Food and Drug Administration Modernization Act of 1997; implementation: Approved drugs for which additional pediatric information may produce health benefits in pediatric population; draft list; availability,

[Federal Register: March 16, 1998 (Volume 63, Number 50)]

[Notices]

[Page 12815-12816]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16mr98-108]

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.

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:

1. 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.

2. 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.

3. 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. 98-6667Filed3-13-98; 8:45 am]

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