【正文】 subsection (a)(1) (relating to human drug applications and supplements)。39。 has the meaning given to the term `pounded positron emission tomography drug39。 and (B) by adding at the end the following: ``(C) Special rules for positron emission tomography ``(i) In as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to onesixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application. ``(ii) Exception from annual establishment person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that ``(I) the person is a notforprofit medical center that has only 1 establishment for the production of positron emission tomography drugs。 and inserting ``subparagraphs (B) and (C)39。 and (3) in paragraph (2) (A) in subparagraph (A), by striking ``subparagraph (B)39。 and (C) by inserting after subparagraph (D) the following: ``(E) Fees for applications previously refused for filing or withdrawn before human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).39。39。39。39。39。39。39。 includes an affiliate thereof. ``(10) The term `active39。 (7) by redesignating paragraph (9) as paragraph (11)。 and inserting ``October 199639。 and (B) by striking ``April 199739。 and inserting ``October of the preceding fiscal year39。 (6) in paragraph (8) (A) by striking ``April of the preceding fiscal year39。 (5) by amending paragraph (6)(F) to read as follows: ``(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities: ``(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. ``(ii) Developing and using improved adverse event datacollection systems, including information technology systems. ``(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. ``(iv) Implementing and enforcing section 505(o) (relating to postapproval studies and clinical trials and labeling changes) and section 505(p) (relating to risk evaluation and mitigation strategies). ``(v) Carrying out section 505(k)(5) (relating to adverse event reports and postmarket safety activities).39。 (4) in paragraph (4), by inserting before the period at the end the following: ``(such as capsules, tablets, or lyophilized products before reconstitution)39。 and (B) by inserting before the period ``(not including the discontinued section of such list)39。 and inserting ``505(j)(7)(A) (not including the discontinued section of such list)39。 (3) in paragraph (3)(C) (A) by striking ``505(j)(7)(A)39。 and inserting ``subparagraph (B)39。 and [[Page 121 STAT. 826]] (D) in the matter following subparagraph (B), as so redesignated, by striking ``subparagraph (C)39。 (B) by striking subparagraph (B)。 and inserting ``505(b), or39。 (2) in paragraph (1) (A) in subparagraph (A), by striking ``505(b)(1),39。 and inserting ``For purposes of this part39。. (b) References in as otherwise specified, amendments made by this title to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 . 301 et seq.). (c) NOTE: 21 USC 379g note. Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the rev