65084 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Notices

(HF–32), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD, 20857, 301–827–3340.

SUPPLEMENTARY INFORMATION: FDA is

announcing the formation of a

subcommittee of the Science Board. The

subcommittee has been established to

address issues related to the scientific

quality, mission relevance, and

scientific management and leadership of

research programs conducted by FDA.

The subcommittee will meet several

times over the next 2 years to collect

and review information on FDA’s

scientific research programs and to

discuss a validated process for a

coordinated, external, scientific peer

review of the agency’s research

programs. The subcommittee’s findings

will be presented to the Science Board

for full public discussion at future

meetings that will be announced in the

Federal Register prior to the meetings.

This notice is issued under the Federal

Advisory Committee Act of October 6,

1972 (Pub. L. 92–463 (5 U.S.C. app.2)).

Dated: December 4, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–32276 Filed 12–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0504]

The Goodyear Tire and Rubber Co.;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the Goodyear Tire and Rubber Co.

has filed a petition proposing that the

food additive regulations be amended to

provide for the expanded safe use of

butylated reaction product of p-cresol

and dicyclopentadiene for use as an

antioxidant in acrylonitrile/butadiene/

styrene copolymers in contact with

food.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

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 8B4561) has been filed by

The Goodyear Tire and Rubber Co., c/

o Keller and Heckman LLP, 1001 G St.

NW., suite 500 West, Washington, DC

20001. The petition proposes to amend

the food additive regulations in

§ 178.2010 Antioxidants and/or

stabilizers for polymers (21 CFR

178.2010) to provide for the expanded

safe use of butylated reaction product of

p-cresol and dicyclopentadiene for use

as an antioxidant in acrylonitrile/

butadiene/styrene copolymers in

contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: December 2, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–32358 Filed 12–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0501]

Abbott Laboratories; Premarket

Approval of IMx PSA and AxSYM

PSA Assays

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the supplemental

application by Abbott Laboratories,

Diagnostics Div., Abbott Park, IL, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the IMx PSA and AxSYM PSA

assay. FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of August 7, 1997, of

the approval of the supplemental

application.

DATES: Petitions for administrative

review by January 9, 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:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293.

SUPPLEMENTARY INFORMATION: On

November 2, 1994, Abbott Laboratories,

Diagnostics Div., Abbott Park, IL 60064,

submitted to CDRH a supplemental

application for premarket approval of

IMx PSA and AxSYM PSA assays.

The devices are microparticle enzyme

immunoassays (MEIA) for the

quantitative measurement of Prostate

Specific Antigen (PSA) in human serum

as an aid in the detection of prostate

cancer when used in conjunction with

digital rectal exam (DRE) in men aged

50 years or older. Prostatic biopsy is

required for diagnosis of cancer.

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 Immunology

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 7, 1997, CDRH approved

the supplemental application by a letter

to the applicant from the Deputy

Director of Clinical and Review Policy,

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
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Notices 65085

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 the 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 January 9, 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

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: October 31, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32216 Filed 12–9–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–320]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Corrective

Action Plan (Medicaid Eligibility

Quality Control); Form No.: HCFA–320;

Use: Medicaid eligibility quality control

(MEQC) is a State-administered system

designed to improve the management of

the Medicaid program and reduce the

level of misspent Medicaid funds. Each

month, States select a sample of

Medicaid cases from their inventory of

eligible cases and conduct QC reviews

to determine the accuracy of the

eligibility determinations. This

Corrective Action Plan allows HCFA to

determine the types of corrective actions

used by States. Sound and effective

corrective actions used by one State to

correct causes of errors and reduce

erroneous Medicaid payments are

shared with other States experiencing

the same types of error-causing

problems. Frequency: Annually;

Affected Public: State, Local or Tribal

Government; Number of Respondents:

51; Total Annual Responses: 51; Total

Annual Hours: 20,400.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: December 2, 1997

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–32320 Filed 12–9–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Availability of the HRSA Competitive

Grants Preview

Correction

In notice document 97–26645

appearing on page 52905 of the issue on

Thursday, October 9, 1997, make the

following correction:

On page 52905, in the second column

under the heading ‘‘Centers of

Excellence (COE)’’ in the sixth

paragraph labeled as ‘‘Estimated

Amount of This Competition,’’ the

amount should read ‘‘$1,500,000.’’

Dated: December 3, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–32277 Filed 12–9–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Final Review Criteria for Grants for the

National Research Service Awards:

Primary Care Research for Fiscal Year

1998

The Health Resources and Services

Administration (HRSA) National

Research Service Awards: Primary Care

Research (NRSA) institutional training

grants (T32) are provided to accredited

public or private nonprofit schools of

medicine, osteopathy, dentistry, or a

public or private nonprofit hospital or

other entity which is affiliated with an

entity that has received grants or

contracts under section 747, 748, or 749

of the PHS Act, agrees to use the

funding for research in primary medical

care, and is located in a State. The

NRSA program is authorized by Title IV,

Section 487(d)(3)(A) of the Public

Health Service Act.

A notice was published in the Federal

Register at 62 FR 49521 on September

22, 1997, for review criteria for the

above-referenced program. No

comments were received within the 30

day comment period. Therefore, the

review criteria remain as proposed.

Final Review Criteria

The following criteria are for National

Research Service Awards in primary

care research: