7-3078

21.

Defendants admit the allegations of paragraph

46 of the complaint except allege that HEW's proposed
legislation permits the Secretary of HEW to make such
modification of the Guidelines as he deems necessary.

22.

Defendants lack knowledge or information sufficient to form a belief as to the truth or falsity of the allegations of paragraph 50 of the complaint.

ANSWER TO PLAINTIFF'S FOURTH CLAIM

23.

Defendants answer paragraph 55 by repeating defendants' responses to paragraphs 1 through 37 of the complaint.

24. Defendants admit the allegations contained

in paragraphs 60 through 66, 71, 72 and 77 of the complaint.
25. Defendants deny each and every allegation
contained in paragraphs 67 through 70, 78 through 84 of
the complaint.

26. Defendants neither admit nor deny the allegations of paragraphs 56 through 59 of the complaint because those paragraphs contain only allegations of law rather than allegations of fact, to which no responsive pleading is required. Defendants respectfully refer the Court to the text of the statutes, regulations and guidelines cited by plaintiff, and cases decided thereunder for full statements of the applicable law.

27. Defendants admit the allegations of paragraph 73 of the complaint and allege that notice was published in the Federal Register on January 14, 1976 (41 F.R. 2105)

stating that copies of the proposed guidelines were available from NIH on request.

-4

GG: bmj

7-3078

28.

Defendants deny the allegations of paragraphs

74, 75 and 76 of the complaint except admit that the Guide-
lines were published at page 27902 of 41 Federal Register on
July 7, 1976 to which the Court is respectfully referred for
a complete and accurate statement of the contents thereof.
29. Defendants deny the allegations of paragraph
82 of the complaint except admit that defendants have
implemented and continue to apply the Recombinant DNA
Research Guidelines as though they have full force and
effect.

ANSWER TO PLAINTIFF'S FIFTH CLAIM

30. Defendants answer paragraph 85 by repeating defendants' responses to paragraphs 1 through 40 and 55 through 84 of the complaint.

31. Defendants deny each and every allegation in

paragraphs 86 and 87 of the complaint.

ANSWER TO PLAINTIFF'S SIXTH CLAIM

32. Defendants answer paragraph 88 by repeating defendants' responses to paragraphs 1 through 40 and 55 through 87 of the complaint.

33. Defendants admit the allegations contained in

paragraphs 89 and 90 of the complaint.

34. Defendants deny each and every allegation contained in paragraphs 92 through 99 of the complaint. 35. Defendants deny each and every allegation contained in paragraph 91 of the complaint; and allege that pursuant to HEW Reorganization Plan No. 3 all functions of the Surgeon General were transferred to the Secretary of HEW, that certain of the aforementioned functions were delegated to the Assistant Secretary for Health, and that certain functions were in turn redelegated to the Director,

NIH.

-5

7-3078

ANSWER TO PLAINTIFF'S SEVENTH CLAIM

36. Defendants answer paragraph 100 by repeating
defendants' responses to paragraphs 1 through 40 and 55
through 99 of the complaint.

37. Defendants admit the allegations of paragraph

102 of the complaint.

38.

Defendants deny each and every allegation
contained in paragraphs 104 and 105 of the complaint.

39. Defendants deny each and every allegation of
paragraph 103 of the complaint and allege that as of June
13, 1977 the Recombinant DNA Molecule Committee had 14
members.

40.

Defendants neither admit nor deny the allega-
tions of paragraph 101 of the complaint because that
paragraph contains only allegations of law rather than
allegations of fact, to which no responsive pleading is
required. Defendants respectfully refer the Court to the
text of the statutes, regulations and guidelines cited by
plaintiff, and cases decided thereunder for full statements
of the applicable law.

AS A FIRST AFFIRMATIVE DEFENSE

41. The complaint fails to state a claim upon

which relief can be granted.

AS A SECOND AFFIRMATIVE DEFENSE

42. Plaintiff lacks standing to assert the claims
for relief set forth in the complaint under the Administra-
tive Procedure Act, 5 U.S.C. §551 et seq., the Public Health
Service Act, 42 U.S.C. § 201 et seq., and the Federal
Advisory Committee Act, 5 U.S.C. App. I, and the regulations
promulgated pursuant to the cited statutes.

-6-

GG:bmj 7-3078

AS A THIRD AFFIRMATIVE DEFENSE

43. Plaintiff's assertion of claims purportedly arising out of past funding by defendants of research projects in which recombinant DNA techniques are used is barred by laches.

AS A FOURTH AFFIRMATIVE DEFENSE

44.

Plaintiff has failed to join a number of

indespensable parties to the action, to wit, each recipient
of NIH grants that conducts research using the recombinant
DNA technique and each person and each entity with con-
tracts with defendants concerning the renovation or construc-
tion of facilities in which recombinant DNA research is
presently in progress or is proposed.

WHEREFORE defendants respectfully request judgment

dismissing the complaint, the award to defendants of their costs and disbursements, and such other relief as this Court deems proper.