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Influenza Virus from Immunocompromised Director, Center for Veterinary Medicine. Amendments of 1976 (the amendments),
Patients: A Case Series,’’ Journal of Infectious [FR Doc. 06–2689 Filed 3–20–06; 11:00 am]
Diseases, vol. 193, pp. 760–764, 2006.
generally referred to as postamendments
23. U.S. Prescribing Information for
BILLING CODE 4160–01–S devices, are classified automatically by
Tamiflu (Roche Pharmaceuticals, December statute into class III without any FDA
2005) and Relenza (GlaxoSmithKline, April rulemaking process. These devices
2003). remain in class III and require
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14378 Federal Register / Vol. 71, No. 55 / Wednesday, March 22, 2006 / Rules and Regulations
premarket approval, unless and until CDC’s Influenza A/H5 (Asian lineage) control specified in the classification
the device is classified or reclassified Virus Real-time RT-PCR Primer and regulation generally addresses the risks
into class I or II or FDA issues an order Probe Set can be classified in class II to health identified in the previous
finding the device to be substantially with the establishment of special paragraph. Therefore, on February 3,
equivalent, in accordance with section controls. FDA believes these special 2006, FDA issued an order to the
513(i) of the act, to a predicate device controls, in addition to general controls, petitioner classifying the device into
that does not require premarket will provide reasonable assurance of class II. FDA is codifying this
approval. The agency determines safety and effectiveness of the device. classification by adding § 866.3332.
whether new devices are substantially The device is assigned the generic
Following the effective date of this
equivalent to previously marketed name, ‘‘Reagents for detection of
final classification rule, any firm
devices by means of premarket specific novel influenza A viruses.’’ The
submitting a 510(k) premarket
notification procedures in section 510(k) Influenza A/H5 (Asian lineage) Virus
notification for reagents for detection of
of the act (21 U.S.C. 360(k)) and part 807 Real-time RT-PCR Primer and Probe Set
(21 CFR part 807) of FDA’s regulations. is intended for the in vitro qualitative specific novel influenza A viruses will
Section 513(f)(2) of the act provides detection of Influenza A/H5 (Asian need to address the issues covered in
that any person who submits a lineage) virus RNA either directly in the special controls guidance, which
premarket notification under section patient respiratory specimens or in viral contains recommendations for the
510(k) of the act for a device that has not cultures for the presumptive laboratory contents of premarket notification
previously been classified may, within identification of Influenza A/H5 (Asian submissions including performance
30 days after receiving an order lineage) virus. Testing with the testing, labeling, and postmarket data
classifying the device in class III under Influenza A/H5 (Asian lineage) Virus collection and analysis; and will have to
section 513(f)(1) of the act, request FDA Real-time RT-PCR Primer and Probe Set limit distribution of these reagents to
to classify the device under the criteria should be used in conjunction with laboratories with: (1) Experienced
set forth in section 513(a)(1) of the act. other laboratory testing and clinical personnel who have training in
FDA shall, within 60 days of receiving observations for the following standardized molecular testing
such a request, classify the device by indications: (1) Providing procedures and expertise in viral
written order. This classification shall epidemiological information for the diagnosis, and (2) appropriate biosafety
be the initial classification of the device. surveillance of human infection with equipment and containment. However,
Within 30 days after the issuance of an Influenza A/H5 (Asian lineage) virus; (2) regarding the issues covered in the
order classifying the device, FDA must identifying patients who may be special controls guidance, the firm need
publish a notice in the Federal Register infected with Influenza A/H5 (Asian only show that its device meets the
announcing such classification lineage) virus based on clinical and recommendations of the guidance or in
(513(f)(2) of the act). epidemiological risk factors. some other way provides equivalent
In accordance with section 513(f)(1) of FDA has identified the risks to health assurance of safety and effectiveness.
the act, FDA issued a notice on January associated with this type of device as Section 510(m) of the act provides
26, 2006, classifying the Centers for improper patient management and that FDA may exempt a class II device
Disease Control and Prevention (CDC)’s public health response, laboratory- from the premarket notification
Influenza A/H5 (Asian lineage) Virus acquired infection, and potential requirements under section 510(k) of the
Real-time RT-PCR Primer and Probe Set influenza A virus reassortment. Failure act, if FDA determines that premarket
in class III, because it was not of testing with reagents for detection of notification is not necessary to provide
substantially equivalent to a class I or specific novel influenza A viruses to reasonable assurance of the safety and
class II device that was introduced or correctly identify a specific novel effectiveness of the device. For this type
delivered for introduction into interstate influenza A virus, or failure to properly of device, however, FDA has
commerce for commercial distribution interpret test results obtained with these determined that premarket notification
before May 28, 1976, or a device which reagents, could lead to incorrect patient is necessary because FDA review of
was subsequently reclassified into class management decisions and performance characteristics, test
I or class II. On January 26, 2006, CDC inappropriate public health responses. methodology, and labeling to satisfy
submitted a petition requesting Also, the use of reagents for detection of requirements of 21 CFR 807.87(e), will
classification of the Influenza A/H5 specific novel influenza A viruses provide reasonable assurance that
(Asian lineage) Virus Real-time RT-PCR without appropriate biosafety
acceptable levels of performance for
Primer and Probe Set under section equipment and containment could
both safety and effectiveness will be
513(f)(2) of the act. The manufacturer result in laboratory-acquired infection
recommended that the device be addressed before marketing clearance.
and viral reassortment.
classified into class II. The class II special controls guidance Thus, persons who intend to market this
In accordance with section 513(f)(2) of document provides information on how type of device must submit to FDA a
the act, FDA reviewed the petition in to meet premarket (510(k)) submission premarket notification containing
order to classify the device under the requirements for the device, including information on the reagents for
criteria for classification set forth in recommendations on validation of detection of specific novel influenza A
section 513(a)(1) of the act. Devices are performance characteristics and viruses before marketing the device.
to be classified into class II if general labeling. It also addresses postmarket II. Environmental Impact
controls, by themselves, are insufficient measures to assure the continued safety
to provide reasonable assurance of and effectiveness of the device by The agency has determined under 21
safety and effectiveness, but there is identifying changes in performance that CFR 25.34(b) that this action is of a type
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sufficient information to establish may result from mutation in the virus that does not individually or
special controls to provide reasonable that the device is intended to detect or cumulatively have a significant effect on
assurance of the safety and effectiveness changes in the prevalence of human the human environment. Therefore,
of the device for its intended use. After infection. FDA believes that following neither an environmental assessment
review of the information submitted in the class II special controls guidance nor an environmental impact statement
the petition, FDA determined that the document and the additional special is required.
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Federal Register / Vol. 71, No. 55 / Wednesday, March 22, 2006 / Rules and Regulations 14379
III. Analysis of Impacts the Executive Order and, consequently, aids in the presumptive laboratory
FDA has examined the impacts of the a federalism summary impact statement identification of specific novel influenza
final rule under Executive Order 12866, is not required. A viruses to provide epidemiological
the Regulatory Flexibility Act (5 U.S.C. information on influenza. These
V. Paperwork Reduction Act of 1995
601–612), and the Unfunded Mandates reagents include primers, probes, and
This final rule contains no collections specific influenza A virus controls.
Reform Act of 1995 (Public Law 104–4). of information. Therefore, clearance by
Executive Order 12866 directs agencies (b) Classification. Class II (special
the Office of Management and Budget controls). The special controls are:
to assess all costs and benefits of (OMB) under the Paperwork Reduction
available regulatory alternatives and, (1) FDA’s guidance document entitled
Act of 1995 (PRA) is not required. FDA ‘‘Class II Special Controls Guidance
when regulation is necessary, to select concludes that the special controls
regulatory approaches that maximize Document: Reagents for Detection of
guidance document contains Specific Novel Influenza A Viruses.’’
net benefits (including potential information collection provisions that
economic, environmental, public health See § 866.1(e) for information on
are subject to review and clearance by obtaining this document.
and safety, and other advantages; OMB under the PRA. Elsewhere in this (2) The distribution of these devices is
distributive impacts; and equity). The issue of the Federal Register, FDA is limited to laboratories with experienced
agency believes that this final rule is not publishing a notice announcing the personnel who have training in
a significant regulatory action under the availability of the guidance document standardized molecular testing
Executive order. entitled, ‘‘Class II Special Controls
The Regulatory Flexibility Act procedures and expertise in viral
Guidance Document: Reagents for diagnosis, and appropriate biosafety
requires agencies to analyze regulatory
Detection of Specific Novel Influenza A equipment and containment.
options that would minimize any
Viruses’’; the notice contains an analysis Dated: March 10, 2006.
significant impact of a rule on small
of the paperwork burden for the
entities. Because classification of these Jeffrey Shuren,
guidance.
devices into class II will relieve Assistant Commissioner for Policy.
manufacturers of the device of the cost VI. Reference [FR Doc. 06–2742 Filed 3–21–06; 8:45 am]
of complying with the premarket The following reference has been BILLING CODE 4160–01–S
approval requirements of section 515 of placed on display in the Division of
the act (21 U.S.C. 360e), and may permit Dockets Management (HFA–305), Food
small potential competitors to enter the and Drug Administration, 5630 Fishers DEPARTMENT OF HOMELAND
marketplace by lowering their costs, the Lane, rm. 1061, Rockville, MD 20852, SECURITY
agency certifies that the final rule will and may be seen by interested persons
not have a significant impact on a between 9 a.m. and 4 p.m., Monday Coast Guard
substantial number of small entities. through Friday.
Section 202(a) of the Unfunded 33 CFR Part 165
1. Petition from CDC, dated January 26,
Mandates Reform Act of 1995 requires
2006. [CGD13–06–011]
that agencies prepare a written
statement, which includes an List of Subjects in 21 CFR Part 866 RIN 1625–AA00
assessment of anticipated costs and Biologics, Laboratories, Medical
benefits, before proposing ‘‘any rule that devices. Safety Zone: Camp Rilea Offshore
includes any Federal mandate that may Small Arms Firing Range; Warrenton,
■ Therefore, under the Federal Food,
result in the expenditure by State, local, OR
Drug, and Cosmetic Act and under
and tribal governments, in the aggregate, authority delegated to the Commissioner AGENCY: Coast Guard, DHS.
or by the private sector, of $100,000,000 of Food and Drugs, 21 CFR part 866 is
or more (adjusted annually for inflation) ACTION: Temporary final rule.
amended as follows:
in any one year.’’ The current threshold SUMMARY: The Coast Guard is
after adjustment for inflation is $115 PART 866—IMMUNOLOGY AND establishing a temporary safety zone
million, using the most current (2003) MICROBIOLOGY DEVICES offshore of Camp Rilea, Warrenton,
Implicit Price Deflator for the Gross Oregon. Small arms training and fire
Domestic Product. FDA does not expect ■ 1. The authority citation for 21 CFR will be conducted within this zone, and
this final rule to result in any 1-year part 866 continues to read as follows: a safety zone is needed to ensure the
expenditure that would meet or exceed Authority: 21 U.S.C. 351, 360, 360c, 360e, safety of persons and vessels operating
this amount. 360j, 371. in this area during the specified periods.
IV. Federalism ■ 2. Section 866.3332 is added to Entry into this safety zone is prohibited
subpart D to read as follows: unless authorized by the Captain of the
FDA has analyzed this final rule in Port or his/her designated
accordance with the principles set forth § 866.3332 Reagents for detection of
representative.
in Executive Order 13132. FDA has specific novel influenza A viruses.
determined that the rule does not (a) Identification. Reagents for DATES: This rule is effective from 5 a.m.
contain policies that have substantial detection of specific novel influenza A to 8 p.m. from March 10, 2006 through
direct effects on the States, on the viruses are devices that are intended for March 20, 2006. This rule is enforced
relationship between the National use in a nucleic acid amplification test during daylight hours from March 10,
Government and the States, or on the to directly detect specific virus RNA in 2006 through March 20, 2006.
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distribution of power and human respiratory specimens or viral ADDRESSES: Documents indicated in this
responsibilities among the various cultures. Detection of specific virus preamble as being available in the
levels of government. Accordingly, the RNA aids in the diagnosis of influenza docket are part of docket CGD13–06–
agency has concluded that the rule does caused by specific novel influenza A 011 and are available for inspection or
not contain policies that have viruses in patients with clinical risk of copying at Coast Guard Sector Portland,
federalism implications as defined in infection with these viruses, and also 6767 North Basin Avenue, Portland, OR
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