Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Proposed Rules 185

16. Bishop, N. J. et al., ‘‘Increased

Concentration of Aluminum in the Brain of

an Infant,’’ Archives of Disease in Childhood,

64:1316–1317, 1989.

17. Koo, W. W. K. et al.,‘‘Aluminum in

Parenteral Nutrition Solution—Sources and

Possible Alternatives,’’ Journal of Parental

and Enteral Nutrition, 10:591–595, 1986.

18. Heyman, M. B. et al., ‘‘Aluminum Does

Not Accumulate in Teenagers and Adults on

Prolonged Parenteral Nutrition Containing

Free Amino Acids,’’ Journal of Parenteral

and Enteral Nutrition, 10:86–87, 1986.

19. Klein, G. L., ‘‘Unusual Sources of

Aluminum,’’ in Aluminum and Renal

Failure, edited by M. E. Debroe and J. W.

Coburn, Kluwer, Boston, 1989.

20. Bishop, N. J. et al., ‘‘Aluminum

Neurotoxicity in Preterm Infants Receiving

Intravenous Feeding Solutions,’’ New

England Journal of Medicine, 336:1557–1561,

1997.

21. Eastern Research Group, Compliance

Cost Analysis of a Regulation for Parenteral

Drug Products Containing Aluminum, March

11, 1996.

22. March 3, 1986, Meeting Minutes for the

Advisory Committee on Endocrinologic and

Metabolic Drug Products.

23. November 6, 1986, Meeting Minutes for

Public Workshop on aluminum toxicity in

clinical medicine, existing aluminum

monitoring, clinical effects of aluminum

loading, and methodology for quantitative

aluminum determination in parenteral

products.

24. June 25 and 26, 1987, Meeting Minutes

of the Allergenic Products Advisory

Committee—available in Docket No. 84N–

0387.

List of Subjects in 21 CFR Part 201

Drugs, Labeling, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, it is proposed that 21 CFR

part 201 be amended as follows:

PART 201—LABELING

1. The authority citation for 21 CFR

part 201 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 358, 360, 360b, 360gg–

360ss, 371, 374, 379e; 42 U.S.C. 216, 241,

262, 264.

2. New § 201.323 is added to subpart

G to read as follows:

§ 201.323 Aluminum in large and small

volume parenterals used in total parenteral

nutrition.

(a) The aluminum content of all large

volume parenteral (LVP) drug products

used in total parenteral nutrition (TPN)

therapy shall not exceed 25 micrograms

per liter (μg/L).

(b) The package insert of all LVP’s

used in TPN therapy shall state that the

drug product contains no more than 25

μg/L. This information shall be

contained in the ‘‘Precautions’’ section

of the labeling of all LVP’s used in TPN

therapy.

(c) The maximum level of aluminum

present at expiry shall be stated on the

immediate container label of all small

volume parenteral (SVP) drug products

and pharmacy bulk packages used in the

preparation of TPN solutions. The

aluminum content shall be stated as

follows: ‘‘Contains no more than lll

μg/L.’’ The immediate container label of

all SVP drug products and pharmacy

bulk packages that are lyophilized

powders used in the preparation of TPN

solutions shall contain the following

statement: ‘‘When reconstituted in

accordance with the package insert

instructions, the concentration of

aluminum will be no more than lll

μg/L.’’ This maximum level of

aluminum shall be stated as the highest

of:

(1) The highest level for the batches

produced during the last 3 years;

(2) The highest level for the latest five

batches; or

(3) The maximum historical level, but

only until completion of production of

the first five batches after this rule takes

effect.

(d) The package insert for all LVP’s,

SVP’s, and pharmacy bulk packages

shall contain the following warning

statement, intended for patients with

impaired kidney function and for

neonates receiving TPN therapy. This

information shall be contained in the

‘‘Warnings’’ section of the labeling of all

SVP’s and LVP’s as follows:

WARNING: This product contains

aluminum that may be toxic. Aluminum may

reach toxic levels with prolonged parenteral

administration if kidney function is

impaired. Premature neonates are

particularly at risk because their kidneys are

immature, and they require large amounts of

calcium and phosphate solutions, which

contain aluminum.

(e) Applicants and manufacturers

shall develop validated assay methods

to determine the aluminum content in

parenteral drug products. The assay

methods shall comply with current good

manufacturing practice requirements.

Applicants shall submit to the Food and

Drug Administration (FDA) both

validation of the method used and

release data for several batches.

Manufacturers of parenteral drug

products not subject to an approved

application shall make assay

methodology available to FDA during

inspections. Holders of pending

applications shall submit an

amendment under § 314.60 or § 314.96

of this chapter.

Dated: December 5, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–76 Filed 1-2-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Chapter II

Workshops on The Federal Oil and Gas

Royalty Simplification and Fairness

Act of 1996 (RSFA)

AGENCY: Minerals Management Service,

Interior.

ACTION: Notice of workshop.

SUMMARY: The Minerals Management

Service (MMS), Royalty Management

Program, is implementing the

requirements of the Federal Oil and Gas

Royalty Simplification and Fairness Act

of 1996. The purpose of this notice is to

inform the public of a public workshop

session on assessing for chronic

erroneous reporting.

DATES: The workshop will be held on

Tuesday, January 27, 1998, from 2 p.m.

until 4 p.m., Mountain time.

ADDRESSES: The workshop will be held

at the Embassy Suites Denver Southeast,

7525 East Hampden Avenue, Denver,

Colorado 80231, telephone (303) 696–

6644. Mail comments to: David S. Guzy,

Chief, Rules and Publications Staff,

Royalty Management Program, Minerals

Management Service, P.O. Box 25165,

MS 3021, Denver, Colorado 80225–

0165; courier delivery to building 85,

Denver Federal Center, Denver,

Colorado 80225; or e-mail

DavidlGuzy@mms.gov.

FOR FURTHER INFORMATION CONTACT:

David S. Guzy, Chief, Rules and

Publications Staff, telephone (303) 231–

3432; Fax (303) 231–3385; e-mail:

DavidlGuzy@mms.gov.

SUPPLEMENTARY INFORMATION: President

Clinton signed the Federal Oil and Gas

Royalty Simplification and Fairness Act

(RSFA) on August 13, 1996, to improve

the management of royalties from

Federal oil and gas leases. This is the

first major legislation affecting royalty

management since the Federal Oil and

Gas Royalty Management Act of 1982

(FOGRMA) was passed in January 1983.

In our Federal Register Notice dated

October 30, 1996 (61 FR 55941), MMS

listed key issues involved in

implementing RSFA. This workshop

will focus on assessing for chronic

erroneous reporting and will follow and
186 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Proposed Rules

be held at the same location as the

appeals workshop.

In order to accomplish a broad based

fact finding on how the requirements of

RSFA affect our customers and

stakeholders, comments from the public

are encouraged. In addition to

attendance at this meeting, comments

can be made in writing and sent directly

to MMS using instructions in the

ADDRESSES part of this notice.

Dated: December 29, 1997.

Lucy Querques Denett,

Associate Director for Royalty Management.

[FR Doc. 98–121 Filed 1–2–98; 8:45 am]

BILLING CODE 4310–MR–P

PANAMA CANAL COMMISSION

35 CFR Parts 133 and 135

RIN 3207–AA45

Tolls for Use of Canal; Rules for

Measurement of Vessels

AGENCY: Panama Canal Commission.

ACTION: Notice of proposed rulemaking;

request for comments; notice of hearing.

SUMMARY: The Panama Canal

Commission (Commission) proposes to

set a fixed, minimum toll rate for certain

small vessels transiting the Panama

Canal. The Commission has determined

an efficient use of existing Canal

capacity and resources requires a

change in the method of calculating

tolls used to meet the transit needs of

certain small vessels. A minimum toll

for small vessels will ensure the

Commission can recover at least part of

the resources it expends on this type of

transits.

The proposed increase complies with

the statutory requirement tolls be set at

rates which produce revenues sufficient

to cover Canal costs of operation and

maintenance, including capital for plant

replacement, expansion and

improvements, and working capital.

This notice of proposed rulemaking

also announces the availability from the

Commission of an analysis showing the

basis and justification for the proposed

change, solicits written data, views or

arguments from interested parties, and

sets the time and place for a public

hearing.

DATES: The agency must receive written

comments and requests to present oral

testimony on or before February 6, 1998.

A public hearing will be held at 9 a.m.,

February 13, 1998, in the Republic of

Panama.

ADDRESSES: Mail comments and

requests to testify at the hearing to: John

A. Mills, Secretary, Panama Canal

Commission, 1825 I Street NW., Suite

1050, Washington, DC 20006–5402; or

Department of Financial Management,

Panama Canal Commission, Balboa,

Ancon, Republic of Panama.

The hearing location is at the

Miraflores Visitors Pavilion Theater,

Building 6–A, Miraflores Locks,

Republic of Panama (accessible from

Gaillard Highway).

FOR FURTHER INFORMATION CONTACT: John

A. Mills, Telephone: (202) 634–6441,

Facsimile: (202) 634–6439, E-mail:

pancanalwo@aol.com; or Department of

Financial Management, Telephone: 011

(507) 272–3137, Facsimile: 011 (507)

272–3040, E-mail: fmfp@pancanal.com.

SUPPLEMENTARY INFORMATION: Section

1604 of the Panama Canal Act of 1979,

as amended, 22 U.S.C. 3794, establishes

procedures for proposing toll rate

increases and changes in the rules for

measurement of vessels. Those

procedures have been supplemented by

regulations in 35 CFR part 70, which

also provides interested parties with

instructions for participating in the

process governing changes in toll rates

and measurement rules. The

Commission strongly encourages all

interested parties to present in writing,

or orally at the hearing, pertinent data,

views or arguments, along with other

relevant information. Oral presentations

should be limited to 20 minutes. Further

information governing the content of the

notice of appearance or intention to

present supplementary data at the

hearing appear at 35 CFR 70.8 and

70.10.

Section 1602(b) of the Panama Canal

Act of 1979, as amended, 22 U.S.C.

3792(b), requires Canal tolls be

prescribed at rates calculated to produce

revenues to cover as nearly as

practicable all costs of maintaining and

operating the Panama Canal and the

facilities and appurtenances related

thereto. In analyzing the issue of tolls

for certain small vessels, it is recognized

the primary purpose of the Commission

is to provide a safe and efficient transit

service to the oceangoing vessels of the

world, primarily those engaged in

commerce. The waterway, however, also

attracts a considerable number of small

vessels, such as yachts, fishing craft,

and tugboats. Such small vessel transits

are incidental to the primary mission of

the Canal. They also consume a

disproportionately large share of

available Canal capacity and resources,

creating costly inefficiencies in Canal

operations. In addition, and perhaps

more importantly, small vessels

(especially yachts), impose

administrative costs and logistical

problems which currently are not offset

by the tolls they pay. Consequently, last

November, Congress amended section

1602(a) of the Panama Canal Act of

1979, 22 U.S.C. 3792(a) by Pub. L. 105–

85 to allow the Commission to set tolls

for yachts and other small vessels

transiting the Canal based on other than

net vessel tons of earning capacity.

The Commission is attempting to

reduce the administrative costs and

logistical requirements of small vessel

transits. It is also trying to improve the

scheduling options available for these

vessels with the goal of minimizing the

negative impact on the Commission’s

resources and capacity, and, wherever

possible, reduce the expenses associated

with the transit of these small vessels.

All of these steps are taken in order to

maintain the transit service offered to

these vessels. Even with these measures,

however, the Commission’s analysis of

small vessel transits indicates the cost of

providing the service far exceeds the toll

charged for the service. To address this

issue, the Commission’s Board of

Directors approved a recommendation

to set a fixed, minimum toll for certain

small vessels to recover these expenses

in a proportionate manner.

The Commission will consider all

submissions before publishing the final

rule in the Federal Register. The final

rule, as approved and published by the

Commission, will be effective no earlier

than 30 days after the date of its

publication as final in the Federal

Register.

The Commission is exempt from

Executive Order 12866. Accordingly,

provisions of that directive do not apply

to this rule. Even if the Order were

applicable, this change would not

constitute a ‘‘rule’’ as that term is

defined in the Regulatory Flexibility Act

[5 U.S.C. 601(2)] because it concerns

‘‘rates’’ and ‘‘practices relating’’ thereto.

Furthermore, the Commission has

determined implementation of this rule

will have no adverse effect on

competition, employment, investment,

productivity, innovation, or on the

ability of the United States based

enterprises to compete with foreign

based enterprises in domestic or export

markets.

The Secretary of the Commission

certifies these proposed regulatory

changes meet the applicable standards

of sections 3(a) and 3(b)(2) of Executive

Order No. 12988 of February 7, 1996.

List of Subjects

35 CFR Part 133

Navigation, Panama Canal, Tolls,

Vessels.

35 CFR Part 135

Measurement, Vessels.