National Park Hospitality Assn. v. Department of Interior, 538 U.S. 803, 8 (2003)

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810 NATIONAL PARK HOSPITALITY ASSN. v.

DEPARTMENT OF INTERIOR Opinion of the Court

Moreover, § 51.3 does not affect a concessioner's primary conduct. Toilet Goods Assn., Inc. v. Gardner, 387 U. S. 158, 164 (1967); Ohio Forestry Assn., supra, at 733-734. Unlike the regulation at issue in Abbott Laboratories, which required drug manufacturers to change the labels, advertisements, and promotional materials they used in marketing prescription drugs on pain of criminal and civil penalties, see 387 U. S., at 152-153, the regulation here leaves a concessioner free to conduct its business as it sees fit. See also Gardner v. Toilet Goods Assn., Inc., 387 U. S. 167, 171 (1967) (regulations governing conditions for use of color additives in foods, drugs, and cosmetics were "self-executing" and had "an immediate and substantial impact upon the respondents").

We have previously found that challenges to regulations similar to § 51.3 were not ripe for lack of a showing of hardship. In Toilet Goods Assn., for example, the Food and Drug Administration (FDA) issued a regulation requiring producers of color additives to provide FDA employees with access to all manufacturing facilities, processes, and formulae. 387 U. S., at 161-162. We concluded the case was not ripe for judicial review because the impact of the regulation could not "be said to be felt immediately by those subject to it in conducting their day-to-day affairs" and "no irremediabl[y] adverse consequences flow[ed] from requiring a later challenge." Id., at 164. Indeed, the FDA regulation was more onerous than § 51.3 because failure to comply with it resulted in the suspension of the producer's certification and, consequently, could affect production. See id., at 165, and n. 2. Here, by contrast, concessioners suffer no practical harm as a result of § 51.3. All the regulation does is announce the position NPS will take with respect to disputes arising out of concession contracts. While it informs the public of NPS' view that concessioners are not entitled to take advantage of the provisions of the CDA, nothing in the

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