[Federal Register Volume 63, Number 43 (Thursday, March 5, 1998)]
[Proposed Rules]
[Pages 10792-10798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5521]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify over-the-counter (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 the premarket notification 
(510(k)) and current good manufacturing practice (CGMP) requirements. 
FDA is also proposing to designate OTC test sample collection systems 
for drugs of abuse testing as restricted devices under the Federal 
Food, Drug, and Cosmetic Act (the act), and 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. 
Finally, FDA is proposing 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: Written comments on the proposed rule by July 6, 1998. FDA 
proposes that any final regulation based on this proposal become 
effective 1 year after its date of publication in the Federal Register.
    Written comments on the information collection requirements should 
be submitted by April 6, 1998.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
Submit written comments on the information collection requirements to 
the Office of Information and Regulatory

[[Page 10793]]

Affairs, Office of Management and Budget (OMB), New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk 
Officer for FDA.

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 recent years, there has been increasing interest in extending 
testing for drugs of abuse to the home setting and test sample 
collection systems for such purposes have been developed and marketed. 
Test sample collection systems that have been developed for use in the 
home setting have generally consisted of: A collection cup or other 
container for collecting a specimen; directions for use; packaging for 
storage or mailing; access to a laboratory testing service; and access 
to test results. The consumer collects a specimen (such as urine) from 
the body and mails it to a laboratory, which performs the actual 
testing for the drugs or their metabolites. The specimen usually is 
identified by a code number, which maintains confidentiality and 
protects against mix-ups. The test results are communicated back to the 
consumer. Because these test systems for OTC use were not in commercial 
distribution prior to enactment of the 1976 Medical Device Amendments, 
they are new devices that are automatically classified by statute into 
class III. FDA's proposal would reclassify these test sample collection 
systems into class I and subject them to less stringent controls.
    A specimen transport and storage container is one component of an 
OTC drugs of abuse test sample collection system. Under 21 CFR 
864.3250, a specimen transport and storage container is identified as a 
device intended to contain biological specimens, body waste, or body 
exudate during storage and transport in order that the matter contained 
therein can be destroyed or used effectively for diagnostic 
examination. The container is classified as class I under the 
regulation and, if intended for professional use, it has been exempt 
from the premarket notification requirements. If the container is 
intended for OTC use, i.e., a specimen from the body is collected 
outside of a medical setting (e.g., at home) and mailed to a laboratory 
for testing, the agency has historically required the submission of a 
premarket notification (510(k)) or premarket approval application 
(PMA). FDA's proposal would amend this identification to recognize that 
a specimen collection container that is intended to be part of an OTC 
test sample collection system for drugs of abuse should be regulated as 
part of that system and subject to less stringent controls.
    The appropriate level of regulation for OTC test sample collection 
systems for drugs of abuse testing has been the subject of considerable 
public discussion. Two public hearings on the issue have been held by 
the House Subcommittee on Oversight and Investigations--the first on 
September 26, 1996, and the second on February 6, 1997. Critics at the 
September hearing argued that the agency's categorization of these test 
systems as class III medical devices is unnecessarily stringent and 
that there are benefits to making these products available to parents. 
Another criticism raised at that time was the inconsistency between the 
agency's regulation of drugs of abuse test systems for use in the home 
setting and its exercise of enforcement discretion with respect to the 
same or similar products used in the workplace, insurance, sports, and 
law enforcement settings.
    After considering these concerns, the agency committed to 
reevaluate its policy to determine the appropriate level of regulation 
for home drugs of abuse test sample collection systems. While the 
policy was being reevaluated, FDA established an interim policy on the 
availability of home test sample collection systems sold directly to 
parents for drugs of abuse testing. The interim policy, dated October 
3, 1996, set forth FDA's intention to exercise its enforcement 
discretion and not take regulatory action against persons distributing 
home drugs of abuse test sample collection systems so long as three 
criteria were met: (1) The laboratory conducting the testing used an 
FDA-cleared test; (2) the testing laboratory met standards set by the 
Substance Abuse and Mental Health Services Administration (SAMHSA) or 
equivalent standards for performing such testing; and (3) the product 
had accurate labeling (Ref. 1).
    In reevaluating the policy on home drugs of abuse test sample 
collection systems, the agency reached a number of conclusions, as 
described in testimony before the House Subcommittee on Oversight and 
Investigations on February 6, 1997 (Ref. 2).
    The first conclusion was that these test sample collection systems 
must be accurate and reliable. Because there currently are more than 
200 FDA-cleared urine tests for detecting drugs of abuse and hundreds 
of laboratories believed to be capable of conducting this testing, the 
agency concluded that accurate and reliable testing is readily 
available.
    The second conclusion was that there is a public benefit in having 
drugs of abuse test sample collection systems available for use in the 
home setting. Thus, the agency should reduce the difficulty of getting 
these products onto the market for such use. FDA believes it can 
accomplish this and still ensure that consumers get accurate and 
reliable answers from these test sample collection systems.
    The third conclusion related to the degree of consistency needed 
between FDA's regulation of drugs of abuse test sample collection 
systems for use in the home setting and the regulation of such systems 
used in the workplace, insurance, and sports settings. Because the same 
concerns about getting an accurate and reliable answer apply in all of 
these settings, FDA concluded that the same rules should govern drugs 
of abuse test sample collection systems used in all of these 
nonprofessional settings.
    Fourth, FDA concluded that the agency should continue to exercise 
its enforcement discretion with respect to testing for drugs of abuse 
in the law enforcement setting because there are other protections to 
ensure sample integrity and test accuracy that are not 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.
    Finally, FDA concluded that it is important to give the marketplace 
time to adjust to any changes in regulatory approach.Therefore, FDA 
would propose to provide an adequate transition period for implementing 
its proposed policy.
    FDA's testimony also noted that, on January 21, 1997, the agency 
approved the first PMA for an OTC test sample collection system for 
drugs of abuse. The product is marketed as Dr. Brown's Home Drug 
Testing System, made by Personal Health and Hygiene Inc. (Ref. 3). The 
product met all the criteria in FDA's interim policy of October 3, 
1996.
    FDA recognizes the importance of empowering parents to address the 
abuse of drugs by their children through access to products that can 
detect drug use. FDA also recognizes that it has a statutory obligation 
to assure parents of the accuracy and reliability of such products for 
home use. In light of these

[[Page 10794]]

conclusions, FDA is proposing a new approach for the regulation of OTC 
test sample collection systems for drugs of abuse.

II. Proposal for Regulating OTC Test Sample Collection Systems for 
Drugs of Abuse

    Based on FDA's knowledge of these products, the accuracy and 
reliability of the tests currently available, and the low potential 
risk to health, FDA believes that use of sample collection systems for 
drugs of abuse testing outside of a medical setting does not raise new 
issues that warrant premarket approval. Accordingly, FDA is proposing 
to reclassify OTC test sample collection systems for drugs of abuse 
testing from class III into class I, the least restrictive of the three 
regulatory classes, and is proposing to exempt such systems from the 
requirements of premarket review subject to restrictions established in 
accordance with section 520(e) of the act (21 U.S.C. 360j(e)). Under 
the proposed rule, three restrictions would be established, as follows.
    First, the laboratory test(s) incorporated in these systems would 
be required to have been cleared, approved, or otherwise recognized by 
FDA as accurate and reliable for laboratory use. This would ensure that 
drugs of abuse test sample collection systems that are sold to 
consumers are accurate and reliable. Under the proposed rule, FDA would 
be able to utilize the expertise of another Federal agency (e.g., 
SAMHSA) when that agency reaches a formal determination regarding the 
suitability of a particular laboratory test or method for identifying 
the presence of drugs of abuse or their metabolites.
    Because FDA has already cleared more than 200 laboratory urine 
tests to detect drugs of abuse, companies would have a relatively easy 
route to marketing OTC drugs of abuse urine test sample collection 
systems. Once this new policy is implemented, however, companies 
seeking to market a system that uses any test that has not been 
recognized by FDA (e.g., tests using hair as the test specimen) would 
need to establish the validity of the test with FDA prior to marketing. 
FDA's proposed transition period would allow ample time for companies 
to make this showing.
    The second proposed criterion for ensuring that drugs of abuse test 
sample collection systems are accurate and reliable for use in a 
nonprofessional setting is that the laboratory performing the 
underlying test(s) must be able to reliably perform the necessary 
screening and confirmatory tests. This would ensure that testing is 
performed by individuals with appropriate levels of training, 
knowledge, and proficiency; that confirmatory testing is systematically 
performed on presumptively positive samples prior to issuance of the 
test results; and that assistance with interpretation of the test 
results and followup counseling is available to the consumer by a 
trained health professional, if requested. FDA plans to rely on 
existing laboratory certification programs to identify those individual 
laboratories that meet this criterion.
    FDA believes that this criterion can also be readily met. There are 
70 laboratories certified by SAMHSA that would clearly meet these 
requirements (Ref. 4). In addition, FDA believes that high-complexity 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) that are certified in the area of toxicology by the Health 
Care Financing Administration, the College of American Pathologists, or 
other organizations with deemed status in the area of toxicology 
accreditation, would also have the appropriate types of controls (Ref. 
5). FDA solicits comment on whether these or other existing 
certification programs would be adequate to establish competency of 
testing laboratories for these purposes. FDA also solicits comments on 
whether mandatory confirmatory testing of presumptive positive samples 
is an appropriate restriction on such OTC test sample collection 
systems.
    The third proposed criterion to ensure that drugs of abuse test 
sample collection systems are accurate and reliable for use in a 
nonprofessional setting is that samples be adequately identified to 
avoid mix-ups and the test sample collection system be accurately 
labeled so that consumers can readily use it. This would ensure that 
the test sample collection system is accompanied by adequate directions 
that enable the lay person to: (a) Understand the purpose of the test--
i.e., what drugs are and are not to be identified in the specimen; (b) 
understand the detection period; and (c) properly collect the test 
specimen and mail it to the laboratory. The labeling also would provide 
information regarding interpretation of test results (e.g., false 
positives and false negatives) and how the consumer can contact a 
qualified health professional for assistance in that interpretation, 
and obtain professional counseling, if needed.
    To help manufacturers meet this criterion, FDA plans to develop 
guidance on issues such as how to label the test sample collection 
system so that the consumer can understand the test results and how to 
ensure that the specimen and the container remain properly identified 
and intact during mailing to the laboratory. The guidance also would 
address methods for providing consumers with adequate professional 
assistance in interpreting/understanding test results and providing 
counseling referrals, if needed. FDA believes this third criterion 
would also be relatively easy to meet.
    FDA believes that these three criteria are needed to ensure that 
drugs of abuse test sample collection systems are accurate and reliable 
for use in a nonprofessional setting--e.g., in the home, insurance, 
sports, or workplace setting. Without these restrictions, FDA believes 
that there cannot otherwise be reasonable assurance of the safety and 
effectiveness of OTC test sample collection systems for drugs of abuse 
testing. FDA is interested in comments from other agencies concerned 
with drug testing about the impact of the agency's proposal.
    If the above criteria are met, FDA proposes to allow companies to 
market OTC drugs of abuse test sample collection systems without first 
obtaining premarket approval or clearance, i.e., if the criteria are 
met, manufacturers or distributors of the product could go directly to 
market. FDA believes that these three criteria are clear and that 
manufacturers or distributors of OTC drugs of abuse test sample 
collection systems can readily determine for themselves if those 
criteria are met. Should a manufacturer or distributor market such a 
product without meeting these restrictions, the product would be 
adulterated under section 502(q) of the act (21 U.S.C. 352) and subject 
to enforcement action. FDA solicits comments on whether 510(k)'s for 
these devices should be required, rather than the 510(k) exempt status 
that is being proposed.
    Under FDA's proposal, FDA would regulate drugs of abuse test sample 
collection systems used in the insurance, workplace, and sports 
settings in a consistent manner with those systems that are used in the 
home, because the need for providing assurance of test accuracy and 
reliability applies equally in all these areas. However, as noted 
above, FDA would continue to exercise its enforcement discretion with 
respect to testing for drugs of abuse in the law enforcement setting 
because there are other protections to ensure sample integrity and test 
accuracy that are not available in the home, workplace, insurance, and 
sports settings.

[[Page 10795]]

    FDA believes it is important to give the marketplace time to adjust 
to any changes in regulatory approach. Therefore, the agency is 
proposing that the final rule become effective 1 year after publication 
in the Federal Register, but not earlier than 2 years from the date of 
publication of this proposed rule. FDA believes this provides 
manufacturers and distributors adequate notice so that, if they wish to 
market a test sample collection system that uses a specimen for which 
there is currently no cleared laboratory test (e.g., hair), there is 
adequate time to conduct the necessary testing and submit the results 
to FDA for review. Following the 2-year period, a manufacturer or 
distributor would not be able to market an OTC test sample collection 
system for drugs of abuse testing unless the underlying test has been 
cleared by FDA.
    Following publication of this proposed rule, FDA will hold a public 
hearing to solicit additional public comment on its proposal. A 
separate Federal Register notice will announce the date, location, and 
proposed agenda for the hearing.
    FDA's interim policy for drugs of abuse home test sample collection 
systems will remain in place until the final rule becomes effective. 
During that time, FDA intends to exercise its enforcement discretion 
with respect to drugs of abuse test sample collection systems used in 
the workplace, insurance, or sports settings. Because the exercise of 
that discretion has been FDA's policy for test sample collection 
systems used in those settings, the agency believes it is appropriate 
to provide notice and an opportunity for comment before instituting a 
change in this policy.
    This 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 the 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.

III. Proposed Reclassification

    As part of this new regulatory scheme, and in accordance with 
section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)), FDA, on its own 
initiative, is proposing to reclassify test sample collection systems 
for drugs of abuse testing from class III to class I. The device would 
be identified in proposed Sec. 864.3260 as 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); to 
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 
to provide access to test results and counseling.
    FDA is also proposing that the device be exempt from the premarket 
notification requirements and, unless it is labeled or otherwise 
represented as sterile, that it would be exempt from the current good 
manufacturing practice regulations, with the exception of 21 CFR 
820.198, with respect to complaint files. FDA solicits comments on 
whether there may be other unique circumstances for which the exemption 
from CGMP regulations would not be appropriate.
    Reclassification of a postamendments class III device is governed 
by section 513(f)(2) of the act. This section provides that FDA may, on 
its own initiative or in response to a petition, reclassify a 
postamendments device classified by statute into class III. When FDA 
reclassifies a postamendments device on its own initiative, the agency 
follows the same statutory provisions and regulations that apply to 
reclassifications of such devices in response to a petition.
    Under section 513(f)(2) of the act, the agency is authorized, in 
accordance with section 513(d)(2)(A), to exempt a generic type of 
device from, among other things, the requirement of premarket 
notification in section 510(k) of the act (21 U.S.C. 360(k)) after 
stating the reasons for making such requirement inapplicable. Such an 
exemption permits manufacturers to introduce into commercial 
distribution generic types of devices without first submitting a 
premarket notification to FDA.
    The primary risk to health presented by these products is the 
possibility that they may result in an incorrect diagnosis. No in vitro 
diagnostic test yields perfect results. Sometimes the test misses the 
presence of what it is supposed to be detecting (false negative). 
Sometimes it registers the presence of the substance even though it is 
not present (false positive). False positives and/or false negatives 
may also result from an error in the laboratory testing process. 
Knowing the probability of false negatives and false positives, not 
just in abstract terms, but why they occur and whether and how the rate 
varies among different populations, and at various intervals following 
drug exposure, is essential in order to properly interpret and 
communicate the results.
    FDA believes that this risk to health would be adequately 
controlled by the proposed restrictions on the sale, distribution and 
use of these products. The proposed restrictions, which focus on the 
accuracy and reliability of the underlying test(s), the capability of 
the laboratory performing the underlying test(s), and the adequacy of 
the products' labeling, would be sufficient to ensure that drugs of 
abuse test sample collection systems are accurate and reliable for use 
in a nonprofessional setting. Further, FDA believes that premarket 
notification is unnecessary because a manufacturer or distributor can 
determine for themselves if their product meets the restrictions being 
proposed in accordance with section 520(e) of the act.
    In developing its proposed regulatory approach for these products, 
FDA relied upon the existence of more than 200 FDA-cleared urine tests 
for detecting drugs of abuse and several hundred laboratories with 
sufficient capability to conduct the testing, as well as the agency's 
experience with premarket review of such test sample collection 
systems. This information led FDA to conclude that the agency can 
ensure the accuracy and reliability of OTC drugs of abuse test sample 
collection systems, while minimizing the disruption to the marketplace, 
by reclassifying them into class I and exempting them from premarket 
notification subject to restrictions on the sale, distribution, and use 
under section 520(e) of the act.

IV. Comments

    Interested persons may, on or before July 6, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 10796]]

V. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday:
    1. ``Parents' Access to Tests for Drugs of Abuse;'' Interim 
Policy; October 3, 1996.
    2. Testimony of William Schultz before the House Subcommittee on 
Oversight and Investigations; February 6, 1997.
    3. Summary of Safety and Effectiveness for P950040; Dr. Brown's 
Home Drug Testing System.
    4. Mandatory Guidelines for Federal Workplace Testing; Substance 
Abuse and Mental Health Services Administration; June 9, 1994.
    5. Clinical Laboratory Improvement Amendments of 1988.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) that this 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.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). The 
proposed rule has been determined to be a significant regulatory action 
as defined by the Executive Order and so is subject to review under the 
Executive Order. 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 proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. The proposed 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 would provide benefits to 
families similar to that which workplace drug testing now provides to 
employers. First, testing may serve as a deterrent to drug use. Because 
these products are marketed to parents for testing their children, they 
have the potential to prevent the initial experimentation with drugs of 
abuse by children. Next, where test results already indicate the use of 
drugs, intervention and treatment based on evidence may be initiated 
earlier than intervention and treatment based on suspicion of drug use 
alone. 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.
    FDA cannot quantify the beneficial effect on the nation's 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 $66 billion in 1990, 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 is a class III medical device requiring a 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 exempt, 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. Because this proposed rule would not require 
premarket review of the vast majority of OTC test sample collection 
systems for drugs of abuse testing, the agency certifies that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection requirements 
which are subject to review by OMB under the Paperwork Reduction Act of 
1995. The title, description, and respondent description of the 
information collection are shown below with an estimate of the annual 
reporting burden. Included in the estimate is the time for reviewing 
instructions, gathering and maintaining the data needed, and completing 
and reviewing the collection of information.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
Title: OTC Test Sample Collection Systems for Drugs of Abuse Testing.
Description: The proposed rule would amend 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 assure 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.

[[Page 10797]]



                                  Table 1.--Estimated Annual Reporting Burden1                                  
----------------------------------------------------------------------------------------------------------------
                                                      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       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    FDA requests comments on the accuracy of these estimates concerning 
the number of entities likely to be affected by the rule and the costs 
to meet these requirements.
    As required by section 3507(d) of the Paperwork Reduction Act of 
1995, FDA has submitted the collections of information contained in the 
proposed rule to OMB for review. Other organizations and individuals 
desiring to submit comments regarding the burden estimate or any aspect 
of these information collection requirements, including suggestions for 
reducing the burden, should direct them to the Office of Information 
and Regulatory Affairs, OMB (address above). Written comments on the 
information collection requirements should be submitted by April 6, 
1998.

List of Subjects

21 CFR Part 809

    Labeling, Medical devices.

21 CFR Part 864

    Blood, Medical devices, Packaging and containers, Specimen 
collection systems.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR parts 809 and 864 be 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, 357, 360b, 360c, 360d, 
360h, 360i, 360j, 371, 372, 374, 381.
    2. Section 809.10 is amended by adding new 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 and are not to be identified in the specimen, a quantitative 
description of the performance characteristics for those drugs (e.g., 
sensitivity and specificity), 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. New Sec. 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) 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 FDA 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 Specimen transport and storage container is 
amended in paragraph (a) by adding the following sentence to the end of 
the paragraph:


Sec. 864.3250  Specimen transport and storage container.

    (a) * * * This section does not apply to specimen transport and 
storage containers that are intended for use as part of an OTC test 
sample collection system for drugs of abuse testing.
* * * * *
    6. New Sec. 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.

[[Page 10798]]

    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification requirements in part 807, 
subpart E of this chapter 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, with respect to complaint files.

    Dated: September 25, 1997.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 98-5521 Filed 3-3-98; 8:45 am]
BILLING CODE 4160-01-F