[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Page 57883-57884]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

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://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: Maria Chan, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0493


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://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 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]