Department of Health and Human Services November 23, 2015 – Federal Register Recent Federal Regulation Documents

This notice amends Federal Register notice 80 FR 61831, published October 14, 2015, announcing the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) meeting and requesting comments. The deadline for written public comment submission has been changed to January 8, 2016. Persons submitting comments for the BSC meeting are encouraged to send them by November 30, 2015, to facilitate review by the BSC and NTP staff prior to the meeting. NTP is extending the written public comment period beyond the BSC meeting to provide additional opportunity for the public to comment on two draft concepts, Mountaintop Removal Mining: Impacts on Health in the Surrounding Community and Systematic Review on Fluoride and Developmental Toxicity. All other information in the original notice has not changed. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/165.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsContent and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is ``not'' required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance.

The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.