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

Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations 12849

prior notice to the agency unless the

notice of the meeting specifies

otherwise.

(3) No official transcript or recording

of the meeting will be made unless it

appears to the agency that it will be

useful. A written memorandum

summarizing the substance of the

meeting will be prepared by an FDA

representative in all cases.

(c) A meeting with a person outside

the Department, including a person in

the executive or legislative branch of the

Federal Government, concerning a

pending court case, administrative

hearing, or other regulatory action or

decision, which involves more than a

brief description of the matter, is to be

summarized in a written memorandum,

which is filed in the administrative file

on the matter.

(d) Every person outside the Federal

Government may request and obtain a

private meeting with a representative of

FDA in agency offices to discuss a

matter.

(1) The person requesting a meeting

may be accompanied by a reasonable

number of employees, consultants, or

other persons with whom there is a

commercial arrangement within the

meaning of § 20.81(a). Neither FDA nor

any other person may require the

attendance of a person who is not an

employee of the executive branch of the

Federal Government without the

agreement of the person requesting the

meeting. Any person may attend by

mutual consent of the person requesting

the meeting and FDA.

(2) FDA will determine which

representatives of the Agency will

attend the meeting. The person

requesting the meeting may request but

not require or preclude the attendance

of a specific FDA employee.

(3) Whenever appropriate (e.g., the

meeting involves a matter covered by

paragraph (c) of this section or other

important matter, a decision on an

issue, or statements or advice or

conclusions to which future reference

may be desirable), a written

memorandum summarizing the

substance of the meeting will be

prepared by an FDA representative.

(4) A person who wishes to attend a

private meeting, but who either is not

permitted to attend by the person

requesting the meeting or by FDA or

who cannot attend because the meeting

is conducted by telephone, may obtain

a separate meeting with FDA to discuss

the same matter or an additional matter.

(e) FDA employees have a

responsibility to meet with all segments

of the public to promote the objectives

of the laws administered by the Agency.

In pursuing this responsibility the

following general policy applies where

agency employees are invited by

persons outside the Federal Government

to attend or participate in meetings

outside agency offices as representatives

of the Agency.

(1) A person outside the executive

branch may invite an agency

representative to attend or participate in

a meeting outside agency offices. The

agency representative is not obligated to

attend or participate, but may do so

where it is in the public interest and

will promote the objectives of the act.

(2) The agency representative may

request that the meeting be open if that

would be in the public interest. The

agency representative may decline to

participate in a meeting held as a

private meeting if that will best serve

the public interest.

(3) An agency representative may not

knowingly participate in a meeting

which is closed on the basis of sex, race,

or religion.

(4) A meeting, whether open or

closed, is subject to paragraph (d)(3) of

this section with respect to memoranda

summarizing the substance of the

meeting.

(f) Representatives of FDA may

initiate a meeting or correspondence

with any person outside the Federal

Government on any matter concerning

the laws administered by the

Commissioner.

(1) A meeting initiated by FDA

representatives which involves a small

number of interested persons, for

example, a meeting with a petitioner or

with two manufacturers of a particular

product which requires additional

testing or with a trade association

employee to discuss an industry

labeling problem, may be a private

meeting. A meeting initiated by FDA

representatives which involves a large

number of interested persons, for

example, 10 manufacturers of an

ingredient in a discussion of appropriate

testing or labeling, must be held as an

open conference or meeting under

paragraph (b) of this section.

(2) Whenever appropriate (e.g., the

meeting involves a matter covered by

paragraph (c) of this section or another

important matter, a decision on an

issue, or statements or advice or

conclusions to which future reference

may be desirable), a written

memorandum summarizing the

substance of the meeting will be

prepared by an FDA representative.

(g) A person who participates in a

meeting described in paragraphs (b)

through (f) of this section may also

prepare and submit to FDA for inclusion

in the administrative file a written

memorandum summarizing the

substance of the meeting.

(h) Memoranda of meetings prepared

by an FDA representative or by any

other person and all correspondence

which relate to a matter pending before

the agency will promptly be filed in the

administrative file of the proceeding.

(i) A meeting with a representative of

Congress relating to a pending or

potential investigation, inquiry, or

hearing by a congressional committee or

a Member of Congress will be

summarized in a written memorandum

which is to be forwarded to the Food

and Drug Administration, Office of

Legislative Affairs. This provision does

not restrict the right of an agency

employee to participate in the meeting.

(j) A meeting of an advisory

committee is subject to the requirements

of part 14.

(k) Under 42 U.S.C. 2631(a)(8), a log

or summary is to be made of all

meetings between representatives of

FDA and industry and other interested

parties to implement the Radiation

Control for Health and Safety Act of

1968.

§ 10.100 [Stayed]

8. Section 10.100 is stayed from

January 22, 2001, to April 22, 2001.

9. Section 10.100a is added to subpart

B from January 22, 2001, to April 22,

2001, to read as follows:

§ 10.100a Public calendars.

(a) Prospective public calendar of

public proceedings. (1) A public

calendar will be prepared and made

publicly available each week showing,

to the extent feasible, for the following

4 weeks, the public meetings,

conferences, hearings, advisory

committee meetings, seminars, and

other public proceedings of FDA, and

other significant public events involving

FDA, e.g., congressional hearings.

(2) A copy of this public calendar will

be placed on public display in the

following places:

(i) Dockets Management Branch.

(ii) Office of the Associate

Commissioner for Public Affairs.

(iii) A central place in each center.

(iv) A central place in each field

office.

(v) A central place at the National

Center for Toxicological Research.

(b) Retrospective public calendar of

meetings. (1) A public calendar will be

prepared and made publicly available

each week showing for the previous

week meetings with persons outside the

executive branch and other significant

events involving the representatives of

FDA designated under paragraph (b)(3)

of this section, but telephone

12850 Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Rules and Regulations

conversations will be included on an

optional basis and meetings with the

working press, except for ‘‘house

organs’’ (i.e., publications of firms that

manufacture or distribute regulated

products, or industry associations), and

with on-site contractors will not be

included. Meetings with members of the

judiciary, representatives of Congress, or

staffs of congressional committees will

be included when the meeting relates to

a pending court case, administrative

hearing, or other regulatory action or

decision and involves more than a brief

description of the matter.

(2) The calendar will include all

meetings, conferences, seminars, social

events sponsored by the regulated

industry, and speeches. The calendar

will specify the date and the person and

subject matter involved. When more

than one FDA representative is in

attendance, only the presiding or head

representative will report the meeting

on the public calendar. If a large number

of persons is involved, the name of each

need not be specified. Meetings that

would prejudice law enforcement

activities (e.g., a meeting with an

informant) or invade privacy (e.g., a

meeting with a candidate for possible

employment in FDA) will not be

reported.

(3) The following FDA representatives

and their deputies are subject to the

requirements of paragraphs (b)(1) and

(2) of this section:

(i) Commissioner of Food and Drugs.

(ii) Deputy Commissioner.

(iii) Associate Commissioners.

(iv) Executive and Special Assistants

to the Commissioner.

(v) [Reserved]

(vi) Director, National Center for

Toxicological Research.

(vii) Center Directors.

(viii) Chief Counsel for the Food and

Drug Administration, or any

representative of that office attending on

behalf of the Chief Counsel.

(4) A copy of the public calendar will

be placed on public display in the

following places:

(i) Dockets Management Branch.

(ii) Office of the Associate

Commissioner for Public Affairs.

(iii) A central place in each center.

(iv) A central place in each field

office.

(v) A central place at the National

Center for Toxicological Research.

PART 14—PUBLIC HEARING BEFORE

A PUBLIC ADVISORY COMMITTEE

10. The authority citation for 21 CFR

part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C.

1451–1461; 21 U.S.C. 141–149, 321–394,

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

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

11. Section 14.20 is amended by

adding paragraph (e) from January 22,

2001, to April 22, 2001, to read as

follows:

§ 14.20 Notice of hearing before an

advisory committee.

* * * * *

(e) All advisory committee meetings

are to be included on the public

calendar described in § 10.100(a).

PART 16—REGULATORY HEARING

BEFORE THE FOOD AND DRUG

ADMINISTRATION

12. The authority citation for 21 CFR

part 16 continues to read as follows:

Authority: 15 U.S.C. 1451–1461; 21 U.S.C.

141–149, 321–394, 467f, 679, 821, 1034; 28

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.

13. Section 16.60 is amended by

adding paragraph (a)(3) from January 22,

2001, to April 22, 2001, to read as

follows:

§ 16.60 Hearing procedure.

(a) * * *

(3) If the hearing is a public hearing,

it will be announced on the public

calendar described in § 10.100(a)

whenever feasible, and any interested

person who attends the hearing may

participate to the extent of presenting

relevant information.

* * * * *

Dated: February 23, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–4962 Filed 2–28–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 203 and 205

[Docket No. 92N–0297]

RIN 0905–AC81

Prescription Drug Marketing Act of

1987; Prescription Drug Amendments

of 1992; Policies, Requirements, and

Administrative Procedures; Delay of

Effective Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; delay of effective

date.

SUMMARY: The Food and Drug

Administration (FDA) is further

delaying, until April 1, 2002, the

effective date regarding certain

requirements of the final rule published

in the Federal Register of December 3,

1999 (64 FR 67720). The final rule

implements the Prescription Drug

Marketing Act of 1987 (PDMA), as

modified by the Prescription Drug

Amendments of 1992 (PDA), and the

Food and Drug Administration

Modernization Act of 1997 (the

Modernization Act). FDA is further

delaying the effective date for certain

requirements in the PDMA final rule

relating to wholesale distribution of

prescription drugs by distributors that

are not authorized distributors of record,

and distribution of blood derivatives by

entities that meet the definition of a

‘‘health care entity’’ in the final rule. In

the Federal Register of May 3, 2000 (65

FR 25639), the agency previously

delayed until October 1, 2001, the

effective date of these requirements. The

other provisions of the final rule became

effective on December 4, 2000. The

agency is taking this action to address

concerns about the requirements raised

by affected parties.

FDA believes that this further delay of

the effective date of certain

requirements in the PDMA final rule

satisfies 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 on January 24,

2001 (66 FR 7702). That memorandum

requested Federal agencies to delay by

60 days the effective date of any

regulation that was not effective as of

January 20, 2001. The action taken in

this document to further delay the

effective date of certain requirements of

PDMA exceeds 60 days. To the extent

that 5 U.S.C. 553 applies to this action,

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. As

explained in the SUPPLEMENTARY

INFORMATION section entitled ‘‘Need to

Further Delay the Effective Date,’’ the

delay will give distributors additional

time to exhaust inventories of drugs that

do not have acceptable pedigrees to

avoid economic harm. Additionally, the

delay will allow more time for FDA to

make recommendations to Congress, for

Congress to evaluate those

recommendations and, if necessary,