Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Notices 67083

process, and eventual publication in

both the Journal of AOAC International

and OMA. AOAC International’s

existence as an internationally

recognized organization means that

AOAC International official methods are

internationally acceptable based on the

association’s prior efforts to

‘‘harmonize’’ standards of

acceptability.Methods are developed

and subjected to interlaboratory

collaborative study by Associate

Referees, under the guidance of General

Referees and the Official Methods Board

and its Committees. AOAC International

staff and methods committee members

assist in recruiting laboratories with

appropriate expertise to participate in

approved collaborative studies.

Volunteer statisticians assigned to the

Committee by AOAC International assist

the Associate Referee in evaluating

study results. If the statistical evaluation

of analytical results demonstrates that

the method is capable of producing

accurate and precise results in multiple

laboratories, it is recommended for

official status. After assenting mail vote

by the association, the description of the

newly approved official method is

incorporated by the editorial staff into

the next annual revision of OMA;

details of the collaborative study are

published in the Journal of AOAC

International. AOAC International conducts an

annual international meeting, which

includes presentation of symposia,

reports methods and collaborative

studies, and deliberation decisions by

the Official Methods Board and its

Committees.

III. Substantive Involvement by the

FDA

FDA supports AOAC International

under this cooperative agreement

because the existence of AOAC

Interantional and its programs benefits

both FDA and other regulators

monitoring regulated products;

regulated industries benefit equally

from these activities. The availability of

validated methods also benefits FDAregulated industry which needs

validated analytical methods to comply

with regulatory requirements under the

Federal Food, Drug, and Cosmetic Act.

Beyond the financial support, this

agreement also commits FDA’s

personnel to participation in the

scientific and administrative operations

of AOAC International.

Members of AOAC International are

chemists, microbiologists, toxicologists

and others engaged in the analysis of

foods, animal feeds, drugs, agricultural

commodities and environmental

matrixes. Members identify and develop

methods to be tested and organize the

interlaboratory validation studies.

Members receive and review the results

of validation studies. Members receive

and review methods recommendations,

and members study, devise and

recommend policies and protocols

addressing methods, validation studies,

quality assurance, safety and statistical

analysis. FDA involvement in AOAC

International activities continues at a

high level, with a significant percentage

of Associate and General Referee and

Committee positions filled by FDA

personnel. Any laboratory or individual

may participate in the development,

testing, and collaborative study of new

or improved methods. The international

voluntary participation among scientists

in government, academic, and industry

laboratories enhances the credibility

and acceptability of methods and saves

time and money through shared efforts

and costs.

IV. Review Procedure

This application will undergo dual

peer review. An ad hoc review panel of

experts will review and evaluate the

application based on its scientific merit.

A second level review will be

conducted by the National Advisory

Environmental Health Sciences Council.

V. Mechanism of Support

A. Award Instrument

Support for this program, if granted,

will be in the form of a cooperative

agreement. In 1998, FDA is providing

approximately $100,000 for this award.

The award will be subject to all policies

and requirements that govern the

research grant programs of the Public

Health Service (PHS), including the

provisions of 42 CFR part 52, 45 CFR

part 74, and the PHS Grants Policy

Statement.

B. Length of Support

The length of support will be one (1)

year with the possibility of an

additional four (4) years of

noncompetitive support. Continuation,

beyond the first year, will be based

upon performance during the preceding

year and the availability of Federal

fiscal year appropriations.

C. Memorandum of Understanding

(MOU)

FDA and AOAC International will

develop a MOU to cover and clarify

AOAC International’s publication of

FDA manuals.

VI. Reporting Requirement

Program progress reports and

financial status reports will be required

annually, based on date of award. These

reports will be due within 30 days after

the end of the budget period. A final

program progress report and financial

status report will be due 90 days after

expiration of the project period of the

cooperative agreement.

VII. Application Due Date

Applications should be submitted to

Robert L. Robins (address above) by

January 6, 1998.

Dated: December 16, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33371 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0160]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Food Labeling: Nutrient Content

Claims and Health Claims; Restaurant

Foods’’ has been approved by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act of

1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: On

September 17, 1997, the agency

submitted the proposed information

collection to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0349. The

approval expires on November 30, 2000.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33374 Filed 12-22-97; 8:45 am]

BILLING CODE 4160–01–F