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GUIDANCE DOCUMENT

Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry October 2016

Final
Docket Number:
FDA-2015-D-4012
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Contains Nonbinding Recommendations1 Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request Guidance for Industry1This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance addresses the process for (1) withdrawal of a request submitted under section 586A (586A request)2 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Public Law 113-195 (also referred to as the Sunscreen Innovation Act or SIA)3 and (2) withdrawal of a pending request, as defined under section 586(6) of the FD&C Act.4 The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of whether a nonprescription sunscreen active ingredient5 or a combination of nonprescription sunscreen active ingredients is generally recognized as safe and effective (GRASE) for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph


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