67482 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

Documents from November 1995 to

the present can be viewed and printed

from FERC’s Home Page using the

RIMS link or the Energy Information

Online icon. Descriptions of

documents back to November 18,

1981, are also available from RIMSon-the-Web; requests for copies of

these and other older documents

should be submitted to the Public

Reference Room.

Users assistance is available for RIMS,

CIPS, and the Website during normal

business hours from our Help Line at

(202) 208–2222 (E-mail to

WebMaster@ferc.fed.us) or the Public

Reference at (202) 208–1371 (E-Mail to

public.referenceroom@ferc.fed.us).

During normal business hours,

documents can also be viewed and/or

printed in FERC’s Public Reference

Room, where RIMS, CIPS, and the FERC

Website are available. User assistance is

also available.

List of Subjects in 18 CFR Part 385

Administrative practice and

procedure, Electric power, Penalties,

Pipelines, and Reporting and

recordkeeping requirements.

By the Commission.

Linwood A. Watson, Jr.,

Acting Secretary.

In consideration of the foregoing, the

Commission amends part 385, Chapter I,

Title 18, Code of Federal Regulations, as

follows.

PART 385—RULES OF PRACTICE AND

PROCEDURE

1. The authority citation continues to

read as follows:

Authority: 5 U.S.C. 551–557; 15 U.S.C.

717–717z, 3301–3432; 16 U.S.C. 791a–825r,

2601–2645; 31 U.S.C. 9701; 42 U.S.C. 7101–

7352; 49 U.S.C. 60502; 49 App. U.S.C. 1–85

(1988).

§ 385.2201 Rules governing off-the-record

communications. (Rule 2201).

* * * * *

2. In § 385.2201 paragraphs (e)(1)(viii)

and (g)(3) are added to read as follows:

(e) Exempt off-the-record

communications. (1) * * *

(viii) An off-the-record

communication from any person related

to any national security-related issue

concerning a facility regulated by the

Commission or a facility that provides

Commission-regulated services.

* * * * *

(g) Disclosure of exempt off-the-record

communications. ***

(3) Any document, or a summary of

the substance of any oral

communications, obtained through an

exempt off-the-record communication

under paragraphs (e)(1)(viii) of this

section, will be submitted promptly to

the Secretary and placed in a non-public

decisional file of the relevant

Commission proceeding and made

available to parties to the proceeding,

subject to their signing a non-disclosure

agreement. Responses will also be

placed in the non-public decisional file

and held confidential. If the

Commission determines that the

communication does not contain

sensitive national security-related

information, it will be placed in the

decisional file.

* * * * *

[FR Doc. 01–32068 Filed 12–28–01; 8:45 am]

BILLING CODE 6717–01–P

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Parts 122 and 178

[T.D. 02—01]

RIN 1515—AC99

Passenger and Crew Manifests

Required for Passenger Flights in

Foreign Air Transportation to the

United States

AGENCY: U.S. Customs Service,

Department of the Treasury.

ACTION: Interim rule; solicitation of

comments.

SUMMARY: This document amends the

Customs Regulations, on an interim

basis, in order to implement a provision

of the Aviation and Transportation

Security Act which requires that each

air carrier, foreign and domestic,

operating a passenger flight in foreign

air transportation to the United States

electronically transmit to Customs in

advance of arrival a passenger and crew

manifest that contains certain specified

information. The submission of this

information to Customs is required for

purposes of ensuring aviation safety and

protecting national security.

DATES: Interim rule is effective

December 31, 2001. Comments must be

received on or before March 1, 2002.

ADDRESSES: Written comments may be

addressed to and inspected at the

Regulations Branch, Office of

Regulations and Rulings, U.S. Customs

Service, 1300 Pennsylvania Avenue,

NW., 3rd Floor, Washington, DC 20229.

FOR FURTHER INFORMATION CONTACT: For

legal matters: Larry L. Burton, Office of

Regulations and Rulings, 202–927–1287;

For operational matters: James Jeffers,

Office of Field Operations,202–927–

4444.

SUPPLEMENTARY INFORMATION:

Background

On November 19, 2001, the President

signed into law the Aviation and

Transportation Security Act (Act),

Public Law 107–71. Section 115 of that

law amended 49 U.S.C. 44909, to add a

new paragraph (c) in order to provide

that, not later than 60 days after the date

of enactment of the Act, each air carrier,

foreign and domestic, operating a

passenger flight in foreign air

transportation to the United States must

electronically transmit to Customs a

passenger and crew manifest containing

certain information in advance of

arrival. Under this statutory provision,

the transmission of passenger and crew

manifest information will be required

even for flights where the passengers

and crew have already been preinspected or pre-cleared at the foreign

location for admission to the United

States.

Specifically, under 49 U.S.C.

44909(c)(2)(A)-(E), for each passenger

and crew manifest relating to a

passenger flight in foreign air

transportation to the United States, the

following information is required to be

submitted to Customs: The full name of

each passenger and crew member; the

date of birth and citizenship of each

passenger and crew member; the gender

of each passenger and crew member; the

passport number and country of

issuance of the passport of each

passenger and crew member if a

passport is required for travel; and the

United States visa number or resident

alien card number of each passenger

and crew member, as applicable.

In addition, under 49 U.S.C.

44909(c)(2)(F), such other information

concerning passenger and crew

manifests may be required to be

transmitted to Customs, as may be

determined to be reasonably necessary

to ensure aviation safety.

Moreover, the statute provides that

the electronic transmission of a

passenger and crew manifest required

for a covered flight must be received by

Customs in advance of the aircraft

landing in the United States in such

manner, time and form as Customs may

prescribe (49 U.S.C. 44909(c)(4)).

Passenger Manifest; Crew Manifest

This document amends the Customs

Regulations to implement 49 U.S.C.

44909(c)(2)(A)-(E) in a new § 122.49a.

This section requires air carriers, for

each flight subject to the statute, to

Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations 67483

transmit to Customs, by means of an

electronic data interchange system that

is approved by Customs, a passenger

manifest and, by way of a separate

transmission using the same system, a

crew manifest. (The system currently in

effect for this purpose is called the

Advance Passenger Information System

(APIS)). Furthermore, the air carrier

must transmit each manifest so that the

crew manifest is received by Customs

electronically in advance of departure

from the last foreign port or place, and

the passenger manifest is received not

later than 15 minutes after the departure

of the aircraft from the last foreign port

or place (after the wheels are up on the

aircraft and the aircraft is directly en

route to the United States). To

distinguish the two manifests

transmitted for a given flight, the crew

manifest must have the alpha character

‘‘C’’ included in the transmission to

denote that the manifest information

pertains to the crew members for the

flight.

Required Data Elements for the

Manifests

The following data elements

comprising the passenger and crew

manifests for each flight under 49 U.S.C.

44909(c) must be electronically

transmitted to Customs:

(1) The International Air Transport

Authority (IATA) airline code; the flight

number (followed by the alpha character

‘‘C’’ in the case of the message

transmitting the crew manifest for the

flight); the departure location IATA

code; the U.S. arrival location(s) IATA

code(s); the date of flight arrival; and

whether each passenger and crew

member on the flight is destined for the

U.S. or in transit through the U.S.;

(2) The full name of each passenger

and crew member; the date of birth and

citizenship of each passenger and crew

member; the gender of each passenger

and crew member; the passport number

and country of issuance of the passport

of each passenger and crew member if

required for travel; and the United

States visa number or resident alien

card number of each passenger and crew

member, as applicable; and

(3) The foreign airport where each

passenger began his air transportation to

the United States; for each passenger

and crew member destined for the

United States, the airport in the United

States where the passenger and crew

member will process through Customs

and Immigration formalities; and for

each passenger and crew member

transiting through the United States and

not clearing through Customs and

Immigration formalities, the foreign

airport of final destination for the

passenger and crew member.

Many of the data elements contained

in item ‘‘2’’ above describing each

passenger and crew member on a flight

are contained in travel documents that

air carriers review prior to the boarding

of the passenger. Air carriers are to

transmit the data elements listed in item

‘‘2’’ above, by transmitting

electronically to Customs one, and only

one, travel document, selected in the

following order of preference: U.S.

Alien Registration Card; U.S. Border

Crossing Card; U.S. non-immigrant visa;

a U.S. Refugee Travel Document or ReEntry Permit; U.S. Passport; or non-U.S.

passport.

Even though Customs recognizes that

the travel document information being

transmitted to Customs by the air carrier

may not contain all the informational

elements required by the statute and set

forth in the regulations, Customs’ timely

receipt of the electronic transmission of

the preferred travel document

pertaining to each passenger or crew

member for a particular flight will at the

present time be considered as

constituting full compliance with the

informational requirements of 49 U.S.C.

44909(c)(2)(A)-(E). Air carriers will be

required to transmit any informational

elements required by the statute and

this regulation which are not contained

in transmitted travel documents by a

date that will be announced in a future

Federal Register document.

It is further observed that the data

elements contained in passenger and

crew manifests for flights subject to 49

U.S.C. 44909(c)(1) that are 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)).

Lastly, it is noted that the requirement

in 49 U.S.C. 44909(c)(3) that carriers

make passenger name record

information available to Customs upon

request will be the subject of a separate

document published in the Federal

Register.

Comments

Before adopting this interim

regulation as a final rule, consideration

will be given to any written comments

that are timely submitted to Customs.

Customs specifically requests comments

on the clarity of this interim rule and

how it may be made easier to

understand. Comments submitted will

be available for inspection in

accordance with the Freedom of

Information Act (5 U.S.C. 552), § 1.4,

Treasury Department Regulations (31

CFR 1.4), and § 103.11(b), Customs

Regulations (19 CFR 103.11(b)), on

regular business days between the hours

of 9:00 a.m. and 4:30 p.m. at the

Regulations Branch, U.S. Customs

Service, 1300 Pennsylvania Avenue,

NW., 3rd Floor, Washington, DC.

Administrative Procedure Act,

Executive Order 12866 and the

Regulatory Flexibility Act

This interim regulation has been

determined to be critically necessary for

purposes of ensuring aviation safety and

protecting national security. Further,

Congress has directed air carriers to

comply no later than 60 days from

enactment of the Aviation and

Transportation Security Act. For these

reasons, Customs finds that good cause

exists in this case for dispensing with

the notice and public comment

procedures of the Administrative

Procedure Act (5 U.S.C. 553) as being

contrary to the public interest pursuant

to 5 U.S.C. 553(b)(B), and, in this

connection, pursuant to 5 U.S.C.

553(d)(3), a delayed effective date is not

required. Because this document is not

subject to the requirements of 5 U.S.C.

553, as noted, it is not subject to the

provisions of the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). Nor does the

interim regulation result in a

‘‘significant regulatory action’’ under

E.O. 12866.

Paperwork Reduction Act

This interim regulation is being

issued without prior notice and public

procedure pursuant to the

Administrative Procedure Act (5 U.S.C.

553). For this reason, the collection of

information contained in this interim

regulation has been reviewed and,

pending the receipt and evaluation of

public comments, approved by the

Office of Management and Budget

(OMB) in accordance with the

requirements of the Paperwork

Reduction Act of 1995 (44 U.S.C. 3507)

under control number 1515–0232. An

agency may not conduct, and a person

is not required to respond to, a

collection of information unless the

collection of information displays a

valid control number assigned by OMB.

The collection of information required

in this document is contained in

§ 122.49a. This information is required

in connection with passenger flights in

foreign air transportation to the United

States. The likely respondents and/or

recordkeepers are business

organizations, specifically air carriers,

including foreign air carriers.

Estimated total annual reporting and/

or recordkeeping burden: 2,380 hours.

Estimated average annual burden per

respondent/recordkeeper: .0028 hours.

67484 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Rules and Regulations

Estimated number of respondents

and/or recordkeepers: 200.

Estimated annual frequency of

responses: 850,000.

Comments on the collection of

information should be sent to the Office

of Management and Budget, Attention:

Desk Officer of the Department of the

Treasury, Office of Information and

Regulatory Affairs, Washington, DC

20503. A copy should also be sent to the

Regulations Branch, Office of

Regulations and Rulings, U.S. Customs

Service, 1300 Pennsylvania Avenue,

NW., 3rd Floor, Washington, DC 20229.

Comments should be submitted within

the same time frame that comments are

due regarding the substance of the

interim regulation.

Comments are invited on: (a) Whether

the collection is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(b) the accuracy of the agency’s estimate

of the burden of the collection of the

information; (c) ways to enhance the

quality, utility, and clarity of the

information to be collected; (d) ways to

minimize the burden of the collection of

information on respondents, including

through the use of automated collection

techniques or other forms of information

technology; and (e) estimates of capital

or startup costs and costs of operations,

maintenance, and purchase of services

to provide information.

Part 178, Customs Regulations (19

CFR part 178), containing the list of

approved information collections, is

appropriately revised to make provision

for this information collection.

List of Subjects

19 CFR Part 122

Air carriers, Aircraft, Airports, Air

transportation, Customs duties and

inspection, Entry procedure, Reporting

and recordkeeping requirements,

Security measures.

19 CFR Part 178

Administrative practice and

procedure, Collections of information,

Paperwork requirements, Reporting and

recordkeeping requirements.

Amendments to the Regulations

Parts 122 and 178, Customs

Regulations (19 CFR parts 122 and 178),

are amended as set forth below.

PART 122—AIR COMMERCE

REGULATIONS

1. The authority citation for part 122

continues to read, and a specific

sectional authority citation is added to

read, as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66,

1433, 1436, 1448, 1459, 1590, 1594, 1623,

1624, 1644, 1644a.

§ 122.49a also issued under 19 U.S.C. 1431

and 49 U.S.C. 44909(c).

2. Subpart E of part 122 is amended

by adding § 122.49a to read as follows:

§ 122.49a Passenger and crew manifests.

(a) General requirement. Each air

carrier, foreign and domestic, operating

a passenger flight in foreign air

transportation to the United States,

including flights where the passengers

and crew have already been preinspected or pre-cleared at the foreign

location for admission to the United

States, must transmit to Customs a

passenger manifest and a crew manifest

containing the information set forth in

paragraph (c) of this section, as required

by 49 U.S.C. 44909(c)(1). The electronic

transmission of manifest information

must be effected through an electronic

data interchange system approved by

Customs. This information must be

transmitted to the U.S. Customs Data

Center, Customs Headquarters.

(b) Passenger and crew manifests

separately transmitted; advance receipt

by Customs. For each flight subject to

paragraph (a) of this section, the air

carrier must separately transmit to

Customs the passenger manifest and the

crew manifest. The crew manifest must

be received in advance of departure

from the last foreign port or place. The

passenger manifest must be received by

Customs no later than 15 minutes after

the flight has departed from the last

foreign port or place (after the wheels

are up on the aircraft and the aircraft is

en route directly to the United States).

(c) Information required—(1) Airline

and flight information. For each

passenger manifest and crew manifest

relating to a flight falling within the

scope of paragraph (a) of this section,

the following airline and flight

information must be electronically

transmitted to Customs: the airline

IATA (International Air Transport

Authority) code; the flight number

(followed by the alpha character ‘‘C’’ in

the case of the crew manifest for the

flight); the departure location IATA

code; the U.S. arrival location(s) IATA

code(s); the date of flight arrival in the

United States; and whether each

passenger and crew member on the

flight is destined for the U.S. or in

transit through the U.S.

(2) Identifying information for each

passenger or crew member. In the

manner prescribed in paragraph (c)(3) of

this section, for each passenger manifest

and crew manifest, as applicable, that

relates to a flight falling within the

scope of paragraph (a) of this section,

the following information that identifies

each passenger and crew member on the

flight must be electronically transmitted

to Customs: The full name of each

passenger and crew member; the date of

birth and citizenship of each passenger

and crew member; the gender of each

passenger and crew member; the

passport number and country of

issuance of the passport of each

passenger and crew member if a

passport is required for travel; and the

United States visa number or resident

alien card number of each passenger

and crew member, as applicable (49

U.S.C. 44909(c)(2)(A)–(E)).

(3) Use of travel document to obtain

data. Air carriers are to provide the data

elements set out in paragraph (c)(2) of

this section that describe each passenger

and crew member on a flight subject to

paragraph (a) of this section by

transmitting to Customs one, and only

one, travel document per passenger or

crew member, selected in the following

order of preference: U.S. Alien

Registration Card; U.S. Border Crossing

Card; U.S. non-immigrant visa; U.S.

Refugee Travel Document or Re-Entry

Permit; U.S. Passport; or non-U.S.

passport. Customs timely receipt of the

electronic transmission of the preferred

travel document pertaining to a

passenger or crew member for a covered

flight will be considered as constituting

full compliance with the informational

requirements of 49 U.S.C.

44909(c)(2)(A)–(E), subject to paragraph

(c)(5) of this section.

(4) Additional information required;

travel itinerary of each passenger and

crew member. In addition, for each

passenger manifest and crew manifest,

as applicable, that relates to a flight

falling within the scope of paragraph (a)

of this section, air carriers are required

to transmit for each passenger and crew

member, the foreign airport where they

began their air transportation to the

United States. Also, for passengers and

crew members destined for the United

States, the air carrier must designate the

airport in the United States where the

passenger will be processed through

Customs and Immigration formalities.

Likewise, for passengers and crew

members that are transiting through the

United States and not clearing Customs

and Immigration formalities, the air

carrier bringing them into the United

States must transmit the foreign airport

of ultimate destination.

(5) Receipt of all required data

elements. Air carriers will be required to

transmit any informational elements

required by paragraph (c) of this section

which are not contained in the

transmitted travel documents by a date

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