3752 Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices

1This draft guidance document represents the

FDA’s current thinking on efficacy studies to

support marketing of fibrin sealant products

manufactured for commercial use. It does not create

or confer any rights for or on any person and does

not operate to bind FDA or the public. An

alternative approach may be used if such approach

satisfies the requirements fo the applicable statute,

regulations, or both. For additional copies of this

guidance, contact the Office of Communication,

Training and Manufacturers Assistance, HFM–40,

Center for Biologics Evaluation and Research, Food

and Drug Administration, 1401 Rockville Pike,

Rockville, MD 20852-1448. Send one self-addressed

adhesive label to assist that office in processing

your requests. The document may also be obtained

by mail by calling the CBER Voice Information

System at 1–800–835–4709 or 301–827–1800, or by

fax by calling the FAX Information System at 1–

888–CBER–FAX or 301–827–3844. Persons with

access to the INTERNET may obtain the document

using the World Wide Web (WWW) by connecting

to CBER at ‘‘http//www.fda.gov/cber/

guidelines.htm’’.

Draft-Not for Implementation

Guidance for Industry 1: Efficacy Studies to

Support Marketing of Fibrin Sealant

Products Manufactured for Commercial Use

I. Introduction

This document pertains to commerciallyproduced fibrin sealants composed of

purified, virus-inactivated/removed human

fibrinogen and human or bovine thrombin,

with or without added components such as

virus-inactivated/removed human factor XIII

and/or aprotinin. Such products are currently

available in Europe and Canada as

hemostasis agents. Although manufacturers

and clinicians in the United States have been

actively engaged in the development and

testing of fibrin sealants, no fibrin sealant

product has been licensed in this country.

This document outlines the agency’s current

position with regard to clinical data used to

support licensure of safe and effective

commercially-produced fibrin sealants in the

United States.

II. Background

As early as 1909, surgeons were reporting

the hemostatic properties of fibrin powder

used in the operative field. In the 1940s,

combinations of fibrinogen and thrombin

were first utilized. The development of Cohn

fractionation in the 1940s, and a method for

cryoprecipitation of fibrinogen in the 1960s,

led to the development of fibrin sealants in

the 1970s. However, fibrinogen concentrates

were found to transmit hepatitis and thus all

U.S. licenses for Fibrinogen (Human) were

revoked on December 7, 1977. Since that

time, a number of manufacturers have been

evaluating a new generation of virusinactivated/removed fibrin sealants.

In 1994, the FDA co-sponsored a

conference on the characteristics and clinical

uses of fibrin sealants, held at the Uniformed

Services University of the Health Sciences,

Bethesda, Maryland (summarized in

Transfusion 35:783–790, 1995). A number of

academic investigators presented data from

clinical trials in which fibrin sealants either

reduced blood loss or reduced the time to

achieve hemostasis. However, based on the

available data, FDA representatives were of

the opinion that a direct clinical benefit to

patients treated with fibrin sealant should be

demonstrated in a well-controlled clinical

trial to support product licensure for a

narrow indication.

Despite FDA’s requests for well-controlled

trials with patient outcomes as endpoints,

many clinicians have been reluctant to

conduct placebo-controlled trials in settings

where they view the standard of care to be

the use of fibrin sealant prepared on site from

commercial bovine thrombin and various

sources of fibrinogen. These clinicians

consider the use of locally-prepared fibrin

sealant to be of such benefit in controlling

bleeding in confined or nearly inaccessible

areas that a placebo-controlled trial would

put the control patients at significant and

unnecessary risk. However, locally-prepared

fibrin sealants are not standardized or

consistent, and the available sources of

fibrinogen are not treated to inactivate or

remove viruses.

III. Guidance

Based on clinical trial experience since

1994, FDA’s Center for Biologics Evaluation

and Research (CBER) proposes to consider,

for licensure of commercially-produced

fibrin sealants, data from pivotal studies in

which the primary endpoint is hemostasis

effectiveness. This review standard is similar

to that used by the Center for Devices and

Radiological Health, in clearing a number of

commercial medical devices on the basis of

clinical studies in which the primary

endpoint was control of hemostasis within a

specific time in a variety of clinical settings.

CBER proposes that time to hemostasis could

also serve as a primary endpoint for pivotal

studies of fibrin sealants.

As in the past, CBER also encourages

manufacturers to conduct well-controlled

clinical trials using a variety of other

endpoints, including blood loss, transfusion

requirements, tissue sealing, and wound

healing. Endpoints for such trials will be

reviewed on a case-by-case basis.

Manufacturers who demonstrate the safety

and efficacy of their fibrin sealant

preparations for specific indications may,

upon FDA licensure, label and promote their

products for these indications. FDA licensure

for a given indication will denote that the

specific formulation of fibrin sealant is safe

and effective for that specific indication.

For fibrin sealant products containing

multiple biologic components, the

contribution of each component may be

demonstrated in a non-clinical setting

appropriate to the indication(s) sought,

although the overall efficacy of multiplecomponent fibrin sealant products should be

demonstrated in clinical trials. Proposals to

utilize in vitro and/or animal studies to

support the inclusion of multiple biologic

components into a fibrin sealant product

should be discussed with CBER.

The following points are proposed for

review of pivotal clinical trials of fibrin

sealant products:

1) Fibrin sealant products should be tested in

settings and under conditions where they

would normally be expected to be used in

clinical practice.

2) Fibrin sealant products may be tested

against a placebo, a cleared hemostatic

device, or other control, as appropriate.

3) Efficacy of fibrin sealant products may be

tested by using either hemostasis endpoints

or other measures of clinical benefit,

depending on the indications sought.

IV. Comments

The agency will review all submitted

comments and consider them in the

preparation of any final guidance document.

Two copies of any comment should be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number found in

brackets in the heading of this document.

Comments received are available for public

examination in the Dockets Management

Branch (address above) between 9 a.m. and

4 p.m., Monday through Friday.

[FR Doc. 98–1664 Filed 1–23–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

HCFA–2005-NC

RIN 0938–AI39

Medicaid Program; State Allotments

for Payment of Medicare Part B

Premiums for Qualifying Individuals:

Federal Fiscal Year 1998

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice with Comment Period.

SUMMARY: Section 4732 of the Balanced

Budget Act of 1997 (Public Law 105–33)

amended the Social Security Act to

provide for two additional eligibility

groups of low-income Medicare

beneficiaries for whom Medicaid

payment can be made for Medicare Part

B premiums during the period

beginning January 1998 and ending

December 2002. This notice announces

the Federal fiscal year 1998 State

allotments that are available to pay

Medicare Part B premiums for these two

new eligibility groups and describes the

methodology used to determine each

State’s allotment.

DATES: Effective Date: This is a major

rule under 5 U.S.C. section 804(2). As

indicated in the preamble of this notice,

pursuant to section 5 U.S.C. section

553(b)(B), for good cause we find that

prior notice and comment procedures

are unnecessary and impracticable.

Pursuant to 5 U.S.C. section 808(2), this

notice is effective January 1, 1998, for
Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices 3753

allotments for payment of Medicare Part

B premiums for individuals in calendar

year 1998 from the allocation for fiscal

year 1998.

Comment Date: Written comments

will be considered if we receive them at

the appropriate address, as provided

below, no later than 5 p.m. on March 27,

1998.

ADDRESSES: Mail written comments (one

original and three copies) to the

following address: Health Care

Financing Administration, Department

of Health and Human Services,

Attention: HCFA–2005–NC, P.O. Box

7517, Baltimore, MD 21207–0517, or

If you prefer, you may deliver your

written comments (one original and

three copies to one of the following

addresses:

Room 309–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW, Washington, DC 20201, or

Room C5–09–26, 7500 Security

Boulevard, Baltimore, MD 21244–

1850.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

HCFA–2005–NC. Comments received

timely will be available for public

inspection as they are received,

generally beginning approximately 3

weeks after the publication of a

document, in Room 309-G of the

Department’s offices at 200

Independence Avenue, SW, Washington

DC, on Monday through Friday of each

week from 8:30 a.m. to 5 p.m. (phone:

(202) 690–7890).

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

37194, Pittsburgh, PA 15250–7954.

Specify the date of the issue requested

and enclose a check or money order

payable to the Superintendent of

Documents, or enclose your Visa or

Master Card number and expiration

date. Credit card orders can also be

placed by calling the order desk at (202)

512–1800 or by faxing to (202) 512–

2250. The cost for each copy is $8.00.

As an alternative, you can view and

photocopy the Federal Register

document at most libraries designated

as Federal Depository Libraries and at

many other public and academic

libraries throughout the country that

receive the Federal Register.

This Federal Register document is

also available from the Federal Register

online database through GPO Access, a

service of the U.S. Government Printing

Office. Free public access is available on

a Wide Area Information Server (WAIS)

through the Internet and via

asynchronous dial-in. Internet users can

access the database by using the World

Wide Web; the Superintendent of

Documents home page address is http:/

/www.access.gpo.gov/suldocs/, by

using local WAIS client software, or by

telnet to swais.access.gpo.gov, then

login as guest (no password required).

Dial-in users should use

communications software and modem

to call (202) 512-1661; type swais, then

login as guest (no password required).

FOR FURTHER INFORMATION CONTACT:

Miles McDermott, (410) 786–3722

SUPPLEMENTARY INFORMATION:

I. Background

Section 1902 of the Social Security

Act (the Act) sets forth the requirements

for State plans for medical assistance.

Prior to August 5, 1997, section

1902(a)(10)(E) of the Act specified that

the State Medicaid plan must provide

for Medicare cost-sharing for three

eligibility groups of low-income

Medicare beneficiaries. These three

groups included qualified Medicare

beneficiaries (QMBs), specified lowincome Medicare beneficiaries (SLMBs),

and qualified disabled and working

individuals (QDWIs).

A QMB is an individual entitled to

Medicare Part A with income at or

below the Federal poverty line and

resources below $4,000 for an

individual and $6,000 for a couple. A

SLMB is an individual who meets the

QMB criteria, except that his or her

income is between a State established

level (at or below the Federal poverty

line) and 120 percent of the Federal

poverty line. A QDWI is an individual

who is entitled to enroll in Medicare

Part A, whose income does not exceed

200 percent of the Federal poverty line

for a family of the size involved, whose

resources do not exceed twice the

amount allowed under the

Supplementary Security Income (SSI)

program, and who is not otherwise

eligible for Medicaid. The definition of

Medicare cost-sharing at section

1905(p)(3) of the Act includes payment

for premiums for Medicare Part B.

Section 4732 of the Balanced Budget

Act of 1997 (BBA), enacted on August

5, 1997, amended section 1902(a)(10)(E)

of the Act to require States to provide

for Medicaid payment of the Medicare

Part B premiums for two additional

eligibility groups of low-income

Medicare beneficiaries, referred to as

qualifying individuals (QIs).

Specifically, a new section

1902(a)(10)(E)(iv)(I) of the Act is added,

under which States must pay the full

amount of the Medicare Part B premium

for selected qualifying individuals who

would be QMBs but for the fact that

their income level is at least 120 percent

but less than 135 percent of the Federal

poverty line for a family of the size

involved. These individuals cannot

otherwise be eligible for medical

assistance under the approved State

Medicaid plan.

The second group of QIs, added under

section 1902(a)(10)(E)(iv)(II) of the Act,

includes Medicare beneficiaries who

would be QMBs except that their

income is between 135 percent and 175

percent of the Federal poverty line for

a family of the size involved, who are

not otherwise eligible for Medicaid

under the approved State plan. These

QIs are eligible for a portion of Medicare

cost-sharing consisting only of a

percentage of the increase in the

Medicare Part B premium attributable to

the shift of Medicare home health

coverage from Part A to Part B (as

provided in section 4611 of the BBA).

The BBA also added a new section

1933 to the Act to provide for Medicaid

payment of Medicare Part B premiums

for QIs. (The previous section 1933 is

redesignated as section 1934.) Section

1933(a) specifies that a State plan must

provide, through a State plan

amendment, for medical assistance to

pay for the cost of Medicare cost-sharing

on behalf of qualifying individuals who

are selected to receive assistance.

Section 1933(b) of the Act sets forth

the rules that States must follow in

selecting QIs and providing payment for

Medicare Part B premiums. Specifically,

the State must permit all qualifying

individuals to apply for assistance and

must select individuals on a first-come,

first-served basis (that is, the State must

select QIs in the order in which they

apply). Under section 1933(b)(2)(B) of

the Act, in selecting persons who will

receive assistance in years after 1998,

States must give preference to those

individuals who received assistance as

QIs, QMBs, SLMBs, or QDWIs in the last

month of the previous year and who

continue to be (or become) QIs. Under

section 1933(b)(4), persons selected to

receive assistance in a calendar year are

entitled to receive assistance for the

remainder of the year, but not beyond,

as long as they continue to qualify. The

fact that an individual is selected to

receive assistance at any time during the

year does not entitle the individual to

continued assistance for any succeeding

year. Because the State’s allotment is

limited by law, section 1933(b)(3) of the

Act provides that the State must limit

the number of QIs so that the amount of

assistance provided during the year is

approximately equal to the State’s

allotment for that year.
3754 Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices

Section 1933(c) of the Act limits the

total amount of Federal funds available

for payment of Part B premiums each

fiscal year and specifies the formula that

is to be used to determine an allotment

for each State from this total amount.

For States that execute a State plan

amendment in accordance with section

1933(a) of the Act, a total of $1.5 billion

is allocated over 5 years as follows: $200

million in FY 1998; $250 million in FY

1999; $300 million in FY 2000; $350

million in FY 2001; and $400 million in

FY 2002.

The Federal matching rate for

Medicaid payment of Medicare Part B

premiums for qualifying individuals is

100 percent for expenditures up to the

amount of the State’s allotment. No

Federal matching funds are available for

expenditures in excess of the State

allotment amount. Administrative

expenses associated with the payment

of Medicare Part B premiums for QIs

remain at the 50 percent matching level

and are not part of the State’s allotment.

The amount appropriated for each

fiscal year is to be allocated among

States according to the formula set forth

in section 1933(c)(2) of the Act. The

formula provides for an amount to each

State that is to be based on each State’s

share of the Secretary’s estimate of the

ratio of: (1) an amount equal to the sum

of (a) twice the total number of

individuals who meet all but the income

requirements for QMBs, whose incomes

are at least 120 percent but less than 135

percent of the Federal poverty line, and

who are not otherwise eligible for

Medicaid, and (b) the total number of

individuals in the State who meet all

but the income requirements for QMBs,

whose incomes are at least 135 percent

but less than 175 percent of the Federal

poverty line, and who are not otherwise

eligible for Medicaid, to (2) the sum of

all of these individuals under item (1)

for all eligible States.

II. Provisions of this Notice

This notice announces the availability

of individual State allotments for

Federal fiscal year 1998 for the

Medicaid payment of Medicare Part B

premiums for qualifying individuals

identified under sections

1902(a)(10)(E)(iv) (I) and (II) of the Act.

In this notice, we are not applying

precisely the statutory formula to

determine the individual State

allotments. A precise application of the

allocation formula in the statute would

require us to determine State-specific

estimates of the number of individuals

who:

• Are entitled to Medicare Part A;

• Have incomes in the poverty level

ranges specified;

• Have assets not exceeding twice the

amount allowed under the SSI program;

and

• Would not be eligible for Medicaid

but for the provisions of section

1902(a)(10)(E) of the Act regarding QIs.

Section 4732(c)(2) of the BBA allows

HCFA to take an estimate of the ration

of the relevant numbers. We have not

been able to locate any available current

data that would permit us to directly

produce the estimates specified in the

statute. As an alternative to direct

measurement, we believe that estimates

might be derived from models of

income, assets, and State Medicaid

eligibility. Estimates could be

constructed using available data

sources; however such an approach

would be very time-consuming and

resource-intensive and may still not

produce credible State-level estimates.

Consequently, we are approximating the

required estimates by using data from

the U.S. Census Bureau on the number

of individuals who, according to its

March Current Population Survey (CPS),

are Medicare beneficiaries, have

incomes in the appropriate ranges, and

are not enrolled in Medicaid.

In order to reduce the variability of

State-level estimates derived from CPS

data, we have used a moving average of

the most recent 3 years of available data.

For the FY 1998 allotments shown in

the table below, we have averaged CPS

data for the years 1994 through 1996.

Specifically, the Federal fiscal year 1998

allotments have been calculated as

follows:

AT=Total amount to be allocated

M1i=3-year average of the number of

Medicare beneficiaries in state i who are

not enrolled in Medicaid and whose

incomes are at least 120 percent but less

than 135 percent of Federal poverty line

M2i=3-year average of the number of

Medicare beneficiaries in State i who

are not enrolled in Medicaid and whose

incomes are at least 135 percent but less

than 175 percent of Federal poverty

line.

Then, the allotment reserved for State i

is determined by the following formula:

A

M M

M M

i A i i

j j

j

T = ⋅ +

( ) ⋅ +

























⋅

∑

2 1 2

2 1 2

.

The resulting allotments are shown by

State in the table below.

ESTIMATED STATE ALLOTMENTS FOR MEDICAID PAYMENTS OF MEDICARE PART B PREMIUMS

State

(a)

M11

(b)

M22

(c)

[2×(a)]+(b) State share of

(c) (percent)

State FY 98

allocation (in

thousands)

AK ......................................................................................... 0 2 2 0.03 $63

AL .......................................................................................... 36 65 137 2.14 4,283

AR ......................................................................................... 21 37 79 1.23 2,470

AZ ......................................................................................... 18 50 86 1.34 2,688

CA ......................................................................................... 99 311 509 7.96 15,911

CO ......................................................................................... 13 33 59 0.92 1,844

CT ......................................................................................... 13 65 91 1.42 2,845

DC ......................................................................................... 2 3 7 0.11 219

DE ......................................................................................... 4 9 17 0.27 531

FL .......................................................................................... 89 270 448 7.00 14,004

GA ......................................................................................... 42 102 186 2.91 5,814

HI .......................................................................................... 4 9 17 0.27 531

IA ........................................................................................... 15 49 79 1.23 2,470

ID .......................................................................................... 4 15 23 0.36 719

IL ........................................................................................... 75 167 317 4.95 9,909

IN .......................................................................................... 25 92 142 2.22 4,439

KS ......................................................................................... 13 41 67 1.05 2,094

KY ......................................................................................... 18 91 127 1.98 3,970

LA .......................................................................................... 27 56 110 1.72 3,439

MA ......................................................................................... 37 83 157 2.45 4,908
Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices 3755

ESTIMATED STATE ALLOTMENTS FOR MEDICAID PAYMENTS OF MEDICARE PART B PREMIUMS—Continued

State

(a)

M11

(b)

M22

(c)

[2×(a)]+(b) State share of

(c) (percent)

State FY 98

allocation (in

thousands)

MD ........................................................................................ 25 72 122 1.91 3,814

ME ......................................................................................... 7 27 41 0.64 1,282

MI .......................................................................................... 44 122 210 3.28 6,565

MN ........................................................................................ 18 55 91 1.42 2,845

MO ........................................................................................ 30 81 141 2.20 4,408

MS ......................................................................................... 26 42 94 1.47 2,938

MT ......................................................................................... 8 16 32 0.50 1,000

NC ......................................................................................... 58 110 226 3.53 7,065

ND ......................................................................................... 5 11 21 0.33 656

NE ......................................................................................... 10 26 46 0.72 1,438

NH ......................................................................................... 7 17 31 0.48 969

NJ .......................................................................................... 51 118 220 3.44 6,877

NM ........................................................................................ 10 29 49 0.77 1,532

NV ......................................................................................... 7 19 33 0.52 1,032

NY ......................................................................................... 92 271 455 7.11 14,223

OH ......................................................................................... 56 167 279 4.36 8,721

OK ......................................................................................... 26 47 99 1.55 3,095

OR ......................................................................................... 22 53 97 1.52 3,032

PA ......................................................................................... 82 213 377 5.89 11,785

RI .......................................................................................... 7 18 32 0.50 1,000

SC ......................................................................................... 27 52 106 1.66 3,314

SD ......................................................................................... 5 9 19 0.30 594

TN ......................................................................................... 39 56 134 2.09 4,189

TX ......................................................................................... 78 221 377 5.89 11,785

UT ......................................................................................... 4 18 26 0.41 813

VA ......................................................................................... 19 81 119 1.86 3,720

VT ......................................................................................... 4 7 15 0.23 469

WA ........................................................................................ 9 67 85 1.33 2,657

WI .......................................................................................... 10 56 76 1.19 2,376

WV ........................................................................................ 19 39 77 1.20 2,407

WY ........................................................................................ 2 4 8 0.13 250

Total ........................................................................... 1362 3674 6398 100.00 200,000

1Three-year average of number (000) of Medical beneficiaries in State who are not enrolled in Medicaid but whose incomes are at least 120

but less than 135 of Federal Poverty Line. 2Three-year average of number (000) of Medicare beneficiaries in State who are not enrolled in Medicaid but whose incomes are at least 135

but less than 175 of Federal Poverty Line.

III. Waiver of Advance Public Comment

and 30-Day Delay in Effective Date

We ordinarily publish an advance

notice in the Federal Register for a

notice containing substantive rules to

provide a period for public comment.

However, we may waive that procedure

if we find good cause that notice and

comment are impractical, unnecessary,

or contrary to the public interest. In

addition, we also normally provide a

delay of 30 days in the effective date.

However, if adherence to this procedure

would be impractical, unnecessary, or

contrary to public interest, we may

waive the delay in the effective date.

We are adopting this notice as a final

with comment period without

publication of a proposed notice

because of the need to notify individual

States in advance of the limitations with

Federal matching funds in their

Medicaid expenditures for payment of

Medicare Part B premiums for

qualifying individuals. Publication of a

proposed notice with a 60-day comment

period prior to publication of a final

notice would, we believe, be contrary to

the public interest. The law is specific

regarding the total amount available for

Medicare Part B premiums for

qualifying individuals and the formula

that is to be used to determine

individual State allotments. Therefore,

we find good cause to waive issuance of

a proposed notice and to issue the

notice as final.

Also, because States can begin making

payments for Medicare Part B premiums

for qualifying individuals as early as

January 1, 1998, we are not making the

effective date of the notice the usual 30

days after publication. For the reasons

discussed above, we find good cause to

waive the usual 30-day delay.

Although we are publishing this as a

final notice, we are providing a 60-day

period for public comment. Because of

the large number of items of

correspondence we normally receive,

we are not able to acknowledge or

respond to the comments individually.

However, if we decide that changes are

necessary as a result of our

consideration of timely comments, we

will issue an additional notice and

respond to the comments in that notice.

IV. Effect of the Contract with America

Advancement Act

Normally, under 5 U.S.C. section 801,

as added by section 251 of Public Law

104–121, the effective date of a major

rule is delayed 60 days for

Congressional review. This has been

determined to be a major rule under 5

U.S.C. section 804(2). However, as

indicated in section III of this notice

with comment period, we have found

that good cause exists to dispense with

prior notice and comment procedures

since they are unnecessary and

impracticable under the circumstances.

Pursuant to 5 U.S.C. section 808(2), a

rule shall take effect at such time as the

Federal agency promulgating the rule

determines if it finds, for good cause,

that prior notice and comment

procedures are unnecessary or

impracticable. Accordingly, under the

exemption provided in 5 U.S.C. section
3756 Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices

808(2), this notice with comment period

is effective January 1, 1998, for

allotments for payments of Medicare

Part B premiums for individuals in

calendar year 1998 from the allotment

for fiscal year 1998.

V. Regulatory Impact Statement

We have examined the impact of this

notice with comment period as required

by Executive Order 12866 and the

Regulatory Flexibility Act (RFA) (Pub.

L. 96–354). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety

effects; distributive impacts; and

equity). The RFA requires agencies to

analyze options for regulatory relief for

small businesses. For purposes of the

RFA, States and individuals are not

considered to be small entities.

This notice with comment period

implements provisions of the Balanced

Budget Act of 1997 to allocate, among

the States, Federal funds to provide

Medicaid payment for Medicare Part B

premiums for two additional groups of

low-income Medicare beneficiaries. The

total amount of Federal funds available

during a Federal fiscal year and the

formula for determining individual

State allotments are specified in the law.

We have applied the statutory formula

for the State allotments except for the

use of specified data. Because the data

specified in the law were not currently

available, we have used comparable

data from the U.S. Census Bureau on the

number of possible qualifying

individuals in the States.

We believe that the statutory

provisions implemented in this notice

with comment period will have a

positive effect on States and

individuals. Federal funding at the 100

percent matching rate is available for

Medicare cost-sharing for Medicare Part

B premium payments for qualifying

individuals and a greater number of

low-income Medicare beneficiaries will

be eligible to have their Medicare Part

B premiums paid under Medicaid.

Section 1102(b) of the Social Security

Act requires us to prepare a regulatory

impact analysis for any notice that may

have a significant impact on the

operations of a substantial number of

small rural hospitals. Such an analysis

must conform to the provisions of

section 603 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 a Metropolitan

Statistical Area and has fewer than 50

beds.

We are not preparing analyses for

either the RFA or section 1102(b) of the

Act because we have determined and

certify that this notice with comment

period will not have a significant

economic impact on a substantial

number of small entities or a significant

impact on the operations of a substantial

number of small rural hospitals.

In accordance with the provisions of

Executive Order 12866, this notice with

comment period was reviewed by the

Office of Management and Budget.

Authority: Sections 1902(a)(10), 1933 of

the Social Security Act (42 U.S.C. 1396a),

and Public Law 105–33.

(Catalog of Federal Domestic Assistance

Program No. 93.778, Medical Assistance

Program)

Dated: December 12, 1997.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

Dated: January 13, 1998.

Donna E. Shalala,

Secretary.

[FR Doc. 98–1675 Filed 1–23–98; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute on Drug Abuse

(NIDA) Initial Review Group and

Special Emphasis Panel meetings.

Purpose/Agenda: To review and evaluate

grant applications.

Name of Committee: Neurophysiology and

Neuroanatomy Research Subcommittee.

Date: February 9–11, 1998.

Time: 8:30 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Gamil Debbas, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–2620.

Name of Committee: Human Development

Research Subcommittee.

Date: February 10, 1998.

Time: 9:00 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Kesinee Nimit, M.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–9042.

Name of Committee: Basic Behavioral

Science Research Subcommittee.

Date: February 10–12, 1998.

Time: 8:30 a.m.

Place: Key Bridge Marriott Hotel, 1401 Lee

Highway, Arlington, VA 22209.

Contact Person: Mark Swieter, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–42, Telephone (301) 443–2620.

Name of Committee: Epidemiology and

Prevention Research Subcommittee.

Date: February 10–12, 1998.

Time: 8:30 a.m.

Place: Bethesda Marriott Hotel, 5151 Pooks

Hill Road, Bethesda, MD 20814.

Contact Person: Raquel Crider, Ph.D.,

Scientific Review Administrator, Office Of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–9042.

Name of Committee: Molecular, Cellular

and Chemical Neurobiology Research

Subcommittee.

Date: February 10–12, 1998.

Time: 8:30 a.m.

Place: Ritz-Carlton Hotel at Pentagon City,

250 South Hayes Street, Arlington, VA

22202.

Contact Person: Rita Liu, Ph.D., Scientific

Review Administrator, Office of Extramural

Program Review, National Institute on Drug

Abuse, 5600 Fishers Lane, Room 10–22,

Telephone (301) 443–9042.

Name of Committee: NIDA Special

Emphasis Panel (Molecular, Cellular and

Chemical Neurobiology).

Date: February 12, 1998.

Time: 9:00 a.m.

Place: Ritz-Carlton Hotel at Pentagon City,

250 South Hayes Street, Arlington, VA

22202.

Contact Person: Mary C. Custer, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–2620.

Name of Committee: Neuropharmacology

Research Subcommittee.

Date: February 17–19, 1998.

Time: 8:30 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Syed Husain, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–2620.

Name of Committee: Treatment Research

Subcommittee.

Date: March 2–4, 1998.

Time: 8:30 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Kesinee Nimit, M.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–9042.

Name of Committee: NIDA Special

Emphasis Panel (Training and Career

Development).

Date: March 2–4, 1998.

Time: 8:30 a.m.