[Federal Register: July 7, 1999 (Volume 64, Number 129)]
[Notices]               
[Page 36694-36695]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy99-87]                         

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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 Submit written comments on the draft guidance to the Dockets 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