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21 U.S.C. § 379 — Confidential information

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379 — Confidential information

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379

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Stable record: federal_law:legal_authorities:record_usc_8a5078cc469377e725d66c01
Source file: Laws/federal/codes/united-states-code/title-21/section-379-confidential-information--7829606b02.md
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Passage SHA-256: 1e7ef9936a1ff2ea34eec913f8d871de8a69d7a93ee3f78d61c4d75f37417047

Source location: Title 21, Chapter 9, § 379; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Contractors** The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe. **(b) Ability to receive and protect confidential information obtained from foreign governments** (1) **In general** — The Secretary shall not be required to disclose under [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) (commonly referred to as the “Freedom of Information Act”), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if— (A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals; (B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and (C) the information is covered by, and subject to, a written agreement between the Secretary and the foreign government. (2) **Time limitations** — The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) and [section 247d–7e(e)(1) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–7e/e/1&num=0&edition=prelim), as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months. (3) **Disclosures not affected** — Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States. (4) **Relation to other law** — For purposes of [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim), this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552. **(c) Authority to enter into memoranda of understanding for purposes of information exchange** The Secretary may enter into written agreements to provide information referenced in [section 331(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/j&num=0&edition=prelim) to foreign governments subject to the following criteria: (1) **Certification** — The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs. (2) **Written agreement** — The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to [section 247d of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d&num=0&edition=prelim) that is relevant to the information. (3) **Information exchange** — The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in [section 331(j) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/j&num=0&edition=prelim) in only the following circumstances: (A) Information concerning the inspection of a facility may be provided to a foreign government if— (i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and (ii) the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes. (B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals. (4) **Effect of subsection** — Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 552 — Public information; agency rules, opinions, orders, records, and proceedings

**(a)** Each agency shall make available to the public information as follows: (1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public— (A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions; (B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available; (C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations; (D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and (E) each amendment, revision, or repeal of the foregoing. Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register. (2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format— (A) final opinions, including concurring and dissen

Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 247d — Public health emergencies

**(a) Emergencies** If the Secretary determines, after consultation with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination. **(b) Public Health Emergency Fund** (1) **In general** — There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Se

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379dd — Establishment and functions of the Foundation

**(a) In general** A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this part as the “Foundation”) shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e).11 So in original. Probably should be “subsection (g).” The Foundation shall not be an agency or instrumentality of the United States Government. **(b) Purpose of Foundation** The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. **(c) Duties of the Foundation** The Foundation shall— (1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety; (2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1); (3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts; (4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379dd

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 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 application or submission (including a petition, notification, and any other similar form of request) made under this chapter for the approval or classification of an article or made under section 351(a) of the Public Health Service Act ([42 U.S.C. 262(a)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a&num=0&edition=prelim)) with respect to a biological product. Any such contract shall be subject to the requirements of [section 379 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379&num=0&edition=prelim) relating to the confidentiality of information. (2) **Increased efficiency and expertise through contracts** — The Secretary may use the authority granted in paragraph (1) whenever the Secretary determines that use of a contract described in paragraph (1) will improve the timeliness of the review of an application or submission described in paragraph (1), unless using such authority would reduce the quality, or unduly increase the cost, of such review. The Secretary may use such authority whenever the Secretary determines that use of such a contract 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 necessary to review or evaluate new therapies and technol

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 397

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379 — Confidential information

Page 507 TITLE 21—FOOD AND DRUGS § 379 343(a)(2) of this title because of its advertising, or (B) with respect to a food’s advertising which the Secretary determines causes the food to be so misbranded, the Secretary shall, in accordance with para- graph (2), notify in writing the Federal Trade Commission of the action the Secretary pro- poses to take respecting such food or adver- tising. (2) The notice required by paragraph (1) shall— (A) contain (i) a description of the action the Secretary proposes to take and of the adver- tising which the Secretary has determined causes a food to be misbranded, (ii) a state- ment of the reasons for the Secretary’s deter- mination that such advertising has caused such food to be misbranded, and (B) be accompanied by the records, docu- ments, and other written materials which the Secretary determines supports his determina- tion that such food is misbranded because of such advertising. (b) Action by Federal Trade Commission pre- cluding action by Secretary; exception (1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action pro- posed to be taken under subchapter III with re- spect to a food or food advertising and the Com- mission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that— (A) it has initiated under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] an inves- tigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act, (B) it has commenced (or intends to com- mence) a civil action under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has com- menced (or intends to commence) a civil ac- tion un

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 379

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