[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78448-78449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30453]


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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Radiation Biodosimetry Devices; Draft Guidance for Industry and 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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Radiation Biodosimetry 
Devices.'' This draft guidance provides recommendations to assist 
industry in designing studies to establish the analytical and clinical 
performance characteristics of radiation biodosimetry medical 
countermeasure devices. This draft guidance is not final nor is it in 
effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 30, 2015.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requests for a single hard copy of the draft guidance document entitled 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

[[Page 78449]]

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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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

    This draft guidance provides recommendations to assist industry in 
designing studies to establish the analytical and clinical performance 
characteristics of radiation biodosimetry medical countermeasure 
devices.
    Radiation biodosimetry countermeasure devices are devices used for 
the purpose of reconstructing the ionizing radiation dose received by 
individuals or populations using physiological, chemical or biological 
markers of exposure found in humans. Radiation biodosimetry 
technologies may be used at various stages during triage and treatment 
after the exposure of a population to ionizing radiation as a result of 
intentional harm or as an unintended consequence of a disaster. Devices 
may be designed to give quantitative outputs or qualitative information 
around a clinical decision making cut-point. Likewise, devices may be 
designed for use in field triage settings, at patient bedsides, or in 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-
578) certified clinical laboratories. FDA considered both high-
throughput and single-use devices in developing this draft guidance 
document.
    This draft guidance only applies to validation of biodosimetry 
devices intended to be used to assess exposure in non-therapeutic or 
accidental scenarios (e.g. a deliberate attack, such as use of an 
improvised nuclear device, or a natural disaster). This draft guidance 
neither applies to devices that assess deliberate radiation dosing that 
may occur in the course of medical treatment nor to devices that 
measure effects from long term exposure. In addition, dosimeters, which 
are devices that detect radiation exposure on a physical substrate 
rather than through a biological response and are worn by people who 
might be exposed to radiation during the course of their normal work 
(such as film badges), are not addressed in this guidance document. 
Finally, biological assays that might be used to detect the presence of 
ingested radioisotopes in sputum or urine are not considered in this 
draft guidance document.
    This draft guidance document does not provide specific study 
designs; it describes design principles for studies that may be used to 
establish the safety and effectiveness of radiation biodosimetry 
devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on evaluating 
the performance characteristics of radiation biodosimetry devices. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. 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.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 58 have been approved under 
OMB control number 0910-0119; the collections of information in 21 CFR 
parts 801 and 809 have been approved under OMB control number 0910-
0485; the collections of information in 21 CFR part 807, subpart E, 
have been approved under OMB control number 0910-0120; the collections 
of information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231; the collections 
of information in the guidance document entitled ``Informed Consent For 
In Vitro Diagnostic Device Studies Using Leftover Human Specimens That 
Are Not Individually Identifiable'' have been approved under OMB 
control number 0910-0582; and the collections of information in the 
guidance document entitled ``Guidance for Industry and FDA Staff: 
Administrative Procedures for CLIA Categorization'' have been approved 
under OMB control number 0910-0607.

V. 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: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30453 Filed 12-29-14; 8:45 am]
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