[Federal Register Volume 69, Number 226 (Wednesday, November 24, 2004)]
[Notices]
[Pages 68383-68384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0481]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Newborn Screening Test 
Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using 
Tandem Mass Spectrometry; 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: Newborn Screening Test Systems for Amino Acids, Free 
Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.'' This 
guidance document describes a means by which newborn screening test 
systems for amino acids, free carnitine, and acylcarnitines using 
tandem mass spectrometry may comply with the requirements 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 newborn screening test systems for amino 
acids, free carnitine, and acylcarnitines using tandem mass 
spectrometry into class II (special controls). This guidance document 
is immediately in effect as the special control for newborn screening 
test systems for amino acids, free carnitine, and acylcarnitines using 
tandem mass spectrometry, 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 guidances 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: Newborn Screening Test Systems for Amino Acids, Free 
Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry'' 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: Carol C. Benson, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 144.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying newborn screening test systems for amino 
acids, free carnitine, and acylcarnitines using tandem mass 
spectrometry 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 newborn screening test systems for amino acids, free carnitine, and 
acylcarnitines that utilize tandem mass spectrometry. 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 written notice 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)

[[Page 68384]]

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 newborn screening test systems for amino acids, free carnitine, and 
acylcarnitines that utilize tandem mass spectrometry. 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: Newborn 
Screening Test Systems for Amino Acids, Free Carnitine, and 
Acylcarnitines Using Tandem Mass Spectrometry'' by fax machine, 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 (1301) 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 cleared submissions, 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 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 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: November 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-25976 Filed 11-23-04; 8:45 am]
BILLING CODE 4160-01-S