Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Featured Stories
SEC Obtains Judgments as to Chicago-Based Investment Adviser, Its CEO for Allegedly Charging Improper Fees
WASHINGTON, April 1 -- The Securities and Exchange Commission issued the following litigation release (No. 25-civ-07491; N.D. Ill. filed July 3, 2025):* * *
Securities and Exchange Commission v. Eliseo Prisno (a/k/a Jojo Prisno) and PE Capital Investment Management Partners, No. 25-civ-07491 (N.D. Ill. filed July 3, 2025)
On March 10 and March 26, 2026, the United States District Court for the Northern District of Illinois entered judgments in the SEC's enforcement action against P/E Capital Investment Management Partners and its CEO, Eliseo Prisno.
According to the SEC's complaint, filed ... Show Full Article WASHINGTON, April 1 -- The Securities and Exchange Commission issued the following litigation release (No. 25-civ-07491; N.D. Ill. filed July 3, 2025): * * * Securities and Exchange Commission v. Eliseo Prisno (a/k/a Jojo Prisno) and PE Capital Investment Management Partners, No. 25-civ-07491 (N.D. Ill. filed July 3, 2025) On March 10 and March 26, 2026, the United States District Court for the Northern District of Illinois entered judgments in the SEC's enforcement action against P/E Capital Investment Management Partners and its CEO, Eliseo Prisno. According to the SEC's complaint, filedon July 3, 2025, from at least February 2019 through at least July 2023, Prisno and P/E Capital charged more than 200 advisory clients approximately $2.4 million in unauthorized and undisclosed quarterly fees. In some instances, the complaint alleges, Prisno and P/E Capital deceptively accessed client accounts using their clients' login credentials--frequently without their clients' knowledge or consent--to approve such fees.
Without admitting or denying the SEC's allegations, Prisno and P/E Capital consented to entry of the judgments, which permanently enjoin Prisno and P/E Capital from violating the antifraud provisions of Sections 206(1) and 206(2) of the Investment Advisers Act of 1940. The judgments also order each defendant to pay disgorgement with prejudgment interest and a civil penalty, with the amounts to be determined by the Court upon motion of the SEC. Finally, the judgment as to Prisno enjoins him from acting as or being associated with any broker, dealer, or investment adviser, either permanently or for a specified duration, to be determined by the Court upon motion of the SEC.
The SEC's litigation is being conducted by Jonathan Polish and Alyssa Qualls of the SEC's Chicago Regional Office, and Daniel Griffin of the Division of Enforcement's Asset Management Unit.
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Resources
* Final Judgment - Eliseo Jojo Prisno (https://www.sec.gov/files/litigation/litreleases/2026/judg26515-prisno.pdf)
* Final Judgment - P/E Capital Investment Management Partners (https://www.sec.gov/files/litigation/litreleases/2026/judg26515-pe-capital.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26515
OCC Issues Final Rule to Rescind Recovery Planning Guidelines
WASHINGTON, April 1 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following news release on March 31, 2026:* * *
OCC Issues Final Rule to Rescind Recovery Planning Guidelines
The Office of the Comptroller of the Currency (OCC) today announced a final rule to rescind its recovery planning guidelines for certain large insured national banks, federal savings associations, and federal branches (banks).
"Recovery planning guidelines that require large banks to engage in prescriptive planning activities do little to improve their ability to manage through ... Show Full Article WASHINGTON, April 1 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following news release on March 31, 2026: * * * OCC Issues Final Rule to Rescind Recovery Planning Guidelines The Office of the Comptroller of the Currency (OCC) today announced a final rule to rescind its recovery planning guidelines for certain large insured national banks, federal savings associations, and federal branches (banks). "Recovery planning guidelines that require large banks to engage in prescriptive planning activities do little to improve their ability to manage throughstress and distract from the real work of running a safe and sound institution," said Comptroller of the Currency Jonathan V. Gould. "Rescinding these guidelines helps ensure the banks we supervise can focus their resources on serving their customers and communities."
In the final rule, the OCC rescinded its recovery planning guidelines, which apply to banks with at least $100 billion in assets. The final rule is part of the OCC's ongoing effort to identify and eliminate unnecessary regulatory burden. The OCC expects the institutions it supervises to be well managed and have appropriate risk management processes in place to prepare for and respond to stress events, including through appropriate contingency funding plans.
The final rule does not affect OCC-supervised banks with less than $100 billion in average total consolidated assets and has no impact on community banks.
The final rule will become effective 30 days after publication in the Federal Register (https://occ.gov/news-issuances/news-releases/2026/nr-occ-2026-21a.pdf).
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Original text here: https://occ.gov/news-issuances/news-releases/2026/nr-occ-2026-21.html
National Park Service: Grand Canyon National Park Announces Increased Water Restrictions Effective April 1
WASHINGTON, April 1 -- The U.S. Department of the Interior National Park Service issued the following news release on March 31, 2026:* * *
Grand Canyon National Park announces increased water restrictions effective April 1
Beginning April 1, Grand Canyon National Park will implement Stage 3 Water Restrictions due to a break in the water pipeline along the North Kaibab Trail. Until park staff repair the break and water in storage tanks reaches sustainable levels, the park will remain in conservation mode.
Stage 3 Water Restrictions Begin April 1
Operational changes include:
* Camper Services ... Show Full Article WASHINGTON, April 1 -- The U.S. Department of the Interior National Park Service issued the following news release on March 31, 2026: * * * Grand Canyon National Park announces increased water restrictions effective April 1 Beginning April 1, Grand Canyon National Park will implement Stage 3 Water Restrictions due to a break in the water pipeline along the North Kaibab Trail. Until park staff repair the break and water in storage tanks reaches sustainable levels, the park will remain in conservation mode. Stage 3 Water Restrictions Begin April 1 Operational changes include: * Camper Servicesat Mather Campground: closed
* Water spigots at Mather Campground: turned off
* Fires within Mather Campground: prohibited
* Restrooms at Mather Campground: remain open
* RV dump and water station at Mather Campground: remain open
Visitors, residents, and park staff are asked to practice strict water conservation, including:
* Limiting showers to five minutes or less
* Shutting off faucets while brushing teeth or shaving
* Washing only full loads of laundry and dishes
* Selectively flushing toilets
* Reporting leaks to the appropriate office or staff
Hikers in the backcountry should plan to carry all their water or methods to treat water. For the most updated information on water availability in the backcountry visit the park's webpage: Key Hiking Messages - Critical Updates and Closures.
If water conditions do not improve, the park may move to Stage 4 water restrictions. Under Stage 4, lodging for overnight guests could close, Trailer Village would be unavailable, and additional fire restrictions would be implemented.
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Original text here: https://www.nps.gov/grca/learn/news/grand-canyon-national-park-announces-increased-water-restrictions-effective-april-1.htm
FDA Center for Devices & Radiological Health Issues Warning Letter to Physitemp Instruments
WASHINGTON, April 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Physitemp Instruments LLC from its Center for Devices and Radiological Health:* * *
Recipient: Michele J. Cantwell, Vice President of Sales and Marketing, Physitemp Instruments, LLC, 189 Sargeant Avenue, Clifton, NJ 07013, United States, (b)(4)
Issuing Office: Center for Devices and Radiological Health, United States
WARNING LETTER
CMS # 717394
Dear Ms. Cantwell:
During an inspection of your firm located in Clifton, NJ from April 29, 2025 through June ... Show Full Article WASHINGTON, April 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Physitemp Instruments LLC from its Center for Devices and Radiological Health: * * * Recipient: Michele J. Cantwell, Vice President of Sales and Marketing, Physitemp Instruments, LLC, 189 Sargeant Avenue, Clifton, NJ 07013, United States, (b)(4) Issuing Office: Center for Devices and Radiological Health, United States WARNING LETTER CMS # 717394 Dear Ms. Cantwell: During an inspection of your firm located in Clifton, NJ from April 29, 2025 through June18, 2025, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2), and a Needle Microprobe (MT-D). These products are intended to measure human body temperature in clinical settings, for example, profiling tumor temperature during cancer hyperthermia and measuring myocardial temperature during bypass surgery. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Sec. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Quality System Regulation Violation(s)
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. Sec. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Yirelisa Alcantara, Quality Assurance Regulatory Coordinator, dated (b)(4), concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
Specifically, you failed to define and document procedures for process validation. For example, the following processes were not validated or adequately validated to ensure your Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2) and Needle Microprobe (MT-D) meet pre-determined specifications for sterility and laser welding:
A. (b)(4) Sterilization
You have not conducted validations of the (b)(4) sterilization method documented in the respective sterilization guides you supply to customers for sterilization of your esophageal (ESO-1) and rectal (RET-1) Clinical Temperature Monitoring Probes and Needle Microprobe (MT-D) to ensure they consistently produce product that meets pre-determined specifications for sterility.
Moreover, the (b)(4) Sterility Tests for "Mixed Skin Sensors" and "Skin Sensors" conducted between (b)(4) and (b)(4) are inadequate because you were unable to provide objective evidence that the study included the current versions of your clinical skin sensor Clinical Temperature Monitoring Probes (SST-1 and SST-2) as well as other information such as (but not limited to) load configurations and raw data.
B. Laser Welding
Your installation qualifications titled "(b)(4) Installation Qualification" (Rev A; Effective: 4/29/24) and "(b)(4) Operation Qualification" (Rev A; Effective: 4/29/24) are incomplete because they failed to ensure that the (b)(4) (Model #: (b)(4); SN #: (b)(4)), used to weld thermocouple wires of your Clinical Temperature Monitoring Probes and Needle Microprobe (MT-D), was installed in accordance with the manufacturer's electrical requirements for input power voltage and grounding, as described in the "start preparing" section of the (b)(4) User Manual. Furthermore, you have not conducted a validation of your laser welding process to ensure it consistently produces product that meets pre-determined specifications for welding.
We reviewed your firm's response and conclude that it is not adequate. In response to the (b)(4) sterilization validation, you state that the formal (b)(4) validation for skin sensor probes was provided to the investigator during the inspection. However, these studies were found to be inadequate because you were unable to provide objective evidence that they included the current versions of your Clinical Temperature Monitoring Probes (SST-1 and SST-2) as well as other information such as (but not limited to) load configurations and raw data. Overall, your response failed to include any corrective actions to conduct (b)(4) sterilization validations for your Clinical Temperature Monitoring Probes and Needle Microprobe (MT-D) which are intended for human use.
In response to the laser welding validation, you state that there was a mix-up in the documentation that was provided to the investigator and that the current in use laser welder is the (b)(4), not the (b)(4). However, this contradicts the effective dates of (b)(4), for the "(b)(4) Installation Qualification" and "(b)(4) Operation Qualification" which were provided to the investigator during the inspection which point to the (b)(4) Welder as the equipment in current use. Under CAPA-25-003, you removed all legacy material for the (b)(4). Your corrective actions are to (b)(4) by (b)(4), and (b)(4) by (b)(4). By (b)(4), you plan to (b)(4) on (b)(4). In addition, you plan to (b)(4). However, there were no corrective actions identified to define and document an overarching procedure to conduct process validations, with a high degree of assurance, to ensure that your processes consistently produce products that meets pre-determined specifications at worst case and nominal operating parameters.
In your response, you also point out that the requirements of 21 CFR 820.75(a) with regards to (b)(4) sterilization validation for the Implantable Temperature Monitoring Probes (IT-14; IT-18 series; IT-21; IT-23; IT-IE) do not apply because these probes are primarily used in general laboratory research applications such as liquid vials, tissue culture, ex-vivo tissue samples, and subcutaneous use in living research animals and not human use. Under CAPA 25-007, you reviewed all labeling (e.g., instructions, promotional materials, etc.) for the Implantable Temperature Monitoring Probes and communicated the intended use to the sales and customer support teams. The corrective actions are to (b)(4) by (b)(4); update the (b)(4) by (b)(4); and (b)(4) on the (b)(4) by (b)(4). However, you have not identified whether any actions should be taken that are commensurate with the risk of customers using the Implantable Temperature Monitoring Probes already in the field on humans due to ambiguous labeling and for which no (b)(4), autoclaving, (b)(4), hermetic sealing, or laser welding validations were conducted. During correspondence with a customer between (b)(4), through (b)(4), you received a complaint (# 9462) for a broken wire and battery box for the IT-18EXLONG (Batch # (b)(4)) Implantable Temperature Monitoring Probe with a request for replacement "***quickly due to patients coming***" which shows that these devices have been used in humans. Premarket authorization will be required if the intended use of these Implantable Temperature Monitoring Probes is expanded to human use.
Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.
2. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
Specifically, the finished device acceptance activities contained in the respective assembly procedures of your Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2) are inadequate because they fail to establish requirements to verify that these devices meet the claimed (b)(4) C tolerance specification stated in your marketing brochure. For example, the finished device acceptance activities documented in the "Assembly Instructions ***OT-1" (ECO 10390; Rev. 1; Effective: 4/11/14); "Assembly Instructions***ESO-1" (ECO 10371; Rev. 1; Effective: 6/5/13); "Assembly Instructions***RET-1" (ECO 10371; Rev 1; Effective: 2/18/11); "Assembly Instructions***SST-1" (Effective: 2/18/01); and "Assembly Instructions***SST-2" (Effective: 9/99) lack any tests to ensure these finished devices will remain within the (b)(4)degrees Celsius for the specified operating range of temperatures, (b)(4)degrees Celsius to (b)(4)degrees Celsius, after manufacturing steps such as (but not limited to) welding. Furthermore, you stated that there is no finished device acceptance testing to verify the (b)(4)degrees Celsius tolerance for any of the finished Clinical Temperature Monitoring Probes unless specifically requested by a customer.
We reviewed your firm's response and conclude that it is not adequate. You explain that the (b)(4) C tolerance specification is verified during incoming inspection of the thermocouple wires and after completion of the coating step during manufacturing. However, there was no evidence provided that subsequent manufacturing steps such as welding do not adversely change the previously verified tolerances. You further state that you plan to conduct a one-time validation study using a statistically significant sample size of (b)(4) for each type of Clinical Temperature Monitoring Probe to confirm that your manufacturing process consistently produces probes within the (b)(4) C accuracy tolerance specification. However, no rationale was provided for how the sample size selection of (b)(4) clinical probes is statistically significant.
Therefore, please provide a response on how you plan to address this deficiency. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.
3. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
Specifically, your nonconforming product procedure titled "Part 06: Device Investigation" (Rev 2; Effective: 5/17/10) is inadequate in that it fails to require:
A. Identification, documentation, evaluation, segregation, and disposition of nonconformances found during inspections of incoming raw materials, as the current procedure limits identification of nonconformances to (b)(4), (b)(4), and (b)(4) of Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2) and Needle Microprobe (MT-D). For example, your Design Engineer stated that they do not document nonconformances found during incoming inspections, including during the incoming inspection of thermocouple wires conducted per the "NIST Compliance Wire Test" procedure (SOP-EG-006; Rev B; Effective: 11/7/24).
B. Documentation of the evaluation of a nonconformance to determine the need for an investigation, as the procedure only states "***(b)(4)***(b)(4)***." For example, you were unable to provide a documented evaluation on the need for an investigation for (b)(4) nonconformances recorded in the "Rejected Logbook" for your Clinical Temperature Monitoring Probes including (but not limited to) the SST-2 on 4/12/24 for "no reading" (Batch # (b)(4)); ESO-1 on 6/13/24 for "wire broke Red-blue" (Batch # (b)(4)); SST-1 on 8/15/24 for "no reading & duff mark on white area" (Batch # (b)(4)); RET-1 on 1/8/25 for "Tip too big" (Batch # (b)(4)); and OT-1 on 1/21/25 for "scratches" (Batch # (b)(4)). In addition, review of the "Circuit Board Assembly, Fault Record" dated 12/6/23 revealed that at least (b)(4) nonconformances for "cant [sic] set low batt", "cant [sic] count up", or "low battery stays on" found during the pretesting of printed circuit boards (PCBs) pertaining to TH-5 Clinical Electronic Thermometers (Board #: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4) and (b)(4)) lacked documentation of the evaluation of a nonconformance to determine the need for an investigation.
We reviewed your firm's response and conclude that it is not adequate. Under CAPA-25-004 and CAPA-25-006, your immediate corrections were to (b)(4). The corrective actions are to (b)(4) by (b)(4); (b)(4); (b)(4) by (b)(4). However, there were no corrective actions to retrospectively document evaluations of nonconformances for your Clinical Electronic Thermometers, Clinical Temperature Monitoring Probes, and Needle Microprobe (MT-D) for a reasonable period of time, to determine whether an investigation is necessary. Despite claims in your response that TH-5 boards in the Pre-Test Log were conforming units, the issues regarding battery and count failures recorded under "Description of Fault" column for all (b)(4) PCBs classify them as nonconformances that require evaluation for the need for an investigation.
Please provide a response on how you plan to address the above deficiencies. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.
4. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented, as required by 21 CFR 820.90(b)(1); and Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the network upon the product, shall be documented in the DHR, as required by 21 CFR 820.90(b)(2).
Specifically, your nonconforming product procedure titled "Part 06: Device Investigation" (Rev 2; Effective: 5/17/10) is inadequate in that it fails to require:
A. Documentation of the disposition of the nonconforming product, as required by 21 CFR 820.90(b)(1). For example, you were unable to provide documented dispositions for (b)(4) of the (b)(4) nonconformances recorded in the "Rejected Logbook" for your Clinical Temperature Monitoring Probes including (but not limited to) the SST-1 on 8/15/24 for "no reading & duff mark on white area" (Batch # (b)(4)); RET-1 on 1/8/25 for "Tip too big" (Batch # (b)(4)); and OT-1 on 1/21/25 for "scratches" (Batch # (b)(4)). In addition, review of the "Circuit Board Assembly, Fault Record" dated 12/6/23 revealed that at least (b)(4) nonconformances for "cant [sic] set low batt", "cant [sic] count up", or "low battery stays on" found during the pretesting of printed circuit boards (PCBs) pertaining to TH-5 Clinical Electronic Thermometers (Board #: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4) and (b)(4)) lacked documentation of the dispositions.
B. Documentation of the retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications and determination of any adverse effect from the rework upon the product, as required by 21 CFR 820.90(b)(2). Your procedure lacks such requirements as it only states that "***(b)(4)***" and "***(b)(4)***Initiating department will inspect the rework, complete the log and any other paperwork required before continuing normal assembly process***." For example, your Production Manager was unable to provide documentation of retesting and reevaluation of reworks, including determination of any adverse effect from the rework, performed on the nonconforming Clinical Temperature Monitoring Probes logged in the "Rejected Logbook" for RET-1 on 4/5/24 (Batch # (b)(4)); SST-2 on 4/12/24 (Batch # (b)(4)); ESO-1 on 6/13/24 (2 lines, Batch # (b)(4)); and ESO-1 on 6/27/24 (2 lines, Batch # (b)(4)).
We reviewed your firm's response and conclude that it is not adequate. Under CAPA-25-004 and CAPA-25-006, your immediate corrections were to (b)(4). The corrective actions are to (b)(4) by (b)(4); (b)(4) by (b)(4). Despite stating that all future reworks will be (b)(4), this corrective action was not included in either of the CAPAs. Therefore, please provide a response on how you plan to address this deficiency. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.
5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, your complaint procedures titled "Part 10 Complaint, MDR" (Rev. 5; Effective: 12/24/08), "Processing Complaint Forms" (Rev. 1; Effective: 8/22/06), and "Repair Receiving and Service Report" (Complaint Form 2007; Rev. 2; Effective: 3/25/09) are inadequate in that:
* They only require complaint processing of returns from customers and no other forms of written, electronic, or oral communication that allege deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device (i.e., complaint) as defined under 21 CFR 820.3(b). In addition, you stated that medical devices outside of the warranty period are unlikely to be entered into the complaint system. For example, you did not process the complaint received via email on (b)(4), for incorrect display values of the TH-5 Clinical Electronic Thermometer device as a complaint.
* They lack instructions on how to evaluate complaints to determine whether they represent an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting (MDR). For example, your Complaint Form 2007 only includes a "Yes" or "No" field under the "Mandatory Report Needed" field.
We reviewed your firm's response and conclude that it is not adequate. Under CAPA-25-002, your immediate correction is to (b)(4) by (b)(4). Your corrective actions are to (b)(4) by (b)(4) followed up with (b)(4) by (b)(4); (b)(4) by (b)(4); (b)(4) by (b)(4); and (b)(4) by (b)(4). However, there were no actions identified to retrospectively review all correspondence with customers (e.g., emails, letters, phone calls, etc.) for products outside of the warranty period as well as from non-returns, for a reasonable time frame, to determine whether they should have been processed as complaints. Therefore, please provide a response on how you plan to address this deficiency. In addition, please continue to provide updates on the progress of your corrections and/or corrective actions, including any supporting evidence.
6. Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c).
Specifically, you did not review, evaluate, and investigate complaints which involved the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). For example, there was no documented investigation (or reference to another investigation) for the complaint received via email on (b)(4), (b)(4) for incorrect display values of the TH-5 Clinical Electronic Thermometer.
We reviewed your firm's response and conclude that it is not adequate. Under CAPA-25-002, your corrective actions are to (b)(4) by (b)(4) followed up with (b)(4) by (b)(4); (b)(4) (e.g., product, alleged malfunction, impact on user, risk assessment) on the complaint form by (b)(4); and (b)(4) by (b)(4). However, there were no actions identified to investigate any previous correspondence with customers (e.g., emails, letters, phone calls, etc.) that you designate as complaints per a retrospective review when there is an allegation of possible failure of a device, labeling, or packaging to meet any of its specifications. Therefore, please provide a response on how you plan to address this deficiency.
Unapproved Device Violation(s)
Our inspection also revealed that the Clinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2), and at least one of your Needle Microprobes (MT-D) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. Sec. 351(f)(1)(B), because your firm does not have, for any of these devices, an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. Sec. 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. Sec. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. Sec. 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. Sec. 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
As discussed further below, your firm's Clinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2), and Needle Microprobes (MT-D) are class II devices regulated under 21 CFR 880.2910 ("Clinical electronic thermometer"). These devices are not exempt from premarket notification requirements under Sec. 880.2910 because they have continuous temperature measurement functions. See 21 CFR 888.2910(b)(2); 90 Fed. Reg. 25889, 25890 (June 2025) ("Examples of thermometers with continuous temperature measurement functions include temperature probes intended to monitor body temperature during surgical procedures, temperature probes affixed to the skin of neonates or infants intended to monitor body temperature, thermometer patches affixed to the patient's skin, or thermometers that are swallowed to monitor a patient's body temperature.").
First, the Clinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP) are signal amplification, conditioning, and display units intended to measure human body temperature when coupled with a transducer and are class II devices regulated under 21 CFR 880.2910.
Your marketing materials indicate that these thermometers are intended for recording human temperature measurements. For example, page 3 of your firm's product brochure states that the Clinical Electronic Thermometer models (TH-5; TH-5/AOP; TH-8; TH-8/AOP) are intended for "hospital use" and describe "clinical uses" of the thermometers including "profiling tumor temperature during cancer hyperthermia and measuring myocardial temperature during bypass surgery." In addition, your firm's website (https://www.physitemp.com/) states that all of the thermometer model numbers referenced above are "ideal for laboratory or hospital use" and are "intended for continuous monitoring in the hospital or laboratory." Because these products are intended to continuously measure human body temperature, they are not exempt from premarket notification requirements (see 21 CFR 880.2910(b)(2)).
Second, the Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2) are transducers intended to measure human body temperature when coupled with an electronic signal amplification, condition, and display unit, and are class II devices regulated under 21 CFR 880.2910.
Your marketing materials indicate that these probes are either compatible with the aforementioned Clinical Electronic Thermometers or with other marketed clinical electronic thermometers. For example, your firm's website lists probe models OT-1, ESO-1, and RET-1 as "compatible probes" with all of the aforementioned Clinical Electronic Thermometer models and lists probe models SST-1 and SST-2 as "compatible probes" with Clinical Electronic Thermometer model TH-8/AOP.
Your marketing materials also indicate that these probes are intended for recording human temperature measurements. For example, page 6 of your firm's product brochure lists all of the probe model numbers referenced above under the heading "Clinical Probes"; page 6 of your firm's product brochure states that RET-1 is for human use; and page 4 of your firm's product brochure contains a photograph showing SST-1 being held against a human forearm. In addition, your firm's Suggested Sterilizing Cycle Parameters for probe models ESO-1, RET-1, SST-1, and SST-2 states that users should refer to "your hospital standard procedure for a reusable syringe or sterile O.R. pack," demonstrating that the instructions are for users of the probes in a hospital setting. Also, your firm's website indicates that probe models OT-1, ESO-1, RET-1, SST-1, and SST-2 are intended for measuring human temperature on the skin and in the mouth, esophagus, and rectum, and their clinical use in hospitals would include temperature measurements on patients. Lastly, your firm's website provides information for probe models OT-1, ESO-1, RET-1, SST-1, and SST-2 regarding "[w]hen probe is used for continuous measurements." Because these probes are intended to measure continuous body temperature, they are not exempt from premarket notification requirements (see 21 CFR 880.2910(b)(2)).
Third, at least one of your firm's Needle Microprobes (MT-D) is a transducer intended to measure human body temperature when coupled with an electronic signal amplification, condition, and display unit, and is a class II device regulated under 21 CFR 880.2910.
Your marketing materials indicate that these microprobes are compatible with the aforementioned Clinical Electronic Thermometers. For example, page 7 of your firm's product brochure includes a number of different microprobes, including microprobe model MT-D, compatible with the Thermalert Monitoring Thermometers (i.e., Clinical Electronic Thermometers), and your firm's website lists MT-D as a "compatible probe []" with thermometer models TH-5, TH-5/AOP, and TH-8.
Your marketing materials also indicate that some of these microprobes are intended for recording human temperature measurements. For example, page 7 of your firm's product brochure describes microprobe model MT-D as for "locating inflammation, arteries, etc. Also for dental use." In addition, your firm's website states that microprobe model MT-D is "ideal for dental applications," and provides information for "when probe is used for continuous measurements." Because these microprobes are intended to measure continuous body temperature, they are not exempt from premarket notification requirements (see 21 CFR 880.2910(b)(2)).
During the inspection, you stated that you believe the subject devices are pre-amendment devices. However, you have not provided evidence beyond your assertions to demonstrate that the subject devices, in their present form, were labeled, promoted, and introduced into interstate commerce as clinical electronic thermometers prior to May 28, 1976. Your firm's failure to submit 510(k)s for these devices has prevented FDA from determining whether these devices are substantially equivalent to an appropriate predicate device and whether there is reasonable assurance of the safety and effectiveness of these devices.
Medical Device Reporting (MDR) Violation(s)
Our inspection (also) revealed that you have failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17 for your firm's Clinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1; SST-2), and at least one of your Needle Microprobes (MT-D). For example, during the inspection, your firm presented its document titled "Standard Operating Procedure Part 10: Complaint, MDR", Rev 5, dated 12/24/2008, as its written MDR procedure. Upon review, we determined that this one-paragraph MDR procedure does not contain sufficient information to demonstrate that it was developed in accordance with the requirements of 21 CFR 803.17.
We reviewed your firm's response dated (b)(4), and conclude that it is not adequate. In the response, your firm provided a copy of its revised MDR procedure titled "Medical Device Reporting (MDR)", SOP-QA-044, Rev. A, dated July 2, 2025. Your firm also indicated plans to conduct staff training on the revised procedure and to perform a retrospective review of all complaints received over the past four years. Please note that both the training and retrospective review are still ongoing, and no evidence has been provided to assess their adequacy. However, upon review of the revised procedure, we noted the following deficiencies:
1. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure does not include adequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that the procedure does not include definitions from 21 CFR 803.3 for the terms "become aware", "caused or contributed", and the description in 21 CFR 803.20(c)(1) of the type of information that "reasonably suggests" a reportable event, may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50.
2. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports to the FDA, as required by 21 CFR 803.17(a)(3). Specifically, your procedure does not include:
a. Instructions for how to complete the FDA 3500A form.
b. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm's possession.
c. The circumstances under which your firm must submit supplement or follow-up reports and the requirements for such reports, as required by 21 CFR 803.56.
We note that a device is deemed misbranded under section 502(t)(2) of the Act, 21 U.S.C. Sec. 352(t)(2), if there was a failure or refusal to furnish material or information respecting the device required by or under section 519 of the Act, 21 U.S.C. Sec. 360i, and under 21 CFR Part 803 - Medical Device Reporting.
Unique Device Identification (UDI) Violation(s)
The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. Sec. 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. Sec. 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) - which was promulgated under authority of section 519 of the Act, among other provisions - requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the TH-5; TH-5/AOP; TH-8; TH-8/AOP, OT-1; ESO-1; RET-1; MT-D; SST-1; and SST-2 do not bear such a UDI.
Specifically, the labels for TH-5; TH-5/AOP; TH-8; TH-8/AOP, OT-1; ESO-1; RET-1; MT-D; SST-1; and SST-2 devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of the device (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology on the label of the device (see 21 CFR 801.40(a)(2)).
In addition, the TH-5; TH-5/AOP; TH-8; TH-8/AOP, OT-1; ESO-1; RET-1; MT-D; SST-1; and SST-2 devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. Sec. 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. Sec. 360i, respecting this device. In particular, 21 CFR 830.300(a) and 830.320(b) - both of which were promulgated under section 519 of the Act, among other provisions - require that the labeler of a device submit electronically to FDA's Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Our inspection revealed that your firm designs the finished product label for your TH-5; TH-5/AOP; TH-8; TH-8/AOP, OT-1; ESO-1; RET-1; MT-D; SST-1; and SST-2 devices and final product labeling reflects your firm's name, address, and website. Physitemp Instruments, LLC is therefore a "labeler" within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting this device.
Based on review of the Global Unique Device Identification Database (GUDID) on November 3, 2025, there is no company of "Physitemp" found when searching for the names of the various versions/models described in your firm's marketing materials: TH-5; TH-5/AOP; TH-8; TH-8/AOP, OT-1; ESO-1; RET-1; MT-D; SST-1; and SST-2. In addition, the following listings and premarket numbers your firm registers and lists were not found in GUDID: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4).
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm's response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, "CMS Case # 717394" when replying. If you have any questions about the contents of this letter, please contact: Sargum C. Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/ Barbara C. Marsden, Acting Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health
CC:
Yirelisa Alcantara, QA Regulatory Coordinator, yalcantara@physitemp.com
David Pendleton, President and CEO of Glas-Col, LLC, pinnacle@glascol.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/physitemp-instruments-llc-717394-11122025
Department of Justice: Closing the National Center for Disaster Fraud
WASHINGTON, April 1 -- The U.S. Department of Justice issued the following news release:* * *
Closing the National Center for Disaster Fraud
Today, the Justice Department announced the closure of the National Center for Disaster Fraud (NCDF), effective March 31, 2026. The NCDF was established in the fall of 2005 in the wake of Hurricane Katrina to coordinate disaster fraud complaints from victims across the country. Since its founding, the NCDF processed more than a million complaints, and served as a national hub for disaster fraud referrals to federal, state, and local law enforcement.
Over ... Show Full Article WASHINGTON, April 1 -- The U.S. Department of Justice issued the following news release: * * * Closing the National Center for Disaster Fraud Today, the Justice Department announced the closure of the National Center for Disaster Fraud (NCDF), effective March 31, 2026. The NCDF was established in the fall of 2005 in the wake of Hurricane Katrina to coordinate disaster fraud complaints from victims across the country. Since its founding, the NCDF processed more than a million complaints, and served as a national hub for disaster fraud referrals to federal, state, and local law enforcement. Overthe past two decades, the law enforcement landscape has evolved significantly. Following a 2023 program review, the Criminal Division determined that the NCDF's intake function was no longer the most effective avenue for pursuing disaster fraud. Many of the NCDF's original agency partners now operate their own dedicated hotlines, and advances in data analysis have given federal investigators powerful new tools to identify and pursue fraud at scale - particularly the large, multi-district schemes that represent the highest enforcement priorities. This closure will save the Department more than $600,000 per year.
Fraud targeting Americans in their most vulnerable moments, whether following natural disasters or during public health crises, is a serious federal crime that the Department of Justice will continue to investigate and prosecute vigorously. Victims of disaster fraud should report their complaints to the appropriate law enforcement agency based on the type of fraud. Reporting information can be found at www.justice.gov/disaster-fraud.
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Original text here: https://www.justice.gov/opa/pr/closing-national-center-disaster-fraud
BLS: Overtime Hours in Manufacturing Industries
WASHINGTON, April 1 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on March 31, 2026, from Economics Daily:* * *
Overtime hours in manufacturing industries
In 2025, weekly overtime in manufacturing averaged 3.8 hours, compared with 3.6 hours in 2023 and 2024. Average weekly overtime in manufacturing reached 4.6 hours in 2018. In 2025, weekly overtime averaged 3.7 hours in durable goods (such as metal products and machinery) manufacturing and 3.8 hours in nondurable goods (such as food and plastics) manufacturing.
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Chart: Average weekly ... Show Full Article WASHINGTON, April 1 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on March 31, 2026, from Economics Daily: * * * Overtime hours in manufacturing industries In 2025, weekly overtime in manufacturing averaged 3.8 hours, compared with 3.6 hours in 2023 and 2024. Average weekly overtime in manufacturing reached 4.6 hours in 2018. In 2025, weekly overtime averaged 3.7 hours in durable goods (such as metal products and machinery) manufacturing and 3.8 hours in nondurable goods (such as food and plastics) manufacturing. * * * Chart: Average weeklyovertime hours of production and nonsupervisory employees, selected manufacturing industries, 2025, not seasonally adjusted
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Among manufacturing industries, weekly overtime averaged 2.5 hours in machinery manufacturing, 2.6 hours in computer and electronic product manufacturing, and 5.3 hours in transportation equipment manufacturing. Weekly overtime averaged over 5.0 hours in transportation equipment manufacturing during several years of the past decade.
These data are from the Current Employment Statistics (https://www.bls.gov/ces/) program and are not seasonally adjusted. The most recent monthly data are published in "The Employment Situation." Also see more charts of employment, hours, and earnings data (https://www.bls.gov/charts/employment-situation/otm-employment-change-by-industry-confidence-intervals.htm). The Fair Labor Standards Act (FLSA) currently requires covered employees (unless they are exempt) to receive overtime pay at a rate not less than time and one-half their regular rates of pay for work hours in excess of 40 during a workweek. The FLSA became law in 1938; BLS has published data on overtime hours since 1956 9https://www.bls.gov/opub/hom/ces/archive/20240202/history.htm).
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SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, Overtime hours in manufacturing industries at https://www.bls.gov/opub/ted/2026/overtime-hours-in-manufacturing-industries.htm (visited April 01, 2026).
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View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/overtime-hours-in-manufacturing-industries.htm
BLS Issues Report on Job Openings and Labor Turnover February 2026
WASHINGTON, April 1 (TNSLrpt) -- Job Openings and Labor Turnover February 2026 - A report from U.S. Department of Labor Bureau of Labor Statistics - March 31, 2026 (21 pages)* * *
The number of job openings was little changed at 6.9 million in February, the U.S. Bureau of Labor Statistics reported today. Over the month, hires decreased to 4.8 million, and total separations changed little at 5.0 million. Within separations, quits (3.0 million) were little changed while layoffs and discharges (1.7 million) were unchanged.
This release includes estimates of the number and rate of job openings, ... Show Full Article WASHINGTON, April 1 (TNSLrpt) -- Job Openings and Labor Turnover February 2026 - A report from U.S. Department of Labor Bureau of Labor Statistics - March 31, 2026 (21 pages) * * * The number of job openings was little changed at 6.9 million in February, the U.S. Bureau of Labor Statistics reported today. Over the month, hires decreased to 4.8 million, and total separations changed little at 5.0 million. Within separations, quits (3.0 million) were little changed while layoffs and discharges (1.7 million) were unchanged. This release includes estimates of the number and rate of job openings,hires, and separations for the total nonfarm sector, by industry, and by establishment size class. Job openings include all positions that are open on the last business day of the month. Hires and separations include all changes to the payroll during the entire month.
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Chart 1. Job openings rate, seasonally adjusted, February 2024 - February 2026
Chart 2. Hires and total separations rates, seasonally adjusted, February 2024 - February 2026
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Job Openings
The number and rate of job openings were little changed at 6.9 million and 4.2 percent, respectively, in February. The number of job openings decreased in accommodation and food services (-211,000) and in mining and logging (-12,000). (See table 1.)
Hires
The number of hires decreased to 4.8 million (-498,000) in February and was down by 387,000 over the year. The hires rate decreased over the month to 3.1 percent. This was the lowest hires rate since April 2020 when it was also 3.1 percent. In February, the number of hires decreased in accommodation and food services (-178,000) and in construction (-88,000). (See table 2.)
Separations
Total separations include quits, layoffs and discharges, and other separations. Quits are generally voluntary separations initiated by the employee. Therefore, the quits rate can serve as a measure of workers' willingness or ability to leave jobs. Layoffs and discharges are involuntary separations initiated by the employer. Other separations include separations due to retirement, death, disability, and transfers to other locations of the same firm.
In February, the number and rate of total separations were little changed at 5.0 million and 3.1 percent, respectively. The number of total separations decreased in federal government (-16,000). (See table 3.) In February, the number and rate of quits were little changed at 3.0 million and 1.9 percent, respectively. The number of quits decreased in accommodation and food services (-119,000), wholesale trade (-35,000), and federal government (-6,000). Quits increased in nondurable goods manufacturing (+21,000). (See table 4.)
The number of layoffs and discharges remained unchanged at 1.7 million. The layoffs and discharges rate was little changed at 1.1 percent. The number of layoffs and discharges increased in retail trade (+72,000). Layoffs and discharges decreased in nondurable goods manufacturing (-26,000) and in federal government (-3,000). (See table 5.)
The number of other separations decreased to 277,000 (-75,000) in February. (See table 6.)
Establishment Size Class
In February, the job openings rate decreased for establishments with 1 to 9 employees, while the hires, quits, layoffs and discharges, and total separations rates showed little change. For establishments with 5,000 or more employees, all rates showed little or no change. (See table 7.)
January 2026 Revisions
The number of job openings for January was revised up by 294,000 to 7.2 million, the number of hires was revised up by 53,000 to 5.3 million, and the number of total separations was revised up by 39,000 to 5.1 million. Within separations, the number of quits was revised down by 6,000 to 3.1 million, and the number of layoffs and discharges was revised up by 29,000 to 1.7 million. (Monthly revisions result from additional reports received from businesses and government agencies since the last published estimates and from the recalculation of seasonal factors.)
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The Job Openings and Labor Turnover Survey estimates for March 2026 are scheduled to be released on Tuesday, May 5, 2026, at 10:00 a.m. (ET).
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Table A. Job openings, hires, and total separations by industry, seasonally adjusted
Table A. Job openings, hires, and total separations by industry, seasonally adjusted -- Continued
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Technical Note
This news release presents statistics from the Job Openings and Labor Turnover Survey (JOLTS). The JOLTS program provides information on labor demand and turnover. Additional information about the JOLTS program can be found at www.bls.gov/jlt/. Estimates are published for job openings, hires, quits, layoffs and discharges, other separations, and total separations. The JOLTS program covers all private nonfarm establishments, as well as civilian federal, state, and local government entities in the 50 states and the District of Columbia. Starting with data for January 2023, industries are classified in accordance with the 2022 North American Industry Classification System.
Definitions
Employment. Employment includes persons on the payroll who worked or received pay for the pay period that includes the 12th day of the reference month. Full-time, part-time, permanent, short-term, seasonal, salaried, and hourly employees are included, as are employees on paid vacation or other paid leave. Proprietors or partners of unincorporated businesses, unpaid family workers, employees on strike for the entire pay period, and employees on leave without pay for the entire pay period are not counted as employed. Employees of temporary help agencies, employee leasing companies, outside contractors, and consultants are counted by their employer of record, not by the establishment where they are working. JOLTS does not publish employment estimates but uses the reported employment for validation of the other reported data elements.
Job Openings. Job openings include all positions that are open on the last business day of the reference month. A job is open only if it meets all three of these conditions:
* A specific position exists, and there is work available for that position. The position can be full-time or part-time, and it can be permanent, short-term, or seasonal.
* The job could start within 30 days, whether or not the employer can find a suitable candidate during that time.
* The employer is actively recruiting workers from outside the establishment to fill the position. Active recruiting means that the establishment is taking steps to fill a position. It may include advertising in newspapers, on television, or on the radio; posting internet notices, posting "help wanted" signs, networking or making "word-of-mouth" announcements; accepting applications; interviewing candidates; contacting employment agencies; or soliciting employees at job fairs, state or local employment offices, or similar sources.
Excluded are positions open only to internal transfers, promotions or demotions, or recall from layoffs. Also excluded are openings for positions with start dates more than 30 days in the future; positions for which employees have been hired but have not yet reported for work; and positions to be filled by employees of temporary help agencies, employee leasing companies, outside contractors, or consultants. The job openings rate is computed by dividing the number of job openings by the sum of employment and job openings--that is, all filled and unfilled jobs--and multiplying that quotient by 100.
Hires. Hires include all additions to the payroll during the entire reference month, including newly hired and rehired employees; full-time and part-time employees; permanent, short-term, and seasonal employees; employees who were recalled to a job at the location following a layoff (formal suspension from pay status) lasting more than 7 days; on-call or intermittent employees who returned to work after having been formally separated; workers who were hired and separated during the month, and transfers from other locations. Excluded are transfers or promotions within the reporting location, employees returning from strike, employees of temporary help agencies, employee leasing companies, outside contractors, or consultants. The hires rate is computed by dividing the number of hires by employment and multiplying that quotient by 100.
Separations. Separations include all separations from the payroll during the entire reference month and is reported by type of separation: quits, layoffs and discharges, and other separations. Quits include employees who left voluntarily, with the exception of retirements or transfers to other locations. Layoffs and discharges includes involuntary separations initiated by the employer, including layoffs with no intent to rehire; layoffs (formal suspensions from pay status) lasting or expected to last more than 7 days; discharges resulting from mergers, downsizing, or closings; firings or other discharges for cause; terminations of permanent or short-term employees; and terminations of seasonal employees (whether or not they are expected to return the next season). Other separations include retirements, transfers to other locations, separations due to employee disability, and deaths.
Excluded from separations measures are transfers within the same location; employees on strike; and employees of temporary help agencies, employee leasing companies, outside contractors, or consultants. The separations rate is computed by dividing the number of separations by employment and multiplying that quotient by 100. The quits, layoffs and discharges, and other separations rates are computed similarly.
Estimation Method
The JOLTS survey design is a stratified random sample of approximately 21,000 nonfarm business and government establishments. The sample is stratified by ownership, region, industry sector, and establishment size class.
The sampling frame is made up of establishments from two sources: the Bureau of Labor Statistics (BLS) Quarterly Census of Employment and Wages program (QCEW) and the Federal Railroad Administration (FRA). The QCEW database contains establishments that cover approximately 95 percent of nonfarm payroll jobs in the United States. This database is a compilation of administrative data from state unemployment insurance (UI) programs and federal government establishments covered by the Unemployment Compensation for Federal Employees (UCFE) program. A frame of railroad establishments is provided by the FRA. This is added to the QCEW database to complete the JOLTS sampling frame.
The JOLTS estimation method involves the following processes: unit nonresponse adjustment, item nonresponse adjustment, monthly benchmarking and estimation, automatic outlier detection, birth and death model estimation, estimates review and outlier selection, alignment, seasonal adjustment, and variance estimates. Establishment size class levels are also produced. Detailed information about the estimation method can be found in the Handbook of Methods at https://www.bls.gov/opub/hom/jlt/home.htm.
Monthly benchmarking is the process through which the JOLTS weighted employment for each estimation cell is adjusted. JOLTS estimation cells are benchmarked monthly to the current employment level from the BLS Current Employment Statistics (CES) program. The sampled weight is benchmarked to ensure that JOLTS weighted employment is equal to CES employment. Birth/death model. The time lag from the start up, or birth, of an establishment until its appearance on the sampling frame is approximately one year. In addition, many new establishments fail within the first year, referred to as a death. Because new and short-lived universe establishments cannot be reflected in the sampling frame immediately, the JOLTS sample cannot capture job openings, hires, and separations from these establishments during their early existence. BLS has developed a birth/death model that uses establishment birth and death activity from previous years as collected by the QCEW and projects forward to the present using over-the-year change in the CES. The birth/death model also uses historical JOLTS data to calculate the amount of churn (meaning the rates of hires and separations) that exists in establishments of various sizes. The model then combines the calculated churn with the projected employment change to estimate the number of hires and separations that take place in these establishments that cannot be measured through sampling. The estimates of job openings, hires, and separations produced by the birth/death model are added to the sample-based estimates produced from the survey to arrive at the estimates for job openings, hires, and separations.
Alignment. The JOLTS figure for hires minus separations can be used to derive a measure of net employment change. This change should be comparable to the net employment change from the much larger CES survey. However, definitional differences between the two surveys, as well as sampling and nonsampling errors, historically caused JOLTS to diverge from CES over time. To limit the divergence and improve the quality of the JOLTS hires and separations series, BLS implemented the monthly alignment method. There are four steps to this method: seasonally adjust, align, back out the seasonal adjustment factors, and seasonally adjust again.
Seasonal adjustment. After alignment, the seasonal adjustment program (X-13ARIMA-SEATS) is used to seasonally adjust the JOLTS series. Each month, a concurrent seasonal adjustment methodology uses all relevant data, up to and including the current month, to calculate new seasonal adjustment factors. Moving averages are used as seasonal filters in seasonal adjustment. JOLTS seasonal adjustment includes both additive and multiplicative models, as well as regression with autocorrelated errors (REGARIMA) modeling, to improve the seasonal adjustment factors at the beginning and end of the series and to detect and adjust for outliers in the series.
Annual estimates and benchmarking. The JOLTS estimates are revised annually with the issuance of data for January. Five years of data are subject to revision. The revised estimates incorporate: 1) benchmarks based on CES employment estimates newly benchmarked to QCEW, 2) revised seasonal adjustment factors, and 3) any needed special adjustments.
The JOLTS employment levels are ratio-adjusted to the CES employment levels, and the resulting ratios are applied to all JOLTS data elements.
The seasonally adjusted estimates are recalculated for the most recent 5 years to reflect updated seasonal adjustment factors. These annual updates result in revisions to both the seasonally adjusted and not seasonally adjusted JOLTS data series for the period since the last benchmark was established.
Annual levels for hires, quits, layoffs and discharges, other separations, and total separations are the sum of the 12 published monthly levels.
Annual average levels for job openings are calculated by dividing the sum of the 12 published monthly levels by 12.
Annual average rates for hires, quits, layoffs and discharges, other separations, and total separations are calculated by dividing the sum of the 12 monthly JOLTS published levels for each data element by the sum of the 12 monthly CES published employment levels, and multiplying that quotient by 100.
Annual average rates for job openings are calculated by dividing the sum of the 12 monthly JOLTS published levels by the sum of the 12 monthly CES published employment levels plus the sum of the 12 monthly job openings levels, and multiplying that quotient by 100.
Reliability of the estimates
JOLTS estimates are subject to two types of error: sampling error and nonsampling error.
Sampling error can result when a sample, rather than an entire population, is surveyed. There is a chance that the sample estimates may differ from the true population values they represent. The exact difference, or sampling error, varies with the sample selected, and this variability is measured by the standard error of the estimate. BLS analyses are generally conducted at the 90-percent level of confidence. This means that there is a 90-percent chance that the true population mean will fall into the interval created by the sample mean plus or minus 1.65 standard errors. Estimates of median standard errors are released monthly as part of the significant change tables on the JOLTS webpage. Standard errors are updated annually with the most recent 5 years of data. Sampling error estimates are available at www.bls.gov/jlt/jolts_median_standard_errors.htm.
Nonsampling error can occur for many reasons, including the failure to include a segment of the population, the inability to obtain data from all units in the sample, the inability or unwillingness of respondents to provide data on a timely basis, mistakes made by respondents, errors made in the collection or processing of the data, and errors from the employment benchmark data used in estimation. The JOLTS program uses quality control procedures to reduce nonsampling error in the survey's design.
Other information
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Table 1. Job openings levels and rates by industry and region, seasonally adjusted1
Table 2. Hires levels and rates by industry and region, seasonally adjusted1
Table 3. Total separations levels and rates by industry and region, seasonally adjusted1
Table 4. Quits levels and rates by industry and region, seasonally adjusted1
Table 5. Layoffs and discharges levels and rates by industry and region, seasonally adjusted1
Table 6. Other separations levels and rates by industry and region, seasonally adjusted1
Table 7. Job openings, hires, and separations levels and rates by establishment size class, seasonally adjusted
Table 8. Job openings levels and rates by industry and region, not seasonally adjusted1
Table 9. Hires levels and rates by industry and region, not seasonally adjusted
Table 10. Total separations levels and rates by industry and region, not seasonally adjusted1
Table 11. Quits levels and rates by industry and region, not seasonally adjusted1
Table 12. Layoffs and discharges levels and rates by industry and region, not seasonally adjusted1
Table 13. Other separations levels and rates by industry and region, not seasonally adjusted1
Table 14. Job openings, hires, and separations levels and rates by establishment size class, not seasonally adjusted
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View original text plus charts and tables here: https://www.bls.gov/news.release/pdf/jolts.pdf