Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Rules and Regulations 34089

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

314.97 7 1 7 160 1,12011

314.70 2 1 2 20 40 2

Total 1,160

1Reporting burden for manufacturers of nonsterile products.

2Reporting burden for manufacturers of sterile products.

Because of the estimated increase

from the proposed rule to the final rule

in the number of respondents for

nonsterile products, the number of

recordkeepers in the recordkeeping

burden of Table 2 has increased by two

from the proposed rule. FDA estimated

a total of seven recordkeepers in the

proposed rule and now estimates a total

of nine recordkeepers as a result of new

data collected by ERG. The proposed

rule estimated 2 hours per record, and

FDA’s review of that estimate and its

experience with the control and

validation of microbiological

contamination supports this proposed

estimate. Therefore, the total number of

hours for the recordkeeping burden has

increased from 14 hours to 18 hours.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of Recordkeepers

Annual Frequency of Recordkeeping

Total Annual

Records

Hours per

Record Total Hours

211.113(b) 9 1 9 2 18

Total 18

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Individuals and organizations may

submit comments on these burden

estimates or on any other aspect of these

information collection provisions,

including suggestions for reducing the

burden, and should direct them to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

The information collection provisions

of this final rule have been submitted to

OMB for review. Prior to the effective

date of this final rule, FDA will publish

a notice in the Federal Register

announcing OMB’s decision to approve,

modify, or disapprove the information

collection provisions in this final rule.

An agency may not conduct or sponsor,

and a person is not required to respond

to a collection of information unless it

displays a currently valid OMB control

number.

VIII. 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 federalism

implications as defined in the order

and, consequently, a federalism

summary impact statement is not

required.

IX. Reference

The following reference is on display

in the Dockets Management Branch

(address above) and may be seen by

interested persons between 9 a.m. and 4

p.m., Monday through Friday.

1. Eastern Research Group, ‘‘Cost

Impact on the Pharmaceutical Industry

of Final Sterility Requirements for

Inhalation Solution Products,’’ 1998.

List of Subjects in 21 CFR Part 200

Drugs, Prescription drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 200 is

amended as follows:

PART 200—GENERAL

1. The authority citation for 21 CFR

part 200 continues to read as follows:

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

353, 355, 358, 360e, 371, 374, 375.

2. Section 200.51 is added to subpart

C to read as follows:

§ 200.51 Aqueous-based drug products for

oral inhalation.

(a) All aqueous-based drug products

for oral inhalation must be

manufactured to be sterile.

(b) Manufacturers must also comply

with the requirements in § 211.113(b) of

this chapter.

Dated: February 1, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–13210 Filed 5–25–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 123

[Public Notice 3318]

Exports of Commercial

Communications Satellite

Components, Systems, Parts,

Accessories and Associated Technical

Data

AGENCY: Bureau of Political-Military

Affairs, State.

ACTION: Interim final rule.

SUMMARY: Section 1309(a) of the Foreign

Relations Authorization Act for Fiscal

Years 2000 and 2001 requires the

Department of State to establish a

regulatory regime for the export

licensing to U.S. allies of commercial

satellites, technologies, components,

and systems, which shall include

expedited approval, as appropriate,

while ensuring priority to national

security and U.S. commitments under

the Missile Technology Control Regime.

Section 1302(a) of the same Act

requires the Department to promulgate

regulations in order to ensure timely

reporting to the Department (within 15

34090 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Rules and Regulations

days of shipment or export) of all

shipment information concerning items

exported pursuant to section 38 of the

Arms Export Control Act. The

Department will phase-in the reporting

requirements for shipment information

during the remainder of Calendar Year

2000 through publication of a separate

rule change. However, U.S. exporters

wishing to take advantage of the special

regulatory regime for satellite related

licensing to U.S. allies established in

this amendment will need to meet the

reporting requirements of section

1302(a) in accordance and coincident

with the effective date of this

amendment or their initial license

application submissions. In order to

facilitate use of the special regime, the

Office of Defense Trade Controls will

make available free of charge to U.S.

exporters the computer software and

guidance for its use that are needed to

participate fully.

This interim final rule amends the

International Traffic in Arms

Regulations (ITAR) by establishing a

new regulatory regime for

communications satellite related exports

to U.S. allies.

EFFECTIVE DATE: July 1, 2000.

FOR FURTHER INFORMATION CONTACT:

William Lowell or Terry Davis, Office of

Defense Trade Controls, Department of

State, Telephone (202) 663–2700 or FAX

(202) 261–8264, ATTN: Regulatory

Change, Commercial Communications

Satellites.

SUPPLEMENTARY INFORMATION: Section

1309(a) of the Foreign Relations

Authorization Act for Fiscal Years 2000

and 2001 provides that the Secretary of

State shall establish a regulatory regime

for licensing the export of commercial

satellites, satellite technologies, their

components, and systems which shall

include expedited approval, as

appropriate, of the licensing for export

by U.S. companies of such items to

NATO allies and major non-NATO

allies. Pursuant to § 1309(a) the regime

should include expedited processing of

requests for export authorizations that

are time critical (including information

exchange relating to satellite failures or

anomalies); are required to submit bids

to foreign persons for procurements; are

related to re-export of unimproved

materials, products, or data; or are

required to obtain launch and on-orbit

insurance.

Within this legislative framework, the

Department of State (Office of Defense

Trade Controls) and the Department of

Defense (Defense Threat Reduction

Agency/Technology Policy) convened in

January 2000 a task force of U.S.

aerospace industry experts who were

members of the State Department’s

federal advisory committee for defense

trade matters, the Defense Trade

Advisory Group (DTAG). This DTAG

task force met regularly with State and

Defense in the period January–April

2000 for the purpose of setting forth a

special licensing regime involving U.S.

allies that would reflect experience

gained since the transfer of commercial

communications satellites to the U.S.

Munitions List, which became effective

March 15, 1999. This task force also

drew on the technical and business

expertise of other U.S. aerospace

industry representatives in discrete

product lines (particularly those

involved in the supply of components

and systems) and held a town hall

discussion of the special licensing

regime included herein at the April 2–

4, 2000 Spring Conference of the Society

for International Affairs, a non-profit

association comprised of defense firms,

held at Laguna Beach, California.

The ITAR amendment herein

concerns the special satellite regime

involving U.S. allies, provided for by

authorizing legislation for exports and

re-exports of U.S. Munitions List

controlled articles for satellites to,

within and among the territories of the

member countries of NATO (Belgium,

Canada, Czech Republic, Denmark,

France, Germany, Greece, Hungary,

Iceland, Italy, Luxembourg,

Netherlands, Norway, Poland, Portugal,

Spain, Turkey, United Kingdom and the

United States) and countries that have

been designated pursuant to the Foreign

Assistance Act of 1961, as amended, as

major non-NATO allies (Australia, New

Zealand, Japan, Israel, Egypt, Jordan,

Republic of Korea and Argentina). This

coverage also includes exports and reexports of U.S. Munitions List

controlled articles for approved satellite

projects to be launched from the United

States or the territory of a NATO or

major non-NATO ally. Importantly,

unless otherwise specifically authorized

at the time of license approval, this

special satellite regime does not apply

to any other country in any measure,

including but not limited to

intermediate consignment occurring

during the initial export; temporary retransfer or re-export; or launch into

outer space of USML-controlled articles,

whether or not incorporated (e.g.,

embedded) in a satellite when that

activity involves a country that is not a

member of NATO or a major non-NATO

ally of the United States.

The special satellite regime has three

principal features. The first is the ability

to use high volume licenses (e.g., known

in the trade as ‘‘bulk’’ licenses) for

exports of specifically designed or

modified components, parts, systems,

accessories, attachments and certain

associated technical data for commercial

communications satellites under

specified conditions for multiple

shipments to any of the NATO or major

non-NATO allies.

The second principal feature

concerning use of this regime is that all

eligible articles for export must be

confined to an approved list of foreign

aerospace firms located within the

territories of U.S. allies for use in an

approved list of commercial

communications satellite programs of

U.S. allies. The lists of foreign aerospace

firms and commercial communications

satellite programs included within the

coverage of this regime will be kept

under scrutiny by the U.S. Government

and made publicly available on ODTC’s

Website and by other means. New firms

and programs will be added to these

lists following scrutiny within the U.S.

Government (and approved for

inclusion within the regime) in light of

proposals from U.S. aerospace firms

through export license applications.

Third, when exporting pursuant to the

special regime, it is not necessary under

specified conditions for U.S. exporters

to provide in advance the details of

purchase orders or contracts, or non

transfer and end use certificates (e.g.,

form DSP–83) where they may be

required. While all of this

documentation will continue to be

mandatory, and while exporters will

continue to be required to ascertain the

specific end users and end uses prior to

export or re-export, the required

documentation will only be required to

be furnished to ODTC within 15 days

following shipment from the United

States (or re-transfer within the

approved territory), at which time U.S.

exporters will report the appropriate

shipping information (discussed further

below) and furnish the required

documentation.

For sensitive components, such as

MTCR-controlled items, the long

standing controls of the ITAR, including

non-transfer and end use certificates,

parts control plans, and the like, will

continue to be required. But, in most

cases, such documentation may be

furnished within 15 days of shipment,

as described below. Restrictions may

also be imposed on such licenses,

however, in view of the specific items

proposed for export as appropriate in

furtherance of the security and foreign

policy of the United States (e.g., to meet

missile nonproliferation objectives).

Further, for particularly sensitive

articles or information, the U.S.

Government retains the discretion to

require a separate license when

Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Rules and Regulations 34091

necessary in furtherance of the security

and foreign policy of the United States.

The principal articles envisaged for

the special regime are: (1) The supply of

satellite components, parts, systems,

attachments, accessories and associated

technical data, including for off-shore

procurement; and, (2) technical

information needed to respond to bids,

to requests for quotations, plant visits,

acceptance testing of equipment and the

like. Technical data for satellite

insurance purposes, including for onorbit anomalies, involving exports to

insurance firms and their brokers and

consultants located within the

territories of U.S. allies has also been

discussed extensively within DTAG and

will be the subject of separate, informal

guidelines not requiring an amendment

to the ITAR.

Exports of complete commercial

communications satellites for sale to, or

launch by, U.S. allies have been

proceeding expeditiously consistent

with the Department of State’s January

1999 report to Congress concerning

implementation of the Strom Thurmond

National Defense Authorization Act for

Fiscal Year 1999. Such exports

invariably involve contracts of $50

million or more, requiring notification

to Congress pursuant to section 36(c) of

the Arms Export Control Act before an

export license may be issued. As such,

these exports do not lend themselves to

the special regime provided for herein

and no rule change to that effect is being

undertaken at this time. As suggested in

the referenced report, the Department of

State and the interested Committees of

Congress have used all appropriate

opportunities to ensure that U.S.

aerospace companies are able to meet

contract deadlines and launch

schedules consistent with the security

and foreign policy of the United States.

The details of communications satellite

notifications to Congress that have taken

place since March 15, 1999, are

available on the Website of the Office of

Defense Trade Controls (HYPERLINK

http://www.pmdtc.org.).

In carrying out this directive Part 123,

Licenses for the Export of Defense

Articles is being amended.

This amendment involves a foreign

affairs function of the United States and

therefore, is not subject to the

procedures required by 5 U.S.C. 553 and

554. It is exempt from review under

Executive Order 12866 but has been

reviewed internally by the Department

to ensure consistency with the purposes

thereof. This rule does not require

analysis under the Regulatory

Flexibility Act or the Unfunded

Mandates Reform Act. It has been found

to be a minor rule within the meaning

of the Small Business Regulatory

Enforcement Act of 1966. It will not

have substantial direct effects on the

States, the relationship between the

National Government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with § 6 of Executive Order

13132, it is determined that this rule

does not have sufficient federalism

implications to warrant application of

Executive Order Nos. 12372 and 13123.

However, interested parties are invited

to submit written comments to the

Department of State, Office of Defense

Trade Controls, ATTN: Regulatory

Change, Part 123—Commercial

Communications Satellites Components,

Systems, Parts, and Accessories, 13th

Floor, Room H1304, SA–1, Washington,

D.C. 20520–0113. Such persons must be

so registered with the Department’s

Office of Defense Trade Controls

(ODTC) pursuant to the registration

requirements of § 38 of the Arms Export

Control Act.

List of Subjects in 22 CFR Part 123

Arms and munitions, Exports.

Accordingly, for the reasons set forth

above, Title 22, Chapter I, Subchapter

M, Part 123, is amended as follows:

PART 123—LICENSES FOR THE

EXPORT OF DEFENSE ARTICLES

1. The authority citation for Part 123

is revised to read as follows:

Authority: Secs. 2, 38, and 71, Pub.L. 90–

629, 90 Stat. 744 (22 U.S.C. 2752, 2778,

2797); 22 U.S.C. 2753; E.O. 11958, 42 FR

4311; 3 CFR, 1977 Comp. p. 79; 22 U.S.C.

2658; Pub L. 105–261.

2. Section 123.27 is revised to read as

follows:

§ 123.27. Special licensing regime for

export to U.S. allies of commercial

communications satellite components,

systems, parts, accessories, attachments

and associated technical data.

(a) U.S. persons engaged in the

business of exporting specifically

designed or modified components,

systems, parts, accessories, attachments,

associated equipment and certain

associated technical data for commercial

communications satellites, and who are

so registered with the Office of Defense

Trade Controls pursuant to part 122 of

this subchapter, may submit license

applications for multiple permanent and

temporary exports and temporary

imports of such articles for expeditious

consideration without meeting the

documentary requirements of

§ 123.1(c)(4) and (5) concerning

purchase orders, letters of intent,

contracts and non-transfer and end use

certificates, or the documentary

requirements of § 123.9, concerning

approval of re-exports or re-transfers,

when all of the following requirements

are met:

(1) The proposed exports or re-exports

concern exclusively one or more countries of

the North Atlantic Treaty Organization

(Belgium, Canada, Czech Republic, Denmark,

France, Germany, Greece, Hungary, Iceland,

Italy, Luxembourg, The Netherlands,

Norway, Poland, Portugal, Spain, Turkey,

United Kingdom and United States) and/or

one or more countries which have been

designated in accordance with section 517 of

the Foreign Assistance Act of 1961 as a major

non-NATO ally (and as defined further in

section 644(q) of that Act) for purposes of

that Act and the Arms Export Control Act

(Argentina, Australia, Egypt, Israel, Japan,

Jordan, New Zealand and Republic of Korea).

(2) The proposed exports concern

exclusively one or more foreign persons (e.g.,

companies or governments) located within

the territories of the countries identified in

paragraph (a)(1) of this section, and one or

more commercial communications satellite

programs included within a list of such

persons and programs approved by the U.S.

Government for purposes of this section, as

signified in a list of such persons and

programs that will be publicly available

through the Internet Website of the Office of

Defense Trade Controls and by other means.

(3) The articles are not major defense

equipment sold under a contract in the

amount of $14,000,000 or more or defense

articles or defense services sold under a

contract in the amount of $50,000,000 or

more (for which purpose, as is customary,

exporters may not split contracts or purchase

orders). Items meeting these statutory

thresholds must be submitted on a separate

license application to permit the required

notification to Congress pursuant to section

36(c) of the Arms Export Control Act.

(4) The articles are not detailed design,

development, manufacturing or production

data and do not involve the manufacture

abroad of significant military equipment.

(5) The U.S. exporter reports complete

shipment information to the Office of

Defense Trade Controls within 15 days of

shipment in accordance with section 1302 of

the Foreign Relations Authorization Act for

Fiscal Years 2000 and 2001, and at that time

meets the documentary requirements of

§ 123.1(c)(4) and (5), the documentary

requirements of § 123.9 in the case of reexports or re-transfers, and, other

documentary requirements that may be

imposed as a condition of a license (e.g.,

parts control plans for MTCR-controlled

items). The shipment information reported

must include a description of the item and

quantity, value, port of exit and end user and

country of destination of the item.

(6) At any time in which an item exported

pursuant to this section is proposed for retransfer outside of the approved territory,

programs or persons (e.g., such as in the case

of an item included in a satellite for launch

beyond the approved territory), the detailed

requirements of § 123.9 apply with regard to

34092 Federal Register / Vol. 65, No. 103 / Friday, May 26, 2000 / Rules and Regulations

obtaining the prior written consent of the

Office of Defense Trade Controls.

(b) The re-export or re-transfer of the

articles authorized for export (including to

specified re-export destinations) in

accordance with this section do not require

the separate prior written approval of the

Office of Defense Trade Controls provided all

of the requirements in paragraph (a) of this

section are met.

(c) The Office of Defense Trade Controls

will consider, on a case-by-case basis,

requests to include additional foreign

companies and satellite programs within the

geographic coverage of a license application

submitted pursuant to this section from

countries not otherwise covered, who are

members of the European Space Agency or

the European Union. In no case, however,

can the provisions of this section apply or be

relied upon by U.S. exporters in the case of

countries who are subject to the mandatory

requirements of section 1514 of the Strom

Thurmond National Defense Authorization

Act for Fiscal Year 1999, concerning national

security controls on satellite export licensing.

(d) Registered U.S. exporters may request

at the time of a license application submitted

pursuant to this section that additional

foreign persons or communications satellite

programs be added to the lists referred to in

paragraph (a)(2) of this section, which

additions, if approved, will be included

within the publicly available lists of

authorized recipients and programs.

Dated: May 16, 2000.

Eric D. Newsom,

Assistant Secretary, Bureau of PoliticalMilitary Affairs, U.S. Department of State.

[FR Doc. 00–13329 Filed 5–25–00; 8:45 am]

BILLING CODE 4710–25–P

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 914

[SPATS No. IN–147–FOR]

Indiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: The Office of Surface Mining

Reclamation and Enforcement (OSM) is

approving an amendment to the Indiana

regulatory program (Indiana program)

under the Surface Mining Control and

Reclamation Act of 1977 (SMCRA).

Indiana proposed revisions to its

statutes that would allow the use of

money from its post-1977 abandoned

mine reclamation fund, under specified

circumstances, to replace domestic

water supplies disrupted or affected by

surface coal mining and reclamation

operations. Indiana intends to revise its

program in order to provide additional

protection to society and the

environment from the adverse effects of

surface coal mining operations.

EFFECTIVE DATE: May 26, 2000.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Director,

Indianapolis Field Office, Office of

Surface Mining, Minton-Capehart

Federal Building, 575 North

Pennsylvania Street, Room 301,

Indianapolis, Indiana 46204–1521.

Telephone (317) 226–6700. Internet:

INFOMAIL@indgw.osmre.gov.

SUPPLEMENTARY INFORMATION:

I. Background on the Indiana Program

II. Submission of the Amendment

III. Director’s Findings

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the Indiana Program

On July 29, 1982, the Secretary of the

Interior conditionally approved the

Indiana program. You can find

background information on the Indiana

program, including the Secretary’s

findings, the disposition of comments,

and the conditions of approval in the

July 26, 1982 Federal Register (47 FR

32107). You can find later actions on the

Indiana program at 30 CFR 914.10,

914.15, 914.16, and 914.17.

II. Submission of the Amendment

By letter dated February 25, 2000

(Administrative Record No. IND–1686),

the Indiana Department of Natural

Resources (department) sent us an

amendment to its program under

SMCRA and the Federal regulations at

30 CFR 732.17(b). The department sent

the amendment at its own initiative.

The amendment concerns revisions to

the Indiana Surface Coal Mining and

Reclamation Act at Indiana Code (IC)

14–34–6–15. The revisions made to IC

14–34–6–15 will allow the department

to use money from its post-1977

abandoned mine reclamation fund to

replace domestic water supplies

disrupted or affected by surface coal

mining and reclamation operations.

We announced receipt of the

amendment in the March 9, 2000,

Federal Register (65 FR 12492). In the

same document, we opened the public

comment period and provided an

opportunity for a public hearing or

meeting on the adequacy of the

amendment. The public comment

period closed on April 10, 2000.

Because no one requested a public

hearing or meeting, we did not hold

one.

III. Director’s Findings

Following, under SMCRA and the

Federal regulations at 30 CFR 732.15

and 732.17, are our findings concerning

the amendment.

IC 14–34–6–15 Abandoned Mine

Reclamation Fund

Indiana revised IC 14–34–6–15(b) and

(c) to read as follows:

(b) The post-1977 abandoned mine

reclamation fund is established. The fund

consists of bond forfeiture money collected

under section 16 of this chapter and the civil

penalties described in IC 14–34–16–9. The

fund may be used as follows:

(1) To effect the restoration of land not

otherwise eligible for federal funding on

which there has been surface mining activity

after August 3, 1977.

(2) To replace domestic water supplies

disrupted or affected by a surface coal mining

and reclamation operation, including the

disposal of coal combustion waste (as

defined in IC 13–19–3–3), where the surface

coal mining and reclamation operation has

been completed and is no longer subject to

IC 14–34.

The money held for this purpose may not

exceed an amount established by the

department that is sufficient to enable the

director to cover the anticipated cost of

restoration.

(c) At least five hundred thousand dollars

($500,000) in the fund is dedicated as

collateral for the bond pool under IC 14–34–

8 and may not be used for the restoration of

land or replacement of water described in

subsection (b).

Indiana’s post-1977 abandoned mine

reclamation fund (fund) consists of both

bond forfeiture and civil penalty

monies. However, only the monies

collected for civil penalties may be used

for the purposes specified in IC 14–34–

6–15(b). Under IC 14–34–6–16(f), the

bond forfeiture monies are to be used

solely for the purpose of reclaiming the

forfeiture sites to which the bonds

apply. Under IC 14–34–6–16(d), any

excess forfeited bond money must be

returned to the person from whom the

amount was received. Under IC 14–34–

6–15(b)(1), the civil penalty money in

the fund may be used to restore land

affected by surface mining activity after

August 3, 1977, if the land is not eligible

for Federal funding. Under the new

provision at IC 14–34–6–15(b)(2), the

civil penalty money in the fund may be

used to replace domestic water supplies

disrupted or affected by a surface coal

mining and reclamation operation, if the

operation is completed and is no longer

subject to the requirements of the

Indiana program under IC 14–34.

Indiana revised its exception provision

at IC 14–34–6–15(c) to clarify that the

$500,000 that is dedicated as collateral

for the Indiana bond pool may not be