Document ID: FDA-2015-D-0198-0004
Agency: fda
Document Type: Notice
Title: Current Good Manufacturing Practice Requirements for Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; Extension of Comment Period
Posted Date: 2015-03-13T04:00Z

[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13382-13383]
From the Federal Register Online via the Government Printing 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Products; Draft Guidance for Industry and Food and Drug Administration 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Products; Draft Guidance for Industry and Food and Drug Administration 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of a draft guidance for industry and FDA staff and requested comments.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DATES: FDA is extending the comment period on the draft guidance.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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Current Good Manufacturing Practice 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: John.Weiner@fda.hhs.gov.

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]
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