Federal Register / Vol. 66, No. 101 / Thursday, May 24, 2001 / Notices 28753

proposed studies and extent to which

the plan is adequate to accomplish the

objectives. Extent to which applicant

describes specific study protocol(s), the

roles of partners or collaborators or

plans for the development of study

protocols that are appropriate for

achieving project objectives. (30 points)

c. If the proposed project involves

human subjects, 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. (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 will be documented.

(see Other Requirements for additional

information regarding this requirement

for research projects). (5 points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results and for

evaluating progress toward achieving

project objectives. (5 points)

4. Budget (not scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

grant funds.

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 an original plus

two copies of the following:

1. 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 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

AR–15 Proof of Non-Profit Status

AR–22 Research Integrity

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-GRANTS4

(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,

Mailstop K75, Atlanta, GA 30341–4146,

Telephone number: 770–488–2753,

Email address: gcg4@cdc.gov.

For program technical assistance,

contact: Marsha Jones, Health Scientist,

National Center for Infectious Diseases,

Centers for Disease Control and

Prevention, 1600 Clifton Road, N.E.,

Mailstop C–12, Atlanta, GA 30333,

Telephone number: 404–639–2603.

Email address: maj4@cdc.gov.

Dated: May 17, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–13127 Filed 5–23–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Office of Planning, Research and

Evaluation; Grant to the Institute for

Responsible Fatherhood and Family

Revitalization

AGENCY: Office of Planning, Research

and Evaluation, ACF, DHHS.

ACTION: Award announcement.

SUMMARY: Notice is hereby given that a

noncompetitive grant award is being

made to the Institute for Responsible

Fatherhood and Family Revitalization to

build the Institute’s capacity and

infrastructure and expand the provision

of direct services to reunite fathers and

families. As a Congressional setaside,

this one-year project is being funded

noncompetitively. The Institute has

community-based service centers in

several states and has successfully

served so far more than 7000 fathers and

their families. The cost of this one-year

project is $500,000.

FOR FURTHER INFORMATION CONTACT: K.

A. Jagannathan, Administration for

Children and Families, Office of

Planning, Research and Evaluation, 370

L’Enfant Promenade, SW., Washington,

DC 20447, Phone: 202–205–4829.

Dated: May 18, 2001.

Howard Rolston,

Director, Office of Planning, Research and

Evaluation.

[FR Doc. 01–13143 Filed 5–23–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00P–1340]

Determination That ROWASA

(mesalamine) Rectal Suppositories,

500 Milligrams, Was Not Withdrawn

From Sale for Reasons of Safety or

Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that ROWASA

(mesalamine) Rectal Suppositories, 500

milligrams (mg) was not withdrawn

from sale for reasons of safety or

effectiveness. This determination will

allow FDA to approve abbreviated new

drug applications (ANDAs) for