Weekly Legislative & Regulatory Round-up
Week of February 28 - March 6
| GAO reports |
DHS: Organizational Structure and Resources for Providing Health Care to Immigration Detainees GAO-09-308R
Influenza Pandemic: Sustaining Focus on the Nation's Planning and Preparedness Efforts GAO-09-334
American Recovery and Reinvestment Act: GAO's Role in Helping to Ensure Accountability and Transparency GAO-09-453T
| OIG reports |
March 4, 2009
Effect of the Part D Coverage Gap on Medicare Beneficiaries Without Financial Assistance in 2006
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 511 |
3/3/09 |
SAM BROWNBACK (R-KS) |
A bill to amend part B of title XVIII of the Social Security Act to provide for an exemption of pharmacies and pharmacists from certain Medicare accreditation requirements in the same manner as such exemption applies to certain professionals; Referred to the Committee on Finance |
H.R. 1253 |
3/3/09 |
MICHAEL BURGESS (R-TX) |
A bill to require that limitations and restrictions on coverage under group health plans be timely disclosed to group health plan sponsors and timely communicated to participants and beneficiaries under such plans in a form that is easily understandable; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, and Ways and Means. |
S. 525 |
3/4/09 |
BYRON DORGAN (D-ND) |
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 1296 |
3/4/09 |
JAMES CLYBURN (D-SC) |
A bill to achieve access to comprehensive primary health care services for all Americans and to reform the organization of primary care delivery through an expansion of the Community Health Center and National Health Service Corps programs; Referred to the Committee on Energy and Commerce |
H.R. 1298 |
3/4/09 |
MARION BERRY (D-AR) |
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs, and for other purposes; Referred to the Committee on Energy and Commerce |
H.R. 1302 |
3/4/09 |
PHIL HARE (D-IL) |
A bill to amend title 38, United States Code, to establish the position of Director of Physician Assistant Services within the office of the Under Secretary of Veterans Affairs for Health; Referred to the Committee on Veterans' Affairs. |
S. 534 |
3/5/09 |
BILL NELSON (D-FL) |
A bill to amend title XVIII of the Social Security Act to reduce cost-sharing under part D of such title for certain non-institutionalized full-benefit dual eligible individuals; Referred to the Committee on Finance. |
S. 540 |
3/5/09 |
EDWARD KENNEDY (D-MA) |
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices; Referred to the Committee on Health, Education, Labor, and Pensions. |
H.R. 1321 |
3/5/09 |
ANNA ESHOO (D-CA) |
A bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and Oversight and Government Reform, 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. 1322 |
3/5/09 |
JOHN TIERNEY (D-MA) |
A bill to amend title I of the Employee Retirement Income Security Act of 1974 to provide emergency protection for retiree health benefits; Referred to the Committee on Education and Labor. |
H.R. 1330 |
3/5/09 |
DAN BOREN (D-OK) |
A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, the Internal Revenue Code of 1986, and title 5, United States Code, to require that group and individual health insurance coverage and group health plans and Federal employees health benefit plans provide coverage of colorectal cancer screening; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, and Oversight and Government Reform. |
H.R. 1339 |
3/5/09 |
CAROLYN MCCARTHY (D-NY) |
A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require that group and individual health insurance coverage and group health plans provide coverage for treatment of a minor child's congenital or developmental deformity or disorder due to trauma, infection, tumor, or disease; Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Labor, and Ways and Means. |
H.R. 1346 |
3/5/09 |
FRANK PALLONE (D-NJ) |
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices; Referred to the Committee on Energy and Commerce. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation
Principle
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Request for Nominations of Candidates To Serve on the Board of
Scientific Counselors, Coordinating Center for Infectious Diseases
(BSC, CCID)
CDC is soliciting nominations for possible membership on the BSC,
CCID. This board provides advice and guidance to the Secretary,
Department of Health and Human Services (HHS), the Director, CDC, and
the Director, CCID, concerning strategies and goals for the programs
and research within the national centers; shall conduct peer-review of
scientific programs; and monitor the overall strategic direction and
focus of the national centers. The board shall also monitor program
organization and resources for infectious disease prevention and
control.
Food and Drug Administration
Draft Guidance for Industry on the Clinical Pharmacology Section
of Labeling for Human Prescription Drug and Biological Products--
Content and Format; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Clinical
Pharmacology Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.'' This draft guidance is one
of a series of guidance documents intended to assist applicants in
complying with new FDA regulations on the content and format of
labeling for human prescription drug and biological products.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Approval Tests and Standards for Closed-Circuit Escape
Respirators
ACTION: Notice of proposed rulemaking; Reopening of comment period and
notice of public meetings.
SUMMARY: The Department of Health and Human Services (DHHS) is
reopening the comment period until April 10, 2009 and will hold public
meetings concerning the proposed rule for Approval Tests and Standards
for Closed-Circuit Escape Respirators that was published in the Federal
Register on Wednesday, December 10, 2008.
Department of Health and Human Services
Quality Assurance Requirements for Respirators
ACTION: Notice of proposed rulemaking; Reopening of comment period and
notice of public meetings.
SUMMARY: The Department of Health and Human Services (HHS) is reopening
the comment period until April 10, 2009 and will hold public meetings
concerning the proposed rule for Quality Assurance Requirements for
Respirators that was published in the Federal Register on Wednesday,
December 10, 2008.
Health Resources and Services Administration
Reimbursement of Travel and Subsistence Expenses Toward Living
Organ Donation Eligibility Guidelines
SUMMARY: HRSA published the final eligibility guidelines for the
Reimbursement of Travel and Subsistence Expenses Program in the Federal
Register on October 5, 2007 (72 FR 57049). A subsequent amendment to
the Program guidelines was published in the Federal Register on June
20, 2008 (73 FR 35143). HRSA is requesting public comments concerning
recommended changes to a specific section of the reimbursement program
eligibility guidelines.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
SUMMARY: 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: ``Coordinating Care across Primary Care and Specialty Care
Practices.''
Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections.
ACTION: Advanced notice of proposed rulemaking; request for comments.
SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science is seeking information and comments on
whether OHRP should pursue a notice of proposed rulemaking (NPRM) to
enable OHRP to hold institutional review boards (IRB) and the
institutions or organizations operating the IRBs, hereafter referred to
as the IRB organizations (IORG), directly accountable for meeting
certain regulatory requirements of the Department of Health and Human
Services (HHS) regulations for the protection of human subjects. OHRP
is contemplating this regulatory change to encourage institutions to
rely on IRBs that are operated by another institution or organization,
when appropriate.
No relevant notices