[Federal Register Volume 63, Number 228 (Friday, November 27, 1998)]
[Notices]
[Page 65597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Suspension of Site Registration Fee for Facilities Transferring
or Receiving Select Agents
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention is announcing
the suspension of the site registration fee for facilities registered
under (42 CFR 72.6). (Additional Requirements for Facilities
Transferring or Receiving Select Agents; Final Rule).
DATES: Effective date is November 27, 1998.
FOR FURTHER INFORMATION CONTACT: Laboratory Registration/Select Agent
Transfer (LR/SAT) Program, Office of Health and Safety, Centers for
Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mail Stop
F-05, Atlanta, Georgia 30333, telephone (404) 639-4418, LR/SAT Program
website at http://www.cdc.gov/od/ohs/lrsat.htm.
SUPPLEMENTARY INFORMATION: ``The Antiterrorism and Effective Death
Penalty Act of 1996,'' Pub. L. 104-132, (42 U.S.C. 262) note, enacted
on April 24, 1996, established new provisions to regulate transfer of
certain biological agents and toxins (i.e., select agents), and
required HHS to issue rules to implement these provisions. The final
rule was published in the Federal Register on October 24, 1996, and
became effective April 15, 1997. To comply with the final rule,
commercial suppliers of select agents, as well as government agencies,
universities, research institutions, and private companies that
transfer these agents, must register with the Centers for Disease
Control and Prevention (CDC). In return for the registration,
facilities are responsible for paying a site registration fee. (42 CFR
72.6(a)(2)(iv)).
CDC calculated the direct costs to manage the program, and in a
Federal Register Notice dated April 14, 1997, announced those fees.
(Federal Register notice, April 14, 1997, Vol. 62, No. 71:18134-5).
Many facilities wishing to register expressed concern that the fees
were high and constituted a substantial burden, particularly for small
facilities with limited and inflexible budgets. The CDC has reviewed
the situation and has determined that for Fiscal Year 1999, funds are
available within the agency budget to defray the site registration fee.
Suspension of Site Registration Fee for Facilities Transferrring or
Receiving Select Agents: Effective November 27, 1998, the site
registration fee schedule for all facilities will be suspended.
Facilities registered between April 15, 1997, and the effective date of
this notice will be contacted by CDC with information regarding the
refunding of the site registration fee. The decision as to whether to
impose registration fees will be re-evaluated annually to determine
whether appropriated funds may be used to cover registration costs.
The site registration will still cover a three year time period.
All applications for registration of facilities under this regulation
should be mailed to: Centers for Disease Control and Prevention (CDC),
Office of Health and Safety, Laboratory Registration/Select Agent
Transfer Program, 1600 Clifton Road, NE., Mail Stop F-05, Atlanta,
Georgia 30333.
CDC will mail applications to all facilities that express an
interest. Questions about this notice and requests for application
packages should be faxed to CDC, Office of Health and Safety, telephone
(404) 639-0880 or sent by e-mail (lrsat@cdc.gov).
Dated: November 20, 1998.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-31603 Filed 11-25-98; 8:45 am]
BILLING CODE 4163-18-P