[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Notices]
[Pages 38067-38068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Drug and Biological Product Consolidation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is transferring certain 
product oversight responsibilities from the Center for Biologics 
Evaluation and Research (CBER) to the Center for Drug Evaluation and 
Research (CDER). This consolidation initiative provides the opportunity 
to further develop and coordinate scientific and regulatory activities 
between CBER and CDER. FDA believes that as more drug and biological 
products are developed for a broader range of illnesses, such 
interaction is necessary for both efficient and consistent agency 
action.

FOR FURTHER INFORMATION CONTACT: 
    Deborah J. Henderson, Center for Drug Evaluation and Research (HFD-
6), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5406,

[[Page 38068]]

    or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-25), 1401 Rockville Pike, suite 200 N., Rockville, MD 20852, 301-
827-0372.

SUPPLEMENTARY INFORMATION:

I. The Consolidation Initiative

A. Therapeutic Biological Products Transferred to CDER

    As of June 30, 2003, responsibility for regulating most therapeutic 
biologics, with certain exceptions (e.g., cell and gene therapy 
products and therapeutic vaccines) will be transferred from the Office 
of Therapeutics Research and Review (OTRR), CBER, to the Office of New 
Drugs (OND), and the Office of Pharmaceutical Science (OPS), CDER. 
Initially, this transfer of products will take place as the divisions 
of OTRR within CBER are detailed to offices within CDER. As of June 30, 
2003:
    [sbull] The Division of Therapeutic Proteins and the Division of 
Monoclonal Antibodies of OTRR, CBER, will be detailed to OPS, CDER.
    [sbull] The Division of Clinical Trial Design and Analysis, the 
Division of Application Review and Policy, and the immediate office of 
the Director, OTRR, CBER, will be detailed to OND, CDER.
    FDA anticipates that as of the start of fiscal year 2004 on October 
1, 2003, the offices detailed to CDER will be incorporated into CDER's 
organizational structure, including the creation of a new Office of 
Drug Evaluation (ODE) in OND, CDER.

B. Therapeutic Biological Products Remaining in CBER

    Under a previous reorganization, cell and gene therapy products 
from the Division of Cellular and Gene Therapies, OTRR, CBER were 
transferred to a new office, the Office of Cellular, Tissue and Gene 
Therapies (OCTGT).
    Overall responsibility for therapeutic vaccines will remain in 
CBER. The clinical review of therapeutic vaccine-associated 
investigational new drug applications (INDs) and biologics license 
applications (BLAs) will be conducted by CBER and coordinated with the 
consolidated clinical expertise area in CDER.

II. Web Site Listing CBER Applications Transferred to CDER and Contact 
Information

    FDA has created a Web site listing the identification numbers of 
the INDs, BLAs, investigational device exemptions, and new drug 
applications in CBER that are being transferred to CDER. Holders of all 
CBER applications are encouraged to check this Web site to determine 
which, if any, of their applications are being transferred and to find 
new contact information. The Web site address is: http://www.fda.gov/cber/transfer/transfer.htm. Until notified by CDER, submitters should 
continue to send submissions to the CBER Document Control Center.

III. Delegations of Authority

    As a result of this product consolidation and the resulting changes 
to the organizational structure of CDER and CBER, the agency has 
conducted a comprehensive update of the delegations of authority to 
reflect organizational changes. Current program delegations of 
authority for CDER and CBER have been revised to reflect these changes. 
Delegations of authority give particular officials in the Centers the 
legal authority needed to take substantive actions and perform certain 
functions of the Commissioner of Food and Drugs. These changes will be 
made to the agency's Staff Manual Guide (SMG) system available on the 
Internet at http://www.fda.gov/smg. While comprehensive changes have 
been made to the delegations, the agency believes the current 
delegation at SMG 1410.702 provides CDER with all necessary authority 
for the premarket approval of any biological product for which CDER has 
oversight. Furthermore, revised SMG 1410.202 provides CDER with the 
necessary authority to perform all functions of the Director of CBER 
with respect to biological products transferred to CDER.

IV. Regulations Affected by the Product Consolidation

    The agency is in the process of making technical amendments to its 
regulations affected by this reorganization and anticipates these 
revisions will be completed by the beginning of fiscal year 2004 on 
October 1, 2003, or shortly thereafter. Any revisions to FDA's 
regulations will be published in the Federal Register upon completion.

    Dated: June 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16242 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S