[Code of Federal Regulations] [Title 45, Volume 1] [Revised as of October 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 45CFR46.201] [Page 126] TITLE 45--PUBLIC WELFARE SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents Subpart B_Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Sec. 46.201 To what do these regulations apply? Source: 66 FR 56778, Nov. 13, 2001, unless otherwise noted. (a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any person and all research conducted in any facility by DHHS employees. (b) The exemptions at Sec. 46.101(b)(1) through (6) are applicable to this subpart. (c) The provisions of Sec. 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in Sec. 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments. (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.