Department of Health and Human Services November 2011 – Federal Register Recent Federal Regulation Documents

Approaches to Reducing Sodium Consumption; Establishment of Dockets; Request for Comments, Data, and Information; Extension of Comment Period
Document Number: 2011-30865
Type: Notice
Date: 2011-11-30
Agency: Department of Agriculture, Food Safety and Inspection Service, Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) are extending the comment period to January 27, 2012, for the notice entitled ``Approaches to Reducing Sodium Consumption; Establishment of Dockets; Request for Comments, Data, and Information,'' that appeared in the Federal Register of September 15, 2011 (76 FR 57050). In that notice, FDA and FSIS requested comments on research, data, and other information that will better inform both Agencies about current and emerging practices by the private sector regarding sodium reduction in foods; current consumer understanding of the role of sodium in hypertension and other chronic illnesses; sodium consumption practices; motivation and barriers in reducing sodium in consumers' food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction in excess sodium intake. FDA and FSIS are extending the comment period in response to a request from an industry association for additional time to allow interested persons to submit comments.
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2012 Through September 30, 2013
Document Number: 2011-30860
Type: Notice
Date: 2011-11-30
Agency: Department of Health and Human Services
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2013 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2012 through September 30, 2013. This notice announces the calculated FMAP and eFMAP rates that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and Children's Health Insurance Program (CHIP) expenditures, Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. Table 1 gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice also announces the disaster-recovery FMAP adjustments for qualifying states for FY 2013 that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid) and title IV-E Foster Care, Adoption Assistance and Guardianship Assistance programs. Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits given in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 States. Section 1905(b) of the Act specifies the formula for calculating FMAPs as follows:
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: 2011-30846
Type: Notice
Date: 2011-11-30
Agency: Department of Health and Human Services
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart MMedical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination:
Medicare Program; Announcement of a New Application Deadline for the Advance Payment Model
Document Number: 2011-30845
Type: Notice
Date: 2011-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a new application deadline for participation in the Advance Payment Model for certain accountable care organizations participating in the Medicare Shared Savings Program scheduled to begin in 2012.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-30841
Type: Notice
Date: 2011-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-30833
Type: Notice
Date: 2011-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-30832
Type: Notice
Date: 2011-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements
Document Number: 2011-28612
Type: Rule
Date: 2011-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) for CY 2012 to implement applicable statutory requirements and changes arising from our continuing experience with this system. 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 OPPS. 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. In this final rule with comment period, we set forth the relative payment weights and payment amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other ratesetting information for the CY 2012 ASC payment system. We are revising the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, adding new requirements for ASC Quality Reporting System, and making additional changes to provisions of the Hospital Inpatient Value-Based Purchasing (VBP) Program. We also are allowing eligible hospitals and CAHs participating in the Medicare Electronic Health Record (EHR) Incentive Program to meet the clinical quality measure reporting requirement of the EHR Incentive Program for payment year 2012 by participating in the 2012 Medicare EHR Incentive Program Electronic Reporting Pilot. Finally, we are making changes to the rules governing the whole hospital and rural provider exceptions to the physician self-referral prohibition for expansion of facility capacity and changes to provider agreement regulations on patient notification requirements.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-30779
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-30771
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2011-30765
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-30732
Type: Notice
Date: 2011-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-30729
Type: Notice
Date: 2011-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Meeting of the Advisory Committee on Minority Health
Document Number: 2011-30682
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Announcement of Requirements and Registration for the United States Surgeon General's Healthy Apps Challenge
Document Number: 2011-30668
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services
The U.S. Surgeon General's Healthy Apps Challenge will encourage the development and submission of technology applications that will complement and enhance two key aspects of the Surgeon General's prevention agenda: The Surgeon General's Vision for a Healthy and Fit Nation (https://www.surgeongeneral.gov/library/obesityvision/ obesityvision2010.pdf) and the nation's first National Prevention Strategy (https://www.healthcare.gov/prevention/nphpphc/strategy/ report.pdf). Specifically, the challenge will highlight the ability of innovative new technologies to: (1) Provide health information tailored to the needs of the user; and (2) empower users (the general public) to regularly engage in and enjoy health promoting behaviors related to fitness and physical activity, nutrition and healthy eating, and/or physical, mental and emotional well-being. This challenge is being conducted in collaboration with the Office of the National Coordinator for Health IT.
National Healthy Worksite Program; Information Webinar Series
Document Number: 2011-30649
Type: Notice
Date: 2011-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces a series of Webinars to provide information for individuals and groups interested in learning more about the National Healthy Worksite Program. The National Healthy Worksite Program is an HHS/CDC initiative to establish and evaluate comprehensive workplace health programs to improve the health of workers and their families. Registration for the Webinars is free.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-30628
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-30627
Type: Notice
Date: 2011-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2011-30593
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from W.R. Grace and Company in Curtis Bay, Maryland, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2011-30589
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 facility in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2011-30587
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Ames Laboratory at Iowa State University, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2011-30586
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 18, 2011, 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:
Decision To Evaluate a Petition To Designate a Class of Employees From Titanium Alloys Manufacturing in Niagara Falls, NY, To Be Included in the Special Exposure Cohort
Document Number: 2011-30577
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Titanium Alloys Manufacturing in Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Titanium Alloys Manufacturing. Location: Niagara Falls, New York. Job Titles and/or Job Duties: All employees who worked in any area or building. Period of Employment: January 1, 1950 through December 31, 1956.
Submission for OMB Review; Comment Request
Document Number: 2011-30553
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, Administration for Children and Families
Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability
Document Number: 2011-30552
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses.
Proposed Collection; Comment Request: “Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey”
Document Number: 2011-30548
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
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 Department of Bioethics, the Clinical Center, 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.
Submission for OMB Review; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI)
Document Number: 2011-30534
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, 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 21, 2011 (76 FR 58520) and allowed 60 days for public comment. One public comment was received in which the individual suggested asking the respondents to report the number of procedures performed per month rather than per week because of the infrequency of some procedures. The program staff will assess this during the pre- test. 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: Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI). Type of Information Collection Request: Reinstatement with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/2011). Need and Use of Information Collection: By conducting a fourth cohort follow-up survey in an ongoing cohort study of U.S. Radiologic Technologists (USRT), updated information will be collected on cancer and other medical outcomes, personal medical radiation procedures, and other risk factors from all participants, plus detailed employment data from subgroups of participants who performed or assisted with fluoroscopically-guided or radioisotope procedures. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 23,454 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. The fourth survey will be administered by mail to approximately 93,000 living and located cohort members who completed at least one of the three previous surveys to collect information on new cancers and other disease outcomes, detailed work patterns and practices from technologists who worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that may influence health risks. New occupational and medical radiation exposure information will be used to improve radiation dose estimates. The annual reporting burden is reported in Table 1. There are no capital costs, operating costs and/or maintenance costs to report.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-30528
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2011-30526
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings.
Document Number: 2011-30524
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2011-30518
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, Administration for Children and Families
Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability
Document Number: 2011-30474
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.'' The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005.
Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG
Document Number: 2011-30473
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
Determination That TAXOTERE (Docetaxel) Injection, 40 Milligrams/Milliliter Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-30472
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other legal and regulatory requirements are met.
Amended Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants and Their Household Members; Availability
Document Number: 2011-30450
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, as amended on February 25, 2009, and on August 23, 2010, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). Following issuance of FDA's August 23, 2010, amended Authorization letter, on April 8, 2011, BARDA submitted a request on behalf of ASPR to further amend the Authorization to reflect certain programmatic changes, including by replacing references to the CRI with the National Postal Model (NPM). In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization in its entirety on October 14, 2011. The Authorization, as amended and reissued, includes explanations for its reissuance and is reprinted in this document.
Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus
Document Number: 2011-30449
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,'' dated November 2011. The draft guidance document provides recommendations on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the draft guidance provides notification that FDA considers the use of an FDA- licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA concerning the testing of donations for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc), and the management of donors and units mentioned in those documents.
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: 2011-30416
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
Request for Nominations for Voting Members on Public Advisory Committee, Science Board to the Food and Drug Administration
Document Number: 2011-30415
Type: Notice
Date: 2011-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-30281
Type: Notice
Date: 2011-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-30274
Type: Notice
Date: 2011-11-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-30269
Type: Notice
Date: 2011-11-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Office Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012
Document Number: 2011-28597
Type: Rule
Date: 2011-11-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain statutory provisions including provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. In addition, this final rule with comment period discusses payments for Part B drugs; Clinical Laboratory Fee Schedule: Signature on Requisition; Physician Quality Reporting System; the Electronic Prescribing (eRx) Incentive Program; the Physician Resource-Use Feedback Program and the value modifier; productivity adjustment for ambulatory surgical center payment system and the ambulance, clinical laboratory, and durable medical equipment prosthetics orthotics and supplies (DMEPOS) fee schedules; and other Part B related issues.
Agency Emergency Processing Under the Office of Management and Budget Review; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance
Document Number: 2011-30471
Type: Notice
Date: 2011-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
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). The proposed collection of information concerns a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act (FSMA) reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Medicare Program; Renaming and Other Changes to the Advisory Panel on Hospital Outpatient Payment Charter (Formerly the Advisory Panel on Ambulatory Payment Classification Groups) and Request for Nominations
Document Number: 2011-30417
Type: Notice
Date: 2011-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the name change of the Advisory Panel on Ambulatory Payment Classification Groups to the Advisory Panel on Hospital Outpatient Payment (HOP) (the Panel). In addition, it announces the renewal and amendments to the charter including changing the scope of the Panel to include supervision of outpatient hospital services, changing the Panel membership to include Critical Access Hospitals (CAH), and the solicitation of six nominations for individuals to serve on the Panel in 2012.
Statement of Delegation of Authority
Document Number: 2011-30411
Type: Notice
Date: 2011-11-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services, Health Resources and Services Administration
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-30357
Type: Notice
Date: 2011-11-25
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2011-30352
Type: Notice
Date: 2011-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2011-30348
Type: Notice
Date: 2011-11-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
Document Number: 2011-30337
Type: Notice
Date: 2011-11-25
Agency: Department of Health and Human Services
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings 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 range (75 year) projection methods and assumptions in projecting Medicare health expenditures and projecting National Health Expenditures 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 project 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.
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