Department of Health and Human Services November 23, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments; Amended Notice
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.
Draft National Toxicology Program Technical Reports; Availability of Documents; Request for Comments; Notice of Meeting
The National Toxicology Program (NTP) announces the availability of two draft NTP Technical Reports (TRs) scheduled for peer review: Antimony trioxide and TRIM[supreg] VX. The peer review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/36051.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability
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.
Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Sunscreens: Safety and Effectiveness Data.'' This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future.
Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability
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.
Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``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 Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. The recommendations in this guidance apply to 586A requests and pending requests that seek a determination from FDA of whether a nonprescription sunscreen active ingredient, 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. We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
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.
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