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

This document is a request for comments regarding the recently released PCAST report and its implications for the nation's health information technology (HIT) agenda and ONC's implementation of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).

The Food and Drug Administration (FDA) has determined the regulatory review period for COARTEM 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 National Science Advisory Board for Biosecurity (NSABB), an advisory committee to the Federal Government, is hosting a public consultation to obtain input from the scientific community and general public regarding strategies for enhancing personnel reliability and strengthening the culture of responsibility at facilities that conduct research with dangerous pathogens. The discussion will inform NSABB deliberations and ultimately the development of an NSABB report on the topic.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Extramural Research (OER), 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 13, 2010 (Volume 75, Number 176, page 55585) and allowed 60 days for public comment. One public 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 currently valid OMB control number. Proposed Collection: Title: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health. Type of Information Collection Request: NEW. Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds . To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. Frequency of Response: 1 response. Affected Public: Individuals. Type of Respondents: Science professionals (applicants, reviewers, Institutional Officials), adult science trainees, and the general public. The annual reporting burden is as follows: Quantitative surveys: Estimated Number of Respondents per Survey: 9,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.25; Estimated Total Annual Burden Hours Requested per Quantitative Survey: 2,455; Estimated Total Annual Burden Hours Requested for 10 Quantitative Surveys: 24,550. Qualitative surveys: Estimated Number of Respondents per Survey: 30; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.0; Estimated Total Annual Burden Hours Requested per Qualitative Survey: 30; Estimated Total Annual Burden Hours Requested for 4 Qualitative Surveys: 120. Based on an estimated 10 quantitative and 4 qualitative surveys per year: Estimated Total Combined Annual Hours of Burden Requested in Each of 3 Years: 24,670. Estimated Total Combined Cost to Respondents: $728,326. Based on an estimated 10 quantitative and 4 qualitative surveys per year over 3 years: Estimated Total Hours of Burden to Respondents for 2011, 2012, and 2013 Combined: 74,010. Estimated Total Cost to Respondents for 2011, 2012, and 2013 Combined: $2,184,978. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Gwynne L. Jenkins, Special Assistant to the Director, Office of Extramural Programs, OER, NIH, 6705 Rockledge Drive, Suite 350, Bethesda, MD 20892, or call non-toll-free number (301) 496-9232 or e-mail your request, including your address to: OEPMailbox@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

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

This notice announces a public meeting of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: December 13, 2010, 9:30 a.m. to 5 p.m. and December 14, 2010, 8:30 a.m.-1 p.m. e.t.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble powder in drinking water of chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows for control of pyrexia associated with acute bovine mastitis.

The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process.

This document corrects a technical error in an amendatory instruction of the regulations text in the final rule 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).

The Food and Drug Administration (FDA) is announcing that it has added a document to the docket for the proposed rulemaking concerning required textual warnings and accompanying graphics to be displayed on cigarette packages and in cigarette advertisements. The document is a report entitled ``Report: Experimental Study of Graphic Cigarette Warning Labels'' (Experimental Study Report) and it describes the results from a research study that quantitatively evaluated the relative impact of certain color graphics on consumer attitudes, beliefs, perceptions, and intended behaviors related to cigarette smoking. The purpose of this notice is to provide the public an opportunity to review and comment on the Experimental Study Report.

The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 390.500 Definition of ``High-Voltage Vacuum Switch''21 CFR 1002.61(a)(3) and (b)(2) (CPG Sec. 390.500). CPG Sec. 390.500 is included in FDA's Compliance Policy Guides Manual, which was listed in the Annual Comprehensive List of Guidance Documents that published on August 9, 2010.

The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones.

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 reporting and recordkeeping burden requirements associated with additional listing information for medical device registration and listing by non- electronic means.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic ProductsGeneral Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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

The Food and Drug Administration (FDA) is issuing a final order pursuant to the reclassification procedures under the biologics regulations; denying the request by Delmont Laboratories, Inc. (Delmont), for a hearing on FDA's proposal to revoke Delmont's license based on the proposed reclassification of its product, Polyvalent Bacterial Antigens with ``No U.S. Standard of Potency,'' Staphage Lysate[supreg] (SPL) (hereinafter referred to as SPL) into Category II (unsafe, ineffective, or misbranded); and revoking Delmont's U.S. License No. 299. The final order finalizes the proposed order published in the Federal Register of May 15, 2000 (65 FR 31003) (May 2000 proposal), to reclassify Category IIIA bacterial vaccines and bacterial antigens into Category I or Category II.

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 notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, and cosmetics that may not be marketed or sold in the United States.

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. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the availability of the document entitled ``Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers.'' The draft questions and answers (Q&A) guidance addresses the United States Pharmacopeia (USP) General Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and non- compendial drug products. This document answers questions regarding CVM's implementation of USP Residual Solvents.

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 burden hours associated with indexing of legally marketed unapproved new animal drugs for minor species.

AHRQ has accepted a notification of voluntary relinquishment from Helmet Fire, Inc. Patient Safety Group (A Component of Helmet Fire, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

AHRQ has accepted a notification of voluntary relinquishment from Human Performance Technology Group, Inc. of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (Pub. L. 111-3) amended title Xl of the Social Security Act by inserting after section 1139 the new section 1139A, ``Child Health Quality Measures.'': Subsection 1139A(b), ``Advancing and Improving Pediatric Quality Measures,'' directs the Secretary to establish a pediatric quality measures program to: improve and strengthen the initial core child health care quality measures established by the Secretary under section 1139A(a); expand on existing pediatric quality measures used by public and private health care purchasers and advance the development of new quality measures; and increase the portfolio of evidence-based, consensus pediatric quality measures available to public and private purchasers of children's healthcare services, providers, and consumers. Section 1139A(b)(3) requires the Secretary to consult with a broad range of stakeholders to set these priorities. To meet the requirement for extensive stakeholder consultation, we are seeking general public comment on these draft priorities, and asking the public to identify additional priorities as needed.

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 reporting requirements for the animal drug user fees and fee waivers and reductions.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 6, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled ``Guidance on IRB Approval of Research with Conditions.'' The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on OHRP's Web site at https://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or https://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf, is intended primarily for institutional review boards (IRB), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12 individuals and organizations, and those comments were considered as the guidance was finalized.

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with Iowa State University, is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on March 3 and 4, 2011, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Scheman Conference Center, Lincoln Way and University Avenue, Iowa State Center, Ames, IA. Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or email: david.arvelo@fda.hhs.gov. For information on accommodation options, visit https:// www.fshn.hs.iastate.edu/foodlabel/register.php or contact Dr. Ruth MacDonald, 2312 Food Sciences Building, Iowa State University, Ames, IA 50011, 515-294-5991, FAX: 515-294-8181, email: ruthmacd@iastate.edu. Registration: You are encouraged to register by February 21, 2011. The workshop has a $250 registration fee to cover the cost of facilities, materials, lunch on day 1, and breaks. There is no registration fee for FDA employees. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to: ``Iowa State University.'' If you need special accommodations due to a disability, please contact Dr. Ruth MacDonald (see Contact) at least 14 days in advance. Registration Form Instructions: To register, please complete the online registration form at https://www.fshn.hs.iastate.edu/foodlabel/ register.php, or submit your full name, business or organization name, complete mailing address, telephone number, email address, optional fax number, and any special accommodations required due to disability, along with a check or money order for $250 payable to ``Iowa State University.'' Mail to: Dr. Ruth MacDonald, Food Science and Human Nutrition, 2312 Food Sciences Building, Ames, IA 50011. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Requests for workshop handouts may be obtained through David Arvelo (see Contact).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse, 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 in Vol. 75 No. 144, pages 44265-44266, on July 28, 2010 and allowed 60 days for public comment. One public comment was received on the instruments outlined in the 60- day notice. A response to this request was sent to the interested party. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: Online Skills Training for PCPs on Substance Abuse. Type of Information Collection Request: New. Need and Use of Information Collection: This research will evaluate the effectiveness of the Online Skills Training for PCPs on Substance Abuse, via the Web site SBIRTTraining.com, to positively impact the knowledge, attitudes, intended behaviors and clinical skills of primary care physicians in the US who treat substance abuse patients. The Online Skills Training for PCPs on Substance Abuse is a new program developed with funding from the National Institute on Drug Abuse. The primary goal is to assess the impact of the training program on knowledge, attitude, intended behavior, and clinical skills. A secondary goal is to assess learner satisfaction with the program. If the program is a success, there will be a new, proven resource available to primary care physicians to improve their ability to assess and treat substance use disorders. In order to evaluate the effectiveness of the program, information will be collected from primary care physicians before exposure to the Web based materials (pre-test), after exposure to the Web based materials (post-test), and 4-6 weeks after the program has been completed (follow-up). Frequency of Response: On occasion. Affected Public: Primary care physicians who treat patients who have substance abuse. Type of Respondents: Physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 80. Estimated Number of Responses per Respondent: 3. Average Burden Hours per Response: 0.75. Estimated Total Annual Burden Hours Requested: 180. The Annualized Cost to Respondents Is Estimated at: $13,500. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing a program expansion of its Conference Cooperative Agreement Program (U13), awarded to the Engelberg Center for Health Care Reform at the Brookings Institution (Brookings). The goal of this expansion is to plan and hold meetings and conferences that will ensure broad stakeholder input on FDA programs and initiatives related to disseminating information from active medical product surveillance activities and other sources of product information.

The Food and Drug Administration (FDA) is amending certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.

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 focus groups as used by FDA to gauge public opinion on all FDA-regulated products.

This notice announces the availability of one new and six updated final toxicological profiles of priority hazardous substances comprising the twenty-first set prepared by ATSDR.

This notice announces a listening session to receive comments regarding the development of additional imaging efficiency measures for use in the Hospital Outpatient Quality Data Reporting Program (HOP QDRP), which is authorized under section 1833(t)(17) of the Social Security Act. The purpose of this listening session is to solicit input from stakeholders to identify additional potential imaging efficiency measures that CMS could consider. Measure developers, hospitals, medical specialty societies, medical professionals, and other interested stakeholders are invited to participate either in person or via teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available.

This proposed notice acknowledges the receipt of a deeming application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for recognition as a national accrediting organization for providers of outpatient physical therapy and speech-language pathology services that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, the Secretary of the Department of Health and Human Services publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This proposed notice announces the receipt of an application to renew the Medicare Advantage Deeming Authority of the National Committee for Quality Assurance (NCQA) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 4 years. The new term of approval would begin October 19, 2010, and would end October 18, 2014. In addition, this proposed notice announces a 30- day public comment period on the renewal of the application.

In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records (SOR) titled, ``Medicare and Medicaid Electronic Health Record (EHR) Incentive Program National Level Repository'' System No. 09-70-0587. The final rule for the Medicare and Medicaid EHR Incentive Program implements the provisions of the American Recovery and Reinvestment Act of 2009 (the Recovery Act) (Pub. L. 111-5). Specifically, Title IV of Division B of the Recovery Act amends Titles XVIII and XIX of the Social Security Act (the Act) by establishing incentive payments to eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) and Medicare Advantage (MA) Organizations participating in Medicare and Medicaid programs that adopt and successfully demonstrate meaningful use of certified electronic health record (EHR) technology. These Recovery Act provisions, together with Title XIII of Division A of the Recovery Act, may be cited as the ``Health Information Technology for Economic and Clinical Health Act,'' or the ``HITECH Act.'' The final rule specified the initial criteria EPs, eligible hospitals and CAHs, and MA Organizations must meet in order to qualify for an incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs, eligible hospitals and CAHs failing to demonstrate meaningful use of certified EHR technology beginning in 2015; and other program participation requirements. Also, the Office of the National Coordinator for Health Information Technology (ONC) issued a closely related final rule that specified the initial set of standards, implementation specifications, and certification criteria for certified EHR technology. ONC has also issued a separate final rule on the establishment of certification programs for health information technology (HIT). To register for the Medicare and Medicaid EHR Incentive Program, EPs, eligible hospitals and CAHs, and MA Organizations will be required to provide the following information: Name, National Provider Identifier (NPI), business address and business phone for each EP, eligible hospital or CAH; Taxpayer Identification Number (TIN) to which the EP, eligible hospital or CAH wants the incentive payment to be made; For EPs, whether they choose to participate in the Medicare EHR Incentive Program or the Medicaid EHR Incentive Program; For eligible hospitals and CAHs, their CMS Certification Number (CCN); and other information as specified by CMS. EPs, eligible hospitals and CAHs will also have the option to provide their e-mail address at the time of registration. MA Organizations will be required to provide their contract number on behalf of their MA-affiliated EPs and hospitals. At this time, participation in the Medicare and Medicaid EHR Incentive Programs is voluntary for EPs, eligible hospitals and CAHs. Per section 1886(n)(4)(B) of the Act, as added by section 4102(c) of the HITECH Act, the Secretary will post on the Internet Web site of the Centers for Medicare & Medicaid Services, in an easily understandable format, a list of the names, business addresses, and business phone numbers of the Medicare EPs, eligible hospitals and CAHs who are meaningful EHR users in the Medicare EHR Incentive Program. Sections 1853(m)(5) and 1853(l)(7) of the Act, as added by sections 4101(c) and 4102(c) of the HITECH Recovery Act, require the Secretary to post the same information for EPs and eligible hospitals participating in the MA program as would be required if they were in the Medicare FFS program. Additionally, the Secretary must post the names of the qualifying MA Organizations receiving the incentive payment or payments. The routine uses established with this system contain a proper explanation as to the need for the disclosure provisions and provide clarity to CMS' intention to disclose provider- specific information contained in this system. The primary purpose of this system, called the National Level Repository or NLR, is to collect, maintain, and process information that is required for the Medicare and Medicaid EHR Incentive Program. Information in this system will also be disclosed to: (1) Support regulatory, incentive payments and policy functions such as evaluation and reporting, whether performed by the Agency or by an Agency contractor or consultant; (2) assist another Federal and/or state agency, agency of a state government, or an agency established by state law; (3) assist in making the individual physician-level participation data available through an Agency website and by various other means of data dissemination; (4) assist the Department's Office of the National Coordinator of Health Information Technology's (ONC's) grantees for the purpose of supporting ``eligible professional'' (EP) adoption and meaningful use of certified EHR technology; (5) support litigation involving the Agency; (6) combat fraud, waste, and abuse in certain health benefits programs, and (7) assist in a response to a suspected or confirmed breach of the security or confidentiality of information. We have provided background information about this new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for information about the comment period.

The NTP announces the availability of draft NTP Technical Reports (TRs; available at https://ntp.niehs.nih.gov/go/36051) that will be peer-reviewed by an NTP Technical Reports Peer Review Panel at a meeting on January 26, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). Summary minutes from the peer review will be posted on the NTP Web site following the meeting.

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 recordkeeping requirements for manufacturers of medicated animal feeds.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``ANDAs: Impurities in Drug Products.'' This guidance updates recommendations regarding degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in December 1998 in conformance with the revision of the International Conference on Harmonisation (ICH) guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which was announced in August 2006.

The Health Resources and Services Administration (HRSA) will transfer Health Center Program (section 330 of the Public Health Service Act) Increased Demand for Services (IDS) and Capital Improvement Project (CIP) funds, awarded under the American Recovery and Reinvestment Act (ARRA), originally awarded to Harlem United Community AIDS Center, Inc. (HUCAC) to Upper Room AIDS Ministry, Inc. to ensure the provision of critical primary health care services and continuity of services to low-income, underserved homeless patients in New York City.

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 burden hours necessary to complete FDA Form 3546, Animal Drug User Fee Act (ADUFA) Cover Sheet.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.'' The purpose of this guidance is to provide information on FDA's current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this area has evolved in recent years in response to a number of public discussions on the use of active-controlled trials designed to show NI as the basis for approval of antibacterial drug products. This guidance finalizes the draft guidance published in the Federal Register of October 15, 2007.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adoption of FDA Food Code by Local, State and Tribal Governments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice fulfills the Secretary's obligation under section 1153(i) of the Social Security Act (the Act) to provide at least 6 months' advance notice of the expiration dates of contracts with out- of-State Quality Improvement Organizations (QIOs) before renewing any of those QIOs' contracts. It also specifies the period of time in which in-State QIOs may submit a proposal for those contracts.

The final rule with comment period in this document revises the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act). In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2011. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Affordable Care Act. In this final rule with comment period, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other pertinent ratesetting information for the CY 2011 ASC payment system. These changes are applicable to services furnished on or after January 1, 2011. In this document, we also are including two final rules that implement provisions of the Affordable Care Act relating to payments to hospitals for direct graduate medical education (GME) and indirect medical education (IME) costs; and new limitations on certain physician referrals to hospitals in which they have an ownership or investment interest. In the interim final rule with comment period that is included in this document, we are changing the effective date for otherwise eligible hospitals and critical access hospitals that have been reclassified from urban to rural under section 1886(d)(8)(E) of the Social Security Act and 42 CFR 412.103 to receive reasonable cost payments for anesthesia services and related care furnished by nonphysician anesthetists from cost reporting periods beginning on or after October 1, 2010, to December 2, 2010.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being made to reflect changes in the Date and Time, Agenda, and Procedure portions of the document. We also are postponing a session regarding biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured 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 portion of the meeting has been postponed due to the need to complete the review of additional data submitted by the applicant. Future meeting dates may be announced in the Federal Register.

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing renewal of the charter for the Advisory Committee on Blood Safety and Availability (ACBSA).

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 Administration on Aging is announcing the availability of supplemental grant funds for the support of the Senior Medicare Program (SMP). The goal of this supplemental is a program expansion for one award to include direct Medicare fraud prevention intervention activities in high risk areas. Funding Opportunity Title/Program Name: National Hispanic SMP (NHSMP). Announcement Type: Proposed program expansion. Funding Opportunity Number: Program Announcement No. HHS-2011-AoA- MP-1102. Statutory Authority: HIPAA of 1996 (Pub. L. 104-191). Catalog of Federal Domestic Assistance (CFDA) Number: 93.048 Discretionary Projects.

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ACCUTANE (isotretinoin) Capsules held by Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110- 1199. Hoffmann-La Roche Inc. notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.