[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Rules and Regulations]
[Pages 6465-6469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1566]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 14, and 16

[Docket No. 98-1042]


Revision of Administrative Practices and Procedures; Meetings and 
Correspondence; Public Calendars

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations relating to meetings, correspondence, and the agency's 
public calendar. This action makes FDA's procedures more concise and 
understandable to the public, minimizes confusion about publicly 
available information concerning agency meetings, provides for more 
effective disclosure of such information, and allows the FDA to 
reallocate resources to areas of more urgent public health need.

DATES: This rule is effective January 22, 2001.

FOR FURTHER INFORMATION CONTACT: Brian Mayhew, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-5211, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 17, 1998 (63 FR 69575), FDA 
issued a proposed rule to modify certain regulations pertaining to the 
public calendar and public meetings because such regulations are no 
longer effective in serving their intended purposes.
    In that proposed rule, FDA tentatively concluded that the proposed 
action would make its procedures for public calendars and public 
meetings more concise and understandable to the public, minimize 
confusion about publicly available information

[[Page 6466]]

concerning agency meetings, provide for more effective disclosure of 
such information, and allow FDA to reallocate resources to areas of 
more urgent public health need.
    Interested parties were given until March 2, 1999, to comment on 
the proposal. Three letters, each containing one or more comments, were 
received in response to the proposal. Such letters were from a research 
laboratory, a blood bank association, and a research institute. The 
blood bank association supported the proposal, while the two other 
organizations suggested a number of modifications. The comments 
received and FDA's responses are addressed below.

II. Comments and Agency Response

A. The Prospective Public Calendar

    (Comment 1) The proposed regulation would eliminate the prospective 
public calendar. Three comments addressed the elimination. One comment 
suggested that FDA evaluate whether the use of the prospective public 
calendar affects participation in FDA sponsored events before 
eliminating the prospective public calendar. Another comment noted that 
the proposed rule included no data to support the agency's tentative 
conclusion that maintenance of the prospective public calendar is no 
longer practical, workable, or beneficial to the public.
    While the agency has not formally studied the impact of the public 
calendar on the amount of participation in a public event, FDA notes 
that it generally does a great deal of outreach through other 
mechanisms, including the Federal Register, the Internet, direct 
mailings, and other direct communications. In fact, the prospective 
public calendar may be one of the least effective mechanisms for 
notifying the public of upcoming public events, given that maintenance 
of the calendar has been given a lower priority and fewer resources 
have been expended to ensure that information on the public calendar is 
accurate and current. FDA has not performed a study regarding the 
maintenance of the public calendar either. However, the agency believes 
that it is much more efficient to allocate its limited resources to 
more effective methods of communication to its stakeholders.
    (Comment 2) One comment requested that FDA not abandon any 
important communication mechanism such as the prospective public 
calendar that is designed to fulfill its obligation to notify the 
participants about future events until it fully examines whether some 
simple improvements to the existing system will fix problems for FDA 
and the public.
    Due to the extremely positive response that the agency receives at 
its public meetings, public hearings, and other widely-attended events, 
the agency believes that other mechanisms, such as the Internet and the 
Federal Register, are effectively communicating the relevant 
information about FDA events. FDA does not believe that simple 
improvements to the current prospective public calendar will 
significantly improve its effectiveness.
    (Comment 3) One comment asserted that the reasons provided for 
removing the prospective public calendar (i.e., need for frequent 
changes to the calendar, difficulty in projecting entries 4 weeks in 
advance) do not appear sufficient to warrant elimination of the 
availability of this information from the general public, especially in 
light of the resources expended on direct mail, the Federal Register, 
and FDA Internet activities.
    The agency notes that it is precisely because of the availability 
of these other mechanisms that it is deleting the prospective public 
calendar requirements from its regulations. The agency will continue to 
use these very effective and efficient mechanisms in the future. 
Resources devoted to these other mechanisms will more adequately ensure 
that the public receives information regarding FDA meetings than if 
those same resources were devoted to maintaining the prospective public 
calendar.
    (Comment 4) One comment stressed the importance of the agency 
providing adequate advance time for its announcements through other 
mechanisms.
    The agency agrees with this comment, and it will strive to ensure 
that adequate time will be provided to the public when it disseminates 
information about public events via the Internet, the Federal Register, 
or other mechanisms.
    (Comment 5) One comment suggested that with the abandonment of the 
prospective public calendar, it is extremely important that FDA 
maintain the timely publication of all meeting summaries because they 
are important and useful to the public.
    FDA agrees with this comment.
    (Comment 6) One comment argued that it was unrealistic to expect 
that the public at large is able to access the same information via the 
Internet as in the publication it plans to discontinue.
    The agency believes that Internet access has become increasingly 
widespread in recent years. However, even in the event that a person 
did not have Internet access, other mechanisms, including Federal 
Register notices and direct mail, will provide adequate notification to 
the public regarding information previously contained in the 
prospective public calendar.

B. The Retrospective Public Calendar

    (Comment 7) Under the proposed regulations, only meetings between 
certain senior agency officials and persons outside the executive 
branch of Government would be included on the retrospective public 
calendar. If a large number of persons is in attendance at a meeting, 
the name of each person need not be specified in the calendar entry, 
and if more than one FDA representative is in attendance, only the most 
senior official would report the meeting. One comment stated that these 
proposed changes would significantly limit the availability of 
potentially important information and would significantly restrict the 
range of input reflecting the various levels within FDA.
    As stated in the proposed rule (63 FR 69575), the agency finds that 
it has become unduly burdensome for assistants, deputies, and 
representatives of the agency's senior officials to report meetings. 
FDA anticipates that despite this limitation on the reporting of some 
meetings, those meetings that are of greatest interest to the public 
will be reflected on the retrospective public calendar, thereby 
providing an appropriate level of public access to information.

C. Public Meetings

    (Comment 8) Under the proposed regulations, FDA representatives may 
determine when it is appropriate to create an official transcript, 
recording, or memorandum of a meeting. One comment stated that, due to 
these changes in Sec. 10.65(b) through (f) (21 CFR 10.65(b) through 
(f)), the availability of potentially important information will be 
denied to the public.
    Because of limited resources, the agency finds that the 
determination of whether memoranda of a given meeting should be 
prepared should be left to the discretion of the senior agency official 
attending the meeting, taking into consideration the subject matter of 
the meeting, the public interest in the issue, and the value of using 
agency resources to prepare such transcripts, recordings, or memoranda. 
The agency does not believe that this change will significantly 
diminish the amount of important information made available to the 
public. This change will allow resources to be redirected to areas of 
greater public health need. This change does not preclude a participant 
from

[[Page 6467]]

preparing a summary of the meeting for inclusion into the 
administrative record, regardless of whether the agency creates an 
official record.
    (Comment 9) Under the proposed regulations, meetings may be public 
or private at FDA's discretion. One comment requested that FDA exclude 
any individual representing a company that is the sponsor of an 
application pending before the agency from the definition of ``person 
outside the Federal government.'' The reason for this request was that 
the comment did not want such an individual to have his/her meeting 
denied in favor of a meeting with a larger audience, raising issues 
about confidential business information.
    The agency will not schedule larger meetings in place of necessary 
meetings with a sponsor of a product with an application pending before 
the agency. Instead, this clarification in the regulation is intended 
to provide the agency with the discretion to combine certain meeting 
requests of a similar nature. The agency has no intention of denying 
necessary meetings with sponsors where confidential information may be 
discussed. The comment misinterpreted the intent of the amendment, and 
the agency does not, therefore, find it necessary to change the 
definition of ``person outside the Federal Government''
    (Comment 10) One comment suggested that FDA should publish the 
criteria that it uses in making a determination about whether a meeting 
should be public or private.
    The agency believes that this comment suggests a more elaborate 
process for this determination than the agency contemplated or than the 
agency believes necessary. While FDA is increasingly striving to make 
its processes open, transparent, and predictable, the agency is 
continuing to minimize an unnecessary burden on itself or its 
constituents. The agency reserves the discretion to make determinations 
about whether a given meeting is public or private on an informal and 
largely ad hoc basis. However, to the extent possible, FDA will make 
every effort to honor meeting requests and make its meetings as open 
and accessible to the public as practical.
    (Comment 11) One comment suggested that the agency clarify that if 
other publicly available documents, such as hearing transcripts, 
congressional letters, and hearing testimony were not issued in a 
timely fashion from other sources, FDA will then issue a memorandum.
    The agency declines to commit to issuing of a meeting memorandum 
whenever other sources do not make other documents available. However, 
FDA will make every effort to ensure that information about meetings 
with Congress covered by this rule is available as quickly as possible.

III. Changes From the Proposed Rule

    Proposed revised Sec. 10.65(e)(1) and (e)(2) have been modified and 
redesignated as Sec. 10.65(f) to provide information about the filing 
of memoranda or summaries in the administrative file.
    Proposed revised Sec. 10.65(k) has been deleted because the 
statutory requirement upon which it was based has been repealed. 
(Public Law 105-362, title VI, section 601(a)(2)(A), 112 Stat. 3285 
(1998).)
    In this final rule, the agency is amending Sec. 10.100(b)(3) (21 
CFR 10.100(b)(3)) to more accurately reflect the current personnel 
structure of the agency. A reorganization of the Office of the 
Commissioner of Food and Drugs (the Commissioner) has changed the 
organizational structure of that office. This reorganization reduces 
the number of senior officials who would be covered by Sec. 10.100 
(b)(3). Therefore, only the Commissioner, Senior Associate 
Commissioners, Deputy Commissioners, Associate Commissioner for 
Regulatory Affairs, Center Directors, and the Chief Counsel will be 
required to report meetings on the retrospective calendar.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that would not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement would be 
required.

V. Analysis of Impact

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public L. 104-121)) and the Unfunded Mandates Reform Act of 1995 
(Pub. Law 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity).
    The Regulatory Flexibility Act requires an analysis of regulatory 
options that would minimize any significant impact of a rule on small 
entities. The Unfunded Mandates Reform Act requires that agencies 
prepare an assessment of anticipated costs and benefits before 
proposing any rule that may result in an expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100 million (adjusted annually for inflation) in any one year. The 
agency believes that this final rule is consistent with the regulatory 
philosophy and principles identified in the Executive Order. This final 
rule does not impose any mandates on State, local, or tribal 
governments, nor is it a significant regulatory action under the 
Unfunded Mandates Reform Act. Furthermore, the agency certifies that 
this final rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further regulatory flexibility analysis is 
required.

VI. Paperwork Reduction Act of 1995

    This regulation would impose no reporting or recordkeeping 
requirements that would necessitate Office of Management and Budget 
clearance.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 16

    Administrative practice and procedure.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR parts 10, 14, and 16 are amended 
to read 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 Citizen petition is amended in paragraph (i)(6) by 
removing ``Sec. 10.65(h)'' and adding in its place ``Sec. 10.65(f)''.


Sec. 10.33  [Amended]

    3. Section 10.33 Administrative reconsideration of action is 
amended in paragraph (k)(6) by removing

[[Page 6468]]

``Sec. 10.65(h)'' and adding in its place ``Sec. 10.65(f)''.


Sec. 10.35  [Amended]

    4. Section 10.35 Administrative stay of action is amended in 
paragraph (h)(6) by removing ``Sec. 10.65(h)'' and adding in its place 
``Sec. 10.65(f)''.


Sec. 10.40  [Amended]

    5. Section 10.40 Promulgation of regulations for the efficient 
enforcement of the law is amended in paragraph (g)(7) by removing 
``Sec. 10.65(h)'' and adding in its place ``Sec. 10.65(f)''.
    6. Section 10.65 is revised to read as follows:


Sec. 10.65  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, in which any interested person may 
participate.
    (1) The Commissioner shall inform the public of the time and place 
of the meeting and of the matters to be discussed.
    (2) The meeting will be informal, i.e., any interested person may 
attend and participate in the discussion without prior notice to the 
agency unless the notice of the meeting specifies otherwise.
    (c) Every person outside the Federal Government may request a 
private meeting with a representative of FDA in agency offices to 
discuss a matter. FDA will make reasonable efforts to accommodate such 
requests.
    (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) 
of this chapter. 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) A person who wishes to attend a private meeting, but who is not 
invited to attend either by the person requesting the meeting or by 
FDA, or who otherwise cannot attend the meeting, may request a separate 
meeting with FDA to discuss the same matter or an additional matter.
    (d) 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 that is closed on the basis of gender, race, or religion.
    (e) An official transcript, recording, or memorandum summarizing 
the substance of any meeting described in this section will be prepared 
by a representative of FDA when the agency determines that such 
documentation will be useful.
    (f) FDA promptly will file in the appropriate administrative file 
memoranda of meetings prepared by FDA representatives and all 
correspondence, including any written summary of a meeting from a 
participant, that relate to a matter pending before the agency.
    (g) Representatives of FDA may initiate a meeting or correspondence 
on any matter concerning the laws administered by the Commissioner. 
Unless otherwise required by law, meetings may be public or private at 
FDA's discretion.
    (h) A meeting of an advisory committee is subject to the 
requirements of part 14 of this chapter.
    7. Section 10.100 is revised to read follows:


Sec. 10.100  Public calendar.

    (a) Public calendar. A public calendar will be prepared and made 
publicly available by FDA each week showing, to the extent feasible, 
significant events of the previous week, including significant meetings 
with persons outside the executive branch, that involve the 
representatives of FDA designated under paragraph (c) of this section.
    (1) Public calendar entries will include:
    (i) Significant meetings with members of the judiciary, 
representatives of Congress, or staffs of congressional committees when 
the meeting relates to a pending court case, administrative hearing, or 
other regulatory action or decision;
    (ii) Significant meetings, conferences, seminars, and speeches; and
    (iii) Social events sponsored by the regulated industry.
    (2) The public calendar will not include reports of 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 at FDA), meetings with members of the press, or 
meetings with onsite contractors.
    (b) Calendar entries. The calendar will specify for each entry the 
date, person(s), and subject matter involved. If a large number of 
persons are in attendance, the name of each individual need not be 
specified. When more than one FDA representative is in attendance, the 
most senior agency official will report the meeting on the public 
calendar.
    (c) Affected persons. The following FDA representatives are subject 
to the requirements of this section:
    (1) Commissioner of Food and Drugs.
    (2) Senior Associate Commissioners.
    (3) Deputy Commissioners.
    (4) Associate Commissioner for Regulatory Affairs.
    (5) Center Directors.
    (6) Chief Counsel for the Food and Drug Administration.
    (d) Public display. The public calendar will be placed on public 
display at the following locations:
    (1) Dockets Management Branch.
    (2) Office of the Associate Commissioner for Public Affairs.
    (3) The FDA home page, to the extent feasible.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

    8. 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,

[[Page 6469]]

467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.


Sec. 14.20  [Amended]

    9. Section 14.20 Notice of hearing before an advisory committee is 
amended by removing paragraph (e).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    10. 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.


Sec. 16.60  [Amended]

    11. Section 16.60 Hearing procedure is amended by removing 
paragraph (a)(3).

    Dated: January 5, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-1566 Filed 1-19-01; 8:45 am]
BILLING CODE 4160-01-F