[Federal Register Volume 63, Number 97 (Wednesday, May 20, 1998)]
[Notices]
[Pages 27733-27734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0056]


List of Drugs for Which Additional Pediatric Information May 
Produce Health Benefits in the Pediatric Population; 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 a list entitled ``List of Drugs for Which Additional 
Pediatric Information May Produce Health Benefits in the Pediatric 
Population'' (hereinafter referred to as ``the list''). This is a list 
of approved drugs for which additional pediatric information may 
produce health benefits in the pediatric population. The list is being 
published under new statutory requirements of the Food and Drug 
Administration Modernization Act of 1997 (Modernization Act). The 
purpose of the list is to identify certain drugs for which certain 
information is necessary to determine if an approved drug can be used 
safely and effectively in the pediatric population.

DATES: Submit written comments on the procedure and criteria used to 
develop the list at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Submit written requests for single copies of the 
list to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-4573. Send one self-addressed 
adhesive label to assist that office in processing your request. Single 
copies of the list may also be obtained by mail from the Office of 
Communication, Training and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research (CBER), or by calling the CBER 
Voice Information System at 1-800-835-4709, or 301-827-1800. Copies of 
the list may be obtained from CBER's FAX Information System at 1-888-
CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the list.
FOR FURTHER INFORMATION CONTACT:
    Khyati N. Roberts, Center for Drug Evaluation and Research (HFD-6), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-6779, FAX 301-594-5493, e-mail [email protected], or
    David W. Feigal, Center for Biologics Evaluation and Research (HFM-
6), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-0376, FAX 301-827-0440, e-mail [email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, President Clinton signed into law the 
Modernization Act (Pub. L. 105-115). Section 111 of the Modernization 
Act (21 U.S.C. 355A(b)) requires FDA, after consultation with experts 
in pediatric research, to develop, prioritize, and publish a list of 
approved drugs for which additional pediatric information may produce 
health benefits in the pediatric population. Inclusion of a drug on the 
list does not necessarily mean that the drug is entitled to pediatric 
exclusivity.
    FDA developed a draft list in consultation with experts in 
pediatric research, trade organizations, and other interested persons, 
and made the draft list available for public comment (see 63 FR 12815, 
March 16, 1998). After consideration of comments on the draft list, FDA 
is publishing the list of approved drugs for which additional pediatric 
information may produce health benefits in the pediatric population and 
announcing its availability through this notice.

[[Page 27734]]

II. Procedure for Updating the List

    The Modernization Act also requires FDA to update the list 
annually. FDA plans to update the list regularly and at least annually. 
Individuals desiring to comment on the procedure and criteria used to 
develop the list may submit at any time written comments identified 
with the docket number found in brackets in the heading of this 
document. Persons seeking to add a particular drug to the priority 
section of the list or to have a drug removed from the priority section 
of the list may submit to the agency a citizen petition that complies 
with the requirements of 21 CFR part 10. At its discretion, the agency 
may consult with a sitting advisory committee, which may include 
pediatric research experts, before determining whether to include a 
drug on or remove a drug from the list.

III. Electronic Access

    Persons with access to the Internet may obtain the list and all 
updated versions of the list by using the World Wide Web (WWW). For WWW 
access, connect to CDER at http://www.fda.gov/cder/pediatric or to CBER 
at http://www.fda.gov/CBER/publications.htm.

IV. Request for Comments

    Interested persons may submit at any time to the Dockets Management 
Branch (address above) written comments regarding the procedure and 
criteria used to develop the list. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. The list and received comments will be available for 
public examination in the office above between 9 a.m. and 4 p.m., 
Monday through Friday. Received comments will be considered in 
determination whether further revision of the list is warranted.

    Dated: May 13, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13554 Filed 5-19-98; 8:45 am]
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