Department of Health and Human Services April 6, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 23, 2018.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This meeting was announced in the Federal Register of March 16, 2016. The amendment is being made to reflect a change in the Date and Time portion of the document. The Date of the meeting is changed to May 25, 2016. There are no other changes.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a worldwide exclusive license to practice the inventions embodied in: HHS Ref. No. E-135-2015/0, U.S. Provisional Patent Application No. 62/ 155,085, filed April 30, 2015, entitled ``Boron Mimics Of Amino Acids And Uses Thereof,'' to Beijing Lanyears Communication Technology, Ltd., a company formed under the laws of the People's Republic of China and having its principle place of business in Beijing, China. The contemplated exclusive license may be limited to boron neutron capture therapy for brain tumors.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Inorganic Arsenic in Rice Cereals for Infants: Action Level,'' a supporting document entitled ``Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants'' (the supporting document), and a risk assessment report entitled ``Arsenic in Rice and Rice Products Risk Assessment: Report'' (the risk assessment report). The draft guidance, when finalized, will identify for industry an action level for inorganic arsenic in rice cereals for infants that will help protect public health and is achievable with the use of current good manufacturing practice. It also will describe our intended sampling and enforcement approach. The risk assessment report includes a quantitative component (a mathematical model) that estimates occurrence of lung cancer and bladder cancer from long-term exposure to inorganic arsenic in rice and rice products, and a qualitative component that describes our review and evaluation of the scientific literature of certain non-cancer health risks, in certain susceptible life stages, from inorganic arsenic in rice and rice products.

The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).