[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
