[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Notices]
[Page 36472-36473]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy07-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0197]
Medical Devices; General Hospital and Personal Use Devices;
Classification of the Filtering Facepiece Respirator for Use by the
General Public in Public Health Medical Emergencies; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: Filtering Facepiece Respirator for Use by the
General Public in Public Health Medical Emergencies.'' This guidance
document describes a means by which filtering facepiece respirators for
use by the general public in public health medical emergencies may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule to classify the filtering facepiece respirator for use by
the general public in public health medical emergencies into class II
(special controls). This guidance document is immediately in effect as
a special control for the filtering facepiece respirator for use by the
general public in public health medical emergencies, but it remains
subject to comment in accordance with the agency's good guidance
practices (GGPs).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance document are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Filtering Facepiece Respirator for Use by the General Public in Public
Health Medical Emergencies'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to
[[Page 36473]]
assist that office in processing your request, or fax your request to
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sheila Murphey, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying the filtering facepiece respirator for use by
the general public in public health medical emergencies into class II
(special controls) under section 513(f)(2) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This guidance
document will serve as a special control for the filtering facepiece
respirator for use by the general public in public health medical
emergencies. An additional special control is established in 21 CFR
880.6260. Section 513(f)(2) of the act provides that any person who
submits a premarket notification under section 510(k) of the act (21
U.S.C. 360(k)) for a device that has not previously been classified
may, within 30 days after receiving an order classifying the device in
class III under section 513(f)(1) of the act, request FDA to classify
the device under the criteria set forth in section 513(a)(1) of the
act. FDA shall, within 60 days of receiving such a request, classify
the device by written order. This classification shall be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Thus, FDA is issuing this guidance document as a
level 1 guidance document that is immediately in effect. FDA will
consider any comments that are received in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(Sec. 10.115). The guidance represents the agency's current thinking
on special controls for the filtering facepiece respirator for use by
the general public in public health medical emergencies. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Filtering Facepiece Respirator for Use by the General Public
in Public Health Medical Emergencies,'' you may either send an e-mail
request to dsmica@fda.hhs.gov to receive an electronic copy of the
document or send a fax request to 240-276-3151 to receive a hard copy.
Please use the document number 1626 to identify the guidance you are
requesting.
CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations and in NIOSH regulations. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
807, subpart E, have been approved under OMB Control No. 0910-0120; the
collections of information in 21 CFR part 801 have been approved under
OMB Control No. 0910-0485; and the collections of information in 42 CFR
part 84 (relating to NIOSH certification) have been approved under OMB
Control No. 0920-0109. In addition, FDA concludes that the labeling
statement in section 10.A of the guidance does not constitute a
``collection of information'' under the Paperwork Reduction Act of
1995. Rather, this labeling statement is ``public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
V. Comments
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.
Dated: June 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12790 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S