Document ID: FDA-2009-N-0344-0002
Agency: fda
Document Type: Rule
Title: Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Posted Date: 2009-08-25T04:00Z

[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Rules and Regulations]               
[Page 42773-42775]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au09-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2009-N-0344]

 
Microbiology Devices; Reclassification of Herpes Simplex Virus 
Types 1 and 2 Serological Assays

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is implementing a 
direct final rule correcting the regulation classifying herpes simplex 
virus (HSV) serological assays by removing the reference to HSV 
serological assays other than type 1 and type 2. When reclassifying 
this device, FDA mistakenly distinguished between HSV serological 
assays type 1 and type 2 and all other HSV serological assays. At that 
time, and today, the only preamendments HSV serological assays which 
FDA was aware of were type 1 and type 2 and, therefore, the 
classification of HSV assays other than type 1 and type 2 was 
incorrect. FDA is correcting the classification of this device to 
eliminate possible confusion resulting from this error. Elsewhere in 
this issue of the Federal Register, we are publishing a companion 
proposed rule under FDA's usual procedure for notice and comment to 
provide a procedural framework to finalize the rule in the event we 
receive significant adverse comment and withdraw this direct final 
rule.

DATES:  This rule is effective December 7, 2009. Submit written or 
electronic comments on the direct final rule by October 8, 2009. If we 
receive no significant adverse comments within the specified comment 
period, we intend to publish a document confirming the effective date 
of the final rule in the Federal Register within 30 days after the 
comment period on this direct final rule ends. If we receive any timely 
significant adverse comment, we will withdraw this final rule in part 
or in whole by publication of a document in the Federal Register within 
30 days after the comment period ends.

ADDRESSES:  You may submit comments, identified by Docket No FDA-2009-
N-0344, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices 
and Radiological Health WO/66, rm. 5543, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD, 301-796-6217.

SUPPLEMENTARY INFORMATION:

[[Page 42774]]

I. What Is the Background of the Rule?

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-
629), the Food and Drug Modernization Act of 1997 (FDAMA) (Public Law 
105-115), and the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (Public Law 110-85), among other amendments, established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) established three 
categories (classes) of devices, depending on the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Devices that were in commercial distribution before May 28, 1976 
(the date of enactment of the 1976 amendments), are commonly referred 
to as ``preamendments devices.'' Under section 513 of the act, FDA 
classifies preamendments devices according to the following steps: (1) 
FDA receives a recommendation from a device classification panel (an 
FDA advisory committee); (2) FDA publishes the panel's recommendation 
for comment, along with a proposed regulation classifying the device; 
and (3) FDA publishes a final regulation classifying the device. FDA 
has classified most preamendments devices under these procedures.
    Devices that were not in commercial distribution before May 28, 
1976, are commonly referred to as ``postamendments devices.'' These 
devices are classified automatically by statute (section 513(f) of the 
act (21 U.S.C. 360c(f)) into class III and require premarket approval, 
unless and until: (1) FDA reclassifies the device into class I or II; 
(2) FDA issues an order classifying the device into class I or II in 
accordance with section 513(f)(2) of the act; or (3) FDA issues an 
order under section 513(i) of the act (21 U.S.C. 360c(i)) finding the 
device to be substantially equivalent to a predicate device that does 
not require premarket approval.
    In the Federal Register of November 9, 1983 (47 FR 50823), FDA 
classified the preamendments devices, herpes simplex virus serological 
reagents, into class III (Sec.  866.3305 (21 CFR 866.3305)). At the 
time FDA classified the device, the only preamendments HSV serological 
assays FDA was aware of were type 1 and type 2 HSV serological assays. 
Since that time, FDA has not become aware of any other preamendments 
HSV serological assays, nor has it received a premarket notification 
for a HSV serological assay other than a type 1 or type 2 HSV 
serological assay.
    In the Federal Register of April 3, 2007 (72 FR 15828), FDA 
published a final rule reclassifying the preamendments device HSV 
serological assays from class III to class II. In that rulemaking FDA 
identified the device being reclassified as type 1 and type 2 HSV 
serological assays and identified other HSV serological assays as class 
III devices. However, as stated previously, the only preamendments HSV 
serological assays of which FDA is aware are type 1 and type 2 HSV 
serological assays. To avoid any possible confusion, FDA is correcting 
the regulation to accurately describe this generic type of device. This 
direct final rule corrects the classification regulation by removing 
the reference to HSV serological assays other than type 1 and type 2.

II. What Does This Direct Final Rulemaking Do?

    In this direct final rule, FDA is correcting Sec.  866.3305 by 
removing from the regulation the reference to HSV serological assays 
other than type 1 and type 2.

III. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
announced the availability of the guidance document entitled ``Guidance 
for FDA and Industry: Direct Final Rule Procedures'' that described 
when and how FDA will employ direct final rulemaking. We believe that 
this rule is appropriate for direct final rulemaking because it is 
intended to make noncontroversial changes to existing regulations. We 
anticipate no significant adverse comment. Consistent with FDA's 
procedures on direct final rulemaking, we are publishing elsewhere in 
this issue of the Federal Register a companion proposed rule that is 
identical to the direct final rule. The companion proposed rule 
provides a procedural framework within which the rule may be finalized 
in the event the direct final rule is withdrawn because of any 
significant adverse comment. The comment period for this direct final 
rule runs concurrently with the comment period of the companion 
proposed rule. Any comments received in response to the companion 
proposed rule will also be considered as comments regarding this direct 
final rule.
    We are providing a comment period on the direct final rule of 75 
days after the date of publication in the Federal Register. If we 
receive any significant adverse comment, we intend to withdraw this 
final rule before its effective date by publication of a notice in the 
Federal Register within 30 days after the comment period ends. A 
significant adverse comment is defined as a comment that explains why 
the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without change. In determining whether an adverse comment is 
significant and warrants withdrawing a direct final rulemaking, we will 
consider whether the comment raises an issue serious enough to warrant 
a substantive response in a notice-and-comment process in accordance 
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 
553). Comments that are frivolous, insubstantial, or outside the scope 
of the rule will not be considered significant or adverse under this 
procedure. For example, a comment recommending an additional change to 
the rule will not be considered a significant adverse comment, unless 
the comment states why the rule would be ineffective without the 
additional change. In addition, if a significant adverse comment 
applies to part of a rule and that part can be severed from the 
remainder of the rule, we may adopt as final those parts of the rule 
that are not the subject of a significant adverse comment. If we 
withdraw the direct final rule, all comments received will be 
considered under the companion proposed rule in developing a final rule 
under the usual notice-and-comment procedures under the APA (5 U.S.C. 
552a et seq.). If we receive no significant adverse comment during the 
specified comment period, we intend to publish a confirmation document 
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Rule?

    FDA is issuing this direct final rule under the device and general 
administrative provisions of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).

V. What is the Environmental Impact of This Rule?

    FDA has determined under 21 CFR 25.30(i) and 25.34(b) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on

[[Page 42775]]

the human environment. Therefore, neither an environmental assessment 
nor an environmental impact statement is required.

VI. What is the Economic Impact of This Rule?

    FDA has examined the impacts of the direct final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this direct final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because we do not believe any companies are 
currently selling or producing these devices, the agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $133 million, using the most current (2008) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This direct final rule contains no collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. What are the Federalism Impacts of This Rule?

    FDA has analyzed this direct final rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the rule does not contain policies that have substantial direct effects 
on the States, on the relationship between the National Government and 
the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

IX. How Do You Submit Comments on This Rule?

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, and Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed to amend 21 CFR part 866 as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as 
follows:

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

0
2. Section 866.3305 is amended by removing paragraph (c) and by 
revising paragraph (b) to read as follows:

Sec.  866.3305  Herpes simplex virus serological assays.

* * * * *
    (b) Classification. Class II (special controls). The device is 
classified as class II (special controls). The special control for the 
device is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological 
Assays.'' For availability of the guidance document, see Sec.  
866.1(e).

    Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20411 Filed 8-24-09; 8:45 am]

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