[Federal Register Volume 63, Number 50 (Monday, March 16, 1998)]
[Notices]
[Pages 12815-12816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6667]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft List of Approved 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 draft list of approved drugs for which additional 
pediatric information may produce health benefits in the pediatric 
population. The draft list is being compiled under new statutory 
requirements of the Food and Drug Administration Modernization Act of 
1997 (FDAMA). The purpose of the list is to identify drugs for which 
certain information is necessary to determine if an approved drug can 
be used safely and effectively in the pediatric population. Interested 
individuals may comment on the draft list.

DATES: Submit written comments by April 15, 1998.
ADDRESSES: The draft list may be examined at the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Submit written comments on the draft list to 
the office above. See the Supplementary Information section for 
electronic access addresses.

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 Leanne Cusumano, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041, FAX 301-827-5562, e-
mail [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, President Clinton signed FDAMA into law (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 (the list). FDA is to publish

[[Page 12816]]

the list on or before May 20, 1998, and will update the list regularly. 
The purpose of the list is to identify drugs for which certain 
information is necessary to determine if an approved drug can be used 
safely and effectively in the pediatric population. Inclusion of a drug 
on the list does not necessarily mean that the drug is entitled to 
pediatric exclusivity.

II. Procedure for Development of the Draft List

    To develop a draft list, FDA requested that experts in pediatric 
research, trade organizations, and other interested persons, including 
the American Academy of Pediatrics, the Pharmaceutical Research and 
Manufacturers Association, the National Institutes of Health, the 
Pediatric Pharmacology Research Units Network, the National 
Pharmaceutical Alliance, the Generic Pharmaceutical Industry 
Association, the National Association of Pharmaceutical Manufacturers, 
and the United States Pharmacopeia, identify drugs for possible 
inclusion on the list. FDA then reviewed the drugs identified by these 
experts to determine whether studies on the drugs might produce health 
benefits in the pediatric population. FDA is making available in the 
above docket the draft list created as a result of this process, as 
well as a statement of the criteria used by the agency to determine 
whether a drug may produce a health benefit in the pediatric 
population.

III. Request for Comments

    Interested persons may submit written comments regarding the draft 
list on or before April 15, 1998, to the Dockets Management Branch 
(address above). 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 draft list and received comments are available for public 
examination in the office above between 9 a.m. and 4 p.m., Monday 
through Friday. FDA will consider the comments before publishing the 
list on May 20, 1998. Persons with access to the Internet may obtain 
the draft list by using the World Wide Web (WWW). For WWW access, 
connect to CDER at http://www.fda.gov/cder/pediatric.

    Dated: March 4, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-6667 Filed 3-13-98; 8:45 am]
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