[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