30072 Federal Register / Vol. 61, No. 115 / Thursday, June 13, 1996 / Notices

A. Federal Reserve Bank of Atlanta

(Zane R. Kelley, Vice President) 104

Marietta Street, N.W., Atlanta, Georgia

30303:

1. ABC Bancorp, Moultrie, Georgia; to

merge with First National Financial

Corporation, Albany, Georgia, and

thereby indirectly acquire First National

Bank of South Georgia, Albany, Georgia.

Board of Governors of the Federal Reserve

System, June 7, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–14999 Filed 6–12–96; 8:45 am]

BILLING CODE 6210-01-F

Notice of Proposals to Engage in

Permissible Nonbanking Activities or

to Acquire Companies that are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation

Y, (12 CFR part 225) to engage de novo,

or to acquire or control voting securities

or assets of a company that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.25 of Regulation

Y (12 CFR 225.25) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

Once the notice has been accepted for

processing, it will also be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether the proposal complies

with the standards of section 4 of the

BHC Act, including whether

consummation of the proposal can

‘‘reasonably be expected to produce

benefits to the public, such as greater

convenience, increased competition, or

gains in efficiency, that outweigh

possible adverse effects, such as undue

concentration of resources, decreased or

unfair competition, conflicts of

interests, or unsound banking practices’’

(12 U.S.C. 1843). Any request for a

hearing on this question must be

accompanied by a statement of the

reasons a written presentation would

not suffice in lieu of a hearing,

identifying specifically any questions of

fact that are in dispute, summarizing the

evidence that would be presented at a

hearing, and indicating how the party

commenting would be aggrieved by

approval of the proposal.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than June 27, 1996.

A. Federal Reserve Bank of New

York (Christopher J. McCurdy, Senior

Vice President) 33 Liberty Street, New

York, New York 10045:

1. North Fork Bancorporation, Inc.,

Mattituck, New York; to acquire Haven

Bancorp, Inc., Woodhaven, New York,

and thereby indirectly acquire Columbia

Federal Savings Bank, Woodhaven, New

York, and thereby engage in operating a

federal savings and loan association,

pursuant to § 225.25(b)(9) of the Board’s

Regulation Y.

B. Federal Reserve Bank of Kansas

City (John E. Yorke, Senior Vice

President) 925 Grand Avenue, Kansas

City, Missouri 64198:

1. Commercial Guaranty Bancshares,

Inc., Shawnee Mission, Kansas; to

engage de novo through its subsidiary,

C.G. Capital Corporation, Overland

Park, Kansas, in providing financial and

investment advice, pursuant to §

225.25(b)(4) of the Board’s Regulation Y;

and in providing management

consulting services to depository

institutions, pursuant to § 225.25(b)(11)

of the Board’s Regulation Y.

Board of Governors of the Federal Reserve

System, June 7, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–15000 Filed 6–12–96; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[R–13]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Conditions of

Coverage for Organ Procurement

Organizations; Form No.: HCFA–R–13;

Use: Organ procurement organizations

are required to submit accurate data to

HCFA concerning population and

information on donors and organs on an

annual basis in order to assure

maximum effectiveness in the

procurement and distribution of organs.

Frequency: Annually; Affected Public:

Not-for-profit institutions; Number of

Respondents: 66; Total Annual

Responses: 66; Total Annual Hours

Requested: 1.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Planning and

Analysis Staff, Attention: Louis Blank,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: June 5, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources.

[FR Doc. 96–15003 Filed 6–12–96; 8:45 am]

BILLING CODE 4120–03–P

[HSQ–231–N]

Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of 1988

Exemption of Laboratories in the State

of Oregon

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: Section 353(p) of the Public

Health Service Act provides for the

exemption of laboratories from the

requirements of the Clinical Laboratory

Improvement Amendments of 1988

(CLIA) when the State in which they are

located has requirements equal to or

more stringent than those of CLIA. This
Federal Register / Vol. 61, No. 115 / Thursday, June 13, 1996 / Notices 30073

notice grants exemption from CLIA

requirements and is applicable only to

laboratories located within the State of

Oregon that possess a valid State

license.

EFFECTIVE DATE: The provisions of this

notice are effective on June 13, 1996,

through December 31, 1999.

FOR FURTHER INFORMATION CALL: Val

Coppola, (410) 786–3354.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

Section 353 of the Public Health

Service Act, as amended by the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA), requires any laboratory

that performs tests on human specimens

to meet the requirements established by

the Department of Health and Human

Services. Under the provisions of the

sentence following section 1861(s)(14)

and paragraph (s)(16) of the Social

Security Act, any laboratory that also

requests to be paid for services

furnished to Medicare beneficiaries

must meet the requirements of section

353 of the Public Health Service Act.

Subject to specified exceptions,

laboratories must have a current and

valid CLIA certificate to test human

specimens to be eligible for payment

from the Medicare or Medicaid program.

Regulations implementing section 353

of the Public Health Service Act are

contained in 42 CFR part 493,

Laboratory Requirements.

Section 353(p) of the Public Health

Service Act provides for the exemption

of laboratories from CLIA requirements

in a State that applies requirements that

are equal to or more stringent than those

of CLIA. The statute does not

specifically require the promulgation of

criteria for the exemption of laboratories

in a State. The decision to grant CLIA

exemption to laboratories within a State

is at HCFA’s discretion, acting on behalf

of the Secretary of Health and Human

Services.

Part 493, subpart E, Accreditation by

a Private, Nonprofit Accreditation

Organization or Exemption Under an

Approved State Laboratory Program

implements section 353(p) of the Public

Health Service Act. Section 493.513

provides that we may exempt from CLIA

requirements, for a period not to exceed

6 years, State licensed or approved

laboratories in a State if the State meets

specified conditions. Section 493.513(k)

provides that we will publish a notice

in the Federal Register announcing the

names and basis for exemption of States

whose laboratories are exempt from

meeting the requirements of part 493.

II. Notice of Approval of CLIA

Exemption to Laboratories in the State

of Oregon

In this notice, we grant CLIA

exemption for all specialties and

subspecialties to all laboratories located

in the State of Oregon that possess a

valid license to perform laboratory

testing effective June 13, 1996, through

December 31, 1999.

III. Evaluation of The Oregon State

Laboratory Program

The following describes the process

we used to determine whether we

should grant exemption from CLIA

requirements to licensed Oregon

laboratories.

A. Requirements for Granting CLIA

Exemption

To determine whether we should

grant a CLIA exemption to all

laboratories within the State of Oregon,

we conducted a detailed and indepth

comparison of Oregon State’s

requirements for its laboratories to those

of CLIA and evaluated whether Oregon

State’s standards meet the requirements

at § 493.513. In summary, we evaluated

whether the State of Oregon—

• Has laws in effect that provide for

requirements that are equal to or more

stringent than CLIA requirements;

• Has an agency that licenses or

approves laboratories meeting State

requirements that also meet or exceed

CLIA requirements, and would,

therefore, meet the condition level

requirements of the CLIA regulations;

• Demonstrates that it has

enforcement authority and

administrative structures and resources

adequate to enforce its laboratory

requirements;

• Permits us or our agents to inspect

laboratories within the State;

• Requires laboratories within the

State to submit to inspections by us or

our agents as a condition of licensure;

• Agrees to pay the cost of the

validation program administered by us

and the cost of the State’s pro rata share

of the general overhead to develop and

implement CLIA as specified in

§§ 493.645(a) Fee(s) applicable to

accredited laboratories/approved State

licensure programs and 493.646(b)

Payment of fees; and

• Takes appropriate enforcement

action against laboratories found by us

or our agents not to be in compliance

with requirements comparable to

condition level requirements.

We also evaluated whether the State

of Oregon laboratory program meets the

requirements and licenses laboratories

in accordance with § 493.515, Federal

review of laboratory requirements of

State laboratory programs.

As specified in § 493.515, our review

of a State laboratory program includes

(but is not necessarily limited to) an

evaluation of—

• Whether the State’s requirements

for laboratories are equivalent to or

more stringent than the CLIA condition

level requirements;

• The State’s inspection process

requirements to determine—

—The comparability of the full

inspection and complaint inspection

procedures to our procedures;

—The State’s enforcement procedures

for laboratories found to be out of

compliance with its requirements;

and

—The ability of the State to provide us

with electronic data and reports with

the adverse or corrective actions

resulting from proficiency testing

results that constitute unsuccessful

participation in HCFA-approved

proficiency testing programs and with

other data we determine to be

necessary for validation and

assessment of the State’s inspection

process requirements;

• The State’s agreement to—

—Notify us within 30 days of the action

taken against any CLIA-exempt

laboratory that has had its licensure or

approval withdrawn or revoked or

been in any way sanctioned;

—Notify us within 10 days of any

deficiency identified in a CLIAexempt laboratory in cases when the

deficiency poses an immediate

jeopardy to the laboratory’s patients

or a hazard to the general public;

—Notify each laboratory licensed by the

State within 10 days of our

withdrawal of the exemption;

—Provide us with written notification of

any changes in its licensure (or

approval) and inspection

requirements;

—Disclose any laboratory’s proficiency

testing results in accordance with the

State’s confidentiality requirements;

—Take the appropriate enforcement

action against laboratories we find not

to be in compliance with

requirements comparable to condition

level requirements and report these

enforcement actions to us;

—Notify us of all newly licensed

laboratories, including the specialties

and subspecialties for which any

laboratory performs testing, within 30

days; and

—Provide to us, as requested, inspection

schedules for validation purposes.
30074 Federal Register / Vol. 61, No. 115 / Thursday, June 13, 1996 / Notices

B. Evaluation of the Oregon State

Request for CLIA Exemption

The State of Oregon has formally

applied to us for an exemption from the

CLIA requirements for laboratories

located within the State that possess a

valid State license.

We have evaluated the Oregon State’s

CLIA exemption application and all

subsequent submissions for equivalency

against the three major categories of

CLIA rules: The implementing

regulations, the enforcement

regulations, and the deeming/exemption

requirements. The statutory

requirements pertaining to laboratories

in Oregon are found at Chapter 438,

Clinical Laboratories, in the Oregon

Revised Statutes. We found the

Laboratory Licensing Section of the

Center for Public Health Laboratories,

which issues, implements, and enforces

regulations specified in the Oregon

Administrative Rule, Division 24,

Chapter 333, to administer a program

that is equal to the CLIA program, taken

as a whole. We performed an indepth

evaluation of the Oregon application to

verify the State’s assurance of

compliance with the following subparts

of part 493.

Subpart E, Accreditation by a Private,

Nonprofit Accreditation Organization

or Exemption Under an Approved State

Laboratory Program

HCFA and the Centers for Disease

Control and Prevention staff reviewers

have examined the Oregon State

application and all subsequent

submissions against the exemption

requirements that a State must meet in

order to be granted CLIA-exempt status

(§ 493.513 and the applicable parts of

§§ 493.515, 493.517, 493.519, and

493.521, which concern General

requirements for CLIA-exempt

laboratories; Federal review of

laboratory requirements of State

laboratory programs; Validation

inspections of CLIA-exempt

laboratories; Continuing Federal

oversight of an approved State

laboratory program; and Removal of

CLIA exemption and final

determinations review). The State has

complied with the applicable CLIA

requirements for exemption under this

subpart.

Subpart H, Participation in Proficiency

Testing for Laboratories Performing

Tests of Moderate Complexity

(Including the Subcategory), High

Complexity, or Any Combination of

These Tests

The Oregon Administrative Rule

requires licensed laboratories within

Oregon to enroll and participate in a

HCFA-approved proficiency testing

program for all tests listed in Subpart I

of the CLIA regulations. Oregon has

adopted the requirements of Subpart H,

Participation in proficiency testing for

laboratories performing tests of

moderate complexity (including the

subcategory), high complexity, or any

combination of these tests.

Therefore, the proficiency testing

requirements of Oregon are equivalent

to those of CLIA.

Subpart J, Patient Test Management

for Moderate Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

Oregon has modified its requirements

for patient test management to be equal

to those of the CLIA regulations.

Subpart K, Quality Control for Tests of

Moderate Complexity (Including the

Subcategory), High Complexity, or Any

Combination of These Tests

The Oregon Administrative Rule

recognizes the CLIA categorization of

tests and stipulates quality control

requirements for moderate complexity

(including the subcategory of provider

performed microscopy), and high

complexity tests that are equivalent to

the respective CLIA requirements, taken

as a whole.

Subpart M, Personnel for Moderate

Complexity (Including the

Subcategory) and High Complexity

Testing

The personnel requirements of the

Oregon Administrative Rule are

equivalent to those of CLIA for all levels

of testing complexity.

Subpart P, Quality Assurance for

Moderate Complexity (Including the

Subcategory) or High Complexity

Testing, or Any Combination of These

Tests

The applicable standards of the

Oregon Administrative Rule are equal to

the CLIA requirements at §§ 493.1701

through 493.1721, which address

quality assurance.

Subpart Q, Inspection

Oregon laboratories that possess a

license for moderate or high complexity

testing are routinely inspected on-site,

biennially. Routine inspections are

usually announced. All complaint

inspections are unannounced. The

Oregon State Laboratory Licensing

Section implements inspection

requirements and policies that are equal

to those of CLIA.

Subpart R, Enforcement Procedures

We have reviewed documentation of

Oregon State’s enforcement authority,

its administrative structure and the

resources used to enforce its standards.

The State appropriately applies

limitations and revocations of its

licenses for laboratories as well as other

categories of penalties. Dependent upon

probable circumstances, Oregon may

impose a directed plan of correction, it

may refuse to issue a license or permit,

or, if necessary, it could initiate

criminal penalties.

The State of Oregon has provided us

with the mechanism it currently uses to

monitor the proficiency testing

performance of its laboratories. The

initial action taken by Oregon State for

unsuccessful proficiency testing

performance requires the laboratory to

determine the cause of the failure,

document corrective actions and

provide an assurance that patient testing

is correctly performed. If no response or

an inadequate response is received,

procedures to remove the analyte,

subspecialty, or specialty from the

laboratory’s license will be initiated.

The State may perform an on-site

inspection due to unsuccessful

proficiency testing performance.

The State of Oregon has provided

appropriate documentation

demonstrating that its enforcement

policies and procedures are equivalent

to those of CLIA.

IV. Federal Validation Inspections and

Continuing Oversight

The Federal validation inspections of

CLIA-exempt laboratories, as specified

in § 493.517, will be conducted on a

representative sample basis as well as in

response to substantial allegations of

noncompliance (complaint inspections).

The outcome of those validation

inspections will be our principal means

for verifying the appropriateness of the

exemption given to laboratories in

Oregon. This Federal monitoring is an

on-going process. The State of Oregon

will provide us with survey findings for

each laboratory selected for validation.
Federal Register / Vol. 61, No. 115 / Thursday, June 13, 1996 / Notices 30075

V. Removal of Approval of Oregon

State Exemption

We will remove the CLIA exemption

of laboratories located in the State of

Oregon that possess a valid license if we

determine the outcome and

comparability review of validation

inspections are not acceptable as

described under § 493.521 or if the State

fails to pay the required fee as stated

under § 493.645(a).

VI. Laboratory Data

In accordance with

§ 493.513(d)(2)(iii), Oregon State will

provide us with changes to a

laboratory’s specialties or subspecialties

based on the State’s survey and with

changes in a laboratory’s licensure

status.

VII. Required Administrative Actions

CLIA is a user-fee funded program.

The registration fee paid by the

laboratories is used to cover the cost of

the development and administration of

the program. However, when a State’s

application for exemption is approved,

we may not charge a fee to laboratories

in the State that are covered by the

exemption. The State’s share of the costs

associated with CLIA must be collected

from the State. Section 493.645 specifies

that Health and Human Services

assesses fees that a State must pay for

the following:

• Costs of Federal inspection of

laboratories in the State to verify that

standards are enforced in an appropriate

manner. The average cost per validation

survey nationally is multiplied by the

number of surveys that will be

conducted.

• Costs incurred for Federal

investigations and surveys triggered by

complaints that are substantiated. We

bill the State for these costs. We

anticipate that most of these surveys

will be referred to the State and that

there will be little Federal activity in

this area.

• The State’s proportionate share of

general overhead costs for the items and

services it benefits from and only for

those paid for out of registration or

certificate fees we collected.

In order to estimate Oregon State’s

proportionate share of the general

overhead costs, we determined the ratio

of laboratories in Oregon State to the

total number of laboratories nationally.

In that the general overhead costs apply

equally to all laboratories, we

determined the cumulative overhead

costs that should be assumed by the

State of Oregon.

The State of Oregon has agreed to pay

us its pro rata share of the overhead

costs and anticipated costs of actual

validation and complaint investigation

surveys. A final reconciliation for all

laboratories and all expenses will be

made. We will reimburse the State for

any overpayment or bill it for any

balance.

In accordance with the provisions of

Executive Order 12866, this notice was

not reviewed by the Office of

Management and Budget.

Authority: Section 353 of the Public Health

Service Act (42 U.S.C. 263a).

Dated: May 13, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 96–14969 Filed 6–12–96; 8:45 am]

BILLING CODE 4120–01–P

Health Resources and Services

Administration

Availability of Funds for the

Community Scholarship Programs

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of available funds.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces the availability of

approximately $100,000 under section

338L of the Public Health Service (PHS)

Act for competing and project period

renewal Grants to States for Community

Scholarship Programs (CSP).

The purpose of the CSP is to enable

States to increase the availability of

primary health care in urban and rural

federally designated health professional

shortage areas (HPSAs) by assisting

community organizations to provide

scholarships for the education of

individuals to serve as health

professionals in these communities.

The PHS is committed to achieving

the health promotion and disease

prevention objectives of Healthy People

2000, a PHS-led national activity. This

grant program is related to the objectives

of improving access to and availability

of primary health care services for all

Americans, especially the underserved

populations. Potential applicants may

obtain a copy of Healthy People 2000

(Full Report: Stock No. 017–001–00474–

0) or Healthy People 2000 (Summary

Report; Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, D.C. 20402–9325

(telephone number 202–783–3238).

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and promote the non-use of

all tobacco products. In addition, Public

Law 103–227, the Pro-Children Act of

1994, prohibits smoking in certain

facilities (or in some cases, any portion

of a facility) in which regular or routine

education, library, day care, health care

or early childhood development

services are provided to children.

DATES: Applications are due July 15,

1996. Applications will be considered to

have met the deadline if they are (1)

received on or before the deadline date;

or (2) postmarked on or before the

established deadline date and received

in time for orderly processing.

Applicants should request a legibly

dated U.S. Postal Service postmark or

obtain a receipt from a commercial

carrier. Private metered postmarks will

not be acceptable as proof of timely

mailing. Late applications not accepted

for processing will be returned to the

applicant.

ADDRESSES: Application materials may

be obtained from, and completed

applications should be returned to: Ms.

Alice H. Thomas, Grants Management

Officer, Bureau of Primary Health Care

(BPHC), 4350 East-West Highway, 11th

Floor, Bethesda, Maryland 20814, (301)

594–4250. The Grants Management staff

is available to provide assistance on

business management issues.

Applications for these grants will be

made on PHS Form 5161–1 with revised

face sheet DHHS Form 424, as approved

by the Office of Management and

Budget (OMB) under control number

0937–0189.

FOR FURTHER INFORMATION CONTACT: For

general program information and

technical assistance, please contact

Sharley L. Chen, Division of

Scholarships and Loan Repayments,

BPHC, HRSA, 4350 East-West Highway,

10th Floor, Bethesda, Maryland 20814,

at (301) 594–4400.

SUPPLEMENTARY INFORMATION: In FY

1996, approximately $100,000 will be

awarded for 3–5 new and project period

renewal grants ranging from $5,000 to

$75,000 for a 12-month budget period

and up to a 3-year project period. Under

this program, States enter into

agreements with public or private

nonprofit community organizations

located in federally designated HPSAs.

These organizations will recruit

qualified residents of their communities

and provide scholarships to them to

become physicians, certified nurse

practitioners, certified nurse midwives,

or physician assistants based on the

needs of the communities.

This grant program is intended to be

consistent with the efforts of the

National Health Service Corps (NHSC)

Scholarship Program, NHSC Loan

Repayment Program and NHSC State