[Federal Register Volume 66, Number 62 (Friday, March 30, 2001)]
[Rules and Regulations]
[Pages 17359-17360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7833]


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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; 
Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: In accordance with the memorandum of January 20, 2001, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Review Plan,'' published in the Federal Register on 
January 24, 2001 (66 FR 7702), this action temporarily delays for 60 
days the effective date of the rule entitled ``Hematology and Pathology 
Devices; Reclassification; Restricted Devices; OTC Test Sample 
Collection Systems for Drugs of Abuse Testing,'' published in the 
Federal Register on April 7, 2000 (65 FR 18230).

DATES: The effective date of the ``Hematology and Pathology Devices; 
Reclassification; Restricted Devices; OTC Test Sample Collection 
Systems for Drugs of Abuse Testing,'' amending 21 CFR parts 809 and 864 
published in the Federal Register on April 7, 2000 (65 FR 18230), is 
delayed for 60 days, from April 9, 2001, to a new effective date of 
June 8, 2001.

FOR FURTHER INFORMATION CONTACT:  Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: The rule: (1) Reclassifies over-the-counter 
(OTC) test sample collection systems for drugs of abuse testing from 
class III (premarket approval) into class I (general controls) and 
exempts them from premarket notification (510(k)) and current good 
manufacturing practice requirements; (2) designates OTC test sample 
collection systems for drugs of abuse testing as restricted devices 
under the Federal Food, Drug, and Cosmetic Act; and (3) establishes 
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

[[Page 17360]]

methods of communicating test results to consumers.
    The agency's implementation of this delay of effective date without 
opportunity for public comment, effective immediately upon publication 
today in the Federal Register, is based on the good cause exceptions in 
5 U.S.C. 553(b)(B) and (d)(3). Seeking public comment is impracticable, 
unnecessary, and contrary to the public interest. The temporary 60-day 
delay in the effective date is necessary to give the Department of 
Health and Human Services officials the opportunity for further review 
and consideration of new regulations, consistent with the Assistant to 
the President's memorandum of January 20, 2001, sent to all executive 
departments and agencies. Given the imminence of the effective date, 
seeking prior public comment on this temporary delay would have been 
impractical, as well as contrary to the public interest in the orderly 
issuance and implementation of regulations. The imminence of the 
effective date is also good cause for making this action effective 
immediately upon publication.

    Dated: March 23, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7833 Filed 3-29-01; 8:45 am]
BILLING CODE 4160-01-S