[Federal Register Volume 62, Number 69 (Thursday, April 10, 1997)]
[Notices]
[Pages 17624-17625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0029]


``Guidance for Industry for the Evaluation of Combination 
Vaccines for Preventable Diseases: Production, Testing and Clinical 
Studies;'' 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 document entitled ``Guidance for Industry for the 
Evaluation of Combination Vaccines for Preventable Diseases: 
Production, Testing and Clinical Studies.'' This document provides 
information regarding the manufacture and clinical study of combination 
vaccines. This document is intended to assist manufacturers and other 
interested parties with the development and licensure of combination 
vaccines.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry for the Evaluation of Combination Vaccines for Preventable 
Diseases: Production, Testing and Clinical Studies'' to 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. The document may also be obtained by mail by calling the CBER 
Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax 
by calling the FAX Information System at 1-888-CBER-FAX or 301-827-
3844. Persons with access to the Internet may obtain the document using 
the World Wide Web (WWW), or bounce-back e-mail. For WWW access, 
connect to CBER at ``http://www.fda.gov/cber/cberftp.html''. To receive 
the document by bounce-back e-mail, send a message to 
``[email protected]''. Submit written comments on the guidance 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments should be identified with the docket number 
found in brackets in the heading of this document. A copy of this 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
document entitled ``Guidance for Industry for the Evaluation of 
Combination Vaccines for Preventable Diseases: Production, Testing and 
Clinical Studies.'' In the Federal Register of June 25, 1993 (58 FR 
34469), FDA announced the July 28 and 29, 1993, scientific workshop 
entitled ``Combined Vaccines and Simultaneous Administration: Current 
Issues and Perspectives.'' Issues discussed and information gathered in 
this workshop were considered in preparing this document. Prior to 
making this document available for industry use, FDA presented the 
issues discussed in this document at the October 27, 1995, Vaccines and 
Related Biological Products Advisory Committee meeting. FDA announced 
the advisory committee meeting and the availability of a draft guidance 
document in the Federal Register of October 2, 1995 (60 FR 51481 at 
51482). Comments received from the meeting were considered in further 
preparation of this document.
    For the purposes of this guidance document, a combination vaccine 
consists of two or more live organisms, inactivated organisms or 
purified antigens combined either by the manufacturer or mixed 
immediately before administration, and it is intended to: (1) Prevent 
multiple diseases, or (2) prevent one disease caused by different 
strains or serotypes of the same organism. Vectored vaccines and 
conjugated vaccines are combination vaccines, if the prevention of the 
disease caused by the vector organism or the carrier moiety is to be 
one of the combination's indication.
    This guidance document discusses the approach manufacturers, 
sponsors, and investigators should follow in the

[[Page 17625]]

development of combination vaccines for licensure in the United States. 
Topics addressed in this document include: (1) Manufacturing issues for 
combination vaccines; (2) preclinical studies; (3) clinical studies to 
support the licensure of combination vaccines; and (4) vaccines 
administered simultaneously with combination vaccine. This document 
does not cover therapeutic combination vaccines. In addition, not all 
issues outlined in the document will pertain to all types of 
combination vaccines, e.g., some issues related to live vaccines may 
not apply to inactivated vaccines.
    As with other guidance documents, FDA does not intend this document 
to be all-inclusive and cautions that not all information may be 
applicable to all situations. This document is intended to provide 
information and does not set forth requirements. FDA anticipates that 
manufacturers and other interested parties may develop alternative 
methods and procedures, and discuss them with FDA. FDA recognizes that 
advances will continue in the area of combination vaccines, and FDA 
intends to update and revise this document in order to improve its 
usefulness. This guidance document represents the agency's current 
thinking on combination vaccines. 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 statute, regulations, or both.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on this guidance 
document. 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. A copy 
of this document and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered in determining whether further 
revision of this document is warranted.

    Dated: April 1, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-9169 Filed 4-9-97; 8:45 am]
BILLING CODE 4160-01-F