[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36136-36137]
[FR Doc No: 2017-16386]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0618; FRL-9963-97]

Cancellation Order for Certain Pesticide Registrations and/or
Amendments To Terminate Uses; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; correction.

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

SUMMARY: EPA issued a notice in the Federal Register of November 22,
2016, concerning receipt of requests to voluntarily cancel certain
pesticide registrations and/or amend registrations to terminate certain
uses. EPA also issued a notice in the Federal Register of April 10,
2017, concerning cancellation of certain pesticide registrations and/or
amendments to terminate uses. This document corrects a typographical
error in both of these notices. The EPA registration number for one of
the products being voluntarily cancelled was listed incorrectly in the
original notices.

FOR FURTHER INFORMATION CONTACT: Christina Scheltema, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    The Agency included in both the November 22, 2016 and April 10,
2017 notices a list of those who may be potentially affected by this
action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0618, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What does this correction do?

    The EPA registration number for one of the products being
voluntarily cancelled was listed incorrectly in the

original notices as EPA Reg. No. 100-699. The product name was listed
correctly. Therefore, FR Doc. 2016-280906 published in the Federal
Register of November 22, 2016 (81 FR 83833) (FRL-9959-38) is corrected
as follows:
    1. On page 83834, in Table 1, correct 100-699 to read 100-669.
    In addition, FR Doc. 2017-07133 published in the Federal Register
of April 10, 2017 (82 FR 17253) (FRL-9959-38) is corrected as follows:
    1. On page 17254, in Table 1, correct 100-699 to read 100-669.

    Authority:  7 U.S.C. 136 et seq.

    Dated: July 7, 2017.
Yu-Ting Guilaran,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2017-16386 Filed 8-2-17; 8:45 am]
BILLING CODE 6560-50-P


(Docket ID 0087). Electric Boat stated that proprietary recordkeeping
software for OSHA logs is not compatible with requirements to upload to
OSHA and that large companies may have many cases in their logs. It
further maintained that a requirement to manually enter data for each
case would be ``very difficult, costly and potentially inaccurate due
to transcription errors'' (Docket ID 0028). For employers not currently
using software, Electric Boat surmised that information for the Form
301 incident report is often recorded on handwritten forms at
individual establishments, and thus the time and resources needed to
transition to a fully automated system would be considerable.
    The U.S. Poultry and Egg Association, the Employers E-Recordkeeping
Coalition, the Chamber of Commerce, the National Retail Federation, and
the Flexible Packaging Association, and Phylmar Regulatory Roundtable
wrote about increased costs due to either reprogramming recordkeeping
software to meet OSHA's format or investing in new software altogether
(Docket IDs 0053, 0087, 0088, 0090, 0091, 0094). The U.S. Poultry and
Egg Association commented that OSHA's analysis ``does not consider that
some employers utilize proprietary electronic recordkeeping systems
that would require program changes, possibly at a high cost, so that
the information could be electronically submitted to OSHA'' (Docket ID
0053). The Phylmar Regulatory Roundtable (Docket ID 0094) stated that
two or three days of labor would be necessary to reconfigure the coding
and modify programs currently used to electronically upload Form 300A
to include submission of Forms 300 and 301. The Chamber of Commerce
addressed the issue of small businesses that do not have electronic
recordkeeping programs in place and was concerned that small businesses
would not be able to afford the software (Docket ID 0088).
    OSHA believes that employers who use custom software for their
recordkeeping will incur some, though limited, additional costs to
upgrade custom computer systems. OSHA also believes that employers who
use commercially available software are unlikely to incur any
costs.\44\ Many establishments required to submit injury and illness
data from their Form 300A already use software to submit that data.\45\
The larger employers that have created their own custom software,
instead of relying on commercially available software, likely have IT
employees already on staff that conduct system upgrades as part of
their daily

routine. For these companies, existing IT staff can conduct any
software upgrades needed, and OSHA has included a discussion of these
costs below. If upgrading systems is cost prohibitive for an
establishment, the establishment can still submit the required
information from their part 1904 forms manually, which is accounted for
in OSHA's estimates.
---------------------------------------------------------------------------

    \44\ OSHA believes employers who already own and use
commercially available software are unlikely to face any additional
costs because aftermarket software vendors will need to upgrade
their software to ensure the software does not become irrelevant to
the needs of their customers. Research conducted by ERG indicates
that software vendors plan to upgrade software free of charge
(Docket ID 0104). The business model selected by the software
vendors means that they will inherently incur some minor costs as a
result of providing a service without charge. The record is not
sufficient for OSHA to provide a quantitative estimate of what those
costs would be, but the fact that the vendors chose to offer this
service without charge makes it clear that providing this update
would not pose any threat to the economic stability of the software
vendor industry.
    \45\ The use of recordkeeping software provides significant
advantages in terms of streamlining recordkeeping and data
submission capabilities. Specifically, software is available that
produces OSHA-ready reports for work-related injuries and illnesses;
generates files in the exact format required for the OSHA ITA; and
offers additional features, including ways to capture near-misses
and hazards of all types, detailed incident investigations, and the
root cause of an injury.
---------------------------------------------------------------------------

    Nonetheless, after a full consideration of comments, and
notwithstanding the possibility that switching to commercial
aftermarket software might be more economical, OSHA recognizes that
there may be an incremental cost to modifying custom software unique to
the rule. While comments provided limited guidance on what the cost of
updating software may be, including how many firms might be affected,
the agency determined that 20 hours of reprogramming is a reasonable
time for the task (Docket ID 0104). This estimate also corresponds to
the estimate submitted in the comment by the Phylmar Regulatory
Roundtable of 2-3 days (Docket ID 0094).\46\
---------------------------------------------------------------------------

    \46\ The agency has also performed a sensitivity analysis to
recognize that some of the more complex software in the typically
larger firms, with many establishments, might take as much as 50
hours to reprogram, depending on the complexity of the software
(Docket ID 0103). These estimates assume there are not time savings
from bundling these software updates with others needed to maintain
and update the software, or efficiencies to be gained from
incorporating commercial software.
---------------------------------------------------------------------------

    OSHA also estimates that the group of firms affected by the custom
software modification costs is a limited set. OSHA found that
approximately 40 percent of employers who must report injuries
currently already use software to report the files,\47\ and the number
is growing. The agency believes the set of firms using customized
software to report cases is not a randomly distributed group but sorts
heavily by the size of the firm. The agency examined the current
universe of firms currently electronically batch-filing injury reports
via its ITA system and found that of the 716 firms reporting for
affected establishments, approximately 36 percent are reporting for
only one establishment (Docket ID 0106). OSHA believes the cost of
updating custom software would predominantly affect only the other 64
percent of firms (456) that represent more than one establishment and
report data using batch files (ITA cite). Those 456 firms also account
for a disproportionate number of cases reported to the agency. For
those 456 firms to upgrade their software, the agency assumes that this
work would be performed by a software engineer at the wage rate
($94.19) referenced in Table 2. The FEA therefore calculated the cost
of custom software as $859,042 [(456 firms) x (20 hours) x ($94.19/
hour)], or $122,308 annualized over 10 years at a 7 percent discount
rate.\48\
---------------------------------------------------------------------------

    \47\ Docket ID 0105.
    \48\ $100,706 annualized over 10 years at a 3 percent discount
rate.
---------------------------------------------------------------------------

    As indicated previously, employers are not required to modify their
software to comply with the standard, but for very large employers,
this might be their least-cost method for compliance. As laid out
earlier in the analysis, other employers might decide that for purposes
of OSHA compliance, it makes more sense to employ commercially
available software, or even manually enter the cases. Therefore, issues
of software modification do not raise questions of technological
feasibility, as discussed later in the analysis, nor do they pose
questions of economic feasibility.
8. Other Costs
    OSHA also received comments on other potential cost items,
addressed below.
a. Harm to Reputation
    OSHA received multiple comments stating that OSHA should include
costs to capture the argued negative reputational effects to companies
after OSHA publishes their illness and injury information. The Plastics
Industry Association and the Chamber of Commerce commented on the
potential liabilities associated with publishing these work-related
injury reports (Docket IDs 0086, 0088). The Plastics Industry
Association noted the ``unknown consequences of public shaming and
misuse of the information'' that could lead to reputational damage
(Docket ID 0086).
    Related comments are covered in Section III.G of the Summary and
Explanation, but the agency emphasizes here that there is insufficient
basis for altering the economic analysis to reflect this issue.
Regarding reputational and civil liability damages, OSHA disagrees that
the mere posting of injury and illness recordkeeping data on a publicly
available website will adversely impact an employer's reputation. As
the Note to Sec.  1904.0 of OSHA's recordkeeping regulation makes
clear, the recording or reporting of a work-related injury, illness, or
fatality does not mean that an employer or employee was at fault, that
an OSHA rule has been violated, or that the employee is eligible for
workers' compensation or other benefits. In addition, OSHA already
publishes data from the Form 300A that is collected through the ITA, as
well as establishment-specific, case-specific information about
reported work-related fatalities, hospitalizations, amputations, and
losses of an eye (see https://www.osha.gov/severeinjury and https://www.osha.gov/fatalities). Despite online publication of this
information for a number of years, commenters did not provide any
examples of harm to reputation occurring as a result, nor did they
provide any examples of misuse of the data that has already been
published.
b. Additional Time Needed To Review for PII
    As an adjunct to the earlier discussion regarding quality assurance
concerns and the appropriate wage rate for the cost of submitting
cases, some commenters also suggested that it will take additional time
to remove PII from case files before they are submitted. As in that
discussion, OSHA reiterates that this is an action that should already
be addressed when the cases are recorded under existing practices to
meet existing recordkeeping requirements at Sec.  1904.4, Sec.
1904.29, and Sec.  1904.41.\49\ Therefore, this is not a new cost of
this rule, and the agency is not including cost for privacy checks in
the Final Economic Analysis.
---------------------------------------------------------------------------

    \49\ Additionally, OSHA will use software capable of detecting
and redacting PII not redacted by establishments.
---------------------------------------------------------------------------

c. Company Name
    One commenter, the National Demolition Association, stated that the
final rule's new requirement for establishments to submit their company
name as part of their data submissions would impose an additional
administrative and financial burden on employers. This commenter argued
that the requirement, which is in final Sec.  1904.41(b)(10), ``would
be particularly onerous and complex for employers who have multiple
establishments and limited staff resources to comply with the
additional administrative paperwork and reporting requirements''
(Docket ID 0060).
    Submission of an establishment's company name is not expected to be
particularly time consuming. First, most establishments are already
including their company names as part of their 300A data submissions,
so this new requirement will only affect

establishments that are using only codes to identify their
establishments. Second, establishments that are not already submitting
their company name only have to input that one additional field, and
they have to do that only one time if they are doing a batch file
submission (i.e., once per batch file).\50\ Regardless, the time
necessary to include the company name is included in the 15 minutes
OSHA has estimated as the time necessary to complete one
submission.\51\
---------------------------------------------------------------------------

    \50\ As OSHA said in the NPRM, OSHA's review of five years of
electronically submitted Form 300A data indicates that many large
firms with multiple establishments use codes for the Establishment
Name field in their submission (87 FR 18546). This is the type of
employer this new requirement will likely apply to and, because they
are large firms submitting for multiple establishments, they are
likely submitting via batch file. This means that company name would
only need to be inputted once.
    \51\ To the extent the commenter is arguing that determining a
firm's legal name is administratively difficult or would take
substantial time, OSHA presumes that employers know their company
names and has included no cost for that.
---------------------------------------------------------------------------

d. Training Costs
    The U.S. Poultry and Egg Association, Dow, the North American Meat
Institute, the Motor and Equipment Manufacturers Association, the
Chamber of Commerce, and the National Retail Federation commented that
training costs should be included in the cost analysis (Docket IDs
0053, 0054, 0070, 0088, 0090). The U.S. Poultry and Egg Association
wrote that the analysis ``does not consider additional training of
staff that might be required, nor does the rule consider costs
associated with training existing and new staff on the variety of state
and federal privacy laws that could be impacted by employers now
knowing that the information they submit will necessarily be made
available worldwide'' (Docket ID 0053). The Chamber of Commerce
commented on the need for training managers on how to comply with
reporting formats, schedules, and procedures, as well as training for
additional staff ``to cover multiple shifts, absences, and internal
review needs.'' The Chamber further stated that time would be needed to
``train administrative and operational employees in their new
compliance duties'' (Docket ID 0088).
    OSHA concludes that additional training should not be necessary
either to fill in a web form with information that has already been
recorded, or to transmit records from an existing electronic
recordkeeping system with which the employee is already familiar.
Employees have already been trained on how to record injuries and
illnesses on the Forms 300 and 301, pursuant to other previously
existing requirements under part 1904. Thus, OSHA has already accounted
for the time required to learn how to keep the records themselves. Any
time required to learn how to submit the Form 300 and Form 301 data to
the ITA (the only new requirement in this rule) is already included in
OSHA's rule familiarization time estimate, described above.\52\
---------------------------------------------------------------------------

    \52\ This approach is also consistent with that taken in OSHA's
2016 final recordkeeping rule, which also required electronic
submission of injury and illness data to OSHA (see 81 FR 29674).
---------------------------------------------------------------------------

D. Effect on Prices

    An anonymous commenter commented, ``This is unnecessary overreach
which is going to cost employers and cost the tax payers additional
resources to process the collected data . . . It will only cost
employers more, who will charge the consumer more'' (Docket ID 0025).
OSHA disagrees. As discussed throughout this section, the costs to
comply with the final rule for individual employers are expected to be
about $136 per establishment to submit the Form 300 and 301 data. Costs
at this level of magnitude are not expected to lead to price increases
or raise issues of economic feasibility.\53\
---------------------------------------------------------------------------

    \53\ As discussed in the Regulatory Flexibility Certification,
the costs would be no more than approximately .01% of revenues ($136
costs/$13,627 being the 1% threshold of revenues), implying a
negligible price increase, if any, to recoup the increase in costs.
---------------------------------------------------------------------------

E. Budget Costs to the Government

    In the PEA, OSHA included an estimate of the costs of the new
requirement to the government because these costs represent a
significant fraction of the total costs of the new requirement. OSHA
received estimates for the costs from the U.S. Department of Labor
Office of the Chief Information Officer (DOL OCIO). OSHA estimated that
modification of the reporting system hardware and software
infrastructure to accept submissions of Form 300 and 301 data would
have an initial one-time cost of $1.2 million. If annualized over 10
years at a 7 percent discount rate, the $1.2 million total cost would
equal $170,853 per year, or if annualized at 3 percent, it would be
$140,677 per year. The agency also estimated $201,128 as the annual
cost of additional IT transactions necessary to implement this rule
($0.28 per case times 718,316 cases for additional internal IT support
services). Finally, OSHA estimated that annual help desk support costs
would increase by $25,000. This estimate was based on the annual help
desk support costs under the 300A submission provisions. This resulted
in a total cost to the government, annualized over 10 years at a 7
percent rate, of $397,001.\54\
---------------------------------------------------------------------------

    \54\ When preparing the final rule, the agency found inadvertent
discrepancies between the written text of the PEA that was in the
Federal Register notice for the NPRM (87 FR 18550-51) and the
spreadsheet (Ex. 2) used to calculate the estimated governmental
costs in the PEA. The agency describes those discrepancies here for
the purposes of transparency. The annual cost of IT transactions was
listed in the spreadsheet as $107,309 rather than $201,128 in the
Federal Register notice. Annual help desk support costs were listed
as $50,000 in the spreadsheet and $25,000 in the Federal Register
notice. And, the cost of an additional IT Specialist was included in
the spreadsheet (at an estimated $181,162) but omitted from the
discussion in the Federal Register notice. Whereas the total costs
to the government reported in the spreadsheet were $509,324, the
total costs to the government in the Federal Register notice were
$397,001. Because the costs listed in the spreadsheet are more
inclusive of the universe of estimated costs, the estimates in the
FEA are derived from those costs.
---------------------------------------------------------------------------

    OSHA sought comment on this methodology and cost estimate and
received no responses. After consideration, OSHA has decided to
maintain the framework used in the proposal but has updated the
estimate to account for the current wage rate indicated in Table 2,
above. Therefore, OSHA retained the estimate of $1.2 million for the
one-time cost of modifying the reporting system hardware and software
infrastructure to accept submissions of Form 300 and 301 data. If
annualized over 10 years at a 7 percent discount rate, the $1.2 million
total cost would equal $170,853 per year. If annualized at 3 percent,
it would be $140,677 per year. The agency also estimated $128,716 as
the annual cost of additional IT transactions necessary to implement
this rule ($0.28 per case times 459,701 cases for additional internal
IT support services). Next, the agency estimated $204,485, based on
2023 wages, for OSHA to hire an additional IT Specialist. Finally, OSHA
estimated that annual help desk support costs will increase by $50,000.
Summing these figures, and assuming a seven percent discount rate,
results in a total annualized cost to the government of $554,054.

F. Total Cost

    Summing the estimated batch-file submission ($252,048) and manual
submission ($6,647,982) costs results in an estimated total cost of
$6,900,030 to submit 766,257 records. Combined with the annualized cost
of $75,781 per year for familiarization, and $122,308 for software
upgrade cost to employers submitting batch-files using custom computer
software, estimated above (at 7 percent), the estimated total annual
private-sector cost of this part of the

final rule is $7,098,120. To obtain the estimated average cost of
submission per establishment of $136.26, OSHA divided the total
estimated cost of submission ($7,098,120) by the estimated number of
establishments that would be required to submit data (52,092
establishments). Total costs are detailed in Table 3,
below.55 56
---------------------------------------------------------------------------

    \55\ OSHA has determined that the other new regulatory
provisions in this final rule, such as Sec.  1904.41(b)(1) (which is
a clarifying provision), Sec.  1904.41(b)(9) (which sets out which
data should be excluded from submissions), Sec.  1904.41(b)(10)
(which requires employers to provide their company name as part of
their submission), and Sec.  1904.41(c) (which sets the submission
deadline), do not impose costs beyond those accounted for in the
costs of submission and familiarization discussed in this FEA.
    \56\ One commenter, the US Poultry & Egg Association, objected
to OSHA's estimate of costs and suggested that OSHA should ``conduct
a pilot program (preferably on Federal Government agencies) to
determine the actual cost of compliance'' (Ex. 53). OSHA has a long
history of estimating costs of its regulations and standards without
the need for a pilot program. It is confident that the estimates in
this rulemaking, which carefully consider comments from interested
parties, are sufficient to accurately characterize the costs of
compliance for employers.

                       Table 3--Total Cost Summary
------------------------------------------------------------------------
          Cost element                Annual cost        One-time cost
------------------------------------------------------------------------
Annual electronic submission of   $6,900,030........  $0
 OSHA Form 300 Log and OSHA Form
 301 Incident Report by
 establishments with 100 or more
 employees in designated
 industries.
One-Time Rule Familiarization     NA................  532,257
 Cost.
    Annualized 10 yr at 7%......  75,781............  NA
    Annualized 10 yr at 3%......  62,397............  NA
One-Time Software Upgrade.......  NA................  859,042
    Annualized 10 yr at 7%......  122,308...........  NA
    Annualized 10 yr at 3%......  100,706...........  NA
                                 ---------------------------------------
        Total Private Sector      7,098,120.........  1,391,299
         Costs * **.
Average Cost per 52,092           136...............  NA
 Establishments.
------------------------------------------------------------------------
Processing of annual electronic   128,360...........  0
 submissions of OSHA 300/301.
Annual Contractor Software        50,000............  0
 Support.
Annual Government Software        204,485...........  0
 Support.
One-Time Software Design and      NA................  1,200,000
 Development.
    Annualized 10 yr at 7%......  170,853...........  NA
    Annualized 10 yr at 3%......  140,677...........  NA
                                 ---------------------------------------
        Total Government Costs *  553,698...........  1,200,000
         **.
                                 ---------------------------------------
        Total *.................  7,651,818.........  2,591,299
------------------------------------------------------------------------
* One-time costs are annualized and appear in annual cost column; the
  one-time cost is not an additional cost.
** Annualized over 10 years at 7%.

G. Benefits

    As explained in the PEA and elaborated on elsewhere in this
preamble, in particular in Section III.B of the Summary and
Explanation, the main purpose of the final rule is to prevent worker
injuries and illnesses through the collection and use of timely,
establishment- and case-specific injury and illness data. With the
information obtained through this rule, OSHA, employers, employees,
employee representatives, State and local agencies, consultants, and
researchers will be better able to identify and mitigate workplace
hazards and thereby prevent worker injuries and illnesses. The final
rule will support OSHA's statutory directive to assure safe and
healthful working conditions for working people by providing for
appropriate reporting procedures regarding occupational safety and
health that will help achieve the objectives of the OSH Act (29 U.S.C.
651(b); (b)(12)).
    The number of workers in the U.S. who are injured or made ill on
the job remains unacceptably high, and the importance of this final
rule lies largely in increasing access to information to better enable
OSHA and other organizations to prevent workplace injuries and
illnesses. According to BLS's Survey of Occupational Injuries and
Illnesses (SOII), in 2021, employees experienced 2.6 million recordable
nonfatal injuries and illnesses at work.\57\ This number is widely
recognized to be an undercount of the actual number of occupational
injuries and illnesses that occur annually.\58\ As described
extensively above in Section III.B of the Summary and Explanation, the
final rule will increase the agency's ability to focus resources on
those workplaces where workers are at greatest risk. Even with improved
targeting, OSHA Compliance Safety and Health Officers can inspect only
a small proportion of the nation's workplaces each year, and it would
take many decades to inspect each covered workplace in the nation even
once. As a result, to reduce worker injuries and illnesses, it is of
great importance for OSHA to leverage its resources for workplace
safety at the many thousands of establishments in which workers are
being injured or made ill but which OSHA does not have the resources to
inspect.
---------------------------------------------------------------------------

    \57\ See ``Employer-Reported Workplace Injuries and Illnesses--
2021'', news release from the Bureau of Labor Statistics/U.S.
Department of Labor, November 9, 2022 (https://www.bls.gov/news.release/pdf/osh.pdf).
    \58\ See, e.g., Leigh JP, Du J, McCurdy SA. An estimate of the
U.S. government's undercount of nonfatal occupational injuries and
illnesses in agriculture. Ann Epidemiol. 2014 Apr; 24(4):254-9
(https://pubmed.ncbi.nlm.nih.gov/24507952/); Spieler EA, Wagner GR.
Counting matters: Implications of undercounting in the BLS survey of
occupational injuries and illnesses. Am J Ind Med. 2014 Oct;
57(10):1077-84 (https://onlinelibrary.wiley.com/doi/10.1002/ajim.22382).
---------------------------------------------------------------------------

    As discussed in more detail in Section III, Summary and
Explanation, the final rule will help OSHA prevent worker injuries and
illnesses by greatly expanding OSHA's access to the establishment-
specific, case-specific information employers are already required to
record under part 1904. The

provisions requiring regular electronic submission of case-specific
injury and illness data will allow OSHA to obtain a much larger data
set of establishment-specific, case-specific information about injuries
and illnesses in the workplace. This information will help OSHA use its
enforcement and compliance assistance resources more effectively by
enabling OSHA to identify the workplaces where workers are at greatest
risk. In addition, OSHA will be able to use the information to identify
emerging hazards, support an agency response, and reach out to
employers whose workplaces might include those hazards.
    In addition to OSHA obtaining better information, this information
will be available to employers, employees, members of the public,
employee representatives, trade associations, and workplace safety and
health professionals, among others. This increased access and
transparency of information about workplace injuries and illnesses can
be used by all interested parties to better understand workplace
hazards and improve occupational safety and health. OSHA also expects
the information to improve research on the occurrence and prevention of
workplace hazards, injuries, and illnesses.
    In response to the PEA, the National Propane Gas Association and
the Chamber of Commerce said that OSHA should quantify benefits for the
rule (Docket IDs 0050, 0088, Attachments). The National Propane Gas
Association stated that OSHA ``does not provide any details as to how
publicly available information could improve workplace safety'' and
argued that OSHA should ``provide concrete benchmarks to define the
safety improvements that the agency expects to be met by publicly
accessible case-specific, establishment-specific information'' (Docket
ID 0050). The Chamber of Commerce said that OSHA ``makes no attempt to
estimate or quantify the purported economic benefits of this Proposed
Rule; instead, it asserts that these benefits will `significantly
exceed the annual costs,' '' going on to say that OSHA did not
``explain how electronic quarterly reporting or the creation of a
public database that will publish the private and confidential
information of employers and employees will provide any increase in
workplace safety'' (Docket ID 0088).\59\
---------------------------------------------------------------------------

    \59\ Note that the agency did not propose quarterly reporting;
the proposed rule envisioned annual reporting, and the final rule
similarly will require annual reporting.
---------------------------------------------------------------------------

    The agency respectfully disagrees about quantifying the economic
benefits. Quantifying benefits is not always feasible in practice.
However, the infeasibility of quantifying benefits does not demonstrate
a lack of benefits. In contrast to the occupational safety and health
standards the agency promulgates, quantifying benefits for a
recordkeeping regulation is particularly challenging.\60\ OSHA notes
that the commenters did not attempt to themselves quantify the benefits
of the proposed rule, nor did commenters propose any approach that
would allow the agency to effectively quantify those benefits in order
to compare them against the costs.
---------------------------------------------------------------------------

    \60\ For the difference between a standard and a regulation,
please see the discussion in Section II, Legal Authority.
---------------------------------------------------------------------------

H. Economic Feasibility

    In the PEA, OSHA preliminarily concluded that the proposed rule
would be economically feasible and received no comment specifically on
this conclusion. After further consideration, OSHA has concluded that
the final rule will be economically feasible. Under the final rule, for
establishments with 100 or more employees in the industries designated
in appendix B, the average additional cost of electronically submitting
information from the OSHA Forms 300 and 301 will be roughly $136 per
year. These costs will not affect the economic viability of these
establishments.

I. Regulatory Flexibility Certification

    The requirement in the final rule requiring the electronic
submission of Form 300 and 301 information from establishments with 100
or more employees in designated industries will affect some small
entities, as determined by the definitions of small entity used by the
Small Business Administration (SBA). In some sectors, such as
construction, where SBA's definition only includes relatively smaller
firms, there are unlikely to be many entities with establishments with
100 or more employees that meet SBA small entity definitions. In other
sectors, such as manufacturing, many SBA-defined small entities will be
subject to this rule. Thus, this part of the final rule will affect
only a small percentage of all SBA-defined small entities.\61\ However,
because some SBA-defined small entities will be affected, especially in
manufacturing, OSHA has examined the impacts of this final rule on
small businesses.
---------------------------------------------------------------------------

    \61\ The portion of the rule that addresses the submission of
Form 300A information does affect smaller entities, as
establishments with 20 or more employees are required to
electronically submit Form 300A information. However, because this
final rule makes no substantive changes to that submission
requirement, which was enacted as part of the 2016 final rule, there
are no new costs for entities with fewer than 100 employees.
---------------------------------------------------------------------------

    OSHA did not convene a Small Business Advocacy Review panel under
the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA
Panel) for this rule. At least one commenter, the Chamber of Commerce,
argued that OSHA should have convened a SBREFA Panel to further
evaluate the effect of the proposed rule on small businesses (Docket ID
0088). The commenter said that the panel was particularly important
because ``the vast majority of employers and establishments that will
be affected by this Proposed Rule's electronic-only reporting
requirements will be small businesses, many of which do not currently
record injuries electronically.'' This commenter offered no evidence to
support its assertion that the majority of the employers and
establishments affected would be small businesses, nor did it offer
evidence that small businesses do not currently record injuries
electronically.
    OSHA considers the possibility of disproportionate impacts on small
businesses when deciding whether a Small Business Advocacy Review
(SBAR) panel is warranted. Because OSHA preliminarily determined that
the proposed rule would not result in a significant impact on a
substantial number of small businesses (see 87 FR 18553), OSHA
determined that a SBREFA panel was not required for this rule. Nothing
in the record has disturbed OSHA's preliminary determination that this
rule will not have a significant impact on a substantial number of
small businesses. Therefore, OSHA does not believe a SBREFA panel was
required for this rule.
    OSHA's typical procedure for assessing the significance of final
rules on small businesses is to first determine if costs are greater
than one percent of revenues or five percent of profits for the average
firm. If so, OSHA conducts an additional assessment. To meet this level
of significance at an estimated annual average cost of $136 per
affected establishment per year (including annualized familiarization
costs), annual revenues for an establishment with 100 or more employees
would have to be less than $13,627 (or less than $136 per employee,
assuming 100 employees), and annual profits would have to be less than
$2,725 (or less than $28 per employee, assuming 100 employees). There
are no impacted industries that have average revenues of

less than $13,627.\62\ Furthermore, integrating those data with profit
data from the 2013 Corporation Source Book \63\ indicates there are no
impacted industries earning less than $2,725 in profit per
establishment among establishments with 5 or more employees.\64\ These
are extremely unlikely combinations of revenues and profits for firms
of this size and would only occur for a very small number of firms in
severe financial distress. As indicated, OSHA's cost estimates would
have to be in error by more than an order of magnitude to reach these
thresholds.\65\
---------------------------------------------------------------------------

    \62\ The average revenue numbers were obtained from the 2017
Economic Census. This is the most current information available from
this source, which OSHA considers to be the best available source of
revenue data for U.S. businesses. OSHA adjusted these figures to
2019 dollars using the Bureau of Economic Analysis's GDP deflator,
which is OSHA's standard source for inflation and deflation
analysis. These average revenue figures would include any non-
profits falling within the affected industries.
    \63\ Profits were calculated as profit rates multiplied by
revenues. The before-tax profit rates that OSHA used were estimated
using corporate balance sheet data from the 2013 Corporation Source
Book (Internal Revenue Service, 2013; https://www.irs.gov/statistics/soi-tax-stats-corporation-source-book-publication-1053).
The IRS discontinued the publication of these data after 2013, and
therefore the most current years available are 2000-2013. The most
recent version of the Source Book represents the best available
evidence for these data on profit rates.
    \64\ While descriptive of most establishments in these
industries, this figure would significantly underestimate the
profits of the average affected establishment covered by this rule,
which only affects those with 100 or more employees.
    \65\ The lowest potential threshold of impact (for profits) is
$2,725 per establishment. The agency estimates an average cost per
establishment of $136. It would need to be approximately 20 times
higher to reach this threshold.
---------------------------------------------------------------------------

    As a result of these considerations, per Section 605 of the
Regulatory Flexibility Act (5 U.S.C. 605), OSHA certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. Thus, OSHA has not prepared a final
regulatory flexibility analysis.

V. OMB Review Under the Paperwork Reduction Act of 1995

A. Overview

    The final ``Improve Tracking Workplace Injury and Illness'' rule
contains information collection (paperwork) requirements that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., and
OMB regulations, 5 CFR part 1320. The PRA defines a collection of
information as ``the obtaining, causing to be obtained, soliciting, or
requiring the disclosure to third parties or the public, of facts or
opinions by or for an agency, regardless of form or format.'' 44 U.S.C.
3502(3)(A). The aforementioned regulations mandate that the Department
consider the impact of paperwork and other information collection
burdens imposed on the public. Under the PRA, a Federal agency
generally cannot conduct or sponsor a collection of information and the
public will generally not be penalized for not responding to an
information collection, unless it is approved by OMB and the agency
displays a currently valid OMB Control Number. See 44 U.S.C. 3507 and
3512, 5 CFR 1320.5(a) and 1320.6.
    On March 30, 2022, OSHA published a notice of proposed rulemaking
(NPRM) (87 FR 18528) to amend its occupational injury and illness
recordkeeping regulation to require establishments with 100 or more
employees in certain designated industries to be able to electronically
submit information from their OSHA Forms 300, 301, and 300A once a
year. OSHA prepared and submitted an Information Collection Request
(ICR) to OMB, proposing to revise certain collection requirements
currently contained in the package, as required under 44 U.S.C.
3507(d). The proposed rule invited the public to submit comments to
OMB, in addition to OSHA, on the proposed collections of information.
On May 25, 2022, OSHA published a second Federal Register notice (87 FR
31793), extending the comment period to allow the public an additional
30 days to comment on the proposed rule and the information collection
requirements contained in the proposed rule. OSHA received 87 public
comments.
    In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited
public comments on the collection of information contained in the 2022
proposed rule. OSHA encouraged commenters to submit their comments on
the information collection requirements contained in the proposed rule
under docket number OSHA-2021-0006, along with their comments on other
parts of the proposed rule. In addition to generally soliciting
comments on the collection of information requirements, the proposed
rule indicated that OSHA and OMB were particularly interested in
comments that addressed the following:
     Whether the collection of information is necessary for the
proper performance of the agency's functions, including whether the
information is useful;
     The accuracy of OSHA's estimate of the burden (time and
cost) of the collection of information, including the validity of the
methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
    On May 5, 2022, OMB issued a Notice of Action (NOA) assigning the
proposal's ICR a new control number, 1218-0279, to be used in future
ICR submissions. OMB noted that this action had no effect on any
current approvals. OMB also noted that the NOA is not an approval to
conduct or sponsor the information collection contained in the revision
proposal. Finally, OMB requested that, ``[p]rior to publication of the
final rule, [OSHA] should provide a summary of any comments related to
the information collection and their response, including any changes
made to the ICR as a result of comments. In addition, the agency must
enter the correct burden estimates.'' OSHA did not receive any comments
in response to the proposed ICR submitted to OMB for review. However,
the agency did receive 87 comments related to the proposed rule.
    Concurrent with publication of this final rule, the Department of
Labor submitted the final ICR, containing the full analysis and
description of the burden hours and costs associated with the final
rule, to OMB for approval. A copy of this ICR is available at http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0279
(this link will become active on the day following publication of the
final rule). OSHA will publish a separate notice in the Federal
Register that will announce the results of that review. This notice
will also include a list of OMB-approved information collection
requirements and total burden hours and costs imposed by the new
regulation.

B. Summary of Information Collection Requirements

    As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the
following paragraphs provide information about this ICR.
    1. Title: Improve Tracking Workplace Injury and Illness.
    2. Description of the ICR: This final rule revises the currently
approved Recordkeeping and Reporting Occupational Injuries and
Illnesses Information Collection and changes the existing information
collection requirements currently approved by OMB.

    3. Brief Summary of the Information Collection Requirements.
    Under ``Information Requirements on Recordkeeping and Reporting
Occupational Injuries and Illnesses,'' OMB Control Number 1218-0176,
OSHA currently has OMB approval to conduct an information collection
that requires covered employers to, among other things, record each
recordable employee injury and illness on an OSHA Form 300, which is
the ``Log of Work-Related Injuries and Illnesses,'' or equivalent. In
addition, employers must also prepare a supplementary OSHA Form 301
``Injury and Illness Incident Report'' or equivalent that provides
additional details about each case recorded on the OSHA Form 300, and,
at the end of each year, employers are required to prepare a summary
report of all injuries and illnesses on the OSHA Form 300A, which is
the ``Summary of Work-Related Injuries and Illnesses,'' and post the
form in a visible location in the workplace.
    Under 29 CFR 1904.41, certain employers were only required to
electronically submit injury and illness information from their OSHA
Forms 300A (the summary) annually. OSHA did not receive establishment-
specific, case-specific, injury and illness data. For the purposes of
the PRA, the final rule makes two changes to Sec.  1904.41.
    First, OSHA newly requires all establishments that have 100 or more
employees and are in certain designated industries to electronically
submit information from the OSHA Form 300 and 301 to OSHA or OSHA's
designee. This is in addition to the current requirement for these
establishments to electronically submit information from the OSHA Form
300A. Each establishment subject to this provision will require time to
familiarize themselves with the reporting website. This change is
similar to requirements contained in OSHA's Improve Tracking of
Workplace Injuries and Illnesses final rule, 81 FR 29624 (May 12, 2016)
which were removed by the Tracking of Workplace Injuries and Illnesses
final rule, 84 FR 380 (January 25, 2019).
    Second, OSHA newly requires establishments that are required to
electronically report information from their injury and illness records
to OSHA under part 1904, to include their company name as part of the
submission. No additional paperwork burden is associated with the
provision.
    In addition, Docket exhibit OSHA-2021-006-0004 shows an example of
an expanded interface to collect case-specific data. Screenshots of
this interface can also be viewed on OSHA's website at http://www.osha.gov/recordkeeping/proposed_data_form.html.
    4. OMB Control Number: 1218-0279 .
    5. Affected Public: Business or other for-profit.
    6. Total Estimated Number of Respondents: 52,092.
    7. Frequency of Responses: Annually.
    8. Total Estimated Number of Responses: 475,943.
    9. Average Time per Response: Average time per response varies from
10 minutes for establishments using batch file submission to 237
minutes for establishments using manual submission.
    10. Total Estimated Annualized Burden Hours): 118,485.
    11. Total Estimated Costs (Capital-Operation and Maintenance): 0.

VI. Unfunded Mandates

    OSHA reviewed this final rule according to the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.), as well as Executive
Order 13132 (64 FR 43255 (Aug. 4, 1999)). As discussed above in Section
IV, Final Economic Analysis, the agency has determined that this final
rule does not include any Federal mandate that may result in increased
expenditures by State, local, and Tribal governments, or increased
expenditures by the private sector, of $100 million or more in any one
year. In addition, OSHA's regulations do not apply to State and local
governments except in States that have elected voluntarily to adopt a
State Plan approved by OSHA. Consequently, this final rule does not
meet the definition of a ``federal intergovernmental mandate'' (see 2
U.S.C. 1502, 658(5)). Therefore, for the purposes of the UMRA, the
agency certifies that this final rule does not mandate that State,
local, or Tribal governments adopt new, unfunded regulatory obligations
of, or increase expenditures by the private sector by, $100 million or
more in any year.

VII. Federalism

    OSHA reviewed this final rule in accordance with Executive Order
13132 (64 FR 43255 (Aug. 4, 1999)), regarding federalism. E.O. 13132
requires that Federal agencies, to the extent possible, refrain from
limiting State policy options, consult with States before taking
actions that would restrict States' policy options, and take such
actions only when clear constitutional authority exists and the problem
is of national scope.
    Section 18(a) of the OSH Act states that nothing in the Act shall
prevent any State agency or court from asserting jurisdiction under
State law over an occupational safety or health issue with respect to
which no standard is in effect under Section 6 of the Act (29 U.S.C.
667(a)). Because this rulemaking involves a ``regulation'' issued under
Sections 8 and 24 of the OSH Act (29 U.S.C. 657, 673), and not an
``occupational safety and health standard'' issued under Section 6 of
the OSH Act (29 U.S.C. 655), the rule will not preempt State law under
Section 18(a) (see 29 U.S.C. 667(a)). The effect of the final rule on
States and territories with OSHA-approved occupational safety and
health State Plans is discussed in Section VIII, State Plans.

VIII. State Plans

    Pursuant to Section 18 of the OSH Act (29 U.S.C. 667) and the
requirements of 29 CFR 1904.37, 1902.3(j), 1902.7, 1953.4(b), and
1956.10(i), within 6 months after publication of the final OSHA rule,
State Plans must promulgate occupational injury and illness recording
and reporting requirements that are substantially identical to those in
29 CFR part 1904. State Plans must have the same requirements as
Federal OSHA for determining which injuries and illnesses are
recordable and how they are recorded (29 CFR 1904.37(b)(1)). All other
part 1904 injury and illness recording and reporting requirements (for
example, industry exemptions, reporting of fatalities and
hospitalizations, record retention, or employee involvement) that are
promulgated by State Plans may be more stringent than, or supplemental
to, the Federal requirements, but, because of the unique nature of the
national recordkeeping program, States must consult with OSHA and
obtain approval of such additional or more stringent reporting and
recording requirements to ensure that they will not interfere with
uniform reporting objectives (29 CFR 1904.37(b)(2)).
    There are 29 State Plans. The States and territories that cover
both private sector and public sector employers are Alaska, Arizona,
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
Wyoming. Connecticut, Illinois, Maine, Massachusetts, New Jersey, New
York, and the Virgin Islands have OSHA-approved State Plans that apply
to State and local government employees only.

IX. National Environmental Policy Act

    OSHA has reviewed the provisions of this final rule in accordance
with the requirements of the National

Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the
Council on Environmental Quality (CEQ) NEPA regulations (40 CFR parts
1500-1508), and the Department of Labor's NEPA Procedures (29 CFR part
11). As a result of this review, OSHA has determined that the final
rule will have no significant adverse effect on air, water, or soil
quality, plant or animal life, use of land, or other aspects of the
environment.

X. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this final rule in accordance with Executive Order
13175 (65 FR 67249 (Nov. 9, 2000)) and determined that it does not have
``tribal implications'' as defined in that order. The rule does not
have substantial direct effects 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.

List of Subjects in 29 CFR Part 1904

    Health statistics, Occupational safety and health, Reporting and
recordkeeping requirements.

Authority and Signature

    This document was prepared under the direction of Douglas L.
Parker, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue NW,
Washington, DC 20210. It is issued under Sections 8 and 24 of the
Occupational Safety and Health Act (29 U.S.C. 657, 673), Section 553 of
the Administrative Procedure Act (5 U.S.C. 553), and Secretary of
Labor's Order No. 8-2020 (85 FR 58393 (Sept. 18, 2020)).

    Signed at Washington, DC, on July 12, 2023.
Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.

    For the reasons stated in the preamble, OSHA amends part 1904 of
chapter XVII of title 29 as follows:

PART 1904--[AMENDED]

Subpart E--Reporting Fatality, Injury and Illness Information to
the Government

0
1. The authority citation for part 1904, subpart E, is revised to read
as follows:

    Authority: 29 U.S.C. 657, 673, 5 U.S.C. 553, and Secretary of
Labor's Order No. 08-2020 (85 FR 58393, Sept. 18, 2020) or 1-2012
(77 FR 3912, Jan. 25, 2012), as applicable.

0
2. Amend Sec.  1904.41 as follows:
0
a. Revise paragraphs (a)(1) and (2) and (b)(1);
0
b. Add paragraphs (b)(9) and (10); and
0
c. Revise paragraph (c).
    The revisions and additions read as follows:

Sec.  1904.41  Electronic submission of Employer Identification Number
(EIN) and injury and illness records to OSHA.

* * * * *
    (a) * * *
    (1) Annual electronic submission of information from OSHA Form 300A
Summary of Work-Related Injuries and Illnesses. (i) If your
establishment had 20-249 employees at any time during the previous
calendar year, and your establishment is classified in an industry
listed in appendix A to subpart E of this part, then you must
electronically submit information from OSHA Form 300A Summary of Work-
Related Injuries and Illnesses to OSHA or OSHA's designee. You must
submit the information once a year, no later than the date listed in
paragraph (c) of this section of the year after the calendar year
covered by the form.
    (ii) If your establishment had 250 or more employees at any time
during the previous calendar year, and this part requires your
establishment to keep records, then you must electronically submit
information from OSHA Form 300A Summary of Work-Related Injuries and
Illnesses to OSHA or OSHA's designee. You must submit the information
once a year, no later than the date listed in paragraph (c) of this
section of the year after the calendar year covered by the form.
    (2) Annual electronic submission of information from OSHA Form 300
Log of Work-Related Injuries and Illnesses and OSHA Form 301 Injury and
Illness Incident Report by establishments with 100 or more employees in
designated industries. If your establishment had 100 or more employees
at any time during the previous calendar year, and your establishment
is classified in an industry listed in appendix B to subpart E of this
part, then you must electronically submit information from OSHA Forms
300 and 301 to OSHA or OSHA's designee. You must submit the information
once a year, no later than the date listed in paragraph (c) of this
section of the year after the calendar year covered by the forms.
* * * * *
    (b) * * *
    (1) Does every employer have to routinely make an annual electronic
submission of information from part 1904 injury and illness
recordkeeping forms to OSHA? No, only three categories of employers
must routinely submit information from these forms. The first category
is establishments that had 20-249 employees at any time during the
previous calendar year, and are classified in an industry listed in
appendix A to this subpart; establishments in this category must submit
the required information from Form 300A to OSHA once a year. The second
category is establishments that had 250 or more employees at any time
during the previous calendar year, and are required by this part to
keep records; establishments in this category must submit the required
information from Form 300A to OSHA once a year. The third category is
establishments that had 100 or more employees at any time during the
previous calendar year, and are classified in an industry listed in
appendix B to this subpart; establishments in this category must also
submit the required information from Forms 300 and 301 to OSHA once a
year, in addition to the required information from Form 300A. Employers
in these three categories must submit the required information by the
date listed in paragraph (c) of this section of the year after the
calendar year covered by the form (for example, 2024 for the 2023
form(s)). If your establishment is not in any of these three
categories, then you must submit the information to OSHA only if OSHA
notifies you to do so for an individual data collection.
* * * * *
    (9) If I have to submit information under paragraph (a)(2) of this
section, do I have to submit all of the information from the
recordkeeping forms? No, you are required to submit all of the
information from the forms except the following:
    (i) Log of Work-Related Injuries and Illnesses (OSHA Form 300):
Employee name (column B).
    (ii) Injury and Illness Incident Report (OSHA Form 301): Employee
name (field 1), employee address (field 2), name of physician or other
health care professional (field 6), facility name and address if
treatment was given away from the worksite (field 7).
    (10) My company uses numbers or codes to identify our
establishments. May I use numbers or codes as the establishment name in
my submission? Yes, you may use numbers or codes as the establishment
name. However, the submission must include a legal company name, either
as part of the establishment name or separately as the company name.
    (c) Reporting dates. Establishments that are required to submit
under paragraph (a)(1) or (2) of this section

must submit all of the required information by March 2 of the year
after the calendar year covered by the form(s) (for example, by March
2, 2024, for the forms covering 2023).
* * * * *

0
3. Revise appendix A to subpart E to read as follows:

Appendix A to Subpart E of Part 1904--Designated Industries for Sec.
1904.41(a)(1)(i) Annual Electronic Submission of Information From OSHA
Form 300A Summary of Work-Related Injuries and Illnesses by
Establishments With 20-249 Employees in Designated Industries

------------------------------------------------------------------------
           NAICS                               Industry
------------------------------------------------------------------------
11.........................  Agriculture, Forestry, Fishing and Hunting.
22.........................  Utilities.
23.........................  Construction.
31-33......................  Manufacturing.
42.........................  Wholesale Trade.
4413.......................  Automotive Parts, Accessories, and Tire
                              Stores.
4421.......................  Furniture Stores.
4422.......................  Home Furnishings Stores.
4441.......................  Building Material and Supplies Dealers.
4442.......................  Lawn and Garden Equipment and Supplies
                              Stores.
4451.......................  Grocery Stores.
4452.......................  Specialty Food Stores.
4522.......................  Department Stores.
4523.......................  General Merchandise Stores, including
                              Warehouse Clubs and Supercenters.
4533.......................  Used Merchandise Stores.
4542.......................  Vending Machine Operators.
4543.......................  Direct Selling Establishments.
4811.......................  Scheduled Air Transportation.
4841.......................  General Freight Trucking.
4842.......................  Specialized Freight Trucking.
4851.......................  Urban Transit Systems.
4852.......................  Interurban and Rural Bus Transportation.
4853.......................  Taxi and Limousine Service.
4854.......................  School and Employee Bus Transportation.
4855.......................  Charter Bus Industry.
4859.......................  Other Transit and Ground Passenger
                              Transportation.
4871.......................  Scenic and Sightseeing Transportation,
                              Land.
4881.......................  Support Activities for Air Transportation.
4882.......................  Support Activities for Rail Transportation.
4883.......................  Support Activities for Water
                              Transportation.
4884.......................  Support Activities for Road Transportation.
4889.......................  Other Support Activities for
                              Transportation.
4911.......................  Postal Service.
4921.......................  Couriers and Express Delivery Services.
4922.......................  Local Messengers and Local Delivery.
4931.......................  Warehousing and Storage.
5152.......................  Cable and Other Subscription Programming.
5311.......................  Lessors of Real Estate.
5321.......................  Automotive Equipment Rental and Leasing.
5322.......................  Consumer Goods Rental.
5323.......................  General Rental Centers.
5617.......................  Services to Buildings and Dwellings.
5621.......................  Waste Collection.
5622.......................  Waste Treatment and Disposal.
5629.......................  Remediation and Other Waste Management
                              Services.
6219.......................  Other Ambulatory Health Care Services.
6221.......................  General Medical and Surgical Hospitals.
6222.......................  Psychiatric and Substance Abuse Hospitals.
6223.......................  Specialty (except Psychiatric and Substance
                              Abuse) Hospitals.
6231.......................  Nursing Care Facilities (Skilled Nursing
                              Facilities).
6232.......................  Residential Intellectual and Developmental
                              Disability, Mental Health, and Substance
                              Abuse Facilities.
6233.......................  Continuing Care Retirement Communities and
                              Assisted Living Facilities for the Elderly
6239.......................  Other Residential Care Facilities.
6242.......................  Community Food and Housing, and Emergency
                              and Other Relief Services.
6243.......................  Vocational Rehabilitation Services.
7111.......................  Performing Arts Companies.
7112.......................  Spectator Sports.
7121.......................  Museums, Historical Sites, and Similar
                              Institutions.
7131.......................  Amusement Parks and Arcades.
7132.......................  Gambling Industries.
7211.......................  Traveler Accommodation.
7212.......................  RV (Recreational Vehicle) Parks and
                              Recreational Camps.
7223.......................  Special Food Services.
8113.......................  Commercial and Industrial Machinery and
                              Equipment (except Automotive and
                              Electronic) Repair and Maintenance.

8123.......................  Drycleaning and Laundry Services.
------------------------------------------------------------------------

0
4. Add appendix B to subpart E to read as follows:

Appendix B to Subpart E of Part 1904--Designated Industries for Sec.
1904.41(a)(2) Annual Electronic Submission of Information From OSHA
Form 300 Log of Work-Related Injuries and Illnesses and OSHA Form 301
Injury and Illness Incident Report by Establishments With 100 or More
Employees in Designated Industries

------------------------------------------------------------------------
           NAICS                               Industry
------------------------------------------------------------------------
1111.......................  Oilseed and Grain Farming.
1112.......................  Vegetable and Melon Farming.
1113.......................  Fruit and Tree Nut Farming.
1114.......................  Greenhouse, Nursery, and Floriculture
                              Production.
1119.......................  Other Crop Farming.
1121.......................  Cattle Ranching and Farming.
1122.......................  Hog and Pig Farming.
1123.......................  Poultry and Egg Production.
1129.......................  Other Animal Production.
1133.......................  Logging.
1141.......................  Fishing.
1142.......................  Hunting and Trapping.
1151.......................  Support Activities for Crop Production.
1152.......................  Support Activities for Animal Production.
1153.......................  Support Activities for Forestry.
2213.......................  Water, Sewage and Other Systems.
2381.......................  Foundation, Structure, and Building
                              Exterior Contractors.
3111.......................  Animal Food Manufacturing.
3113.......................  Sugar and Confectionery Product
                              Manufacturing.
3114.......................  Fruit and Vegetable Preserving and
                              Specialty Food Manufacturing.
3115.......................  Dairy Product Manufacturing.
3116.......................  Animal Slaughtering and Processing.
3117.......................  Seafood Product Preparation and Packaging.
3118.......................  Bakeries and Tortilla Manufacturing.
3119.......................  Other Food Manufacturing.
3121.......................  Beverage Manufacturing.
3161.......................  Leather and Hide Tanning and Finishing.
3162.......................  Footwear Manufacturing.
3211.......................  Sawmills and Wood Preservation.
3212.......................  Veneer, Plywood, and Engineered Wood
                              Product Manufacturing.
3219.......................  Other Wood Product Manufacturing.
3261.......................  Plastics Product Manufacturing.
3262.......................  Rubber Product Manufacturing.
3271.......................  Clay Product and Refractory Manufacturing.
3272.......................  Glass and Glass Product Manufacturing.
3273.......................  Cement and Concrete Product Manufacturing.
3279.......................  Other Nonmetallic Mineral Product
                              Manufacturing.
3312.......................  Steel Product Manufacturing from Purchased
                              Steel.
3314.......................  Nonferrous Metal (except Aluminum)
                              Production and Processing.
3315.......................  Foundries.
3321.......................  Forging and Stamping.
3323.......................  Architectural and Structural Metals
                              Manufacturing.
3324.......................  Boiler, Tank, and Shipping Container
                              Manufacturing.
3325.......................  Hardware Manufacturing.
3326.......................  Spring and Wire Product Manufacturing.
3327.......................  Machine Shops; Turned Product; and Screw,
                              Nut, and Bolt Manufacturing.
3328.......................  Coating, Engraving, Heat Treating, and
                              Allied Activities.
3331.......................  Agriculture, Construction, and Mining
                              Machinery Manufacturing.
3335.......................  Metalworking Machinery Manufacturing.
3361.......................  Motor Vehicle Manufacturing.
3362.......................  Motor Vehicle Body and Trailer
                              Manufacturing.
3363.......................  Motor Vehicle Parts Manufacturing.
3366.......................  Ship and Boat Building.
3371.......................  Household and Institutional Furniture and
                              Kitchen Cabinet Manufacturing.
3372.......................  Office Furniture (including Fixtures)
                              Manufacturing.
3379.......................  Other Furniture Related Product
                              Manufacturing.
4231.......................  Motor Vehicle and Motor Vehicle Parts and
                              Supplies Merchant Wholesalers.

4233.......................  Lumber and Other Construction Materials
                              Merchant Wholesalers.
4235.......................  Metal and Mineral (except Petroleum)
                              Merchant Wholesalers.
4239.......................  Miscellaneous Durable Goods Merchant
                              Wholesalers.
4244.......................  Grocery and Related Product Merchant
                              Wholesalers.
4248.......................  Beer, Wine, and Distilled Alcoholic
                              Beverage Merchant Wholesalers.
4413.......................  Automotive Parts, Accessories, and Tire
                              Stores.
4422.......................  Home Furnishings Stores.
4441.......................  Building Material and Supplies Dealers.
4442.......................  Lawn and Garden Equipment and Supplies
                              Stores.
4451.......................  Grocery Stores.
4522.......................  Department Stores.
4523.......................  General Merchandise Stores, including
                              Warehouse Clubs and Supercenters.
4533.......................  Used Merchandise Stores.
4543.......................  Direct Selling Establishments.
4811.......................  Scheduled Air Transportation.
4841.......................  General Freight Trucking.
4842.......................  Specialized Freight Trucking.
4851.......................  Urban Transit Systems.
4852.......................  Interurban and Rural Bus Transportation.
4853.......................  Taxi and Limousine Service.
4854.......................  School and Employee Bus Transportation.
4859.......................  Other Transit and Ground Passenger
                              Transportation.
4871.......................  Scenic and Sightseeing Transportation,
                              Land.
4881.......................  Support Activities for Air Transportation.
4883.......................  Support Activities for Water
                              Transportation.
4889.......................  Other Support Activities for
                              Transportation.
4911.......................  Postal Service.
4921.......................  Couriers and Express Delivery Services.
4931.......................  Warehousing and Storage.
5322.......................  Consumer Goods Rental.
5621.......................  Waste Collection.
5622.......................  Waste Treatment and Disposal.
6219.......................  Other Ambulatory Health Care Services.
6221.......................  General Medical and Surgical Hospitals.
6222.......................  Psychiatric and Substance Abuse Hospitals.
6223.......................  Specialty (except Psychiatric and Substance
                              Abuse) Hospitals.
6231.......................  Nursing Care Facilities (Skilled Nursing
                              Facilities).
6232.......................  Residential Intellectual and Developmental
                              Disability, Mental Health, and Substance
                              Abuse Facilities.
6233.......................  Continuing Care Retirement Communities and
                              Assisted Living Facilities for the
                              Elderly.
6239.......................  Other Residential Care Facilities.
6243.......................  Vocational Rehabilitation Services.
7111.......................  Performing Arts Companies.
7112.......................  Spectator Sports.
7131.......................  Amusement Parks and Arcades.
7211.......................  Traveler Accommodation.
7212.......................  RV (Recreational Vehicle) Parks and
                              Recreational Camps.
7223.......................  Special Food Services.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2023-15091 Filed 7-17-23; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39914-39917]
[FR Doc No: 2020-14267]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exceptions or Alternatives To Labeling Requirements
for Products Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice

solicits comments on the information collection requirements related to
the exceptions or alternatives to labeling requirements for products
held by the Strategic National Stockpile (SNS).

DATES: Submit either electronic or written comments on the collection
of information by August 31, 2020.

ADDRESSES: You may submit comments as follows: Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 31, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 31, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-N-0588 for ``Exceptions or Alternatives to Labeling
Requirements for Products Held by the Strategic National Stockpile.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, 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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Exceptions or Alternatives To Labeling Requirements for Products Held
by the Strategic National Stockpile

OMB Control Number 0910-0614--Extension

    Under the Public Health Service Act (PHS Act), the Department of
Health and Human Services stockpiles medical products that are
essential to the health security of the Nation (see 42 U.S.C. 247d-6b).
This collection of medical products for use during national health
emergencies, known as the SNS, is to provide for the emergency health
security of the United States, including the emergency health security
of children and other vulnerable populations, in the event of a

bioterrorist attack or other public health emergency.
    It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
    Under 21 CFR 201.26, 610.68, 801.128, and 809.11 (Sec. Sec.
201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center
Director may grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely affect the safety,
effectiveness, or availability of products that are or will be included
in the SNS. An exception or alternative granted under the regulations
may include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. Any grant of an exception or alternative will
only apply to the specified lots, batches, or other units of medical
products in the request. The appropriate FDA Center Director may also
grant an exception or alternative to the labeling provisions specified
in the regulations on his or her own initiative.
    Under Sec. Sec.  201.26(b)(1)(i) (human drug products),
610.68(b)(1)(i) (biological products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human
use) an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from a SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate FDA Center Director. Except when initiated by an FDA Center
Director, a request for an exception or alternative must be in writing
and must:
     Identify the specified lots, batches, or other units of
the affected product;
     identify the specific labeling provisions under the
regulations that are the subject of the request;
     explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
     describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
     provide copies of the proposed labeling of the specified
lots, batches or other units of the affected product that will be
subject to the exception or alternative; and
     provide any other information requested by the FDA Center
Director in support of the request.
    If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the new drug application, biologics
license application, premarket approval application, or premarket
notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
the regulations may be used to satisfy certain reporting obligations
relating to changes to product applications under Sec. Sec.  314.70,
601.12, 814.39, and 807.81 (21 CFR 314.70 (human drugs), 21 CFR 601.12
(biological products), 21 CFR 814.39 (medical devices subject to
premarket approval), or 21 CFR 807.81 (medical devices subject to
510(k) clearance requirements)). The information collection provisions
in Sec. Sec.  314.70, 601.12, 807.81, and 814.39 have been approved
under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-
0231 respectively. On a case-by-case basis, the appropriate FDA Center
Director may also determine when an exception or alternative is granted
that certain safeguards and conditions are appropriate, such as
additional labeling on the SNS products, so that the labeling of such
products would include information needed for safe and effective use
under the anticipated circumstances of use.
    Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute or store affected SNS products. Based on data from fiscal
years 2017, 2018, and 2019, FDA estimates an average of one request
annually for an exception or alternative received by FDA. FDA estimates
an average of 24 hours preparing each request. The average burden per
response for each submission is based on the estimated time that it
takes to prepare a supplement to an application, which may be
considered similar to a request for an exception or alternative. To the
extent that labeling changes not already required by FDA regulations
are made in connection with an exception or alternative granted under
the regulations, FDA is estimating one occurrence annually in the event
FDA would require any additional labeling changes not already covered
by FDA regulations. FDA estimates 8 hours to develop and revise the
labeling to make such changes. The average burden per response for each
submission is based on the estimated time to develop and revise the
labeling to make such changes.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total  annual    burden per
         21 CFR section             respondents    responses per     responses     response  (in    Total hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i),                               1               1               1              24              24
 610.68(b)(1)(i),
 801.128(b)(1)(i), and
 809.11(b)(1)(i)................
201.26(b)(1)(i),                               1               1               1               8               8
 610.68(b)(1)(i),
 801.128(b)(1)(i), and
 809.11(b)(1)(i)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              32
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Consistent with the PRA, our current estimate of the burden of the
information collection is based on our evaluation over the past 3
years. However, in light of recent consumption of products from the
SNS, we expect future adjustments may be necessary and invite specific
comment in this regard.

    Dated: June 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14267 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P