Department of Health and Human Services April 2, 2014 – Federal Register Recent Federal Regulation Documents

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

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 on Aging (NIA), 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 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. 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: Luigi Ferrucci, M.D., Ph.D., NIA Clinical Research Branch, Harbor Hospital, 5th Floor 3001 S. Hanover, Baltimore, MD 21225 or call non-toll-free number (410) 350-3936 or Email your request, including your address to: Ferruccilu@grc.nia.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: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study(0925- 0631). Reinstatement with ChangeNational Institute on Aging (NIA), National Institutes of Health (NIH). Need and Use of Information Collection: Longevity combined with good health and functionality at the end of life represents a common goal. Although research has examined correlates of long life and functional decline, we still know relatively little about why certain individuals live in excellent health into their eighties while others succumb to failing health at much younger ages. Understanding the mechanisms important to ideal aging may provide new opportunity for health promotion and disability prevention is this rapidly growing segment of the population. The purpose of IDEAL (Insight into the Determinants of Exceptional Aging and Longevity) is to recruit into the Baltimore Longitudinal Study on Aging (BLSA) exceptionally long lived and healthy individuals and to learn what makes them so resilient and resistant to disease and disability, and to identify potential interventions that may contribute to the IDEAL condition. By enrolling the IDEAL cohort in the BLSA their biologic, physiologic, behavioral and functional characteristics will be evaluated using the same methods used with the current cohort who will serve as a type of control group. The first aim is to identify factors and characteristics that distinguish IDEAL from non-IDEAL individuals. We intend to compare the two groups to identify factors that discriminate IDEAL aging from non-IDEAL aging individuals. The second aim is to identify physiological, environmental and behavioral characteristics that are risk factors for losing the IDEAL condition over several years or longer. We postulate that the mechanisms of extreme longevity probably differ from those associated with delay or escape from disease and disability. As is customary in the BLSA, we plan to follow this cohort for life with yearly visits. This is a request for OMB clearance to continue to recruit and screen respondents into the Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study over the next 3 years. OMB approval is requested for 3 years. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 263.

The Administration for Community Living (ACL) is announcing the application deadline and a single case deviation from maximum competition for Technical Assistance (TA) grants providing support to Senior Legal Helplines (SLH) and Model Approaches to Statewide Legal Assistance Systems (Model Approaches) projects under Section 420(a)(2) of the Older Americans Act (OAA). The two (2) TA grants provide focused resource support specifically to SLHs and Model Approaches demonstration projects involved in improving the quality, cost effectiveness, and accessibility of legal assistance and elder rights protections provided to older people. The purpose of this deviation is to award a 4th year non-competing continuation to TA grants, with a three (3) year budget period set to expire May 31, 2014, so that: (1) Stakeholder input can be obtained on the resource support needs of legal and aging/disability service providers across the country; and (2) the current focus of the TA grants can be better directed to support and advance ACL activities anticipated in FY15 in the area of elder rights and elder abuse prevention. Program Name: National Legal Assistance and SupportNational Legal Resource Center. Award Amount: $214,636 ($143,000/$71,636 per grantee). Project Period: 6/1/2011 to 5/31/2015. Award Type: Cooperative Agreement.

The Food and Drug Administration (FDA) has determined the regulatory review period for ONSIOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for POTIGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) has determined that NIMOTOP (Nimodipine) Capsules, 30 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to nimodipine capsules, 30 mg, and it will allow FDA to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements.

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 June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability,'' which explained 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 Administration for Community Living (ACL) is announcing the application deadline and a single case deviation from maximum competition for the National Legal Assistance and Support grants under Section 420(a)(1) of the Older Americans Act (OAA) that constitute the National Legal Resource Center (NLRC). The NLRC program provides resource support to a national system of legal assistance and elder rights programs to improve the quality, cost effectiveness, and accessibility of legal assistance and elder rights protections provided to older people. The purpose of this deviation is to award a 4th year non-competing continuation to the NLRC project grantees with a three (3) year budget period set to expire May 31, 2014 so that: (1) Stakeholder input can be obtained on the resource support needs of legal and aging/disability service providers across the country; and (2) the current work under the NLRC can be better directed to support and advance ACL activities anticipated in FY15 in the area of elder rights and elder abuse prevention. Program Name: National Legal Assistance and SupportNational Legal Resource Center. Award Amount: $655,462 ($143,347 to $185,693 per grantee). Project Period: 6/1/2011 to 5/31/2015. Award Type: Cooperative Agreement.