Federal Register: Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification; Reopening...
[Federal Register: July 28, 2010 (Volume 75, Number 144)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 890
[Docket No. FDA-2009-N-0493]
Neurological and Physical Medicine Devices; Designation of
Special Controls for Certain Class II Devices and Exemption From
Premarket Notification; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; reopening of the comment period.
SUMMARY: The Food and Drug Administration (FDA) is reopening until
September 7, 2010, the comment period for the proposed rule published
in the Federal Register of April 5, 2010 (75 FR 17093). The document
proposed to amend certain neurological and physical medicine device
regulations to establish special controls for these class II devices
and to exempt some of these devices from premarket notification
requirements. FDA is reopening the comment period to allow further
comment and to receive any new information.
DATES: Submit electronic or written comments by September 7, 2010.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0493, and/or RIN number 0910-ZA37, by any of the following methods:
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper, disk, or CD--ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. 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 in 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, 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: Robert J. DeLuca, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993-0002,
email: Robert.DeLuca@fda.hhs.gov, 301-796-6630.
In the Federal Register of April 5, 2010 (75 FR 17093), FDA
published a proposed rule to amend certain neurological device and
physical medicine device regulations to establish special controls for
these class II devices and to exempt some of these devices from the
premarket notification requirements of the Federal Food, Drug, and
Cosmetic Act. Interested persons were given until July 6, 2010, to
comment on the proposed rule.
II. Request for Comments
Following publication of the April 5, 2010, proposed rule, FDA
received requests to allow interested persons additional time to
comment. The requests asserted that the 90-day time period was
insufficient to respond fully to FDA's specific requests for comments
and to allow potential respondents to thoroughly evaluate and address
pertinent issues. The agency has considered the requests and is
reopening the comment period until September 7, 2010. The agency
believes the additional comment period allows adequate time for
interested persons to submit comments without significantly delaying
rulemaking on these important issues.
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
Dated: July 22, 2010.
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18405 Filed 7-27-10; 8:45 am]
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