except in an engine for a gasoline-powered rescue boat.
    (b) OSVs of at least 6,000 GT ITC (500 GRT if GT ITC is not
assigned). (1) Except as provided by paragraph (b)(2) of this section,
each internal-combustion engine installed on an OSV of at least 6,000
GT ITC (500 GRT if GT ITC is not assigned), whether for main propulsion
or for auxiliaries, must be driven by a fuel having a flashpoint not
lower than 60[deg] C (140[deg] F) as determined by ASTM D 93
(incorporated by reference, see Sec.  125.180).
    (2) The use of a fuel with a flashpoint lower than 60[deg] C
(140[deg] F) must be specifically approved by the Commandant (CG-ENG),
except in an engine for a gasoline-powered rescue boat or emergency
generator, or as provided in paragraph (b)(2) of this section.

PART 129--ELECTRICAL INSTALLATIONS

0
43. The authority citation for part 129 is revised to read as follows:

    Authority:  46 U.S.C. 3306; sec. 617, Pub. L. 111-281, 124 Stat.
2905; Department of Homeland Security Delegation No. 0170.1.

0
44. Revise Sec.  129.110 to read as follows:

Sec.  129.110  Applicability.

    (a) Electrical installations on OSVs of at least 6,000 GT ITC (500
GRT if GT ITC is not assigned) must comply with subchapter J of this
chapter.

    (b) Except as specifically provided in this subchapter, electrical
installations on an OSV of less than 6,000 GT ITC (500 GRT if GT ITC is
not assigned) must comply with subchapter J of this chapter.

0
45. Amend Sec.  129.315 by revising the section heading and paragraph
(a) to read as follows:

Sec.  129.315  Power sources for OSVs.

    (a) The requirements of this section apply to OSVs between 100 GRT
and 500 GRT or less than 6,000 GT ITC instead of those in subpart
111.10 of this chapter.
* * * * *

0
46. Add Sec.  129.570 to read as follows:

Sec.  129.570  Overfill protection.

    (a) This section applies to OSVs of at least 6,000 GT ITC (500 GRT
if GT ITC is not assigned).
    (b) Each cargo oil tank with a capacity of 1,000 or more cubic
meters (approximately 6,290 barrels) must have one overfill device that
is permanently installed on each oil tank, with an intrinsically safe
high-level alarm that meets the requirements of this section.
    (c) The high-level alarm and tank overfill alarm required by
paragraph (b) of this section must--
    (1) Be independent of each other;
    (2) Alarm in the event of loss of power to the alarm system or
failure of electrical circuitry to the tank level sensor; and
    (3) Be able to be checked at the tank for proper operation prior to
each transfer or contain an electronic self-testing feature that
monitors the condition of the alarm circuitry and sensor.
    (d) The high-level alarm required by paragraph (b) of this section
must--
    (1) Alarm before the tank overfill alarm, but before the tank
capacity goes below 95 percent;
    (2) Be appropriately marked at the indicator panel; and
    (3) Have audible and visible alarm indications that can be seen and
heard on the vessel where oil transfer is controlled.
    (e) The tank overfill alarm required by paragraph (b) of this
section must--
    (1) Be independent of the oil gauging system;
    (2) Alarm early enough to allow the person in charge of transfer
operations to stop the transfer operation before the oil tank
overflows;
    (3) Be appropriately marked at the indicator panel; and
    (4) Have audible and visible alarm indications that can be seen and
heard on the vessel where oil transfer is controlled and in the cargo
deck area.

PART 130--VESSEL CONTROL, AND MISCELLANEOUS EQUIPMENT AND SYSTEMS

0
47. The authority citation for part 130 is revised to read as follows:

    Authority:  46 U.S.C. 3306; Department of Homeland Security
Delegation No. 0170.1. Sections 130.140 and 130.400 also issued
under sec. 617, Pub. L. 111-281, 124 Stat. 2905.

Sec.  130.140  [Amended]

0
48. In Sec.  130.140(a) introductory text, remove the words ``Each OSV
of 100 or more gross tons'' and add, in their place, the words ``Except
as provided in Sec.  128.110 of this subchapter, each OSV of 100 GRT or
more''.

Sec.  130.400  [Amended]

0
49. In Sec.  130.400, remove the word ``This'' and add, in its place,
the words ``Except as provided in Sec.  128.110 of this subchapter,
this''.

PART 131--OPERATIONS

0
50. The authority citation for part 131 is revised to read as follows:

    Authority:  33 U.S.C. 1321(j); 46 U.S.C. 3306, 6101, 10104; E.O.
12234, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 3 CFR, 1991 Comp., p.
351; Department of Homeland Security Delegation No. 0170.1. Section
131.990 also issued under sec. 617, Pub. L. 111-281, 124 Stat. 2905.

0
51. Add Sec.  131.990 to read as follows:

Sec.  131.990  Maneuvering characteristics.

    This section applies to OSVs of at least 6,000 GT ITC (500 GRT if
GT ITC is not assigned).
    (a) The following maneuvering information must be prominently
displayed in the pilothouse on a fact sheet:
    (1) For full and half speed, a turning circle diagram to port and
starboard that shows the time and the distance of advance and transfer
required to alter the course 90 degrees with maximum rudder angle and
constant power settings.
    (2) The time and distance to stop the vessel from full and half
speed while maintaining approximately the initial heading with minimum
application of rudder.
    (3) For each vessel with a fixed propeller, a table of shaft
revolutions per minute for a representative range of speeds.
    (4) For each vessel with a controllable pitch propeller, a table of
control settings or a representative range of speeds.
    (5) For each vessel that is fitted with an auxiliary device to
assist in maneuvering, such as a bow thruster, a table of vessel speeds
at which the auxiliary device is effective in maneuvering the vessel.
    (b) The maneuvering information must be provided in the normal load
and normal light condition with normal trim for a particular condition
of loading, assuming the following:
    (1) Calm weather--wind 10 knots or less, calm sea.
    (2) No current.
    (3) Deep water conditions--water depth twice the vessel's draft or
more.
    (4) Clean hull.
    (c) At the bottom of the fact sheet, the following statement must
appear:
    (1) Warning, the response of the [NAME OF THE VESSEL] may be
different from those listed above if any of the following conditions,
upon which the maneuvering information is based, are varied:
    (i) Calm weather--wind 10 knots or less, calm sea.
    (ii) No current.
    (iii) Deep water conditions--water depth twice the vessel's draft
or more.
    (iv) Clean hull.
    (v) Intermediate drafts or unusual trim.
    (d) The information on the fact sheet must be--
    (1) Verified 6 months after the vessel is placed into service; or
    (2) Modified 6 months after the vessel is placed into service and
verified within 3 months thereafter.
    (e) The information that appears on the fact sheet may be obtained
from--
    (1) Trial trip observations;
    (2) Model tests;
    (3) Analytical calculations;
    (4) Simulations;
    (5) Information established from another vessel of similar hull
form, power, rudder and propeller; or
    (6) Any combination of the above.
    (f) The accuracy of the information on the fact sheet must be at a
level comparable with that attainable by ordinary shipboard navigation
equipment.
    (g) The requirements for information for fact sheets for
specialized craft, such as semi-submersibles and other vessels of
unusual design, will be specified on a case-by-case basis.

PART 132--FIRE-PROTECTION EQUIPMENT

0
52. The authority citation for part 132 is revised to read as follows:

    Authority:  46 U.S.C. 3306, 3307; sec. 617, Pub. L. 111-281, 124
Stat. 2905; Department of Homeland Security Delegation No. 0170.1.

0
53. Amend Sec.  132.100 by redesignating paragraph (d) as paragraph (e)
and adding paragraph (d) to read as follows:

Sec.  132.100  General.

* * * * *
    (d) Each OSV of at least 6,000 GT ITC (500 GRT if GT ITC is not
assigned) must, in addition to complying with the requirements
necessary to satisfy Sec.  125.105(a) and (b) of this subchapter--
    (1) Have two fire pumps, each capable of delivering water
simultaneously from the two highest outlets at a pitot tube pressure of
approximately 75 p.s.i.; and
    (2) Have fire hoses and nozzles that comply with Sec.  34.10-10 of
this chapter.

0
54. Add Sec.  132.200 to subpart B to read as follows:

Sec.  132.200  General.

    (a) Except as provided by paragraph (b) of this section, each OSV
must be equipped with portable and semiportable fire extinguishers that
comply with this subpart.
    (b) Each OSV of at least 6,000 GT ITC (500 GRT if GT ITC is not
assigned) must, in addition to complying with the requirements
necessary to satisfy Sec.  125.105(a) and (b) of this subchapter, be
equipped with the number and type of portable and semiportable fire
extinguishers listed in Sec.  34.50 of this chapter.

0
55. Add Sec.  132.365 to read as follows:

Sec.  132.365  Emergency outfits.

    (a) Two emergency outfits, stored for use in widely separated,
accessible locations, are required on all OSVs of at least 6,000 GT ITC
(500 GRT if GT ITC is not assigned) that have cargo tanks that exceed
15 feet in depth, measured from the tank top to the lowest point at
which cargo is carried.
    (b) Each emergency outfit must have on board the following
equipment:
    (1) One pressure-demand, open-circuit, self-contained breathing
apparatus, approved by the Mine Safety and Health Administration and by
the National Institute for Occupational Safety and Health and having at
a minimum a 30-minute air supply, a full facepiece, and a spare charge.
    (2) One lifeline with a belt or a suitable harness.
    (3) One Type II or Type III flashlight constructed and marked in
accordance with ASTM F1014--02 (incorporated by reference, see Sec.
125.180).
    (4) One fire axe.
    (5) One pair of boots and gloves of rubber or other electrically
nonconducting material.
    (6) One rigid helmet that provides effective protection against
impact.
    (7) One set of protective clothing of material that will protect
the skin from the heat of fire and burns from scalding steam. The outer
surface must be water resistant.
    (c) Lifelines must be of steel or bronze wire rope. Steel wire rope
must be either inherently corrosion resistant or made so by galvanizing
or tinning. Each end must be fitted with a hook with keeper having a
throat opening that can be readily slipped over a \5/8\-inch bolt. The
total length of the lifeline must be dependent upon the size and
arrangement of the vessel, and more than one line may be hooked
together to achieve the necessary length. No individual lifeline may be
less than 50 feet in length. The assembled lifeline must have a minimum
breaking strength of 1,500 pounds.

0
56. Add Sec.  132.390 to read as follows:

Sec.  132.390  Added requirements for carriage of flammable or
combustible cargo.

    (a) This section applies to OSVs of at least 6,000 GT ITC (500 GRT
if GT ITC is not assigned).
    (b) Cargo tanks containing flammable or combustible liquids must
not be located beneath the accommodations or machinery space.
Separation by cofferdams is not acceptable for meeting this
requirement.
    (c) Except for OSVs complying with paragraph (d)(1) of this
section, each OSV must carry at least two approved semiportable dry
chemical fire extinguishers for the protection of all weather deck
areas within 10 feet (3 m) of any tank openings, pumps, flanges,
valves, vents, or loading manifolds. Each extinguisher must have--
    (1) A minimum capacity of 135 kg. If the protected area exceeds 90
m\2\, additional extinguishers must be provided to supply a total
combined capacity of dry chemical in kilograms equal to the total
combined protected area in square meters multiplied by 3;
    (2) A minimum flow rate of 3 kg/min from each discharge hose;
    (3) A sufficient number of discharge hoses of adequate length to
protect the areas required above without moving any of the
extinguishers; and
    (4) The frame or support for each semi-portable dry chemical fire
extinguisher welded or otherwise permanently attached to the vessel's
structure.
    (d) Each OSV with fixed cargo tanks that have an aggregate capacity
of 3,000 cubic meters or more intended for the carriage of flammable or
combustible liquids with a closed-cup flashpoint of 60[deg] C or below
must have:
    (1) An approved fixed-deck foam system arranged as follows:
    (i) If the flammable or combustible liquid tanks extend vertically
to the weather deck, the foam system must comply with Sec. Sec.  34.20-
10 and 34.20-15 of this chapter, and protect the entire weather deck
cargo area, including any tank openings, pumps, flanges, valves, vents,
or loading manifolds. If petroleum products are carried, the minimum
foam system discharge rate in liters per minute must be determined by
multiplying the total cargo deck area by 6 lpm/m\2\. If polar solvent
cargoes are carried, the minimum foam system discharge rate in liters
per minute must be determined by multiplying the total cargo deck area
by 10 lpm/m\2\, unless the approved foam system design manual specifies
a different rate for the cargoes carried.
    (ii) If the flammable or combustible liquid tanks do not extend
vertically to the weather deck, the foam system must be capable of
protecting all weather deck areas within 10 feet (3 m) of any tank
openings, pumps, flanges, valves, vents, or loading manifolds. The foam
system must consist of at least one hoseline, and either fixed-foam
monitors or fixed-foam nozzles that provide foam coverage of all
required areas. The minimum foam system discharge rate must be
calculated in accordance with paragraph (d)(1)(i) of this section,
using the combined horizontal area of all parts of the deck requiring
protection, instead of the total deck area.
    (iii) All foam liquid concentrate must be compatible with all
flammable or combustible liquids carried.
    (iv) Sufficient foam liquid concentrate must be carried to allow
operation of the system at its maximum discharge rate for at least 20
minutes.
    (2) A fixed-gas fire-suppression system complying with Sec.  34.05-
5(a)(4) of this chapter, or other approved fire-extinguishing system
determined acceptable by the Commandant, for the protection of any
accessible below-deck cargo pump rooms or other spaces that have tank
openings, pumps, flanges, valves, or loading manifolds associated with
tanks carrying flammable or combustible liquids with a closed cup
flashpoint of 60[deg] C or below.

PART 134--ADDED PROVISIONS FOR LIFTBOATS

0
57. The authority citation for part 134 is revised to read as follows:

    Authority:  46 U.S.C. 3306, 3307; Department of Homeland
Security Delegation No. 0170.1. Section 134.100 also issued under
sec. 617, Pub. L. 111-281, 124 Stat. 2905.

0
58. Revise Sec.  134.100 to read as follows:

Sec.  134.100  Applicability.

    (a) This part, as well as parts 125 through 133 of this subchapter,
applies

to each liftboat of United States flag to which this subchapter
applies.
    (b) The design, construction and operating standards for liftboats
of at least 6,000 GT ITC (500 GRT if GT ITC is not assigned) must be
specially approved by Commandant (CG-5PS).

PART 174--SPECIAL RULES PERTAINING TO SPECIFIC VESSEL TYPES

0
59. The authority citation for part 174 is revised to read as follows:

    Authority:  42 U.S.C. 9118, 9119, 9153; 43 U.S.C. 1333; 46
U.S.C. 3306, 3703; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p.
277; Department of Homeland Security Delegation No. 0170.1. Section
174.180 also issued under sec. 617, Pub. L. 111-281, 124 Stat. 2905.

0
60. Revise Sec.  174.180 to read as follows:

Sec.  174.180  Applicability.

    This subpart applies to OSVs except liftboats inspected under
subchapter L of this chapter and OSVs of at least 6,000 GT ITC (500 GRT
if GT ITC is not assigned) as defined in Sec.  125.160 of this chapter.

    Dated: July 28, 2014.
Paul F. Zukunft,
Admiral, U.S. Coast Guard, Commandant.
[FR Doc. 2014-18721 Filed 8-15-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 246 (Friday, December 23, 2022)]
[Rules and Regulations]
[Pages 78871-78874]
[FR Doc No: 2022-27725]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 70

[EPA-R09-OAR-2022-0623; FRL-10031-02-R9]

Clean Air Act Operating Permit Program; California; San Diego
County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: With this direct final rule, the Environmental Protection
Agency (EPA) is promulgating approval of revisions to the Clean Air Act
Operating Permit Program (title V) of the San Diego County Air
Pollution Control District (SDCAPCD or District) in California. The EPA
is taking this final action in accordance with Federal regulations and
the Clean Air Act (CAA or ``Act'').

DATES: Effective February 21, 2023. Comments must be received on or
before January 23, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2022-0623 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI)

or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. If you need assistance in a language other than English or if
you are a person with disabilities who needs a reasonable accommodation
at no cost to you, please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: La Weeda Ward, Permits Office (Air-3-
1), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Why is the EPA using a direct final rule?
II. Background
III. What are the requirements for approval of revisions to Title V
programs?
IV. What is the State's proposed Title V program revision?
V. EPA Evaluation of Title V Program Revision
VI. Final Action
VII. Statutory and Executive Order Reviews

I. Why is the EPA using a direct final rule?

    The EPA is publishing this final rule approving the SDCAPCD's
proposed title V program revisions without prior proposal because we
consider it to be a noncontroversial action and anticipate no adverse
comments. However, elsewhere in this issue of the Federal Register
publication, the EPA is simultaneously publishing a proposal that will
also serve as a public notice of San Diego's proposed title V program
revisions pursuant to title 40 of the Code of Federal Regulations
(CFR), section 70.4(i).

II. Background

    The CAA Amendments of 1990 include title V, which requires states
to develop an operating permits program that meets the Federal criteria
codified in 40 CFR part 70. The title V program requires certain
sources of air pollution to obtain Federal operating permits from their
respective states. These Federal operating permits improve enforcement
and compliance by consolidating all applicable Federal requirements
into one federally enforceable document. Before states can issue title
V permits, the EPA must approve their programs as amendments to
appendix A of part 70. States may submit revisions to their approved
programs for EPA approval.
    Title V of the CAA applies to ``major stationary sources'' as
defined in title I, part D of the Act. 40 CFR 70.2 and 40 CFR
51.165(a)(1)(iv)(A) base the definition of ``major stationary source''
on the nonattainment classification of the area where the source is
located. Table 1 shows the attainment/non-attainment/unclassifiable
status for the applicable national ambient air quality standards
(NAAQS) within the District's jurisdictional boundary. As shown in
Table 1, SDCAPCD's jurisdiction is classified as Severe-15
nonattainment for the 2008 and 2015 8-hour ozone NAAQS.\1\ The area is
designated attainment/unclassifiable for all other NAAQS. See 40 CFR
81.305.
---------------------------------------------------------------------------

    \1\ The EPA reclassified the San Diego region to a Severe ozone
nonattainment area, effective July 2, 2021. This reclassification to
Severe means that a major stationary source is now defined as a
source emitting 25 tons or more per year of either oxides of
nitrogen or volatile organic compounds. 86 FR 29522 (June 2, 2021).

                 Table 1--Air Quality Attainment Status
------------------------------------------------------------------------
                                                  San Diego County (NA =
                                                      Non-attainment/
                                                   Classification,  A =
            NAAQS pollutant/standards                 Attainment, M =
                                                     Maintenance,  U =
                                                       Unclassified)
------------------------------------------------------------------------
Ozone 2008 8-Hour...............................  NA, Severe-15.
Ozone 2015 8-Hour...............................  NA, Severe-15.
Nitrogen dioxide (NO2)..........................  A/U.
PM2.5 2012 24-Hour..............................  A/U.
PM10 1987 24-Hour...............................  A/U.
Sulfur dioxide (SO2) 2010 Standards.............  A/U.
Carbon monoxide 1971 Standards..................  A/U.
Lead (pb) 2008 Standards........................  A/U.
------------------------------------------------------------------------

    The emission thresholds above which a title V operating permit is
required pursuant to 40 CFR 70.3(a) and 40 CFR 51.165(a)(1)(iv)(A)(1)
and (2) are shown in Table 2.

                                     Table 2--Title V Emissions Thresholds a
----------------------------------------------------------------------------------------------------------------
                                                                    VOC or NOX                      PM10  (tpy)
            Non-attainment designation/classification                  (tpy)         CO  (tpy)
----------------------------------------------------------------------------------------------------------------
Marginal........................................................             100             100             100
Moderate........................................................             100             100             100
Serious.........................................................              50              50              70
Ozone transport region (other than Severe or Extreme)...........              50  ..............  ..............
Severe..........................................................              25  ..............  ..............

Extreme.........................................................              10  ..............  ..............
----------------------------------------------------------------------------------------------------------------
\a\ 40 CFR 51.165(a)(1)(iv)(A).

III. What are the requirements for approval of revisions to Title V
programs?

    Pursuant to 40 CFR 70.4(i), either the EPA or the state may
initiate a title V program revision ``when the relevant Federal or
State statutes or regulations are modified or supplemented.'' It is the
responsibility of the state to keep the EPA apprised of any proposed
modifications to its basic statutory or regulatory authority or
procedures. Revision of a state program shall be accomplished as
follows:
    (a) The state submits a modified program description, Attorney
General's statement (if necessary for expanded or additional
authority), or other documents as the EPA determines to be necessary.
40 CFR 70.4(i)(2)(i).
    (b) After the EPA receives a proposed program revision, it will
publish a notice of the proposed change in the Federal Register and
provide for a public comment period of at least 30 days. 40 CFR
70.4(i)(2)(ii).
    (c) The Administrator shall approve or disapprove program revisions
based on the requirements of 40 CFR part 70 and the Act. 40 CFR
70.4(i)(2)(iii).
    (d) The EPA must publish a notice of approval in the Federal
Register for any substantial program revisions. 40 CFR 70.4(i)(2)(iv).
    (e) Approval of nonsubstantial revisions may be given by a letter
from the Administrator to the Governor or a designee. 40 CFR
70.4(i)(2)(iv).
    (f) A program revision shall become effective upon the approval of
the Administrator. 40 CFR 70.4(i)(2)(iv).

IV. What is the State's proposed Title V program revision?

    Table 3 lists the rules submitted as part of the SDCAPCD's title V
program revisions and the dates they were adopted by the District and
submitted by the California Air Resources Board (CARB), which is the
governor's designee for California rule submittals.\2\
---------------------------------------------------------------------------

    \2\ Rule 1401 was amended to revise the definitions of
``complete application'' and ``major stationary source.'' A detailed
explanation of the EPA's evaluation of these proposed revisions as
well as a change copy of the revised rule can be found in the
Technical Support Document (TSD) and docket.

                                            Table 3--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                Rule No.                            Rule title               Amended date     Submitted date \a\
----------------------------------------------------------------------------------------------------------------
1401...................................  Title V Operating Permits--             10/14/2021           1/24/2022
                                          General Provisions.
----------------------------------------------------------------------------------------------------------------
\a\ CARB transmitted the submittal to the EPA by a letter dated January 20, 2022.

    SDCAPCD revised the definition of ``complete application'' in Rule
1401 to incorporate Rule 1418,\3\ ``Action on Applications,'' Section
(a): Completeness Determination, by reference.
---------------------------------------------------------------------------

    \3\ All references to SDCAPCD Rule 1418 refer to the current
EPA-approved version of this rule. 68 FR 74871 (December 29, 2003).
Any future changes to Rule 1418 that amend Section (a) of this rule
will necessitate a conforming amendment to Rule 1401 and a
subsequent title V program revision.
---------------------------------------------------------------------------

    Additionally, SDCAPCD revised the definition of a major stationary
source in Rule 1401, Section (c)(26), to incorporate Rule 20.1,\4\
``New Source Review--General Provisions,'' Section (c)(30), ``Federal
Major Stationary Source'' by reference. Rule 20.1 contains the
definition of a ``Federal Major Stationary Source'' pursuant to 40 CFR
70.2, Definitions, ``Major source.''
---------------------------------------------------------------------------

    \4\ All references to SDCAPCD Rule 20.1 refer to the current
SIP-approved version of this rule. 87 FR 58729 (September 28, 2022).
A correction to this final rule was published on October 27, 2022
(87 FR 65015). Any future changes to Rule 20.1 that amend Table
20.1-5b of this rule will necessitate a conforming amendment to Rule
1401 and a subsequent title V program revision.
---------------------------------------------------------------------------

V. EPA Evaluation of Title V Program Revision

    The EPA finds that the revised definition of a ``complete
application'' aligns with the applicable 40 CFR part 70 elements. The
referenced portion of Rule 1418 outlines the components needed to deem
an application complete in accordance with the requirements listed in
40 CFR 70.7(a).
    The EPA also finds that the revised definition of a ``Major
Stationary Source'' in SDCAPCD Rule 1401, Section (c)(26), is in
accordance with the definition listed in 40 CFR part 70.2. As explained
in Section II of this Notice, SDCAPCD's jurisdiction is classified as
Severe nonattainment for ozone and designated attainment or
unclassifiable for all the other NAAQS. Under the definition of ``major
stationary source'' in 40 CFR 70.2, sources with emission rates equal
to or greater than 25 tons of NOX or VOC per year that are
located in Severe ozone nonattainment areas constitute major sources.
Since Table 20.1--5b of SDCAPCD's Rule 20.1 lists these emission rate
values in its definition of ``Federal Major Stationary Source,''
revised Rule 1401 references the appropriate emissions rates for the
San Diego Air Basin based on the EPA's ozone nonattainment
classifications.
    All of the other revisions to Rule 1401 involve clarifying specific
citations to rules that were already incorporated by reference in the
previous version of the rule that was adopted on August 13, 2003.

VI. Final Action

    As authorized in 40 CFR 70.4(i), the EPA is fully approving the
submitted revisions because we find the proposed changes to Rule 1401
align with 40 CFR part 70 program elements. Rule 1401 refers to the
correct VOC and NOX emission thresholds appropriate for a
Severe ozone nonattainment area. Therefore, the proposed changes are
approvable as title V program revisions. We do not anticipate adverse
comments, so we are finalizing this action without proposing it in
advance. However, in the Proposed Rules section of this Federal
Register, we are simultaneously proposing approval of the same
submitted rule. If we receive adverse comments on the proposed
revisions by

January 23, 2023, we will publish a timely withdrawal in the Federal
Register to notify the public that the direct final approval will not
take effect. The EPA would then address all public comments in a
subsequent final rule based on the proposed action. If we do not
receive timely adverse comments, this direct final approval will be
effective without further notice on December 23, 2022. Pursuant to
section 307(b)(1) of the Act, judicial review of this final agency
action may be sought by filing a petition for review in the United
States Court of Appeals for the appropriate circuit within 60 days of
publication in the Federal Register. We do not plan to open a second
comment period on this action, so any parties interested in commenting
should do so at this time.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator may approve a state title V
program submittal that complies with the provisions of the Act and
applicable Federal regulations; 40 CFR 70.4(i). Thus, in reviewing
title V program submittals, the EPA's role is to approve state choices,
provided they meet the criteria of the CAA and the criteria, standards,
and procedures defined in 40 CFR part 70.
    For that reason, this action:
     Is not a ``significant regulatory action'' 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);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     The state did not evaluate environmental justice
considerations as part of its title V program revision submittal. There
is no information in the record inconsistent with the stated goals of
Executive Order 12898 of achieving environmental justice for people of
color, low-income populations, and indigenous peoples (59 FR 7629,
February 16, 1994).
    In addition, this action is not approved to apply in Indian
country, as defined at 18 U.S.C. 1151, or in any other area where the
EPA or an Indian tribe has demonstrated that a tribe has jurisdiction.
Therefore, this rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    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. The EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 21, 2023. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

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

    Dated: December 14, 2022.
Martha Guzman Aceves,
Regional Administrator, Region IX.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 70--STATE OPERATING PERMIT PROGRAMS

0
1. The authority citation for part 70 continues to read as follows:

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

0
2. Appendix A to part 70 is amended under ``California'' by adding
paragraph (x)(6) to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

California

* * * * *
    (x) * * *
    (6) The District adopted revisions on October 14, 2021. The
California Air Resources Board submitted revisions to the EPA on
January 24, 2022. Approval is effective on December 23, 2022.

[FR Doc. 2022-27725 Filed 12-22-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 68 (Tuesday, April 9, 2019)]
[Proposed Rules]
[Pages 14038-14041]
[FR Doc No: 2019-06794]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0194; Product Identifier 2019-NM-009-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD was
prompted by reports of cracks within the ring gears of a slat geared
rotary actuator (SGRA) resulting from a change in the raw material
manufacturing process. This proposed AD would require replacement of
affected parts with serviceable parts, as specified in an European
Aviation Safety Agency (EASA) AD, which will be incorporated by
reference. We are proposing this AD to address the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by May 24, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the incorporation by reference (IBR) material described in the
``Related IBR material under 1 CFR part 51'' section in SUPPLEMENTARY
INFORMATION, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 89990 1000; email [email protected];
internet www.easa.europa.eu. You may find this IBR material on the EASA
website at https://ad.easa.europa.eu. You may view this IBR material at
the FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at http://www.regulations.gov.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0194; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (telephone 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0194;
Product Identifier 2019-NM-009-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0020, dated January 31, 2019
(``EASA AD 2019-0020'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A350-941 and -1041 airplanes. The
MCAI states:

    Cracks have been found within the ring gears of an SGRA.
Investigation identified that this is due to a change in the
manufacturing process of the 300M steel raw material, that did not
have adequate post-production non destructive testing for potential
cracks. A batch of SGRA has been identified as having been subject
to this manufacturing process.
    This condition, if not detected and corrected, could, in
combination with an independent failure on the second SGRA of the
same slat surface, lead to detachment of the slat surface, possibly
resulting in reduced control of the aeroplane and/or injury to
persons on the ground.
    To address this potential unsafe condition, Airbus issued the SB
[Service Bulletin A350-27-P026] to provide instructions to replace
the affected parts, referencing the applicable Liebherr SB for in-
shop correction.
    For the reason described above, this [EASA] AD requires
replacement of each affected part with a serviceable part.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2019-0020 describes procedures for replacing the affected
SGRAs. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section, and it is publicly
available through the EASA website.

FAA's Determination and Requirements of this Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI referenced
above. We are proposing this AD because we evaluated all pertinent
information and determined an unsafe condition exists and is likely to
exist or develop on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0020 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA worked with Airbus and EASA to develop a process to
use certain EASA ADs as the primary source of information for
compliance with requirements for corresponding FAA ADs. As a result,
EASA AD 2019-0020 will be incorporated by reference in the FAA final
rule. This proposed AD would, therefore, require compliance with the
provisions specified in EASA AD 2019-0020, through that incorporation,
except for any differences identified as exceptions in the regulatory
text of this proposed AD. Service information specified in EASA AD
2019-0020 that is required for compliance with EASA AD 2019-0020 will
be available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0194 after the FAA final rule is
published.

Costs of Compliance

    We estimate that this proposed AD affects 12 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
25 work-hours x $85 per hour = $2,125........................              $0           $2,125          $25,500
----------------------------------------------------------------------------------------------------------------
* We have received no definitive data that would enable us to provide cost estimates for the parts specified in
  this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage for
affected individuals. As a result, we have included all known costs in
our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus SAS: Docket No. FAA-2019-0194; Product Identifier 2019-NM-
009-AD.

(a) Comments Due Date

    We must receive comments by May 24, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by reports of cracks within the ring gears
of a slat geared rotary actuator (SGRA), resulting from a change in
the raw material manufacturing process. We are issuing this AD to
address cracking of SGRA ring gears. This condition, if not detected
and corrected, could, in combination with an independent failure on
the second SGRA of the same slat surface, lead to detachment of the
slat surface, possibly resulting in reduced control of the airplane
and injury to persons on the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (EASA) AD 2019-
0020, dated January 31, 2019 (``EASA AD 2019-0020'').

(h) Exceptions to EASA AD 2019-0020

    (1) For purposes of determining compliance with the requirements
of this AD: Where EASA AD 2019-0020 refers to its effective date,
this AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2019-0020 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (j)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or EASA; or Airbus SAS's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2019-0020 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2019-0020, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; email [email protected]; Internet www.easa.europa.eu.
You may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this EASA AD at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. EASA AD 2019-0020 may be found in the AD docket on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0194.

    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on April 1, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-06794 Filed 4-8-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54324-54326]
[FR Doc No: 2023-17154]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0583]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Radioactive Drug
Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by September 11, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0053. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Radioactive Drug Research Committees

OMB Control Number 0910-0053--Extension

    This information collection request supports the implementation of
statutory and regulatory requirements and associated Agency forms.
Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 355, and 371) establish provisions under which FDA
issues regulations governing the use of radioactive drugs for basic
scientific research. Specifically, Sec.  361.1 (21 CFR 361.1) sets
forth specific regulations about establishing and composing radioactive
drug research committees (RDRCs) and their role in approving and
monitoring basic research studies using radiopharmaceuticals, including
reporting, recordkeeping, and labeling requirements. No basic research
study involving any administration of a radioactive drug to research
subjects is permitted without the authorization of an FDA-approved RDRC
(Sec.  361.1(d)(7)). The type of research that may be undertaken with a
radiopharmaceutical drug must be intended to obtain basic information
and not to carry out a clinical trial for safety or efficacy. The types
of basic research permitted are specified in the regulations and
include studies of metabolism, human physiology, pathophysiology, or
biochemistry.
    To assist respondents with the applicable reporting requirements,
we developed Form FDA 2914 entitled, ``Report on Research Use of
Radioactive Drugs: Membership Summary,'' available at https://www.fda.gov/media/73820/download; and Form FDA 2915, entitled, ``Report
on Research Use of Radioactive Drugs: Study Summary,'' available at
https://www.fda.gov/media/71805/download.
    We also developed the guidance document entitled, ``Radioactive
Drug Research Committee: Human Research Without An Investigational New
Drug Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help determine whether
research studies may be conducted under an FDA-approved RDRC, or
whether research studies must be conducted under an investigational new
drug application (IND). It also offers answers to frequently asked
questions on conducting research with radioactive drugs, and provides
information on the membership, functions, and reporting requirements of
an RDRC approved by FDA. All Agency guidance documents are issued
consistent with our good guidance practice regulations at 21 CFR
10.115.
    Types of research studies not permitted under the regulations are
also specified and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an IND under 21 CFR part 312, and the associated information
collections, are covered in OMB control number 0910-0014.
    The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson or
chairpersons of each individual RDRC, investigators, and participants
in the studies.
    In the Federal Register of March 16, 2023 (88 FR 16272), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
      21 CFR section; FDA form or activity          Number of      responses per     Total annual           Average burden per response           Total
                                                   respondents       respondent       responses                                                   hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(3) reports and (c)(4) approval;               56                1               56  1..........................................       56
 Form FDA 2914 (Membership Summary).
Sec.   361.1(c)(3) reports; Form FDA 2915                     37               10              370  3..........................................    1,110
 (Study Summary).
Sec.   361.1(d)(8); adverse events.............               10                1               10  0.5 (30 mins)..............................        5
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    1,171
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
          21 CFR section; and activity              Number of       records per      Total annual         Average burden per recordkeeping        Total
                                                  recordkeepers    recordkeepers       records                                                    Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   361.1(c)(2); RDRC maintains meeting                    56            10.61              594  4.239......................................    2,518
 minutes involving use in human research
 subjects.
Sec.   361.1(d)(5); RDRC obtains consent of
 human research subjects.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...............  ...............  ...............  ...........................................    2,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden attributed to recordkeeping activities is assumed to be
distributed among the individual elements and averaged among
respondents. In the burden estimate, we assume an average burden per
record of 10 hours for the RDRC respondents to maintain meeting minutes
and 0.75 hours (45 minutes) for a subset of the respondents (37 RDRCs)
to obtain consent of human research subjects.
    Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the burden estimate because they
are information supplied by the Federal Government to the recipient for
the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).
    Our estimated burden for the information collection reflects an
overall decrease of 703 hours and a corresponding decrease of 158
responses. We attribute this adjustment to a decrease in the average
burden per response, from 3.5 hours to 3 hours per response, associated
with the public reporting burden for Form FDA 2915. The decrease is
based on our program experience and matches the burden hours reflected
on the form. In addition, this adjustment is also attributable to the
Agency receiving fewer submissions over the last few years.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17154 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P