Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Proposed Rules 67163

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Medicare & Medicaid

Services

Centers for Disease Control and

Prevention

42 CFR Part 493

[CMS–2094–P]

RIN 0938–AK83

Medicare, Medicaid, and CLIA

Programs; Qualification Requirements

for Directors of Laboratories

Performing High Complexity Testing

AGENCY: Centers for Disease Control and

Prevention (CDC) and Centers for

Medicare & Medicaid Services (CMS),

HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would

revise and expand the qualification

requirements by which an individual

with a doctoral degree may qualify to

serve as a director of a laboratory that

performs high complexity testing.

DATES: We will consider comments if

we receive them at the appropriate

address, as provided below, no later

than 5 p.m. on January 28, 2002.

ADDRESSES: Mail written comments (one

original and three copies) to the

following addresses:

Centers for Disease Control and

Prevention, Department of Health and

Human Services, Attention: CMS–

2094–P, 4770 Buford Hwy., NE., MS

F11, Atlanta, Georgia 30341–3724;

and

Centers for Medicare & Medicaid

Services, Department of Health and

Human Services, Attention: CMS–

2094–P, P.O. Box 8018, Baltimore,

MD 21244–8018

To ensure that mailed comments are

received in time for us to consider them,

please allow for possible delays in

delivering them.

If you prefer, you may deliver your

written comments (one original and

three copies) to one of the following

addresses: Room 443–G, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201, or

Room C5–14–03, 7500 Security

Boulevard, Baltimore, MD 21244–8018.

Comments mailed to the above

addresses may be delayed and received

too late for us to consider them.

Because of staff and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. In

commenting, please refer to file code

CMS–2094–P.

For information on viewing public

comments, see the beginning of the

SUPPLEMENTARY INFORMATION section.

For information on ordering copies of

the Federal Register containing this

document and electronic access, see the

beginning of the SUPPLEMENTARY

INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Rhonda S. Whalen (CDC), (770) 488–

8155. Cecelia Hinkel (CMS), (410) 786–

3531.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments

Comments received timely will be

available for public inspection as they

are received, generally beginning

approximately 3 weeks after publication

of a document, in Room C5–12–17 of

the Centers for Medicare & Medicaid

Services, 7500 Security Blvd.,

Baltimore, MD, on Monday through

Friday of each week from 8:30 a.m. to

5 p.m. To schedule an appointment to

review public comments, phone: (410)

786–9994.

Availability of Copies and Electronic

Access

Copies: To order copies of the Federal

Register containing this document, send

your request to: New Orders,

Superintendent of Documents, P.O. Box

371954, 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 toll free at 1–888–293–

6498) or by faxing to (202) 512–2250.

The cost for each copy is $9. 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. The Website address is: http://

www.access.gpo.gov/nara/index.html.

I. Background

On February 28, 1992, we published

a final rule with comment period in the

Federal Register (57 FR 7002). The

regulation set forth the requirements for

laboratories that are subject to the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA). The

regulation established uniform

requirements for all laboratories

regardless of location, size, or type of

testing performed. In developing the

regulation, we included requirements

that we believed would ensure the

quality of laboratory services and be in

the best interest of the public health. We

recognized that a rule of this scope

required time for laboratories to

understand and implement the new

requirements. Therefore, certain

requirements were given prospective

effective dates.

The February 28, 1992 rule extended

the timeframe to allow a director of a

laboratory performing high complexity

testing to be certified by a board

approved by the Department of Health

and Human Services (HHS). This

extension allowed time for laboratory

directors who were not board certified

to complete the certification

requirements and for HHS to review and

approve certification boards. Until

December 31, 2002, individuals with a

doctoral degree and 2 years of laboratory

training or experience and 2 years of

experience directing or supervising high

complexity testing would be qualified to

be directors of laboratories performing

high complexity testing.

The final rules with comment period

published on December 6, 1994 in the

Federal Register (59 FR 62606), May 12,

1997 in the Federal Register (62 FR

25855), October 14, 1998 in the Federal

Register (63 FR 55031), and December

29, 2000 in the Federal Register (65 FR

82941) extended the date by which an

individual with a doctoral degree was

required to be board certified in order to

qualify as a director of a laboratory that

performs high complexity testing. These

date extensions were established to

allow additional time for laboratory

directors who were not board certified

to complete certification requirements.

Following the publication of the

February 28, 1992 rule, many

individuals expressed concern about

making board certification a mandatory

requirement for directors of laboratories

performing high complexity testing. In

response to the publication of the date

extension regulations, we received

comments suggesting that we develop

alternative provisions to qualify

individuals with a doctoral degree on

the basis of laboratory training or

experience, instead of requiring board

certification.

II. Provisions of the Proposed Rule

Upon consideration, we realize that

individuals currently serving as

laboratory directors are qualified based

on training and experience, and have

demonstrated the level of competency

necessary to direct laboratories

performing high complexity testing.

67164 Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Proposed Rules

Therefore, we are proposing to revise

and expand the qualification

requirements at § 493.1443(b)(3). The

proposed change provides three

alternatives for an individual to meet in

order to be qualified to serve as a

director of a laboratory performing high

complexity testing.

First, an individual who holds an

earned doctoral degree and is certified

by an HHS-approved board is qualified.

Second, an individual who is or has

been the director of a laboratory

performing high complexity testing

before January 1, 2003, and holds an

earned doctoral degree in a chemical,

physical, biological, or clinical

laboratory science from an accredited

institution; and has 2 years of laboratory

training or experience, or both; and 2

years experience directing or

supervising high complexity testing will

be qualified.

Finally, an individual who holds an

earned doctoral degree but has never

been the director of a laboratory

performing high complexity testing

must have at least 6 years of laboratory

training or experience, or both;

including 2 years of experience

directing or supervising high

complexity testing.

We are particularly interested in

receiving comments on the appropriate

combination of education and

experience needed to ensure

competency in directing a laboratory

performing high complexity testing in

the absence of board certification.

III. Response to Comments

Because of the large number of

correspondence we normally receive on

Federal Register documents published

for comment, we are not able to

acknowledge or respond to them

individually. We will consider all

comments we receive by the date and

time specified in the DATES section of

this preamble, and, if we proceed with

a subsequent document, we will

respond to the major comments in the

preamble of that document.

IV. Regulatory Impact Statement

Overall Impact

We have examined the impacts of this

rule as required by Executive Order

12866 (September 1993, Regulatory

Planning and Review) and the

Regulatory Flexibility Act (RFA)

(September 19, 1980, Public Law 96–

354). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

if regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety effects, distributive impacts,

and equity). A regulatory impact

analysis (RIA) must be prepared for

major rules with economically

significant effects ($100 million or more

annually). This rule is not a major rule,

and we do not anticipate that these

provisions will have an impact of $100

million or more in any 1 year.

The RFA requires agencies to analyze

options for regulatory relief of small

businesses. For purposes of the RFA,

small entities include small businesses,

nonprofit organizations, and

government agencies. Most hospitals

and most other providers and suppliers

are small entities, either by nonprofit

status or by having revenues of $10

million or less annually. For purposes of

the RFA, all laboratories are considered

to be small entities. Individuals and

States are not included in the definition

of a small entity.

In addition, section 1102(b) of the Act

requires us to prepare a regulatory

impact analysis if a rule may have a

significant impact on the operations of

a substantial number of small rural

hospitals. This analysis must conform to

the provisions of section 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 of

a Metropolitan Statistical Area and has

fewer than 100 beds.

This rule applies only to the

qualifications of individuals hired to

direct laboratories performing high

complexity testing and does not have

any direct impact on laboratories. In

addition, the rule would allow high

complexity laboratory directors who

have a doctoral degree and laboratory

experience but are not certified by an

HHS-approved board two options to

maintain their director qualifications.

These options would ensure that

currently employed laboratory directors

including those directors of State public

health laboratories would continue their

laboratory director services. The

essential participation of these public

health laboratories in the homeland

defense effort would be compromised

without the options provided in this

rule. In the absence of this proposed

change, the experienced individuals

who have a doctoral degree without

board certification and are serving as

directors of laboratories performing high

complexity testing would be ineligible

to continue serving in their current

positions, further exacerbating the

existing shortage of qualified personnel

in clinical and public health

laboratories.

Therefore, we are proposing certifying

that this rule will not have significant

economic impact on a substantial

number of small entities.

Section 202 of the Unfunded

Mandates Reform Act of 1995 also

requires that agencies assess anticipated

costs and benefits before issuing any

rule that may result in an expenditure

in any 1 year by State, local, or tribal

governments, in the aggregate, or by the

private sector, of $110 million. We do

not anticipate these provisions will have

an impact of $110 million or more in

any 1 year. This proposed rule has no

consequential effect on State, local, or

tribal governments. Therefore, we have

not prepared a regulatory impact

analysis.

Federalism

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.

We have reviewed this proposed rule

under the threshold criteria of Executive

Order 13132, Federalism, and have

determined that this proposed rule

would not have a substantial effect on

State, local, or tribal governments.

In accordance with the provisions of

Executive Order 12866, this regulation

was reviewed by the Office of

Management and Budget.

List of Subjects in 42 CFR Part 493

Grant programs—health, Health

facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping

requirements.

For the reasons set forth in the

preamble, the Centers for Medicare &

Medicaid Services would amend 42 CFR

chapter IV, part 493 as set forth below:

PART 493—LABORATORY

REQUIREMENTS

1. The authority citation for part 493

continues to read as follows:

Authority: Sec. 353 of the Public Health

Service Act, secs. 1102, 1861(e), and the

sentence following sections 1861(s)(11)

through 1861(s)(16) of the Social Security Act

(42 U.S.C. 263a, 1302, 1395x(e), and the

sentence following 1395x(s)(11) through

1395x(s)(16)).

2. In § 493.1443, paragraph (b)

introductory text is republished, and

paragraph (b)(3) is revised to read as

follows:

§ 493.1443 Standard; Laboratory director

qualifications.

* * * * *

(b) The laboratory director must—

* * * * *

Federal Register / Vol. 66, No. 249 / Friday, December 28, 2001 / Proposed Rules 67165

(3) Hold an earned doctoral degree in

a chemical, physical, biological, or

clinical laboratory science from an

accredited institution and—

(i) On or after January 1, 2003, be

certified and continue to be certified by

a board approved by HHS;

(ii) Before January 1, 2003, must have

served or be serving as director of a

laboratory performing high complexity

testing and must have at least—

(A) Two years of laboratory training or

experience, or both; and

(B) Two years of experience directing

or supervising high complexity testing;

or

(iii) Have at least 6 years of laboratory

training or experience, or both;

including 2 years experience directing

or supervising high complexity testing.

* * * * *

(Catalog of Federal Domestic Assistance

Program No. 93.778, Medical Assistance

Program)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: July 23, 2001.

Jeffrey P. Koplan,

Director, Centers for Disease Control and

Prevention.

Dated: August 30, 2001.

Thomas A. Scully,

Administrator, Centers for Medicare &

Medicaid Services.

Dated: October 11, 2001.

Tommy G. Thompson,

Secretary.

[FR Doc. 01–31722 Filed 12–27–01; 8:45 am]

BILLING CODE 4120–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 54 and 69

[CC Docket Nos. 00–256, 96–45; DA 01–

2916]

Multi-Association Group (MAG) Plan

for Regulation of Interstate Services of

Non-Price Cap Incumbent Local

Exchange Carriers and Interexchange

Carriers; Limited Extension of Time for

Filing Comments and Replies in Rateof-Return Access Charge Reform

Proceeding

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule; extension of

time.

SUMMARY: In this document, the

Commission extends the time by 45

days for filing comments and reply

comments in the Rate-of-Return Access

Charge Reform proceeding. Certain

members of the Multi-Association

Group (MAG) requested an extension of

time for filing comments. This

proceeding seeks additional comment

on proposals for incentive regulation,

proposed changes to the ‘‘all-ornothing’’ rule, pricing flexibility for

rate-of-return carriers, and merging the

Long Term Support mechanism into the

new Interstate Common Line Support

mechanism.

DATES: Comments are due on or before

February 14, 2002, and reply comments

are due on or before March 18, 2002.

ADDRESSES: Parties who choose to file

comments by paper should send

comments to Magalie Roman Salas,

Office of the Secretary, Federal

Communications Commission, 445 12th

St., SW; TW-A325, Washington, DC

20554. Comments filed through the

Commission’s Electronic Comment

Filing System (ECFS) can be sent as an

electronic file via the Internet to http:/

/www.fcc.gov/e-file/ecfs.html.

FOR FURTHER INFORMATION CONTACT:

Marvin F. Sacks at (202) 418–2017

(Common Carrier Bureau).

SUPPLEMENTARY INFORMATION: On

November, 8, 2001, the Commission

released the Second Report and Order

and Further Notice of Proposed

Rulemaking (‘‘FNPRM’’) in CC Docket

Nos. 00–256 and 96–45, FCC 01–304,

published at 66 FR 59761, November 30,

2001. Certain members of the MultiAssociation Group (MAG) requested an

extension of time for filing comments in

the FNPRM. This proceeding seeks

additional comment on proposals for

incentive regulation, proposed changes

to the ‘‘all-or-nothing’’ rule, pricing

flexibility for rate-of-return carriers, and

merging the Long Term Support

mechanism into the new Interstate

Common Line Support mechanism.

When filing comments and reply

comments, parties should reference CC

Docket Nos. 00–256 and 96–45, and

conform to the filing procedures

contained in this FNPRM. The complete

text is available for inspection and

copying during normal business hours

in the FCC Reference Center, 445 12th

Street, SW, Washington, DC, and also

may be purchased from the

Commission’s copy contractor, Qualex

International, 445 12th Street, SW, CY–

B402, Washington, DC 20554. The

FNPRM is also available via the Internet

at http://hraunfoss.fcc.gov/

edocs_public/attachmatch/FCC–01–

304A1.pdf.

Federal Communications Commission.

Jack Zinman,

Deputy Division Chief, Competitive Pricing

Division.

[FR Doc. 01–31864 Filed 12–27–01; 8:45 am]

BILLING CODE 6712–01–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

RIN 1018–AH96

Endangered and Threatened Wildlife

and Plants; Proposed Designation of

Critical Habitat for the Northern Great

Plains Breeding Population of the

Piping Plover; Reopening of Public

Comment Period and Notice of

Availability of Draft Economic Analysis

AGENCY: Fish and Wildlife Service,

Interior.

ACTION: Proposed rule; reopening of

public comment period and notice of

availability of economic analysis.

SUMMARY: We, the U.S. Fish and

Wildlife Service, announce the

availability of the draft economic

analysis for the proposal to designate

critical habitat for the northern Great

Plains breeding population of the piping

plover (Charadrius melodus), under the

Endangered Species Act of 1973, as

amended. We also are providing notice

of the reopening of the public comment

period for the proposal to designate

critical habitat for this species, and the

associated draft environmental

assessment, to allow all interested

parties to comment. Comments

previously submitted need not be

resubmitted as they have already been

incorporated into the public record and

will be fully considered in the final rule.

Comments submitted during this

comment period also will be

incorporated into the public record and

will be fully considered in the final rule.

DATES: The comment period is opened

and will close on January 28, 2002. Any

comments that are received after the

closing date may not be considered in

the final decision on this proposal.

ADDRESSES: You may submit written

comments and information to Piping

Plover Comments, South Dakota

Ecological Services Field Office, U.S.

Fish and Wildlife Service, 420 South

Garfield Avenue, Suite 400, Pierre,

South Dakota 57501, or by facsimile to

605–224–9974.

You may hand-deliver written

comments to our South Dakota Field

Office at the address given above.