[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13382-13383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05674]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0198]
Current Good Manufacturing Practice Requirements for Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; 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 the
comment period by 30 days to April 29, 2015, for the notice entitled
``Current Good Manufacturing Practice Requirements for Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability,'' that appeared in the Federal Register of January
27, 2015 (80 FR 4280). In that document, FDA announced the availability
of a draft guidance for industry and FDA staff and requested comments.
The Agency is taking this action in response to a request for an
extension to allow interested persons additional time to submit
comments.
DATES: FDA is extending the comment period on the draft guidance.
Submit either electronic or written comments by April 29, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Current Good Manufacturing Practice
Requirements for Combination Products'' to the Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,
[[Page 13383]]
MD 20993-0002, 301-796-8930, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 27, 2015 (80 FR 4280), FDA
published a notice with a 60-day comment period to request comments on
the draft guidance for industry and FDA staff entitled ``Current Good
Manufacturing Practice Requirements for Combination Products.''
The Agency received a request for a 30-day extension of the comment
period for the draft guidance. The request conveyed concern that the
current 60-day comment period does not allow sufficient time to
respond. FDA has considered the request and is extending the comment
period for the draft guidance for 30 days, until April 29, 2015. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
further FDA action on this guidance document.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm
or http://www.regulations.gov.
Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05674 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P