2388 Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 10 and 800 

[Docket No. FDA–2016–N–2378] 

RIN 0910–AH37 

Internal Agency Review of Decisions; 

Requests for Supervisory Review of 

Certain Decisions Made by the Center 

for Devices and Radiological Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

implement regulations regarding 

internal agency supervisory review of 

certain decisions related to devices 

regulated by the Center for Devices and 

Radiological Health (CDRH) under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to conform to the applicable 

provisions in the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) and the 21st Century 

Cures Act (Cures Act). FDA is taking 

this action to codify the procedures and 

timeframes for supervisory review of 

significant decisions pertaining to 

devices within CDRH. FDA is also 

proposing regulations to provide new 

procedural requirements for requesting 

internal agency supervisory review 

within CDRH of other types of decisions 

made by CDRH not addressed in 

FDASIA and the Cures Act. This action 

is also 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 its public health mission and 

fulfill statutory obligations. 

DATES: Submit either electronic or 

written comments by April 17, 2018. 

See section V of this document for the 

proposed effective date of a final rule 

that may issue based on this proposal. 

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 April 17, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of April 17, 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 Rulemaking 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 Docket No. FDA–2016–N– 

2378 for ‘‘Internal Agency Review of 

Decisions; Requests for Supervisory 

Review of Certain Decisions Made by 

the Center for Devices and Radiological 

Health.’’ 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: 

Adaeze Teme, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5574, Silver Spring, 

MD 20993–0002, 240–402–0768; or the 

Ombudsman for the Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4282, Silver Springs, 

MD 20993–0002, 301–796–5669, or 

CDRHOmbudsman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Purpose of the Proposed Rule 

The purpose of this proposed rule is 

to implement regulations on the 

procedures regarding internal agency 

supervisory review of certain decisions 

made by CDRH under the FD&C Act. 

Section 603 of FDASIA added new 

section 517A to the FD&C Act (21 U.S.C. 

360g–1), which was amended by 


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sections 3051 and 3058 of the Cures Act. 

These provisions established procedures 

and timeframes for supervisory review 

under § 10.75 (21 CFR 10.75) of 

significant decisions by CDRH 

pertaining to devices. After the 

enactment of FDASIA, FDA issued a 

guidance document entitled ‘‘Center for 

Devices and Radiological Health 

Appeals Processes: Questions and 

Answers About 517A—Guidance for 

Industry and Food and Drug 

Administration Staff’’ (Q&A Guidance) 

to provide interpretation of key 

provisions of section 517A, including 

those that pertain to requests for 

supervisory review of significant 

decisions by CDRH (Ref. 1). FDA is 

proposing this regulation to codify (1) 

the procedures and timeframes for 

§ 10.75 appeals of ‘‘significant 

decisions’’ by CDRH established under 

section 517A and (2) the interpretation 

of key provisions of section 517A of the 

FD&C Act regarding supervisory review. 

In addition, the proposed regulations 

would introduce new procedural 

requirements for supervisory review 

within CDRH of other CDRH decisions 

that were not addressed in FDASIA and 

the Cures Act. 

The proposed regulations will provide 

transparency and clarity for internal and 

external stakeholders on CDRH’s 

process for supervisory review of 

decisions and will give requesters new 

predictability through binding deadlines 

for FDA action on a request for 

supervisory review within CDRH and 

the Center’s internal agency review of 

‘‘significant decisions.’’ Furthermore, 

this proposal, when finalized, will 

codify the types of decisions that are 

considered ‘‘significant decisions,’’ for 

which the timeframes apply. The 

proposed regulations will also codify 

the timeframe for submission of requests 

for the review of other decisions within 

CDRH. 

B. Summary of the Major Provisions of 

the Proposed Rule 

FDA proposes to amend part 10 (21 

CFR part 10) by adding § 10.75(e). 

Section 10.75 currently provides that an 

interested person outside the Agency 

may request internal agency review of a 

decision of an FDA employee. FDA 

proposes to amend § 10.75 to add 

paragraph (e), which would require that 

requests for internal agency supervisory 

review within CDRH of a decision also 

comply with proposed § 800.75 (21 CFR 

800.75). This proposed change to the 

regulations would encompass both 

significant decisions under section 

517A of the FD&C Act and other 

decisions by CDRH employees. 

The proposed rule would also add 

new § 800.75 to part 800 (21 CFR part 

800). Proposed § 800.75 would 

incorporate in the regulations the 

provisions of section 517A of the FD&C 

Act for review of ‘‘significant decisions’’ 

related to devices regulated under the 

FD&C Act by CDRH. Proposed § 800.75 

would define ‘‘significant decisions.’’ 

Section 800.75 would also include the 

timeframes for submission of requests 

for internal agency review of significant 

decisions within CDRH and for 

responses to such requests. 

Proposed § 800.75 would further 

address requests for supervisory review 

within CDRH of decisions other than 

section 517A decisions and would 

indicate the timeframe for submission of 

these requests for internal agency 

review. 

C. Legal Authority 

FDA’s legal authority to implement 

requirements pertaining to the process 

and timelines for § 10.75 appeals of 

decisions within CDRH derives from 

sections 510(k), 515, 515C, 517A, and 

520(g) of the FD&C Act (21 U.S.C. 

360(k), 360e, 360e–3, 360g–1, and 360j) 

and other provisions under which a 

decision might be appealed, and 701(a) 

of the FD&C Act (21 U.S.C. 371(a)). 

Section 701(a) of the FD&C Act gives 

FDA general rulemaking authority to 

issue regulations for the efficient 

enforcement of the FD&C Act. 

D. Costs and Benefits 

We expect the costs and benefits of 

the proposed rule to be negligible. 

II. Background 

A. Regulations on Internal Agency 

Review 

FDA has long provided a path for 

outside parties to request internal 

agency review of decisions. A procedure 

for this type of review was first 

published as a proposed regulation in 

1975 (40 FR 40682, September 3, 1975) 

(Ref. 2). In the preamble for the 

proposed rule, the Agency recognized 

that a process for administrative review 

of Agency decisions would advise 

outside parties how they should pursue 

matters that interest and concern them 

(40 FR 40682 at 40693). A final rule 

published in 1977 incorporated these 

provisions into the Code of Federal 

Regulations at 21 CFR 2.17 (42 FR 4680, 

January 25, 1977) (Ref. 3). 

These regulations provided that any 

decision of an FDA employee, other 

than the Commissioner, on any matter 

was subject to review by the employee’s 

supervisor under any of the following 

circumstances: (1) At the request of the 

employee, (2) on the initiative of the 

supervisor, (3) at the request of any 

interested person outside of the Agency, 

or (4) as required by duly promulgated 

delegations of authority. The review 

shall be accomplished by consultation 

between the employee and the 

supervisor, by review of the 

administrative file, or both. The review 

shall ordinarily follow established 

Agency channels of supervision. 

Internal agency review shall be based on 

the data and information available in 

the administrative file. If an interested 

person presents new data or information 

not contained in the administrative file, 

then the matter shall be returned to the 

appropriate lower level within the 

Agency for a reevaluation based upon 

the new information (§ 2.17 (1977)). 

The following year, in 1978, a 

proposed rule was published to 

reorganize and revise the Agency’s 

administrative practices and procedures 

regulations (43 FR 51966, November 7, 

1978) (Ref. 4). When the final rule for 

this action was published, the 

regulations for internal agency review 

were moved from § 2.17 and 

redesignated as § 10.75 (44 FR 22318, 

April 13, 1979) (Ref. 5), where these 

regulations remain today. 

In 1998, § 10.75 was amended to add 

provisions allowing a sponsor, 

applicant, or manufacturer of a drug or 

device to request review of a scientific 

controversy by an appropriate scientific 

advisory panel or advisory committee 

(63 FR 63978, November 18, 1998). 

Aside from the specific situation 

addressed by the amendment, the 

elements of internal agency review 

under § 10.75 relating to who may 

request the review and the information 

on which the review must be based 

remained unchanged. 

Section 10.75 contains regulations 

that establish an orderly process for 

internal agency review of decisions, 

based on information in the FDA 

administrative file. Section 10.75 

applies to requests for review of 

decisions made by any FDA employee, 

other than decisions by the 

Commissioner of Food and Drugs. 

Section 10.75 does not establish 

timelines for requests for Agency review 

or for the Agency to act upon these 

requests. The FDA guidance document 

entitled ‘‘Center for Devices and 

Radiological Health Appeals 

Processes—Guidance for Industry and 

Food and Drug Administration Staff’’ 

describes the § 10.75 appeal processes 

available to outside stakeholders to 

request review of decisions or actions by 

CDRH employees (Ref. 6). 


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B. Agency Documentation and Review 

of Significant Decisions Regarding 

Devices Under Section 517A of the 

Federal Food, Drug, and Cosmetic Act 

On July 9, 2012, the FD&C Act (21 

U.S.C. 301 et seq.) was amended by 

FDASIA. Section 603 of FDASIA added 

new section 517A to the FD&C Act, 

which specifies procedures and 

timeframes for the supervisory review of 

significant decisions pertaining to 

devices regulated by CDRH. 

On December 13, 2016, the FD&C Act 

(21. U.S.C. 301 et seq.) was further 

amended by the Cures Act. Section 3051 

of the Cures Act, ‘‘Breakthrough 

Devices,’’ added section 515C to the 

FD&C Act and amended section 

517A(a)(1) to include any significant 

decision by CDRH regarding a request 

for designation as a breakthrough device 

under section 515C. 

In addition, section 3058, ‘‘Least 

Burdensome Device Review,’’ of the 

Cures Act amended section 517A(a) by 

adding subsection (3), which requires 

that the substantive summary include a 

brief statement of how the least 

burdensome requirements were 

considered and applied consistent with 

sections 513(i)(1)(D), 513(a)(3)(D), and 

515(c)(5) of the FD&C Act, as applicable. 

Section 517A of the FD&C Act 

provides that any person may request a 

supervisory review of any significant 

decision of CDRH regarding the 

submission or review of a report under 

section 510(k), an application under 

section 515, a request for designation 

under section 515C, or an application 

for an exemption under section 520(g) of 

the FD&C Act. Any person may request 

such review, which may be conducted 

at the next supervisory level or higher 

above the individual who made the 

significant decision. Where the request 

for supervisory review was made at the 

organizational level, any person may 

request a supervisory review to the next 

organizational level or higher above the 

level at which the decision was made. 

In addition, the Office or Center Director 

may designate a Deputy Director to be 

their representative as the authority for 

a request made to that level. In this 

situation, a request for review heard by 

a Deputy is rendered on behalf of the 

Director and constitutes a review by that 

level of the organization (Ref. 6). 

Section 517A of the FD&C Act 

includes specific timeframes both for 

the person requesting review and for 

FDA to respond to such a request. A 

request for review of a significant 

decision is required to be submitted to 

FDA not later than 30 days after such 

decision. In responding to this request, 

if the requester seeks an in-person 

meeting or a teleconference review, FDA 

is required to schedule the requested 

interaction not later than 30 days after 

the request is made. FDA is required to 

issue a decision not later than 30 days 

after the interaction, or, in the case of a 

person who does not seek an in-person 

meeting or teleconference review, FDA 

is required to issue a decision no later 

than 45 days after the request for 

supervisory review is received by FDA. 

An exception to the timeframes related 

to scheduling an in-person meeting or 

teleconference review, and to FDA’s 

decision on a request for supervisory 

review of the significant decision, is 

provided in cases that are referred to 

experts outside of FDA. Although the 

procedures and timeframes in section 

517A of the FD&C Act apply to an initial 

request for supervisory review of a 

significant decision by CDRH, CDRH 

has chosen to enhance transparency and 

predictability and apply those 

procedures and timeframes as well to 

sequential requests for supervisory 

review of significant decisions that are 

submitted to CDRH. 

III. Legal Authority 

We are proposing to codify the 

procedures and timeframes in section 

517A of the FD&C Act, added by section 

603 of FDASIA and amended by the 

Cures Act, for § 10.75 appeals of 

‘‘significant decisions’’ regarding the 

submission or review of a report under 

section 510(k), an application under 

section 515, a request for designation 

under section 515C, or an application 

for an exemption under section 520(g) of 

the FD&C Act. 

We are also proposing additional 

procedural requirements for § 10.75 

appeals submitted to CDRH of other 

types of CDRH decisions not addressed 

in the FDASIA and the Cures Act. 

FDA’s legal authority to implement 

requirements pertaining to the process 

and timelines for § 10.75 appeals 

submitted to CDRH derives from 

sections 510(k), 515, 515C, 517A, and 

520(g) of the FD&C Act and other 

provisions under which a decision 

might be appealed, and 701(a) of the 

FD&C Act. Section 701(a) of the FD&C 

Act gives FDA general rulemaking 

authority to issue regulations for the 

efficient enforcement of the FD&C Act. 

IV. Description of the Proposed Rule 

The proposed rule would, if finalized, 

incorporate the procedures and 

timeframes in section 517A to an initial 

or sequential request for supervisory 

review within CDRH of ‘‘significant 

decisions’’ by CDRH into FDA’s 

regulations. The proposed regulations 

would also introduce new procedural 

requirements for requests for 

supervisory review within CDRH under 

§ 10.75 of decisions that do not fall 

under ‘‘significant decisions’’ under 

section 517A of the FD&C Act. 

FDA proposes to amend part 10 by 

adding § 10.75(e). Section 10.75 

currently provides that an interested 

person outside the Agency may request 

internal agency review of a decision of 

an FDA employee. FDA proposes to 

amend § 10.75 to add paragraph (e), 

which would require that requests for 

internal agency supervisory review 

within CDRH also comply with 

proposed § 800.75. This proposed 

change to the regulations would 

encompass both significant decisions 

under section 517A of the FD&C Act 

and other types of decisions. 

The proposed rule would add new 

§ 800.75 to part 800. Proposed § 800.75 

would incorporate, into the regulations, 

the provisions of section 517A of the 

FD&C Act for review of significant 

decisions related to devices regulated 

under the FD&C Act by CDRH. Proposed 

§ 800.75 would define ‘‘significant 

decisions.’’ Section 800.75 would also 

include the timeframes for submission 

of requests for internal agency review of 

significant decisions within CDRH and 

for responses to such requests. 

Proposed § 800.75 would further 

address the review of decisions other 

than 517A decisions and would indicate 

the timeframe for submission of these 

requests for internal agency review 

within CDRH. 

A. Proposed Revisions to § 10.75 

Part 10 would be amended to add 

§ 10.75(e). FDA proposes to add 

language to clarify that requests by 

interested persons outside the Agency 

for internal agency review of a decision 

within CDRH must also comply with 

proposed § 800.75. Proposed § 10.75(e) 

would not be limited to significant 

decisions under section 517A of the 

FD&C Act. Rather, proposed § 10.75(e) 

would also encompass review of 

decisions other than 517A decisions 

made by CDRH. 

B. Proposed § 800.75 

Section 517A of the FD&C Act 

establishes procedural requirements, 

including timeframes for a request for 

internal agency review of a ‘‘significant 

decision’’ by CDRH. ‘‘Significant 

decision’’ is not defined in the statutory 

provision. FDA is proposing to define 

‘‘significant decision,’’ to provide 

greater clarity regarding which 

decisions fall within this statutory term. 

A ‘‘517A decision’’ would be defined 

as a significant decision regarding a 

device as set forth in section 517A of the 


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FD&C Act. We are proposing to use the 

term ‘‘517A decision’’ rather than the 

term ‘‘significant decision’’ because we 

do not want to imply that all other 

decisions of the Agency that do not fall 

within section 517A of the FD&C Act 

are not significant. Similarly, we did not 

want to use the term ‘‘non-significant 

decision’’ when speaking of decisions 

outside of the scope of section 517A, as 

that might imply some unintended 

assessment on our part concerning the 

importance of these types of decisions. 

In addition, because we are proposing 

these regulations to include regulatory 

decisions by CDRH besides those set 

forth in section 517A, we wanted to 

avoid any confusion that might occur in 

distinguishing between these two 

categories of decisions. For these 

reasons, we instead are proposing to use 

the term ‘‘517A decision’’ for those 

decisions that are identified under 

section 517A as significant decisions, 

and to refer to other decisions by CDRH 

as ‘‘non-517A decisions.’’ 

The review procedures under section 

517A of the FD&C Act apply only to a 

request for review of a significant 

decision by CDRH regarding submission 

or review of a report under section 

510(k) (Premarket Notification), an 

application under section 515 

(Premarket Approval or ‘‘PMA’’/ 

Humanitarian Device Exemption or 

‘‘HDE’’), a request for designation under 

section 515C (Breakthrough Devices), or 

an application for an exemption under 

section 520(g) of the FD&C Act 

(Investigational Device Exemption or 

‘‘IDE’’). CDRH is proposing that only the 

following decisions be considered 

significant decisions under section 

517A of the FD&C Act and, thus, 

defined for purposes of this proposed 

rule as ‘‘517A decisions’’: 

• 510(k): Not substantially equivalent; 

Substantially equivalent. 

• PMA/HDE: Not approvable; 

Approvable; Approval; Denial. 

• Breakthrough Devices: Expedited 

access pathway (Ref. 7) program request 

for breakthrough designation for devices 

subject to premarket notification, 

premarket approval, or de novo 

requests. Grant; Denial of request for 

breakthrough designation. 

• IDE: Disapproval; Approval. 

• Failure to reach agreement on 

protocol under section 520(g)(7) of the 

FD&C Act. 

• ‘‘Clinical Hold’’ determinations 

under section 520(g)(8) of the FD&C Act. 

In proposing § 800.75, we are mindful 

that outside parties may use § 10.75 to 

request review of decisions other than 

517A decisions. For this reason, we are 

also proposing new procedural 

requirements for internal agency 

supervisory review within CDRH under 

§ 10.75 of non-517A decisions made by 

CDRH employees. A request for 

supervisory review of a CDRH decision 

other than a 517A decision is to be 

received no later than 60 days after the 

date of the decision that is subject to 

review. Any request received after 60 

days in these cases will be denied as 

untimely, unless CDRH, for good cause 

related to circumstances beyond the 

control of the submitter, such as snow 

emergency, Federal Government 

shutdown, or other unforeseen 

emergency event, permits the request to 

be filed after 60 days. 

Section 800.75 proposes that requests 

for CDRH review of 517A decisions and 

non-517A decisions must be addressed 

to the next organizational level or higher 

above the individual who made the 

decision. Requests to elevate the review 

of such decisions should include a 

rationale. The decision to collapse two 

or more levels of review or to elevate a 

review would solely be at CDRH’s 

discretion. In addition, requesters 

should have exhausted review through 

the supervisory chain below the Center 

Director level prior to request for review 

at the Center Director level. 

As provided in the FDA guidance, 

entitled ‘‘eCopy Program for Medical 

Device Submissions—Guidance for 

Industry and Food and Drug 

Administration Staff’’ (eCopy guidance), 

appeals to submission types identified 

under section 745A(b) of the FD&C Act 

are subject to the electronic format 

requirements. (Ref. 8). Therefore, 10.75 

requests for supervisory review of 517A 

decisions within CDRH, and certain 

decisions other than 517A decisions, 

must be submitted in accordance with 

section 745A(b) and the standards 

established by the eCopy guidance, 

when applicable. In addition, requests 

for breakthrough designation under 

section 515C of the FD&C Act for 

devices under sections 510(k), 513(f)(2), 

and 515(c) of the FD&C Act would be 

considered ‘‘presubmissions’’ to those 

submission types as identified under 

section 745A, and, therefore, requests 

for breakthrough designation would be 

subject to section 745A(b), and likewise, 

§ 10.75 requests for review within 

CDRH. 

Further, § 800.75 proposes that 

requests for supervisory review of CDRH 

decisions other than 517A decisions 

must be sent to the CDRH Ombudsman, 

and those decisions, other than 517A 

decisions not subject to section 745A, 

are to be submitted in electronic format. 

Further instructions will be provided 

regarding submission of such requests 

in electronic format. 

V. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

90 days after the date of publication of 

a final rule in the Federal Register or at 

a later date if stated in the final rule. 

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. 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. It has been determined 

that this proposed rule is an action that 

does not impost more than de minimis 

costs. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because we anticipate that the costs of 

the rule would be de minimis, we 

propose to certify that the proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. 

The Unfunded Mandates 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 $148 million, 

using the most current (2016) 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. We have 

developed a comprehensive Economic 

Analysis of Impacts that assesses the 

impacts of the proposed rule. 

The proposed rule would (1) define 

‘‘517A decision,’’ (2) apply to requests 

submitted to CDRH for review of 517A 


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decisions and decisions other than 517A 

decisions made by CDRH, and (3) 

establish timelines and procedures for 

an interested person to request 

supervisory review of these decisions by 

CDRH. By setting specific timelines for 

persons to submit requests for 

supervisory review, the proposed rule 

would help clarify the supervisory 

review process and provide firms with 

an incentive to promptly submit review 

requests. The proposed rule would also 

establish timelines for CDRH review of 

517A decisions, reducing uncertainty 

about when interested persons would 

know the outcome of their requests for 

supervisory review. Because the 

proposed rule would not change the 

effort needed to prepare and submit a 

request for supervisory review, we 

anticipate that affected interested 

persons would incur only negligible 

costs to read and learn about the 

provisions of the proposed rule. We do 

not expect additional costs for FDA. 

We received 42 requests for review in 

2013, 28 requests for review in 2014, 20 

requests for review in 2015, and 20 

requests for review in 2016. We estimate 

that each request for review required 70 

hours of CDRH staff time. One possible 

benefit of the proposed rule, if finalized, 

is that it may reduce the number of 

hours required per request for review. If 

firms have more clarity about the 

request for review process, they may not 

have to spend as much time navigating 

the process, and we may not need to 

spend as much time guiding them 

through the process. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) 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 

This proposed rule refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information regarding the appeals 

process for devices in the guidance 

document entitled ‘‘Center for Devices 

and Radiological Health Appeals 

Processes’’ have been approved under 

OMB control number 0910–0738; the 

collections of information in 21 CFR 

part 807, subpart E (premarket 

notification) have been approved under 

OMB control number 0910–0120; the 

collections of information for De Novo 

classification requests have been 

approved under the OMB control 

number 0910–0844; the collections of 

information in 21 CFR part 812 

(investigational device exemption) have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 814 

(premarket approval) have been 

approved under OMB control number 

0910–0231; and the collections of 

information in 21 CFR part 814, subpart 

H (humanitarian use devices) have been 

approved under OMB control number 

0910–0332. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule 

does not contain policies that would 

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 proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

X. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and is available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at http://

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. ‘‘Center for Devices and Radiological 

Health Appeals Processes: Questions and 

Answers About 517A—Guidance for 

Industry and Food and Drug 

Administration Staff,’’ July 30, 2014, 

available at: http://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM352254.pdf. 

2. 40 FR 40682, September 3, 1975 http://

heinonline.org/HOL/PDFsearchable

?handle=hein.fedreg/040171&collection=

fedreg§ion=0&id=179&print=

1§ioncount=1&ext=.pdf&nocover=. 

3. 42 FR 4680, January 25, 1977 http://

heinonline.org/HOL/PDFsearchable?

handle=hein.fedreg/042016&collection=

fedreg§ion=0&id=250&print=

1§ioncount=1&ext=.pdf&nocover=. 

4. 43 FR 51966, November 7, 1978 http://

heinonline.org/HOL/PrintRequest?

collection=fedreg&nocover=&handle=

hein.fedreg%2F043216&id=

186§ion=&skipstep=1&fromid=

186&toid=238&format=PDFsearchable&

submitx=Print%2FDownload&submit1=

Print%2FDownload+Custom+Range. 

5. 44 FR 22318, April 13, 1979 http://

heinonline.org/HOL/PrintRequest?

collection=fedreg&nocover=&handle=

hein.fedreg%2F044073&id=

258§ion=&skipstep=1&fromid=

258&toid=376&format=PDFsearchable

&submitx=Print%2FDownload&

submit1=Print%2FDownload+

Custom+Range. 

6. ‘‘Center for Devices and Radiological 

Health Appeals Processes—Guidance for 

Industry and Food and Drug 

Administration Staff,’’ May 17, 2013, 

available at: http://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM284670.pdf. 

7. ‘‘Expedited Access for Premarket Approval 

and De Novo Medical Devices Intended 

for Unmet Medical Need for Life 

Threatening or Irreversibly Debilitating 

Diseases or Conditions—Guidance for 

Industry and Food and Drug 

Administration Staff,’’ April 13, 2015, 

available at: http://www.fda.gov/ 

downloads/medicaldevices/ 

deviceregulationandguidance/guidance

documents/ucm393978.pdf. 

8. ‘‘eCopy Program for Medical Device 

Submissions—Guidance for Industry and 

Food and Drug Administration Staff,’’ 

December 3, 2015, available at: http://

www.fda.gov/downloads/ 

medicaldevices/deviceregulation

andguidance/guidancedocuments/ 

ucm313794.pdf. 

List of Subjects 

21 CFR Part 10 

Administrative practice and 

procedure, News media. 

21 CFR Part 800 

Administrative practice and 

procedure, Medical devices, 

Ophthalmic goods and services, 

Packaging and containers, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 10 and 800 be amended as 

follows: 

PART 10—ADMINISTRATIVE 

PRACTICES AND PROCEDURES 

■ 1. The authority citation for part 10 

continues to read as follows: 

Authority: 5 U.S.C. 551–558, 701–706; 15 

U.S.C. 1451–1461; 21 U.S.C. 141–149, 321– 

397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264. 

■ 2. In § 10.75, add paragraph (e) to read 

as follows: 


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Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 2393 

§ 10.75 Internal agency review of 

decisions. 

* * * * * 

(e) Each request by an interested 

person for review of a decision within 

the Center for Devices and Radiological 

Health shall also comply with § 800.75 

of this chapter. 

PART 800—GENERAL 

■ 3. The authority citation for part 800 

is revised to read as follows: 

Authority: 5 U.S.C. 551–559; 21 U.S.C. 

301–399f. 

■ 4. In part 800, add § 800.75 to subpart 

C to read as follows: 

§ 800.75 Requests for supervisory review 

of certain decisions made by the Center for 

Devices and Radiological Health. 

(a) The following definitions shall 

apply to this section: 

(1) FDA means the Food and Drug 

Administration. 

(2) 517A decision means a significant 

decision made by the Center for Devices 

and Radiological Health, as set forth in 

section 517A of the Federal Food, Drug, 

and Cosmetic Act, and includes one of 

the following decisions: 

(i) A substantially equivalent order 

under § 807.100(a)(1) of this chapter, or 

a not substantially equivalent order 

under § 807.100(a)(2) of this chapter; 

(ii) An approval order under 

§ 814.44(d) of this chapter, an 

approvable letter under § 814.44(e) of 

this chapter, a not approvable letter 

under § 814.44(f) of this chapter, or an 

order denying approval under § 814.45 

of this chapter; 

(iii) An approval order under 

§ 814.116(b) of this chapter, an 

approvable letter under § 814.116(c) of 

this chapter, a not approvable letter 

under § 814.116(d) of this chapter, or an 

order denying approval under § 814.118 

of this chapter; 

(iv) A grant or denial of a request for 

breakthrough device designation under 

section 515C of the Federal Food, Drug, 

and Cosmetic Act; 

(v) An approval order under 

§ 812.30(a) of this chapter or a 

disapproval order under § 812.30(c) of 

this chapter; 

(vi) A failure to reach agreement letter 

under section 520(g)(7) of the Federal 

Food, Drug, and Cosmetic Act; or 

(vii) A clinical hold determination 

under section 520(g)(8) of the Federal 

Food, Drug, and Cosmetic Act. 

(3) CDRH means the Center for 

Devices and Radiological Health. 

(b) Submission of request. 

(1) Review of 517A decisions. 

(i) An initial or sequential request for 

supervisory review within CDRH of a 

517A decision under § 10.75 of this 

chapter must be addressed to the next 

organizational level or higher above the 

individual who made the decision; 

submitted in electronic format in 

accordance with section 745A(b) of the 

Federal Food, Drug, and Cosmetic Act; 

marked ‘‘Appeal: Request for 

Supervisory Review;’’ and received by 

CDRH no later than 30 days after the 

date of the decision involved. Any such 

request for supervisory review not 

received by CDRH within 30 days after 

the date of the decision involved is not 

eligible for review. Except as provided 

in paragraph (b)(1)(ii) or (iii) of this 

section, FDA will render a decision 

within 45 days of the request for 

supervisory review. 

(ii) A person requesting supervisory 

review under paragraph (b)(1)(i) may 

request an in-person meeting or 

teleconference with the supervisor 

reviewing the request for supervisory 

review. Except as provided in paragraph 

(b)(1)(iii) of this section, if a request for 

in-person meeting or teleconference is 

included in the request for supervisory 

review to CDRH, CDRH will schedule 

the meeting or teleconference to occur 

within 30 days of receipt of the request. 

Except as provided in paragraph 

(b)(1)(iii) of this section, a decision will 

be rendered within 30 days of such 

meeting or teleconference. 

(iii) The timeframes for CDRH to 

render a decision provided in (b)(1)(i) 

and (ii), and the timeframe to schedule 

an in-person meeting or teleconference 

review in (b)(1)(ii) of this section do not 

apply, if a matter related to the 517A 

decision under review is referred by 

CDRH to external experts, such as an 

advisory committee, as provided in 

§ 10.75(b) of this chapter. 

(2) An initial or sequential request for 

supervisory review within CDRH under 

§ 10.75 of this chapter of a decision 

other than a 517A decision that is not 

received by CDRH within 60 days after 

the date of the decision involved will be 

denied as untimely, unless CDRH, for 

good cause, permits the request to be 

filed after 60 days. An initial or 

sequential request for supervisory 

review within CDRH of a decision other 

than a 517A decision must be addressed 

to the next organizational level or higher 

above the individual who made the 

decision; submitted in electronic format 

in accordance with section 745A(b) of 

the Federal Food, Drug, and Cosmetic 

Act, when applicable; marked, ‘‘Appeal: 

Request for Supervisory Review’’ in the 

subject line of the electronic request; 

and sent to the CDRH Ombudsman at 

CDRHOmbudsman@fda.hhs.gov. 

Dated: January 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00646 Filed 1–16–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2017–N–0763] 

RIN 0910–AH43 

Food Labeling: Health Claims; Soy 

Protein and Coronary Heart Disease; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

extending the comment period for the 

proposed rule that appeared in the 

Federal Register of October 31, 2017. 

We are taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the proposed rule published 

on October 31, 2017 (82 FR 50324). 

Submit either electronic or written 

comments by March 19, 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 March 19, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of March 19, 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 


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