Department of Health and Human Services March 2015 – 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. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Hanford site in Richland, Washington, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice invites comments on the reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA).

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry'' dated March 2015. The guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014.

The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to obtain comments that will inform our development of FDA Food Safety Modernization Act (FSMA) implementation work plans. FDA is also announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.'' At the public meeting, we will share our current thinking on our operational strategy for implementation work plans. We will also provide interested persons an opportunity to provide input on this operational strategy and the risk- based industry oversight framework that is at the core of FSMA.

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. This notice invites comment on Promotion of the National Amyotrophic Lateral Sclerosis (ALS) Registry to Non-referral Centers.

This document corrects a notice that was published in the Federal Register on March 4, 2015 (Volume 80, Number 42, Page 11677). The time and date should read as follows:

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.