Department of Health and Human Services August 5, 2013 – Federal Register Recent Federal Regulation Documents
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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.
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