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ALA. TISSUE CTR. OF UNIV. OF ALA. HEALTH SERVICE FOUNDATION v. SULLIVAN

No. 91-2738.

975 F.2d 373 (1992)

ALABAMA TISSUE CENTER OF THE UNIVERSITY OF ALABAMA HEALTH SERVICE FOUNDATION, P.C., an Alabama Corporation, American Red Cross Tissue Services, a Division of the American Red Cross, a California Corporation, Lifenet, a Virginia Corporation, et al., Petitioners, v. Louis W. SULLIVAN, Secretary of the United States Department of Health and Human Services and David Kessler, Commissioner of the United States Food and Drug Administration, Respondents.

United States Court of Appeals, Seventh Circuit.

Decided September 16, 1992.

Attorney(s) appearing for the Case

George M. Burditt (argued), Alan I. Becker, Deborah B. Norton, Burditt & Radzius, Chicago, Ill., for petitioners.

Don O. Burley, Dept. of Justice, Consumer Litigation, Washington, D.C., Louis W. Sullivan, Washington, D.C., Margaret Porter, Dept. of Health & Human Services, Chief Counsel, Food & Drug Div., Rockville, Md., for respondents.

Before COFFEY and MANION, Circuit Judges, and SHABAZ, District Judge.

SHABAZ, District Judge.

Six not-for-profit heart valve allograft processors filed a petition for review with this Court contesting the "Notice of Applicability of a Final Rule" ("NAFR") published by the Food and Drug Administration ("FDA") on June 26, 1991 at 56 Federal Register 29,177. The NAFR states that replacement heart valve allografts are subject to the final rule issued by the FDA on May 13, 1987, which requires the filing of a pre-market approval application...

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