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Federal Register Highlights – 3/3/16

March 3, 2016

Unpublished, time-sensitive and proposed rules for March 3, 2016:

PROPOSED RULE: The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information. Submit either electronic or written comments on the proposed order by June 1, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. FDA–2016–N–0400.)

PROPOSED RULE: The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device. Submit either electronic or written comments on this proposed order by June 1, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. FDA–2016–M–0035.)

PROPOSED RULE: NMFS proposes to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico Fishery Management Council (Council). If implemented, this action would revise the recreational closed season for gag and the recreational minimum size limits for gag and black grouper in the Gulf of Mexico (Gulf) exclusive economic zone. The purpose of this proposed rule is to optimize recreational opportunities to harvest gag and to address inconsistencies in the recreational minimum size limits for gag and black grouper in the Gulf and South Atlantic. Written comments must be received on or before April 4, 2016. (To submit comments, visit www.regulations.gov, reference Docket No. NOAA–NMFS–2016–0010.)

PROPOSED RULE: NMFS proposes to modify recreational fishery management measures for Gulf of Maine cod and haddock, including daily bag limits, size limits, and seasonal possession restrictions. This action is necessary to increase recreational fishing opportunities and catch of cod and haddock in a manner consistent with anticipated catch limit increases. The intended effect of this action is to ensure the recreational fishery can achieve but not exceed its catch limits. Comments must be received by March 18, 2016. (To submit comments, visit www.regulations.gov, reference NOAA–NMFS–2016–0011.)

PROPOSED RULE: This proposed rule would revise the provisions governing the Postal Service’s discretionary Semipostal Stamp Program to simplify and expedite the process for selecting causes for semipostal stamps, and facilitate the issuance of five such stamps over a 10-year period. It would also remove certain restrictions on the commencement date for the Postal Service’s discretionary Semipostal Stamp Program, and clarify how many semipostal stamps issued under that program may be on sale at any one time. Comments must be received on or before April 4, 2016. (Mail or deliver written comments to the Manager, Stamp Products & Exhibitions, U.S. Postal Service®, 475 L’Enfant Plaza SW., Room 3306, Washington DC 20260.)

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