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

Results 251 - 300 of 349
Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2011-20118
Type: Notice
Date: 2011-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; Availability
Document Number: 2011-20117
Type: Notice
Date: 2011-08-09
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 ``Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This guidance document describes a means by which the herpes simplex virus types 1 and 2 serological assay device type may comply with the requirement of special controls for class II devices.
Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological Assay Device
Document Number: 2011-20115
Type: Rule
Date: 2011-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens.
Submission for OMB Review; Comment Request
Document Number: 2011-20105
Type: Notice
Date: 2011-08-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
Document Number: 2011-20098
Type: Notice
Date: 2011-08-09
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.
Tribal Consultation Meetings
Document Number: 2011-20071
Type: Notice
Date: 2011-08-09
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Notice of Meetings; Correction
Document Number: 2011-20026
Type: Notice
Date: 2011-08-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-20077
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-20033
Type: Notice
Date: 2011-08-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive License: Use of PKM2 Activators for the Treatment of Cancer
Document Number: 2011-20003
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 61/104,091, entitled ``Activators of Human Pyruvate Kinase,'' filed October 9, 2008, now abandoned [HHS Ref. No. E-326-2008/0-US-01]; PCT/US2009/60237 Application entitled ``Small Molecule Activators of Pyruvate Kinase,'' filed October 9, 2009, now abandoned [HHS Ref. No. E-326-2008/0-PCT-02]; EP Application No. 09740795.1, entitled ``Small Molecule Activators of Pyruvate Kinase,'' filed October 9, 2009 [HHS Ref. No. E-326-2008/0-EP-05]; U.S. Non- Provisional Application No. 13/123,297, entitled ``Small Molecule Activators of Pyruvate Kinase,'' filed April 8, 2011 [HHS Ref. No. E-326-2008/0-US-07]; Australian National Application No. 2009303335, entitled ``Small Molecule Activators of Pyruvate Kinase,'' filed October 9, 2010 [HHS Ref. No. E-326-2008/0-AU-03]; Canadian National Application, entitled ``Small Molecule Activators of Pyruvate Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-CA-04]; Japanese National Application, entitled ``Small Molecule Activators of Pyruvate Kinase,'' filing date pending [HHS Ref. No. E-326-2008/0-JP- 06]; U.S. Provisional Patent Application No. 61/329,158, entitled ``Pyruvate Kinase M2 Activators for the Treatment of Cancer,'' filed April 29, 2010, now abandoned [HHS Ref. No. E-120-2010/0-US-01]; and PCT Application PCT/US2011/033852 entitled ``Pyruvate Kinase M2 Activators for the Treatment of Cancer,'' filed April 26, 2011 [HHS Ref. No. E-120-2010/0-PCT-02] to Forma Therapeutics, Inc., having an office at 790 Memorial Drive, Cambridge, MA 02139. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of PKM2 activators as human therapeutics for the treatment of cancer.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-20000
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting
Document Number: 2011-19996
Type: Notice
Date: 2011-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
Andrew K. Choi: Debarment Order
Document Number: 2011-19976
Type: Notice
Date: 2011-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Andrew K. Choi, M.D. for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Choi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Choi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Choi failed to respond. Dr. Choi's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Submission for OMB Review; Comment Request
Document Number: 2011-19974
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 2011-19973
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Fiscal Year (FY) 2011 Funding Opportunity
Document Number: 2011-19965
Type: Notice
Date: 2011-08-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $300,000 (total costs) per year for up to four years to the Health Service Center, Inc., Anniston, AL. This is not a formal request for applications. Assistance will be provided only to the Health Service Center, Inc., Anniston, AL, based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-11-005.
Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode
Document Number: 2011-19959
Type: Proposed Rule
Date: 2011-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular permanent pacemaker electrode. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cardiovascular permanent pacemaker electrode based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cooperative Manufacturing Arrangements for Licensed Biologics
Document Number: 2011-19958
Type: Notice
Date: 2011-08-08
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.
Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator
Document Number: 2011-19957
Type: Proposed Rule
Date: 2011-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the Cranial Electrotherapy Stimulator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cranial electrotherapy stimulator based on new information. This action implements certain statutory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830
Document Number: 2011-19955
Type: Notice
Date: 2011-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
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 requirements relating to the blood establishment registration and product listing requirements in the Agency's regulations and Form FDA 2830.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011 and Proposal for Future Notices
Document Number: 2011-19954
Type: Notice
Date: 2011-08-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS. It also solicits comments on a process that CMS is considering to provide current up-to-date information in a Web friendly format. We are soliciting feedback on options that would improve accessibility and be less burdensome to beneficiaries, providers, and suppliers.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2012
Document Number: 2011-19544
Type: Rule
Date: 2011-08-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year 2012. In addition, it recalibrates the case-mix indexes so that they more accurately reflect parity in expenditures between RUG-IV and the previous case-mix classification system. It also includes a discussion of a Non-Therapy Ancillary component currently under development within CMS. In addition, this final rule discusses the impact of certain provisions of the Affordable Care Act, and reduces the SNF market basket percentage by the multi-factor productivity adjustment. This rule also implements certain changes relating to the payment of group therapy services and implements new resident assessment policies. Finally, this rule announces that the proposed provisions regarding the ownership disclosure requirements set forth in section 6101 of the Affordable Care Act will be finalized at a later date.
Notice of Scientific Summit; The Science of Compassion-Future Directions in End-of-Life and Palliative Care
Document Number: 2011-20004
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Notice is hereby given that the National Institute of Nursing Research (NINR), National Institutes of Health (NIH), Department of Health and Human Services, will convene a scientific summit titled ``The Science of CompassionFuture Directions in End-of-Life and Palliative Care.'' The summit is cosponsored by the NIH Office of Rare Diseases Research, the NIH Office of Research on Women's Health, the National Center for Complementary and Alternative Medicine, the National Institute on Aging, and the NIH Clinical Center Department of Bioethics. Portions of the event are supported by the Foundation for the National Institutes of Health and Pfizer.
Findings of Research Misconduct
Document Number: 2011-19930
Type: Notice
Date: 2011-08-05
Agency: Office of the Secretary, Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Sheng Wang, PhD, Boston University School of Medicine Cancer Research Center: Based on the Respondent's acceptance of ORI's research misconduct findings, ORI found that Dr. Sheng Wang, who has been an Assistant Professor, Department of Medicine, Boston University School of Medicine Cancer Research Center (BUSM), engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA102940 and R01 CA101992. ORI found that the Respondent engaged in research misconduct by fabricating data that were included in two (2) published papers:
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2011-19910
Type: Notice
Date: 2011-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-19881
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-19878
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health; Proposed Collection; Comment Request; Simulations for Drug Related Science Education
Document Number: 2011-19877
Type: Notice
Date: 2011-08-05
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 Institute on Drug Abuse (NIDA), 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 June 26, 2008 (Vol. 73, No. 124, page 36337) 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 November 15, 2008, unless it displays a currently valid OMB control number. Proposed Collection: Title: Simulations for Drug Related Science Education. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to evaluate an interactive multimedia module developed by ArchieMD. This evaluation seeks to determine whether the multimedia module Archie MD: The Science of Drugs (1) Increases students' knowledge in brain and heart biology and the effects drugs have on the body (2) Increases positive attitudes towards science education for high school students (3) Reinforce or instill negative attitudes towards substance abuse. In order to test the effectiveness of the interactive multimedia module, data will be collected in the form of pre and post test surveys from 10th and 11th grade high school students utilizing the developed module. The findings will provide valuable information regarding information pertaining to the use of interactive multimedia educational modules in high school science classrooms and their ability to increase knowledge and change attitudes and perceptions. Frequency of Response: 3. Affected Public: High school students engaged with the ArchieMD: The Science of Drugs program. Type of Respondent: Participants will include high school students enrolled in the tenth and eleventh grade. Estimated Total Annual Number of Respondents: 360. Estimated Number of Responses per Respondent: 4. Average Burden Hours per Response: 25 minutes. Estimated Total Annual Burden Hours Requested: 450.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2011-19869
Type: Notice
Date: 2011-08-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability
Document Number: 2011-19867
Type: Notice
Date: 2011-08-05
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 small business entities entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand FDA's thinking on compliance with the positron emission tomography drugs (PET) CGMP regulations, including appropriate resources, procedures, and documentation for PET drug production facilities.
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2011-19863
Type: Notice
Date: 2011-08-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Fiscal Year (FY) 2011 Funding Opportunity
Document Number: 2011-19860
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $3,800,000 (total costs) for up to one year to the National Council for Behavioral Healthcare. This is not a formal request for applications. Assistance will be provided only to the National Council for Behavioral Healthcare based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-11-013.
Award of Replacement Grant for Preventive Health to Lutheran Social Services of North Dakota, Fargo, ND
Document Number: 2011-19847
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
In Fiscal Year 2006, in an effort to assist States and local health departments to ensure that newly arriving refugees have access to preventive health screenings, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Division of Refugee Assistance (DRA) awarded, through competition, a Refugee Preventive Health grant to the North Dakota Department of Human Services for a project period of July 1, 2006 to June 30, 2011. The North Dakota Department of Human Services has relinquished the grant. ORR announces the award of a single-source replacement grant to Lutheran Social Services of North Dakota of Fargo, ND, a non-profit organization engaged in the resettlement of refugees, to continue services under the Refugee Preventive Health grant. Services provided under the grant to Lutheran Social Services of North Dakota are within the scope and operation of the original award, and address the preventive health needs of refugees in their first year in the United States. The program includes initial health screening, treatment of immediate health needs, follow up on chronic illnesses, nursing case management, interpretation services and preventive health education. The project period for the award is July 1, 2010 to June 30, 2011.
Indian Alcohol and Substance Abuse Memorandum of Agreement Between U.S. Department of Health and Human Services (DHHS), U.S. Department of the Interior (DOI), and U.S. Department of Justice (DOJ)
Document Number: 2011-19816
Type: Notice
Date: 2011-08-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This serves as notice that the Department of Health and Human Services (DHHS), the Department of the Interior (DOI), and the Department of Justice (DOJ), have entered into a Memorandum of Agreement (MOA), pursuant to the Indian Alcohol and Substance Abuse Treatment Act of 1986 (the Act), as amended by the Tribal Law and Order Act of 2010 (TLOA).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-19768
Type: Notice
Date: 2011-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-19766
Type: Notice
Date: 2011-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units
Document Number: 2011-19516
Type: Rule
Date: 2011-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will implement section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a 2 percent reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This final rule will also update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification and weighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are also consolidating, clarifying, and revising existing policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhance consistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Order entitled ``Improving Regulation and Regulatory Review,'' we are amending existing regulatory provisions regarding ''new'' facilities and changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and remove obsolete material.
Expediting Research Tools to NIH Licensees Through the Use of Pay.gov for Rapid Processing of Royalty Payments
Document Number: 2011-19821
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, National Institutes of Health
NIH licensees can now expedite the receipt of research tools through the use of Pay.gov for rapid processing of their royalty payments.
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-19817
Type: Notice
Date: 2011-08-04
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 Neurological Disorders and Stroke Amended; Notice of Meeting
Document Number: 2011-19813
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Document Number: 2011-19806
Type: Notice
Date: 2011-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2011-19804
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
Privacy Act of 1974; Report of Modified or Altered System
Document Number: 2011-19803
Type: Notice
Date: 2011-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR titled, ``Medicare Advantage Prescription Drug (MARx) System, No. 09-70-4001,'' last modified at 70 FR 60530 (October 18, 2005). CMS proposes to broaden the data collected and stored by this system as part of a redesign and modernization of the MARx System. On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). MMA amended the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandated that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the Medicare Part D benefit, the Act allows Medicare payment to plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) 423.401. The MARx System processes all enrollment/disenrollment transactions associated with the Part D program. The modified MARx System will accept and store Health Plan-supplied beneficiary residence addresses on an initial Part C and/or Part D enrollment or a subsequent record update transaction from the Plan. The main source of beneficiary residence address is the Social Security Administration (SSA). The address SSA provides, however, may not be the beneficiary's residence address. Beneficiary addresses are initially provided by SSA from the beneficiary's enrollment in Part A and/or Part B, and frequently reflect an address of a representative payee or a Post Office (P.O.) Box, not the residence of the beneficiary. This limits the effectiveness of geographically-sensitive Plan payment decisions. Plans have more accurate beneficiary address information, which is updated on a case-by-case basis. CMS wishes to allow this data to be transmitted in initial enrollment and subsequent record update transactions from the Plans, and additionally translated into valid residence address State and County Codes for subsequent use in service area determination. Support for Plan-supplied residence address will improve the accurate application of geographically sensitive rates in Plan payment calculation. The Plan-supplied beneficiary residence address will be updated and saved with the beneficiary's enrollment data in the MARx System. The residence address provided by the Plan will only apply to periods when the beneficiary is enrolled in that Plan. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charges with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 7 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. We will broaden the scope of published routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We will add a new routine use authorizing disclosure of individually identifiable information to assist in efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in these systems of records. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update language in the administrative sections to correspond with language used in other CMS SORs. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0588. The primary purpose of the SOR is to maintain a master file of Medicare Advantage (MA) and Medicare Advantage Prescription Drug (MA- PD) plan members for accounting and payment control; expedite the exchange of data with MA and MA-PD; control the posting of pro-rata amounts to the Part B deductible of currently enrolled MA members; and track participation of the prescription drug benefits provided under prescription drug plans (PDPs) and Medicare employer plans. Information in this system is disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by a contractor, consultant, or CMS grantee contracted by the Agency; (2) support another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist providers and suppliers of service directly or dealing through contractors, fiscal intermediaries (FI) or carriers for the administration of Title XVIII Medicaid state agency; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) assist insurance companies, third party administrators, employers, self-insurers, managed care organizations, and other supplemental insurers; (6) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (7) support litigation involving the Agency; (8) combat fraud and abuse in certain health benefits programs, and (9) assist in a response to a suspected or confirmed breach of the security or confidentiality of information. CMS has provided background information about the modified 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 comment period.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2011-19796
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-19792
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Notices of Filing of Petitions for Food Additives and Color Additives; Relocation in the Federal Register
Document Number: 2011-19765
Type: Notice
Date: 2011-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is notifying the public that notices of filing of petitions for food additives and color additives that are published in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) will now be published in the ``Proposed Rules'' section of the Federal Register. Notices of filing have historically been published in the ``Notices'' section of the Federal Register. The Office of the Federal Register (OFR) recently informed FDA that, under OFR rules, these documents actually fall into the ``Proposed Rules'' category and requested that FDA reclassify these notices of filing documents as proposed rules. This change is effective immediately.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2011-19739
Type: Notice
Date: 2011-08-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2011-19734
Type: Notice
Date: 2011-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer
Document Number: 2011-19733
Type: Proposed Rule
Date: 2011-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device pacemaker programmers. The agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of the aforementioned device based on new information. This action implements certain statutory requirements.
Submission for OMB Review; Comment Request
Document Number: 2011-19715
Type: Notice
Date: 2011-08-04
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
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