Department of Health and Human Services May 28, 2014 – Federal Register Recent Federal Regulation Documents

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 the responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that appeared in the Federal Register of April 25, 2014. That proposed rule would deem products meeting the statutory definition of ``tobacco product,'' except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Option 1 of the proposed rule would extend the Agency's ``tobacco product'' authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of ``tobacco product'' in the FD&C Act. Option 2 of the proposed rule would extend the Agency's ``tobacco product'' authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of ``tobacco product'' in the FD&C Act. FDA also is proposing to prohibit the sale of ``covered tobacco products'' to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to address the public health concerns associated with the use of tobacco products. The document published with several technical errors, including some errors in reference numbers cited in section VII.B. of the document. This document corrects those errors. We are placing a corrected copy of the proposed rule in the docket.

The Food and Drug Administration (FDA) has determined the regulatory review period for MENHIBRIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYRBETRIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for ADCETRIS based on biologics license application (BLA) 125388 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product, ADCETRIS.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency (EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priorities List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA, as amended, also requires that the Priority List of Hazardous Substances be revised periodically. This announcement provides notice that a revised Priority List of 275 Hazardous Substances has been developed and is now available. CERCLA, as amended, also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list. Thus, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP). Address for Printed Copy: Requests for a printed copy of the 2013 Priority List of Hazardous Substances and Support Document, including the CEP report, should be submitted to Ms. Nickolette Roney, Division of Toxicology and Human Health Sciences, ATSDR, Mail Stop F-57, 1600 Clifton Road, NE., Atlanta, GA 30333. Electronic Availability: The 2013 Priority List of Hazardous Substances and Support Document are posted on ATSDR's Web site located at www.atsdr.cdc.gov/SPL. The CEP Report is posted at www.atsdr.cdc.gov/CEP.

The National Institutes of Health (NIH) proposes to issue regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes (UGSP). The purpose of the program is to recruit appropriately qualified undergraduate students from disadvantaged backgrounds to conduct research in the intramural research program as employees of the NIH by providing scholarship support.