[Federal Register Volume 62, Number 71 (Monday, April 14, 1997)]
[Notices]
[Pages 18134-18135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Site Registration Fee Schedule and Related Matters for Facilities 
Transferring or Receiving Select Agents

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention is announcing 
its site registration fee schedule for facilities registered under 42 
CFR 72.6. This notice includes the total fee for facilities in three 
categories, small, medium, and large. The fee is broken down into 
subtotals that illustrate how the agency derived the total fee. In 
return for the fee, the facility receives a 3 year site registration 
and is subject to inspection during that time period. Also included in 
this notice is clarification of the exemption of certain toxins, as 
well as clarification of biosafety levels for certain viruses in the 
regulation.

DATES: Effective date is April 15, 1997.

FOR FURTHER INFORMATION CONTACT: Lynn Myers, Office of Health and 
Safety, Centers for Disease Control and Prevention (CDC), 1600 Clifton 
Road, NE., MS-F05, Atlanta, GA 30333, telephone (404) 639-3235.

SUPPLEMENTARY INFORMATION:

Background

    ``The Antiterrorism and Effective Death Penalty Act of 1996,'' 
enacted on April 24, 1996, established new provisions to regulate 
transfer of hazardous 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 will become effective April 15, 1997. 
To comply with the final rule, commercial suppliers of select agents, 
as well as government agencies, universities, research institutions, 
individuals, and private companies that transfer or obtain these 
agents, must register with the Centers for Disease Control and 
Prevention (CDC). The rule also authorizes CDC to inspect those 
facilities seeking registration to determine whether the applicant 
facility meets the appropriate biosafety level requirements. In return 
for the certification and inspection, facilities are responsible for a 
site registration fee. This notice lays out those fees and provides 
technical clarification of related matters in the regulation.

Site Registration Fees

    According to 42 CFR 72.6(a)(2)(iv), registration of a facility is 
to include ``[c]ollection of a periodic site registration fee by [CDC]. 
A schedule of fees collected by [CDC] to cover the direct costs (e.g., 
salaries, equipment, travel) and indirect costs (e.g., rent, telephone 
service and a proportionate share of management and administration 
costs) related to administration of this part will be published in the 
Federal Register and updated annually.''

Definitions

    A facility is defined in 42 CFR 72.6(j) as ``any individual or 
government agency, university, corporation, company, partnership, 
society, association, firm, or other legal entity located at a single 
geographic site that may transfer or receive through any means a select 
agent subject to this part.'' For the purpose of assessing the site 
registration fees, facilities are broken down into three categories, 
small, medium, and large, depending upon the size of the facility, the 
number of personnel working in the facility, and the amount of work 
done in the facility.
    A small facility has one laboratory area (one biological safety 
cabinet (BSC) and supporting supplies and equipment) or one room 
housing one or more animals (animal room) doing work with one select 
agent, or group of closely related select agents, at one biosafety 
level (BSL), by one principal investigator and his/her support staff. 
If the one laboratory area is used by more than one principal 
investigator or for more than one select agent/group of closely related 
select agents, the facility is a medium facility.
    A medium facility has laboratory areas and animal rooms that in 
combination total between two and five. All laboratories must be under 
the supervision of one responsible facility official and must be 
located in the same single geographic site. These laboratories shall be 
used by no more than five principal investigators and their support 
staffs, for work on no more than five select agents/groups of closely 
related select agents during the three year registration period. If 
more than five principal investigators work in the laboratories or more 
than five select agents (or groups of closely related select agents) 
are used, the facility is a large facility.
    A large facility has laboratory areas and animal rooms that in 
combination total more than five. All laboratories must be under the 
supervision of one responsible facility official and must be located in 
the same single geographic site.
    Any facility working with select agents at BSL 4, whether small, 
medium or large, is assessed an additional fee. In addition, any 
facility that makes more than 50 select agent transfers per year, 
whether small, medium or large, is assessed an additional fee.

Fee Schedule

    Site registration fees for facilities registering before March 31, 
1998 will be as follows:

Small Facility, $13,000
Medium Facility, $14,000
Large Facility, $15,000
Biosafety Level 4 Laboratory--add $2,000 to facility fee
More than 50 select agent transfers per year--add $1,000 to facility 
fee

    The fee and site registration covers a three year time period. The 
fee is due at the time of application for registration.

Cost Estimates on Which Fees Are Based

    Site registration fees listed above are based on cost estimates for 
administering the program for the three year period 1997-99. We 
estimate that there will be approximately 50 small facilities, 100 
medium facilities and 50 large facilities registered. The fee cost 
calculation is based on an estimate of contractor and government costs.
    A contractor will carry out most activities related to facility 
registration,

[[Page 18135]]

facility inspections, and tracking of select agent transfers. CDC will 
manage the program by collecting the site registration fees and 
tracking program costs, providing oversight of contractor activities, 
reviewing applications before laboratories are registered, reviewing 
questionable select agent transfers, acting as liaison with federal, 
state, and local agencies, and inspecting BSL 4 facilities. The 
contractor will be responsible for providing application materials to 
facilities, reviewing completed applications for registration, making 
recommendations to CDC regarding those registrations, inspecting all 
BSL 3 facilities, tracking select agent transfers, and maintaining data 
and information systems related to the program.
    Cost estimates for contractor activities have been prepared using 
estimates of labor categories, labor hours, travel costs, and 
contractor overhead . Labor categories and hours include the following: 
Project Manager/Sr. Microbiologist--2080 hours per year; 
Microbiologist, Mid-level--2080 hours per year; Technical Writer--200 
hours per year; General Clerks--4160 hours per year; Computer Systems 
Analyst--200 hours per year; Computer Programmer--400 hours per year; 
Laboratory Inspector--1000 hours per year.
    In addition, the Government will provide a Project Officer, 
Microbiologist, Chemist/Biosafety expert, Technical Information 
Specialist, Clerk, Laboratory Inspector, and Administrative Officer to 
work on this program for various numbers of hours throughout the years.
    Labor rates were calculated using the Government General Schedule 
(GS) equivalent, step 5 with Atlanta area locality pay. Fringe benefits 
were calculated based upon an average for this type of service 
industry. Contractor overhead and profit were estimated based upon 
industry averages. The Government estimates that the travel costs 
associated with Inspection of facilities will be approximately $70,000 
per year.
    The Government will incur additional costs associated with 
Government inspection of BSL 4 laboratories and close monitoring of 
transfers of BSL 4 select agents.
    The fee schedule is then calculated by adding the hourly labor 
costs for contractor and agency employees, plus travel costs and 
overhead, and dividing by the estimated number of small, medium, and 
large facilities, respectively.

Clarification of Toxin Exemptions

    The conditions under which transfers of toxins will be exempt are 
as stated in 42 CFR 72.6, Appendix A: ``Toxins for medical use, 
inactivated for use as vaccines, or toxin preparations for biomedical 
research use at an LD<INF>50 for vertebrates of more than 100 nanograms 
per kilogram body weight are exempt.'' 42 CFR 72.6(h)(1)(ii) should 
also be interpreted consistently with this definition.
    The LD<INF>50 values to be used under this regulation are those for 
mice dosed by the intraperitoneal route. These values may be found in 
the Registry of Toxic Effects of Chemical Substances (R-TECS) (produced 
by the National Institute for Occupational Safety and Health), 1996 or 
later version. A list of LD<INF>50 values may be obtained from CDC (fax 
request to 404-639-3236).

Biosafety Levels of Certain Viruses

    As indicated in the regulation, the biosafety levels for handling 
the select agents are listed in the CDC/NIH Biosafety in 
Microbiological and Biomedical Laboratories (BMBL), 3rd edition. The 
biosafety levels for morbillivirus and Sabia virus, two newly 
discovered viruses are not included in the BMBL. The biosafety level 
for Equine morbillivirus is BSL 4, and for Sabia virus is BSL 4. The 
correct BSL for Junin virus is BSL 3, as is stated on page 134 of the 
BMBL. The use of BSL 4 for Junin virus as listed on page 137 of the 
BMBL is incorrect.
    CDC will mail applications for registration of facilities under 
this regulation 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 (404-639-3236).

    Dated: April 8, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-9510 Filed 4-11-97; 8:45 am]
BILLING CODE 4163-18-P