[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Notices]
[Page 68383-68384]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-96]
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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://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: 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://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 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