58346 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

PART 71—DESIGNATION OF CLASS A,

CLASS B, CLASS C, CLASS D, AND

CLASS E AIRSPACE AREAS;

AIRWAYS; ROUTES; AND REPORTING

POINTS

1. The authority citation for part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9H,

Airspace Designations and Reporting

Points, dated September 1, 2000, and

effective September 16, 2000, is

amended as follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ACE MO E5 Moberly, MO [Revised]

Moberly, Omar N. Bradley Airport, MO

(Lat 39°27′50′′ N., long. 92°25′40′′ W.)

That airspace extending upward from 700

feet above the surface within a 6.5-mile

radius of Omar N. Bradley Airport.

* * * * *

Issued in Kansas City, MO, on September

20, 2000.

Herman J. Lyons, Jr.,

Manager, Air Traffic Division, Central Region.

[FR Doc. 00–24932 Filed 9–28–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0044]

RIN 0910–AB97

Regulations on Statements Made for

Dietary Supplements Concerning the

Effect of the Product on the Structure

or Function of the Body; Partial Stay of

Compliance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial stay of

compliance.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

partial stay of compliance for the final

rule defining the types of statements

that can be made concerning the effect

of a dietary supplement on the structure

or function of the body for certain

dietary supplement products. Dietary

supplement products that were labeled,

or for which labeling had been printed,

on or before January 6, 2000, the

publication date of the final rule, are

eligible for the stay. This action is in

response to two petitions for stay and

reconsideration.

DATES: This rule is effective October 30,

2000. Submit written comments by

October 30, 2000. Submit written

comments on the information collection

provisions of this final rule by October

10, 2000. Notifications of products that

are eligible for the stay of compliance

may be submitted to FDA at any time

following the effective date of this rule;

it is to manufacturers’ advantage to

submit such notifications as soon as

possible, as only products for which

FDA has received a notification qualify

for the stay.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

written comments on the information

collection provisions of this final rule to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget (OMB), 725 K St. NW., rm.

10235, Washington, DC 20503, Attn:

Desk Officer for FDA. Send notifications

of products that are eligible for the stay

of compliance to Food and Drug

Administration, Office of Nutritional

Products, Labeling, and Dietary

Supplements, Division of Compliance

and Enforcement (HFS–810), 200 C St.

SW., Washington, DC 20204.

FOR FURTHER INFORMATION CONTACT:

Robert J. Moore, Office of Nutritional

Products, Labeling, and Dietary

Supplements (HFS–800), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4605.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of January 6,

2000 (65 FR 1000), FDA published a

final rule entitled ‘‘Regulations on

Statements Made for Dietary

Supplements Concerning the Effect of

the Product on the Structure or

Function of the Body’’ (hereinafter

referred to as ‘‘the final rule’’). In the

final rule, FDA established regulations

to define the types of statements that

may be made without prior FDA review

about the effects of dietary supplements

on the structure or function of the body

(structure/function claims), and to

distinguish these claims from claims

that a product treats, prevents, cures,

diagnoses, or mitigates disease (disease

claims).

In the preamble to the final rule, FDA

stated that the final rule would become

effective on February 7, 2000,

approximately 30 days after publication.

FDA also stated that any product that is

marketed for the first time after

publication of the final rule, and any

new claims made for an existing

product for the first time after the

publication of the final rule, would be

expected to be in compliance as of the

effective date, February 7, 2000.

However, small businesses that

marketed a product as of January 6,

2000, the date of publication of the final

rule, would have an additional 17

months (until July 7, 2001) to bring

existing claims (i.e., claims already in

the product’s labeling on January 6,

2000) for those products into

compliance. For all other products that

were on the market as of January 6,

2000, FDA allowed an additional 11

months beyond the effective date (until

January 7, 2001) to bring existing claims

for those products into compliance.

II. Petitions for Reconsideration and

Stay of Action

FDA received one petition under

§ 10.35 (21 CFR 10.35) for stay of the 30-

day effective date and one petition

under 21 CFR 10.33 for stay and

reconsideration of part of the

implementation plan in the final rule. A

petition for stay submitted jointly by the

Council for Responsible Nutrition (CRN)

and the Consumer Healthcare Products

Association (CHPA) (Docket No. 99N–

0044/PSA1) (Ref. 1) (hereinafter referred

to as the ‘‘joint petition’’) requested that

FDA stay its 30-day effective date for

‘‘pipeline’’ products, i.e., products that

were labeled, or for which labeling had

been printed, but that had not yet been

marketed when the final rule was

published on January 6, 2000. The joint

petition requested that such products be

given the 11 or 17 months for

compliance afforded to products that

were being marketed as of the

publication date of the final rule. The

joint petition stated that in the nearly 2

years between publication of the

proposed and final rules, dietary

supplement manufacturers and

distributors had relied on the criteria

and examples of acceptable structure/

function claims in the proposed rule to

develop marketing strategies,

manufacture products, and design and

produce labeling. The petition stated

that in many cases, this reliance had

involved a significant investment of

resources.

The joint petition further stated that

the implementation of the final rule will

involve, among other things, package

redesign, redesign of websites and

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58347

promotional literature, and sometimes,

new packaging equipment. The joint

petition argued that the short

implementation period (30 days for

products not yet marketed) would not

provide a long enough transition period

to enable ‘‘pipeline’’ products to be

brought into compliance. Moreover, the

joint petition asserted that giving such

products the same transition

compliance period as products that had

actually been marketed by January 6,

2000, would provide a fair and

reasonable implementation plan for

firms that had invested energy and

resources, in good faith, developing a

new product with labeling bearing

claims based on the proposed rule, but

that narrowly missed marketing the

product by January 6, 2000.

The petition for stay and

reconsideration was submitted by the

American Herbal Products Association

(Docket No. 98N–0044/PRC4) (Ref. 2)

(hereinafter referred to as the ‘‘AHPA

petition’’). The AHPA petition requested

that FDA reconsider two provisions of

the final rule, one of which was the

implementation plan. This notice will

address only the request in the AHPA

petition that concerns the

implementation plan in the final rule;

the other part of the AHPA petition will

be addressed separately at a later time.

The AHPA petition requested two

actions by FDA concerning the

implementation plan. First, the AHPA

petition requested that FDA treat certain

products labeled before the February 7,

2000, effective date the same way as

products marketed before the

publication of the final rule on January

6, 2000. Specifically, the petition

requested that FDA allow any product

labeled before the February 7, 2000,

effective date to be marketed during the

11-month or 17-month transition

compliance period, provided that a

notification has been submitted to FDA

as required by section 403 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 343(r)(6)), that FDA has not

objected to the notification, and that the

product bears the required disclaimer.

Second, the AHPA petition requested

that products subject to the transition

compliance period be allowed to be

shipped after that period has ended,

provided that the label had been affixed

to the product prior to the applicable

11-month or 17-month compliance date.

The AHPA petition stated that the

requested relief is necessary for two

reasons. First, the AHPA petition

asserted that the 30-day effective date

does not provide enough time to relabel

products that were in the pipeline, but

were not marketed, before the

publication of the final rule. The AHPA

petition also stated that products

labeled at any point during the 11-

month or 17-month transition period

should be allowed to be marketed even

after the applicable compliance date to

reduce the costs of the rule by

eliminating the need to relabel or

destroy inventory not marketed by the

end of the transition period. The AHPA

petition further stated that there is no

basis to distinguish the implementation

scheme for the final rule from that used

to implement the dietary supplement

nutrition labeling final regulations

published in the Federal Register of

September 23, 1997 (62 FR 49826 at

49842), which provided that any

product labeled before the effective date

did not have to be relabeled to comply

after the effective date.

III. Response to Petitions

FDA has fully evaluated the two

petitions for stay and reconsideration of

the implementation plan in the final

rule. FDA agrees that there may be

manufacturers who, relying on the

criteria and examples of acceptable

structure/function claims in the

proposed rule, produced labeling with

claims that would have been considered

structure/function claims under the

proposed rule, but that are classified as

disease claims under the final rule. We

also agree that the 30-day effective date

of the final rule may not have provided

a long enough transition period to

enable products close to being marketed

when the final rule was published to be

brought into compliance. Therefore,

FDA is announcing a stay of compliance

for a limited class of products. Products

that were labeled no later than the

publication date of the final rule,

January 6, 2000, or for which labeling

had been printed by that date

(hereinafter referred to as ‘‘eligible

products’’) will be eligible for the stay.

To prevent the partial stay from

becoming effectively a blanket stay of

the 30-day effective date for all

products, FDA is requiring that any firm

wishing to take advantage of the stay

notify FDA of that fact before it markets

its eligible products. The notification

must: (1) Include the name and

complete address of the firm submitting

it; (2) identify the eligible products; (3)

provide documentation that the eligible

products were in fact labeled no later

than January 6, 2000, or that labeling for

the products had been printed by that

date; and (4) include a certification,

signed by a responsible individual, that

the products are eligible for the stay.

The eligible products must be described

with sufficient specificity to enable FDA

to identify them in the marketplace and

distinguish them from other products

(including other lots of the same

product) that do not qualify for the stay.

For example, the identification might

consist of the name of the product and

a unique identifier code, such as a

product identification or lot code that

the manufacturer uses to track its

products.

FDA believes that the notification

requirement is necessary for effective

enforcement of the final rule. Without

the notification, the agency would be

unable to verify whether individual

products are eligible for the stay and

therefore would not be able to

determine which products in the

marketplace bear violative claims and

are subject to enforcement action.

Firms must send the required

notification to: Food and Drug

Administration, Office of Nutritional

Products, Labeling, and Dietary

Supplements, Division of Compliance

and Enforcement (HFS–810), 200 C St.

SW., Washington, DC 20204.

Notifications may be submitted at any

time after the effective date of this final

rule. It is to a manufacturers’ advantage

to submit such notifications as soon as

possible, as only products for which

FDA has received a notification qualify

for the partial stay of compliance.

Small businesses that have eligible

products and that submit the required

notification to FDA will have 17 months

after the effective date of the final rule

(until July 7, 2001) to bring their eligible

products into compliance, and other

firms will have 11 months after the

effective date of the final rule (until

January 7, 2001) to bring their eligible

products into compliance. We believe

that this action provides a fair and

reasonable implementation plan for

firms that made a substantial investment

in products that narrowly missed being

marketed by the publication date of the

final rule.

We are not granting the request in the

AHPA petition that FDA allow products

labeled before the 11-month or 17-

month compliance date to be shipped

after that date. In the preamble to the

final rule (65 FR 1000 at 1044), FDA

concluded that the compliance periods

of 11 and 17 months following the

effective date of the final rule were

reasonable and fair. The agency stated

that these compliance periods,

uniformly applied, are sufficiently long

and that an extension of the time to

comply is not needed. The purpose of

the compliance period is to give firms

time to develop new labels that comply

with the requirements of the act and

regulation and to ensure a level playing

field for all firms marketing dietary

supplements. We find no basis to permit

some firms to continue to market

58348 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

products with claims that violate the act

and that may give them a competitive

advantage over products marketed by

firms that have made the investment in

time and expense to meet the applicable

compliance dates.

Moreover, granting AHPA’s request

would create an incentive for

manufacturers to perpetuate existing

claims that are defined as disease claims

under the final rule and, in fact, to label

as many products as possible with such

claims between now and the applicable

compliance date. FDA believes that

creating such an incentive would be

unwise and that the agency should

maintain the policy in the final rule,

which was designed to encourage

manufacturers to change their labeling

in accordance with the final rule as

quickly as possible, but no later than the

applicable compliance date. Having a

date by which all products must comply

will reduce consumer confusion and

greatly simplify enforcement, as after

that date the agency will be able to take

action against any product that bears

unapproved disease claims, without

also having to determine when the

product was labeled.

We disagree that the basis for the

effective date of the September 23, 1997,

final rule implementing the nutrition

labeling requirements for dietary

supplements is relevant to the current

rulemaking. In deciding to base the

effective date of the September 23, 1997,

final rule on the date of labeling, rather

than the date of marketing, FDA relied

on language in section 7 of the Dietary

Supplement Health and Education Act

of 1994 (DSHEA). Section 7 of DSHEA

states that dietary supplements ‘‘may be

labeled after the date of the enactment

of this Act in accordance with the

amendments made by this section, and

shall be labeled after December 31,

1996, in accordance with such

amendments.’’ The final rule

implements section 6 of DSHEA, which

does not contain the same language as

section 7 and is not subject to section 7.

Therefore, the fact that FDA allowed

products labeled before the effective

date of the September 23, 1997, final

rule to be marketed after the effective

date of that rule does not compel that

the same approach be taken to

implement the final rule. For the

reasons discussed above, namely, to

encourage prompt implementation of

the rule and ensure a level playing field

after the compliance date, the agency is

not staying the compliance dates in the

implementation plan for products

labeled on or before the appropriate

compliance date. Consistent with the

implementation plan in the final rule

(65 FR 1000 at 1044), all products in

interstate commerce that are subject to

the final rule must be in compliance

with the act and regulations by July 7,

2001 (for products marketed by small

businesses), or January 7, 2001 (for other

products).

Under § 10.35(a) and (d)(1), FDA may

stay the effective date of a rule, or any

other administrative action, upon a

finding that the stay is in the public

interest. FDA finds that this partial stay

of compliance is in the public interest

because it will allow a fair and

reasonable transition compliance period

for firms that made a substantial

investment in dietary supplement

products that were close to marketing

when the final rule was published.

The Administrative Procedure Act

and FDA regulations provide that the

agency may issue a regulation without

notice and comment procedures when

the agency for good cause finds that

such procedures are impracticable,

unnecessary, or contrary to the public

interest (5 U.S.C. 553(b)(3)(B); 21 CFR

10.40(e)(1)). Because this final rule is a

stay of compliance, FDA finds that there

is good cause to dispense with notice

and comment procedures. Notice and

comment procedures are unnecessary

because this final rule does not change

the substantive requirements of the final

rule, only the date on which compliance

with those requirements is expected for

a limited class of products. Further,

notice and comment procedures are not

in the public interest because the final

rule has already become effective, and

therefore a prompt response to the

petitions for stay and reconsideration is

important.

IV. Analysis of Impacts

The economic impact of the final rule

was discussed in the Federal Register

(65 FR 1000 at 1044 through 1049). A

partial stay of compliance for the final

rule will provide additional time for

companies to relabel products and will

reduce label obsolescence, as there will

be additional time to use up more

existing labeling. Although this rule

granting a partial stay of compliance

will impose some small administrative

costs on those industry members that

wish to take advantage of it, these costs

are expected to be much smaller than

the savings that will be realized from

reduced inventory losses. Thus, this

final rule granting a partial stay of

compliance should reduce the economic

impact on industry.

FDA has examined the impacts of this

final rule under Executive Order 12866,

the Regulatory Flexibility Act (5 U.S.C.

601–612) and the Unfunded Mandates

Reform Act. Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

Under the Regulatory Flexibility Act,

if a rule has a significant economic

impact on a substantial number of small

entities, the agency must analyze

regulatory options that would minimize

any significant impact of the rule on

small entities. This final rule provides a

stay of compliance, which will allow

manufacturers additional time to use up

existing product labeling. Accordingly,

the agency certifies that the final rule

will not have a significant economic

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4) requires that agencies

prepare a written statement of

anticipated costs and benefits before

issuing any rule that may result in an

expenditure by State, local, and tribal

governments, in the aggregate, or by the

private sector, of $100 million in any

one year (adjusted annually for

inflation).

The Unfunded Mandates Reform Act

does not require FDA to prepare a

statement of costs and benefits for this

rule, because this rule is not expected to

result in expenditures that would

exceed $100 million, adjusted for

inflation, in any one year. The current

inflation-adjusted statutory threshold is

$110 million.

V. Paperwork Reduction Act of 1995

This final rule contains information

collection provisions that are subject to

review by OMB under the Paperwork

Reduction Act of 1995 (the PRA) (44

U.S.C. 3501–3520). A description of

these provisions is given below with an

estimate of the annual reporting burden.

Included in the estimate is the time for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing each

collection of information.

With respect to the following

collection of information, FDA invites

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58349

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Notification of Products Eligible

for a Stay of the Effective Date of FDA’s

Regulations on Statements Made for

Dietary Supplements Concerning the

Effect of the Product on the Structure or

Function of the Body.

Description: Under sections 301,

403(r)(1)(B) and (r)(6), and 505(a) of the

act (21 U.S.C. 331, 343(r)(1)(B) and

(r)(6)), and 355(a)) FDA is responsible

for preventing distribution in interstate

commerce of products marketed as

dietary supplements with claims about

the effect of the product on a disease,

unless the claim is an authorized health

claim. Section 701(a) of the act (21

U.S.C. 371(a)) gives FDA the authority

to issue regulations for the efficient

enforcement of the act. In the final rule

(65 FR 1000), FDA published a

regulation that defined the types of

statements that can be made concerning

the effect of a dietary supplement on the

structure or function of the body. In the

preamble to the final rule, the agency

stated that the final rule would become

effective on February 7, 2000,

approximately 30 days after the date of

the final rule’s publication in the

Federal Register. The final rule further

provided that any product that is

marketed for the first time after

publication of the final rule, and any

new claims made for an existing

product for the first time after the

publication of the final rule, would have

to be in compliance as of the effective

date.

In response to two petitions asking

the agency to stay and/or reconsider the

30-day effective date for the final rule,

FDA is granting a partial stay of

compliance with the rule for those

dietary supplement products that were

labeled or for which labeling had been

printed on or before January 6, 2000, the

publication date of the final rule. A

manufacturer that wishes to market

products that are eligible for the stay

would have to notify FDA of the

identity of its eligible products; provide

documentation that the products were

labeled by January 6, 2000, or that

labeling for the products had been

printed by that date; and certify that the

products that are the subject of the

notification meet the eligibility criteria.

Information that is required in the

notification includes: (1) The name and

complete address of the firm submitting

the notification; (2) a description of the

products that are the subject of the

notification. The description must be

sufficient to enable FDA to identify the

firm’s qualifying products in the

marketplace and distinguish them from

other products (including other lots of

the same product) that are not eligible

for the stay. For example, the

description might consist of the name of

the product and a unique identifier code

(such as a product identification or lot

code that the manufacturer uses to track

its products); (3) documentation that the

products were labeled by January 6,

2000, or that the labeling for the

products had been printed by that date

(for example, purchase records from a

label manufacturer or production

records that showed that the products

had been labeled by January 6, 2000);

and (4) a certification, signed by a

responsible individual, that the

products are eligible for the stay.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per

Response Total Annual Responses Hours per Response Total Hours

48 1 48 2 96

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on the

number of firms that may have products

that are eligible for the stay. In the final

rule (65 FR 1000 at 1047), FDA

estimated that 1,000 firms manufacture

dietary supplement products that would

be covered by the final rule. FDA also

estimated that approximately 4.81

percent of the 17,400 dietary

supplement products currently being

marketed with structure/function claims

would be required to change their labels

because of the requirements in the final

rule (65 FR 1000 at 1046). Therefore,

assuming that products affected by the

final rule are uniformly distributed

throughout the industry, approximately

48 firms (4.8 percent of 1,000 firms) may

have products affected by the partial

stay of compliance.

The notification burden would consist

of the preparation of the letter notifying

FDA and accompanying documentation

that the products were labeled before

January 6, 2000, or that the labeling had

been printed by that date. FDA believes

this burden will be small since firms

already have the information needed to

describe their own products with

specificity. With respect to the

supporting documentation, the firm

would already have identified the

relevant documents as part of

ascertaining which products are eligible

for the stay. Therefore, the firm would

only need to reproduce the relevant

documents to accompany the

notification. The notification is a onetime action, and all of a firm’s eligible

products can be listed in a single

notification. Therefore, FDA anticipates

receiving only one notification per firm.

The information collection provisions

of this final rule have been submitted to

OMB for review. Interested persons may

send comments regarding information

collection by October 10, 2000, to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FDA has requested expedited

processing of this information collection

request under section 3507(j) of the PRA

and 5 CFR 1320.13. The information to

be collected under this final rule is

needed before clearance could be

obtained under the normal PRA

clearance time periods. Further, the use

of normal PRA clearance procedures is

impracticable and would be likely to

prevent or disrupt the collection of

information because the compliance

periods during which products that

qualify for the partial stay may be

marketed without relabeling would have

ended or would be close to ending.

Prior to the effective date of this final

rule, FDA will publish a notice in the

Federal Register announcing OMB’s

decision to approve, modify, or

58350 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

disapprove the information collection

provisions in this final rule. An agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless it

displays a currently valid OMB control

number.

VI. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

final rule by October 30, 2000, except

that comments regarding information

collection are to submitted to OMB

(address above) by October 10, 2000.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

VII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Council for Responsible Nutrition

and Consumer Healthcare Products

Association, Petition for Stay of Action,

February 7, 2000.

2. American Herbal Products

Association, Petition for

Reconsideration and Petition for Stay of

Action, February 7, 2000.

Dated: September 21, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24960 Filed 9–28–00; 8:45 am]

BILLING CODE 4160–01–F

OCCUPATIONAL SAFETY AND

HEALTH REVIEW COMMISSION

29 CFR Part 2200

Rules of Procedure

AGENCY: Occupational Safety and Health

Review Commission.

ACTION: Final rule; elimination of

expiration date.

SUMMARY: On February 19, 1999 the

Occupational Safety and Health Review

Commission issued a final rule

amending its rules of procedure to add

a new Subpart H to part 2200 consisting

of § 2200.120 64 FR 8243. In that section

the Commission established a

mandatory settlement process known as

the Settlement Part as a pilot program

for a one-year trial period.

In order to more effectively evaluate

the Settlement Part the Commission, on

February 15, 2000, extended the pilot

program through September 30, 2000.

65 FR 7434. While the evaluation was

based on limited data, it showed

generally positive results, including

substantial satisfaction among the

program’s users. Accordingly, the

Commission has determined to

eliminate the expiration date and make

the Settlement Part a permanent part of

its Rules of Procedure. The Chairman

will continue to monitor the program

and to assess its effectiveness.

EFFECTIVE DATE: As of September 29,

2000 the expiration date for Subpart H

consisting of § 2200.120 is removed and

the subpart becomes a permanent part of

29 CFR part 2200.

FOR FURTHER INFORMATION CONTACT: Earl

R. Ohman, Jr., General Counsel, One

Lafayette Centre, 1120 20th St., NW.,

9th Floor, Washington, DC 20036–3419,

phone (202) 606–5410.

Dated: September 26, 2000.

Thomasina V. Rogers,

Chairman.

Gary L. Visscher,

Commissioner.

Stuart E. Weisberg,

Commissioner.

[FR Doc. 00–25138 Filed 9–28–00; 8:45 am]

BILLING CODE 7600–01–M

POSTAL SERVICE

39 CFR Part 20

Global Express Guaranteed

AGENCY: Postal Service.

ACTION: Amendment to interim rule.

SUMMARY: The Postal Service is

amending the interim rule on Priority

Mail Global Guaranteed service to

establish it as a permanent international

mail service, to announce a name

change, and to expand the service to

include a new classification for nondocument (merchandise) shipments.

This interim rule will also extend the

optional insurance coverage to nondocuments and establish and publish

rates for the non-document service. This

interim rule corrects and amends the

interim rule published on August 28,

2000, 65 FR 52023–52028.

EFFECTIVE DATE: October 1, 2000.

Comments on the amendment to the

interim rule must be received on or

before Ocotber 30, 2000.

ADDRESSES: Written comments should

be mailed or delivered to Business

Initiatives, Expedited/Package Services,

U.S. Postal Service, 200 E Mansell

Court, Suite 300, Roswell GA 30076–

4850. Copies of all written comments

will be available for public inspection

between 9 a.m. and 4 p.m., Monday

through Friday, in Business Initiatives,

200 E Mansell Court, Suite 300, Roswell

GA.

FOR FURTHER INFORMATION CONTACT:

Malcolm E. Hunt, (770) 360–1104.

SUPPLEMENTARY INFORMATION: On April

19, 1999, the Postal Service announced

in the Federal Register (64 FR 19039–

19042) the introduction of Priority Mail

Global Guaranteed (PMGG) service on

an interim basis. With PMGG, the USPS

provided customers with a fully

featured premium international service

for documents with full track and trace

capability. This service was initially

available from 3,000 retail locations for

delivery to a total of 19 countries.

On November 4, 1999, the Postal

Service announced in the Federal

Register (64 FR 60106–60109) the

expansion of PMGG service to permit

acceptance at a total of 10,000 retail

locations, with destinating locations

being expanded to 65 countries and

territories.

On May 26, 2000, the Postal Service

announced in the Federal Register (65

FR 34096–34101) the further expansion

of PMGG service to a total of 202

destinating countries and territories. A

revised rate structure was also

introduced.

On August 28, 2000, the Postal

Service announced in the Federal

Register (65 FR 52023–52028) a further

expansion of PMGG service. The

number of retail locations was increased

to a total of 20,000, document service

rates were adjusted, optional document

reconstruction insurance was increased

to $2,499, and delivery service was

extended to China. An incorrect listing

of 3-digit ZIP Codes was included in the

list of participating post offices in this

rule. The correct list of participating

post offices by 3-digit ZIP Code is

incorporated in this interim rule.

Based on the successive and

successful expansion of PMGG service,

the Postal Service has determined to

establish it as a permanent international

mail service. To effectuate this change,

the Postal Service is changing the name

of the service to Global Express

Guaranteed (GXG) and completing the

expansion to include a new

classification for merchandise

shipments. GXG will now consist of two

mail classifications:

a. GXG Document service.

b. GXG Non-Document service.

The GXG Document service mail

classification is for shipments that