[Federal Register Volume 65, Number 242 (Friday, December 15, 2000)]
[Notices]
[Pages 78493-78494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1223]


International Conference on Harmonisation; Guidance on E11 
Clinical Investigation of Medicinal Products 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 guidance entitled ``E11 Clinical Investigation of 
Medicinal Products in the Pediatric Population.'' The guidance was 
prepared under the auspices of the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH). The guidance sets forth critical 
issues in pediatric drug development and approaches to the safe, 
efficient, and ethical study of medicinal products in the pediatric 
population. The guidance is intended to encourage and facilitate the 
timely development of pediatric medicinal products internationally.

DATES: This guidance is effective December 15, 2000. Submit written 
comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, or the Office of Communication, Training and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, 301-827-3844, FAX 888-CBERFAX. Send two self-addressed 
adhesive labels to assist that office in processing your requests. 
Submit written comments on the guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Requests and comments should be identified 
with the docket number found in brackets in the heading of this 
document. See the SUPPLEMENTARY INFORMATION section of this document 
for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: M. Dianne Murphy, Center for Drug 
Evaluation and Research (HFD-104), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2350, or Karen Weiss, Center 
for Biologics Evaluation and Research (HFM-570), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5093.
    Regarding the ICH: Janet J. Showalter, Office of Health Affairs 
(HFY-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0864.

SUPPLEMENTARY INFORMATION: In recent years, many important initiatives 
have been undertaken by regulatory authorities and industry 
associations to promote international harmonization of regulatory 
requirements. FDA has participated in many meetings designed to enhance 
harmonization and is committed to seeking scientifically based 
harmonized technical procedures for pharmaceutical development. One of 
the goals of harmonization is to identify and then reduce differences 
in technical requirements for drug development among regulatory 
agencies.
    ICH was organized to provide an opportunity for tripartite 
harmonization initiatives to be developed with input from both 
regulatory and industry representatives. FDA also seeks input from 
consumer representatives and others. ICH is concerned with 
harmonization of technical requirements for the registration of 
pharmaceutical products among three regions: The European Union, Japan, 
and the United States. The six ICH sponsors are the European 
Commission, the European Federation of Pharmaceutical Industries 
Associations, the Japanese Ministry of Health and Welfare, the Japanese 
Pharmaceutical Manufacturers Association, the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA, and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the preparation of documentation, is 
provided by the International Federation of Pharmaceutical 
Manufacturers Associations (IFPMA). The ICH Steering Committee includes 
representatives from each of the ICH sponsors and the IFPMA, as well as 
observers from the World Health Organization, the Canadian Health 
Protection Branch, and the European Free Trade Area.
    In accordance with FDA's good guidance practices (GGP's) regulation 
(65 FR 56468, September 19, 2000), this document is being called a 
guidance, rather than a guideline.
    To facilitate the process of making ICH guidances available to the 
public, the agency is changing its procedure for publishing ICH 
guidances. Beginning April 2000, we will no longer include the text of 
ICH guidances in the Federal Register. Instead, we will publish a 
notice in the Federal Register announcing the availability of an ICH 
guidance. The ICH guidance will be placed in the docket and can be 
obtained through regular agency sources (see the ADDRESSES section of 
this document). Draft guidances will be left in the original ICH 
format. Final guidances will be reformatted to conform to the GGP style 
before publication.
    In the Federal Register of April 12, 2000 (65 FR 19777), FDA 
published a draft tripartite guidance entitled ``E11: Clinical 
Investigation of Medicinal Products in the Pediatric Population.'' The 
notice gave interested persons an opportunity to submit comments by May 
30, 2000.
    After consideration of the comments received and revisions to the 
guidance,

[[Page 78494]]

a final draft of the guidance was submitted to the ICH Steering 
Committee and endorsed by the three participating regulatory agencies 
in July 2000.
    The guidance sets forth critical issues in pediatric drug 
development and approaches to the safe, efficient, and ethical study of 
medicinal products in the pediatric population. The guidance addresses 
the following clinical study issues: (1) Considerations when initiating 
a pediatric program for a medicinal product; (2) timing of initiation 
of pediatric studies during medicinal product development; (3) types of 
studies (pharmacokinetic, pharmacokinetic/pharmacodynamic, efficacy, 
safety); (4) age categories for studies; and (5) ethics of pediatric 
clinical investigation. The guidance is not comprehensive, but is 
intended to be used in conjunction with other ICH guidances and 
documents from regional regulatory authorities and pediatric societies. 
The guidance is intended to encourage and facilitate the timely 
development of pediatric medicinal products internationally.
    This guidance represents the agency's current thinking on clinical 
investigation of medicinal products in the pediatric population. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes, 
regulations, or both.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance at any time. 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 guidance and 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday.

Electronic Access

    Copies of the guidance are available on the Internet at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/publications.htm.

    Dated: December 7, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31947 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F