33256 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Notices

implementing collaborative research.

CDC may accept staff, facilities,

equipment, supplies, and money from

the other participants in a CRADA; CDC

may provide staff, facilities, equipment,

and supplies to the project. There is a

single restriction in this exchange: CDC

MAY NOT PROVIDE FUNDS to the

other participants in a CRADA.

DATES: This opportunity is available

until July 23, 2001. Respondents may be

provided a longer period of time to

furnish additional information if CDC

finds this necessary.

ADDRESSES: The responses must be

made to: Lisa Blake-DiSpigna,

Technology Transfer Coordinator,

National Center for Infectious Diseases,

Centers for Disease Control and

Prevention, 1600 Clifton Rd. NE.,

Mailstop C–19, Atlanta, GA 30333.

FOR FURTHER INFORMATION CONTACT:

Technical: Ralph A. Tripp, Ph.D.,

Respiratory and Enteric Viruses,

Division of Viral and Rickettsial

Diseases, National Center for

Infectious Diseases, Centers for

Disease Control and Prevention, 1600

Clifton Rd. NE., Mailstop G–09,

Atlanta, GA 30333, telephone (404)

639–3427.

Business: Lisa Blake-DiSpigna,

Technology Transfer Coordinator,

National Center for Infectious

Diseases, Centers for Disease Control

and Prevention, 1600 Clifton Rd. NE.,

Mailstop C–19, Atlanta, GA 30333,

telephone (404) 639–3227.

SUPPLEMENTARY INFORMATION: The goal

of this CRADA is to seek a partner for

collaboration to examine the

development and use of anti-substance

P antibodies and/or anti-SP F(ab)’2

antibody fragments to prevent and/or

treat an inflammatory response

mediated by substance P that is

associated with respiratory viral

infection (particularly RSV). The

methods comprise the administration to

the subject of a pharmaceutically

effective amount of anti-SP antibodies

or anti-SP F(ab)’2 antibody fragments to

inhibit the activity of endogenous SP in

the subject. Anti-SP antibody or anti-SP

F(ab)’2 antibody treatment will be used

in combination with anti-viral drugs

and anti-viral reagents to inhibit the

activity of endogenous SP in the subject

so as to reduce the level of cytokine/

chemokine-based inflammation and

pulmonary cell infiltration and alter the

disease course.

Respondents should provide evidence

of expertise in the development and

evaluation of anti-viral drugs and antiviral reagents, evidence of experience in

animal models systems including nonhuman primate models,

commercialization of anti-viral drugs

and anti-viral reagents, and supporting

data (e.g., publications, proficiency

testing, certifications, resumes, etc.) of

qualifications for the principle

investigator who would be involved in

the CRADA. The respondent will

develop the final research plan in

collaboration with CDC.

Applicant submissions will be judged

according to the following criteria:

1. Expertise in development and

evaluation of anti-viral drugs and antiviral reagents;

2. Expertise in evaluation of anti-viral

drugs, reagents and anti-viral treatments

in animal model systems including nonhuman primates;

3. Evidence of scientific credibility.

The company has the capability of

bringing the product to fruition, in part

determined by past accomplishments

with similar products, and/or that the

company has published related studies

in peer-reviewed journals;

4. Evidence of commitment and

ability to develop anti-substance P

monoclonal antibodies for use with antiviral drugs, anti-viral reagents or

antiviral treatments; and

5. Evidence of an existing

infrastructure to commercialize

successful technologies.

This CRADA is proposed and

implemented under the 1986 Federal

Technology Transfer Act: Public Law

99–502.

Dated: June 14, 2001.

Thena M. Durham,

Director, Executive Secretariat, Office of the

Director, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–15602 Filed 6–20–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Low Income Home Energy

Assistance Program (LIHEAP) Grantee

Survey.

OMB No.: 0970–0076.

Description: The LIHEAP Grantee

Survey is an annual data collection

activity, which is sent to the 50 States

and the District of Columbia grantees

administering the Low Income Home

Energy Assistance Program (LIHEAP).

The survey requests estimates on

sources and uses of funds under

LIHEAP—preliminary estimates for the

current fiscal year and final estimates

for the previous fiscal year. We are

proposing changes in the collection of

data using the Grantee Survey, generally

to reduce the burden on grantees, In

addition, the annual submission of the

Grantee Survey will be changed from

voluntary to mandatory. The change to

a mandatory submission is necessary to

increase the reliability of the data and

to make it available on a more time

basis. Section 2605(b)(14) of the Low

Income Home Energy Assistance Act, as

amended, requires grantees to provide

assurance that they will cooperate with

the Secretary with respect to data

collecting and reporting. This is one of

16 assurances a State’s governor or

someone specifically designated by the

governor makes as part of each year’s

LIHEAP application.

To be in full compliance with section

2605(b)(14), grantees must return the

completed survey by the due date.

The preliminary estimates collected

by the Grantee Survey for the current

fiscal year are needed to provide the

Administration and Congress with fiscal

and case load estimates in time for

hearings about LIHEAP appropriations

and program performance. Final

estimates for the previous fiscal year

will be included in the Department’s

annual LIEHAP Report to Congress and

will be posted on the Department’s

LIHEAP web site for access by grantees

and other interested parties.

Respondents: 50 States and the

District of Columbia.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden

hours per

response

Total burden

hours

Survey ...................................................................................................... 51 1 3.5 178.5

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Notices 33257

ANNUAL BURDEN ESTIMATES—Continued

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden

hours per

response

Total burden

hours

Estimated Total Annual Burden Hours: ................................................... .......................... .......................... .......................... 178.5

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Attn: ACF Reports Clearance

Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: June 18, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–15627 Filed 6–20–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA).The meeting will be open to the

public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 9, 2001, 10 a.m. to 6 p.m.,

and July 10, 2001, 8 a.m. to 6 p.m.

Location: Marriott Washingtonian

Center, Salons A, B, and C, 9751

Washingtonian Blvd., Gaithersburg, MD.

Contact: Megan Moynahan, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8517, ext. 171, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12625.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 9, 2001, the

committee will hear brief presentations

on issues related to endovascular

grafting systems for the treatment of

abdominal aortic aneurysms. The

committee will then discuss, make

recommendations, and vote on a

premarket approval application (PMA)

for a percutaneous myocardial

revascularization system used in the

treatment of angina. On July 10, 2001,

the committee will discuss, make

recommendations, and vote on two

separate PMAs for implantable cardiac

devices used in the treatment of

congestive heart failure.

Background information for each

day’s topic, including the agenda and

questions for the committee, will be

available to the public 1 business day

before the meeting on the Internet at

http://www.fda.gov/cdrh/

panelmtg.html. Material for the July 9

meeting will be posted on July 6, 2001;

material for the July 10 meeting will be

posted on July 9, 2001.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 2, 2001. On July 9, 2001,

oral presentations from the public will

be scheduled between approximately

10:45 a.m. and 11:30 a.m., and near the

end of the committee deliberations. On

July 10, 2001, oral presentations from

the public will be scheduled between

approximately 8 a.m. and 8:30 a.m., and

between approximately 1:30 p.m. and 2

p.m., and near the end of the committee

deliberations on each submission. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 2, 2001, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 14, 2001.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 01–15590 Filed 6–20–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2124–N]

RIN 0938–AK52

State Children’s Health Insurance

Program (SCHIP); Redistribution and

Continued Availability of Unexpended

SCHIP Funds From the Appropriation

for FY 1998

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

application of new statutory provisions

concerning the redistribution and

availability of unexpended funds

appropriated for the fiscal year (FY)

1998 for the State Children’s Health

Insurance Program under title XXI of the

Social Security Act. It sets forth the

amounts available for each of the 50

States, the District of Columbia, and the

Commonwealths and Territories from

the FY 1998 appropriation for a second

period of availability under the statutory

formula. It specifies amounts of

allotments that may remain available

(‘‘retained allotments’’) to the States to

which those amounts were originally

allotted during the initial period, and

the amounts of allotments that are

redistributed from the States to which

they were allotted during the initial

period to be available to other States

(‘‘redistributed allotments’’). This notice

implements section 801 of the Medicare,

Medicaid and SCHIP Benefits