Page:United States Statutes at Large Volume 90 Part 1.djvu/633

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 583

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. "PRESUMPTION

"SEC. 709. In any action to enforce the requirements of this Act 21 USC 379a. respecting a device the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.". COLOR ADDITIVES

SEC. 9. (a) Section 706 is amended (1) by inserting "or device" after 21 USC 376. "drug" each time it occurs, (2) by inserting "or devices" after "drugs" each time it occurs, and (S) by adding at the end of subsection (a) the following new sentences: "A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color additives in or on devices which are subject to this section.". (b)(1) Section 501(a) is amended (A) by inserting "(3) if its" in 21 USC 351. lieu of "(3) if it is a drug and its"; (2) by inserting "(4) if (A) it bears or contains" in lieu of "(4) if (A) it is a drug which bears or contains"; and (3) by inserting "or devices" after "drugs" in subclause (B) of clause (4). (2) Section 502(m) is amended by striking out "in or on drugs". 21 USC 352. ASSISTANCE FOR SMALL MANUFACTURERS OF DEVICES

SEC. 10. The Secretary of Health, Education, and Welfare shall Office, establish within the Department of Health, Education, and Welfare ^J^^^irJlTo' an identifiable office to provide technical and other nonfinancial assist- '*2 USC 3512. ance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act, as amended by this Act. Approved May 28, 1976.

LEGISLATIVE HISTORY: HOUSE REPORTS: No. 94-853 accompanying H.R. 11124 (Coram, on Interstate and Foreign Commerce) and No. 94-1090 (Coram, of Conference). SENATE REPORT No. 94-33 (Coram, on Labor and Public Welfare). CONGRESSIONAL RECORD: Vol. 121 (1975): Apr. 17, considered and passed Senate. Vol. 122 (1976): Mar. 9, considered and passed House, amended, in lieu of H.R. 11124. May 13, House and Senate agreed to conference report. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS: Vol. 12, No. 22 (1976): May 28, Presidential statement.

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