[Federal Register Volume 66, Number 41 (Thursday, March 1, 2001)]
[Rules and Regulations]
[Pages 12848-12850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4962]


=======================================================================
-----------------------------------------------------------------------

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.


Sec. 10.30  [Amended]

    2. Section 10.30(i)(6) is amended by removing ``Sec.  10.65(f)'' 
and by adding in its place ``Sec. 10.65(h)'' from January 22, 2001, to 
April 22, 2001.


Sec. 10.33  [Amended]

    3. Section 10.33(k)(6) is amended by removing ``Sec. 10.65(f)'' and 
by adding in its place ``Sec. 10.65(h)'' from January 22, 2001, to 
April 22, 2001.


Sec. 10.35  [Amended]

    4. Section Sec. 10.35(h)(6) is amended by removing 
``Sec. 10.65(f)'' and by adding in its place ``Sec. 10.65(h)'' from 
January 22, 2001, to April 22, 2001.


Sec. 10.40  [Amended]

    5. Section 10.40(g)(7) is amended by removing ``Sec. 10.65(f)'' and 
by adding in its place ``Sec. 10.65(h)'' from January 22, 2001, to 
April 22, 2001.


Sec. 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:


Sec. 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 Sec. 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 Sec. 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

[[Page 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 Sec. 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.


Sec. 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:


Sec. 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

[[Page 12850]]

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:


Sec. 14.20  Notice of hearing before an advisory committee.

* * * * *
    (e) All advisory committee meetings are to be included on the 
public calendar described in Sec. 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:


Sec. 16.60  Hearing procedure.

    (a) * * *
    (3) If the hearing is a public hearing, it will be announced on the 
public calendar described in Sec. 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