[Federal Register Volume 81, Number 217 (Wednesday, November 9, 2016)]
[Notices]
[Page 78896]
[FR Doc No: 2016-27092]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Office of Commercial Space Transportation; Adoption and Notice of
Availability of the Finding of No Significant Impact (FONSI) for Boost-
back and Landing of the Falcon 9 Full Thrust First Stage at SLC-4 West
at Vandenberg Air Force Base, California and Offshore Landing
Contingency Option

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of availability of the FONSI.

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SUMMARY: In accordance with the National Environmental Policy Act of
1969, as amended (NEPA; 42 United States Code 4321 et seq.), Council on
Environmental Quality (CEQ) NEPA implementing regulations (40 Code of
Federal Regulations [CFR] parts 1500 to 1508), and FAA Order 1050.1F,
Environmental Impacts: Policies and Procedures, the FAA is announcing
the adoption of, and availability of a FONSI for, the U.S. Air Force's
(USAF's) Environmental Assessment, Boost-Back and Landing of the Falcon
9 Full Thrust First Stage at SLC-4 West, Vandenberg Air Force Base,
California and Offshore Landing Contingency Option (EA).

FOR FURTHER INFORMATION CONTACT: Mr. Daniel Czelusniak, Environmental
Specialist, Federal Aviation Administration, 800 Independence Ave. SW.,
Room 325, Washington, DC 20591; email<EMAIL_ADDRESS>or
phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The USAF acted as the lead agency, and the
FAA was a cooperating agency, in the preparation of the EA. The EA
analyzed the potential environmental impacts of Space Exploration
Technologies Corp. (SpaceX) constructing a landing pad and improving
infrastructure at Space Launch Complex 4 West (SLC-4W) at Vandenberg
Air Force Base (VAFB), as well as conducting boost-backs and landings
of the Falcon 9 first stage booster at SLC-4W or on a special-purpose
barge, no less than 31 miles offshore in the Pacific Ocean. The EA was
prepared in accordance with NEPA, CEQ NEPA implementing regulations,
the USAF's Environmental Impact Analysis Process (32 CFR 989), and FAA
Order 1050.1F, Environmental Impacts: Policies and Procedures.
    As the activities considered in the EA would require Federal
actions (as defined in 40 CFR 1508.18) involving the USAF and FAA, the
EA was prepared to satisfy the NEPA obligations of both agencies. The
FAA's Federal action in this matter pertains to its role in issuing
licenses for the operation of commercial launch and reentry vehicles at
launch sites. The USAF issued a FONSI on April 26, 2016, which stated
that implementing the Proposed Action would not have a significant
effect on the human environment. Based upon its independent review and
consideration of the EA, the FAA formally adopts the EA--concurring
with the EA's analysis of impacts and findings--and issues a FONSI to
support the issuance of launch licenses to SpaceX for Falcon 9 boost-
back and landing operations at VAFB or in the Pacific Ocean. If, in
their license application to the FAA, SpaceX makes changes to their
operations which fall outside the scope of the EA, additional
environmental review would be required prior to the FAA issuing a
license associated with such an application.
    After reviewing and analyzing available data and information on
existing conditions and potential impacts, the FAA has determined that
issuing launch licenses to SpaceX for Falcon 9 boost-back and landing
operations at VAFB or in the Pacific Ocean is a Federal action that
would not significantly affect the quality of the human environment
within the meaning of NEPA. The FAA made this determination in
accordance with all applicable environmental laws and FAA regulations.
    The FAA has posted the FONSI on the internet at http://www.faa.gov/about/office_org/headquarters_offices/ast/environmental/nepa_docs/review/launch/.

    Issued in Washington, DC on: November 2, 2016.
 Daniel Murray,
Manager, Space Transportation Development Division.
[FR Doc. 2016-27092 Filed 11-8-16; 8:45 am]
 BILLING CODE 4310-13-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26052-26054]
[FR Doc No: 2021-10011]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1156]

Q3D(R2)--Guideline for Elemental Impurities; International
Council for Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Q3D(R2)--
Guideline for Elemental Impurities.'' The draft guidance was prepared
under the auspices of the International Council for Harmonisation
(ICH), formerly the International Conference on Harmonisation. The
draft guidance provides Permissible Daily Exposures (PDEs) for the
cutaneous and transcutaneous routes of administration and relevant risk
assessment considerations to supplement previous guidance for the oral,
parenteral, and inhalation routes of administration. In addition, error
corrections to previously identified PDEs for gold (oral, parenteral,
and inhalation routes), silver (parenteral route), and nickel
(inhalation route) are provided. The draft guidance is intended to
recommend acceptable amounts for the listed elemental impurities in
pharmaceuticals for the safety of the patient and provide
recommendations for conducting a risk assessment for pharmaceutical
products.

DATES: Submit either electronic or written comments on the draft
guidance by June 11, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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-2013-D-1156 for ``Q3D(R2)--Guideline for Elemental Impurities.''
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 this 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 the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Timothy McGovern, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg 22, Rm. 6426, Silver Spring, MD 20993-0002, 240-
402-0477<EMAIL_ADDRESS>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,
240-402-7911.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Q3D(R2)--Guideline for Elemental Impurities.'' The draft
guidance was prepared under the auspices of ICH. ICH has the mission of
achieving greater regulatory harmonization worldwide to ensure that
safe, effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.

    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In September 2020, the ICH Assembly endorsed the draft guidance
entitled ``Q3D(R2)--Guideline for Elemental Impurities'' and agreed
that the guidance should be made available for public comment. The
draft guidance is the product of the Quality Expert Working Group of
the ICH. Comments about this draft guidance will be considered by FDA
and the Quality Expert Working Group.
    The draft guidance provides guidance on PDEs for the cutaneous and
transcutaneous routes of administration and relevant risk assessment
considerations to supplement previous guidance for the oral,
parenteral, and inhalation routes of administration. In addition, error
corrections to previously identified PDEs for gold (oral, parenteral,
and inhalation routes), silver (parenteral route), and nickel
(inhalation route) are provided.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``Q3D(R2)--Guideline for Elemental
Impurities.'' 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

    FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10011 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


worthwhile and obvious. The commenter believes that the proposed
modifications to 40 C.F.R. § 82 would further the purpose of minimizing
the use of class I and class II substances as stated in § 608 of the
CAA, and emphasizes the need for HVAC and industrial maintenance
industries to keep pace with the design and new construction industry as
they move towards more sustainable refrigerant technologies. The
commenter believes that any move towards the standardizing of
maintenance procedures and the decommissioning of cooling systems that
leak substantial levels of refrigerant is a step in the proper
direction. The commenter also describes a major corollary benefit
resulting from the decommissioning of repeatedly-leaking systems: the
replacement of those systems with more efficient systems, decreasing
industrial and commercial energy usage for HVAC and industrial
processes.  [0124]

General Opposition to the Proposed Regulations

EPA received seven comments stating general opposition to the proposed
regulations. Five commenters (USEC, FPA, CIBO, Alcoa Inc., and NEDA/CAP)
posit that the emission reduction benefits associated with the proposed
rule are not enough to justify the new requirements. Two of these five
commenters (USEC and FPA) question the cost-effectiveness of the
proposal. Three commenters (FPA, CIBO, and NEDA/CAP) are concerned that
the proposed regulations will add significant compliance costs and
impose a significant burden on the industry.  Three commenters (USEC,
FPA, and NEDA/CAP) state that EPA has failed to clarify, simplify, or
streamline existing regulations. One commenter believes that voluntary
partnerships (e.g., GreenChill) and other business incentives are the
way forward instead of regulations. Lastly, one commenter believes EPA
is overstepping its bounds by regulating GHG emissions.

USEC opposes the proposed changes and believes that EPA has not
clarified, simplified, or streamlined existing regulatory requirements.
USEC finds this this to be the case in several instances, including the
proposed changes to record-keeping requirements, full charge
determination methodology, leak rate calculations, etc. The commenter
asserts that many of the issues identified as requiring clarification
have already been addressed with the 1995 issuance of EPA 300-B-95-010,
Compliance Guidance for Industrial Process Refrigeration Leak Repair
Regulations under Section 608 of the CAA. Further, USEC states that many
of the current proposals conflict with information in the Compliance
Guidance which will make it of limited value if the proposals are
finalized. USEC questions what will replace the simple and
straightforward Compliance Guide, and raises issue with making changes
to practices that have been in place and accepted for over 15 years.
USEC conservatively estimates total costs for the proposed changes to be
$80 million, which is over double the amount of the cost of the
proposal’s preferred scenario (i.e., $38.2 million).  USEC’s
estimates include both a negative learning curve (incurring costs of up
to $27.6 million) and administrative expenses (incurring $13.7 million
across affected appliance owners/operators). Therefore, USEC states that
the proposed changes are not cost effective, especially considering the
current U.S. economic climate.  [0125]

FPA believes that some of the changes in the proposed rule clarify
requirements by eliminating phrases that may be confusing, while other
changes may add significant costs to compliance by adding new
requirements. Additionally, FPA believes that the proposed rule does not
“streamline” the leak detection and repair regulations at 40 CFR
Part 92, Subpart F. FPA asserts that the proposed regulation imposes
significant costs on certain FPA members who would be affected by lower
leak rates, repairs, and potential for appliance retrofits or
replacements.  Further, FPA opposes the proposed rules because they
believe EPA has not provided proper justification and because EPA’s
cost benefit analysis does not support the proposal.  [0152]

CIBO states that EPA’s proposed changes would make the current leak
detection and repair procedures even more burdensome and costly. Rather
than “simplifying” and “clarifying” the current rules, CIBO
believes that EPA is reducing flexibility for compliance. The commenter
believes that while EPA has done some work to try to quantify the costs
and benefits associated with revisions to leak rate trigger revisions,
EPA has not demonstrated benefits associated with the majority of the
changes proposed that are sufficient to justify proposed revisions, and
the revisions should, therefore, not be made. The commenter also
believes that the proposed regulations will impose a substantial burden
to the community that has adjusted to regulations that have been in
place for a substantial amount of time. CIBO asserts that industry will
continue to make significant investment in refrigerants with lower
ozone-depleting substances into the future.  [0145]

Alcoa Inc. strongly disagrees with EPA’s proposal to change well
established, long standing leak repair requirements via this rulemaking.
 The commenter believes that the relatively small reduction in
refrigerant emissions does not warrant the proposed change and states
that the more appropriate action would be to restate the regulatory
interpretation regarding leak repairs found in EPA’s final rule that
was published in the January 11, 2005 Federal Register. [0134]

NEDA/CAP does not support finalizing the proposed revisions to Section
608.  The commenter finds EPA’s statement that the proposed rule would
merely “streamline” the leak detection and repair regulations at 40
CFR part 82, Subpart F to be misleading. While NEDA/CAP agrees that some
of the changes clarify requirements by eliminating phrases that may be
confusing, other proposed revisions are likely to add significant
compliance costs for manufacturers and blur important distinctions
between industrial refrigeration and air conditioning systems. The
commenter notes that these changes are predicted to result in costs
between 30 and 50 times higher than the monetized benefits they are
intended to drive (i.e., reduction of “leaks” of ODS). The commenter
also states that the agency has provided little evidence of a problem
that these extensive costs will solve. [0151]

FMI notes that the commercial refrigeration industry has a strong
business incentive to prevent leaks in the first place, and to detect
and repair leaks as quickly as possible. The commenter notes that leaks
may result in significant costs due to product losses, food safety
hazards, and fewer perishable product offerings for customers. FMI
believes that the industry is not incentivized to minimize leaks by
regulations, but rather by the desire to provide consumers with quality
products and uphold environmental values. The commenter believes that
voluntary partnerships like GreenChill and the implementation of
industry best practices are already achieving many of the goals EPA
seeks to attain in the Proposed Rule. FMI asserts that these means,
rather than burdensome regulations, are the way to move forward in
continuing to reduce the emissions of ODS.  [0150]

An anonymous commenter opposes the proposed regulations on the grounds
that EPA is overstepping its boundaries in regulating GHG emissions.
[0098]

Applicability to systems with a charge less than or equal to 50 lbs

EPA received four comments requesting clarification on the applicability
of the rule to systems with a charge less than or equal to 50 lbs. Two
commenters (ESS and Occidental) believe there is some confusion around
using the language “greater than 50 lbs” instead of “50 lbs and
greater” per the 1993 rules. Similarly, one commenter seeks further
clarification on whether the requirements only apply to units with a
full charge greater than 50 lbs. One commenter seeks clarification on a
particular scenario that entails two independent refrigerant circuits,
each with 30 lbs of refrigerant.

ESS notes that the 1993 rules used the language “50 lbs and
greater,” and this proposed rule switched to “greater than 50
lbs,” which leaves a 50 lb., 0 oz. system in question. The commenter
believes that EPA must return to the original 1993 “50 lb. and
greater” statement so a person is not temped to assume EPA is
exempting a 50 pound, zero ounce system to eliminate this loophole.
[0140]

OCC states that EPA should confirm when issuing the final rule that
systems designed for a maximum of 50 pounds, are not subject to the leak
repair requirements of Section 608. In several sections of the rule and
in the proposal (FR Vol. 75, No. 240 Wednesday, December 15, 2010), the
requirements appear to apply only to units operating with charge levels
in excess of 50 pounds of refrigerant. Nonetheless, there has been some
confusion in the application of the rule concerning units with an exact
50 pound charge capacity. The commenter requests that the EPA confirm
that systems designed for no more than a 50 pound full charge are not
subject to the rule.  [0144]

CWI requests that further clarification be provided on whether this
proposed rule only applies to refrigeration units with a full charge
greater than 50 pounds of refrigerant. [0155]

One commenter would like to confirm that the threshold determination
should be made on a per circuit basis for systems that have multiple,
but independent refrigeration circuits. The commenter raises a
hypothetical example of a chiller that has 2 independent (physically
isolated from each other) refrigerant circuits, each with a charge of 30
pounds of refrigerant. The commenter presumes that because the circuits
are physically isolated from each other and the charge per circuit is
less than 50 pounds, the leak repair requirements for systems with a
charge greater than 50 pounds would not apply to this chiller.  [0132]

Preamble discussion of “knowingly venting”

EPA received two comments that disagree with EPA’s interpretation of
“knowingly venting” in the preamble. Bother commenters believe that
EPA’s interpretation is not authorized by Section 608 of the Clean Air
Act.

The Forum holds that EPA’s conclusion—that the mere existence or
knowledge of the existence of a leak below the leak trigger rate
constitutes a violation of the requirement not to knowingly vent—is
incorrect and is inconsistent with prior EPA guidance on the issue. The
commenter states that EPA is expanding the regulatory requirements by
inserting the word “all” in several places in front of the word
“leaks” to create a requirement that all leaks be repaired once an
appliance exceeds the applicable trigger rate. The Forum believes that
EPA’s guidance has long interpreted the regulations to require that
the leak rate be brought below the trigger level, not that every single
leak be discovered and repaired. The commenter points out that the
direct regulation of refrigerants during use also does not appear to be
authorized by Section 608, which refers to the use “during the
service, repair, or disposal of appliances and industrial process
refrigeration” and in terms of prohibitions prohibits knowingly
venting or releasing/disposing “in the course of maintaining,
servicing, repairing, or disposing of an appliance or industrial process
refrigeration.” The commenter believes that the proposed construction
of the “purpose” and “scope” provision combined with the
statements in the preamble seem to: 1) go beyond EPA’s authority and
2) expand the requirements without providing adequate notice to the
public. Further, the Forum states that EPA’s explanation of the
provision at page 78,560 of the preamble does not alert the reader that
the Agency is departing from a previously published interpretation and
making regulatory changes to try to effectuate that change in policy.
Before the Agency can issue a final rule that would adopt this more
stringent view, it must provide clear and adequate notice to interested
parties. Lastly, the commenter notes that EPA goes back and forth
between the use of the term “refrigerant” and “substance.” For
consistency, EPA should select one term and if it uses a different term
should explain if there is an intended difference in meaning.  [0148]

ACC believes EPA is mistaken in claiming that a failure to repair a
known leak from an appliance, when the leak rate is below the repair
trigger level, constitutes “knowingly venting” the refrigerant, or
that using a leaking appliance that is not required to be repaired under
Subpart F violates the CAA’s venting prohibition. ACC cites section
608(c)(1) of the CAA, which the commenter argues refers only to
maintaining, servicing, repairing, and disposing—not “using” a
refrigerant. ACC asserts that the statute does not address leaking that
may occur during the mere use of an appliance. ACC believes that in the
preamble to the final rule, EPA should disavow its interpretation of the
statute’s “knowingly vent” provision and acknowledge that it does
not apply to leaks during use of an appliance when the leak rate is less
than the repair threshold.  [0139]

Other Issues

EPA received seven comments on other issues related to the proposed
regulations.  Three comments (from Southern Company, TVA, and CIBO)
noted concern over the timing of implementing new leak rate
requirements.  NEDA/CAP is concerned with how EPA is considering ODS
substitutes with high GWPs. Coto Consulting requests that EPA hold a
webinar to summarize the public comments and discuss the final rule.
NRDC objects to the notion that it is appropriate to discount the
tonnage of GHG and ODS emissions emitted or avoided in the future. TVA
provided a copy of previous comments submitted August 31, 1998 regarding
Proposed Rule 63 FR 32043-32099; Protection of Stratospheric Ozone;
Refrigerant Recycling; and Substitute Refrigerants.

Southern Company and TVA believe that if EPA decides to finalize its
proposal to lower the leak rate trigger, the new requirements should be
phased in over a period of several years so that the replacement or
retrofitting of equipment could occur over a reasonable time, rather
than forcing numerous replacements all at once. [0135,0163]

CIBO objects to the brevity of the period between finalization of rules
and rule effectiveness date, saying that it is unreasonable to expect
facilities to be able to complete compliance preparations within the
required 60 days. The commenter believes that facilities will need
sufficient time to review full charge calculations for each of their
units; revise calculations; put in new procedures; and establish new
recordkeeping. [0145]

NEDA/CAP states that EPA should examine the policies and goals of the
CAA (Title VI) with respect to GHG emissions. The commenter believes
that the GWP of an ODS substitute is a critical aspect to be considered
and is concerned that, under the ODS substitution program, a number of
replacement options have very high GWPs (e.g., R-134A). NEDA/CAP also
states that it is incongruent that EPA requires retrofits of
manufacturing equipment that emit carbon dioxide, which has a much lower
GWP than R-134A and R-22.  [0150]

Coto Consulting requests that EPA hold a webinar to summarize the public
comments and discuss the final rule, and provide an estimate of when
this webinar, or (should the webinar not be possible) when the final
rule will take place.  [0161]

NRDC objects to the notion that it is appropriate to discount the
tonnage of GHG and ODS emissions emitted or avoided in the future (see
footnote discussing “undiscounted avoided emissions” on page
78,561). NRDC states that a ton is a ton whenever it is emitted;
likewise, a case of fatal skin cancer, non-fatal skin cancer, or
cataracts is a case whenever it occurs. NRDC says that EPA guidelines
should apply a discount rate only to the monetization of the costs and
benefits.  NRDC notes that they recently filed comments on the EPA and
Department of Transportation joint rulemaking to set GHG emission and
fuel economy standards under the CAA and the Energy Independence and
Security Act, and NRDC has provided a copy of those comments as an
attachment. NRDC states that the comments are equally applicable to
ozone-depleting and heat-trapping substances, which share the common
characteristic that the impacts of emissions – and the benefits of
avoided emissions – unfold over very long time periods. NRDC notes
that the comments set forth the reasons why conventional approaches to
discounting of the monetary value of these kinds of benefits are
inappropriate and recommend alternative, much lower discount rates. NRDC
believes that EPA should reject the idea of discounting physical
quantities, like tons of emissions or cases of skin cancer, and that the
stratospheric ozone program should continue its past practice of
presenting the data as they are, without any such discounting.  [0147]

TVA provided a copy of previous comments submitted August 31, 1998
regarding Proposed Rule 63 FR 32043-32099; Protection of Stratospheric
Ozone; Refrigerant Recycling; and Substitute Refrigerants.  In the 1998
comments, TVA suggests that for the calculation of “leak rate,” EPA
should select the option that provides a choice of annualizing or
rolling average; TVA notes that it is of paramount importance that every
effort be made to assure that each specific appliance is classified into
the “Type” (commercial, industrial process, comfort cooling) that
most closely fits to assure that no undue burden is placed on an
owner/operator of an appliance, resulting in the application of an
inappropriately low leak-rate; TVA suggests that the criteria upon which
a multi-level leak rate system is based should be reformulated; and TVA
proposes that refrigeration systems that use river water to cool
condenser tubes be placed in a new special category that is allowed a 35
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follows: “A field-erected refrigeration or comfort cooling system
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,ystem that consists of two components connected by pipe or tubing.  The
length of the pipe or tubing varies from one installation to another.
As a result the manufacturer has specified how much refrigerant is in a
full charge for the two components, but NOT for the pipe or tubing.  You
may calculate how much refrigerant is in the length of pipe or tubing
for your system and then add that amount to the manufacturers’
estimate for the two components.”

Draft Summary of Comments on HCFC Rulemaking 	-  PAGE   \* MERGEFORMAT
2 -				March 2014


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52329-52335]
[FR Doc No: 2016-18534]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]

Refuse To Accept Procedures for Premarket Tobacco Product
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a rule
describing when FDA will refuse to accept a tobacco product submission
(or application) because the application has not met a minimum
threshold for acceptability for FDA review. Under the rule, FDA will
refuse to accept a tobacco product submission, for example, that is not
in English, does not pertain to a tobacco product, or does not identify
the type of submission. By refusing to accept submissions that have the
deficiencies identified in the rule, FDA will be able to focus our
review resources on submissions that meet a threshold of acceptability
and encourage quality submissions. FDA is issuing this action directly
as a final rule because we believe there is little likelihood that we
will receive any significant adverse comments opposing the rule given
the specific deficiencies identified that will result in FDA's refusal
to accept the submission.

DATES: This rule is effective December 21, 2016. Submit either
electronic or written comments on this direct final rule by October 24,
2016. If we receive no significant adverse comments during the
specified comment period, we intend to publish a confirmation document
on or before the effective date by publication of a document in the
Federal Register.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1555 for ``Refuse to Accept Procedures for Premarket Tobacco
Submissions.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Paul Hart, Office
of Regulations, Center for Tobacco Products (CTP), Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose of the Rule

    FDA is issuing this refuse to accept rule under direct final rule
procedures. The rule identifies deficiencies that will result in FDA's
refusal to accept certain tobacco product submissions under sections
905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as amended by the Family Smoking Prevention and Tobacco Control
Act (Tobacco Control Act) (21 U.S.C. 387e, 387j, and 387k).\1\ Because
these submissions will be refused before they enter FDA's review queue,
more resources will be available for submissions that are ready for
further review. This rule establishes a refuse to accept process for
premarket tobacco product submissions, including premarket tobacco
product applications (PMTAs), modified risk tobacco product
applications (MRTPAs), substantial equivalence (SE) applications (also
called SE reports), and exemption requests (including subsequent
abbreviated reports).
---------------------------------------------------------------------------

    \1\ FDA has published a final rule extending the Agency's
``tobacco product'' authorities in the FD&C Act to all categories of
products that meet the statutory definition of ``tobacco product''
in the FD&C Act, except accessories of such newly deemed tobacco
products (Final Rule Deeming Tobacco Products To Be Subject to the
Federal Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Restrictions on the Sale
and Distribution of Tobacco Products and Required Warning Statements
for Tobacco Products (81 FR 28974, May 10, 2016)). This direct final
rule applies to all tobacco products FDA regulates under Chapter IX
of the FD&C Act.
---------------------------------------------------------------------------

B. Summary of the Major Provisions of the Regulatory Action

    The rule explains when FDA will refuse to accept a premarket
submission, including PMTAs, MRTPAs, SE applications, and exemption
requests (including subsequent abbreviated reports). The rule is based
on FDA's experience in reviewing these submissions. Under the rule, FDA
will refuse to accept a premarket submission that: (1) Does not pertain
to a tobacco product; (2) is not in English (or does not include a
complete translation); (3) is submitted in an electronic format that
FDA cannot process, read, review, or archive; (4) does not include the
applicant's contact information; (5) is from a foreign applicant and
does not include the name and contact information of an authorized U.S.
agent (authorized to act on behalf of the applicant for the
submission); (6) does not include a required form(s); (7) does not
identify the tobacco product; (8) does not identify the type of
submission; (9) does not include the signature of a responsible
official authorized to represent the applicant; or (10) does not
include an environmental assessment or claim of a categorical
exclusion, if applicable. If FDA refuses to accept the submission, FDA
will send the contact (if available) a notification. If the submission
is accepted for further review, FDA will send an acknowledgement
letter.

II. Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described the procedures on when and how the Agency will employ direct
final rulemaking (this guidance document may be accessed at http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm). We have
determined that this rule is appropriate for direct final rulemaking
because we believe it is noncontroversial and we anticipate no
significant adverse comments. Consistent with our procedures on direct
final rulemaking, FDA is publishing elsewhere in this issue of the
Federal Register a companion proposed rule with the same codified
language as this direct final rule to add a rule describing when FDA
would refuse to accept submissions due to deficiencies. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event that the direct final rule is withdrawn
because of any significant adverse comments. The comment period for the

direct final rule runs concurrently with the companion proposed rule.
    We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule action before its effective date by publication of a
notification in the Federal Register. A significant adverse comment is
defined as a comment that explains why the rule would be inappropriate,
including challenges to the rule's underlying premise or approach, or
would be ineffective or unacceptable without a change. In determining
whether an adverse comment is significant and warrants terminating a
direct final rulemaking, we will consider whether the comment raises an
issue serious enough to warrant a substantive response in a notice and
comment process in accordance with section 553 of the Administrative
Procedure Act (5 U.S.C. 553). Comments that are frivolous,
insubstantial, or outside the scope of the rule will not be considered
significant or adverse under this procedure. A comment recommending a
regulation change in addition to those in the rule would not be
considered a significant adverse comment unless the comment provides a
reasonable explanation for why the rule would be ineffective without
the additional change. In addition, if a significant adverse comment
applies to an amendment, paragraph, or section of this rule and that
provision can be severed from the remainder of the rule, we may adopt
as final those provisions of the rule that are not subject of a
significant adverse comment.
    If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of this direct
final rule, a document withdrawing the direct final rule. If we
withdraw the direct final rule, any comments received will be applied
to the proposed rule and will be considered in developing a final rule
using the usual notice and comment procedures. If FDA receives no
significant adverse comments during the specified comment period, FDA
intends to publish a confirmation document, before the effective date
of the direct final rule, confirming the effective date.

III. Purpose and Legal Authority

A. Purpose

    FDA is issuing this refuse to accept rule as a means of efficiently
handling submissions that do not meet a threshold of acceptability for
FDA review, e.g., the submission lacks certain information FDA needs
for substantive review of the submission. Currently, FDA often expends
extensive time and resources in attempts to obtain information and
resolve the deficiencies identified in the rule simply to begin
substantively processing the submission. FDA expects that the rule will
enhance the quality of the submissions and that submissions will move
expeditiously through the review process. In addition, this rule will
help submitters better understand the common hurdles FDA encounters in
conducting a substantive review of submissions.
    The rule identifies deficiencies that FDA has seen across types of
premarket submissions and will result in FDA refusing to accept the
submission. This rule applies to all tobacco product applications; we
note that there are additional deficiencies that are not covered in
this rule that may arise for specific types of premarket submissions
that will also result in FDA's refusal to accept that specific type of
premarket submission (e.g., a PMTA fails to contain specimens of the
labeling proposed to be used for such tobacco product under section
910(b)(1)(F) of the FD&C Act).
    FDA's refusal to accept a tobacco product submission will not
preclude an applicant from resubmitting a new submission that addresses
the deficiencies. In addition, acceptance of a submission will not mean
that FDA has determined that the submission is complete, but rather
only that the submission has met the basic, minimum threshold for
acceptance. Substantive review of the submission will begin once FDA
accepts the submission, and for submissions with filing requirements
(i.e., PMTAs and MRTPAs), once filed. The rule establishes a general
process for refusing to accept submissions for premarket tobacco
product review, including PMTAs, MRTPAs, SE applications, and exemption
requests (including subsequent abbreviated reports). Because
administratively incomplete submissions will be refused before FDA
begins substantive review, we will be able to use our resources on
submissions that are more complete and better prepared for further
review. In addition, FDA intends to determine, as soon as practicable,
whether the submission will be accepted. We expect the amount of time
it takes FDA to make this determination to be relatively quick,
however, it may vary depending on the volume of submissions received at
any one time. FDA remains committed to an efficient product review
process and intends to establish and implement performance goals for
this action once it has experience with the volume of submissions it
will receive after the deeming rule becomes effective. FDA expects the
performance goals to be generally similar to other Agency performance
goals, i.e. a certain percentage of RTA determinations made within a
defined period of time, and with the percentage rising over time.

B. Legal Authority

    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides FDA with
authority to issue regulations for the efficient enforcement of the
FD&C Act. This rule allows FDA to more efficiently use our resources to
review premarket submissions under sections 905, 910, and 911 of the
FD&C Act. FDA has processed and reviewed many submissions since the
enactment of the Tobacco Control Act, and submissions with the
deficiencies identified in the rule have been repeatedly identified by
FDA as reflecting submissions that are incomplete and not prepared for
further review.

IV. Description of the Direct Final Rule

    We are adding part 1105 (21 CFR part 1105) to title 21,
specifically Sec.  1105.10. Section 1105.10(a) provides that FDA will
refuse to accept, as soon as practicable, PMTAs, MRTPAs, SE
applications, and exemption requests (including subsequent abbreviated
reports), for the reasons listed in paragraphs (a)(1) through (10), if
applicable:
     Section 1105.10(a)(1) states that FDA will refuse to
accept a tobacco product submission that does not pertain to a tobacco
product. This provision addresses a submission that refers to a product
that does not meet the definition of a ``tobacco product'' under
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) and, therefore, is
not subject to FDA's tobacco product authorities.
     Section 1105.10(a)(2) states that FDA will refuse to
accept a submission that is not in the English language or does not
contain complete English translations of any information included with
the submission. FDA is unable to read and process such submissions.
     Section 1105.10(a)(3) provides that FDA will refuse to
accept a submission if it is provided in an electronic format that FDA
cannot process, read, review, and archive. As with submissions that are
not in English (or fail to include an English translation), FDA is
unable to read and process such submissions. FDA provides information
on the electronic formats that it can read, process, review, and
archive at http://www.fda.gov/tobaccoproducts/

guidancecomplianceregulatoryinformation/manufacturing/default.htm.
     Section 1105.10(a)(4) provides that FDA will refuse to
accept any submission that does not contain contact information,
including the applicant's name and address. If a submission omits the
contact information, FDA will not be able to contact the applicant
regarding the submission, e.g., with questions or followup related to
the submission. In this instance, FDA also will likely be unable to
provide notice of the Agency's refusal to accept the submission under
Sec.  1105.10(c).
     Section 1105.10(a)(5) provides that FDA will refuse to
accept a submission from a foreign applicant if the submission does not
list an authorized U.S. agent, including the agent's U.S. address. FDA
is requiring identification of a U.S. agent for two reasons. First, a
U.S. agent is important to help CTP ensure adequate notice is provided
to applicants for official Agency communications. FDA may be unable to
confirm that adequate notice of Agency action or correspondence
concerning premarket submissions is provided to foreign applicants as
FDA cannot necessarily confirm receipt of correspondence sent
internationally. Accordingly, the designation of a U.S. agent provides
an official contact to the Agency who can receive the information or
documentation on behalf of the applicant. Providing notice regarding
that application to the U.S. agent will constitute notice to the
foreign applicant. Second, FDA requires identification of a U.S. agent
to assist FDA in communication with the foreign applicant and help the
Agency to efficiently process applications and avoid delays. In many
instances during the application review process, FDA has reached out
numerous times to foreign applicants and has either been unable to
speak with the applicant or unable to directly communicate questions
and/or concerns. This impediment, which occurs more for foreign
applicants than domestic applicants, has resulted in delays or
terminations in the review of specific applications and a slowdown of
the premarket application process as a whole. A U.S. agent will act as
a communications link between FDA and the applicant and will facilitate
timely correspondence between FDA and foreign applicants, including
responding to questions concerning pending applications and, if needed,
assisting FDA in scheduling meetings with the foreign applicants to
resolve outstanding issues before Agency action is taken. Additionally,
the identified U.S. agent will be authorized to act on behalf of the
foreign applicant for that specific application.
     Section 1105.10(a)(6) provides that FDA will refuse to
accept the submission if it does not include any required FDA form(s).
At the time of this direct final rule, FDA has not yet issued any forms
to accompany premarket submissions. In the event that FDA does issue
such a form(s), the Agency will give interested parties notice and
opportunity to comment on such forms in accordance with rulemaking
procedures and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).
     Section 1105.10(a)(7) provides that FDA will refuse to
accept a submission that does not contain the following product-
identifying information (for the product that is the subject of the
submission and, if applicable, for the predicate): The manufacturer of
the tobacco product; the product name, including brand and subbrand;
product category (e.g., cigarette) and subcategory (e.g., combusted,
filtered); package type (e.g., box) and package quantity (e.g., 20 per
box); and characterizing flavor (i.e., applicants must state the
characterizing flavor, such as menthol, or state that there is no
characterizing flavor present in the tobacco product). For example, in
table 1, FDA has supplied a list of recommended categories and
subcategories of some tobacco products to assist applicants in
providing product-identifying information in their submissions. Note
that there may be other information FDA needs to identify a particular
product, e.g., descriptors (such as ``premium'') that are separate from
the product name. If this is the case, such information should be
provided by the applicant in the initial submission to facilitate FDA's
efficient review.

          Table 1--Tobacco Product Categories and Subcategories
------------------------------------------------------------------------
        Tobacco product category           Tobacco product subcategory
------------------------------------------------------------------------
Cigarettes.............................  Combusted, Filtered.
                                         Combusted, Non-Filtered.
                                         Combusted, Other.
                                         Non-Combusted.
Roll-Your-Own Tobacco Products.........  Roll-Your-Own Tobacco Filler.
                                         Rolling Paper.
                                         Filtered Cigarette Tube.
                                         Non-Filtered Cigarette Tube.
                                         Filter.
                                         Paper Tip.
                                         Roll-Your-Own Co-Package.
                                         Other.
Smokeless Tobacco Products.............  Loose Moist Snuff.
                                         Portioned Moist Snuff.
                                         Loose Snus.
                                         Portioned Snus
                                         Loose Dry Snuff.
                                         Dissolvable.
                                         Loose Chewing Tobacco.
                                         Portioned Chewing Tobacco.
                                         Smokeless Co-Package.
                                         Other.
ENDS (Electronic Nicotine Delivery       Open E-Liquid.
 System).                                Closed E-Liquid.
                                         Closed E-Cigarette.
                                         Open E-Cigarette.
                                         ENDS Component.

                                         ENDS Co-Package.
                                         ENDS Other.
Cigars.................................  Filtered, Sheet-Wrapped Cigar.
                                         Unfiltered, Sheet-Wrapped
                                          Cigar.
                                         Leaf-Wrapped Cigar.
                                         Cigar Component.
                                         Cigar Tobacco Filler.
                                         Cigar Co-Package.
                                         Other.
Pipe Tobacco Products..................  Pipe.
                                         Pipe Tobacco Filler.
                                         Pipe Component.
                                         Pipe Co-Package.
                                         Other.
------------------------------------------------------------------------

    This product-specific information helps ensure that the product is
within CTP's purview and enables FDA to appropriately identify the
specific product that is the subject of the submission. Specifically,
this information is necessary to both review the submission itself and
to issue an order that appropriately identifies the tobacco product
that is subject to the order. For example, an SE submission contains a
comparison between the predicate and new products. If FDA does not know
the exact products that are being compared, FDA will be unable to
sufficiently understand and evaluate the comparison to determine
whether the products are substantially equivalent. As another example,
if an applicant does not specify whether its proposed new product
contains a characterizing flavor, FDA will not be able to issue an
order as it will not know the specific product for which the applicant
is seeking an order (e.g., product X menthol or product X cinnamon.)
     Section 1105.10(a)(8) provides that FDA will refuse to
accept a submission if the applicant fails to indicate the type of
submission (i.e., PMTA, MRTPA, SE application, or exemption request or
subsequent abbreviated report), because that information is necessary
to enable FDA to begin an appropriate review of the submission.
     Section 1105.10(a)(9) provides that FDA will refuse to
accept a submission if it does not contain a signature of a responsible
official, authorized to represent the applicant who either resides in
or has a place of business in the United States. A signature provides
assurance to FDA that the submission is both intended by the applicant
and ready for review. Responsible officials also should be aware that
under 18 U.S.C. 1001, it is illegal to knowingly and willingly submit
false information to the U.S. Government.
     Section 1105.10(a)(10) applies only to PMTAs, MRTPAs, SE
applications, and exemption requests (this subsection does not apply to
the subsequent abbreviated report). For these submissions, this
paragraph provides that FDA will refuse to accept the submission if it
does not include an environmental assessment (EA) or a valid claim of
categorical exclusion. Under Sec.  25.15(a) (21 CFR 25.15(a)), all
submissions requesting FDA action require the submission of either a
claim of categorical exclusion or an EA. Because an EA is required for
an initial exemption request, it is not also required for an
abbreviated report, and thus is not a basis for FDA to refuse to accept
an abbreviated report. In addition, Sec.  25.15(a) provides that FDA
may refuse to file a submission if the included EA fails to address
``the relevant environmental issues.'' Because the SE and SE Exemption
pathways do not include a filing stage, FDA intends to determine such
adequacy at the acceptance stage for those pathways.\2\ The EA or claim
of categorical exclusion must be made for the Agency action being
proposed (e.g., issuance of an SE order for introduction of such new
tobacco product into interstate commerce for commercial distribution in
the United States.). For information on preparing an EA, refer to Sec.
25.40.
---------------------------------------------------------------------------

    \2\ The PMTA and MRTPA pathways, by contrast, have a filing
stage.
---------------------------------------------------------------------------

    Section 1105.10(b) provides that if FDA does not identify a reason
under paragraph (a) for refusing to accept a submission, then the
Agency may accept it for processing and further review. If FDA does
accept the submission, the Agency intends to send the submitter an
acknowledgement letter stating that FDA has accepted the submission for
processing and further review. This letter will also include a
premarket submission tracking number.
    Section 1105.10(c) provides that if FDA identifies a reason under
paragraph (a) for refusing to accept a premarket review submission, we
will notify the applicant in writing of the reason(s) and that FDA has
not accepted the submission for processing and further review. However,
FDA will be unable to provide this notification when the contact
information is insufficient, for example, has not been provided or is
not legible. If FDA refuses to accept the submission for one or more of
the reasons stated in Sec.  1105.10, the submitter may revise the
submission to correct the deficiencies and resubmit it to FDA as a new
submission.

V. Effective Date

    This direct final rule will be effective 60 days after the comment
period ends.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this direct final rule contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, we conclude that the
rule does not contain policies that have federalism implications as
defined in the Executive Order and, consequently, a federalism summary
impact statement is not required.

VIII. Tribal Consultation

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have substantial direct effects on one
or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order;
consequently, a tribal summary impact statement is not required.

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Economic Analysis of Impacts

    We have examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We believe that this direct final rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this final rule establishes a procedure that FDA is
responsible for implementing and has the effect of providing entities
with useful feedback on the readiness of a submission, we certify that
the direct final rule will not have a significant economic impact on a
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $146 million, using the most current (2015) Implicit
Price Deflator for the Gross Domestic Product. This direct final rule
would not result in expenditure in any year that meets or exceeds this
amount.
    This rule identifies 10 significant and common deficiencies in
premarket tobacco submissions that will cause FDA to refuse to accept
them. Encouraging submissions that are free of the deficiencies listed
in this rule does not represent a change in Agency expectations. One of
the 10 deficiencies is required by statute (i.e., must be a tobacco
product). One of the deficiencies is required by another regulation
(i.e., must comply with environmental considerations). The remaining
eight deficiencies are basic expectations for an application to enter
the review process. Therefore, this rule clarifies these expectations.
This clarification will result in cost savings for both the applicant
and FDA as less time is spent by FDA working with applicants to address
these significant deficiencies. Applicants will have clarity about
basic expectations of the requirements needed for acceptance of
premarket applications. In addition, refusing to accept submissions
with these deficiencies allows Agency staff to more efficiently process
submissions and quickly move those submissions without these
deficiencies into review of substantial scientific issues.

List of Subjects in 21 CFR Part 1105

    Administrative practices and procedures, Tobacco, Tobacco products.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
chapter I is amended by adding part 1105 to subchapter K to read as
follows:

PART 1105--GENERAL

Subpart A--General Submission Requirements
Sec.
1105.10 Refusal to accept a premarket tobacco product submission.

    Authority: 21 U.S.C. 371(a), 387e, 387j, and 387k.

Subpart A--General Submission Requirements

Sec.  1105.10  Refusal to accept a premarket tobacco product
submission.

    (a) FDA will refuse to accept for review, as soon as practicable, a
premarket tobacco product application; modified risk tobacco product
application; substantial equivalence application; or exemption request
or subsequent abbreviated report for the following reasons, if
applicable:
    (1) The submission does not pertain to a tobacco product as defined
in 21 U.S.C. 321(rr).
    (2) The submission is not in English or does not contain complete
English translations of any information submitted within.
    (3) If submitted in an electronic format, the submission is in a
format that FDA cannot process, read, review, and archive.
    (4) The submission does not contain contact information, including
the applicant's name and address.
    (5) The submission is from a foreign applicant and does not
identify an authorized U.S. agent, including the agent's name and
address, for the submission.
    (6) The submission does not contain a required FDA form(s).
    (7) The submission does not contain the following product-
identifying information: The manufacturer of the tobacco product; the
product name, including the brand and subbrand; the product category
and subcategory; package type and package quantity; and characterizing
flavor.
    (8) The type of submission is not specified.
    (9) The submission does not contain a signature of a responsible
official, authorized to represent the applicant who either resides in
or has a place of business in the United States.
    (10) For premarket tobacco applications, modified risk tobacco
product applications, substantial equivalence applications, and
exemption requests only: The submission does not include an
environmental assessment, or a valid claim of categorical exclusion in
accordance with part 25 of this chapter.
    (b) If FDA finds that none of the reasons in paragraph (a) of this
section exists for refusing to accept a premarket submission, FDA may
accept the submission for processing and further review. FDA will send
to the submitter an acknowledgement letter stating the submission has
been accepted for processing and further review and will provide the
premarket submission tracking number.
    (c) If FDA finds that any of the reasons in paragraph (a) of this
section exist for refusing to accept the submission, FDA will notify
the submitter in writing of the reason(s) and that the submission has
not been accepted, unless insufficient contact information was
provided.

    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18534 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Rules and Regulations]
[Pages 30976-30979]
[FR Doc No: 2017-13994]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2016-0601; FRL-9964-41-Region 4]

Air Plan Approval and Designation of Areas; KY; Redesignation of
the Kentucky Portion of the Cincinnati-Hamilton 2008 8-Hour Ozone
Nonattainment Area to Attainment

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: On August 26, 2016, the Commonwealth of Kentucky, through the
Kentucky Energy and Environment Cabinet, Division for Air Quality
(DAQ), submitted a request for the Environmental Protection Agency
(EPA) to redesignate the Kentucky portion of the tri-state Cincinnati-
Hamilton, Ohio-Kentucky-Indiana 2008 8-hour ozone nonattainment area
(hereinafter referred to as the ``Cincinnati-Hamilton, OH-KY-IN Area''
or ``Area'') to attainment for the 2008 8-hour ozone National Ambient
Air Quality Standards (NAAQS) and to approve the portions of the State
Implementation Plan (SIP) revision containing a maintenance plan and
base year emissions inventory for the Area. EPA is taking final action
to

approve the Commonwealth's base year emissions inventory for the
Kentucky portion of the Area; to approve the Commonwealth's plan for
maintaining attainment of the 2008 8-hour ozone NAAQS in the Area,
including motor vehicle emission budgets (MVEBs) for nitrogen oxides
(NOX) and volatile organic compounds (VOC) for the years
2020 and 2030 for the Kentucky portion of the Area; and to redesignate
the Kentucky portion of the Area to attainment for the 2008 8-hour
ozone NAAQS. Through separate actions, EPA has approved the
redesignation requests and maintenance plans for both the Ohio and
Indiana portions of the Area.

DATES: This rule is effective July 5, 2017.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2016-0601. All documents in the docket
are listed on the 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 www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. 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 a.m. to 4:30 p.m.,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Richard Wong, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Richard Wong may be reached by phone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the background for EPA's proposed actions?

    Effective July 20, 2012, EPA designated areas as unclassifiable/
attainment or nonattainment for the 2008 8-hour ozone NAAQS that was
promulgated on March 27, 2008. See 77 FR 30088 (May 21, 2012). The
Cincinnati-Hamilton, OH-KY-IN Area was designated as nonattainment for
the 2008 8-hour ozone NAAQS and classified as a marginal nonattainment
area.\1\ On May 4, 2016 (81 FR 26697), EPA issued a determination that
the Area had attained the 2008 8-hour ozone NAAQS. On August 26, 2016,
Kentucky requested that EPA redesignate the Area to attainment for the
2008 8-hour ozone NAAQS and submitted a SIP revision containing the
Commonwealth's plan for maintaining attainment of the 2008 8-hour ozone
standard in the Area through 2030, including 2020 and 2030 MVEBs for
NOX and VOC for the Cincinnati-Hamilton, OH-KY-IN Area. In
addition, the Commonwealth requested approval of the base year
emissions inventory for the 2008 8-hour ozone NAAQS pursuant to CAA
section 182(a)(1).
---------------------------------------------------------------------------

    \1\ The Cincinnati-Hamilton, OH-KY-IN Area is composed of
portions of Boone, Campbell, and Kenton Counties in Kentucky;
Butler, Clermont, Clinton, Hamilton, and Warren Counties in Ohio;
and a portion of Dearborn County in Indiana.
---------------------------------------------------------------------------

    In a notice of proposed rulemaking (NPRM) published on May 1, 2017
(82 FR 20297), EPA proposed to approve the base year emissions
inventory; to approve the maintenance plan, including the 2020 and 2030
MVEBs for NOX and VOC, and incorporate the plan into the
Kentucky SIP; and to redesignate the Area to attainment for the 2008 8-
hour ozone NAAQS. In that notice, EPA also notified the public of the
status of the Agency's adequacy determination for the NOX
and VOC MVEBs for the Cincinnati-Hamilton, OH-KY-IN Area. No adverse
comments were received on the May 1, 2017, proposed rulemaking. The
details of Kentucky's submittal and the rationale for EPA's actions are
further explained in the NPRM.

II. Final Action

    EPA is taking three separate, but related, final actions. First,
EPA is approving the 2008 8-hour ozone NAAQS base year emissions
inventory for the Kentucky portion of the Cincinnati-Hamilton, OH-KY-IN
Area as meeting the requirements of CAA section 182(a)(1) and
incorporating it into the SIP. Approval of the base year emissions
inventory is a prerequisite to redesignating an ozone nonattainment
area to attainment.
    Second, EPA is approving the maintenance plan for the Cincinnati-
Hamilton, OH-KY-IN Area, including the NOX and VOC MVEBs for
2020 and 2030, as meeting the requirements of CAA section 175A and
incorporating it into the Kentucky SIP. The maintenance plan
demonstrates that the Area will continue to maintain the 2008 8-hour
ozone NAAQS through 2030, and the MVEBs meet all of the adequacy
criteria contained in 40 CFR 93.118(e)(4) and (5).
    Third, EPA is approving Kentucky's redesignation request for the
2008 8-hour ozone NAAQS for the Cincinnati-Hamilton, OH-KY-IN Area
pursuant to CAA section 107(d)(3)(E). Approval of the redesignation
request changes the official designation of the portions of Boone
County, Campbell County, and Kenton County in the Cincinnati-Hamilton,
OH-KY-IN Area for the 2008 8-hour ozone NAAQS from nonattainment to
attainment, as found at 40 CFR part 81.
    EPA is also notifying the public that EPA finds the newly-
established NOX and VOC MVEBs for the Cincinnati-Hamilton,
OH-KY-IN Area adequate for the purpose of transportation conformity.
Within 24 months from this final rule, the transportation partners will
need to demonstrate conformity to the new NOX and VOC MVEBs
pursuant to 40 CFR 93.104(e).
    EPA has determined that these actions are effective immediately
upon publication under the authority of 5 U.S.C. 553(d)(1) and (d)(3).
The purpose of the 30-day waiting period prescribed in section 553(d)
is to give affected parties a reasonable time to adjust their behavior
and prepare before the final rule takes effect. Section 553(d)(1)
allows an effective date less than 30 days after publication if a
substantive rule ``relieves a restriction.'' These actions qualify for
the exception under section 553(d)(1) because they relieve the State of
various requirements for the Area. Furthermore, section 553(d)(3)
allows an effective date less than 30 days after publication ``as
otherwise provided by the agency for good cause found and published
with the rule.'' EPA finds good cause to make these actions effective
immediately pursuant to section 553(d)(3) because they do not create
any new regulatory requirements such that affected parties would need
time to prepare before the actions take effect.

III. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those

imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable federal regulations. See 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 CAA.
Accordingly, these actions merely approve state law as meeting federal
requirements and do not impose additional requirements beyond those
imposed by state law. For this reason, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     are 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.);
     do 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);
     do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     are 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 CAA; and
     will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it 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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 5, 2017. 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

40 CFR Part 52

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

40 CFR Part 81

    Environmental protection, Air pollution control.

    Dated: June 16, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart S--Kentucky

0
2. Section 52.920(e) is amended by adding new entries for ``2008 8-hour
ozone Maintenance Plan for the Kentucky portion of the Cincinnati-
Hamilton, OH-KY-IN Area'' and ``2008 8-hour ozone base year emissions
inventory for the Kentucky portion of the Cincinnati-Hamilton, OH-KY-IN
Area'' at the end of the table to read as follows:

Sec.  52.920   Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                                               State
   Name of non-regulatory SIP     Applicable geographic   submittal date/  EPA approval date     Explanations
           provision              or nonattainment area   effective date
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
2008 8-hour ozone Maintenance    Portions of Boone (2000       8/26/2016  7/5/2017..........  ..................
 Plan for the Kentucky portion    Census tracts: 702,                     [Insert citation
 of the Cincinnati-Hamilton, OH-  703.05, 703.06,                          of publication].
 KY-IN Area.                      703.07, 703.08,
                                  703.09, 704.01,
                                  704.02, 705.01,
                                  705.02, 706.01,
                                  706.03, 706.04),
                                  Campbell (2000 Census
                                  tracts: 501, 502, 503,
                                  504, 505, 506, 512,
                                  513, 519.01, 519.03,
                                  519.04, 520.01,
                                  520.02, 521, 522,
                                  523.01, 523.02, 524,
                                  525, 526, 528, 529,
                                  530, 531), and Kenton
                                  (2000 Census tracts:
                                  603, 607, 609, 610,
                                  611, 612, 613, 614,
                                  616, 636.03, 636.04,
                                  636.05, 636.06, 638,
                                  640, 641, 642, 643,
                                  644, 645, 646, 647,
                                  648, 649, 650, 651,
                                  652, 653, 654, 655.01,
                                  655.02, 656, 657, 658,
                                  659, 668, 669, 670,
                                  671) Counties, KY.

2008 8-hour ozone base year      Portions of Boone,            8/26/2016  7/5/2017..........  182(a)(1) base-
 emissions inventory for the      Campbell and Kenton                     [Insert citation     year emissions
 Kentucky portion of the          Counties in Kentucky.                    of publication].    inventory
 Cincinnati-Hamilton, OH-KY-IN
 Area.
----------------------------------------------------------------------------------------------------------------

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

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

0
4. In Sec.  81.318, the table entitled ``Kentucky-2008 8-Hour Ozone
NAAQS (Primary and secondary)'' is amended by revising the entries for
``Cincinnati, OH-KY-IN'' to read as follows:

Sec.  81.318   Kentucky.

* * * * *

                                        Kentucky--2008 8-Hour Ozone NAAQS
                                             [Primary and secondary]
----------------------------------------------------------------------------------------------------------------
                                                      Designation                         Classification
           Designated area            --------------------------------------------------------------------------
                                          Date \1\                Type               Date \1\          Type
----------------------------------------------------------------------------------------------------------------
Cincinnati, OH-KY-IN: \2\                    7/5/2017  Attainment...............
    Boone County (part)..............  ..............  Attainment...............
        2000 Census tracts: 702,
         703.05, 703.06, 703.07,
         703.08, 703.09, 704.01,
         704.02, 705.01, 705.02,
         706.01, 706.03, 706.04.
    Campbell County (part)...........  ..............  Attainment...............
        2000 Census tracts: 501, 502,
         503, 504, 505, 506, 512,
         513, 519.01, 519.03, 519.04,
         520.01, 520.02, 521, 522,
         523.01, 523.02, 524, 525,
         526, 528, 529, 530, 531.
    Kenton County (part).............  ..............  Attainment...............
        2000 Census tracts: 603, 607,
         609, 610, 611, 612, 613,
         614, 616, 636.03, 636.04,
         636.05, 636.06, 638, 640,
         641, 642, 643, 644, 645,
         646, 647, 648, 649, 650,
         651, 652, 653, 654, 655.01,
         655.02, 656, 657, 658, 659,
         668, 669, 670, 671.
----------------------------------------------------------------------------------------------------------------
 * * * * * * *
\1\ This date is July 20, 2012, unless otherwise noted.
\2\ Excludes Indian country located in each area, unless otherwise noted.

* * * * *
[FR Doc. 2017-13994 Filed 7-3-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1837-1838]
[FR Doc No: 2022-00451]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Modifications to
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before January 27, 2022.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.
    Copies of the applications are available for inspection in the
Records Center, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on January 7, 2022.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special
          Application No.                   Applicant        Regulation(s) affected        permits thereof
----------------------------------------------------------------------------------------------------------------
9221-M.............................  Applied Pressure        173.302a(a)...........  To modify the special
                                      Vessels, Inc.                                   permit to authorize an
                                                                                additional cylinder.
                                                                                (modes 1, 2, 3, 4).
10945-M............................  Structural Composites   173.302a(a),            To modify the special
                                      Industries LLC.         173.304a(a), 175.3,     permit to authorize
                                                              180.205.                additional hazardous
                                                                                materials. (modes 1, 2, 3,
                                                                                4, 5).
16410-M............................  Snap-On Incorporated..  ......................  To modify the special
                                                                                permit to authorize
                                                                                lithium ion or metal cells
                                                                                or batteries conforming to
                                                                                49 CFR 173.185(c)(iv).
                                                                                (mode 1).
21139-M............................  KULR Technology         172.200, 172.700(a)...  To modify the special
                                      Corporation.                                    permit to increase the
                                                                                authorized aggregate
                                                                                energy content of a single
                                                                                inner package to 2.5 kWh.
                                                                                (modes 1, 2).
21163-M............................  United Initiators, Inc  178.345-10(b)(1)......  To modify the special
                                                                                permit to clarify the
                                                                                synopsis and to authorize
                                                                                customers to load and
                                                                                unload the packagings.
                                                                                (mode 1).
21167-M............................  KULR Technology         173.185(a)(1).........  To modify the special
                                      Corporation.                                    permit to increase the
                                                                                authorized aggregate
                                                                                energy content of a single
                                                                                inner package to 2.5 kWh.
                                                                                (modes 1, 2, 3, 4).
21193-M............................  KULR Technology         172.200, 172.300,       To modify the special
                                      Corporation.            172.700(a), 172.400,    permit to increase the
                                                              172.500, 172.600,       authorized aggregate
                                                              173.185(f).             energy content of a single
                                                                                inner package to 2.5 kWh.
                                                                                (modes 1, 2).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-00451 Filed 1-11-22; 8:45 am]
BILLING CODE 4909-60-P