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 under section 5 [15 U.S.C. 45] with respect to such advertising, (C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or (D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to the Attorney General respecting such advertising, the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary’s notice to the Federal Trade Commission. (2) If, before the expiration of the 60-day pe- riod beginning on the date the Secretary re- ceives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)— (A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this sub- section respecting the advertising described in the Secretary’s notice, (B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or (C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respect- ing such advertising, or, if the Commission does make such a certification to the Attor- ney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate crimi- nal proceedings to be brought against such ad- vertising, the Secretary may, after the expiration of such period, initiate the action described in the no- tice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Com- mission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising. (c) Secretary’s determination of imminent haz- ard to health as suspending applicability of provisions The requirements of subsections (a) and (b) do not apply with respect to action under sub- chapter III with respect to any food or food ad- vertising if the Secretary determines that such action is required to eliminate an imminent haz- ard to health. (d) Coordination of action by Secretary with Federal Trade Commission For the purpose of avoiding unnecessary dupli- cation, the Secretary shall coordinate any ac- tion taken under subchapter III because of ad- vertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect to such advertising. (June 25, 1938, ch. 675, § 707, as added Pub. L. 94–278, title V, § 502(b), Apr. 22, 1976, 90 Stat. 412.) Editorial Notes REFERENCES IN TEXT The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is classified generally to subchapter I (§ 41 et seq.) of chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see sec- tion 58 of Title 15 and Tables. § 379. Confidential information (a) Contractors The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Depart- ment if the Secretary determines such other person requires the information in connection with an activity which is undertaken under con- tract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or em- ployee 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 re- specting the information as the Secretary may by regulation prescribe. Page 508 TITLE 21—FOOD AND DRUGS § 379a (b) Ability to receive and protect confidential in- formation obtained from foreign govern- ments (1) In general The Secretary shall not be required to dis- close under section 552 of title 5 (commonly re- ferred to as the ‘‘Freedom of Information Act’’), or any other provision of law, any infor- mation relating to drugs obtained from a for- eign government agency, if— (A) the information concerns the inspec- tion 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 sub- ject to, a written agreement between the Secretary and the foreign government. (2) Time limitations The written agreement described in para- graph (1)(C) shall specify the time period for which paragraph (1) shall apply to the volun- tarily disclosed information. Paragraph (1) shall not apply with respect to such informa- tion after the date specified in such agree- ment, but all other applicable legal protec- tions, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such in- formation. If no date is specified in the writ- ten 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 offi- cial to withhold, or to authorize the with- holding of, information from Congress or in- formation 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, this subsection shall be considered a statute de- scribed in subsection (b)(3)(B) of such section 552. (c) Authority to enter into memoranda of under- standing for purposes of information ex- change The Secretary may enter into written agree- ments to provide information referenced in sec- tion 331(j) of this title 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 dis- closure. Responsibility for this certification shall not be delegated to any officer or em- ployee other than the Commissioner of Food and Drugs. (2) Written agreement The written agreement to provide informa- tion to the foreign government under this sub- section shall include a commitment by the foreign government to protect information ex- changed under this subsection from disclosure unless and until the sponsor gives written per- mission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is rel- evant to the information. (3) Information exchange The Secretary may provide to a foreign gov- ernment that has been certified under para- graph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title 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 para- graph (2) establishes, that the government has authority to otherwise obtain such in- formation; 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 subpara- graph (A) may be provided as part of an in- vestigation, or to alert the foreign govern- ment to the potential need for an investiga- tion, if the Secretary has reasonable grounds to believe that a drug has a reasonable prob- ability of causing serious adverse health consequences or death to humans or ani- mals. (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. (June 25, 1938, ch. 675, § 708, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, § 710, July 9, 2012, 126 Stat. 1070.) Editorial Notes AMENDMENTS 2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c). § 379a. Presumption of existence of jurisdiction In any action to enforce the requirements of this chapter respecting a device, tobacco prod- uct, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist. (June 25, 1938, ch. 675, § 709, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 583; amended Pub. L. 105–115, title IV, § 419, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 111–31, div. A, title I, § 103(k), June 22, 2009, 123 Stat. 1837.)