Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38149 

entry, where the person has no other 

conviction or program entry under 

Section 19, where it has been five years 

since the conviction or program entry 

(30 months in the case of a person 21 

or younger as described above) and 

which does not involve an insured 

financial institution or insured credit 

union is considered de minimis. Simple 

theft excludes burglary, forgery, robbery, 

identity theft, and fraud. 

Convictions or program entries for the 

use of a fake, false or altered 

identification card: 

The use of a fake, false or altered 

identification card used by person 

under the legal age for the purpose of 

obtaining or purchasing alcohol, or used 

for the purpose of entering a premise 

where alcohol is served but for which 

age appropriate identification is 

required, provided that there is no other 

conviction or program entry for a 

covered offense, will be considered de 

minimis. 

Any person who meets the criteria 

under (5) above shall be covered by a 

fidelity bond to the same extent as 

others in similar positions, and shall 

disclose the presence of the conviction 

or program entry to all insured 

institutions in the affairs of which he or 

she intends to participate. 

Further, no conviction or program 

entry for a violation of the Title 18 

sections set out in 12 U.S.C. 1829(a)(2) 

can qualify under any of the de minimis 

exceptions to filing set out in 5 above. 

C. Procedures 

When an application is required, 

forms and instructions should be 

obtained from, and the application filed 

with, the appropriate FDIC Regional 

Director. The application must be filed 

by an insured institution on behalf of a 

person (bank-sponsored) unless the 

FDIC grants a waiver of that requirement 

(individual waiver). Such waivers will 

be considered on a case-by-case basis 

where substantial good cause for 

granting a waiver is shown. The 

appropriate Regional Office for a banksponsored application is the office 

covering the state where the bank’s 

home office is located. The appropriate 

Regional Office for an individual filing 

for a waiver of the institution filing 

requirement is the office covering the 

state where the person resides. 

D. Evaluation of Section 19 

Applications 

The essential criteria in assessing an 

application are whether the person has 

demonstrated his or her fitness to 

participate in the conduct of the affairs 

of an insured institution, and whether 

the affiliation, ownership, control or 

participation by the person in the 

conduct of the affairs of the insured 

institution may constitute a threat to the 

safety and soundness of the insured 

institution or the interests of its 

depositors or threaten to impair public 

confidence in the insured institution. In 

determining the degree of risk, the FDIC 

will consider, in conjunction with the 

factors set out in 12 CFR 308.157: 

(1) Whether the conviction or program 

entry and the specific nature and 

circumstances of the offense are a 

criminal offense under Section 19; 

(2) Whether the participation directly 

or indirectly by the person in any 

manner in the conduct of the affairs of 

the insured institution constitutes a 

threat to the safety and soundness of the 

insured institution or the interests of its 

depositors or threatens to impair public 

confidence in the insured institution; 

(3) Evidence of rehabilitation 

including the person’s reputation since 

the conviction or program entry, the 

person’s age at the time of conviction or 

program entry, and the time that has 

elapsed since the conviction or program 

entry; 

(4) The position to be held or the level 

of participation by the person at an 

insured institution; 

(5) The amount of influence and 

control the person will be able to 

exercise over the management or affairs 

of an insured institution; 

(6) The ability of management of the 

insured institution to supervise and 

control the person’s activities; 

(7) The level of ownership the person 

will have of the insured institution; 

(8) The applicability of the insured 

institution’s fidelity bond coverage to 

the person; and 

(9) Any additional factors in the 

specific case that appear relevant 

including but not limited to the opinion 

or position of the primary Federal and/ 

or state regulator. 

The foregoing criteria will also be 

applied by the FDIC to determine 

whether the interests of justice are 

served in seeking an exception in the 

appropriate court when an application 

is made to terminate the ten-year ban 

under 12 U.S.C. 1829(a)(2) for certain 

Federal offenses, prior to its expiration 

date. 

Some applications can be approved 

without an extensive review because the 

person will not be in a position to 

constitute any substantial risk to the 

safety and soundness of the insured 

institution. Persons who will occupy 

clerical, maintenance, service, or purely 

administrative positions, generally fall 

into this category. A more detailed 

analysis will be performed in the case 

of persons who will be in a position to 

influence or control the management or 

affairs of the insured institution. All 

approvals and orders will be subject to 

the condition that the person shall be 

covered by a fidelity bond to the same 

extent as others in similar positions. In 

cases in which a waiver of the 

institution filing requirement has been 

granted to an individual, approval of the 

application will also be conditioned 

upon that person disclosing the 

presence of the conviction(s) or program 

entry(ies) to all insured institutions in 

the affairs of which he or she wishes to 

participate. When deemed appropriate, 

bank sponsored applications are to 

allow the person to work in a specific 

job at a specific bank and may also be 

subject to the condition that the prior 

consent of the FDIC will be required for 

any proposed significant changes in the 

person’s duties and/or responsibilities. 

In the case of bank applications such 

proposed changes may, in the discretion 

of the Regional Director, require a new 

application. In situations in which an 

approval has been granted for a person 

to participate in the affairs of a 

particular insured institution and who 

subsequently seeks to participate at 

another insured depository institution, 

another application must be submitted. 

By order of the Board of Directors, 

July 19, 2018. 

Dated at Washington, DC, on July 19, 2018. 

By order of the Board of Directors. 

Valerie Best, 

Assistant Executive Secretary. 

[FR Doc. 2018–16634 Filed 8–2–18; 8:45 am] 

BILLING CODE 6714–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1093] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Additive 

Petitions and Investigational Food 

Additive Exemptions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 


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38150 Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of our regulations 

regarding Food Additive Petitions and 

Investigational Food Additive 

Exemptions. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 2, 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 October 2, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 2, 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– 

2012–N–1093 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Additive Petitions and Investigational 

Food Additive Exemptions.’’ 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: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Food Additive Petitions and 

Investigational Food Additive 

Exemptions—21 CFR 570.17, 571.1, and 

571.6 

OMB Control Number 0910–0546— 

Extension 

Section 409(a) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 348(a)) provides that a food 

additive shall be deemed to be unsafe 

unless its use is permitted by a 

regulation which prescribes the 

condition(s) under which it may safely 

be used, or unless it is exempted by 


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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38151 

regulation for investigational use. 

Section 409(b) of the FD&C Act (21 

U.S.C. 348(b)) specifies the information 

that must be submitted by a petitioner 

to establish the safety of a food additive 

and to secure the issuance of a 

regulation permitting its use. 

To implement the provisions of § 409 

of the FD&C Act, we issued procedural 

regulations under 21 CFR part 571. 

These procedural regulations are 

designed to specify more thoroughly the 

information that must be submitted to 

meet the requirement set down in 

broader terms by the FD&C Act. The 

regulations add no substantive 

requirements to those indicated in the 

FD&C Act, but attempt to explain these 

requirements and provide a standard 

format for submission to speed 

processing of the petition. Labeling 

requirements for food additives 

intended for animal consumption are 

also set forth in various regulations 

contained in 21 CFR parts 501, 573, and 

579. The labeling regulations are 

considered by FDA to be crossreferenced to § 571.1, which is the 

subject of this same OMB clearance for 

food additive petitions. 

With regard to the investigational use 

of food additives, § 409(j) of the FD&C 

Act (§ 409(j)) (21 U.S.C. 348(j)) provides 

that any food additive, or any food 

bearing or containing such an additive, 

may be exempted from the requirements 

of this section if intended solely for 

investigational use by qualified experts. 

Investigational use of a food additive is 

typically to address the safety and/or 

intended physical or technical effect of 

the additive. 

To implement the provisions of 

§ 409(j), we issued regulations under 21 

CFR 570.17. These regulations are 

designed to specify more thoroughly the 

information that must be submitted to 

meet the requirement set down in broad 

terms by the FD&C Act. Labeling 

requirements for investigational food 

additives are also set forth in various 

regulations contained in 21 CFR 501. 

The labeling regulations are considered 

by FDA to be cross-referenced to 

§ 570.17, which is the subject of this 

same OMB clearance for investigational 

food additive files. 

The information collected is 

necessary to protect the public health. 

We use the information submitted by 

food manufacturers or food additive 

manufacturers to ascertain whether the 

data establish the identity of the 

substance, justify its intended effect in/ 

on the food, and establish that its 

intended use in/on food is safe. 

Description of Respondents: 

Respondents to this collection of 

information are food manufacturers or 

food additive manufacturers. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Food Additive Petitions: 

571.1(c) Moderate Category ......................................... 12 1 12 3,000 36,000 

571.1(c) Complex Category .......................................... 12 1 12 10,000 120,000 

571.6 Amendment of Petition ....................................... 2 1 2 1,300 2,600 

Investigational Food Additive Files: 

570.17 Moderate Category ........................................... 4 1 4 1,500 6,000 

570.17 Complex Category ............................................ 5 1 5 5,000 25,000 

Total Hours ............................................................ ........................ ........................ ........................ ........................ 189,600 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We base our estimate of the total 

annual responses on submissions 

received during fiscal years 2016 and 

2017. We base our estimate of the hours 

per response upon our experience with 

the petition and filing processes. 

§ 571.1(c) Moderate Category: For a 

food additive petition without complex 

chemistry, manufacturing, efficacy or 

safety issues, the estimated time 

requirement per petition is 

approximately 3,000 hours. We estimate 

that, annually, 12 respondents will each 

submit 1 such petition, for a total of 

36,000 hours. 

§ 571.1(c) Complex Category: For a 

food additive petition with complex 

chemistry, manufacturing, efficacy and/ 

or safety issues, the estimated time 

requirement per petition is 

approximately 10,000 hours. We 

estimate that, annually, 12 respondents 

will each submit 1 such petition, for a 

total of 120,000 hours. 

§ 571.6: For a food additive petition 

amendment, the estimated time 

requirement per petition is 

approximately 1,300 hours. We estimate 

that, annually, two respondents will 

each submit one such amendment, for a 

total of 2,600 hours. 

§ 570.17 Moderate Category: For an 

investigational food additive file 

without complex chemistry, 

manufacturing, efficacy, or safety issues, 

the estimated time requirement per file 

is approximately 1,500 hours. We 

estimate that, annually, four 

respondents will each submit one such 

file, for a total of 6,000 hours. 

§ 570.17 Complex Category: For an 

investigational food additive file with 

complex chemistry, manufacturing, 

efficacy, and/or safety issues, the 

estimated time requirement per file is 

approximately 5,000 hours. We estimate 

that, annually, five respondents will 

each submit one such file, for a total of 

25,000 hours. 

The burden for this information 

collected has not changed since the last 

OMB approval. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16616 Filed 8–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0405] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 


amozie on DSK3GDR082PROD with NOTICES1