As discussed above, in the November 23, 2015, Federal Register, FDA
announced the availability of a draft guidance for industry titled
"Sunscreen Innovation Act: Withdrawal of a 586A Request or
Pending Request." This draft guidance provides recommendations
for the process for withdrawing a 586A request submitted under the
FD&C Act, as amended by the SIA, and withdrawing a pending
request, as defined by the SIA. This guidance applies to requests
that seek a determination from FDA of whether a nonprescription
sunscreen active ingredient, or a combination of nonprescription
sunscreen active ingredients, is GRASE for use under specified
conditions and should be included in the OTC sunscreen drug
monograph. Comments are due January 22,
2016.
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