2011—Subsecs. (h), (i). Pub. L. 111–353 added subsecs. (h) and (i).
2009—Subsec. (d)(2)(C). Pub. L. 111–31, § 103(m), struck out “and” after “cosmetics,” and inserted “, and tobacco products” after “devices”.
1997—Subsec. (b). Pub. L. 105–115, § 406(a)(2), added subsec. (b). Former subsec. (b) redesignated (d).
Subsec. (c). Pub. L. 105–115, § 414, added subsec. (c). Former subsec. (c) redesignated (e).
Subsecs. (d), (e). Pub. L. 105–115, § 406(a)(1), redesignated subsecs. (b) and (c) as (d) and (e), respectively.
Subsecs. (f), (g). Pub. L. 105–115, § 406(b), added subsecs. (f) and (g).
1988—Subsec. (b)(2). Pub. L. 100–690 substituted “shall be responsible for executing this chapter and” for “shall be responsible”.
Amendment by Pub. L. 105–115 effective 90 days after
Pub. L. 100–607, title V, § 503(c), “(1) Except as provided in paragraph (2), the amendments made by this title [enacting this section and amending sections 5315 and 5316 of Title 5, Government Organization and Employees] shall take effect on the date of enactment of this Act [“(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section) [now 1003(d)(1), 21 U.S.C. 393(b)(1)] shall apply to the appointments of Commissioners of Food and Drugs made after the date of enactment of this Act.”
Pub. L. 117–328, div. FF, title II, § 2505, “(a) The Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall develop, and publish on the website of the Food and Drug Administration—“(1) a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents, within centers, across the Food and Drug Administration, and across other applicable agencies; and“(2) a plan for implementation of such best practices, including across other applicable agencies, which shall address—“(A) streamlining development and review of guidance documents within centers and across the Food and Drug Administration;“(B) streamlining processes for regulatory submissions to the Food and Drug Administration, including through the revision or issuance of guidance documents; and“(C) implementing innovative guidance development processes and practices and transitioning or updating guidance issued during the COVID–19 public health emergency, as appropriate.“(b) The Secretary, acting through the Commissioner of Food and Drugs, shall develop and publish on the website of the Food and Drug Administration a report on the practices of the Food and Drug Administration to broadly communicate with external stakeholders, other than through guidance documents, which shall include—“(1) a review of the types and methods of public communication that the Food and Drug Administration uses to communicate and interact with medical product sponsors and other external stakeholders;“(2) the identification of best practices for the efficient development, issuance, and use of such communications; and“(3) a plan for implementation of best practices for communication with external stakeholders, which shall address—“(A) advancing the use of innovative forms of communication, including novel document types and formats, to provide increased regulatory clarity to product sponsors and other stakeholders, and advancing methods of communicating and interacting with medical product sponsors and other external stakeholders, including the use of tools such as product submission templates, webinars, and frequently asked questions communications;“(B) streamlining processes for regulatory submissions; and“(C) implementing innovative communication development processes and transitioning or updating communication practices used during the COVID–19 public health emergency, as appropriate.“(c) In developing and publishing the report and implementation plan under this section, the Secretary shall consult with stakeholders, including researchers, academic organizations, pharmaceutical, biotechnology, and medical device developers, clinical research organizations, clinical laboratories, health care providers, patient groups, and other appropriate stakeholders.“(d) For purposes of carrying out this section, the Secretary may update an existing report or plan, and may combine the reports and implementation plans described in subsections (a) and (b) into one or more documents.“(e) The Secretary shall—“(1) not later than 1 year after the date of enactment of this Act [“(2) not later than 180 days after publication of the draft reports and plans under paragraph (1)—“(A) publish a final report and plan; and“(B) begin implementation of the best practices pursuant to such final plan.”
Pub. L. 117–328, div. FF, title III, § 3627(a), “(a) “(1) Not later than “(2) The Food and Drug Administration Strategic Information Technology Plan under paragraph (1) shall include—“(A) agency-wide strategic goals and priorities for modernizing the information technology systems of the Food and Drug Administration to maximize the efficiency and effectiveness of such systems for enabling the Food and Drug Administration to fulfill its public health mission;“(B) specific activities and strategies for achieving the goals and priorities identified under subparagraph (A), and specific milestones, metrics, and performance measures for assessing progress against such strategic goals and priorities;“(C) specific activities and strategies for improving and streamlining internal coordination and communication within the Food and Drug Administration, including for activities and communications related to signals of potential public health concerns;“(D) challenges and risks the Food and Drug Administration will face in meeting its strategic goals and priorities, and the activities the Food and Drug Administration will undertake to overcome those challenges and mitigate those risks;“(E) the ways in which the Food and Drug Administration will use the Plan to guide and coordinate the projects and activities of the Food and Drug Administration across its offices and centers; and“(F) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.“(3) Each Food and Drug Administration Strategic Information Technology Plan issued pursuant to this subsection, with the exception of the first such Food and Drug Administration Strategic Information Technology Plan, shall include an evaluation of—“(A) the progress the Secretary has made, based on the metrics, benchmarks, and other milestones that measure successful development and implementation of information technology systems; and“(B) whether actions taken in response to the previous Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities set forth in such previous Plans.”
Pub. L. 108–282, title I, § 102(b)(7),
Pub. L. 105–115, title I, § 129,
Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.
Pub. L. 112–144, title XI, § 1124, “(a) Not later than 1 year after the date of enactment of this Act [“(b) The strategy and implementation plan developed under subsection (a) shall be consistent with the user fee performance goals in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on “(1) identify a clear vision of the fundamental role of efficient, consistent, and predictable, science-based decisions throughout regulatory decisionmaking of the Food and Drug Administration with respect to medical products;“(2) identify the regulatory science priorities of the Food and Drug Administration directly related to fulfilling the mission of the agency with respect to decisionmaking concerning medical products and allocation of resources toward such regulatory science priorities;“(3) identify regulatory and scientific gaps that impede the timely development and review of, and regulatory certainty with respect to, the approval, licensure, or clearance of medical products, including with respect to companion products and new technologies, and facilitating the timely introduction and adoption of new technologies and methodologies in a safe and effective manner;“(4) identify clear, measurable metrics by which progress on the priorities identified under paragraph (2) and gaps identified under paragraph (3) will be measured by the Food and Drug Administration, including metrics specific to the integration and adoption of advances in regulatory science described in paragraph (5) and improving medical product decisionmaking, in a predictable and science-based manner; and“(5) set forth how the Food and Drug Administration will ensure that advances in regulatory science for medical products are adopted, as appropriate, on an ongoing basis and in an [sic] manner integrated across centers, divisions, and branches of the Food and Drug Administration, including by senior managers and reviewers, including through the—“(A) development, updating, and consistent application of guidance documents that support medical product decisionmaking; and“(B) adoption of the tools, methods, and processes under section 566 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5).“(c) The annual performance reports submitted to Congress under sections 736B(a) [21 U.S.C. 379h–2(a)] (as amended by section 104 of this Act), 738A(a) [21 U.S.C. 379j–1(a)] (as amended by section 204 of this Act), 744C(a) [21 U.S.C. 379j–43(a)] (as added by section 303 of this Act), and 744I(a) [21 U.S.C. 379j–53(a)] (as added by section 403 of this Act) of the Federal Food, Drug, and Cosmetic Act for each of fiscal years 2014 and 2016, shall include a report from the Secretary on the progress made with respect to—“(1) advancing the regulatory science priorities identified under paragraph (2) of subsection (b) and resolving the gaps identified under paragraph (3) of such subsection, including reporting on specific metrics identified under paragraph (4) of such subsection;“(2) the integration and adoption of advances in regulatory science as set forth in paragraph (5) of such subsection; and“(3) the progress made in advancing the regulatory science goals outlined in the Prescription Drug User Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment letter, and the Biosimilar User Fee Agreement commitment letter transmitted by the Secretary to Congress on “(d) In this section, the term ‘medical product’ means a drug, as defined in subsection (g) of section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].”
Pub. L. 112–144, title XI, § 1125, “(a) Not later than 1 year after the date of enactment of this Act [“(1) report to Congress on—“(A) the milestones and a completion date for developing and implementing a comprehensive information technology strategic plan to align the information technology systems modernization projects with the strategic goals of the Food and Drug Administration, including results-oriented goals, strategies, milestones, performance measures;“(B) efforts to finalize and approve a comprehensive inventory of the information technology systems of the Food and Drug Administration that includes information describing each system, such as costs, system function or purpose, and status information, and incorporate use of the system portfolio into the information investment management process of the Food and Drug Administration;“(C) the ways in which the Food and Drug Administration uses the plan described in subparagraph (A) to guide and coordinate the modernization projects and activities of the Food and Drug Administration, including the interdependencies among projects and activities; and“(D) the extent to which the Food and Drug Administration has fulfilled or is implementing recommendations of the Government Accountability Office with respect to the Food and Drug Administration and information technology; and“(2) develop—“(A) a documented enterprise architecture program management plan that includes the tasks, activities, and timeframes associated with developing and using the architecture and addresses how the enterprise architecture program management will be performed in coordination with other management disciplines, such as organizational strategic planning, capital planning and investment control, and performance management; and“(B) a skills inventory, needs assessment, gap analysis, and initiatives to address skills gaps as part of a strategic approach to information technology human capital planning.“(b) Not later than “(1) the development and implementation of a comprehensive information technology strategic plan, including the results-oriented goals, strategies, milestones, and performance measures identified in subsection (a)(1)(A);“(2) the effectiveness of the comprehensive information technology strategic plan described in subsection (a)(1)(A), including the results-oriented goals and performance measures; and“(3) the extent to which the Food and Drug Administration has fulfilled recommendations of the Government Accountability Office with respect to such agency and information technology.”
Pub. L. 105–115, title IV, § 413, “(a) The Secretary of Health and Human Services shall, acting through the Food and Drug Administration—“(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and“(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 [“(b) The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.“(c) “(1) The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate—“(A) the scope of mercury use as a drug or dietary supplement; and“(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.“(2) If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies.”
Pub. L. 102–571, title II, § 205,
Pub. L. 100–607, title V, § 502, “(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years;“(2) the presence and importance of the Food and Drug Administration must be guaranteed; and“(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health.”