Revocation of the Test for Mycoplasma, 12534-12537 [2019-06188]
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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:
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■
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.
VerDate Sep<11>2014
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(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.
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 https://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: https://
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.
(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-inservice 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–
¨ M 42–1097 Gustlock on Co-Pilot Side
MA
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.
[FR Doc. 2019–06280 Filed 4–1–19; 8:45 am]
(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
SUMMARY:
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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.
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.
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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
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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/201523389.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:
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
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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-theregulatory-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
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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
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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.
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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
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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
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12537
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]
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Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Proposed Rules]
[Pages 12534-12537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06188]
=======================================================================
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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
[[Page 12535]]
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 Sec. [thinsp]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
[[Page 12536]]
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 Sec. 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 Sec. [thinsp]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 Sec. [thinsp]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 Sec. 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 Sec.
[thinsp]610.30 from the regulations. As a result of removing Sec.
[thinsp]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 Sec. [thinsp]601.12(c). FDA would review
proposed changes to a manufacturer's approved biologics license in the
context of that particular license to
[[Page 12537]]
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 Sec. 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
0
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]
0
2. Remove and reserve subpart D, consisting of Sec. 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