[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regulations and to eliminate or modify those that are outdated or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
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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
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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.
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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]
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