Department of Health and Human Services August 2013 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; 30-day Comment Request: Autism Spectrum Disorder Research Portfolio Analysis
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 24, 2013, Volume 78, Number 101, Pages 31568-31569 and allowed 60-days for public comment. One public comment was received; in this comment, a request was made for access to any data that is collected on autism projects that are funded. This comment was considered, but it did not result in alteration to the data collection or data management process because steps are already in place to make the data publicly accessible via an online Web Tool on the IACC Web site. No comments that specifically addressed cost and hour burden were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Submission for OMB Review; 30-day Comment Request: National Institute of Mental Health Data Access Request and Use Certification
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 28, 2013, Volume 78, Number 102, Pages 31947-31948 and allowed 60-days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Medicare Program; Revised Process for Making National Coverage Determinations
This notice updates the process we use for opening, deciding or reconsidering national coverage determinations (NCDs) under the Social Security Act (the Act). It addresses external requests and internal reviews for new NCDs or for reconsideration of existing NCDs. The notice further outlines an expedited administrative process to remove certain NCDs, thereby enabling local Medicare contractors to determine coverage under the Act. This notice does not alter or amend our regulations that establish rules related to the administrative review of NCDs.
Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions; Amended Notice of Meeting
On June 26, 2013, the Department of Health and Human Services (HHS) published in the Federal Register an announcement of a public meeting to be held on August 28, 2013, to discuss how certain provisions of the HHS protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context (78 FR 38343). In the June 26, 2013 meeting announcement, HHS stated that presenters will be scheduled to speak at the public meeting in the order in which they register. Notice is hereby provided that HHS may group presenters according to the topic of their presentation.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Clinical Laboratory Improvement Amendments Waiver Applications
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Clinical Laboratory Improvement Amendments Waiver Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances
The Food and Drug Administration (FDA) is announcing an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. Guidances that are no longer up to date, and for which more current information is available, will be withdrawn. Guidances that reflect CDER's current thinking, CDER will decide whether to revise or finalize. This notice describes CDER's initiative, announces the first group of guidances to be withdrawn, describes in general terms draft guidances under consideration for revision or finalization, and explains how CDER is making this process as transparent as possible.
Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time.
Privacy Act of 1974; CMS Computer Match No. 2013-12; HHS Computer Match No. 1307; SSA Computer Match No. 1097-1899
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Social Security Administration (SSA).
Privacy Act of 1974; CMS Computer Match No. 2013-02; HHS Computer Match No. 1306; DoD-DMDC Match No. 12
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a CMP that CMS plans to conduct with the Department of Defense (DoD).
Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring.'' This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies.
Medicare Program; FY 2014 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements; and Updates on Payment Reform
This final rule updates the hospice payment rates and the wage index for fiscal year (FY) 2014, and continues the phase out of the wage index budget neutrality adjustment factor (BNAF). Including the FY 2014 15 percent BNAF reduction, the total 5 year cumulative BNAF reduction in FY 2014 will be 70 percent. The BNAF phase-out will continue with successive 15 percent reductions in FY 2015 and FY 2016. This final rule also clarifies how hospices are to report diagnoses on hospice claims, and provides updates to the public on hospice payment reform. Additionally, this final rule changes the requirements for the hospice quality reporting program by discontinuing currently reported measures and implementing a Hospice Item Set with seven National Quality Forum (NFQ) endorsed measures beginning July 1, 2014, as proposed. Finally, this final rule will implement the hospice Experience of Care Survey on January 1, 2015, as proposed.
Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for OXYCONTIN (oxycodone hydrochloride) Extended-Release Tablets, held by Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily requested that approval of this application (NDA 20-553) be withdrawn and has waived its opportunity for a hearing.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 032
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). Specifically, this publication announces the addition of a list of recognized standards that are relevant to interoperability of medical devices. This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 032'' (Recognition List Number: 032), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 031
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 031'' (Recognition List Number: 031), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Pratima Karnik, Ph.D., Case Western Reserve University: Based on the admission of the Respondent, ORI found that Dr. Pratima Karnik, Assistant Professor, Department of Dermatology, Case Western Reserve University (CWRU), engaged in research misconduct in research submitted to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), in grant application R01 AR062378. ORI found that the Respondent engaged in research misconduct by plagiarizing significant portions from research grant application R21 AR061881 that she had reviewed for NIAMS, NIH, and inserting that text into her submitted grant application R01 AR062378-01. Respondent also plagiarized significant portions of text from the following scientific articles and one U.S. patent application available on the Internet: BMC Med Genomics 4:8, 2011 J Am Col. Cardiol 52:117-123, 2008 Nature 457:910-914, 2009 J Autoimmun 29:310-318, 2007 U.S. Patent Application No. 20090047269 (published Feb. 19, 2009) Toxicol Pathol 35:952-957, 2007 BMC Med Genomics 1:10, 2008 Open Systems Biology Journal 1:1-8, 2008 Endocrinology 146:4189-4191, 2005. Dr. Karnik has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on July 22, 2013: (1) To have her research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; she agreed that she shall not participate in any PHS- supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) That any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the content is free of plagiarized material, data provided by Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) To exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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. This notice invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014
This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year (FY) 2014. In addition, it revises and rebases the SNF market basket, revises and updates the labor related share, and makes certain technical and conforming revisions in the regulations text. This final rule also includes a policy for reporting the SNF market basket forecast error in certain limited circumstances and adds a new item to the Minimum Data Set (MDS), Version 3.0 for reporting the number of distinct therapy days. Finally, this final rule adopts a change to the diagnosis code used to determine which residents will receive the AIDS add-on payment, effective for services provided on or after the October 1, 2014 implementation date for conversion to ICD-10- CM.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2014
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. This final rule also revised the list of diagnosis codes that may be counted toward an IRF's ``60 percent rule'' compliance calculation to determine ``presumptive compliance,'' update the IRF facility-level adjustment factors using an enhanced estimation methodology, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.
Proposed Collection; 60-Day Comment Request: Community Evaluation of the National Diabetes Education Program's Diabetes HealthSense Web site
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 collections projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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) The quality, utility, and clarity of the information to be collected; and (4) 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 Joanne M. Gallivan, MS, RD, Director, National Diabetes Education Program, OCPL, NIDDK, 31 Center Drive, Room 9A06, Bethesda, MD, 20892 or call non toll-free number 301-496-6110 or Email your request including your address to joanne_gallivan@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: Community Evaluation of the National Diabetes Education Program's Diabetes HealthSense Web site. 0925-NEW, National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goal of the NDEP is to reduce the burden of diabetes and pre-diabetes in the United States, and its territories, by facilitating the adoption of proven strategies to prevent or delay the onset of diabetes and its complications. The NDEP objectives are to: (1) Increase awareness and knowledge of the seriousness of diabetes, its risk factors, and effective strategies for preventing type 2 diabetes and complications associated with diabetes; (2) Increase the number of people who live well with diabetes and effectively manage their disease to prevent or delay complications and improve quality of life; (3) Decrease the number of Americans with undiagnosed diabetes; (4) Among people at risk for type 2 diabetes, increase the number who make and sustain effective lifestyle changes to prevent diabetes; (5) Facilitate efforts to improve diabetes-related health care and education, as well as systems for delivering care; (6) Reduce health disparities in populations disproportionately burdened by diabetes; and (7) Facilitate the incorporation of evidence-based research findings into health care practices. One product that NDEP has developed to address many of these objectives is Diabetes HealthSense, an online compendium of psychosocial and behavioral resources to support lifestyle changes. This study will be a multi-component 3-year evaluation of Diabetes HealthSense. The required forms will support the following evaluation tasks: (1) Assessing community educators' experience and satisfaction with NDEP resources such as the Diabetes HealthSense Web site; (2) Assess the extent to which, through participation in Diabetes HealthSense educational sessions, community educators can increase their knowledge and ability to promote and use NDEP resources; and (3) Assess the extent to which the Web site, with guided exploration, can facilitate changes in lifestyle to help prevent or manage diabetes. The data collected from this evaluation will provide NDEP with information about how community educators use NDEP-created resources in their communities and whether the Diabetes HealthSense resource has its intended effect on participants. Such data will help inform NDEP's future decisions about the Diabetes HealthSense Web site, including whether to make changes to Diabetes HealthSense, and whether to invest additional resources to support, promote or expand this resource. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 328.
Food Labeling; Gluten-Free Labeling of Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
Fee Schedule for Reference Biological Standards and Biological Preparations
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces that HHS/CDC has reviewed and updated its fee schedule for reference biological standards and biological preparations required by OMB Circular A-25, User Charges. This notice also announces current contact information to obtain information on the availability of these products and the fees for these products.
Preventing Skin Cancer Through Reduction of UV Exposure
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information from the public on preventing skin cancer through the reduction of UV exposure. The information obtained will be used for an anticipated Office of the Surgeon General response to the public health problem of skin cancer.
Determination That CYTOXAN (Cyclophosphamide) for Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations), 100 milligrams (mg)/vial, 200 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection (non- lyophilized formulations), 100 mg/vial and 200 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for these products, if all other legal and regulatory requirements are met.
Privacy Act of 1974; Report of an Altered System of Records
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records entitled and numbered National Practitioner Data Bank for Adverse Information on Physicians and other Health Care Practitioners (NPDB), 09-15-0054, to include information covered under a related system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), SORN 09-90-0103, which is being deleted. The NPDB SORN was last published March 30, 2012 (77 FR 19295). The proposed alterations to the NPDB SORN include revising the Purpose section, expanding the Categories of Individuals, Categories of Records, and Record Sources Categories sections, revising two existing routine uses and adding one new routine use, deleting three unnecessary routine uses, and updating the Authority and Policies and Practices sections.
National Practitioner Data Bank and Privacy Act; Exempt Records System; Technical Correction
These correcting amendments update a cross reference cited in the Privacy Act regulations. The National Practitioner Data Bank (NPDB) system of records (09-15-0054) is exempt from certain provisions of the Privacy Act, and the cross reference cited refers to the regulations that govern the NPDB. As a result of Section 6403 of the Affordable Care Act, the regulations governing the NPDB were revised and certain section numbers in the NPDB regulations were changed, including the NPDB regulation that was cross referenced. This change is technical in nature and does not significantly alter the current NPDB exemption.
Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for BEXTRA (valdecoxib) 10 milligram (mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd St., New York, NY 10017-5755. Pfizer has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device User Fee Cover Sheet, Form FDA 3601
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA 3601'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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