Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms; Availability, 9084 [05-3593]
Download as PDF
<![CDATA[
9084
Federal Register / Vol. 70, No. 36 / Thursday, February 24, 2005 / Notices
Food and Drug Administration
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
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling the CBER Voice
Information System at 1–800–835–4709
or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
[Docket No. 2003N–0528]
I. Background
Draft Guidance for Industry:
Manufacturing Biological Drug
Substances, Intermediates, or
Products Using Spore-Forming
Microorganisms; Availability
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Manufacturing Biological Drug
Substances, Intermediates, or Products
Using Spore-Forming Microorganisms’’
dated February 2005. The draft
document is intended to provide
guidance to manufacturers using sporeforming microorganisms in the
production of certain biological
products. The draft guidance document
provides recommendations to industry
in response to changes made to the
requirements for spore-forming
microorganisms to allow greater
flexibility in manufacturing.
In the Federal Register of December
30, 2003, FDA published the direct final
rule entitled ‘‘Revision of the
Requirements for Spore-Forming
Microorganisms’’ (68 FR 75116) and the
accompanying proposed rule entitled
‘‘Revision of the Requirements for
Spore-Forming Microorganisms;
Companion to Direct Final Rule’’ (68 FR
75179) to modify the regulatory
requirements for the manufacturing of
biological products with spore-formers
to allow greater manufacturing
flexibility. The modifications were
intended to provide alternatives to the
then-existing requirements for separate,
dedicated facilities and equipment for
work with spore-forming
microorganisms. In the Federal Register
of May 14, 2004 (69 FR 26768), FDA
published the ‘‘Revision of the
Requirements for Spore-Forming
Microorganisms; Confirmation of
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either http:/
/www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–3592 Filed 2–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Manufacturing
Biological Drug Substances,
Intermediates, or Products Using SporeForming Microorganisms’’ dated
February 2005. The draft document is
intended to provide guidance to
manufacturers using spore-forming
microorganisms in the production of
certain biological products. The draft
guidance document provides
recommendations to industry in
response to changes made to the
requirements for spore-forming
microorganisms to allow greater
flexibility in manufacturing.
DATES: Submit written or electronic
comments on the draft guidance by May
25, 2005, to ensure their adequate
consideration in preparation of the final
guidance. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
VerDate jul<14>2003
18:49 Feb 23, 2005
Jkt 205001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Effective Date’’ confirming the effective
date of June 1, 2004, for the direct final
rule.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on this topic. 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 requirement
of the applicable statutes and
regulations.
II. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit written or electronic
comments to ensure adequate
consideration in preparation of the final
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: February 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–3593 Filed 2–23–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Notices]
[Page 9084]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0528]
Draft Guidance for Industry: Manufacturing Biological Drug
Substances, Intermediates, or Products Using Spore-Forming
Microorganisms; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry:
Manufacturing Biological Drug Substances, Intermediates, or Products
Using Spore-Forming Microorganisms'' dated February 2005. The draft
document is intended to provide guidance to manufacturers using spore-
forming microorganisms in the production of certain biological
products. The draft guidance document provides recommendations to
industry in response to changes made to the requirements for spore-
forming microorganisms to allow greater flexibility in manufacturing.
DATES: Submit written or electronic comments on the draft guidance by
May 25, 2005, to ensure their adequate consideration in preparation of
the final guidance. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance 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 the
office in processing your requests. The draft guidance may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Manufacturing Biological Drug Substances,
Intermediates, or Products Using Spore-Forming Microorganisms'' dated
February 2005. The draft document is intended to provide guidance to
manufacturers using spore-forming microorganisms in the production of
certain biological products. The draft guidance document provides
recommendations to industry in response to changes made to the
requirements for spore-forming microorganisms to allow greater
flexibility in manufacturing.
In the Federal Register of December 30, 2003, FDA published the
direct final rule entitled ``Revision of the Requirements for Spore-
Forming Microorganisms'' (68 FR 75116) and the accompanying proposed
rule entitled ``Revision of the Requirements for Spore-Forming
Microorganisms; Companion to Direct Final Rule'' (68 FR 75179) to
modify the regulatory requirements for the manufacturing of biological
products with spore-formers to allow greater manufacturing flexibility.
The modifications were intended to provide alternatives to the then-
existing requirements for separate, dedicated facilities and equipment
for work with spore-forming microorganisms. In the Federal Register of
May 14, 2004 (69 FR 26768), FDA published the ``Revision of the
Requirements for Spore-Forming Microorganisms; Confirmation of
Effective Date'' confirming the effective date of June 1, 2004, for the
direct final rule.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
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 requirement of the applicable
statutes and regulations.
II. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final guidance. Submit a single copy of electronic
comments or two paper copies of any mailed comments, except that
individuals may submit one paper copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. A copy of the draft guidance and received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: February 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3593 Filed 2-23-05; 8:45 am]
BILLING CODE 4160-01-S
