[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
