[Federal Register: May 20, 1998 (Volume 63, Number 97)] [Notices] [Page 27733-27734] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr20my98-70] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 robertsk@cder.fda.gov, 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 feigal@cber.fda.gov. 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] BILLING CODE 4160-01-F