Department of Health and Human Services October 2, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2018 and outlines the payment procedures for such fees.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff.'' When finalized, this guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that apply to electronic products. When finalized, this document will supersede the ``Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs); Guidance for Industry and Food and Drug Administration Staff,'' issued February 18, 2015. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This draft guidance is not final nor is it in effect at this time.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or we) is proposing to extend the compliance dates by approximately 1.5 years for the final rules providing updated nutrition information on the label of food, including dietary supplements; defining a single-serving container; requiring dual-column labeling for certain containers; updating, modifying, and establishing certain reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. The final rules appeared in the Federal Register of May 27, 2016. We are taking this action because, after careful consideration, we have tentatively determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they are able to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.'' The purpose of the public workshop is to engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and to gain input regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-abbreviated new drug applications (ANDA) interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products.