Weekly Legislative & Regulatory Round-up
Week of December 21, 2009 - January 8, 2010
| GAO reports |
VA Health Care: Improved Oversight and Compliance Needed for Physician Credentialing and Privileging Processes GAO-10-26
Medicare Managed Care: Observations about Medicare Cost Plans GAO-10-185
Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs GAO-10-118R
Recovery Act: Planned Efforts and Challenges in Evaluating Compliance with Maintenance of Effort and Similar Provisions GAO-10-247
Nursing Homes: Addressing the Factors Underlying Understatement of Serious Care Problems Requires Sustained CMS and State Commitment GAO-10-70
Nursing Homes: Responses from Two Web-based questionnaires to Nursing Home Surveyors and State Agency Directors (GAO-10-74SP), an e-supplement to GAO-10-70 GAO-10-74SP
State and Local Government Retiree Health Benefits: Liabilities Are Largely Unfunded, but Some Governments Are Taking Action GAO-10-61
Medicaid: Ongoing Federal Oversight of Payments to Offset Uncompensated Hospital Care Costs Is Warranted GAO-10-69
Nursing Homes: Opportunities Exist to Facilitate the Use of the Temporary Management Sanction GAO-10-37R
| OIG reports |
Adverse Events in Hospitals: Public Disclosure of Information about Events (PDF)
Follow-Up Audit of the Medicaid Drug Rebate Program in Maine (A-01-09-00001)
Medicare Power Wheelchair Claims Frequently Did Not Meet Documentation Requirements (PDF) (OEI-04-07-00401)
Vulnerabilities in Medicare Payments for Pressure Reducing Support Surfaces (PDF) (OEI-02-07-00421)
Solicitation of New Safe Harbors and Special Fraud Alerts: Federal Register (PDF)
CDCs CHEMPACK Project: Nerve Agent Antidote Storage (PDF) (OEI-04-08-00040)
Monthly Recovery Act Report: November
Summary of Inspectors General Reports on Federal Agencies' Data-Quality Review Processes (A-09-10-01002)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
S. 2873 |
2009-12-11 |
Mark Begich (D- AK) |
A bill to amend the Internal Revenue Code of 1986 to deny the deduction for direct to consumer advertising expenses for prescription pharmaceuticals and to provide a deduction for fees paid for the participation of children in certain organizations which promote physical activity; Referred to the Committee on Finance. |
S. 2882 |
2009-12-15 |
John Kerry (D MA) |
A bill to amend the Internal Revenue Code of 1986 to modify the rules relating to the treatment of individuals as independent contractors or employees, and for other purposes; Referred to the Committee on Finance. |
S. 2883 |
2009-12-15 |
Mike Johanns (R NE) |
A bill to amend the Internal Revenue Code of 1986 to provide for the distribution of remaining balances in flexible spending arrangements upon termination from employment; Referred to the Committee on Finance. |
H.R. 4310 |
2009-12-15 |
Dennis Kucinich (D- OH 10) |
A bill to amend the Internal Revenue Code of 1986 to protect children's health by denying any deduction for advertising and marketing directed at children to promote the consumption of food at fast food restaurants or of food of poor nutritional quality; Referred to the Committee on Ways and Means. |
H.R. 4313 |
2009-12-15 |
Don Young (R AK AL) |
A bill to amend Part B of title XVIII of the Social Security Act to eliminate the sunset for reimbursement for services furnished by certain Indian hospitals and clinics; 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.Res. 971 |
2009-12-15 |
Debbie Wasserman Schultz (D FL 20) |
A resolution expressing the sense of the House of Representatives regarding guidelines for breast cancer screening for women ages 40 to 49; Referred to the Committee on Energy and Commerce. Resolution was considered and agreed to. |
H. Res. 975 |
2009-12-15 |
Allyson Schwartz (D- PA 13) |
A resolution recognizing the potential for a national fresh food financing initiative to provide an effective and economically sustainable solution to the problem of limited access to healthy foods in underserved urban, suburban, and rural low-income communities, while also improving health and stimulating local economic development; Referred to the Committee on Agriculture. |
H.R. 4371 |
2009-12-16 |
Charles Gonzalez (D TX 20) |
A bill to amend title XVIII of the Social Security Act to continue using 2009 Medicare practice expense relative value units for certain cardiology services; 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. 4373 |
2009-12-16 |
Doc Hastings (R WA 4) |
A bill to amend title XVIII of the Social Security Act to stabilize and modernize the provision of partial hospitalization services under the Medicare Program, and for other purposes; Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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. 4383 |
2009-12-16 |
Jim Marshall (D- GA 8) |
A bill to amend the Public Health Service Act and title XIX of the Social Security Act to provide for a screening and treatment program for prostate cancer in the same manner as is provided for breast and cervical cancer; Referred to the Committee on Energy and Commerce. |
H.R. 4390. |
2009-12-16 |
Scott Murphy (D NY 20) |
A bill to amend title XI of the Social Security Act to provide for enhanced program and provider protections under the Medicare, Medicaid, and Children's Health Insurance programs; 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. 4404 |
2009-12-16 |
Maxine Waters (D CA 35) |
A bill to amend the Public Health Service Act to authorize grants to provide treatment for diabetes in minority communities; Referred to the Committee on Energy and Commerce. |
H. Res. 983 |
2009-12-16 |
Michael Burgess (R TX 26) |
A resolution requesting the President, and directing the Secretary of Health and Human Services, to transmit to the House of Representatives copies of documents, records, and communications in their possession relating to certain agreements regarding health care reform; Referred to the Committee on Energy and Commerce. |
H.R. 4409 |
2009-12-19 |
Gene Green (D TX) |
A bill to amend the Public Health Service Act to authorize a program for the training of medical residents in community-based settings; Referred to the Committee on Energy and Commerce. |
S. 2922 |
2009-12-22 |
Orrin Hatch (R UT) |
A bill to amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to extend the Rural Community Hospital Demonstration Program; Referred to the Committee on Finance. |
| Federal Register notices |
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: The Health Education Assistance Loan (HEAL) Program
Regulations (OMB No. 0915-0108) Extension
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: Advanced Education Nursing Traineeship (AENT) and
Nurse Anesthetist Traineeship (NAT) (OMB No. 0915-0305) [Extension]
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on
Addendum to International Conference on Harmonisation S6; Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1);
Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Addendum to ICH S6:
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
S6(R1).'' The draft guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The draft guidance
provides recommendations on nonclinical studies to support the safety
of clinical trials and marketing applications for biotechnology-derived
pharmaceuticals. The draft guidance is intended to clarify and provide
greater detail to the nonclinical recommendations in the ICH guidance
entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived
Pharmaceuticals'' (ICH S6) published in the Federal Register of
November 18, 1997 (62 FR 61515).
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by February 1, 2010.
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 11 on
Capillary Electrophoresis General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
International Conference on Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 12 on
Analytical Sieving General Chapter; Availability
ACTION: Notice.
Food and Drug Administration
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance and Good Clinical Practices; Public Workshop
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) Florida District, in
cosponsorship with The Society of Clinical Research Associates, Inc.
(SoCRA), is announcing a public workshop entitled ``FDA Clinical Trial
Requirements, Regulations, Compliance and GCP.'' This 2-day public
workshop is intended to provide information about FDA clinical trial
requirements to the regulated industry.
Date and Time: The public workshop will be held on Wednesday, March
3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8
a.m. to 4:35 p.m.
Location: The public workshop will be held at The Wyndham Orlando
Resort, 8001 International Dr., Orlando, FL 32819, 407-351-2420.
Centers for Disease Control and Prevention
Total Inward Leakage Requirements for Respirators
ACTION: Notice of proposed rulemaking; extension of comment period.
SUMMARY: The Centers for Disease Control and Prevention (CDC) is
extending to March 29, 2010, the comment period for the notice of
proposed rulemaking by the National Institute for Occupational Safety
and Health (NIOSH) of CDC, entitled ``Total Inward Leakage Requirements
for Respirators,'' published in the Federal Register on Friday, October
30, 2009 (74 FR 56141). In the notice of proposed rulemaking, CDC
requested comments by December 29, 2009. The Agency is taking this
action in response to requests for an extension to allow interested
parties additional time to submit comments.
Health Resources and Services Administration
Health Center Program
ACTION: Notice of noncompetitive replacement awards to Regional Health
SUMMARY: The Health Resources and Services Administration (HRSA) will
be transferring Health Center Program (section 330 of the Public Health
Service Act) New Access Point (NAP) and Increased Demand for Service
(IDS) funds originally awarded to Trover Health System to Regional
Health Care Affiliates to ensure the provision of critical primary
health care services to underserved populations in Webster and McLean
Counties, Kentucky.
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: New Collection; Title of
Information Collection: State Plan Amendment Template for the Option to
Cover Certain Children and Pregnant Women Lawfully residing in U.S.
2. Type of Information Collection Request: New collection; Title of
Information Collection: State Plan Amendment Templates for Additional
State Plan Option for Providing Premium Assistance under Title XIX and
XXI.
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: Intermediate Care
Facility (ICF) for the Mentally Retarded (MR) or Persons with Related
Conditions Survey Report Form and Supporting Regulations.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Organ Procurement
Organization's (OPO's) Health Insurance Benefits Agreement and
Supporting Regulations at 42 CFR 486.301-486.348.
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Services
Participation Report.
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: State Health
Insurance Assistance Program (SHIP) Client Contact Form, Public and
Media Form, and Resource Report Form.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: End Stage Renal
Disease (ESRD) Medical Information Facility Survey.
6. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Notification of
Fiscal Intermediaries and CMS of co-located Medicare providers and
Supporting Regulations in 42 CFR 412.22 and 412.533.
7. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Examination and
Treatment for Emergency Medical Conditions and Women in Labor (EMTALA).
8. 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.
9. 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
Medicaid Program and Children's Health Insurance Program; Model
of Interstate Coordinated Enrollment and Coverage Process for Low-
Income Children
ACTION: Notice with comment.
SUMMARY: This notice requests comments to assist in the development of
a model process for the coordination of enrollment, retention, and
coverage for low-income Medicaid and Children's Health Insurance
Program eligible children as required under the Children's Health
Insurance Program Reauthorization Act (CHIPRA) of 2009. CHIPRA requires
this model process to be developed by August 4, 2010 and the Secretary
is required to submit a Report to Congress describing additional steps
or authority needed to make further improvements to coordinate the
enrollment, retention, and coverage under CHIP and Medicaid of low-
income children who frequently change their State of residence.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on January 19, 2010.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--July Through September 2009
ACTION: Notice.
SUMMARY: This notice lists CMS manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published from July 2009 through September 2009, relating to the
Medicare and Medicaid programs.
Centers for Medicare & Medicaid Services
Medicare Program; First Semi-Annual Meeting of the Advisory Panel
on Ambulatory Payment Classification Groups--February 17-19, 2010
ACTION: Notice.
SUMMARY: This notice announces the first semi-annual meeting of the
Advisory Panel on Ambulatory Payment Classification (APC) Groups (the
Panel) for 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) (the Secretary) and the
Administrator of the Centers for Medicare & Medicaid Services (CMS)
(the Administrator) concerning the clinical integrity of the APC groups
and their associated weights. We will consider the Panel's advice as we
prepare the proposed and final rules that would update the hospital
Outpatient Prospective Payment System (OPPS) for CY 2011.
DATES: Meeting Dates: We are scheduling the first semi-annual meeting
in 2010 for the following dates and times:
Wednesday, February 17, 2010, 1 p.m. to 5 p.m. eastern
standard time (e.s.t.) \1\
Thursday, February 18, 2010, 8 a.m. to 5 p.m. (e.s.t.)
Friday, February 19, 2010, 8 a.m. to 12 noon (e.s.t.)
Centers for Medicare & Medicaid Services
Medicare Program; Meeting of the Advisory Panel on Medicare
Education, February 3, 2010
ACTION: Notice of meeting.
SUMMARY: This notice announces a meeting of the Advisory Panel on
Medicare Education (the Panel) in accordance with the Federal Advisory
Committee Act. The Panel advises and makes recommendations to the
Secretary of Health and Human Services and the Administrator of the
Centers for Medicare & Medicaid Services on opportunities to enhance
the effectiveness of consumer education strategies concerning the
Medicare program. This meeting is open to the public.
DATES: Meeting Date: Wednesday, February 3, 2010 from 8:30 a.m. to 3
p.m., eastern standard time (e.s.t.).
ADDRESSES: Meeting Location: Hilton Washington Hotel Embassy Row, 2015
Massachusetts Avenue, NW., Washington, DC 20036, (202) 265-6800.
Centers for Medicare & Medicaid Services
Medicare Program; Physician Quality Reporting Initiative (PQRI):
Listening Session-February 2, 2010.
ACTION: Notice of meeting.
SUMMARY: This notice announces a listening session to discuss the
Physician Quality Reporting Initiative (PQRI).
The meeting is open to the public, but attendance is limited to
space and teleconference lines available.
DATES: Meeting Date: The listening session will be held on Tuesday,
February 2, 2010 from 10 a.m. until 4:30 p.m. Eastern Standard Time
(E.S.T).
Meeting Registration and Request for Special Accommodations
Deadline: Registration opens on Monday, December 21, 2009. For security
reasons, registration must be completed no later than 5 p.m. E.S.T. on
Wednesday, January 27, 2010.
Food and Drug Administration
Incorporation of New Science Into Regulatory Decisionmaking
Within the Center for Devices and Radiological Health; Public Meeting;
Request for Comments
ACTION: Notice of public meeting; request for comments.
Dates and Time: The public workshop will be held on February 9,
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting
must register by 5 p.m. on February 3, 2010.
Location: The public meeting will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry on the Timeframe for Submission of Tobacco
Health Documents; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Timeframe for Submission of
Tobacco Health Documents.'' This document provides written guidance to
tobacco product manufacturers and importers on enforcement of the
requirement to submit certain documents to FDA under the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act).
DATES: The guidance is final upon the date of publication. However, you
may submit electronic or written comments on the guidance at any time.
Indian Health Service
Notice of Re-Designation of the Service Delivery Area for the
Cowlitz Indian Tribe
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Agency Forms Undergoing Paperwork Reduction Act Review
Proposed Project: Model Performance Evaluation Program for Mycobacterium tuberculosis
and Non-tuberculous Mycobacterium Drug Susceptibility Testing (OMB
Control No. 0920-0600, expiration date 03/31/2010)--Revision--National
Center for Preparedness, Detection, and Control of Infectious Diseases
(NCPDCID), Centers for Disease Control and Prevention (CDC).
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 8 on Sterility
Test General Chapter; Availability
ACTION: Notice.
DATES: Submit written or electronic comments on agency guidance at any
time.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
International Conference on Harmonisation; Guidance on Q4B
Evaluation and Recommendation of Pharmacopoeial Texts for Use in the
International Conference on Harmonisation Regions; Annex 5 on
Disintegration Test General Chapter; Availability
ACTION: Notice.
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection
Proposed Project: Data Collection Tool for State Offices of Rural
Health Grant Program: (OMB Number: 0915-0322)Extension.
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Tobacco Health Document
Submission; Availability
ACTION: Notice.
Office of the Secretary, HHS
Agency Information Collection Request. 30-Day Public Comment
Proposed Project: Research Mentoring Dyad: Comparing the Views of
Faculty Advisors/Mentors and Their Ph.D. Students on Training/Learning
to Be a Responsible Researcher -OMB No. 0990-New-Office of Research
Integrity (ORI).
Office of the Secretary, HHS
Agency Information Collection Request; 30-Day Public Comment
Proposed Project: HITECH Act Breach Notification-OMB No. 0990-0346-
Extension-Office of Civil Rights.
Office of the Secretary, Office of Public Health and Science, Office of Minority
Health
ACTION: Notice of meeting.
Meeting of the Advisory Committee on Minority Health
DATES: The meeting will be held on Tuesday, January 5, 2010 from 9 a.m.
to 5 p.m. and Wednesday, January 6, 2010 from 9 a.m. to 1 p.m.
ADDRESSES: The meeting will be held at the Doubletree Hotel, 1515 Rhode
Island Ave., NW., Washington, DC 20005.
Office of the National Coordinator for Health Information
Technology HIT Policy Committee's NHIN Workgroup Meeting; Notice of
Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on January 7, 2010, from 9
a.m. to 12:30 p.m./Eastern Time.
Location: To be determined. Please check the ONC Web site for
additional information as it becomes available. The meeting will be
available via webcast; visit http://healthit.hhs.gov for instructions
on how to listen via telephone or Web.
Office of the President's Council on Physical Fitness and Sports
Opportunity for Co-Sponsorship of the President's Challenge
Physical Activity and Fitness Awards Program
ACTION: Notice.
SUMMARY: The Office of the President's Council on Physical Fitness and
Sports (PCPFS) announces the opportunity for non-Federal public and
private sector entities to co-sponsor and administer a series of
financially self-sustaining activities related to the President's
Challenge Physical Activity and Fitness Awards Program (President's
Challenge). Potential co-sponsors must have a demonstrated interest in
and be capable of managing the day to day operations associated with
the program and be willing to participate substantively in the co-
sponsored activity.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Proposed Project: Drug Pricing Program Reporting Requirements (OMB No.
0915-0176)--[Extension]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Medicaid and CHIP Programs; Initial Core Set of Children's
Healthcare Quality Measures for Voluntary Use by Medicaid and CHIP
Programs
ACTION: Notice with comment period.
SUMMARY: This notice identifies and solicits public comments on the
initial, recommended core set of children's health care quality
measures for voluntary use by State programs administered under titles
XIX and XXI of the Social Security Act, health insurance issuers and
managed care entities that enter into contracts with Medicaid and
Children's Health Insurance Programs, and providers of items and
services under these programs, in accordance with the Children's Health
Insurance Program Reauthorization Act of 2009 (Pub. L. 111-3). This
notice also discusses steps already underway to facilitate the
programs' voluntary use of the children's health care quality measures.
In addition, this notice solicits comments on how the steps might be
enhanced, and recommendations for additional steps to facilitate use of
the measures.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 1, 2010.
Food and Drug Administration
Guidance to Pharmacies on Advance Compounding of Tamiflu Oral
Suspension to Provide for Multiple Prescriptions; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Guidance to
Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide
for Multiple Prescriptions.'' This guidance describes the circumstances
in which FDA will not object to certain compounding of Tamiflu Oral
Suspension in advance of receiving prescriptions.
DATES: Submit electronic or written comments on agency guidances at any
time.
Food and Drug Administration
Informed Consent Elements
ACTION: Proposed rule; opportunity for public comment.
SUMMARY: The Food and Drug Administration (FDA or agency) is issuing a
proposed rule that, if finalized, would amend the informed consent
regulations to require that the informed consent documents and
processes for applicable drug, biologic, and device clinical
investigations include a statement that clinical trial information for
such clinical investigations has been or will be submitted to the
National Institutes of Health/National Library of Medicine (NIH/NLM)
for inclusion in the clinical trial registry databank. The Food and
Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA
update its informed consent regulations to require that the informed
consent documents and processes for certain clinical investigations
include a statement that clinical trial information for such
investigations has been or will be submitted for inclusion in the
clinical trial registry databank.
DATES: Submit written or electronic comments on the proposed rule by
March 1, 2010.
Office of Inspector General
Solicitation of New Safe Harbors and Special Fraud Alerts
ACTION: Notice of intent to develop regulations.
SUMMARY: In accordance with section 205 of the Health Insurance
Portability and Accountability Act (HIPAA) of 1996, this annual notice
solicits proposals and recommendations for developing new and modifying
existing safe harbor provisions under the Federal anti-kickback statute
(section 1128B(b) of the Social Security Act), as well as developing
new OIG Special Fraud Alerts.
DATES: To assure consideration, public comments must be delivered to
the address provided below by no later than 5 p.m. on March 1, 2010.
ADDRESSES: In commenting, please refer to file code OIG-114-N. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device Interoperability; Public Workshop
ACTION: Notice of public workshop.
Dates and Times: The public workshop will be held on January 25 and
26, 2010, from 9 a.m. to 5 p.m. and on January 27, 2010, from 9 a.m. to
12 noon. Participants are encouraged to arrive early to ensure time for
parking and security screening before the meeting. Security screening
will begin at 8 a.m. and registration will begin at 8:30 a.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Food and Drug Administration
Second Annual Sentinel Initiative Public Workshop
ACTION: Notice of public workshop.
Date and Time: The workshop will be held on January 11, 2010, from
8:30 a.m. to 4:45 p.m.
Location: The workshop will be held at Marriott Metro Center at 775
12th Street NW., Washington, DC 20005.
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: ``Development and Evaluation of AHRQ's Quality Indicators
Improvement Toolkit.'' In accordance with the Paperwork Reduction Act,
44 U.S.C. 3501-3520, AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received by March 1, 2010.
Agency for Healthcare Research and Quality
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program: Changes to the Hospital Outpatient Prospective
Payment System and CY 2010 Payment Rates; Changes to the Ambulatory
Surgical Center Payment System and CY 2010 Payment Rates
ACTION: Correction of final rule with comment period.
SUMMARY: This document corrects technical errors that appeared in the
final rule with comment period found in the Federal Register (FR) on
November 20, 2009, entitled ``Medicare Program: Changes to the Hospital
Outpatient Prospective Payment System and CY 2010 Payment Rates;
Changes to the Ambulatory Surgical Center Payment System and CY 2010
Payment Rates.''
DATES: Effective Date: This correction document is effective January 1,
2010.
Agency for Healthcare Quality and Research
Date: January 20, 2010 (Open on January 20 from 8 a.m. to 8:15
a.m. and closed for the remainder of the meeting).
Place: Marriott RIO, Conference Room TBD, 9751 Washingtonian
Blvd., Gaithersburg, MD 20878.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the National Coordinator for Health Information
Technology, HIT Policy Committee
ACTION: Notice of Meeting
Date and Time: The meeting will be held on January 13, 2010, from 9
a.m. to 5 p.m./Eastern Time.
Location: The Park Hyatt Hotel, 24th and M Streets, NW.,
Washington, DC. The hotel telephone is 202-789-1234.
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee
ACTION: Notice of meeting.
Date and Time: The meeting will be held on January 20, 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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
1. Type of Information Collection Request: New collection; Title of
Information Collection: Consumer Research on Public Reporting of
Hospital Outpatient Measures.
Food and Drug Administration
Event Problem Codes Web Site; Center for Devices and Radiological
Health; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a Web site where the Center for Devices and
Radiological Health (CDRH) is posting updates to the problem codes used
in conjunction with the medical device adverse event reports (MDR)
regulation.
DATES: Submit electronic or written comments at any time.
Food and Drug Administration
Memorandum of Understanding Between the United States Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research and Northeastern University
ACTION: Notice.
Food and Drug Administration
Medical Device Quality System Regulation Educational Forum on
Risk Management Through the Product Life Cycle; Public Workshop
ACTION: Notice of public workshop.
Date and Time: The public workshop will be held on April 2, 2010,
from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the new Cowboy
Stadium in Irving, TX. Directions to the facility are available at the
FMDIC Web site at http://www.fmdic.org/.
Office of the National Coordinator for Health Information
Technology; HIT Policy Committee's Workgroup
ACTION: Notice of meetings.
Date and Time: The HIT Policy Committee Workgroups will hold the
following public meetings during the month of January 2010: January 8th
Meaningful Use Workgroup, 11 a.m. to 12 p.m./Eastern Time; January 11th
Privacy & Security Policy Workgroup, 10 a.m. to 12 p.m./Eastern Time;
January 12th Strategic Plan Workgroup, 9 a.m. to 12 p.m./Eastern Time;
January 12th NHIN Workgroup, 1 p.m. to 4 p.m./Eastern Time; January
22nd Privacy & Security Policy Workgroup, 10 a.m. to 12 p.m./Eastern
Time; and January 28th Meaningful Use Workgroup, 10 a.m. to 12 p.m./
Eastern Time.
Office of the National Coordinator for Health Information
Technology; HIT Standards Committee's Workgroup
ACTION: Notice of meetings.
Date and Time: The HIT Standards Committee Workgroups will hold the
following public meetings during the month of January 2010: January
21st Clinical Operations' Vocabulary Task Force, 9 a.m. to 3 p.m./
Eastern Time; January 26th Implementation Workgroup, 10 a.m. to 12
p.m./Eastern Time; January 26th Privacy & Security Workgroup, 3 p.m. to
5 p.m./Eastern Time; and January 28th Clinical Quality Workgroup, 2
p.m. to 4 p.m./Eastern Time.
Location: All workgroup meetings will be available via webcast;
visit http://healthit.hhs.gov for instructions on how to listen via
telephone or Web. Please check the ONC Web site for additional
information as it becomes available.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry on New Contrast Imaging Indication
Considerations for Devices and Approved Drug and Biological Products;
Availability
ACTION: Notice.
Health Resources and Services Administration
Extramural Support Reimbursement of Travel and Subsistence
Expenses Toward Living Organ Donation Program
ACTION: Request for Information.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
HHS Intent To Publish Grant and Contract Solicitations for
Comparative Effectiveness Research (CER) Projects With Funds Allocated
to the Office of the Secretary From the American Recovery and
Reinvestment Act (ARRA)
ACTION: Notice of intent.
SUMMARY: The Department of Health and Human Services announces its
intention to support new CER projects with funds allocated by the
American Recovery and Reinvestment Act (ARRA). The ARRA appropriated
$400 million to the Office of the Secretary for support of CER. AHRQ
has been designated point of contact for management of these funds.
DATES: HHS anticipates grant and contract solicitations to be published
over the next several months.
Agency for Healthcare Research and Quality
Medicare Prescription Drug, Improvement, and Modernization Act of
2003 Section 1013: Request for Nominations--The Effective Health Care
Stakeholder Group
ACTION: Notice of invitation to submit nominations for the Effective
Health Care Stakeholder Group.
SUMMARY: The DHHS Agency for Healthcare Research and Quality (AHRQ)
invites nominations from interested organizations and knowledgeable
individuals for members of the Stakeholder Group to support the work of
the Effective Health Care Program, established [for consultation]
pursuant to Section 1013 of the Medicare Prescription Drug,
Improvement, and Modernization Act (MMA) of 2003.
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: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Bid
Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription
Drug Plans (PDP)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: CY 2011 Plan
Benefit Package (PBP) Software and Formulary Submission
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Advantage Appeals and Grievance Data Disclosure Requirements (42 CFR
Sec. 422.111)
4. Type of Information Collection Request: Extension of the
currently approved collection; Title of Information Collection:
Indirect Medical Education (IME).
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: The Fiscal
Soundness Reporting Requirements.
Food and Drug Administration
Draft Guidance for Industry on Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug
Products; Availability
ACTION: Notice.
President's Advisory Council for Faith-based and Neighborhood
Partnerships
Action: Meeting
Time and Date: January 11th and January 12th from 4-6 p.m. EST.
Place: Meetings will be held via conference call. Please contact
Mara Vanderslice for call-in information at mara.vanderslice@hhs.gov.
Status: Open to the public, limited only by the space available.
Conference call line will be available.