[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Rules and Regulations]
[Pages 18230-18234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8598]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 809 and 864

[Docket No. 97N-0135]


Hematology and Pathology Devices; Reclassification; Restricted 
Devices; OTC Test Sample Collection Systems for Drugs of Abuse Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying over-
the-counter (OTC) test sample collection systems for drugs of abuse 
testing from class III (premarket approval) into class I (general 
controls) and exempting them from premarket notification (510(k)) and 
current good manufacturing practice (CGMP) requirements. FDA is also 
designating OTC test sample collection systems for drugs of abuse 
testing as restricted devices under the Federal Food, Drug, and 
Cosmetic Act (the act) and establishing restrictions intended to assure 
consumers that: The underlying laboratory test(s) are accurate and 
reliable; the laboratory performing the test(s) has adequate expertise 
and competency; and the product has adequate labeling and methods of 
communicating test results to consumers. Finally, FDA is adding a 
conforming amendment to the existing classification regulation for 
specimen transport and storage containers to clarify that it does not 
apply to specimen transport and storage containers that are part of an 
OTC test sample collection system for the purpose of testing for the 
presence of drugs of abuse or their metabolites in a laboratory.

DATES: This rule is effective April 9, 2001.

ADDRESSES: Comments on the burden estimates or on any other aspect of 
the information collection provisions should be sent to the Office of 
Device Evaluation (HFZ-440), Center for Devices and Radiological 
Health, Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 
20850.

FOR FURTHER INFORMATION CONTACT: Steven Gutman, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 5, 1998 (63 FR 10792), FDA 
published a proposed rule to: (1) Reclassify OTC test sample collection 
systems for drugs of abuse testing from class III (premarket approval) 
into class I (general controls) and to exempt them from premarket 
notification (510(k)) and CGMP requirements; (2) to designate OTC test 
sample collection systems for drugs of abuse testing as restricted 
devices under the act; and (3) to establish restrictions intended to 
assure consumers that: The underlying laboratory test(s) are accurate 
and reliable, the laboratory performing the test(s) has adequate 
expertise and competency, and the product has adequate labeling and 
methods of communicating test results to consumers.
    The proposed rule does not affect OTC tests for drugs of abuse that 
are performed in the home setting--i.e., the testing is performed in 
the home setting and the test results are read and interpreted directly 
by the consumer, without involvement or input from a health 
professional. These are referred to as ``point of care'' tests. When 
manufacturers or distributors market ``point of care'' tests, they are 
selling the consumers the actual test rather than a collection system 
that uses a laboratory to perform a test. Under these circumstances, 
FDA cannot determine whether the test is accurate and reliable without 
premarket review of the product. Accordingly, no changes are being 
proposed in FDA's current policy of reviewing ``point of care'' tests 
prior to marketing.
    Interested persons were given until July 6, 1998, to submit written 
comments on the proposed rule. FDA received nine comments.
    In the Federal Register of May 28, 1998 (63 FR 29174), FDA 
announced that on June 19, 1998, it would hold a public hearing on the 
proposed rule. FDA held that hearing as announced.

II. Response to Comments

    FDA received nine comments on the proposed rule from individuals, 
manufacturers, and professional societies. The majority of comments 
supported FDA's proposed rule. A summary of the written comments as 
well as comments made at the public hearing and FDA's response is set 
forth in this section II.

A. General Comments

    1. Six comments generally supported regulating OTC test sample 
collection systems for drugs of abuse as class I devices exempt from 
the premarket notification requirements. These comments asserted that 
deregulation of home drug test collection systems outlined in the 
proposed rule made drug testing more affordable and more accessible. 
These comments indicated support for the testing laboratory to provide 
a health care professional to communicate the proper interpretation of 
test results from the laboratory to the lay user.

B. Consumer Versus Workplace Test Kits

    2. One comment stated that the rule fails to distinguish between 
test systems marketed directly to consumers and those intended for use 
in the workplace because the rule fails to take into account the 
additional safeguards that are present when drug testing is performed 
in the workplace. This comment went on to suggest that even if FDA 
concludes that it has jurisdiction to regulate all test systems, it 
should nevertheless exercise enforcement discretion with respect to 
drugs of abuse tests for the workplace because the workplace setting 
offers sufficient protections to ``ensure sample integrity and test 
accuracy.''
    FDA disagrees with this comment. As explained in the proposed rule, 
FDA concluded that there should be consistency in its regulation of 
drugs of abuse test sample collection systems used in the home, 
workplace, insurance, and sports settings. Issues related to consumer 
use and quality are similar in all these settings, including concerns 
about sample integrity and test accuracy. FDA believes the need to 
provide assurance of test accuracy and reliability applies equally in 
all these areas.
    However, FDA will continue to exercise its enforcement discretion 
with respect to the use of these products in the law enforcement 
setting because there are protections to ensure sample integrity and 
test accuracy that are not generally available in the home, workplace, 
insurance and sports settings. The additional protections include the 
use of rules of evidence in judicial proceedings and the representation 
of the accused (i.e., the person being tested) through the judicial 
process.

[[Page 18231]]

C. FDA Oversight

    3. One comment expressed concern over the proposal to exempt 
manufacturers from the 510(k) process and suggested the need for data 
to be presented to demonstrate that each analyte is unaffected by 
storage and transport, i.e., stored and not altered or interfered with. 
This comment stated that there is a potential for materials in 
collection cups to interfere with an accurate test result.
    Mail-in drug testing is practiced routinely in many settings. The 
materials and methods for shipping urine are in widespread use for 
drugs of abuse testing in Substance Abuse and Mental Health Service 
Administration (SAMHSA) or equivalent certified laboratories. Data 
submitted to the FDA have shown drugs of abuse test specimens to be 
stable when shipped in accordance with the requirements of SAMHSA or 
equivalent certified laboratories. Although FDA has exempted the OTC 
test sample collection systems for drugs of abuse testing from 
premarket review, all of these systems will be required to use 
screening tests that have been approved, cleared, or otherwise 
recognized by FDA as accurate and reliable for testing. The final rule 
further requires manufacturers and suppliers to comply with medical 
device reporting requirements (21 CFR part 803) and report adverse 
events that may have been due to the OTC collection containers. FDA 
believes these general controls, without premarket notification, 
provide reasonable assurance that these products will be used safely 
and effectively.

D. In-House Tests

    4. One comment stated that FDA's proposed rule would impose on 
clinical laboratories using in-house (home brew) assays additional and 
burdensome requirements that are unnecessary under the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA 88).
    FDA disagrees with this comment. In order for products to be used 
OTC, they must be cleared by FDA. The agency believes that the FDA 
requirements will be complementary to those of CLIA and will address 
issues related to device safety and effectiveness outside the usual 
CLIA review program. CLIA requirements focus on the proficiency of the 
laboratories performing tests and the new regulation recognizes the 
need for such laboratories to have adequate expertise.
    5. One comment stated that the rule unfairly discriminates against 
companies using screening assays for which there are no FDA-cleared 
screening tests, thereby imposing premarket approval requirements for 
the test system.
    FDA does not agree that the rule discriminates unfairly. This rule 
is designed to ensure that there is a level playing field and that all 
manufacturers marketing home test collection systems use testing 
methods that have been approved, cleared, or otherwise recognized by 
FDA as accurate and reliable.
    6. One comment voiced opposition to the FDA proposal to require 
companies marketing drugs-of-abuse test systems that employ in-house 
screening tests to establish validity of these tests with FDA before 
marketing the test system. This comment stated that FDA lacks 
jurisdiction to regulate the provision of laboratory testing services 
by clinical laboratories.
    The agency believes that in-house (home brew) laboratory tests are 
medical devices subject to regulation by FDA. FDA considers clinical 
laboratories that develop such tests to be acting as manufacturers. In 
a recent regulation to classify/reclassify analyte specific reagents 
FDA stated its desire to regulate in-house developed tests in a way 
that would not inhibit the development of such tests or diminish the 
contribution they make to public health (62 FR 62243 at 62249, November 
21, 1997). However, in instances where these tests are part of systems 
intended for lay users, the agency believes that the additional 
oversight provided by agency premarket review of the test is necessary 
to ensure the safety and effectiveness of the device.
    7. One comment asked if the drugs of abuse testing required under 
the proposed rule would be covered under CLIA requirements for high 
complexity testing.
    The answer is yes. Because the confirmation testing of presumptive 
positives is designated as a high complexity test under CLIA, CLIA 
standards for high complexity testing would apply.

E. Laboratory Standards

    8. Three comments emphasized the importance of confirmation of 
presumptive results and suggested that this be a mandatory part of OTC 
test sample collection systems.
    FDA agrees with these comments. The rule specifically requires that 
the laboratory performing the test shall have adequate capability to 
reliably perform the necessary screening and confirmatory testing.
    9. One comment suggested that laboratories testing any drugs of 
abuse or their metabolites not covered by SAMHSA should meet standards 
of organizations with deemed accreditation status such as College of 
American Pathologists (CAP).
    FDA agrees with this comment. The agency's rule clearly stated that 
the laboratory performing the test shall have, and shall be recognized 
as having, adequate capability to reliably perform the necessary 
screening and confirmatory tests. Such recognition would include CAP 
accreditation.
    10. One comment expressed concern that a high complexity CLIA 
certified laboratory (e.g., toxicology laboratory) would not meet the 
SAMHSA standards that are required for laboratories performing Federal 
workplace drug-testing. The comment stated that OTC products relying on 
non-SAMHSA certified laboratories would lower the standards of 
competency for drugs of abuse testing.
    FDA recognizes that there are differences in toxicology laboratory 
certification programs. However, the agency believes that the standards 
established by the rule, as proposed, are appropriate, because they 
ensure an acceptable level of testing performance. As discussed 
previously, the rule requires the laboratory to be recognized as being 
able to reliably perform screening and confirmatory testing, including 
the capability to check biological specimens for possible adulteration. 
FDA believes that such recognition of capability and good laboratory 
practice may be demonstrated in a number of ways including SAMHSA 
certification, CAP accreditation, and CLIA high complexity designation.
    11. One comment suggested FDA consider allowing laboratories to 
report the lowest concentration of drug they are able to detect in 
order to encourage improvement in the sensitivity of the system.
    FDA has not specified concentration levels for drugs being tested 
in these systems. The agency expects sponsors to label their products 
to reflect the chosen performance levels using appropriate cut-off 
points.
    12. One comment suggested it would be helpful to clarify whether 
the screening and confirmation testing must be performed at the same 
physical site in the same laboratory.
    The regulation requires the laboratory performing the test to have 
adequate capability to reliably perform the necessary screening and 
confirmatory testing. While the expectation is that this testing 
usually will be performed at

[[Page 18232]]

a single site, the rule does not preclude a laboratory operating as a 
single entity from housing different analytical functions at different 
sites. The rule also does not prevent laboratories from making 
contractual agreements to acquire or share analytical resources so long 
as the other laboratory meets the necessary standards.
    13. One comment noted that laboratory customers are often not aware 
of the limits of the SAMHSA coverage and suggested that the regulation 
should make clear the actual jurisdiction of the SAMHSA standards.
    FDA agrees that this is useful information. The dissemination of 
this information, however, falls outside of the scope of this rule.

F. FDA Labeling

    14. One comment suggested that the guidance document that FDA 
intends to develop should encourage manufacturers to list all drugs 
that will not be covered under the test.
    The agency does not agree that an exhaustive listing of drugs not 
being tested is reasonable or user-friendly. FDA believes the labeling 
for the test should clearly indicate: (1) What drugs are being tested, 
(2) what limitations exist, and (3) examples of these limitations. For 
example, a label may include the information that strong oxidizing 
agents such as bleach can oxidize drug analytes and explain that, if a 
sample is suspected of being adulterated, a new sample must be 
obtained. The agency intends to include examples of appropriate 
labeling in its guidance.
    15. One comment suggested that test labeling should explicitly 
offer guidance on how to contact a resource for test interpretation as 
well as identifying resources for counseling and treatment.
    FDA agrees with this comment. The regulation does require labeling 
of these products to include adequate instructions on how to obtain 
test results from a person who can explain their meaning, including the 
probability of false positive and false negative results, as well as 
how to contact a trained health professional if additional information 
on interpretation of test results from the laboratory or followup 
counseling is desired. In the Federal Register of December 21, 1999 (64 
FR 71461), FDA announced the availability of a draft guidance document 
entitled ``Draft Guidance on Labeling for Over-the-Counter Sample 
Collection Systems for Drugs of Abuse Testing.'' The draft guidance 
provides to manufacturers FDA's thinking on ways to comply with the 
labeling requirements in this rule. For example, it states the labeling 
should include advice on contacting a physician for options for 
identifying and/or treating substance use and abuse problems, and 
should include a statement on how to obtain information for talking to 
children about drug use and abuse. FDA intends to finalize the guidance 
before the effective date of this final rule.
    16. One comment stated that training of users is essential in 
collection of these specimens.
    FDA agrees that this is an important issue. Guidance on labeling of 
home use devices is available both from NCCLS (GP-14-A ``Labeling for 
Home Use In-Vitro Products'') and from FDA (``Write It Right'' and 
``Points to Consider Regarding Labeling and Premarket Submissions for 
Home Use In-Vitro Diagnostic Devices''). These guidances can help 
manufacturers to develop high quality instruction manuals for users of 
medical devices in the home that are easy to read, understand, and 
follow. The manufacturers also can enlist the aid of health care 
professionals and home medical equipment suppliers to stress the 
importance of the manual to the lay users.

G. Hair Testing

    17. One comment objected that OTC drugs of abuse test kits are not 
medical devices under section 201(h) of the act (21 U.S.C. 321(h)). The 
comment argued that FDA lacks jurisdiction to regulate test kits that 
detect drugs of abuse in hair because they are not considered devices 
for medical diagnosis and treatment. This comment stated that hair 
analysis provides no information concerning intoxication or addiction.
    FDA disagrees with the comment. The definition of device as set 
forth in section 201(h) of the act includes the following:

    The term ``device'' * * * means an instrument, apparatus, 
implement, machine, contrivance, implant, in vitro reagent, or other 
similar or related article, including any component, part, or 
accessory, which is-- * * * (2) intended for use in the diagnosis of 
disease or other conditions * * * [emphasis added]

    The test for evidence of drug abuse is intended to provide 
information about a condition, namely, whether drugs of abuse are being 
used or have been used by the subject. In addition, such information 
can be used to diagnose other conditions or diseases, including 
addiction or intoxication, and may also be used to eliminate such 
conditions as part of a diagnosis of an underlying disease.
    18. One comment endorsed the use of hair testing and indicated that 
it provided a valuable extension of the window for testing for hard 
drugs of abuse in children.
    FDA agrees that hair testing may be a valuable test. To date the 
agency has not received a premarket submission for such a test. The 
agency does believe that these tests should be subject to appropriate 
premarket scientific review. The review standards applied to these 
tests will depend on the claims the manufacturer makes. FDA is 
committed to working with companies to develop appropriate study design 
and generate data sets to help characterize performance and establish 
labeling for these products that would be of benefit to lay users.
    19. One comment said that, if FDA requires agency premarket review 
of tests for hair or other nonurine specimens, the agency cannot impose 
a higher regulatory burden on hair-based testing than on urine-based 
testing.
    FDA is not imposing a higher regulatory burden on hair-based 
testing than on urine-based testing. This rule applies to the OTC test 
sample collection system, not the test itself, and applies equally, 
whether the sample collected is hair or urine. The regulatory burden 
imposed on a device is contingent upon the intended use, indications 
for use, and technological characteristics of the individual device.
    20. One comment suggested FDA's proposal is irrational in requiring 
premarket notification for a specimen collection container for hair 
while exempting from premarket notification urine specimen collection 
containers and other specimen collection containers that are used in 
conjunction with screening tests previously approved, cleared, or 
otherwise recognized by FDA.
    The comment appears to misunderstand the rule. FDA will treat all 
collection containers used in these products in an equivalent manner. 
Whenever such containers are part of a system that uses a cleared, 
approved, or recognized test performed in an appropriately regulated 
laboratory, the collection container will be exempt from any premarket 
review.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed 
classification action is of a 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.

[[Page 18233]]

IV. Analysis of Impacts

    FDA has examined the impacts of the rule under Executive Order 
12866, and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4). Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
The Office of Management and Budget (OMB) has determined that this 
final rule is a significant regulatory action subject to review under 
the Executive Order.
    The reclassification of OTC test sample collection systems for 
drugs of abuse testing (class III into class I exempt) is reasonably 
expected to provide economic benefit to the health care system, 
individual consumers, and regulated industry. At this time, only a very 
limited number of OTC products for drugs of abuse testing (without 
professional assistance) are available to parents. By greatly 
increasing access, this reclassification may provide benefits to 
families. First, testing may serve as a deterrent to drug use and 
prevent the initial experimentation with drugs of abuse by children. 
Next, when drugs are being used, increased access to testing may allow 
for earlier detection of this condition and provide opportunities for 
earlier intervention and treatment. Early intervention and treatment 
has the potential to be more successful. Finally, products for drugs of 
abuse testing marketed to parents may be used to monitor children 
already undergoing treatment for drug use, deterring or at least 
detecting recidivism, which is currently estimated at 30 to 50 percent. 
In addition, the regulation, which regulates such testing systems 
consistently in home, workplace, athletic, and insurance settings, will 
help ensure all consumers that the product produces accurate and 
reliable results.
    FDA cannot quantify the beneficial effect on the public health that 
will result from easier access to these tests. Nevertheless, the agency 
finds that the product has significant potential to reduce drug use. As 
the nation's economic costs of drug abuse are staggering, estimated at 
up to $110 billion in 1995, the potential benefit from even a modest 
reduction would be substantial.
    Moreover, the cost to industry will fall. Under the current 
classification, OTC test sample collection systems for drugs of abuse 
testing are class III medical devices requiring a premarket approval 
application (PMA). FDA has found that the median development cost for a 
PMA ranges from $0.5 to $ 1 million. Reclassifying these devices as 
class I devices exempt from premarket notification, which do not 
undergo premarket review, means that neither new sponsors nor product 
purchasers will incur these costs. Consequently, FDA expects the rule 
to reduce regulatory costs at the same time that it decreases the 
economic burdens of drug abuse.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Reclassification of this device from class III to 
class I will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act (21 U.S.C. 360e). Because this rule will not require premarket 
review of the vast majority of OTC test sample collection systems for 
drugs of abuse testing, the agency certifies that this rule will not 
have a significant economic impact on a substantial number of small 
entities. In addition, this proposed rule will not impose costs of $100 
million or more in any one year on either the private sector or State, 
local, and tribal governments in the aggregate, and therefore a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of these information collection 
provisions is given in this section V with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: OTC Test Sample Collection Systems for Drugs of Abuse 
Testing.
    Description: The final rule amends the labeling requirements for 
certain in vitro diagnostic products to require that manufacturers of 
OTC test sample collection systems for drugs of abuse testing provide 
certain information to consumers for the proper use of the test sample 
collection system and for interpreting the results. The purpose of the 
regulation is to ensure that lay persons collecting samples for testing 
have adequate instructions for sample collection and handling and for 
receiving and understanding the test results reported by laboratories 
performing the analyses.
    Description of Respondents: Businesses and other for-profit 
organizations.
    There were no comments on the paperwork provisions in the proposed 
rule.

                                   Table1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
809.10(f)                              20               1              20             100          2,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Individuals and organizations may submit comments on these burden 
estimates or on any other aspect of these information collection 
provisions, including suggestions for reducing the burden, and should 
direct them to the Office of Device Evaluation (HFZ-440), Center for 
Devices and Radiological Health, Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850.
    The information collection provisions in this final rule have been 
approved under OMB control number 0910-0368. This approval expires 
April 30, 2001. An agency may not conduct or sponsor,

[[Page 18234]]

and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

List of Subjects

21 CFR Part 809

    Labeling, Medical devices.

21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
809 and 864 are amended as follows:

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

    1. The authority citation for 21 CFR part 809 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.

    2. Section 809.10 is amended by adding paragraph (f) to read as 
follows:


Sec. 809.10  Labeling for in vitro diagnostic products.

* * * * *
    (f) The labeling for over-the-counter (OTC) test sample collection 
systems for drugs of abuse testing shall bear the following information 
in language appropriate for the intended users:
    (1) Adequate instructions for specimen collection and handling, and 
for preparation and mailing of the specimen to the laboratory for 
testing.
    (2) An identification system to ensure that specimens are not mixed 
up or otherwise misidentified at the laboratory, and that user 
anonymity is maintained.
    (3) The intended use or uses of the product, including what drugs 
are to be identified in the specimen, a quantitative description of the 
performance characteristics for those drugs (e.g., sensitivity and 
specificity) in terms understandable to lay users, and the detection 
period.
    (4) A statement that confirmatory testing will be conducted on all 
samples that initially test positive.
    (5) A statement of warnings or precautions for users as established 
in the regulations contained in 16 CFR part 1500 and any other warnings 
appropriate to the hazard presented by the product.
    (6) Adequate instructions on how to obtain test results from a 
person who can explain their meaning, including the probability of 
false positive and false negative results, as well as how to contact a 
trained health professional if additional information on interpretation 
of test results from the laboratory or followup counseling is desired.
    (7) Name and place of business of the manufacturer, packer, or 
distributor.
    3. Section 809.40 is added to subpart C to read as follows:


Sec. 809.40  Restrictions on the sale, distribution, and use of OTC 
test sample collection systems for drugs of abuse testing.

    (a) Over-the-counter (OTC) test sample collection systems for drugs 
of abuse testing (Sec. 864.3260 of this chapter) are restricted devices 
under section 520(e) of the Act subject to the restrictions set forth 
in this section.
    (b) Sample testing shall be performed in a laboratory using 
screening tests that have been approved, cleared, or otherwise 
recognized by the Food and Drug Administration as accurate and reliable 
for the testing of such specimens for identifying drugs of abuse or 
their metabolites.
    (c) The laboratory performing the test(s) shall have, and shall be 
recognized as having, adequate capability to reliably perform the 
necessary screening and confirmatory tests, including adequate 
capability to perform integrity checks of the biological specimens for 
possible adulteration.
    (d) All OTC test sample collection systems for drugs of abuse 
testing shall be labeled in accordance with Sec. 809.10(f) and shall 
provide an adequate system to communicate the proper interpretation of 
test results from the laboratory to the lay purchaser.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    4. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    5. Section 864.3250 is amended in paragraph (a) by adding a 
sentence to the end of the paragraph to read as follows:


Sec. 864.3250  Specimen transport and storage containers.

    (a) * * * This section does not apply to specimen transport and 
storage containers that are intended for use as part of an over-the-
counter test sample collection system for drugs of abuse testing.
* * * * *
    6. Section 864.3260 is added to subpart D to read as follows:


Sec. 864.3260  OTC test sample collection systems for drugs of abuse 
testing.

    (a) Identification. An over-the-counter (OTC) test sample 
collection system for drugs of abuse testing is a device intended to: 
Collect biological specimens (such as hair, urine, sweat, or saliva), 
outside of a medical setting and not on order of a health care 
professional (e.g., in the home, insurance, sports, or workplace 
setting); maintain the integrity of such specimens during storage and 
transport in order that the matter contained therein can be tested in a 
laboratory for the presence of drugs of abuse or their metabolites; and 
provide access to test results and counseling. This section does not 
apply to collection, transport, or laboratory testing of biological 
specimens for the presence of drugs of abuse or their metabolites that 
is performed to develop evidence for law enforcement purposes.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification requirements in part 807, 
subpart E of this chapter subject to the limitations in Sec. 864.9 if 
it is sold, distributed, and used in accordance with the restrictions 
set forth in Sec. 809.40 of this chapter. If the device is not labeled 
or otherwise represented as sterile, it is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with 
the exception of Sec. 820.198 of this chapter with respect to complaint 
files.

    Dated: December 22, 1999.
Jane E. Henney,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 00-8598 Filed 4-6-00; 8:45 am]
BILLING CODE 4160-01-F