[Federal Register Volume 69, Number 44 (Friday, March 5, 2004)]
[Rules and Regulations]
[Pages 10331-10332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4887]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882


Neurological Devices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a 
neurological device classification regulation. FDA is changing the name 
of the device from ``cottonoid paddie'' to ``neurosurgical paddie.'' 
FDA is making this change because interested persons have advised FDA 
that the word ``cottonoid'' is a registered trademark and its use has 
created problems for competitors of the company that has registered the 
trademark. FDA is also removing the word ``cotton'' from the 
identification because devices of this type are not always made of 
cotton.

DATES:  This rule is effective March 5, 2004.

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:

I. Background

    In the Federal Register of September 4, 1979 (44 FR 51758), FDA 
published a final rule to classify the cottonoid paddie, a neurological 
device into class II (performance standards at that time). Only 
recently, several people have brought to the attention of FDA that the 
word, cottonoid, is a registered trademark, of Johnson & Johnson. These 
persons pointed out that the use of this classification name has 
created some problems for competitors of Johnson & Johnson. FDA is 
therefore changing the name of the device from cottonoid

[[Page 10332]]

paddie to neurosurgical paddie. FDA is also removing the word 
``cotton'' from the identification of the device because many of the 
devices of this type are made of materials other than cotton.

II. Environmental Impact

    The agency has previously determined under 21 CFR 25.30(i) that 
this final rule 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 was 
required. The changes in these amendments do not alter this conclusion.

III. Analysis of Impacts

    FDA has examined the impacts of the 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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
order and so is not subject to review 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 this rule only changes the name of the 
device and does not change in any way how the device is regulated, the 
agency certifies that the final 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.

IV. Paperwork Reduction Act of 1995

    FDA has determined that this final rule contains no additional 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

V. Federalism

    FDA has analyzed this 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.

List of Subjects in 21 CFR Part 882

    Medical devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

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


0
2. Section 882.4700 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec.  882.4700   Neurosurgical paddie.

    (a) A neurosurgical paddie is a pad used during surgery to protect 
nervous tissue, absorb fluids, or stop bleeding.
* * * * *

    Dated: February 25, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices 
and Radiological Health.
[FR Doc. 04-4887 Filed 3-4-04; 8:45 am]
BILLING CODE 4160-01-S