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Reg roundup: FDA updates research rules, Education renews grant fund
The Food and Drug Administration (FDA) has brought regulations aimed at protecting children in clinical trials in line with the Children’s Health Act of 2000.
The agency has finalized an interim rule from more than a decade ago that strengthens the safety standards for children involved in research of FDA-regulated products.
The 56-page rule includes corrections made in response to public comments. Pharmaceutical companies, healthcare professionals, national membership organizations and other state and federal officials weighed in with suggested changes to the interim rule. In response, FDA tweaked the definitions of terms such as “guardian” to make the rule’s intent more clear.
DEPARTMENT OF EDUCATION
The Department of Education has sent a rule to the White House extending the Investing in Innovation Fund grants that were established in 2010.
According to federal records, the department has already gone through three years of the program and awarded a total of 72 grants. The rule has been deemed “economically significant,” which means it has an impact of $100 million or more on the economy.
DEPARTMENT OF COMMERCE
The National Oceanic and Atmospheric Administration has set the hunting quota for bowhead whales used as food in native populations. The bowhead catch limits were based on a joint request by the United States and the Russian Federation and apply to Alaska Eskimos and the Chukotka Natives in the Russian Far East. For 2013, the catch limit is 75 whales, according to a Federal Register document.
