[Federal Register: July 7, 2003 (Volume 68, Number 129)]
[Notices]               
[Page 40270-40271]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy03-81]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0209]

 
Guidance for Industry and FDA Staff on Class II Special Controls 
Guidance Document; Breath Nitric Oxide Test System; 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: Breath Nitric Oxide Test System.'' This guidance 
describes a means by which the breath nitric oxide test system 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 breath nitric oxide test system into class 
II (special controls). This guidance is effective immediately as the 
special control for the breath nitric oxide test system, but it remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).

DATES: Submit written or electronic comments on agency guidances 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: Breath Nitric Oxide Test System'' 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 two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818.
    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. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.

FOR FURTHER INFORMATION CONTACT: Jean Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying the breath nitric oxide test system 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 the breath nitric oxide 
test system device. 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 GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on the breath nitric oxide test system. 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. 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 USC 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 the PRA under OMB control 
number 0910-0485.

IV. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance 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.

V. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Breath 
Nitric Oxide Test System'' 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 (1211) followed by the pound sign 
([numsign]). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a paper 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

[[Page 40271]]

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.

    Dated: June 23, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-16954 Filed 7-3-03; 8:45 am]

BILLING CODE 4160-01-S