51635 Federal Register / Vol. 85, No. 163 / Friday, August 21, 2020 / Rules and Regulations 
719 U.S.C. 1318(b)(1)(C) provides that 
‘‘[n]otwithstanding any other provision of law, the 
Secretary of the Treasury, when necessary to respond to a national emergency declared under the National Emergencies Act (50 U.S.C. 1601 et seq.) or to a specific threat to human life or national interests,’’ is authorized to ‘‘[t]ake any . . . action that may be necessary to respond directly to the 
national emergency or specific threat.’’ On March 1, 2003, certain functions of the Secretary of the Treasury were transferred to the Secretary of Homeland Security. See 6 U.S.C. 202(2), 203(1). 
Under 6 U.S.C. 212(a)(1), authorities ‘‘related to Customs revenue functions’’ were reserved to the Secretary of the Treasury. To the extent that any authority under section 1318(b)(1) was reserved to the Secretary of the Treasury, it has been delegated to the Secretary of Homeland Security. See Treas. 
Dep’t Order No. 100–16 (May 15, 2003), 68 FR 28322 (May 23, 2003). Additionally, 19 U.S.C. 1318(b)(2) provides that ‘‘[n]otwithstanding any other provision of law, the Commissioner of U.S. Customs and Border Protection, when necessary to respond to a specific threat to human life or national interests, is authorized to close temporarily any Customs office or port of entry or take any other lesser action that may be necessary to respond to the specific threat.’’ Congress has vested in the Secretary of Homeland Security the ‘‘functions of all officers, employees, and organizational units of the Department,’’ including the Commissioner of CBP. 6 U.S.C. 112(a)(3). U.S. and Canadian officials have 
mutually determined that non-essential 
travel between the United States and Canada poses additional risk of transmission and spread of the virus associated with COVID–19 and places the populace of both nations at increased risk of contracting the virus associated with COVID–19. Moreover, given the sustained human-to-human transmission of the virus, returning to previous levels of travel between the two nations places the personnel staffing land ports of entry between the United States and Canada, as well as the individuals traveling through these ports of entry, at increased risk of exposure to the virus associated with COVID–19. Accordingly, and consistent with the authority granted in 19 U.S.C. 1318(b)(1)(C) and (b)(2),
7I have 
determined that land ports of entry along the U.S.-Canada border will continue to suspend normal operations and will only allow processing for entry into the United States of those travelers engaged in ‘‘essential travel,’’ as defined below. Given the definition of ‘‘essential travel’’ below, this temporary alteration in land ports of entry operations should not interrupt legitimate trade between the two nations or disrupt critical supply chains that ensure food, fuel, medicine, and other critical materials reach individuals on both sides of the border. 
For purposes of the temporary 
alteration in certain designated ports of entry operations authorized under 19 U.S.C. 1318(b)(1)(C) and (b)(2), travel through the land ports of entry and ferry terminals along the United States- Canada border shall be limited to 
‘‘essential travel,’’ which includes, but is not limited to— 
•U.S. citizens and lawful permanent 
residents returning to the United States; 
•Individuals traveling for medical 
purposes (e.g., to receive medical 
treatment in the United States); 
•Individuals traveling to attend 
educational institutions; 
•Individuals traveling to work in the 
United States (e.g., individuals working 
in the farming or agriculture industry who must travel between the United States and Canada in furtherance of such work); 
•Individuals traveling for emergency 
response and public health purposes (e.g., government officials or emergency 
responders entering the United States to support federal, state, local, tribal, or territorial government efforts to respond to COVID–19 or other emergencies); 
•Individuals engaged in lawful cross- 
border trade (e.g., truck drivers 
supporting the movement of cargo between the United States and Canada); 
•Individuals engaged in official 
government travel or diplomatic travel; 
•Members of the U.S. Armed Forces, 
and the spouses and children of members of the U.S. Armed Forces, returning to the United States; and 
•Individuals engaged in military- 
related travel or operations. 
The following travel does not fall 
within the definition of ‘‘essential travel’’ for purposes of this Notification— 
•Individuals traveling for tourism 
purposes (e.g., sightseeing, recreation, 
gambling, or attending cultural events). 
At this time, this Notification does not 
apply to air, freight rail, or sea travel between the United States and Canada, but does apply to passenger rail, passenger ferry travel, and pleasure boat travel between the United States and Canada. These restrictions are temporary in nature and shall remain in effect until 11:59 p.m. EDT on September 21, 2020. This Notification may be amended or rescinded prior to that time, based on circumstances associated with the specific threat. 
The Commissioner of U.S. Customs 
and Border Protection (CBP) is hereby directed to prepare and distribute appropriate guidance to CBP personnel on the continued implementation of the temporary measures set forth in this Notification. The CBP Commissioner may determine that other forms of travel, such as travel in furtherance of economic stability or social order, constitute ‘‘essential travel’’ under this Notification. Further, the CBP Commissioner may, on an individualized basis and for humanitarian reasons or for other purposes in the national interest, permit the processing of travelers to the United States not engaged in ‘‘essential travel.’’ 
The Acting Secretary of Homeland 
Security, Chad F. Wolf, having reviewed and approved this document, is delegating the authority to electronically sign this document to Chad R. Mizelle, who is the Senior Official Performing the Duties of the General Counsel for DHS, for purposes of publication in the Federal Register. 
Chad R. Mizelle, 
Senior Official Performing the Duties of the 
General Counsel, U.S. Department of Homeland Security. 
[FR Doc. 2020–18470 Filed 8–19–20; 4:15 pm] 
BILLING CODE 9112–FP–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Part 610 
[Docket No. FDA–2018–N–4757] 
RIN 0910–AH95 
Revocation of the Test for Mycoplasma 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final rule. 
SUMMARY : The Food and Drug 
Administration (FDA, the Agency, or 
we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and 
inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly 
restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides 
flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA’s implementation of Executive Orders under which FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations. 
DATES : This rule is effective September 
21, 2020. 
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ADDRESSES : For access to the docket to 
read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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 : 
Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. 
SUPPLEMENTARY INFORMATION : 
Table of Contents 
I. Executive Summary 
A. Purpose of the Final Rule 
B. Summary of the Major Provisions of the 
Final Rule 
C. Legal Authority D. Costs and Benefits 
II. Background 
A. Introduction B. Need for the Regulation C. Summary of Comments to the Proposed 
Rule 
III. Legal Authority IV. Comments on the Proposed Rule and FDA 
Response 
A. Introduction B. Comments and FDA Response 
V. Effective Date VI. Economic Analysis of Impacts 
A. Introduction B. Summary of Costs and Benefits 
VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. Consultation and Coordination With 
Indian Tribal Governments 
XI. References 
I. Executive Summary 
A. Purpose of the Final Rule 
FDA is removing the regulation 
requiring a specified test for the 
presence of Mycoplasma for live virus 
vaccines produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures because the regulation is overly restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the required test for Mycoplasma provides flexibility 
for accommodating new and evolving technology and capabilities without diminishing public health protections. 
B. Summary of the Major Provisions of 
the Final Rule 
The final rule removes § 610.30 (21 
CFR 610.30), which details the method for Mycoplasma testing of samples of 
the virus harvest pool and control fluid 
pool of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. 
C. Legal Authority 
FDA is taking this action under the 
biological products provisions of the 
Public Health Service Act (the PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
D. Costs and Benefits 
Because this final rule will not 
impose any additional regulatory 
burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal. 
II. Background A. Introduction 
On February 24, 2017, Executive 
Order 13777, ‘‘Enforcing the Regulatory 
Reform Agenda’’ (https://www.federalregister.gov/documents/ 2017/03/01/2017-04107/enforcing-the- regulatory-reform-agenda; 82 FR 12285, 
March 1, 2017) was issued. One of the provisions in the Executive Order requires Agencies to evaluate existing regulations and make recommendations to the Agency head regarding their repeal, replacement, or modification, consistent with applicable law. As part of this initiative, FDA is revoking a regulation as specified in this final rule. 
B. Need for the Regulation 
It has become increasingly clear that 
the requirement specifying a test for 
Mycoplasma is too restrictive for live 
virus vaccines and inactivated virus 
vaccines produced from in vitro living cell cultures because they specify particular methodologies when alternatives may be available that provide the same or greater level of assurance of safety. Modifications to Mycoplasma testing described in 
§ 610.30 must meet the requirements of 21 CFR 610.9. 
Thus, the Agency believes that the 
regulation may no longer reflect the current testing procedures as a general matter and that it is more appropriate, flexible, and efficient to identify appropriate testing requirements for particular products in the biologics license application (BLA). 
This final rule removes the specified 
test for the presence of Mycoplasma to 
provide flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. Removal of this regulation allows manufacturers of live 
virus vaccines produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures to select the most scientifically appropriate Mycoplasma testing method 
to assure the safety, purity, and potency of their vaccines. 
These newer technologies can result 
in higher sensitivity and specificity of Mycoplasma detection and could reduce 
the time required to complete testing for Mycoplasma. Removal of this regulation 
does not remove Mycoplasma testing 
requirements specified in individual BLAs. A manufacturer of a live virus vaccine produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures will continue to be required to follow the Mycoplasma test 
requirements specified in its BLA, unless the BLA was revised to modify or replace the test through a supplement in accordance with § 601.12(c) (21 CFR 601.12(c)). FDA would review proposed 
changes to a manufacturer’s approved biologics license in the context of that particular application to ensure that any such action is appropriate. 
Although the final rule removes the 
regulation, a manufacturer continues to be required to test for Mycoplasma as 
specified in its BLA. This action provides regulated industry with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections. As appropriate, the Agency will describe the appropriate tests for particular products in manufacturers’ BLAs. 
C. Summary of Comments to the 
Proposed Rule 
We received comments on the 
proposed rule from individuals and industry submitters. The comments were generally supportive, with some comments suggesting new testing procedures be proposed. These comments are further summarized in section IV. 
III. Legal Authority 
We are issuing this final rule under 
the biological products provisions of the 
PHS Act (42 U.S.C. 216, 262, 263, 263a, and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the 
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introduction, transmission, and spread 
of communicable disease. 
IV. Comments on the Proposed Rule 
and FDA Response 
A. Introduction 
We received comments on the 
proposed rule from individuals and 
industry submitters. We describe and respond to the comments in section IV.B. We have combined comments on similar topics and have numbered each comment to help distinguish between different comments. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment’s value or importance or the order in which comments were received. 
B. Comments and FDA Response 
(Comment 1) One comment requested 
that FDA not finalize the rule, but 
instead amend the proposal to revoke the current test for Mycoplasma. The 
commenter proposed that FDA include methodologies on newer tests and how they are distinguishable from the present test; comparable data on the accuracy of Mycoplasma detection 
between the present and newer tests, and any other additional information that would support FDA’s argument that the newer tests are more efficient. 
(Response 1) FDA interprets this 
comment to support the proposal to remove the currently described methodology and to amend the regulation to specify alternative acceptable tests. The purpose of this rulemaking is to permit manufacturers of live virus vaccines produced from in vitro living cell cultures and inactivated virus vaccines produced from such living cell cultures to select the most scientifically appropriate Mycoplasma testing method to assure the safety, purity, and potency of their vaccines. Thus, FDA declines to amend the regulation to specify alternative acceptable tests because this would not achieve the goal of allowing flexibility, as appropriate, to employ advances in science and technology as they become available without diminishing public health protections. However, FDA acknowledges that guidance is helpful to describe FDA’s current thinking on alternative methods of testing for Mycoplasma in manufacturing samples 
of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA notes that recommended alternative methods for Mycoplasma testing for viral vaccines 
are described in ‘‘Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications’’ (February 2010) (https://www.fda.gov/media/78428/download). 
(Comment 2) One comment supported 
the proposed rule. 
(Response 2) We acknowledge and 
appreciate the supportive comment. 
(Comment 3) One comment did not 
comment specifically on finalizing the rule, but stated that with changes to technology, it makes sense to update testing procedures. The comment stated that ‘‘a list of the new proposed test methods would be beneficial to compare the overall benefits and disadvantages.’’ Another comment suggested that if the rule is finalized, FDA should provide guidance for alternative methods of testing for Mycoplasma. 
(Response 3) While the comment 
states that it would be helpful to have a list of new proposed test methods, FDA does not believe the regulation should be amended to include such a list because that list could become outdated. License holders are welcome to discuss with FDA proposals to change their existing test methods and to submit proposals to FDA to revise the current test methods in use. 
FDA also acknowledges that guidance 
is helpful to describe FDA’s current thinking on acceptable alternative methods of testing for Mycoplasma in 
manufacturing samples of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA notes that recommended alternative methods for Mycoplasma testing for viral vaccines are described in ‘‘Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications’’ (February 2010) (https://www.fda.gov/media/78428/download). 
(Comment 4) One comment strongly 
supported removal of the regulation and agreed that more sensitive test methods exist; however, the commenter wanted the scope of the impact to be expanded to include all biological product manufacturers. 
(Response 4) We acknowledge and 
appreciate the supportive comment. The request to expand the revocation to include all biological product manufacturers is beyond the scope of this rule making because § 610.30 pertains to manufacturers of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. V. Effective Date 
The final rule will become effective 
30 days after the date of publication in the Federal Register. 
VI. Economic Analysis of Impacts 
A. Introduction 
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 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). 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 as defined by Executive Order 12866. 
The Regulatory Flexibility Act 
requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule would increase flexibility and does not add any new regulatory responsibilities, we certify that the final 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 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 $154 million, using the most current (2018) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount. 
B. Summary of Costs and Benefits 
This final rule will amend the 
biologics regulations under § 610.30 by 
removing the specified test for Mycoplasma in the production of live 
virus vaccines produced from in vitro living cell cultures and inactivated virus 
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vaccines produced from such living cell 
cultures. 
Removing the § 610.30 Test for 
Mycoplasma will provide manufacturers 
with the flexibility to determine the most appropriate and effective Mycoplasma testing methods. FDA 
guidance dated after § 610.30, codified in 1973 (November 20, 1973, 38 FR 32056), outlines up-to-date scientific practices to identify Mycoplasma in 
production of live virus vaccines 
produced from in vitro living cell cultures and inactivated virus vaccines produced from in vitro living cell 
cultures. In practice, a vaccine manufacturer can change its procedures at any time with submission and prior approval of a supplement to its BLA. As a result, we do not expect the repeal of the § 610.30 Test for Mycoplasma to significantly influence the behavior or procedures of vaccine manufacturers. 
Because manufacturers already have 
the ability to pursue alternative testing procedures, we anticipate no 
measurable change in industry or FDA behavior from this final rulemaking. We therefore expect the elimination of the 
§ 610.30 Test for Mycoplasma to be cost 
neutral. This final rule will therefore produce no quantifiable savings, costs, or transfers. We also expect no public health benefits to be lost as a result of this revocation. Finally, we note that this final rulemaking may drive some manufacturers to streamline their procedures and search for more efficient Mycoplasma testing methods. This 
optimization may produce some unquantifiable efficiencies. 
TABLE 1—S UMMARY OF BENEFITS , COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE 
Category Primary 
estimate Low 
estimate High 
estimate Units 
Notes 
Year dollars Discount 
rate 
(%) Period 
covered 
Benefits: 
Annualized .............................. .................... .................... .................... .................... 7 
Monetized $millions/year ........ .................... .................... .................... .................... 3 
Annualized .............................. .................... .................... .................... .................... 7 
Quantified ............................... .................... .................... .................... .................... 3 
Qualitative ............................... Benefits to manufacturers from flexibility 
to determine appropriate and effective 
Mycoplasma testing methods. .................... ....................
Costs: 
Annualized .............................. .................... .................... .................... .................... 7 
Monetized $millions/year ........ .................... .................... .................... .................... 3 
Annualized .............................. .................... .................... .................... .................... 7 
Quantified ............................... .................... .................... .................... .................... 3 
Qualitative ............................... Costs to manufacturers to change 
Mycoplasma testing methods, if 
voluntarily pursued. .................... ....................
Transfers: 
Federal .................................... .................... .................... .................... .................... 7 
Annualized .............................. .................... .................... .................... .................... 3 
Monetized $millions/year ........ .................... .................... .................... .................... ............... .....
From/To .................................. From: To: 
Other ....................................... .................... .................... .................... .................... 7 
Annualized .............................. .................... .................... .................... .................... 3 
Monetized $millions/year ........ .................... .................... .................... .................... ............... .....
From/To .................................. From: To: 
Effects: 
State, Local or Tribal Government: None. 
Small Business: None. Wages: None. Growth: None. 
In line with Executive Order 13771, in 
table 2 we present annualized values of 
costs and cost savings over an infinite time horizon. There are no quantifiable costs or cost savings from this rule. This final rule would be considered a deregulatory action under Executive 
Order 13771. 
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TABLE 2—E XECUTIVE ORDER 13771 S UMMARY TABLE 
[in $ Millions 2016 Dollars, Over an Infinite Time Horizon] 
Item Primary 
estimate 
(7%) Lower 
estimate 
(7%) Upper 
estimate 
(7%) 
Present Value of Costs ......................................................................................................... ....... ........................ ........................ ........................
Present Value of Cost Savings .................................................................................................. . ........................ ........................ ........................
Present Value of Net Costs ..................................................................................................... .... ........................ ........................ ........................
Annualized Costs ............................................................................................................... .......... ........................ ........................ ........................
Annualized Cost Savings ........................................................................................................ ..... ........................ ........................ ........................
Annualized Net Costs ........................................................................................................... ....... ........................ ........................ ........................
We have developed a comprehensive 
Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 1) and at https://www.fda.gov/ about-fda/reports/economic-impact- analyses-fda-regulations. 
VII. Analysis of Environmental Impact 
We have determined under 21 CFR 
25.31(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 final rule contains no collection 
of information. Therefore, clearance by 
the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. 
IX. Federalism 
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 conclude 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. 
X. Consultation and Coordination With 
Indian Tribal Governments 
We have analyzed this rule in 
accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required. 
XI. Reference 
The following reference is on display 
at 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; it is also available electronically at https://www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 
1. FDA/Economics Staff, ‘‘Elimination of the 
21 CFR 610.30 Test for Mycoplasma 
Preliminary Regulatory Impact Analysis, Preliminary Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis,’’ 2018. (Available at https://www.fda.gov/about-fda/reports/ economic-impact-analyses-fda- regulations.) 
List of Subjects in 21 CFR part 610 
Biologics, Labeling, Reporting and 
recordkeeping requirements. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is amended as follows: 
PART 610—GENERAL BIOLOGICAL 
PRODUCTS STANDARDS 
■1. The authority citation for part 610 
continues to read as follows: 
Authority: 21 U.S.C. 321, 331, 351, 352, 
353, 355, 360, 360c, 360d, 360h, 360i, 371, 
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264. 
Subpart D—[Removed and Reserved] 
■2. Remove and reserve subpart D, 
consisting of § 610.30. Dated: July 29, 2020. 
Stephen M. Hahn, 
Commissioner of Food and Drugs. 
[FR Doc. 2020–17085 Filed 8–20–20; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF JUSTICE 
Drug Enforcement Administration 
21 CFR Parts 1308 and 1312 
[Docket No. DEA–500] 
RIN 1117–AB53 
Implementation of the Agriculture 
Improvement Act of 2018 
AGENCY : Drug Enforcement 
Administration (DEA), Department of Justice. 
ACTION : Interim final rule with request 
for comments. 
SUMMARY : The purpose of this interim 
final rule is to codify in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), regarding the scope of regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents. This interim final rule merely conforms DEA’s regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations. 
DATES : Effective August 21, 2020. 
Electronic comments must be submitted, and written comments must be postmarked, on or before October 20, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. 
ADDRESSES : To ensure proper handling 
of comments, please reference ‘‘RIN 1117–AB53/Docket No. DEA–500’’ on all correspondence, including any 
attachments. 
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