Sec. 9. Resources
3,888 words·~18 min read·
/bill/118/hr/2369/ih/section-9A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Congress finds that the fees authorized by this section will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. Beginning not later than October 1, 2025, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall initiate the development of recommendations in accordance with this section to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of in vitro clinical test submissions and applications under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, for the first 4 fiscal years after fiscal year 2028 and for the authorization of the In Vitro Clinical Test User Fee Program for such fiscal years.
In developing such recommendations, the Secretary shall consult with— the Committee on Health, Education, Labor, and Pensions of the Senate; the Committee on Energy and Commerce of the House of Representatives; scientific and academic experts; health care professionals; representatives of patient and consumer advocacy groups; and the regulated industry. Prior to beginning negotiations with the regulated industry on the authorization of the In Vitro Clinical Test User Fee Program, as described in this section, the Secretary shall— publish a notice in the Federal Register requesting public input on the authorization of user fees; hold a public meeting at which the public may present its views on the authorization, including specific suggestions for the recommendations submitted under subparagraph (E); provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to the In Vitro Clinical Test User Fee Program; and publish any comments received under clause
(iii)on the website of the Food and Drug Administration. Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of the authorization of the In Vitro Clinical Test User Fee Program and to solicit suggestions to be included in the recommendations transmitted to Congress under subparagraph (F). The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of the In Vitro Clinical Test User Fee Program to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. After negotiations with the regulated industry, the Secretary shall— present the recommendations developed under subparagraph
(A)to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; publish such recommendations in the Federal Register; provide for a period of 30 days for the public to provide written comments on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary. Not later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under subparagraph (A), a summary of the views and comments received under such subparagraph, and any changes made to the recommendations in response to such views and comments. The recommendations transmitted under this subparagraph shall— include the number of full-time equivalent employees per fiscal year that are agreed to be hired to carry out the goals included in such recommendations for each year of the 5-year period; provide that the amount of operating reserve balance in the user fee program established under this section is not more than the equivalent of 10 weeks of operating reserve; require the development of a strategic plan for any surplus within the operating reserve account above the 10-week operating reserve within 2 years of the establishment of the program; include an operating reserve adjustment such that, if the Secretary has an operating reserve balance in excess of 10 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 10 weeks of such operating reserves; if an adjustment is made as described in subclause (IV), provide the rationale for the amount of the decrease in fee revenue and fees shall be contained in the Federal Register; and provide that the fees assessed and collected for the full-time equivalent employees at the Center for Devices and Radiological Health, with respect to which the majority of time reporting data indicates are dedicated to the process for the review of in vitro clinical test submissions and applications under paragraph (5), are not supported by the funds authorized to be collected and assessed under section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ). The Secretary shall publish on the website of the Food and Drug Administration the revised recommendations under subparagraph (F), a summary of the recommendations, views, and comments received under subparagraphs (B), (C), and (E), and any changes made to the recommendations originally proposed by the Secretary in response to such recommendations, views, and comments. The Secretary shall make publicly available, on the website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry not later than 30 days after such meeting. The minutes described under clause
(i)shall summarize any substantive proposal made by any party to the negotiations, any significant controversies or differences of opinion during the negotiations, and the resolution of any such controversy or difference of opinion. Effective on October 1, 2028, provided that the Secretary transmits the recommendations under paragraph (1)(F), the Secretary is authorized to collect user fees relating to the review of in vitro clinical test submissions and applications submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and any other activities or goals included in recommendations transmitted to Congress pursuant to this subsection. Fees under such program shall be assessed and collected only if the requirements under paragraph
(4)are met. Beginning 2 years after first receiving a user fee applicable to submission of an in vitro clinical test application submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, the Secretary shall, on a biennial basis, perform an audit of the costs of reviewing such applications and any other activities under such subchapter J included in recommendations transmitted to Congress pursuant to this subsection. Such an audit shall compare the costs of reviewing such applications and other activities under such subchapter J to the amount of the user fee applicable to such applications and make any necessary adjustments as described in subparagraph (B). The following adjustments shall apply with respect to audits performed under subparagraph (A): If the audit performed 2 years after first receiving a user fee applicable to submission of an in vitro clinical test application described under subparagraph
(A)indicates that the user fees collected for purposes of such subchapter J exceed 33 percent of the costs of reviewing such applications and carrying out activities included in recommendations transmitted to Congress pursuant to this subsection, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. If the audit performed 6 years after first receiving a user fee applicable to submission of an in vitro clinical test application described under subparagraph
(A)indicates that the user fees collected for purposes of such subchapter J exceed 40 percent of the costs of reviewing such applications, and carrying out activities included in recommendations transmitted to Congress pursuant to this subsection, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. If the audit performed 12 years after first receiving a user fee applicable to submission of an in vitro clinical test application described under subparagraph (A), and any audit performed after such date, indicates that the user fees collected for purposes of such subchapter J exceed 49 percent of the costs of reviewing such applications, and carrying out activities included in recommendations transmitted to Congress pursuant to this subsection, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. The Secretary shall perform an audit under subparagraph
(A)in conformance with the accounting principles, standards, and requirements prescribed by the Comptroller General of the United States under section 3511 of title 31, United States Code, to ensure the validity of any potential variability. In the event that the Secretary fails to promulgate the regulations described in section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, by the applicable deadline for each such regulations as described in section 5(a)(2)(A)(ii), the Secretary shall provide that the user fees applicable to applications submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by section 3, do not exceed 30 percent of the costs of reviewing such applications. The user fee program described in this subsection shall take effect only if the Food and Drug Administration issues a regulation related to the review requirements for in vitro diagnostic tests that would be subject to premarket review under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 3, the review requirements for test categories eligible for technology certification under section 587D of such Act, as added by section 3, and the parameters for the test categories that would be exempt from any review under subchapter J of chapter V of such Act. The term process for the review of in vitro clinical test submissions and applications means the following activities of the Secretary with respect to the review of in vitro clinical test premarket and technology certification applications including supplements for such applications: The activities necessary for the review of premarket applications, premarket reports, technology certification applications, and supplements to such applications. Actions related to submissions in connection with in vitro clinical test development, the issuance of action letters that allow the marketing of in vitro clinical tests or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to support the development of in vitro clinical tests. The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, technology certifications, and supplements. Monitoring of research conducted in connection with the review of such applications, supplements, and submissions. Review of in vitro clinical test applications subject to section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and activities conducted in anticipation of the submission of such applications for investigational use under section 587S of the Federal Food, Drug, and Cosmetic Act (as added by section 3). The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, technology certification applications, and supplements. The development of voluntary test methods, consensus standards, or mandatory performance standards in connection with the review of such applications, supplements, or submissions and related activities. The provision of technical assistance to in vitro clinical test developers in connection with the submission of such applications, reports, supplements, or submissions. Any activity undertaken in connection with the initial classification or reclassification of an in vitro clinical test in connection with any requirement for approval or eligibility for an exemption from premarket review of an in vitro clinical test. Any activity undertaken in connection with making a pathway determination of an in vitro clinical test, including the identification, establishment, and implementation of mitigation measures. Evaluation of postmarket studies required as a condition of an approval of a premarket application of an in vitro clinical test and ensuring such studies are conducted as required. Any activity undertaken in connection with ensuring in vitro clinical tests offered under an exemption from premarket review pursuant to section 587C or 587G meet the criteria for such exemption and the applicable standard. Compiling, developing, and reviewing information on in vitro clinical tests necessary to identify issues with the ability of in vitro clinical tests to meet the applicable standard, as applicable. Fees collected and assessed under this section shall be used for the process for the review of in vitro clinical test applications, as described in subparagraph (A), and shall— be subject to the limitation under section 738(g)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(g)(3) ), in the same manner that fees collected and assessed under section 737(9)(C) of such Act ( 21 U.S.C. 379i(9)(C) ) are subject to such limitation; include travel expenses for officers and employees of the Food and Drug Administration only if the Secretary determines that such travel is directly related to an activity described in subparagraph (A); and not be allocated to purposes described under section 722(a) of the Consolidated Appropriations Act, 2018 ( Public Law 115–141 ). Beginning with fiscal year 2028, for each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. Beginning with fiscal year 2028, the annual report under this subparagraph shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including— the number of premarket applications filed under section 587B of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year; the number of technology certification applications submitted under section 587D of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year for each review division; the number of breakthrough designations under section 587I of the Federal Food, Drug, and Cosmetic Act during the applicable fiscal year; and the number of information requests requested by the Secretary pursuant to section 587G(d) of such Act. Not later than 30 calendar days after the end of the second quarter of fiscal year 2028, 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 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. The Secretary shall post the following data in accordance with subclause (I): The number and titles of draft and final regulations on topics related to the process for the review of in vitro clinical test submissions and applications, and whether such regulations were required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). The number and titles of draft and final guidance on topics related to the process for the review of in vitro clinical test submissions and applications, and whether such guidances were issued as required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). The number and titles of public meetings held on topics related to the process for the review of in vitro clinical tests, and if such meetings were required by statute or pursuant to the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). Beginning with fiscal year 2028, the Secretary shall include in the annual performance report under paragraph (1)— data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F) and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to this section, 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; data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of in vitro clinical test submissions and applications, including identifying— drivers of such changes; and changes in the average total cost per full-time equivalent in the in vitro clinical test review program; 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; and data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of in vitro clinical test application. For each fiscal year, the Secretary shall include in the report under clause
(i)an analysis of the following: The difference between the aggregate number of premarket applications filed under section 587B or section 587D of the Federal Food, Drug, and Cosmetic Act and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for— the number of applications filed under each of sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and the aggregate number of applications under each of sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act for each fiscal year that did not meet the goals as identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). The most common causes and trends for external or other circumstances affecting the ability of the Food and Drug Administration to meet review time and performance enhancement goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F). With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F), the Secretary shall make such information publicly available on the website of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. The Secretary shall include in each report under subparagraph
(A)information on all previous cohorts for which the Secretary has not given a complete response on all in vitro clinical test premarket applications and technology certification orders and supplements, premarket, and technology certification notifications in the cohort. Beginning with fiscal year 2029, for each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit a corrective action report to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives. The report shall include the following information, as applicable: For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(v), that each of the goals identified by the recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F) for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the in vitro clinical test premarket application and technology certification review process. For each of the goals identified by the letters described in recommendations transmitted to Congress by the Secretary pursuant to subsection (b)(1)(F) for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include— a justification for such determination; a description of the types of circumstances, in the aggregate, under which applications or reports submitted under sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act missed the review goal times but were approved during the first cycle review, as applicable; a summary and any trends with regard to the circumstances for which a review goal was missed; and the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year. For fiscal years 2029 and annually thereafter, not later than 120 days after the end of each fiscal year during which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made. Such report shall include expenditures delineated by budget authority and user fee dollars related to administrative expenses and information technology infrastructure contracts and expenditures. Such report shall provide the amount of operating reserves of carryover user fees available each year, and any planned allocations or obligations of such balance of operating reserves for the program. The Secretary shall make the reports required under paragraphs
(1)through
(3)available to the public on the website of the Food and Drug Administration. Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of in vitro clinical tests shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section. Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this section.
Connectionstraces to 4
Traces to 4 documents
Citation graph
cites case law
Cites 4Cited by 0 across 0 sources