[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Notices]
[Pages 67081-67083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Program Announcement Number FDA-CFSAN-98-1 Cooperative Agreement 
for Validation of Analytical Methods, Standards, and Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Food Safety 
and Applied Nutrition (CFSAN), is announcing its intention to accept 
and consider a single source application for award of a cooperative 
agreement to support AOAC International in the amount of $100,000. The 
cooperative agreement will provide support for the Validation of 
Analytical Methods, Standards, and Procedures.


[[Page 67082]]


DATES: Submit applications by January 6, 1998.
ADDRESSES: An application is available from and should be submitted to 
Robert L. Robins (address below). Applications hand carried or 
commercially delivered should be addressed to the Park Bldg., 12420 
Parklawn Dr., rm. 3-40, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Regarding the administrative and financial management aspects of 
this notice: Robert L. Robins, Grants Management Officer, or Rosemary 
T. Springer, Grants Management Specialist, Office of Regulatory Affairs 
Support and Assistance Management Branch, State Contracts and 
Assistance Agreements Branch (HFA-520), Food and Drug Administration, 
Park Bldg., 5600 Fishers Lane, rm. 3-40, Rockville, MD 20857, 301-443-
6170.
    Regarding the programmatic aspects of this program: Bernadette 
McMahon, Office of Plant and Dairy Foods and Beverages (HFS-337), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4038.

SUPPLEMENTARY INFORMATION: FDA is announcing its intention to accept 
and consider a single source application from AOAC International for 
supporting the Validation of Analytical Methods, Standards, and 
Procedures. FDA's authority to enter into grants and cooperative 
agreements is set out in section 301 of the Public Health Service Act 
(42 U.S.C. 241). FDA's research program is described in the Catalog of 
Federal Domestic Assistance at section 93.103. Before entering into 
cooperative agreements, FDA carefully considers the benefits such 
agreements will provide to the public.

I. Background

    Until 1979, AOAC International operated as part of the U.S. FDA, 
whose employees performed as Executive Director and Journal Editor, 
among other positions. At that time, on the recommendation of an 
independent panel, AOAC International became independent of FDA and was 
established as a nonprofit association.
    Since the separation of FDA and AOAC International, FDA has 
continued to provide financial support to AOAC International through a 
cooperative agreement. In the beginning, FDA was motivated to ensure 
that AOAC International would have funds needed to continue publishing 
new editions (every 5 years) of Official Methods of Analysis of AOAC 
(OMA), the compilation of all methods validated through the 
collaborative process, which is of interest to regulated industry. AOAC 
International no longer requires FDA's support to underwrite the 
publication of OMA, which is now AOAC International's main source of 
revenue. FDA's current support for AOAC International, both financially 
and with activities of its employees, is motivated by its recognition 
of AOAC International's critical role in organizing, operating, and 
maintaining an internationally recognized system for establishing 
collaborated methods of analysis. It is imperative to FDA that an 
organization such as AOAC International continue to function 
efficiently, especially in scientific areas in which internationally 
recognized analytical methods are required to support regulatory 
decisions.
    AOAC International consists of the following members: A governing 
board (Board of Directors, including officers) concerned with 
administration and policy making; Official Methods Board; Editorial 
Board; special and standing committees which serve in advisory and 
liaison capacities; other groups concerned with development of methods, 
publication, and general activities; and the headquarters staff which 
conducts the day-to-day business.
    In recent years, AOAC International has initiated additional 
activities aimed at the improvement of the analytical sciences, 
including training programs on critical subjects such as modern 
analytical technologies, application of quality assurance principles, 
and statistical principles and applications. The association 
established a Research Foundation to assess and certify commercial test 
kits, defined an additional level of validated methods (the ``peer 
verified'' methods), and is investigating the potential for developing 
analytical standard reference materials. AOAC International has 
embraced opportunities to use electronic media to distribute its 
validated methods and other supporting materials through use of the 
World Wide Web and CD-ROM formats.

II. Purpose of Agreement

    The primary purpose is to provide financial and scientific support 
for AOAC International cooperative volunteer system of scientific 
analytical methods development and approval. This system produces 
methods that meet predetermined levels of quality for analysis of 
foods, animal feeds, drugs and cosmetics; such methods are critical to 
the acceptability of regulatory analytical results performed by FDA and 
by the regulated industry. AOAC International has excelled in planning, 
coordinating, and managing the activities essential to developing 
tested analytical procedures applicable to a wide range of sample types 
of interest to industry, government, and academia. This is one of very 
few programs which provide methodology validated through a formal 
interlaboratory collaborative study process.
    To accomplish this overall goal, AOAC International will:
    1. Develop standards and criteria for evaluation of results in 
analytical methods validation, balancing the needs for statistical 
acceptability, international harmonization, and practicality in an era 
of shrinking fiscal resources.
    2. Identify needs for new and improved analytical methods for food 
composition and safety, vitamins and nutrients, food additives, 
pesticide and industrial chemical residues, drug formulations, animal 
drug residues, cosmetics chemistry and microbiology, color additives 
and any other products or substances affecting the public health and 
safety.
    3. Recruit and support logistically the volunteer experts necessary 
to the successful development, review, and testing of needed methods.
    4. Apply quality assurance principles to validation studies.
    5. Encourage FDA and regulated industry to do more related research 
in analytical sciences.
    6. Sponsor and participate in international forums.
    7. Promote wider use of validated methods.
    8. Increase opportunities for interaction of FDA-related science in 
international activities.
    AOAC International maintains no laboratories itself, conducts no 
research, performs no tests. The actual work of developing and testing 
methods is done by scientists of Federal, State, provincial and 
municipal regulatory agencies, colleges and universities, commercial 
firms, and other private laboratories.
    AOAC International provides the framework within which the 
collaborative study process occurs. With AOAC International as a focal 
point of analytical expertise, sufficient cooperating volunteer members 
can be found to effect the complex process of testing a method 
simultaneously in multiple laboratories. AOAC International staff 
members facilitate logistics required for operations, including the 
necessary meetings, recruitment of volunteers and collaborating 
laboratories, the voting

[[Page 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 FDA-regulated 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