  SEQ CHAPTER \h \r 1 SUPPORTING STATEMENT

NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS: SECONDARY
ALUMINUM PRODUCTION

PART A

1.0	Identification of the Information Collection

(a)	Title and Number of the Information Collection.

	“National Emission Standards for Secondary Aluminum Production.”
This is a new information collection request (ICR), and the EPA tracking
number is 2453.01.

(b)	Short Characterization.

	This ICR covers information collection requirements in the proposed
amendments to the Secondary Aluminum NESHAP (40 CFR part 63, subpart
RRR).

	The potential respondents are owners or operators of any existing, new,
or reconstructed secondary aluminum production plant. Per the
applicability section of subpart RRR, the following affected sources at
a secondary aluminum production plant are covered: aluminum scrap
shredders;  thermal chip dryers; scrap dryers/delacquering
kilns/decoating kilns; group 2 furnaces; sweat furnaces; dross-only
furnaces; rotary dross coolers;  and secondary aluminum processing
units, which includes group 1 furnaces and  in-line fluxers. The
secondary aluminum industry consists of approximately 161 secondary
aluminum production facilities, 53 of which the EPA estimates to be
major sources of HAP. The proposed amendments would correct and clarify
various rule requirements and provisions. Specifically, the proposed
amendments would require selected affected sources to comply with the
emissions limits at all times including periods of startup and shutdown;
add a definition of affirmative defense; add a requirement to report
performance testing through the Electronic Reporting Tool (ERT); add
provisions allowing owners and operators to change furnaces
classifications; add requirements to test uncontrolled furnaces; add
requirements to test for hydrogen fluoride; add operating requirements
such as monitoring of lime injection rates; and make corrections and
clarifications to the applicability, definitions, operating, monitoring,
and performance testing requirements. The information collection
requirements associated with the proposed amendments to the NESHAP are
listed in Attachment 1.

2.	Need For and Use of the Collection

(a)	Need/Authority for the Collection.

	Section 112 of the Clean Air Act (CAA) requires the EPA to establish
NESHAP for both major and area sources of HAP that are listed for
regulation under CAA section 112(c). A major source is a stationary
source that emits or has the potential to emit more than 10 tons per
year (tpy) of any single HAP or more than 25 tpy of any combination of
HAP. An area source is a stationary source that is not a major source
(i.e., an area source does not emit and does not have the potential to
emit more than 10 tpy of any single HAP or more than 25 tpy of any
combination of HAP). Both major and area sources are subject to subpart
RRR. For major sources, these technology-based standards must reflect
the maximum degree of emission reductions of HAP achievable (after
considering cost, energy requirements and non-air quality health and
environmental impacts) and are commonly referred to as maximum
achievable control technology (MACT) standards. Section 112(d)(6)
requires the EPA to review these technology-based standards and to
revise them “as necessary (taking into account developments in
practices, processes, and control technologies)” no less frequently
than every 8 years. In addition, section 112(f) of the CAA requires the
EPA to determine for source categories subject to certain CAA section
112(d) standards whether the emissions limitations provide an ample
margin of safety to protect public health. For MACT standards for HAP
“classified as a known, probable, or possible human carcinogen” that
“do not reduce lifetime excess cancer risks to the individual most
exposed to emissions from a source in the category or subcategory to
less than 1-in-1 million,” the EPA must promulgate residual risk
standards for the source category (or subcategory) as necessary to
provide an ample margin of safety to protect public health. In doing so,
the EPA may adopt standards equal to existing MACT standards, if the EPA
determines that the existing standards are sufficiently protective. The
EPA must also adopt more stringent standards, if necessary, to prevent
an adverse environmental effect, but must consider cost, energy, safety
and other relevant factors in doing so.

	Certain records and reports are necessary for the Administrator to
confirm the compliance status of sources subject to NESHAP, identify any
new or reconstructed sources subject to the standards, and confirm that
the standards are being achieved on a continuous basis. These
recordkeeping and reporting requirements are specifically authorized by
section 114 of the Clean Air Act (42 U.S.C. 7414) and set out in the
part 63 NESHAP General Provisions. The recordkeeping and reporting
requirements for operating permits (i.e., title V permits) are contained
in 40 CFR 70.6 and 40 CFR 71.6. Under parts 63 and 70 or 71, the owner
or operator must keep each record for 5 years following the date of each
occurrence, measurement, maintenance, corrective action, report or
record.

(b)	Use/Users of the Data.

	The information will be used by the delegated authority (state agency,
or Regional Administrator if there is no delegated state agency) to
ensure that the standards and other requirements are being achieved.
Based on review of the recorded information at the site and the reported
information, the delegated permitting authority can identify facilities
that may not be in compliance and decide which facilities, records or
processes may need inspection.

3.	Nonduplication, Consultations and Other Collection Criteria

(a)	Nonduplication.

A computer search of the EPA’s ongoing ICRs revealed no duplication of
information-gathering efforts.

(b)	Public Notice Required Prior to ICR Submission to OMB.

	This section is not applicable because this is a rule-related ICR.

(c)	Consultations.

The proposed amendments were developed in consultation with individual
secondary aluminum production companies and trade associations. The
non-EPA persons consulted on the information collection activities are
identified in Table 1.

TABLE 1. PERSONS CONSULTED ON THE INFORMATION COLLECTION ACTIVITIES

Contact	Organization	Telephone No.

Charles Johnson, Jr.	The Aluminum Association, Inc.<PHONE_NUMBER>

Mike Palazzolo	Alcoa, Inc.<PHONE_NUMBER>

Gary Barnett	Aleris International, Inc.<PHONE_NUMBER>

Steve Royer	Logan Aluminum, Inc.<PHONE_NUMBER>

(d)	Effects of Less Frequent Collection.

	If the relevant information was collected less frequently, the
delegated permitting authority (state or the EPA) will not be reasonably
assured that a facility is in compliance with the standards.

(e)	General Guidelines.

	None of the guidelines in 5 CFR 1320.6 are being exceeded.

(f)	Confidentiality.

	All 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 39999, September 28, 1978; 43 FR
42251, September 28, 1978; 44 FR 17674, March 23, 1979).

(g)	Sensitive Questions.

	This section is not applicable because this ICR does not involve
matters of a sensitive nature.

4.	The Respondents and the Information Requested

(a)	Respondents/NAICS Codes.

Potential respondents under subpart RRR are owners or operators of any
existing or new facility engaged in Secondary Aluminum Productions
operations. Secondary Aluminum Production facilities are primarily
classified under NAICS code 331314, Secondary Aluminum Production. There
are an estimated 161 facilities that would be subject to the proposed
amendments to the NESHAP.

 (b)	Information Requested.

	(i) Data Items, Including Recordkeeping Requirements. Attachment 1,
Information Requirements, summarizes the data items, including
recordkeeping and reporting requirements, for the Secondary Aluminum
Production source category.

	(ii) Respondent Activities. The respondent activities that will be
required by the proposed amendments to the Secondary Aluminum Production
NESHAP are identified in Table 3 and are introduced in section 6(a).

(iii) Summary of Requirements. The EPA is including in Table 2 an
estimate of the burden associated with performing an affirmative
defense. The EPA is providing this as an illustrative example of the
potential additional administrative burden a source may incur to assert
an Affirmative Defense in response to an action to enforce the standards
set forth in subpart RRR.

This illustrative estimate is not considered a duplicate estimate of
cost under the General Duty to Minimize Emissions clause under 40 CFR
63.6(e)(1)(i), which states: “At all times, the owner and operator
must operate and maintain any affected source, including associated air
pollution control equipment and monitoring equipment, in a manner
consistent with safety and good air pollution control practices for
minimizing emissions. Determining whether such operation and maintenance
procedures are being used will be based on information available to the
Administrator which may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of
operation and maintenance records, and inspection of the source.”

To provide the public with an estimate of the relative magnitude of the
burden associated with an assertion of the affirmative defense position
adopted by a source, the EPA provides an administrative adjustment to
this ICR that estimates the costs of the notification, recordkeeping and
reporting requirements associated with the assertion of the affirmative
defense. The EPA’s estimate for the required notification, reports and
records, including the root cause analysis, associated with a single
incident totals approximately $3,142 and is based on the time and effort
required of a source to review relevant data, interview plant employees
and document the events surrounding a malfunction that has caused an
exceedance of an emission limit. The estimate also includes time to
produce and retain the records and reports for submission to the EPA.
The EPA provides this illustrative estimate of this burden because these
costs are only incurred if there has been a violation and a source
chooses to take advantage of the affirmative defense.

In this source category, we estimate that one facility per year will
have a control device malfunction that would cause an exceedence of an
emission limit and for which the facility would choose to assert the use
of the affirmative defense provisions. Thus for this source category,
the EPA is assigning annual burden of $3,142 associated with affirmative
defense.

TABLE 2. COST ESTIMATE FOR ROOT CAUSE ANALYSIS

Personnel	Number of Personnel	Time Requirement (hours)	Total Hours
Hourly Rate ($/hr)	Total

Technical Personnel	3	6	18	98.20	$ 1,768

Managerial Personnel	2	6	12	114.49	$ 1,374

Total	5

30

$ 3,142

5.	The Information Collected–Agency Activities, Collection Methodology
and Information Management

(a)	Agency Activities.

	The Agency activities associated with the proposed amendments to the
Secondary Aluminum Production NESHAP are provided in Table 4 and are
introduced in section 6(c).

(b)	Collection Methodology and Management.

	Data and records maintained by the respondents are tabulated and
published for use in compliance and enforcement programs of the
delegated permitting authority. The EPA is the permitting authority
until the state or local agency is delegated authority to implement the
final amendments to the rule. Therefore, information contained in any
report submitted to the Regional Administrator will be entered into the
Air Facility System (AFS), which is operated and maintained by the
EPA’s Office of Compliance. AFS is the EPA’s database for the
collection, maintenance and retrieval of compliance data for
approximately 125,000 industrial and government-owned facilities. The
EPA uses the AFS for tracking air pollution compliance and enforcement
by local and state regulatory agencies, EPA regional offices and EPA
headquarters. The EPA and its delegated authorities can edit, store,
retrieve and analyze the compliance data.

(c)	Small Entity Flexibility.

	The Small Business Administration defines a small entity engaging in
Secondary Aluminum Production as a firm having no more than 750
employees. Of the 28 entities affected by this proposed rule, nine of
them are small. Of these nine, all of them are estimated to experience a
negative cost (i.e., a cost savings) as a result of the rule. After
considering the economic impacts of these proposed changes on small
entities, this action will not have a significant economic impact on a
substantial number of small entities. To reduce impacts, we are
proposing new provisions that would increase the industry’s
flexibility as to how they operate group 1 furnaces. In addition, we are
correcting certain provisions of the rule as well as proposing revisions
to help clarify the rule’s intent.

(d)	Collection Schedule.

	The specific frequency for each information collection activity within
this request is shown in Table 3 for the Secondary Aluminum Production
source category.

6.	Estimating the Burden and Cost of the Collection

(a)	Estimating Respondent Burden.

	The annual burden estimates for the proposed amendments to the
Secondary Aluminum Production NESHAP are shown in Table 3. These numbers
were derived from estimates based on the EPA’s experience with other
standards. No burden estimates are provided for new sources because no
new facilities are expected to become affected sources during the
three-year implementation period of this ICR.  Because all the proposed
amendments to this rule become effective 90 days after promulgation of
the final rule, the burden estimates provided are for annual costs for
each year following promulgation.

(b)	Estimating Respondent Costs.

	(i) Estimating Labor Costs. Table 3 presents estimated costs for the
required data collection activities. Labor rates and associated costs
are based on Bureau of Labor Statistics (BLS) data. Technical,
management and clerical average hourly rates for private industry
workers and were taken from the United States Department of Labor,
Bureau of Labor Statistics, September 2011, “Table 2. Civilian
Workers, by occupational and industry group,” available at
www.bls.gov/news.release/ecec.t02.htm. Wages for occupational groups are
used as the basis for the labor rates with a total compensation of
$47.21 per hour for technical, $57.82 per hour for managerial and $23.72
per hour for clerical. These rates represent salaries plus fringe
benefits and do not include the cost of overhead. An overhead rate of
110 percent is used to account for these costs. The fully-burdened
hourly wage rates used to represent respondent labor costs are:
technical at $99.14, management at $121.42 and clerical at $49.81.

	(ii) Estimating Capital and Operations and Maintenance (O&M) Costs.
Capital costs are estimated at $226,000 per facility at an estimated 27
facilities that would need to install temporary hoods and conduct
testing every 5 years on uncontrolled group 1 furnaces for a total
capital cost of $6,102,000. As a result of the proposed requirement to
measure HF emissions, 20 affected facilities would incur a total annual
O&M cost of $11,000. The proposed amendments would also allow
owners/operators to switch furnace classifications, which would result
in total annual O&M costs for testing of $500,000/yr or, for an
estimated 50 furnaces, a cost of $10,000 per furnace, or $14,706/yr per
facility at 34 facilities.

	(iii) Annualizing Capital Costs. Annualized capital costs are
approximately $1,200,000 or $45,200/facility.

(iv) Affirmative Defense/Root Cause Analysis/Malfunction Costs. The
EPA’s estimate for a root cause analysis is based on general
experience to calculate the time and effort required of a source to
review relevant data, interview plant employees and reconstruct the
events prior to a malfunction in order to determine primary and
contributing causes. The level of effort also includes time to produce
and retain the report in document form so that the source will have it
available should the EPA or state enforcement agencies ever request to
review it.

(c)	Estimating Agency Burden and Cost.

	Because the information collection requirements were developed as an
incidental part of standards development, no costs can be attributed to
the development of the information collection requirements. Because
reporting and recordkeeping requirements on the part of the respondents
are required under the operating permits rules in 40 CFR part 70 or part
71 and the part 63 NESHAP General Provisions, no operational costs will
be incurred by the Federal Government. Publication and distribution of
the information are part of the Compliance Data System, with the result
that no Federal costs can be directly attributed to the ICR. Examination
of records to be maintained by the respondents will occur incidentally
as part of the periodic inspection of sources that is part of the
EPA’s overall compliance and enforcement program, and, therefore, is
not attributable to the ICR. The only costs that the Federal government
will incur are user costs associated with the analysis of the reported
information, as presented in Table 4.

	The Agency labor rates are from the Office of Personnel Management
(OPM) 2011 General Schedule, which excludes locality rates of pay. These
rates can be obtained from Salary Table 2011-GS available on the OPM
website,   HYPERLINK "http://www.opm.gov/oca/11tables/pdf/gs_h.pdf"
http://www.opm.gov/oca/11tables/pdf/gs_h.pdf . The government employee
labor rates are $15.63/hour for clerical (GS-6, Step 3), $28.88 for
technical (GS-12, Step 1) and $38.92/hr for management (GS-13, Step 5).
These rates were increased by 60 percent to include fringe benefits and
overhead. The fully-burdened wage rates used to represent Agency labor
costs are: clerical at $25.01/hour, technical at $46.21/hour and
management at $62.27/hour.

(d)	Estimating the Respondent Universe and Total Burden and Costs.

There are an estimated 161 existing facilities that are currently
subject to the Secondary Aluminum Production NESHAP. No new major
sources are expected the year following promulgation of these
amendments. Consequently, the number of secondary aluminum respondents
in the year following promulgation is 161 respondents per year.

For the proposed amendments to the Secondary Aluminum Production NESHAP,
the components of the total annual burden attributable to this ICR
include reading the amendments to the NESHAP; monthly verification of
lime injection rates; analysis of performance test samples for HF;
construction of temporary hooding and performing emissions tests on
uncontrolled group 1 furnaces; and when a furnace classification is
being changed, the requisite reporting and emissions testing to
demonstrate compliance. All other recordkeeping and reporting activities
are already accounted for in the ICR for the NESHAP.

(e)	Bottom Line Burden Hours and Cost Tables.

(i) Respondent tally. The bottom line respondent burden hours and costs
presented in Table 3 are calculated by adding person-hours per year down
each column for technical, managerial and clerical staff, and by adding
down the cost column. The average annual burden for the recordkeeping
and reporting requirements in the proposed amendments to subpart RRR for
the 161existing facilities that are subject to the Secondary Aluminum
Production NESHAP is 1,725 person-hours, with an annual average cost of
$165,521. The estimated annual operations and maintenance costs (O&M) as
a result of these amendments is $511,000. Estimated annualized capital
costs to the industry for the proposed amendments are $1,200,000 for a
total estimated annualized costs (annualized capital and O&M) of
$1,711,000.

	(ii) The Agency tally. The average annual Federal Government cost is
$12,231 for 271 hours for the proposed amendments to subpart RRR. The
bottom line Agency burden hours and costs presented in Table 4 are
calculated by adding person-hours per year down each column for
technical, managerial and clerical staff and by adding down the cost
column.

	(iii) Variations in the annual bottom line. This section does not apply
since no significant variation is anticipated.

(f)	Reasons for Change in Burden.

The EPA provides an adjustment to this ICR that estimates the costs of
the notification, recordkeeping and reporting requirements associated
with the assertion of the affirmative defense. The EPA’s estimate for
the required notification, reports and records, including the root cause
analysis, associated with a single incident totals approximately $3,142
and is based on the time and effort required of a source to review
relevant data, interview plant employees and document the events
surrounding a malfunction that has caused an exceedance of an emission
limit. The estimate also includes time to produce and retain the records
and reports for submission to the EPA.

 (g)	Burden Statement

	The average annual respondent burden for the proposed amendments to the
Secondary Aluminum Production NESHAP is estimated at 11 person-hours.

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 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 currently
valid OMB control number. The OMB control numbers for the EPA’s
regulations in 40 CFR part 63 are listed in 40 CFR part 9.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates and any suggestions for minimizing
respondent burden, including through the use of automated collection
techniques, the EPA has established a public docket for this ICR under
Docket ID No. EPA-HQ-OAR-2010-0544 which is available for online viewing
at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
, or in person viewing at the Air and Radiation Docket and Information
Center in the EPA Docket Center (EPA/DC), EPA West, Room B-102, 1301
Constitution Ave., 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 Air Docket is (202)
566-1927. An electronic version of the public docket is available at
HYPERLINK "http://www.regulations.gov."  http://www.regulations.gov.
This site can be used 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 relevant Docket ID Number (EPA-HQ-OAR-2011-0797) in
any correspondence.

PART B

	This section is not applicable because statistical methods are not used
in data collection associated with the proposed rule.

TABLE 3. ANNUAL RESPONDENT BURDEN AND COST - AMENDMENTS TO PRIMARY
ALUMINUM NESHAPa

Burden item	(A)

Person-hours per occurrence	(B)

No. of occurrences per respondent	(C)

Person-hours per respondent (C=A*B)	(D)

Respondents per year	(E)

Technical person-hours per year (E=C*D)	(F)

Management person-hours per year

(E*0.05)	(G)

Clerical person-hours per year (E*0.1)	(H)

Costa, $

1.	Applications	N/A

	2.	Surveys and Studies	N/A

	3.	Acquisition, Installation, and Utilization of Technology and Systems
N/A

	4.	Reporting Requirements

A.	Read instructionsb	4	1	4	161	644	32.2	64.4	$70, 964

B.	Required activities

C.	Create information	N/A

	D.	Gather existing information	N/A

	 E. Write report (changing furnace classification)c	2	1	2	50	100	5	10
$11,019

F.  Affirmative defense reporting/root cause analysisd	6	1

1	18

	12

$3,142

5.	Recordkeeping Requirements

A.	Read instructions	See 4A

	B.	Plan activities	N/A

	C.	Implement activities

Verify lime injection rate	0.1	36	3.6	161	579.6	28.98	57.96	$63,867

Changing furnace classification	2	1	2	50	100	5	10	$11,019

D.	Develop record system	N/A

	E.	Time to enter information	See 4C

	F.	Time to train personnel	N/A

	G.	Time to adjust existing ways to comply with previously applicable
requirements	N/A

	H.	Time to transmit or disclose information	1	1	1	50	50	2.5	5	$5,510

I.	Time for audits	N/A

	TOTAL ANNUAL LABOR BURDEN AND COST (SALARY)

	1503.6	73.68	147.36	$165,521

ANNUAL COSTS (O&M)

	      HF testinge	$11,000

      Changing furnace classification, testingc	$500,000

ANNUALIZED CAPITAL COSTSf

$1,200,000

TOTAL ANNUALIZED COSTS (annualized capital cost and annual O&M costs)

$1,711,000

N/A = not applicable.

a	This ICR uses the following labor rates: $121.42 for managerial labor,
$99.14 for technical labor, and $49.81 for clerical labor. These rates
are based on the U.S. Department of Labor, Bureau of Labor Statistics,
Occupational Employment and Wages, September, 2011.

b	There is an estimated 161 existing facilities; no new facilities are
expected.

c   An estimated 50 facilities would change furnace classifications once
per year. Testing for furnace changing is estimated at a cost of $10,000
per facility.

d   See Section 4(b)(iii) above for breakdown of affirmative defense
burden.

e   An estimated 20 facilities would be required to test HF with a total
cost of $11,000.

f	27 facilities would be required to construct temporary hoods for
testing at $226,000/facility every 5 years.

TABLE 4. ANNUAL BURDEN AND COST TO THE AGENCY - AMENDMENTS TO PRIMARY
ALUMINUM NESHAP

Burden item	(A)

Person-hours per occurrence	(B)

Occurrences per respondent	(C)

EPA person-hours/year (C=A*B)	(D)

Facilities per year	(E)

Technical person-hours/year (E=C*D)	(F)

Management person-hours/year (F=0.05*E)	(G)

Clerical person-hours/year (G=0.1*E)	(H)

Costa, $

Report Review:

Review performance test reports and reports from facilities changing
furnace  classificationb	4	1	4	59	236	11.8	23.6	$12,231

TOTAL BURDEN AND COST

$12,231

a	This ICR uses the following average hourly labor rates: $62.27 for
managerial (GS-13, Step 5), $46.21 (GS-12, Step 1) for technical, and
$25.01 (GS-6, Step 3) for clerical. These rates are from the Office of
Personnel Management (OPM) 2011 General Schedule, which excludes
locality rates of pay.

b	Assumes agency will review all of the annual reports - including the 4
HF tests/yr, 5 tests/yr for uncontrolled furnaces and 50 reports/yr for
changing furnace classification.

ATTACHMENT 1. INFORMATION REQUIREMENTS - AMENDMENTS TO PRIMARY ALUMINUM
NESHAP

Requirement	Citation for existing sources	Citation for new sources
General Provisions citation

Lime injection rate verification 	§63.1510(i)(4)	§63.1510(i)(4)

	Measurements of HF in addition to HCl	§63.1503, 63.1505,
63.1511(c)(9), 63.1513	§63.1503, 63.1505, 63.1511(c)(9), 63.1513

	Uncontrolled furnaces that do not comply with ACGIH hooding guidelines
§63.1512(e)(4)	§63.1512(e)(4)

	Changing furnace classification	§63.1514	§63.1514

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[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Page 4628]
[FR Doc No: 2022-01692]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-N-0742; FDA-2018-N-0180; FDA-2019-N-2854; FDA-
2021-N-0515; FDA-2014-N-1960; FDA-2017-D-6069; and FDA-2019-N-3325]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, 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: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Registration of Producers of Drugs and         0910-0045      12/31/2024
 Listing of Drugs in Commercial
 Distribution...........................
Generic Clearance for the Collection of        0910-0810      12/31/2024
 Qualitative Data on Tobacco Products
 and Communications.....................
Premarket Tobacco Product Applications         0910-0879      12/31/2024
 and Recordkeeping Requirements.........
Postmarketing Adverse Experience               0910-0230       1/31/2025
 Reporting and Recordkeeping............
MedWatch: Adverse Event and Product            0910-0291       1/31/2025
 Experience Reporting System (Paper
 Based).................................
De Novo Classification Process                 0910-0844       1/31/2025
 (Evaluation of Automatic Class III
 Designation)...........................
Laboratory Accreditation for Analyses of       0910-0898       1/31/2025
 Foods..................................
------------------------------------------------------------------------

    Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01692 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Notices]
[Pages 55039-55040]
[FR Doc No: 2023-17361]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0335; FRL-10664-01-OCSPP]

Agency Information Collection Activities; Proposed Renewal of an
Existing ICR Collection and Request for Comment; School Integrated Pest
Management Awards Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces the availability of and solicits public comment on
the following Information Collection Request (ICR) that EPA is planning
to submit to the Office of Management and Budget (OMB): ``School
Integrated Pest Management Awards Program,'' identified by EPA ICR No.
2531.03 and OMB Control No. 2070-0200. This ICR represents a renewal.
This ICR will expire on May 31, 2024. Before submitting the ICR to OMB
for review and approval under the PRA, EPA is soliciting comments on
specific aspects of the information collection that is summarized in
this document. The ICR and accompanying material are available in the
docket for public review and comment.

DATES: Comments must be received on or before October 13, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0335, through the Federal eRulemaking
Portal at https://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Nora Stoner, Mission Support Division
(7101M), Office of Program Support, Office of Chemical Safety and
Pollution Prevention, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-0355; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: School Integrated Pest Management Awards Program.
    EPA ICR No.: 2531.03.
    OMB Control No.: 2070-0200.
    ICR status: This ICR is currently approved through May 31, 2024.
Under the PRA, an 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. The OMB control numbers
for EPA's regulations in title 40 of the Code of Federal Regulations
(CFR), after appearing in the Federal Register when approved, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers for certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This is a renewal information collection request (ICR)
that will cover the paperwork activities associated with the U.S.
Environmental Protection Agency's new program to encourage the use of
Integrated Pest Management (IPM) as the preferred approach to pest
control in the nation's schools. IPM is a smart, sensible, and
sustainable approach to pest control that emphasizes the remediation of
pest conducive conditions. IPM combines a variety of pest management
practices to provide effective, economical pest control with the least
possible hazard to people, property, and the environment. These
practices involve exclusion of pests, maintenance of sanitation, and
the judicious use of pesticides.
    The EPA's vision is that all students in the U.S. will experience
the benefits provided by an IPM program in their school district. The
Agency's IPM implementation efforts are based on a wholesale approach
aimed at kindergarten through 12th grade public and Tribal schools. The
Agency intends to use the information collected through this ICR to
encourage school districts to implement IPM programs and to recognize
those that have attained a notable level of success. Since IPM
implementation occurs along a continuum, the School IPM (SIPM)
incentive program will recognize each milestone step a school district
must take to begin, grow, and sustain an IPM program.
    This program has five award categories (1) Great Start, (2)
Leadership, (3) Excellence, (4) Sustained Excellence, and (5)
Connector. The first four categories are stepwise levels that are
reflective of the effort, experience, and, ultimately, success that
results from implementing EPA-recommended IPM tactics that protect
human health and the environment. Schools with pest infestations are
not only exposed to potential harm to health and property, but also to
stigmatization. The School IPM recognition program will give districts
across the nation the opportunity to receive positive reinforcement
through public recognition of their efforts in implementing pest
prevention and management strategies.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 914
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:

    Respondents/affected entities: Entities potentially affected by
this ICR are school districts or entities that represent them. Entities
potentially affected by this ICR are the following corresponding North
American Industry Classification System (NACIS) Codes for respondents
which include: 6111-Elementary and Secondary Schools, 6244-Child Day
Care Services, 56172-Janitorial Services, 56173-Landscaping Services,
56171-Exterminating and Pest Control Services, and 5617-Services to
Buildings and Dwellings.
    Respondent's obligation to respond: Voluntary, required to retain a
benefit.
    Forms: EPA Form No. 9600-054.
    Frequency of response: Occasional.
    Total estimated number of potential respondents: 53.
    Total estimated average number of responses for each respondent: 1.
    Total estimated annual burden hours: 914 hours.
    Total estimated annual costs: $ 98,358. This includes an estimated
burden cost of $ 98,358 and an estimated cost of $ 0 for capital
investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There are minor corrections to the burden from the last renewal for
the Great Start, Sustained Excellence and the Connector Award which
were miscalculated in error but still reflect no change in the actual
burden. There were no changes in the number of respondents and the
respondent and Agency burden hours over the previous renewal cycle. The
only change from the last renewal cycle is that the cost estimates were
updated using the latest May 2022 wage rates. This change is an
adjustment.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal
agencies and departments and is based on the submission instructions
established by OMB in 1995, replacing the alternate format developed by
EPA and OMB prior to 1995. EPA intends to update this Supporting
Statement during the comment period to reflect the 18-question format,
and has included the questions in an attachment to this Supporting
Statement. In doing so, the Agency does not expect the change in format
to result in substantive changes to the information collection
activities or related estimated burden and costs.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.
    Authority: 44 U.S.C. 3501 et seq.

    Dated: July 30, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-17361 Filed 8-11-23; 8:45 am]
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