Document ID: FDA-2009-N-0344-0001
Agency: fda
Document Type: Proposed 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)]
[Proposed Rules]               
[Page 42810-42812]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au09-19]                         

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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:  Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its device classification regulations by 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 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 
direct final rule. This proposed rule will provide a procedural 
framework to finalize the rule in the event we receive significant 
adverse comment and withdraw the direct final rule.

DATES:  Submit written or electronic comments by November 9, 2009.

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 20993, 301-796-6217.

SUPPLEMENTARY INFORMATION:

I. Why Is This Companion Proposed Rule Being Issued?

    This proposed rule is a companion to the direct final rule 
correcting Sec.  866.3305 (21 CFR 866.3305) by removing HSV serological 
assays other than type 1 and type 2 from the regulation. The direct 
final rule and this companion proposed rule are substantively 
identical. This companion proposed rule provides the procedural 
framework to finalize the rule in the event that the direct final rule 
receives any significant adverse comment and is withdrawn. We are 
publishing the direct final rule because we believe the rule is 
noncontroversial, and we do not anticipate receiving any significant 
adverse comments. If no significant

[[Page 42811]]

adverse comment is received in response to the direct final rule, no 
further action will be taken related to this proposed rule. Instead, we 
will publish a confirmation document within 30 days after the comment 
period ends confirming when the direct final rule will go into effect.
    If we receive any significant adverse comment regarding the direct 
final rule, we will withdraw the direct final rule within 30 days after 
the comment period ends and proceed to respond to all of the comments 
under this companion proposed rule using usual notice-and-comment 
rulemaking procedures under the Administrative Procedure Act (APA) (5 
U.S.C. 552a et seq.). The comment period for this companion proposed 
rule runs concurrently with the direct final rule's comment period. Any 
comments received under this companion proposed rule will also be 
considered as comments regarding the direct final rule and vice versa. 
We will not provide additional opportunity for comment. 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 a 
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 APA (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of 
the rule will not be considered 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.
    In the Federal Register of November 21, 1997 (62 FR 62466), you can 
find additional information about FDA's direct final rulemaking 
procedures in the guidance document entitled ``Guidance for FDA and 
Industry: Direct Final Rule Procedures.'' This guidance document may be 
accessed at http://www.fda.gov/regulatoryinformation/guidances.htm.

II. 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 (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 which FDA is aware of 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 
proposed final rule corrects the classification regulation by removing 
the reference to HSV serological assays other than type 1 and type 2.

III. What Does This Companion Proposed Rule Do?

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

IV. What is the Legal Authority for This Proposed Rule?

    FDA is issuing this proposed 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 Proposed Rule?

    FDA has determined under 21 CFR 25.30(i) and 21 CFR 25.34(b) 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.

VI. What is the Economic Impact of This Proposed Rule?

    FDA has examined the impacts of the proposed 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

[[Page 42812]]

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 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 proposes to 
certify 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 
proposed 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 
Proposed Rule?

    This proposed 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 Proposed Rule?

    FDA has analyzed this proposed 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 Proposed 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.
    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

    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.
    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. E9-20415 Filed 8-24-09; 8:45 am]

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