[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Page 38696]
[FR Doc No: 2015-16562]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1951]

CHEMBIOMED, LTD.; Revocation of U.S. License No. 0916

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the biologics license (U.S. License No. 0916) issued to
CHEMBIOMED, LTD. (CHEMBIOMED) for the manufacture of Anti-A (Murine
Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal)
and Anti-Le\b\ (Murine Monoclonal). CHEMBIOMED did not respond to a
notice of opportunity for a hearing on a proposal to revoke its
license.

DATES: The revocation of the biologics license (U.S. License No. 0916)
is effective July 7, 2015.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, 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:
    FDA is revoking the biologics license (U.S. License No. 0916)
issued to CHEMBIOMED, 9515 107th St., Rm. 401, Edmonton AB T5K 2C3,
Canada, for the manufacture of Anti-A (Murine Monoclonal), Anti-B
(Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\
(Murine Monoclonal). Proceedings to revoke U.S. License No. 0916 were
initiated under Sec.  601.5(b) (21 CFR 601.5(b)) because FDA determined
through various means that a meaningful inspection of CHEMBIOMED could
not be conducted because the manufacturer was no longer in operation.
    In a phone conversation that occurred on July 7, 1992, a former
CHEMBIOMED employee informed FDA that CHEMBIOMED was no longer in
business, had ceased the manufacture of licensed products, and had also
ceased shipments of licensed products to the United States.
    In a letter dated June 16, 1995, FDA requested from the Authorized
Official (Responsible Head) of CHEMBIOMED a status update for the
production of all of the products for which CHEMBIOMED held a U.S.
license. This letter requested that the firm notify FDA in writing of
the firm's status and also informed the Authorized Official that in the
absence of a response to this letter that FDA would take action to
revoke CHEMBIOMED's U.S. license. FDA did not receive a response to its
letter dated June 16, 1995.
    In a certified, return-receipt letter dated October 18, 1995, FDA
requested that the Authorized Official of CHEMBIOMED inform FDA whether
or not the firm intended to pursue a product license application
supplement request dated May 6, 1987. In the October 18, 1995 letter,
FDA also informed the Authorized Official that the product license
application supplement request had been placed in the FDA inactive
files. FDA did not receive a response to its certified, return-receipt
letter dated October 18, 1995.
    In a letter to CHEMBIOMED dated December 19, 2012, FDA provided
notice of FDA's intent to revoke U.S. License No. 0916, and announced
its intent to offer an opportunity for a hearing. FDA indicated that
FDA registrations for CHEMBIOMED facilities have not been updated since
May 12, 1994. The letter also advised the Authorized Official that,
under Sec.  601.5(b)(1)(i) and (ii) of FDA's regulations, proceedings
for license revocation may be instituted when FDA finds that authorized
FDA employees have been unable to gain access to an establishment for
the purpose of carrying out an inspection, or when the manufacturing of
a product has been discontinued to an extent that a meaningful
inspection cannot be made at the establishment. The December 19, 2012
letter to CHEMBIOMED, sent via United Parcel Service, was returned as
undeliverable.
    In addition, Health Canada advised FDA that CHEMBIOMED was no
longer in operation, according to the Industry Canada Web site:
www.ic.gc.ca. CHEMBIOMED (Corporation No. 0228176 and Business No.
100938521RC0001 under the governing legislation of the Canada Business
Corporations Act) was issued a Certificate of Incorporation on August
15, 1977, and later was issued a Certificate of Dissolution on March
17, 1999.
    Under Sec.  12.21(b) (21 CFR 12.21(b)), FDA published in the
Federal Register of January 14, 2015 (80 FR 1917), a notice of
opportunity for a hearing (NOOH) on a proposal to revoke the biologics
license (U.S. License No. 0916) issued to CHEMBIOMED for the
manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal),
Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ (Murine Monoclonal). In
the NOOH, FDA explained that the proposed license revocation was based
on information that the firm was no longer in operation and the
manufacture of its licensed products has been discontinued. FDA also
noted in the NOOH that the documentation in support of the license
revocation had been placed on file with the Division of Dockets
Management under the docket number found in brackets in the heading of
the notice.
    The NOOH provided the firm 30 days to submit an electronic or
written request for a hearing and 60 days to submit any data and
information justifying a hearing. The NOOH provided other interested
persons with 60 days to submit electronic or written comments on the
proposed revocation. The firm did not respond within the 30-day time
period with an electronic or written request for a hearing, and under
Sec.  12.21(b), the 30-day time period prescribed in the NOOH may not
be extended. No comments from other interested persons were received
within the 60-day time period.
    Accordingly under 21 CFR 12.38, section 351 of the Public Health
Service Act (42 U.S.C. 262), and under the authority delegated to the
Commissioner of Food and Drugs and redelegated to the Director and
Deputy Director of the Center for Biologics Evaluation and Research
(FDA Staff Manual Guide 1410.203), the biologics license (U.S. License
No. 0916) issued to CHEMBIOMED, LTD. for the manufacture of Anti-A
(Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine
Monoclonal) and Anti-Le\b\ (Murine Monoclonal) is revoked, effective
July 7, 2015.

    Dated: June 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16562 Filed 7-6-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 7, 2008 (Volume 73, Number 217)]
[Proposed Rules]
[Page 66205-66207]
[DOCID:fr07no08-17]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 25, 121, and 129

[Docket No. FAA-2006-24281]

Aviation Rulemaking Advisory Committee Meeting on Transport
Airplane and Engine Issues--Aging Aircraft Program: Widespread Fatigue
Damage

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of public meeting, reopening of comment period.

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SUMMARY: This notice announces a public meeting of the FAA's Aviation
Rulemaking Advisory Committee (ARAC) to discuss transport airplane and
engine (TAE) issues. The purpose of the meeting is to solicit comments
and information on a technical document related to a notice of proposed
rulemaking that the FAA published on April 18, 2006, on Widespread
Fatigue Damage, and its accompanying initial regulatory evaluation.
This notice also announces the opening of a period of public comment on
that technical document, which has been posted in docket FAA-2006-
24281. Commenters may post their comments in the docket.

DATES: The meeting is scheduled for Thursday, December 11, 2008,
starting at 9 a.m. Pacific Standard Time. Persons unable to attend the
meeting are invited to provide written comments to the Federal Docket
Management System, on or before December 22, 2008. Persons planning to
make oral presentations at the meeting must request arrangements for
that with the FAA by December 1, 2008 by contacting the appropriate
person under the FOR FURTHER INFORMATION CONTACT section. We also ask
those who are not planning to make a presentation but are planning to
attend the meeting to inform us as well.

ADDRESSES: The meeting will be held at the Best Western Hotel, 15901
West Valley Hwy., Tukwila, WA 98188. Attendance is open to the public,
but will be limited to space available. Persons unable to attend the
meeting may send comments identified by Docket Number FAA-2006-24281
using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Bring comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the electronic form of all comments received into any of
our dockets, including the name of the individual sending the comment
(or signing the comment for an association, business, labor union,
etc.). You may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477-78) or you
may visit http://DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time and follow the online
instructions for accessing the docket. Or, go to the Docket Operations
in Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Requests to present a statement at the
meeting or questions regarding the logistics of the meeting, as well as
responses from persons planning to attend the meeting, should be
directed to Annette Kovite, Federal Aviation Administration, Transport
Airplane Directorate, Aircraft Certification Service, Standardization
Branch, ANM-113, 1601 Lind Avenue, SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Please provide us with the following
information: Full legal name, country of citizenship, and name of your
industry association or applicable affiliation. If you are attending as
a private citizen, please indicate that.
    Questions concerning this proposed rule should be directed to
Walter Sippel, FAA, Transport Airplane Directorate, Aircraft
Certification Service, Transport Airplane Airframe/Cabin Safety Branch,
ANM-115, 1601 Lind Avenue, SW., Renton, WA 98057-3356; telephone (425)
227-2774, fax<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463; 5 U.S.C. app. III), notice is
given of an ARAC meeting to be held at the Best Western Hotel in
Tukwila, WA on December 11, 2008. This ad hoc meeting is being held to
review and receive public comments on changes made to the notice of
proposed rulemaking and initial regulatory evaluation on Widespread
Fatigue Damage published on April 18, 2006 (74 FR 19928).
    The agenda for the meeting is as follows:
     Opening remarks.
     Presentation and explanation of technical document related
to notice of proposed rulemaking No. 06-04, Aging Aircraft Program:
Widespread Fatigue Damage, published on April 18, 2006 (71 FR 19928),
and its accompanying initial regulatory evaluation, which may be found
in Docket FAA-2006-24281.
     Oral presentation of public comments.

Background

    The FAA received extensive comments on the Widespread Fatigue
Damage (WFD) notice of proposed rulemaking (74 FR19928) and on the
estimated costs and benefits of that proposed rule specified in its
accompanying regulatory evaluation, which may be found in the docket.
Based on those comments, and on our analysis of those comments, we have
developed a technical document that suggests changes to both the
proposed rule and to the assumptions made in our initial regulatory
evaluation. Those changes could decrease the estimated cost of the
proposed rule from $360 million to $4 million in present value.

Comment Period

    To allow the public to comment on the technical document we are
reopening the comment period. We have posted it in the docket for the
Widespread Fatigue Damage rulemaking (FAA-2006-24281) with the title
``Technical Document--Aging Aircraft Program: Widespread Fatigue
Damage.'' A period of public comment on that document begins with
publication of this notice in the Federal Register and ends on December
22, 2008. Public comments may be posted to the docket at any time
during the comment period by following any of the means of posting
comments listed in the ADDRESSES section of this document. In addition,
as discussed below, we invite attendance at the public meeting of ARAC
on Transport Airplane and Engine Issues on December 11, 2008, where
people may make comments in person. If you are posting comments to the
docket and would like us to address them at the meeting, it would help
us if you would post those comments by December 1. All comments posted
to the docket will be considered, but we may not be able to address
late-posted comments at the meeting.

Participation at the Meeting

    The purpose of the meeting of the Transport Airplane and Engine
Issues Group on December 11, 2008, is to discuss the technical document
and the effect our analysis could have on the proposed rule and initial
regulatory evaluation for Widespread Fatigue Damage. The public is
invited to make oral presentations and comments on the

technical document at this meeting. To assist us in planning for this
meeting, please notify us by December 1, 2008 if you are planning to
attend. Persons who wish to present oral statements at the meeting
should arrange with the FAA in advance for time to do this at the
meeting. We should receive requests from persons who wish to present
oral statements at the meeting no later than December 1, 2008. Requests
to speak should include a written summary of oral remarks to be
presented and an estimate of time needed for the presentation. An
agenda of speakers will be available at the meeting. The names of those
individuals who make their request to present oral statements after the
date specified above may not appear on the written agenda. To
accommodate as many speakers as possible, the amount of time allocated
to each speaker may be less than the amount of time requested. Persons
requiring audiovisual equipment should notify the FAA when requesting
to be placed on the agenda.

Public Meeting Procedures

    The FAA will use the following procedures to facilitate the
meeting:
    (1) There will be no admission fee or other charge to attend or to
participate in the meeting. The meeting will be open to all persons who
are scheduled to attend or present statements or who register between 8
a.m. and 9 a.m. on the day of the meeting. While the FAA will make
every effort to accommodate all persons wishing to participate,
admission will be subject to availability of space in the meeting room.
Advising us in advance if you're planning to attend the meeting will
help us plan for adequate room to accommodate those who wish to attend.
The meeting may adjourn early if scheduled speakers complete their
statements in less time than is scheduled for the meeting.
    (2) An individual presenting oral remarks, whether speaking in a
personal capacity or as a representative of an organization, may be
limited to a 10-minute statement. If possible, we will notify the
speaker if additional time is available.
    (3) We will try to accommodate all speakers. If the available time
does not permit this, speakers generally will be scheduled on a first-
come-first-served basis. However, the FAA reserves the right to exclude
some speakers if necessary to present a balance of viewpoints and
issues.
    (4) If you need assistance or require a reasonable accommodation
for the meeting or meeting documents, please contact Annette Kovite,
listed in the FOR FURTHER INFORMATION CONTACT section. Sign and oral
interpretation can be made available at the meeting, as well as an
assistive listening device, if requested by December 1, 2008.
    (5) The committee's Assistant Chair for Transport Airplane and
Engine Issues will preside over the meeting. The Designated Federal
Official and a panel of FAA personnel involved in this rulemaking will
be present to address the technical document and questions and comments
presented.
    (6) The meeting will be recorded by a court reporter. A transcript
of the meeting and any material accepted by the FAA representatives
during the meeting will be included in the public docket. Any person
who is interested in purchasing a copy of the transcript should contact
the court reporter directly. Additional transcript purchase information
will be available at the meeting.
    (7) The FAA will review and consider all material presented by
participants at the meeting. Position papers or material presenting
views or arguments related to the rulemaking may be accepted at the
discretion of the presiding officer and subsequently placed in the
public docket. We request that persons participating in the meeting
provide enough copies of all materials for distribution to the
committee and FAA representatives; other copies may be provided to the
audience at the discretion of the participant.
    (8) Statements made by FAA representatives are intended to
facilitate discussion of the issues or to clarify issues. Any statement
made during the meeting by an FAA representative is not intended to be,
and should not be construed as, a position of the FAA.
    (9) The meeting is designed to solicit public views and gather
additional information on the rulemaking. Therefore, the meeting will
be conducted in an informal and non-adversarial manner. No individual
will be subject to cross-examination by any other participant; however,
FAA representatives may ask questions to clarify a statement and to
ensure a complete and accurate record.

    Issued in Washington, DC, on November 3, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
 [FR Doc. E8-26566 Filed 11-6-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Rules and Regulations]
[Pages 22411-22414]
[FR Doc No: 2017-09844]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2017-0368; Special Conditions No. 25-671-SC]

Special Conditions: Airbus, Models A318, A319, A320, and A321
Series Airplanes; Non-Rechargeable Lithium Battery Installations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comment.

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SUMMARY: These special conditions are issued for non-rechargeable
lithium battery installations on Airbus Models A318, A319, A320, and
A321 series airplanes. Non-rechargeable lithium batteries are a novel
or unusual design feature when compared to the state of technology
envisioned in the airworthiness standards for transport category
airplanes. The applicable airworthiness regulations do not contain
adequate or appropriate safety standards for this design feature. These
special conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.

DATES: This action is effective on Airbus on May 16, 2017. We must
receive your comments by June 30, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0368
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC, 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA

docket, including the name of the individual sending the comment (or
signing the comment for an association, business, labor union, etc.).
DOT's complete Privacy Act Statement can be found in the Federal
Register published on April 11, 2000 (65 FR 19477-19478), as well as at
http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nazih Khaouly, Airplane and Flight
Crew Interface Branch, ANM-111, Transport Airplane Directorate,
Aircraft Certification Service, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Future Requests for Installation of Non-Rechargeable Lithium Batteries

    The FAA anticipates that non-rechargeable lithium batteries will be
installed in most makes and models of transport category airplanes. We
intend to require special conditions for certification projects
involving non-rechargeable lithium battery installations to address
certain safety issues until we can revise the airworthiness
requirements. Applying special conditions to these installations across
the range of transport category airplanes will ensure regulatory
consistency.
    Typically, the FAA issues special conditions after receiving an
application for type certificate approval of a novel or unusual design
feature. However, the FAA has found that the presence of non-
rechargeable lithium batteries in certification projects is not always
immediately identifiable, since the battery itself may not be the focus
of the project. Meanwhile, the inclusion of these batteries has become
virtually ubiquitous on in-production transport category airplanes,
which shows that there will be a need for these special conditions.
Also, delaying the issuance of special conditions until after each
design application is received could lead to costly certification
delays. Therefore the FAA finds it necessary to issue special
conditions applicable to these battery installations on particular
makes and models of aircraft.
    On April 22, 2016, the FAA published special conditions no. 25-612-
SC in the Federal Register (81 FR 23573) applicable to Gulfstream
Aerospace Corporation for the GVI airplane. Those were the first
special conditions the FAA issued for non-rechargeable lithium battery
installations. We explained in that document our decision to make those
special conditions effective one year after publication in the Federal
Register, which is April 22, 2017. In those special conditions, the FAA
stated its intention to apply non-rechargeable lithium battery special
conditions to design changes on other makes and models applied for
after this same date.
    Section 1205 of the FAA Reauthorization Act of 1996 requires the
FAA to consider the extent to which Alaska is not served by
transportation modes other than aviation and to establish appropriate
regulatory distinctions when modifying airworthiness regulations that
affect intrastate aviation in Alaska. In consideration of this
requirement and the overall impact on safety, the FAA does not intend
to require non-rechargeable lithium battery special conditions for
design changes that only replace a 121.5 megahertz (MHz) emergency
locator transmitter (ELT) with a 406 MHz ELT that meets Technical
Standard Order C126b, or later revision, on transport airplanes
operating only in Alaska. This will support our efforts of encouraging
operators in Alaska to upgrade to a 406 MHz ELT. These ELTs provide
significantly improved accuracy for lifesaving services to locate an
accident site in Alaskan terrain. The FAA considers that the safety
benefits from upgrading to a 406 MHz ELT for Alaskan operations will
outweigh the battery fire risk.

Comments Invited

    The substance of these special conditions has been subjected to the
notice and comment period in prior instances and has been derived
without substantive change from those previously issued. It is unlikely
that prior public comment would result in a significant change from the
substance contained herein. Therefore, the FAA has determined that
prior public notice and comment are unnecessary and impracticable, and
good cause exists for adopting these special conditions upon
publication in the Federal Register. The FAA is requesting comments to
allow interested persons to submit views that may not have been
submitted in response to the prior opportunities for comment described
above.
    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    Airbus holds type certificate no. A28NM, which provides the
certification basis for the A318, A319, A320, and A321 series
airplanes. The A318, A319, A320, and A321 series airplanes are twin
engine, transport category airplanes with a passenger seating capacity
of 136 to 220 and a maximum takeoff weight of 123,458 to 206,132
pounds, depending on the specific design.
    The FAA is issuing these special conditions for non-rechargeable
lithium battery installations on A318, A319, A320, and A321 series
airplanes. The current battery requirements in title 14, Code of
Federal Regulations (14 CFR) part 25 are inadequate for addressing an
airplane with non-rechargeable lithium batteries.

Type Certification Basis

    Under the provisions of 14 CFR 21.101, Airbus must show that the
A318, A319, A320, and A321 series airplanes meet the applicable
provisions of the regulations listed in type certificate no. A28NM or
the applicable regulations in effect on the date of application for the
change, except for earlier amendments as agreed upon by the FAA. In
addition, the certification basis includes certain special conditions,
exemptions, or later amended sections that are not relevant to these
special conditions.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the A318, A319, A320, and A321 series
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the airplane model
for which they are issued. Should the type certificate for that model
be amended later to include any other model that incorporates the same
novel or unusual design feature, or should any other model already
included on the same type certificate be modified to incorporate the
same novel or unusual design feature, these special conditions

would also apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the A318, A319, A320, and A321 series airplanes must comply
with the fuel vent and exhaust emission requirements of 14 CFR part 34
and the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Feature

    The novel or unusual design feature is the installation of non-
rechargeable lithium batteries.
    For the purpose of these special conditions, we refer to a battery
and battery system as a battery. A battery system consists of the
battery and any protective, monitoring, and alerting circuitry or
hardware inside or outside of the battery. It also includes vents
(where necessary) and packaging.

Discussion

    The FAA derived the current regulations governing installation of
batteries in transport category airplanes from Civil Air Regulations
(CAR) 4b.625(d) as part of the recodification of CAR 4b that
established 14 CFR part 25 in February 1965. This recodification
basically reworded the CAR 4b battery requirements, which are currently
in Sec.  25.1353(b)(1) through (4). Non-rechargeable lithium batteries
are novel and unusual with respect to the state of technology
considered when these requirements were codified. These batteries
introduce higher energy levels into airplane systems through new
chemical compositions in various battery cell sizes and construction.
Interconnection of these cells in battery packs introduces failure
modes that require unique design considerations, such as provisions for
thermal management.
    Recent events involving rechargeable and non-rechargeable lithium
batteries prompted the FAA to initiate a broad evaluation of these
energy storage technologies. In January 2013, two independent events
involving rechargeable lithium-ion batteries revealed unanticipated
failure modes. A National Transportation Safety Board (NTSB) letter to
the FAA, dated May 22, 2014, which is available at http://www.ntsb.gov,
filename A-14-032-036.pdf, describes these events.
    On July 12, 2013, an event involving a non-rechargeable lithium
battery in an emergency locator transmitter installation demonstrated
unanticipated failure modes. The United Kingdom's Air Accidents
Investigation Branch Bulletin S5/2013 describes this event.
    Some known uses of rechargeable and non-rechargeable lithium
batteries on airplanes include:
     Flight deck and avionics systems such as displays, global
positioning systems, cockpit voice recorders, flight data recorders,
underwater locator beacons, navigation computers, integrated avionics
computers, satellite network and communication systems, communication
management units, and remote-monitor electronic line-replaceable units;
     Cabin safety, entertainment, and communications equipment,
including emergency locator transmitters, life rafts, escape slides,
seatbelt air bags, cabin management systems, Ethernet switches, routers
and media servers, wireless systems, internet and in-flight
entertainment systems, satellite televisions, remotes, and handsets;
     Systems in cargo areas including door controls, sensors,
video surveillance equipment, and security systems.
    Some known potential hazards and failure modes associated with non-
rechargeable lithium batteries are:
     Internal failures: In general, these batteries are
significantly more susceptible to internal failures that can result in
self-sustaining increases in temperature and pressure (i.e., thermal
runaway) than their nickel-cadmium or lead-acid counterparts. The
metallic lithium can ignite, resulting in a self-sustaining fire or
explosion.
     Fast or imbalanced discharging: Fast discharging or an
imbalanced discharge of one cell of a multi-cell battery may create an
overheating condition that results in an uncontrollable venting
condition, which in turn leads to a thermal event or an explosion.
     Flammability: Unlike nickel-cadmium and lead-acid
batteries, lithium batteries use higher energy and current in an
electrochemical system that can be configured to maximize energy
storage of lithium. They also use liquid electrolytes that can be
extremely flammable. The electrolyte, as well as the electrodes, can
serve as a source of fuel for an external fire if the battery casing is
breached.
    Special condition no. 1 of these special conditions requires that
each individual cell within a non-rechargeable lithium battery be
designed to maintain safe temperatures and pressures. Special condition
no. 2 addresses these same issues but for the entire battery. Special
condition no. 2 requires the battery be designed to prevent propagation
of a thermal event, such as self-sustained, uncontrollable increases in
temperature or pressure from one cell to adjacent cells.
    Special conditions nos. 1 and 2 are intended to ensure that the
non-rechargeable lithium battery and its cells are designed to
eliminate the potential for uncontrollable failures. However, a certain
number of failures will occur due to various factors beyond the control
of the battery designer. Therefore, other special conditions are
intended to protect the airplane and its occupants if failure occurs.
    Special conditions 3, 7, and 8 are self-explanatory.
    Special condition no. 4 makes it clear that the flammable fluid
fire protection requirements of Sec.  25.863 apply to non-rechargeable
lithium battery installations. Section 25.863 is applicable to areas of
the airplane that could be exposed to flammable fluid leakage from
airplane systems. Non-rechargeable lithium batteries contain an
electrolyte that is a flammable fluid.
    Special condition no. 5 requires that each non-rechargeable lithium
battery installation not damage surrounding structure or adjacent
systems, equipment, or electrical wiring from corrosive fluids or gases
that may escape in such a way as to cause a major or more severe
failure condition.
    While special condition no. 5 addresses corrosive fluids and gases,
special condition no. 6 addresses heat. Special condition no. 6
requires that each non-rechargeable lithium battery installation have
provisions to prevent any hazardous effect on airplane structure or
systems caused by the maximum amount of heat the battery installation
can generate due to any failure of it or its individual cells. The
means of meeting special conditions nos. 5 and 6 may be the same, but
the requirements are independent and address different hazards.
    These special conditions apply to all non-rechargeable lithium
battery installations in lieu of Sec.  25.1353(b)(1) through (4) at
Amendment 25-123 or Sec.  25.1353(c)(1) through (4) at earlier
amendments. Those regulations remain in effect for other battery
installations.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Applicability

    These special conditions are applicable to A318, A319, A320, and
A321 series airplanes. Should Airbus

apply at a later date for a change to the type certificate to include
another model incorporating the same novel or unusual design feature,
these special conditions would apply to that model as well.
    These special conditions are only applicable to design changes
applied for after the effective date.
    These special conditions are not applicable to changes to
previously certified non-rechargeable lithium battery installations
where the only change is either cosmetic or to relocate the
installation to improve the safety of the airplane and occupants.
Previously certified non-rechargeable lithium battery installations, as
used in this paragraph, are those installations approved for
certification projects applied for on or before the effective date of
these special conditions. A cosmetic change is a change in appearance
only, and does not change any function or safety characteristic of the
battery installation. These special conditions are also not applicable
to unchanged, previously certified non-rechargeable lithium battery
installations that are affected by a change in a manner that improves
the safety of its installation. The FAA determined that these
exclusions are in the public interest because the need to meet all of
the special conditions might otherwise deter these design changes that
improve safety.

Conclusion

    This action affects only a certain novel or unusual design feature
on the subject models of airplanes. It is not a rule of general
applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in prior instances and has been derived
without substantive change from those previously issued. It is unlikely
that prior public comment would result in a significant change from the
substance contained herein. Therefore, the FAA has determined that
prior public notice and comment are unnecessary and impracticable, and
good cause exists for adopting these special conditions upon
publication in the Federal Register. The FAA is requesting comments to
allow interested persons to submit views that may not have been
submitted in response to the prior opportunities for comment described
above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and record keeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Airbus Models A318, A319, A320, and
A321 series airplanes.

Non-Rechargeable Lithium Battery Installations

    In lieu of Sec.  25.1353(b)(1) through (4) at Amendment 25-123 or
Sec.  25.1353(c)(1) through (4) at earlier amendments, each non-
rechargeable lithium battery installation must:
    1. Be designed to maintain safe cell temperatures and pressures
under all foreseeable operating conditions to prevent fire and
explosion.
    2. Be designed to prevent the occurrence of self-sustaining,
uncontrollable increases in temperature or pressure.
    3. Not emit explosive or toxic gases, either in normal operation or
as a result of its failure, that may accumulate in hazardous quantities
within the airplane.
    4. Meet the requirements of Sec.  25.863.
    5. Not damage surrounding structure or adjacent systems, equipment,
or electrical wiring from corrosive fluids or gases that may escape in
such a way as to cause a major or more severe failure condition.
    6. Have provisions to prevent any hazardous effect on airplane
structure or systems caused by the maximum amount of heat it can
generate due to any failure of it or its individual cells.
    7. Have a failure sensing and warning system to alert the
flightcrew if its failure affects safe operation of the airplane.
    8. Have a means for the flightcrew or maintenance personnel to
determine the battery charge state if the battery's function is
required for safe operation of the airplane.

    Note: A battery system consists of the battery and any
protective, monitoring, and alerting circuitry or hardware inside or
outside of the battery. It also includes vents (where necessary) and
packaging. For the purpose of these special conditions, a
``battery'' and ``battery system'' are referred to as a battery.

    Issued in Renton, Washington, on May 9, 2017.
Michael Kaszycki,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
[FR Doc. 2017-09844 Filed 5-15-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53107]
[FR Doc No: 2021-20706]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4494-DR; Docket ID FEMA-2021-0001]

Michigan; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Michigan (FEMA-4494-DR), dated March 27, 2020, and
related determinations.

DATES: This amendment was issued August 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
dated March 27, 2020 for the State of Michigan is hereby amended to
include the Hazard Mitigation Grant Program.

    All areas within the State of Michigan are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-20706 Filed 9-23-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 21, 2009 (Volume 74, Number 75)]
[Rules and Regulations]
[Page 18148-18149]
[DOCID:fr21ap09-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0863; FRL-8784-2]

Revisions to the California State Implementation Plan, Approval
of the Ventura County Air Pollution Control District--Reasonably
Available Control Technology Analysis

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the Ventura County
Air Pollution Control District portion of the California State
Implementation Plan (SIP). These revisions were proposed in the Federal
Register on December 12, 2008 and concern the District's analysis of
whether its rules met reasonably available control technology (RACT)
under the 8-hour ozone National Ambient Air Quality Standards (NAAQS).
We are approving the analysis under the Clean Air Act as amended in
1990 (CAA or the Act).

DATES: Effective Date: This rule is effective on May 21, 2009.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2008-0863 for
this action. The index to the docket is available electronically at
http://www.regulations.gov and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco, California. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, (415)
947-4122<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On December 12, 2008 (73 FR 75626), EPA proposed to approve the
following document into the California SIP.

----------------------------------------------------------------------------------------------------------------
           Local agency                           Document                      Adopted            Submitted
----------------------------------------------------------------------------------------------------------------
VCAPCD............................  2006 Reasonably Available Control    06/27/06............  01/31/07
                                     Technology Analysis.
----------------------------------------------------------------------------------------------------------------

    We proposed to approve this analysis and certification because we
determined that they complied with the relevant CAA requirements. Our
proposed action contains more information on the submitted RACT
analysis and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, no comments were received.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted RACT analysis complies with the relevant CAA requirements
under the 8-hour ozone NAAQS. Therefore, as authorized in section
110(k)(3) of the Act, EPA is fully approving this document into the
California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 22, 2009. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: March 5, 2009.
Jane Diamond,
Acting Regional Administrator, Region IX.

0
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(358)(i)(B) to read
as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (358) * * *
    (i) * * *
    (B) Ventura County Air Pollution Control District.
    (1) Ventura County Air Pollution Control Board Resolution approving
and adopting the 2006 Reasonably Available Control Technology State
Implementation Plan Revision, dated June 27, 2006.
    (2) Final Ventura County Air Pollution Control District 2006
Reasonably Available Control Technology (RACT) State Implementation
Plan (SIP) Revision, including Tables A-1, A-2, B, C, and D, dated June
27, 2006.
* * * * *
[FR Doc. E9-9021 Filed 4-20-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 214 (Friday, November 4, 2011)]
[Rules and Regulations]
[Pages 68317-68322]
[FR Doc No: 2011-28527]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2009-0556; FRL-9486-2]

Approval and Promulgation of Air Quality Implementation Plans;
North Dakota; Revisions to the Air Pollution Control Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving revisions to the North Dakota State
Implementation Plan (SIP) that the Governor of North Dakota submitted
with a letter dated April 6, 2009. The revisions affect North Dakota's
air pollution control rules regarding general provisions (including
rules regarding shutdowns and malfunctions), ambient air quality
standards, emissions of particulate matter, permitting, and fees. In
addition, EPA is making administrative corrections to the regulatory
text for North Dakota that will be codified in the Code of Federal
Regulations; we made errors in the identification of plan table when we
approved the North Dakota State Implementation Plan revisions for
Interstate Transport of pollution, which the Governor also submitted on
April 6, 2009. EPA proposed approval of these rules on May 5, 2011 and
received no adverse comments. This action is being taken under section
110 of the Clean Air Act (CAA).

DATES: This action is effective on December 5, 2011.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R08-OAR-2009-0556. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at EPA Region 8, Air Quality Planning Unit (8P-AR), 1595
Wynkoop Street, Denver, Colorado 80202. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jody Ostendorf, Air Program, Mailcode
8P-AR, Environmental Protection Agency, Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, the following definitions apply:
    (i) The words or initials Act or CAA mean or refer to the Federal
Clean Air

Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The initials NAAQS mean or refer to the National Ambient Air
Quality Standards.
    (v) The words State or ND mean the State of North Dakota, unless
the context indicates otherwise.
    (vi) The initials NDDH mean or refer to the North Dakota Department
of Health.

Table of Contents

I. Background
II. Analysis of SIP Revisions
III. Corrections to Regulatory Text
IV. Response to Comments
V. Section 110(l)
VI. Final Action
VII. Statutory and Executive Order Reviews

I. Background

    The Act requires States to follow certain procedures in developing
implementation plans and plan revisions for submission to us. Sections
110(a)(2) and 110(l) of the Act provide that each implementation plan
must be adopted after reasonable notice and public hearing.
    To provide for public comment, the North Dakota Department of
Health (NDDH), after providing notice, held a public hearing on October
7, 2008 to consider the revisions to the Air Pollution Control Rules.
Following the public hearing, comment period, and legal review by the
North Dakota Attorney General's Office, NDDH adopted the revisions. The
revisions to the Air Pollution Control Rules became effective on April
1, 2009. The North Dakota Governor submitted the SIP revisions to us
with a letter dated April 6, 2009. This submittal also included (1) SIP
revisions to address Interstate Transport requirements related to the
1997 8-hour ozone and PM2.5 NAAQS, which we acted on in 2010
(75 FR 31290, June 3, 2010, and 75 FR 71023, November 22, 2010), and
(2) SIP revisions (commonly referred to as ``infrastructure''
requirements) to address implementation of current NAAQS for
PM10, PM2.5, and ozone, which we will be acting
on separately. In our June 3, 2010 and November 22, 2010 actions on
North Dakota's Interstate Transport SIP revisions, we made errors in
the identification of plan table located in 40 CFR 52.1820(e). We
describe these errors in section III, below.

II. Analysis of SIP Revisions

    The SIP revisions in the April 6, 2009 submittal that we are acting
on in this document involve the following chapters of the North Dakota
Administrative Code (N.D.A.C.): 33-15-01, ``General Provisions;'' 33-
15-02, ``Ambient Air Quality Standards;'' 33-15-05, ``Emissions of
Particulate Matter Restricted;'' 33-15-14, ``Designated Air Contaminant
Sources, Permit to Construct, Minor Source Permit to Operate, Title V
Permit to Operate;'' and 33-15-23, ``Fees.'' The following is our
description and analysis of the revisions.

A. Chapter 33-15-01, N.D.A.C., General Provisions

    The State revised sections 33-15-01-04, 33-15-01-05, and 33-15-01-
13 and submitted the entire revised sections to us for approval. In
section 33-15-01-04, the State made the following changes: (1) The
State revised the definition of ``air contaminant'' to add the words,
``emitted to the ambient air'' to the end of the definition; (2) the
State added definitions for ``excess emissions'' and
``PM2.5;'' (3) the State re-numbered the definitions to
account for the addition of new definitions; and (4) the State cross-
referenced and incorporated by reference the version of 40 CFR
51.100(s) as it existed on March 1, 2008 for purposes of defining
``volatile organic compounds'' (the prior date used was January 1,
2006). These changes are minor and are consistent with relevant CAA and
regulatory requirements.
    In section 33-15-01-05, the State added abbreviations for PM and
PM2.5. These revisions are minor and are consistent with the
CAA.
    The State made several revisions to 33-15-01-13, ``Shutdown and
Malfunction of an Installation--Requirement for notification.'' In 33-
15-01-13.1, ``Maintenance shutdowns,'' the State adopted new
subdivision f, which reads, ``Nothing in this subsection shall in any
manner be construed as authorizing or legalizing the emission of air
contaminants in excess of the rate allowed by this article or a permit
issued pursuant to this article.'' Previously, we had been concerned
that the language of 33-15-01-13.1 could be construed as exempting from
enforcement excess emissions during shutdown of air pollution control
equipment for scheduled maintenance. EPA's interpretation is that the
CAA requires that all periods of excess emissions, regardless of cause,
be treated as violations and that automatic exemptions from emissions
limits are not appropriate.\1\ Subdivision f clarifies that excess
emissions are not authorized during maintenance shutdowns. Subdivision
f is consistent with CAA requirements.
---------------------------------------------------------------------------

    \1\ This interpretation has been expressed in several documents.
Most relevant to this action are the following: memorandum dated
September 28, 1982, from Kathleen M. Bennett, Assistant
Administrator for Air, Noise, and Radiation, entitled ``Policy on
Excess Emissions During Startup, Shutdown, Maintenance, and
Malfunctions'' (the 1982 Memorandum); a clarification to that
memorandum from Kathleen M. Bennett issued on February 15, 1983 (the
1983 Memorandum); and a memorandum dated September 20, 1999 entitled
``State Implementation Plans: Policy Regarding Excess Emissions
During Malfunctions, Startup, and Shutdown,'' from Steven A. Herman,
Assistant Administrator for Enforcement and Compliance Assurance,
and Robert Perciasepe, Assistant Administrator for Air and Radiation
(the 1999 Memorandum). As explained in these memoranda, because
excess emissions might aggravate air quality so as to prevent
attainment and maintenance of the NAAQS and compliance with other
CAA requirements, EPA views all periods of excess emissions as
violations of the applicable emission limitation. Therefore, EPA
will disapprove SIP revisions that automatically exempt from
enforcement excess emissions claimed to result from an equipment
malfunction. In addition, as made explicit in the 1999 Memorandum,
EPA will disapprove SIP revisions that give discretion to a state
director to determine whether an instance of excess emissions is a
violation of an emission limitation, because such a determination
could bar EPA and citizens from enforcing applicable requirements.
---------------------------------------------------------------------------

    In 33-15-01-13.2, ``Malfunctions,'' the State removed certain
language and added other language. In 33-15-01-13.2.a, the State
removed language indicating that the State could permit the continued
operation of an installation during a malfunction resulting in a
violation of an emissions limit. We were concerned that this language
could be construed to exempt excess emissions caused by malfunctions
when the State granted permission to continue operations. EPA's
interpretation is that such an exemption would be inconsistent with the
CAA. The removal of the language is consistent with CAA requirements.
    The State added 33-15-01-13.2.c to 33-15-01-13.2. This new
subdivision c identifies procedures sources and the State will follow
with respect to unavoidable malfunctions. Where a source believes that
excess emissions have resulted from an unavoidable malfunction, the
source must submit a written report to the State that includes evidence
relevant to six criteria specified in the rule. The report must be
submitted within thirty days of the end of the calendar quarter in
which the malfunction occurred or within thirty days of a written
request by North Dakota, whichever is sooner. The rule provides that
North Dakota will evaluate

the information submitted by the source on a case-by-case basis to
determine whether to pursue an enforcement action and that North Dakota
may elect not to pursue an enforcement action after considering whether
excess emissions resulted from an unavoidable equipment malfunction.
The rule also provides that the burden of proof is on the source to
provide sufficient information to demonstrate that an unavoidable
equipment malfunction occurred.
    Under EPA's interpretations of the CAA as set forth in the 1982,
1983, and 1999 Memoranda, if a state in its SIP chooses to address
violations that occur as a result of claimed malfunctions, the state
may take two approaches. The first, the ``enforcement discretion''
approach, allows a state director to refrain from taking an enforcement
action for a violation if certain criteria are met. The second, the
``affirmative defense'' approach, allows a source to avoid penalties if
it can prove that certain conditions are met. North Dakota's 33-15-01-
13.2.c follows the enforcement discretion approach.
    We have evaluated North Dakota's enforcement discretion provisions
for excess emissions caused by unavoidable equipment malfunctions and
find that they are consistent with EPA's interpretations of the CAA as
described in the memoranda above. In particular, the criteria specified
in 33-15-01-13.2.c that the State will consider in deciding whether to
pursue an enforcement action generally parallel the criteria outlined
in the 1982 and 1983 Memoranda.
    As noted in footnote 1, above, the 1999 Memorandum also discusses a
point not explicitly addressed in North Dakota's new rule--i.e., EPA
will not approve SIP revisions that recognize or appear to recognize a
state's decision not to pursue enforcement as barring enforcement
action by EPA or citizens. Rule 33-15-01-13.2.c only addresses the
State's exercise of its enforcement discretion and contains no language
suggesting that a State decision not to pursue an enforcement action
for a particular violation bars EPA or citizens from taking an
enforcement action. Therefore, EPA interprets the rule, consistent with
EPA's interpretations of the CAA, as not barring EPA and citizen
enforcement of violations of applicable requirements when the State
declines enforcement.
    In 33-15-01-13.3, ``Continuous emission monitoring system
failures,'' the State removed the phrase, ``acceptable to the
department,'' from the text, ``When a failure of a continuous emission
monitoring system occurs, an alternative method, acceptable to the
department, for measuring or estimating emissions must be undertaken as
soon as possible.'' Following this sentence, the State added a new
sentence that reads as follows: ``The owner or operator of a source
that uses an alternative method shall have the burden of demonstrating
that the method is accurate.'' We had asked the State to remove the
language ``acceptable to the department'' from the rule and find that
the new language is consistent with CAA requirements.
    In previous rulemakings, we referenced an April 11, 2003 submission
of revisions to 33-15-01-13 and indicated that we would act on that
submission at a later date. See 69 FR 61762, October 21, 2004; 70 FR
45539, October 8, 2005; and 71 FR 3764, January 24, 2006. However, in
an August 17, 2009 letter, North Dakota advised EPA that the April 11,
2003 submission erroneously indicated there had been revisions to 33-
15-01-13.1.d, and that in fact the cited revisions to 33-15-01-13.1.d
had not been adopted and were not submitted to EPA with the Governor's
April 11, 2003 letter. Therefore, there are no remaining revisions from
the April 11, 2003 submittal awaiting EPA's action.

B. Chapter 33-15-02, N.D.A.C., Ambient Air Quality Standards

    Table 1 was revised to amend the PM10 and ozone
standards and to add the 2006 PM 2.5 standard. These
revisions were made to reflect the Federal standards and are consistent
with CAA requirements.

C. Chapter 33-15-05, N.D.A.C., Emissions of Particulate Matter
Restricted

    The State removed section 33-15-05-03.2.2.d., which provided that
the State could approve continued operation of a trash incinerator
during a malfunction of combustion equipment, emission control
equipment, monitoring equipment, or waste charging equipment. We were
concerned that section 33-15-05-03.2.2.d could be construed to exempt
excess emissions at trash incinerators caused by malfunctions when the
State granted permission to the source to continue operations. EPA's
interpretation is that such an exemption would be inconsistent with the
CAA. We asked the State to address our concern. The removal of section
33-15-05-03.2.2.d addresses our concern and is consistent with CAA
requirements. The SIP will no longer provide a potential exemption to
trash incinerators operating during malfunctions based on State
approval of continued operation during such periods. Instead,
malfunctions at trash incinerators would be treated the same as
malfunctions at other sources subject to SIP requirements--i.e., the
source would need to follow the procedures contained in section 33-15-
01-13.2.

D. Chapter 33-15-14, N.D.A.C., Designated Air Contaminant Sources,
Permit To Construct, Minor Source Permit To Operate, Title V Permit To
Operate

    In section 33-15-14-01, ``Designated Air Contaminant Sources,'' the
State revised the list of sources ``capable of causing or contributing
to air pollution.'' Specifically, the State added the word ``major'' to
33-15-14-01.14 so that it now reads as follows: ``Any major source to
which a national emission standard for hazardous air pollutants for
source categories (40 CFR 63) would apply.'' This change only affects
the applicability of certain permitting requirements contained in
Chapter 33-15-14. It does not affect emission limits in the SIP or
other requirements that would affect ambient concentrations of criteria
pollutants. It also does not affect the applicability of 40 CFR part 63
requirements. This change is consistent with CAA requirements.

E. Chapter 33-15-23, N.D.A.C., Fees

    The State revised section 33-15-23-03, ``Minor source permit to
operate fees.'' The State simplified the definition of a ``designated''
source. (The rule establishes a fee for designated sources.) The State
also expanded the exemption from fees for State government facilities
to include local government facilities. This latter revision simply
codified the State's standing practice of not collecting fees from
local governments. In addition, the State made a minor change to the
due date for sources to submit the annual permit fee; the fee is now
due within 60 days following the date of the State's fee notice rather
than within 60 days of receipt of the fee notice. These are minor
clarifying changes that do not impact compliance with CAA requirements.

III. Corrections to Regulatory Text

    On June 3, 2010 and November 22, 2010 we published final rules
approving portions of the revised North Dakota SIP for Interstate
Transport of Pollution for the 1997 PM2.5 and 8-Hour Ozone
NAAQS. See 75 FR 31290 and 75 FR 71023. When we published those rules,
we included regulatory text that was incorrect. Specifically, we made
errors in the ``Identification of plan'' table contained in 40 CFR
52.1820(e), ``EPA-

approved nonregulatory provisions.'' As published in our November 22,
2010 action (which augmented and revised the table contained in our
June 3, 2010 action), the first portion of the explanation for item (1)
In the table read as follows: ``Excluding subsequent revisions, as
follows: Chapters 1, 2, 6, 7, 9, 11, and 12; Sections 2.11, 3.7, 6.8,
6.10, 6.11, 6.13, 7.7, and 8.3; subsections 7.8.1.B., 7.8.1.D., and
8.3.1.'' \2\ It should have read, ``Excluding subsequent revisions, as
follows: Chapters 6, 11, and 12; Sections 2.11, 3.7, 6.10, 6.11, 6.13,
and 8.3; and Subsections 3.2.1, 5.2.1, 7.8.1.A, 7.8.1.B, 7.8.1.C, and
8.3.1.'' We also incorrectly listed the submittal date for items (21)
and (22) in the table as 4/09/09 instead of 4/06/09. We are also
revising part of the explanation for item (21) without changing its
meaning. Therefore, we are correcting the identification of plan table
in 40 CFR 52.1820(e) accordingly.
---------------------------------------------------------------------------

    \2\ As of the date of signature of this action, the official,
published version of 40 CFR 52.1820 was current as of July 1, 2010
and does not reflect the regulatory language contained in our
November 22, 2010 action. The regulatory language as contained in
our November 22, 2010 action does appear in the unofficial
electronic CFR on the GPOAccess Web site: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=4d2eed6d6a2a14bd914c123a19f553c3&rgn=div8&view=text&node=40:<IP_ADDRESS>.<IP_ADDRESS>&idno=40.
---------------------------------------------------------------------------

IV. Response to Comments

    EPA did not receive any adverse comments on our May 5, 2011
proposal.

V. Section 110(l)

    Under section 110(l) of the CAA, EPA cannot approve a SIP revision
if the revision would interfere with any applicable requirement
concerning attainment and reasonable further progress toward attainment
of the NAAQS or any other applicable requirement of the Act. As
described in section II, above, most of the revisions we are approving
conform the North Dakota SIP to relevant CAA requirements. In
particular, the State revised shutdown and malfunction provisions to
comport with CAA requirements. The other changes we are approving are
minor and will not interfere with attainment or reasonable further
progress toward attainment of the NAAQS \3\ or any other CAA
requirements.
---------------------------------------------------------------------------

    \3\ North Dakota has no nonattainment areas. Thus, CAA part D
requirements, including the requirement to make reasonable further
progress toward attainment, do not apply in North Dakota.
---------------------------------------------------------------------------

VI. Final Action

    EPA is approving revisions to the North Dakota SIP that the
Governor of North Dakota submitted with a letter dated April 6, 2009
and that were State-effective April 1, 2009. Specifically, EPA is
approving North Dakota's revisions to the following portions of the
North Dakota Administrative Code: Chapter 33-15-01, ``General
Provisions,'' sections 33-15-01-04, 33-15-01-05, and 33-15-01-13;
Chapter 33-15-02, ``Ambient Air Quality Standards,'' section 33-15-02,
Table 1; Chapter 33-15-05, ``Emissions of Particulate Matter
Restricted,'' subsection 33-15-05-03.2.2; Chapter 33-15-14,
``Designated Air Contaminant Sources, Permit to Construct, Minor Source
Permit to Operate, Title V Permit to Operate,'' subsection 33-15-14-
01.14; and Chapter 33-15-23, ``Fees,'' section 33-15-23-03. See section
II of this action, above, for a description of these revisions.
    In addition, EPA is making administrative corrections to the
regulatory text for North Dakota that will appear in the Code of
Federal Regulations. Specifically, we are changing the identification
of plan table that will appear at 40 CFR 52.1820(e) as follows:
    a. We are changing the first portion of the explanation for item
(1) in the table to read, ``Excluding subsequent revisions, as follows:
Chapters 6, 11, and 12; Sections 2.11, 3.7, 6.10, 6.11, 6.13, and 8.3;
and Subsections 3.2.1, 5.2.1, 7.8.1.A, 7.8.1.B, 7.8.1.C, and 8.3.1.''
    b. We are changing the submittal dates for items (21) and (22) in
the table to read, ``4/06/09,'' and revising part of the explanation
for item (21) without changing its meaning.
    See section III of this action, above, for further information
regarding these corrections.

VII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' under the terms
of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Volatile organic compounds,
Incorporation by reference.

    Dated: October 25, 2011.
James B. Martin,
Regional Administrator, Region 8.

    40 CFR part 52 is amended to read as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart JJ--North Dakota

0
2. Section 52.1820 is amended as follows:
0
a. In paragraph (c) by revising the table entries for ``33-15-01-04;''
``33-15-01-05;'' ``33-15-01-13,'' ``33-15-02, Table 1;'' ``33-15-05-
03.2;'' ``33-15-14-01;'' and ``33-15-23-03;'' and by removing the entry
for ``33-15-14-01.1''.
0
b. In paragraph (e) by revising the table entries for ``(1)'',
``(21)'', and ``(22).''

Sec.  52.1820  Identification of plan.

* * * * *
    (c) * * *

                                        State of North Dakota Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State       EPA approval date and
         State citation             Title/subject    effective date        citation \1\          Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
33-15-01-04....................  Definitions.......          4/1/09  11/4/11, [Insert
                                                                      Federal Register page
                                                                      number where the
                                                                      document begins.].
33-15-01-05....................  Abbreviations.....          4/1/09  11/4/11, [Insert
                                                                      Federal Register page
                                                                      number where the
                                                                      document begins.].

                                                  * * * * * * *
33-15-01-13....................  Shutdown and                4/1/09  11/4/11, [Insert
                                  malfunction of an                   Federal Register page
                                  installation--Req                   number where the
                                  uirement for                        document begins.].
                                  notification.

                                                  * * * * * * *
33-15-02, Table 1..............  Ambient Air                 4/1/09  11/4/11, [Insert
                                  Quality Standards.                  Federal Register page
                                                                      number where the
                                                                      document begins.].

                                                  * * * * * * *
33-15-05-03.2..................  Refuse                      4/1/09  11/4/11, [Insert
                                  incinerators.                       Federal Register page
                                                                      number where the
                                                                      document begins.].

                                                  * * * * * * *
33-15-14-01....................  Designated air              8/1/95  11/4/11, [Insert
                                  contaminant                         Federal Register page
                                  sources.                            number where the
                                                                      document begins.].

                                                  * * * * * * *
33-15-23-03....................  Minor source                4/1/09  11/4/11, [Insert
                                  permit to operate                   Federal Register page
                                  fees.                               number where the
                                                                      document begins.].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                      Applicable        State submittal    EPA approval
   Name of nonregulatory SIP     geographic or  non-     date/adopted        date and           Explanations
           provision               attainment area           date          citation \3\
----------------------------------------------------------------------------------------------------------------
(1) Implementation Plan for     Statewide............  Submitted: 1/24/  5/31/72, 37 FR    Excluding subsequent
 the Control of Air Pollution                           72; Adopted: 1/   10842.            revisions, as
 for the State of North Dakota.                         24/72.                              follows: Chapters 6,
                                                                                11, and 12; Sections
                                                                                2.11, 3.7, 6.10,
                                                                                6.11, 6.13, and 8.3;
                                                                                and Subsections
                                                                                3.2.1, 5.2.1,
                                                                                7.8.1.A, 7.8.1.B,
                                                                                7.8.1.C, and 8.3.1.
                                                                                Revisions to these
                                                                                non-regulatory
                                                                                provisions have
                                                                                subsequently been
                                                                                approved. See below.
Chapters:
    1. Introduction...........  .....................  Clarification     With all
                                                        submitted: 6/14/  clarifications:
                                                        73, 2/19/74, 6/   3/2/76, 41 FR
                                                        26/74, 11/21/     8956.
                                                        74, 4/23/75.
    2. Legal Authority........
    3. Control Strategy.......
    4. Compliance Schedule....
    5. Prevention of Air
     Pollution Emergency
     Episodes.

    7. Review of New Sources
     and Modifications.
    8. Source Surveillance....
    9. Resources..............
    10. Inter-governmental
     Cooperation.
    11. Rules and Regulations.
With subsequent revisions to
 the chapters as follows:

                                                  * * * * * * *
(21) Section 7.8, Interstate    Statewide............  Submitted: 4/6/   6/3/10, 75 FR     Includes portions of
 Transport of Air Pollution                             09; Adopted: 4/   31290.            Subsection 7.8.1 as
 (only 7.8.1.A, portions of                             01/09.                              indicated below:
 7.8.1.B, and 7.8.1.C, see                                                                  7.8.1.A,
 explanation).                                                                              ``Overview,'' the
                                                                                language of
                                                                                Subsection 7.8.1.B,
                                                                                ``Nonattainment and
                                                                                Maintenance Area
                                                                                Impact,'' that
                                                                                specifically
                                                                                addresses the
                                                                                ``significant
                                                                                contribution to
                                                                                nonattainment''
                                                                                requirement of CAA
                                                                                Section
                                                                                110(a)(2)(D)(i), and
                                                                                all of 7.8.1.C.
(22) Section 7.8, Interstate    Statewide............  Submitted: 4/6/   11/22/10, 75 FR   Includes portions of
 Transport of Air Pollution                             09; Adopted: 4/   71023.            Subsection 7.8.1.B,
 (only portion of 7.8.1.B).                             01/09.                              ``Nonattainment and
                                                                                Maintenance Area
                                                                                Impact,'' that
                                                                                specifically address
                                                                                the ``interference
                                                                                with maintenance''
                                                                                requirement of CAA
                                                                                Section
                                                                                110(a)(2)(D)(i).
----------------------------------------------------------------------------------------------------------------
\3\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

[FR Doc. 2011-28527 Filed 11-1-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33309-33310]
[FR Doc No: 2021-13394]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0409]

COVID-19: Master Protocols Evaluating Drugs and Biological
Products for Treatment or Prevention; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``COVID-19:
Master Protocols Evaluating Drugs and Biological Products for Treatment
or Prevention.'' FDA is issuing this guidance to assist sponsors
developing master protocols for trials evaluating drugs and biological
products for the treatment or prevention of COVID-19. This guidance
primarily focuses on the trial design and conduct as well as
statistical considerations for master protocols intended to generate
substantial evidence of effectiveness and adequate characterization of
safety for COVID-19. Additionally, this guidance provides
administrative and procedural recommendations to sponsors of master
protocols for COVID-19. Given the public health emergency presented by
COVID-19, this guidance document is being implemented without prior
public comment because FDA has determined that prior public
participation is not feasible or appropriate, but it remains subject to
comment in accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on June 24, 2021. The guidance document is immediately in
effect, but it remains subject to comment in accordance with the
Agency's good guidance practices.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0409 for ``COVID-19: Master Protocols Evaluating Drugs and
Biological Products for Treatment or Prevention.'' Received comments
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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ei Thu Lwin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6236, Silver Spring, MD 20993-0002, 301-
796-0728; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled

``COVID-19: Master Protocols Evaluating Drugs and Biological Products
for Treatment or Prevention.'' This guidance describes FDA's current
recommendations regarding master protocols for trials evaluating drugs
and biological products for the treatment or prevention of COVID-19.
Well-designed and -conducted master protocols can accelerate drug
development by maximizing the amount of information obtained from the
research effort. These efficiencies are of particular importance in the
setting of a public health emergency such as the current COVID-19
pandemic, where the burden of disease is high and there is a critical
need for the development of therapies. This guidance focuses on the
trial design and conduct as well as statistical considerations for
master protocols intended to generate substantial evidence of
effectiveness and adequate characterization of safety for COVID-19.
Additionally, this guidance provides administrative and procedural
recommendations to sponsors of master protocols for COVID-19.
    In light of the public health emergency related to COVID-19
declared by the Secretary of the Department of Health and Human
Services (HHS), FDA has determined that prior public participation for
this guidance is not feasible or appropriate and is issuing this
guidance without prior public comment (see section 701(h)(1)(C)(i) of
the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This
guidance document is being implemented immediately, but it remains
subject to comment in accordance with the Agency's good guidance
practice statute and regulation.
    This guidance is intended to remain in effect for the duration of
the public health emergency related to COVID-19 declared by HHS,
including any renewals made by the Secretary in accordance with section
319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
However, the recommendations and processes described in the guidance
are expected to assist the Agency more broadly in its continued efforts
to assist sponsors in the clinical development of drugs for the
treatment or prevention of COVID-19 beyond the termination of the
COVID-19 public health emergency and reflect the Agency's current
thinking on this issue. Therefore, within 60 days following the
termination of the public health emergency, FDA intends to revise and
replace this guidance with any appropriate changes based on comments
received on this guidance and the Agency's experience with
implementation.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``COVID-19: Master Protocols Evaluating
Drugs and Biological Products for Treatment or Prevention.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312, Investigational New Drug
Application, have been approved under OMB control number 0910-0014 and
the collections of information required for institutional review boards
and informed consent are approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents,
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov.

    Dated: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13394 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P