[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Page 33166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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 

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diskette of the draft guidance document entitled ``Pediatric Expertise 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


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 
    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 

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 

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]