[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Radiation Biodosimetry Devices; Draft Guidance for Industry and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availability of a draft guidance entitled ``Radiation Biodosimetry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 This draft guidance provides recommendations to assist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 This draft guidance is not final nor is it in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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 30, 2015.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requests for a single hard copy of the draft guidance document entitled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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 [email protected] 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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