Federal Register / Vol. 63, No. 3 / Tuesday, January 6, 1998 / Notices 565

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture human and

veterinary drugs, veterinary drugs, and

commercial feed mills.

FDA estimate the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 200 120 24,000 0.75 18,000

226.58 200 120 24,000 1.75 42,000

226.80 200 120 24,000 0.75 18,000

226.102 200 120 24,000 1.75 42,000

226.110 200 120 24,000 0.25 6,000

226.115 200 120 24,000 1.00 24,000

Total burden hours 150,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: December 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–151 Filed 1–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0520]

Abbott Laboratories, Premarket

Approval of IMx Tacrolimus II Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Abbott Laboratories, Abbott Park, IL,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the IMx Tacrolimus II

Assay. FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of August 26, 1997,

of the approval of the application.

DATES: Petitions for administrative

review by February 5, 1998.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Steven I. Gutman, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, –2098

Gaither Rd., Rockville, MD 20850, 301–

594–1243.

SUPPLEMENTARY INFORMATION: On

February 18, 1997, Abbott Laboratories,

Abbott Park, IL 60064–3537, submitted

to CDRH an application for premarket

approval of the IMx Tacrolimus II

Assay. The device is an in vitro reagent

system for the quantitative

determination of tacrolimus and some

metabolites in human whole blood as an

aid in the management of liver allograft

patients receiving tacrolimus therapy.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Clinical

Chemistry and Toxicology Devices

Panel of the Medical Devices Advisory

Committee, an FDA advisory committee,

for review and recommendation because

the information in the PMA

substantially duplicates information

previously reviewed by this panel.

On August 26, 1997, CDRH approved

the application by a letter to the

applicant from the Deputy Director,

Clinical and Review Policy, the Office of

Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under 21 CFR part 12 of FDA’s

administrative practices and procedures

regulations or a review of the

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

21 CFR 10.33(b). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before February 5, 1998, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the
566 Federal Register / Vol. 63, No. 3 / Tuesday, January 6, 1998 / Notices

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: December 1, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 98–153 Filed 1–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Appointment of Performance Review

Board (PRB) Members

The Health Care Financing

Administration (HCFA) announces the

names of new and current members of

the Performance Review Board as

required by 5 U.S.C. 4314(c)(4). HCFA’s

PRB consists of: Mary May Smith,

Chairperson; David S. Cade; Richard S.

Foster; Barbara S. Cooper; A. Peter

Bouxsein; Linda A. Ruiz; and Charles R.

Booth.

For further information, contact the

Director, Human Resources

Management Group, Office of Internal

Customer Support, Teresa A. Smith,

7500 Security Boulevard, Room C2–09–

27, Baltimore, Maryland 21244–1850,

telephone number 410–786–5489.

Dated: December 17, 1997.

Teresa A. Smith,

Director, Human Resources Management

Group.

[FR Doc. 98–211 Filed 1–5–98; 8:45 am]

BILLING CODE 4120–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 1998 Funding

Opportunities

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of funding availability.

SUMMARY: The Substance Abuse and

Mental Health Services Administration

(SAMHSA) Center for Mental Health

Services and Center for Substance

Abuse Prevention announce the

availability of FY 1998 funds for grants

and/or cooperative agreements for the

following activities. These activities are

discussed in more detail under Section

4 of this notice. This notice is not a

complete description of the activities;

potential applicants must obtain a copy

of the Guidance for Applicants (GFA)

before preparing an application.

Activity Application

deadline

Estimated

funds available (million)

Estimated

number of

awards

Project period (years)

State Incentive Program ................................................................................................... 03/06/98 $42.0 12–18 3

HIV/AIDS Education ......................................................................................................... 04/03/98 2.0 7–9 3

Child Mental Health Initiative ............................................................................................ 04/03/98 8–12 8–12 5

Note: SAMHSA plans to publish additional

notices of available funding opportunities for

FY 1998 in subsequent issues of the Federal

Register.

The actual amount available for

awards and their allocation may vary,

depending on unanticipated program

requirements and the volume and

quality of applications. Awards are

usually made for grant periods from one

to three years in duration. FY 1998

funds for activities discussed in this

announcement were appropriated by the

Congress under Public Law 105–78.

SAMHSA’s policies and procedures for

peer review and Advisory Council

review of grant and cooperative

agreement applications were published

in the Federal Register (Vol. 58, No.

126) on July 2, 1993.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The SAMHSA Centers’

substance abuse and mental health

services activities address issues related

to Healthy People 2000 objectives of

Mental Health and Mental Disorders;

Alcohol and Other Drugs; Clinical

Preventive Services; HIV Infection; and

Surveillance and Data Systems.

Potential applicants may obtain a copy

of Healthy People 2000 (Full Report:

Stock No. 017–001–00474–0) or

Summary Report: Stock No. 017–001–

00473–1) through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325

(Telephone: 202–512–1800).

General Instructions: Applicants must

use application form PHS 5161–1 (Rev.

5/96; OMB No. 0937–0189). The

application kit contains the GFA

(complete programmatic guidance and

instructions for preparing and

submitting applications), the PHS 5161–

1 which includes Standard Form 424

(Face Page), and other documentation

and forms. Application kits may be

obtained from the organization specified

for each activity covered by this notice

(see Section 4).

When requesting an application kit,

the applicant must specify the particular

activity for which detailed information

is desired. This is to ensure receipt of

all necessary forms and information,

including any specific program review

and award criteria.

The PHS 5161–1 application form and

the full text of each of the activities (i.e.,

the GFA) described in Section 4 are

available electronically via SAMHSA’s

World Wide Web Home Page (address:

http://www.samhsa.gov). The GFAs are

also available on SAMHSA’s Bulletin

Board (800–424–2294 or 301–443–

0040).

Application Submission: Unless

otherwise stated in the GFA,

applications must be submitted to:

SAMHSA Programs, Center for

Scientific Review, National Institutes of

Health, Suite 1040, 6701 Rockledge

Drive MSC–7710, Bethesda, Maryland

20892–7710*

(* Applicants who wish to use express mail

or courier service should change the zip code

to 20817)

Application Deadlines: The deadlines

for receipt of applications are listed in

the table above. Please note that the

deadlines may differ for the individual

activities.

Competing applications must be

received by the indicated receipt dates

to be accepted for review. An

application received after the deadline

may be acceptable if it carries a legible

proof-of-mailing date assigned by the

carrier and that date is not later than

one week prior to the deadline date.