Department of Health and Human Services August 29, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) has determined that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if all other legal and regulatory requirements are met.

Administration for Children and Families (ACF) is announcing its evaluation policy for research or demonstration projects as authorized by 42 U.S.C. 1310.

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 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. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are, however, requesting an emergency review of the information collection reference below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the ICR currently approved under Office of Management and Budget (OMB) control number 0938-0760, entitled Medicare and Medicaid Programs OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations. The revisions contained in this request pertain only to the Outcome Assessment and Information Set, C-1/ICD-9 Version (OASIS-C1/ICD-9 Version); therefore all other requirements in the currently approved PRA package are not being revised. The approval of this data collection instrument is essential because OASIS data is used in the calculation of provider payment as well as for measurement of the quality of care provided by Home Health Agencies (HHAs).

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in: (E-147- 1999/0 &1) US provisional patent application No. 60/128/898 filed 4/12/ 1999, and PCT application No. PCT/US00/09839 filed 4/12/2000, and U.S. patent No. 6,977,245 filed 02/06/2002 issued 12/20/2005, and U.S. patent No. 7,960,356 filed 05/17/2005 and issued 06/14/2011, and EP1176966 granted 4/3/2013, each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; and (E-036-2005/0) US provisional patent application No. 60/713,547 filed August 31, 2005, and PCT application No. PCT/US2006/033774 filed August 28, 2006, and US patent 7,892,569 filed 8/31/2005 issued 2/22/2011, and Canada application number 2620582 filed 2/28/08, and Australia patent 2006284889 filed 8/28/2006 issued 12/1/11, and Japan patent 5481068 filed 8/28/2006 issued 2/21/2014, each entitled ``Method of Altering an Immune Response Induced by CpG Oligodeoxynucleotides''; and (E-214- 2001/0) US provisional patent application No. 60/312,190 filed August 14, 2001, and PCT application No. PCT/US202/025732, and US patent 7,354,909 filed February 2, 2004 issued April 8, 2008, and US patent 7,959,934 filed March 28, 2008 issued June 14, 2011, each entitled ``Method for Rapid Generation of Mature Dendritic Cells'' by Klinman et al. (FDA), to Neuralexo, LLC, having a place of business at 17367 Canal Circle, Lake Oswego, Oregon 97035. The United States of America is an assignee to the patent rights of these inventions. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to: preventative treatment for ischemic injury in organs.

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 health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of NHS, 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. AHRQ has accepted a notification of voluntary relinquishment from Patient Safety Services, LLC of its status as a PSO, and has delisted the PSO accordingly.