5428 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

term maintenance of a complete Statebased PbB surveillance system. In

particular, specific activities that will be

undertaken by the State during the

project period to ensure that the

surveillance program continues after

completion of the project period.

4. Personnel (10 points).

The extent to which the qualifications

and time commitments of project

personnel are clearly documented and

appropriate for implementing the

proposal.

5. Use of Existing Resources (5

points).

The extent to which the proposal

would make effective use of existing

resources and expertise within the

applicant agency or through

collaboration with other agencies.

6. BUDGET (Not Scored).

The extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

funds.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants should contact

their State Single Point of Contact

(SPOC) as early as possible to alert them

to the prospective applications and

receive any necessary instructions on

the State process. For proposed projects

serving more than one State, the

applicant is advised to contact the SPOC

for each affected State. A current list of

SPOCs is included in the application

kit. If they have comments it should be

sent to Lisa G. Tamaroff, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Atlanta, GA

30305, no later than 60 days after the

application due date. The Program

Announcement Number and Program

Title should be referenced on the

document. The granting agency does not

guarantee to ‘‘accommodate or explain’’

State process recommendations it

receives after that date.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.197.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the grant will be subject

to review by the Office of Management

and Budget(OMB)under the Paperwork

Reduction Act.

Application Submission and Deadline

The original and two copies of the

PHS 5161–1 (OMB Number 0937-0189)

must be submitted to Lisa G. Tamaroff,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Atlanta, GA 30305, on or before April 9,

1997.

1. 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 for

the review process. 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.

2. Late Applications

Applications which do not meet the

criteria in 1.A. or 1.B. above are

considered late applications. Late

applications will not be considered in

the current competition and will be

returned to the applicant.

A one-page, single-spaced, typed

abstract must be submitted with the

application. The heading should

include the title of the grant program,

project title, organization, name and

address, project director and telephone

number.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 721.

You will receive a complete program

description, information on application

procedures and application forms.

If you have questions after reviewing

the contents of all documents, business

management technical assistance may

be obtained from Lisa G. Tamaroff,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6796. Internet

address lgt1.@ops.cdc.gov.

This and other CDC announcements

are also available through the CDC

homepage on the Internet. The address

for the CDC homepage is http://

www.cdc.gov.

CDC will not send application kits by

facsimile or express mail.

Please refer to Announcement

Number 721 when requesting

information and submitting an

application.

Technical assistance on prevention

activities may be obtained from

Claudette A. Grant, Acting Chief,

Program Services Section, Lead

Poisoning Prevention Branch, Division

of Environmental Hazards and Health

Effects, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

42, Atlanta, GA 30341–3724, telephone

(770) 488–7330, Internet address

cag4@ceh.cdc.gov.

Technical assistance on surveillance

activities may be obtained from Carol

Pertowski, M.D., Medical

Epidemiologist, Surveillance and

Programs Branch, Division of

Environmental Hazards and Health

Effects, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

42, Atlanta, GA 30341–3724, telephone

(770) 488–7330, Internet address

cap4@ceh.cdc.gov.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: January 30, 1997.

Joseph R. Carter,

Acting Associate Director, Management and

Operations, Centers for Disease Control and

Prevention.

[FR Doc. 97–2799 Filed 2–4–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 97F–0038]

Alcide Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5429

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Alcide Corp. has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of acidified sodium chlorite

solutions for red meat disinfection in

processing plants.

DATES: Written comments on the

petitioner’s environmental assessment

by March 7, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–217), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3074.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7A4532) has been filed by

Alcide Corp., 8561 154th Ave. NE.,

Redmond, WA 98052. The petition

proposes to amend part 173 (21 CFR

part 173) of the food additive

regulations to provide for the safe use of

acidified sodium chlorite solutions for

red meat disinfection in processing

plants.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before March 7, 1997

submit to the Dockets Management

Branch (address above) written

comments. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: January 17, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–2820 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

Studies of Adverse Effects of Marketed

Drugs, Biologics, and Devices;

Availability of Grants (Cooperative

Agreements); Request for Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for Drug

Evaluation and Research, is announcing

the availability of $1.4 million in Fiscal

Year 1997 funds for cooperative

agreements to study adverse effects of

marketed drugs, biologics, and devices.

This amount is consistent with the level

of funding in the President’s budget.

FDA expects to make four to six awards

in the range of $250,000 to $350,000 for

direct and indirect costs. The

Government’s obligation is contingent

upon the availability of appropriated

funds from which the cooperative

agreements will be funded. The purpose

of these agreements is to conduct drug,

biologic, and device safety analysis for

public health benefit; respond

expeditiously to urgent public safety

concerns; provide a mechanism for

collaborative pharmacoepidemiological

research designed to test hypotheses,

particularly those arising from

suspected adverse reactions reported to

FDA; and enable rapid access to

multiple data sources to ensure public

safety when necessary.

DATES: Application receipt date is

March 21, 1997.

ADDRESSES: Application kits are

available from, and completed

applications should be submitted to:

Robert L. Robins, Grants Management

Officer, Division of Contracts and

Procurement Management (HFA–520),

Food and Drug Administration, Park

Bldg., rm. 3–40, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–6170.

Note: Applications hand-carried or

commercially delivered should be

addressed to the Park Bldg., rm. 3–40,

12420 Parklawn Dr., Rockville, MD

20857. Please do NOT send applications

to the Division of Research Grants,

National Institutes of Health (NIH).

FOR FURTHER INFORMATION CONTACT:

Regarding the administrative and

financial management aspects of

this notice: Robert L. Robins

(address above).

Regarding the programmatic aspects

of this notice: Charles M. Maynard,

Division of Pharmacovigilance and

Epidemiology (HFD–733), Food and

Drug Administration, 5600 Fishers

Lane, rm. 15B–18, Rockville, MD

20857, 301–827–3187.

SUPPLEMENTARY INFORMATION: FDA’s

authority to fund research projects is set

out in section 301 of the Public Health

Service Act (the PHS Act) (42 U.S.C.

241). FDA’s research program is

described in the Catalog of Federal

Domestic Assistance, No. 93.103.

Applications submitted under this

program are not subject to the

requirements of Executive Order 12372.

I. Background

New drugs, biologics, and devices are

required to undergo extensive testing

before marketing. With the submission

of adequate data on safety and

effectiveness, FDA approves a new drug,

biologic, and device application (NDA/

PLA/PMA) that permits a manufacturer

to market its product in the United

States. Although the information

provided before marketing is sufficient

for approval, it is not adequate to

anticipate all effects of a product once

it comes into general use.

This request for applications (RFA) is

intended to encourage collaboration

between FDA and researchers with

pharmacoepidemiological data bases to

address postmarketing issues

confronting the agency. FDA is also

interested in the ability to measure and/

or estimate incidence rates and test

hypotheses based on signals of possible

drug, biologic, and device safety

problems originating from reports of

adverse reactions received by FDA.

II. Program Research Goals

FDA would prefer to fund a variety of

data bases representing, without

overlap, different patient populations

and/or types of patient care settings.

The data bases maintained through

these agreements must be able to: (1)

Provide data on exposure to new

chemical entities; (2) perform feasibility

studies of multiple drugs and/or

multiple outcomes; (3) identify adverse

drug, biologic, and device events that

occur infrequently; and (4) provide a

substantive response within a very short

timeframe.

The goal for these cooperative

agreements is to investigate suspected

associations between specific drug and