[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22615-22617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Radiation Biodosimetry Medical Countermeasure Devices; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Radiation Biodosimetry 
Medical Countermeasure Devices.'' FDA has developed this guidance to 
provide industry and Agency staff with recommendations for the types of 
information that should be submitted to support marketing authorization 
for radiation biodosimetry medical countermeasure devices.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential,

[[Page 22616]]

if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-2065 for ``Radiation Biodosimetry Medical Countermeasure 
Devices.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 guidance document entitled 
``Radiation Biodosimetry Medical Countermeasure 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.

FOR FURTHER INFORMATION CONTACT: Jennifer Dickey, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5648, Silver Spring, MD 20993-0002, 301-
796-5028.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance provides recommendations for the types of information 
that should be submitted to support marketing authorization (e.g., the 
clearance or approval) for radiation biodosimetry medical 
countermeasure devices (referred to as ``biodosimetry devices'' or 
``biodosimeters'' throughout this document).
    This guidance applies to premarket submissions for medical device 
systems intended to measure biological responses to unintended (non-
therapeutic) radiation absorption. Biodosimetry 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. Biodosimetry 
technologies may be used at various stages during triage, including 
both early mass casualty triage and subsequent clinical evaluation. 
Such exposures could be the result of intentional harm or as a 
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 guidance document.
    This guidance only applies to validation of diagnostic biodosimetry 
devices intended to be used to assess radiation absorption that occurs 
as a result of non-therapeutic or accidental exposures (e.g., a 
deliberate attack, such as use of an improvised nuclear device, or a 
natural disaster), and does not apply to medical devices intended to be 
used to measure doses delivered as a result of radiation therapy nor to 
devices that measure effects from long-term radiation 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 guidance document.
    This guidance document does not provide specific study designs; it 
describes design principles for studies that may be used to establish a 
reasonable assurance of the safety and effectiveness of biodosimetry 
devices.
    In the Federal Register of December 30, 2014 (79 FR 78448), the 
Agency announced the issuance of the draft guidance entitled 
``Radiation Biodosimetry Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff.'' In the Federal Register of May 28, 
2015 (80 FR 30466), FDA reopened and extended the comment period on the 
draft guidance. The Agency has considered the comments, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Radiation Biodosimetry Medical 
Countermeasure Devices.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 
Medical Countermeasure 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.

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IV. Paperwork Reduction Act of 1995

    This 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; 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; and the collections of information 
in the guidance document entitled ``Requests for Feedback on Medical 
Device Submissions: The Pre-Submission Program and Meetings with Food 
and Drug Administration Staff'' have been approved under OMB control 
number 0910-0756.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08899 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P