§ 393. Food and Drug Administration

§ 393. Food and Drug Administration

(a) In general There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”).

(b) Mission The Administration shall—

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that—

(A) foods are safe, wholesome, sanitary, and properly labeled;

(B) human and veterinary drugs are safe and effective;

(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use;

(D) cosmetics are safe and properly labeled; and

(E) public health and safety are protected from electronic product radiation;

(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

(c) Interagency collaboration The Secretary shall implement programs and policies that will foster collaboration between the Administration, the National Institutes of Health, and other science-based Federal agencies, to enhance the scientific and technical expertise available to the Secretary in the conduct of the duties of the Secretary with respect to the development, clinical investigation, evaluation, and postmarket monitoring of emerging medical therapies, including complementary therapies, and advances in nutrition and food science.

(d) Commissioner

(1) Appointment There shall be in the Administration a Commissioner of Food and Drugs (hereinafter in this section referred to as the “Commissioner”) who shall be appointed by the President by and with the advice and consent of the Senate.

(2) General powers The Secretary, through the Commissioner, shall be responsible for executing this chapter and for—

(A) providing overall direction to the Food and Drug Administration and establishing and implementing general policies respecting the management and operation of programs and activities of the Food and Drug Administration;

(B) coordinating and overseeing the operation of all administrative entities within the Administration;

(C) research relating to foods, drugs, cosmetics, devices, and tobacco products in carrying out this chapter;

(D) conducting educational and public information programs relating to the responsibilities of the Food and Drug Administration; and

(E) performing such other functions as the Secretary may prescribe.

(e) Technical and scientific review groups The Secretary through the Commissioner of Food and Drugs may, without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under this chapter, and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.

(f) Agency plan for statutory compliance

(1) In general Not later than 1 year after November 21, 1997, the Secretary, after consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry, shall develop and publish in the Federal Register a plan bringing the Secretary into compliance with each of the obligations of the Secretary under this chapter. The Secretary shall review the plan biannually and shall revise the plan as necessary, in consultation with such persons.

(2) Objectives of agency plan The plan required by paragraph (1) shall establish objectives and mechanisms to achieve such objectives, including objectives related to—

(A) maximizing the availability and clarity of information about the process for review of applications and submissions (including petitions, notifications, and any other similar forms of request) made under this chapter;

(B) maximizing the availability and clarity of information for consumers and patients concerning new products;

(C) implementing inspection and postmarket monitoring provisions of this chapter;

(D) ensuring access to the scientific and technical expertise needed by the Secretary to meet obligations described in paragraph (1);

(E) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in this chapter for the review of all applications and submissions described in subparagraph (A) and submitted after November 21, 1997; and

(F) eliminating backlogs in the review of applications and submissions described in subparagraph (A), by January 1, 2000.

(g) Annual report The Secretary shall annually prepare and publish in the Federal Register and solicit public comment on a report that—

(1) provides detailed statistical information on the performance of the Secretary under the plan described in subsection (f);

(2) compares such performance of the Secretary with the objectives of the plan and with the statutory obligations of the Secretary; and

(3) identifies any regulatory policy that has a significant negative impact on compliance with any objective of the plan or any statutory obligation and sets forth any proposed revision to any such regulatory policy.

(h) Annual report regarding food Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding—

(1) information about food facilities including—

(A) the appropriations used to inspect facilities registered pursuant to section 350d of this title in the previous fiscal year;

(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;

(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that the Secretary inspected in the previous fiscal year;

(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 350d of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;

(E) the number of high-risk facilities identified pursuant to section 350j of this title that the Secretary inspected in the previous fiscal year; and

(F) the number of high-risk facilities identified pursuant to section 350j of this title that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.

(2) information about food imports including—

(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;

(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and

(C) the average cost of physically inspecting or sampling a line of food subject to this chapter that is imported or offered for import into the United States; and

(3) information on the foreign offices of the Food and Drug Administration including—

(A) the number of foreign offices established; and

(B) the number of personnel permanently stationed in each foreign office.

(i) Public availability of annual food reports The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.

(June 25, 1938, ch. 675, § 1003, formerly § 903, as added Pub. L. 100–607, title V, § 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100–690, title II, § 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L. 105–115, title IV, §§ 406, 414, Nov. 21, 1997, 111 Stat. 2369, 2377; renumbered § 1003 and amended Pub. L. 111–31, div. A, title I, §§ 101(b)(2), 103(m), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 201(b), Jan. 4, 2011, 124 Stat. 3925.)

Editorial Notes

Amendments

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”.

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date

Pub. L. 100–607, title V, § 503(c), Nov. 4, 1988, 102 Stat. 3121, provided that: “(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 [Nov. 4, 1988]. “(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.”

Improving FDA Guidance and Communication

Pub. L. 117–328, div. FF, title II, § 2505, Dec. 29, 2022, 136 Stat. 5802, provided that: “(a) FDA Report and Implementation of Good Guidance Practices.—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) Report and Implementation of FDA Best Practices for Communicating With External Stakeholders.—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) Consultation.—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) Manner of Issuance.—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) Timing.—The Secretary shall—“(1) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], publish a draft of the reports and plans required under this section; and “(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.”

Improving Information Technology Systems of the Food and Drug Administration

Pub. L. 117–328, div. FF, title III, § 3627(a), Dec. 29, 2022, 136 Stat. 5888, provided that: “(a) FDA Strategic Information Technology Plan.—“(1) In general.—Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary [of Health and Human Services] shall develop and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated information technology strategic plan to modernize the information technology systems of the Food and Drug Administration. Each such report shall be known as the ‘Food and Drug Administration Strategic Information Technology Plan’. The first such report may include the Data and Technology Modernization Strategy, as set forth in the letters described in section 1001(b) of the FDA User Fee Reauthorization Act of 2022 (division F of Public Law 117–180) [21 U.S.C. 379g note]. “(2) Content of strategic plan.—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) Evaluation of progress.—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.”

Office of Minor Use and Minor Species Animal Drug Development