Federal Register: November 27, 1998 (Volume 63, Number 228)NoticesPage 65597From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr27no98-64

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. 98-31603Filed11-25-98; 8:45 amBILLING CODE 4163-18-P