Relative to the applicability to new drugs and biological products.

1. 1

   Change 1: Inserts “solely because of that failure” after “misbranded”

   InsertsPage 14, line 18Printed page

   In S. 650 · Reported to Senate

   "(d) Submission of Assessments.--If a person fails to submit an assessment described in subsection (a)(2), or a request for approval of a pediatric formulation described in subsection (a) or (b), in accordance with applicable provisions of subsections (a) and (b)--

   "(1) the drug or biological product that is the subject of the assessment or request may be considered misbranded [inserted: solely because of that failure ]and subject to relevant enforcement action (except that the drug or biological product shall not be subject to action under section 303); but "(2) the failure to submit the assessment or request shall not be the basis for a proceeding--

   "(A) to withdraw approval for a drug under section 505(e); or

   Original wording

   On page 14, line 18, after “misbranded”, insert “solely because of that failure”.

2. 2

   Change 2: Rewrites page 19, lines 5–6

   ReplacesPrinted page

   Removes page 19, lines 5–6 of the printed bill. See that page

   Inserted: (a) In General.--Subject to subsection (b), this Act and the amendments made by this Act take effect on the date of enactment of this Act.

   Inserted: (b) Applicability to New Drugs and Biological Products.--

   Inserted: (1) In general.--Subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act (as added by section 2) shall apply to an application described in paragraph (1) of that subsection submitted to the Secretary of Health and Human Services on or after April 1, 1999.

   Inserted: (2) Waivers and deferrals.--

   Inserted: (A) Waiver or deferral granted.--If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act, a waiver or deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the waiver or deferral shall be a waiver or deferral under subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act, except that any date specified in such a deferral shall be extended by the number of days that is equal to the number of days between October 17, 2002, and the date of enactment of this Act.

   Inserted: (B) Waiver and deferral not granted.--If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act, neither a waiver nor deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the person that submitted the application shall be required to submit assessments under subsection (a)(2) of section 505B of the Federal Food, Drug, and Cosmetic Act on the date that is the later of--

   Inserted: (i) the date that is 1 year after the date of enactment of this Act; or

   Inserted: (ii) such date as the Secretary may specify under subsection (a)(3) of that section;

   Inserted: unless the Secretary grants a waiver under subsection (a)(4) of that section.

   Original wording

   On page 19, strike lines 5 and 6 and insert the following:

3. 3

   Change 3: Replaces “(b)” with “(c)”

   ReplacesPage 19, line 7Printed page

   [struck: (b)][inserted: (c)]

   Original wording

   On page 19, line 7, strike “(b)” and insert “(c)”.

Read automatically from the Congressional Record. Check the original before relying on it.

As printed