Department of Health and Human Services January 2012 – Federal Register Recent Federal Regulation Documents

The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed extension of an existing collection of information by the agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Performance Reports for Title VI grants.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers of natriuretic peptide measurement assays. Scientific information is being solicited to inform our Comparative Effectiveness Review of Use of Natriuretic Peptide Measurement in the Management of Heart Failure, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review.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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Nursing Home Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 2nd, 2011 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.

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.

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.

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.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, NIDA has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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. Preregistration 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 Food and Drug Administration (FDA) is announcing that Mars, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of spirulina blue, an extract made from the biomass of Anthrospira platensis (spirulina), to color candy and chewing gum.