Radiation Biodosimetry Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 78448-78449 [2014-30453]

Download as PDF 78448 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices TABLE 2—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND SPECIFIC BE RECOMMENDATIONS HUMAN SERVICES FOR DRUG PRODUCTS—Continued Food and Drug Administration Sevelamer hydrochloride. [Docket No. FDA–2014–N–0001] For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to http:// www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft and revised draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency’s current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. IV. Comments Interested persons may submit either electronic comments on any of the specific BE recommendations posted on FDA’s Web site 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. The guidances, notices, and 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. V. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http://www. regulations.gov. mstockstill on DSK4VPTVN1PROD with NOTICES Dated: December 23, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30514 Filed 12–29–14; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 21:42 Dec 29, 2014 Jkt 235001 Advisory Committees; Filing of Closed Meeting Reports AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2014. ADDRESSES: Copies are available at the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You also may access the docket at http:// www.regulations.gov for the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2014. Insert the docket number found in brackets in the heading of this document at http:// www.regulations.gov into the ‘‘Search’’ box, clear filter under Document Type (left side of screen), and check ‘‘Supporting and Related Material,’’ then Sort By Best Match (from the dropdown menu; top right side of screen), ‘‘ID Number (Z–A)’’ or Sort By Best Match (from the drop-down menu) ‘‘Title (A–Z),’’ also found in the heading of this document. FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Committee Management Officer, Advisory Committee and Oversight Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8220. SUPPLEMENTARY INFORMATION: Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2013, through September 30, 2014: Center for Biologics Evaluation and Research: Blood Products Advisory Committee Cellular, Tissue, and Gene Therapies Advisory Committee Vaccines and Related Biological Products Advisory Committee National Center for Toxicological Research: SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Science Board to the National Center for Toxicological Research Annual Reports are available for public inspections between 9 a.m. and 4 p.m., Monday through Friday at the following locations: (1) The Library of Congress, Madison Bldg., Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE., Rm. 133, Washington, DC; and (2) The Dockets Management Branch (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 22, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30460 Filed 12–29–14; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed 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: mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 21:42 Dec 29, 2014 Jkt 235001 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 CDRHGuidance@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 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 78449 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] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78448-78449]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P