1276 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. 00N–1634]

Public Hearing Before a Public

Advisory Committee; Examination of

Administrative Record and Other

Advisory Committee Records

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its administrative regulations

governing the public disclosure of

written information for consideration by

an advisory committee at an advisory

committee meeting. This action would

amend the regulations to state that

written information for consideration by

an advisory committee at a committee

meeting is available for public

disclosure, whenever practicable, before

or at the time of the meeting. FDA is

proposing this action to reflect current

FDA policy in conformance with

applicable law. This proposed rule is a

companion document to the direct final

rule published elsewhere in this issue of

the Federal Register.

DATES: Submit written comments on the

proposed rule by March 26, 2001. If

FDA receives no significant adverse

comment on the amendment of these

regulations within the specified

comment period, the agency intends to

publish a document confirming the

effective date of the final rule in the

Federal Register within 30 days after

the comment period in the direct final

rule ends. The direct final rule will be

effective 30 days after publication of the

confirmation notice in the Federal

Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Discussion

As described more fully in the related

direct final rule, FDA’s procedures for

the administration of advisory

committees are set forth in part 14 (21

CFR part 14). Section 14.75(a)(1) states

that unless it is otherwise exempt from

disclosure, written information for

consideration by the committee at the

meeting should be available for public

disclosure at the same time it is made

available to the committee. FDA finds

that this provision for simultaneous

disclosure is not required by the Federal

Advisory Committee Act (5 U.S.C. app.

2) and that compliance with this

provision would be detrimental to the

advisory committee process. Therefore,

the agency is proposing to amend

§ 14.75(a)(1) to state that the written

information for consideration by an

advisory committee at any meeting is

available for public disclosure,

whenever practicable, before or at the

time of the meeting.

II. Additional Information

This proposed rule is a companion to

the direct final rule published in the

final rules section of this issue of the

Federal Register. This companion

proposed rule and the direct final rule

are identical. This companion proposed

rule will provide the procedural

framework to finalize the rule in the

event the direct final rule receives

significant adverse comments and is

withdrawn. The comment period for

this companion proposed rule runs

concurrently with the comment period

of the direct final rule. Any comments

received under the companion proposed

rule will be treated as comments

regarding the direct final rule.

If no significant adverse comment is

received in response to the direct final

rule, no further action will be taken

related to this proposed rule. Instead,

FDA will publish a confirmation

document within 30 days after the

comment period ends, and FDA intends

the direct final rule to become effective

30 days after publication of the

confirmation document. If FDA receives

significant adverse comments, the

agency will withdraw the direct final

rule. FDA will proceed to respond to all

of the comments received regarding the

rule and, if appropriate, the rule will be

finalized under this companion

proposed rule using usual notice-andcomment procedures.

For additional information, see the

corresponding direct final rule

published in the final rules section of

this issue of the Federal Register. FDA

will not provide additional opportunity

for comment. A significant adverse

comment is one that explains why the

rule would be inappropriate, including

challenges to the rule’s underlying

premise or approach, or would be

ineffective or unacceptable without a

change. A comment recommending a

rule change in addition to this rule will

not be considered a significant adverse

comment, unless the comment states

why this rule would be ineffective

without the additional change.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of this

proposed rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (2 U.S.C.

1501 et seq.). 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

Executive Order 12866 and in the other

two statutes. This proposed rule is not

a significant regulatory action as defined

by the Executive order.

Under the Regulatory Flexibility Act,

if a rule has a significant impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities. The

agency has considered the effect that

this proposed rule will have on small

entities. Because the proposed rule will

amend only internal agency procedures,

the agency certifies that the 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

proposing 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). FDA is not required to

prepare a statement of the costs and

benefits of this proposed rule because

the proposed rule is not expected to

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Proposed Rules 1277

result in any 1-year expenditure that

would exceed $100 million adjusted for

inflation. The current inflation-adjusted

statutory threshold is $110 million.

V. Federalism

FDA has analyzed this proposed rule

in accordance with the principles set

forth in Executive Order 13132. FDA

has determined that the proposed rule

does not contain policies that have

substantial direct effects on the States,

on the relationship between the

National Government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the proposed

rule does not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

proposed rule contains no collections of

information. Therefore, clearance by the

Office of Management and Budget under

the Paperwork Reduction Act of 1995 is

not required.

VII. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by March 26, 2001. This

comment period runs concurrently with

the comment period for the direct final

rule; any comments received will be

considered as comments regarding the

direct final rule. 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. In the

event the direct final rule is withdrawn,

all comments received will be

considered comments on this proposed

rule.

List of Subjects in 21 CFR Part 14

Administrative practice and

procedure, Advisory committees, Color

additives, Drugs, Radiation protection.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 14 be amended to read as

follows:

PART 14—PUBLIC HEARING BEFORE

A PUBLIC ADVISORY COMMITTEE

1. The authority citation for 21 CFR

part 14 is revised to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C.

1451–1461; 21 U.S.C. 41–50, 141–149, 321–

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42

U.S.C. 201, 262, 263b, 264.

2. Section 14.75 is amended by

revising paragraph (a)(1) to read as

follows:

§ 14.75 Examination of administrative

record and other advisory committee

records.

(a) * * *

(1) The written information for

consideration by the committee at any

meeting: Whenever practicable, before

or at the time of the meeting.

* * * * *

Dated: December 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–390 Filed 1–5–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 256

RIN 1010–AC–68

Revision of Requirements Governing

Surety Bonds for Outer Continental

Shelf Leases.

AGENCY: Minerals Management Service

(MMS), Interior.

ACTION: Proposed rule.

SUMMARY: The MMS is proposing to

modify requirements governing surety

bonds for activities on the Outer

Continental Shelf (OCS). These changes

will codify the terms and conditions

under which a surety will be relieved of

responsibility when MMS terminates

the period of liability of a bond.

Codifying these terms and conditions is

necessary to clarify the responsibilities

of the lessee and the surety after the

lease expires.

DATES: We will consider all comments

we receive by March 9, 2001. We will

begin reviewing comments then and

may not fully consider comments we

receive after March 9, 2001.

ADDRESSES: If you wish to comment,

you may submit your comments by any

one of several methods. You may mail

or hand-carry comments (three copies)

to the Department of the Interior;

Minerals Management Service; Mail

Stop 4024; 381 Elden Street; Herndon,

Virginia 20170–4817; Attention: Rules

Processing Team (RPT). You may also

send your comments by e-mail or e-mail

attachment. The RPT’s e-mail address is:

rules.comments@mms.gov.

FOR FURTHER INFORMATION CONTACT: John

Mirabella, Engineering and Operations

Division, (703) 787–1607.

SUPPLEMENTARY INFORMATION: OCS

lessees must comply with regulations

governing operations, payments of rents

and royalties, and end-of-lease

obligations. To ensure that the lessee

will be financially able to meet all

requirements, including end-of-lease

requirements, MMS requires the lessee

to post a bond. This rule would amend

the provisions of 30 CFR 256.58

concerning the cancellation of a bond.

When the lessee has met all end-oflease obligations, MMS terminates the

liability period of the bond. This

amendment addresses situations when

the lessee appears to meet all end-oflease requirements and we later

discover that obligations still exist. For

example, an audit may reveal that the

lessee owes us additional royalty. As

another example, a plugged well may

start to leak. In either case, the lessee

must correct the problem.

In the case of royalties, the liability

would be discovered when the audit is

conducted after the end of the surety’s

liability period. By statute, any demand

for performance of a monetary

obligation must be made within 7 years.

In the example of the leaking well, there

is not a stipulated time period. Problems

associated with plugged wells in the

OCS are rare; when they do occur, they

are generally discovered within a few

years of the plugging activity.

Should the lessee fail to perform a

lease obligation, MMS turns to the

surety for performance. This rule

addresses how long a bond will be held

before cancellation to assure availability

to cover a problem that is discovered

after the liability period on a bond has

ended. The current regulation does not

set a limit on the period that MMS may

continue to hold the bond company

responsible for a problem that occurs

during the liability period.

OCS wells rarely start to leak

following plugging operations.

Therefore, we have difficulty predicting

when a leak might occur. This notice

proposes a period of 7 years (plus such

additional time taken for appeals or

litigation) during which MMS may hold

the bond for claims based upon

obligations that accrued during the

period of liability. During this period,

we will retain security or collateral

pledged to MMS in lieu of a surety. The

bond will be canceled after 7 years and