39798 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations

[FR Doc. 00–16338 Filed 6–27–00; 8:45 am]

BILLING CODE 4910—13—M

DEPARTMENT OF COMMERCE

National Institute of Standards and

Technology

15 CFR Part 280

[Docket No: 980623159–0166–04]

RIN 0693–AB47

Procedures for Implementation of the

Fastener Quality Act

AGENCY: National Institute of Standards

and Technology and the Bureau of

Export Administration and the United

States Patent and Trademark Office,

United States Department of Commerce.

ACTION: Final rule.

SUMMARY: The Director of the National

Institute of Standards and Technology

(NIST), United States Department of

Commerce, and the Under Secretary of

the Bureau of Export Administration,

United States Department of Commerce,

and the Under Secretary for Intellectual

Property and Director of the United

States Patent and Trademark Office,

United States Department of Commerce

(collectively referred to as the

Department) are today issuing a final

rule amending regulations found at 15

CFR part 280 implementing the Fastener

Quality Act (FQA). A notice of proposed

rulemaking on this topic was published

in the Federal Register on December 15,

1999. This final rule responds to

comments received on the December 15,

1999 notice of proposed rulemaking and

incorporates into the regulations

amendments to the Fastener Quality Act

contained in the Fastener Quality Act

Amendments of 1999. The changes

include the elimination of testing and

paperwork requirements and of NIST’s

role in evaluating and approving bodies

that accredit laboratories and registrars.

The final rule amends the regulations

to set forth the procedures under which

NIST will accept petitions for approval

of certain documents and selfdeclarations for accreditation bodies.

The final rule also amends the

enforcement provisions of the

regulations to set forth violations as they

are contained in the amended FQA. The

final rule amends the recordal of

insignia provisions of the regulations to

remove all references to private label

distributors and to provide that

fasteners whose insignia must be

recorded are those fasteners that are

required by the applicable consensus

standards to bear ‘‘an insignia’’ rather

than a ‘‘raised or depressed insignia,’’

and that these fasteners are not subject

to the recordal requirements if the

specifications provide otherwise.

DATES: This rule is effective July 28,

2000.

FOR FURTHER INFORMATION CONTACT: Dr.

Subhas Malghan, Director’s Office,

Technology Services, National Institute

of Standards and Technology, Mail Stop

2000, Gaithersburg, MD 20899–2000,

telephone number (301) 975–4510.

SUPPLEMENTARY INFORMATION:

Background

The Fastener Quality Act (FQA) was

originally enacted in 1990 to protect the

public safety by: (1) Requiring that

certain fasteners which are sold in

commerce conform to the specifications

to which they are represented to be

manufactured, (2) providing for

accreditation of laboratories engaged in

fastener testing; and (3) requiring

inspection, testing and certification, in

accordance with standardized methods,

of fasteners covered by the Act. Since its

enactment, the FQA has been amended

three times (Pub. L. 104–113, Pub. L.

105–234, and Pub. L. 106–34). The

Department of Commerce published

final implementing regulations for the

original FQA on September 26, 1996

and for the FQA as amended by Pub. L.

104–113 on September 8, 1998.

On June 8, 1999, the Fastener Quality

Act Amendments of 1999 (the Act) (Pub.

L. 106–34, 113 Stat. 118) were enacted

‘‘to amend the Fastener Quality Act to

strengthen the protection against the

sale of mismarked, misrepresented, and

counterfeit fasteners and eliminate

unnecessary requirements, and for other

purposes.’’ The Act made significant

changes to the FQA. Under the Act, the

Secretary retains his enforcement

functions and the responsibility for

establishing and maintaining an insignia

recordation program, and the National

Institute of Standards and Technology

(NIST) must continue its fastener

laboratory accreditation program

established under the National

Voluntary Laboratory Accreditation

Program (15 CFR part 285). In addition,

the Act creates new responsibilities for

NIST, including: acting upon petitions

requesting approval of documents

setting forth guidance/requirements for

certification of manufacturing systems

as fastener quality assurance systems by

accredited third parties; acting upon

petitions requesting approval of

documents setting forth guidance/

requirements for accreditation of

laboratories; and acting upon petitions

requesting approval of documents

setting forth guidance/requirements for

approval of accreditation bodies to

accredit laboratories. NIST also must

accept affirmations, in the form of selfdeclarations that the accreditation

bodies meet the requirements of the

applicable Guide, from accreditation

bodies accrediting third parties who

certify manufacturing systems as

fastener quality assurance systems and

from accreditation bodies accrediting

laboratories.

The Act eliminates many of the

responsibilities delegated by the

Secretary of Commerce to NIST under

the FQA, including: establishing

procedures for private entities (domestic

and foreign) to accredit laboratories;

establishing conditions for recognizing

foreign laboratories accredited by their

governments or organizations;

establishing the size, selection, and

integrity of samples of fasteners to be

inspected if not provided in the

standards and specifications to which

the fasteners are manufactured;

establishing a required form for written

inspection and testing reports;

establishing which entities must retain

custody of laboratory testing reports and

certificates of conformance and for what

period of time.

The Department published a notice of

proposed rule making in the Federal

Register on December 15, 1999 (64 FR

69969), seeking public comment on

proposed amendments to the

regulations to implement the FQA as

amended by the Fastener Quality Act

Amendments of 1999. The comment

period was to close on January 14, 2000.

During the comment period, the

Department received five responses

requesting an extension of the comment

period. On January 11, 2000, the

Department published a notice in the

Federal Register ((65 FR 1572)(2000))

extending the comment period to

January 28, 2000.

Summary of Public Comments Received

by the Department in Response to the

December 15, 1999 Notice of Proposed

Rulemaking, and the Department’s

Response to Those Comments

In addition to the five responses

requesting an extension of the comment

period, the Department received

thirteen responses to the request for

comments. Five responses were

received from domestic associations;

two were from accreditation bodies, one

domestic and one foreign; one was from

a domestic fastener manufacturer; one

was from a foreign steel manufacturer;

one was from a domestic fastener

importer; one was from a domestic

fastener distributor; and one was a

domestic quality consultant. A detailed

analysis of the comments follows.

Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations 39799

Comments on the Fastener Quality Act

Amendments of 1999

Comment: Five commenters raised

concerns with the Fastener Quality Act

Amendments of 1999, not the

implementing regulations.

Response: The Department is

implementing the legislation enacted by

Congress. Comments raising concerns

with the Act, itself, are outside the

scope of this rulemaking.

Comments on the Establishment of a

Hotline System To Facilitate the

Reporting of Alleged Violations of the

FQA

Comment: Four comments related to

the fastener hotline system to facilitate

the reporting of alleged violations of the

FQA that the Secretary is required to

establish and maintain under section

6(d)(2) of the FQA, as amended. All

favored the speedy establishment of the

hotline. The three associations that

commented on this subject said that the

hotline should be operated by the

Bureau of Export Administration (BXA)

since ‘‘BXA is an experienced

enforcement agency and has

responsibility under sections 280.203

through 280.222 of the proposed

regulations for administrative

enforcement proceedings.’’ The fourth

commenter, a domestic manufacturer of

products that incorporate fasteners, said

that the National Institute of Standards

and Technology (NIST) should

implement the mandate to establish and

maintain the hotline system.

Response: Since the hotline system is

to facilitate the reporting of alleged

violations of the hotline, and is not a

general line for information regarding

the FQA, and based on the comments

received, the hotline will be operated by

BXA, with NIST providing technical

support. The telephone number for the

hotline is: 1–800–424–2980, and it will

be available beginning immediately.

This hotline is only for reporting alleged

violations, not for obtaining general

FQA information.

Comments on Laboratory

Accreditations, Laboratory

Accreditation Bodies, and Use of

Accredited Laboratories

Comment: Three commenters (all

domestic associations) noted that the

proposed rule was inconsistent with the

amended FQA on the issue of what

entities may accredit laboratories. All

three commenters noted that, while

section 3(1)(B) of the amended FQA (15

U.S.C. 5402(1)(B)) allows for

laboratories to be accredited by any

‘‘laboratory accreditation body that

meets the requirements of ISO/IEC

Guide 58 (or another document

approved by the Director under section

10(d), including revisions from time to

time,’’ section 280.103 of the proposed

rule limited laboratory accreditation

bodies to ‘‘any voluntary laboratory

accreditation program that may be

established by private sector person(s)

or by the National Voluntary Laboratory

Accreditation Program (NVLAP) for

fasteners, established by the Director

under Part 285 of this Title.’’

Response: The Department agrees.

Based on these comments, and to

eliminate the discrepancy between the

proposed rule and the amended FQA,

the Department has revised section

280.103 of the final rule. The regulation

now makes clear that both public and

private sector accreditation bodies that

meet the requirements of ISO/IEC Guide

58, in addition to NVLAP, may be

authorized to accredit fastener

laboratories.

Comment: One commenter suggested

that NIST maintain a list of laboratory

accreditation bodies that have selfaffirmed to NIST and that NIST make

the list publicly available on its website.

Response: Since NIST no longer has

authority to accept and verify

documentation regarding the

conformance of laboratory accreditation

bodies to the requirements of ISO/IEC

Guide 58 or another document approved

by the Director under section 10(d) of

the Act, NIST cannot list laboratory

accreditation bodies as meeting these

requirements. However, NIST will

maintain and make publicly available

on its website a list of laboratory

accreditation bodies that have selfdeclared to NIST. That website is: http:/

/www.nist.gov/fqa/.

Comment: One commenter pointed

out that ISO/IEC Guide 25 is being

replaced by ISO/IEC 17025 and asked if

the Department could incorporate the

new international standard into the final

rule.

Response: The FQA as amended

references ‘‘ISO/IEC Guide 25 . . .,

including revisions from time to time.’’

(15 U.S.C. 5403(3)(1)(A).) Section

280.100 of the final rule states: ‘‘For

purposes of this subpart, the term

‘‘revisions’’ includes changes made to

existing ISO/IEC Guides or other

documents, and redesignations of those

Guides or documents.’’ As a change to

and the redesignation of ISO/IEC Guide

25, ISO/IEC 17025 is acceptable under

the amended FQA and the final rule.

Comment: Two commenters had

questions about the use of accredited

laboratories for testing the chemistry of

fasteners and whether ‘‘mill test

reports’’ would be permitted as the

record of conformance on chemistry.

One of the two commenters asked: (1)

Until June 2001, would the ‘‘mill test

report issued by steel melter be

permitted as the record of conformance

on chemistry retained by

manufacturers? (2) What if the ‘‘mill test

report’’ above contains the statement

that the chemistry was tested and

certified by its entrusted subsidiary-lab?

(3) After June 2001, would the ‘‘mill test

report’’ issued by steel melter be

permitted as the record of conformance

on chemistry, if it contains the

statement that the chemistry was tested

and certified by its entrusted subsidiarylab which is accredited? The other

commenter stated: ‘‘The Department

proposed the repeal of the regulations

implementing the section 280.15, found

at 15 CFR part 280. Therefore I

understand that ‘(F) the chemistry and

grade of material’ of section 3(13) of the

Fastener Quality Act Amendments of

1999 don’t require the results tested by

the accredited laboratory.’’

Response: The answers to these

questions require a legal opinion

applying the statute to specific facts.

The Department is not authorized to

issue such opinions. Therefore, the

Department suggests that these

commenters seek counsel from their

attorneys.

Comments on Redesignated Subpart C:

Enforcement

Comment: One commenter suggested

that, since (at least in his view) almost

all fasteners are exempt from the law, it

is useless to make it a violation of the

FQA to knowingly falsify or

misrepresent fasteners, or to sell

fasteners without the manufacturers’

insignia. Another commenter stated that

the language of the proposed new

section 280.201(b) and (c) exceeded the

Department’s authority under the FQA

as it expanded the scope of the FQA.

Response: It was the Department’s

intent in the proposed new section

280.201(b) and (c) to follow the

prohibitions established by the Congress

in the FQA. In response to the comment

that this regulation is ‘‘useless,’’ the

Department notes that it is reciting the

prohibitions from the statute in the

regulations. The FQA makes it a

violation to knowingly falsify or

misrepresent certain fasteners, or to sell

some fasteners without the

manufacturers’ insignia. In response to

the second comment, the Department

was in no way attempting to expand the

authority provided to it under the FQA.

In order to make clear that the

Department is not seeking to expand

either the scope of the FQA or the

authority provided to the Department

under the FQA, it has revised these two

39800 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations

provisions to track verbatim the

language of the FQA.

Comments on Redesignated Subpart D:

Recordal of Insignia

Comment: Three commenters

suggested that the rules provide that

private label distributors of certain

fasteners be allowed to record their

insignia at the USPTO on a voluntary

basis, and to obtain certificates of

recordal. Two of these three

commenters further suggested that

original equipment manufacturers

likewise be allowed to record insignia at

the USPTO on a voluntary basis, and

one of these three commenters

suggested that any party that contracts

for the production of fasteners bearing

its insignia be allowed to record its

insignia at the USPTO on a voluntary

basis.

Response: This suggestion has not

been adopted. The FQA as amended

does not give the USPTO the authority

to issue recordals to entities that are not

fastener manufacturers. Although the

previous version of the FQA required

that both various manufacturers and

various private label distributors record

their insignias, the Fastener Quality Act

Amendments of 1999 explicitly limited

this requirement to manufacturers:

Congress specifically chose to exclude

private label distributors by deleting the

authority to register insignias of private

label distributors. Congress left in the

FQA authority to register insignias of

manufacturers only, and required that

covered fasteners bear the

manufacturer’s insignia. Hence, it

would be contrary to the Congressional

intent to record the insignia of any nonmanufacturer.

Comment: Four commenters

suggested that the wording ‘‘unless the

specifications provide otherwise’’ be

moved from section 280.300(a) to

section 280.300.

Response: This suggestion has been

adopted.

Comment: One commenter suggested

that the requirement that the insignia be

applied through a raised or depressed

impression be retained. Three

commenters suggested that this

requirement be eliminated. These

commenters noted that references to

raised or depressed insignias had been

removed from the FQA as amended, and

suggested that it was therefore

impermissible for the proposed rules to

require that the insignia be raised or

depressed. One of these three

commenters further suggested that the

proposed rule did not give

consideration to marking or

identification techniques that

manufacturers might develop either

through the consensus standards

process or independently of this

process. Another of these three

commenters suggested that the

requirement that the insignia be applied

through a raised or depressed

impression be replaced with a

requirement that the insignia be applied

so that it is permanent.

Response: The suggestion that the rule

take account of insignia marking

techniques developed through the

consensus standards, and that the

requirement that insignia be applied

through a raised or depressed

impression be eliminated has been

accepted. The Department has revised

Section 280.300(b) of the final rule to

provide that the insignia must be

applied to the fastener using the method

for applying a permanent insignia that

is provided for in the applicable

consensus standard(s), or, if the

applicable consensus standards do not

specify a method for applying a

permanent insignia, through any means

of applying a permanent insignia.

Comment: One commenter suggested

that the requirements that the insignia

appear on the head of the fastener and

that the insignia be readable with no

greater than 10x magnification are not

supported by the FQA as amended, and

that these requirements should therefore

be eliminated.

Response: This suggestion has been

adopted. The Department agrees that it

is unnecessary to specify the size and

location of the insignia. However, the

Department does believe that it is

necessary that the insignia be readable.

Accordingly, the Department has

revised Section 280.300(b) of the final

rule to remove the requirements that the

insignia be readable with no greater that

10x magnification and that the insignia

be placed on the head of the fastener,

and the Department has further revised

Section 280.300(b) to provide that the

insignia must be readable.

Comment: One commenter suggested

that Sec. 280.320(c)(6) be amended to

allow private label distributors of

fasteners and original equipment

manufacturers of fasteners to renew

their existing certificates of recordal.

Response: This suggestion has not

been adopted. The FQA as amended

does not give the USPTO the authority

to issue recordals to entities that are not

fastener manufacturers. Although the

previous version of the FQA required

that both various manufacturers and

various private label distributors record

their insignia, the amended FQA limits

this requirement to manufacturers:

Congress specifically chose to exclude

private label distributors and others

who are not manufacturers. Hence, it

would be contrary to the Congressional

intent to renew the insignia of any nonmanufacturer.

As explained in detail above, the

Department is adopting the proposed

rule with certain changes suggested by

commenters, revisions to several

sections, and some editorial corrections

and clarifications, in issuing this final

rule.

Additional Information

Executive Order 12866

This rule has been determined not to

be significant under section 3(f) of

Executive Order 12866.

Executive Order 12612

This rule does not contain policies

with Federalism implications sufficient

to warrant preparation of a Federalism

assessment under Executive Order

12612.

Regulatory Flexibility Act

The Chief Counsel for Regulation of

the Department of Commerce certified

to the Chief Counsel for Advocacy of the

Small Business Administration that this

rule will not have a significant

economic impact on a substantial

number of small entities. The basis of

this certification was published in the

notice of proposed rulemaking. No

comments were received regarding this

certification. Therefore, the Department

reaffirms the basis of the certification.

As a result, a final regulatory flexibility

analysis is not required and none has

been prepared.

Paperwork Reduction Act

Notwithstanding any other provision

of the law, no person is required to, nor

shall any person be subject to penalty

for failure to comply with, a collection

of information, subject to the

requirements of the Paperwork

Reduction Act, unless that collection of

information displays a currently valid

OMB Control Number.

This proposed rule contains

collection of information requirements

subject to the Paperwork Reduction Act

that have been cleared under OMB

Control Nos. 0693–0015 and 0651–0028.

The public reporting burden for these

collections of information are estimated

to average 1.5 hours per response for

affirmations, 20 hours per response for

petitions, and .17 hours per response for

the PTO recordal, renewal forms. The

estimated response time shown includes

the time for reviewing instructions,

gathering information, and completing

and reviewing the collections of

information.

Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations 39801

National Environmental Policy Act

This rule will not significantly affect

the quality of the human environment.

Therefore, an environmental assessment

or Environmental Impact Statement is

not required to be prepared under the

National Environmental Policy Act of

1969.

List of Subjects in 15 CFR Part 280

Business and industry, Fastener

industry, Imports.

Dated: June 14, 2000.

Karen H. Brown,

Deputy Director, National Institute of

Standards and Technology.

Dated: June 20, 2000.

William Reinsch,

Under Secretary, Bureau of Export

Administration.

Dated: June 21, 2000.

Q. Todd Dickinson,

Under Secretary of Commerce for Intellectual

Property and Director of the United States

Patent and Trademark Office.

For reasons set forth in the preamble,

Title 15 of the Code of Federal

Regulations is amended as follows:

PART 280—FASTENER QUALITY

1. The authority citation for Part 280

is revised to read as follows:

Authority: 15 U.S.C. 5401 et seq.; Pub. L.

101–592, 104 Stat. 2943, as amended by Pub.

L. 104–113, 110 Stat. 775; Pub. L. 105-234,

112 Stat. 1536; and Pub. L. 106–34, 113 Stat.

118.

2. Section 280.1 is revised to read as

follows:

§ 280.1 Description of rule/Delegation of

authority.

(a) Description of rule. The Fastener

Quality Act (the Act) (15 U.S.C. 5401 et

seq., as amended by Public Law 104–

113, Public Law 105–234, and Public

Law 106–34):

(1) Protects against the sale of

mismarked, misrepresented, and

counterfeit fasteners; and

(2) Eliminates unnecessary

requirements.

(b) Delegations of authority. The

Director, National Institute of Standards

and Technology has authority to

promulgate regulations in this part

regarding certification and

accreditation. The Secretary of

Commerce has delegated concurrent

authority to amend the regulations

regarding enforcement of the Act, as

contained in subpart C of this part, to

the Under Secretary for Export

Administration. The Secretary of

Commerce has also delegated

concurrent authority to amend the

regulations regarding record of insignia,

as contained in subpart D of this part,

to the Under Secretary for Intellectual

Property and Director of the United

States Patent and Trademark Office.

§ 280.2 [Removed]

§ 280.601 [Redesignated as § 280.2]

3. Section 280.2 is removed, and

§ 280.601 is redesignated as § 280.2 and

amended by revising the introductory

text and adding the following

definitions in alphabetical order to read

as follows:

§ 280.2 Definitions.

In addition to the definitions

provided in 15 U.S.C. 5402, the

following definitions are applicable to

this part:

Abandonment of the Application. The

application for registration of a

trademark on the Principal Register is

no longer pending at the United States

Patent and Trademark Office.

Act. The Fastener Quality Act (15

U.S.C. 5401 et seq., as amended by Pub.

L. 104–113, Pub. L. 105–234, and Public

Law 106–34).

* * * * *

Director, NIST. The Director of the

National Institute of Standards and

Technology.

Director, USPTO. The Under

Secretary for Intellectual Property and

Director of the United States Patent and

Trademark Office.

Fastener Insignia Register. The

register of recorded fastener insignias

maintained by the Director.

* * * * *

Principal Register. The register of

trademarks established under 15 U.S.C.

1051.

* * * * *

Revisions includes changes made to

existing ISO/IEC Guides or other

documents, and redesignations of those

Guides or documents.

* * * * *

4. Sections 280.3 through 280.16 and

Subparts C through F (§§ 280.200

through 280.504) and I through L

(§§ 280.800 through 280.1127) are

removed, and Subpart B is revised to

read as follows:

Subpart B—Petitions, Affirmations, and

Laboratory Accreditation

Sec.

280.101 Petitions for Approval of

Documents.

280.102 Affirmations.

280.103 Laboratory Accreditation.

Subpart B—Petitions, Affirmations,

and Laboratory Accreditation

§ 280.101 Petitions for Approval of

Documents.

(a) Certification. (1) A person

publishing a document setting forth

guidance or requirements for the

certification of manufacturing systems

as fastener quality assurance systems by

an accredited third party may petition

the Director, NIST, to approve such

document for use as described in

section 3(7)(B)(iii)(I) of the Act (15

U.S.C. 5402(7)(B)(iii)(I)).

(2) Petitions should be submitted to:

FQA Document Certification, NIST, 100

Bureau Drive, Gaithersburg, MD 20899.

(3) The Director, NIST, shall approve

such petition if the document provides

equal or greater rigor and reliability as

compared to ISO/IEC Guide 62,

including revisions from time to time. A

petition shall contain sufficient

information to allow the Director, NIST,

to make this determination.

(b) Accreditation. (1) A person

publishing a document setting forth

guidance or requirements for the

approval of accreditation bodies to

accredit third parties described in

paragraph (a) of this section may

petition the Director, NIST, to approve

such document for use as described in

section 3(7)(B)(iii)(I) of the Act (15

U.S.C. 5402(7)(B)(iii)(I)).

(2) Petitions should be submitted to:

FQA Document Certifications, NIST,

100 Bureau Drive, Gaithersburg, MD

20899.

(3) The Director, NIST, shall approve

such petition if the document provides

equal or greater rigor and reliability as

compared to ISO/IEC Guide 61,

including revisions from time to time. A

petition shall contain sufficient

information to allow the Director, NIST,

to make this determination.

(c) Laboratory Accreditation. (1) A

person publishing a document setting

forth guidance or requirements for the

accreditation of laboratories may

petition the Director, NIST, to approve

such document for use as described in

section 3(1)(A) of the Act (15 U.S.C.

5402(1)(A)).

(2) Petitions should be submitted to:

FQA Document Certifications, NIST,

100 Bureau Drive, Gaithersburg, MD

20899.

(3) The Director, NIST, shall approve

such petition if the document provides

equal or greater rigor and reliability as

compared to ISO/IEC Guide 25,

including revisions from time to time. A

petition shall contain sufficient

information to allow the Director, NIST,

to make this determination.

39802 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations

(d) Approval of Accreditation Bodies.

(1) A person publishing a document

setting forth guidance or requirements

for the approval of accreditation bodies

to accredit laboratories may petition the

Director, NIST, to approve such

document for use as described in

section 3(1)(B) of the Act (15 U.S.C.

5402(1)(B)).

(2) Petitions should be submitted to:

FQA Document Certifications, NIST,

100 Bureau Drive, Gaithersburg, MD

20899.

(3) The Director, NIST, shall approve

such petition if the document provides

equal or greater rigor and reliability as

compared to ISO/IEC Guide 58,

including revisions from time to time. A

petition shall contain sufficient

information to allow the Director, NIST,

to make this determination.

(e) Electronic copies of ISO/IEC

Guides may be purchased through the

American National Standards Institute

(ANSI), Internet: http://www.ansi.org.

Copies of the relevant ISO/IEC Guides

are available for inspection in the U.S.

Department of Commerce Reading

Room, 14th Street and Constitution

Avenue, NW, Washington, DC 20230,

Room B–399.

§ 280.102 Affirmations.

(a)(1) An accreditation body

accrediting third parties who certify

manufacturing systems as fastener

quality assurance systems as described

in section 3(7)(B)(iii)(I) of the Act (15

U.S.C. 5402(7)(B)(iii)(I)) shall affirm to

the Director, NIST, that it meets the

requirements of ISO/IEC Guide 61 (or

another document approved by the

Director, NIST, under section 10(b) of

the Act (15 U.S.C. 5411a(b)) and

§ 280.101(a) of this part), including

revisions from time to time.

(2) An accreditation body accrediting

laboratories as described in section

3(1)(B) of the Act (15 U.S.C. 5402(1)(B))

shall affirm to the Director, NIST, that

it meets the requirements of ISO/IEC

Guide 58 (or another document

approved by the Director, NIST, under

section 10(d) of the Act (15 U.S.C.

5411a(d)) and § 280.101(d) of this part),

including revisions from time to time.

(b) An affirmation required under

paragraph (a)(1) or (a)(2) of this section

shall take the form of a self-declaration

that the accreditation body meets the

requirements of the applicable Guide,

signed by an authorized representative

of the accreditation body. No supporting

documentation is required.

(c) Affirmations should be submitted

to: FQA Document Certifications, NIST,

100 Bureau Drive, Gaithersburg, MD

20899.

(d) Any affirmation submitted in

accordance with this section shall be

considered to be a continuous

affirmation that the accreditation body

meets the requirements of the applicable

Guide, unless and until the affirmation

is withdrawn by the accreditation body.

§ 280.103 Laboratory accreditation.

A laboratory may be accredited by any

laboratory accreditation program that

may be established by any entity or

entities, which have affirmed to the

Director, NIST, under § 280.102 of this

subpart, or by the National Voluntary

Laboratory Accreditation Program for

fasteners, established by the Director,

NIST, under part 285 of this chapter.

Subpart G [Redesignated as Subpart

C]

5. Subpart G (§§ 280.600, 280.602

through 280.623) is redesignated as

Subpart C, consisting of §§ 280.200

through 280.222.

6. Redesignated § 280.200 is revised to

read as follows:

§ 280.200 Scope.

Section 280.201 of this part specifies

that failure to take any action required

by or taking any action prohibited by

this part constitutes a violation of this

part. Section 280.202 describes the

penalties that may be imposed for

violations of this part. Sections 280.204

through 280.222 establish the

procedures for imposing administrative

penalties for violations of this part.

7. Redesignated § 280.201 is amended

by revising paragraphs (b) and (c), and

removing paragraphs (d) through (o) to

read as follows:

§ 280.201 Violations.

* * * * *

(b) Sale of fasteners. It shall be

unlawful for a manufacturer or

distributor, in conjunction with the sale

or offer for sale of fasteners from a single

lot, to knowingly misrepresent or

falsify—

(1) The record of conformance for the

lot of fasteners;

(2) The identification, characteristics,

properties, mechanical or performance

marks, chemistry, or strength of the lot

of fasteners; or

(3) The manufacturers’ insignia.

(c) Manufacturers’ insignia. Unless

the specifications provide otherwise,

fasteners that are required by the

applicable consensus standard or

standards to bear an insignia identifying

their manufacturer shall not be offered

for sale or sold in commerce unless

(1) The fasteners bear such insignia;

and

(2) The manufacturer has complied

with the insignia recordation

requirements established under 15

U.S.C. 5407(b).

8. Redesignated § 280.203 is revised to

read as follows:

§ 280.203 Administrative enforcement

proceedings.

Sections 280.204 through 280.222 set

forth the procedures for imposing

administrative penalties for violations of

the Act and this part.

9. Redesignated § 280.210 is amended

by revising the last sentence of

paragraph (d) to read as follows:

§ 280.210 Discovery.

* * * * *

(d) * * * In addition, enforcement by

a district court of the United States may

be sought under 15 U.S.C. 5408(b)(6).

§§ 280.11 and 280.218 [Amended]

10. The reference to ‘‘§ 280.607’’ is

revised to read ‘‘§ 280.206’’ in the

following sections:

Redesignated § 280.211(b);

Redesignated § 280.218(c).

§§ 280.204 and 280.208 [Amended]

11. The reference to ‘‘§ 280.608’’ is

revised to read ‘‘§ 280.207’’ in the

following sections:

Redesignated § 280.204(a);

redesignated § 280.208(b)(1).

§§ 280.204 and 280.218 [Amended]

12. The reference to ‘‘§ 280.609’’ is

revised to read ‘‘§ 280.208’’ in the

following sections:

Redesignated § 280.204(a);

redesignated § 280.218(a).

§ 280.214 [Amended]

13. In redesignated § 280.214(b), the

reference to ‘‘§ 280.613’’ is revised to

read ‘‘§ 280.212’’.

§ 280.207 [Amended]

14. In redesignated § 280.207(c), the

reference to ‘‘§ 280.617’’ is revised to

read ‘‘§ 280.216’’.

15. In redesignated § 280.207(a), the

reference to ‘‘§ 280.618’’ is revised to

read ‘‘§ 280.217’’.

§ 280.219 [Amended]

16. In redesignated § 280.219(c), the

reference to ‘‘§ 280.619(c)’’ is revised to

read ‘‘§ 280.218(c)’’.

§§ 280.221 and 280.222 [Amended]

17. The reference to ‘‘§ 280.622’’ is

revised to read ‘‘§ 280.221’’ in the

following sections:

Redesignated § 280.221(b);

redesignated § 280.222(f).

Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations 39803

§§ 280.208, 280.218, 280.219, 280.220 and

280.221 [Amended]

18. The reference to ‘‘§ 280.623’’ is

revised to read ‘‘§ 280.222’’ in the

following sections:

Redesignated § 280.208(a);

redesignated § 280.218(b); redesignated

§ 280.219(b)(2); redesignated § 280.220;

redesignated § 280.221(a).

18a. Redesignated § 280.221 is

amended by revising the second

sentence of paragraph (b) to read as

follows:

§ 280.221 Record for decision and

availability of documents.

* * * * *

(b) * * * A party seeking to restrict

access to any portion of the record is

responsible for submitting, at the time

specified in paragraph (c)(2) of this

section, a version of the document

proposed for public availability that

reflects the requested deletion. * * *

* * * * *

Subpart H [Redesignated as Subpart

D]

19. Subpart H (§§ 280.700, 280.710

through 280.713, and 280.720 through

280.726) is redesignated as Subpart D,

consisting of §§ 280.300, 280.310

through 280.313, and 280.320 through

280.326.

20. Redesignated § 280.300 is revised

to read as follows:

§ 280.300 Recorded insignia required prior

to offer for sale.

Unless the specifications provide

otherwise, if a fastener is required by

the applicable consensus standard(s) to

bear an insignia identifying its

manufacturer, the manufacturer must:

(a) Record the insignia with the U.S.

Patent and Trademark Office prior to

any sale or offer for sale of the fastener;

and

(b) Apply the insignia to any fastener

that is sold or offered for sale. The

insignia must be readable, and must be

applied using the method for applying

a permanent insignia that is provided

for in the applicable consensus

standard(s), or, if the applicable

consensus standard(s) do(es) not specify

a method for applying a permanent

insignia, through any means of

imprinting a permanent impression.

21. Redesignated § 280.310 is

amended by revising the heading,

paragraph (a), paragraphs (b)(1), (b)(2),

(b)(3), (b)(4), and (b)(5); redesignating

existing paragraphs (b)(6) through (b)(8)

as paragraphs (b)(7) through (b)(9),

respectively; adding new paragraph

(b)(6); revising redesignated paragraph

(b)(7); and revising paragraphs (c) and

(d) to read as follows:

§ 280.310 Application for insignia.

(a) Each manufacturer must submit a

written application for recordal of an

insignia on the Fastener Insignia

Register along with the prescribed fee.

The application must be in a form

prescribed by the Director, USPTO.

(b) * * *

(1) The name of the manufacturer;

(2) The address of the manufacturer;

(3) The entity, domicile, and state of

incorporation, if applicable, of the

manufacturer;

(4) Either:

(i) A request for recordal and issuance

of a unique alphanumeric designation

by the Director, USPTO, or

(ii) A request for recordal of a

trademark, which is the subject of either

a duly filed application or a registration

for fasteners in the name of the

manufacturer in the U.S. Patent and

Trademark Office on the Principal

Register, indicating the application

serial number or registration number

and accompanied by a copy of the

drawing that was included with the

application for trademark registration,

or a copy of the registration;

(5) A statement that the manufacturer

will comply with the applicable

provisions of the Fastener Quality Act;

(6) A statement that the applicant for

recordal is a ‘‘manufacturer’’ as that

term is defined in 15 U.S.C. 5402;

(7) A statement that the person

signing the application on behalf of the

manufacturer has personal knowledge of

the facts relevant to the application and

that the person possesses the authority

to act on behalf of the manufacturer;

* * * * *

(c) A manufacturer may designate

only one trademark for recordal on the

Fastener Insignia Register in a single

application. The trademark application

or registration that forms the basis for

the fastener recordal must be in active

status, that is, a pending application or

a registration which is not expired, or

canceled, at the time of the application

for recordal.

(d) Applications and other documents

should be addressed to: Box Fastener,

Director, United States Patent and

Trademark Office, Washington, DC

20231.

22. Redesignated § 280.311 is revised

to read as follows:

§ 280.311 Review of the application.

The Director, USPTO, will review the

application for compliance with

§ 280.310. If the application does not

contain one or more of the elements

required by § 280.310, the Director,

USPTO, will not issue a certificate of

recordal, and will return the papers and

fees. The Director, USPTO, will notify

the applicant for recordal of any defect

in the application. Applications for

recordal of an insignia may be resubmitted to the Director, USPTO, at

any time.

23. Redesignated § 280.312 is revised

to read as follows:

§ 280.312 Certificate of recordal.

(a) If the application complies with

the requirements of § 280.310, the

Director, USPTO, shall accept the

application and issue a certificate of

recordal. Such certificate shall be issued

in the name of the United States of

America, under the seal of the United

States Patent and Trademark Office, and

a record shall be kept in the United

States Patent and Trademark Office. The

certificate of recordal shall display the

recorded insignia of the manufacturer,

and state the name, address, legal entity

and domicile of the manufacturer, as

well as the date of issuance of such

certificate.

(b) Certificates that were issued prior

to June 8, 1999, shall remain in active

status and may be maintained in

accordance with the provisions of

§ 280.320 of this subpart, but only if:

(1) The certificate is held by a

manufacturer, and

(2) The fasteners associated with the

certificate are fasteners that must bear

an insignia pursuant to 15 U.S.C. 5407.

24. Redesignated § 280.313 is

amended by revising paragraph (a) and

the first sentence of paragraph (b) to

read as follows:

§ 280.313 Recordal of additional insignia.

(a) A manufacturer to whom the

Director, USPTO, has issued an

alphanumeric designation may apply for

recordal of its trademark for fasteners if

the trademark is the subject of a duly

filed application or is registered in the

United States Patent and Trademark

Office on the Principal Register. Upon

recordal, either the alphanumeric

designation or the trademark, or both,

may be used as recorded insignias.

(b) A manufacturer for whom the

Director, USPTO, has recorded a

trademark as its fastener insignia may

apply for issuance and recordal of an

alphanumeric designation as a fastener

insignia. * * *

25. Redesignated § 280.320 is

amended by revising paragraphs (a) and

(b) and paragraphs (c)(1) through (c)(5);

redesignating existing paragraphs (c)(6)

through (c)(8) as paragraphs (c)(7)

through (c)(9), respectively; adding a

new paragraph (c)(6); and revising

redesignated paragraph (c)(7) to read as

follows:

39804 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Rules and Regulations

§ 280.320 Maintenance of the certificate of

recordal.

(a) Certificates of recordal remain in

an active status for five years and may

be maintained in an active status for

subsequent five-year periods running

consecutively from the date of issuance

of the certificate of recordal upon

compliance with the requirements of

paragraph (c) of this section.

(b) Maintenance applications shall be

required only if the holder of the

certificate of recordal is a manufacturer

at the time the maintenance application

is required.

(c) * * *

(1) The name of the manufacturer;

(2) The address of the manufacturer;

(3) the entity, domicile, and state of

incorporation, if applicable, of the

manufacturer;

(4) a copy of manufacturer’s certificate

of recordal;

(5) a statement that the manufacturer

will comply with the applicable

provisions of the Fastener Quality Act;

(6) a statement that the applicant for

recordal is a ‘‘manufacturer’’ as that

term is defined in 15 U.S.C. 5402;

(7) a statement that the person signing

the application on behalf of the

manufacturer has knowledge of the facts

relevant to the application and that the

person possesses the authority to act on

behalf of the manufacturer;

* * * * *

26. Redesignated § 280.321 is

amended by revising the first sentence

to read as follows:

§ 280.321 Notification of changes of

address.

The applicant for recordal or the

holder of a certificate of recordal shall

notify the Director, USPTO, of any

change of address or change of name no

later than six months after the change.

***

27. Redesignated § 280.323 is

amended by revising the second and

third sentences of paragraph (a),

revising the first sentence of paragraph

(b), revising paragraph (d), revising the

first sentence of paragraph (e), and

adding new paragraph (f) to read as

follows:

§ 280.323 Transfer or assignment of the

trademark registration or recorded insignia.

(a) * * * Any transfer or assignment

of such an application or registration

must be recorded in the United States

Patent and Trademark Office within

three months of the transfer or

assignment. A copy of such transfer or

assignment must also be sent to: Box

Fastener, Director, United States Patent

and Trademark Office, Washington, DC

20231.

(b) Upon transfer or assignment of a

trademark application or registration

which forms the basis of a certificate of

recordal, the Director, USPTO, shall

designate the certificate of recordal as

inactive. * * *

* * * * *

(d) A fastener insignia consisting of an

alphanumeric designation issued by the

Director, USPTO, can be transferred or

assigned.

(e) Upon transfer or assignment of an

alphanumeric designation, the Director,

USPTO, shall designate such

alphanumeric designation as inactive.

***

(f) An alphanumeric designation that

is reactivated after it has been

transferred or assigned shall remain in

active status until the expiration of the

five year period that began upon the

issuance of the alphanumeric

designation to its original owner.

28. Redesignated § 280.324 is

amended by revising the introductory

sentence of paragraph (a), revising

paragraphs (a)(1) through (a)(3);

redesignating existing paragraph (b) as

paragraph (a)(4); revising the first two

sentences of redesignated paragraph

(a)(4); redesignating paragraph (c) as

paragraph (b); and revising redesignated

paragraph (b) to read as follows:

§ 280.324 Change in status of trademark

registration or amendment of the

trademark.

(a) The Director, USPTO, shall

designate the certificate of recordal as

inactive, upon:

(1) issuance of a final decision on

appeal which refuses registration of the

application which formed the basis for

the certificate of recordal;

(2) abandonment of the application

which formed the basis for the

certificate of recordal;

(3) cancellation or expiration of the

trademark registration which formed the

basis of the certificate of recordal; or

(4) an amendment of the mark in a

trademark application or registration

that forms the basis for a certificate of

recordal. The certificate of recordal shall

become inactive as of the date the

amendment is filed. * * *

(b) Certificates of recordal designated

inactive due to cancellation, expiration,

or amendment of the trademark

registration, or abandonment or

amendment of the trademark

application, cannot be reactivated.

29. Redesignated § 280.325 is revised

to read as follows:

§ 280.325 Cumulative listing of recordal

information.

The Director, USPTO, shall maintain

a record of the names, current

addresses, and legal entities of all

recorded manufacturers and their

recorded insignia.

30. Redesignated § 280.326 is

amended by revising the heading and

the second sentence to read as follows:

§ 280.326 Records and files of the United

States Patent and Trademark Office

* * * Copies of any such records may

be obtained upon request and payment

of the fee set by the Director, USPTO.

§§ 280.311, 280.312 and 280.323

[Amended]

31. The reference to ‘‘§ 280.710’’ is

revised to read ‘‘§ 280.310’’ in the

following sections:

Redesignated § 280.311; redesignated

§ 280.312; redesignated § 280.323(e).

[FR Doc. 00–16212 Filed 6–27–00; 8:45 am]

BILLING CODE 3510–13–P

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

Civilian Health and Medical Program of

the Uniformed Services (CHAMPUS);

TRICARE Prime Enrollment

AGENCY: Office of the Secretary, DOD.

ACTION: Interim final rule.

SUMMARY: This interim final rule

provides for automatic enrollment of

certain family members of E–4 and

below in TRICARE Prime. When

affected family members reside in a

catchment area of a military medical

treatment facility offering TRICARE

Prime, the family members will be

automatically enrolled in TRICARE

Prime and will choose or be assigned a

Primary Care Manager located in the

military medical treatment facility. Such

automatic enrollment may be

terminated at any time.

DATES: This rule is effective July 28,

2000. Public comments must be

received by August 28, 2000.

ADDRESSES: TRICARE Management

Activity (TMA), Program Development

Branch, Aurora, CO 80045–6900.

FOR FURTHER INFORMATION CONTACT: Lt

Col Kathleen Larkin, Office of the

Assistant Secretary of Defense (Health

Affairs)/TRICARE Management Activity,

telephone (703) 681–3628.

Questions regarding payment of

specific claims under the CHAMPUS

allowable charge method should be

addressed to the appropriate TRICARE/

CHAMPUS contractor.

SUPPLEMENTARY INFORMATION: