[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Pages 76838-76840]
[FR Doc No: 2013-30137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Tobacco Products, Exemptions From Substantial
Equivalence Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the

proposed collection of certain information by the Agency. Under the
Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are
required to publish notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, and to allow 60 days for
public comment in response to the notice. This notice solicits comments
on exemptions from substantial equivalence requirements for tobacco
products.

DATES: Submit either electronic or written comments on the collection
of information by February 18, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Exemptions From Substantial Equivalence Requirements for Tobacco
Products (OMB Control Number 0910-0684)--Extension

    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 Federal Food, Drug,
and Cosmetic Act (the FD&C Act) by adding a chapter granting FDA
important authority to regulate the manufacture, marketing, and
distribution of tobacco products to protect the public health generally
and to reduce tobacco use by minors.
    The FD&C Act, as amended by the Tobacco Control Act, requires that
before a new tobacco product may be introduced or delivered for
introduction into interstate commerce, a manufacturer must submit a
premarket application to FDA, and FDA must issue an order finding that
the new product may be introduced or delivered for introduction into
interstate commerce (section 910 of the FD&C Act (21 U.S.C. 387j)). An
order under section 910 is not required, however, if a manufacturer
submits a report under section 905(j) of the FD&C Act (21 U.S.C.
387e(j) demonstrating the new tobacco product's substantial equivalence
to an appropriate predicate product, and FDA issues an order finding
the new product to be substantially equivalent to the predicate product
and in compliance with the requirements of the FD&C Act.
    FDA has established a pathway for manufacturers to request
exemptions from the substantial equivalence requirements of the FD&C
Act in Sec.  1107.1 (21 CFR 1107.1) of the Agency's regulations. As
described in Sec.  1107.1(a), FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that: (1) The modification would be a minor modification of
a tobacco product; (2) a report demonstrating substantial equivalence
is not necessary for the protection of public health; and (3) an
exemption is otherwise appropriate.
    Section 1107.1(b) states that a request for exemption under section
905(j)(3) of the FD&C Act may be made only by the manufacturer of a
legally marketed tobacco product for a minor modification to that
tobacco product and that the manufacturer must submit the request and
all information supporting it to FDA. The request must be made in an
electronic format that FDA can process, review, and archive (or a
written request must be made by the manufacturer explaining in detail
why the company cannot submit the request in an electronic format and
requesting an alternative means of submission to the electronic
format).
    An exemption request must contain: (1) The manufacturer's address
and contact information; (2) identification of the tobacco product(s);
(3) a detailed explanation of the purpose for the modification; (4) a
detailed description of the modification, including a statement as to
whether the modification involves adding or deleting a tobacco
additive, or increasing or decreasing the quantity of the existing
tobacco additive; (5) a detailed explanation of why the modification is
a minor modification of a tobacco product that can be sold under the
FD&C Act; (6) a detailed explanation of why a report under section
905(j)(1) of the FD&C Act intended to demonstrate substantial
equivalence is not necessary to ensure that permitting the tobacco
product to be marketed would be appropriate for protection of the
public health; (7) a certification (i.e., a signed statement by a
responsible official of the company) summarizing the supporting
evidence and providing the rationale for the official's determination
that the modification does not increase the tobacco product's appeal to
or use by minors, toxicity, addictiveness, or abuse liability; (8)
other information justifying an exemption; and (9) an environmental
assessment (EA) under part 25 (21 CFR part 25) prepared in accordance
with the requirements of Sec.  25.40.
    The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347)
states national environmental objectives and imposes upon each Federal
agency the duty to consider the environmental effects of its actions.
Section 102(2)(C) of NEPA requires the preparation of an environmental
impact statement for every major Federal action that will significantly
affect the quality of the human environment.
    The FDA NEPA regulations are contained in part 25. All applications
for exemption from substantial

equivalence require the submission of an EA. An EA provides information
that is used to determine whether an FDA action could result in a
significant environmental impact. Section 25.40(a) and (c) specifies
the content requirements for EAs for nonexcluded actions.
    The information required by Sec.  1107.1(b) is submitted to FDA so
FDA can determine whether an exemption from substantial equivalence to
the product is appropriate for the protection of the public health.
Section 1107.1(c) states that FDA will review the information submitted
and determine whether to grant or deny an exemption based on whether
the criteria in section 905(j)(3) of the FD&C Act are met. FDA may
request additional information if necessary to make a determination and
may consider the exemption request withdrawn if the information is not
provided within the requested timeframe.
    Section 1107.1(d) provides that FDA may rescind an exemption where
necessary to protect the public health.
    Section 905(j)(1)(A)(ii) of the FD&C Act states that if an
exemption has been requested and granted, a report must be submitted to
FDA that demonstrates that the tobacco product is modified within the
meaning of section 905(j)(3), the modifications are to a product that
is commercially marketed and in compliance with the requirements of the
FD&C Act, and all of the modifications are covered by exemptions
granted by the Secretary pursuant to section 905(j)(3).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
21 CFR 1107.1(b): Preparation of             500               1             500              12           6,000
 tobacco product exemption from
 substantial equivalence request
21 CFR 1107.1(c): Preparation of             150               1             150               3             450
 additional information for
 tobacco product exemption from
 substantial equivalence request
21 CFR 25.40: Preparation of an              500               1             500              12           6,000
 environmental assessment.......
Section 905(j)(1)(A)(ii) of the              750               1             750               3           2,250
 FD&C Act: If exemption granted,
 report submitted to demonstrate
 tobacco product is modified
 under section 905(j)(3),
 modifications are to a product
 that is commercially marketed
 and compliant product, and
 modifications are covered by
 exemptions granted by Secretary
 pursuant to section 905(j)(3)..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          14,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 500 requests for exemption will be submitted
annually, and that it will take approximately 12 hours to prepare an
exemption request. FDA also estimates that up to 30 percent (150) of
the initial requests for information may require additional information
in support of the initial exemption request, and it is expected that it
will take an average of 3 hours to prepare the additional information.
FDA also estimates that 750 manufacturers will take approximately 12
hours to prepare and submit an EA under part 25 in accordance with the
requirements of Sec.  25.40, as referenced in Sec.  1107.1(b)(9).
    FDA estimates that 750 respondents will take 3 hours to prepare a
report under section 905(j)(1)(A)(ii) of the FD&C Act, which requires a
manufacturer to submit a report at least 90 days prior to making an
introduction or delivery into interstate commerce for commercial
distribution of a tobacco product. The report will contain the
manufacturer's basis that the tobacco product is modified within the
meaning of section 905(j)(3) of the FD&C Act, the modifications are to
a product that is commercially marketed and compliant with the FD&C
Act, the modifications are covered by exemptions granted pursuant to
section 905(j)(3), and a listing of actions taken to comply with any
applicable requirements of section 907 of the FD&C Act. FDA's estimates
are based on experience with and information on other FDA-regulated
products and indications from industry.

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30137 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P


 1 Design Flow gpm 304 SS 316 SS CuNi 304 SS 316 SS CuNi 304 SS 316 SS CuNi 304 SS 316 SS CuNi Freshwater Saltwater Zebra Mussels Freshwater Saltwater Zebra Mussels Freshwater Saltwater Zebra Mussels Freshwater Saltwater Zebra Mussels 2,500 $ 99,693 $ 101,526 $ 103,042 $ 127,159 $ 132,487 $ 130,508 $ 159,856 $ 169,346 $ 163,206 $ 225,251 $ 243,064 $ 228,601 5,700 $ 119,651 $ 124,624 $ 131,831 $ 160,600 $ 173,563 $ 172,780 $ 209,349 $ 231,824 $ 221,529 $ 306,847 $ 348,346 $ 319,027 10,000 $ 153,804 $ 159,690 $ 176,185 $ 202,743 $ 216,620 $ 225,124 $ 261,004 $ 284,393 $ 283,385 $ 377,526 $ 419,939 $ 399,907 15,800 $ 192,786 $ 202,967 $ 225,520 $ 269,691 $ 293,355 $ 302,425 $ 361,244 $ 400,959 $ 393,978 $ 544,350 $ 616,168 $ 577,084 22,700 $ 243,404 $ 262,395 $ 297,757 $ 350,272 $ 396,229 $ 404,625 $ 477,495 $ 555,555 $ 531,848 $ 731,941 $ 874,207 $ 786,294 31,000 $ 291,077 $ 313,773 $ 364,766 $ 436,896 $ 490,553 $ 510,585 $ 610,490 $ 701,006 $ 684,179 $ 957,678 $ 1,121,912 $ 1,031,367 40,750 $ 350,065 $ 379,015 $ 445,982 $ 530,840 $ 597,743 $ 626,758 $ 746,049 $ 858,134 $ 841,967 $ 1,176,467 $ 1,378,916 $ 1,272,385 81,500 $ 556,250 $ 614,150 $ 748,085 $ 917,801 $ 1,051,607 $ 1,109,636 $ 1,348,219 $ 1,572,389 $ 1,540,054 $ 2,209,055 $ 2,613,953 $ 2,400,890 122,250 $ 786,489 $ 873,340 $ 1,074,242 $ 1,328,816 $ 1,529,525 $ 1,616,568 $ 1,974,443 $ 2,310,698 $ 2,262,195 $ 3,265,697 $ 3,873,044 $ 3,553,449 163,000 $ 1,009,571 $ 1,125,372 $ 1,393,241 $ 1,732,673 $ 2,000,285 $ 2,116,343 $ 2,593,509 $ 3,041,849 $ 2,977,179 $ 4,315,181 $ 5,124,977 $ 4,698,851 Total Costs 20 Meters Offshore Total Costs 125 Meters Offshore Total Costs 250 Meters Offshore Total Costs 500 Meters Offshore 316b Phase II Cost Module 1.2 Add Submerged Fine Mesh Passive Screens to Existing Offshore Intakes Please note that much of the supporting documentation has been previously described in Section 1.1.

Capital Costs Adding passive screens to an existing submerged offshore intake requires many of the same construction steps and components described in section 1.1 above, excluding those related to the main trunk of the manifold pipe and connecting wall. Similar construction components include: modifying the submerged inlet to connect the new screens, installing T screens, and installing the airburst backwash air supply equipment and the blowpipes. Nearly all of these components will require similar equipment, construction steps and costs as described in Section 1.1 for the specific components. One possible difference is that the existing submerged piping distance may not match one of the four lengths for which costs were estimated. This is a somewhat important consideration because the costs of the blowpipes are dependent on length. However, this difference only affects this component of cost. The cost scenario distance chosen is the one that closely matches or exceeds the existing offshore distance. Table 1 11 presents the combined costs of the installed T screens, airburst air supply system, and air supply pipes. The costs in Table 1 11 include direct and indirect costs, as described in Section 1.1. Figures 1 6, 1 7, and 1 8 present plots of Table 1 11 data, including the second order, best fit equations are used to estimate technology costs for specific facilities.

TABLE 1 11 CAPITAL COST OF INSTALLING PASSIVE T SCREENS AT AN EXISTING SUBMERGED OFFSHORE INTAKE O& M Costs O& M costs are assumed to be nearly the same as for relocating the intake offshore with passive screens. EPA assumes there are some offsetting costs associated with the fact that the existing intake should already have periodic inspection/ cleaning by divers. The portion of the costs representing a single annual inspect has therefore been deducted. Table 1 12 presents the annual O& M costs for low debris and high debris locations. Figure 1 9 presents the plotted O& M data along with the second order, best fit equations.  2 Design Flow Annual Power Costs Annual Power Costs Annual Labor Cost Annual Labor Cost Dive Team Costs Dive Team Costs Total O& M Costs Total O& M Costs gpm Low Debris High Debris Low Debris High Debris Low Debris High Debris Low Debris High Debris 2,500 $ 24 $ 145 $ 9,982 $ 22,314 $ 0 $ 5,260 $ 10,007 $ 27,719 5,700 $ 61 $ 363 $ 9,982 $ 22,314 $ 0 $ 5,260 $ 10,043 $ 27,937 10,000 $ 121 $ 726 $ 9,982 $ 22,314 $ 0 $ 5,260 $ 10,103 $ 28,300 15,800 $ 145 $ 871 $ 11,891 $ 24,222 $ 0 $ 7,250 $ 12,036 $ 32,343 22,700 $ 182 $ 1,089 $ 11,891 $ 24,222 $ 0 $ 7,250 $ 12,072 $ 32,561 31,000 $ 242 $ 1,452 $ 11,891 $ 24,222 $ 0 $ 7,250 $ 12,133 $ 32,924 40,750 $ 303 $ 1,815 $ 11,891 $ 24,222 $ 0 $ 7,250 $ 12,193 $ 33,287 81,500 $ 605 $ 3,631 $ 13,799 $ 26,130 $ 0 $ 9,240 $ 14,404 $ 39,001 122,250 $ 908 $ 5,446 $ 13,799 $ 26,130 $ 0 $ 9,240 $ 14,707 $ 40,816 TABLE 1 12 NET INTAKE O& M COSTS FOR PASSIVE T SCREENS INSTALLED AT EXISTING SUBMERGED OFFSHORE INTAKES Construction Downtime Unlike the cost for relocating the intake from shore based to submerged offshore, the only construction activities that would require shutting down the intake is to modify the inlet and install the T screens. Installing the air supply system and the major portion of the air blowpipes can be performed while the intake is operating. Downtimes are assumed to be similar to those for adding velocity caps, which were reported to range from two to seven days. An additional one to two days maybe needed to connect the blowpipes to the T screens. The total estimated intake downtime of three to nine days can easily be scheduled to coincide with the routine maintenance period for power plants ( approximately four weeks).

Application Separate capital costs have been developed for freshwater, freshwater with Zebra mussels, and saltwater environments. In selecting the materials of construction, the same methodology described in Section 1.1 is used. BECAUSE the retrofit is an addition to an existing intake, selecting the distance offshore involves matching the existing distance to the nearest or next highest distance costed.

Similarly, the O& M costs are applied using the same method as described in Section 1.1.  3 Figure 1 6 Capital Costs for Passive Screen Existing Offshore in Freshwater at Selected Offshore Distances y = 3E 06x 2 + 25.095x + 154574 R 2 = 0.9999 y =  4E 07x 2 + 15.21x + 123289 R 2 = 0.9999 y =  2E 06x 2 + 10.267x + 107646 R 2 = 0.9997 y =  3E 06x 2 + 6.1145x + 94506 R 2 = 0.999 $ 0 $ 1,000,000 $ 2,000,000 $ 3,000,000 $ 4,000,000 $ 5,000,000 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 Design Intake Flow ( gpm)

Total Capital Costs 20 Meter 125 Meter 250 Meter 500 Meter  4 Figure 1 7 Capital Costs for Passive Screen at Existing Offshore in Saltwater at Selected Offshore Distances y = 3E 06x 2 + 30.025x + 161224 R 2 = 0.9998 y =  5E 07x2 + 17.945x + 126572 R 2 = 0.9998 y =  2E 06x 2 + 11.905x + 109246 R 2 = 0.9997 y =  3E 06x 2 + 6.8309x + 94692 R 2 = 0.9991 $ 0 $ 1,000,000 $ 2,000,000 $ 3,000,000 $ 4,000,000 $ 5,000,000 $ 6,000,000 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 Design Intake Flow ( gpm)

Total Capital Costs 20 Meter 125 Meter 250 Meter 500 Meter  5 Figure 1 8 Capital Costs for Passive Screen Existing Offshore in Freshwater with Zebra Mussels at Selected Offshore Distances y = 2E 06x 2 + 27.504x + 152489 R 2 = 0.9999 y =  7E 07x 2 + 17.618x + 121204 R 2 = 0.9999 y =  2E 06x 2 + 12.675x + 105561 R 2 = 0.9998 y =  4E 06x 2 + 8.5232x + 92421 R 2 = 0.9994 $ 0 $ 1,000,000 $ 2,000,000 $ 3,000,000 $ 4,000,000 $ 5,000,000 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 Design Intake Flow ( gpm)

Total Capital Costs 20 Meter 125 Meter 250 Meter 500 Meter  6 Figure 1 9 Total O& M Cost for Passive Screen Existing Offshore with Airburst Backwash y =  3E 07x 2 + 0.0845x + 11155 R 2 = 0.9376 y =  4E 07x 2 + 0.1741x + 30519 R 2 = 0.9651 $ 0 $ 10,000 $ 20,000 $ 30,000 $ 40,000 $ 50,000 $ 60,000 0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 Design Intake Flow Annual O&

M Costs Low Debris High Debris  7


[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16553-16556]
[FR Doc No: 2023-05593]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0220]
RIN 1625-AA00

Safety Zone; Atlantic Ocean, Cape Canaveral Offshore Launch Area,
FL

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
waters of the Atlantic Ocean, adjacent to Cape Canaveral, FL. This
safety zone would implement a special activities provision of the
William M. (Mac) Thornberry National Defense Authorization Act for
Fiscal Year 2021. The Coast Guard is establishing this safety zone for
the launch of the Terran 1 rocket, which is being launched by
Relativity Space. The temporary safety zone will be located within the
Coast Guard District Seven area of responsibility offshore of Cape
Canaveral, Florida. This rule prohibits U.S.-flagged vessels from
entering the temporary safety zone unless authorized by the District
Commander of the Seventh Coast Guard District or a designated
representative. Foreign-flagged vessels are encouraged to remain
outside the safety zone. This action is necessary to protect vessels
and waterway users from the potential hazards created by launch of the
Terran 1 rocket, flying over the U.S. Exclusive Economic Zone (EEZ).

DATES: This rule is effective without actual notice from March 20,
2023, through 4 p.m. on March 23, 2023. For the purposes of
enforcement, actual notice will be used from 10 a.m. on March 16, 2023,
through March 20, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0220 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Ryan Gilbert, District Seven, Waterways Management
Branch, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

BNM Broadcast Notice to Mariners
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
EEZ Exclusive Economic Zone
FAA Federal Aviation Administration
FL Florida
FR Federal Register
MSIB Marine Safety Information Bulletin
NASA National Aeronautics and Space Administration
NM Nautical Mile
NPRM Notice of Proposed Rulemaking
RNA Regulated Navigation Area
Sec.  Section
U.S. United States
U.S.C. United States Code

II. Background Information and Regulatory History

    On January 1, 2021, the William M. (Mac) Thornberry National
Defense Authorization Act for Fiscal Year 2021 (Pub. L. 116-283)
(Authorization Act) was enacted. Section 8343 (134 Stat. 4710) calls
for the Coast Guard to conduct a 2-year pilot program to establish and
implement a process to establish safety zones to address special
activities,\1\ including space activities carried out by United States
(U.S.) citizens in the U.S. Exclusive Economic Zone (EEZ).\2\ Terms
used to describe space activities, including launch, are defined in 51
U.S.C. 50902.
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    \1\ Special Activities means space activities, including launch
and reentry, as such terms are defined in section 50902 of Title 51,
United States Code, carried out by United States citizens.
    \2\ The Coast Guard defines the U.S. exclusive economic zone in
33 CFR 2.30(a). Territorial sea is defined in 33 CFR 2.22.
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    The Coast Guard has long monitored space activities impacting the
maritime domain and taken actions to ensure the safety of vessels and
the public as needed during space launch operations. In conducting this
activity, the Coast Guard engages with other government agencies,
including the Federal Aviation Administration (FAA) and National
Aeronautics and Space Administration (NASA). This engagement is
necessary to ensure statutory and regulatory obligations are met to
ensure the safety of launch operations and waterway users.
    The Coast Guard has an existing permanent regulated navigation area
(RNA) that prevents vessels from operating in the waters adjacent to
the Cape Canaveral launch area; however, that area only extends to the
limits of the territorial sea.\3\ With this temporary final rule, the
Coast Guard is establishing a temporary safety zone in the Atlantic
Ocean in the U.S. EEZ that will abut the existing RNA near Cape
Canaveral, FL. The Coast Guard intends to activate the existing RNA in
33 CFR 165.775 concurrently with the temporary safety zone established
by this rule for the launch of the Terran 1 rocket.
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    \3\ See 33 CFR 165.775.
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    The Terran 1 will be the first rocket launched of the Terran
Program. Rockets built by Relativity Space for the Terran program are
constructed using a novel 3D printing technology that has never been
successfully employed in the United States. While the Terran rocket has
conducted tests of its engines, it has not yet been launched into low
earth orbit. Therefore, this launch presents a higher risk profile than
with a typical launch. Based on these factors, it has been determined
that the best way to reduce risk is to establish this temporary safety
zone abutting the established RNA in Sec.  165.775.
    Once the Terran 1 rocket has been launched, the Coast Guard will
notify the public through a Broadcast Notice to Mariners (BNM) that any
remaining safety zone enforcement times and dates are no longer needed.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. This
safety zone must be established by March 16, 2023, in order to protect
vessels and waterway users from the potential hazards associated with
the launch of the Terran 1 rocket.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the rule's objectives of ensuring the
protection of vessels and waterway users in the U.S. EEZ from the
potential hazards created by the launch operation.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under section 8343 of the
Authorization Act. The Seventh District Commander has determined that
there are potential hazards in the U.S. EEZ created by the launch of
the Terran 1 rocket. The purpose of this rule is to ensure safety of
vessels and waterway users before, during, and after the scheduled
launch.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone that will be subject
to enforcement starting on March 16, 2023, through March 23, 2023, from
10 a.m. to 4 p.m. each day, until the Terran 1 rocket is launched. Once
the Terran 1 rocket has been launched, the Coast Guard will notify the
public that the temporary safety zone has been cancelled, through a
BNM.
    This temporary safety zone will cover certain navigable waters in
the path of the rocket being launched from Cape Canaveral, FL. The
safety zone will cover approximately 650 square miles and is roughly
shaped like an elongated trapezoid. It will directly abut the RNA
established in Sec.  165.775. U.S.-flagged vessels will be prohibited
from entering the temporary safety zone unless authorized by the
District Commander of the Seventh Coast Guard District or a designated
representative. Foreign-flagged vessels are encouraged to remain
outside the safety zone. The coordinates of the safety zone are
provided in the regulatory text, and a map will be provided in the
docket.
    No U.S.-flagged vessel or person will be permitted to enter the
safety zone without obtaining permission from the District Commander or
a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, duration, and scope of the temporary safety zone. The
temporary safety zone is limited in size and location to only to the
areas where Terran 1 rocket launch may pose a danger to vessels outside
the RNA. The temporary safety zone is limited in scope, as vessel
traffic will be able to

safely transit around the zone. The safety zone is expected to be
enforced for approximately 8 hours. After the launch has been
completed, and there is no longer any danger to vessels from the Terran
1 rocket, the Coast Guard will notify waterway users and vessels that
the safety zone is no longer subject to enforcement. The safety zone
will ensure the protection of vessels and waterway users from the
potential hazards created by the launch of the Terran 1 rocket.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect 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.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves
enforcement of a safety zone for approximately 5 or 6 hours during the
duration of the rocket launch of the Terran 1 rocket. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T07-0220 to read as follows:

Sec.  165.T07-0220  Safety Zone; Atlantic Ocean, Cape Canaveral
Offshore Launch Area, Cape Canaveral, FL.

    (a) Location. The following area is a safety zone: All waters of
the Atlantic Ocean, from surface to bottom, encompassed by a line
connecting the following points beginning at Point 1: 28[deg]38'19.3''
N 80[deg]21'22.9'' W, thence to Point 2: 28[deg]45'14'' N
79[deg]58'51.2'' W, thence to Point 3: 28[deg]15'39.7'' N
79[deg]58'51.2'' W, thence to Point 4: 28[deg]22'27.7'' N
80[deg]18'59'' W, thence following the 12NM line back to point 1. These
coordinates are based on World Geodetic System (WGS) 84.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel, U.S.
Space Force range safety personnel, and Federal, State, and local
officers designated by or assisting the District Commander in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of

this part, U.S.-flagged vessels may not enter the safety zone described
in paragraph (a) of this section unless authorized by the District
Commander or a designated representative. All foreign-flagged vessels
are encouraged to remain outside the safety zone.
    (2) To seek permission to enter, transit through, anchor in or
remain within the safety zone contact Sector Jacksonville by telephone
at<PHONE_NUMBER> or the District Commander's representative via VHF-FM
radio on channel 16. Those in the safety zone must comply with all
lawful orders or directions given to them by the District Commander or
a designated representative.
    (d) Notification of enforcement. (1) The Coast Guard intends to
enforce the temporary safety zone for the Terran 1 rocket launch with
assets on scene to ensure the temporary safety zone is cleared of
persons and vessels.
    (2) Once the Terran 1 rocket has been launched, the safety zone
will no longer be needed. At that time, the Coast Guard will notify the
public of the cancellation of the safety zone through a Broadcast
Notice to Mariners on VHF-FM channel 16, and through social media.
    (e) Enforcement period. This section will be enforced from 10 a.m.
on March 16, 2023, through 4 p.m. on March 23, 2023. This section is
subject to enforcement from 10 a.m. to 4 p.m. each day.

    Dated: March 14, 2023.
Brendan C. McPherson,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2023-05593 Filed 3-17-23; 8:45 am]
BILLING CODE 9110-04-P