65836 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Part 744

[Docket No. 010220046–1046–01]

RIN 0694–AC40

Entity List: Removal of Two Russian

Entities

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: This rule removes two

Russian entities from the Entity List:

INOR Scientific Center, Moscow,

Russia; and Polyus Scientific

Production Association, 3 Ulitsa

Vvedenskogo, 117342, Moscow. The

Export Administration Regulations

(EAR) provide that the Bureau of Export

Administration (BXA) may inform

exporters, individually or through

amendment to the EAR, that a license is

required for exports or reexports to

certain entities. The EAR contain a list

of such entities called the Entity List.

EFFECTIVE DATE: This rule is effective

December 21, 2001.

FOR FURTHER INFORMATION CONTACT:

Eileen M. Albanese, Office of Exporter

Services, Bureau of Export

Administration, Telephone: (202) 482–

0436.

SUPPLEMENTARY INFORMATION:

Background

Consistent with Section 6 of

Executive Order 12938 of November 14,

1994, as amended, this action removes

the following Russian entities, their subunits and successors from the Entity List

found in Supplement No 4. to Part 744

of the EAR: INOR Scientific Center,

Moscow, Russia; and, Polyus Scientific

Production Association, 3 Ulitsa

Vvedenskogo, 117342, Moscow.

BXA maintains an Entity List to

provide notice to the public of export

license requirements for such entities.

These two Russian entities were added

to BXA’s Entity List on July 29, 1998 (63

FR 40363), due to an investigation then

underway by the Russian government of

these entities for suspected activities

involving weapons of mass destruction

and missile technology. However, the

State Department determined on

November 17, 2000, that it is in the

foreign policy and national security

interests of the United States to remove

nonproliferation measures on these two

entities. These entities have taken action

on the issues that caused the U.S. to

impose these measures in 1998.

Removing these additional license

requirements and restoring the previous

license review policy for these entities

in light of the action taken by them will

support U.S. nonproliferation policy.

Although the Export Administration

Act expired on August 20, 2001,

Executive Order 13222 of August 17,

2001 (66 FR 44025, August 22, 2001)

continues the Regulations in effect

under the International Emergency

Economic Powers Act.

Rulemaking Requirements

1. This final rule has been determined

to be not significant for purposes of

Executive Order 12866.

2. Notwithstanding any other

provision of law, no person is required

to respond to, nor shall any person be

subject to a 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

Office of Management and Budget

Control Number. This rule involves a

collection of information subject to the

Paperwork Reduction Act of 1980 (44

U.S.C. 3501 et seq.). This collection has

been approved by the Office of

Management and Budget under control

number 0694–0088, ‘‘Multi-Purpose

Application,’’ which carries a burden

hour estimate of 45 minutes for a

manual submission and 40 minutes for

an electronic submission.

3. This rule does not contain policies

with Federalism implications as this

term is defined under Executive Order

13132.

4. The provisions of the

Administrative Procedure Act (5 U.S.C.

553) requiring notice of proposed

rulemaking, the opportunity for public

participation, and a delay in effective

date, are inapplicable because this

regulation involves a military and

foreign affairs function of the United

States (5 U.S.C. 553(a)(1)). Further, no

other law requires that a notice of

proposed rulemaking and an

opportunity for public comment be

given for this interim rule. Because a

notice of proposed rulemaking and an

opportunity for public comment are not

required to be given for this rule under

the Administrative Procedure Act or by

any other law, the analytical

requirements of the Regulatory

Flexibility Act (5 U.S.C. 601 et seq.) are

not applicable. Therefore, this

regulation is issued in final form.

Although there is no formal comment

period, public comments on this

regulation are welcome on a continuing

basis. Comments should be submitted to

Sharron Cook, Office of Exporter

Services, Bureau of Export

Administration, Department of

Commerce, P.O. Box 273, Washington,

DC 20044, or scook@bxa.doc.gov.

List of Subjects in 15 CFR Part 744

Exports, Foreign trade, Reporting and

recordkeeping requirements.

Accordingly, part 744 of the Export

Administration Regulations (15 CFR

parts 730–799) is amended as follows:

PART 744—[AMENDED]

1. The authority citation for 15 CFR

part 744 continues to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;

42 U.S.C. 2139a; E.O. 12058, 43 FR 20947, 3

CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR

33181, 3 CFR, 1993 Comp., p. 608; E.O.

12938, 59 FR 59099, 3 CFR, 1994 Comp., p.

950; E.O. 13026, 61 FR 58767, 3 CFR, 1996

Comp., p. 228; E.O. 13222, 66 FR 44025,

August 22, 2001; Notice of November 9,

2000, 65 FR 68063, 3 CFR, 2000 Comp., p.

408.

2. Supplement No. 4 to part 744 is

amended removing the entities ‘‘INOR

Scientific Center, Moscow, Russia’’; and

‘‘Polyus Scientific Production

Association, 3 Ulitsa Vvedenskogo,

117342, Moscow’’ listed under ‘‘Russia’’

in the table.

Dated: December 17, 2001.

James J. Jochum,

Assistant Secretary for Export

Administration.

[FR Doc. 01–31508 Filed 12–20–01; 8:45 am]

BILLING CODE 3510–33–P

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1700

Child-Resistant Packaging for Certain

Over-the-Counter Drug Products;

Correction

AGENCY: Consumer Product Safety

Commission.

ACTION: Final rule; correction.

SUMMARY: The Consumer Product Safety

Commission (CPSC or Commission)

corrects the rule published in the

Federal Register of August 2, 2001 that

requires child-resistant (CR) packaging

of certain previously prescription-only

oral drug products approved by the

Food and Drug Administration (FDA)

for over-the-counter (OTC) sale. Drug

products that are the subject of the

August 2 rule are members of the

category known as ‘‘OTC switched drug

products.’’

The Commission intended that the

August 2 rule apply to an oral drug

product that is granted OTC status as

Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations 65837

1Of course the situation where the OTC switch

application has been submitted to the FDA and also

approved prior to the effective date of the CPSC rule

is covered by this example.

the result of an application to switch the

product from prescription to OTC status

(an OTC switch application) submitted

to the FDA on or after the January 29,

2002 effective date of the CPSC rule,

except in the following circumstances.

The rule was not intended to cover a

drug product that contains only active

ingredients covered by prior OTC

switch applications submitted by the

same or any other applicant before the

effective date of the CPSC rule. Since

publication of the August 2 rule, the

Commission has become aware that a

correction is necessary to avoid

confusion over this point and is thus

issuing a clarifying amendment.

DATES: Effective on January 29, 2002.

FOR FURTHER INFORMATION CONTACT:

Suzanne Barone, Ph.D., Directorate for

Health Sciences, Consumer Product

Safety Commission, Washington, D.C.

20207; telephone (301)504–0477 ext.

1196 or Geri Smith, Office of

Compliance, Consumer Product Safety

Commission, Washington, D.C. 20207;

telephone (301)504–0608 ext. 1160.

SUPPLEMENTARY INFORMATION:

A. The Technical Correction

The Commission published, in the

Federal Register of August 2, 2001, a

regulation to require CR packaging of

oral drug products approved by the FDA

for OTC sale that contain active

ingredients previously available only by

prescription. 66 FR 40111. The

regulation as proposed and as issued in

final form was intended to apply only

to an OTC drug product containing one

or more previously prescription-only

active ingredients first granted OTC

status as a result of applications

submitted to the FDA on or after the

January 29, 2002 effective date of the

final OTC-switch rule.

Nevertheless, the August 2, 2001 rule

can be read to require CR packaging of

a drug product approved for the switch

to OTC status after the rule becomes

effective on January 29, 2002, even if

that drug product contains only an

active ingredient or ingredients for

which application(s) for OTC switch

were submitted to the FDA by any

manufacturer(s) prior to the effective

date. The CR packaging requirement of

the rule could also be interpreted to be

triggered by non-prescription active

ingredients in previously prescriptiononly drug products. This was not the

intent of the rule.

The following examples are intended

to clarify the scope of the rule as

corrected today:

Example 1: Manufacturer A submitted an

application to the FDA in December 2001 for

OTC switch of an oral drug product

containing only prescription-only active

ingredient X. Manufacturer A’s application is

approved by the FDA after the January 29,

2002 effective date of this rule. Manufacturer

B submits an application to the FDA in

February 2002 for OTC switch of another oral

drug product containing only the same active

ingredient X.

Neither drug product is subject to this rule.

Manufacturer A’s drug product is not subject

to this rule because the OTC switch

application was submitted before the January

29, 2002 effective date. Manufacturer B’s

drug product is not subject to this rule

because it contains only formerly

prescription-only active ingredients for

which an OTC switch application was

submitted to the FDA by some manufacturer

before the effective date of the rule.1

Example 2: Manufacturer A submits an

application to the FDA in February 2002 for

OTC switch of an oral drug product

containing prescription-only oral active

ingredient X. Active ingredient X is not the

subject of an OTC switch application

submitted by any manufacturer prior to the

January 29, 2002 effective date of this rule.

Manufacturer A’s drug product must be in

CR packaging under this rule because no

application for OTC switch of prescriptiononly active ingredient X was submitted to the

FDA by any manufacturer prior to the

January 29, 2002 effective date of the rule.

Example 3: Manufacturer A obtained FDA

approval in December 2001 for OTC switch

of an oral drug product containing formerly

prescription-only active ingredient X.

Manufacturer B submits an application to the

FDA in February 2002 for OTC switch of an

oral drug product containing active

ingredient X and prescription-only active

ingredient Y. Active ingredient Y is not the

subject of any OTC switch application

submitted by any manufacturer prior to the

effective date of this rule.

Manufacturer A’s drug product is not

subject to this rule. Manufacturer B’s drug

product must be in CR packaging under this

rule because no OTC switch application for

prescription-only active ingredient Y was

submitted to the FDA by any manufacturer

prior to the January 29, 2002 effective date

of the rule.

Each of these examples pertains only

to the scope of this rule. Any other

special packaging requirements of 16

CRF 1700.14 otherwise applicable to a

drug product remain in full force and

effect.

B. The Administrative Procedure Act

(APA)

Section 553(b)(3)(B) of the APA

authorizes an agency to dispense with

certain notice procedures for a rule

when it finds ‘‘good cause’’ to do so. 5

U.S.C. 553(b)(3)(B). Specifically, under

section 553(b)(3)(B), the requirement for

notice and an opportunity to comment

does not apply when the agency, for

good cause, finds that those procedures

are ‘‘impracticable, unnecessary, or

contrary to the public interest.’’ This

amendment does not alter the intended

scope of the August 2, 2001 rule or

otherwise widen its applicability.

Accordingly, the Commission hereby

finds that notice of, and public

comment on, this technical amendment

are unnecessary.

C. Other Rulemaking Requirements

Because this amendment makes no

change in the intended scope or

applicability of the August 2, 2001 rule,

the Commission hereby incorporates by

reference the findings made with

respect to it concerning the Regulatory

Flexibility Act, 5 U.S.C. 601, et seq., the

National Environmental Policy Act, 42

U.S.C.4321, et seq., and Executive Order

No. 12988. See 66 FR 40114–5 (August

2, 2001).

For the foregoing reasons, the

Commission corrects rule FR Doc. 01–

19225 published in the Federal Register

on August 2, 2001, (66 FR 40111) by

making the following correcting

amendment. On page 40115, in the third

column, revise paragraph (a)(30)(i) in

§ 1700.14 to read as follows:

§ 1700.14 Substances requiring special

packaging.

(a) * * *

* * * * *

(30) Over-the-Counter Drug Products.

(i) Any over-the-counter (OTC) drug

product in a dosage form intended for

oral administration that contains any

active ingredient that was previously

available for oral administration only by

prescription, and thus was required by

paragraph (a)(10) of this section to be in

special packaging, shall be packaged in

accordance with the provisions of

§ 1700.15(a),(b), and (c). This

requirement applies whether or not the

amount of that active ingredient in the

OTC drug product is different from the

amount of that active ingredient in the

prescription drug product. This

requirement does not apply if the OTC

drug product contains only active

ingredients of any oral drug product or

products approved for OTC marketing

based on an application for OTC

marketing submitted to the Food and

Drug Administration (FDA) by any

entity before January 29, 2002.

Notwithstanding the foregoing, any

special packaging requirement under

this § 1700.14 otherwise applicable to

an OTC drug product remains in effect.

* * * * *

65838 Federal Register / Vol. 66, No. 246 / Friday, December 21, 2001 / Rules and Regulations

Dated: December 17, 2001.

Todd A. Stevenson,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 01–31400 Filed 12–20–01; 8:45 am]

BILLING CODE 6355–01–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[COTP TAMPA–01–139]

RIN 2115–AA97

Security Zones; Tampa Bay, Florida

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing temporary fixed security

zones in all waters extending 100 feet

around all bridge supports and rocky

outcroppings at the base of the supports

for the Sunshine Skyway Bridge in

Tampa Bay. These security zones are

needed for national security reasons to

protect the bridge and passing marine

traffic from potential subversive acts.

Entry into these zones is prohibited,

unless specifically authorized by the

Captain of the Port, Tampa, Florida or

his designated representative.

DATES: This regulation is effective at 6

p.m. EST on December 7, 2001 and will

remain in effect until 6 p.m. EDT on

June 15, 2002.

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 number COTP Tampa 01–139

and are available for inspection or

copying at Marine Safety Office Tampa,

155 Columbia Drive, Tampa, Florida

33606–3598 between 8 a.m. and 3 p.m.

Monday through Friday, except Federal

holidays.

FOR FURTHER INFORMATION CONTACT: LT

David G. McClellan, Coast Guard

Marine Safety Office Tampa, at (813)

228–2189 extension 102.

SUPPLEMENTARY INFORMATION:

Regulatory Information

We did not publish a notice of

proposed rulemaking (NPRM) for this

regulation. Under 5 U.S.C. 553(b)(B), the

Coast Guard finds that good cause exists

for not publishing a NPRM. Publishing

a NPRM and delaying the rule’s

effective date would be contrary to the

public interest since immediate action is

needed to protect the public, ports and

waterways of the United States. As

appropriate the Coast Guard will issue

a broadcast notice to mariners and place

Coast Guard or other law enforcement

vessels in the vicinity of these zones to

advise mariners of the restriction.

For the same reasons, under 5 U.S.C.

553(d)(3), the Coast Guard finds that

good cause exists for making this rule

effective less than 30 days after

publication in the Federal Register.

Background and Purpose

Based on the September 11, 2001,

terrorist attacks on the World Trade

Center buildings in New York and the

Pentagon in Arlington, Virginia, there is

an increased risk that subversive

activity could be launched by vessels or

persons in close proximity to the

Sunshine Skyway Bridge in Tampa Bay,

located at approximate position 27°

37′12′′ N Latitude, 82° 39′20′′ W

Longitude. These security zones will

encompass all waters extending 100 feet

around all bridge supports and rocky

outcroppings at the base of the supports

for the Sunshine Skyway Bridge in

Tampa Bay. Entry into these security

zones is prohibited, unless specifically

authorized by the Captain of the Port,

Tampa, Florida or his designated

representative.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866, Regulatory

Planning and Review, 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)

because this will only affect a small

group of recreational fisherman that

occasionally fish next to the bridge

supports and they may be allowed to

enter these zones with the permission of

the Captain of the Port.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601–612), the Coast Guard

considered whether this rule would

have a significant economic effect upon

a substantial number of small entities.

‘‘Small entities’’ include small

businesses, not-for-profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations of 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

because small entities may be allowed

to enter these zones on a case by case

basis with the authorization of the

Captain of the Port.

Assistance for Small Entities

Under section 213(a) of the Small

Business Regulatory Enforcement

Fairness Act of 1996 (Public Law 104–

121), we offer to assist small entities in

understanding the rule so that they can

better evaluate its effects on them and

participate in the rulemaking process. If

the rule will affect your small business,

organization, or government jurisdiction

and you have questions concerning its

provisions or options for compliance,

please contact the person listed under

FOR FURTHER INFORMATION CONTACT for

assistance in understanding this rule.

Small businesses may send comments

on the actions of Federal employees

who enforce, or otherwise determine

compliance with, Federal regulations to

the Small Business and Agriculture

Regulatory Enforcement Ombudsman

and the Regional Small Business

Regulatory Fairness Boards. The

Ombudsman evaluates these actions

annually and rates each agency’s

responsiveness to small business. If you

wish to comment on actions by

employees of the Coast Guard, call 1–

888–REG–FAIR (1–888–734–3247).

Collection of Information

This rule calls for no new collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501–3520).

Federalism

A rule has implication for federalism

under Executive Order 13132,

Federalism, if it has a substantial direct

effect on State or local governments and

would either preempt State law or

impose a substantial direct cost of

compliance on them. We have analyzed

this rule under that Order and have

determined that it does not have

implications for federalism.

Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act

of 1995 (2 U.S.C. 1531–1538) requires

Federal agencies to assess the effects of

their discretionary regulatory actions. In

particular, the Act addresses actions

that may result in the expenditure by a

State, local, or tribal government, in the

aggregate, or by the private sector of

$100,000,000 or more in any one year.

Though this rule will not result in such

expenditure, we do discuss the effects of

this rule elsewhere in this preamble.