Wildfire Suppression Aircraft Transfer Act of 1996, 27201-27202 [2019-12354]
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Federal Register / Vol. 84, No. 113 / Wednesday, June 12, 2019 / Rules and Regulations
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
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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 Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance
document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Paul
Hart, Center for Tobacco Products, Food
and Drug Administration, Document
Control Center, 10903 New Hampshire
Ave., Bldg. 71, Rm. G335, Silver Spring,
MD 20993–0002, 1–877–CTP–1373,
email: CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Premarket Tobacco Product
Applications for Electronic Nicotine
Delivery Systems.’’
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
FD&C Act and granted FDA authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect public health generally and to
reduce tobacco use by minors. Under
section 901(b) of the FD&C Act (21
U.S.C. 387a(b)), FDA’s tobacco product
authorities in chapter IX of the FD&C
Act apply to all cigarettes, cigarette
tobacco, roll-your-own tobacco, and
smokeless tobacco and to any other
tobacco products that the Secretary of
Health and Human Services by
regulation deems to be subject to
chapter IX. On May 10, 2016, in the
Federal Register, FDA published its
final rule, ‘‘Deeming Tobacco Products
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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’’
(Deeming rule) extending FDA’s tobacco
product authority to ENDS, among other
products (81 FR 28973). In the same
issue of the Federal Register, FDA
concurrently announced the availability
of the draft guidance, ‘‘Premarket
Tobacco Product Applications for
Electronic Nicotine Delivery Systems,
Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request’’ (81 FR
28781). FDA received comments on the
draft guidance and those comments
were considered as the guidance was
finalized. Changes made as a result of
public comments include
recommendations for constituent
testing, single applications for new
tobacco products that an applicant
intends to market as a modified risk
tobacco product, and the number
batches and replicates related to product
testing.
Under section 910 of the FD&C Act
(21 U.S.C. 387j), persons seeking to
market a new tobacco product (as
defined in section 910(a)(1) of the FD&C
Act) must first submit a PMTA to FDA
and obtain a marketing authorization
order, unless FDA has issued an order
that the new tobacco product is
substantially equivalent to a tobacco
product commercially marketed in the
United States as of February 15, 2007,
or the new tobacco product is exempt
from demonstrating substantial
equivalence pursuant to the reasons
outlined in section 905(j)(3) of the FD&C
Act (21 U.S.C. 387e(j)(3)). ENDS
products, the subject of this guidance,
likely would be considered new tobacco
products. Given the relatively new
presence of ENDS on the U.S. market,
FDA anticipates that many
manufacturers of these new tobacco
products will seek a marketing
authorization order by filing a PMTA.
This guidance explains, among other
things, when a PMTA is required,
general procedures for review of an
ENDS PMTA, what information the
FD&C Act requires applicants to submit
in a PMTA, and what information FDA
recommends applicants submit in an
ENDS PMTA to show whether
permitting such new tobacco product to
be marketed is appropriate for the
protection of the public health.
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27201
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on PMTAs for ENDS.
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. This guidance is not subject
to Executive Order 12866.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 1107.1 have been approved
under OMB control number 0910–0768.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/tobacco-products/
products-guidance-regulations/rulesregulations-and-guidance.
Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12389 Filed 6–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 171
[Docket ID: DOD–2018–OS–0051]
RIN 0790–AK42
Wildfire Suppression Aircraft Transfer
Act of 1996
Office of the Assistant
Secretary of Defense for Sustainment,
DoD.
ACTION: Final rule.
AGENCY:
This final rule removes the
DoD regulation which implemented law
authorizing the sale of aircraft and
aircraft parts to entities that contract
with the Federal government for the
delivery of fire retardant by air in order
to suppress wildfire. This authorization
has since expired. Existing statutory
authorities allow the sale or transfer of
aircraft and aircraft parts to Fire Fighter
SUMMARY:
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27202
Federal Register / Vol. 84, No. 113 / Wednesday, June 12, 2019 / Rules and Regulations
Agencies, rendering this part obsolete
and unnecessary.
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
This rule is effective on June 12,
2019.
Lt.
Col. Shonry Webb at 571–372–5217.
FOR FURTHER INFORMATION CONTACT:
It has been
determined that publication of this CFR
part removal for public comment is
impracticable, unnecessary, and
contrary to public interest since it is
removing obsolete information. This
rule implemented the Wildfire
Suppression Aircraft Transfer Act of
1996. The law authorized DoD, during
the period October 1996 through
September 2005, to sell aircraft and
aircraft parts to entities that contract
with the Federal government for the
delivery of fire retardant by air in order
to suppress wildfire. This authorization
was extended from October 2012
through September 2017, but it has
since expired. Existing authorities in 10
U.S. Code 2576—Surplus military
equipment: Sale to state and local law
enforcement, firefighting, homeland
security, and emergency management
agencies, allow the sale or transfer of
aircraft and aircraft parts to Fire Fighter
Agencies. This part is obsolete and
unnecessary.
This rule is not significant under
Executive Order (E.O.) 12866,
‘‘Regulatory Planning and Review,’’
therefore, the requirements of E.O.
13771, ‘‘Reducing Regulation and
Controlling Regulatory Costs’’ do not
apply.
SUPPLEMENTARY INFORMATION:
List of Subjects in 32 CFR Part 171
Fire prevention.
PART 171—[REMOVED]
Accordingly, by the authority of 5
U.S.C. 301, 32 CFR part 171 is removed.
■
Dated: June 7, 2019.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison
Officer, Department of Defense.
[FR Doc. 2019–12354 Filed 6–11–19; 8:45 am]
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BILLING CODE 5001–06–P
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40 CFR Part 52
[EPA–R03–OAR–2018–0371; FRL–9995–06–
Region 3]
Approval and Promulgation of Air
Quality Implementation Plans; District
of Columbia; Administrative
Corrections and Emissions Statements
Certification for the 2008 Ozone
National Ambient Air Quality Standard
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving two state
implementation plan (SIP) revisions
submitted by the District of Columbia
(the District). Under the Clean Air Act
(CAA), states’ SIPs must require
stationary sources in ozone
nonattainment areas to report annual
emissions of nitrogen oxides (NOX) and
volatile organic compounds (VOC). The
District formally submitted, as a SIP
revision, a statement certifying that the
District’s existing SIP-approved
emissions statements program satisfies
these CAA requirements for the 2008
ozone National Ambient Air Quality
Standards (NAAQS). Upon review of the
District’s submittal, EPA noted minor
discrepancies between the District’s SIPapproved provisions, including the
provision containing the District’s
emissions statements requirements, and
the current edition of the District of
Columbia Municipal Regulations
(DCMR) referenced in the District’s
submittal. Therefore, to correct these
minor discrepancies and update the
District’s SIP, the District also formally
submitted a revised edition of the
sections of the DCMR which addresses
the discrepancies. EPA is proposing to
approve the District’s SIP with the
current edition of these SIP-approved
provisions. EPA is also proposing to
approve the District’s emissions
statements program certification for the
2008 ozone NAAQS. EPA is proposing
to approve these SIP revisions in
accordance with the requirements of the
CAA.
DATES: This final rule is effective on July
12, 2019.
ADDRESSES: EPA has established a
docket for this action under Docket ID
Number EPA–R03–OAR–2018–0371. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, e.g., confidential business
information (CBI) or other information
SUMMARY:
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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 through https://
www.regulations.gov, or please contact
the person identified in the FOR FURTHER
INFORMATION CONTACT section for
additional availability information.
FOR FURTHER INFORMATION CONTACT: Sara
Calcinore, Planning & Implementation
Branch (3AD30), Air & Radiation
Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The
telephone number is (215) 814–2043.
Ms. Calcinore can also be reached via
electronic mail at calcinore.sara@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the CAA, EPA establishes
NAAQS for criteria pollutants in order
to protect human health and the
environment. In response to scientific
evidence linking ozone exposure to
adverse health effects, EPA promulgated
the first ozone NAAQS, the 0.12 parts
per million (ppm) 1-hour ozone
NAAQS, in 1979. See 44 FR 8202
(February 8, 1979). The CAA requires
EPA to review and reevaluate the
NAAQS every five years in order to
consider updated information regarding
the effects of the criteria pollutants on
human health and the environment. On
July 18, 1997, EPA promulgated a
revised ozone NAAQS, referred to as the
1997 ozone NAAQS, of 0.08 ppm
averaged over eight hours. See 62 FR
38855. This 8-hour ozone NAAQS was
determined to be more protective of
public health than the previous 1979 1hour ozone NAAQS. In 2008, EPA
strengthened the 8-hour ozone NAAQS
from 0.08 to 0.075 ppm. The 0.075 ppm
standard is referred to as the 2008 ozone
NAAQS. See 73 FR 16436 (March 27,
2008).
On May 21, 2012 and June 11, 2012,
EPA designated nonattainment areas for
the 2008 ozone NAAQS. 77 FR 30088
and 77 FR 34221. Effective July 20,
2012, the Washington, DC–MD–VA area
was designated as marginal
nonattainment for the 2008 ozone
NAAQS. The Washington, DC–MD–VA
marginal nonattainment area includes
the District of Columbia. 40 CFR 81.309.
Section 182 of the CAA identifies
additional plan submissions and
requirements for ozone nonattainment
areas. Specifically, section 182(a)(3)(B)
of the CAA requires that states develop
and submit, as a revision to their SIP,
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Agencies
[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Rules and Regulations]
[Pages 27201-27202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12354]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 171
[Docket ID: DOD-2018-OS-0051]
RIN 0790-AK42
Wildfire Suppression Aircraft Transfer Act of 1996
AGENCY: Office of the Assistant Secretary of Defense for Sustainment,
DoD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule removes the DoD regulation which implemented
law authorizing the sale of aircraft and aircraft parts to entities
that contract with the Federal government for the delivery of fire
retardant by air in order to suppress wildfire. This authorization has
since expired. Existing statutory authorities allow the sale or
transfer of aircraft and aircraft parts to Fire Fighter
[[Page 27202]]
Agencies, rendering this part obsolete and unnecessary.
DATES: This rule is effective on June 12, 2019.
FOR FURTHER INFORMATION CONTACT: Lt. Col. Shonry Webb at 571-372-5217.
SUPPLEMENTARY INFORMATION: It has been determined that publication of
this CFR part removal for public comment is impracticable, unnecessary,
and contrary to public interest since it is removing obsolete
information. This rule implemented the Wildfire Suppression Aircraft
Transfer Act of 1996. The law authorized DoD, during the period October
1996 through September 2005, to sell aircraft and aircraft parts to
entities that contract with the Federal government for the delivery of
fire retardant by air in order to suppress wildfire. This authorization
was extended from October 2012 through September 2017, but it has since
expired. Existing authorities in 10 U.S. Code 2576--Surplus military
equipment: Sale to state and local law enforcement, firefighting,
homeland security, and emergency management agencies, allow the sale or
transfer of aircraft and aircraft parts to Fire Fighter Agencies. This
part is obsolete and unnecessary.
This rule is not significant under Executive Order (E.O.) 12866,
``Regulatory Planning and Review,'' therefore, the requirements of E.O.
13771, ``Reducing Regulation and Controlling Regulatory Costs'' do not
apply.
List of Subjects in 32 CFR Part 171
Fire prevention.
PART 171--[REMOVED]
0
Accordingly, by the authority of 5 U.S.C. 301, 32 CFR part 171 is
removed.
Dated: June 7, 2019.
Aaron T. Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2019-12354 Filed 6-11-19; 8:45 am]
BILLING CODE 5001-06-P