The new RAC: Restructuring of the National Institutes of Health Recombinant DNA Advisory Committee

Food and Drug Law Journal

Volumn 54, Issue 1, 1999, Pages 49-53

  Beach, Judith E ^a  

^a IQVIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT DNA; RECOMBINANT RNA;

ETHICS; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; GENE TRANSFER; HEALTH CARE ORGANIZATION; LEGAL ASPECT; POLICY; PRACTICE GUIDELINE; PUBLIC HEALTH; RECOMBINANT DNA TECHNOLOGY; REVIEW;

CLINICAL PROTOCOLS; DNA, RECOMBINANT; GENE THERAPY; GENE TRANSFER TECHNIQUES; GUIDELINES; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); ORGANIZATIONAL INNOVATION; PUBLIC POLICY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032907379     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (36)

1. Nat'l Inst. of Health, Office of Recombinant DNA Activities (ORDA), Recombinant DNA Advisory Committee Charter (visited Feb. 12, 1999) 〈www.nih/gov/od/orda/charter.htm〉.
2. 62 Fed. Reg. 4782 (Jan. 31, 1997).
3. 62 Fed. Reg. 59,032 (Oct. 31, 1997).
4. Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, § 505, 52 Stat. 1040, 1052 (1938) (codified as amended at 21 U.S.C. § 355 (1994)); 21 C.F.R. pt. 312 (1998).
5. 62 Fed. Reg. at 4783.
6. See infra note 9, app. L.
7. Id.
8. Letter from Debra Knorr, Acting Dir., ORDA, to Chairs, Institutional Biosafety Comms.; Contact Persons, Institutional Biosafety Comms.; Principal Investigators, Human Gene Transfer Protocols; Sponsors, Human Gene Transfer Protocols (May 11, 1998) (regarding procedures for submission of human gene transfer protocols) 〈www.nih.gov/od/orda/pi-ibc.htm〉.
9. U.S. DEP'T OF HEALTH & HUMAN SERVS., PUB. HEALTH SERV., NAT'L INST. OF HEALTH, NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (May 1998) [hereinafter NIH GUIDELINES].
10. U.S. DEP'T OF HEALTH & HUMAN SERVS., PUB. HEALTH SERV., NAT'L INST. OF HEALTH, NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (May 1998) [hereinafter NIH GUIDELINES].
11. Id. § II (safety considerations).
12. Id. §§ I-D-1, I-D-2 (compliance with NIH Guidelines).
13. Id. §§ IV-D-2-IV-D-5-b.
14. Id. § I-C & app. M. Reports submitted to NIH/ORDA should be sent to ORDA, National Institutes of Health/MSC 7010, 6000 Executive Blvd., Suite 302, Bethesda, MD 20892-7010, ph. 301-496-9838. Id. app. M-I. See infra note 14.
15. NIH GUIDELINES, supra note 9, app. M (stating the Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Subjects).
16. 59 Fed. Reg. 34,496 (July 5, 1994).
17. 63 Fed. Reg. 26,018 (May 11, 1998).
18. Any future modifications in RAC oversight of human gene transfer research may be monitored through the NIH/ORDA website. Nat'l Inst. of Health, Office of Recombinant DNA Activities (visited Feb. 12, 1999) 〈www.nih.gov/od/orda〉. In addition, the following documents may be obtained from the website: the NIH Guidelines with app. M; the Human Gene Therapy Protocol List; Principal Investigator List; Data Management Reports; Minutes of RAC meetings; and ORDA News.
19. See NIH GUIDLEINES, supra note 9, app. M-I.
20. Id. app. M-II-M-V.
21. Id. app. M-III.
22. Nat'l Inst. of Health, RAC: Minutes of Meeting, Dec. 15-16, 1997 (visited Feb. 12, 1999) 〈www.nih.gov/ od/orda/12151697.htm〉 (Agenda Item XII, Comm. Motion 9).
23. Id.
24. Id.
25. 62 Fed. Reg. at 26,018.
26. Id. The documents submitted electronically included: a human gene transfer protocol; responses to app. M-II-M-V; Points to Consider information; and the ORDA registration document. Id.
27. Id.
28. This information is derived from documentation submitted to NIH/ORD A in compliance with 1) app. M-I (listing submission requirements for human gene transfer experiments) and 2) app. M-VII (listing the reporting requirements for human gene transfer protocols).
29. NIH GUIDLELINES, supra note 9, app. M.
30. Id.
31. Id.
32. See id. app. M-VII-B (describing Annual Data Reporting and [the] Gene Therapy Database).
33. See id. app. M-VII-A (investigational new drug application reporting).
34. Gene Therapy Protocol Information Submitted to FDA Will Be Provided to NIH to Monitor Studies, F-D-C REP. ("The Blue Sheet"), Mar. 12, 1997, at 2-4 (statements by Andrea Miller, CBER Product. Reviewer).
35. Id.
36. Gene Therapy: RAC Public Discussion of Gene Therapy Protocols Prior to FDA Approval Will Be Guaranteed by NIH, F-D-C REP. ("The Blue Sheet"), Sept. 30, 1998.