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 
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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 
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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 
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