[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]
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