Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Proposed Rules 40995

remain the responsibility of the pilot or

person in charge of the importing

aircraft or the agent thereof until it is

removed from his control in accordance

with this paragraph. If the bonded

warehouse operator fails to take

possession of the merchandise or

baggage within five working days after

receipt of notification of the presence of

the unentered and unreleased

merchandise or baggage, he shall be

liable for the payment of liquidated

damages under the terms and conditions

of his custodial bond (see § 113.63(a)(1)

of this chapter).

§ 122.161 [Amended]

5. In § 122.161, the first sentence is

amended by removing the reference

‘‘§ 122.14’’ and adding, in its place, the

words ‘‘subpart S of this part’’ and by

removing the reference ‘‘49 U.S.C. App.

1474’’ and adding, in its place, the

reference ‘‘19 U.S.C. 1644 and 1644a’’.

§ 122.165 [Amended]

6. In § 122.165, the first sentence of

paragraph (a) is amended by removing

the parenthetical reference ‘‘(49 U.S.C.

App. 1508(b))’’ and adding, in its place,

the parenthetical reference ‘‘(49 U.S.C.

41703)’’, and the second sentence of

paragraph (b) is amended by removing

the reference ‘‘49 U.S.C. App. 1471’’ and

adding, in its place, the reference ‘‘49

U.S.C. Chapter 463’’.

PART 123—CUSTOMS RELATIONS

WITH CANADA AND MEXICO

1. The general authority citation for

part 123 and the specific authority

citation for § 123.8 are revised to read,

and the specific authority citation for

§ 123.1 continues to read, as follows:

Authority: 19 U.S.C. 66, 1202 (General

Note 20, Harmonized Tariff Schedule of the

United States (HTSUS)), 1431, 1433, 1436,

1448, 1624.

Section 123.1 also issued under 19 U.S.C.

1459;

* * * * *

Section 123.8 also issued under 19 U.S.C.

1450–1454, 1459;

* * * * *

2. The specific authority citation for

§ 123.11 is removed.

§ 123.1 [Amended]

3. In § 123.1, paragraph (a)(2) is

amended by removing the words

‘‘sections 1433 or 1644 of title 19,

United States Code (19 U.S.C. 1433,

1644), or section 1509 of title 49, United

States Code App. (49 U.S.C. App.

1509),’’ and adding, in their place, the

words ‘‘section 1433, 1644 or 1644a of

title 19, United States Code (19 U.S.C.

1433, 1644, 1644a),’’.

4. In subpart A, § 123.10 is added to

read as follows:

§ 123.10 Lay order; general order.

(a) Any merchandise or baggage

regularly landed but not covered by a

permit for its release shall be allowed to

remain at the place of unlading until the

close of business on the fifth working

day after the day the vehicle was

entered. Within an additional fiveworking-day lay order period following

the expiration of the original fiveworking day period after unlading, 19

U.S.C. 1448(a) requires the operator or

owner of the vehicle or the agent thereof

to notify Customs of any such

merchandise or baggage for which entry

has not been made. Such notification

shall be provided in writing or by any

Customs-authorized electronic data

interchange system. Failure to provide

such notification may result in

assessment of a monetary penalty of up

to $1,000 per bill of lading against the

operator or owner of the vehicle or the

agent thereof as provided in 19 U.S.C.

1448(a).

(b) In addition to the notification to

Customs referred to in paragraph (a) of

this section, within five working days

following the expiration of the lay order

period specified in paragraph (a) of this

section, 19 U.S.C. 1490(a) requires the

operator or owner of the vehicle or the

agent thereof to provide notification of

the presence of such unreleased and

unentered merchandise or baggage to a

bonded warehouse certified by the port

director as qualified to receive general

order merchandise. Such notification

shall be provided in writing or by any

Customs-authorized electronic data

interchange system. It shall then be the

responsibility of the bonded warehouse

proprietor to arrange for the

transportation and storage of the

merchandise or baggage at the risk and

expense of the consignee. Any

unentered merchandise or baggage shall

remain the responsibility of the operator

or person in charge of the importing

vehicle or the agent thereof until it is

removed from his control in accordance

with this paragraph. If the bonded

warehouse operator fails to take

possession of the merchandise or

baggage within five working days after

receipt of notification of the presence of

the unentered and unreleased

merchandise or baggage, he shall be

liable for the payment of liquidated

damages under the terms and conditions

of his custodial bond (see § 113.63(a)(1)

of this chapter).

PART 148—PERSONAL

DECLARATIONS AND EXEMPTIONS

1. The authority citation for part 148

continues to read in part as follows:

Authority: 19 U.S.C. 66, 1496, 1498, 1624.

The provisions of this part, except for subpart

C, are also issued under 19 U.S.C. 1202

(General Note 20, Harmonized Tariff

Schedule of the United States).

* * * * *

§ 148.67 [Amended]

2. In § 148.67, paragraph (b) is

amended by removing the words

‘‘section 1474 of title 49, United States

Code,’’ and adding, in their place, the

reference ‘‘19 U.S.C. 1644 and 1644a’’.

PART 192—EXPORT CONTROL

1. The authority citation for Part 192

continues to read as follows:

Authority: 19 U.S.C. 66, 1624, 1627a,

1646a.

§ 192.4 [Amended]

2. In § 192.4, the first sentence is

amended by removing the reference ‘‘46

U.S.C. App. 91’’ and adding, in its

place, the reference ‘‘19 U.S.C. 1436’’

and the second sentence is amended by

removing the words ‘‘a liability of not

more than $1,000 nor less than $500

will be incurred’’ and adding, in their

place, the words ‘‘a liability for

penalties may be incurred’’.

Samuel H. Banks,

Acting Commissioner of Customs.

Approved: May 21, 1997.

Dennis M. O’Connell,

Acting Deputy Assistant Secretary of the

Treasury.

[FR Doc. 97–20227 Filed 7–30–97; 8:45 am]

BILLING CODE 4820–02–P

RAILROAD RETIREMENT BOARD

20 CFR Part 295

RIN 3220–AB29

Payments Pursuant to Court Decree or

Court-Approved Property Settlement

AGENCY: Railroad Retirement Board.

ACTION: Proposed rule.

SUMMARY: The Railroad Retirement

Board hereby proposes to amend its

regulations under part 295 by

eliminating the Medicare Part B

premium as a deduction from the

amount of benefits available for division

in a divorce proceeding or property

settlement related to a divorce or legal

separation.

DATES: Comments must be received on

or before September 29, 1997.
40996 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Proposed Rules

ADDRESSES: Secretary to the Board,

Railroad Retirement Board, 844 North

Rush Street, Chicago, Illinois 60611.

FOR FURTHER INFORMATION CONTACT:

Thomas W. Sadler, Senior Attorney,

Railroad Retirement Board, 844 North

Rush Street, Chicago, Illinois 60611,

telephone (312) 751–4513, TTD (312)

751–4701.

SUPPLEMENTARY INFORMATION: Part 295

describes the Board’s requirements for

obtaining an enforceable order directing

the Board to partition a railroad

retirement annuity incident to a divorce,

settlement, or annulment. Section

295.1(b) describes what benefits are

subject to division under this part.

Section 295.5(e)(1) further defines the

net amount of benefits subject to

division as excluding amounts deducted

for an employee’s elected Medicare Part

B premium. When § 295.5(e)(1) was

initially approved in 1986, the Board

was concerned about the risk that

Medicare premium deductions might

not be satisfied from the nondivisible

portion of an employee’s annuity in the

event that the portion would not be

payable due to work deductions. In

practice, however, the agency has

determined that only in rare cases is the

nondivisible portion insufficient to

accommodate the Medicare Part B

deduction. The Medicare Part B

premium is a personal expense elected

to be made by the employee. The Board

believes that it is more consistent with

the nature of the Part B premium that it

be paid entirely by the employee rather

than, in effect, partly by the employee

and partly by the divorced spouse.

Accordingly, the agency proposes that

the Medicare Part B deduction need not

be deducted from the divisible benefits

prior to partition in an action for

divorce, settlement, or annulment.

The Board, with the concurrence of

the Office of Management and Budget,

has determined that this is not a

significant regulatory action under

Executive Order 12866; therefore, no

regulatory impact analysis is required.

There are no information collections

associated with this rule.

List of Subjects in 20 CFR Part 295

Railroad employees, Railroad

retirement.

For the reasons set out in the

preamble, chapter II of title 20 of the

Code of Federal Regulations is proposed

to be amended as follows:

PART 295—PAYMENTS PURSUANT

TO COURT DECREE OR COURTAPPROVED PROPERTY SETTLEMENT

1. The authority for part 295

continues to read as follows:

Authority: 45 U.S.C. 231f; 45 U.S.C. 231m.

§ 295.5 [Amended]

2. Section 295.5(e)(1) is amended by

removing the comma after ‘‘Board’’ and

by removing ‘‘and the amount of any

Medicare Part B premium’’.

Dated: July 24, 1997.

By authority of the Board.

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 97–20206 Filed 7–30–97; 8:45 am]

BILLING CODE 7905–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 50

[Docket No. 90N–0302]

Accessibility to New Drugs for Use in

Military and Civilian Exigencies When

Traditional Human Efficacy Studies

Are Not Feasible; Determination Under

the Interim Rule That Informed

Consent Is Not Feasible for Military

Exigencies; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

written comments related to the

advisability of revoking or amending the

interim final rule that permitted the

Commissioner of Food and Drugs (the

Commissioner) to determine that

obtaining informed consent from

military personnel for the use of an

investigational drug or biologic is not

feasible in certain situations related to

military combat. The agency is also

soliciting written comments identifying

the evidence needed to demonstrate

safety and effectiveness for such

investigational drugs that cannot

ethically be tested on humans for

purposes of determining their efficacy.

FDA is seeking written comments from

all interested parties, including, but not

limited to: Consumers, patient groups,

veterans and veteran groups, active-duty

military personnel, organizations and

departments, ethicists, scientists,

researchers with particular expertise in

this area, and health care professionals.

The written comments are intended to

provide FDA with information to help

the agency in making policy decisions

on the use of investigational products

during military exigencies and the

appropriate evidence needed to

demonstrate safety and effectiveness for

drug and biological products used in

military or other exigencies when

traditional human efficacy studies are

not feasible.

DATES: Submit written comments by

October 29, 1997.

ADDRESSES: Submit written comments

on the questions identified in section II

of this document (specifically

referencing the number of the

question(s) being addressed) to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Bonnie M. Lee, Office of the Executive

Secretariat (HF–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4450.

SUPPLEMENTARY INFORMATION:

I. Background

There will continue to be military

combat situations in which there will be

a threat to U.S. military personnel from

the possible use of chemical and

biological weapons. The Department of

Defense (DOD), therefore, has a

legitimate interest in protecting military

personnel by using products which may

provide protection from such chemical

and biological agents. In order to

support this interest of DOD, FDA

issued an interim rule during the

Persian Gulf War that permitted DOD to

use specified investigational products

intended to provide potential protection

against chemical and biological warfare

agents without obtaining informed

consent. A copy of the interim rule that

published in the Federal Register of

December 21, 1990 (55 FR 52813), can

be viewed on FDA’s website at http://

www.fda.gov.

Specifically, following a request from

the DOD, FDA granted waivers from its

informed consent requirements for the

use of two products in specific protocols

in the Persian Gulf War: Pyridostigmine

bromide and botulinum toxoid vaccine.

FDA recognizes that the interim final

rule did not work the way that the

agency anticipated it would work;

therefore, the agency is seeking broad

public input to provide information to

help FDA in making policy decisions on

the future use of such investigational

products and possible efficacy

demonstrations for these products.

In order to provide a context for the

decisionmaking process on the use of

pyridostigmine bromide and the