[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Draft Guidance for Industry on Submission of Documentation in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November 14, 1997, the comment period on the agency's draft guidance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of the draft guidance in the Federal Register of July 15, 1997 (62 FR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draft guidance.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FDA published a notice announcing the availability of a draft guidance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 The draft guidance discusses information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
