Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

This notice identifies an initial core set of health quality measures recommended for Medicaid-eligible adults, as required by section 2701 of the Affordable Care Act, for voluntary use by State programs administered under title XIX of the Social Security Act (the Act), health insurance issuers and managed care entities that enter into contracts with Medicaid, and providers of items and services under these programs. This notice also solicits comments on these initial measures, on facilitating the use of these measures by States and on identifying priority areas for measure enhancement and development.

The National Institute for Occupational Safety and Health (NIOSH), Personal Protective Technology (PPT) Program and National Personal Protective Technology Laboratory (NPPTL) will conduct a stakeholders meeting to provide updates on NIOSH-funded research, certification and standards, educate participants on resources to reinforce the proper use of NIOSH-certified respirators, and explore personal protective technology use in industry sectors. In addition, conformity assessment (certification and standards) needs and gaps relative to the personal protective technology will be discussed at this meeting.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 09-27-2010 at 08:45:00 (https://federalregister.gov/a/2010-24277, Vol. 75, No. 187, Page: 59723-59724 (2 pages); Document Citation: 75 FR 59723; Document Number: 2010-24277) and allowed 60-days for public comment. One comment was received from an organization who requested to be considered as a contractor for NIA's project. No other public comments were received. 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 currently valid OMB control number. Proposed Collection: Title: Testing successful health communications surrounding aging-related issues from the National Institute on Aging (NIA). Type of Information Collection Request: New. Need and Use of Information Collection: This study will support NIA's mission ``to communicate information about aging and advances in research on aging to the scientific community, health care providers, and the public.'' The primary objectives of this study are to: Assess audiences' trusted/preferred sources for information, knowledge, attitudes, behaviors, and other characteristics for the planning/development of health messages and communications strategies; Pre-test health messages and outreach strategies while they are in developmental form to assess audience response, including their likes and dislikes.

This document corrects typographical and technical errors identified in the final rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program'' that appeared in the July 28, 2010 Federal Register.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal Child Support Enforcement databases under title IV-D of the Social Security Act (the Act) and significantly enhanced access to information for title IV-D child support purposes. States are moving toward a more integrated service delivery to better serve families and further the mission of the Child Support Enforcement program, while protecting confidential data. This final rule specifies requirements for: State Parent Locator Service responses to authorized location requests; and State Child Support Enforcement program safeguards for confidential information and authorized disclosures of this information. This final rule revises certain aspects of the State Parent Locator Service; Safeguarding Child Support Information final rule published on September 26, 2008 with an effective date delayed until December 30, 2010. This final rule will prohibit the disclosure of confidential and personally identifiable information to private collection agencies and expand disclosure to child welfare programs and the Supplemental Nutrition Assistance Program (SNAP).

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Research Resources, the National Institutes of Health 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 October 12, 2010, pages 62543-62544, 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. 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 currently valid OMB control number. Proposed Collection: Title: The National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative. Type of Information Collection Request: New. Need and Use of Information Collection: The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice. The primary purpose of this data collection is to provide information about the process and early outcomes associated with 46 awardees participating in the first four cohorts of CTSA awards, in order to fulfill the congressional expectations for external program evaluation. NIH will use the results to understand the extent to which the CTSA Initiative is bringing about transformational changes in clinical and translational science among academic medical centers and their research partners, increasing the efficiency of the research process, and enhancing the capacity of the field to conduct clinical and translational research. All information collected will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH's Government Performance and Results Act (GPRA) report. Frequency of Response: Biennial. Affected Public: Individuals. Type of Respondents: Scientific researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 3,563; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.13; Estimated Total Annual Burden Hours Requested: 451.5. The annualized cost to respondents is estimated at $14,056. There are no capital or start-up costs, and no maintenance or service cost components to report.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2011.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Thorn Bioscience LLC. The NADA provides for the use of deslorelin acetate injectable suspension in mares for inducing ovulation.

The Food and Drug Administration (FDA) has determined that TRANDATE (labetalol hydrochloride) tablets, 300 milligrams (mg) and 400 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule published in the Federal Register of April 17, 1997 (the 1997 proposed rule). The 1997 proposed rule would replace the voluntary petition process to affirm the generally recognized as safe (GRAS) status of a substance intended for use in food for humans or animals with a voluntary notification procedure. FDA is reopening the comment period to update comments. The proposed rule would also clarify the criteria for exempting the use of a substance as GRAS.

This document corrects a technical error that appeared in the November 17, 2010 Federal Register entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices'' final rule (75 FR 70372).

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of Head Start (OHS). This reorganization creates the Grants and Contracts Division and the State Initiatives Division. It renames the Educational Development and Partnership Division, titling it the Education and Comprehensive Services Division. It also renames the Immediate Office of Head Start, the Office of the Director. Additionally, it renames the Policy and Budget Division, the Policy and Planning Division.

The meeting of the Oncologic Drugs Advisory Committee scheduled for February 9, 2011, is cancelled. This meeting was announced in the Federal Register of December 6, 2010 (75 FR 75680). On February 9, 2011, the Oncologic Drugs Advisory Committee was scheduled to discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY (ipilimumab), submitted by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. This meeting has been cancelled because the issues for which FDA was seeking the scientific input of the committee have been resolved.

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 Cancer Institute (NCI), 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.

On Wednesday, April 8, 2009 [74 FR 15985], the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announced in the Federal Register plans to evaluate the scientific data on carbon nanotubes and to issue its findings on the potential health risks. A draft Current Intelligence Bulletin entitled ``Occupational Exposure to Carbon Nanotubes and Nanofibers'' has been developed which contains an assessment of the toxicological data and provides recommendations for the safe handling of these materials. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/docket/review/docket161A/ default.html. This guidance publication does not have the force or effect of the law. Public Comment Period: Comments must be received by February 18, 2011. Public Meeting Time and Date: 9 a.m.-4 p.m., February 3, 2011. Place: Millennium Hotel Cincinnati, Grand Ballroom A, 150 West 5th Street, Cincinnati, OH 45202. Purpose of Meeting: To discuss and obtain comments on the draft document, ``Occupational Exposure to Carbon Nanotubes and Nanofibers''. Special emphasis will be placed on discussion of the following: (1) Whether the hazard identification, risk estimation, and discussion of health effects for carbon nanotubes and nanofibers are a reasonable reflection of the current understanding of the evidence in the scientific literature; (2) Workplaces and occupations where exposure to carbon nanotubes and nanofibers occur; (3) Current strategies for controlling occupational exposure to carbon nanotubes and nanofibers (e.g., engineering controls, work practices, personal protective equipment; (4) Current exposure measurement methods and challenges in measuring workplace exposures to carbon nanotubes and nanofibers; (5) Areas for future collaborative efforts (e.g., research, communication, development of exposure measurement and control strategies). Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room accommodates 100 people. Interested parties should contact the NIOSH Docket Office at nioshdocket@cdc.gov, (513) 533-8611, or fax (513) 533-8285, for information about how to register for the meeting. Due to limited space, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than January 28, 2011. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come basis. Persons wanting to provide oral comments will be permitted 15 minutes. If additional time becomes available, presenters will be notified. All requests to present should contain the name, address, telephone number, and relevant business affiliations of the presenter, topic of the presentation, and the approximate time requested for the presentation. Oral comments made at the public meeting must also be submitted to the NIOSH Docket Office in writing in order to be considered by the Agency. Request for Information: NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to carbon nanotubes and nanofibers. Examples of requested information include, but are not to be limited to: (1) Identification of industries or occupations in which exposures to carbon nanotubes and nanofibers can occur; (2) Trends in the production and use of carbon nanotubes and nanofibers; (3) Exposure measurement data; (4) Case reports or other health information demonstrating possible health effects in workers exposed to carbon nanotubes or nanofibers; (5) Reports of experimental in vivo and in vitro studies that provide evidence of a dose-relationship between exposure to carbon nanotubes and nanofibers and biological activity; (6) Reports of experimental data on the airborne characteristics of carbon nanotubes or nanofibers, including information on the amounts that are inhalable and respirable; (7) Criteria and rationale for including workers in a medical surveillance and screening program; (8) Description of work practices and engineering controls used to reduce or prevent workplace exposure to carbon nanotubes and nanofibers; and (9) Educational materials for worker safety and training on the safe handling of carbon nanotubes and nanofibers.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This advance notice of proposed rulemaking announces the intention of CMS to solicit comment on the need to publish a proposed rule to address two policies related to the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, this document serves as a request for comments regarding our need to revisit the policies articulated in the September 9, 2003 Federal Register (68 FR 53243) and the August 19, 2008 Federal Register (73 FR 48656) concerning the applicability of EMTALA to hospital inpatients and the responsibilities of hospitals with specialized capabilities, respectively.

The Food and Drug Administration (FDA) is announcing the availability of draft ``Compliance Policy Guide Sec. 510.800 BeveragesServing Size Labeling'' (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on FDA's exercise of enforcement discretion related to serving size labeling for certain beverages that are packaged in containers larger than 20 fluid ounces and that display calories per 12 fluid ounce serving on the front of the container.

The Food and Drug Administration (FDA) is announcing the availability of Compliance Policy Guide Sec. 527.300 Dairy Products Microbial Contaminants and Alkaline Phosphatase Activity (the CPG). The CPG provides guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.

This document contains proposed regulations implementing the rules for health insurance issuers regarding the disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The proposed rule would establish a rate review program to ensure that all rate increases that meet or exceed an established threshold are reviewed by a State or HHS to determine whether the rate increases are unreasonable.

This notice describes the methodology for calculating the higher federal matching funding that is made available under section 1905(aa) of the Social Security Act, as amended by section 2006 of the Patient Protection and Affordable Care Act of 2010 (``Affordable Care Act'') and provides the adjusted Federal Medical Assistance Percentage (FMAP) rates for the fourth quarter of Fiscal Year 2011 and Fiscal Year 2012 for disaster-recovery FMAP adjustment states. Section 1905(aa) of the Social Security Act provides for an increase in the FMAP rate for qualifying states that have experienced a major, statewide disaster.

This notice announces an administrative hearing to be held on February 10, 2011, at the CMS San Francisco Regional Office, 90 7th Street, 5-300 (5W), San Francisco, California 94103 to reconsider CMS' decision to disapprove California SPAs 08-009A; 08- 009B1; 08-009B2; 08-009D; and 08-019.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MERIDIA (sibutramine hydrochloride (HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2011. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs). The Agency decided that to require a GLP quality system for all facilities/laboratories, as well as to more completely address nonclinical studies as they are presently conducted, the Agency would need to modify the existing regulations.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding compounds of carcinogenic concern used in food-producing animals. Specifically, the Agency is clarifying the definition of ``So'' and revising the definition of ``Sm'' so that it conforms to the clarified definition of So. Other clarifying and conforming changes are also being made.

The Food and Drug Administration (FDA) has determined the regulatory review period for LIVALO 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) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ehigiator O. Akhigbe, MD for 25 years from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Akhigbe was convicted of 17 felonies for conduct involving fraud, false statement and falsification or destruction of records. Dr. Akhigbe was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Akhigbe failed to respond. Dr. Akhigbe's failure to respond constitutes a waiver of his right to a hearing concerning this action.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, 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: Study of Substance Abuse doc.com Module Project. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a two-year generic clearance to a conduct research study to assess the efficacy of a specific interactive web-based teaching module in the field of professional education of healthcare providers. This online module was developed as a work product by the same team of investigators from Drexel University College of Medicine (DUCOM) and University of Pennsylvania School of Medicine (Penn Med) under a contract as part of NIDA's Center of Excellence (CoE) for Physician Information. This project will assess efficacy of the NIDA CoE online teaching module with educational interventions in enhancing: (1) The knowledge of healthcare professionals about substance use disorders; (2) attitudes of healthcare professionals toward patients with these disorders and (3) communication skills in providing assessment and referral to treatment for patients who abuse substances. The overall goal of this project is to assess the efficacy of an educational intervention, which should result in an increase in the involvement of primary care providers in the screening, managing and, when appropriate, referring patients with substance use disorders. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. The project will utilize a randomized cluster controlled trial design that compares the group that receives educational exposure to the set of new educational interventions (NIDA online teaching module plus educational adjuncts) to a control group that receives exposure to the standard medical school or residency educational curriculum related to substance use disorders. The project will use a repeated measures approach to assess the educational intervention's efficacy (i.e., individuals will take surveys before and after exposure to the intervention or to the control curriculum). The outcomes of the study will be based on changes in knowledge, attitudes and indirect measures of communication skills before and after the intervention, compared to the changes in these parameters in the control group. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals and businesses. Type of Respondents: medical students and resident physicians. The annual reporting burden is calculated as follows: Estimated Total Annual Number of Respondents: 708; Estimated Number of Responses per Respondent: 4 for medical students; 2 for resident physicians; Average Burden Hours per Response: 0.17. Estimated Total Annual Burden Hours Requested: 377; There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

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 September 28, 2010, Volume 75, No. 187, pages 59724-59725 and allowed 60 days for public comment. 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: Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the U.S. blood supply through hemovigilance. Type of Information Collection Request: NEW. Need and Use of Information Collection: Information on current risk factors in blood donors as assessed using analytical study designs is largely unavailable in the U.S. Studies of risk factor profiles among HIV-infected donors were funded by the CDC for approximately 10 years after implementation of serologic screening in the mid-1980s, whereas studies of HTLV- and HCV-seropositive (and indeterminate) donors, funded by NIH, were conducted in the early 1990s, but unfortunately, none of these studies is ongoing. Infection trend analyses have been conducted by the American Red Cross (ARC). The findings show continued HIV risk with the prevalence of HIV in first time donors hovering around 10 per 100,000 donations in each of the last 10 years and the incidence in repeat donors increasing from 1.49 per 100,000 person-years in 1999-2000 to 2.16 per 100,000 persons-years in 2007-2008. While the prevalence of HCV in first time donors decreased over this time interval from 345 to 163 per 100,000 donations, the incidence in repeat donors did not decrease and evidence of incident infection in first time donors increased. Moreover specific age, gender and race/ethnicity groups were over-represented. Significantly increased incidence of both HIV and HCV were observed in 2007/2008 compared to 2005/2006. Similar analyses for HBV have shown an incidence in all donors of 3.4 per 100,000 person-years which is lower than earlier estimates, but remains higher than for HIV and HCV. This project represents a collaborative pilot research study that will include a comprehensive interview study of viral infection positive blood donors at the American Red Cross (ARC), Blood Systems Inc. (BSI) and New York Blood Center (NYBC) in order to identify the current predominant risk factors for virus positive donations and will also establish a donor biovigilance capacity that currently does not exist in the U.S. At this time it is not easy to integrate risk factor data and disease marker surveillance information within or across different blood collection organizations because common interview procedures and laboratory confirmation procedures are not being used and so we cannot easily tabulate and analyze behavioral risks or viral infections in U.S. blood donors. This creates the potential for gaps in our understanding of absolute incidence and prevalence as well as risks that could lead to transfusion-transmitted disease. Combined data are critical for appropriate national surveillance efforts. For example, this information could be used to target educational interventions to reduce donations from persons with high risk behaviors. This is particularly important in the case of behaviors associated with incident (recently acquired) infections because these donations have the greatest potential transmission risk because they could be missed during routine testing. As part of the project a comprehensive research-quality biovigilance database will be created that integrates existing operational information on blood donors, disease marker testing and blood components collected by participating organizations into a research database. The combined database will capture infectious disease and risk factor information on nearly 60% of all blood donors and donations in the country. Following successful completion of the risk factor interviews and research database development, the biovigilance network pilot can be expanded to include additional blood centers and/or re-focused on other safety threats as warranted, such as XMRV. This pilot biovigilance network will thereby establish a standardized process for integration of information across blood collection organizations. The Specific Aims are to: (1) Define consensus infectious disease testing classification algorithms for HIV, HCV, HBV, and HTLV that can be used to consistently classify donation testing results across blood collection organizations in the U.S. This will allow for better estimates of infection disease marker prevalence and incidence in the U.S. (2) Determine current behavioral risk factors associated with prevalent and incident (when possible) HIV, HCV, HBV and HTLV infections in blood donors, including parenteral and sexual risks, across the participating blood collection organizations using a case- control study design. (3) Determine nationally-representative infectious disease marker prevalence and incidence for HIV, HCV, HBV, and HTLV overall and by demographic characteristics of donors. This will be accomplished by forming research databases from operational data at BSI and NYBC into formats that can be combined with the ARC research database. (4) Analyze integrated risk factor and infectious marker testing data together because when taken together these may show that blood centers are not achieving the same degree of success in educational efforts to prevent donation by donors with risk behaviors across all demographic groups. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult blood donors. The annual reporting burden is as follows: Estimated Number of Respondents:4150; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.58 and Estimated Total Annual Burden Hours Requested: 2407. The annualized cost to respondents is estimated at: $43,326 (based on $18 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 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 requirements governing applications for FDA approval to market a new drug.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2010, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month timeframe.

This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS), as requested by the Secretary, whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We have a special interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and physically challenged individuals are adequately represented on the MEDCAC. Therefore, we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule and an interim final rule published in the Federal Register of June 25, 2007, and is intended to set forth in plain language the requirements of that final rule and interim final rule and to help small businesses understand the regulations. In addition, the SECG includes several recommendations made by FDA in that final rule so that the guidance in those recommendations will be readily accessible to small businesses.

The Food and Drug Administration (FDA) has determined the regulatory review period for ANGIOMAX 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.

On November 5, 2009, President Obama signed the ``Memorandum for the Heads of Executive Departments and Agencies on Tribal Consultation.'' The President stated that his Administration is committed to regular and meaningful consultation and collaboration with tribal officials in policy decisions that have tribal implications, including, as an initial step, through complete and consistent implementation of Executive Order 13175. The United States has a unique legal and political relationship with Indian tribal governments, established through and confirmed by the Constitution of the United States, treaties, statutes, executive orders, and judicial decisions. In recognition of that special relationship, pursuant to Executive Order 13175 of November 6, 2000, executive departments and agencies are charged with engaging in regular and meaningful consultation and collaboration with tribal officials in the development of Federal policies that have tribal implications, and are responsible for strengthening the government-to-government relationship between the United States and Indian Tribes. The Department of Health and Human Services (HHS) has taken its responsibility to comply with Executive Order 13175 very seriously over the past decade, including the initial implementation of a Department- wide policy on tribal consultation and coordination in 1997, and through multiple evaluations and revisions of that policy, most recently in 2008. Many HHS agencies have already developed their own agency-specific consultation policies that complement the Department- wide efforts. Since 2005, the Administration for Children and Families (ACF) has been working under the guidance of the HHS policy issued in 2005, and updated in 2008. Due to the various programs administered by ACF and the many requests from Tribes for consultation for specific programs, as well as specific program mandates for tribal consultation, ACF has decided to create an ACF Tribal Consultation Policy to help ACF program and regional offices better engage Federally recognized Indian Tribes in the development or revision of policies, regulations, and proposed legislation that impact American Indians. ACF firmly believes that to create a good policy, ACF needs input from Tribes to ensure that ACF is meeting tribal needs and to establish a partnership that can carry into the future. ACF solicited membership for an ACF Tribal/Federal Workgroup to develop the initial draft policy. The Workgroup met August 23 and 24, 2010, in Washington, DC, and again in Minneapolis, Minnesota, on September 16 and 17, 2010. The draft was reviewed by tribal leaders attending the ACF Tribal Consultation Session held in Washington, DC on September 29, 2010, and the Workgroup met again to address the comments heard at the Tribal Consultation Session. ACF will convene the Tribal/Federal Workgroup again to review and address the comments received from this publication.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 the collection of information associated with the Agency's Voluntary Cosmetic Registration Program (VCRP).

The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

This notice announces a Town Hall Meeting to discuss the Physician Quality Reporting System (previously known as the Physician Quality Reporting Initiative (PQRI)). The purpose of the Town Hall Meeting is to solicit input from participating stakeholders on the individual quality measures and measures groups being considered for possible inclusion in the proposed set of quality measures for use in the 2012 Physician Quality Reporting System and key components of the design of the Physician Quality Reporting System. Measure developers, eligible professionals, professionals associations, such as medical specialty societies, and other interested stakeholders are invited to participate, in person or by teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging (NIA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on September 17, 2010, page 57038 and allowed 60-days for public comment. No public comments were 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 currently valid OMB control number.

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.

The Food and Drug Administration (FDA) has determined the regulatory review period for VIBATIV 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 patents which claim that human drug product.

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.

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 the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States.

The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.