SHERLEY et al v. SEBELIUS et al

Filing 66

ADMINISTRATIVE RECORD by FRANCIS S. COLLINS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, NATIONAL INSTITUTES OF HEALTH, KATHLEEN SEBELIUS. (Attachments: # 1 Part 1 of 41, # 2 Part 2 of 41, # 3 Part 3 of 41, # 4 Part 4 of 41, # 5 Part 5 of 41, # 6 Part 6 of 41, # 7 Part 7 of 41, # 8 Part 8 of 41, # 9 Part 9 of 41, # 10 Part 10 of 41, # 11 Part 11 of 41, # 12 Part 12 of 41, # 13 Part 13 of 41, # 14 Part 14 of 41, # 15 Part 15 of 41, # 16 Part 16 of 41, # 17 Part 17 of 41, # 18 Part 18 of 41, # 19 Part 19 of 41, # 20 Part 20 of 41, # 21 Part 21 of 41, # 22 Part 22 of 41, # 23 Part 23 of 41, # 24 Part 24 of 41, # 25 Part 25 of 41, # 26 Part 26 of 41, # 27 Part 27 of 41, # 28 Part 28 of 41, # 29 Part 29 of 41, # 30 Part 30 of 41, # 31 Part 31 of 41, # 32 Part 32 of 41, # 33 Part 33 of 41, # 34 Part 34 of 41, # 35 Part 35 of 41, # 36 Part 36 of 41, # 37 Part 37 of 41, # 38 Part 38 of 41, # 39 Part 39 of 41, # 40 Part 40 of 41, # 41 Part 41 of 41)(Moore, Tamra)

SHERLEY et al v. SEBELIUS et al

Doc. 66

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ) ) ) ) ) ) ) ) ) ) )

DR. JAMES L. SHERLEY, et al. Plaintiffs, v. KATHLEEN SEBELIUS, et al. Defendants.

Civil Action No. 1:09-cv-01575 (RCL)

ADMINISTRATIVE RECORD

-1-

Dockets.Justia.com

Index Item 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. NIH Guidelines for Human Stem Cell Research, 74 Fed. Reg. 32,170 (July 7, 2009) Draft NIH Guidelines for Human Stem Cell Research, 74 Fed. Reg. 18,578 (Apr. 23, 2009) Executive Order No. 13,505, 74 Fed. Reg. 10,667 (Mar. 9, 2009) Executive Order No. 13,435, 72 Fed. Reg. 34,591 (June 22, 2007) Address to the Nation on Stem Cell Research, 37 Weekly Comp Pres. Doc. 1149 (Aug. 9, 2001) Guidelines for Research Using Human Pluripotent Stem Cells, 66 Fed. Reg. 57,107 (Nov. 14, 2001) Guidelines for Research Using Human Pluripotent Stem Cells, Correction, 65 Fed. Reg. 69,951 (Nov. 21, 2000) Guidelines for Research Using Human Pluripotent Stem Cells, 65 Fed. Reg. 51,976 (Aug. 25, 2000) National Academies' 2008 Guidelines for Human Embryonic Stem Cell Research (2008) Australian Government, National Health and Medical Research Council, Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (June 2007) United Kingdom Stem Cell Bank, Code of Practice for the use of Human Stem Cell Lines (Aug. 2006) Int'l Soc. for Stem Cell Research ("ISSCR"), Guidelines for the Conduct of Human Embryonic Stem Cell Research (Dec. 21, 2006) California Institute of Regenerative Medicine, Regulations, 17 Cal. Code of Regs § 100010 et seq. Memorandum to Ruth Kingston, Acting Director, NIH, from Alex Azar, General Counsel, HHS (Jan. 11, 2002) Memorandum to Harold Varmus, Director, NIH from Harriet S. Rabb, Page 1 7 10 14 19 22 23 24 31 95

11. 12. 13. 14. 15.

185 256 271 303 311

General Counsel, HHS (Jan. 15, 1999) 16. 17. 18. 19. 20. ISSCR Sample research consent forms Consent forms for hESC lines eligible for funding under Bush Administration policy Robert Streiffer, Informed Consent and Federal Funding for Stem Cell Research, Hastings Center Report (May/June 2008) Guidance on Engagement of Institutions in Human Subjects Research, Office of Human Research Protections ("OHRP"), HHS (Oct. 16, 2008) Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles, OHRP (Mar. 19, 2002) Guidance on Research Involving Coded Private Information or Biological Specimens, OHRP (Oct. 16, 2008) Protection of Human Subjects, 45 C.F.R. part 46 Best Practices for the Licensing of Genomic Inventions, 70 Fed. Reg. 18,413 (Apr. 11, 2005) Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, 64 Fed. Reg. 72,090 (Dec. 23, 1999) Ethical Issues in Human Stem Cell Research: Report and Recommendations of the National Bioethics Advisory Commission (Sept. 1999) Understanding Stem Cells: An Overview of the Science and the Issues from the National Academies (2008) National Institutes of Health, Regenerative Medicine 2006 National Institutes of Health, Stem Cell Information: FAQs National Institutes of Health, Stem Cell Basics National Institutes of Health, Highlights of Stem Cell Research Public comments on NIH proposed stem cell guidelines 316 346 392 400 411

21. 22. 23. 24.

416 422 436 439

25. 26. 27. 28. 29. 30. 31.

446 585 611 703 707 723 739