New regs for Monday: Fighting drug shortages and regulating tramadol

Regulations on drugs, endangered species, energy conservation and school lunches are on the docket for Monday.

Here’s what’s scheduled to come out after the weekend:

Drugs:

The Food and Drug Administration is proposing a regulation designed to reduce the number of drug shortages

The draft regulation which was first unveiled on Thursday, will require drug companies to let the federal government know if they plan to stop making a drug or anticipate an interruption that could lead to a drug shortage. 

Additionally, the Drug Enforcement Administration (DEA) wants to put new restrictions on the opiate tramadol

By classifying the drug as a Schedule 4 substance, it would join the ranks of Xanax, Ambien and other substances that the agency considers to have a low risk of abuse or dependence.

The DEA says that the action is based on a recommendation from the Department of Health and Human Services and its own evaluations. 

School lunches:

The Obama administration wants to make changes to the federal program that provides free and reduced price meals to children from low-income families to make it easier for some schools to offer free food to kids.

The proposal would modify the National School Lunch Program and the School Breakfast Program to let local schools in high poverty areas offer free meals to all students without collecting individual applications.

“It is intended to improve access to free school meals in eligible high poverty [local educational agencies] and schools, and eliminate the administrative burden associated with collecting household applications,” the U.S. Department of Agriculture’s food agency said in the rule.

The program was started in the 2012-2013 school year by a memorandum, but will now be codified by formal regulation.

Environment:

The Environmental Protection Agency is changing its air emissions rules for plants that produce polyurethane foam, which is used to line the walls of refrigerators and freezers as well as in upholstery and other places.

The new rules would prohibit certain blowers used at some foam plants. 

Energy:

The Department of Energy is proposing new procedures for testing the energy efficiency of water heaters.

By law, the department is required to review the procedures at least once every seven years. 

Animals:

The Fish and Wildlife Service wants to take a type of bird called the Inyo California towhee off of the endangered species list because its population has bounced back. 

The agency is also proposing a control order for two types of nonnative birds in Hawaii, trying to remove outdated regulations for migratory birds and reopening the public comment period on a proposal to declare the Gunnison sage grouse, a type of bird, endangered.

Wildlife regulators for the ocean are also removing a population of sea lions from the endangered species list. 

Health data:

The Department of Health and Human Services is changing the rules for how electronic health records incorporate dental data.

The new regulation is designed to allow for more flexibility to represent the data, the department said. 

Worker safety:

The Occupational Safety and Health Administration is withdrawing a proposal on sign standards, since it already issued a rule on the issue in June.

Legal:

The Legal Services Corporation, which provides legal aid to low-income Americans, is proposing to update its rules for criminal proceedings.

Fishing:

The National Marine Fisheries Service is halting fishing for bigeye tuna in the eastern Pacific to prevent overfishing. 

Flooding:

The Department of Homeland Security is listing communities where flood insurance sales will be suspended because they have not met federal requirements. 

Tags Federal Register Pharmaceutical drug

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