Page:United States Statutes at Large Volume 90 Part 1.djvu/626

 90 STAT. 576 Statement.

Report. Review. Transcription.

PUBLIC LAW 94-295—MAY 28, 1976 "(4) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or written information relevant to such action. "(5) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing. "(6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.". Amendments to Section 301

21 USC 331. Ante, pp. 562, 565. Ante, p. 564.

(b)(1) Section 301 is amended by adding at the end the following new paragraphs: " (q)(l) The failure or refusal to (A) comply with any requirement prescribed under section 518 or 520(g), or (B) furnish any n =tification or other material or information required by or under .- -tion 519 or 520(g). '2) With respect to any device, the submission of any report that is reiriired by or under this Act that is false or misleading in any ^^'3 sal respect.". (I) •ection 301(e) is amended by striking out "or" before "512" a i l by inserting after " (m) " a comma and the following: "515(f), (3) Section 301(j) is amended by inserting "510," before "512", by inserting "513, 514, 515, 516, 518,.519, 520," before "704", and by striking out "or 706" and inserting in lieu thereof "706, or 708". (4) Section 301(1) is amended (A) by inserting "or device" after "drug" each time it occurs, and (B) by striking out "505" and inserting in lieu thereof "505, 515, or 520(g), as the case may be". Amendments to Section 304

21 USC 334.

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(c) Section 304(a) is amended (1) by striking out "device," in paragraph (1), and (2) by striking out "and" before " (C) " in paragraph (2), and (3) by striking out the period at the end of that paragraph and inserting in lieu thereof a comma and the following: "and (D) Any adulterated or misbranded device.". Amendments to Section 501

21 USC 351. Ante, p. 546.

Ante, p. 552.

(d) Section 501 is amended by adding at the end the following new paragraphs: ^ "(e) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 514, unless such device is in all respects in conformity with such standard. "(f)(1) If it is a class III device— "(A)(i) which is required by a regulation promulgated under subsection (b) of section 515 to have an approval under such section of an application for premarket approval and which is not exempt from section 515 under section 520(g), and

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