80_FR_37121 80 FR 36997 - Notice of Publication of the Revised Guidebook for the National Practitioner Data Bank (NPDB)

80 FR 36997 - Notice of Publication of the Revised Guidebook for the National Practitioner Data Bank (NPDB)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 124 (June 29, 2015)

Page Range36997-36997
FR Document2015-15802

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.

Federal Register, Volume 80 Issue 124 (Monday, June 29, 2015) 
[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Page 36997]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15802]


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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)

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Notice.

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SUMMARY: 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.

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: [email protected] 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

Federal Register / Vol. 80, No. 124 / Monday, June 29, 2015 / Notices 36997 Administration, 10903 New Hampshire is not binding on FDA or the public. DEPARTMENT OF HEALTH AND Ave., Bldg. 66, Rm. 5431, Silver Spring, You can use an alternative approach if HUMAN SERVICES MD 20993–0002. Send one self- it satisfies the requirements of the addressed adhesive label to assist that applicable statutes and regulations. Health Resources and Services office in processing your request. Administration Submit electronic comments on the III. Electronic Access draft guidance to http:// Notice of Publication of the Revised Persons interested in obtaining a copy www.regulations.gov. Submit written Guidebook for the National Practitioner of the draft guidance may do so by comments to the Division of Dockets Data Bank (NPDB) downloading an electronic copy from Management (HFA–305), Food and Drug the Internet. A search capability for all AGENCY:Health Resources and Services Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify Center for Devices and Radiological Administration (HRSA), HHS. comments with the docket number Health guidance documents is available at http://www.fda.gov/MedicalDevices/ ACTION: Notice. found in brackets in the heading of this document. DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. SUMMARY: The National Practitioner FOR FURTHER INFORMATION CONTACT: Guidance documents are also available Data Bank (NPDB) announces the Wolfgang Kainz, Center for Devices and at http://www.regulations.gov. Persons release of the revised user Guidebook. Radiological Health, Food and Drug Administration, 10903 New Hampshire unable to download an electronic copy The NPDB is a confidential information Ave., Bldg. 62, Rm. 1129, Silver Spring, of ‘‘Assessment of Radiofrequency- clearinghouse created by Congress and MD 20993–0002, 301–661–7595. Induced Heating in the Magnetic intended to facilitate a comprehensive Resonance (MR) Environment for Multi- review of the professional credentials of SUPPLEMENTARY INFORMATION: Configuration Passive Medical Devices’’ health care practitioners, entities, and I. Background may send an email request to CDRH- suppliers. The Guidebook is the primary FDA is announcing the availability of Guidance@fda.hhs.gov to receive an policy document explaining the statutes a draft guidance to provide an electronic copy of the document. Please and regulations behind and operation of assessment paradigm for RF-induced use the document number 1500001 to the NPDB. It serves as an essential heating on or near multi-component or identify the guidance you are reference for NPDB users, offering multi-configuration passive medical requesting. reporting and querying examples, devices in the MR environment. During explanations, definitions, and IV. Paperwork Reduction Act of 1995 frequently asked questions. The new MR scanning, applied RF excitation pulses induce currents that can cause This draft guidance refers to Guidebook incorporates legislative and heating of electrically conductive previously approved collections of regulatory changes adopted since its last materials. RF-induced heating of information found in FDA regulations. edition, including the NPDB’s merger medical devices made with conductive These collections of information are with the Healthcare Integrity and materials may lead to patient burns. To subject to review by the Office of Protection Data Bank. minimize the risk of patient burns Management and Budget (OMB) under In November 2013, the Health during MR scanning, sponsors should the Paperwork Reduction Act of 1995 Resources and Services Administration comprehensively assess devices in all (44 U.S.C. 3501–3520). The collections (HRSA) released a draft Guidebook to configurations and combinations. However, multi-component passive of information in 21 CFR part 814 have the public for review and comment by devices, such as orthopedic fixation been approved under OMB control NPDB stakeholders and other interested devices, may permit a very large number number 0910–0231. parties. It announced the draft of possible device configurations and Guidebook’s availability in the Federal V. Comments combinations of individual components. Register. HRSA received more than 360 Testing all possibilities may be Interested persons may submit either separate comments, consisting of impracticable and unnecessary. This electronic comments regarding this analyses of issues raised by the draft draft guidance provides an approach to document to http://www.regulations.gov Guidebook. The NPDB carefully studied identify a manageable number of device or written comments to the Division of all comments received, and many led to configurations or combinations for the Dockets Management (see ADDRESSES). It detailed analyses of how NPDB explains testing of RF-induced heating in the MR is only necessary to send one set of its policies to its audiences. The final environment. Additionally, this draft comments. Identify comments with the Guidebook is now available at guidance provides recommendations on docket number found in brackets in the www.npdb.hrsa.gov and replaces how to assess RF-induced device heading of this document. Received previous Guidebooks. heating for multi-configuration passive comments may be seen in the Division FOR FURTHER INFORMATION CONTACT: medical devices. of Dockets Management between 9 a.m. Ernia P. Hughes, MBA, Director of the II. Significance of Guidance and 4 p.m., Monday through Friday, and Division of Practitioner Data Bank, will be posted to the docket at http:// Bureau of Health Workforce, Health This draft guidance is being issued consistent with FDA’s good guidance www.regulations.gov. Resources and Services Administration at: NPDBPolicy@hrsa.gov or 301–443– mstockstill on DSK4VPTVN1PROD with NOTICES practices regulation (21 CFR 10.115). Dated: June 23, 2015. The draft guidance, when finalized, will Leslie Kux, 2300. represent the current thinking of FDA Associate Commissioner for Policy. Dated: June 18, 2015. on the assessment of RF-induced [FR Doc. 2015–15833 Filed 6–26–15; 8:45 am] James Macrae, heating of multi-component, or multi- configuration, passive medical devices BILLING CODE 4164–01–P Acting Administrator. in the MR environment. It does not [FR Doc. 2015–15802 Filed 6–26–15; 8:45 am] establish any rights for any person and BILLING CODE 4165–15–P VerDate Sep<11>2014 17:13 Jun 26, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 E:\FR\FM\29JNN1.SGM 29JNN1


Document Created: 2015-12-15 14:24:50
Document Modified: 2015-12-15 14:24:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactErnia P. Hughes, MBA, Director of the Division of Practitioner Data Bank, Bureau of Health Workforce, Health Resources and Services Administration at: [email protected] or 301- 443-2300.
FR Citation80 FR 36997 
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