Weekly Legislative & Regulatory Round-up
Week of February 14 - 20
| GAO reports |
No relevant reports
| OIG reports |
No relevant reports.
| Bills introduced |
Congress on recess this week
| Federal Register notices |
February 16
No Federal Register issued.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Phonetic Orthographic Computer Analysis Software Program for
Review of Proprietary Drug and Biologic Names; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the source code and supporting technical documentation
for the Phonetic Orthographic Computer Analysis (POCA) software
program. POCA is an analytic tool designed to help identify drug and
biologic names and medical terminology that are phonetically and
orthographically similar to one another. POCA is one analytic tool that
FDA uses to review proposed proprietary drug and biologic names.
Office of the Secretary
Solicitation of Written Comments on Draft Strategic National
Vaccine Plan; Extension of Period for Public Comments
ACTION: Notice.
SUMMARY: The Department of Health and Human Services published a notice
in the Federal Register of January 14, 2009 (Vol. 74, No. 9, pages
2076-2078) soliciting comments on the draft strategic National Vaccine
Plan. Comments were requested no later than 5 p.m. on January 30, 2009.
Because many stakeholders responded that they did not have adequate
time to coordinate comments from their respective constituencies, the
National Vaccine Program Office (NVPO) is extending the period for
public comments.
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicare Program; Changes to the Competitive Acquisition of
Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) by Certain Provisions of the Medicare Improvements for
Patients and Providers Act of 2008 (MIPPA)
ACTION: Delay of effective date.
SUMMARY: In accordance with the memorandum of January 20, 2009, from
the Assistant to the President and Chief of Staff, entitled
``Regulatory Review Plan,'' this action temporarily delays for 60 days
the effective date of the final rule entitled ``Medicare Program;
Changes to the Competitive Acquisition of Certain Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain
Provisions of the Medicare Improvements for Patients and Providers Act
of 2008 (MIPPA)'' published in the January 16, 2009 Federal Register
(74 FR 2873). The temporary 60-day delay in effective date is necessary
to give Department officials the opportunity for further review of the
issues of law and policy raised by this rule. In addition, this action
solicits additional comments on the delay of the effective date.
Office of the Secretary
Opportunity for Cosponsorship of Educational Program
ACTION: Notice.
SUMMARY: The Office of the Assistant Secretary for Preparedness and
Response (ASPR), Office of Preparedness and Emergency Operations (OPEO)
announces the opportunity to cosponsor a national tactical medicine
education program to train medical personnel serving on military,
Federal, state and local law enforcement special response teams.
Potential cosponsors must have a demonstrated interest in the subject
matter and be willing to contribute substantively to the cosponsored
activity.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Influenza: Developing Drugs for
Treatment and/or Prophylaxis; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Influenza:
Developing Drugs for Treatment and/or Prophylaxis.'' Recent concerns
about the possibility of pandemic spread of novel influenza strains
have increased interest in influenza drug development for both seasonal
and pandemic settings. The purpose of this guidance is to assist
sponsors in all phases of influenza drug development and to address
questions FDA often receives regarding the potential for emergency use
of influenza drugs for the treatment and/or prophylaxis of influenza.