[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 robertsk@cder.fda.gov, 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 cusumanol@cder.fda.gov.
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]
BILLING CODE 4160-01-F
