Department of Health and Human Services January 25, 2012 – Federal Register Recent Federal Regulation Documents
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Collection; Comment Request: Revision of the National Diabetes Education Program Comprehensive Evaluation Plan
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 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. This is a request for a revision to an existing approved information collection request. Proposed Collection: Title: The National Diabetes Education Program (NDEP) Comprehensive Evaluation Plan. Type of Information Collection Request: Revision of a currently approved collection (0925- 0552). Need and Use of Information Collection: The National Diabetes Education Program 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 longterm 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. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Promoting and implementing culturally and linguistically- appropriate diabetes awareness and education campaigns for a wide variety of audiences; (2) identifying, disseminating, and supporting the adoption of evidence-based, culturally and linguistically- appropriate tools and resources that support behavior change, improved quality of life, and better diabetes outcomes; (3) expanding NDEP reach and visibility through collaborations with public, private, and nontraditional partners, and use of national, state, and local media, traditional and social media, and other relevant channels.; and (4) conducting and supporting the evaluation of NDEP resources, promotions, and other activities to improve future NDEP initiatives. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This revision request is continued collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Continued approval and revision to revise and/or add questions is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families, and the public. Burden Statement: The burden for the collection of information, conducted every two to three years (2-3 years) is estimated to average 0.03 hours per response screening interview with ineligible persons and 0.25 hours per response for the eligible respondent interview. Respondents/Affected Entities: Adult individuals. Estimated Number of Respondents: 3759. Frequency of Response: Once per respondent. Estimated Total Annual Hour Burden: 575. There are no Capital Costs, Operating or Maintenance Costs to report. Changes in the Estimates: There is no change in estimate from the last ICR renewal. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on 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.
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate and betamethasone valerate topical spray in dogs.
Yuri Izurieta: Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Yuri Izurieta for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Izurieta was convicted of six felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Izurieta was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 10, 2011 (30 days after receipt of the notice), Mr. Izurieta had not responded. Mr. Izurieta's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Pediatric Medical Devices; Public Workshop; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until March 5, 2012, the comment period for the notice entitled ``Pediatric Medical Devices; Public Workshop; Request for Comments'' that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463). In the notice, FDA announced a public workshop to consider factors affecting the use of scientific research data to support pediatric medical device efficacy claims. This is part of an on-going effort to address the ways scientific research data can be used to support pediatric effectiveness claims for medical devices and pediatric device approvals or clearance; the scientific and regulatory limitations and issues of using existing scientific research data to support pediatric effectiveness claims and pediatric indication approvals for medical devices; and methods to overcome the pitfalls and data gaps, including statistical approaches and modeling. The agency is taking this action to allow interested persons additional time to submit comments on the use of scientific research data, including published scientific literature, to support and establish pediatric indications for medical devices.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.'' The guidance is intended to clarify for applicants the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products. This guidance finalizes the draft guidance published in January 1999.
Import Tolerances for Residues of Unapproved New Animal Drugs in Food
The Food and Drug Administration (FDA) is proposing to establish procedures by which a person may request that the Agency establish or amend tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances), as well as procedures to revoke an existing import tolerance. Such import tolerances provide a basis for legally marketing food of animal origin that is imported into the United States and contains residues of unapproved new animal drugs.
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