[Federal Register Volume 64, Number 129 (Wednesday, July 7, 1999)]
[Notices]
[Pages 36694-36695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0268]
Guidance for Industry on Container Closure Systems for Packaging
Human Drugs and Biologics; Chemistry, Manufacturing, and Controls
Documentation; 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 for industry entitled ``Container Closure
Systems for Packaging Human Drugs and Biologics; Chemistry,
Manufacturing, and Controls Documentation.'' This guidance provides
recommendations on the container closure systems information that
applicants should provide to the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER) in support of new drug applications, abbreviated new drug
applications, biologics license applications, and supplements to these
applications.
DATES: Written comments may be submitted at any time.
ADDRESSES: Copies of this guidance for industry are available on the
Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single
copies of the guidance for industry to the Drug Information Branch
(HFD-210), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, or to the
Office of Communication, Training and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research, 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. Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
W. Mike Adams, Center for Drug Evaluation and Research (HFD-180),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-7310, or
John D. Finkbohner, Center for Biologics Evaluation and Research
(HFM-676), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301827-3031.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Container Closure Systems for
Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and
Controls Documentation.'' This guidance provides recommendations on the
container closure system information that applicants should provide to
CDER or CBER for initial applications and supplements. In addition, the
document provides guidance on qualification and quality control of
packaging components used for particular dosage forms and routes of
administration, including the following: Drug products for injection
and ophthalmic drug products, liquid-based oral and topical drug
products and topical delivery systems, solid oral dosage forms and
powders for reconstitution, and other dosage forms. This guidance
supersedes the agency's ``Guideline for Submitting Documentation for
Packaging for Human Drugs and Biologics,'' issued February 1987.
This Level 1 guidance is being issued consistent with FDA's good
guidance practice (62 FR 8961, February 27, 1997). In the Federal
Register of July 15, 1997 (62 FR 37925), FDA announced the availability
of a draft version of this guidance. The July 1997 document gave
interested persons an opportunity to submit comments through September
15, 1997. On September 5, 1997, in response to requests from the
public, the agency extended the comment period until November 14, 1997
(62 FR 46980). All comments received during the comment period have
been carefully reviewed and incorporated in this revised guidance where
appropriate. As a result of public input during the comment period, the
final guidance is clearer and more concise than the draft version. The
guidance represents the agency's current thinking on submitting
information in drug applications on container closure systems used in
packaging human drugs and biologics. 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 written comments on the
guidance to the Dockets Management Branch (address above). Two copies
of
[[Page 36695]]
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 the guidance and received comments are available
for public examination in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 29, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-17157 Filed 7-6-99; 8:45 am]
BILLING CODE 4160-01-F
