Department of Health and Human Services January 2014 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors in the correcting document that appeared in the January 2, 2014 Federal Register entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014; Correction.''

The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease.'' This draft guidance provides a statement of qualification for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome instrument and summarizes the concept of interest and context of use (COU) for which the tool is qualified through the Center for Drug Evaluation and Research's (CDER's) drug development tool (DDT) qualification program. Qualification of the EXACT represents a conclusion that, within the stated COU, the instrument can be relied on to have a specific interpretation and application in drug development and regulatory review. This draft guidance is an attachment to the guidance for industry entitled ``Qualification Process for Drug Development Tools.''

The Food and Drug Administration (FDA or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) to be legally marketed.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia (CABP). The science of clinical trial design and our understanding of this disease have advanced in recent years, and this draft guidance informs sponsors of our current recommendations for clinical development. FDA is specifically requesting comment on critical areas of scientific interest including the appropriate primary efficacy endpoints, the use of an intent-to-treat (ITT) population for the primary analysis population, and the use of antibacterial therapy by patients before participating in clinical trials. This draft guidance revises the draft guidance of the same name that published March 20, 2009.

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.

The proposed rule would revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; strengthen beneficiary protections; exclude plans that perform poorly; improve program efficiencies; and clarify program requirements. The proposed rule also includes several provisions designed to improve payment accuracy.

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 license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/727,038, entitled ``Method of Sequencing Whole Viral Genomes, Related Compositions, and Genome Sequences'', filed October 14, 2005 (HHS Ref. No. E-326-2013/0- US-01); PCT Patent Application No. PCT/US2006/040134, entitled ``Rabies Virus Compositions and Methods'', filed October 13, 2006, (E-326-2013/ 0-PCT-02); and Chinese Patent Application No. 200680038314.4, entitled ``Rabies Virus Compositions and Methods'', filed October 13, 2006 (HHS Ref. No. E-326-2013/0-CN-06). The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory is China, and the field of use may be limited to ``Rabies vaccines based on the ERAg3m virus strain for veterinary use only.''

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $1.162 million (total costs) for up to three years to NASADAD for Technical Assistance to States for Implementation of the Substance Abuse Block Grant (SABG) for Prevention and Treatment (Short Title: SABG-TA). The purpose of this program is to provide technical assistance (TA) to substance abuse Single State Agencies (SSAs) to increase service capacity, including recovery support services, develop integrated systems of care, improve behavioral health outcomes, and support strategies for addressing health disparities in use of the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care. In addition, the program will provide TA support to the National Prevention Network (NPN) leadership in support of the further development of state prevention systems as it relates to the implementation of the SABG program. SABG- TA funds will be used to assist states in responding to emerging issues, such as the Affordable Care Act, parity, information technology innovations, implementation of evidence-based practices, and issues related to program integrity. These funds are used for prevention, treatment, recovery support, and other services that will assist in the development, implementation, and management of the SABG program. Funding Opportunity Title: TI-14-002. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 1935 of the Public Health Services Act, as amended. Justification: Eligibility for this award is limited to NASADAD. NASADAD is in the unique position to facilitate these activities because: NASADAD is the sole and unique organization with a direct official relationship with the SSAs and is the only agency of its type representing all the SSAs for substance use disorder treatment and primary prevention activities. NASADAD has helped to professionalize the field, and support the systematic development of evidence-based models of screening, assessment, treatment, and recovery support services. Such interventions yield favorable outcomes, are cost-effective, scalable, and sustainable. Significant investments in training and workforce development have made these interventions accessible to providers of treatment and prevention services around the country. Over the years, NASADAD has built an extensive array of constituency groups and has maintained these ongoing memberships in order to coordinate group activities via teleconference, net conference, or in person meetings, as necessary for the purpose of educating the public about the value and importance of substance use disorder treatment and prevention. NASADAD is the sole organization that has been utilizing a Web-based process to facilitate SSA dialogue on SSA management, clinical program and research issues practices within the SSAs/NPNs, and recognizes and promotes a number of critical prevention research products. NASADAD's constituency and staff are a repository of knowledge on state issues related to substance abuse treatment indicators and are accountable for performance in the SABG grant. This knowledge is critical to the grant project. As a result, NASADAD is uniquely qualified and positioned to carry out the requirements of this announcement. Contact: Cathy Friedman, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1097, Rockville, MD 20857; telephone: (240) 276-2316; email: cathy.friedman@samhsa.hhs.gov.