Department of Health and Human Services July 2013 – 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 Kidney Disease Education Program, the National Institute of Diabetes and Digestive and Kidney Diseases, the 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 to address 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: Eileen Newman, Associate Director, National Kidney Disease Education Program, OCPL, NIDDK, NIH, Building 31, Room 9A06, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number 301-435-8116 or Email your request, including your address to: Eileen.newman@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. Proposed Collection: Evaluation of a Kidney Disease Education Program with Promotores in the Hispanic Community, 0925-NEW, National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). Need and Use of Information Collection: NKDEP is developing a kidney disease education program to raise awareness among the Hispanic community at risk for kidney disease. Since diabetes is the most common cause of kidney disease, the program is being developed for inclusion in existing diabetes programs being conducted by ``promotores de salud'' (Spanish/English-speaking community health workers). A pilot evaluation will assess: (a) Overall quality of the program from the client and promotor/a perspective, including strengths and weaknesses of the program and the training, and areas for program improvement; (b) effectiveness of the program on the clients (the community members being educated); and (c) effectiveness of materials and training, including promotores' ability to deliver education to the client and administer the client pre-test/post-test surveys. The pilot study will deliver strategic and actionable guidance for refining the educational and training materials for national dissemination. Based on outcomes from the pilot study, a national evaluation is planned that will use the client pre-test/post-test surveys to assess: (a) Knowledge gains about kidney disease, (b) awareness of NKDEP resources and importance of kidney health, (c) reported behavior change outcomes and (d) reported health status. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 101 (see table below).

The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 27, 2013, about interagency collaboration to improve outcomes in Chronic Kidney Disease (CKD). The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for narcolepsy. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy.

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 (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', European Patent Application Number 02739358.6 (now European Patent Number 1402075, validated in Austria, Belgium, Switzerland/Liechtenstein, Germany, Denmark, Spain, Finland, France, the United Kingdom, Ireland, Italy, the Netherlands, Sweden and Turkey), filed May 22, 2002, United States Patent Application Number 10/719,547 (now U.S. Patent Number 7,226,602), filed November 21, 2003, Canadian Patent Application Number 2448329 (now Canadian Patent Number 2448329), filed May 22, 2002, Australian Patent Application Number 20022312011 (now Australian Patent Number 20022312011), filed May 22, 2002, Australian Patent Application Number 2008203275 (now Australian Patent Number 2008203275), filed May 22, 2002, Australian Patent Application Number 2012200637, filed May 22, 2002, United States Patent Application Number 11/446,050, filed June 2, 2006, now U.S. Patent Number 7,560,118, issued July 14, 2009, United States Patent Application Number 12/396,376 (now United States Patent Number 8,039,003), filed March 2, 2009, United States Patent Application Number 13/240,849, filed September 22, 2011, European Patent Application Number 10181776.5, filed May 22, 2002, European Patent Application Number 10181786.4, filed May 22, 2002, and European Patent Application Number 10181804.5, filed May 22, 2002 (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in The 3'-UTR of Dengue Types 1,2,3, And 4, or Antigenic Chimeric Dengue Viruses 1,2,3, And 4'', United States Patent Application Number 10/970,640 (now United States Patent Number 7,517,531), filed October 21, 2004, Canadian Patent Application Number 2483653, filed April 25, 2003, European Patent Application Number 03724319.3 (now European Patent Number 1554301, validated in Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Estonia, Finland, France, the United Kingdom, Ireland, Iceland, Italy, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Cyprus, Croatia, Czech Republic, Denmark, Germany, Greece, Hungary, Latvia, Luxembourg, and Monaco), filed April 25, 2003, Japanese Patent Application Number 2004-50077, filed April 25, 2003, Australian Patent Application 2003231185 (now Australian Patent Number 2003231185), filed April 25, 2003, United States Patent Application Number 12/398,043 (now United States Patent Number 8,075,903), filed March 4, 2009, United States Patent Application Number 13/305,639, filed November 28, 2011, European Patent Application Number 10177735.7, filed April 25, 2003, and European Patent Application Number 10177740.7, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Australian Patent Application 2007285929, filed August 15, 2007, Canadian Patent Application Number 2661296, filed August 15, 2007, Chinese Patent Application Number 200780031489.4, filed August 15, 2007, European Patent Application Number 07840969.5, filed August 15, 2007, United States Patent Application Number 12/376,756 (now U.S. Patent Number 8,337,860), filed February 6, 2009, and United States Patent Application Number 13/692,557, filed December 3, 2012 to Merck Sharp & Dohme Corp., having a place of business in Whitehouse Station, New Jersey, U.S.A. The patent rights in this invention have been assigned to the United States of America.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award a programmatic supplement of approximately $583,330 (total costs) for up to one year to the current grantee of the Suicide Prevention Resource Center program. The current grantee is Education Development Center, Inc., Waltham, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Center, Inc. based on receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-13-008. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 520A and 520C of the Public Health Service Act, as amended. Justification: The purpose of this 1-year supplement is to support implementation of the National Strategy for Suicide Prevention (NSSP) and to support the infrastructure of the National Action Alliance (Action Alliance) for Suicide Prevention, with the overall goal of reducing suicides and suicidal behaviors in the country. Funds will be used to support implementation of the Action Alliance high priority area, to transform health care systems to significantly reduce suicide and suicide attempts. This will also build on the momentum of the 2011 report released by the Action Alliance's Clinical Care and Intervention Task Force, Suicide Care in Systems Framework, including the informal ``zero suicide'' learning collaborative, which currently involves six states and health care systems. Funds will also be used to directly support the infrastructure of the Action Alliance such as funding staff support for key Alliance initiatives, including the Action Alliance Executive Committee and task forces, and for direct meeting expenses of the Executive Committee and select task forces. SAMHSA funds only one Suicide Prevention Resource Center, SAMHSA's primary vehicle for providing technical assistance to the field. Therefore, this program supplement will be awarded to the grantee that manages the SPRC, specifically to the Education Development Center, Inc., Waltham, Massachusetts. There are no other sources with the available resources and expertise to successfully complete the tasks of this proposal within the one-year grant period. 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.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Hospital Value-Based Purchasing (VBP) Program. We are proposing changes to the conditions for coverage (CfCs) for organ procurement organizations (OPOs); revisions to the Quality Improvement Organization (QIO) regulations; changes to the Medicare fee-for-service Electronic Health Record (EHR) Incentive Program; and changes relating to provider reimbursement determinations and appeals.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement Policy Regarding IND Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,'' dated July 2013. This guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies. FDA intends to exercise this discretion provided that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. Informed consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its potential risks. This policy does not extend to other uses of FMT. FDA intends to exercise this discretion on an interim basis while we further consider the matter. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), 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 reinstatement of a previously-approved information collection assigned OMB control number 4040-0003, which expired on November 30, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. 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.

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.

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.

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.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions on imaging tests for the staging of colorectal cancer (e.g., Chest x-ray, computed tomography, multidetector computed tomography (MD-CT), CT colonography, magnetic resonance imaging (MRI), transabdominal ultrasound (TUS), endoscopic ultrasound (EUS), transrectal ultrasound (TRUS), positron emission tomography (PET), positron emission tomography combined with computed tomography (PET/CT fusion), or positron emission tomography combined with magnetic resonance imaging (PET/MRI fusion)) from medical device manufacturers. Scientific information is being solicited to inform our Comparative Effectiveness Review of Imaging Tests for the Staging of Colorectal Cancer, which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). AHRQ is republishing this document due to errors found on our first publication of June 27, 2013 (https://www.gpo.gov/fdsys/pkg/FR-2013-06- 27/pdf/2013-15288.pdf). Please disregard the June 27 publication.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.