Department of Health and Human Services January 2018 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DUAVEE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN XT TRANSCATHETER HEART VALVE 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOBI-C CERVICAL DISC PROSTHESIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection project entitled ``Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection.'' The collection is part of a research study designed to evaluate the efficacy of a locally developed and potentially effective intervention, TransLife Center (TLC), which provides combination HIV prevention services to adult transgender women at high risk for HIV infection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualified Infectious Disease Product Designation Questions and Answers.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) creates incentives for the development of antibacterial and antifungal drug products that treat serious or life-threatening infections. The purpose of this draft guidance is to provide a resource for information on FDA's policies and procedures related to the designation of a qualified infectious disease product (QIDP).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VIEKIRA PAK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CARDIOMEMS HF MONITORING SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEPATIER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GALLIPRANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Planning, Research and Evaluation (HHS/ACF/OPRE), is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs), ``Information Comparisons and Disclosure to Assist in Administering the Public Assistance Reporting Information System (PARIS) Program.'' The matching program provides VA pay and pension data to SPAAs, which SPAAs use to identify individual public assistance clients (applicants and recipients) who are receiving compensation and pension payments from VA, in order to determine their eligibility for benefits under HHS' Medicaid and Temporary Assistance to Needy Families (TANF) programs and the Department of Agriculture's Supplemental Nutrition Assistance Program (SNAP). HHS/ACF/OPRE facilitates the matching program, with computer assistance from the Department of Defense, Defense Manpower Data Center (DOD/DMDC).