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

This notice announces the second semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel), (the Ambulatory Payment Classification (APC) Panel) for 2012. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the APC groups and their associated weights, and hospital outpatient therapeutic supervision issues.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 12, 2011, Volume 77 No. 44, pages 14531-14533 and allowed 60-days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The 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 current valid OMB control number. Proposed Collection: Title: Web-Based Assessment of the Clinical Studies Support Center (CSSC). Type of Information Collection Request: New. Need and Use of Information Collection: Over the past decade Data Safety Monitoring Boards (DSMBs), Observational Safety Monitoring Boards (OSMBs), and Protocol Review Committees (PRCs) have become an important quality standard in clinical trials and research involving human subjects. The National Heart, Lung, and Blood Institute (NHLBI) alone currently has approximately 60 active review Committees. These include DSMBs, OSMBs, and PRCs which are independent groups convened to review study protocols developed under NHLBI funded Clinical Trial Networks. These committees are composed of members with expertise in biostatistics, clinical trials, bioethics, and other specific scientific and research areas. The NHLBI is charged with ensuring the highest quality of each Institute-funded clinical research project and compliance with Department of Health and Human Services (DHHS)/National Institutes of Health (NIH)/NHLBI regulations regarding human subject protections and safety monitoring. To carry out this responsibility, the NHLBI program staff instituted a new methodology for supporting the administration of NHLBI-appointed Committees in 2009. The new methodology included the establishment of the Clinical Studies Support Center (CSSC) under the direction of Westat, Inc. The CSSC is a pilot program to support the operations of NHLBI's DSMBs, Observational OSMBs, and PRCs for the Division of Blood Diseases and Resources. Utilizing Executive Secretaries to support each NHLBI safety monitoring board, the CSSC is responsible for documenting standardized operating procedures related to the administration of monitoring committees and the support center in a CSSC Manual of Operations and Procedures (MOP); coordinating meeting space and logistics for in-person meetings, Web conferences, and teleconferences; managing distribution of adverse event notifications to DSMB chairs and members, new protocols, and proposed amendments; and providing Executive Secretaries who provide scientific and administrative support to document board recommendations related to the safety and efficacy of trial interventions and the quality and completeness of clinical research study data. To move forward with full knowledge of current Committee operations and to monitor the effect of newly established procedures, Westat is required, as part of this contract, to conduct an assessment of the efficiency and effectiveness of NHLBI CSSC committee operations. As part of this assessment, the NHLBI requires feedback and advice regarding the support provided by the CSSC for monitoring board operations. To this end, a Web-based questionnaire will be administered to Chairs and members of monitoring boards to learn about their opinions about specific CSSC activities and their satisfaction with the performance of CSSC staff. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Monitoring board members. The annual reporting burden is a follows: Estimated Number of Respondents: 90; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.33 and Estimated Total Annual Burden Hours Requested: 30.36. The annualized cost to respondents is estimated at: $ 3.036 (based on $100 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.

The Food and Drug Administration (FDA) is announcing the following meeting: ``Requirements for Importing Food and Drug Administration Regulated Products Into the United States.'' The topics to be discussed are FDA regulations with respect to importing pharmaceutical products, medical devices, food products, as well as technology which applies to brokers and forwarders. Date and Time: The meeting will be held on July 18, 2012, from 8:30 a.m. to 5 p.m. in Des Plaines, IL. Location: The meeting will be held at the Illinois Department of Transportation Building, 9511 West Harrison St., Des Plaines, IL, 60016. Contact: Lisa Misevicz, Food and Drug Administration, 550 West Jackson Blvd., suite 1500, Chicago, IL 60661; 312-596-4217; email: lisa.misevicz@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) to the contact person by July 2, 2012. If you need special accommodations due to a disability, please contact Lisa Misevicz at least 7 days in advance.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain 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 investigational device exemptions reports and records.

The Health Resources and Services Administration (HRSA) announces updates and clarifications for the implementation of the Scholarships for Disadvantaged Students (SDS) program under authority of Section 737 of the Public Health Service Act (PHS Act). This notice supersedes all previous notices regarding the SDS program. A notice which proposed updates and clarified implementation of the SDS program was published in the Federal Register on March 20, 2012 (77 FR 16244). A period of 30 days was established to allow public comment concerning the proposed updates and implementation. Twenty-two letters were received, each with multiple comments. This notice discusses the comments and sets forth the final updates and implementation to the SDS program.

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 Drug Abuse (NIDA), 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. Proposed Collection: Title: Cognitive Testing of Instrumentation and Materials for Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The PATH study will establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions implemented as part of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) by the Food and Drug Administration (FDA). NIDA is requesting generic approval from OMB for cognitive testing of the PATH study's instrumentation, materials to support data collection (e.g., advance mailings, reminder letters, etc.), consent forms, and methods of administration (e.g., computer assisted personal interviews [CAPI], audio computer assisted self-interviews [ACASI], web-based interviews). Cognitive testing of these materials and methods will help to ensure that their design and content are valid and meet the PATH study's objectives. Additionally, results from cognitive testing will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of the information collection to help minimize its estimated cost and public burden. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Members of the public. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). Annual Reporting Burden: See Table 1. The annualized cost to respondents is estimated at: $11,861. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces draft recommendations for identification of persons with HCV chronic infection, available for public comment. The recommendations are intended to increase the proportion of persons with chronic HCV who are diagnosed, provided appropriate prevention services, and linked to needed care and treatment. Public comment will be used to inform the final recommendations. The Recommendations may be found at https:// www.regulations.gov, Docket No. CDC-2012-0005.

The Administration for Children and Families (ACF), Office of the Assistant Secretary (OAS), announces the award of a single source cooperative agreement for $3,000 with the Congressional Hunger Center (CHC) in Washington, DC, to support a Bill Emerson National Hunger Fellow who will work on hunger and obesity issues for young children. The Fellow will work closely with the ACF health team on strengthening its strategic vision to improve health and nutrition in children's programs. The Fellow will work with the team to examine programs in the Office of Child Care (OCC), OCC Tribal Maternal, Infant, and Early Childhood Home Visiting (TMIECHV) Grant Program under the Affordable Care Act (ACA), and the Office of Head Start, and will communicate with other agencies on child-focused nutrition programs. There is currently no individual in ACF designated to work specifically on these nutrition- and hunger-related issues. Additionally, the Fellow will work with the ACF health team to synthesize ideas emergent from this investigative work to further develop strategies for integrating hunger- and obesity-prevention strategies into ACF's childhood programming.