[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Notices]
[Page 57883-57884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc05-75]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0342]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: AFP-L3% Immunological Test
Systems; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Class II Special Controls
Guidance Document: AFP-L3% Immunological Test Systems.'' This guidance
document describes a means by which AFP-L3% (alpha-fetoprotein L3
subfraction percent) immunological test systems 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 AFP-L3% immunological test systems into class II (special
controls). This guidance document is immediately in effect as the
special control for AFP-L3% immunological test systems, 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 documents are welcome at any
time
ADDRESSES: Submit written requests for single copies on a
3.5 diskette of the guidance document entitled ``Class II
Special Controls Guidance Document: AFP-L3% Immunological Test
Systems'' 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 assist that office in
processing your request, or fax your request to 301-443-8818. 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://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Maria Chan, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0493
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying AFP-L3% immunological test systems 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 document
announces the guidance document that will serve as the special control
for AFP-L3% immunological test systems. 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 (21 U.S.C. 360c(a)(1)). 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. Therefore, 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 good guidance
practices regulation (Sec. 10.115). The guidance represents the
agency's current thinking on AFP-L3% immunological test systems. 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
To receive ``Class II Special Controls Guidance Document: AFP-L3%
Immunological Test Systems'' by fax, call the CDRH Facts-On-Demand
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone.
Press 1 to enter the system. At the second voice prompt, press 1 to
order a document. Enter the document number (1570) followed by the
pound sign (). Follow the remaining voice prompts to complete
your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. 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://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork
[[Page 57884]]
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections
of information addressed in the guidance document have been approved by
OMB in accordance with the PRA under the regulations governing
premarket notification submissions (21 CFR part 807, subpart E, OMB
control number 0910-0120), and the quality system regulation (21 CFR
part 820, OMB control number 0910-0073). The labeling provisions
addressed in the guidance have been approved by OMB under OMB control
number 0910-0485.
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: September 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-19853 Filed 10-3-05; 8:45 am]
BILLING CODE 4160-01-S