Pub. L. 117-328, div. FF, tit. III, subtit. F, ch. 3, sec. 3628
REPORTING ON MAILROOM AND OFFICE OF THE EXECUTIVE SECRETARIAT OF THE FOOD AND DRUG ADMINISTRATION.
SEC. 3628. REPORTING ON MAILROOM AND OFFICE OF THE EXECUTIVE SECRETARIAT OF THE FOOD AND DRUG ADMINISTRATION.(a) Report.—Not later than 90 days after the date of enactment of this Act, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on—136 STAT. 5890(1) information related to policies, procedures, and activities of the mailroom and the Office of the Executive Secretariat of the Food and Drug Administration, including—(A) taking receipt, tracking, managing, and prioritizing confidential informant complaints; (B) taking receipt of common carrier packages to the Food and Drug Administration; (C) the organizational structure and management of the mailroom; (D) the organizational structure and management of the Office of the Executive Secretariat; (E) the total number of employees and contractors in the mailroom including those working remotely and those working in person; (F) the total number of employees and contractors in the Office of the Executive Secretariat; (G) the number of vacant positions in the mailroom; (H) the number of vacant positions in the Office of the Executive Secretariat; (I) the average number of days for response to correspondence received by the Office of the Secretariat; (J) the extent to which there is a backlog of common carrier packages received by the mailroom and the number of common carrier packages in any backlog; (K) the extent to which there is a backlog of correspondence in the Office of the Executive Secretariat that has not been appropriately responded to by the Food and Drug Administration and the number of correspondence or common carrier packages in any backlog; (L) a rationale for the failure of the Office of the Executive Secretariat to respond to correspondence in any backlog and the position of the decision-making official who determined not to respond to such correspondence; (M) the number of whistleblower correspondence received, including within each agency center; (N) the amount of resources expended for the mailroom, including a breakdown of budget authority and user fee dollars; (O) the amount of resources expended for the Office of the Executive Secretariat and correspondence-related activities, including a breakdown of budget authority and user fee dollars; and (P) the performance of third-party contractors responsible for correspondence-related activities with respect to the receipt and tracking of correspondence, and efforts by the Food and Drug Administration to improve performance by such contractors; and (2) the development and implementation of new or revised policies and procedures of the Food and Drug Administration to monitor and ensure—(A) the effective receipt, tracking, managing, and prioritization of such complaints; and (B) the effective receipt of common carrier packages to the Food and Drug Administration. (b) Annual Report.—Not later than the end of each of fiscal years 2023 and 2024, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate 136 STAT. 5891 and the Committee on Energy and Commerce of the House of Representatives on the implementation of the new or revised policies of the Food and Drug Administration reported under subsection (a)(2), and since such implementation—(1) the volume of incoming common carrier packages to the mailroom; (2) the volume of incoming correspondence to the Office of the Executive Secretariat; (3) the extent to which new backlogs occur in the processing of common carrier packages received by the mailroom; (4) the extent to which new backlogs occur in the processing of correspondence received by the Office of the Executive Secretariat; (5) the length of time required to resolve each such backlog; (6) any known issues of unreasonable delays in correspondence being provided to the intended recipient, or in correspondence being lost, and the measures taken to remedy such delays or lost items; (7) the average number of days it takes to respond to correspondence received by the Office of the Executive Secretariat; (8) the resources expended by the mailroom, including a breakdown of budget authority and user fee dollars; and (9) the resources expended by the Office of the Executive Secretariat on correspondence-related activities, including a breakdown of budget authority and user fee dollars. (c) GAO Report.—Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall 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 assessing the policies and practices of the Division of Executive Operations of the Office of the Executive Secretariat of the Food and Drug Administration with respect to the receipt, tracking, managing, and prioritization of correspondence.