Department of Health and Human Services March 23, 2015 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Nicole Moore, Division of Cancer Biology, 9609 Medical Center Drive, Room 6W508, Bethesda, MD 20892-9714 or call non-toll-free number 301-325- 7534 or Email your request, including your address to: Nicole.Moore@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Electronic Submission of Lot Distribution Reports; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs). FDA recently published in the Federal Register a final rule requiring that, among other things, lot distribution reports be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014, and is intended to help licensed manufacturers of products distributed under an approved BLA (henceforth referred to as applicants) comply with the final rule.

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 start-up exclusive commercial license to practice the inventions embodied in U.S. Patent Application No. 62/034,995 entitled ``Human Monoclonal Antibodies Specific for 5T4 and Methods of Their Use'' filed August 8, 20014 [HHS Ref. E-158-2014/0-US-01] and all related continuing and foreign patents/patent applications for the technology family to Concortis, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive commercial license territory may be worldwide and the field of use may be limited to the development of 5T4 antibody drug conjugate therapeutics for the treatment of human cancers using Concortis' proprietary conjugation technologies.

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 a start-up exclusive evaluation option license agreement to practice the inventions embodied in U.S. Patent Application No. 61/172,099 entitled ``Anti-human ROR1 Antibodies'' filed April 23, 2009 [HHS Ref. E-097-2009/0-US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human ROR1 Antibodies'' filed April 23, 2010 [HHS Ref. E-097-2009/0-PCT-02], European Patent Application No. 10715077.3 entitled, ``Anti-human ROR1 Antibodies'' filed October 24, 2011 [HHS Ref. No. E-097-2009/0-EP-03], U.S. Patent Application No. 13/265,582 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-US-04], Australian Patent Application No. 2010238723 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-AU- 04], Canadian Patent Application No. 2,759,733 entitled, ``Anti-human ROR1 Antibodies'' filed October 21, 2011 [HHS Ref. No. E-097-2009/0-CA- 05], US Provisional Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed December 1, 2010 [HHS Ref. E-039- 2011/0-US-01], PCT Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT-02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-AU-03], Canadian Patent Application No. 2818992 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04], European Patent Application No. 11791733.6 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05] and U.S. Patent Application No. 13/990,977 entitled, ``Chimeric rabbit/ human ROR1 antibodies'' filed May 31, 2013 [HHS Ref. E-039-2011/0-US- 06] and all related continuing and foreign patents/patent applications for the technology family to NBE Therapeutics, Ltd. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers utilizing enzymatic conjugation methods linking a small molecule to a full-length antibody, wherein the full-length antibody moiety comprises the anti-ROR1 antibodies or CDR3s within the scope of the Licensed Patent Rights. For avoidance of doubt, this Agreement explicitly excludes the following: (a) Antibody-drug conjugates utilizing non-enzymatic conjugation linking small molecules to said antibodies, (b) immunotoxins comprising anti-ROR1 antibodies and Pseudomonas exotoxins, and (c) non-full-length bispecific antibodies. Upon expiration or termination of the start-up exclusive evaluation option license, NBE Therapeutics, Ltd. will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing from the Premerus PSO, LLC has expired and AHRQ has delisted the PSO accordingly.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.