21 U.S.C. § 397 — Contracts for expert review

Page 707 TITLE 21—FOOD AND DRUGS § 397 than $20,000 of the principal and interest of the educational loans of such health professionals. (2) Limitation The Secretary may not enter into an agree- ment with a health professional pursuant to paragraph (1) unless such professional— (A) has a substantial amount of edu- cational loans relative to income; and (B) agrees to serve as an employee of the Food and Drug Administration for purposes of paragraph (1) for a period of not less than 3 years. (b) Applicability of certain provisions With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health Service Act [42 U.S.C. 254l et seq.], the provisions of such subpart shall, except as in- consistent with subsection (a) of this section, apply to the program established in such sub- section in the same manner and to the same ex- tent as such provisions apply to the National Health Service Corps Loan Repayment Program. (c) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996. (June 25, 1938, ch. 675, § 1005, formerly § 905, as added Pub. L. 103–43, title XX, § 2006(2), June 10, 1993, 107 Stat. 210; renumbered § 1005, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (b), is act July 1, 1944, ch. 373, 58 Stat. 682. Subpart III of part D of title III of the Act is classified generally to subpart III [§ 254l et seq.] of part D of subchapter II of chapter 6A of Title 42, The Public Health and Wel- fare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. § 396. Practice of medicine Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This sec- tion shall not limit any existing authority of the Secretary to establish and enforce restric- tions on the sale or distribution, or in the label- ing, of a device that are part of a determination of substantial equivalence, established as a con- dition of approval, or promulgated through reg- ulations. Further, this section shall not change any existing prohibition on the promotion of un- approved uses of legally marketed devices. (June 25, 1938, ch. 675, § 1006, formerly § 906, as added Pub. L. 105–115, title II, § 214, Nov. 21, 1997, 111 Stat. 2348; renumbered § 1006, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. § 397. Contracts for expert review (a) In general (1) Authority The Secretary may enter into a contract with any organization or any individual (who is not an employee of the Department) with relevant expertise, to review and evaluate, for the purpose of making recommendations to the Secretary on, part or all of any applica- tion or submission (including a petition, noti- fication, and any other similar form of re- quest) made under this chapter for the ap- proval or classification of an article or made under section 351(a) of the Public Health Serv- ice Act (42 U.S.C. 262(a)) with respect to a bio- logical product. Any such contract shall be subject to the requirements of section 379 of this title relating to the confidentiality of in- formation. (2) Increased efficiency and expertise through contracts The Secretary may use the authority grant- ed in paragraph (1) whenever the Secretary de- termines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission de- scribed in paragraph (1), unless using such au- thority would reduce the quality, or unduly increase the cost, of such review. The Sec- retary may use such authority whenever the Secretary determines that use of such a con- tract will improve the quality of the review of an application or submission described in paragraph (1), unless using such authority would unduly increase the cost of such review. Such improvement in timeliness or quality may include providing the Secretary increased scientific or technical expertise that is nec- essary to review or evaluate new therapies and technologies. (b) Review of expert review (1) In general Subject to paragraph (2), the official of the Food and Drug Administration responsible for any matter for which expert review is used pursuant to subsection (a) shall review the recommendations of the organization or indi- vidual who conducted the expert review and shall make a final decision regarding the mat- ter in a timely manner. (2) Limitation A final decision by the Secretary on any such application or submission shall be made within the applicable prescribed time period for review of the matter as set forth in this chapter or in the Public Health Service Act (42 U.S.C. 201 et seq.). (June 25, 1938, ch. 675, § 1007, formerly § 907, as added Pub. L. 105–115, title IV, § 415, Nov. 21, 1997, 111 Stat. 2377; renumbered § 1007, Pub. L. 111–31, Page 708 TITLE 21—FOOD AND DRUGS § 398 div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classi- fication of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. § 398. Notices to States regarding imported food (a) In general If the Secretary has credible evidence or infor- mation indicating that a shipment of imported food or portion thereof presents a threat of seri- ous adverse health consequences or death to hu- mans or animals, the Secretary shall provide no- tice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appro- priate, if any, to protect the public health re- garding the food involved. (b) Rule of construction Subsection (a) may not be construed as lim- iting the authority of the Secretary with respect to food under any other provision of this chap- ter. (June 25, 1938, ch. 675, § 1008, formerly § 908, as added Pub. L. 107–188, title III, § 310, June 12, 2002, 116 Stat. 673; renumbered § 1008, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 399. Grants to enhance food safety (a) In general The Secretary is authorized to make grants to eligible entities to— (1) undertake examinations, inspections, and investigations, and related food safety activi- ties under section 372 of this title; (2) train to the standards of the Secretary for the examination, inspection, and investiga- tion of food manufacturing, processing, pack- ing, holding, distribution, and importation, in- cluding as such examination, inspection, and investigation relate to retail food establish- ments; (3) build the food safety capacity of the lab- oratories of such eligible entity, including the detection of zoonotic diseases; (4) build the infrastructure and capacity of the food safety programs of such eligible enti- ty to meet the standards as outlined in the grant application; and (5) take appropriate action to protect the public health in response to— (A) a notification under section 398 of this title, including planning and otherwise pre- paring to take such action; or (B) a recall of food under this chapter. (b) Eligible entities; application (1) In general In this section, the term ‘‘eligible entity’’ means an entity— (A) that is— (i) a State; (ii) a locality; (iii) a territory; (iv) an Indian tribe (as defined in section 5304(e) of title 25); or (v) a nonprofit food safety training enti- ty that collaborates with 1 or more insti- tutions of higher education; and (B) that submits an application to the Sec- retary at such time, in such manner, and in- cluding such information as the Secretary may reasonably require. (2) Contents Each application submitted under paragraph (1) shall include— (A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a); (B) a description of the types of activities to be funded by the grant; (C) an itemization of how grant funds re- ceived under this section will be expended; (D) a description of how grant activities will be monitored; and (E) an agreement by the eligible entity to report information required by the Sec- retary to conduct evaluations under this sec- tion. (c) Limitations The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided di- rectly or through donations from public or pri- vate entities and may be in cash or in-kind, fair- ly evaluated, including plant, equipment, or services. (d) Additional authority The Secretary may— (1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and (2) award a grant under this section in a fis- cal year for which the requirement of sub- section (c) has not been met only if such re- quirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating cir- cumstances that the Secretary may determine appropriate.