In a Sept. 25 letter to the Senate Finance Committee leader, CMS Administrator Tom Scully is requesting action on the administration's top legislative priorities: contractor reform, competitive bidding for durable medical equipment, and Medicare benefit improvements. Scully advises, however, that many provisions in the Senate's original regulatory reform bill, which was introduced last year, could be counterproductive as CMS has already implemented such changes.


21

Subject: HHS Regulatory Reform Committee Final Meeting -- 11/21/02

Please be advised that the final meeting of the Department of Health and Human Services (HHS) Secretary's Advisory Committee on Regulatory Reform which had originally been scheduled for October 1-2, 2002 has been rescheduled as follows:

Times: 8:00 am - 6:00 pm

Location: Washington, DC

The exact location and agenda for the meeting will be posted on the Regulatory Reform web-site at www.regreform.hhs.gov before the meeting.


of BLAs

On May 14, 1996 (61 FR 24227), FDA issued a final rule to amend the licensing regulations by eliminating the ELA requirement for specified biotechnology and synthetic biological products regulated under the Public Health Service (PHS) Act. Upon approval, manufacturers of these products would receive a single biologics license instead of product and establishment licenses (21 CFR 601.2(c)).


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October 4, 2002

The Honorable Max Baucus

Chairman

Senate Finance Committee

United States Senate

Washington, D.C. 20510

The Honorable Charles Grassley

Ranking Member

Senate Finance Committee

United States Senate

Washington, D.C. 20510

Dear Senator Baucus and Senator Grassley:

On behalf of the nation's Governors, we very much appreciate your willingness to include a modified Rockefeller-Nelson-Collins state fiscal relief provision in your Medicare provider give-backs package.


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FDA Issues Cyber Letter to Yellow Jackets Promoter FDA announced that it has issued a Cyber Letter (a letter sent via email to notify a company of potential violations) to the operator of an internet web site for promoting and selling Yellow Jackets, an herbal product, as an alternative to illicit street drugs.


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AAP SUPPORTS 'RING VACCINATION' IN CASE OF SMALLPOX OUTBREAK

Below is a news release on a policy statement published in the October issue of Pediatrics, the peer-reviewed, scientific journal of the American Academy of Pediatrics (AAP) or Pediatrics electronic pages, the Internet extension of Pediatrics.

For Release: October 7, 2002, 12:01 am (ET)


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Background

Definition of Compounding:


For immediate release:

Wednesday, October 2, 2002

BINGAMAN BLASTS NARROW BUSH ADMINISTRATION RULE THAT WILL LIMIT "CHIP" FUNDS DIRECTED TO PREGNANT WOMEN

WASHINGTON - U.S. Senator Jeff Bingaman today said a new Bush administration regulation that will allow states to provide federally funded children's health care to fetuses but not directly to pregnant woman is too narrowly written and does not go far enough to expand health care to those who need it most.


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New Supplement Certification Program May Mislead Consumers

USP Mark Does Not Mean Ingredient Is Safe Or Effective


October 2, 2002

Contact: CDC, Media Relations

(404) 6393286

CDC provides $1.2 million to fund pilot program for early warning system for terrorism-related illness outbreaks


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