[Federal Register: August 25, 2005 (Volume 70, Number 164)]
[Notices]               
[Page 49929-49930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au05-52]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0264]

 
Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Ribonucleic Acid 
Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and 
Purification Systems for Real Time Polymerase Chain Reaction Used in 
Molecular Diagnostic Testing); 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: RNA Preanalytical Systems (RNA Collection, 
Stabilization and Purification Systems for RT-PCR used in Molecular 
Diagnostic Testing).'' This guidance document describes a means by 
which Ribonucleic Acid (RNA) preanalytical 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 RNA preanalytical systems into class II (special controls). 
This guidance document is immediately in effect as the special control 
for RNA preanalytical 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: RNA Preanalytical Systems (RNA Collection, 
Stabilization and Purification Systems for RT-PCR used in Molecular 
Diagnostic Testing)'' 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: Uwe Scherf, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying RNA preanalytical systems into class II 
(special controls) under

[[Page 49930]]

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 the 
special control for RNA preanalytical 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. 
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 GGP regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on RNA preanalytical 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: RNA 
Preanalytical Systems (RNA Collection, Stabilization and Purification 
Systems for RT-PCR used in Molecular Diagnostic Testing)'' by fax call 
the Center for Devices and Radiological Health (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 (1563) followed by the 
pound sign (). Follow the remaining voice prompts to complete 
your request.
    To receive ``Class II Special Controls Guidance Document: RNA 
Preanalytical Systems (RNA Collection, Stabilization and Purification 
Systems for RT-PCR used in Molecular Diagnostic Testing),'' you may 
either send a fax request to 301-443-8818 to receive a hard copy of the 
document, or send an e-mail request to gwa@cdrh.fda.gov to receive a 
hard copy or an electronic copy. Please use the document number (1563) 
to identify the guidance you are requesting.
    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 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). The labeling provisions addressed in 
the guidance have been approved by OMB under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit written or electronic comments 
regarding this document to the Division of Dockets Management (see 
ADDRESSES). 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: August 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-16913 Filed 8-24-05; 8:45 am]

BILLING CODE 4160-01-S