excluded from this 

calculation hospitals whose payments 

are not based on the inpatient 

prospective payment system because 

their payments are based on alternate 

prospective payment systems or 

reasonable costs.) We used Medicare 

bills from prospective payment 

hospitals that we received as of July 

2013. These bills represent a total of 

about 7.8 million Medicare discharges 

for FY 2013 and provide the most recent 

case-mix data available at this time. 

Based on these bills, the change in 

average case-mix in FY 2013 is 0.89 

percent. Based on these bills and past 

experience, we expect the overall case 

mix change to be 1.0 percent as the year 

progresses and more FY 2013 data 

become available. 

Section 1813 of the Act requires that 

the inpatient hospital deductible be 

adjusted only by that portion of the 

case-mix change that is determined to 

be real. We estimate that the change in 

real case mix will be 1.0 percent. 

Thus, the estimate of the paymentweighted average of the applicable 

percentage increases used for updating 

the payment rates is 1.73 percent, and 

the real case-mix adjustment factor for 

the deductible is 1.0 percent. Therefore, 

under the statutory formula, the 

inpatient hospital deductible for 

services furnished in CY 2014 is $1,216. 

This deductible amount is determined 

by multiplying $1,184 (the inpatient 

hospital deductible for CY 2013) by the 

payment-weighted average increase in 

the payment rates of 1.0173 multiplied 

by the increase in real case-mix of 1.01, 

which equals $1,216.53 and is rounded 

to $1,216. 

III. Computing the Inpatient Hospital 

and Extended Care Services 

Coinsurance Amounts for CY 2014 

The coinsurance amounts provided 

for in section 1813 of the Act are 

defined as fixed percentages of the 

inpatient hospital deductible for 

services furnished in the same CY. The 

increase in the deductible generates 

increases in the coinsurance amounts. 

For inpatient hospital and extended care 

services furnished in CY 2014, in 

accordance with the fixed percentages 

defined in the law, the daily 

coinsurance for the 61st through 90th 

day of hospitalization in a benefit 

period will be $304 (one-fourth of the 

inpatient hospital deductible); the daily 

coinsurance for lifetime reserve days 

will be $608 (one-half of the inpatient 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 210 / Wednesday, October 30, 2013 / Notices 64955 

hospital deductible); and the daily 

coinsurance for the 21st through 100th 

day of extended care services in a 

skilled nursing facility in a benefit 

period will be $152 (one-eighth of the 

inpatient hospital deductible). 

IV. Cost to Medicare Beneficiaries 

Table 1 below summarizes the 

deductible and coinsurance amounts for 

CYs 2013 and 2014, as well as the 

number of each that is estimated to be 

paid. 

TABLE 1—PART A DEDUCTIBLE AND COINSURANCE AMOUNTS FOR CALENDAR YEARS 2013 AND 2014 TYPE OF COST

SHARING

Value Number paid (in millions) 

2013 2014 2013 2014 

Inpatient hospital deductible ............................................................ $1,184 $1,216 7.91 8.07 

Daily coinsurance for 61st–90th Day .............................................. 296 304 2.04 2.09 

Daily coinsurance for lifetime reserve days ..................................... 592 608 1.02 1.04 

SNF coinsurance ............................................................................. 148 152 42.10 43.40 

The estimated total increase in costs 

to beneficiaries is about $870 million 

(rounded to the nearest $10 million) due 

to—(1) the increase in the deductible 

and coinsurance amounts; and (2) the 

increase in the number of deductibles 

and daily coinsurance amounts paid. 

V. Waiver of Proposed Notice and 

Comment Period 

The Medicare statute, as discussed 

previously, requires publication of the 

Medicare Part A inpatient hospital 

deductible and the hospital and 

extended care services coinsurance 

amounts for services for each CY. The 

amounts are determined according to 

the statute. As has been our custom, we 

use general notices, rather than notice 

and comment rulemaking procedures, to 

make the announcements. In doing so, 

we acknowledge that, under the 

Administrative Procedure Act (APA), 

interpretive rules, general statements of 

policy, and rules of agency organization, 

procedure, or practice are excepted from 

the requirements of notice and comment 

rulemaking. 

We considered publishing a proposed 

notice to provide a period for public 

comment. However, we may waive that 

procedure if we find good cause that 

prior notice and comment are 

impracticable, unnecessary, or contrary 

to the public interest. We find that the 

procedure for notice and comment is 

unnecessary because the formulae used 

to calculate the inpatient hospital 

deductible and hospital and extended 

care services coinsurance amounts are 

statutorily directed, and we can exercise 

no discretion in following the formulae. 

Moreover, the statute establishes the 

time period for which the deductible 

and coinsurance amounts will apply 

and delaying publication would be 

contrary to the public interest. 

Therefore, we find good cause to waive 

publication of a proposed notice and 

solicitation of public comments. 

VI. 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). 

VII. Regulatory Impact Analysis 

A. Statement of Need 

Section 1813(b)(2) of the Act requires 

the Secretary to determine and publish, 

between September 1 and September 15 

of each year, the amount of the inpatient 

hospital deductible and the hospital and 

extended care services coinsurance 

amounts applicable for services 

furnished in the following calendar year 

(CY). 

B. Overall Impact 

We have examined the impacts of this 

rule 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., Part I, Ch. 8). 

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 

notices with economically significant 

effects ($100 million or more in any 1 

year). As stated in section IV of this 

notice, we estimate that the total 

increase in costs to beneficiaries 

associated with this notice is about $870 

million due to—(1) the increase in the 

deductible and coinsurance amounts; 

and (2) the increase in the number of 

deductibles and daily coinsurance 

amounts paid. As a result, this notice is 

economically significant under section 

3(f)(1) of Executive Order 12866 and 

thus, is a major action under the 

Congressional Review Act. In 

accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. 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 $7.0 million to $35.5 

million in any 1 year (for details, see the 

Small Business Administration’s Web 

site at http://www.sba.gov/sites/default/ 

files/files/Size_Standards_Table.pdf). 

Individuals and states are not 

included in the definition of a small 

entity. As discussed above, this annual 

notice announces the inpatient hospital 

deductible and the hospital and 

extended care services coinsurance 

amounts for services furnished in CY 

2014 under Medicare’s Hospital 

Insurance Program (Medicare Part A). 

As a result, we are not preparing an 


emcdonald on DSK67QTVN1PROD with NOTICES
64956 Federal Register / Vol. 78, No. 210 / Wednesday, October 30, 2013 / Notices 

analysis for the RFA because the 

Secretary has determined that this 

notice will not have a significant 

economic impact on a substantial 

number of small entities. 

In addition, section 1102(b) of the 

Social Security 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. As discussed above, we are not 

preparing an analysis for section 1102(b) 

of the Act because the Secretary has 

determined that this notice will 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 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. 

For 2013, that threshold accounting for 

inflation is approximately $141 million. 

This notice does not impose mandates 

that will have a consequential effect of 

$141 million or more on state, local, or 

tribal governments or on the private 

sector. However, states may be required 

to pay the deductibles and coinsurance 

for dually-eligible beneficiaries. 

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 any 

costs on state or local governments, 

preempt state law or have Federalism 

implications, the requirements of 

Executive Order 13132 are not 

applicable. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 20, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: October 18, 2013. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2013–25595 Filed 10–28–13; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–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 December 11, 2013, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center (rm. 1503), 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You,’’ click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Karen AbrahamBurrell, 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, email: 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 biologic 

license application (BLA) 125390, 

metreleptin for injection, sponsored by 

Amylin Pharmaceuticals, LLC, a wholly 

owned subsidiary of Bristol-Myers 

Squibb. The proposed indication for 

metreleptin is the treatment of 

metabolic disorders associated with 

lipodystrophy, including diabetes 

mellitus and/or hypertriglyceridemia 

(elevated triglyceride levels in the 

blood) in pediatric and adult patients 

with inherited or acquired 

lipodystrophy. (Lipodystrophies are rare 

medical conditions of abnormal loss of 

the body’s fatty tissues.) 

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 November 26, 2013. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 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 November 18, 2013. 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 

November 19, 2013. 

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 


emcdonald on DSK67QTVN1PROD with NOTICES