to modify provisions related to pediatric testing and medical products.
What it does: 18 changes: replaces text in 10 places, inserts text in 6 places, strikes text in 2 places
Sen. Michael B. Enzi (R-WY)What it changes
18 changes to S. 1082 · 3 shown in the bill's text
We couldn't read part of this amendment. That part is shown as written below.
Change 1: Replaces “later” with “if the determination made under subsection (d)(3) is made less”
[struck: later][inserted: if the determination made under subsection (d)(3) is made less]Original wording
On page 226, line 4, strike “later” and insert “if the determination made under subsection (d)(3) is made less”.
Change 2: Replaces “later” with “if the determination made under subsection (d)(3) is made less”
[struck: later][inserted: if the determination made under subsection (d)(3) is made less]Original wording
On page 228, line 3, strike “later” and insert “if the determination made under subsection (d)(3) is made less”.
Change 3: Inserts “, such as expertise in child and adolescent psychiatry,” after “expertise”
…expertise[inserted: , such as expertise in child and adolescent psychiatry,]…
Original wording
On page 233, line 12, insert “, such as expertise in child and adolescent psychiatry,” after “expertise”.
Change 4: Replaces “including” with “which may include”
[struck: including][inserted: which may include]Original wording
On page 233, line 15, strike “including” and insert “which may include”.
Change 5: Inserts new text on page 233, between lines 18 and 19
InsertsPrinted pageInserted: (C) Action by committee.--The committee established under this paragraph may perform a function under this section using appropriate members of the committee under subparagraph (B) and need not convene all members of the committee under subparagraph (B) in order to perform a function under this section.
Inserted: (D) Documentation of committee action.--The committee established under this paragraph shall document for each function under paragraphs (2) and (3), which members of the committee participated in such function.
Original wording
On page 233, between lines 18 and 19, insert the following:
Change 6: Replaces “determine” with “make a recommendation to the Secretary”
[struck: determine][inserted: make a recommendation to the Secretary]Original wording
On page 234, line 1, strike “determine” and insert “make a recommendation to the Secretary”.
Change 7: Strikes “and”
Struck: and
Original wording
On page 235, line 2, strike “and”.
Change 8: Strikes “.”
Struck: .
Original wording
On page 235, line 6, strike “.”;
Change 9: Inserts new text on page 235, between lines 6 and 7
InsertsPrinted pageInserted: (H) the number of times the committee established under paragraph (1) made a recommendation to the Secretary under paragraph (3), the number of times the Secretary did not follow such a recommendation to accept reports under subsection (d)(3), and the number of times the Secretary did not follow such a recommendation to reject such reports under section (d)(3).
Inserted: (5) Committee.--The committee established under paragraph (1) is the committee established under section 505B(f)(1).
Original wording
On page 235, between lines 6 and 7, insert the following:
Change 10: Replaces “of a letter, or a written request under section 505A that was declined by the sponsor or…” with “of a written request under section 505A that was declined by the sponsor or holder, or a…”
In S. 1082 · Reported to Senate
(1) by striking paragraph (1) and inserting the following:
"(1) In general.--After providing notice in the form of a
[struck: letter, or a ]written request under section 505A that was declined by the sponsor or holder, [inserted: or a letter referencing such declined written request,, ]and an opportunity for written response and a meeting, which may include an advisory committee meeting, the Secretary may (by order in the form of a letter) require the sponsor or holder of an approved application for a drug under section 505 or the holder of a license for a biological product under section 351 of the Public Health Service Act (42 U.S.C. 262) to submit by a specified date the assessments described in subsection (a)(2) and the written request, as appropriate, if the Secretary finds that--"(A)(i) the drug or biological product is used for a substantial number of pediatric patients for the labeled indications; and
Original wording
On page 260, lines 17 through 19, strike “of a letter, or a written request under section 505A that was declined by the sponsor or holder” and insert “of a written request under section 505A that was declined by the sponsor or holder, or a letter referencing such declined written request,”.
Change 11: Replaces “appropriate” with “appropriate, for the labeled indication or indications,”
[struck: appropriate][inserted: appropriate, for the labeled indication or indications,]Original wording
On page 261, line 3, strike “appropriate” and insert “appropriate, for the labeled indication or indications,”.
Change 12: Inserts “, such as expertise in child and adolescent psychiatry,” after “expertise”
…expertise[inserted: , such as expertise in child and adolescent psychiatry,]…
Original wording
On page 263, line 14, insert “, such as expertise in child and adolescent psychiatry,” after “expertise”
Change 13: Inserts new text on page 263, between lines 19 and 20
InsertsPrinted pageOriginal wording
On page 263, between lines 19 and 20, insert the following
Change 14: Inserts new text on page 265, between lines 18 and 19
InsertsPrinted pageInserted: (7) Committee.--The committee established under paragraph (1) is the committee established under section 505A(f)(1).
Original wording
On page 265, between lines 18 and 19, insert the following:
Change 15: Replaces “SURVEILLANCES” with “POSTMARKET SURVEILLANCE”
In S. 1082 · Reported to Senate
(iii) in subparagraph (C), by inserting "(including drugs and biological products) and medical devices" after "therapeutics".
SEC. 427.
[struck: SURVEILLANCES][inserted: POSTMARKET SURVEILLANCE].(a) Postmarket Surveillances.--Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
Original wording
On page 289, line 16, strike “SURVEILLANCES” and insert “POSTMARKET SURVEILLANCE”.
Change 16: Replaces “Surveillances” with “Surveillance”
In S. 1082 · Reported to Senate
SEC. 427. SURVEILLANCES.
(a) Postmarket
[struck: Surveillances][inserted: Surveillance].--Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--(1) by striking subsection (a) and inserting the following:
Original wording
On page 289, line 17, strike “Surveillances” and insert “Surveillance”.
Change 17: Rewrites page 290, lines 9–12
ReplacesPrinted pageRemoves page 290, lines 9–12 of the printed bill. See that page
Inserted: (iii) that is intended to be--
Inserted: (I) implanted in the human body for more than 1 year; or
Inserted: (II) a life-sustaining or life-supporting device used outside a device user facility.
Original wording
On page 290, strike lines 9 through 12 and insert the following:
Change 18: Replaces “of an” through “section 510(k) only for” with “or clearance of”
[struck: of an … section 510(k) only for][inserted: or clearance of]Original wording
On page 290, line 15, strike “of an” and all that follows through “section 510(k) only for” on line 19, and insert “or clearance of”.
Shown as written
” and insert “; and”
redesignate the remaining paragraphs accordingly: “(2) Action by the committee.--The committee established under paragraph (1) may perform a function under this section using appropriate members of the committee under paragraph (1) and need not convene all members of the committee under paragraph (1) in order to perform a function under this section. “(3) Documentation of committee action.--For each drug or biological product, the committee established under this paragraph shall document for each function under paragraph (4) or (5), which members of the committee participated in such function.
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 1053. Mr. ENZI (for himself, Mr. Kennedy, Mr. Dodd, and Mrs. Clinton) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
On page 226, line 4, strike “later” and insert “if the determination made under subsection (d)(3) is made less”.
On page 228, line 3, strike “later” and insert “if the determination made under subsection (d)(3) is made less”.
On page 233, line 12, insert “, such as expertise in child and adolescent psychiatry,” after “expertise”.
On page 233, line 15, strike “including” and insert “which may include”.
On page 233, between lines 18 and 19, insert the following:
“(C) Action by committee.--The committee established under this paragraph may perform a function under this section using appropriate members of the committee under subparagraph (B) and need not convene all members of the committee under subparagraph (B) in order to perform a function under this section.
“(D) Documentation of committee action.--The committee established under this paragraph shall document for each function under paragraphs (2) and (3), which members of the committee participated in such function.
On page 234, line 1, strike “determine” and insert “make a recommendation to the Secretary”.
On page 235, line 2, strike “and”.
On page 235, line 6, strike “.”;” and insert “; and”
On page 235, between lines 6 and 7, insert the following:
“(H) the number of times the committee established under paragraph (1) made a recommendation to the Secretary under paragraph (3), the number of times the Secretary did not follow such a recommendation to accept reports under subsection (d)(3), and the number of times the Secretary did not follow such a recommendation to reject such reports under section (d)(3).
“(5) Committee.--The committee established under paragraph (1) is the committee established under section 505B(f)(1).”;
On page 260, lines 17 through 19, strike “of a letter, or a written request under section 505A that was declined by the sponsor or holder” and insert “of a written request under section 505A that was declined by the sponsor or holder, or a letter referencing such declined written request,”.
On page 261, line 3, strike “appropriate” and insert “appropriate, for the labeled indication or indications,”.
On page 263, line 14, insert “, such as expertise in child and adolescent psychiatry,” after “expertise”
On page 263, between lines 19 and 20, insert the following and redesignate the remaining paragraphs accordingly:
“(2) Action by the committee.--The committee established under paragraph (1) may perform a function under this section using appropriate members of the committee under paragraph (1) and need not convene all members of the committee under paragraph (1) in order to perform a function under this section.
“(3) Documentation of committee action.--For each drug or biological product, the committee established under this paragraph shall document for each function under paragraph (4) or (5), which members of the committee participated in such function.
On page 265, between lines 18 and 19, insert the following:
“(7) Committee.--The committee established under paragraph (1) is the committee established under section 505A(f)(1).
On page 289, line 16, strike “SURVEILLANCES” and insert “POSTMARKET SURVEILLANCE”.
On page 289, line 17, strike “Surveillances” and insert “Surveillance”.
On page 290, strike lines 9 through 12 and insert the following:
“(iii) that is intended to be--
“(I) implanted in the human body for more than 1 year; or
“(II) a life-sustaining or life-supporting device used outside a device user facility.
On page 290, line 15, strike “of an” and all that follows through “section 510(k) only for” on line 19, and insert “or clearance of”.
Legislative Activity
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Senate amendment agreed to: Amendment SA 1053 agreed to in Senate by Unanimous Consent.
May 8, 2007
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Senate amendment agreed to: Amendment SA 1053 agreed to in Senate by Unanimous Consent.
May 8, 2007
Senate amendment proposed (on the floor): Amendment SA 1053 proposed by Senator Brown for Senator Enzi.(consideration: CR S5699-5705; text: CR S5702-5703)
May 8, 2007
Amendment SA 1053 proposed by Senator Brown for Senator Enzi. (consideration: CR S5699-5705; text: CR S5702-5703) to modify provisions related to pediatric testing and medical products.
May 8, 2007
Amendment SA 1053 agreed to in Senate by Unanimous Consent.
May 8, 2007
Senate amendment submitted
May 7, 2007