Weekly Legislative & Regulatory Round-up
Week of March 26 - April 2, 2010
| GAO reports |
Medicare Recovery Audit Contracting: Weaknesses Remain in Addressing Vulnerabilities to Improper Payments, Although Improvements Made to Contractor Oversight GAO-10-143
VA Health Care: VA Has Taken Steps to Make Services Available to Women Veterans, but Needs to Revise Key Policies and Improve Oversight Processes GAO-10-287
Defense Health Care: 2008 Access to Care Surveys Indicate Some Problems, but Beneficiary Satisfaction Is Similar to Other Health Plans GAO-10-402
| OIG reports |
Payments by the Centers for Disease Control and Prevention to Vaccine Manufacturers and Suppliers (A-04-06-01042)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H.R. 4887 |
3/19/10 |
IKE SKELTON (D-MO) |
A bill to amend the Internal Revenue Code of 1986 to ensure that health coverage provided by the Department of Defense is treated as minimal essential coverage; Referred to the Committee on Ways and Means. |
H.R. 4894 |
3/20/10 |
STEVE BUYER (R-IN) |
A bill to amend the Patient Protection and Affordable Care Act to ensure appropriate treatment of Department of Veterans Affairs and Department of Defense health programs; Referred to the Committee on Energy and Commerce. |
S. 3147 |
3/22/10 |
DAVID VITTER (R-LA) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred to the Committee on Finance. |
S. 3148 |
3/22/10 |
JIM WEBB (D-VA) |
A bill to amend the Internal Revenue Code of 1986 to provide for the treatment of Department of Defense health coverage as minimal essential coverage; Referred to the Committee on Finance. |
S. 3151 |
3/22/10 |
JOHN KERRY (D-MA) |
A bill to establish the Office for Global Women's Issues and the Women's Development Advisor to facilitate interagency coordination and the integration of gender considerations into the strategies, programming, and associated outcomes of the Department of State and the United States Agency for International Development, and for other purposes; Referred to the Committee on Foreign Relations. |
H.R. 4903 |
3/22/10 |
MICHELE BACHMANN (R-MN) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, the Judiciary, Natural Resources, House Administration, Appropriations, and Rules. |
H.R. 4910 |
3/22/10 |
DAN BURTON (R-IN) |
A bill to repeal the Patient Protection and Affordable Care Act and enact the Empowering Patients First Act in order to provide incentives to encourage health insurance coverage; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Natural Resources, Education and Labor, Ways and Means, the Judiciary, Rules, the Budget, Appropriations, House Administration, and Oversight and Government Reform. |
H.R. 4911 |
3/22/10 |
JIM COOPER (D-TN) |
A bill to repeal specific provisions in the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means. |
S. 3152 |
3/23/10 |
JIM DeMINT (R-SC) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred read the first time, read the second time, placed on calendar. |
S. 3154 |
3/23/10 |
LISA MURKOWSKI (R-AK) |
A bill to amend the Public Health Service Act to reauthorize and extend the Fetal Alcohol Syndrome prevention and services program, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 4919 |
3/24/10 |
CONNIE MACK (R-FL) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, the Judiciary, Natural Resources, House Administration, Appropriations, and Rules. |
H.R. 4923 |
3/24/10 |
MARTIN HEINRICH (D-NM) |
A bill to amend title 10, United States Code, to extend TRICARE coverage to certain dependents under the age of 26; Referred to the Committee on Armed Services. |
H.R. 4926 |
3/24/10 |
TAMMY BALDWIN (D-WI) |
A bill to provide for the coverage of medically necessary food under Federal health programs and private health insurance; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and Armed Services. |
H.R. 4933 |
3/24/10 |
BARBARA LEE (D-CA) |
A bill to establish a strategy to coordinate all health-related United States foreign assistance, to assist developing countries in improving delivery of health services, and to establish an initiative to assist developing countries in strengthening their indigenous health workforces, and for other purposes; Referred to the Committee on Foreign Affairs, and in addition to the Committee on Financial Services. |
S. 3174 |
3/25/10 |
CHARLES GRASSLEY (R-IA) |
A bill to amend the Patient Protection and Affordable Care Act to provide for participation in the Exchange of the President, Vice-President, Members of Congress, political appointees, and congressional staff; Referred to the Committee on Homeland Security and Governmental Affairs. |
H.R. 4939 |
3/25/10 |
TIM MURPHY (R-PA) |
A bill to establish a procedure to safeguard the surpluses of the Social Security and Medicare hospital insurance trust funds; Referred to the Committee on the Budget, and in addition to the Committee on Rules. |
H.R. 4951 |
3/25/10 |
MCIAHEL BURGESS (R-TX) |
A bill to amend the Patient Protection and Affordable Care Act to provide for participation in the Exchange of the President, Vice-President, Members of Congress, political appointees, and congressional staff; Referred to the Committee on Oversight and Government Reform, and in addition to the Committees on House Administration, and Energy and Commerce. |
H.R. 4956 |
3/25/10 |
MARY BONO MACK (R-CA) |
A bill to amend the Patient Protection and Affordable Care Act to provide for participation in the Exchange of the President, Vice-President, Members of Congress, political appointees, and congressional staff; Referred to the Committee on Oversight and Government Reform, and in addition to the Committees on House Administration, and Energy and Commerce. |
H.R. 4960 |
3/25/10 |
MICHELE BACHMANN (R-MN) |
A bill to eliminate sweetheart deals under the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. |
H.R. 4972 |
3/25/10 |
STEVE KING (R-IA) |
A bill to repeal the Patient Protection and Affordable Care Act; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, the Judiciary, Natural Resources, Rules, House Administration, and Appropriations. |
H.R. 4982 |
3/25/10 |
BILL POSEY (R-FLA) |
A bill to amend the Patient Protection and Affordable Care Act to clarify the coverage for congressional employees through Exchanges under title I of such Act; Referred to the Committee on House Administration, and in addition to the Committee on Energy and Commerce. |
H.R. 4985 |
3/25/10 |
PHIL ROE (R-TN) |
A bill to repeal the provisions of the Patient Protection and Affordable Care Act providing for the Independent Payment Advisory Board; Referred to the Committee on Ways and Means, and in addition to the Committees on Rules, and Energy and Commerce. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Paid Feeding
Assistants in Long Term Care Facilities and Supporting Regulations at
42 CFR 483.160
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: The Fiscal
Soundness Reporting Requirements.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: New collection; Title of
Information Collection: Patient Safety Survey Under the 9th Scope of
Work: Nursing Home in Need (NHIN).
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups About Drug Products, as Used by the Food
and Drug Administration
ACTION: Notice.
DATES: Submit written or electronic comments on the collection of
information by May 21, 2010.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection:
Comment Request: Guidance for Industry Entitled Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
Food and Drug Administration
Impact of Dissolvable Tobacco Use on Public Health; Request for
Comments
ACTION: Notice; request for comments.
Food and Drug Administration
Revised Draft Guidance for Industry on Pharmacokinetics in
Patients With Impaired Renal Function--Study Design, Data Analysis, and
Impact on Dosing and Labeling; Availability
ACTION: Notice.
Indian Health Service
Office of Clinical and Preventive Services: National HIV Program
Announcement Type: Cooperative Agreement.
SUMMARY: The Indian Health Service (IHS) announces that competitive
cooperative agreement applications are now being accepted by the IHS
Office of Clinical and Preventive Services (OCPS) for the National
Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/
AIDS) Program. This program is authorized under the Snyder Act, 25
U.S.C. 13, and the Indian Health Care Improvement Act, 25 U.S.C.
1602(a)(b)(42)(43). This program is described under 93.933 in the
Catalog of Federal Domestic Assistance (CFDA). There will be only one
funding cycle during Fiscal Year (FY) 2010.
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Proposed Project: Assessment of the Town Hall Meetings on Underage
Drinking Prevention—Revision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical
Evaluation of Products for Treatment; Availability
ACTION: Notice.
Food and Drug Administration
Food and Drug Administration and Process Analytical Technology
for Pharma Manufacturing: Food and Drug Administration--Partnering With
Industry; Public Conference
ACTION: Notice of public conference.
Food and Drug Administration
Guidance for Industry on the Content and Format of the Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products; Availability
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Statement of Organization, Functions, and Delegations of
In an effort to improve the value and service that CMS provides to
the Nation, the CMS has modified its structure to align similar
functions under common executive leadership and allow CMS to establish
a Center for Program Integrity and to strengthen its focus on
beneficiary services and strategic planning.
The structure includes the following, which all report to the
Administrator, CMS: (1) Center for Medicare, (2) Center for Medicaid,
CHIP and Survey & Certification, (3) Center for Strategic Planning, (4)
Center for Program Integrity, and (5) Office of External Affairs and
Beneficiary Services. In addition, the current role of the Chief
Operating Officer (COO) has been formalized and remains responsible for
operations, information systems, contracts, finance, E-health standards
and services, and the Consortia. The COO continues to report to the
Administrator, CMS. The following organizations remain substantively
unchanged and continue to report to the Administrator, CMS: Office of
Equal Opportunity and Civil Rights, Office of Legislation, Office of
the Actuary, Office of Clinical Standards and Quality, and the Office
of Strategic Operations and Regulatory Affairs (will be renamed the
Office of Executive Operations and Regulatory Affairs to more
accurately reflect the work of the organization). New administrative
codes were assigned to all organizations, including the immediate
office of the Administrator.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Statement of Organization, Functions, and Delegations of
AND
Statement of Organization, Functions, and Delegations of
Food and Drug Administration
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practices; Public Workshop
ACTION: Notice of public workshop.
Food and Drug Administration
Determination That DIDREX (Benzphetamine Hydrochloride) Tablets,
25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
ACTION: Notice.
Health Resources and Service Administration
Advisory Committee on Interdisciplinary, Community-Based
Linkages; Notice of Meeting
Dates and Times: April 22, 2010, 8:30 a.m. to 5 p.m., EST. April
23, 2010, 8:30 a.m. to 3 p.m., EST.
Place: Doubletree Hotel and Executive Meeting Center, 8120
Wisconsin Avenue, Bethesda, Maryland 20814, Telephone: 301-652-2000.
Status: The meeting will be open to the public.
Health Resources and Services Administration
Advisory Committee on Training in Primary Care Medicine and
Dentistry; Notice of Meeting
Date and Time: April 22, 2010, 8 a.m.-4:30 p.m. EST.
Place: DoubleTree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, Maryland 20814.
Status: The meeting will be open to the public.
Health Resources and Services Administration
Council on Graduate Medical Education; Notice of Meeting
Dates and Times: April 22, 2010, 8:30 a.m.-4:15 p.m. EST; April
23, 2010, 8:30 a.m.-4:15 p.m. EST.
Place: DoubleTree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814, Telephone: (301) 652-2000.
Status: The meeting will be open to the public except on Friday,
April 23 from 12 p.m.-1 p.m.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--October Through December 2009
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from October 2009 through December 2009, relating to the
Medicare and Medicaid programs. This notice provides information on
national coverage determinations (NCDs) affecting specific medical and
health care services under Medicare. Additionally, this notice
identifies certain devices with investigational device exemption (IDE)
numbers approved by the Food and Drug Administration (FDA) that
potentially may be covered under Medicare. This notice also includes
listings of all approval numbers from the Office of Management and
Budget for collections of information in CMS regulations and a list of
Medicare-approved carotid stent facilities. Included in this notice is
a list of the American College of Cardiology's National Cardiovascular
Data registry sites, active CMS coverage-related guidance documents,
and special one-time notices regarding national coverage provisions.
Also included in this notice is a list of National Oncologic Positron
Emissions Tomography Registry sites, a list of Medicare-approved
ventricular assist device (destination therapy) facilities, a list of
Medicare-approved lung volume reduction surgery facilities, a list of
Medicare-approved clinical trials for fluorodeoxyglucose positron
emissions tomogrogphy for dementia, and a list of Medicare-approved
bariatric surgery facilities.
Centers for Medicare & Medicaid Services
Medicare Program; Request for Nominations to the Advisory Panel
on Ambulatory Payment Classification Groups
ACTION: Notice.
SUMMARY: This notice solicits nominations of five new members to the
Advisory Panel on Ambulatory Payment Classification (APC) Groups (the
Panel). There will be five vacancies on the Panel as of September 30,
2010.
The purpose of the Panel is to review the APC groups and their
associated weights and to advise the Secretary of the Department of
Health and Human Services (DHHS) and the Administrator of the Centers
for Medicare & Medicaid Services (CMS), concerning the clinical
integrity of the APC groups and their associated weights.
The Secretary re-chartered the Panel in 2008 for a 2-year period
effective through November 21, 2010.
DATES: Submission of Nominations: We will consider nominations if they
are received no later than 5 p.m. (e.s.t.), May 26, 2010.
Food and Drug Administration
Implementation of Device Registration and Listing Requirements
Enacted in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, the Medical Device User Fee and Modernization Act
of 2002, and Title II of the Food and Drug Administration Amendments
Act of 2007
ACTION: Proposed rule.
DATES: Submit written or electronic comments on the proposed rule by
June 24, 2010. Submit comments on information collection issues under
the Paperwork Reduction Act of 1995 by April 26, 2010, (see the
``Paperwork Reduction Act of 1995'' section of this document). See
sections IX and X of this document for the proposed effective and
proposed compliance dates of a final rule based on this document.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Managed
Care Regulations for 42 CFR 438.6, 438.8, 438.10, 438.12, 438.50,
438.56, 438.102, 438.114, 438.202, 438.204, 438.206, 438.207, 438.240,
438.242, 438.402, 438.404, 438.406, 438.408, 438.410, 438.414, 438.416,
438.604, 437.710, 438.722, 438.724, and 438.810
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Drug
Program Monthly and Quarterly Drug Reporting Format
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Collection
Requirements for Compendia for Determination of Medically-accepted
Indications for Off-label Uses of Drugs and Biologicals in an Anti-
cancer Chemotherapeutic Regimen
4. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Requests by Hospitals for an Alternative Cost-to-Charge Ratio.
5. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Subpart D--Private Contracts and Supporting Regulations contained in 42
CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455.
6. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Skilled Nursing Facility and Skilled Nursing Facility Health Care
Complex Cost Report.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: New Collection; Title of
Information Collection: State Medicaid HIT Plan and Templates for
Implementation of Section 4201 of ARRA; Form Number: CMS-10292
(OMB: 0938-NEW).
2. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: Business Proposal Forms for Quality Improvement
Organizations (QIOs)
3. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease (ESRD) Network Semi-Annual Cost
Report Forms and Supporting Regulations in 42 CFR 405.2110 and 42 CFR
405.2112.
Food and Drug Administration
Direct-to-Consumer Prescription Drug Advertisements; Presentation
of the Major Statement in Television and Radio Advertisements in a
Clear, Conspicuous, and Neutral Manner
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations concerning direct-to-consumer (DTC) advertisements of
prescription drugs. Specifically, the proposed rule would implement a
new requirement of the Federal Food, Drug, and Cosmetic Act (the act),
added by the Food and Drug Administration Amendments Act of 2007
(FDAAA), that the major statement in DTC television or radio
advertisements (or ads) relating to the side effects and
contraindications of an advertised prescription drug intended for use
by humans be presented in a clear, conspicuous, and neutral manner. FDA
is also proposing, as directed by FDAAA, standards that the agency
would consider in determining whether the major statement in these
advertisements is presented in the manner required by FDAAA.
DATES: Submit written or electronic comments on the proposed rule by
June 28, 2010. Submit comments on information collection issues under
the Paperwork Reduction Act of 1995 by April 28, 2010, (see section
``VI. Paperwork Reduction Act of 1995'' of this document). See section
II.D of this document for the proposed effective date of a final rule
based on this proposed rule.
Food and Drug Administration
Food and Drug Administration/Xavier University Global Medical
ACTION: Notice of public conference.
SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
co-sponsorship with Xavier University, is announcing a public
conference entitled ``FDA/Xavier University Global Medical Device
Conference.'' This 3-day public conference includes presentations from
key FDA officials, global regulators, and industry experts. The public
conference has three separate tracks of interest for quality,
regulatory affairs, and clinical research professionals, and is
intended for companies of all sizes and employees at all levels.
Dates and Times: The public conference will be held on May 5, 2010,
from 8 a.m. to 5 p.m.; May 6, 2010, from 8 a.m. to 5 p.m.; and May 7,
2010, from 8 a.m. to 1 p.m.
Food and Drug Administration
Guidance for Industry on Standards for Securing the Drug Supply
Chain--Standardized Numerical Identification for Prescription Drug
Packages; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Standards for
Securing the Drug Supply Chain-Standardized Numerical Identification
for Prescription Drug Packages.'' This guidance is being issued under
the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA
to develop standards for standardized numerical identifiers for
prescription drugs.
DATES: Submit written or electronic comments on agency guidances at any
time.
Food and Drug Administration
Advancing the Development of Diagnostic Tests and Biomarkers for
Tuberculosis; Public Workshop; Request for Comments
ACTION: Notice of public workshop; request for comments.
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: Federally Qualified Health Centers (FQHC) Application
Forms: (OMB No. 0915-0285 Revisions)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Process Evaluation of
the NIH's Roadmap Interdisciplinary Research Work Group Initiatives.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
Proposed Project:
Studying the Implementation of a Chronic Care Toolkit and Practice
Coaching In Practices Serving Vulnerable Populations
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
Proposed Project:
Reductions of Infection Caused by Carbapenem Resistant
Enterobacteriaceae (KPC) Producing Organisms Through the Application of
Recently Developed CDC/HICPAC Recommendations
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
Proposed Project:
Collection of Information for Agency for Healthcare Research and
Quality's (AHRQ) Consumer Assessment of Healthcare Providers and
Systems (CAHPS) Health Plan Survey Comparative Database
Agency for Healthcare Research and Quality
Common Formats for Patient Safety Data Collection and Event
Reporting
ACTION: Notice of Availability--Common Formats Version 1.1.
SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation
of Patient Safety Organizations (PSOs), which collect, aggregate, and
analyze confidential information regarding the quality and safety of
healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23)
authorizes the collection of this information in a standardized manner,
as explained in the related Patient Safety and Quality Improvement
Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the
Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized
by the Secretary of HHS, AHRQ coordinates the development of a set of
common definitions and reporting formats (Common Formats) that allow
healthcare providers to voluntarily collect and submit standardized
information regarding patient safety events. The purpose of this notice
is to announce the availability of the expanded and enhanced Common
Formats Version 1.1--including updated event descriptions, reports,
data elements, and technical specifications for software developers--
and the process for their continued refinement.
DATES: Ongoing public input.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
DEPARTMENT OF LABOR
Employee Benefits Security Administration
Medicaid and CHIP Programs; Meeting of the CHIP Working Group--
April 26, 2010
ACTION: Notice.
DATES: Meeting Date: Monday, April 26, 2010 from 9 a.m. to 5 p.m.,
Eastern Standard Time (E.S.T.).
ADDRESSES: Meeting Location: The meeting will be held at the Omni
Shoreham, 2500 Calvert Street, NW. at Connecticut Avenue in Washington,
DC 20008.
Food and Drug Administration
Pharmaceutical Supply Chain; Public Workshop
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop--
Enough Talk: Let's Find and Implement Solutions.'' The workshop,
cosponsored with the Parenteral Drug Association (PDA), will focus on
solutions to reduce the risk to product quality in the pharmaceutical
supply chain.
Date and Time: The conference will be held on Monday, April 26,
2010, from 8 a.m. to 6 p.m.; Tuesday, April 27, 2010, from 7:15 a.m. to
5:45 p.m.; and Wednesday, April 28, 2010, from 7:15 a.m. to 1:15 p.m.
Location: The public workshop will be held at the Hyatt Regency
Bethesda, 7400 Wisconsin Ave., 1 Bethesda Metro Center, Bethesda, MD
20814; Phone: 301-657-1234; FAX: 301-657-6453.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary, Office of Public Health and Science, Office of Healthcare
Quality
Call for Co-Sponsors for Office of Healthcare Quality's Programs
to Strengthen Coordination and Impact National Efforts in the
Prevention of Healthcare-Associated Infections (HAIs)
ACTION: Notice.
SUMMARY: The U.S. Department of Health and Human Services (HHS), Office
of Public Health and Science (OPHS), Office for Healthcare Quality
(OHQ) announces the opportunity to collaborate with the U.S. Department
of Health and Human Services (HHS). HHS invites public and private
professional health related organizations to participate as
collaborating co-sponsors in the development and implementation of an
innovative program that advances the goals enumerated in the HHS Action
Plan to prevent Healthcare-Associated Infections.
DATES: Expressions of interest for FY 2010-11 must be received no later
than cob April 15, 2010.
Office of the National Coordinator for Health Information
Technology; HIT Policy Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on April 21, 2010, from 10
a.m. to 4 p.m./Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700.
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on April 28, 2010, from 9
a.m. to 4 p.m./Eastern Time.
Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC. The hotel telephone number is 202-234-0700.
Office of Public Health and Science, Office of the Secretary
Establishment of the Presidential Commission for the Study of
Bioethical Issues
ACTION: Notice.
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: The Health Education Assistance Loan (HEAL) Program:
Physician's Certification of Borrower's Total and Permanent Disability
Form (OMB No. 0915-0204)—Extension
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure; Direct Final Rule
ACTION: Direct final rule.
Food and Drug Administration
Revision of Organization and Conforming Changes to Regulations
ACTION: Final rule.
Food and Drug Administration
Administrative Practices and Procedures; Good Guidance Practices;
Technical Amendment
ACTION: Final rule; technical amendment.
DATES: The rule is effective April 1, 2010.
Food and Drug Administration
Medical Devices; Technical Amendment
ACTION: Final rule; technical amendment.
Food and Drug Administration
Medical Devices; Pediatric Uses of Devices; Requirement for
Submission of Information on Pediatric Subpopulations That Suffer From
a Disease or Condition That a Device Is Intended to Treat, Diagnose, or
Cure
ACTION: Proposed rule.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Meeting for Software Developers on the Technical Specifications
for Common Formats for Patient Safety Data Collection and Event
Reporting
ACTION: Notice of public meeting.
SUMMARY: This notice announces a meeting to discuss the technical
specifications for AHRQ's common definitions and reporting formats
(Common Formats) Version 1.1 that allow for reporting of patient safety
information to Patient Safety Organizations (PSOs). The Patient Safety
and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26,
(Patient Safety Act) provides for the formation of PSOs, which collect,
aggregate, and analyze confidential information regarding the quality
and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C.
299b-23) authorizes the collection of this information in a
standardized manner, as explained in the related Patient Safety and
Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule),
published in the Federal Register on November 21, 2008: 73 FR 70731-
70814. As authorized by the Secretary of HHS, AHRQ coordinates the
development of the Common Formats that allow healthcare providers to
voluntarily collect and submit standardized information regarding
patient safety events. More information on the Common Formats Version
1.1, including the technical specifications, can be obtained through
AHRQ's PSO Web site: http://www.PSO.AHRQ.gov/index.html.
DATES: The meeting will be held from 10 a.m. to 5 p.m. on May 5, 2010.
ADDRESSES: The meeting will be held at the Hyatt Regency Baltimore, 300
Light Street, Baltimore, Maryland 21202.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Evaluation of the
Medicare National Competitive Bidding Program for DME.
DEPARTMENT OF LABOR
Employee Benefits Security Administration
Proposed Extension of Information Collection Request Submitted
for Public Comment; COBRA Notification Requirements--American Recovery
and Reinvestment Act of 2009 as Amended
ACTION: Notice.
DEPARTMENT OF LABOR
Employee Benefits Security Administration
Proposed Extension of Information Collection Request Submitted
for Public Comment; Model Employer CHIP Notice
ACTION: Notice.
Office of the Secretary
Determination and Declarations Regarding Emergency Use of Certain
In vitro Diagnostic, Antiviral, and Personal Respiratory Products
Accompanied by Emergency Use Information
ACTION: Notice.