Federal Register / Vol. 66, No. 34 / Tuesday, February 20, 2001 / Rules and Regulations 10815

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. 99N–1852]

Postmarketing Studies for Approved

Human Drug and Licensed Biological

Products; Status Reports; Delay of

Effective Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; delay of effective

date.

SUMMARY: In accordance with the

memorandum of January 20, 2001, from

the Assistant to the President and Chief

of Staff, entitled ‘‘Regulatory Review

Plan,’’ published in the Federal Register

on January 24, 2001 (66 FR 7702), this

action temporarily delays for 60 days

the effective date of the rule entitled

‘‘Postmarketing Studies for Approved

Human Drug and Licensed Biological

Products; Status Reports,’’ published in

the Federal Register on October 30,

2000 (65 FR 64607).

DATES: The effective date of the

‘‘Postmarketing Studies for Approved

Human Drug and Licensed Biological

Products; Status Reports,’’ amending 21

CFR parts 314 and 601 published in the

Federal Register on October 30, 2000

(65 FR 64607), is delayed for 60 days,

from February 27, 2001, to a new

effective date of April 30, 2001.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: The rule

concerns the requirements for annual

postmarketing status reports for

approved human drug and biological

products, and requires applicants to

submit annual status reports for certain

postmarketing studies of licensed

biological products. The rule describes

the types of postmarketing studies

covered by these status reports, the

information to be included in the

reports, and the type of information that

the Food and Drug Administration

would consider appropriate for public

disclosure. The rule will implement

specific provisions of the Food and Drug

Administration Modernization Act of

1997 (FDAMA). To the extent that 5

U.S.C. 553 applies to this action, it is

exempt from notice and comment

because it constitutes a rule of

procedure under 5 U.S.C. 553(b)(A).

Alternatively, the agency’s

implementation of this action without

opportunity for public comment,

effective immediately upon publication

today in the Federal Register , is based

on the good cause exceptions in 5 U.S.C.

553(b)(B) and (d)(3). Seeking public

comment is impracticable, unnecessary

and contrary to the public interest. The

temporary 60-day delay in effective date

is necessary to give Department of

Health and Health and Human Services

(Department) officials the opportunity

for further review and consideration of

new regulations, consistent with the

Assistant to the President’s

memorandum of January 20, 2001, sent

to all executive departments and

agencies. Given the imminence of the

effective date, seeking prior public

comment on this temporary delay

would have been impractical, as well as

contrary to the public interest in the

orderly issuance and implementation of

regulations. The imminence of the

effective date is also good cause for

making this action effective

immediately upon publication. As

originally published in the Federal

Register on October 30, 2000, this rule

would have required some firms to file

annual progress reports for

postmarketing study commitments

shortly after February 27, 2001, if the

anniversary date of U.S. approval of the

application of the drug or licensed

biological product under postmarketing

study commitment fell on or shortly

after February 27, 2001. An immediate

effective date for this rule delaying

implementation is necessary to assure

that those applicants are not singled out

and required to submit postmarketing

study reports before Department

officials have had the opportunity for

further review and consideration of this

regulation.

Dated: February 13, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4141 Filed 2–16–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 151

RIN 1076–AD90

Acquisition of Title to Land in Trust;

Delay of Effective Date; Correction

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Correction to final rule.

SUMMARY: This document corrects the

final rule published on Monday,

February 5, 2001 (66 FR 8899). The

February 5th rule delayed the effective

date of the rule entitled ‘‘Acquisition of

Title to Land in Trust,’’ published in the

Federal Register on January 16, 2001, at

66 FR 3452.

EFFECTIVE DATE: February 20, 2001.

FOR FURTHER INFORMATION CONTACT:

Terry Virden, Director, Office of Trust

Responsibilities, Mail Stop: 4513–MIB,

1849 ‘‘C’’ Street NW., Washington, DC

20240; telephone: 202–208–5831;

electronic mail: TerryVirden@BIA.GOV.

SUPPLEMENTARY INFORMATION: On

January 20, 2001, the Assistant to the

President and Chief of Staff signed a

memo to the heads of all executive

Departments and agencies entitled

‘‘Regulatory Review Plan.’’ (This memo

was published in the Federal Register

on January 24, 2001, at 66 FR 7701). To

comply with this memo, we must delay

for 60 days the effective date of any final

rule that was published but not yet

effective on or before January 20, 2001.

On February 5th we published a final

rule to delay the effective date of a rule

titled ‘‘Acquisition of Title to Land in

Trust.’’ (We published the original

‘‘Acquisition of Title to Land in Trust’’

rule in the Federal Register on January

16, 2001, at 66 FR 3452.) In the DATES

section of our February 5th rule, we

incorrectly stated two dates, as shown

in the following table:

In the February 5 rule

we said that

What we should have

said was

The effective date of

the January 16 rule

was January 16.

The effective date of

the January 16 rule

was February 15.

The new, delayed effective date of the

January 16 rule

was March 17.

The new, delayed effective date of the

January 16 rule

was April 16.

The delayed effective date that we

published on February 5 would

postpone the effective date for only 30

days, rather than the required 60 days.

In this correction, we are making the

following changes to the rule that we

published on February 5th:

(1) Correcting the original effective

date of the January 16 rule from January

17, 2001 to February 15, 2001; and

(2) Correcting the delayed effective

date of the January 16 rule from March

17, 2001, to April 16, 2001.

Need for Correction

As published, the final rule contains

errors that may prove to be misleading

and are in need of correction.

10816 Federal Register / Vol. 66, No. 34 / Tuesday, February 20, 2001 / Rules and Regulations

Correction of Publication

Accordingly FR document 01–2963,

published on February 5, 2001, is

corrected as follows: On page 8899, in

the first column, the material in the

DATES heading is corrected to read in its

entirety as follows:

DATES: The effective date of the

Acquisition of Title to Land in Trust

rule, amending 25 CFR part 151,

published in the Federal Register on

January 16, 2001, at 66 FR 3452, is

delayed for 60 days, from February 15,

2001, to a new effective date of April 16,

2001.

Dated: February 13, 2001.

Timothy S. Elliott,

Acting Deputy Solicitor.

[FR Doc. 01–4095 Filed 2–16–01; 8:45 am]

BILLING CODE 4310–02–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD01–00–234]

RIN 2115–AE47

Drawbridge Operation Regulations:

Fort Point Channel, MA

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is changing

the drawbridge operating regulations for

the Northern Avenue Bridge, mile 0.1,

across the Fort Point Channel at Boston,

Massachusetts. This rule will revise the

drawbridge operating regulations to

provide bridge openings during times

the bridge previously did not open and

also place the bridge on an advance

notice basis during times when there

have been few requests to open the

bridge. This action is expected to better

meet the present needs of navigation.

DATES: This rule is effective March 22,

2001.

ADDRESSES: Comments and material

received from the public, as well as

documents indicated in this preamble as

being available in the docket, are part of

docket (CGD01–00–234) and are

available for inspection or copying at

the First Coast Guard District, Bridge

Branch Office, 408 Atlantic Avenue,

Boston, Massachusetts 02110, 7 a.m. to

3 p.m., Monday through Friday, except

Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr.

John W. McDonald, Project Officer, First

Coast Guard District, (617) 223–8364.

SUPPLEMENTARY INFORMATION:

Regulatory Information

On November 8, 2000, we published

a notice of proposed rulemaking

(NPRM) entitled Drawbridge Operation

Regulations; Fort Point Channel,

Massachusetts, in the Federal Register

(65 FR 66939). We received six

comment letters in response to the

notice of proposed rulemaking. All the

comment letters were in favor of the

rule change. No public hearing was

requested and none was held.

Background and Purpose

The Northern Avenue Bridge, mile

0.1, across the Fort Point Channel has a

vertical clearance of 7 feet at mean high

water and 17 feet at mean low water in

the closed position. The existing

operating regulations in 33 CFR 117.599

require the bridge to open on signal

from 6 a.m. to 8 p.m. From 8 p.m. to 6

a.m., the bridge need not open for the

passage of vessels. The Coast Guard

received a request to change the

operating regulations from a commercial

tour boat operator and the mariners

located at a marina upstream from the

Northern Avenue Bridge. The mariners

requested that the bridge be crewed and

available to open for vessel traffic after

8 p.m. during the boating season. The

bridge presently does not open from 8

p.m. to 6 a.m., daily.

The Coast Guard published a notice of

temporary deviation and request for

comments on April 27, 2000, in order to

test an expanded operating schedule for

the bridge and to provide immediate

relief for the mariners during the

summer of 2000. The deviation required

the bridge to open on signal from 6 a.m.

to 8 p.m. and from 8 p.m. to 6 a.m. to

open on signal if at least a two-hour

advance notice was provided by calling

the number posted at the bridge. The

Coast Guard received four letters in

favor of expanding the operating hours

for the bridge. After the comment period

for the deviation concluded on

September 30, 2000, the Coast Guard

had discussions regarding the expansion

of the operating hours for the bridge

with officials from the City of Boston,

the owner of the bridge. As a result of

these discussions, the bridge owner

agreed to crew the bridge additional

hours as well as provide openings on an

advance notice basis during times when

the bridge is not crewed. The following

schedule was established:

From May 1 through October 31, the

draw shall open on signal from 7 a.m.

to 11 p.m. From 11 p.m. to 7 a.m. the

draw shall open on signal if at least a

two-hour advance notice is given by

calling the number posted at the bridge.

From November 1 through April 30,

the draw shall open on signal from 7

a.m. to 3 p.m. From 3 p.m. to 7 a.m. the

draw shall open on signal if at least a

twenty-four hours advance notice is

given by calling the number posted at

the bridge.

The Coast Guard believes this is a

reasonable operating schedule because

the mariners will now be able to get

bridge openings during the times the

bridge is crewed or upon the required

advance notice, and the bridge owner

will not be required to crew the bridge

during periods when there have been

few requests to open the bridge.

Discussion of Comments and Changes

The Coast Guard received six

comment letters all in favor of the rule

change. No changes will be made to the

final rule.

Regulatory Evaluation

This rule is not a ‘‘significant

regulatory action’’ under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

Order. The Office of Management and

Budget has not reviewed it under that

Order. It is not ‘‘significant’’ under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). This

conclusion is based on the fact that the

bridge will be crewed at times to meet

the needs of navigation and will be on

an advance notice basis during the times

when there have been few requests to

open the bridge.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612) we considered

whether this rule would have a

significant economic impact on a

substantial number of small entities.

‘‘Small entities’’ comprises small

businesses, not-for profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations less than 50,000.

The Coast Guard certifies under 5

U.S.C. 605(b) that this rule will not have

a significant economic impact on a

substantial number of small entities.

This conclusion is based on the fact that

the bridge will be crewed at times to

meet the needs of navigation and will be

on an advance notice basis during the

times when there have been few

requests to open the bridge.

Collection of Information

This rule calls for no new collection

of information under the Paperwork