[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Proposed Rules]
[Pages 69575-69579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-1042]

21 CFR Parts 10, 14, and 16


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations relating to meetings and correspondence and the 
agency's public calendar. This proposed action would make FDA's 
procedures more concise and understandable to the public, minimize 
confusion about publicly available information concerning agency 
meetings and correspondence, provide for more effective disclosure of 
such information, and allow FDA to reallocate resources to areas of 
more urgent public health need. The agency is proposing these 
amendments in response to initiatives announced in the President's 
``Regulatory Reinvention Initiative.''

DATES: Written comments by March 2, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360, e-mail: ``[email protected]''.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 4, 1995, President Clinton issued a memorandum entitled 
``Regulatory Reinvention Initiative.'' This memorandum, part of the 
reform of the Federal regulatory system, directed heads of departments 
and agencies to undertake a page-by-page review of their existing 
regulations and to eliminate or modify those that are outdated or 
otherwise in need of reform. As part of their review, agencies were 
requested to consider whether their regulations were obsolete and 
whether the intended goals of their regulations could be achieved in 
more efficient, less intrusive ways.
    In response to the President's initiative, FDA conducted a 
comprehensive review of its existing regulations and identified those 
that could be eliminated or modified to create a more streamlined, less 
burdensome approach to government. Since the agency's resources are 
limited, it is in the best interest of the public health to ensure that 
resources are allocated to specific programs in a manner that is 
proportionate to their need.
    In furtherance of the Reinventing Government initiatives, FDA is 
proposing to modify certain regulations pertaining to the public 
calendar and public meetings because such regulations are no longer 
effective in serving their intended purposes.
    FDA procedures for maintaining a prospective calendar were 
originally established in 1977 to ensure that all persons outside the 
agency were given adequate notice of upcoming agency events and an 
accurate picture of the parties with whom agency officials were to 
meet. However, as explained in more detail as follows, the agency's 
experience has demonstrated that the maintenance of a prospective 
public calendar is no longer practical, workable, or beneficial to the 
public. Thus, the agency is now proposing to delete the prospective 
public calendar requirement from its regulations.
    The agency is also proposing to revise its public calendar and 
public meetings regulations to make them more concise and useful to the 
public and industry by restructuring them, removing unduly burdensome 
provisions, and eliminating duplicative language and obsolete 
references. The proposed rule would reorganize the provisions so that 
information on certain topics is grouped together. The agency solicits 
comments and suggestions for further improvement of these regulations.

II. Specific Proposed Changes

A. Public Calendars

    FDA regulations in Sec. 10.100 (21 CFR 10.100) describe the 
agency's procedures for maintaining public calendars. Section 10.100 
establishes requirements for the public calendars, including the agency 
personnel who are responsible for following the procedures, the 
requisite time period to be included in the calendars (4 weeks 
prospective and 1 week retrospective), and the locations where hard 
copies of the calendars are to be placed on public display.
1. Prospective Public Calendar
    Current Sec. 10.100(a) describes requirements for the maintenance 
of the prospective public calendar. This prospective calendar is to 
show public meetings, conferences, hearings, advisory committee 
meetings, seminars, and other public proceedings of FDA, as well as 
other significant public events involving FDA (e.g., Congressional 
hearings) for the upcoming 4 weeks. A hard copy of this prospective 
calendar is to be maintained in several places: (1) At the Dockets 
Management Branch; (2) in the Office of the Associate Commissioner for 
Public Affairs; (3) in a central place in each Center; and (4) in a 
central place in each field office.
    In following the requirements for the prospective calendar, the 
agency has experienced significant difficulty in projecting calendar 
entries 4 weeks in advance. As a result, the information provided on 
the public calendar often is incomplete or incorrect. Frequently, the 
inclusion and later deletion of information in the prospective calendar 
creates confusion for the public. Furthermore, it is difficult to amend 
information in the prospective calendar after it has been placed on 
public display.
    When FDA participates in meetings that are scheduled far in advance 
and involve a large number of people, such as public meetings or 
hearings held under 21 CFR part 15, the agency generally notifies the 
public through mechanisms other than the prospective calendar. Such 
mechanisms may include targeted mailings, notices on the World Wide Web 
(WWW), or publication in the Federal Register. Therefore, the 
prospective public calendar does not generally provide information to 
the public about large meetings that is not already available through 
other means. Occasionally, senior FDA officials participate in smaller 
public meetings with specific groups of outside participants, including 
members of industry, patient, consumer, or trade groups. These smaller 
meetings are often subject to last minute change, due to the highly 
unpredictable nature of the calendars of senior agency officials, 
making their inclusion on the prospective public calendar unduly 
burdensome to the agency. Thus, the agency tentatively

[[Page 69576]]

finds that the maintenance of a prospective public calendar is no 
longer practical, workable, or beneficial to the public.
    To address these concerns, FDA is proposing that Sec. 10.100(a) be 
removed. This action would eliminate the requirement for a 4-week 
prospective public calendar which, in turn, would allow agency staff to 
provide the most complete and accurate information possible to the 
public. The agency anticipates that members of the public who are 
interested in obtaining information regarding an open public meeting 
will not be significantly affected by this change because such 
information is already made available by FDA through mailings, notices 
on the WWW and in the Federal Register.
    Furthermore, as discussed as follows, the agency is proposing to 
maintain its requirements for a retrospective public calendar. Through 
the retrospective calendar, interested persons would be able to obtain 
information about other meetings, including private meetings attended 
by FDA representatives, and to make requests (under the Freedom of 
Information Act) for publicly available documents relating to such 
meetings.
    Ultimately, the proposed removal of the prospective calendar 
requirement would result in the devotion of less time and fewer agency 
resources to the public calendar, and the dissemination of more 
complete and more accurate information to the public, without 
diminishing the availability of essential information about upcoming 
meetings.
    FDA regulations pertaining to public hearings before advisory 
committees (part 14 (21 CFR part 14)) and regulatory hearings before 
the agency (part 16 (21 CFR part 16)) include provisions that such 
hearings are to be included in the prospective public calendar 
(Secs. 14.20(e) and 16.60(a)(3)). Since the agency is proposing to 
remove the prospective public calendar requirement in Sec. 10.100(a), 
FDA also proposes to remove Secs. 14.20(e) and 16.60(a)(3) as 
conforming amendments.
2. The Retrospective Calendar
    Current Sec. 10.100(b) requires FDA to maintain a 1-week 
retrospective public calendar. Section 10.100(b)(1) and (b)(2) describe 
the types of meetings that are to be listed on the retrospective 
calendar, including meetings with persons outside the executive branch 
and other significant events involving certain FDA officials. Current 
regulations do not require the retrospective public calendar to 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 in FDA), meetings with members 
of the press, or meetings with on-site contractors.
    FDA is proposing to reorganize Sec. 10.100(b)(1) and (b)(2) to 
clarify their meaning and to eliminate statements, e.g., references to 
``house organs,'' that are no longer relevant to the day-to-day 
workings of the agency. The agency intends to list the types of 
meetings that are to be included in the retrospective public calendar 
in proposed Sec. 10.100(a), which would state that entries are limited 
to: (1) Significant meetings with members of the Judiciary, 
representatives of Congress, or staffs of the congressional committees 
when the meetings relate to pending court cases, administrative 
hearings, or other regulatory actions or decisions; (2) significant 
meetings, conferences, seminars, and speeches; and (3) social events 
sponsored by the regulated industry. FDA would consider a meeting, 
conference, seminar, or speech to be ``significant'' if it addresses a 
matter that is of interest to a large number of people, or concerns a 
new policy or regulatory initiative. Under the proposed regulations, 
only meetings with persons outside of the executive branch of 
government would be included on the retrospective public calendar, and 
if there were no entries for a particular week, a statement to that 
effect would be issued in lieu of a calendar.
    Current Sec. 10.100(b)(2) states that the retrospective public 
calendar will include the date, person(s), and subject matter involved 
in any meeting that is reported on the calendar. If a large number of 
persons is involved, the name of each need not be specified, and if 
more than one FDA representative is in attendance, only the most senior 
official will report the meeting. The agency intends to maintain these 
requirements in proposed Sec. 10.100(b).
    Current Sec. 10.100(b)(3) identifies the specific senior agency 
officials who are subject to the public calendar requirements. The 
current provision lists the Commissioner of Food and Drugs; Deputy 
Commissioner; Associate Commissioners; Executive and Special Assistants 
to the Commissioner; Director, National Center for Toxicological 
Research; Center Directors; and Chief Counsel for the Food and Drug 
Administration, or any representative of that office attending on 
behalf of the Chief Counsel, and their deputies. The agency is 
proposing to amend Sec. 10.100(b)(3) to more accurately reflect the 
current personnel structure of the agency and to reduce the number of 
senior officials covered. The agency proposes that only the 
Commissioner of Food and Drugs, Deputy Commissioners, Center Directors, 
and the Chief Counsel be required to report meetings on the 
retrospective calendar because 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, meetings that are of greatest interest to the public will 
be reflected on the retrospective public calendar.
    Current Sec. 10.100(b)(4) states that a hard copy of the 
retrospective public calendar is to be kept in specific locations, 
including the Dockets Management Branch, the Office of the Associate 
Commissioner for Public Affairs, in each Center, and in each field 
office. FDA finds that keeping paper copies in all of these locations 
is not practical, and is unnecessarily burdensome to the agency. 
Consequently, the agency is proposing that Sec. 10.100(b)(4) be amended 
to state that a copy will be available in the Dockets Management 
Branch, in the Office of the Associate Commissioner for Public Affairs 
and, to the extent feasible, on FDA's home page (http//www.fda.gov). 
Posting the retrospective calendar in such locations would enable FDA 
to provide access to the most recent version of the calendar to persons 
inside and outside the agency at all times. This proposed amendment 
would also reduce the paper burden on the agency.

B. Public Meetings

    Section 10.65 (21 CFR 10.65) describes FDA's procedures for holding 
meetings and exchanging correspondence between agency representatives 
and persons outside FDA, including other Federal Government employees. 
Current Sec. 10.65(b)(1) requires that the Commissioner give public 
notice of the time and place of open public meetings through the 
prospective public calendar, and gives the Commissioner the option of 
publishing notice of meetings. As discussed in section II.A.1 of this 
document, FDA is proposing to remove the provisions regarding the 
prospective public calendar in current Sec. 10.100(a). The agency would 
need to amend Sec. 10.65(b)(1) to conform with the removal of this 
regulation. FDA proposes that amended Sec. 10.65(b)(1) state that the 
agency shall inform the public of the time and place of the meeting and 
of the matters to be discussed. This proposed change would give the 
agency the flexibility to choose the most effective manner of notifying 
the public of each public meeting. Such

[[Page 69577]]

notification may be achieved through notice in the Federal Register, 
posting on the WWW, or any other effective means of communication.
    Current Sec. 10.65(b)(3), 10.65(c), 10.65(d)(3), 10.65(e)(4), and 
10.65(f)(2) require that the agency prepare a written memorandum 
summarizing the substance of all open public meetings initiated by FDA 
and certain public and private meetings with persons outside the 
agency. The agency may prepare a transcript or recording of an open 
public meeting initiated by FDA under Sec. 10.65(b)(3) if the agency 
believes it would be useful. The current structure of the regulations 
may lead to confusion and FDA does not believe that the preparation of 
memoranda of meetings for the public meetings described previously is 
an efficient use of limited agency resources. Therefore, the agency is 
proposing to consolidate Sec. 10.65(b)(3), (c), (d)(3), (e)(4), and 
(f)(2) in proposed Sec. 10.65(e), which would require transcripts, 
recordings, or memoranda of meetings only when the agency determines 
that it would be useful. This determination will 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.
    Under current Sec. 10.65(d), every person outside the Federal 
Government may request and obtain a private meeting with an FDA 
representative to discuss a matter. A person who wishes to attend a 
private meeting with FDA but is not permitted or able to attend may, 
under current Sec. 10.65(d)(4), obtain a separate meeting with FDA to 
discuss the matter. FDA believes that it may be beneficial to meet with 
every individual outside the agency who requests a meeting, yet it 
simply is not feasible to guarantee a meeting to every such person. 
Consequently, FDA is proposing to amend Sec. 10.65(d) and (d)(4) to 
state that any person may ``request'' a meeting with a representative 
of FDA, and that the agency will make a reasonable effort to 
accommodate such a request. Under these proposed amendments, an 
interested person would not necessarily ``obtain'' a meeting. These 
proposed amendments to Sec. 10.65(d) and (d)(4) would enable the agency 
to better focus its energy and resources on matters involving public-
health priorities.
    Meetings with individuals outside the Federal Government that are 
initiated by FDA officials are addressed in current Sec. 10.65(f). 
Under this provision, an FDA-initiated meeting that involves a large 
number of interested persons must be held as an open public conference 
or meeting. FDA is proposing to amend current Sec. 10.65(f) to state 
that unless otherwise required by law, meetings may be public or 
private at FDA's discretion. FDA anticipates that significant meetings, 
i.e., those addressing matters that are of interest to a large number 
of people or that concern new policy or regulatory initiatives, 
generally will be held as open public meetings. Under this proposed 
revision, the determining factors for a public meeting would be the 
issue to be discussed and available agency resources, not the number of 
persons in attendance.
    Current Sec. 10.65(i) requires that FDA prepare a written 
memorandum of any meeting with a representative of Congress relating to 
a pending or potential investigation, inquiry, or hearing by a 
congressional committee or member of Congress. FDA proposes to remove 
this requirement because the agency generally does not believe that FDA 
resources should be expended to prepare such memoranda, given that any 
Congressional investigation or hearing typically involves many other 
publicly available documents, such as hearing transcripts, 
Congressional letters, and hearing testimony. Due to FDA's 
participation in a large number of meetings of this nature, the removal 
of Sec. 10.65(i) would enable the agency to save a significant amount 
of resources that otherwise would be devoted to preparing such 
memoranda. Furthermore, if the agency were to determine that such 
documentation would be useful, a memorandum could be prepared under 
proposed Sec. 10.65(e).
    Current Sec. 10.65(k) requires a log or summary to be maintained of 
all meetings between FDA and interested parties to implement the 
Radiation Control for Health and Safety Act of 1968 (Radiation Control 
Act) (42 U.S.C. 263l(a)(8)). Under section 19 of the Safe Medical 
Devices Act of 1990, Pub. L. 101-629, 104 Stat. 4511, 4530 (1990) the 
provisions of the Radiation Control Act were incorporated into section 
540 of the act (21 U.S.C. 360qq). The agency proposes to reissue this 
provision in Sec. 10.65(h) and to amend its text to reflect the change 
in statutory authority.
    Conforming changes to Secs. 10.30, 10.33, 10.35, and 10.40 are also 
being proposed to reflect the proposed changes in Sec. 10.65.

III. Environmental Impact

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

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 (Pub. L. 104-121) and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 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 agency believes that this proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the proposed rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Accordingly, the agency certifies that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

V. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VI. Request for Comments

    Interested persons may, on or before March 2, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposed rule. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 69578]]

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, it is proposed that 21 CFR parts 10, 
14, and 16 be amended 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''.


Sec. 10.33  [Amended]

    3. Section 10.33 Administrative reconsideration of action is 
amended in paragraph (k)(6) by removing ``Sec. 10.65(h)'' and adding in 
its place ``Sec. 10.65''.


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''.


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''.
    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 which 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.
    (1) Any other person who participates in a meeting described in 
this section may prepare and submit to FDA for inclusion in the 
administrative file a written memorandum summarizing the substance of 
the meeting.
    (2) Memoranda of meetings prepared by FDA representatives or by any 
other person and all correspondence that relate to a matter pending 
before the agency will promptly be filed in the administrative file of 
the proceeding.
    (f) 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.
    (g) A meeting of an advisory committee is subject to the 
requirements of part 14 of this chapter.
    (h) Under 21 U.S.C. 360qq(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 Electronic Product Radiation 
Control provisions of the act.
    7. Section 10.100 is revised to read as 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

[[Page 69579]]

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 on-site 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) Deputy Commissioners.
    (3) Center Directors.
    (4) 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 is revised 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.


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: December 10, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-33456 Filed 12-16-98; 8:45 am]
BILLING CODE 4160-01-F