Sec. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING
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## SEC. 903 STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING ###
(a)PDUFA Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2(a)), as amended by section 103, is further amended by inserting after paragraph
(2)the following: > > #### “(3) Real time reporting > > > ##### “(A) In general > > Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph
(B)on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection. > > > ##### “(B) Data > > The Secretary shall post the following data in accordance with subparagraph (A): > > > ###### “(i) > > The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017. > > > ###### “(ii) > > The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017. > > > ###### “(iii) > > The number of new drug applications and biological licensing applications approved. > > > ###### “(iv) > > The number of new drug applications and biological licensing applications filed. > > > #### “(4) Rationale for pdufa program changes > > Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)— > > > ##### “(A) > > data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; > > > ##### “(B) > > data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and > > > ##### “(C) > > for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.” > . ###
(b)MDUFA Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)), as amended by section 204, is further amended— ####
(1)by striking “ Beginning with ” and inserting the following: > > ###### “(i) General requirements > > Beginning with” > ; and ####
(2)by adding at the end the following: > > ###### “(ii) Additional information > > Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including— > > > ###### “(I) > > the number of premarket applications filed under section 515 per fiscal year for each review division; > > > ###### “(II) > > the number of reports submitted under section 510(k) per fiscal year for each review division; and > > > ###### “(III) > > the number of expedited development and priority review designations under section 515C per fiscal year. > > > ###### “(iii) Real time reporting > > > ###### “(I) In general > > Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause
(II)on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph. > > > ###### “(II) Data > > The Secretary shall post the following data in accordance with subclause (I): > > > ###### “(aa) > > The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and > > > ###### “(bb) > > The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017. > > > ###### “(iv) Rationale for mdufa program changes > > Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)— > > > ###### “(I) > > data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; > > > ###### “(II) > > data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and > > > ###### “(III) > > for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.” > . ###
(c)GDUFA Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43(a)), as amended by section 304, is further amended— ####
(1)by striking “ Beginning with ” and inserting the following: > > #### “(1) General requirements > > Beginning with” > ; and ####
(2)by adding at the end the following: > > #### “(2) Real time reporting > > > ##### “(A) In general > > Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph
(B)on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection. > > > ##### “(B) Data > > The Secretary shall post the following data in accordance with subparagraph (A): > > > ###### “(i) > > The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017. > > > ###### “(ii) > > The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017. > > > #### “(3) Rationale for gdufa program changes > > Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)— > > > ##### “(A) > > data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; > > > ##### “(B) > > data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and > > > ##### “(C) > > for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.” > . ###
(d)BsUFA Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53(a)), as amended by section 404, is further amended— ####
(1)by striking “ Beginning with ” and inserting the following: > > #### “(1) General requirements > > Beginning with” > ; and ####
(2)by adding at the end the following: > > #### “(2) Additional information > > Beginning with fiscal year 2018, the report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including— > > > ##### “(A) > > information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort; > > > ##### “(B) > > the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and > > > ##### “(C) > > the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals letters issued by the agency for such applications. > > > #### “(3) Real time reporting > > > ##### “(A) In general > > Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph
(B)for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection. > > > ##### “(B) Data > > The Secretary shall post the following data in accordance with subparagraph (A): > > > ###### “(i) > > The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017. > > > ###### “(ii) > > The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017. > > > #### “(4) Rationale for bsufa program changes > > Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)— > > > ##### “(A) > > data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; > > > ##### “(B) > > data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and > > > ##### “(C) > > for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.” > .
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Sec. 903
STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING
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