Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance Environment for Multi-Configuration Passive Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 36996-36997 [2015-15833]

Download as PDF 36996 Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Notices of this notice. Comments may be submitted to: Jeannie L. Chaffin, Director, Office of Community Services, 370 L’Enfant Promenade SW., 5th Floor—West, Washington, DC 20447. After considering any comments submitted, the Chief Executive Officers will be notified of the final reallotment amount. This decision will be published in the Federal Register. If funds are reallotted, they will be allocated in accordance with section 2604 of the Act (42 U.S.C. 8623) and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2015. As FY 2015 funds, they will be subject to all requirements of the Act, including section 2607(b)(2) (42 U.S.C. 8626(b)(2)), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2015. ESTIMATED REALLOTMENT AMOUNTS OF FY 2014 LIHEAP FUNDS DEPARTMENT OF HEALTH AND HUMAN SERVICES FY 2014 reallotment amount Administration for Children and Families Grantee name Pueblo of Laguna ................... Delaware Tribe of Indians ...... Colorado River Indian Tribes of the Colorado River Indian Reservation ......................... Five Sandoval Indian Pueblos, Inc ....................................... Kodiak Area Native Association ...................................... West Virginia .......................... $27,708 8,841 1,070 4,289,352 Total .................................... 4,352,881 12,667 13,243 Statutory Authority: 42 U.S.C. 8626. Mary M. Wayland, Senior Grants Policy Specialist, Office of Administration, Division of Grants Policy. [FR Doc. 2015–15859 Filed 6–26–15; 8:45 am] BILLING CODE 4184–80–P Submission for OMB Review; Comment Request Title: Grants to States for Access and Visitation. OMB No.: 0970–0204. 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Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, Email: OIRA_SUBMISSION@ OMB.EOP.GOV, Attn: Desk Officer for VerDate Sep<11>2014 17:13 Jun 26, 2015 Jkt 235001 54 331 the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–15889 Filed 6–26–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–2104] Assessment of RadiofrequencyInduced Heating in the Magnetic Resonance Environment for MultiConfiguration Passive Medical 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 or Agency) is announcing the availability of the draft guidance entitled ‘‘Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical SUMMARY: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden hours per response 16 16 Total burden hours 864 5296 Devices.’’ The purpose of this guidance is to provide an assessment paradigm for radiofrequency (RF)-induced heating on, or near, multi-component, or multiconfiguration, passive medical devices in the magnetic resonance environment. 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 August 28, 2015. 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 ‘‘Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug ADDRESSES: E:\FR\FM\29JNN1.SGM 29JNN1 Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Notices 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 https:// 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: Wolfgang Kainz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 1129, Silver Spring, MD 20993–0002, 301–661–7595. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance to provide an assessment paradigm for RF-induced heating on or near multi-component or multi-configuration passive medical devices in the MR environment. During MR scanning, applied RF excitation pulses induce currents that can cause heating of electrically conductive materials. RF-induced heating of medical devices made with conductive materials may lead to patient burns. To minimize the risk of patient burns during MR scanning, sponsors should comprehensively assess devices in all configurations and combinations. However, multi-component passive devices, such as orthopedic fixation devices, may permit a very large number of possible device configurations and combinations of individual components. Testing all possibilities may be impracticable and unnecessary. This draft guidance provides an approach to identify a manageable number of device configurations or combinations for the testing of RF-induced heating in the MR environment. Additionally, this draft guidance provides recommendations on how to assess RF-induced device heating for multi-configuration passive medical devices. mstockstill on DSK4VPTVN1PROD with NOTICES 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 current thinking of FDA on the assessment of RF-induced heating of multi-component, or multiconfiguration, passive medical devices in the MR environment. It does not establish any rights for any person and VerDate Sep<11>2014 17:13 Jun 26, 2015 Jkt 235001 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 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Assessment of RadiofrequencyInduced Heating in the Magnetic Resonance (MR) Environment for MultiConfiguration Passive Medical Devices’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500001 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 814 have been approved under OMB control number 0910–0231. V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. Dated: June 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–15833 Filed 6–26–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 36997 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Publication of the Revised Guidebook for the National Practitioner Data Bank (NPDB) Health Resources and Services Administration (HRSA), HHS. AGENCY: ACTION: Notice. The National Practitioner Data Bank (NPDB) announces the release of the revised user Guidebook. The NPDB is a confidential information clearinghouse created by Congress and intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, and suppliers. The Guidebook is the primary policy document explaining the statutes and regulations behind and operation of the NPDB. It serves as an essential reference for NPDB users, offering reporting and querying examples, explanations, definitions, and frequently asked questions. The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the NPDB’s merger with the Healthcare Integrity and Protection Data Bank. In November 2013, the Health Resources and Services Administration (HRSA) released a draft Guidebook to the public for review and comment by NPDB stakeholders and other interested parties. It announced the draft Guidebook’s availability in the Federal Register. HRSA received more than 360 separate comments, consisting of analyses of issues raised by the draft Guidebook. The NPDB carefully studied all comments received, and many led to detailed analyses of how NPDB explains its policies to its audiences. The final Guidebook is now available at www.npdb.hrsa.gov and replaces previous Guidebooks. SUMMARY: FOR FURTHER INFORMATION CONTACT: Ernia P. Hughes, MBA, Director of the Division of Practitioner Data Bank, Bureau of Health Workforce, Health Resources and Services Administration at: NPDBPolicy@hrsa.gov or 301–443– 2300. Dated: June 18, 2015. James Macrae, Acting Administrator. [FR Doc. 2015–15802 Filed 6–26–15; 8:45 am] BILLING CODE 4165–15–P Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\29JNN1.SGM 29JNN1

Agencies

[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Pages 36996-36997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15833]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2104]


Assessment of Radiofrequency-Induced Heating in the Magnetic 
Resonance Environment for Multi-Configuration Passive Medical 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical Devices.'' The 
purpose of this guidance is to provide an assessment paradigm for 
radiofrequency (RF)-induced heating on, or near, multi-component, or 
multi-configuration, passive medical devices in the magnetic resonance 
environment. 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 August 28, 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 
``Assessment of Radiofrequency-Induced Heating in the Magnetic 
Resonance (MR) Environment for Multi-Configuration Passive Medical 
Devices'' to the Office of the Center Director, Guidance and Policy 
Development, Center for Devices and Radiological Health, Food and Drug

[[Page 36997]]

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 https://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: Wolfgang Kainz, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 1129, Silver Spring, MD 20993-0002, 301-661-7595.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance to provide 
an assessment paradigm for RF-induced heating on or near multi-
component or multi-configuration passive medical devices in the MR 
environment. During MR scanning, applied RF excitation pulses induce 
currents that can cause heating of electrically conductive materials. 
RF-induced heating of medical devices made with conductive materials 
may lead to patient burns. To minimize the risk of patient burns during 
MR scanning, sponsors should comprehensively assess devices in all 
configurations and combinations. However, multi-component passive 
devices, such as orthopedic fixation devices, may permit a very large 
number of possible device configurations and combinations of individual 
components. Testing all possibilities may be impracticable and 
unnecessary. This draft guidance provides an approach to identify a 
manageable number of device configurations or combinations for the 
testing of RF-induced heating in the MR environment. Additionally, this 
draft guidance provides recommendations on how to assess RF-induced 
device heating for multi-configuration passive medical 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 current thinking of FDA on the assessment 
of RF-induced heating of multi-component, or multi-configuration, 
passive medical devices in the MR environment. 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 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Assessment of 
Radiofrequency-Induced Heating in the Magnetic Resonance (MR) 
Environment for Multi-Configuration Passive Medical 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 1500001 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 814 have been approved under 
OMB control number 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://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 https://www.regulations.gov.

    Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15833 Filed 6-26-15; 8:45 am]
 BILLING CODE 4164-01-P
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