21 CFR 17.17 - Summary decisions.

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There is 1 rule appearing in the Federal Register for 21 CFR 17. View below or at eCFR (GPOAccess)
§ 17.17 Summary decisions.
(a) At any time after the filing of a complaint, a party may move, with or without supporting affidavits (which, for purposes of this part, shall include declarations under penalty of perjury), for a summary decision on any issue in the hearing. The other party may, within 30 days after service of the motion, which 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 shall grant the motion if the pleadings, affidavits, and other material filed in the record, or matters officially noticed, show that there is no genuine issue as to any material fact and that the party is entitled to summary decision as a matter of law.
(c) Affidavits shall set forth only such facts as would be admissible in evidence and shall show affirmatively that the affiant is competent to testify to the matters stated. When a motion for summary decision is made and supported as provided in this regulation, a party opposing the motion may not rest on 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 material fact for the hearing.
(d) If, on motion under this section, a summary decision is not rendered on all issues or for all the relief asked, and if additional 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 on facts still at issue. The facts specified not to be at issue shall be deemed established.
(e) Except as provided in § 17.18, a party may not obtain interlocutory review by the entity deciding the appeal (currently the DAB) of a partial summary decision of the presiding officer. A review of final summary decisions on all issues may be had through the procedure set forth in § 17.47.

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-06; vol. 79 # 109 - Friday, June 6, 2014
    1. 79 FR 32643 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; Confirmation of effective date.
      Effective date of the direct final rule published in the Federal Register of February 3, 2014 (79 FR 6088), confirmed: June 18, 2014.
      21 CFR Part 17

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 17 after this date.

  • 2014-06-06; vol. 79 # 109 - Friday, June 6, 2014
    1. 79 FR 32643 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule; Confirmation of effective date.
      Effective date of the direct final rule published in the Federal Register of February 3, 2014 (79 FR 6088), confirmed: June 18, 2014.
      21 CFR Part 17