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Notes

§13.25. Disclosure of data and information by the participants. — Inbound Citations

21 C.F.R. § 13.25

Statutory Authority

Cited by 6 regulations in release Current.

Citations to 21 C.F.R. § 13.25 as a whole

  • 21 C.F.R. § 12.32(e)(6)(iii)
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    (iii) Participants should submit written information under § 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 Staff before the notice is published. Additional copies of material already submitted under § 13.25 need not be included with any later submissions.
  • 21 C.F.R. § 13.30(b)
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    (b) A Board may not hold its first hearing until after all participants have submitted the information required by § 13.25.

Citations to §13.25(a)(2)

  • 21 C.F.R. § 13.25(b)
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    (b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Dockets Management Staff all 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 information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.

Citations to §13.25(a)(3)

  • 21 C.F.R. § 13.25(b)
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    (b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Dockets Management Staff all 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 information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.

Citations to §13.25(a)(4)

  • 21 C.F.R. § 13.25(b)
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    (b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Dockets Management Staff all 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 information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.

Citations to §13.25(a)(5)

  • 21 C.F.R. § 13.25(b)
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    (b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Dockets Management Staff all 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 information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.