New regs for Thursday: Tropical diseases and student loans

New regs for Thursday: Tropical diseases and student loans
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Thursday’s edition of the Federal Register contains additions to the list of designated tropical diseases from the Food and Drug Administration and plans from the Department of Education to create a committee to draft rules for student loans.

Here’s what to look for:

Tropical diseases: The Food and Drug Administration (FDA) is adding Chagas' disease and neurocysticercosis to the list of designated tropical diseases.

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Under the Federal Food, Drug, and Cosmetic Act, the agency gives priority reviews to products that treat tropical diseases. Because diseases most often disproportionately afflict poor and marginalized populations that lack the resources to develop, encourage development of, or purchase disease preventions or treatments, the agency said it offers this priority incentive to encourage the development of new drugs.

Chagas' disease, also known as American trypanosomiasis, is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi (T. cruzi), found mainly in endemic areas of 21 Latin American countries, according to the World Health Organization.

The disease, which is curable if treated soon after infection, can cause organ or tissue damage. According to the FDA, Chagas' disease sufferers who contract the disease during childhood, die in early adulthood due to heart arrhythmias or other effects of organ damage.

Cysticercosis is contracted when a person ingests tapeworm eggs. The tapeworm then enters the larval stage and begins to infect the host’s tissues. The most severe form of the disease, called neurocysticercosis, occurs when larvae enter the central nervous system and establish cysts that can cause epilepsy.

The final order will take effect on Thursday.

Student loans: The Department of Education plans to establish a negotiated rulemaking committee to create rules for Federal Student Aid programs authorizes by the Higher Education Act.

The regulations developed by the committee will determine which institutional acts or omissions a borrower can use as defense in repaying a loan and what the consequences will be for borrowers, institutions and the secretary of education.

The agency will hold two public hearings, which will be scheduled in a subsequent notice, and the public can submit written comments until Sept. 16.