Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67485

that will be announced in the Federal

Register.

(d) Carrier responsibility for

comparing information collected with

travel document. The carrier collecting

the information described in paragraph

(c)(2) of this section is responsible for

comparing this information with the

related travel document under

paragraph (c)(3) of this section, in order

to ensure that the information is correct,

that the document appears to be valid

for travel to the United States, and that

the passenger or crew member, as

applicable, is the person to whom the

travel document was issued.

(e) Sharing of manifest information

with other Federal agencies. Information

contained in passenger and crew

manifests for flights subject to paragraph

(a) of this section (49 U.S.C. 44909(c)(1))

that is received by Customs

electronically may, upon request, be

shared with other Federal agencies for

the purpose of protecting national

security (49 U.S.C. 44909(c)(5)).

PART 178—APPROVAL OF

INFORMATION COLLECTION

REQUIREMENTS

1. The authority citation for part 178

continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 1624; 44

U.S.C. 3501 et seq.

2. Section 178.2 is amended by

adding the following in appropriate

numerical sequence according to the

section number under the columns

indicated:

§ 178.2 Listing of OMB control numbers.

19 CFR

section Description OMB controlno.

*****

§ 122.49a Passenger and

crew manifests.

1515–0232

*****

Approved: December 21, 2001.

Robert C. Bonner,

Commissioner of Customs.

Timothy E. Skud,

Acting Deputy Assistant Secretary of the

Treasury.

[FR Doc. 01–32034 Filed 12–28–01; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N–0038]

RIN 0910–AA01

Sunscreen Drug Products for Over-theCounter Human Use; Final Monograph;

Partial Stay; Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial stay.

SUMMARY: The Food and Drug

Administration (FDA) is staying the

final monograph for over-the-counter

(OTC) sunscreen drug products that

published in the Federal Register of

May 21, 1999 (64 FR 27666). The final

monograph established conditions

under which OTC sunscreen drug

products are generally recognized as

safe and effective and not misbranded.

This stay of effective date applies to all

OTC sunscreen drug products that

would be regulated under part 352 (21

CFR part 352). This action does not stay

the effective date for products that

would be regulated under parts 310 and

700 (21 CFR parts 310 and 700). This

action is being taken because the agency

will be amending part 352 to address

formulation, labeling, and testing

requirements for both ultraviolet A

(UVA) radiation protection and

ultraviolet B (UVB) radiation protection.

This action is part of FDA’s ongoing

review of OTC drug products.

DATES: This rule is effective January 30,

2002. Part 352, added at 64 FR 27666 at

27687, is stayed until further notice.

Written or electronic comments by April

1, 2002.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2307.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 21,

1999, FDA published a final rule in the

form of a final monograph for OTC

sunscreen drug products in part 352.

The monograph included 16 active

ingredients, required labeling for

products that contain one or more of

these active ingredients, a standardized

test for measuring sun protection factor

(SPF) values, and standard methods for

measuring the water resistant properties

of sunscreens. The labeling and test

methods covered products intended to

provide UVB radiation protection. The

monograph did not, however, address

active ingredients, labeling, and test

methods for products intended to

provide UVA protection. The final rule

also included related nonmonograph

conditions in § 310.545(a)(29) (21 CFR

310.545(a)(29)) and new § 700.35 (21

CFR 700.35), which addressed labeling

for cosmetic products that contain

sunscreen active ingredients for

nontherapeutic, nonphysiologic uses

(e.g., as a color additive or to protect the

color of the product). The agency set a

2-year effective date (May 21, 2001) for

part 352 and for §§ 310.545(a)(29) and

700.35.

In the Federal Register of June 8, 2000

(65 FR 36319), the agency extended the

effective date for all OTC sunscreen

drug and cosmetic products that would

be regulated under parts 310, 352, and

700 to December 31, 2002. The agency

stated that this extension would be in

the public interest as the agency

developed a comprehensive sunscreen

final monograph that addresses

formulation, labeling, and testing

requirements for both UVB and UVA

radiation protection under part 352. The

agency stated in this notice that it

intended to move forward and publish

a proposed rule for a comprehensive

final monograph, receive comments on

that proposal, and issue a final rule by

December 31, 2001. That final rule

would then have a 1-year effective date

of December 31, 2002.

II. Stay of Part 352

The June 8, 2000, extension of

effective date also included a reopening

of the administrative record to allow for

comment on specific information the

agency requested in that document. The

comment period closed on September 6,

2000. Since that time, the agency has

been developing a proposed amendment

to part 352 that addresses both UVB and

UVA radiation protection.

The agency expects to publish the

proposal to amend part 352 next year.

Following that publication, there will be

a comment period and then the agency

will prepare an amended final

monograph for publication in a future

issue of the Federal Register. Because

the agency has not yet published the

proposed amendment to part 352, it is

not possible for manufacturers of OTC

sunscreen drug products to relabel and

67486 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

test their products in accord with an

amended final monograph by the

current effective date of December 31,

2002.

Accordingly, the agency is staying

part 352 until further notice is provided

in a future issue of the Federal Register.

The agency will propose a new effective

date for part 352 within the proposed

amendment. The agency anticipates that

this new effective date will not be before

January 1, 2005.

This stay of effective date does not

apply to parts 310 or 700, because the

amendment of the monograph in part

352 has no effect on the requirements in

these parts. The agency has already

extended the effective dates for parts

310 and 700 to December 31, 2002, and

finds there is no reason to further

extend that date.

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)(3)(A). Alternatively, the agency’s

implementation of this action without

opportunity for public comment comes

within the good cause exceptions in 5

U.S.C. 553(b)(3)(B) and (d)(3) in that

obtaining public comment is

impracticable, unnecessary, and

contrary to the public interest. The

agency is staying part 352 because the

agency has determined that it is not

possible for manufacturers of OTC

sunscreen drug products to relabel and

test their products in accord with an

amended final monograph by the

current effective date of December 31,

2002. The agency intends to publish a

proposal to amend part 352 next year in

order to develop a comprehensive

sunscreen monograph that addresses

formulation, labeling, and testing

requirements for both UVB and UVA

radiation protection. This amendment

will propose a new effective date for

part 352. Thus, there will be an

opportunity for public comment on the

new effective date within the proposed

amendment to part 352. In accordance

with 21 CFR 10.40(e)(1), FDA is

providing an opportunity for comment

on whether this partial stay should be

modified or revoked.

III. Analysis of Impacts

The economic impact of the final

monograph was discussed in the final

rule (64 FR 27666 at 27683). The

economic impact of the extension of the

effective date of the monograph until

December 31, 2002, was discussed in

the final rule extending that date (65 FR

36319 at 36323). This stay of the

effective date provides additional time

for companies to relabel and retest

products, eliminates a second relabeling

of sunscreen drug products when UVA

labeling is included in the monograph,

and reduces label obsolescence, as there

will be additional time to use up more

existing labeling. Thus, staying the

effective date will significantly reduce

the economic impact on industry.

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), and the Unfunded Mandates

Reform Act of 1995 (Public Law 104–4).

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). Under

the Regulatory Flexibility Act, if a rule

has a significant economic 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.

Section 202(a) of the Unfunded

Mandates Reform Act requires that

agencies prepare a written statement of

anticipated costs and benefits before

proposing any rule that may result in an

expenditure in any one year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation).

The agency concludes that this final

rule is consistent with the regulatory

philosophy and principles set out in the

Executive order and in these two

statutes. 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. FDA has determined that the final

rule does not have a significant

economic impact on a substantial

number of small entities. The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million adjusted for inflation.

The purpose of this final rule is to

stay the effective date of the final

monograph for OTC sunscreen drug

products in part 352. This will provide

additional time for manufacturers to

relabel and retest products and to use

up existing product labeling. The

agency encourages manufacturers who

use up their existing product labeling

before the amended final monograph is

issued to prepare new labeling in accord

with the existing final monograph in

part 352 in the format set forth in §

201.66 (21 CFR 201.66). Accordingly,

the agency certifies that this 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.

IV. Paperwork Reduction Act of 1995

This final 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.

V. Environmental Impact

The agency has determined under 21

CFR 25.31(a) 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.

VI. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the 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 rule does

not contain policies that have

federalism implications as defined in

the Executive order and, consequently,

a federalism summary impact statement

is not required.

VII. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

regarding this rule by April 1, 2002.

Three copies of all written comments

are to be submitted. Individuals

submitting written comments or anyone

submitting electronic comments may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document and may be accompanied by

a supporting memorandum or brief.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

This final rule (partial stay) is issued

under sections 201, 501, 502, 503, 505,

510, and 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 351,

352, 353, 355, 360, and 371) and under

Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67487

authority delegated to the Commissioner

of Food and Drugs.

Dated: December 21, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–32086 Filed 12–28–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–01–207]

RIN 2115–AA97

Security Zone: Seabrook Nuclear

Power Plant, Seabrook, New

Hampshire

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary security zone

around the Seabrook Nuclear Power

Plant in Seabrook, New Hampshire. The

security zone will close off public

access to all land and waters within 250

yards of the waterside property

boundary of Seabrook Nuclear Power

Plant. This action is necessary to ensure

public safety and prevent sabotage or

terrorist acts. Entry into this security

zone is prohibited unless authorized by

the Captain of the Port, Portland, Maine.

DATES: This rule is effective from

December 7, 2001 until June 15, 2002.

ADDRESSES: Documents indicated in this

preamble as being available in the

docket are part of docket CGD01–01–

207 and are available for inspection or

copying at Marine Safety Office

Portland, Maine, 103 Commercial Street,

Portland, Maine between 8 a.m. and 4

p.m., Monday through Friday, except

Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Lieutenant (Junior Grade) W. W. Gough,

Port Operations Department, Captain of

the Port, Portland, Maine at (207) 780–

3251.

SUPPLEMENTARY INFORMATION:

Regulatory History

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 an NPRM. On

September 11, 2001, two commercial

aircraft were hijacked from Logan

Airport in Boston, Massachusetts and

flown into the World Trade Center in

New York, New York inflicting

catastrophic human casualties and

property damage. National security and

intelligence officials warn that future

terrorist attacks against civilian targets

may be anticipated. The Seabrook

Nuclear Power Plant is open to possible

attack from waters adjacent to nearby

Hampton Harbor. Due to the potential

catastrophic effect an exposure of

radiation from the nuclear processes at

the plant would have on the

surrounding area, this rulemaking is

urgently required to prevent potential

future terrorist strikes against the

Seabrook Nuclear Power Plant. The

delay inherent in the NPRM process is

contrary to the public interest insofar as

it may render people and facilities

within and adjacent to the Seabrook

Nuclear Power Plant property

vulnerable to subversive activity,

sabotage or terrorist attack.

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. The measures implemented in

this rule are intended to prevent

possible terrorist attacks against the

Seabrook Nuclear Power Plant and are

needed to protect the facility, persons at

the facility, the public and the

surrounding community from potential

sabotage or other subversive activity,

sabotage and terrorist attacks, either

from the water or by access to the

facility by utilizing public trust lands

between the low water and high water

tide lines. Immediate action is required

to accomplish these objectives. Any

delay in the effective date of this rule is

impracticable and contrary to the public

interest.

This zone should have minimal

impact on the users of Hampton Harbor,

New Hampshire and the surrounding

waters as vessels are able to pass safely

outside the zone. Public notifications

will be made to the maritime

community via local notice to mariners

and signs posted to inform the public of

the boundaries of the zone.

Background and Purpose

In light of terrorist attacks on New

York City and Washington D.C. on

September 11, 2001 a security zone is

being established to safeguard the

Seabrook Nuclear Power Plant, persons

at the facility, the public and

surrounding communities from sabotage

or other subversive acts, accidents, or

other events of a similar nature. The

Seabrook Nuclear Power Plant presents

a possible target of terrorist attack due

to the catastrophic impact a release of

nuclear radiation would have on the

surrounding area. This security zone

prohibits entry into or movement within

the specified areas.

This rulemaking establishes a security

zone in all land and waters within 250

yards of the waterside property

boundary of Seabrook Nuclear Power

Plant in Seabrook, New Hampshire

bounded by a line beginning at position

42°53′58′′ N, 070°51′06′′ W, then

running along the Seabrook Nuclear

Power Plant property boundaries,

ending at position 42°53′46′′ N,

070°51′06′′ W. The area along the Plant

property boundaries is an area

delineated by a fence, and runs east

around the easternmost point of the

property boundaries of Seabrook

Nuclear Power Plant, then turns west to

the point of termination. This security

zone also closes all land within the zone

to prevent access along areas

traditionally reserved for public use

between the mean low water tide line

and the mean high water tide line. This

rulemaking is necessary to provide

complete protection of the waterfront

areas of the Seabrook Nuclear Power

Plant.

No person or vessel may enter or

remain in the prescribed security zone

at any time without the permission of

the Captain of the Port. Each person or

vessel in a security zone shall obey any

direction or order of the Captain of the

Port. The Captain of the Port may take

possession and control of any vessel in

a security zone and/or remove any

person, vessel, article or thing from a

security zone. No person may board,

take or place any article or thing on

board any vessel or waterfront facility in

a security zone without permission of

the Captain of the Port.

Regulatory Evaluation

This temporary final 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).

The Coast Guard expects the

economic impact of this proposal to be

so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

The effect of this regulation will not

be significant for several reasons: The

protected area is not regularly

navigated; there is ample room for

vessels to navigate around the security

zone; notifications will be made to the

local maritime community; and signs