[Federal Register Volume 72, Number 6 (Wednesday, January 10, 2007)]
[Notices]
[Pages 1231-1232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0515]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Quality Control Material 
for Cystic Fibrosis Nucleic Acid Assays; 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: Quality Control Material for Cystic Fibrosis Nucleic 
Acid Assays.'' This guidance document describes a means by which 
quality control material for cystic fibrosis nucleic acid assays may 
comply with the requirement of special controls for class II devices. 
It includes recommendations for validation of performance 
characteristics and recommendations for product labeling. Elsewhere in 
this issue of the Federal Register, FDA is publishing a final rule to 
classify quality control material for cystic fibrosis nucleic acid 
assays into class II (special controls). This guidance document is 
being immediately implemented as the special control for quality 
control material for cystic fibrosis nucleic acid assays, 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.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Quality Control Material for Cystic Fibrosis Nucleic Acid Assays'' 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 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://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496 ext. 117.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying quality control material for cystic fibrosis 
nucleic acid assays 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 the special 
control for quality control material for cystic fibrosis nucleic acid 
assays devices. 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 time frames 
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 good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on quality control material for cystic 
fibrosis nucleic acid assays. 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

[[Page 1232]]

such approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Quality Control Material for Cystic Fibrosis Nucleic Acid Assays,'' you 
may either send an e-mail request to [email protected] 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 1614 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://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 refers to previously approved collections of 
information found in FDA 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 814 have been approved under OMB Control No 
0910-0231; the collections of information in 21 CFR part 809 have been 
approved under OMB Control No. 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Submit two paper copies of any mailed comments, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Comments 
received may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-120 Filed 1-9-07; 8:45 am]
BILLING CODE 4160-01-S