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

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications: 1. U.S. Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0-US-01); 2. U.S. Patent No. 8,383,099 issued February 26, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E-273-2009/0- US-02); 3. U.S. Patent Application No. 13/742,541 filed January 16, 2013 entitled ``Adoptive cell therapy with young T cells'' (HHS Ref No. E- 273-2009/0-US-03); 4. U.S. Provisional Patent Application No. 61/466,200 filed March 22, 2011 entitled ``Methods of growing tumor infiltrating lymphocytes in gas-permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 5. PCT Application No. PCT/US2012/029744 filed March 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 6. U.S. Patent Application No. 13/424,646 filed May 20, 2012 entitled ``Methods of growing tumor infiltrating lymphocytes in gas- permeable containers'' (HHS Ref No. E-114-2011/0-US-01); 7. U.S. Provisional Patent Application No. 61/846,161 filed July 15, 2013 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-US-01); 8. PCT Application No. PCT/US2014/046478 filed July 14, 2014 entitled ``Methods of Preparing Anti-human Papillomavirus Antigen T Cells'' (HHS Ref No. E-494-2013/0-PCT-02); The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, manufacture, distribute, sell and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of lung, breast, bladder, and HPV- positive cancers. Specifically excluded from this license are methods of generating or using selected subpopulations of TIL and the use of T cell receptors isolated from TIL.

This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare Conditions of Participation (CoPs).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 18, 2015, expiration date.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for FLUCELVAX 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 human biological product.

The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single-source cooperative agreement in the amount of $1,200,000 for each of 3 years to the American Public Human Services Association for its affiliate the Association of Administrators of the Interstate Compact on the Placement of Children (AAICPC), Washington, DC, for the national expansion of the NEICE to improve the administrative efficiency in the interstate process of the ICPC nationally. The ICPC establishes uniform legal and administrative procedures governing the interstate placement of children for the purposes of foster care, adoption and residential placement in all 52 member jurisdictions of the ICPC. Award funds will support the development of the NEICE beyond the original six pilot sites to include all 50 states, the District of Columbia and the U.S. Virgin Islands. The NEICE system was previously developed as a pilot project through the Partnership Fund for Program Integrity Innovation with funding directed through The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF). Implementation of a national inter-jurisdictional Interstate Compact on the Placement of Children (ICPC) electronic system is intended to improve the administrative efficiency in the interstate process via the ICPC. The AAICPC as an affiliate of the APHSA is uniquely positioned to scale up this project due to their governance of the placement of children across state lines for purposes of foster care, adoption and residential placements.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for inactivated and live attenuated influenza vaccines.

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 Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.

The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA's understanding of antimicrobial animal drug sales intended for use in specific food- producing animal species.