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Sent via email to: <FDADOCKETS@OC.FDA.GOV>

Subject: Docket No 2003D-0522 March 1 , 2004

Dear Sirs,

As the developer and manufacturer of the first on-site oral-based test
for drugs-of-abuse, Avitar respectfully submits its comments relative to
the FDA's **Draft Guidance on Drugs of Abuse Screening Tests.**

Avitar applauds the FDA's efforts to more effectively oversee the
marketing of drugs-of-abuse testing products, with respect to laboratory
tests, and non-laboratory tests targeted at the consumer or healthcare
markets. The FDA's proposed guidelines will assist companies serving
these sectors in preparing pre-market submissions and better complying
with FDA regulations.

We respectfully request, however, that the proposed guidelines be
modified relative to the workplace sector.

The proposed guidelines would significantly raise the cost to employers
for on-site drugs of abuse testing, potentially lessen the amount of
testing done, and threaten a growing number of small innovative test
manufactures that are developing products to meet market needs.

The following supportive comments are offered for your review:

1\. Employers have traditionally expressed frustration with the cost and
long turnaround times for test results associated with traditional
laboratory-based testing practices. As a result, innovative companies
such as Avitar developed rapid on-site tests for drugs of abuse. While
Avitar develops and manufactures oral-based saliva tests, on-site tests
are available from other manufactures for using urine.

Its is these new technologies that are enabling employers to
cost-effectively increase and optimize their drugs of abuse testing
policies. For example, testing can be expanded beyond pre-employment
testing to include random testing, a process proven to be more effective
in reducing the level of drug usage on the job.

2\. The requirement to run controls by the users would add significant
costs to the test. Quality control for on-site drugs of abuse tests is
done at the time of manufacturing. Additionally, a control line present
on each oral-based on-site test that shows that the device has been
stored properly and is operational. We respectfully submit that FDA
approved tests such as OTC pregnancy and glucose monitoring, both of
which are medical tests, are not presently required to run controls.

The cost of running clinical trials, requiring that samples be taken in
the workplace, would be also dramatically increase costs, as a
prohibitive number of samples from the workplace would be required to
yield the requisite positive samples..

Larger firms are better positioned to fund the additional costs noted
above, which we submit are not needed. The smaller, innovative test
manufactures would be disproportionately affected and likely be
eliminated from the market.

3\. If costs for on-site testing increase, and employers respond by
testing less frequently and/or effectively, there may be a significantly
negative impact upon the US economy.

The time required to test and hire an employee would be increased, and
less effective drugs of abuse policies would be employed, reversing the
current trends toward reduction of drug usage in the workforce.
Furthermore, in an economic environment where U.S. jobs are at risk due
to foreign competition, adding additional costs and time to the hiring
process is clearly not in the national interest (Note: On-site tests are
approximately 65% less costly than traditional laboratory tests, and
yields significant time savings, as an initial screen result is
available within minutes of taking the test.)

4\. A significant degree of self-regulation is in place. Manufacturers
and employers have developed and presently use accurate and reliable
products, complete with appropriate labeling and training materials.
Labeling typically includes both pictures and text that enable the lay
person to understand what drugs the test can identify, the time frame
within which the drugs can be detected, how to properly collect the
specimen, run the test, and determine a result. The workplace has
procedures in place for non-negative results, such as subsequent
confirmation via laboratory testing. MRO procedures and EAP programs are
in place to support confirmed positives, obtain professional counseling
if needed, etc.

5\. In addition to manufacturer and employer self-regulation, the
nation's legal system supports a rigorous framework of established
practices for drugs of abuse testing.

Hundreds of historical cases support drugs of abuse testing in the
workplace, and precedent for their appropriate usage.

In summary, Avitar's drugs of abuse screening products are not medical
devices. Our products are used in the workplace to screen for potential
drug use only. Effective procedures for collecting samples and
conducting tests are already in place and are rigorously supported by
both our firm and employers. Avitar's screening products are not sold to
consumers

As an innovative industry-leading private sector partner in the fight
against drug use in America, we respectfully request that the FDA
reconsider the inclusion of the workplace sector in its proposed
guidelines, or make appropriate modifications.

Your assistance in this matter will allow our firm, working with
employers throughout the Nation, and all interested and affected
constituencies, to continue to provide the benefits of quality,
cost-effective, drugs of abuse testing.

Please contact me directly with any questions. Also, I would be pleased
to visit with you in Washington at your convenience.

Sincerely,

Doug Scott

President, Avitar Technologies www.avitarinc.com