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").
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.
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.
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.
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.
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.
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.
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.
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) of this section;
(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.
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.
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.)
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