§12.85. Disclosure of data and information by the participants. — Inbound Citations
21 C.F.R. § 12.85
Statutory Authority
Cited by 10 regulations in release Current.
Citations to 21 C.F.R. § 12.85 as a whole
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(9) The time within which participants should submit written information and views under § 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 Staff before the notice is published. Additional copies of material already submitted under § 12.85 need not be included with any later submissions.
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(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 § 12.85 or the prehearing order issued under § 12.92. Any person whose participation is stricken may petition the Commissioner for interlocutory review.
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(i) Any additional information to supplement the submission filed under § 12.85, which may be filed if approved under § 12.85(c).
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(iii) The evidence was not submitted as required by § 12.85.
Citations to §12.85(a)(2)
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(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 Staff 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.
Citations to §12.85(a)(3)
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(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 Staff 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.
Citations to §12.85(a)(4)
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(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 Staff 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.
Citations to §12.85(a)(5)
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(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 Staff 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.
Citations to §12.85(c)
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(i) Any additional information to supplement the submission filed under § 12.85, which may be filed if approved under § 12.85(c).