Department of Health and Human Services September 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing this notice to request that industry trade associations, whose members include drug companies currently engaged in development or manufacture of biosimilar biological products in the U.S., or drug companies intending to engage in these activities during the period of FY 2018-2022, notify FDA of their intent to participate in industry stakeholder meetings in support of timely reauthorization of the Biosimilar User Fee Act of 2012 (BsUFA). The statutory authority for BsUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees to fund the biosimilar biological product review process. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA engage in negotiations with regulated industry to develop recommendations to present to Congress with respect to the reauthorization of BsUFA. The purpose of this request for notification is to ensure that qualifying industry organizations notify FDA of their intention to participate in the planned negotiation process.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts 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 (PRA). This notice invites comment on the three- year extension of information collection clearance for the ``Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation'' project (OMB Control No. 0923-0046; expiration date 05/31/2016). The purpose of the study is to examine the potential association between environmental contaminants (i.e., uranium and other heavy metal exposures) and reproductive birth outcomes by recruiting Navajo mothers to assess and follow theirs and their children's uranium exposures at birth and at key developmental milestones.

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide and guidance for industry #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' This guidance aids industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule that published in the Federal Register on June 3, 2015. The purpose of this document is to describe the Veterinary Feed Directive requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a Veterinary Feed Directive drug (VFD feed).

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the Public Health Service, Department of Health and Human Services, is contemplating the grant of an exclusive license to Research Think Tank Molecular Diagnostics, Inc. (RTTMDx) having a principal place of business in Georgia, U.S.A., to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 577,696, filed June 07, 2004, entitled ``Real-Time PCR Point Mutation Assays for Detecting the 103N and 184V Mutations in the Reverse Transcriptase of HIV-1'' (HHS Ref. No. E-198-2013/0-U.S.-01); PCT Application No. PCT/U.S.2005/019907, filed June 07, 2005, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-PCT-02); U.S. Patent Application No. 14/059,085, filed October 21, 2013, entitled ``Real- Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-11); U.S. Patent No. 8,043,809, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-07); U.S. Patent No. 8,318,428, filed January 24, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance for Antiviral Drugs'' (HHS Ref. No. E-198- 2013/0-U.S.-08); U.S. Patent No. 8,592,146, filed September 04, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-198-2013/0-U.S.-09); Australian Patent No. 20055252685, issued March 31, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs,'' (HHS Ref. No. E-198-2013/0-AU-03); Indian Patent No. 19/DELNP/2007, issued December 19, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-IN-06); Canadian Patent Application No. 2,891,079, filed May 19, 2015, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-12); Canadian Patent Application No. 259747, filed December 07, 2006, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-198-2013/0-CA-04); U.S. Provisional Patent Application No. 61/443,926, filed February 17, 2011, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Antiviral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-01); PCT Patent Application No. PCT/ U.S.2012/025638, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-PCT-02); U.S. Application No. 13/ 985,499, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-U.S.-06); Canadian Patent Application No. 2827324, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-CA-03); European Patent Application No. 12747199.3, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-EP-04); Indian Patent Application No. 7110/ DELNP/2013, filed February 17, 2012, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-214-2013/0-IN-05); U.S. Provisional Patent Application No. 61/829,473, filed May 31, 2013, entitled ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs (HHS Ref. No. E-511-2013/0-U.S.-01); PCT Application No. PCT/U.S.2014/ 040514, filed June 02, 2014, entitled, ``Real-Time PCR Point Mutation Assays for Detecting HIV-1 Resistance to Anti-Viral Drugs'' (HHS Ref. No. E-511-2013/0-PCT-02). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Patent License may be worldwide, and the field of use may be limited to ``Development, manufacture, and sale of an FDA-approved or foreign equivalent-approved Class III real-time PCR diagnostic assay for HIV-1 genotyping utilizing whole HIV-1 pol viral sequencing, limited to use in humans.''

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that Xuriden (uridine triacetate), manufactured by Wellstat Therapeutics Corp., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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 U.S. Centers for Disease Control and Prevention (CDC) is providing $1,300,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the New York City Department of Health (NYC HD)to combat an outbreak of Legionella. As of August 18, 2015 NYC HD has identified 127 cases and 12 deaths associated with this public health emergency. These funds will be used by NYC HD to (1) create sustainable environmental and laboratory capacity at NYC HD to respond to Legionella outbreak, (2) enhance laboratory capacity of detection, isolation, and molecular characterization of clinical and environmental strains at the New York City public health laboratory, (3) include sequence-based typing and eventually whole genome sequencing, and (4) allow NYC HD to characterize the geographic distribution of Legionella strains throughout New York City, support the new public health engineering program to monitor the compliance of building owners with the new cooling tower regulations, and work with CDC to evaluate the impact of these regulations.