Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 37886-37888 [2019-16505]

Download as PDF 37886 Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices completing the Prescription Drug User Fee Cover Sheet and generating the user fee ID number. Secure electronic payments can be submitted using the User Fees Payment Portal at https:// userfees.fda.gov/pay (Note: Only full payments are accepted. No partial payments can be made online). Once an invoice is located, ‘‘Pay Now’’ should be selected to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances that are less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards. If a check, bank draft, or postal money order is submitted, make it payable to the order of the Food and Drug Administration and include the user fee ID number to ensure that the payment is applied to the correct fee(s). Payments can be mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197–9000. If a check, bank draft, or money order is to be sent by a courier that requests a street address, the courier should deliver your payment V. Fee Schedule for FY 2020 to: U.S. Bank, Attention: Government The fee rates for FY 2020 are Lockbox 979107, 1005 Convention displayed in table 7: Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery TABLE 7—FEE SCHEDULE FOR FY only. If you have any questions 2020 concerning courier delivery, contact the U.S. Bank at 314–418–4013. This Fee rates telephone number is only for questions Fee category for FY 2020 about courier delivery). Please make sure that the FDA post office box Application: Requiring clinical data ....... $2,942,965 number (P.O. Box 979107) is written on Not requiring clinical data .. 1,471,483 the check, bank draft, or postal money Program .................................... 325,424 order. For payments made by wire transfer, include the unique user fee ID number VI. Fee Payment Options and to ensure that the payment is applied to Procedures the correct fee(s). Without the unique A. Application Fees user fee ID number, the payment may The appropriate application fee not be applied, which could result in established in the new fee schedule FDA not filing an application and other must be paid for any application subject penalties. The originating financial to fees under PDUFA that is submitted institution may charge a wire transfer on or after October 1, 2019. Payment fee. Applicable wire transfer fees must must be made in U.S. currency by be included with payment to ensure fees electronic check, check, bank draft, wire are fully paid. Questions about wire transfer, or U.S. postal money order transfer fees should be addressed to the payable to the order of the Food and financial institution. The account Drug Administration. The preferred information for wire transfers is as payment method is online using follows: U.S. Department of the electronic check (Automated Clearing Treasury, TREAS NYC, 33 Liberty St., House (ACH) also known as eCheck) or New York, NY 10045, Acct. No.: credit card (Discover, VISA, MasterCard, 75060099, Routing No.: 021030004, American Express). SWIFT: FRNYUS33. If needed, FDA’s FDA has partnered with the U.S. tax identification number is 53– Department of the Treasury to use 0196965. Pay.gov, a web-based payment B. Prescription Drug Program Fees application, for online electronic payment. The Pay.gov feature is FDA will issue invoices and payment available on the FDA website after instructions for FY 2020 program fees jbell on DSK3GLQ082PROD with NOTICES program fees for a fiscal year for prescription drug products identified in a single approved NDA or BLA (see section 736(a)(2)(C)). Applicants are assessed a program fee for a fiscal year only for user fee eligible prescription drug products identified in a human drug application approved as of October 1 of such fiscal year. FDA estimates 2,740 program fees will be invoiced in FY 2020 before factoring in waivers, refunds, and exemptions. FDA approximates that there will be 54 waivers and refunds granted. In addition, FDA approximates that another 44 program fees will be exempted in FY 2020 based on the orphan drug exemption in section 736(k) of the FD&C Act. FDA estimates 2,642 program fees in FY 2020, after allowing for an estimated 98 waivers and reductions, including the orphan drug exemptions. The FY 2020 prescription drug program fee rate is calculated by dividing the adjusted total revenue from program fees ($859,771,200) by the estimated 2,642 program fees, for a FY 2020 program fee of $325,424. VerDate Sep<11>2014 18:02 Aug 01, 2019 Jkt 247001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 under the new fee schedule in August 2019. Payment will be due on October 1, 2019. FDA will issue invoices in December 2019 for FY 2020 program fees that qualify for fee assessments after the August 2019 billing. Dated: July 29, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16435 Filed 8–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–2837] Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.’’ FDA developed this draft guidance to provide FDA’s recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This draft guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by October 1, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to E:\FR\FM\02AUN1.SGM 02AUN1 Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–2837 for ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 VerDate Sep<11>2014 18:02 Aug 01, 2019 Jkt 247001 for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’’ to the Office of Policy, 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: Terry Woods, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2116, Silver Spring, MD 20993–0002, 301–796–2503. SUPPLEMENTARY INFORMATION: I. Background The MR Environment presents unique safety hazards for patients and other persons with devices near or inside an MR system. Ensuring safety and effectiveness for a medical device intended to enter the MR Environment should be an integral part of the device PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 37887 risk management. Appropriate testing and labeling, such as well supported MR Conditional labeling, should form the basis of adequate mitigations for the unique safety hazards in the MR Environment. This guidance document outlines FDA’s current thinking on the testing needed for assessing the safety and compatibility of medical devices in the MR Environment and the recommended format for MRI Safety Information in device labeling. 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 ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (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. This guidance is not subject to Executive Order 12866. 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/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500059 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table: E:\FR\FM\02AUN1.SGM 02AUN1 37888 Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices Topic 807, subpart E ............................................................................ 814, subparts A through E ......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 801 and 809 ............................................................................... Premarket notification ................................................................. Premarket approval .................................................................... Humanitarian Device Exemption ................................................ Investigational Device Exemption .............................................. De Novo classification process .................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Q-Submissions ........................................................................... 0910–0756 Medical Device Labeling Regulations ........................................ 0910–0485 Dated: July 29, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16505 Filed 8–1–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3560] Biosimilar User Fee Rates for Fiscal Year 2020 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2019, through September 30, 2020. FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 61075, Beltsville, MD 20705–4304, 240–402–4585. SUPPLEMENTARY INFORMATION: SUMMARY: jbell on DSK3GLQ082PROD with NOTICES OMB control No. 21 CFR part or guidance VerDate Sep<11>2014 18:02 Aug 01, 2019 Jkt 247001 I. Background Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j–51, 379j–52, and 379j–53), as amended by BsUFA II (title IV of the FDA Reauthorization Act of 2017, Pub. L. 115–52), authorize the collection of fees for biosimilar biological products. Under section 744H(a)(1)(A) of the FD&C Act, the initial BPD fee for a product is due when the sponsor submits an investigational new drug (IND) application that FDA determines is intended to support a biosimilar biological product application or within 5 calendar days after FDA grants the first BPD meeting, whichever occurs first. A sponsor who has paid the initial BPD fee is considered to be participating in FDA’s BPD program for that product. Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has paid the initial BPD fee for a product, the annual BPD fee is assessed beginning with the next fiscal year. The annual BPD fee is assessed for the product each fiscal year until the sponsor submits a marketing application for the product that is accepted for filing or the sponsor discontinues participation in FDA’s BPD program for the product. Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has discontinued participation in FDA’s BPD program and wants to re-engage with FDA on development of the product, the sponsor must pay a reactivation fee to resume participation in the program. The sponsor must pay the reactivation fee by the earlier of the following dates: No later than 5 calendar days after FDA grants the sponsor’s request for a BPD meeting for that product or upon the date of submission by the sponsor of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application for that product. The sponsor will be assessed an annual BPD fee beginning with the first fiscal year after payment of the reactivation fee. BsUFA II also authorizes fees for certain biosimilar biological product applications and for each biosimilar PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 biological product identified in an approved biosimilar biological product application (section 744H(a)(2) and (3) of the FD&C Act). Under certain conditions, FDA will grant a small business a waiver from its first biosimilar biological product application fee (section 744H(d)(1) of the FD&C Act). For FY 2018 through FY 2022, the base revenue amounts for the total revenues from all BsUFA fees are established by BsUFA II. For FY 2020, the base revenue amount is the FY 2019 inflation adjusted fee revenue amount of $40,947,463. The FY 2020 base revenue amount is to be adjusted for inflation and may be reduced, as appropriate, for long-term financial planning purposes. This document provides fee rates for FY 2020 for the initial and annual BPD fee ($117,987), for the reactivation fee ($235,975), for an application requiring clinical data ($1,746,745), for an application not requiring clinical data ($873,373), and for the program fee ($304,162). These fees are effective on October 1, 2019, and will remain in effect through September 30, 2020. For applications that are submitted on or after October 1, 2019, the new fee schedule must be used. II. Fee Revenue Amount for FY 2020 The base revenue amount for FY 2020 is $40,947,463 prior to adjustments for inflation and operating reserves (see section 744H(c)(1) and (3) of the FD&C Act). A. FY 2020 Statutory Fee Revenue Adjustments for Inflation BsUFA II specifies that the $40,947,463 is to be adjusted for inflation increases for FY 2020 using two separate adjustments—one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 744H(c)(1) of the FD&C Act). The component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent (FTE) positions at FDA for the first 3 of the preceding 4 FYs, E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37886-37888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16505]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2837]


Testing and Labeling Medical Devices for Safety in the Magnetic 
Resonance Environment; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Testing and Labeling 
Medical Devices for Safety in the Magnetic Resonance (MR) 
Environment.'' FDA developed this draft guidance to provide FDA's 
recommendations on the testing needed for assessing the safety and 
compatibility of medical devices in the Magnetic Resonance (MR) 
Environment and the recommended format for Magnetic Resonance Imaging 
(MRI) Safety Information in medical device labeling. This draft 
guidance document is anticipated to aid in consistency of reviews, 
testing, and MRI safety labeling across a variety of medical devices. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by October 1, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to

[[Page 37887]]

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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-2837 for ``Testing and Labeling Medical Devices for Safety 
in the Magnetic Resonance (MR) Environment.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Testing and Labeling Medical Devices for Safety in the Magnetic 
Resonance (MR) Environment'' to the Office of Policy, 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: Terry Woods, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 2116, Silver Spring, MD 20993-0002, 301-796-2503.

SUPPLEMENTARY INFORMATION: 

I. Background

    The MR Environment presents unique safety hazards for patients and 
other persons with devices near or inside an MR system. Ensuring safety 
and effectiveness for a medical device intended to enter the MR 
Environment should be an integral part of the device risk management. 
Appropriate testing and labeling, such as well supported MR Conditional 
labeling, should form the basis of adequate mitigations for the unique 
safety hazards in the MR Environment. This guidance document outlines 
FDA's current thinking on the testing needed for assessing the safety 
and compatibility of medical devices in the MR Environment and the 
recommended format for MRI Safety Information in device labeling.

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 ``Testing and 
Labeling Medical Devices for Safety in the Magnetic Resonance (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. This guidance is not subject to Executive Order 12866.

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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Testing and Labeling Medical Devices for Safety in 
the Magnetic Resonance (MR) Environment'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1500059 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 37888]]



------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
801 and 809.......................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
------------------------------------------------------------------------


    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16505 Filed 8-1-19; 8:45 am]
 BILLING CODE 4164-01-P

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