Department of Health and Human Services May 4, 2015 – Federal Register Recent Federal Regulation Documents

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Office of Child Care (OCC) in the Administration for Children and Families (ACF) within the Department of Health and Human Services (HHS) is withdrawing a previously published notice of proposed rulemaking that solicited public comment on reforms to the Child Care and Development Fund (CCDF) program.

The Food and Drug Administration (FDA) has determined the regulatory review period for NESINA 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) has determined the regulatory review period for KAZANO 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) has determined the regulatory review period for BOSULIF 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 Centers for Disease Control and Prevention (CDC), 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. This notice invites comment on the proposed information collection request entitled ``Employer Perspectives of an Insurer-Sponsored Wellness Grant''. This collection is a part of an employer study to understand the impact of integrating wellness programs with traditional occupational safety and health (OSH) programs.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in U.S. Patent Application 61/706,396 entitled ``Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/0-US-01], PCT Application PCT/US2013/059883 entitled ``Mesothelin Antibodies And Methods For Eliciting Potent Antitumor Activity'' [HHS Ref. E-236-2012/ 0-PCT-02], and all related continuing and foreign patents/patent applications for the technology family, to Oncolinx Pharmaceuticals, LLC. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to: The use of bispecific antibodies having: (a) The complementary determining regions (CDRs) of the monoclonal antibody SD1; and (b) the CDRs of an anti-CD3 antibody, for the treatment of mesothelin-expressing cancers. The Licensed Field of Use explicitly excludes the use of the CDR sequences of SD1 in a monospecific antibody, or in the form of an immunotoxin, antibody-drug conjugate, or chimeric antigen receptor. Upon the expiration or termination of the exclusive start-up option license, Oncolinx Pharmaceuticals, LLC will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive start-up option license with no greater field of use and territory than granted in the exclusive start-up option license.