[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 LD50 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 LD50 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 LD50 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
