Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices 38833

in addressing the emergence of

antimicrobial resistance.

DATES: Comments must be submitted in

writing on or before August 4, 2000.

FOR FURTHER INFORMATION CONTACT:

Requests for copies of the Draft Public

Health Action Plan to Combat

Antimicrobial Resistance should be

made to the Office of Health

Communication, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, Mailstop C–14,

1600 Clifton Road, Atlanta, GA 30333;

fax: 404–639–5489; or e-mail:

ncid@cdc.gov; or Internet URL: http://

www.cdc.gov.drugresistance/

actionplan/.

ADDRESSES: Comments on the Draft

Public Health Action Plan to Combat

Antimicrobial Resistance should be

submitted to the Office of Health

Communication, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, Mailstop C–14,

1600 Clifton Road, Atlanta, GA 30333;

fax: 404–639–5489; e-mail:

aractionplan@cdc.gov; or Internet URL:

http://www.cdc.gov.drugresistance/

actionplan/.

SUPPLEMENTARY INFORMATION:

Antimicrobial resistance is an emerging

public health threat that has been

identified as an important priority by

the Institute of Medicine and other

expert bodies and is the subject of

several proposed Healthy People 2010

goals relative to Infectious Diseases. In

late 1998, CDC, FDA, and NIH

recognized the need for better

coordination and stimulation of the

Federal response to this threat. In

addition, in December of 1998, Senators

William Frist and Edward Kennedy held

a roundtable discussion on

antimicrobial resistance, and a hearing

was held in February 1999. Shortly

thereafter, an Interagency Task Force on

Antimicrobial Resistance was created to

develop a Public Health Action Plan to

Combat Antimicrobial Resistance. The

Task Force is co-chaired by CDC, FDA,

and NIH, and includes the Health Care

Financing Administration, the Health

Resources and Services Administration,

Agency for Healthcare Research and

Quality, the Department of Agriculture,

the Department of Defense, the

Department of Veterans Affairs, and the

Environmental Protection Agency.

The Draft Public Health Action Plan

to Combat Antimicrobial Resistance,

Part I focuses on domestic issues. Since

AR transcends national borders and

requires a global approach to its

prevention and control, Part II of the

plan, to be developed subsequently, will

identify actions that more specifically

address international issues. The Plan

includes a summary and a list of issues,

goals, and 87 action items addressing

four focus areas: Surveillance,

Prevention and Control, Research, and

Product Development. For each action

item, ‘‘coordinator’’ and ‘‘collaborator’’

agencies/departments and timelines are

specified. The Interagency Task Force

will monitor, and if necessary, update

the Plan, during the coming years.

Jeffrey P. Koplan,

Director, Centers for Disease Control and

Prevention (CDC).

Ruth Kirschstein,

Acting Director, National Institutes of Health

(NIH).

Jane E. Henney,

Commissioner, Food and Drug

Administration (FDA).

[FR Doc. 00–15847 Filed 6–21–00; 8:45 am]

BILLING CODE 4160–18–P 4140–01–P 4150–04–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00055]

Surveillance for Invasive Fungal

Infections in Transplant Recipients;

Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for surveillance for invasive

fungal infections among transplant

recipients. CDC is committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010,’’ a national

activity to reduce morbidity and

mortality and improve the quality of

life. This announcement is related to the

focus area of Immunization and

Infectious Disease. For the conference

copy of ‘‘Healthy People 2010,’’ visit the

internet site: <http://www.health.gov/

healthypeople>.

The purpose of the program is to

conduct active, prospective surveillance

to estimate the incidence and describe

the epidemiology of opportunistic

invasive fungal infections (OI’s) in bone

marrow/stem cell and solid organ

transplant recipients, and to establish

through this surveillance, a network of

bone marrow/stem cell and solid organ

transplant centers.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes or Indian

tribal organizations.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $200,000 is available

in FY 2000 to fund one award. It is

expected that the award will begin on or

about September 30, 2000, and will be

made for a 12-month budget period

within a project period of up to 3 years.

The funding estimate may change.

A continuation award within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

listed under 1. (Recipient Activities),

and CDC will be responsible for the

activities listed under 2. (CDC

Activities).

1. Recipient Activities

a. Develop and implement a plan to

network transplant medical centers to

conduct surveillance for invasive fungal

infections. This network should consist

of multiple centers with large numbers

of transplants performed per year (a

minimum of 100 to 200 bone marrow/

stem cell per center a year and a

minimum of 200 solid organ transplants

per year) to have adequate estimates of

the incidence of various invasive fungal

OIs (a total transplant population of at

least 5000 per year (i.e. 10 to 20

centers)).

b. Design a network that will consider

centers of various sizes and affiliations

and includes centers from various U.S.

regions to ensure representativeness.

c. Develop a work plan to manage

surveillance activities at the different

transplant centers.

d. Design a strategy for the

participating medical centers to report

every case of invasive fungal OI’s that

occurs in any of their transplant

recipients, even if not hospitalized.

e. Design a data collection form for

reporting each individual incident case

of invasive fungal OI in a transplant

recipient.

38834 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices

f. Develop a standardized protocol for

surveillance for invasive fungal

infections in stem cell/bone marrow and

solid organ transplant recipients.

g. Analyze findings and publish as

necessary.

2. CDC Activities

a. Provide technical assistance in the

development of a data collection form.

b. Provide periodic laboratory

confirmation of identified isolates, and

pathology confirmation of available

diagnostic tissues, as needed and

appropriate.

c. Assist with data management and

statistical support to analyze the

surveillance data, as needed.

d. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project. The CDC IRB will

review and approve the protocol

initially and on at least an annual basis

until the research project is completed.

E. Application Content

Use the information in the Program

Requirements, Other Requirements and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 30 double spaced pages printed on

one side, with one inch margins and

unreduced font.

F. Submission and Deadline

Letter of Intent (LOI)

In order to assist CDC in planning the

evaluation of applications submitted

under this Program Announcement, all

parties intending to submit an

application are requested to submit an

LOI to inform CDC of their intention to

do so. The LOI should include (1) name

and address of institution and (2) name,

address, and telephone number of

contact person. Notification can be

provided by facsimile, postal mail, or

Email.

On or before July 15, 2000, submit the

letter of intent to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Application

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are available in the application

kit.

On or before July 31, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Background and Need (10 points)

Extent to which applicant

demonstrates a clear understanding of

the purpose, and objectives of the focus

area being addressed. Extent to which

applicant demonstrates that the

proposed project addresses the purpose.

2. Capacity (45 points)

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. Extent to which

applicant documents that professional

personnel involved in the project are

qualified and have past experience and

achievements in research related to that

proposed as evidenced by curriculum

vitae, publications, etc. If applicable,

extent to which applicant includes

letters of support from participating

non-applicant organizations,

individuals, etc., and the extent to

which such letters clearly indicate the

author’s commitment to participate as

described in the operational plan.

3. Objectives and Technical Approach

(45 points total)

a. Extent to which applicant describes

measurable and time-phased objectives

of the proposed project which are

consistent with the purpose of the focus

area being addressed. (10 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

recipient activities for the specific

programmatic focus area being

addressed. Extent to which applicant

clearly identifies specific assigned

responsibilities of all key professional

personnel. Extent to which the plan

clearly describes applicant’s technical

approach/methods for conducting the

proposed studies and extent to which

the approach/methods are feasible,

appropriate, and adequate to

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

clearly describes collaboration with

CDC and/or others during various

phases of the project. (25 points)

c. Extent to which applicant provides

a detailed and adequate plan for

evaluating progress toward achieving

project process and outcome objectives.

(5 points)

d. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes (1) the

proposed plan for the inclusion of both

sexes and racial and ethnic minority

populations for appropriate

representation, (2) the proposed

justification when representation is

limited or absent, (3) a statement as to

whether the design of the study is

adequate to measure differences when

warranted and (4) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships

with community(ies) and recognition of

mutual benefits. (5 points)

4. Budget (not scored)

Extent to which the line-item budget

is detailed, clearly justified, and

consistent with the purpose and

objectives of this program.

5. Human Subjects (not scored)

Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. Semi-annual progress reports;

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period. Send all

reports to the Grants Management

Specialist identified in the ‘‘Where to

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices 38835

Obtain Additional Information’’ section

of this announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) and 317(k)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a) and 247b(k)(2)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’ To receive

additional written information and to

request an application kit, call 1–888–

GRANTS (1–888–472–6874). You will

be asked to leave your name and

address and will be instructed to

identify the announcement number of

interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Gladys

Gissentanna, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Atlanta, GA 30341–4146. Telephone

Number: 770–488–2753; Email Address:

gcg4@cdc.gov.

For program technical assistance,

contact: Rana A. Hajjeh, M.D., National

Center for Infectious Diseases, Centers

for Disease Control and Prevention,

1600 Clifton Road, NE., Atlanta, GA

30333, Telephone Number: 404–639–

4753; E-mail Address: rfh5@cdc.gov.

Dated: June 16, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–15769 Filed 6–21–00; 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: State Human Services System.

OMB No.: New Collection.

Description: Collect Data from States

to Provide Updated Information on what

systems software each State has created

in the area of State Systems which effect

TANF, CW, OCSE and Child Care

Projects.

Respondents: 54 States and

Territories.

Annual Burden Estimates:

Instrument Number of respondents

Number of responses per respondentAverage burden

hours per response

Total burden

hours

Survey ...................................................................................................... 54 4 1 216

Estimated Total Annual Burden

Hours: 216.

In compliance with the requirements

of Section 350(c)(2)(A) of the Paperwork

Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded 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. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: June, 15, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–15844 Filed 6–21–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Temporary Deferment of Activities

Relating to Certain Biologics

Submissions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the Center for Biologics Evaluation

and Research (CBER) will be converting

its current biologics license application

(BLA) data base system into a new data

base system. During the period required

for this conversion, the agency will

temporarily defer certain submissions

subject to CBER review and approval,

and the review period, if any, on

pending submissions will be suspended.

FDA plans to temporarily defer action

on submissions related to BLA’s,

product license applications (PLA’s),

establishment license applications

(ELA’s), and any related

correspondence. FDA is also requesting

that sponsors voluntarily refrain from

filing the affected submissions during

this period. FDA estimates that the

deferment period will be about 1 month.

FOR FURTHER INFORMATION CONTACT:

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–2000.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 201 et seq.) and section 351

of the Public Health Service Act (42

U.S.C. 262), CBER is responsible for