School of Medicine 550 FIRST AVENUE, NEW YORK, N.Y. 10016 AREA 212 679-3200 CABLE ADDRESS: NYUMEDIC Department of Pediatrics December 8,1978 William J. Gartland, Jr., Ph.D. Director Office of Recombinant DNA Activities National Institute of General Medical Sciences I am writing to you on behalf of the Society for Pediatric Research (SPR) concerning the Proposed Revised NIH Guidelines for Recombinant DNA research. Unfortunately, the document reached us too late for comments. However we would like to register an offical opinion. After careful reading of the regulations the SPR feels that these guidelines are lucid, concise, and excellently formed. We heartily endorse them. Would you kindly send me a copy of the final guidelines and let me know when they will (or did) appear in the Federal Register. [This appendix contains the summons and answer of the still-pending case of Friends of the Earth v. Califano et al., alleging the failure of the defendants to comply with the National Environmental Policy Act in issuing the NIH Guidelines in June 1976.] [Appendix B-1] an, answer to the complaint which is herewith served upon you, within 60 days after service of this summons upon you, exclusive of the day of service. If you fail to do so, judgment by default will be taken against you for the relief demanded in the complaint. NOTE::S-JMy Aummans bi Essucit pursuant to Rule 4 of the Federal Rules of Civil Procedure, Plaintiffs, as and for their complaint, by their attorney named below, allege as follows: This action is brought against the above-named defendants for their failure to comply with the requirements of the National Environmental Policy Act of 1969 (NEPA), P.L. 91-190, 83 Stat. 852, 42 U.S.C. 84321 et seq., as amended by P.L. 94-83, 89 Stat. 424; the requirements of the Administrative Procedure Act (APA), 5 U.S.C. §551 et seq. (original version at P.L. 79-404, 60 Stat. 237); and numerous other laws and regulations (a) with respect to the funding of recombinant DNA research and its profound environmental impacts and consequences, (b) with respect to the Recombinant DNA Rescarch Guidelines promulgated by the defendants to regulate the recombinant DNA research program, and (c) with respect to the proposals for legislation regulating recombinant DNA activities. Plaintiff seeks, inter alia, a declaration from the Court: A. That the actions of the defendants in connection with the recombinant DNA research program, including the actions and determinations (1) to conduct recombinant DNA research; 1. |