18134 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

By the Federal Housing Finance Board.

Bruce A. Morrison,

Chairman.

[FR Doc. 97–8692 Filed 4–11–97; 8:45 am]

BILLING CODE 6725–01–P

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS

ANNOUNCEMENT: 62 FR 15895, April 3,

1997.

PREVIOUSLY ANNOUNCED TIME AND DATE OF

THE MEETING: 10:00 A.M. Wednesday,

April 9, 1997.

CANCELLATION OF THE MEETING: Notice is

hereby given of the cancellation of the

Board of Directors meeting scheduled

for April 9, 1997.

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

Bruce A. Morrison,

Chairman.

[FR Doc. 97–9644 Filed 4–10–97; 11:53 am]

BILLING CODE 6725–01–P

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.

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,
Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices 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 (RTECS) (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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Epidemiology Program Office, Office of

the Director, Centers for Disease

Control and Prevention (CDC); Meeting

Name: Guide to Community

Preventive Services (GCPS) Task Force

Meeting.

Times and Dates: 8:30 a.m.–5 p.m.,

April 28, 1997; 8:30 a.m.–5 p.m., April

29, 1997.

Place: Washington Plaza Hotel, 10

Thomas Circle, at Massachusetts

Avenue and 14th Street, Washington,

DC 20005.

Status: Open to the public, limited

only by the space available.

Purpose: The mission of the Task

Force is to develop and publish a Guide

to Community Preventive Services,

which is based on the best available

scientific evidence and current expertise

regarding essential public health

services and what works in the delivery

of those services.

Matters to be Discussed: Agenda items

include discussion on the organization

and contents of the Guide; discussion

on the methods to develop the Guide;

progress reports on the development of

Chapters on Preventing Vaccine

Preventable Diseases and Preventing

Motor Vehicle Injuries; brief progress

reports on the development of chapters

on tobacco, nutrition, physical activity,

heart disease and stroke, family

planning, environment, and violence;

and discussion on field testing,

implementing, and evaluating the

Guide.

Agenda items are subject to change as

priorities dictate.

Contact person for additional

information: Marguerite Pappaioanou,

Chief, Community Preventive Service

Guide Development Activity, Division

of Prevention Research and Analytic

Methods, Epidemiology Program Office,

CDC, 1600 Clifton Road, NE, M/S D–01,

Atlanta, Georgia 30333. Persons wishing

to reserve a space for this meeting

should call 404/639–4301 by close of

business on April 21, 1997.

Dated: April 4, 1997.

Carolyn Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–9512 Filed 4–11–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request Proposed

Projects

Title: Notice of Interstate Lien.

OMB No.: 0970–0153.

Description: PRWORA ’96 (Pub L.

104–193), section 324, requires the

Secretary of DHHS to promulgate an

interstate lien form to be used by the

State CSE programs to secure delinquent

child support obligations.

Respondents: State, Local or Tribal

Govt.