The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ``single-entity'' and ``co-packaged'' combination products.
What is it about a narrow, rectangular compartment that can so excite a middle-school or junior-high student? Is it that oh-so-fashionable industrial-metal-meets-bland- institutional look? Or could it be the simple thrill of having mastered a combination lock?
The FMCSA proposes to revise the definition of ``gross combination weight rating'' (or GCWR) to clarify that a GCWR is the greater of: the GCWR specified by the manufacturer of the power unit, if displayed on the Federal Motor Vehicle Safety Standard (FMVSS) certification label required by the National Highway Traffic Safety Administration (NHTSA), or the sum of the gross vehicle weight ratings (GVWRs) or gross vehicle weights (GVWs) of the power unit and towed unit(s), or any combination thereof, that produces the highest value.
The Federal Motor Carrier Safety Administration (FMCSA) amends the definition of ``gross combination weight rating'' (GCWR) in our regulations. The definition currently prescribes how the GCWR is calculated if the vehicle manufacturer does not include the information on the vehicle certification label required by the National Highway Traffic Safety Administration (NHTSA). The Agency has determined the definition should not include what is essentially guidance that is difficult for the motor carrier and enforcement communities to use. Therefore, FMCSA amends this definition to state that the GCWR is the value specified by the commercial motor vehicle manufacturer.
Little is known about firms disappearing not through failure, but rather by business combination. Is merger an intentional act allowing continued exploitation of strategic assets, or a final effort to salvage an underperforming firm? Exits via merger for young firms represent "creative combination", whereby the established firms obtain novel technology or other resources necessary for adaptation to the changed environment, rather than being forced out of the marketplace through "creative destruction." We analyze exit type and dates of incorporation and dissolution of more than 18 thousand young businesses in a Midwestern state from 1900 through 2000. We find that young firms exit earlier through merger than through explicit dissolution, and at a higher rate during economic growth. This ...
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of bottom mount combination refrigerator-freezers (bottom mount refrigerators) from the Republic of Korea (Korea). For information on the estimated subsidy rates, see the ``Suspension of Liquidation'' section of this notice.
-- First demonstration of 100% SVR with once-daily, interferon- and ribavirin-free regimen in treatment-naive genotype 1 HCV patients -- First report of a study designed to assess antiviral efficacy of a NS5A replication complex inhibitor and a NS5B nucleotide polymerase inhibitor as potential combination HCV therapy
FMCSA withdraws its August 27, 2012, direct final rule (DFR) amending the definition of ``gross combination weight rating'' (GCWR) in 49 CFR parts 383 and 390. The DFR would have taken effect on October 26, 2012. However, the Agency received several adverse comments in response to the DFR and will, therefore develop a notice of proposed rulemaking to request public comments on proposed changes to the GCWR definition.
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