Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations 12845

DaimlerChrysler Aviation Inc. It is not

a rule of general applicability and

affects only the applicant who applied

to the FAA for approval of these features

on the airplane.

The substance of these special

conditions has been subjected to the

notice and comment period in several

prior instances and has been derived

without substantive change from those

previously issued. It is unlikely that

prior public comments would result in

a significant change from the substance

contained herein. For this reason, and

because a delay would significantly

affect the certification of the airplane,

which is imminent, the FAA has

determined that prior public notice and

comment are unnecessary and

impracticable, and good cause exists for

adopting these special conditions upon

issuance. The FAA is requesting

comments to allow interested persons to

submit views that may not have been

submitted in response to the prior

opportunities for comment described

above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting

and recordkeeping requirements.

The authority citation for these

special conditions is as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701,

44702, 44704.

The Special Conditions

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the following special

conditions are issued as part of the

supplemental type certification basis for

the Gulfstream Aerospace Corporation

G–1159 airplanes modified by

DaimlerChrysler Aviation Inc.

1. Protection from Unwanted Effects

of High-Intensity Radiated Fields

(HIRF). Each electrical and electronic

system that performs critical functions

must be designed and installed to

ensure that the operation and

operational capability of these systems

to perform critical functions are not

adversely affected when the airplane is

exposed to high-intensity radiated

fields.

2. For the purpose of these special

conditions, the following definition

applied: Critical Functions: Functions

whose failure would contribute to or

cause a failure condition that would

prevent the continued safe flight and

landing of the airplane.

Issued in Renton, Washington, on February

16, 2001.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 01–4675 Filed 2–28–01; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 738, 740, 744, and 746

[Docket No. 010208031–1031–01]

RIN 0694–AC36

Exports to the Federal Republic of

Yugoslavia; Revision of Foreign Policy

Controls

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: This final rule amends the

Export Administration Regulations

(EAR) by removing the additional

license requirements imposed on Serbia

in May 1999. However, a license is

required for all exports and reexports by

U.S. persons of any item subject to the

EAR to persons listed pursuant to

Executive Order 13088, as amended by

Executive Order 13192 of January 17,

2001. The persons subject to sanctions

under amended Executive Order 13088

include Slobodan Milosevic, his family,

his close associates, and those indicted

for war crimes. These sanctioned

persons are identified on the list of

specially designated nationals and

blocked persons maintained by the

Department of the Treasury’s Office of

Foreign Assets Control and identified by

the bracketed suffix initials [FRYM].

Controls are maintained under the EAR

on arms and related materiel to the

Federal Republic of Yugoslavia (Serbia

and Montenegro) consistent with United

Nations Security Council Resolution

1160 of March 3, 1998.

DATES: This rule is effective March 1,

2001.

FOR FURTHER INFORMATION CONTACT:

Brian Nilsson, Office of Strategic Trade

and Foreign Policy Controls, Telephone:

(202) 482–4196.

SUPPLEMENTARY INFORMATION:

Background

Executive Order 13088 of June 9,

1998, as amended by Executive Order

13121 on April 30, 1999, imposed,

among other measures, comprehensive

U.S. export and reexport prohibitions on

the Federal Republic of Yugoslavia

(Serbia and Montenegro). On May 4,

1999, the Bureau of Export

Administration (BXA) issued a final rule

imposing a license requirement for

exports and reexports to Serbia of all

items subject to the EAR and a case-bycase review of applications with a

presumption of denial for other than

humanitarian items. These measures

were intended to deter Serbia’s human

rights offenses against ethnic Albanians

in Kosovo and to prevent the expansion

of the ethnic conflict. BXA’s May 4,

1999 rule did not impose similar

comprehensive controls on exports or

reexports to Montenegro.

Effective January 19, 2001, Executive

Order 13192 amended Executive Order

13088 to revoke previously imposed

prohibitions, including those on exports

and reexports. BXA is taking action

under its export control authorities

consistent with amended Executive

Order 13088. Specifically, this rule

removes the additional license

requirements imposed under the EAR

by the May 4, 1999, rule on exports and

reexports to Serbia, and thus restores

Serbia to the export control status it had

prior to May 4, 1999. However, persons

listed in the Annex to Executive Order

13192, as well as persons designated by

the Secretary of the Treasury, in

consultation with the Secretary of State

pursuant to that order, are subject to

sanctions administered by the

Department of the Treasury’s Office of

Foreign Assets Control. Exports and

reexports of any item subject to the EAR

by a U.S. person to a person designated

pursuant to amended Executive Order

13088 are subject to a license

requirement and a licensing policy of

denial. These sanctioned persons are

included on a list of specially

designated nationals and blocked

persons (SDNs) maintained by the

Department of the Treasury, Office of

Foreign Assets Control (OFAC) and

identified by the bracketed suffix

initials [FRYM]. To obtain additional

information regarding the list of SDNs,

contact OFAC at telephone number 202/

622–2520. BXA provisions regarding

these sanctioned persons are included

in new section 744.16 of the EAR.

This rule eliminates the distinctions

previously applicable to Serbia, Kosovo

and Montenegro, which had been

established by the final rule of

November 5, 1999, for export control

purposes. With the publication of this

rule, Serbia (including the province of

Kosovo) and Montenegro will be listed

together as the Federal Republic of

Yugoslavia (Serbia and Montenegro) for

License Exception eligibility purposes,

as members of ‘‘Country Group B’’ (see

Supplement No. 1 to part 740),

12846 Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations

‘‘Computer Tier 3’’ (see § 740.7), and in

the ‘‘Commerce Country Chart’’ (see

Supplement No. 1 part 738).

Note that the arms embargo mandated

by United Nations Security Council

Resolution 1160 of March 3, 1998

remains in effect. This embargo

prohibits the sale or supply of arms and

arms-related items to the Federal

Republic of Yugoslavia (Serbia and

Montenegro), including those controlled

under the EAR for crime control and

regional stability reasons.

A foreign policy report on the new

controls imposed by this rule on

designated persons pursuant to

amended Executive Order 13088 was

submitted to the Congress on February

23, 2001.

Rulemaking Requirements

1. This rule was determined to be not

significant for purposes of Executive

Order 12866.

2. This rule involves a collection of

information subject to the Paperwork

Reduction Act (P.R.A.) of 1995 (U.S.C.

3501 et seq.). This collection has been

approved by the Office of Management

and Budget under control number 0694–

0088, ‘‘Multi-Purpose Application,’’

which carries a burden hour estimate of

45 minutes per manual submission on

form BXA–748P and 40 minutes per

electronic submission. Notwithstanding

any other provision of law, no person is

required to respond to, nor shall any

person be subject to a penalty for failure

to comply with a collection of

information subject to the requirements

of the P.R.A., unless that collection of

information displays a currently valid

OMB Control Number.

3. This rule does not contain policies

with Federalism implications sufficient

to warrant preparation of a Federalism

assessment under Executive Order

13132

4. The provisions of the

Administrative Procedure Act (5 U.S.C.

553) requiring notice of proposed

rulemaking, the opportunity for public

participation, and a delay in effective

date, are inapplicable because this

regulation involves a military and

foreign affairs function of the United

States (Sec. 5 U.S.C. 553(a)(1)). Further,

no other law requires that a notice of

proposed rulemaking and an

opportunity for public comment be

given for this final rule. Because a

notice of proposed rulemaking and an

opportunity for public comment are not

required to be given for this rule under

5 U.S.C. 553, or by any other law, the

analytical requirements of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.) are not applicable. Therefore,

this regulation is issued in final form.

Although there is no formal comment

period, public comments on this

regulation are welcome on a continuing

basis. Comments should be submitted to

Sheila Quarterman, Office of Exporter

Services, Bureau of Export

Administration, Department of

Commerce, P.O. Box 273, Washington,

DC 20044.

List of Subjects

15 CFR Part 738

Administrative practice and

procedure, Exports, Foreign trade.

15 CFR Part 740

Administrative practice and

procedure, Exports, Foreign trade,

Reporting and Recordkeeping

requirements.

15 CFR Part 744

Exports, Foreign trade, Reporting and

recordkeeping requirements.

15 CFR Part 746

Embargoes, Exports, Foreign trade,

Reporting and recordkeeping

requirements.

Accordingly, parts 738, 740, 744, and

746 of the Export Administration

Regulations (15 CFR Parts 730–799) are

amended as follows:

1. The authority citation for part 738

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.;

Public Law No. 106–508; 50 U.S.C. 1701 et

seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 18

U.S.C. 2510 et seq.; 22 U.S.C. 287c; 22 U.S.C.

3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s),

185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43

U.S.C. 1354; 46 U.S.C. app. 466c; 50 U.S.C.

app. 5; E.O. 12924, 59 FR 43437, 3 CFR, 1994

Comp., p. 917; E.O. 13026, 61 FR 58767, 3

CFR, 1996 Comp., p. 228; Notice of August

3, 2000 (65 FR 48347, August 8, 2000).

2. The authority citation for part 740

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.;

Public Law No. 106–508; 50 U.S.C. 1701 et

seq.; E.O. 12924, 59 FR 43437, 3 CFR, 1994

Comp., p. 917; E.O. 13026, 61 FR 58767, 3

CFR, 1996 Comp., p. 228; Notice of August

3, 2000 (65 FR 48347, August 8, 2000).

3. The authority citation for part 744

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.;

Public Law No. 106–508; 50 U.S.C. 1701 et

seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a;

E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp.,

p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993

Comp., p. 608; E.O. 12924, 59 FR 43437, 3

CFR, 1994 Comp., p. 917; E.O. 12938, 59 FR

59099, 3 CFR, 1994 Comp., p. 950; E.O.

13026, 61 FR 58767, 3 CFR, 1996 Comp., p.

228; E.O. 13088, 63 FR 32109, 3 CFR, 1998

Comp., p. 191; E.O. 13121 of April 30, 1999,

64 FR 24021 (May 5, 1999); E.O. 13192 of

January 17, 2001, 66 FR 7379 (January 23,

2001); Notice of November 12, 1998, 63 FR

63589, 3 CFR, 1998 Comp., p. 305; Notice of

August 3, 2000 (65 FR 48347, August 8,

2000).

4. The authority citation for Part 746

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.;

Public Law No. 106–508; 50 U.S.C. 1701 et

seq.; 22 U.S.C. 287c; 22 U.S.C. 6004; E.O.

12854, 58 FR 36587, 3 CFR 1993 Comp., p.

614; E.O. 12918, 59 FR 28205, 3 CFR, 1994

Comp., p. 899; E.O. 12924, 59 FR 43437, 3

CFR, 1994 Comp., p. 917; Notice of August

3, 2000 (65 FR 48347, August 8, 2000).

PART 738—[AMENDED]

5. Supplement No. 1 to Part 738 is

amended by removing the entries

‘‘Kosovo (Serbian province of)’’ and

‘‘Montenegro’’, by revising the entry

heading ‘‘Serbia (not including

Kosovo)’’ to read ‘‘Yugoslavia (Serbia

and Montenegro), Federal Republic of’’,

and by revising the newly designated

‘‘Yugoslavia (Serbia and Montenegro),

Federal Republic of’’ row, to read as

follows:

Supplement No. 1 to Part 738—

(Commerce Country Chart)

COMMERCE COUNTRY CHART—REASON FOR CONTROL

Countries

Chemical & biological weaponsNuclear nonproliferationNational security Missile techRegional stability Firearms conventionCrime control Anti-terrorism

CB 1 CB 2 CB 3 NP 1 NP 2 NS 1 NS 2 MT 1 RS 1 RS 2 FC 1 CC 1 CC 2 CC 3 AT 1 AT 2

*******

Yugoslavia (Serbia and

Montenegro), Federal

Republic of 1 .................. X X X X X X X X X X X

* * * * * **

1This country is subject to United Nations Sanctions. See part 746 of the EAR for additional OFAC licensing requirements thatm ay apply to your proposed transaction.

Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations 12847

PART 740—[AMENDED]

6. Section 740.7 is amended by

revising paragraph (d)(1) to read as

follows:

§ 740.7 Computers (CTP).

* * * * *

(d) Computer Tier 3—(1) Eligible

countries. The countries that are eligible

to receive exports and reexports under

this License Exception are Afghanistan,

Albania, Algeria, Andorra, Angola,

Armenia, Azerbaijan, Bahrain, Belarus,

Bosnia & Herzegovina, Bulgaria,

Cambodia, China (People’s Republic of),

Comoros, Croatia, Djibouti, Egypt, and

Yugoslavia (Serbia and Montenegro),

Federal Republic of, Georgia, India,

Israel, Jordan, Kazakhstan, Kuwait,

Kyrgyzstan, Laos, Latvia, Lebanon,

Lithuania, Macau, Macedonia (The

Former Yugoslav Republic of),

Mauritania, Moldova, Mongolia,

Morocco, Oman, Pakistan, Qatar, Russia,

Saudi Arabia, Tajikistan, Tunisia,

Turkmenistan, Ukraine, United Arab

Emirates, Uzbekistan, Vanuatu,

Vietnam, Yemen and Yugoslavia. As of

May 19, 2001, Lithuania moves to

Computer Tier 1.

* * * * *

7. Supplement No. 1 to part 740 is

amended by removing ‘‘Kosovo (Serbian

province of)’’ and ‘‘Montenegro’’ from

the list of ‘‘Country Group B’’ countries

and by adding, in alphabetical order,

‘‘Yugoslavia (Serbia and Montenegro),

Federal Republic of’’.

PART 744—AMENDED

8. Part 744 is amended by adding new

section 744.16 to read as follows:

§ 744.16 Restrictions on exports and

reexports by U.S. persons to specially

designated persons on the list of Specially

Designated Nationals identified by the

bracketed suffix initials [FRYM].

BXA maintains restrictions on exports

and reexports of any item subject to the

EAR by U.S. persons to persons

designated pursuant to Executive Order

13088 of June 9, 1998, as amended by

Executive Order 13192 of January 17,

2001 (Executive Order 13088, as

amended). These designated persons

include individuals listed in the Annex

to Executive Order 13192, as well as

persons designated by the Secretary of

the Treasury, in consultation with the

Secretary of State pursuant to that order

(e.g., the former President of the Federal

Republic of Yugoslavia, Slobodan

Milosevic; his close associates; persons

determined to be under open indictment

by the International Criminal Tribunal

for the former Yugoslavia; and persons

determined to have sought, or to be

seeking, to maintain or reestablish

illegitimate control over the political

processes or economic resources of the

Federal Republic of Yugoslavia (Serbia

and Montenegro)). Persons designated

pursuant to Executive Order 13088, as

amended, are included on the list of

Specially Designated Nationals

maintained by the Department of the

Treasury’s Office of Foreign Assets

Control (OFAC) and identified by the

bracketed suffix initials [FRYM]. The

requirements set forth in this section

further the objectives of Executive Order

13088, as amended.

(a) License requirements. (1) A license

is required for all exports and reexports

of any item subject to the EAR by a U.S.

person to a person on the list of

Specially Designated Nationals

maintained by OFAC and identified by

the bracketed initials [FRYM].

(2) A U.S. person may also be

required to seek separate authorization

from OFAC for an export or reexport to

a designated person identified by the

bracketed initials [FRYM].

(b) License policy. Applications for

exports and reexports of any item

subject to the EAR by a U.S. person to

a Specially Designated National

identified by the bracketed initials

[FRYM] will be reviewed with a general

policy of denial.

PART 746—[AMENDED]

9. Section 746.9 is revised to read as

follows:

§ 746.9 The Federal Republic of

Yugoslavia (Serbia and Montenegro).

United Nations Security Council

Resolution 1160 of March 31, 1998

provides that all member States shall

prevent the sale or supply to the Federal

Republic of Yugoslavia, including

Kosovo, by their nationals or from their

territories or using their flag vessels and

aircraft, of arms and related materiel of

all types, such as weapons and

ammunition, military vehicles and

equipment and spare parts for the

aforementioned, and shall prevent the

arming and training for terrorist

activities there. Executive Order 12918

of May 26, 1994 (3 CFR, 1994 comp., p.

899) authorizes the Secretary of State

and the Secretary of Commerce, under

section 5 of the United Nations

Participation Act and other authorities

available to the respective Secretaries, to

take all actions necessary to implement

any arms embargo mandated by

resolution of the UNSC.

(a) License requirements. (1) Under

Executive Order 12918 of May 26, 1994,

and in conformity with UNSC

Resolution 1160 of March 31, 1998, an

embargo applies to the sale or supply to

the Federal Republic of Yugoslavia

(Serbia and Montenegro), of arms and

related materiel of all types and

regardless of origin, such as weapons

and ammunition, military vehicles and

equipment, and spare parts for such

items. You will, therefore, need a

license for the sale, supply or export to

the Federal Republic of Yugoslavia

(Serbia and Montenegro) from the

United States of embargoed items, as

listed in paragraphs (a)(1)(i) and (ii) of

this section. You will also need a

license for the sale, supply, export or

reexport to the Federal Republic of

Yugoslavia (Serbia and Montenegro) of

such items by any U.S. person in any

foreign country or other location.

(Reexport controls imposed by this

embargo apply only to reexports by U.S.

persons. Reexport controls on U.S.-

origin items to the Federal Republic of

Yugoslavia (Serbia and Montenegro) set

forth in other parts of the EAR remain

in effect.) You will also need a license

for the use of any U.S.-registered aircraft

or vessel to supply or transport to the

Federal Republic of Yugoslavia (Serbia

and Montenegro) any such items. These

requirements apply to the following

items, regardless of origin.

(i) Crime Control and Detection

Equipment as identified on the CCL

under CC Columns No. 1, 2 or 3 in the

Country Chart column of the ‘‘License

Requirements’’ section of the applicable

ECCN.

(ii) Items described by ECCNs ending

in ‘‘018’’; and 0A978, 0A979, 0A982,

0A983, 0A984, 0A985, 0A986, 0A987,

0A988, 0A989, 0B986, 0E982, 0E984,

1A005, 1A984, 1A985, 1C992.b.–k.,

2A993, 3A980, 3A981, 3D980, 3E980,

4A980, 4D980, 4E980, 5A980, 6A002,

6A003.b.3 and b.4, 6E001, 6E002,

9A980, and 9A991.a.

(2) Date of embargo. The licensing

requirements in paragraph (a)(1) of this

section were effective on July 14, 1998,

except for ECCN 0E982, which took

effect on September 13, 2000.

(b) Licensing policy. Applications for

export or reexport of all items listed in

paragraphs (a)(1)(i) and (ii) of this

section are subject to a general policy of

denial. Consistent with United Nations

Security Council Resolution 1160, this

embargo is effective notwithstanding the

existence of any rights or obligations

conferred or imposed by any

international agreement or any contract

entered into or any license or permit

granted prior to the appropriate date

referred to in paragraph (a)(2) of this

section, except to the extent provided in

regulations, orders, directives or

licenses that may be issued in the future

under Executive Order 12918 or under

the EAR.

12848 Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations

(c) Related controls. The Department

of State, Office of Defense Trade

Controls, maintains related controls on

arms and military equipment under the

International Traffic in Arms

Regulations (22 CFR parts 120 through

130). You should also contact the

Department of the Treasury’s Office of

Foreign Assets Control concerning any

restrictions which might apply to U.S.

persons involving financial transactions

or dealings with the Federal Republic of

Yugoslavia (Serbia and Montenegro).

Dated: February 26, 2001.

Matthew S. Borman,

Deputy Assistant Secretary for Export

Administration.

[FR Doc. 01–5007 Filed 2–28–01; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 14, and 16

[Docket No. 98N–1042]

Revision of Administrative Practices

and Procedures; Meetings and

Correspondence; Public Calendars;

Partial Stay, Amendments, and

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; partial stay,

amendments, and correction.

SUMMARY: In accordance with the

memorandum of January 20, 2001, from

the Assistant to the President and Chief

of Staff, entitled ‘‘Regulatory Review

Plan,’’ published in the Federal Register

of January 24, 2001 (66 FR 7702), this

action temporarily stays until April 23,

2001, the effectiveness of the rule

entitled ‘‘Revision of Administrative

Practices and Procedures; Meetings and

Correspondence, Public Calendars’’

published in the Federal Register of

January 22, 2001 (66 FR 6465). The

Food and Drug Administration (FDA) is

also correcting an error in the docket

number that appeared in the Federal

Register of January 22, 2001, final rule.

DATES: This final rule is effective from

January 22, 2001, to April 22, 2001. The

correction to the docket number is

effective January 22, 2001.

FURTHER INFORMATION CONTACT: Carol A.

Kimbrough, Office of Policy (HF–26),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3480.

SUPPLEMENTARY INFORMATION: The final

rule made the regulations relating to

meetings, correspondence, and the

agency’s public calendar more concise

and understandable to the public,

minimized confusion about publicly

available information concerning agency

meetings, provided more effective

disclosure of such information, and

allowed FDA to reallocate resources to

areas of more urgent public health need.

To the extent that 5 U.S.C. 553 applies

to this partial stay of effective date, it is

exempt from notice and comment

because it constitutes a rule of

procedure under 5 U.S.C. 553(b)(A).

Alternatively, the agency’s

implementation of this action without

opportunity for public comment,

effective immediately upon publication

today in the Federal Register, is based

on the good cause exceptions in 5 U.S.C.

553(b)(B) and (d)(3). Seeking public

comment is impracticable, unnecessary

and contrary to the public interest. The

partial stay of effective date is necessary

to give Department of Health and

Human Services officials the

opportunity for further review and

consideration of new regulations,

consistent with the Assistant to the

President’s memorandum of January 20,

2001. Seeking prior public comment on

this partial stay and amendments would

have been impractical, as well as

contrary to the public interest in the

orderly promulgation and

implementation of regulations.

In FR Doc. 01–1566 appearing on page

6465 in the Federal Register of Monday,

January 22, 2001, the following

correction is made: On page 6465, in the

third column, in the fifth line, ‘‘[Docket

No. 98–1042]’’ is corrected to read

‘‘[Docket No. 98N–1042]’’.

As stated in the summary, the rule is

stayed until April 23, 2001, in

accordance with the memorandum of

January 20, 2001, from the Assistant to

the President and Chief of Staff, entitled

‘‘Regulatory Review Plan,’’ published in

the Federal Register of January 24,

2001. Because the January 22, 2001, rule

entitled ‘‘Revision of Administrative

Practices and Procedures; Meetings and

Correspondence, Public Calendars’’

inadvertently published with an

immediate effective date, the

mechanism for delaying the effective

date is in some instances shown below

to temporarily amend the rule to return

to the provisions it contained before

January 22, 2001.

For the reasons set forth in this

document, FDA amends 21 CFR chapter

I as follows:

PART 10—ADMINISTRATIVE

PRACTICES AND PROCEDURES

1. The authority citation for 21 CFR

part 10 continues to read as follows:

Authority: 5 U.S.C. 551–558, 701–706; 15

U.S.C. 1451–1461; 21 U.S.C. 141–149; 321–

397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42

U.S.C. 201, 262, 263b, 264.

§ 10.30 [Amended]

2. Section 10.30(i)(6) is amended by

removing ‘‘§ 10.65(f)’’ and by adding in

its place ‘‘§ 10.65(h)’’ from January 22,

2001, to April 22, 2001.

§ 10.33 [Amended]

3. Section 10.33(k)(6) is amended by

removing ‘‘§ 10.65(f)’’ and by adding in

its place ‘‘§ 10.65(h)’’ from January 22,

2001, to April 22, 2001.

§ 10.35 [Amended]

4. Section § 10.35(h)(6) is amended by

removing ‘‘§ 10.65(f)’’ and by adding in

its place ‘‘§ 10.65(h)’’ from January 22,

2001, to April 22, 2001.

§ 10.40 [Amended]

5. Section 10.40(g)(7) is amended by

removing ‘‘§ 10.65(f)’’ and by adding in

its place ‘‘§ 10.65(h)’’ from January 22,

2001, to April 22, 2001.

§ 10.65 [Stayed]

6. Section 10.65 is stayed from

January 22, 2001, to April 22, 2001.

7. Section 10.65a is added to subpart

B from January 22, 2001, to April 22,

2001, to read as follows:

§ 10.65a Meetings and correspondence.

(a) In addition to public hearings and

proceedings established under this part

and other sections of this chapter,

meetings may be held and

correspondence may be exchanged

between representatives of FDA and an

interested person outside FDA on a

matter within the jurisdiction of the

laws administered by the

Commissioner. Action on meetings and

correspondence does not constitute final

administrative action subject to judicial

review under § 10.45.

(b) The Commissioner may conclude

that it would be in the public interest to

hold an open public meeting to discuss

a matter (or class of matters) pending

before FDA, at which any interested

person may participate.

(1) The Commissioner shall give

public notice through the public

calendar described in § 10.100(a) of the

time and place of the meeting and of the

matters to be discussed, and may also

publish notice of the meeting.

(2) The meeting will be informal, i.e.,

any interested person may attend and

participate in the discussion without