Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act

The information collection supports the filing of certain citizen petitions and agency guidance. The guidance describes how FDA will determine whether the provisions of section 505(q) addressing the treatment of citizen petitions and petitions for stay of agency action (collectively, petitions) apply to a particular petition and whether a petition would delay approval of a pending abbreviate new drug application or a 505(b)(2) application. The guidance also describes the provisions of section 505(q) requiring that a petition include a certification and that supplemental information or comments to a petition include a verification.

The latest form for Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act expires 2020-06-30 and can be found here.

Certification for citizen petitions 505(q)(H)

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