65294 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations 

Items Controlled), and ‘‘specially 

designed’’ ‘‘parts’’ and ‘‘components’’ 

therefor. 

License Requirements 

Reason for Control: MT, AT 

Control(s) 

Country chart 

(See Supp. No. 1 

to part 738) 

MT applies to entire 

entry.

MT Column 1 

AT applies to entire 

entry.

AT Column 1 

List Based License Exceptions (See Part 740 

for a description of all license exceptions) 

LVS: N/A 

GBS: N/A 

CIV: N/A 

List of Items Controlled 

Related Controls: (1) See also 7A005, 7A611 

and 7A994. (2) See USML Category XII(d) 

for GNSS receiving equipment subject to 

the ITAR and USML Category XI(c)(10) for 

antennae that are subject to the ITAR. (3) 

Items that otherwise would be covered by 

ECCN 7A105.b.2 are ‘‘subject to the ITAR’’ 

(see 22 CFR parts 120 through 130). (4) See 

USML Category XII(d) for GPS receiving 

equipment in 7A105.a, b.1 and b.3 that are 

subject to the ITAR. 

Related Definitions: ‘Navigation satellite 

systems’ include Global Navigation 

Satellite Systems (GNSS; e.g. GPS, 

GLONASS, Galileo or BeiDou) and 

Regional Navigation Satellite Systems 

(RNSS; e.g. NavIC, QZSS). 

Items: 

a. Designed or modified for use in 

‘‘missiles’’; or 

b. Designed or modified for airborne 

applications and having any of the following: 

b.1. Capable of providing navigation 

information at speeds in excess of 600 m/s; 

b.2. Employing decryption, designed or 

modified for military or governmental 

services, to gain access to a ‘navigation 

satellite system’ secure signal/data; or 

b.3. Being ‘‘specially designed’’ to employ 

anti-jam features (e.g., null steering antenna 

or electronically steerable antenna) to 

function in an environment of active or 

passive countermeasures. 

Note: 7A105.b.2 and 7A105.b.3 do not 

control equipment designed for commercial, 

civil or Safety of Life (e.g., data integrity, 

flight safety) ‘navigation satellite system’ 

services. 

* * * * * 

Dated: December 17, 2018. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2018–27542 Filed 12–19–18; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2000–N–0011] 

Uniform Compliance Date for Food 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

establishing January 1, 2022, as the 

uniform compliance date for food 

labeling regulations that are published 

on or after January 1, 2019, and on or 

before December 31, 2020. We 

periodically announce uniform 

compliance dates for new food labeling 

requirements to minimize the economic 

impact of label changes. 

DATES: This rule is effective December 

20, 2018. Submit electronic or written 

comments by February 19, 2019. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

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– 

2000–N–0011 for ‘‘Uniform Compliance 

Date for Food Labeling Regulations.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 


khammond on DSK30JT082PROD with RULES
Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations 65295 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Philip L. Chao, Center for Food Safety 

and Applied Nutrition (HFS–24), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2112. 

SUPPLEMENTARY INFORMATION: We 

periodically issue regulations requiring 

changes in the labeling of food. If the 

effective dates of these labeling changes 

were not coordinated, the cumulative 

economic impact on the food industry 

of having to respond separately to each 

change would be substantial. Therefore, 

we periodically have announced 

uniform compliance dates for new food 

labeling requirements (see, e.g., the 

Federal Register of October 19, 1984 (49 

FR 41019); December 24, 1996 (61 FR 

67710); December 27, 1996 (61 FR 

68145); December 23, 1998 (63 FR 

71015); November 20, 2000 (65 FR 

69666); December 31, 2002 (67 FR 

79851); December 21, 2006 (71 FR 

76599); December 8, 2008 (73 FR 

74349); December 15, 2010 (75 FR 

78155); November 28, 2012 (77 FR 

70885); December 10, 2014 (79 FR 

73201); and November 25, 2016 (81 FR 

85156)). Use of a uniform compliance 

date provides for an orderly and 

economical industry adjustment to new 

labeling requirements by allowing 

sufficient lead time to plan for the use 

of existing label inventories and the 

development of new labeling materials. 

We have determined under 21 CFR 

25.30(k) 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. 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

We have examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, Executive Order 

13771, the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Orders 12866 and 

13563 direct Agencies 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). Executive Order 

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 final 

rule is not a significant regulatory action 

under Executive Order 12866. 

The establishment of a uniform 

compliance date does not in itself lead 

to costs or benefits. We will assess the 

costs and benefits of the uniform 

compliance date in the regulatory 

impact analyses of the labeling rules 

that take effect at that date. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant economic impact of a rule on 

small entities. Because the final rule 

does not impose compliance costs on 

small entities, we certify that the final 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before issuing ‘‘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. We do not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

determined that the 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 

have concluded that the 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. 

This action is not intended to change 

existing requirements for compliance 

dates contained in final rules published 

before January 1, 2019. Therefore, all 

final rules published by FDA in the 

Federal Register before January 1, 2019, 

will still go into effect on the date stated 

in the respective final rule. We generally 

encourage industry to comply with new 

labeling regulations as quickly as 

feasible, however. Thus, when industry 

members voluntarily change their 

labels, it is appropriate that they 

incorporate any new requirements that 

have been published as final regulations 

up to that time. 

In rulemaking that began with 

publication of a proposed rule on April 

15, 1996 (61 FR 16422), and ended with 

a final rule on December 24, 1996 (61 

FR 67710) (together ‘‘the 1996 

rulemaking’’), we provided notice and 

an opportunity for comment on the 

practice of establishing uniform 

compliance dates by issuance of a final 

rule announcing the date. We received 

no comments objecting to this practice 

during the 1996 rulemaking, nor have 

we received comments objecting to this 

practice since we published a uniform 

compliance date on November 25, 2016 

(81 FR 85156). Therefore, we find good 

cause to dispense with issuance of a 

proposed rule inviting comment on the 

practice of establishing the uniform 

compliance date because such prior 

notice and comment are unnecessary. 

Interested parties will have an 

opportunity to comment on the 

compliance date for each individual 

food labeling regulation as part of the 

rulemaking process for that regulation. 

Consequently, FDA finds any further 

advance notice and opportunity for 

comment unnecessary for establishment 

of the uniform compliance date. 

Nonetheless, under 21 CFR 10.40(e)(1), 

we are providing an opportunity for 

comment on whether the uniform 

compliance date established by this 

final rule should be modified or 

revoked. 

In addition, we find good cause for 

this final rule to become effective on the 

date of publication of this action. A 

delayed effective date is unnecessary in 

this case because the establishment of a 

uniform compliance date does not 

impose any new regulatory 

requirements on affected parties. 

Instead, this final rule provides affected 

parties with notice of our policy to 

identify January 1, 2022, as the 

compliance date for final food labeling 

regulations that require changes in the 

labeling of food products and that 

publish on or after January 1, 2019, and 

on or before December 31, 2020, unless 

special circumstances justify a different 

compliance date. Thus, affected parties 

do not need time to prepare before the 

rule takes effect. Therefore, we find 

good cause for this final rule to become 

effective on the date of publication of 

this action. 

The new uniform compliance date 

will apply only to final FDA food 

labeling regulations that require changes 


khammond on DSK30JT082PROD with RULES
65296 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations 

in the labeling of food products and that 

publish on or after January 1, 2019, and 

on or before December 31, 2020. Those 

regulations will specifically identify 

January 1, 2022, as their compliance 

date. All food products subject to the 

January 1, 2022, compliance date must 

comply with the appropriate regulations 

when initially introduced into interstate 

commerce on or after January 1, 2022. 

If any food labeling regulation involves 

special circumstances that justify a 

compliance date other than January 1, 

2022, we will determine for that 

regulation an appropriate compliance 

date, which will be specified when the 

final regulation is published. 

Dated: December 13, 2018. 

Scott Gottlieb, 

Commissioner of Food and Drugs. 

[FR Doc. 2018–27429 Filed 12–19–18; 8:45 am] 

BILLING CODE 4164–01–P 

EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION 

29 CFR Part 1630 

[EEOC–2018–0004] 

RIN 3046–AB01 

Removal of Final ADA Wellness Rule 

Vacated by Court 

AGENCY: Equal Employment 

Opportunity Commission. 

ACTION: Final rule. 

SUMMARY: This final rule removes from 

the Code of Federal Regulations a 

section of the final rule published on 

May 17, 2016, entitled ‘‘Regulations 

Under the Americans With Disabilities 

Act.’’ This action responds to a decision 

of the U.S. District Court for the District 

of Columbia that vacated the incentive 

section of the ADA rule effective 

January 1, 2019. 

DATES: The action is effective on January 

1, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Christopher J. Kuczynski, (202) 663– 

4665 (voice), christopher.kuczynski@

eeoc.gov; or Joyce Walker-Jones, (202) 

663–7031 (voice); joyce.walker-jones@

eeoc.gov; or (202) 663–7026 (TTY). 

SUPPLEMENTARY INFORMATION: On May 

17, 2016, the Equal Employment 

Opportunity Commission (EEOC) 

published a final rule entitled 

‘‘Regulations Under the Americans With 

Disabilities Act’’ under the authority of 

Title I of the Americans with 

Disabilities Act (ADA), 42 U.S.C. 

12101–12117. 81 Federal Register 

31126. The rule ‘‘provide[d] guidance 

on the extent to which employers may 

use incentives to encourage employees 

to participate in wellness programs that 

ask them to respond to disability-related 

inquiries and/or undergo medical 

examinations.’’ 

On October 24, 2016, AARP filed a 

complaint in the U.S. District Court for 

the District of Columbia challenging the 

incentive section of the ADA rule. On 

August 22, 2017, the District Court 

concluded that the Commission did not 

provide sufficient reasoning to justify 

the incentive limit adopted in the ADA 

rule and remanded the rule to the EEOC 

for reconsideration without vacating it. 

Following a motion by AARP to alter or 

amend the court’s summary judgment 

order, the court issued an order vacating 

the incentive section of the rule, 29 CFR 

1630.14(d)(3), effective January 1, 2019. 

AARP v. EEOC, D.D.C., No. 16–2113 

(D.D.C. December 20, 2017). Consistent 

with that decision, this rule removes the 

incentive section of the ADA regulations 

at 29 CFR 1630.14(d)(3). 

This rule is not subject to the 

requirement to provide public comment 

because it falls under the good cause 

exception at 5 U.S.C. 553(b)(B). The 

good cause exception is satisfied when 

notice and comment is ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Id. This rule is an 

administrative step that implements the 

court’s order vacating the incentive 

section of the ADA rule. Additionally, 

because this rule implements a court 

order already in effect, the Commission 

has good cause to waive the 30-day 

effective date under 5 U.S.C. 553(d)(3). 

List of Subjects in 29 CFR Part 1630 

Administrative practice and 

procedure, Equal employment 

opportunity. 

For the reasons set forth in the 

preamble, under the authority of 42 

U.S.C. 12101–12117, the Commission 

amends chapter XIV of title 29 of the 

Code of Federal Regulations as follows: 

PART 1630—REGULATIONS TO 

IMPLEMENT THE EQUAL 

EMPLOYMENT PROVISIONS OF THE 

AMERICANS WITH DISABILITIES ACT 

■ 1. The authority citation for part 1630 

continues to read as follows: 

Authority: 42 U.S.C. 12116 and 12205a of 

the Americans with Disabilities Act, as 

amended. 

§ 1630.14 [Amended] 

■ 2. Amend § 1630.14 by removing and 

reserving paragraph (d)(3). 

Dated: December 14, 2018. 

Victoria A. Lipnic, 

Acting Chair, U.S. Equal Employment 

Opportunity Commission. 

[FR Doc. 2018–27539 Filed 12–19–18; 8:45 am] 

BILLING CODE 6570–01–P 

EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION 

29 CFR Part 1635 

EEOC–2018–0005] 

RIN 3046–AB02 

Removal of Final GINA Wellness Rule 

Vacated by Court 

AGENCY: Equal Employment 

Opportunity Commission. 

ACTION: Final rule. 

SUMMARY: This final rule removes from 

the Code of Federal Regulations a 

section of the final rule published on 

May 17, 2016, entitled, ‘‘Genetic 

Information Nondiscrimination Act.’’ 

This action responds to a decision of the 

U.S. District Court for the District of 

Columbia that vacated the incentive 

section of the GINA rule effective 

January 1, 2019. 

DATES: The action is effective on January 

1, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Christopher J. Kuczynski, (202) 663– 

4665 (voice), christopher.kuczynski@

eeoc.gov; or Kerry E. Leibig, (202) 663– 

4516 (voice), kerry.leibig@eeoc.gov; or 

(202) 663–7026 (TTY). 

SUPPLEMENTARY INFORMATION: On May 

17, 2016, the Equal Employment 

Opportunity Commission (EEOC) 

published a final rule entitled, ‘‘Genetic 

Information Nondiscrimination Act’’ 

under the authority of Title II of the 

Genetic Information Nondiscrimination 

Act of 2008 (GINA), 42 U.S.C. 2000ff– 

2000ff–11. 81 Federal Register 31143. 

The rule ‘‘addressed the extent to which 

an employer may offer an inducement to 

an employee for the employee’s spouse 

to provide his or her current health 

status information as part of a health 

risk assessment (HRA) administered in 

connection with an employee-sponsored 

wellness program.’’ Id. 

On October 24, 2016, AARP filed a 

complaint in the U.S. District Court for 

the District of Columbia challenging the 

incentive section of the GINA rule. On 

August 22, 2017, the District Court 

concluded that the Commission did not 

provide sufficient reasoning to justify 

the incentive limit adopted in the GINA 

rule and remanded the rule to the EEOC 

for further consideration without 

vacating it. Following a motion by 


khammond on DSK30JT082PROD with RULES