This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16]
[Page 175-176]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart A--General Provisions
Sec.
16.1 Scope.
16.5 Inapplicability and limited applicability.
Subpart B--Initiation of Proceedings
16.22 Initiation of regulatory hearing.
16.24 Regulatory hearing required by the act or a regulation.
16.26 Denial of hearing and summary decision.
Subpart C--Commissioner and Presiding Officer
16.40 Commissioner.
16.42 Presiding officer.
16.44 Communication to presiding officer and Commissioner.
Subpart D--Procedures for Regulatory Hearing
16.60 Hearing procedure.
16.62 Right to counsel.
[[Page 176]]
Subpart E--Administrative Record and Decision
16.80 Administrative record of a regulatory hearing.
16.85 Examination of administrative record.
16.95 Administrative decision and record for decision.
Subpart F--Reconsideration and Stay
16.119 Reconsideration and stay of action.
Subpart G--Judicial Review
16.120 Judicial review.
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.
Source: 44 FR 22367, Apr. 13, 1979, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.1]
[Page 176-177]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart A--General Provisions
Sec. 16.1 Scope.
The procedures in this part apply when:
(a) The Commissioner is considering any regulatory action, including
a refusal to act, and concludes, as a matter of discretion, on the
Commissioner's initiative or at the suggestion of any person, to offer
an opportunity for a regulatory hearing to obtain additional information
before making a decision or taking action.
(b) The act or a regulation provides a person with an opportunity
for a hearing on a regulatory action, including proposed action, and the
act or a regulation either specifically provides an opportunity for a
regulatory hearing under this part or provides an opportunity for a
hearing for which no procedures are specified by regulation. Listed
below are the statutory and regulatory provisions under which regulatory
hearings are available:
(1) Statutory provisions:
Section 304(g) of the act relating to the administrative detention of
devices (see Sec. 800.55(g) of this chapter).
Section 515(e)(1) of the act relating to the proposed withdrawal of
approval of a device premarket approval application.
Section 515(e)(3) of the act relating to the temporary suspension of
approval of a premarket approval application.
Section 515(f)(6) of the act relating to a proposed order revoking a
device product development protocol or declaring a protocol not
completed.
Section 515(f)(7) of the act relating to revocation of a notice of
completion of a product development protocol.
Section 516 of the act relating to a proposed banned device regulations
(see Sec. 895.21(d) of this chapter).
Section 518(b) of the act relating to a determination that a device is
subject to a repair, replacement, or refund order or that a correction
plan, or revised correction plan, submitted by a manufacturer, importer,
or distributor is inadequate.
Section 518(e) of the act relating to a cease distribution and
notification order or mandatory recall order concerning a medical device
for human use.
Section 520(f)(2)(D) of the act relating to exemptions or variances from
device current good manufacturing practice requirements (see
Sec. 820.1(d)).
Section 520(g)(4) and (g)(5) of the act relating to disapproval and
withdrawal of approval of an application from an investigational device
exemption (see Secs. 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of
this chapter).
(2) Regulatory provisions:
Sec. 56.121(a), relating to disqualifying an institutional review board
or an institution.
Sec. 71.37(a), relating to use of food containing a color additive.
Sec. 80.31(b), relating to refusal to certify a batch of a color
additive.
Sec. 80.34(b), relating to suspension of certification service for a
color additive.
Sec. 99.401(c), relating to a due diligence determination concerning the
conduct of studies necessary for a supplemental application for a new
use of a drug or device.
Sec. 130.17(1), relating to a temporary permit to vary from a food
standard.
Sec. 170.17(b), relating to use of food containing an investigational
food additive.
Sec. 202.1(j)(5), relating to approval of prescription drug
advertisements.
Sec. 312.70, relating to whether an investigator is entitled to receive
investigational new drugs.
Sec. 312.70(d) and 312.44, relating to termination of an IND for a
sponsor.
Sec. 312.160(b), relating to termination of an IND for tests in vitro
and in laboratory research animals for a sponsor.
Sec. 511.1(b)(5), relating to use of food containing an investigational
new animal drug.
Sec. 511.1(c)(1), relating to termination of an INAD for an
investigator.
Sec. 511.1(c) (4) and (d), relating to termination of an INAD for a
sponsor.
Sec. 814.46(c) relating to withdrawal of approval of a device premarket
approval application.
Sec. 900.7, relating to approval, reapproval, or withdrawal of approval
of mammography accreditation bodies or rejection of a proposed fee for
accreditation.
[[Page 177]]
Sec. 900.14, relating to suspension or revocation of a mammography
certificate.
Sec. 900.25, relating to approval or withdrawal of approval of
certification agencies.
Sec. 1003.11(a)(3), relating to the failure of an electronic product to
comply with an applicable standard or to a defect in an electronic
product.
Sec. 1003.31(d), relating to denial of an exemption from notification
requirements for an electronic product which fails to comply with an
applicable standard or has a defect.
Sec. 1004.6, relating to plan for repurchase, repair, or replacement of
an electronic product.
Sec. 1210.30, relating to denial, suspension, or revocation of a permit
under the Federal Import Milk Act.
Sec. 1270.15(e), relating to the retention, recall, and destruction of
human tissue.
[44 FR 22367, Apr. 13, 1979, as amended at 45 FR 3750, Jan 18, 1980; 45
FR 10332, Feb. 15, 1980; 46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb.
27, 1981; 51 FR 26364, July 22, 1986; 54 FR 9037, Mar. 3, 1989; 57 FR
58403, Dec. 10, 1992; 58 FR 65520, Dec. 14, 1993; 62 FR 40444, July 29,
1997; 62 FR 55976, Oct. 28, 1997; 63 FR 26697, May 13, 1998; 63 FR
64581, Nov. 20, 1998; 67 FR 5467, Feb. 6, 2002]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.5]
[Page 177]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart A--General Provisions
Sec. 16.5 Inapplicability and limited applicability.
(a) This part does not apply to the following:
(1) Informal presentation of views before reporting a criminal
violation under section 305 of the act and section 5 of the Federal
Import Milk Act and Sec. 1210.31.
(2) A hearing on a refusal of admission of a food, drug, device, or
cosmetic under section 801(a) of the act and Sec. 1.94, or of an
electronic product under section 360(a) of the Public Health Service Act
and Sec. 1005.20.
(3) Factory inspections, recalls (except mandatory recalls of
medical devices intended for human use), regulatory letters, and similar
compliance activities related to law enforcement.
(4) A hearing on an order for relabeling, diversion, or destruction
of shell eggs under section 361 of the Public Health Service Act (42
U.S.C. 264) and Secs. 101.17(h) and 115.50 of this chapter.
(b) If a regulation provides a person with an opportunity for
hearing and specifies some procedures for the hearing but not a
comprehensive set of procedures, the procedures in this part apply to
the extent that they are supplementary and not in conflict with the
other procedures specified for the hearing. Thus, the procedures in
subpart A of part 108 relating to emergency permit control are
supplemented by the nonconflicting procedures in this part, e.g., the
right to counsel, public notice of the hearing, reconsideration and
stay, and judicial review.
[44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992;
65 FR 76110, Dec. 5, 2000]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.22]
[Page 177-178]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart B--Initiation of Proceedings
Sec. 16.22 Initiation of regulatory hearing.
(a) A regulatory hearing is initiated by a notice of opportunity for
hearing from FDA. The notice will--
(1) Be sent by mail, telegram, telex, personal delivery, or any
other mode of written communication;
(2) Specify the facts and the action that are the subject of the
opportunity for a hearing;
(3) State that the notice of opportunity for hearing and the hearing
are governed by this part; and
(4) State the time within which a hearing may be requested, and
state the name, address, and telephone number of the FDA employee to
whom any request for hearing is to be addressed.
(5) Refer to FDA's guideline on electronic media coverage of its
administrative proceedings (21 CFR part 10, subpart C).
(b) A person offered an opportunity for a hearing has the amount of
time specified in the notice, which may not be less than 3 working days
after receipt of the notice, within which to request a hearing. The
request may be filed by mail, telegram, telex, personal delivery, or any
other mode of written communication, addressed to the designated FDA
employee. If no response is filed within that time, the offer is deemed
to have been refused and no hearing will be held.
(c) If a hearing is requested, the Commissioner will designate a
presiding officer, and the hearing will take place at a time and
location agreed upon by the party requesting the hearing, the FDA,
[[Page 178]]
and the presiding officer or, if agreement cannot be reached, at a
reasonable time and location designated by the presiding officer.
(d) A notice of opportunity for hearing under this section will not
operate to delay or stay any administrative action, including
enforcement action by the agency unless the Commissioner, as a matter of
discretion, determines that delay or a stay is in the public interest.
[44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.24]
[Page 178]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart B--Initiation of Proceedings
Sec. 16.24 Regulatory hearing required by the act or a regulation.
(a) A regulatory hearing required by the act or a regulation under
Sec. 16.1(b) will be initiated in the same manner as other regulatory
hearings subject to the additional procedures in this section.
(b) [Reserved]
(c) The notice will state whether any action concerning the matter
that is the subject of the opportunity for hearing is or is not being
taken pending the hearing under paragraph (d) of this section.
(d) The Commissioner may take such action pending a hearing under
this section as the Commissioner concludes is necessary to protect the
public health, except where expressly prohibited by statute or
regulation. A hearing to consider action already taken, and not stayed
by the Commissioner, will be conducted on an expedited basis.
(e) The hearing may not be required to be held at a time less than 2
working days after receipt of the request for hearing.
(f) Before the hearing, FDA will give to the party requesting the
hearing reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for the
decision or action taken or proposed that is the subject of the hearing
and a general summary of the information that will be presented by FDA
at the hearing in support of the decision or action. This information
may be given orally or in writing, in the discretion of FDA.
(g) FDA and the party requesting the hearing will, if feasible, at
least 1 day before the hearing provide to each other written notice of
any published articles or written information to be presented at or
relied on at the hearing. A copy will also be provided in advance if the
other participant could not reasonably be expected to have or be able to
obtain a copy. If written notice or a copy is not provided, the
presiding officer may, if time permits, allow the party who did not
receive the notice or copy additional time after the close of the
hearing to make a submission concerning the article or information.
[44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982;
54 FR 9037, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.26]
[Page 178]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart B--Initiation of Proceedings
Sec. 16.26 Denial of hearing and summary decision.
(a) A request for a hearing may be denied, in whole or in part, if
the Commissioner or the FDA official to whom the authority to make the
final decision on the matter has been delegated under part 5 determines
that no genuine and substantial issue of fact has been raised by the
material submitted. If the Commissioner or his or her delegate
determines that a hearing is not justified, written notice of the
determination will be given to the parties explaining the reason for
denial.
(b) After a hearing commences, the presiding officer may issue a
summary decision on any issue in the hearing if the presiding officer
determines from the material submitted in connection with the hearing,
or from matters officially noticed, that there is no genuine and
substantial issue of fact respecting that issue. For the purpose of this
paragraph, a hearing commences upon the receipt by FDA of a request for
hearing submitted under Sec. 16.22(b).
(c) The Commissioner or his or her delegate may review any summary
decision of the presiding officer issued under paragraph (b) of this
section at the request of a party or on the Commissioner's or his or her
delegate's own initiative.
[53 FR 4615, Feb. 17, 1988]
[[Page 179]]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.40]
[Page 179]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart C--Commissioner and Presiding Officer
Sec. 16.40 Commissioner.
Whenever the Commissioner has delegated authority under part 5 on a
matter for which a regulatory hearing is available under this part, the
functions of the Commissioner under this part may be performed by any of
the officials to whom the authority has been delegated, e.g., a center
director.
[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.42]
[Page 179]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart C--Commissioner and Presiding Officer
Sec. 16.42 Presiding officer.
(a) An FDA employee to whom the Commissioner delegates such
authority, or any other agency employee designated by an employee to
whom such authority is delegated, or, consistent with 5 CFR 930.209(b)
or (c), an administrative law judge to whom such authority is delegated,
may serve as the presiding officer and conduct a regulatory hearing
under this part.
(b) In a regulatory hearing required by the act or a regulation, the
presiding officer is to be free from bias or prejudice and may not have
participated in the investigation or action that is the subject of the
hearing or be subordinate to a person, other than the Commissioner, who
has participated in such investigation or action.
(c)(1) The Commissioner or the delegate under Sec. 16.40 is not
precluded by this section from prior participation in the investigation
or action that is the subject of the hearing. If there has been prior
participation, the Commissioner or the delegate should, if feasible,
designate a presiding officer for the hearing who is not a subordinate.
Thus, if the Commissioner's authority to make a final decision has been
delegated to a center director, the presiding officer may be an official
in another center or the office of the Commissioner. The exercise of
general supervisory responsibility, or the designation of the presiding
officer, does not constitute prior participation in the investigation or
action that is the subject of the hearing so as to preclude the
Commissioner or delegate from designating a subordinate as the presiding
officer.
(2) The party requesting a hearing may make a written request to
have the Commissioner or the delegate under Sec. 16.40 be the presiding
officer, notwithstanding paragraph (c)(1) of this section. If accepted,
as a matter of discretion, by the Commissioner or the delegate, the
request is binding upon the party making the request.
(3) A different presiding officer may be substituted for the one
originally designated under Sec. 16.22 without notice to the parties.
[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 67
FR 53306, Aug. 15, 2002]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.44]
[Page 179]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart C--Commissioner and Presiding Officer
Sec. 16.44 Communication to presiding officer and Commissioner.
(a) Regulatory hearings are not subject to the separation of
functions rules in Sec. 10.55.
(b) Those persons who are directly involved in the investigation or
presentation of the position of FDA or any party at a regulatory hearing
that is required by the act or a regulation should avoid any off-the-
record communication on the matter to the presiding officer or the
Commissioner or their advisors if the communication is inconsistent with
the requirement of Sec. 16.95(b)(1) that the administrative record be
the exclusive record for decision. If any communication of this type
occurs, it is to be reduced to writing and made part of the record, and
the other party provided an opportunity to respond.
(c) A copy of any letter or memorandum of meeting between a
participant in the hearing and the presiding officer or the
Commissioner, e.g., a response by the presiding officer to a request for
a change in the time of the hearing, is to be sent to all participants
by the person writing the letter or the memorandum.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.60]
[Page 179-180]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart D--Procedures for Regulatory Hearing
Sec. 16.60 Hearing procedure.
(a) A regulatory hearing is public, except when the Commissioner
determines that all or part of a hearing should be closed to prevent a
clearly unwarranted invasion of personal privacy; to prevent the
disclosure of a
[[Page 180]]
trade secret or confidential commercial or financial information that is
not available for public disclosure under Sec. 20.61; or to protect
investigatory records complied for law enforcement purposes that are not
available for public disclosure under Sec. 20.64.
(1) The Commissioner may determine that a regulatory hearing is
closed either on the Commissioner's initiative or on a request by the
party asking for a regulatory hearing, in the request for the hearing.
(2) If the hearing is a private hearing, no persons other than the
party requesting the hearing, counsel and witnesses, and an employee or
consultant or other person subject to a commercial arrangement as
defined in Sec. 20.81(a) and FDA representatives with a direct
professional interest in the subject matter of the proceeding are
entitled to attend.
(b) A regulatory hearing will be conducted by a presiding officer.
Employees of FDA will first give a full and complete statement of the
action which is the subject of the hearing, together with the
information and reasons supporting it, and may present any oral or
written information relevant to the hearing. The party requesting the
hearing may then present any oral or written information relevant to the
hearing. All parties may confront and conduct reasonable cross-
examination of any person (except for the presiding officer and counsel
for the parties) who makes any statement on the matter at the hearing.
(c) The hearing is informal in nature, and the rules of evidence do
not apply. No motions or objections relating to the admissibility of
information and views will be made or considered, but any other party
may comment upon or rebut all such data, information, and views.
(d) The presiding officer may order the hearing to be transcribed.
The party requesting the hearing may have the hearing transcribed, at
the party's expense, in which case a copy of the transcript is to be
furnished to FDA. Any transcript of the hearing will be included with
the presiding officer's report of the hearing.
(e) The presiding officer shall prepare a written report of the
hearing. All written material presented at the hearing will be attached
to the report. Whenever time permits, the parties to the hearing will be
given the opportunity to review and comment on the presiding officer's
report of the hearing.
(f) The presiding officer shall include as part of the report of the
hearing a finding on the credibility of witnesses (other than expert
witnesses) whenever credibility is a material issue, and shall include a
recommended decision, with a statement of reasons, unless the
Commissioner directs otherwise.
(g) The presiding officer has the power to take such actions and
make such rulings as are necessary or appropriate to maintain order and
to conduct a fair, expeditious, and impartial hearing, and to enforce
the requirements of this part concerning the conduct of hearings. The
presiding officer may direct that the hearing be conducted in any
suitable manner permitted by law and these regulations.
(h) The Commissioner or the presiding officer has the power under
Sec. 10.19 to suspend, modify, or waive any provision of this part.
[44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66
FR 12850, Mar. 1, 2001]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.62]
[Page 180]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart D--Procedures for Regulatory Hearing
Sec. 16.62 Right to counsel.
Any party to a hearing under this part has the right at all times to
be advised and accompanied by counsel.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.80]
[Page 180-181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart E--Administrative Record and Decision
Sec. 16.80 Administrative record of a regulatory hearing.
(a) The administrative record of the regulatory hearing consists of
the following:
(1) The notice of opportunity for hearing and the response.
(2) All written information and views submitted to the presiding
officer at the hearing or after if specifically permitted by the
presiding officer.
(3) Any transcript of the hearing.
(4) The presiding officer's report of the hearing and comments on
the report under Sec. 16.60(e).
(5) All letters and memoranda of meetings or communications between
[[Page 181]]
participants and the presiding officer or the Commissioner referred to
in Sec. 16.44(c).
(b) The record of the regulatory hearing is closed to the submission
of information and views, at the close of the hearing, unless the
presiding officer specifically permits additional time for a further
submission.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.85]
[Page 181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart E--Administrative Record and Decision
Sec. 16.85 Examination of administrative record.
Part 20 governs the availability for public disclosure of each
document that is a part of the administrative record of a regulatory
hearing.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.95]
[Page 181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart E--Administrative Record and Decision
Sec. 16.95 Administrative decision and record for decision.
(a) With respect to a regulatory hearing at the Commissioner's
initiative under Sec. 16.1(a), the Commissioner shall consider the
administrative record of the hearing specified in Sec. 16.80(a) together
with all other relevant information and views available to FDA in
determining whether regulatory action should be taken and, if so, in
what form.
(b) With respect to a regulatory hearing required by the act or a
regulation under Sec. 16.1(b)--
(1) The administrative record of the hearing specified in
Sec. 16.80(a) constitutes the exclusive record for decision;
(2) On the basis of the administrative record of the hearing, the
Commissioner shall issue a written decision stating the reasons for the
Commissioner's administrative action and the basis in the record; and
(3) For purposes of judicial review under Sec. 10.45, the record of
the administrative proceeding consists of the record of the hearing and
the Commissioner's decision.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.119]
[Page 181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart F--Reconsideration and Stay
Sec. 16.119 Reconsideration and stay of action.
After any final administrative action that is the subject of a
hearing under this part, any party may petition the Commissioner for
reconsideration of any part or all of the decision or action under
Sec. 10.33 or may petition for a stay of the decision or action under
Sec. 10.35.
[44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR16.120]
[Page 181]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
Subpart G--Judicial Review
Sec. 16.120 Judicial review.
Section 10.45 governs the availability of judicial review concerning
any regulatory action which is the subject of a hearing under this part
