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5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b).
56 FR 28012, 28022, June 18, 1991, unless otherwise noted.
71 FR 6168, Feb. 6, 2006, unless otherwise noted.
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(a) Except as provided in paragraph (b) of this section, this subpart applies to all observational research involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the Environmental Protection Agency (EPA). This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees.
(b) The exemptions at § 26.104(d) are applicable to this subpart.
(c) The provisions of § 26.101(c) through (m) are applicable to this subpart.
(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.
[71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019]