WAIS Document Retrieval[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: 21CFR12]

[Page 124-142]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

                      Subpart A--General Provisions

Sec.
12.1  Scope.

                  Subpart B--Initiation of Proceedings

12.20  Initiation of a hearing involving the issuance, amendment, or 
          revocation of a regulation.
12.21  Initiation of a hearing involving the issuance, amendment, or 
          revocation of an order.
12.22  Filing objections and requests for a hearing on a regulation or 
          order.
12.23  Notice of filing of objections.
12.24  Ruling on objections and requests for hearing.
12.26  Modification or revocation of regulation or order.
12.28  Denial of hearing in whole or in part.
12.30  Judicial review after waiver of hearing on a regulation.
12.32  Request for alternative form of hearing.
12.35  Notice of hearing; stay of action.
12.37  Effective date of a regulation.
12.38  Effective date of an order.

                 Subpart C--Appearance and Participation

12.40  Appearance.
12.45  Notice of participation.
12.50  Advice on public participation in hearings.

                      Subpart D--Presiding Officer

12.60  Presiding officer.
12.62  Commencement of functions.
12.70  Authority of presiding officer.
12.75  Disqualification of presiding officer.
12.78  Unavailability of presiding officer.

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                      Subpart E--Hearing Procedures

12.80  Filing and service of submissions.
12.82  Petition to participate in forma pauperis.
12.83  Advisory opinions.
12.85  Disclosure of data and information by the participants.
12.87  Purpose; oral and written testimony; burden of proof.
12.89  Participation of nonparties.
12.90  Conduct at oral hearings or conferences.
12.91  Time and place of prehearing conference.
12.92  Prehearing conference procedure.
12.93  Summary decisions.
12.94  Receipt of evidence.
12.95  Official notice.
12.96  Briefs and argument.
12.97  Interlocutory appeal from ruling of presiding officer.
12.98  Official transcript.
12.99  Motions.

                    Subpart F--Administrative Record

12.100  Administrative record of a hearing.
12.105  Examination of record.

                 Subpart G--Initial and Final Decisions

12.120  Initial decision.
12.125  Appeal from or review of initial decision.
12.130  Decision by Commissioner on appeal or review of initial 
          decision.
12.139  Reconsideration and stay of action.

                       Subpart H--Judicial Review

12.140  Review by the courts.
12.159  Copies of petitions for judicial review.

    Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 
701-721; 28 U.S.C. 2112.

    Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

                      Subpart A--General Provisions

Sec. 12.1  Scope.

    The procedures in this part apply when--
    (a) A person has a right to an opportunity for a hearing under the 
laws specified in Sec. 10.50; or
    (b) The Commissioner concludes that it is in the public interest to 
hold a formal evidentiary public hearing on any matter before FDA.

                  Subpart B--Initiation of Proceedings

Sec. 12.20  Initiation of a hearing involving the issuance, amendment, 
          or revocation of a regulation.

    (a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or 
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling 
Act may be initiated--
    (1) By the Commissioner on the Commissioner's own initiative, e.g., 
as provided in Sec. 170.15 for food additives; or
    (2) By a petition--
    (i) In the form specified elsewhere in this chapter, e.g., the form 
for a color additive petition in Sec. 71.1; or
    (ii) If no form is specified, by a petition under Sec. 10.30.
    (b) If the Commissioner receives a petition under paragraph (a)(2) 
of this section, the Commissioner will--
    (1) If it involves any matter subject to section 701(e) of the act 
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the 
requirements for filing, follow the provisions of Sec. 10.40 (b) through 
(f);
    (2) If it involves a color additive or food additive, and meets the 
requirements for filing in Secs. 71.1 and 71.2, or in Secs. 171.1, 
171.6, 171.7, and 171.100, publish a notice of filing of the petition 
within 30 days after the petition is filed instead of a notice of 
proposed rulemaking.
    (c) [Reserved]
    (d) The notice promulgating the regulation will describe how to 
submit objections and requests for hearing.
    (e) On or before the 30th day after the date of publication of a 
final regulation, or of a notice withdrawing a proposal initiated by a 
petition under Sec. 10.25(a), a person may submit to the Commissioner 
written objections and a request for a hearing. The 30-day period may 
not be extended except that additional information supporting an 
objection may be received after 30 days upon a showing of inadvertent 
omission and hardship, and if review of the objection and request for 
hearing will not thereby be impeded. If, after a final color additive 
regulation is published, a petition or proposal relating to the 
regulation is referred to an advisory committee in accordance with 
section 721(b)(5)(C) of the act, objections and

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requests for a hearing may be submitted on or before the 30th day after 
the date on which the order confirming or modifying the Commissioner's 
previous order is published.

[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]

Sec. 12.21  Initiation of a hearing involving the issuance, amendment, 
          or revocation of an order.

    (a) A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) 
or (4), of section 515(g)(1) of the act, or section 351(a) of the Public 
Health Service Act, may be initiated--
    (1) By the Commissioner on the Commissioner's own initiative;
    (2) By a petition in the form specified elsewhere in this chapter, 
e.g., Sec. 314.50 for new drug applications, Sec. 514.1 for new animal 
drug applications, Sec. 514.2 for applications for animal feeds, or 
Sec. 601.3 for licenses for biologic products; or
    (3) By a petition under Sec. 10.30.
    (b) A notice of opportunity for hearing on a proposal to deny or 
revoke approval of all or part of an order will be published together 
with an explanation of the grounds for the proposed action. The notice 
will describe how to submit requests for hearing. A person subject to 
the notice has 30 days after its issuance to request a hearing. The 30-
day period may not be extended.
    (c) The Commissioner may use an optional procedure specified in 
Sec. 10.30(h) to consider issuing, amending, or revoking an order.
    (d) In a proceeding under sections 505(e), 512(e) or (m), or 515(e) 
of the act in which a party wishes to apply for reimbursement of certain 
expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504 
note), FDA will follow the Department of Health and Human Services' 
regulations in 45 CFR part 13.

[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 25734, June 15, 1982; 
54 FR 9035, Mar. 3, 1989]

Sec. 12.22  Filing objections and requests for a hearing on a regulation 
          or order.

    (a) Objections and requests for a hearing under Sec. 12.20(d) must 
be submitted to the Dockets Management Branch and will be accepted for 
filing if they meet the following conditions:
    (1) They are submitted within the time specified in Sec. 12.20(e).
    (2) Each objection is separately numbered.
    (3) Each objection specifies with particularity the provision of the 
regulation or proposed order objected to.
    (4) Each objection on which a hearing is requested specifically so 
states. Failure to request a hearing on an objection constitutes a 
waiver of the right to a hearing on that objection.
    (5) Each objection for which a hearing is requested includes a 
detailed description and analysis of the factual information to be 
presented in support of the objection. Failure to include a description 
and analysis for an objection constitutes a waiver of the right to a 
hearing on that objection. The description and analysis may be used only 
for the purpose of determining whether a hearing has been justified 
under Sec. 12.24, and do not limit the evidence that may be presented if 
a hearing is granted.
    (i) A copy of any report, article, survey, or other written document 
relied upon must be submitted, except if the document is--
    (a) An FDA document that is routinely publicly available; or
    (b) A recognized medical or scientific textbook that is readily 
available to the agency.
    (ii) A summary of the nondocumentary testimony to be presented by 
any witnesses relied upon must be submitted.
    (b) Requests for hearing submitted under Sec. 12.21 will be 
submitted to the Dockets Management Branch and will be accepted for 
filing if they meet the following conditions:
    (1) They are submitted on or before the 30th day after the date of 
publication of the notice of opportunity for hearing.
    (2) They comply with Secs. 314.200, 514.200, or 601.7(a).
    (c) If an objection or request for a public hearing fails to meet 
the requirements of this section and the deficiency becomes known to the 
Dockets Management Branch, the Dockets Management Branch shall return it 
with a copy of the applicable regulations, indicating those provisions 
not complied

[[Page 127]]

with. A deficient objection or request for a hearing may be supplemented 
and subsequently filed if submitted within the 30-day time period 
specified in Sec. 12.20(e) or Sec. 12.21(b).
    (d) If another person objects to a regulation issued in response to 
a petition submitted under Sec. 12.20(a)(2), the petitioner may submit a 
written reply to the Dockets Management Branch.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 69190, Dec. 10, 1999]

Sec. 12.23  Notice of filing of objections.

    As soon as practicable after the expiration of the time for filing 
objections to and requests for hearing on agency action involving the 
issuance, amendment, or revocation of a regulation under sections 
502(n), 701(e), or 721(d) of the act or sections 4 or 5 of the Fair 
Packaging and Labeling Act, the Commissioner shall publish a notice in 
the Federal Register specifying those parts of the regulation that have 
been stayed by the filing of proper objections and, if no objections 
have been filed, stating that fact. The notice does not constitute a 
determination that a hearing is justified on any objections or requests 
for hearing that have been filed. When to do so will cause no undue 
delay, the notice required by this section may be combined with the 
notices described in Secs. 12.28 and 12.35.

Sec. 12.24  Ruling on objections and requests for hearing.

    (a) As soon as possible the Commissioner will review all objections 
and requests for hearing filed under Sec. 12.22 and determine--
    (1) Whether the regulation should be modified or revoked under 
Sec. 12.26;
    (2) Whether a hearing has been justified; and
    (3) Whether, if requested, a hearing before a Public Board of 
Inquiry under part 13 or before a public advisory committee under part 
14 or before the Commissioner under part 15 has been justified.
    (b) A request for a hearing will be granted if the material 
submitted shows the following:
    (1) There is a genuine and substantial issue of fact for resolution 
at a hearing. A hearing will not be granted on issues of policy or law.
    (2) The factual issue can be resolved by available and specifically 
identified reliable evidence. A hearing will not be granted on the basis 
of mere allegations or denials or general descriptions of positions and 
contentions.
    (3) The data and information submitted, if established at a hearing, 
would be adequate to justify resolution of the factual issue in the way 
sought by the person. A hearing will be denied if the Commissioner 
concludes that the data and information submitted are insufficient to 
justify the factual determination urged, even if accurate.
    (4) Resolution of the factual issue in the way sought by the person 
is adequate to justify the action requested. A hearing will not be 
granted on factual issues that are not determinative with respect to the 
action requested, e.g., if the Commissioner concludes that the action 
would be the same even if the factual issue were resolved in the way 
sought, or if a request is made that a final regulation include a 
provision not reasonably encompassed by the proposal. A hearing will be 
granted upon proper objection and request when a food standard or other 
regulation is shown to have the effect of excluding or otherwise 
affecting a product or ingredient.
    (5) The action requested is not inconsistent with any provision in 
the act or any regulation in this chapter particularizing statutory 
standards. The proper procedure in those circumstances is for the person 
requesting the hearing to petition for an amendment or waiver of the 
regulation involved.
    (6) The requirements in other applicable regulations, e.g., 
Secs. 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and in the 
notice promulgating the final regulation or the notice of opportunity 
for hearing are met.
    (c) In making the determination in paragraph (a) of this section, 
the Commissioner may use any of the optional procedures specified in 
Sec. 10.30(h) or in other applicable regulations, e.g., Secs. 314.200, 
514.200, and 601.7(a).
    (d) If it is uncertain whether a hearing has been justified under 
the principles in paragraph (b) of this section, and the Commissioner 
concludes that

[[Page 128]]

summary decision against the person requesting a hearing should be 
considered, the Commissioner may serve upon the person by registered 
mail a proposed order denying a hearing. The person has 30 days after 
receipt of the proposed order to demonstrate that the submission 
justifies a hearing.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 
FR 399, Jan. 5, 1999]

Sec. 12.26  Modification or revocation of regulation or order.

    If the Commissioner determines upon review of an objection or 
request for hearing that the regulation or order should be modified or 
revoked, the Commissioner will promptly take such action by notice in 
the Federal Register. Further objections to or requests for hearing on 
the modification or revocation may be submitted under Secs. 12.20 
through 12.22 but no further issue may be taken with other provisions in 
the regulation or order. Objections and requests for hearing that are 
not affected by the modification or revocation will remain on file and 
be acted upon in due course.

Sec. 12.28  Denial of hearing in whole or in part.

    If the Commissioner determines upon review of the objections or 
requests for hearing that a hearing is not justified, in whole or in 
part, a notice of the determination will be published.
    (a) The notice will state whether the hearing is denied in whole or 
in part. If the hearing is denied in part, the notice will be combined 
with the notice of hearing required by Sec. 12.35, and will specify the 
objections and requests for hearing that have been granted and denied.
    (1) Any denial will be explained. A denial based on an analysis of 
the information submitted to justify a hearing will explain the 
inadequacy of the information.
    (2) The notice will confirm or modify or stay the effective date of 
the regulation or order involved.
    (b) The record of the administrative proceeding relating to denial 
of a public hearing in whole or in part on an objection or request for 
hearing consists of the following:
    (1) If the proceeding involves a regulation--
    (i) The documents specified in Sec. 10.40(g);
    (ii) The objections and requests for hearing filed by the Dockets 
Management Branch;
    (iii) If the proceeding involves a color additive regulation 
referred to an advisory committee in accordance with section 
721(b)(5)(C) of the act, the committee's report and the record of the 
committee's proceeding; and
    (iv) The notice denying a formal evidentiary public hearing.
    (2) If the proceeding involves an order--
    (i) The notice of opportunity for hearing;
    (ii) The requests for hearing filed by the Dockets Management 
Branch;
    (iii) The transcripts, minutes of meetings, reports, Federal 
Register notices, and other documents constituting the record of any of 
the optional procedures specified in Sec. 12.24(c) used by the 
Commissioner, but not the transcript of a closed portion of a public 
advisory committee meeting; and
    (iv) The notice denying the hearing.
    (c) The record specified in paragraph (b) of this section is the 
exclusive record for the Commissioner's decision on the complete or 
partial denial of a hearing. The record of the proceeding will be closed 
as of the date of the Commissioner's decision unless another date is 
specified. A person who requested and was denied a hearing may submit a 
petition for reconsideration under Sec. 10.33 or a petition for stay of 
action under Sec. 10.35. A person who wishes to rely upon information or 
views not included in the administrative record shall submit them to the 
Commissioner with a petition under Sec. 10.25(a) to modify the final 
regulation or order.
    (d) Denial of a request for a hearing in whole or in part is final 
agency action reviewable in the courts, under the statutory provisions 
governing the matter involved, as of the date of publication of the 
denial in the Federal Register.
    (1) Before requesting a court for a stay of action pending review, a 
person shall first submit a petition for a stay of action under 
Sec. 10.35.

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    (2) Under 28 U.S.C. 2112(a), FDA will request consolidation of all 
petitions on a particular matter.
    (3) The time for filing a petition for judicial review of a denial 
of a hearing on an objection or issue begins on the date the denial is 
published in the Federal Register, (i) When an objection or issues 
relates to a regulation, if a hearing is denied on all objections and 
issues concerning a part of the proposal the effectiveness of which has 
not been deferred pending a hearing on other parts of the proposal; or 
(ii) when an issue relates to an order, if a hearing is denied on all 
issues relating to a particular new drug application, new animal drug 
application, device premarket approval application or product 
development protocol, or biologics license. The failure to file a 
petition for judicial review within the period established in the 
statutory provision governing the matter involved constitutes a waiver 
of the right to judicial review of the objection or issue, regardless 
whether a hearing has been granted on other objections and issues.

Sec. 12.30  Judicial review after waiver of hearing on a regulation.

    (a) A person with a right to submit objections and a request for 
hearing under Sec. 12.20(d) may submit objections and waive the right to 
a hearing. The waiver may be either an explicit statement, or a failure 
to request a hearing, as provided in 12.22(a)(4).
    (b) If a person waives the right to a hearing, the Commissioner will 
rule upon the person's objections under Secs. 12.24 through 12.28. As a 
matter of discretion, the Commissioner may also order a hearing on the 
matter under any of the provisions of this part.
    (c) If the Commissioner rules adversely on a person's objection, the 
person may petition for judicial review in a U.S. Court of Appeals under 
the act.
    (1) The record for judicial review is the record designated in 
Sec. 12.28(b)(1).
    (2) The time for filing a petition for judicial review begins as of 
the date of publication of the Commissioner's ruling on the objections.

Sec. 12.32  Request for alternative form of hearing.

    (a) A person with a right to request a hearing may waive that right 
and request one of the following alternatives:
    (1) A hearing before a Public Board of Inquiry under part 13.
    (2) A hearing before a public advisory committee under part 14.
    (3) A hearing before the Commissioner under part 15.
    (b) The request--
    (1) May be on the person's own initiative or at the suggestion of 
the Commissioner.
    (2) Must be submitted in the form of a citizen petition under 
Sec. 10.30 before publication of a notice of hearing under Sec. 12.35 or 
a denial of hearing under Sec. 12.28; and
    (3) Must be--
    (i) In lieu of a request for a hearing under this part; or
    (ii) If submitted after or with a request for hearing, in the form 
of a waiver of the right to request a hearing conditioned on an 
alternative form of hearing. Upon acceptance by the Commissioner, the 
waiver becomes binding and may be withdrawn only by waiving any right to 
any form of hearing unless the Commissioner determines otherwise.
    (c) When more than one person requests and justifies a hearing under 
this part, an alternative form of hearing may by used only if all the 
persons concur and waive their right to request a hearing under this 
part.
    (d) The Commissioner will determine whether an alternative form of 
hearing should be used, and if so, which alternative is acceptable, 
after considering the requests submitted and the appropriateness of the 
alternatives for the issues raised in the objections. The Commissioner's 
acceptance is binding unless, for good cause, the Commissioner 
determines otherwise.
    (e) The Commissioner will publish a notice of an alternative form of 
hearing setting forth the following information:
    (1) The regulation or order that is the subject of the hearing.
    (2) A statement specifying any part of the regulation or order that 
has been stayed by operation of law or in the Commissioner's discretion.

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    (3) The time, date, and place of the hearing, or a statment that 
such information will be contained in a later notice.
    (4) The parties to the hearing.
    (5) The issues at the hearing. The statement of issues determines 
the scope of the hearing.
    (6) If the hearing will be conducted by a Public Board of Inquiry, 
the time within which--
    (i) The parties should submit nominees for the Board under 
Sec. 13.10(b);
    (ii) A notice of participation under Sec. 12.45 should be filed; and
    (iii) Participants should submit written information under 
Sec. 13.25. The notice will list the contents of the portions of the 
administrative record relevant to the issues at the hearing before the 
Board. The portions listed will be placed on public display in the 
office of the Dockets Management Branch before the notice is published. 
Additional copies of material already submitted under Sec. 13.25 need 
not be included with any later submissions.
    (f)(1) The decision of a hearing before a Public Board of Inquiry or 
a public advisory committee under this section has legal status of and 
will be handled as an initial decision under Sec. 12.120.
    (2) The decision of a public hearing before the Commissioner under 
this section will be issued as a final order. The final order will have 
the same content as an initial decision, as specified in Sec. 12.120 (b) 
and (c).
    (3) Thereafter, the participants in the proceeding may pursue the 
administrative and court remedies specified in Secs. 12.120 through 
12.159.
    (g) If a hearing before a public advisory committee or a hearing 
before the Commissioner is used as an alternative form of hearing, all 
submissions will be made to the Dockets Management Branch, and 
Sec. 10.20(j) governs their availability for public examination and 
copying.
    (h) This section does not affect the right to an opportunity for a 
hearing before a public advisory committee under section 515(g)(2) of 
the act regarding device premarket approval applications and product 
development protocols. Advisory committee hearing procedures are found 
in part 14.

Sec. 12.35  Notice of hearing; stay of action.

    (a) If the Commissioner determines upon review of the objections and 
requests for hearing that a hearing is justified on any issue, the 
Commissioner will publish a notice setting forth the following:
    (1) The regulation or order that is the subject of the hearing.
    (2) A statement specifying any part of the regulation or order that 
has been stayed by operation of law or in the Commissioner's discretion.
    (3) The parties to the hearing.
    (4) The issues of fact on which a hearing has been justified.
    (5) A statement of any objections or requests for hearing for which 
a hearing has not been justified, which are subject to Sec. 12.28.
    (6) The presiding officer, or a statement that the presiding officer 
will be designated in a later notice.
    (7) The time within which notices of participation should be filed 
under Sec. 12.45.
    (8) The date, time, and place of the prehearing conference, or a 
statement that the date, time, and place will be announced in a later 
notice. The pre-hearing conference may not commence until after the time 
expires for filing the notice of participation required by 
Sec. 12.45(a).
    (9) The time within which participants should submit written 
information and views under Sec. 12.85. The notice will list the 
contents of the portions of the administrative record relevant to the 
issues at the hearing. The portions listed will be placed on public 
display in the office of the Dockets Management Branch before the notice 
is published. Additional copies of material already submitted under 
Sec. 12.85 need not be included with any later submissions.
    (b) The statement of the issues determines the scope of the hearing 
and the matters on which evidence may be introduced. The issues may be 
revised by the presiding officer. A participant may obtain interlocutory 
review by the Commissioner of a decision by the presiding officer to 
revise the issues to include an issue on which the Commissioner has not 
granted a hearing or to

[[Page 131]]

eliminate an issue on which a hearing has been granted.
    (c) A hearing is deemed to begin on the date of publication of the 
notice of hearing.

[44 FR 22339, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]

Sec. 12.37  Effective date of a regulation.

    (a) If no objections are filed and no hearing is requested on a 
regulation under Sec. 12.20(e), the regulation is effective on the date 
specified in the regulation as promulgated.
    (b) The Commissioner shall publish a confirmation of the effective 
date of the regulation. The Federal Register document confirming the 
effective date of the regulation may extend the time for compliance with 
the regulation.

Sec. 12.38  Effective date of an order.

    (a) If a person who is subject to a notice of opportunity for 
hearing under Sec. 12.21(b) does not request a hearing, the Commissioner 
will--
    (1) Publish a final order denying or withdrawing approval of an NDA, 
NADA, device premarket approval application, or biologics license, in 
whole or in part, or revoking a device product development protocol or 
notice of completion, or declaring that such a protocol has not been 
completed, and stating the effective date of the order; and
    (2) If the order involves withdrawal of approval of an NADA, 
forthwith revoke, in whole or in part, the applicable regulation, under 
section 512(i) of the act.
    (b) If a person who is subject to a notice of opportunity for 
hearing under Sec. 12.21(b) requests a hearing and others do not, the 
Commissioner may issue a final order covering all the drug or device 
products at once or may issue more than one final order covering 
different drug or device products at different times.

                 Subpart C--Appearance and Participation

Sec. 12.40  Appearance.

    (a) A person who has filed a notice of participation under 
Sec. 12.45 may appear in person or by counsel or other representative in 
any hearing and, subject to Sec. 12.89, may be heard concerning all 
relevant issues.
    (b) The presiding officer may strike a person's appearance for 
violation of the rules of conduct in Sec. 12.90.

Sec. 12.45  Notice of participation.

    (a) Within 30 days after publication of the notice of hearing under 
Sec. 12.35, a person desiring to participate in a hearing is to file 
with the Dockets Management Branch under Sec. 10.20 a notice of 
participation in the following form:

      (Date)

    Dockets Management Branch, Food and Drug Administration, Department 
of Health and Human Services, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

                         Notice of Participation

                             Docket No. ----

    Under 21 CFR part 12, please enter the participation of:

      (Name)____________________________________________________________
      (Street address)__________________________________________________
      (City and State)__________________________________________________
      (Telephone number)________________________________________________

    Service on the above will be accepted by:

      (Name)____________________________________________________________
      (Street address)__________________________________________________
      (City and State)__________________________________________________
      (Telephone number)________________________________________________

    The following statements are made as part of this notice of 
participation:
    A. Specific interests. (A statement of the specific interest of the 
person in the proceeding, including the specific issues of fact 
concerning which the person desires to be heard. This part need not be 
completed by a party to the proceeding.)
    B. Commitment to participate. (A statement that the person will 
present documentary evidence or testimony at the hearing and will comply 
with the requirements of 21 CFR 12.85, or, in the case of a hearing 
before a Public Board of Inquiry, with the requirements of 21 CFR 
13.25.)

      (Signed)__________________________________________________________

    (b) An amendment to a notice of participation should be filed with 
the Dockets Management Branch and served on all participants.
    (c) No person may participate in a hearing who has not filed a 
written notice of participation or whose participation has been stricken 
under paragraph (e) of this section.

[[Page 132]]

    (d) The presiding officer may permit the late filing of a notice of 
participation upon a showing of good cause.
    (e) The presiding officer may strike the participation of a person 
for nonparticipation in the hearing or failure to comply with any 
requirement of this subpart, e.g., disclosure of information as required 
by Sec. 12.85 or the prehearing order issued under Sec. 12.92. Any 
person whose participation is stricken may petition the Commissioner for 
interlocutory review.

[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 
FR 14364, Mar. 28, 1994]

Sec. 12.50  Advice on public participation in hearings.

    (a) Designated agency contact. All inquiries from the public about 
scheduling, location, and general procedures should be addressed to the 
Deputy Commissioner for Policy (HF-22), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, or telephone 301-443-3480. The 
staff of the Associate Commissioner for Regulatory Affairs will attempt 
to respond promptly to all inquiries from members of the public, as well 
as to simple requests for information from participants in hearings.
    (b) Hearing schedule changes. Requests by hearing participants for 
changes in the schedule of a hearing or for filing documents, briefs, or 
other pleadings should be made in writing directly to the Administrative 
Law Judge (HF-3), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857.
    (c) Legal advice to individuals. FDA does not have the resources to 
provide legal advice to members of the public concerning participation 
in hearings. Furthermore, to do so would compromise the independence of 
the Commissioner's office and invite charges of improper interference in 
the hearing process. Accordingly, the Deputy Commissioner for Policy 
(HF-22) will not answer questions about the strengths or weaknesses of a 
party's position at a hearing, litigation strategy, or similar matters.
    (d) Role of the office of the Chief Counsel. Under no circumstances 
will the office of the Chief Counsel of FDA directly provide advice 
about a hearing to any person who is participating or may participate in 
the hearing. In every hearing, certain attorneys in the office are 
designated to represent the center or centers whose action is the 
subject of the hearing. Other members of the office, including 
ordinarily the Chief Counsel, are designated to advise the Commissioner 
on a final decision in the matter. It is not compatible with these 
functions, nor would it be professionally responsible, for the attorneys 
in the office of the Chief Counsel also to advise other participants in 
a hearing, or for any attorney who may be called on to advise the 
Commissioner to respond to inquiries from other participants in the 
hearing, for such participants may be urging views contrary to those of 
the center involved or to what may ultimately be the final conclusions 
of the Commissioner. Accordingly, members of the office of the Chief 
Counsel, other than the attorneys responsible for representing the 
center whose action is the subject of the hearing, will not answer 
questions about the hearing from any participant or potential 
participant.
    (e) Communication between participants and attorneys. Participants 
in a hearing may communicate with the attorneys responsible for 
representing the center whose action is the subject of the hearing, in 
the same way that they may communicate with counsel for any other party 
in interest about the presentation of matters at the hearing. It would 
be inappropriate to bar discussion of such matters as stipulations of 
fact, joint presentation of witnesses, or possible settlement of hearing 
issues. Members of the public, including participants at hearings, are 
advised, however, that all such communications, including those by 
telephone, will be recorded in memoranda that can be filed with the 
Dockets Management Branch.

[44 FR 22329, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989; 58 FR 17096, Apr. 1, 1993]

                      Subpart D--Presiding Officer

Sec. 12.60  Presiding officer.

    The presiding officer in a hearing will be the Commissioner, a 
member of the Commissioner's office to whom the responsibility for the 
matter involved

[[Page 133]]

has been delegated, or an administrative law judge qualified under 5 
U.S.C. 3105.

Sec. 12.62  Commencement of functions.

    The functions of the presiding officer begin upon designation and 
end upon the filing of the initial decision.

Sec. 12.70  Authority of presiding officer.

    The presiding officer has all powers necessary to conduct a fair, 
expeditious, and orderly hearing, including the power to--
    (a) Specify and change the date, time, and place of oral hearings 
and conferences;
    (b) Establish the procedures for use in developing evidentiary 
facts, including the procedures in Sec. 12.92(b) and to rule on the need 
for oral testimony and cross-examination under Sec. 12.87(b);
    (c) Prepare statements of the areas of factual disagreement among 
the participants;
    (d) Hold conferences to settle, simplify, or determine the issues in 
a hearing or to consider other matters that may expedite the hearing;
    (e) Administer oaths and affirmations;
    (f) Control the course of the hearing and the conduct of the 
participants;
    (g) Examine witnesses and strike their testimony if they fail to 
respond fully to proper questions;
    (h) Rule on, admit, exclude, or limit evidence;
    (i) Set the time for filing pleadings;
    (j) Rule on motions and other procedural matters;
    (k) Rule on motions for summary decision under Sec. 12.93;
    (l) Conduct the hearing in stages if the number of parties is large 
or the issues are numerous and complex;
    (m) Waive, suspend, or modify any rule in this subpart under 
Sec. 10.19 if the presiding officer determines that no party will be 
prejudiced, the ends of justice will be served, and the action is in 
accordance with law;
    (n) Strike the participation of any person under Sec. 12.45(e) or 
exclude any person from the hearing under Sec. 12.90, or take other 
reasonable disciplinary action; and
    (o) Take any action for the fair, expeditious, and orderly conduct 
of the hearing.

Sec. 12.75  Disqualification of presiding officer.

    (a) A participant may request the presiding officer to disqualify 
himself/herself and withdraw from the proceeding. The ruling on any such 
request may be appealed in accordance with Sec. 12.97(b).
    (b) A presiding officer who is aware of grounds for disqualification 
shall withdraw from the proceeding.

Sec. 12.78  Unavailability of presiding officer.

    (a) If the presiding officer is unable to act for any reason, the 
Commissioner will assign the powers and duties to another presiding 
officer. The substitution will not affect the hearing, except as the new 
presiding officer may order.
    (b) Any motion based on the substitution must be made within 10 
days.

                      Subpart E--Hearing Procedures

Sec. 12.80  Filing and service of submissions.

    (a) Submissions, including pleadings in a hearing, are to be filed 
with the Dockets Management Branch under Sec. 10.20 except that only two 
copies need be filed. To determine compliance with filing deadlines in a 
hearing, a submission is considered submitted on the date it is actually 
received by the Dockets Management Branch. When this part allows a 
response to a submission and prescribes a period of time for the filing 
of the response, an additional 3 days are allowed for the filing of the 
response if the submission is served by mail.
    (b) The person making a submission shall serve copies of it on the 
other participants. Submissions of documentary data and information are 
not required to be served on each participant, but any accompanying 
transmittal letter, pleading, summary, statement of position, 
certification under paragraph (d) of this section, or similar document 
must be served on each participant.
    (c) Service is accomplished by mailing a submission to the address 
shown

[[Page 134]]

in the notice of participation or by personal delivery.
    (d) All submissions are to be accompanied by a certificate of 
service, or a statement that service is not required.
    (e) No written submission or other portion of the administrative 
record may be held in confidence, except as provided in Sec. 12.105.

Sec. 12.82  Petition to participate in forma pauperis.

    (a) A participant who believes that compliance with the filing and 
service requirements of this section constitutes an unreasonable 
financial burden may submit to the Commissioner a petition to 
participate in forma pauperis.
    (b) The petition will be in the form specified in Sec. 10.30 except 
that the heading will be ``Request to Participate in Forma Pauperis, 
Docket No. ----.'' Filing and service requirements for the petition are 
described in paragraph (c) of this section, whether or not the petition 
is granted. The petition must demonstrate that either: (1) The person is 
indigent and a strong public interest justifies participation, or (2) 
the person's participation is in the public interest because it can be 
considered of primary benefit to the general public.
    (c) The Commissioner may grant or deny the petition. If the petition 
is granted, the participant need file only one copy of each submission 
with the Dockets Management Branch. The Dockets Management Branch will 
make sufficient additional copies for the administrative record, and 
serve a copy on each other participant.

Sec. 12.83  Advisory opinions.

    Before or during a hearing, a person may, under Sec. 10.85, request 
the Commissioner for an advisory opinion on whether any regulation or 
order under consideration in the proceeding applies to a specific 
situation.

Sec. 12.85  Disclosure of data and information by the participants.

    (a) Before the notice of hearing is published under Sec. 12.35, the 
director of the center responsible for the matters involved in the 
hearing shall submit the following to the Dockets Management Branch:
    (1) The relevant portions of the administrative record of the 
proceeding. Portions of the administrative record not relevant to the 
issues in the hearing are not part of the administrative record.
    (2) All documents in the director's files containing factual 
information, whether favorable or unfavorable to the director's 
position, which relate to the issues involved in the hearing. Files 
means the principal files in the center in which documents relating to 
the issues in the hearing are ordinarily kept, e.g., the food additive 
master file and the food additive petition in the case of issues 
concerning a food additive, or the new drug application in the case of 
issues concerning a new drug. Internal memoranda reflecting the 
deliberative process, and attorney work product and material prepared 
specifically for use in connection with the hearing, are not required to 
be submitted.
    (3) All other documentary data and information relied upon.
    (4) A narrative position statement on the factual issues in the 
notice of hearing and the type of supporting evidence the director 
intends to introduce.
    (5) A signed statement that, to the director's best knowledge and 
belief, the submission complies with this section.
    (b) Within 60 days of the publication of the notice of hearing or, 
if no participant will be prejudiced, within another period of time set 
by the presiding officer, each participant shall submit to the Dockets 
Management Branch all data and information specified in paragraph (a)(2) 
through (5) of this section, and any objections that the administrative 
record filed under paragraph (a)(1) of this section is incomplete. With 
respect to the data and information specified in paragraph (a)(2) of 
this section, participants shall exercise reasonable diligence in 
identifying documents in files comparable to those described in that 
paragraph.
    (c) Submissions required by paragraphs (a) and (b) of this section 
may be supplemented later in the proceeding, with the approval of the 
presiding officer, upon a showing that the material contained in the 
supplement was not reasonably known or available

[[Page 135]]

when the submission was made or that the relevance of the material 
contained in the supplement could not reasonably have been forseen.
    (d) A participant's failure to comply substantially and in good 
faith with this section constitutes a waiver of the right to participate 
further in the hearing; failure of a party to comply constitutes a 
waiver of the right to a hearing.
    (e) Participants may reference each other's submissions. To reduce 
duplicative submissions, participants are encouraged to exchange and 
consolidate lists of documentary evidence. If a particular document is 
bulky or in limited supply and cannot reasonably be reproduced, and it 
constitutes relevant evidence, the presiding officer may authorize 
submission of a reduced number of copies.
    (f) The presiding officer will rule on questions relating to this 
section.

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]

Sec. 12.87  Purpose; oral and written testimony; burden of proof.

    (a) The objective of a formal evidentiary hearing is the fair 
determination of relevant facts consistent with the right of all 
interested persons to participate and the public interest in promptly 
settling controversial matters affecting the public health and welfare.
    (b) Accordingly, the evidence at a hearing is to be developed to the 
maximum extent through written submissions, including written direct 
testimony, which may be in narrative or in question-and-answer form.
    (1) In a hearing, the issues may have general applicability and 
depend on general facts that do not concern particular action of a 
specific party, e.g., the safety or effectiveness of a class of drug 
products, the safety of a food or color additive, or a definition and 
standard of identity for a food; or the issues may have specific 
applicability to past action and depend upon particular facts concerning 
only that party, e.g., the applicability of a grandfather clause to a 
particular brand of a drug or the failure of a particular manufacturer 
to meet required manufacturing and processing specifications or other 
general standards.
    (i) If the proceeding involves general issues, direct testimony will 
be submitted in writing, except on a showing that written direct 
testimony is insufficient for a full and true disclosure of relevant 
facts and that the participant will be prejudiced if unable to present 
oral direct testimony. If the proceeding involves particular issues, 
each party may determine whether, and the extent to which, each wishes 
to present direct testimony orally or in writing.
    (ii) Oral cross-examination of witnesses will be permitted if it 
appears that alternative means of developing the evidence are 
insufficient for a full and true disclosure of the facts and that the 
party requesting oral cross-examination will be prejudiced by denial of 
the request or that oral cross-examination is the most effective and 
efficient means to clarify the matters at issue.
    (2) Witnesses shall give testimony under oath.
    (c) Except as provided in paragraph (d) of this section, in a 
hearing involving issuing, amending, or revoking a regulation or order, 
the originator of the proposal or petition or of any significant 
modification will be, within the meaning of 5 U.S.C. 556(d), the 
proponent of the regulation or order, and will have the burden of proof. 
A participant who proposes to substitute a new provision for a provision 
objected to has the burden of proof in relation to the new provision.
    (d) At a hearing involving issuing, amending, or revoking a 
regulation or order relating to the safety or effectiveness of a drug, 
device, food additive, or color additive, the participant who is 
contending that the product is safe or effective or both and who is 
requesting approval or contesting withdrawal of approval has the burden 
of proof in establishing safety or effectiveness or both and thus the 
right to approval. The burden of proof remains on that participant in an 
amendment or revocation proceeding.

[44 FR 22339, Apr. 13, 1979 as amended at 64 FR 399, Jan. 5, 1999]

Sec. 12.89  Participation of nonparties.

    (a) A nonparty participant may--

[[Page 136]]

    (1) Attend all conferences (including the prehearing conference), 
oral proceedings, and arguments;
    (2) Submit written testimony and documentary evidence for inclusion 
in the record;
    (3) File written objections, briefs, and other pleadings; and
    (4) Present oral argument.
    (b) A nonparty participant may not--
    (1) Submit written interrogatories; and
    (2) Conduct cross-examination.
    (c) A person whose petition is the subject of the hearing has the 
same right as a party.
    (d) A nonparty participant will be permitted additional rights if 
the presiding officer concludes that the participant's interests would 
not be adequately protected otherwise or that broader participation is 
required for a full and true disclosure of the facts, but the rights of 
a nonparty participant may not exceed the rights of a party.

[44 FR 22339, Apr. 13, 1979, as amended at 48 FR 51770, Nov. 14, 1983]

Sec. 12.90  Conduct at oral hearings or conferences.

    All participants in a hearing will conduct themselves with dignity 
and observe judicial standards of practice and ethics. They may not 
indulge in personal attacks, unseemly wrangling, or intemperate 
accusations or characterizations. Representatives of parties shall, to 
the extent possible, restrain clients from improprieties in connection 
with any proceeding. Disrespectful, disorderly, or contumacious language 
or conduct, refusal to comply with directions, use of dilatory tactics, 
or refusal to adhere to reasonable standards of orderly and ethical 
conduct during any hearing, constitute grounds for immediate exclusion 
from the proceeding by the presiding officer.

Sec. 12.91  Time and place of prehearing conference.

    A prehearing conference will commence at the date, time, and place 
announced in the notice of hearing, or in a later notice, or as 
specified by the presiding officer in a notice modifying a prior notice. 
At that conference the presiding officer will establish the methods and 
procedures to be used in developing the evidence, determine reasonable 
time periods for the conduct of the hearing, and designate the times and 
places for the production of witnesses for direct and cross-examination 
if leave to conduct oral examination is granted on any issue, as far as 
practicable at that time.

Sec. 12.92  Prehearing conference procedure.

    (a) Participants in a hearing are to appear at the prehearing 
conference prepared to discuss and resolve all matters specified in 
paragraph (b) of this section.
    (1) To expedite the hearing, participants are encouraged to prepare 
in advance for the prehearing conference. Participants should cooperate 
with each other, and request information and begin preparation of 
testimony at the earliest possible time. Failure of a participant to 
appear at the prehearing conference or to raise matters that could 
reasonably be anticipated and resolved at that time will not delay the 
progress of the hearing, and constitutes a waiver of the rights of the 
participant regarding such matters as objections to the agreements 
reached, actions taken, or rulings issued by the presiding officer and 
may be grounds for striking the participation under Sec. 12.45.
    (2) Participants shall bring to the prehearing conference the 
following specific information, which will be filed with the Dockets 
Management Branch under Sec. 12.80:
    (i) Any additional information to supplement the submission filed 
under Sec. 12.85, which may be filed if approved under Sec. 12.85(c).
    (ii) A list of all witnesses whose testimony will be offered, orally 
or in writing, at the hearing, with a full curriculum vitae for each. 
Additional witnesses may later be identified, with the approval of the 
presiding officer, on a showing that the witness was not reasonably 
available at the time of the prehearing conference or the relevance of 
the witness' views could not reasonably have been foreseen at that time.
    (iii) All prior written statements including articles and any 
written statement signed or adopted, or a recording

[[Page 137]]

or transcription of an oral statement made, by persons identified as 
witnesses if--
    (a) The statement is available without making request of the witness 
or any other person;
    (b) The statement relates to the subject matter of the witness' 
testimony; and
    (c) The statement either was made before the time the person agreed 
to become a witness or has been made publicly available by the person.
    (b) The presiding officer will conduct a prehearing conference for 
the following purposes:
    (1) To determine the areas of factual disagreement to be considered 
at the hearing. The presiding officer may hold conferences off the 
record in an effort to reach agreement on disputed factual questions.
    (2) To identify the most appropriate techniques for developing 
evidence on issues in controversy and the manner and sequence in which 
they will be used, including, where oral examination is to be conducted, 
the sequence in which witnesses will be produced for, and the time and 
place of, oral examination. The presiding officer may consider--
    (i) Submission of narrative statements of position on factual issues 
in controversy;
    (ii) Submission of evidence or identification of previously 
submitted evidence to support such statements, such as affidavits, 
verified statements of fact, data, studies, and reports;
    (iii) Exchange of written interrogatories directed to particular 
witnesses;
    (iv) Written requests for the production of additional 
documentation, data, or other relevant information;
    (v) Submission of written questions to be asked by the presiding 
officer of a specific witness; and
    (vi) Identification of facts for which oral examination and/or 
cross-examination is appropriate.
    (3) To group participants with substantially like interests for 
presenting evidence, making motions and objections, including motions 
for summary decision, filing briefs, and presenting oral argument.
    (4) To hear and rule on objections to admitting into evidence 
information submitted under Sec. 12.85.
    (5) To obtain stipulations and admissions of facts.
    (6) To take other action that may expedite the hearing.
    (c) The presiding officer shall issue, orally or in writing, a 
prehearing order reciting the actions taken at the prehearing conference 
and setting forth the schedule for the hearing. The order will control 
the subsequent course of the hearing unless modified by the presiding 
officer for good cause.

Sec. 12.93  Summary decisions.

    (a) After the hearing commences, a participant may move, with or 
without supporting affidavits, for a summary decision on any issue in 
the hearing. Any other participant may, within 10 days after service of 
the motion, which time may be extended for an additional 10 days for 
good cause, serve opposing affidavits or countermove for summary 
decision. The presiding officer may set the matter for argument and call 
for the submission of briefs.
    (b) The presiding officer will grant the motion if the objections, 
requests for hearing, other pleadings, affidavits, and other material 
filed in connection with the hearing, or matters officially noticed, 
show that there is no genuine issue as to any material fact and that a 
participant is entitled to summary decision.
    (c) Affidavits should set forth facts that would be admissible in 
evidence and show affirmatively that the affiant is competent to testify 
to the matters stated. When a properly supported motion for summary 
decision is made, a participant opposing the motion may not rest upon 
mere allegations or denials or general descriptions of positions and 
contentions; affidavits or other responses must set forth specific facts 
showing that there is a genuine issue of fact for the hearing.
    (d) Should it appear from the affidavits of a participant opposing 
the motion that for sound reasons stated, facts essential to justify the 
opposition cannot be presented by affidavit, the presiding officer may 
deny the motion for summary decision, order a continuance to permit 
affidavits or additional

[[Page 138]]

evidence to be obtained, or issue other just order.
    (e) If on motion under this section a summary decision is not 
rendered upon the whole case or for all the relief asked. and 
evidentiary facts need to be developed, the presiding officer will issue 
an order specifying the facts that appear without substantial 
controversy and directing further evidentiary proceedings. The facts so 
specified will be deemed established.
    (f) A participant may obtain interlocutory review by the 
Commissioner of a summary decision of the presiding officer.

Sec. 12.94  Receipt of evidence.

    (a) A hearing consists of the development of evidence and the 
resolution of factual issues as set forth in this subpart and in the 
prehearing order.
    (b) All orders, transcripts, written statements of position, written 
direct testimony, written interrogatories and responses, and any other 
written material submitted in the proceeding is a part of the 
administrative record of the hearing, and will be promptly placed on 
public display in the office of the Dockets Management Branch, except as 
provided in Sec. 12.105.
    (c) Written evidence, identified as such, is admissible unless a 
participant objects and the presiding officer excludes it on objection 
of a participant or on the presiding officer's own initiative.
    (1) The presiding officer may exclude written evidence as 
inadmissible only if--
    (i) The evidence is irrelevant, immaterial, unreliable, or 
repetitive;
    (ii) Exclusion of part or all of the written evidence of a 
participant is necessary to enforce the requirements of this subpart; or
    (iii) The evidence was not submitted as required by Sec. 12.85.
    (2) Items of written evidence are to be submitted as separate 
documents, sequentially numbered, except that a voluminous document may 
be submitted in the form of a cross-reference to the documents filed 
under Sec. 12.85.
    (3) Written evidence excluded by the presiding officer as 
inadmissible remains a part of the administrative record, as an offer of 
proof, for judicial review.
    (d) Testimony, whether on direct or on cross-examination, is 
admissible as evidence unless a participant objects and the presiding 
officer excludes it.
    (1) The presiding officer may exclude oral evidence as inadmissible 
only if--
    (i) The evidence is irrelevant, immaterial, unreliable, or 
repetitive; or
    (ii) Exclusion of part or all of the evidence is necessary to 
enforce the requirements of this part.
    (2) If oral evidence is excluded as inadmissible, the participant 
may take written exception to the ruling in a brief to the Commissioner, 
without taking oral exception at the hearing. Upon review, the 
Commissioner may reopen the hearing to permit the evidence to be 
admitted if the Commissioner determines that its exclusion was erroneous 
and prejudicial.
    (e) The presiding officer may schedule conferences as needed to 
monitor the program of the hearing, narrow and simplify the issues, and 
consider and rule on motions, requests, and other matters concerning the 
development of the evidence.
    (f) The presiding officer will conduct such proceedings as are 
necessary for the taking of oral testimony, for the oral examination of 
witnesses by the presiding officer on the basis of written questions 
previously submitted by the parties, and for the conduct of cross-
examination of witnesses by the parties. The presiding officer shall 
exclude irrelevant or repetitious written questions and limit oral 
cross-examination to prevent irrelevant or repetitious examination.
    (g) The presiding officer shall order the proceedings closed for the 
taking of oral testimony relating to matters specified in 
Sec. 10.20(j)(2)(i) (a) and (b). Such closed proceedings will be 
conducted in accordance with Sec. 10.20(j)(3). Participation in closed 
proceedings will be limited to the witness, the witness' counsel, and 
Federal Government executive branch employees and special government 
employees. Closed proceedings will be permitted only for, and will be 
limited to, oral testimony directly relating to matters specified in 
Sec. 10.20(j)(3).

[[Page 139]]

Sec. 12.95  Official notice.

    (a) Official notice may be taken of such matters as might be 
judicially noticed by the courts of the United States or of any other 
matter peculiarly within the general knowledge of FDA as an expert 
agency.
    (b) If official notice is taken of a material fact not appearing in 
the evidence of record, a participant, on timely request, will be 
afforded an opportunity to show the contrary.

Sec. 12.96  Briefs and arguments.

    (a) Promptly after the taking of evidence is completed, the 
presiding officer will announce a schedule for the filing of briefs. 
Briefs are to be filed ordinarily within 45 days of the close of the 
hearing. Briefs must include a statement of position on each issue, with 
specific and complete citations to the evidence and points of law relied 
on. Briefs must contain proposed findings of fact and conclusions of 
law.
    (b) The presiding officer may, as a matter of discretion, permit 
oral argument after the briefs are filed.
    (c) Briefs and oral argument are to refrain from disclosing specific 
details of written and oral testimony and documents relating to matters 
specified in Sec. 10.20(j)(2)(i)(a) and (b), except as specifically 
authorized in a protective order issued under Sec. 10.20(j)(3).

Sec. 12.97  Interlocutory appeal from ruling of presiding officer.

    (a) Except as provided in paragraph (b) of this section and in 
Secs. 12.35(b), 12.45(e), 12.93(f), and 12.99(d), when an interlocutory 
appeal is specifically authorized by this subpart, rulings of the 
presiding officer may not be appealed to the Commissioner before the 
Commissioner's consideration of the entire record of the hearing.
    (b) A ruling of the presiding officer is subject to interlocutory 
appeal to the Commissioner if the presiding officer certifies on the 
record or in writing that immediate review is necessary to prevent 
exceptional delay, expense, or prejudice to any participant, or 
substantial harm to the public interest.
    (c) When an interlocutory appeal is made to the Commissioner, a 
participant may file a brief with the Commissioner only if specifically 
authorized by the presiding officer or the Commissioner, and if such 
authorization is granted, within the period the Commissioner directs. If 
a participant is authorized to file a brief, any other participant may 
file a brief in opposition, within the period the Commissioner directs. 
If no briefs are authorized, the appeal will be presented as an oral 
argument to the Commissioner. The oral argument will be transcribed. If 
briefs are authorized, oral argument will be heard only at the 
discretion of the Commissioner.

Sec. 12.98  Official transcript.

    (a) The presiding officer will arrange for a verbatim stenographic 
transcript of oral testimony and for necessary copies of the transcript.
    (b) One copy of the transcript will be placed on public display in 
the office of the Dockets Management Branch upon receipt.
    (c) Except as provided in Sec. 12.105, copies of the transcript may 
be obtained by application to the official reporter and payment of costs 
thereof or under part 20.
    (d) Witnesses, participants, and counsel have 30 days from the time 
the transcript becomes available to propose corrections in the 
transcript of oral testimony. Corrections are permitted only for 
transcription errors. The presiding officer shall promptly order 
justified corrections.

Sec. 12.99  Motions.

    (a) A motion on any matter relating to the proceeding is to be filed 
under Sec. 12.80, and must include a draft order, except one made in the 
course of an oral hearing before the presiding officer.
    (b) A response may be filed within 10 days of service of a motion. 
The time may be shortened or extended by the presiding officer for good 
cause shown.
    (c) The moving party has no right to reply, except as permitted by 
the presiding officer.
    (d) The presiding officer shall rule upon the motion and may certify 
that ruling to the Commissioner for interlocutory review.

[[Page 140]]

                    Subpart F--Administrative Record

Sec. 12.100  Administrative record of a hearing.

    (a) The record of a hearing consists  of--
    (1) The order or regulation or notice of opportunity for hearing 
that gave rise to the hearing;
    (2) All objections and requests for hearing filed by the Dockets 
Management Branch under Secs. 12.20 through 12.22;
    (3) The notice of hearing published under Sec. 12.35;
    (4) All notices of participation filed under Sec. 12.45;
    (5) All Federal Register notices pertinent to the proceeding;
    (6) All submissions filed under Sec. 12.82, e.g., the submissions 
required by Sec. 12.85, all other documentary evidence and written 
testimony, pleadings, statements of position, briefs, and other similar 
documents;
    (7) The transcript, written order, and all other documents relating 
to the prehearing conference, prepared under Sec. 12.92;
    (8) All documents relating to any motion for summary decision under 
Sec. 12.93;
    (9) All documents of which official notice is taken under 
Sec. 12.95;
    (10) All pleadings filed under Sec. 12.96;
    (11) All documents relating to any interlocutory appeal under 
Sec. 12.97;
    (12) All transcripts prepared under Sec. 12.98; and
    (13) Any other document relating to the hearing and filed with the 
Dockets Management Branch by the presiding officer or any participant;
    (b) The record of the administrative proceeding is closed--
    (1) With respect to the taking of evidence, when specified by the 
presiding officer; and
    (2) With respect to pleadings, at the time specified in 
Sec. 12.96(a) for the filing of briefs.
    (c) The presiding officer may reopen the record to receive further 
evidence at any time before the filing of the initial decision.

Sec. 12.105  Examination of record.

    Documents in the record will be publicly available in accordance 
with Sec. 10.20(j). Documents available for examination or copying will 
be placed on public display in the office of the Dockets Management 
Branch promptly upon receipt in that office.

                 Subpart G--Initial and Final Decisions

Sec. 12.120  Initial decision.

    (a) The presiding officer shall prepare and file an initial decision 
as soon as possible after the filing of briefs and oral argument.
    (b) The initial decision must contain--
    (1) Findings of fact based issued upon relevant, material, and 
reliable evidence of record;
    (2) Conclusions of law;
    (3) A discussion of the reasons for the findings and conclusions, 
including a discussion of the significant contentions made by any 
participant;
    (4) Citations to the record supporting the findings and conclusions;
    (5) An appropriate regulation or order supported by substantial 
evidence of record and based upon the findings of fact and conclusions 
of law; and
    (6) An effective date for the regulation or order.
    (c) The initial decision must refrain from disclosing specific 
details of matters specified in Sec. 10.20(j)(2)(i) (a) and (b), except 
as specifically authorized in a protective order issued pursuant to 
Sec. 10.20(j)(3).
    (d) The initial decision is to be filed with the Dockets Management 
Branch and served upon all participants. Once the initial decision is 
filed with the Dockets Management Branch, the presiding officer has no 
further jurisdiction over the matter, and any motions or requests filed 
with the Dockets Management Branch will be decided by the Commissioner.
    (e) The initial decision becomes the final decision of the 
Commissioner by operation of law unless a participant files exceptions 
with the Dockets Management Branch under Sec. 12.125(a) or the 
Commissioner files a notice of review under Sec. 12.125(f).
    (f) Notice that an initial decision has become the decision of the 
Commissioner without appeal to or review by the Commissioner will be 
published in

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the Federal Register, or the Commissioner may publish the decision when 
it is of widespread interest.

Sec. 12.125  Appeal from or review of initial decision.

    (a) A participant may appeal an initial decision to the Commissioner 
by filing exceptions with the Dockets Management Branch, and serving 
them on the other participants, within 60 days of the date of the 
initial decision.
    (b) Exceptions must specifically identify alleged errors in the 
findings of fact or conclusions of law in the initial decision, and 
provide supporting citations to the record. Oral argument before the 
Commissioner may be requested in the exceptions.
    (c) Any reply to the exceptions is to be filed and served within 60 
days of the end of the period for filing exceptions.
    (d) The Commissioner may extend the time for filing exceptions under 
paragraph (a) of this section or replies to exceptions under paragraph 
(c) of this section only upon a showing by a participant of 
extraordinary circumstances. Such an extension shall be requested by 
filing a written request with the Commissioner's Executive Secretariat 
(HF-40) and serving copies of the request on the Dockets Management 
Branch (HFA-305), the Chief Counsel (GCF-1), and all hearing 
participants.
    (e) If the Commissioner decides to hear oral argument, the 
participants will be informed of the date, time, and place, the amount 
of time allotted to each participant, and the issues to be addressed.
    (f) Within 10 days following the expiration of the time for filing 
exceptions (including any extensions), the Commissioner may file with 
the Dockets Management Branch, and serve on the participants, a notice 
of the Commissioner's determination to review the initial decision. The 
Commissioner may invite the participants to file briefs or present oral 
argument on the matter. The time for filing briefs or presenting oral 
argument will be specified in that or a later notice.

[44 FR 22339, Apr. 13, 1979, as amended at 53 FR 29453, Aug. 5, 1988]

Sec. 12.130  Decision by Commissioner on appeal or review of initial 
          decision.

    (a) On appeal from or review of the initial decision, the 
Commissioner has all the powers given to make the initial decision. On 
the Commissioner's own initiative or on motion, the Commissioner may 
remand the matter to the presiding officer for any further action 
necessary for a proper decision.
    (b) The scope of the issues on appeal is the same as the scope of 
the issues at the public hearing unless the Commissioner specifies 
otherwise.
    (c) As soon as possible after the filing of briefs and any oral 
argument, the Commissioner will issue a final decision in the 
proceeding, which meets the requirements established in Sec. 12.120 (b) 
and (c).
    (d) The Commissioner may adopt the initial decision as the final 
decision.
    (e) Notice of the Commissioner's decision will be published in the 
Federal Register, or the Commissioner may publish the decision when it 
is of widespread interest.

Sec. 12.139  Reconsideration and stay of action.

    Following notice or publication of the final decisions, a 
participant may petition the Commissioner for reconsideration of any 
part or all of the decision under Sec. 10.33 or may petition for a stay 
of the decision under Sec. 10.35.

                       Subpart H--Judicial Review

Sec. 12.140  Review by the courts.

    (a) The Commissioner's final decision constitutes final agency 
action from which a participant may petition for judicial review under 
the statutes governing the matter involved. Before requesting an order 
from a court for a stay of action pending review, a participant shall 
first submit a petition for a stay of action under Sec. 10.35.
    (b) Under 28 U.S.C. 2112(a), FDA will request consolidation of all 
petitions related to a particular matter.

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Sec. 12.159  Copies of petitions for judicial review.

    The Chief Counsel for FDA has been designated by the Secretary as 
the officer on whom copies of petitions of judicial review are to be 
served. This officer is responsible for filing the record on which the 
final decision is based. The record of the proceeding is certified by 
the Commissioner.