Weekly Legislative & Regulatory Round-up
Week of March 6 - 12, 2010
| GAO reports |
No relevant notices.
| OIG reports |
2010 Compendium of Unimplemented Office of Inspector General Recommendations (PDF)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 3094 |
3/9/10 |
JIM BUNNING (R-KY) |
A bill to allow individuals to elect to opt out of the Medicare part A benefits; to the Committee on Finance. |
H.R. 4787 |
3/9/10 |
TAMMY BALDWIN (D-WI) |
A bill to amend title XIX of the Social Security Act to improve and protect rehabilitative services and case management services provided under Medicaid to improve the health and welfare of the nation's most vulnerable seniors and children; to the Committee on Energy and Commerce. |
H.R. 4789 |
3/9/10 |
ALAN GRAYSON (D-FL) |
A bill to amend title XVIII of the Social Security Act to provide for an option for any citizen or permanent resident of the United States to buy into Medicare; to the Committee on Ways and Means. |
H.R. 4796 |
3/9/10 |
PATRICK MURPHY (D-PA) |
A bill to amend title XVIII of the Social Security Act with respect to the application of Medicare secondary payer rules for certain claims; to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce. |
H.R. 4799 |
3/9/10 |
ZACK SPACE (D-OH) |
A bill to direct the Secretary of Health and Human Services to develop a strategic plan to retrain displaced workers to become health care professionals serving areas with a shortage of such professionals, and for other purposes; to the Committee on Energy and Commerce. |
H.R. 4803 |
3/10/10 |
JOE BARTON (R-TX) |
A bill to ensure health care consumer and provider access to certain health benefits plan information and to amend title XIX of the Social Security Act to provide transparency in hospital price and quality information; to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Oversight and Government Reform. |
H.R. 4808 |
3/10/10 |
DIANA DEGETTE (D-CO) |
A bill to amend the Public Health Service Act to provide for human stem cell research, including human embryonic stem cell research, and for other purposes; to the Committee on Energy and Commerce. |
H.R. 4813 |
3/10/10 |
MARION BERRY (D-AR) |
A bill to provide for insurance reform (including health insurance reform), amend title XVIII of the Social Security Act to reform Medicare Advantage and reduce disparities in the Medicare Program, regulate the importation of prescription drugs, and for other purposes; to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, Oversight and Government Reform, Ways and Means, and Education and Labor. |
H.R. 4816 |
3/10/10 |
MAURINCE HINCHEY (D-NY) |
A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes; to the Committee on Energy and Commerce. |
H. Res. 1158 |
3/10/10 |
EDDIE BERNICE JOHNSON (D-TX) |
resolution recognizing Certified Nurses Day; to the Committee on Oversight and Government Reform. |
H. Res. 1162 |
|
LUCILLE ROYBAL-ALLARD (D-CA) |
A resolution recognizing National Public Health Week; to the Committee on Energy and Commerce. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Guidance on S9
Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability
ACTION: Notice.
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Expanded Access to Direct-Acting Antiviral Agents for the
Treatment of Chronic Hepatitis C Infection in Patients With Unmet
Medical Need; Public Hearing; Request for Comments
ACTION: Notice of public hearing; request for comments.
DATES: The public hearing will be held April 30, 2010, from 9 a.m. to 4
p.m. The meeting may be extended or may end early depending on the
level of public participation. Submit written or electronic requests
for oral presentations and comments by April 8, 2010 (see section III
of this document for details). Written or electronic comments will be
accepted after the hearing until June 25, 2010 (see section V of this
document for details).
Office of the National Coordinator for Health Information
Technology
Proposed Establishment of Certification Programs for Health
Information Technology
ACTION: Proposed rule.
SUMMARY: Under the authority granted to the National Coordinator for
Health Information Technology (the National Coordinator) by section
3001(c)(5) of the Public Health Service Act (PHSA) as added by the
Health Information Technology for Economic and Clinical Health (HITECH)
Act, this rule proposes the establishment of two certification programs
for purposes of testing and certifying health information technology.
While two certification programs are described in this proposed rule,
we anticipate issuing separate final rules for each of the programs.
DATES: To be assured consideration, written or electronic comments on
the proposals for the temporary certification program must be received
at one of the addresses provided below, no later than 5 p.m. on April
9, 2010. To be assured consideration, written or electronic comments on
the proposals for the permanent certification program must be received
at one of the addresses provided below, no later than 5 p.m. on May 10,
2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
ACTION: Notice.
Proposed Project: Development and Evaluation of AHRQ's Quality Indicators Improvement
Toolkit
DATES: Comments on this notice must be received by April 12, 2010.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Form FDA 3356;
Eligibility Determination for Donors; and Current Good Tissue Practice
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mammography Quality Standards Act Requirements
ACTION: Notice.
Food and Drug Administration
Determination That PRO-BANTHINE (Propantheline Bromide) Tablets
and 14 Other Drug Products Were Not Withdrawn From Sale for Reasons of
Safety or Effectiveness
ACTION: Notice.
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: Reinstatement without
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease (ESRD) Medical Information Facility
Survey.
2. Type of Information Collection Request: New collection; Title of
Information Collection: Information Collection Requirements and
Supporting Information for Chronic Kidney Disease Surveys under the 9th
Scope of Work.
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage.
Food and Drug Administration
Food and Drug Administration Transparency Task Force; Request for
Comments
ACTION: Notice; request for comments.
SUMMARY: The Food and Drug Administration (FDA) is soliciting comments
from interested persons on ways in which FDA can increase transparency
between FDA and regulated industry.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Comments on Proposed NIH, AHRQ and CDC Process Change
for Electronic Submission of Grant Applications
ACTION: Process change.
SUMMARY: The National Institutes of Health (NIH), the Agency for
Healthcare Research and Quality (AHRQ), and the Center of Disease
Control (CDC) seek comments from the public on the impact of
eliminating the correction window from the electronic grant application
submission process on our applicant organizations and the timing of
such a change.
DATES: To assure consideration, comments must be received by April 19,
2010.