[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Notices]
[Page 33166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn03-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03D-0181]
Guidance for Industry and FDA on Pediatric Expertise for Advisory
Panels; 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 ``Pediatric Expertise for
Advisory Panels; Guidance for Industry and FDA.'' The guidance defines
pediatric subpopulations by age and specifies when we would seek
pediatric expertise on our advisory panels. This guidance document is
immediately in effect, 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diskette of the draft guidance document entitled ``Pediatric Expertise
for Advisory Panels; Guidance for Industry and FDA'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health (CDRH), 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 Dockets
Management Branch (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. Comments are to be identified
with the docket number found in brackets in the heading of this
document. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT: Nancy J. Pluhowski, Center for Devices
and Radiological Health (HFZ- 400), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2022, ext. 133
SUPPLEMENTARY INFORMATION:
I. Background
This guidance describes internal office procedures to ensure that
an advisory panel reviewing a premarket submission or other regulatory
documents includes or consults with one or more pediatric experts, when
appropriate.
FDA is making this guidance effective immediately because there is
a statutory requirement that requires immediate implementation, and
guidance is needed to help effect such implementation. On October 26,
2002, the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) was signed into law. MDUFMA amended section 515(c) (21 U.S.C.
360e(c)) Application for Premarket Approval of the Federal Food, Drug,
and Cosmetic Act to read in part, ``Where appropriate, the Secretary
shall ensure that such panel includes, or consults with, one or more
pediatric experts.'' The guidance describes circumstances where FDA
believes that pediatric expertise on the advisory panel is appropriate
as well as the steps FDA will take to ensure pediatric expertise is
available.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on pediatric expertise in FDA advisory panels. 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. Comments
Interested persons may submit to the Dockets Management Branch (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
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
IV. Electronic Access
You may obtain a copy of ``Pediatric Expertise for Advisory Panels;
Guidance for Industry and FDA'' via your fax machine, by calling 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, then enter the document number
(1208) followed by the pound sign ([numsign]). Then follow the
remaining voice prompts to complete your request.
You may also obtain a copy of the guidance though 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: (1) Device safety alerts; (2) Federal Register
reprints; (3) information on premarket submissions (including lists of
approved and cleared applications and submissions, and manufacturers'
addresses); (4) small manufacturer's assistance; (5) information on
video conferencing and electronic submissions; (6) mammography matters;
and (7) 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 Dockets
Management Branch Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
Dated: May 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13753 Filed 6-2-03; 8:45 am]
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