46444 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

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.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. 

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: 

Diane.Garcia@fda.hhs.gov. 

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, 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 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.gpo.gov/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 


daltland on DSKBBV9HB2PROD with PROPOSALS
46446 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

(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

Category Primary 

estimate Low estimate High estimate 

Units 

Notes 

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% ........................


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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 

Category Primary 

estimate Low estimate High estimate 

Units 

Notes 

Year dollars Discount rate Period 

covered 

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 

estimate 

(3%) 

Lower bound 

(3%) 

Upper bound 

(3%) 

Primary 

estimate 

(7%) 

Lower bound 

(7%) 

Upper bound 

(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/ElectronicSubmissions

Gateway/default.htm. 

3. Preliminary economic impacts analysis for 

this proposed rule available at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/Reports/ 

EconomicAnalyses/default.htm. 


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46448 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 

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 

■ 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. 

■ 2. In § 807.90, revise paragraph (a), 

remove and reserve paragraph (b), and 

revise paragraph (c). 

The revisions read as follows: 

§ 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/cdrhsubmission

address. 

(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/OfficeofMedicalProducts

andTobacco/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. 

* * * * * 

■ 3. Amend § 807.95 by revising 

paragraph (b)(1) introductory text to 

read as follows: 

§ 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 

■ 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. 

■ 5. Amend § 812.19 by revising 

paragraphs (a)(1) and (2) to read as 

follows: 

§ 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. 

* * * * * 

■ 6. Amend § 812.20 by revising 

paragraph (a)(3) to read as follows: 

§ 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 § 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 

■ 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. 

■ 8. Amend § 814.20 by: 

■ a. Revising paragraph (b) introductory 

text and paragraph (b)(2); 

■ 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); 

■ c. Revising paragraph (c); 

■ d. Revising paragraph (e) introductory 

text; and 

■ e. Revising paragraphs (f) and (h)(1) 

and (2). 

The revisions read as follows: 

§ 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 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Proposed Rules 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 § 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. 

* * * * * 

■ 9. Amend § 814.39 by revising 

paragraph (c)(1) to read as follows: 

§ 814.39 PMA supplements. 

* * * * * 

(c)(1) All procedures and actions that 

apply to an application under § 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 

§ 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 § 814.40 for a PMA. 

* * * * * 

■ 10. Amend § 814.104 by revising 

paragraphs (d) introductory text and 

(d)(1) and (2) to read as follows: 

§ 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0713] 

RIN 1625–AA00 

Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

reduce the size of the Navy Pier 

Southeast Safety Zone within the 

Chicago Harbor. This action is necessary 

to alleviate congestion near the Chicago 

Lock during regularly scheduled 

fireworks events. The current safety 

zone encompasses part of the lock 

restricting vessels during events. This 

proposed rulemaking would still 

prohibit persons and vessels from 

entering the safety zone, but would 

allow the lock to remain in full 

operation during the fireworks display. 

We invite your comments on this 

proposed rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before October 15, 2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2018–0713 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email LT John Ramos, Waterways 

Management Division, Marine Safety 

Unit Chicago, U.S. Coast Guard; 

telephone (630) 986–2155, email D09- 

DG-MSUChicago-Waterways@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background, Purpose, and Legal 

Basis 

The Coast Guard regularly enforces 

the Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL listed in 33 

CFR 165.931 for weekly fireworks 

events during the boating season. The 


daltland on DSKBBV9HB2PROD with PROPOSALS