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Ce is being issued consistent with FDA s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency s current thinking on citizen petitions and petitions for stay of action that are subject to section 505(q) of the FD&C Act. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperw.

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