[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Notices]
[Page 46980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0268]


Draft Guidance for Industry on Submission of Documentation in 
Drug Applications for Container Closure Systems Used for the Packaging 
of Human Drugs and Biologics; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
November 14, 1997, the comment period on the agency's draft guidance 
for industry entitled ``Submission of Documentation in Drug 
Applications for Container Closure Systems Used for the Packaging of 
Human Drugs and Biologics.'' FDA published a notice of the availability 
of the draft guidance in the Federal Register of July 15, 1997 (62 FR 
37925). FDA is extending the comment period in response to requests 
from the industry for additional time to review and comment on the 
draft guidance.

DATES: Written comments by November 14, 1997. General comments on 
agency guidance documents are welcomed at any time.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Alan C. Schroeder, Center for Drug 
Evaluation and Research (HFD-570), 5600 Fishers Lane, Rockville, MD 
20857, 301-827-1050.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 15, 1997, 
FDA published a notice announcing the availability of a draft guidance 
for industry entitled ``Submission of Documentation in Drug 
Applications for Container Closure Systems Used for the Packaging of 
Human Drugs and Biologics.'' The draft guidance discusses information 
on container closure systems used in packaging drugs that manufacturers 
should provide to FDA's Center for Drug Evaluation and Research in 
meeting regulatory requirements for new drug applications, abbreviated 
new drug applications, investigational new drug applications, 
abbreviated antibiotic applications, and supplements to these 
applications, and to the Center for Biologics Evaluation and Research 
in meeting requirements for biologics license applications and product 
license applications. The notice invited interested persons to submit 
written comments on the draft guidance by September 15, 1997.
    FDA has received requests from several industry sources for 
additional time to review the draft guidance on container closure 
systems. FDA has considered these requests and is extending the comment 
period for 60 days.
    Interested persons may, on or before November 14, 1997, submit to 
the Dockets Management Branch (address above) written comments on the 
draft guidance. 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. The draft guidance and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 29, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23586 Filed 9-4-97; 8:45 am]
BILLING CODE 4160-01-F