12534 Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Proposed Rules 
This AD is issued in accordance with 
authority delegated by the Executive 
Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division. 
Regulatory Findings 
We determined that this proposed AD 
would not have federalism implications 
under Executive Order 13132. This proposed AD would not have a substantial direct effect 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. 
For the reasons discussed above, I 
certify this proposed regulation: 
(1) Is not a ‘‘significant regulatory 
action’’ under Executive Order 12866, 
(2) Is not a ‘‘significant rule’’ under 
the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), 
(3) Will not affect intrastate aviation 
in Alaska, and 
(4) Will not have a significant 
economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. 
List of Subjects in 14 CFR Part 39 
Air transportation, Aircraft, Aviation 
safety, Incorporation by reference, 
Safety. 
The Proposed Amendment 
Accordingly, under the authority 
delegated to me by the Administrator, 
the FAA proposes to amend 14 CFR part 39 as follows: 
PART 39—AIRWORTHINESS 
DIRECTIVES 
■1. The authority citation for part 39 
continues to read as follows: 
Authority: 49 U.S.C. 106(g), 40113, 44701. 
§ 39.13 [Amended] 
■2. The FAA amends § 39.13 by adding 
the following new airworthiness directive (AD): 
Diamond Aircraft Industries GmbH: Docket 
No. FAA–2019–0203; Product Identifier 
2018–CE–052–AD. (a) Comments Due Date 
We must receive comments by May 17, 
2019. 
(b) Affected ADs 
None. 
(c) Applicability 
This AD applies to Diamond Aircraft 
Industries GmbH (Diamond) Model DA 42 
NG and Model DA 42 M–NG airplanes, serial numbers 42.N202, 42.N203, 42.N205 through 42.N207, 42.N210 through 42.N214, 42.N229 
through 42.N338, 42.N340, 42.MN055, 42.MN057, and 42.MN058, certificated in any category. 
(d) Subject 
Air Transport Association of America 
(ATA) Code 27: Flight Controls. (e) Reason 
This AD was prompted by mandatory 
continuing airworthiness information (MCAI) 
originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The unsafe condition reported by the MCAI is insufficient clearance of the gust lock mounts on the pilot side rudder pedals. We are issuing this AD to prevent restricted rudder travel, which could result in reduced control of the airplane. 
(f) Actions and Compliance 
Unless already done, do the following 
actions in paragraphs (f)(1) and (2) of this 
AD. 
(1) Within the next 100 hours time-in- 
service after the effective date of this AD: 
(i) Remove the pilot (left-hand) side rudder 
pedal gust lock mounts in accordance with steps 1 through 5 of the Instructions in Diamond Aircraft Industries GmbH Work Instruction WI–MSB 42NG–077, dated August 20, 2018. 
(ii) Revise the airplane flight manual 
(AFM) by adding the figures on page 8–11a of Diamond Aircraft Temporary Revision TR– MA¨M 42–1097 Gustlock on Co-Pilot Side 
only, Doc. #7.01.15–E, dated July 18, 2018, into Chapter 8 of the AFM. 
(2) As of the effective date of this AD, do 
not install on any airplane a pilot (left-hand) side rudder pedal gust lock mount. 
(g) Other FAA AD Provisions 
The following provisions also apply to this 
AD: 
(1) Alternative Methods of Compliance 
(AMOCs): The Manager, Small Airplane 
Standards Branch, FAA, has the authority to 
approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4144; fax: (816) 329–4090; email: mike.kiesov@faa.gov. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. 
(2) Contacting the Manufacturer: For any 
requirement in this AD to obtain corrective actions from a manufacturer, the action must 
instead be accomplished using a method approved by the Manager, Small Airplane Standards Branch, FAA, or the European Aviation Safety Agency (EASA). 
(h) Related Information 
Refer to MCAI EASA AD No. 2018–0214, 
dated October 4, 2018; and Diamond 
Mandatory Service Bulletin MSB 42NG–077, dated August 20, 2018, for related information. You may examine the MCAI on the internet at http://www.regulations.gov by 
searching for and locating Docket No. FAA– 2019–0203. For service information related to this AD, contact Diamond Aircraft Industries GmbH, N.A. Otto-Stra+e 5, A–2700 Wiener Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622 26780; email: office@diamond-air.at; internet: http://www.diamondaircraft.com. You may review this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329–4148. 
Issued in Kansas City, Missouri, on March 
25, 2019. 
Melvin J. Johnson, Aircraft Certification Service, Deputy 
Director, Policy and Innovation Division, AIR–601. 
[FR Doc. 2019–06280 Filed 4–1–19; 8:45 am] 
BILLING CODE 4910–13–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 : Proposed rule. 
SUMMARY : The Food and Drug 
Administration (FDA, Agency, or we) is 
proposing to amend the biologics regulations by removing the specified test for the presence of Mycoplasma for 
live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is 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 
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diminishing public health protections. 
This action is part of FDA’s implementation of Executive Orders 13771 and 13777. Under these Executive orders, 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 : Submit either electronic or 
written comments on the proposed rule by June 17, 2019. 
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 June 17, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 17, 2019. 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– 2018–N–4757 for ‘‘Revocation of the Test for Mycoplasma.’’ 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 : 
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 Proposed Rule 
B. Summary of the Major Provisions of the 
Proposed Rule 
C. Legal Authority D. Costs and Benefits 
II. Background 
A. Introduction B. Need for Regulation 
III. Legal Authority IV. Description of the Proposed Rule 
A. Scope B. Appropriate Controls Would Remain in 
Place 
V. Proposed Effective Date VI. Economic Analysis of Impacts 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 Proposed Rule 
FDA proposes to remove 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 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 Proposed Rule 
The proposed 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 
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administrative provisions of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). 
D. Costs and Benefits 
Because this proposed rule would 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 proposing to revoke a regulation as specified in this proposed rule. 
B. Need for Regulation 
It has become increasingly clear that 
the test for Mycoplasma requirements 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 proposed rule would remove 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 would allow 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 
would 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 would continue to be required to follow the Mycoplasma test 
requirements specified in its BLA, unless the BLA were 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. 
The proposed rule, if finalized, will 
remove the regulation; however, a manufacturer would continue to be required to test for Mycoplasma as 
specified in its BLA. If finalized, this action will provide 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. 
III. Legal Authority 
FDA is issuing this proposed 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 introduction, transmission, and spread of communicable disease. 
IV. Description of the Proposed Rule A. Scope 
The test for Mycoplasma in § 610.30 
is intended to ensure that live virus 
vaccines produced from in vitro living cell cultures, and inactivated virus vaccines produced from such living cell cultures do not contain Mycoplasma. Currently the regulation 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. Removal of this regulation would eliminate a restrictive and duplicative requirement and accommodate new and 
evolving technology. 
We are proposing to remove the 
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. FDA is proposing this action because the existing specified test for the presence of Mycoplasma is restrictive 
and duplicative of requirements that are also specified in the BLA. This change is intended to remove restrictive or duplicative requirements and accommodate new and evolving technology and capabilities without diminishing public health protections. Removal of this regulation would not remove Mycoplasma testing 
requirements specified in individual BLAs. A biological product manufacturer would continue to be required to follow the Mycoplasma testing requirements specified in its BLA unless the BLA were revised to modify or replace the test through a supplement in accordance with § 601.12(c). FDA would review proposed changes to a manufacturer’s approved biologics license in the context of that particular license to ensure that any such action is appropriate. 
FDA is proposing to remove the 
requirements contained in § 610.30 from the regulations. As a result of removing § 610.30, we would also remove and reserve 21 CFR part 610, subpart D. FDA is proposing this action because the testing method described in the regulation is restrictive and more sensitive and specific testing methods are now available. 
B. Appropriate Controls Would Remain 
in Place 
FDA believes that if this rulemaking 
becomes finalized as proposed, we would be able to continue to ensure that 
appropriate controls remain in place. If the proposed rule is finalized and the regulation calling for a specific test for Mycoplasma is eliminated, 
manufacturers would continue to be required to perform a test for Mycoplasma described in their BLAs for 
their licensed live virus vaccines produced from in vitro living cell cultures and their inactivated virus vaccines produced from such cultures. Such requirement would remain in effect unless the BLA were revised to modify or replace the test through a supplement in accordance with § 601.12(c). FDA would review proposed changes to a manufacturer’s approved biologics license in the context of that particular license to 
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ensure that any such action is 
appropriate. 
V. Proposed Effective Date 
FDA is proposing that any final rule 
based on this proposed rule become 
effective 30 days after the date of its publication in the Federal Register. 
VI. Economic Analysis of Impacts 
We have examined the impacts of the 
proposed 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 proposed 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 proposed rule would increase flexibility and does not add any new regulatory responsibilities, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. 
The Unfunded Mandates Reform Act 
of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount. 
We believe industry will largely 
maintain their current practices following the removal of § 610.30 Test for Mycoplasma. Although 
manufacturers of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures may experience some unquantifiable cost savings from streamlining their testing procedures, we predict no quantifiable cost savings. FDA will also maintain its current practices, similarly generating no quantifiable cost savings. Therefore, we expect this proposed rule to be cost neutral. 
We have developed a comprehensive 
Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule and at https://www.fda.gov/ AboutFDA/ReportsManualsForms/ Reports/EconomicAnalyses/default.htm. 
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 
FDA tentatively concludes that this 
proposed 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 proposed rule 
in accordance with the principles set 
forth in Executive Order 13132. We have determined that this proposed 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 proposed rule 
in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would 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. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action. 
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 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/ AboutFDA/ReportsManualsForms/ Reports/EconomicAnalyses/ default.htm.) 
List of Subjects in 21 CFR Part 610 
Biologics, Labeling, Reporting and 
recordkeeping requirements. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 610 be 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: March 26, 2018. 
Scott Gottlieb, 
Commissioner of Food and Drugs. 
[FR Doc. 2019–06188 Filed 4–1–19; 8:45 am] 
BILLING CODE 4164–01–P 
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