[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Pages 30466-30467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2065]


Radiation Biodosimetry Devices; Draft Guidance for Industry and 
Food and Drug Administration Staff; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for an additional 30 days, for the notice of 
availability

[[Page 30467]]

entitled ``Radiation Biodosimetry Devices; Draft Guidance for Industry 
and Food and Drug Administration Staff; Availability'', published in 
the Federal Register of December 30, 2014. 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announced the availability of a draft guidance for industry and FDA 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DATES: FDA is reopening and extending the comment period on the draft 
guidance. Submit either electronic or written comments by June 29, 
2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Radiation Biodosimetry Devices'' to the Office of the Center 
Director, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Jennifer Dickey, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5262, Silver Spring, MD 20993-0002, 301-
796-5028.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 30, 2014 (79 FR 78448), FDA 
published a notice with a 90-day comment period to request comments on 
the draft guidance for industry and FDA staff entitled ``Radiation 
Biodosimetry Devices''.
    The Agency received a request for an extension of the comment 
period for the draft guidance (Docket No. FDA-2014-D-2065-0005). The 
request conveyed concern that the current 90-day comment period does 
not allow sufficient time to respond. FDA has considered the request 
and is reopening and extending the comment period for the draft 
guidance for 30 days. 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Radiation Biodosimetry 
Devices'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1400045 to identify the guidance you are requesting.

III. 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.

    Dated: May 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.12854
[FR Doc. 2015-12854 Filed 5-27-15; 8:45 am]
 BILLING CODE 4164-01-P