83 FR 46444 - Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 178 (September 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 178 (September 13, 2018)
| Page Range | 46444-46449 | |
| FR Document | 2018-19865 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Proposed Rules] [Pages 46444-46449] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19865] [[Page 46444]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 807, 812, and 814 [Docket No. FDA-2018-N-0628] RIN 0910-AH48 Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is proposing to amend requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. If finalized, this action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations. DATES: Submit either electronic or written comments on this proposed rule by December 12, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 12, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 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-2018-N-0628 for ``Medical Device Submissions: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format.'' Received comments, those filed in a timely manner (see ADDRESSES), 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.thefederalregister.org/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. FOR FURTHER INFORMATION CONTACT: Diane Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-796-6559, email: [email protected]. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary II. Background III. Legal Authority IV. Description of the Proposed Rule V. Proposed Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. Consultation and Coordination with Indian Tribal Governments XI. References I. Executive Summary This proposed rule would amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies and replace them with requirements for a single submission in electronic format to improve the FDA's premarket submission program for medical devices and to create a more efficient submission program. Because a medical device premarket submission in electronic format is easily reproducible, [[Page 46445]] and the requirement for multiple copies, whether in electronic format or paper form, is no longer necessary, FDA believes it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies. II. Background On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform Agenda'' (https://www.thefederalregister.org/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf, 82 FR 12285 (March 1, 2017)) was issued. One of the provisions in the E.O. requires Agencies to evaluate existing regulations and make recommendations to the Agency head regarding their repeal, replacement, or modification, consistent with applicable law. As part of this initiative, FDA is updating regulations as specified in this proposed rule. FDA's current medical device regulations that require multiple copies and paper submissions predate the authority provided to FDA in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require electronic submissions (see 21 CFR parts 807, 812, and 814 and section 745A of the FD&C Act (21 U.S.C. 379k-1)). The FD&C Act was amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144) (see section 745A(b) of the FD&C Act and section 1136 of FDASIA). The amendments in FDASIA provided that after FDA issued guidance on the submission of electronic copies (eCopies), the submission of eCopies will be required for presubmissions and submissions and any supplements to these presubmissions and submissions for medical devices. (For sections requiring submission, see sections 510(k), 513(f)(2)(A), 515(c), (d) and (f), 520(g) and (m), or 564 of the FD&C Act (21 U.S.C. 360(k), 360c(f)(2)(A), 360e(c), (d) and (f), 360j(g) and (m), and 360bbb-3 or section 351 of the Public Health Service Act (42 U.S.C. 262).) Congress granted explicit statutory authorization to FDA to implement eCopy requirements by providing through guidance the standards and criteria for waivers and exemptions (section 745(b)(1) and (2) of the FD&C Act). On January 2, 2013, FDA published the guidance entitled ``eCopy Program for Medical Device Submissions'' (eCopy guidance). The issuance of the eCopy guidance marked the beginning of the eCopy program. The 2013 guidance was superseded by an updated guidance of the same title issued on December 3, 2015. The eCopy guidance recommends that one paper copy should be submitted, and that any additional copies required under the regulations be submitted as eCopies. While the eCopy guidance does not change the overall number of copies required for any submission, the guidance states that eCopies should be provided in lieu of some of the paper copies. The guidance also outlines other requirements for eCopies. The eCopy guidance provides instructions for the processing and technical standards for eCopies based on FDA's experience with the program (Ref. 1). In 2017, the FD&C Act was amended by the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) (see section 745A(b) of the FD&C Act and section 207 of FDARA). The amended provisions in the FD&C Act require presubmissions and submissions, any supplements to such presubmissions or submissions for devices, and any appeals of action taken with respect to such presubmissions or submissions, including devices under the Public Health Service Act to be submitted solely in electronic format as specified by FDA in guidance (section 745A(b)(3) of the FD&C Act). III. Legal Authority FDA is issuing this proposed rule from the same authority under which FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360h-360j, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264, 271. In addition, section 745A of the FD&C Act and section 207 of FDARA provide FDA authority with respect to electronic format for submissions and any appeals, and section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act. IV. Description of the Proposed Rule We are proposing to revise FDA's regulations for devices to remove the requirements for multiple copies of submissions and to instead require one electronic version. The affected submissions include premarket notification submissions (510(k) submissions) (21 CFR 807.90), including confidentiality of information certification (21 CFR 807.95); investigational device exemption applications (21 CFR 812.20); premarket approval applications (PMA) (21 CFR 814.20), including PMA supplements (21 CFR 814.39); and humanitarian device exemption applications (21 CFR 814.104). This proposed rule also affects submissions for Center for Biologics Evaluation and Research (CBER) regulated devices. Another amendment that the proposed rule will make, if finalized, is to the sections of the regulations that identify FDA's mailing addresses for submissions. Current regulations include specific mailing addresses for submissions. If a mailing address needs to be updated, this necessitates an amendment to the regulations to update that address. A simpler and more efficient means of providing current mailing addresses is to create a website that can list current mailing addresses. Any changes to mailing addresses can be added to the website without the need for an amendment to the regulations. This proposed rule will amend the regulations to remove the mailing addresses for submissions and replace those addresses with a website address for the Center for Devices and Radiological Health (CDRH) and CBER. The submission of an eCopy is separate and distinct from FDA's electronic submission programs (eSubmitter), which include the Electronic Submission Gateway (ESG) and CDRH's 510(k) eSubmissions Pilot Program (79 FR 24732, May 1, 2014). Nevertheless, FDA considers both to be submissions in electronic format. While eCopy provides for submissions to be in electronic format, the eCopy submissions must still be mailed to FDA. By contrast, eSubmitter allows for electronic submissions to be transmitted over the internet. FDA has been moving toward transforming all regulatory submissions from mailed copies to electronic means via the internet. Since January 1999, FDA has accepted voluntary electronic submissions through eSubmitter. FDA presently utilizes the ESG for the receipt and processing of many types of electronic regulatory submissions (Ref. 2). FDA considers eCopies, submissions copied to a CD, DVD, or flash drive and mailed to FDA, and eSubmissions, to be submissions in electronic format. These changes are intended to improve the efficiency of the review process by allowing immediate availability of an electronic version for review, rather than relying solely on the paper version. Because a submission in electronic format is easily reproducible, the requirement for multiple copies (whether in electronic format or paper form) is no longer necessary. Furthermore, FDA believes it is beneficial to the public to limit any burdens and expenses to submitters caused by requiring additional copies. FDA is proposing to amend current medical device regulations that require multiple copies and paper submissions [[Page 46446]] (21 CFR parts 807, 812, and 814). FDA is taking this action because the requirement for multiple copies (whether in electronic format or paper form) listed in the regulation is no longer necessary, and it is beneficial to the public to limit any burden and expense to submitters caused by requiring additional copies. V. Proposed Effective Date FDA is proposing that any final rule based on this proposal become effective 30 days after the date of publication of a final rule in the Federal Register. VI. Economic Analysis of Impacts We have examined the impacts of the proposed rule under E.O. 12866, E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601- 612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). E.O. 13771 requires that the costs associated with significant new regulations ``shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.'' We believe that this proposed rule is not a significant regulatory action as defined by E.O. 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule amends the existing premarket regulations requiring multiple copies and paper submissions to electronic format submissions without imposing any new requirements, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandate's Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ``any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount. The purpose of this proposed rule is to amend device regulations requiring that firms submit a specific number of copies with a premarket presubmission or submission to a single submission in electronic form. The proposed rule also amends all device regulations containing references to submission media (i.e., paper copies) to a submission in electronic form. The amendment will produce cost savings for firms without imposing any additional regulatory burdens for submissions. Firms will incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits. We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 3) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. Summary of Costs and Benefits The proposed rule, if finalized, would amend device regulations requiring the number of copies firms must submit with a premarket presubmission or submission. The proposed rule would also amend all device regulations containing a reference to the specific form of a submission to require an electronic submission. The amendment would produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency's ability to review submissions. Firms would incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits. Table 1 summarizes the benefits, costs, and distributional effects of the proposed rule. We find that the proposed rule would result in annualized net benefits in the form of cost savings of around $2.80 million with a 3 percent discount rate and $2.71 million with a 7 percent discount rate. Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule -------------------------------------------------------------------------------------------------------------------------------------------------------- Units Category Primary Low estimate High estimate ------------------------------------------------ Notes estimate Year dollars Discount rate Period covered -------------------------------------------------------------------------------------------------------------------------------------------------------- Benefits: Annualized.................... $3.37 $1.31 $5.47 2016 7% 10 years Benefits are cost savings. Monetized $millions/year...... $3.37 $1.31 $5.47 2016 3% 10 years Benefits are cost savings. Annualized.................... .............. .............. .............. .............. 7% .............. .................... Quantified.................... .............. .............. .............. .............. 3% .............. .................... Qualitative................... .............. .............. .............. .............. .............. .............. .................... Costs: Annualized.................... $0.67 $0.67 $0.67 2016 7% 10 years .................... Monetized $millions/year...... $0.57 $0.57 $0.57 2016 3% 10 years .................... Annualized.................... .............. .............. .............. .............. 7% .............. .................... Quantified.................... .............. .............. .............. .............. 3% .............. .................... Qualitative................... .............. .............. .............. .............. .............. .............. .................... Transfers: Federal Annualized............ .............. .............. .............. .............. 7% .............. .................... Monetized $millions/year...... .............. .............. .............. .............. 3% .............. .................... --------------------------------------------------------------------------------------------------------------------- [[Page 46447]] From/To....................... From: To: --------------------------------------------------------------------------------------------------------------------- Other Annualized.............. .............. .............. .............. .............. 7% .............. .................... --------------------------------------------------------------------------------------------------------------------- Monetized $millions/year...... .............. .............. .............. .............. 3% .............. .................... From/To....................... From: To: -------------------------------------------------------------------------------------------------------------------------------------------------------- Table 2 summarizes the E.O. 13771 impacts of the proposed rule. Over an infinite time horizon, the present value of the total net costs would range from $40.01 million to $182.94 million at a 3 percent discount rate and from $15.04 million to $78.67 million at a 7 percent discount rate. Over an infinite time horizon, the total annualized net costs would range from $1.17 million to $5.33 million at a 3 percent discount rate, and range from $0.98 million to $5.15 million at a 7 percent discount rate. This proposed rule, if finalized, is considered an Executive Order 13771 deregulatory action. Table 2--Summary of the Executive Order 13771 Impacts of the Proposed Rule Over an Infinite Time Horizon [2016 $ millions] -------------------------------------------------------------------------------------------------------------------------------------------------------- Primary Lower bound Upper bound Primary Lower bound Upper bound estimate (3%) (3%) (3%) estimate (7%) (7%) (7%) -------------------------------------------------------------------------------------------------------------------------------------------------------- Present Value of Costs.................................. $5.01 $5.01 $5.01 $5.01 $5.01 $5.01 Present Value of Cost Savings........................... 115.79 45.02 187.95 51.55 20.04 83.68 Present Value of Net Costs.............................. (110.78) (40.01) (182.94) (46.54) (15.04) (78.67) Annualized Costs........................................ 0.15 0.15 0.15 0.33 0.33 0.33 Annualized Cost Savings................................. 3.37 1.31 5.47 3.37 1.31 5.47 Annualized Net Costs.................................... (3.23) (1.17) (5.33) (3.04) (0.98) (5.15) -------------------------------------------------------------------------------------------------------------------------------------------------------- Note: Values in parentheses denote net negative costs (i.e. cost-savings). VII. Analysis of Environmental Impact We have determined under 21 CFR 25.30(h) and 25.34(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VIII. Paperwork Reduction Act of 1995 FDA tentatively concludes that this proposed rule contains no collection of information subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995. Rather, it proposes to remove requirements to submit multiple paper copies of certain medical device presubmissions and submissions and to replace them with one copy in an electronic format. IX. Federalism We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the E.O. and, consequently, a federalism summary impact statement is not required. X. Consultation and Coordination With Indian Tribal Governments We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action. XI. References The following references are on display at Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. ``eCopy Program for Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff'' available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf. 2. Electronic Submission Gateway procedure for electronic regulatory submission is available at: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 3. Preliminary economic impacts analysis for this proposed rule available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. [[Page 46448]] List of Subjects 21 CFR Part 807 Confidential business information, Imports, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 812 Health records, Medical devices, Medical research, Reporting and recordkeeping requirements. 21 CFR Part 814 Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 807, 812, and 814 are proposed to be amended as follows: PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 0 1. The authority citation for part 807 is revised to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271. 0 2. In Sec. 807.90, revise paragraph (a), remove and reserve paragraph (b), and revise paragraph (c). The revisions read as follows: Sec. 807.90 Format of a premarket notification submission. * * * * * (a)(1) For devices regulated by the Center for Devices and Radiological Health, be addressed to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress. (2) For devices regulated by the Center for Biologics Evaluation and Research, be addressed to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices regulated by the Center for Drug Evaluation and Research, be addressed to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. Information about devices regulated by the Center for Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm. (3) All inquiries regarding a premarket notification submission should be sent the address in this section or one of the current addresses displayed on the Food and Drug Administration's website. * * * * * (c) Be submitted as a single version in electronic format. * * * * * 0 3. Amend Sec. 807.95 by revising paragraph (b)(1) introductory text to read as follows: Sec. 807.95 Confidentiality of information. * * * * * (b) * * * (1) The person submitting the premarket notification submission requests in the submission that the Food and Drug Administration hold as confidential commercial information the intent to market the device and submits a certification to the Commissioner: * * * * * PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS 0 4. The authority citation for part 812 is revised to read as follows: Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n. 0 5. Amend Sec. 812.19 by revising paragraphs (a)(1) and (2) to read as follows: Sec. 812.19 Addresses for IDE correspondence. (a) * * * (1) For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress. (2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm. * * * * * 0 6. Amend Sec. 812.20 by revising paragraph (a)(3) to read as follows: Sec. 812.20 Application. (a) * * * (3) A sponsor shall submit a signed ``Application for an Investigational Device Exemption'' (IDE application), together with accompanying materials in electronic format, to one of the addresses in Sec. 812.19, and if eCopy by registered mail or by hand. Subsequent correspondence concerning an application or a supplemental application shall be submitted in electronic format and if eCopy by registered mail or by hand. * * * * * PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES 0 7. The authority citation for part 814 is revised to read as follows: Authority: 21 U.S.C. 351, 352, 353, 360, 360bbb-8b, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 379k-1, 381. 0 8. Amend Sec. 814.20 by: 0 a. Revising paragraph (b) introductory text and paragraph (b)(2); 0 b. Removing the phrase ``of the act'' and adding in its place ``of the Federal Food, Drug, and Cosmetic Act'' in paragraphs (b)(5) introductory text, (b)(5)(i), and (b)(10); 0 c. Revising paragraph (c); 0 d. Revising paragraph (e) introductory text; and 0 e. Revising paragraphs (f) and (h)(1) and (2). The revisions read as follows: Sec. 814.20 Application. * * * * * (b) Unless the applicant justifies an omission in accordance with paragraph (d) of this section, a PMA shall include in electronic format: * * * * * (2) A table of contents that specifies the volume and page number for each item referred to in the table. A PMA shall include separate sections on nonclinical laboratory studies and on clinical investigations involving human subjects. A PMA shall be submitted as a single version. The applicant shall include information that it believes to be trade secret or confidential commercial or financial information in the PMA and identify the information that it believes to be trade secret or confidential commercial or financial information. * * * * * (c) Pertinent information in FDA files specifically referred to by an applicant may be incorporated into a PMA by reference. Information in a master file or other information submitted to FDA by a person other than the applicant will not be considered part of a PMA unless such reference is authorized in a record submitted to FDA by the person who submitted the information or the master file. If a master file is not referenced within 5 years after the date that it is submitted to FDA, FDA will return the master file to the person who submitted it. * * * * * (e) The applicant shall periodically update its pending application with [[Page 46449]] new safety and effectiveness information learned about the device from ongoing or completed studies that may reasonably affect an evaluation of the safety or effectiveness of the device or that may reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the draft labeling. The update report shall be consistent with the data reporting provisions of the protocol. The applicant shall submit any update report in electronic format and shall include in the report the number assigned by FDA to the PMA. These updates are considered to be amendments to the PMA. The time frame for review of a PMA will not be extended due to the submission of an update report unless the update is a major amendment under Sec. 814.37(c)(1). The applicant shall submit these reports-- * * * * * (f) If a color additive subject to section 721 of the Federal Food, Drug, and Cosmetic Act is used in or on the device and has not previously been listed for such use, then, in lieu of submitting a color additive petition under part 71 of this chapter, at the option of the applicant, the information required to be submitted under part 71 may be submitted as part of the PMA. When submitted as part of the PMA, the information shall be submitted in electronic format. A PMA for a device that contains a color additive that is subject to section 721 of the Federal Food, Drug, and Cosmetic Act will not be approved until the color additive is listed for use in or on the device. * * * * * (h) * * * (1) For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website http://www.fda.gov/cdrhsubmissionaddress. (2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm. * * * * * 0 9. Amend Sec. 814.39 by revising paragraph (c)(1) to read as follows: Sec. 814.39 PMA supplements. * * * * * (c)(1) All procedures and actions that apply to an application under Sec. 814.20 also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change. A summary under Sec. 814.20(b)(3) is required for only a supplement submitted for new indications for use of the device, significant changes in the performance or design specifications, circuits, components, ingredients, principles of operation, or physical layout of the device, or when otherwise required by FDA. The applicant shall submit a PMA supplement in electronic format and shall include information relevant to the proposed changes in the device. A PMA supplement shall include a separate section that identifies each change for which approval is being requested and explains the reason for each such change. The applicant shall submit additional information, if requested by FDA, in electronic format. The time frames for review of, and FDA action on, a PMA supplement are the same as those provided in Sec. 814.40 for a PMA. * * * * * 0 10. Amend Sec. 814.104 by revising paragraphs (d) introductory text and (d)(1) and (2) to read as follows: Sec. 814.104 Original applications. * * * * * (d) Address for submissions and correspondence. All original HDEs, amendments and supplements, as well as any correspondence relating to an HDE, must be provided in electronic format. These materials must be sent or delivered to one of the following: (1) For devices regulated by the Center for Devices and Radiological Health, send it to the current address found on the website https://www.fda.gov/cdrhsubmissionaddress. (2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm. * * * * * Dated: September 7, 2018. Scott Gottlieb, Commissioner of Food and Drugs. [FR Doc. 2018-19865 Filed 9-12-18; 8:45 am] BILLING CODE 4164-01-P
![46444 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules
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Food and Drug Administration comment will be made public, you are redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
21 CFR Parts 807, 812, and 814 comment does not include any https://www.regulations.gov. Submit
[Docket No. FDA–2018–N–0628]
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
RIN 0910–AH48 such as medical information, your or contact information to be made publicly
anyone else’s Social Security number, or available, you can provide this
Medical Device Submissions: confidential business information, such information on the cover sheet and not
Amending Premarket Regulations That as a manufacturing process. Please note in the body of your comments and you
Require Multiple Copies and Specify that if you include your name, contact must identify this information as
Paper Copies To Be Allowed in information, or other information that ‘‘confidential.’’ Any information marked
Electronic Format identifies you in the body of your as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, comments, that information will be except in accordance with 21 CFR 10.20
HHS. posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment more information about FDA’s posting
ACTION: Proposed rule. with confidential information that you of comments to public dockets, see 80
SUMMARY: The Food and Drug do not wish to be made available to the FR 56469, September 18, 2015, or access
Administration (FDA, Agency, or we) is public, submit the comment as a the information at: https://www.gpo.gov/
proposing to amend requirements for written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
medical device premarket submissions manner detailed (see ‘‘Written/Paper 23389.pdf.
to remove paper and multiple copies Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
and replace them with requirements for read background documents or the
Written/Paper Submissions
a single submission in electronic format. electronic and written/paper comments
Submit written/paper submissions as received, go to https://
If finalized, this action would reduce
follows: www.regulations.gov and insert the
the number of copies in electronic • Mail/Hand delivery/Courier (for
format required, thus improving and docket number, found in brackets in the
written/paper submissions): Dockets heading of this document, into the
making more efficient the FDA’s Management Staff (HFA–305), Food and
premarket submission program for ‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers and/or go to the Dockets Management
medical devices. This action is part of Lane, Rm. 1061, Rockville, MD 20852.
FDA’s implementation of Executive Staff, 5630 Fishers Lane, Rm. 1061,
• For written/paper comments Rockville, MD 20852.
Orders (EOs) 13771 and 13777. Under submitted to the Dockets Management
these EOs, FDA is comprehensively FOR FURTHER INFORMATION CONTACT:
Staff, FDA will post your comment, as Diane Garcia, Center for Devices and
reviewing existing regulations to well as any attachments, except for
identify opportunities for repeal, Radiological Health, Food and Drug
information submitted, marked and Administration, 10903 New Hampshire
replacement, or modification that will identified, as confidential, if submitted
result in meaningful burden reduction Ave., Bldg. 66, Rm. 5424, Silver Spring,
as detailed in ‘‘Instructions.’’ MD 20993, 301–796–6559, email:
while allowing the Agency to achieve Instructions: All submissions received
our public health mission and fulfill Diane.Garcia@fda.hhs.gov.
must include the Docket No. FDA–
statutory obligations. SUPPLEMENTARY INFORMATION:
2018–N–0628 for ‘‘Medical Device
DATES: Submit either electronic or Submissions: Amending Premarket Table of Contents
written comments on this proposed rule Regulations that Require Multiple I. Executive Summary
by December 12, 2018. Copies and Specify Paper Copies to be II. Background
ADDRESSES: You may submit comments Allowed in Electronic Format.’’ III. Legal Authority
as follows. Please note that late, Received comments, those filed in a IV. Description of the Proposed Rule
untimely filed comments will not be timely manner (see ADDRESSES), will be V. Proposed Effective Date
considered. Electronic comments must placed in the docket and, except for VI. Economic Analysis of Impacts
be submitted on or before December 12, those submitted as ‘‘Confidential VII. Analysis of Environmental Impact
Submissions,’’ publicly viewable at VIII. Paperwork Reduction Act of 1995
2018. The https://www.regulations.gov IX. Federalism
electronic filing system will accept https://www.regulations.gov or at the X. Consultation and Coordination with
comments until midnight Eastern Time Dockets Management Staff between 9 Indian Tribal Governments
at the end of December 12, 2018. a.m. and 4 p.m., Monday through XI. References
Comments received by mail/hand Friday.
• Confidential Submissions—To I. Executive Summary
delivery/courier (for written/paper
submissions) will be considered timely submit a comment with confidential This proposed rule would amend
if they are postmarked or the delivery information that you do not wish to be regulations on medical device
service acceptance receipt is on or made publicly available, submit your premarket submissions to remove
before that date. comments only as a written/paper requirements for paper and multiple
daltland on DSKBBV9HB2PROD with PROPOSALS
submission. You should submit two copies and replace them with
Electronic Submissions copies total. One copy will include the requirements for a single submission in
Submit electronic comments in the information you claim to be confidential electronic format to improve the FDA’s
following way: with a heading or cover note that states premarket submission program for
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS medical devices and to create a more
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The efficient submission program. Because a
instructions for submitting comments. Agency will review this copy, including medical device premarket submission in
Comments submitted electronically, the claimed confidential information, in electronic format is easily reproducible,
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![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46447
TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE—Continued
Units
Primary
Category Low estimate High estimate Notes
estimate Period
Year dollars Discount rate covered
From/To ................ From: To:
Other Annualized ........................ ........................ ........................ ........................ 7% ........................
Monetized ........................ ........................ ........................ ........................ 3% ........................
$millions/year.
From/To ................ From: To:
Table 2 summarizes the E.O. 13771 million to $78.67 million at a 7 percent million at a 7 percent discount rate.
impacts of the proposed rule. Over an discount rate. Over an infinite time This proposed rule, if finalized, is
infinite time horizon, the present value horizon, the total annualized net costs considered an Executive Order 13771
of the total net costs would range from would range from $1.17 million to $5.33 deregulatory action.
$40.01 million to $182.94 million at a 3 million at a 3 percent discount rate, and
percent discount rate and from $15.04 range from $0.98 million to $5.15
TABLE 2—SUMMARY OF THE EXECUTIVE ORDER 13771 IMPACTS OF THE PROPOSED RULE OVER AN INFINITE TIME
HORIZON
[2016 $ millions]
Primary Primary
Lower bound Upper bound Lower bound Upper bound
estimate estimate
(3%) (3%) (7%) (7%)
(3%) (7%)
Present Value of Costs ............................ $5.01 $5.01 $5.01 $5.01 $5.01 $5.01
Present Value of Cost Savings ................ 115.79 45.02 187.95 51.55 20.04 83.68
Present Value of Net Costs ..................... (110.78) (40.01) (182.94) (46.54) (15.04) (78.67)
Annualized Costs ..................................... 0.15 0.15 0.15 0.33 0.33 0.33
Annualized Cost Savings ......................... 3.37 1.31 5.47 3.37 1.31 5.47
Annualized Net Costs .............................. (3.23) (1.17) (5.33) (3.04) (0.98) (5.15)
Note: Values in parentheses denote net negative costs (i.e. cost-savings).
VII. Analysis of Environmental Impact on the relationship between the XI. References
National Government and the States, or
We have determined under 21 CFR The following references are on
25.30(h) and 25.34(a) that this action is on the distribution of power and
responsibilities among the various display at Dockets Management Staff
of a type that does not individually or (see ADDRESSES) and are available for
cumulatively have a significant effect on levels of government. Accordingly, we
viewing by interested persons between
the human environment. Therefore, conclude that the rule does not contain
9 a.m. and 4 p.m., Monday through
neither an environmental assessment policies that have federalism
Friday; they are also available
nor an environmental impact statement implications as defined in the E.O. and, electronically at https://
is required. consequently, a federalism summary www.regulations.gov. FDA has verified
impact statement is not required. the website addresses, as of the date this
VIII. Paperwork Reduction Act of 1995
X. Consultation and Coordination With document publishes in the Federal
FDA tentatively concludes that this Register, but websites are subject to
Indian Tribal Governments
proposed rule contains no collection of change over time.
information subject to review by the We have analyzed this proposed rule
Office of Management and Budget under 1. ‘‘eCopy Program for Medical Device
in accordance with the principles set Submissions; Guidance for Industry and
the Paperwork Reduction Act of 1995. forth in E.O. 13175. We have Food and Drug Administration Staff’’
Rather, it proposes to remove determined that the rule does not available at: https://www.fda.gov/
requirements to submit multiple paper contain policies that would have a downloads/MedicalDevices/
copies of certain medical device substantial direct effect on one or more DeviceRegulationandGuidance/
presubmissions and submissions and to GuidanceDocuments/UCM313794.pdf.
Indian Tribes, on the relationship
replace them with one copy in an 2. Electronic Submission Gateway procedure
between the Federal Government and
electronic format. for electronic regulatory submission is
Indian Tribes, or on the distribution of
daltland on DSKBBV9HB2PROD with PROPOSALS
IX. Federalism power and responsibilities between the available at: https://www.fda.gov/
ForIndustry/ElectronicSubmissions
We have analyzed this proposed rule Federal Government and Indian Tribes.
Gateway/default.htm.
in accordance with the principles set The Agency solicits comments from
3. Preliminary economic impacts analysis for
forth in E.O. 13132. We have tribal officials on any potential impact this proposed rule available at: https://
determined that this proposed rule does on Indian Tribes from this proposed www.fda.gov/AboutFDA/
not contain policies that have action. ReportsManualsForms/Reports/
substantial direct effects on the States, EconomicAnalyses/default.htm.
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![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 46449
new safety and effectiveness § 814.20(b)(3) is required for only a DEPARTMENT OF HOMELAND
information learned about the device supplement submitted for new SECURITY
from ongoing or completed studies that indications for use of the device,
may reasonably affect an evaluation of significant changes in the performance Coast Guard
the safety or effectiveness of the device or design specifications, circuits,
or that may reasonably affect the components, ingredients, principles of 33 CFR Part 165
statement of contraindications, operation, or physical layout of the [Docket Number USCG–2018–0713]
warnings, precautions, and adverse device, or when otherwise required by
reactions in the draft labeling. The RIN 1625–AA00
FDA. The applicant shall submit a PMA
update report shall be consistent with supplement in electronic format and
the data reporting provisions of the Safety Zone; Chicago Harbor, Navy
shall include information relevant to the Pier Southeast, Chicago, IL
protocol. The applicant shall submit any proposed changes in the device. A PMA
update report in electronic format and AGENCY: Coast Guard, DHS.
supplement shall include a separate
shall include in the report the number ACTION: Notice of proposed rulemaking.
section that identifies each change for
assigned by FDA to the PMA. These
updates are considered to be which approval is being requested and
SUMMARY: The Coast Guard proposes to
amendments to the PMA. The time explains the reason for each such reduce the size of the Navy Pier
frame for review of a PMA will not be change. The applicant shall submit Southeast Safety Zone within the
extended due to the submission of an additional information, if requested by Chicago Harbor. This action is necessary
update report unless the update is a FDA, in electronic format. The time to alleviate congestion near the Chicago
major amendment under § 814.37(c)(1). frames for review of, and FDA action on, Lock during regularly scheduled
The applicant shall submit these a PMA supplement are the same as fireworks events. The current safety
reports— those provided in § 814.40 for a PMA. zone encompasses part of the lock
* * * * * * * * * * restricting vessels during events. This
(f) If a color additive subject to section ■ 10. Amend § 814.104 by revising
proposed rulemaking would still
721 of the Federal Food, Drug, and prohibit persons and vessels from
paragraphs (d) introductory text and
Cosmetic Act is used in or on the device entering the safety zone, but would
(d)(1) and (2) to read as follows:
and has not previously been listed for allow the lock to remain in full
such use, then, in lieu of submitting a § 814.104 Original applications. operation during the fireworks display.
color additive petition under part 71 of We invite your comments on this
* * * * *
this chapter, at the option of the proposed rulemaking.
applicant, the information required to (d) Address for submissions and DATES: Comments and related material
be submitted under part 71 may be correspondence. All original HDEs, must be received by the Coast Guard on
submitted as part of the PMA. When amendments and supplements, as well or before October 15, 2018.
submitted as part of the PMA, the as any correspondence relating to an ADDRESSES: You may submit comments
information shall be submitted in HDE, must be provided in electronic identified by docket number USCG–
electronic format. A PMA for a device format. These materials must be sent or 2018–0713 using the Federal
that contains a color additive that is delivered to one of the following: eRulemaking Portal at http://
subject to section 721 of the Federal (1) For devices regulated by the www.regulations.gov. See the ‘‘Public
Food, Drug, and Cosmetic Act will not Center for Devices and Radiological Participation and Request for
be approved until the color additive is Health, send it to the current address Comments’’ portion of the
listed for use in or on the device. found on the website https:// SUPPLEMENTARY INFORMATION section for
* * * * * www.fda.gov/cdrhsubmissionaddress. further instructions on submitting
(h) * * * comments.
(1) For devices regulated by the (2) For devices regulated by the
Center for Biologics Evaluation and FOR FURTHER INFORMATION CONTACT: If
Center for Devices and Radiological
Research, send it to the current address you have questions about this rule, call
Health, send it to the current address
displayed on the website https:// or email LT John Ramos, Waterways
displayed on the website http://
www.fda.gov/AboutFDA/CentersOffices/ Management Division, Marine Safety
www.fda.gov/cdrhsubmissionaddress.
OfficeofMedicalProductsandTobacco/ Unit Chicago, U.S. Coast Guard;
(2) For devices regulated by the
CBER/ucm385240.htm. telephone (630) 986–2155, email D09-
Center for Biologics Evaluation and
DG-MSUChicago-Waterways@uscg.mil.
Research, send it to the current address * * * * *
displayed on the website https:// SUPPLEMENTARY INFORMATION:
Dated: September 7, 2018.
www.fda.gov/AboutFDA/CentersOffices/ I. Table of Abbreviations
OfficeofMedicalProductsandTobacco/ Scott Gottlieb,
Commissioner of Food and Drugs. CFR Code of Federal Regulations
CBER/ucm385240.htm.
DHS Department of Homeland Security
* * * * * [FR Doc. 2018–19865 Filed 9–12–18; 8:45 am]
FR Federal Register
■ 9. Amend § 814.39 by revising BILLING CODE 4164–01–P NPRM Notice of proposed rulemaking
paragraph (c)(1) to read as follows: § Section
U.S.C. United States Code
daltland on DSKBBV9HB2PROD with PROPOSALS
§ 814.39 PMA supplements.
* * * * * II. Background, Purpose, and Legal
(c)(1) All procedures and actions that Basis
apply to an application under § 814.20 The Coast Guard regularly enforces
also apply to PMA supplements except the Safety Zone; Chicago Harbor, Navy
that the information required in a Pier Southeast, Chicago, IL listed in 33
supplement is limited to that needed to CFR 165.931 for weekly fireworks
support the change. A summary under events during the boating season. The
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Document Created: 2018-09-13 01:01:13
Document Modified: 2018-09-13 01:01:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Submit either electronic or written comments on this proposed rule by December 12, 2018. | |
| Contact | Diane Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993, 301-796-6559, email: [email protected] | |
| FR Citation | 83 FR 46444 | |
| RIN Number | 0910-AH48 | |
| CFR Citation | 21
CFR
807 21 CFR 812 21 CFR 814 | |
| CFR Associated | Confidential Business Information; Imports; Medical Devices; Reporting and Recordkeeping Requirements; Health Records; Medical Research and Administrative Practice and Procedure |
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