62260 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations

(1) In vitro diagnostic manufacturers;

or

(2) Organizations that use the reagents

to make tests for purposes other than

providing diagnostic information to

patients and practitioners, e.g., forensic,

academic, research, and other

nonclinical laboratories.

PART 864—HEMATOLOGY AND

PATHOLOGY DEVICES

4. The authority citation for 21 CFR

part 864 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

5. Section 864.4010 is amended by

revising paragraph (a) to read as follows:

§ 864.4010 General purpose reagent.

(a) A general purpose reagent is a

chemical reagent that has general

laboratory application, that is used to

collect, prepare, and examine specimens

from the human body for diagnostic

purposes, and that is not labeled or

otherwise intended for a specific

diagnostic application. It may be either

an individual substance, or multiple

substances reformulated, which, when

combined with or used in conjunction

with an appropriate analyte specific

reagent (ASR) and other general purpose

reagents, is part of a diagnostic test

procedure or system constituting a

finished in vitro diagnostic (IVD) test.

General purpose reagents are

appropriate for combining with one or

more than one ASR in producing such

systems and include labware or

disposable constituents of tests; but they

do not include laboratory machinery,

automated or powered systems. General

purpose reagents include cytological

preservatives, decalcifying reagents,

fixative and adhesives, tissue processing

reagents, isotonic solutions and pH

buffers. Reagents used in tests for more

than one individual chemical substance

or ligand are general purpose reagents

(e.g., Thermus aquaticus (TAQ)

polymerase, substrates for enzyme

immunoassay (EIA)).

* * * * *

6. New § 864.4020 is added to subpart

E to read as follows:

§ 864.4020 Analyte specific reagents.

(a) Identification. Analyte specific

reagents (ASR’s) are antibodies, both

polyclonal and monoclonal, specific

receptor proteins, ligands, nucleic acid

sequences, and similar reagents which,

through specific binding or chemical

reaction with substances in a specimen,

are intended for use in a diagnostic

application for identification and

quantification of an individual chemical

substance or ligand in biological

specimens. ASR’s that otherwise fall

within this definition are not within the

scope of subpart E of this part when

they are sold to:

(1) In vitro diagnostic manufacturers;

or

(2) Organizations that use the reagents

to make tests for purposes other than

providing diagnostic information to

patients and practitioners, e.g., forensic,

academic, research, and other

nonclinical laboratories.

(b) Classification. (1) Class I (general

controls). Except as described in

paragraphs (b)(2) and (b)(3) of this

section, these devices are exempt from

the premarket notification requirements

in part 807, subpart E of this chapter.

(2) Class II (special controls/guidance

documents), when the analyte is used in

blood banking tests that have been

classified as class II devices (e.g., certain

cytomegalovirus serological and

treponema pallidum nontreponemal test

reagents). Guidance Documents:

1. ‘‘Specifications for Immunological

Testing for Infectious Disease; Approved

Guideline,’’ NCCLS Document I/LA18–A,

December 1994.

2. ‘‘Assessment of the Clinical Accuracy of

Laboratory Tests Using Receiver Operating

Characteristic (ROC) Plots; Tentative

Guideline,’’ NCCLS Document KGP10–T,

December 1993.

3. ‘‘Review Criteria for Assessment of In

Vitro Diagnostic Devices for Direct Detection

of Mycobacterium spp,’’ FDA, July 6, 1993,

and its ‘‘Attachment 1,’’ February 28, 1994.

4. ‘‘Draft Review Criteria for Nucleic Acid

Amplification-Based In Vitro Diagnostic

Devices for Direct Detection of Infectious

Microorganisms,’’ FDA, July 6, 1993.

5. The Center for Biologics Evaluation and

Research, FDA, ‘‘Points to Consider in the

Manufacture and Clinical Evaluation of In

Vitro Tests to Detect Antibodies to the

Human Immunodeficiency Virus, Type I’’ (54

FR 48943, November 28, 1989).

(3) Class III (premarket approval),

when:

(i) The analyte is intended as a

component in a test intended for use in

the diagnosis of a contagious condition

that is highly likely to result in a fatal

outcome and prompt, accurate diagnosis

offers the opportunity to mitigate the

public health impact of the condition

(e.g., human immunodeficiency virus

(HIV/AIDS)or tuberculosis (TB)); or

(ii) The analyte is intended as a

component in a test intended for use in

donor screening for conditions for

which FDA has recommended or

required testing in order to safeguard

the blood supply or establish the safe

use of blood and blood products (e.g.,

tests for hepatitis or tests for identifying

blood groups).

(c) Date of 510(k), or date of PMA or

notice of completion of a product

development protocol is required. (1)

Preamendments ASR’s; No effective

date has been established for the

requirement for premarket approval for

the device described in paragraph (b)(3)

of this section. See § 864.3.

(2) For postamendments ASR’s;

November 23, 1998.

(d) Restrictions. Restrictions on the

sale, distribution and use of ASR’s are

set forth in § 809.30 of this chapter.

Dated: November 13, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–30334 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 657

RIN 2125–AE20

Truck Size and Weight; Office of

Management and Budget Control

Number and Expiration Date

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Final rule; technical

amendment.

SUMMARY: This document adopts a

technical amendment to the regulations

at 23 CFR part 657 to provide the Office

of Management and Budget (OMB)

control number for the Federal Highway

Administration’s (FHWA) collection of

information from the States about their

size and weight enforcement programs

and explains the significance of

referencing that number in 23 CFR part

657.

EFFECTIVE DATE: November 21, 1997.

FOR FURTHER INFORMATION CONTACT: Mr.

Tom Klimek, Office of Motor Carrier

Information Analysis, (202) 366–2212,

or Mr. Charles Medalen, Office of the

Chief Counsel, (202) 366–1354, Federal

Highway Administration, 400 Seventh

Street, SW., Washington, D.C. 20590.

Office hours are from 7:45 a.m. to 4:15

p.m., e.s.t., Monday through Friday,

except Federal holidays.

SUPPLEMENTARY INFORMATION: Federal

law requires each State to certify to the

Secretary of Transportation before

January 1 of each year that it is

enforcing: (1) Federal law regarding (i)

vehicle weight on the Interstate System

and (ii) vehicle size on the former

Federal-aid primary, secondary and

urban systems; and (2) State size and

weight laws on the former Federal-aid

primary, secondary and urban systems

[23 U.S.C. 141(a)].
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Rules and Regulations 62261

If the weight laws that apply on the

Interstate System in a State are not

consistent with the Federal standard [23

U.S.C. 127], the State is subject to the

withholding of its National Highway

System (NHS) funds. If the size laws

that apply on the former Federal-aid

systems mentioned above (now

designated the National Network [NN]

for trucks) are not consistent with the

Federal standard [49 U.S.C. 31111–

31114], the State is subject to injunctive

action in Federal court. If the State does

not file a certification at all, or if the

certification fails to demonstrate

adequate enforcement of State size and

weight laws, the Federal-aid funds that

would otherwise be apportioned under

23 U.S.C. 104 must be reduced by 10

percent [23 U.S.C. 141(b)(2)].

The FHWA regulations implement

these statutory mandates by requiring

each State annually to file: (1) an

enforcement plan setting forth

measurable goals; and (2) a certification

that discusses the consistency of State

law with Federal requirements and the

State’s success in achieving its

enforcement goals for the previous fiscal

year (23 CFR part 657).

Under the Paperwork Reduction Act

of 1995 [44 U.S.C. 3501 et seq.],

regulations which impose an

information collection requirement

must be authorized by the Office of

Management and Budget (OMB). The

information collection requirements of

23 CFR part 657 are currently

authorized under OMB Control Number

2125–0034, which is valid until May 31,

2000. The FHWA, however,

inadvertently failed to list the control

number in part 657 or to inform the

States of its legal significance, as

required by OMB rules [5 CFR

1320.5(b)]. When a currently valid OMB

control number is not displayed, failure

to submit to the FHWA an annual

enforcement plan or certification with

the form and content specified by part

657 would not be grounds for

withholding 10 percent of a State’s

Federal-aid highway funds [44 U.S.C.

3512(a)]. The reporting requirement [23

U.S.C. 141(a)–(b)] would remain in

effect, but any kind of ‘‘certification’’

that met the terms of the statute would

be adequate.

The FHWA is therefore amending 23

CFR part 657 to add a note at the end

stating that the information collection

requirements of that part have been

approved by OMB. The agency has held

OMB approvals for the information

collection requirements associated with

part 657 since the Paperwork Reduction

Act became effective. The FHWA finds

good cause pursuant to 5 U.S.C. 553(b)

to dispense with prior notice and an

opportunity for public comment on this

document. Part 657 was adopted

through notice and comment

rulemaking, and the FHWA applied for

and received the OMB control number

in the normal manner. This amendment

simply displays the control number, as

required by OMB rules, and is not

separately subject to notice and

comment rulemaking procedures. The

agency also finds good cause under 5

U.S.C. 553(d)(3), for the reasons given

above, to make this amendment to part

657 final upon publication in the

Federal Register.

Rulemaking Analyses and Notices

Executive Order 12866 (Regulatory

Planning and Review) and DOT

Regulatory Policies and Procedures

The FHWA has determined that this

action is neither a significant regulatory

action within the meaning of Executive

Order 12866 nor significant within the

meaning of Department of

Transportation regulatory policies and

procedures. It merely adds the OMB

control number to the regulations

requiring States to submit information

about their size and weight programs. It

is anticipated that the economic impact

of this rulemaking will be minimal;

therefore, a full regulatory evaluation is

not required.

Regulatory Flexibility Act

In compliance with the Regulatory

Flexibility Act (Pub. L. 96–354, 5 U.S.C.

601–612), the FHWA has evaluated the

effects of this rule on small entities.

Since it deals with regulations

applicable to the States, it should have

no effect on any small entities. Based on

this evaluation, the FHWA hereby

certifies that this action will not have a

significant economic impact on a

substantial number of small entities.

Executive Order 12612 (Federalism

Assessment)

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

it does not have sufficient federalism

implications to warrant the preparation

of a federalism assessment.

Executive Order 12372

(Intergovernmental Review)

Catalog of Federal Domestic

Assistance Program Number 20.205,

Highway Planning and Construction.

The regulations implementing Executive

Order 12372 regarding

intergovernmental consultation on

Federal programs and activities apply to

this program.

Paperwork Reduction Act

The information collection

requirements necessary for States to be

able to certify that they are enforcing

their size and weight laws, as provided

in 23 CFR 657, have been approved by

the OMB under control number OMB

2125–0034 in accordance with the

Paperwork Reduction Act of 1995, 44

U.S.C. 3501 et seq. The approval expires

on May 31, 2000.

National Environmental Policy Act

The agency has analyzed this action

for the purpose of the National

Environmental Policy Act of 1969 (42

U.S.C. 4321 et seq.) and has determined

that this action would not have any

effect on the quality of the environment.

Regulation Identification Number

A regulatory identification number

(RIN) is assigned to each regulatory

action listed in the Unified Agenda of

Federal Regulations. The Regulatory

Information Service Center publishes

the Unified Agenda in April and

October of each year. The RIN number

contained in the heading of this

document can be used to cross-reference

this action with the Unified Agenda.

List of Subjects 23 CFR 657

Grant programs—transportation,

Highways and roads, Motor carrier size

and weight.

Issued on: November 7, 1997.

Gloria J. Jeff,

Acting Administrator.

In consideration of the foregoing, the

FHWA amends title 23 CFR part 657 as

set forth below:

PART 657—[AMENDED]

1. The authority citation for 23 CFR

part 657 is revised to read as follows:

Authority: Sec. 123, Pub. L. 95–599, 92

Stat. 2689; 23 U.S.C. 127, 141, and 315; 49

U.S.C. 31111, 31113, and 31114; sec. 1023,

Pub. L. 102–240, 105 Stat. 1914; and 49 CFR

1.48(b)(19), (b)(23), (c)(1), and (c)(19).

2. Part 657 is amended by adding the

following note:

Note: The recordkeeping requirements

contained in this part have been approved by

the Office of Management and Budget under

control number 2125–0034.

[FR Doc. 97–30655 Filed 11–20–97; 8:45 am]

BILLING CODE 4910–22–P