[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Rules and Regulations]
[Pages 41502-41504]
[FR Doc No: 2023-13586]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0491]
RIN 1625-AA87

Security Zones; Corpus Christi Ship Channel, Corpus Christi, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing two temporary, 500-yard
radius, moving security zones around the Motor Vessel (M/V) ARC
DEFENDER and M/V OCEAN JAZZ. These zones are needed to protect the
vessels, which will be carrying military cargo onboard, while they are
transiting the Corpus Christi Ship Channel, in Corpus Christi, TX.
Entry of vessels or persons into the zones are prohibited unless
specifically authorized by the Captain of the Port Sector Corpus
Christi (COTP) or a designated representative.

DATES: This rule is effective without actual notice from June 27, 2023,
through July 19, 2023. For the purposes of enforcement, actual notice
will be used from June 21, 2023 through July 19, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Anthony Garofalo, Sector Corpus
Christi Waterways Management Division, U.S. Coast Guard; telephone 361-
939-5130, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Corpus Christi
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    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 it is impracticable. We must
establish this security zone by June 21, 2023 to ensure security of the
vessel and lack sufficient time to provide a reasonable comment period
and then consider those comments before issuing the rule.
    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 public interest because immediate
action is needed to provide for the security of the vessel and cargo.

III. Legal Authority and Need for Rule

    The Coast Guard may issue security zone regulations under authority
in 46 U.S.C. 70051 and 70124. The Captain of the Port Sector Corpus
Christi (COTP) has determined that potential hazards associated with
the transit of the M/V ARC DEFENDER and M/V OCEAN JAZZ when loaded with
military cargo will be a security concern within a 500-yard radius of
the vessel. This rule is needed to provide for the safety and security
of the vessels, their cargo, and surrounding waterway from terrorist
acts, sabotage or other subversive acts, accidents, or other events of
a similar nature from June 21, 2023 through July 19, 2023.

IV. Discussion of the Rule

    The Coast Guard is establishing two 500-yard radius temporary
security zones around M/V ARC DEFENDER and M/V OCEAN JAZZ. The vessel
names will be clearly marked on the port, starboard, and stern. The
zone for the vessel will be enforced from the time the vessel transits
the Corpus Christi Ship Channel between June 21, 2023 and July 19,
2023. The duration of the zone is intended to protect the vessel and
military cargo on board while the vessel is in transit. No vessel or
person will be permitted to enter the security zone without obtaining
permission from the COTP or a designated representative.
    Entry into these security zones is prohibited unless authorized by
the COTP or a designated representative. A designated representative is
a commissioned, warrant, or petty officer of the U.S. Coast Guard
(USCG) assigned to units under the operational control of USCG Sector
Corpus Christi. Persons or vessels desiring to enter or pass through
each zone must request permission from the COTP or a designated
representative on VHF-FM channel 16 or by telephone at<PHONE_NUMBER>. If
permission is granted, all persons and vessels shall comply with the
instructions of the COTP or designated representative. The COTP or a
designated representative will inform the public through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Bulletins (MSIBs) as appropriate for the
enforcement times and dates for each security zone.

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,
duration, and location of the security zone. This rule will impact a
small designated area of the Corpus Christi Ship Channel during the
vessel's transits while loaded with cargo over a thirty-day period.
Moreover, the Coast Guard will issue BNMs via VHF-FM marine channel 16
about the zones as appropriate and the rule allows vessels to seek
permission to enter the zones.

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
temporary security 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
contact 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

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 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 a security zone lasting for the
duration of time that the M/V ARC DEFENDER and M/V OCEAN JAZZ are
within the Corpus Christi Ship Channel. It will prohibit entry within a
500 yard radius of the M/V ARC DEFENDER and M/V OCEAN JAZZ while the
vessel is carrying military cargo onboard and transiting within the
Corpus Christi Ship Channel. It is categorically excluded from further
review under L60(a) in 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 contact 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.T08-0491 to read as follows:

Sec.  165.T08-0491  Security Zones; Corpus Christi Ship Channel. Corpus
Christi, TX.

    (a) Location. The following area are security zones: All navigable
waters encompassing a 500-yard radius around the M/V ARC DEFENDER and
M/V OCEAN JAZZ while the vessel is carrying military cargo onboard and
in the Corpus Christi Ship Channel.
    (b) Enforcement period. This section will be enforced from June 21,
2023 through July 19, 2023.
    (c) Regulations. (1) The general regulations in Sec.  165.33 of
this part apply. Entry into the zones is prohibited unless authorized
by the Captain of the Port Sector Corpus Christi (COTP) or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector Corpus Christi.
    (2) Persons or vessels desiring to enter or pass through the zones
must request permission from the COTP Sector Corpus Christi on VHF-FM
channel 16 or by telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP or designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public through Broadcast Notices to Mariners (BNMs),
Local

Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins
(MSIBs) as appropriate of the enforcement times and dates for these
security zones.

    Dated: June 16, 2023.
J.B. Gunning,
Captain, U.S. Coast Guard, Captain of the Port Sector Corpus Christi.
[FR Doc. 2023-13586 Filed 6-26-23; 8:45 am]
BILLING CODE 9110-04-P


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC) ( Renewal)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC) ( Renewal)

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) From Petroleum Refineries, published at 40 CFR part 63, subpart CC, were proposed on July 15, 1994, and promulgated on August 18, 1995. These regulations apply to the following existing and new petroleum refining process units and emission points located at refineries that are major sources of HAPs: miscellaneous process vents, storage vessels, wastewater streams and treatment operations, equipment leaks, gasoline loading racks, and marine vessel loading operations. These regulations also apply to storage vessels and equipment leaks associated with bulk gasoline terminals or pipeline breakout stations that are related to an affected petroleum refinery. New facilities include those that commenced construction or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart CC.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NESHAP.

Any owner or operator subject to the provisions of this part shall maintain a file of these measurements and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) regional office. Once received by the authority, reports are reviewed and the data is entered, analyzed, and maintained in the Air Facility System ( AFS). Information from these reports can be used by any regions, states, agencies and offices with access to AFS and may be used in determining where inspections and enforcement actions may be necessary.

Approximately 134 sources are currently subject to the regulation, and it is estimated that no additional sources per year will become subject to the regulation in the next three years. Although no additional sources are expected to become subject to the regulation, some sources will construct new affected facilities or will reconstruct currently affected facilities in order to 2 increase their refining capacities. It is assumed that, on average, a refinery will reconstruct ten percent of the existing storage vessels, process units subject to equipment leak provisions, and process vents. The annual cost of this ICR will be $ 0 dollars for nonlabor and $ 26,163,230 for labor ( based on a labor burden of 410,054 hours) for a total of $ 26,163,230 dollars.

These estimates are based on the Oil and Gas Journal's Pennwell Surveys, industry contacts, and information from the previous ICR.

The OMB approved the currently active ICR without any " Terms of Clearance."

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction. In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from petroleum refineries cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NESHAP were promulgated for this source category at 40 CFR part 63, subpart CC.

2( b) Practical Utility/ Users of the Data The control of emissions of HAP from petroleum refineries requires not only the 3 installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of HAP from petroleum refineries are the result of operation of the affected facilities. The subject standards are achieved by the capture of HAP emissions using control devices and the reduction of emissions through leak detection and repair procedures. Depending on the emission point being controlled, affected sources may use flares, carbon adsorbers, combustion devices ( including incinerators, boilers and process heaters), or other control devices that meet minimum control requirements. The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated, leaks are being detected and repaired, and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. In general, control devices other than flares must achieve HAP reductions of at least 95 percent by weight. Flares must be operated with no visible emissions and a flame must be present at all times. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that sources affected by the NESHAP continue to operate the control equipment in compliance with the regulation. Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR part 63, subpart CC.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

Some of the facilities subject to this NESHAP will also be subject to requirements under the New Source Performance Standards ( NSPS) subparts J, K, Ka, Kb, VV, and QQQ, NESHAP ( part 61) subpart FF, and NESHAP ( part 63) subparts G, H, J, R, and Y. The burden requested for this NESHAP does not duplicate any of the burden accounted for under those subparts. 4 Efforts were made before and after promulgation to streamline overlapping recordkeeping and reporting requirements of other rules affecting the petroleum refinery industry. The applicability section of this NESHAP delineates requirements where there are overlapping rules.

This NESHAP does not require additional recordkeeping or reporting for marine vessel tank loading and unloading operations, bulk gasoline loading racks, and wastewater sources, provided that they are not included in emissions averaging. These sources would only be affected by those records and reports required already by other rules. Therefore, the recordkeeping and reporting cost for these sources was not included in the burden estimate for this rule.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register ( 69 FR 29718) on May 25, 2004. No comments were received on the burden published in the Federal Register.

3( c) Consultations In addition to holding a public comment period following the First Federal Register Notice ( FFRN), the EPA consulted with industry representatives ( i. e., respondents) ( Tom Wigglesworth, National Petroleum Refiners Association, 202 457 0480) and industry trade association journals to obtain information about the regulated universe. The Oil and Gas Journal's PennWell Surveys were the primary sources of information regarding the number of existing affected sources. Consultations with industry representatives were used to verify such information and provide other key data ( e. g., industry growth rate, level of electronic reporting). The EPA databases OTIS ( Online Tracking Information System) and TRI ( Toxic Release Inventory) were also consulted.

EPA solicited input from industry representatives to determine whether it would be possible to reduce the recordkeeping and reporting burden or improve the language in the standards to facilitate industry compliance. EPA did not receive any suggestions on how to revise the rule.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease. 5 3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.5.

These standards require respondents to maintain all records, including reports and notifications, for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent the Part 70 permit program and the five year statute of limitations on which the permit program is based. Also, the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

3( f) Confidentiality Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, part 2, subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are petroleum refineries that are major sources of HAP emissions. The SIC code for the respondents affected by the standards is SIC ( United States Standard Industrial Classification) 2911, which corresponds to NAICS ( North American Industry Classification System) 324110 for petroleum refineries.

4( b) Information Requested ( i) Data Items 6 All data in this ICR that are recorded and/ or reported are required by 40 CFR part 63, subpart CC  National Emission Standards for Hazardous Air Pollutants From Petroleum Refineries.

A source must make the following reports:

Notification Reports Notification of Compliance, Status Report, Periodic Report for Emissions Averaging ( optional) 63.653( a) & ( c)

Notification of intent to construct/ reconstruct. 63.9( b)( 4), 63.654( d)( 2)

Notification of date of construction/ reconstruction. 63.9( b)( 4), 63.654( d)( 2)

Notification of date of actual startup. 63.9( b)( 4), 63.654( d)( 2)

Application for approval of construction/ reconstruction. 63.5( d), 63.9( b)( 5), 63.566( b), 63.640( k)( 2)( i), 63.654( c), 63.654( h)( 6)

Notification of intent to construct/ reconstruct a control device. 63.5( b)( 6), 63.5( d)( 1)

Notification of Compliance Status. 63.182( c), 63.428( c)( 2), 63.640( k)( 2)( ii), 63.654( b), 63.654( d), 63.654( f), 63.654( h)( 6)

Notification of performance test and site specific test plan. 63.567( d), ( f), 63.642( d)( 2), 63.654( c),

Results of performance test. 63.567( d), 63.654( c), 63.654( d) 7 Notification Reports Request for extension of compliance. 63.9( c)

Notification of special compliance requirements. 63.9( d)

Engineering report of vapor collection system for marine tank vessel loading operations. 63.567( f), 63.654( c)

Notifications for wastewater streams. 61.357, 63.654( a)

Notifications of inspections of storage vessels. 63.654( h)( 2)

Notification of determination of applicability to flexible process units. 63.654( h)( 6)( i)

Notification of determination of applicability to variable storage vessels. 63.654( h)( 6)( ii)

Notification of determination of applicability to variable distillation units. 63.654( h)( 6)( iii)

Reports Submission of Implementation Plan for approval ( optional) 63.652( b), 63.653( c) & ( d)

Periodic Report for Emissions Averaging ( optional) 63.652( l)

Reports for wastewater streams. 61.357, 63.654( a)

Reports for gasoline loading racks. 63.428( b), ( c), ( g)( 1), and ( h)( 1) through ( h)( 3), 63.654( b)

Annual reports of excess emissions and continuous monitoring system performance, or summary report, for marine tank vessel loading operations. 63.567( e), 63.654( c)

Reports for equipment leaks. 60.487 or 63.182, 63.654( d) 8 Reports Semiannual (" Periodic") and immediate reports, including startup, shutdown, and malfunction reports. 63.10( d)( 5), 63.654( g), 63.654( h)( 1)

A source must keep the following records:

Recordkeeping Records for Implementation Plan ( optional) 63.653( a), ( b), & ( d)

Records for wastewater streams. 61.356, 63.654( a)

Records for gasoline loading racks. 63.428( c), 63.654( b)

Records for vapor collection system for marine tank vessel loading operations. 63.567( g), 63.654( c)

Records of vapor tightness for marine tank vessel loading operations. 63.567( h), 63.654( c)

Records of current vapor tightness test results for marine tank vessel loading operations. 63.567( i), 63.654( c)

Records for equipment leaks. 60.486 or 63.181, 63.654( d)

Records for storage vessels. 63.123, 63.654( i)( 1)

Records of performance test results and test reports. 63.654( i)( 2)

Records for monitoring of miscellaneous process vents. 63.654( i)( 3)

Records of miscellaneous notifications and reports. 63.654( i)( 4)

Records of startup, shutdown, and malfunction of processes. 63.10( b)( 2)( i)

Records of malfunction of control equipment. 63.10( b)( 2)( ii)

Records of corrective actions taken during periods of startup, shutdown, and malfunction. 63.10( b)( 2)( iv) 9 Recordkeeping 1 Consultation with Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association. Records to demonstrate conformance with startup, shutdown, and malfunction plan. 63.10( b)( 2)( v)

Records of calibration checks, adjustments and maintenance on CMS. 63.10( b)( x), ( xi)

Electronic Reporting The majority of the recordkeeping requirements associated with this rule are related to visual inspections of affected facilities. Personnel at the affected source must perform these inspections and note the nature of the corrective actions taken. Because of the human labor involved with these requirements, there are few record keeping requirements that could be easily automated. As a result, automated record keeping appears to be rare among respondents. Some regulatory agencies are setting up electronic reporting systems to allow sources to report electronically which is reducing the reporting burden. However, electronic reporting systems are still not widely used by the regulatory agencies. It is believed that electronic reporting is not common among respondents1.

( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate continuous temperature monitors or other monitoring devices for HAP control devices.

Perform initial performance test and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information. 10 Respondent Activities Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and observe repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System ( AFS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority may inspect the source to check if the pollution control devices are properly installed and operated, leaks are being detected and repaired, and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. In general, control devices other than flares must achieve HAP reductions of at least 95 percent by weight. Flares must be operated with no visible emissions and a flame must be present at all times. Data and records maintained by the respondents are tabulated and published for use in compliance and 11 2 Consultation with Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association. enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS, which is operated and maintained by EPA's Office of Compliance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government owned facilities. EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses) 2. However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC).

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory. 12 In the original burden estimate, it was assumed that 50 percent of refineries complying with the petroleum refineries NESHAP would make use of the emissions averaging provisions. Emissions averaging allows regulated facilities to control emission points to levels less than required by the rule if other emission points are controlled to levels greater than required by the rule. Additional recordkeeping and reporting is required of refineries using emissions averaging in order to ensure that the net decrease in emissions achieved is greater than the decrease that would have been achieved without emissions averaging.

Currently, it is expected none of the refineries subject to the NESHAP will use emissions averaging. The date has passed by which facilities are required to submit an implementation plan ( required when applying for emissions averaging) and no implementation plans have been received. Consequently, no hours are included in the estimated burden for recordkeeping and reporting activities associated with emissions averaging.

Also, as discussed in Section 3( a), no hours are included in the estimated burden for recordkeeping and reporting activities associated with marine vessel tank loading and unloading operations, bulk gasoline loading racks, and wastewater sources. The petroleum refineries NESHAP does not have any additional recordkeeping or reporting requirements for these sources, provided that they are not included in emissions averaging.

The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 410,054 hours. These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates:

Managerial $ 95.32 ($ 45.39 + 110%) Technical $ 64.60 ($ 30.76 + 110%) Clerical $ 40.09 ($ 19.09 + 110%) 13 These rates are from the United States Department of Labor, Bureau of Labor Statistics, December, 2003, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The only costs to the regulated industry resulting from information collection activities required by the subject standard are labor costs. There are no capital/ startup or operation and maintenance costs.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs The petroleum refineries NESHAP incorporates requirements for parametric monitoring of control devices that are included in other rules to which petroleum refineries are already subject. No additional new monitoring equipment is required in order to comply with the recordkeeping and reporting requirements of the petroleum refineries NESHAP. Therefore, no capital/ startup or operation and maintenance costs are associated with this rule.

The total capital/ startup costs for this ICR are $ 0. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR are $ 0. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M).

The total respondent costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 0. This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 165,485. 14 This cost is based on the average hourly labor rate as follows:

Managerial $ 54.66 ( GS 13, Step 5, $ 34.16 x 1.6) Technical $ 40.56 ( GS 12, Step 1, $ 25.35 x 1.6) Clerical $ 21.95 ( GS 6, Step 3, $ 13.72 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2: Annual Agency Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC), below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, approximately 134 existing sources are currently subject to the standard. It is estimated that no additional sources per year will become subject to the standard in the next three years. Although no additional sources are expected to become subject to the regulation, some sources will construct new affected facilities or will reconstruct currently affected facilities in order to increase their refining capacities. It is assumed that, on average, a refinery will reconstruct ten percent of the existing storage vessels, process units subject to equipment leak provisions, and process vents.

The number of respondents is calculated using the following table, which addresses the three years covered by this ICR.

Number of Respondents Respondents That Submit Reports Respondents That Do Not Submit Any Reports Year ( A) Number of New Respondents ( B) Number of Existing Respondents ( C) Number of Existing Respondents that keep records but do not submit reports ( D) Number of Existing Respondents That Are Also New Respondents1 ( E) Number of Respondents ( E= A+ B+ C D)

1 13 134 0 13 134 2 13 134 0 13 134 3 13 134 0 13 134 Average 13 134 0 13 134 15 1 New respondents include sources with constructed and reconstructed affected facilities. In this standard existing respondents submit initial notifications.

To avoid double counting respondents column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 134. This number appears on the OMB 83 I form in block 13( a), Number of respondents.

The total number of annual responses per year is calculated using the following table. Note that this table does not account for responses that are required by other regulations to which petroleum refineries are already subject ( i. e., requirements that are not attributable to the petroleum refineries NESHAP):

Total Annual Responses ( A)

Information Collection Activity ( B)

Number of Respondents ( C)

Number of Responses ( D) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( BxC)+ D Notification of construction/ reconstruction of process vents 67 1 0 67 Notification of actual startup of process vents 67 1 0 67 Notification of performance test of process vents 20 1 0 20 Notification of compliance status 134 1 0 134 Semiannual reports 67 2 0 134 Annual tank inspection failure reports 67 1 0 67 Total 489 The number of Total Annual Responses is 489. This number is shown on the OMB 83 I form in block 13( b), Total annual responses.

The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 26,163,236. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC), below. 16 17 Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC)

Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions 1. Applications Not applicable 2. Survey and Studies Not applicable 3. Reporting Requirements A. Read instructions Initial i. Applicability/ general recordkeeping and reporting 20 1 20 13 260 13 26 19,078 Assumed 10% of respondents are adding new affected facility per year, and must therefore read instructions ii. Storage vessels 20 1 20 13 260 13 26 19,078 iii. Equipment leaks 20 1 20 13 260 13 26 19,078 iv. Process vents 20 1 20 13 260 13 26 19,078 Periodic v. Applicability/ general recordkeeping and reporting 4 2 8 134 1,072 53.6 107.2 78,658 vi. Storage vessels 1 2 2 134 268 13.4 26.8 19,665 vii. Equipment leaks 2 2 4 134 536 26.8 53.6 39,329 viii. Process vents 2 2 4 134 536 26.8 53.6 39,329 B. Required activities Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 18 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions Initial i. Storage vessels

perform design analysis and establish operating parameters for one closed vent system 80 0.9 72 134 9,648 482.4 964.8 707,922 80 hrs/ closed vent system, 9 vessels with controls, 10%

reconstructed ii. Equipment leaks 2 1.1 2.2 134 294.8 14.74 29.48 21,631 2 hrs/ unit, 11 units per respondent,

10% reconstructed iii. Process vents

initial performance test 10 0.2 2 134 268 13.4 26.8 19,665 10 hrs/ test, 2 control devices for vents, 10% of controls reconstructed iv. Process vents

repeat performance test 10 0.1 1 134 134 6.7 13.4 9,832 Assume 50% of performance tests require a retest.

Periodic v. Storage vessels

annual inspections 3 9 27 134 3,618 180.9 361.8 265,471 annual  9 vessels per respondent,

three hours per tank per year vi. Equipment leaks

monitoring This estimate does not include the monitoring of Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 19 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions equipment leak components. The cost for monitoring equipment leak components is included as part of the cost of the leak detection and repair program, which is a requirement of the regulation.

vii. Process vents

monitoring 1 24 24 134 3,216 160.8 321.6 235,974 monthly  one hour per control device,

two monitored devices, 12 months per year C. Create information See 3B D. Gather existing information See 3E E. Write reports Initial i. Notification of Compliance Status

Group 1 storage vessels 1 0.9 0.9 134 120.6 6.03 12.06 8,849 1 hr/ Group 1 vessel, 9 vessels,

10% reconstructed ii. Notification of 4 1.1 4.4 134 589.6 29.48 58.96 43,262 4 hrs/ unit, 11 units, Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 20 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions Compliance Status

equipment leaks 10% reconstructed iii. Notification of Compliance Status

Group 1 process vents 1 0.9 0.9 134 120.6 6.03 12.06 8,849 1 hr/ Group 1 vent,

9 vents, 10% reconstructed iv. Notification of storage vessel inspection 1 0.9 0.9 134 120.6 6.03 12.06 8,849 1 hr/ vessel, 9 vessels, 10% reconstructed v. Notification of process vent control device test 4 0.4 1.6 134 214.4 10.72 21.44 15,732 4 hrs/ notification, 2 notifications per test ( two dates), 2 controls, 10% of controls reconstructed and tested Periodic vi. Semiannual reports

overall 18 2 36 134 4,824 241.2 482.4 353,961 vii. Semiannual reports

storage vessels 1 18 18 134 2,412 120.6 241.2 176,981 1 hr/ vessel, 9 vessels, twice yearly viii. Semiannual reports  storage vessel seal gap failure 3 2 6 134 804 40.2 80.4 58,994 3 hrs/ failure, 1 failure per report,

twice yearly ix. Semiannual reports  3 22 66 134 8,844 442.2 884.4 648,929 3 hours per unit, 11 Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 21 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions equipment leaks units, twice yearly x. Semiannual reports

process vents 1.5 4 6 134 804 40.2 80.4 58,994 1.5 hours per control device, two monitored devices,

twice yearly xi. Results of performance test See 3B 4. Recordkeeping Requirements A. Read instructions See 3A B. Plan activities Initial i. Applicability/ general recordkeeping and reporting 10 1 10 134 1,340 67 134 98,323 Assume 10% of vessels/ units/ vents are reconstructed each year. ( 9 vessels, 11 units, 9 vents)  8 hrs/ vessel initial. 6 hrs/ unit initial, 2 hrs/ vent initial ii. Storage vessels 8 0.9 7.2 134 964.8 48.24 96.48 70,792 iii. Equipment leaks 6 1.1 6.6 134 884.4 44.22 88.44 64,893 iv. Process vents 2 0.9 1.8 134 241.2 12.06 24.12 17,698 Periodic Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 22 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions v. Applicability/ general recordkeeping and reporting 3 2 6 134 804 40.2 80.4 58,994 semiannual vi. Storage vessels 1 9 9 134 1,206 60.3 120.6 88,490 annual  9 vessels per respondent, one hour per tank per year vii. Equipment leaks 1 11 11 134 1,474 73.7 147.4 108,155 annual  11 units per respondent, one hour per unit per year viii. Process vents 1 9 9 134 1,206 60.3 120.6 88,490 annual  9 vents per respondent, one hour per vent per year C. Implement activities Not applicable D. Develop record system Initial i. Storage vessels 2 0.9 1.8 134 241.2 12.06 24.12 17,698 2 hrs/ vessel, 9 vessels, 10% reconstructed ii. Equipment leaks 75 1.1 82.5 134 11,055 552.75 1,105.5 811,161 75 hrs/ unit, 11 units, 10% reconstructed iii. Process vents 2 0.9 1.8 134 241.2 12.06 24.12 17,698 2 hrs/ vent, 9 vents, Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 23 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions 10% reconstructed Periodic iv. Storage vessels 2 18 36 134 4,824 241.2 482.4 353,961 semiannual  9 vessels per respondent, two hours per period v. Equipment leaks 75 11 825 134 110,550 5,527.5 11,055 8,111,606 annual  11 units per respondent, 75 hours per period vi. Process vents 2 9 18 134 2,412 120.6 241.2 176,981 annual  9 vents per respondent, 2 hours per period E. Enter information Initial i. Storage vessels 4 0.9 3.6 134 482.4 24.12 48.24 35,396 4 hrs per vessel, 9 vessels, 10% reconstructed ii. Equipment leaks 24 1.1 26.4 134 3,537.6 176.88 353.76 259,571 24 hrs per unit, 11 units, 10% reconstructed iii. Process vents 12 0.2 2.4 134 321.6 16.08 32.16 23,597 12 hrs per control,

2 controls, 10% reconstructed Periodic Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 24 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions iv. Storage vessels 1.5 18 27 134 3,618 180.9 361.8 265,471 semiannual  9 vessels per respondent, 1.5 hours per vessel per period v. Equipment leaks 2 132 264 134 35,376 1,768.8 3,537.6 2,595,714 monthly  11 units per respondent, 2 hours per unit per period vi. Process vents 0.08 700 56 134 7,504 375.2 750.4 550,606 daily ( 350 days)  5 minutes per control device, two monitored devices F. Train personnel Initial i. Storage vessels 1 0.9 0.9 134 120.6 6.03 12.06 8,849 Assume 10% of vessels/ units/ vents are reconstructed each year. ( 9 vessels, 11 units, 4 vents with controls)

1 hr each initial ii. Equipment leaks 1 1.1 1.1 134 147.4 7.37 14.74 10,815 iii. Process vents 1 0.4 0.4 134 53.6 2.68 5.36 3,933 Periodic Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 25 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions iv. Equipment leaks 0.5 11 5.5 134 737 36.85 73.7 54,077 0.5 hours per year,

11 units v. Process vents 1 4 4 134 536 26.8 53.6 39,329 4 out of 9 vents vent to controls. 1 hour per year, 4 vents G. Perform audits Not applicable H. Record and disclose information Initial i. Storage vessels 2 0.9 1.8 134 241.2 12.06 24.12 17,698 2 hrs per vessel, 9 vessels, 10% reconstructed ii. Equipment leaks

address enforcement actions 75 1.1 82.5 134 11,055 552.75 1,105.5 811,161 75 hrs/ unit, 11 units, 10% reconstructed Periodic iii. Storage vessels 2 18 36 134 4,824 241.2 482.4 353,961 semiannual  9 vessels per respondent, two hours per vessel iv. Equipment leaks

address enforcement actions 75 11 825 134 110,550 5,527.5 11,055 8,111,606 annual  address enforcement actions  11 units Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 26 Activity Technical Hrs/ Occurrence ( A) Occurrences / Respondent / Yr.

( B) Hours/ Respondent/

Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/

Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr. ($)

( H) 1 Assumptions per respondent, 75 hours per unit v. Process vents 1 4 4 134 536 26.8 53.6 39,329 semiannual  one hour per control device, two monitored devices TOTAL LABOR BURDEN AND COST ( rounded) 410,054 $ 26,163,236 1 This cost is based on the sum of personnel hours multiplied by their hourly labor rates [( Technical hours x $ 64.60) + ( Management hours x $ 95.32) + ( Clerical hours x $ 40.09)]. Notes/ assumptions:

° 9 storage vessels per refinery require controls;

° 11 units per refinery are subject to equipment leak provisions;

° 9 process vents per refinery  5 are routed to fuel gas systems ( which do not require performance tests), 4 are routed to control devices  2 control devices require testing and monitoring;

° 134 refineries are subject to MACT Subpart CC;

° Refineries construct or reconstruct 10% of affected facilities per year; and ° Nearly all of the hour/ activity estimates are from the previous ICR. 27 Table 2: Annual Agency Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC)

Activity Technical Hrs/ Occurrence ( A) Occurrences/

Respondent/

Yr.

( B) Hours/ Respondent/ Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/ Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr.

($) ( H) 1 Assumptions 1. Review of notification of construction/ reconstruction 1 1 1 67 67 3.35 6.7 3,048 Applies only to process vents and assumes one vent per source. Assumes that 50% of refineries are affected by the requirement per year.

2. Review of notification of actual start up 1 1 1 67 67 3.35 6.7 3,048 Applies only to process vents and assumes one vent per source. Assumes that 50% of refineries are affected by the requirement per year.

3. Review of notification of performance test 1 1 1 20 20 1 2 910 Assume 20 respondents based on previous ICR.

4. Review of notification of compliance status 10 1 10 134 1,340 67 134 60,954 5. Review of semiannual equipment leak reports 10 2 20 67 1,340 67 134 60,954 Assumes 50% of sources affected by the rule are already submitting reports to comply with existing regulations.

6. Review of semiannual parameter 4 2 8 67 536 26.8 53.6 24,382 Assumes 50% of sources affected by the rule are Table 2: Annual Agency Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR Part 63, Subpart CC), Continued 28 Activity Technical Hrs/ Occurrence ( A) Occurrences/

Respondent/

Yr.

( B) Hours/ Respondent/ Yr.

( C)

( C = A x B) # Respondents ( D) Technical Hrs/ Yr.

( E)

( E = C x D) Management Hours/ Yr.

( F)

( F = 0.05 x E) Clerical Hours/ Yr.

( G)

( G = 0.1 x E) Total Labor Costs/ Yr.

($) ( H) 1 Assumptions exceedance reports already submitting reports to comply with existing regulations. Assumes parameter monitoring of one vent per refinery and one exceedance per year.

7. Review of annual tank inspection failure reports 4 1 4 67 268 13.4 26.8 12,191 Assumes 50% of sources affected by the rule are already submitting reports to comply with existing regulations.

TOTAL LABOR BURDEN AND COST ( rounded) 4,184 $ 165,485 1 This cost is based on the sum of personnel hours multiplied by their hourly labor rates [( Technical hours x $ 40.56) + ( Management hours x $ 54.66) + ( Clerical hours x $ 21.95)]. 29 6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively, and summarized below.

( i) Respondent Tally The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 26,163,236. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC), above. Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 839 hours per response.

The total annual capital/ startup and O& M costs to the regulated entity are $ 0. This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The cost calculations are detailed in Section 6( b)( iii), Capital/ Startup vs. Operation and Maintenance ( O& M) Costs.

( ii) The Agency Tally The average annual Agency burden and cost over next three years is estimated to be 4,184 labor hours at a cost of $ 165,485. See Table 2: Annual Agency Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC), above.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to adjustments. This adjustment decrease in burden is due to several factors, including: a decrease in the number of respondents, the removal of capital/ startup costs resulting from performance tests, and revisions to the approach to calculating costs for newly subject facilities.

The most recently approved ICR considered costs from performance tests to be capital/ startup costs. In this ICR, the burden associated with performance tests has not been included in the estimate for capital/ startup costs because these costs are now intended to include only nonlabor burden. The hour burden associated with conducting performance tests is included in the labor burden for industry, as presented in Table 1: Annual Respondent Burden and Cost, NESHAP for Petroleum Refineries ( 40 CFR part 63, subpart CC), above.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 839 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the 30 time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed at 40 CFR part 9 and 48 CFR Chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number OECA 2004 0016, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OECA 2004 0016 and OMB Control Number 2060 0340 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56274-56276]
[FR Doc No: 2021-22043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 November 8, 2021.

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 0910-0485. 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_ADDRESS>
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.

Medical Device Labeling Regulations

OMB Control No. 0910-0485--Revision

    This information collection supports implementation of medical
device labeling requirements governed by section 502 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in
Agency regulations, and discussed in associated Agency guidance.
Medical device labeling requirements, among other things, provide for
the label or labeling content of a medical device so that it is not
misbranded and subject to regulatory action. Certain provisions under
section 502 of the FD&C Act require that manufacturers, importers, and
distributors of medical devices disclose information about themselves
or the devices on the labels or labeling for the devices. Section 502
provides, in part, that a device shall be misbranded if, among other
things, its label or labeling fails to bear certain required
information concerning the device, is false or misleading in any
particular way, or fails to contain adequate directions for use.
Medical device labeling regulations in parts 800, 801, 809, and
associated regulations in parts 660 and 1040 (21 CFR parts 660, 800,
801, 809, and 1040), prescribe the disclosure of specific information
by manufacturers, importers, and distributors of medical devices about
themselves and/or the devices, on the label or labeling for the
devices, to health professionals and consumers.
    In conjunction with provisions in part 800, part 801, subpart A
sets forth general labeling provisions applicable to all medical
devices, including content and format requirements pertaining to
intended uses, adequate directions for use, misleading statements, and
the prominence of required labeling. Provisions found in part 801,
subpart B pertaining to labeling requirements for Unique Device
Identification are currently approved under OMB control number 0910-
0720 and not covered in this information collection request.
Information collection associated with labeling requirements for Over-
the-Counter (OTC) Devices are found in part 801, subpart C, and cover
principal display panel; statement of identity; declaration of net
quantity of contents; and certain warning statement elements.
Information collection associated with exemptions from adequate
directions for use and other exemptions are found in part 801, subparts
D and E, respectively. Information collection associated with special
labeling requirements applicable to specific devices are found in part
801, subpart H. We also include information collection associated with
labeling for in vitro diagnostic products for human use, as set forth
in part 809, subpart B. In addition to the labeling requirements in
part 801 and the certification and identification requirements of 21
CFR 1010.2 and 1010.3, sunlamp products and ultraviolet lamps are
subject to specific labeling requirements as set forth in part 1040.
    The information collection also includes provisions associated with
stand-alone symbols (not accompanied by explanatory text adjacent to
the symbol), when accompanied by a symbols glossary, as set forth in
part 660, additional standards for diagnostic substances for laboratory
standards for biological products, subparts A, C, D, E, and F. The
requirements are also found in the general medical device labeling
regulations part 801, subpart A, and part 809, subpart B.
    The information collection also helps to implement section 502(b)
of the FD&C Act which requires that, for packaged devices, labeling
must bear the name and place of business of the manufacturer, packer,
or distributor; and an accurate statement of the quantity of the
contents. Section 502(f) of the FD&C Act requires also that the
labeling for a device must contain adequate directions for use unless
FDA grants an exemption. Section 502(u) requires reprocessed single-use
devices (SUDs) to bear prominently and conspicuously the name of the
manufacturer, a generally recognized abbreviation of such name, or a
unique and generally recognized symbol identifying the manufacturer.
Under this provision, if the original SUD or an attachment to it
prominently and conspicuously bears the name of the manufacturer, then
the reprocessor of the SUD is required to identify itself by

name, abbreviation, or symbol in a prominent and conspicuous manner on
the device or attachment to the device. If the original SUD does not
prominently and conspicuously bear the name of the manufacturer, the
manufacturer who reprocesses the SUD for reuse may identify itself
using a detachable label that is intended to be affixed to the patient
record. As required by the Medical Device User Fee Stabilization Act of
2005 (MDUFSA), FDA issued the guidance document, ``Compliance with
Section 301 of the Medical Device User Fee and Modernization Act of
2002, as amended--Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices'' (May 2006), to assist respondents with these
requirements. The guidance document was issued consistent with our Good
Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website, and this guidance is available at https://www.fda.gov/media/71187/download. The guidance document is intended to identify
circumstances in which the name or symbol of the original SUD
manufacturer is not prominent and conspicuous, as used in section
502(u) of the FD&C Act.
    In the Federal Register of July 13, 2021 (86 FR 36752), 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 citation                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                            Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part 809, subpart B: Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary--660.2; antibody to Hepatitis B surface antigen              3,000                1            3,000                1            3,000
 requirements, 660.28; blood grouping labeling, 660.35; reagent red
 blood cell labeling, 660.45, hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling, 801.15; medical devices
 labeling and use of symbols; 809.10, labeling for in vitro
 diagnostic products...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our figures are based on data from the FDA Unified Registration and
Listing System and the OASIS shipment information. FDA regulations
allow for the use of stand-alone graphical representations of
information, or symbols, in the labeling for the medical devices and
diagnostic substances for laboratory standards, if the symbol has been
established in a Standards Development Organization developed standard,
provided that such symbol is explained in a symbols glossary that is
included in the labeling for the medical device and otherwise complies
with section 502 (misbranding) of the FD&C Act. These labeling
requirements are set forth in part 660, subparts A, C, D, E, and F, in
the additional standards for diagnostic substances for laboratory
standards for biological products, including: General requirements
(Sec.  660.2), using antibody to Hepatitis B surface antigen (Sec.
660.28), blood grouping reagent (Sec.  660.35), reagent red blood cells
(Sec.  660.45), Hepatitis B surface antigen (Sec.  660.45); and anti-
human globulin (Sec.  660.55). The requirements are also found in the
general medical device labeling regulations part 801, subpart A and in
the in vitro diagnostic product labeling regulations part 809, subpart
B.

                                                   Table 2--Estimated Annual Recordkeeping Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR citation                   Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Processing, labeling, or repacking                     7,500             887       6,652,500  0.5 (30 minutes)..........................       3,326,250
 agreement; 801.150.
Impact resistant lenses; invoices, shipping            1,591          47,050      74,856,550  0.0008 (0.048 minutes)....................          59,885
 documents, and records of sale or
 distribution; 801.410(e) and (f).
Hearing aid records; 801.421................          10,000             160       1,600,000  0.25 (15 minutes).........................         400,000
Menstrual tampons, sampling plan for                      33              11             363  80........................................          29,040
 measuring absorbency; 801.430(f).
Latex condoms; justification for the                      51            3.65             186  1.........................................             186
 application of testing data to the
 variation of the tested product; 801.435(g).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      83,109,599  ..........................................       3,815,361
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    As set forth in Sec.  801.150(a)(2), device manufacturers are
required to retain a copy of the agreement containing the
specifications for the processing, labeling, or repacking of the device
for 2 years after the final shipment or delivery of the device. Section
801.150(a)(2) requires that copies of this agreement be made available
for inspection at any reasonable hour upon request by any officer or
employee of the Department of Health and Human Services (HHS). In Sec.
801.410(e) copies of invoices, shipping documents, and records of sale
or distribution of all impact resistant lenses, including finished
eyeglasses and sunglasses, are required to be maintained for 3 years by
the retailer and made available upon request by any officer or employee
of FDA or by any other officer or employee

acting on behalf of the Secretary of HHS. Section 801.410(f) requires
that the results of impact tests and description of the test method and
apparatus be retained for a period of 3 years. Specific recordkeeping
requirements applicable to hearing aid dispensers, manufacturers of
menstrual tampons, and manufacturers of latex condoms are set forth in
Sec. Sec.  801.421(d), 801.430(f), and 801.435(g), respectively.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR citation                   Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                               Part 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Contact lens cleaning solution labeling;                  47               8             376  1.........................................             376
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling;                   25               8             200  1.........................................             200
 800.10(b)(2).
Manufacturer, packer, or distributor                  19,407               7         135,849  1.........................................         135,849
 information; 801.1.
Adequate directions for use; 801.5..........           8,526               6          51,156  22.35 (22 hours and 21 minutes)...........       1,143,337
Statement of identity; 801.61...............           8,526               6          51,156  1.........................................          51,156
Declaration of net quantity of contents;               8,526               6          51,156  1.........................................          51,156
 801.62.
Prescription device labeling; 801.109.......           9,681               6          58,086  17.77 (17 hours and 46.2 minutes).........       1,032,188
Retail exemption for prescription devices;            30,000             667      20,010,000  0.25 (15 minutes).........................       5,002,500
 801.110.
Processing, labeling, or repacking; non-                 453              34          15,402  4.........................................          61,608
 sterile devices; 801.150(e).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Part 801, subpart H: Special Requirements for Specific Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling of articles intended for lay use in              35               1              35  4.........................................             140
 the repairing and/or refitting of dentures;
 801.405(b)(1).
Dentures; information regarding temporary                 35               1              35  4.........................................             140
 and emergency use; 801.405(c).
Hearing aids professional and patient                    136              12           1,632  80........................................         130,560
 labeling; 801.420.
Hearing aids, availability of User                    10,000               5          50,000  0.17 (10 minutes).........................           8,500
 Instructional Brochure; 801.421.
User labeling for menstrual tampons; 801.430              16               8             128  2.........................................             256
User labeling for latex condoms; 801.437....              52               6             312  100.......................................          31,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
                              Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and content of labeling for IVDs;               1,700               6          10,200  80........................................         816,000
 809.10.
Advertising and promotional materials for                300              25           7,500  1.........................................           7,500
 ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d)....              30               1              30  10........................................             300
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               FD&C Action Section 502(u)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishments listing <10 SUDs.............             161               2             322  0.1 (6 minutes)...........................              32
Establishments listing >10 SUDs.............              14              45             630  0.1 (6 minutes)...........................              63
--------------------------------------------------------------------------------------------------------------------------------------------------------
   Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
                      Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary--660.2; antibody to                   3,000               1           3,000  4.........................................          12,000
 Hepatitis B surface antigen requirements,
 660.28; blood grouping labeling, 660.35;
 reagent red blood cell labeling, 660.45,
 hepatitis B surface antigen labeling,
 660.55; anti-human globulin labeling,
 801.15; medical devices labeling and use of
 symbols; 809.10, labeling for in vitro
 diagnostic products.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      20,447,205  ..........................................       8,485,061
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Because many labeling provisions correspond to specific
recordkeeping requirements, we have accounted for burden attendant to
the provisions enumerated in table 3 as third-party disclosures. These
figures reflect what we believe to be the average burden incurred by
respondents to applicable information collection activities.
    Overall, the information collection reflects changes and
adjustments. For efficiency of operations, we have consolidated related
information collection previously approved under OMB control numbers
0910-0577 and 0910-0740. This results in an increase to the information
collection by 15,095 burden hours annually (for reporting and
disclosure burden related to the symbols glossary regulatory
requirements and disclosure burden related to Section 502(u)). We have
increased our estimate of the total responses by 21,647,170 annually.
The increase is due to adjustments reflecting updated data and the
inclusion of the consolidated information collection. At the same time,
we have reduced our estimate of disclosure responses by 1,597,520
annually. Upon review, we believe we previously double-counted burden
ascribed to disclosures provisions having accounted for the same burden
as that associated with recordkeeping activities. Finally, upon
submission of the ICR, we are correcting inadvertent calculation errors
to the burden hour increase (by adding 12,000 burden hours to account
for disclosure of the symbols glossary) and decrease in total responses
displayed in our 60-day notice in the Federal Register of July 13,
2021.

    Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22043 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P