Census Bureau
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
U.S. Customs and Border Protection
Fish and Wildlife Service
Drug Enforcement Administration
Federal Procurement Policy Office
Institute of Museum and Library Services
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Consumer Product Safety Commission.
Direct final rule.
In June 2012, the U.S. Consumer Product Safety Commission (CPSC) published a consumer product safety standard for infant swings under section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The standard incorporated by reference ASTM F2088-12a,
The rule is effective on September 14, 2024, unless the Commission receives a significant adverse comment by July 1, 2024. If the Commission receives such a comment, it will publish a document in the
You can submit comments, identified by Docket No. CPSC-2013-0025, by any of the following methods:
Will Cusey, Small Business Ombudsman, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7945 or (888) 531-9070; email:
Section 104(b)(1) of the CPSIA requires the Commission to assess the effectiveness of voluntary standards for durable infant or toddler products and adopt mandatory standards for these products. 15 U.S.C. 2056a(b)(1). The mandatory standard must be “substantially the same as” the voluntary standard, or it may be “more stringent than” the voluntary standard, if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product.
Section 104(b)(4)(B) of the CPSIA specifies the process for updating the Commission's rules when a voluntary standards organization revises a standard that the Commission incorporated by reference under section 104(b)(1). First, the voluntary standards organization must notify the Commission of the revision. Once the Commission receives this notification, the Commission may reject or accept the revised standard. The Commission may reject the revised standard by notifying the voluntary standards organization, within 90 days of receiving notice of the revision, that it has determined that the revised standard does not improve the safety of the consumer product and that it is retaining the existing standard. If the Commission does not take this action to reject the revised standard, the revised voluntary standard will be considered a consumer product safety standard issued under section 9 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 2058), effective 180 days after the Commission received notification of the revision or on a later date specified by the Commission in the
Under section 104(b)(1) of the CPSIA, the Commission adopted a mandatory rule for infant swings, codified in 16 CFR part 1223, “Safety Standard for Infant Swings.” The rule incorporated by reference ASTM F2088-12a,
In 2013, ASTM notified CPSC that it had issued a revised standard and the Commission published a direct final rule to update 16 CFR part 1223, incorporating by reference the new ASTM F2088-13, with no modifications. 78 FR 37706 (June 24, 2013). ASTM later approved two more revisions: ASTM F2088-15 and ASTM F2088-19. However, ASTM did not notify CPSC of these revisions under CPSIA section 104(b)(4)(B). Consequently, these revised standards did not become the mandatory standards by operation of law, and the Commission did not update the mandatory standard to incorporate by reference these revised ASTM standards. In 2020, ASTM notified CPSC that it had issued a further revised standard, ASTM F2088-20, and the Commission published a direct final rule to update 16 CFR part 1223, incorporating by reference ASTM F2088-20, with no modifications.
In February 2024, ASTM published a revision to the voluntary standard, approving ASTM F2088-24. On March 18, 2024, ASTM notified CPSC of the revision. On March 28, 2024, the Commission provided notice in the
As discussed below, based on CPSC staff's review of ASTM F2088-24, the Commission will allow the revised voluntary standard to become the mandatory standard because the revised requirements in the voluntary standard either improve the safety of infant and cradle swings, or are neutral with respect to safety.
ASTM F2088-24 includes several substantive additions and revisions, revisions to clarify existing requirements, and editorial revisions that do not alter substantive requirements in the standard or affect safety. The standard continues to apply to both infant and cradle swings.
ASTM F2088-24 contains substantive changes to requirements in section 6.9 that address the strangulation and entrapment hazard to non-occupants associated with tethered straps and cords on swings. 16 CFR part 1223, incorporating by reference ASTM F2088-22, addresses the strangulation hazard posed by a length of strap that can wrap around an infant's neck and specifies that any accessible tethered straps on the underside of the seat must not exceed 16 inches. The 16-inch length limit is based on the approximate perimeter of a 5th percentile 6-month-old small head probe used in other infant product standards (section X1.4).
However, accessible tethered straps on the underside of the seat can form an opening with other parts of the swing, also posing an entanglement or strangulation hazard. CPSC staff identified two incidents demonstrating this hazard involving products that would have passed the 16-inch ASTM F2088-22 tethered strap requirement and raised the issue with ASTM.
Revisions in ASTM F2088-24 address the head entrapment and strangulation hazard by requiring that: (1) an opening under the swing (formed by the tethered strap by itself, with other straps, or in conjunction with the product) is either too small to allow an infant's head to fit or large enough to allow an infant's torso (and head) to pass through, and (2) if the opening is large enough to pass an infant's torso, the tethered strap portion of the opening cannot be manipulated to loop around an infant's neck. The revised requirements and corresponding test methods ensure that any openings bounded by the strap are either too small for an infant's head to enter or are large enough for the infant's head to escape (without also posing a strangulation hazard in the strap portion of the opening). Several revisions in the standard relate to this change.
First, the Terminology section of ASTM F2088-24 adds definitions for “cord” (section 3.1.3) and “strap” (section 3.1.13) and revises the definition of “tethered strap” (section 3.1.15). ASTM added the word “cord” to the requirements related to tethered straps throughout the standard. Using both “cord” and “strap” in the relevant requirements and defining these terms ensures that all components that present the same hazard are included within the relevant requirements. Consistent with this change, the defined term “tethered strap” was expanded to include “and/or cord,” and the wording of the definition was revised—previously it included only straps that attached a restraint system or seat to the product frame; as revised, it includes any accessible and exposed strap or cord behind or below the occupant support surface with both ends secured to the product or itself. This revised definition addresses the
Second, ASTM F2088-24 includes revised provisions in the Performance Requirements section (section 6.9) and Test Methods section (section 7.16). Where ASTM F2088-22 simply specified a 16-inch length limit for a tethered strap that is accessible on the underside of the seat, ASTM F2088-24 states that when tested under conditions specified in section 7 of the standard, all tethered straps and cords that form a bounded opening, alone or in conjunction with the product (1) must not allow the passage of the small head probe, or (2) must allow the passage of the large head probe, and the strap/cord portion of the bounded opening must not form a loop with a perimeter greater than 7.4 inches. Revised test methods in section 7.16 modify the test set-up and initial conditions for testing to ensure that the product is secured, the loop formed below the product is not influenced by weight in the seat, and the buckles and/or hardware are positioned to allow for the maximum length of any strap/cord to be accessible from behind or below the occupant support surface during testing.
ASTM F2088-24 also adds the use of a 3/4-inch diameter clamping surface tool during the strap/cord evaluation test method to ensure consistency during the application of the pull force. During the assessment of the bounded openings, the test methods specify the insertion forces to be used with the small and large head probes (10 and 5 pounds, respectively).
CPSC considers the revisions in ASTM F2088-24 to be an improvement to safety because the revisions address entrapment and strangulation hazards posed by openings created by accessible tethered straps under the swing and other parts of the product; this hazard is not addressed by ASTM F2088-22. Limiting the length of a tethered strap alone, as ASTM F2088-22 does, is less effective to address the entrapment and strangulation hazard because it does not address the size of an opening formed with the strap/cord and other parts of the product. The intent of the 16-inch maximum length requirement was to prevent the head of a child 6-months or older from becoming entangled if an exposed tethered strap formed a loop with itself. However, the requirement does not account for a strap that creates a bounded opening with other parts of the swing, which could create an opening large enough to allow the head of an infant to enter, and consequently, become entangled. Additionally, the requirement did not address that adjoined straps can pose an entrapment hazard. The revised requirements in ASTM F2088-24 address those hazard patterns. The revised requirements ensures that the opening formed in conjunction with the strap/cord is either (1) small enough to prevent an infant's head from entering and getting entrapped and posing a strangulation hazard,
These revisions in ASTM F2088-24 are an improvement to the safety of the swings because they address the head entrapment and entanglement hazards demonstrated in incidents with exposed straps/cords behind or below swings.
ASTM F2088-24 also includes several minor additions and revisions that are editorial and do not alter any substantive requirements in the standard. In particular, ASTM F2088-24 updates the list of Referenced Documents and includes several minor wording changes for consistency with the revisions to the tethered strap/cord requirements (
Because these revisions do not change any substantive requirements, they are neutral regarding the safety of infant and cradle swings.
Section 1223.2 of the direct final rule incorporates by reference ASTM F2088-24. The Office of the Federal Register (OFR) has regulations regarding incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to a final rule, ways in which the material the agency incorporates by reference is reasonably available to interested parties and how interested parties can obtain the material. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b).
In accordance with the OFR regulations, section II. Revisions to ASTM F2088 of this preamble summarizes the major provisions of ASTM F2088-24 that the Commission incorporates by reference into 16 CFR part 1223. The standard is reasonably available to interested parties in several ways. Until the direct final rule takes effect, a read-only copy of ASTM F2088-24 is available for viewing on ASTM's website at:
Section 14(a) of the Consumer Product Safety Act (15 U.S.C. 2063(a)) requires manufacturers, including importers, of products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, to certify that the products comply with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program, or, for children's products, on tests of a sufficient number of samples by a third-party conformity assessment body accredited by CPSC to test according to the applicable requirements. As noted, standards issued under section 104(b)(1)(B) of the CPSIA are “consumer product safety standards.” Thus, they are subject to the testing and certification requirements of section 14 of the CPSA.
Because infant and cradle swings are children's products, a CPSC-accepted third party conformity assessment body must test samples of the products. Products subject to part 1223 also must comply with all other applicable CPSC requirements, such as the lead content requirements in section 101 of the CPSIA;
In accordance with section 14(a)(3)(B)(vi) of the CPSA, the Commission previously published a notice of requirements (NOR) for accreditation of third-party conformity assessment bodies (third-party labs) for testing infant and cradle swings and codified the requirement at 16 CFR 1112.15(b)(8). 78 FR 15836 (March 12, 2013). The NOR provided the criteria and process for CPSC to accept accreditation of third-party conformity assessment bodies for testing infant and cradle swings to 16 CFR part 1223. The NORs for all mandatory standards for durable infant or toddler products are listed in the Commission's rule, “Requirements Pertaining to Third Party Conformity Assessment Bodies,” codified in 16 CFR part 1112.
ASTM F2088-24 includes revised requirements for testing infant and cradle swings. The revision requires the use of a small head probe, a large head probe, a
However, third-party labs will need to buy or construct a cylindrical probe of 2.355 inches in diameter to perform the strap/cord length and tautness test (section 7.16.8). The building materials are easily accessible from supply stores and the probe would be simple to construct. The cost to procure or build the cylindrical probe is estimated to be approximately $50.
Accordingly, the revisions do not significantly change the way that third-party labs test these products for compliance with the safety standard for swings. In addition, the existing accreditations that the Commission has accepted for testing requirements in earlier versions of ASTM F2088, including ASTM F2088-22, will cover testing to the revised standard. Therefore, the Commission considers the existing CPSC-accepted laboratories for the testing requirements in ASTM F2088-22 to be capable of testing to ASTM F2088-24 as well. Accordingly, the existing NOR for this standard will remain in place, and CPSC-accepted third party conformity assessment bodies are expected to update the scope of the testing laboratories' accreditations to reflect the revised standard in the normal course of renewing their accreditations.
On March 28, 2024, the Commission provided notice in the
The purpose of this direct final rule is to update the reference in the Code of Federal Regulations (CFR) so that it reflects the version of the standard that takes effect by statute. This rule updates the reference in the CFR, but under the terms of the CPSIA, ASTM F2088-24 would take effect as the new CPSC standard for infant and cradle swings in the absence of any action by the Commission. Thus, public comments would not lead to substantive changes to the standard or to the effect of the revised standard as a consumer product safety rule under section 104(b) of the CPSIA. Under these circumstances, notice and comment are unnecessary.
In Recommendation 95-4, the Administrative Conference of the United States (ACUS) endorses direct final rulemaking as an appropriate procedure to expedite rules that are noncontroversial and that are not expected to generate significant adverse comments.
Unless CPSC receives a significant adverse comment within 30 days of this notification, the rule will become effective on September 14, 2024. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be “one where the commenter explains why the rule would be inappropriate,” including an assertion
If the Commission receives a significant adverse comment, the Commission will withdraw this direct final rule. Depending on the comment and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.
The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) generally requires agencies to review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603, 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA.
The current mandatory standard includes requirements for marking, labeling, and instructional literature that constitute a “collection of information,” as defined in the Paperwork Reduction Act (PRA; 44 U.S.C. 3501-3521). The Commission took the steps required by the PRA for information collections when it promulgated 16 CFR part 1223, and the marking, labeling, and instructional literature for infant and cradle swings are currently approved under Office of Management and Budget (OMB) Control Number 3041-0159. The revision does not affect the information collection requirements or approval related to the standard.
The Commission's regulations provide for a categorical exclusion from any requirement to prepare an environmental assessment or an environmental impact statement where they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.
Section 26(a) of the CPSA provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the Federal standard. 15 U.S.C. 2075(a). Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to CPSC for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA deems rules issued under that provision “consumer product safety standards.” Therefore, once a rule issued under section 104 of the CPSIA takes effect, it will preempt in accordance with section 26(a) of the CPSA.
Under the procedure set forth in section 104(b)(4)(B) of the CPSIA, when a voluntary standards organization revises a standard that the Commission adopted as a mandatory standard, the revision becomes the CPSC standard 180 days after notification to the Commission, unless the Commission determines that the revision does not improve the safety of the product, or the Commission sets a later date in the
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission must indicate whether the rule is a “major rule.” The CRA states that the Office of Information and Regulatory Affairs (OIRA) determines whether a rule qualifies as a “major rule.”
Pursuant to the CRA, OIRA has determined that this rule does not qualify as a “major rule,” as defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit the required information to each House of Congress and the Comptroller General.
Consumer protection, Third party conformity assessment body requirements, Audit.
Consumer protection, Imports, Incorporation by reference, Infants and children, Labeling, Law enforcement, Safety, Toys.
For the reasons discussed in the preamble, the Commission amends 16 CFR chapter II as follows:
15 U.S.C. 2063.
(b) * * *
(8) 16 CFR part 1223, Safety Standard for Infant and Cradle Swings;
15 U.S.C. 2056a.
This part establishes a consumer product safety standard for infant and cradle swings (including combination swings).
Each infant and cradle swing (including combination swings) must comply with all applicable provisions of ASTM F2088-24,
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or Agency) is announcing the termination of the Science Advisory Board to the National Center for Toxicological Research (NCTR). This document announces the reasons for termination and removes the Science Advisory Board to the NCTR from the Agency's list of standing advisory committees.
This rule is effective May 30, 2024.
Ashley Groves, Designated Federal Officer, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Rd., 50-719, Jefferson, AR 72079, 870-543-7956,
The Science Advisory Board to the National Center for Toxicological Research (the Committee) was established on June 2, 1973 (38 FR 18478). The Committee advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and as required, any other product for which FDA has regulatory responsibility.
The Committee is no longer needed and will be terminated on June 2, 2024. Over the past several years, the Committee has met very infrequently, and the effort and expense of maintaining the Committee are no longer justified. The Science Board to FDA (Science Board) provides advice to the Commissioner and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Committee provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. It also provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. In the future, any issues on which NCTR requires expert advice will be addressed by utilizing the Science Board with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on that committee.
Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary because the Committee is not being adequately used, and termination of the committee is effective on June 2, 2024, in accordance with 21 CFR 14.55. This final rule merely removes the name of the Science Advisory Board to the National Center for Toxicological Research from the list of standing advisory committees in § 14.100 (21 CFR 14.100).
Therefore, the Agency is amending § 14.100(e) as set forth in the regulatory text of the document.
Administrative practice and procedure, Advisory committee, Color additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:
5 U.S.C. 1001
Office of Foreign Assets Control, Treasury.
Publication of a Web General License.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing one general license (GL) issued pursuant to the Venezuela Sanctions Regulations: GL 8N, which was previously made available on OFAC's website.
GL 8N was issued on May 10, 2024. See
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Compliance, 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On May 10, 2024, OFAC issued GL 8N to authorize certain transactions otherwise prohibited by the Venezuela Sanctions Regulations (VSR), 31 CFR part 591. GL 8N was made available on OFAC's website (
(a) Except as provided in paragraphs (c) and (d) of this general license, all transactions and activities prohibited by Executive Order (E.O.) 13850 of November 1, 2018, as amended by E.O. 13857 of January 25, 2019, or E.O. 13884 of August 5, 2019, each as incorporated into the Venezuela Sanctions Regulations, 31 CFR part 591 (the VSR), that are ordinarily incident and necessary to the limited maintenance of essential operations, contracts, or other agreements, that: (i) are for safety or the preservation of assets in Venezuela; (ii) involve PdVSA or any entity in which PdVSA owns, directly or indirectly, a 50 percent or greater interest; and (iii) were in effect prior to July 26, 2019, are authorized through 12:01 a.m. eastern standard time, November 15, 2024, for the following entities and their subsidiaries (collectively, the “Covered Entities”):
Transactions and activities necessary for safety or the preservation of assets in Venezuela that are authorized by paragraph (a) of this general license include: transactions and activities necessary to ensure the safety of personnel, or the integrity of operations and assets in Venezuela; participation in shareholder and board of directors meetings; making payments on third-party invoices for transactions and activities authorized by paragraph (a) of this general license, or incurred prior to April 21, 2020, provided such activity was authorized at the time it occurred; payment of local taxes and purchase of utility services in Venezuela; and payment of salaries for employees and contractors in Venezuela.
(b) Except as provided in paragraph (d) of this general license, all transactions and activities prohibited by E.O. 13850, as amended, or E.O. 13884, each as incorporated into the VSR, that are ordinarily incident and necessary to the wind down of operations, contracts, or other agreements in Venezuela involving PdVSA or any entity in which PdVSA owns, directly or indirectly, a 50 percent or greater interest, and that were in effect prior to July 26, 2019, are authorized through 12:01 a.m. eastern standard time, November 15, 2024, for the Covered Entities.
(c) Paragraph (a) of this general license does not authorize:
(1) The drilling, lifting, or processing of, purchase or sale of, or transport or shipping of any Venezuelan-origin petroleum or petroleum products;
(2) The provision or receipt of insurance or reinsurance with respect to the transactions and activities described in paragraph (c)(1) of this general license;
(3) The design, construction, installation, repair, or improvement of any wells or other facilities or infrastructure in Venezuela or the purchasing or provision of any goods or services, except as required for safety;
(4) Contracting for additional personnel or services, except as required for safety; or
(5) The payment of any dividend, including in kind, to PdVSA, or any entity in which PdVSA owns, directly or indirectly, a 50 percent or greater interest.
(d) This general license does not authorize:
(1) Any transactions or dealings related to the exportation or reexportation of diluents, directly or indirectly, to Venezuela;
(2) Any loans to, accrual of additional debt by, or subsidization of PdVSA, or any entity in which PdVSA owns, directly or indirectly, a 50 percent or greater interest, including in kind, prohibited by E.O. 13808 of August 24, 2017, as amended by E.O. 13857, and incorporated into the VSR; or
(3) Any transactions or activities otherwise prohibited by the VSR, or any other part of 31 CFR chapter V, or any transactions or activities with any blocked person other than the blocked persons identified in paragraphs (a) and (b) of this general license.
(e) Effective May 10, 2024, General License No. 8N, dated November 16, 2023, is replaced and superseded in its entirety by this General License No. 8N.
Dated: May 10, 2024.
National Archives and Records Administration (NARA).
Direct final rule.
In June 2023, the National Archives and Records Administration (NARA) issued GRS Transmittal 34, which introduced GRS 4.5 Digitizing Records. NARA is updating the regulations to incorporate GRS 4.5 and ensure agencies use the proper authorization for disposing of temporary records that have been digitized. We added guidance directing agencies to manage temporary digital records according to the requirements. We also clarified language regarding when agencies may dispose of the scheduled source records. Additionally, we are harmonizing language in existing regulations with the new amendments.
This rule is effective August 28, 2024 without further action, unless adverse comment is received by July 1, 2024. If adverse comment is received, NARA will publish a timely withdrawal of the rule in the
You may submit comments on this rule, identified by RIN 3095-AC18, by any of the following methods:
•
•
•
•
Edward Germino, Strategy and Performance Division, by email at
In June 2023, the National Archives and Records Administration (NARA) released GRS Transmittal 34, which introduced a new schedule called GRS 4.5 Digitizing Records to specifically address the handling of digitized source records. Previously, these records were covered under GRS 5.2 Transitory and Intermediary Records. With this update, we have revised 36 CFR 1236.36 to provide agencies with the proper authority for managing digitized temporary records. We also clarified language in § 1236.36 regarding when agencies may dispose of the scheduled source records.
In subpart D, we previously used the term “original source records.” However, we removed the word “original” because the source records may or may not be the original versions. We are also making this change in the heading for § 1236.36. The term “source records” refers to the records that underwent digitization and validation as part of a digitization project.
Finally, we have added guidance to § 1236.30 directing agencies to manage temporary digital records according to the requirements in 36 CFR part 1236 subparts A, B, and C.
The Office of Management and Budget (OMB) has reviewed this rulemaking and determined it is not “significant” under section 3(f) of Executive Order 12866. It is not significant because it applies only to Federal agencies, updates the regulations due to a statutory requirement, the new requirements are being added to clarify ones that agencies have already been required to follow, and is not establishing a new program. The requirements are necessary to comply with statute and to ensure agencies are appropriately preserving records.
This review requires an agency to prepare an initial regulatory flexibility analysis and publish it when the agency publishes the proposed rule. This requirement does not apply if the agency certifies that the rulemaking will not, if promulgated, have a significant economic impact on a substantial number of small entities (
The Paperwork Reduction Act of 1995 (PRA) (
The Unfunded Mandates Reform Act requires that agencies determine whether any Federal mandate in the rulemaking may result in State, local, and Tribal governments, in the aggregate, or the private sector, expending $100 million in any one year. NARA certifies that this rulemaking does not contain a Federal mandate that may result in such an expenditure.
Archives and records, Digital records, Digitization, Records management.
For the reasons discussed in the preamble, NARA amends 36 CFR part 1236 as follows:
44 U.S.C. 2904, 3101, 3102, 3105, 3301, 3302, and 3312.
(a) If an agency intends to digitally reproduce (digitize) temporary records in order to use the digitized records in place of the source records, the agency must:
(1) Digitize the record to the standards in § 1236.32;
(2) Validate the digitization according to § 1236.34; and
(3) Manage the digital records according to the requirements in subparts A, B, and C of this part.
(b) When an agency disposes of source records, the agency must follow the requirements in § 1236.36.
(a) Capture all information contained in the source records;
(b) Include all the pages or parts from the source records;
(c) Ensure the agency can use the digitized records for all the purposes the source records serve, including the ability to attest to transactions and activities;
(a) Agencies must validate that the digitized records are of suitable quality to replace source records.
(b) Agencies may establish their own validation process or use third-party processes to validate that the digitized records comply with § 1236.32. The process may be project-based or agency-wide policy.
(a) When an agency disposes of source records, it must have an approved agency records schedule or identify an applicable General Records Schedule.
(b) When an agency has validated that the digitized versions meet the standards in § 1236.32, the agency may destroy the source records according to General Records Schedule (GRS) 4.5 Digitizing Records.
(c) Agencies must consider any existing legal restrictions, such as a litigation hold, before destroying the source records.
(d) Agencies must manage the digitized records in the same way it would have managed the source records. Agencies must retain the digitized records for the remaining portion of any retention period established by the applicable records schedule.
(e) Agencies do not need NARA approval to destroy scheduled temporary source records they have digitized according to this part.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 that clarifies the data to be provided for certain procurements related to major weapon systems.
Effective May 30, 2024.
Ms. Jeanette Snyder, telephone 703-508-7524.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided as follows:
There are no significant changes from the proposed rule.
The text at DFARS 234.7002(d)(4) is amended to add the following to the end of the phrase for clarity: “then the offeror is required to”. Paragraph (b)(1)(ii) of the basic and alternate I of the provision at DFARS 252.215-7010 is amended to clarify that the information to be provided by the offeror pursuant to this paragraph is also for purposes of determining commerciality. Paragraph (d)(3) of the basic and alternate I of the provision at DFARS 252.215-7010 is also amended to add a cross reference to DFARS 234.7002(e) for clarity. In addition, minor editorial changes are made in the basic and alternate I of the provision.
This final rule amends the provision at DFARS 252.215-7010, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data. However, this proposed rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The provision will continue to not apply to acquisitions at or below the SAT and will continue to apply to acquisitions of commercial products, excluding COTS items, and to acquisitions of commercial services.
DoD does not expect this final rule to have a significant impact on the Government or offerors because it merely clarifies the data an offeror is required to provide to the contracting officer when a subsystem of a major weapon system or a component or spare part of a major weapon system or of a subsystem of a major weapon system is proposed as a commercial product. Specifically, this rule clarifies the data an offeror is required to provide to support the contracting officer's determination of price reasonableness and commerciality. This rule will also allow an offeror to give the contracting officer access to the data, in lieu of submitting it, and to redact certain customer information from such data.
This rule is expected to result in the timely submission of data, which may decrease the time it takes for a contracting officer to determine a product to be commercial, to determine price reasonableness, and to award a contract.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is necessary to implement section 803 of the James M. Inhofe National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2023. The objective of this rule is to implement section 803, which modifies 10 U.S.C. 3455 to clarify the data an offeror is required to provide to the contracting officer to support a commerciality determination and a price reasonableness determination when a subsystem of a major weapon system or a component or spare part of a major weapon system or of a subsystem of a major weapon system is proposed as a commercial product.
No significant issues were raised by the public comments in response to the initial regulatory flexibility analysis.
Based on data from the Federal Procurement Data System for fiscal years 2021 through 2023, DoD awarded an average of approximately 50,260 commercial contracts related to major weapon systems to an average of 2,685 unique small entities per year. Therefore, this rule is expected to apply to approximately 2,685 small entities per fiscal year.
This rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities. The information being collected falls under the currently approved information collection requirements under Office of Management and Budget (OMB) Control Number 0704-0574, Defense Federal Acquisition Regulation Supplement (DFARS) Part 215; Only One Offer and Related Clauses in DFARS 252.
There are no known alternatives that would accomplish the stated objectives of the applicable statute.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this final rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved by OMB under OMB Control Number 0704-0574, Defense Federal Acquisition Regulation Supplement (DFARS) Part 215; Only One Offer and Related Clauses in DFARS 252.
Government procurement.
Therefore, 48 CFR parts 212, 215, 235, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(A) * * *
(iii) * * *
(A) Determine in writing that the acquisition meets the “commercial product” or “commercial service” definition in FAR 2.101. See 234.7002(b) and (c) for subsystems of major weapon systems and components and spare parts of major weapon systems and of subsystems of major weapon systems;
(a) * * *
(1) In the case of major weapon systems, for subsystems of major weapon systems and components and spare parts of major weapon systems and of subsystems of major weapon systems acquired as commercial products in accordance with subpart 234.70, shall use information submitted under 234.7002(e); and
(c) * * *
(3) * * *
(A) Follow the procedures at PGI 215.403-1(c)(3) for pricing commercial products or commercial services, except see 234.7002(e) for pricing commercial subsystems of major weapon systems and components and spare parts of major weapon systems and of subsystems of major weapon systems.
The revisions and additions read as follows:
(b) * * *
(2) The contracting officer determines in writing that the subsystem is a commercial product in accordance with 212.102(a)(iii). For a subsystem of a major weapon system proposed as a commercial product that has not previously been determined to be a commercial product (see 212.102(a)(ii)), follow the procedures in paragraph (d) of this section.
(3) This paragraph (b) shall apply only to subsystems of major weapon systems that are acquired by DoD through a—
(i) Prime contract;
(ii) Modification to a prime contract; or
(iii) Subcontract under a prime contract for the acquisition of a subsystem proposed as a commercial product that has not previously been determined to be a commercial product (see 212.102(a)(ii)).
(c) * * *
(1) * * *
(ii) The contracting officer determines in writing that the component or spare part is a commercial product in accordance with 212.102(a)(iii). For a component or spare part proposed as a commercial product that has not previously been determined to be a commercial product (see 212.102(a)(ii)), follow the procedures in paragraph (d) of this section.
(2) This paragraph (c) shall apply only to components and spare parts that are acquired by DoD through a—
(i) Prime contract;
(ii) Modification to a prime contract; or
(iii) Subcontract under a prime contract for the acquisition of a component or spare part proposed as a commercial product that has not previously been determined to be a commercial product (see 212.102(a)(ii)).
(d)
(1) Identify the comparable commercial product the offeror sells to the general public or nongovernmental entities for other than governmental purposes;
(2) Provide a comparison between the physical characteristics and functionality of the comparable commercial product and the subsystem, component, or spare part, including—
(i) For products under paragraph (3)(i) of the “commercial product” definition at FAR 2.101, a description of the modification and documentation to support that the modification is customarily available in the marketplace; or
(ii) For products under paragraph (3)(ii) of the “commercial product” definition at FAR 2.101, a detailed description of the modification and detailed technical data to demonstrate that the modification is minor (
(3) Provide the national stock number (NSN) for the comparable commercial product, if one is assigned, and the NSN for the subsystem, component, or spare part, if one is assigned; or
(4) If the offeror does not sell a comparable commercial product to the general public or nongovernmental entities for other than governmental
(i) Notify the contracting officer in writing that it does not sell such a comparable product; and
(ii) Provide the contracting officer a comparison between the physical characteristics and functionality of the most comparable commercial product in the commercial market and the subsystem, component, or spare part, if available.
(e)
(1) Unless an exception at FAR 15.403-1(b)(1) or (2) applies—
(i) To the extent necessary to make a determination of price reasonableness, the contracting officer shall require the offeror to submit to or provide the contracting officer access to a representative sample, as determined by the contracting officer, of prices paid for the same or similar commercial products under comparable terms and conditions by both Government and commercial customers and the terms and conditions of such sales; or
(ii) If the contracting officer determines that the offeror cannot provide or give access to sufficient information described in this paragraph (e)(1) to determine the reasonableness of price, the contracting officer shall require the offeror to submit or provide the contracting officer access to a representative sample, as determined by the contracting officer, of the prices paid for the same or similar commercial products sold under different terms and conditions and the terms and conditions of such sales.
(2) The contracting officer shall allow the offeror to redact only information provided pursuant to paragraph (e)(1) of this section that identifies the customer, if the offeror certifies in writing for each sale that the customer is a—
(i) Government customer (
(ii) Commercial customer purchasing the product for governmental purposes; or
(iii) Commercial customer purchasing the product for a commercial, mixed, or unknown purpose.
(3) If the contracting officer determines that the information submitted pursuant to paragraph (e)(1) of this section is not sufficient to determine the reasonableness of price because the comparable commercial product provided by the offeror is not a valid basis for price analysis or the proposed price is not reasonable after evaluating sales data, then the contracting officer shall obtain approval from an official one level above the contracting officer, without power of delegation, and require the offeror to submit other relevant information regarding the basis for price or cost, including information on labor costs, material costs, and overhead rates.
(4) An offeror shall not be required to submit information described in paragraph (e)(1) of this section with regard to a commercially available off-the-shelf item. An offeror may be required to submit such information with regard to any other item that was developed exclusively at private expense only after the head of the contracting activity determines in writing that the information submitted pursuant to paragraph (e)(1) of this section is not sufficient to determine the reasonableness of price.
(5) An offeror may submit information or analysis relating to the value of a commercial product to aid in the determination of the reasonableness of the price of such commercial product. A contracting officer may consider such information or analysis in addition to the information submitted pursuant to paragraph (e)(1) of this section. For additional guidance see PGI 234.7002(e)(5).
The additions, revisions and republications read as follows:
(a) * * *
(b)
(i)
(ii)
(A) For products or services previously determined to be commercial, the contract number and military department, defense agency, or other DoD component that rendered such determination, and if available, a Government point of contact;
(B) For subsystems of a major weapon system and components and spare parts of a major weapon system or subsystem of a major weapon system that have not previously been determined to be commercial—
(
(
(
(
(
(
(
(
(C) For items priced based on a catalog—
(
(
(D) For items priced based on market pricing, a description of the nature of the commercial market, the methodology used to establish a market price, and all relevant sales data. The description shall be adequate to permit the DoD to verify the accuracy of the description;
(E) For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item; or
(F) For items provided by nontraditional defense contractors, a statement that the entity is not currently performing and has not performed, for at least the 1-year period preceding the solicitation of sources by DoD for the procurement or transaction, any contract or subcontract for DoD that is subject to full coverage under the cost accounting standards prescribed pursuant to 41 U.S.C. 1502 and the regulations implementing such section.
(d)
(2) In cases in which uncertified cost data is required, the information shall be provided in the form in which it is regularly maintained by the Offeror or prospective subcontractor in its business operations.
(3) If the Offeror redacts data that identifies the customer (see DFARS 234.7002(e)(2)), then the Offeror shall include, for each sale, the following signed statement with the data submitted:
“By submission of this data, the Offeror
(4) Within 10 days of a written request from the Contracting Officer for additional information to permit an adequate evaluation of the proposed price in accordance with FAR 15.403-3 or DFARS 234.7002(e), the Offeror shall provide either the requested information, or a written explanation for the inability to fully comply.
(5)
(ii) No cost data may be required from a prospective subcontractor in any case in which there are sufficient non-Government sales of the same item to establish reasonableness of price.
(iii) If the Offeror relies on relevant sales data for similar items to determine the price is reasonable, the Offeror shall obtain only that technical information necessary—
(A) To support the conclusion that items are technically similar; and
(B) To explain any technical differences that account for variances between the proposed prices and the sales data presented.
(a) * * *
(b)
(i)
(ii)
(A) For products or services previously determined to be commercial, the contract number and military department, defense agency, or other DoD component that rendered such determination, and if available, a Government point of contact;
(B) For subsystems of a major weapon system and components and spare parts of a major weapon system or subsystem of a major weapon system that have not previously been determined to be commercial—
(
(
(
(
(
(
(
(
(C) For items priced based on a catalog—
(
(
(D) For items priced based on market pricing, a description of the nature of the commercial market, the methodology used to establish a market price, and all relevant sales data. The description shall be adequate to permit the DoD to verify the accuracy of the description;
(E) For items included on an active Federal Supply Service Multiple Award Schedule contract, proof that an exception has been granted for the schedule item; or
(F) For items provided by nontraditional defense contractors, a statement that the entity is not currently performing and has not performed, for at least the 1-year period preceding the solicitation of sources by the DoD for the procurement or transaction, any contract or subcontract for the DoD that is subject to full coverage under the cost accounting standards prescribed pursuant to 41 U.S.C. 1502 and the regulations implementing such section.
(2) The Offeror grants the Contracting Officer or an authorized representative the right to examine, at any time before award, books, records, documents, or other directly pertinent records to verify any request for an exception under this provision, and to determine the reasonableness of price.
(d)
(2) In cases in which uncertified cost data is required, the information shall be provided in the form in which it is regularly maintained by the Offeror or prospective subcontractor in its business operations.
(3) If the Offeror redacts data that identifies the customer (see DFARS 234.7002(e)(2)), then the Offeror shall include, for each sale, the following signed statement with the data submitted:
“By submission of this data, the Offeror
(4) The Offeror shall provide information described as follows:
(5) Within 10 days of a written request from the Contracting Officer for additional information to support proposal analysis, the Offeror shall provide either the requested information, or a written explanation for the inability to fully comply.
(6)
(ii) No cost information may be required from a prospective subcontractor in any case in which there are sufficient non-Government sales of the same item to establish reasonableness of price.
(iii) If the Offeror relies on relevant sales data for similar items to determine the price is reasonable, the Offeror shall obtain only that technical information necessary—
(A) To support the conclusion that items are technically similar; and
(B) To explain any technical differences that account for variances between the proposed prices and the sales data presented.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement two sections of the National Defense Authorization Act for Fiscal Year 2021, one section of the National Defense Authorization Act for Fiscal Year 2022, one section of the National Defense Authorization Act for Fiscal Year 2023, and one section of the Consolidated Appropriations Act, 2023. These statutes remove limitations and restrictions on certain components that are no longer required and add new limitations on other components, subject to exceptions.
Effective May 30, 2024.
Kimberly Bass, telephone 703-717-3446.
DoD published a proposed rule in the
One respondent submitted public comments in response to the proposed rule. There are no changes made to the final rule.
DoD reviewed the public comments in the development of the final rule. A discussion of the comments is provided, as follows:
Moreover, the DFARS clause at 252.225-7064, Restriction on Acquisition of Satellite Star Trackers, is prescribed at DFARS 225.7004-7(d) for use in solicitations and contracts requiring the acquisition of satellite star trackers, including solicitations and contracts that exceed the simplified acquisition threshold (SAT) and that use FAR part 12 procedures for the acquisition of commercial products, including COTS items, and for the acquisition of commercial services. Lastly, as provided in section III of this preamble, DoD intends to apply the clause to contracts for the acquisition of commercial products including COTS items and for the acquisition of commercial services.
The clause at DFARS 252.225-7063, Restriction on Acquisition of Components of T-AO 205 Class Vessels, is prescribed at DFARS 225.7004-7(c) for use in solicitations and contracts requiring the acquisition of components of T-AO 205 and T-ARC class vessels, including solicitations and contracts that exceed the SAT and that use FAR part 12 procedures for the acquisition of commercial products, including COTS items, and for the acquisition of commercial services. The clause at DFARS 252.225-7064, Restriction on Acquisition of Satellite Star Trackers, is prescribed at DFARS 225.7004-7(d) for use in solicitations and contracts requiring the acquisition of satellite star trackers, including solicitations and contracts that exceed the SAT and that use FAR part 12 procedures for the acquisition of commercial products, including COTS items, and for the acquisition of commercial services.
Consistent with the analysis that DoD provided in the proposed rule with regard to the application of the requirements of sections 845 and 1603 of the NDAA for FY 2021 (Pub. L. 116-283) and section 852 of the NDAA for FY 2023 (Pub. L. 117-263), which amend 10 U.S.C. 4864, DoD has made the determination to apply the statute, as implemented in the clauses at DFARS 252.225-7063 and 252.225-7064 to contracts and subcontracts for the acquisition of commercial products including COTS items, and to the acquisition of commercial services, as defined at Federal Acquisition Regulation 2.101.
The requirements of 10 U.S.C. 4864 do not apply to a contract or subcontract for an amount at or below the SAT. Therefore, the clauses will not apply to acquisitions at or below the SAT.
The final rule adds procurement limitations on the acquisition of star trackers for certain national security satellites and certain components for T-AO 205 and T-ARC class vessels, requiring they are manufactured in the national technology and industrial base: the United States, Australia, Canada, New Zealand or the United Kingdom in accordance with 10 U.S.C. 4864.
The rule is not expected to have a significant impact on the Government, offerors, or contractors. The satellite star trackers and components for the T-AO 205 and T-ARC class of vessels are the types of items that are readily available in the marketplace, so limitation to national technology and industrial base sources is not viewed as having a significant impact on the availability of sources. Further, the rule provides waiver procedures to the limitation.
The domestic source restriction does not apply to—
(1) Contracts or subcontracts that do not exceed the simplified acquisition threshold;
(2) The acquisition of spare or repair parts needed to support components for naval vessels manufactured outside the United States; and
(3) Large medium-speed diesel engines for icebreakers or special mission ships.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement statutes that remove limitations and restrictions no longer required, and that require the procurement of star trackers for certain national security satellites, as well as certain components for T-AO 205 and T-ARC class vessels, from the national technology and industrial base: the United States, Australia, Canada, New Zealand, or the United Kingdom.
The objective of the rule is to implement sections 845 and 1603 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283); section 816 of the NDAA for FY 2022 (Pub. L. 117-81); and section 853 of the NDAA for FY 2023 (Pub. L. 117-263). Section 845 of the NDAA for FY 2021 amends 10 U.S.C. 4864(a) to update the list of components for naval vessels at paragraphs (a)(2)(A) through (E). Subsequently, section 816 of the NDAA for FY 2022 added to the list of components for naval vessels welded shipboard anchor and mooring chain, without size restrictions, at 10 U.S.C. 4864(a)(2)(F). Section 845 also added components for T-AO 205 class vessels at 10 U.S.C. 4864(a)(4). Section 853 of the NDAA for FY 2023 added T-ARC class vessels at 10 U.S.C. 4864(a)(4) along with the component list for T-AO 205 class vessels. Section 1603 of the NDAA for FY 2021 added limitations on procurement of satellite star trackers at 10 U.S.C. 4864(a)(5).
No significant issues were raised by public comments regarding the initial regulatory flexibility analysis.
DoD reviewed data from the Federal Procurement Data System for FY 2021, 2022, and 2023, excluding contracts that do not exceed the simplified acquisition threshold, for the following product service codes: 7G22, 2835, 2010, 3815, 1040, 5925, 2040, beginning with 70 (for example, information technology hardware and software), and 7435. DoD made an average of 712 awards per year, of which 401 were made to small entities, an average of 56 percent awarded to small entities over the three fiscal years.
It is expected that this rule will benefit small businesses. The rule will continue to provide small businesses the opportunity to participate in the manufacture of star trackers for certain national security satellites and certain components for T‐AO 205 and T-ARC class vessels in support of the national technology and industrial base.
This rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses.
The rule exempts acquisitions equal to or less than the simplified acquisition threshold. There are no other known significant alternative approaches to the rule that would meet the requirements of the statute.
This final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 212, 225, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The additions read as follows:
(f) * * *
(x) * * *
(M) Use the clause at 252.225-7019, Restriction on Acquisition of Anchor and Mooring Chain, as prescribed in 225.7004-7(a), to comply with 10 U.S.C. 4864 and section 8041 of the Fiscal Year 1991 DoD Appropriations Act (Pub. L. 101-511) and similar sections in subsequent DoD appropriations acts.
(NN) Use the clause at 252.225-7063, Restriction on Acquisition of Components of T-AO 205 and T-ARC Class Vessels, as prescribed in 225.7004-7(c), to comply with 10 U.S.C. 4864.
(OO) Use the clause at 252.225-7064, Restriction on Acquisition of Certain Satellite Components, as prescribed in 225.7004-7(d), to comply with 10 U.S.C. 4864.
This section implements 10 U.S.C. 4864.
As used in this section—
Except as provided in 225.7004-3, do not acquire any of the following items, either as end products or components, unless the manufacturer of the items is part of the national technology and industrial base:
(a) Buses, if multipassenger motor vehicles are purchased, leased, rented, or made available under contracts for transportation services.
(b) Components for naval vessels, to the extent they are unique to marine applications (see also 225.7004-4 for implementation of the restriction for naval vessels):
(1) Gyrocompasses.
(2) Electronic navigation chart systems.
(3) Steering controls.
(4) Propulsion and machinery control systems.
(5) Totally enclosed lifeboats.
(6) Welded shipboard anchor and mooring chain. See also 225.7004-5.
(c) Large medium-speed diesel engines for new construction of auxiliary ships using funds available for National Defense Sealift Fund programs or Shipbuilding and Conversion, Navy.
(d) For T-AO 205 and T-ARC class vessels:
(1) Auxiliary equipment, including pumps, for all shipboard services.
(2) Propulsion system components, including engines, reduction gears, and propellers.
(3) Shipboard cranes.
(4) Spreaders for shipboard cranes.
(e) Star trackers.
(a)
(b)
(1) Buses manufactured outside the national technology and industrial base are needed for temporary use because buses manufactured in the national technology and industrial base are not available to satisfy requirements that cannot be postponed. Such use may not, however, exceed the lead time required for acquisition and delivery of buses manufactured in the national technology and industrial base.
(2) The requirement for buses is temporary in nature. For example, to meet a special, nonrecurring requirement or a sporadic and infrequent recurring requirement, buses manufactured outside the national technology and industrial base may be used for temporary periods of time. Such use may not however, exceed the period of time needed to meet the special requirement.
(3) Buses manufactured outside the national technology and industrial base are available at no cost to the U.S. Government.
(c)
(d)
(e)
(a) The statute at 10 U.S.C. 4864(h) prohibits the use of contract clauses or certifications to implement the restriction at 225.7004-2(b) for naval vessel components.
(b) Agencies shall accomplish implementation of the restriction at 225.7004-2(b) through use of management and oversight techniques that achieve the objectives of this section without imposing a significant management burden on the Government or the contractor involved.
(a) In accordance with section 8041 of the Fiscal Year 1991 DoD Appropriations Act (Pub. L. 101-511) and similar sections in subsequent DoD appropriations acts, do not acquire welded shipboard anchor and mooring chain, unless—
(1) It is manufactured in the United States, including cutting, heat treating, quality control, testing, and welding (both forging and shot blasting process); and
(2) The cost of the components manufactured in the United States exceeds 50 percent of the total cost of components.
(b) The statute at 10 U.S.C. 4864 also restricts acquisition of welded shipboard anchor and mooring chain, when used as a component of a naval vessel; however, the Appropriations Act restriction described in paragraph (a) of this section takes precedence over the restriction of 10 U.S.C. 4864 cited in 225.7004-2(b)(6).
(a)
(i) Sufficient domestic suppliers are not available to meet DoD requirements on a timely basis; and
(ii) The acquisition is necessary to acquire capability for national security purposes.
(2) Document the waiver in a written determination and findings containing—
(i) The factors supporting the waiver; and
(ii) A certification that the acquisition must be made in order to acquire capability for national security purposes.
(3) Provide a copy of the determination and findings to the House and Senate Committees on Appropriations.
(b)
(c)
(1)(i) USD(A&S), without power of delegation, may waive a restriction for a particular item for a particular foreign country upon determination that—
(A) U.S. producers of the item would not be jeopardized by competition from a foreign country, and that country does not discriminate against defense items produced in the United States to a greater degree than the United States discriminates against defense items produced in that country; or
(B) Application of the restriction would impede cooperative programs entered into between DoD and a foreign country, or would impede the reciprocal procurement of defense items under a memorandum of understanding providing for reciprocal procurement of defense items under 225.872, and that country does not discriminate against defense items produced in the United States to a greater degree than the United States discriminates against defense items produced in that country.
(ii) A notice of the determination to exercise the waiver authority shall be published in the
(iii) The effective period of the waiver shall not exceed 1 year.
(iv) For contracts entered into prior to the effective date of a waiver, provided adequate consideration is received to modify the contract, the waiver shall be applied as directed or authorized in the waiver to—
(A) Subcontracts entered into on or after the effective date of the waiver; and
(B) Options for the procurement of items that are exercised after the effective date of the waiver, if the option prices are adjusted for any reason other than the application of the waiver.
(2) The head of the contracting activity may waive a restriction on a case-by-case basis upon execution of a determination and findings that any of the following applies:
(i) The restriction would cause unreasonable delays.
(ii) Satisfactory quality items manufactured in the national technology and industrial base are not available.
(iii) Application of the restriction would result in the existence of only one source for the item in the national technology and industrial base.
(iv) Application of the restriction is not in the national security interests of the United States.
(v) Application of the restriction would adversely affect a U.S. company.
(3) A restriction is waived when it would cause unreasonable costs. The cost of an item of national technology and industrial base origin is unreasonable if it exceeds 150 percent of the offered price, inclusive of duty, of items that are not of national technology and industrial base origin.
(a) Unless a waiver has been granted, use the clause at 252.225-7019, Restriction on Acquisition of Anchor and Mooring Chain, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, that exceed the simplified acquisition threshold and that require welded shipboard anchor or mooring chain.
(b) Use the clause at 252.225-7062, Restriction on Acquisition of Large Medium-Speed Diesel Engines, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, that exceed the simplified acquisition threshold and that require large medium-speed diesel engines for new construction of auxiliary ships using funds available for National Defense Sealift Fund programs or Shipbuilding and Conversion, Navy unless—
(1) An exception at 225.7004-3(d) applies; or
(2) A waiver has been granted.
(c) Unless a waiver has been granted, use the clause at 252.225-7063, Restriction on Acquisition of Components of T-AO 205 and T-ARC Class Vessels, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, that exceed the simplified acquisition threshold and that require components of T-AO 205 and T-ARC class vessels.
(d) Use the clause at 252.225-7064, Restriction on Acquisition of Certain Satellite Components, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, that exceed the simplified acquisition threshold unless—
(1) An exception at 225.7004-3(e) applies; or
(2) A waiver has been granted.
The revisions read as follows:
As prescribed in 225.7004-7(a), use the following clause:
(a)
As prescribed in 225.7004-7(c), use the following clause:
(a)
(1) In accordance with 10 U.S.C. 4864, the following components of T-AO 205 and T-ARC class vessels must be manufactured in the United States, Australia, Canada, New Zealand, or the United Kingdom of Great Britain and Northern Ireland (United Kingdom):
(i) Auxiliary equipment, including pumps, for all shipboard services.
(ii) Propulsion system components, including engines, reduction gears, and propellers.
(iii) Shipboard cranes.
(iv) Spreaders for shipboard cranes.
(2) The Contractor shall deliver under this contract only T-AO 205 and T-ARC class vessel components, as described in paragraph (a)(1) of this clause, manufactured in the United States, Australia, Canada, New Zealand, or the United Kingdom (10 U.S.C. 4864).
(b)
As prescribed in 225.7004-7(d), use the following clause:
(a)
(b)
(c)
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act of Fiscal Year 2021 that provides restrictions on the acquisition of certain covered materials from The Democratic People's Republic of North Korea, The People's Republic of China, The Russian Federation, and The Islamic Republic of Iran.
Effective May 30, 2024.
Kimberly Bass, telephone 703-717-3446.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. A discussion of the comments and the changes made to the rule as a result of those comments is provided, as follows:
Revisions were made at DFARS 225.7018-2 to implement the new effective date of the restriction in accordance with section 854 of the NDAA for FY 2024. Consequently, the dates of the current restrictions were revised to provide an effective date through December 31, 2026, and to reflect that the new restrictions will be effective on January 1, 2027. Conforming revisions were also made in the DFARS clause at 252.225-7052, Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten.
In regard to further expanding the restriction to include cobalt metal powder and refined cobalt, the statutory restriction includes, for samarium-cobalt magnets, the entire supply chain from mining or production of a cobalt and samarium ore, through production of finished magnets. (Also see the response provided for the comment category at 8b, Commercially Available Off-the-Shelf (COTS) Items Applicability.)
The statutory sourcing requirement is important to transition supply chains to secure suppliers of strategic and critical materials. The existing regulations authorize DoD to issue individual and class nonavailability determinations if needed for national security in cases where compliant materials are not available. The process for class nonavailability determinations also provides opportunity for interested parties and manufacturers to provide information to DoD regarding the availability of compliant materials that would be relevant to the decision.
As provided at DFARS 225.7018-4, the Under Secretary of Defense for Acquisition and Sustainment (USD(A&S)) must issue a public notice of the intent to make a class nonavailability determination at least 30 days prior to issuing the nonavailability determination, to the maximum extent practicable consistent with the protection of national security. Following the public notice, interested parties, including producers of covered materials, may provide relevant information. The USD(A&S) will take the information provided into consideration when determining whether to issue a class nonavailability determination. When issuing the final class nonavailability determination, the USD(A&S) will ensure that the class nonavailability determination and supporting rationale will be made publicly available, consistent with the protection of national security and confidential business information.
This rule amends the clause at DFARS 252.225-7052, Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten. However, this final rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items. DFARS 252.225-7052 does not apply to acquisitions below the SAT, in accordance with 41 U.S.C. 1905, but it applies to contracts for the acquisition of commercial products, including COTS items, except as provided in the statute at 10 U.S.C. 4872(c)(3).
This rule will impact the Government and industry because this rule significantly expands the scope of compliance in accordance with section 844 of the NDAA for FY 2021, section 854 of the FY 2024 NDAA, and 10 U.S.C. 4872.
The current restriction at DFARS 225.7018-2 covers the melting of precursor metals (
This rule expands the scope of product coverage to all upstream mining, refining, separation, and melting of covered materials. Taken together with the overlapping restriction requirement on specialty metals at 225.7003-2 and the clause at DFARS 252.225-7009, Restriction on Acquisition of Specialty Metals, covered materials that are compliant with the
For example, assume that a contractor purchases a component from a United Kingdom-based supplier, and the assembly contains a samarium-cobalt magnet manufactured in China. This component would be compliant with the specialty metals clause, because the specialty metals clause exempts qualifying country components. However, this rule has no exemption for qualifying country components, and thus the assembly would be noncompliant with the current restriction at DFARS 225.7018-2 and the clause at DFARS 252.225-7052, Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten, in its current form and as amended by this rule.
Further, assume that a company purchases a motor from a U.S. manufacturer, and that U.S. motor manufacturer purchases a magnet from a U.S. company. The U.S. magnet company purchases cobalt metal and samarium metal from China, and these metals are melted in the United States. This magnet would be compliant with both the restriction required by the specialty metals clause at DFARS 252.225-7009, Restriction on Acquisition of Specialty Metals, and the current restriction at 225.7018-2 and the clause at DFARS 252.225-7052, Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten. However, this magnet would not be compliant with the requirements that will be effective on January 1, 2027.
Further, assume that a company produces business jets and modifies them for military use. During a given year, the business jet manufacturer purchases 50 percent of its samarium-cobalt magnet needs from a U.S. source that mines and conducts all subsequent processing steps in the United States. The balance of the company's samarium-cobalt magnets is procured from Chinese sources and the company commingles domestically and Chinese-produced magnets on its production line. In this scenario, the modified business jet is compliant with the restriction at DFARS 225.7003-2 and the clause at DFARS 252.225-7009, Restriction on Acquisition of Specialty Metals, because it is a commercial derivative military article, and the company procures 50 percent of its total needs from a domestic source. However, the modified business jet is potentially noncompliant with the final rule, given the commingling of Chinese and U.S. samarium-cobalt magnets in each aircraft.
Notwithstanding the significant change in scope, DoD notes that Congress enacted this requirement on January 1, 2021, through Public Law 116-283. This five-year phase-in period, now revised to six years by section 854 of the NDAA for FY 2024, provides a reasonable period for industry to develop alternative sources of supply for covered materials from sources other than the People's Republic of China, the Russian Federation, the Democratic People's Republic of North Korea, and the Islamic Republic of Iran.
DoD also notes that it has invested and continues to invest in domestic supply chains for covered materials, such as light and heavy rare earth elements and rare earth magnet manufacture, using authorities under 50 U.S.C. 4533 and 10 U.S.C. 4817 among others. For those materials not currently covered by DoD investments, such as tantalum and tungsten, publicly-traded U.S. companies, including DoD contractors and their subcontractors, already are required to conduct supply chain due diligence on these minerals when they are necessary to the functionality or production of a product manufactured by that company. This requirement stems from section 1502 of Public Law 111-203 (enacted at 17 CFR 240.13p-1) to ensure that such minerals are not supporting armed conflict in the Democratic Republic of Congo and adjoining countries.
The principal benefit of this rule is that it continues to transition the defense industrial base towards the procurement of strategic and critical materials from sources other than North Korea, Russia, Iran, or the People's Republic of China, with the latter constituting the pacing challenge identified in the National Defense Strategy. Notwithstanding the current and long-term challenge posed by China, Russia continues to pose an acute threat. Russia is a major producer and exporter of a wide array of strategic and critical materials, and the extreme volatility in these markets since Russia's invasion of Ukraine demonstrates the national security imperative to build resilience into supply chains for covered materials of this rule.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
As required by the Congressional Review Act (5 U.S.C. 801-808) before an interim or final rule takes effect, DoD will submit a copy of the interim or final rule with the form, Submission of Federal Rules under the Congressional Review Act, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the Congressional Review Act cannot take effect until 60 days after it is published in the
A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is required to implement section 844 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2021 (Pub. L. 116-283), which amends 10 U.S.C. 2533c (now 10 U.S.C. 4872), and section 854 of the NDAA for FY 2024 (Pub. L. 118-31). The objective of the rule is to implement the section 844 revisions to the restriction on the acquisition of covered materials melted or produced in any covered country (
There were no significant issues raised by the public comments in response to the initial regulatory flexibility analysis.
Based on data from the Federal Procurement Data System for FY 2021, 2022, and 2023, DoD awarded in the United States 26,697 contracts that exceeded the simplified acquisition threshold of $250,000 and were for the acquisition of manufactured end products, excluding those categories that could not include restricted metals (such as clothing and fabrics, books, or lumber products). These contracts were awarded to a total of 3,127 unique entities, of which 1,783 were unique small entities; contracts were awarded to a median of 611 unique small entities per year. It is not known what percentage of these awards involved the specific covered materials from China, North Korea, Russia, or Iran.
There are no projected reporting or recordkeeping requirements. However, there may be compliance costs to track the origin of covered materials.
DoD is exempting acquisitions equal to or less than the simplified acquisition threshold in accordance with 41 U.S.C. 1905. DoD was unable to identify any other alternatives that would reduce burden on small businesses and still meet the objectives of the statute.
This final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR parts 225 and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
This section implements 10 U.S.C. 4872.
(a)
(1) Effective through December 31, 2026, do not acquire any covered material melted or produced in any covered country, or any end item, manufactured in any covered country, that contains a covered material; and
(2) Effective January 1, 2027, do not acquire any covered material mined, refined, separated, melted, or produced in any covered country, or any end item, manufactured in any covered country, that contains a covered material. (Section 854, Pub. L. 118-31; 10 U.S.C. 4872.)
(b)
(i) Melting samarium with cobalt to produce the samarium-cobalt alloy or melting neodymium with iron and boron to produce the neodymium-iron-boron alloy; and
(ii) All subsequent phases of production of the magnets, such as powder formation, pressing, sintering or bonding, and magnetization.
(2) Effective January 1, 2027, for samarium-cobalt magnets this restriction includes the entire supply chain from mining or production of a cobalt and samarium ore or feedstock, including recycled material, through production of finished magnets, except as provided at 225.7018-3.
(3) The restriction on melting and producing of samarium-cobalt magnets is in addition to any applicable restrictions on melting of specialty metals at 225.7003 and the clause at 252.225-7009, Restriction on Acquisition of Certain Articles Containing Specialty Metals.
(4) Effective January 1, 2027, for neodymium-iron-boron magnets, this restriction includes the entire supply chain from mining of neodymium, iron, and boron through production of finished magnets, except as provided at 225.7018-3.
(c)
(2) Effective January 1, 2027, for production of tantalum metals of any kind and alloys, this restriction includes mining or production of a tantalum ore or feedstock, including recycled material, through production of metals of any kind and alloys, except as provided at 225.7018-3.
(d)
(i) Atomization;
(ii) Calcination and reduction into powder;
(iii) Final consolidation of non-melt derived metal powders; and
(iv) All subsequent phases of production of tungsten metal powder, tungsten heavy alloy, or any finished or semi-finished component containing tungsten heavy alloy.
(2) Effective January 1, 2027, for production of tungsten metal powder, tungsten heavy alloy, or any finished or semi-finished component containing tungsten heavy alloy, this restriction includes mining or production of a tungsten ore or feedstock, including recycled material, through production of tungsten metal powders, except as provided at 225.7018-3.
The revision reads as follows:
(c) * * *
(1) A commercially available off-the-shelf item (but see PGI 225.7018-3(c)(1) with regard to commercially available samarium-cobalt magnets), other than—
(i) A commercially available off-the-shelf item that is—
(A) 50 percent or more tungsten by weight effective through December 31, 2026; or
(B) 50 percent or more covered material by weight effective January 1, 2027;
(ii) Effective through December 31, 2026, a tantalum metal, tantalum alloy, or tungsten heavy alloy mill product, such as bar, billet, slab, wire, cube, sphere, block, blank, plate, or sheet, that has not been incorporated into an end item, subsystem, assembly, or component; or
(iii) Effective January 1, 2027, a covered material that is a mill product such as bar, billet, slab, wire, cube, sphere, block, blank, plate, or sheet, that has not been incorporated into an end item, subsystem, assembly, or component;
The revisions read as follows:
(b)
(i) Effective through December 31, 2026, the Contractor shall not deliver under this contract any covered material melted or produced in any covered country, or any end item, manufactured in any covered country, that contains a covered material; and
(ii) Effective January 1, 2027, the Contractor shall not deliver under this contract any covered material mined, refined, separated, melted, or produced in any covered country, or any end item, manufactured in any covered country, that contains a covered material (section 854, Pub. L. 118-31; 10 U.S.C. 4872).
(2)(i)(A) Effective through December 31, 2026, for samarium-cobalt magnets and neodymium-iron-boron magnets, this restriction includes—
(
(
(B) Effective January 1, 2027, for samarium-cobalt magnets this restriction includes the entire supply chain from mining or production of a cobalt and samarium ore or feedstock, including recycled material, through production of finished magnets.
(ii) The restriction on melting and producing of samarium-cobalt magnets is in addition to any applicable restrictions on melting of specialty metals if the clause at 252.225-7009, Restriction on Acquisition of Certain Articles Containing Specialty Metals, is included in the contract.
(3) Effective January 1, 2027, for neodymium-iron-boron magnets, this restriction includes entire supply chain from mining of neodymium, iron, and boron through production of finished magnets.
(4)(i) Effective through December 31, 2026, for production of tantalum metals of any kind and alloys, this restriction includes the reduction or melting of any form of tantalum to create tantalum metal including unwrought, powder, mill products, and alloys. The restriction also covers all subsequent phases of production of tantalum metals and alloys.
(ii) Effective January 1, 2027, for production of tantalum metals of any kind and alloys, this restriction includes mining or production of a tantalum ore or feedstock, including recycled material, through production of metals of any kind and alloys.
(5)(i) Effective through December 31, 2026, for production of tungsten metal powder and tungsten heavy alloy, this restriction includes—
(A) Atomization;
(B) Calcination and reduction into powder;
(C) Final consolidation of non-melt derived metal powders; and
(D) All subsequent phases of production of tungsten metal powder, tungsten heavy alloy, or any finished or semi-finished component containing tungsten heavy alloy.
(ii) Effective January 1, 2027, for production of tungsten metal powder, tungsten heavy alloy, or any finished or semi-finished component containing tungsten heavy alloy, this restriction includes mining or production of a tungsten ore or feedstock, including recycled material, through production of tungsten metal powders, tungsten heavy alloy, or any finished or semi-finished component containing tungsten heavy alloy.
(c)
(1) To an end item containing a covered material that is—
(i) A commercially available off-the-shelf item, other than—
(A) A commercially available off-the-shelf item that is—
(
(
(B) Effective through December 31, 2026, a tantalum metal, tantalum alloy, or tungsten heavy alloy mill product, such as bar, billet, slab, wire, cube, sphere, block, blank, plate, or sheet, that has not been incorporated into an end item, subsystem, assembly, or component;
(ii) Effective January 1, 2027, a covered material that is a mill product such as bar, billet, slab, wire, cube, sphere, block, blank, plate, or sheet, that has not been incorporated into an end item, subsystem, assembly, or component;
(iii) An electronic device, unless otherwise specified in the contract; or
(iv) A neodymium-iron-boron magnet manufactured from recycled material if the milling of the recycled material and sintering of the final magnet takes place in the United States.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule; technical amendment.
DoD is amending the Defense Federal Acquisition Regulation Supplement (DFARS) to make needed editorial changes.
Effective May 30, 2024.
Ms. Jennifer D. Johnson, Defense Acquisition Regulations System, telephone 703-717-8226.
This final rule amends the DFARS to make needed editorial changes to update two outdated hyperlinks at DFARS 252.204-7012.
Government procurement.
Therefore, 48 CFR part 252 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The revision reads as follows:
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), are issuing this final rule to comply with a court order to vacate Subunit 4b and a portion of Unit 3 in Arizona from the March 5, 2014, final rule designating lands in Arizona as critical habitat for the jaguar (
This rule is effective May 30, 2024. However, the court order had legal effect immediately upon being filed on August 11, 2023.
Heather Whitlaw, U.S. Fish and Wildlife Service, 9828 North 31st Avenue #C3, Phoenix, AZ 85051; telephone: 602-242-0210; email at
On March 5, 2014, we published in the
On July 22, 2021, we published in the
In 2016, we issued a biological opinion, as required under the Act (16 U.S.C. 1536), regarding the development of a copper mine by the Rosemont Copper Company (Rosemont) on lands administered by the Coronado National Forest. The action area of the proposed mine and associated infrastructure included portions of the critical habitat designation for the jaguar, specifically portions of Unit 3 and Subunit 4b. In our biological opinion, we found that the proposed mine was not likely to jeopardize the continued existence of the jaguar or result in the destruction or adverse modification of its critical habitat.
On September 25, 2017, the Center for Biological Diversity filed a lawsuit against the Service and the U.S. Forest Service. The Center for Biological Diversity alleged that we violated the Act and the Administrative Procedure Act (APA; 5 U.S.C. 551
Rosemont appealed the district court decision to the U.S. Court of Appeals for the Ninth Circuit. On May 17, 2023, the appellate court affirmed in part and reversed in part the decision of the district court and remanded the relevant portions of the jaguar critical habitat rule for proceedings consistent with its decision. See
This rulemaking is necessary to comply with the August 11, 2023, court order remanding to the agency to vacate the critical habitat designations challenged by Rosemont. Therefore, under these circumstances, the Service Director (Director) has determined, pursuant to 5 U.S.C. 553(b)(3)(B), that prior notice and opportunity for public comment are impracticable and unnecessary. Because the court order had legal effect immediately upon being filed on August 11, 2023, the Director has further determined, pursuant to 5 U.S.C. 553(d)(3), that the agency has good cause to make this rule effective immediately upon publication.
This rule is an administrative action to remove approximately 64,797 acres (26,222 hectares) of land within Arizona from the jaguar's critical habitat designation at 50 CFR 17.95(a).
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below.
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(a) * * *
(5)
(6) Units 1, 2, 3, and 4: Baboquivari, Atascosa, Patagonia, and Whetstone Units, Pima, Santa Cruz, and Cochise Counties, Arizona. Map of Units 1, 2, 3, and 4 follows:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; correction.
This action makes two corrections to the 2024 Area 2A Pacific halibut recreational management measures implemented on April 4, 2024. Specifically, NMFS is correcting the open fishing dates listed for the Washington South Coast subarea fishery and a reference to the subarea allocation amount for the Oregon Central Coast nearshore fishery. The date and allocation corrections are to address minor inadvertent transcriptional errors, non-substantive changes to the final rule, and this rule is needed to avoid confusion with the public, enforcement, and management agencies.
Effective May 29, 2024.
Melissa Mandrup, phone: 562-980-3231, or email:
NMFS manages the Pacific halibut fishery in International Pacific Halibut Commission (IPHC) Regulatory Area 2A (waters off Washington, Oregon, and California) in accordance with the Northern Pacific Halibut Act of 1982 (Halibut Act), 16 U.S.C. 773-773k. As provided in the Halibut Act, the regional fishery management council having authority for the geographic area concerned may develop, and the Secretary of Commerce may implement, regulations governing Pacific halibut fishing in U.S. waters that are in addition to, and not in conflict with, approved IPHC regulations (16 U.S.C. 773c(c)). Since 1988, the Pacific Fishery Management Council (Council) has developed a Catch Sharing Plan, through the Council's public process, that allocates the Area 2A Pacific halibut catch limit, also known as the Fishery Constant Exploitable Yield (FCEY), between treaty tribal and non-tribal harvesters, and among non-tribal commercial and recreational (sport) fisheries, and adopts management measures for these fisheries. NMFS has implemented at 50 CFR 300.63
On page 22967 of the final rule, NMFS inadvertently excluded 2 days the Washington Department of Fish and Wildlife (WDFW) and the Council intended the fishery to be open in the Washington South Coast subarea: May 28 and 30. At its November meeting, the Council recommended NMFS implement specific season dates for fishing in the Washington South Coast subarea. These dates were developed through public meetings held by WDFW, as well as at the Council's September and November meetings. Specifically, the Council recommended to NMFS, based on WDFW's recommendation, that fishing days in the Washington South Coast subarea be “Open May 2 through May 30, three days per week, Thursday, Sunday, and Tuesday. Memorial Day weekend: open Thursday, May 23. If sufficient quota remains, open June 13, 16, 18, 20, 23, 25, 27, 30. If quota remains after June 30, open up to seven days per week in August and September.” However, the final rule inadvertently excluded the last Tuesday and Thursday in May: May 28 and 30.
As such, consistent with the intent of the Council, the corrected season dates for the Washington South Coast subarea in May are: May 2, 5, 7, 9, 12, 14, 16, 19, 21, 23, 28, and 30. Closed May 25, 26 and 27.
Under the allocation framework the Council adopted in the Catch Sharing Plan, the Oregon recreational fishery is allocated 29.7 percent of the non-tribal share of the FCEY. The Oregon recreational fishery allocation is further allocated to two subareas; the Oregon Central Coast receiving 93.79 percent and Southern Oregon receiving 3.91 percent (up to 8,000 pounds (lb) [3.6 metric tons [mt]] with the remainder going to the Columbia River subarea). The Oregon Central Coast subarea allocation is further divided into the nearshore fishery receiving 12 percent, the spring all-depth fishery receiving 63 percent, and the summer all-depth fishery receiving 25 percent. Consistent with the allocation the IPHC set for Area 2A in 2024 (89 FR 19275, March 18, 2024) and this framework, the overall Oregon Central Coast subarea allocation is 266,161 lb (120.7 mt) and the nearshore fishery allocation should therefore be 31,939 lb (14.5 mt). However, page 22968 of the final rule incorrectly states the pounds allocated to the nearshore fishery as 31,393 lb (14.5 mt). Therefore, this action corrects that value and establishes the Oregon Central Coast nearshore fishery allocation at 31,939 lb (14.5 mt). The amount in metric tons of 14.5 mt was stated correctly in the original final rule.
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Assistant Administrator for Fisheries determined there is good cause to waive prior notice and an opportunity for public comment on this action as notice and comment would be impracticable and contrary to the public interest because this action is necessary to correct an inadvertent error in a final rule (89 FR 22966).
Immediate correction of the error is necessary to prevent confusion among participants in the fishery and to ensure that management of the fishery is consistent with State Fish and Wildlife agency recommendations, which were developed with stakeholder feedback, and the Council's intent for the regulations, as developed over two public meetings. The proposed regulations were available for public review during a 30-day public comment period in the proposed rule (89 FR 9105, February 9, 2024), and the final rule (89 FR 22966, April 3, 2024) provided responses to the comments received. Therefore, there is good cause to waive additional public comment and immediate correction of the error is needed to meet the public's expectations based on recommendations made in the Council's 2024 Catch Sharing Plan and in outreach materials distributed by the States of Washington and Oregon. Delaying this correction to engage in notice-and-comment rulemaking would be contrary to the public interest because it would undermine the intent of the rule.
Under section 553(d) of the APA, an agency must delay the effective date of regulations for 30 days after publication, unless the agency finds good cause to make the regulations effective sooner. For the same reasons stated above, the Assistant Administrator for Fisheries has determined good cause exists to waive the 30-day delay in effectiveness. This rule makes only two minor corrections to the final rule, which became effective April 4, 2024. Delaying effectiveness of these corrections would result in conflicts in the regulations and confusion among fishery participants, and would therefore be contrary to the public interest. Additionally, without waiving the 30-day delay in effectiveness, this correction to the season dates would not be effective by May 28 and 30, which the final rule inadvertently omitted as open fishing days in the Washington South Coast subarea, but which were intended to be included.
The Regulatory Flexibility Act, 5 U.S.C. 603 and 604, requires an agency to prepare an initial and a final regulatory flexibility analysis whenever an agency is required by section 553 of the APA, or any other law, to publish a general notice of proposed rulemaking. Because NMFS found good cause under section 553(b)(3)(B) of the APA to forgo publication of a notice of proposed rulemaking, the regulatory flexibility analyses described in 5 U.S.C. 603 and 604 are not required for this rulemaking.
This final rule is not significant under Executive Order 12866.
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
Following the Atlantic States Marine Fisheries Commission's (Commission) withdrawal of Lobster Conservation Management Area 2 and 3 ownership caps and Area 3 maximum trap cap reductions from its Interstate Fishery Management Plan for American Lobster (Lobster Plan), this action
As of July 1, 2024, the revision to § 697.19(c) and (m) in amendatory instruction 6 of the IFR, 88 FR 67667, 67687-67679 (October 2, 2023), is withdrawn.
You may request copies of the supplemental information report prepared for this action at: National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930-2276 or by calling (978) 281-9315. The supporting document is also accessible via the internet at:
Allison Murphy, Fishery Policy Analyst, (978) 281-9122.
These regulations modify Federal lobster fishery management measures in the Exclusive Economic Zone (EEZ) under the authority of section 803(b) of the Atlantic Coastal Act. This authority states that, in the absence of an approved and implemented Fishery Management Plan under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801
The purpose of this action is to manage the American lobster fishery to maximize resource sustainability, recognizing that Federal management occurs in concert with State management and compatibility between State and Federal measures is crucial to the overall success of American lobster management and required by the Atlantic Coastal Act. NMFS indicated that the agency could make changes to the IFR measures and requested comment on that possibility in the IFR, see 88 FR at 67669; see also 87 FR 41084 (July 11, 2022) (proposed rule requesting comments on measures ultimately included in the IFR); 82 FR 52871 (November 15, 2017) (advance notice of proposed rulemaking (ANPR) requesting comments on change to control date for trap limits in Areas 2 and 3); 79 FR 4319 (January 27, 2014) (ANPR establishing control date and requesting comments). In light of public comments received and to achieve the purpose of the Atlantic Coastal Act, we are withdrawing the Area 2 and 3 ownership caps and Area 3 maximum trap cap reductions that we implemented in the IFR.
The IFR implemented ownership caps in Areas 2 and 3 and maximum trap cap reductions in Area 3, effective May 1, 2025. These measures complemented the Commission's Addenda XXI and XXII to Amendment 3 to the Lobster Plan, both of which were approved by the Commission in 2013. The objective of these addenda was to scale the southern New England lobster fishery to the diminished size of the resource by addressing latent effort in the fishery and reducing trap limits in an attempt to control harvest to allow for potential stock rebuilding. A full description of those measures is included in the IFR and not repeated here.
During the proposed rule (87 FR 41084, July 11, 2022) comment period, we received several comments stating that our management partners and industry needed additional time to understand these measures, consider them in the current context of the fishery, and provide adequate comment. We delayed implementation of the measures until May 1, 2025, while we accepted additional public comments on these measures as provided in the IFR, which indicated that we would consider any additional comments received and would, if necessary and appropriate, publish a subsequent rule to address any changes. See 88 FR at 67669.
On January 23, 2024, the Commission's Lobster Board withdrew its prior recommendation for implementation of Area 2 and 3 ownership caps and Area 3 maximum trap cap reductions, determining that these measures are no longer relevant in the current context of the fishery. On February 12, 2024, the Commission confirmed the decision of the Lobster Board in a letter to NMFS, citing numerous ways in which the fishery in these Areas has changed. The Commission noted that while the Addenda that originally called for the Area 2 and 3 measures attempted to prevent consolidation, the lag time between Commission approval and NMFS implementation has allowed for consolidation to occur, removing the need for these specific measures. In addition, the Commission expressed concern that the implementation of these measures would change how permits and traps will be bought and sold. The Commission also explained the economics of the fishery in these areas and changing operational needs of harvesters to maintain their businesses, citing increased costs, loss of fishing grounds due to other ocean uses, additional management measures on the American lobster fishery to reduce the risk to North Atlantic right whales posed by the fishery, and the evolution of the fishery in these areas from a lobster fishery to a mixed-crustacean fishery targeting both lobsters and Jonah crabs.
The Atlantic Coastal Act provides that the Secretary “may implement regulations” affecting fisheries also regulated by the Commission if no fishery management plan exists pursuant to the Magnuson-Stevens Act and the regulations are “compatible with the effective implementation of a coastal fishery management plan.” 16 U.S.C. 5103(b)(1)(A). Removing the Area 2 and 3 measures ensures that Federal regulations continue to complement the Commission's Lobster Plan. Further, this action will minimize confusion between State and Federal requirements. If we do not remove these Area 2 and 3 measures, there would be inconsistent State and Federal lobster regulations, potentially undermining management of the fishery.
The IFR also implemented mandatory electronic harvester reporting requirements and corrections. This final
As noted above, the IFR delayed implementation of certain measures and solicited public comment on them. The comment period ended on December 1, 2023. We received comments from 10 groups: The Atlantic Offshore Lobstermen's Association (AOLA), the Animal Welfare Institute, a group of environmental organizations, 6 members of the fishing industry, and 1 member of the public. Only comments that were applicable to the proposed measures are addressed below.
The NMFS Assistant Administrator has determined that this final rule is consistent with the Atlantic Coastal Fisheries Cooperative Management Act, applicable provisions of the Magnuson-Stevens Fishery Conservation and Management Act, and other applicable law. The agency finds public comment is unnecessary under the Administrative Procedure Act. See 5 U.S.C. 553(b)(B). The Atlantic Coastal Act requires Federal regulations to be “compatible with the effective implementation of a coastal fishery management plan,” 16 U.S.C. 5103(b)(1)(A), and following the Commission's modification of the Lobster Plan, the only regulatory option to ensure the regulations are compatible with the revised plan is to maintain the status quo,
This final rule has been determined to not be significant for purposes of Executive Order 12866.
A final regulatory flexibility analysis (FRFA) was prepared for this action and described in the IFR. The FRFA incorporated the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA and NMFS responses to those comments, and a summary of the analyses completed to support the action. The IRFA and FRFA analyzed the suite of measures considered during this rulemaking, including actions that minimize impacts to small entities. Therefore, the analysis included in the FRFA remains valid. This final rule would remove some of the measures in the IFR, and will, therefore, reduce the overall costs of this action.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, letters to permit holders that also serves as this small entity compliance guide were prepared at both the interim final rule and this final rule stage. Copies of these guide and this rule are available upon request from the Greater Atlantic Regional Office (see
This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
Fisheries, Fishing.
For the reasons set out in the preamble, 50 CFR part 697 is amended as follows:
16 U.S.C. 1501
Office of Personnel Management.
Proposed rule.
The Office of Personnel Management (OPM) is proposing a rule to abolish the Calhoun, Alabama (AL), nonappropriated fund (NAF) Federal Wage System (FWS) wage area and define Calhoun County, AL, to the Cobb, Georgia, NAF FWS wage area, and Jefferson County, AL, to the Madison, AL, NAF FWS wage area. These changes are necessary because NAF FWS employment in the survey area is now below the minimum criterion of 26 wage employees to maintain a wage area, and the local activities no longer have the capability to conduct local wage surveys.
Send comments on or before July 1, 2024.
You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) and title, by the following method:
•
All comments received must include the agency name and docket number or RIN for this document. The general policy for comments from members of the public is to make them available for public viewing at
Ana Paunoiu, by telephone at (202) 606-2858 or by email at
Under 5 CFR 532.219, OPM may establish a NAF wage area when there are a minimum of 26 NAF wage employees in the survey area, a local activity has the capability to host annual local wage surveys, and the survey area has at least 1,800 private enterprise employees in establishments within survey specifications. The Calhoun, AL, NAF FWS wage area is presently composed of one survey county, Calhoun County, AL, and one area of application county: Jefferson County, AL. The Department of Defense (DOD) notified OPM that there has been a continuing decline of NAF FWS employment in the survey area and the local activities no longer have the capability to conduct local wage surveys. Currently, 15 DOD NAF FWS employees work in Calhoun County.
Since Jefferson County, AL, will have continuing NAF employment and does not meet the regulatory criteria under 5 CFR 532.219 to be a separate survey area, it must be defined as an area of application to another wage area. Section 532.219 lists the regulatory criteria OPM considers when defining FWS wage area boundaries. This rulemaking allows consideration of the following criteria: proximity of largest activity in each county, transportation facilities and commuting patterns, and similarities of the counties in overall population, private employment in major industry categories, and kinds and sizes of private industrial establishments.
In selecting a wage area to which Calhoun County, AL, should be redefined, proximity favors the Cobb, GA, NAF wage area. All other criteria are indeterminate. Based on these findings, OPM is defining Calhoun County as an area of application to the Cobb NAF wage area.
In selecting a wage area to which Jefferson County, AL, should be redefined, proximity favors the Madison, AL, NAF wage area. All other criteria are indeterminate. Based on these findings, OPM is defining Jefferson County as an area of application to the Madison NAF wage area.
The Cobb, GA, wage area would consist of one survey county (Cobb County, GA), and 4 area of application counties (Calhoun County, AL; and Bartow, De Kalb, and Fulton Counties, GA).
The Madison, AL, wage area would consist of one survey county (Madison, AL) and 5 area of application counties (Coffee, Davidson, Hamilton, Jefferson, and Rutherford Counties, AL).
The Federal Prevailing Rate Advisory Committee, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended these changes by consensus. These changes would be effective on the first day of the first applicable pay period beginning on or after 30 days following publication of the final regulations.
Section 5343 of title 5, U.S. Code, provides OPM with the authority and responsibility to define the boundaries of NAF FWS wage areas. Any changes in wage area definitions can have the long-term effect of increasing pay for Federal employees in affected locations. OPM expects this rulemaking to impact approximately 21 NAF FWS employees. Considering the small number of employees affected, OPM does not anticipate that this proposed rule will substantially impact local economies or have a large impact in local labor markets. However, OPM is requesting comment in this rulemaking regarding the impact. As this and future wage area changes may impact higher volumes of employees in geographical areas and could rise to the level of impacting local labor markets, OPM will continue to study the implications of such impacts in this or future rules as needed.
OPM has examined the impact of this rulemaking as required by Executive Orders 12866, 13563, and 14094, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). OMB has determined that this rulemaking is not a “significant regulatory action” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094.
The Director of OPM certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities.
OPM has examined this rulemaking in accordance with Executive Order 13132, Federalism, and has determined that this rule will not have any negative impact on the rights, roles and responsibilities of State, local, or tribal governments.
This rulemaking meets the applicable standard set forth in Executive Order 12988.
This rulemaking will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rulemaking does not impose any reporting or record-keeping requirements subject to the Paperwork Reduction Act.
Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.
Accordingly, OPM is proposing to amend 5 CFR part 532 as follows:
5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement sections of the National Defense Authorization Acts for Fiscal Year 2022 and Fiscal Year 2024 that authorize DoD to establish a pilot program that allows for the noncompetitive award of certain follow-on contracts to certain employee-owned businesses.
Comments on the proposed rule should be submitted in writing to the address shown below on or before July 29, 2024, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2024-D004, using either of the following methods:
○
○
Comments received generally will be posted without change to
Ms. Jeanette Snyder, telephone 703-508-7524.
DoD is proposing to revise the DFARS to implement section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) as amended by section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note). Sections 874 and 872 authorize DoD to establish a pilot program that allows for the noncompetitive award of certain follow-on contracts to employee-owned businesses that meet the definition of a qualified business. The Office of the Under Secretary of Defense (Acquisition and Sustainment), Defense Pricing and Contracting implemented section 874 via a contract policy memorandum dated November 8, 2022.
This rule proposes to add new DFARS part 270, Defense Contracting Programs, to include new subpart 270.X, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, to implement section 874 of the NDAA for FY 2022 and section 872 of the NDAA for FY 2024. This proposed new part 270 will contain contracting programs that are unique to DoD but are not socioeconomic programs such as those located in DFARS part 226, Other Socioeconomic Programs. The proposed subpart 270.X provides the scope, definition, policy, limitations, procedures, solicitation provisions, and contract clause associated with the pilot program. This proposed rule, at DFARS 270.X02, Policy, authorizes contracting officers to award one sole-source, follow-on contract for the continued development, production, or provision of products or services that are the same or substantially similar to those procured under previous contracts awarded by or for DoD to contractors that meet the definition of a qualified business. Although section 874 allows for noncompetitive awards, the proposed rule requires such awards to be supported by written justifications and approvals as required at Federal Acquisition Regulation (FAR) 6.303 and FAR 6.304.
Under the pilot program, contracts are awarded to qualified businesses. Therefore, a definition of “qualified business” is added to DFARS 270.X01, Definition, as follows: An S corporation as defined in 26 U.S.C. 1361(a)(1) for which 100 percent of the outstanding stock is held through an employee stock ownership plan as defined in 26 U.S.C. 4975(e)(7).
The proposed rule, at 270.X03, Limitations, specifies that—
• Only a contracting officer may submit an application to participate in the pilot program;
• Contracting officers may only award contracts to contractors that meet the definition of a qualified business;
• Contracting officers may only award one sole-source, follow-on contract to a qualified business for each predecessor contract, unless a waiver is obtained; and
• Unless waived, a qualified business shall not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not qualified businesses, except when the contract is for a product and subcontracts for materials are not available from another qualified business.
Proposed section 270.X00, Scope of subpart, provides references to the NDAA sections implemented by the subpart. In addition, this section also advises contracting officers the authority to award contracts under the pilot program expires on December 27, 2029.
The proposed solicitation provision, 252.270-70WW, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation, requires offerors to represent that they are a qualified business. The proposed solicitation provision, 252.270-70XX, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Subcontracting Certification, requires offerors to certify that they will comply with the limitations on subcontracting.
The proposed contract clause, 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, requires contractors to comply with the limitations on subcontracting. In addition, the clause specifies the information contractors are required to report to contracting officers not later than 30 days after the end of the period of performance of the contract.
Changes are proposed at DFARS 206.302-5 to add the pilot program to the list of authorities agencies may utilize to justify the use of other than full and open competitive procedures. Changes are also proposed at DFARS 212.301 to add the proposed solicitation provisions and contract clause to the list of provisions and clauses that apply to DoD solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services.
This proposed rule proposes two new provisions and a new clause to implement the requirements of section 874 of the NDAA for FY 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) as amended by section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note): (1) DFARS clause 252.270-70WW, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation; (2) DFARS 252.270-70XX, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Certification; and (3) DFARS 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses. The provisions and clause at DFARS 252.270-70WW, 252.270-70XX and 252.270-70YY are prescribed at DFARS 270.X05 for use in solicitations and contracts for approved acquisitions under the Pilot Program to Incentivize Contracting with Employee-Owned Businesses. DoD does not intend to apply the proposed rule to contracts at or below the SAT. DoD does intend to apply the proposed rule to contracts for the acquisition of commercial products, excluding COTS items, and commercial services.
41 U.S.C. 1905 governs the applicability of laws to contracts or subcontracts in amounts not greater than the simplified acquisition threshold. It is intended to limit the applicability of laws to such contracts or subcontracts. 41 U.S.C. 1905 provides that if a provision of law contains criminal or civil penalties, or if the Federal Acquisition Regulatory Council makes a written determination that it is not in the best interest of the Federal Government to exempt contracts or
10 U.S.C. 3452 exempts contracts and subcontracts for the acquisition of commercial products, including COTS items, and commercial services from provisions of law enacted after October 13, 1994, unless the Under Secretary of Defense (Acquisition and Sustainment) (USD(A&S)) makes a written determination that it would not be in the best interest of DoD to exempt contracts for the procurement of commercial products and commercial services from the applicability of the provision or contract requirement, except for a provision of law that—
• Provides for criminal or civil penalties;
• Requires that certain articles be bought from American sources pursuant to 10 U.S.C. 4862, or that strategic materials critical to national security be bought from American sources pursuant to 10 U.S.C. 4863; or
• Specifically refers to 10 U.S.C. 3452 and states that it shall apply to contracts and subcontracts for the acquisition of commercial products (including COTS items) and commercial services.
The statutes implemented in this proposed rule do not impose criminal or civil penalties, do not require purchase pursuant to 10 U.S.C. 4862 or 4863, and do not refer to 10 U.S.C. 3452. Therefore, section 874 of the NDAA for FY 2022, as amended by section 872 of the NDAA for FY 2024, will not apply to the acquisition of commercial products, including COTS items, or commercial services unless a written determination is made. Due to delegations of authority, the Principal Director, DPC is the appropriate authority to make this determination. DoD intends to make that determination to apply the statutes to the acquisition of commercial products, excluding COTS items, and to the acquisition of commercial services. Therefore, this proposed rule will apply to the acquisition of commercial products, excluding COTS items, and to the acquisition of commercial services.
Given that the requirements of section 874 of the NDAA for FY 2022 and section 872 of the NDAA for FY 2024 were enacted to authorize DoD to establish a pilot program to incentivize contracting with employee-owned businesses for the continued development, production, or provision of products or services, and since the pilot program, thus far, has been utilized for commercial products and commercial services, it is in the best interest of the Government to apply the statutes to contracts for the acquisition of commercial products, excluding COTS items, and commercial services, as defined at Federal Acquisition Regulation 2.101. An exception for contracts for the acquisition of commercial products, excluding COTS items, and commercial services would exclude the contracts intended to be covered by the law, thereby undermining the overarching public policy purpose of the law.
This proposed rule implements section 874 of the NDAA for FY 2022, as amended by section 872 of the NDAA for FY 2024, which authorizes DoD to establish a pilot program to incentivize contracting with employee-owned businesses that meet the proposed definition of “qualified business.” This proposed rule, when finalized, is expected to impact the Government and contractors that participate in the pilot program. This proposed rule is expected to incentivize and expedite the award of follow-on contracts to qualified businesses for the continued development, production, or provision of products or services previously procured by or for DoD. As a result, employee-owned businesses may benefit from more opportunities to contract with DoD, which may benefit DoD by expanding the defense industrial base.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
DoD does not expect this proposed rule, when finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This proposed rule is necessary to implement section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note). Sections 874 and 872 authorize DoD to establish a pilot program to incentivize contracting with employee-owned businesses. The pilot program provides for the use of noncompetitive procedures for certain follow-on contracts to qualified businesses wholly-owned through an employee stock ownership plan. A “qualified business” is defined as an S corporation (as defined in 26 U.S.C. 1361(a)(1)) for which 100 percent of the outstanding stock is held through an employee stock ownership plan as defined in 26 U.S.C. 4975(e)(7).
The objective of this proposed rule is to implement section 874 of the NDAA for FY 2022 and section 872 of the NDAA for FY 2024 to establish a pilot program to incentivize contracting with employee-owned businesses. The legal basis for the rule is section 874 of the NDAA for FY 2022 and section 872 of the NDAA for FY 2024.
Data from the System for Award Management (SAM) revealed there were 330,704 small entities registered in SAM as of June 2023. Data on the number of small entities that are a qualified business, as defined in the proposed rule, is not available.
The pilot program was implemented on November 8, 2022. To date, eight businesses are participating in the pilot, six of which are small entities. DoD cannot estimate the number of contracting officers who will submit applications for participation in the pilot program, how many applications will be approved for participation, or how many of the subsequent awards will be made to small entities. However, based on current participation, DoD
This proposed rule imposes a new reporting requirement. Not later than 30 days after the end of the period of performance of the contract, contractors participating in the pilot program will be required to submit to the contracting officer the following information: (1) the number of years the contractor has been wholly-owned by its employee stock ownership plan; (2) the contractor's challenges in attracting and retaining a talented workforce; (3) challenges the contractor experienced due to its corporate ownership structure that hinder its ability to contract with DoD in order to scale its technologies and capabilities due to its corporate ownership structure; and (4) challenges the contractor experienced due to its corporate ownership structure in obtaining capital necessary to bridge funding gaps, for example, between prototype demonstration and full-scale development. The annual reporting burden is estimated as follows: 16 respondents, with 16 total annual responses (1 response per respondent), and a total annual burden of 16 hours.
The proposed rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no known alternatives that would accomplish the stated objectives of the applicable statutes.
DoD invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2024-D004), in correspondence.
This proposed rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). Accordingly, DoD has submitted a request for approval of a new information collection requirement concerning DFARS case 2024-D004, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, to the Office of Management and Budget.
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Written comments and recommendations on the proposed information collection, including suggestions for reducing this burden, should be submitted using the Federal eRulemaking Portal at
Public comments are particularly invited on: whether this collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of DoD's estimate of the burden of this information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
To obtain a copy of the supporting statement and associated collection instruments, please email
Government procurement.
Therefore, Defense Acquisition Regulations System proposes to amend 48 CFR parts 206, 212, and 252, and add 270 as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(b)
(i) Acquire supplies and services from military exchange stores outside the United States for use by the armed forces outside the United States in accordance with 10 U.S.C. 2424(a) and subject to the limitations of 10 U.S.C. 2424(b). The limitations of 10 U.S.C. 2424(b)(1) and (2) do not apply to the purchase of soft drinks that are manufactured in the United States. For the purposes of 10 U.S.C. 2424, soft drinks manufactured in the United States are brand name carbonated sodas, manufactured in the United States, as evidenced by product markings.
(ii) Acquire police, fire protection, airfield operation, or other community services from local governments at military installations to be closed under the circumstances in 237.7401 (section 2907 of Fiscal Year 1994 Defense Authorization Act (Pub. L. 103-160)).
(iii) Acquire products and services under the Pilot Program to Incentivize Contracting with Employee-Owned Businesses (see subpart 270.X).
(c)
(i) 10 U.S.C. 4141 precludes use of this exception for awards to colleges or universities for the performance of research and development, or for the construction of any research or other facility, unless—
(A) The statute authorizing or requiring award specifically—
(
(
(
(B) The Secretary of Defense provides Congress written notice of intent to award. The contract cannot be awarded until 180 days have elapsed since the date Congress received the notice of intent to award. Contracting activities must submit a draft notice of intent with supporting documentation through channels to the Principal Director, Defense Pricing and Contracting, Office of the Under Secretary of Defense (Acquisition and Sustainment).
(ii) The limitation in paragraph (c)(i) of this subsection applies only if the statute authorizing or requiring award was enacted after September 30, 1989.
(iii) Subsequent statutes may provide different or additional constraints on the award of contracts to specified colleges and universities. Contracting officers should consult legal counsel on a case-by-case basis.
41 U.S.C. 1303 and 48 CFR chapter 1.
(f) * * *
(xxii)
(A) Use the provision at 252.270-70WW, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation, as prescribed at 270.X05(a) to comply with section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note).
(B) Use the provision at 252.270-70XX, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Subcontracting Certification, as prescribed at 270.X05(b), to comply with section 874 of the NDAA for FY 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note).
(C) Use the clause at 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, as prescribed at 270.X05(c), to comply with section 874 of the NDAA for FY 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note).
41 U.S.C. 1303 and 48 CFR chapter 1.
As prescribed in 270.X05(a), use the following provision:
(a)
(b)
(End of provision)
As prescribed in 270.X05(b), use the following provision:
(a)
(b)
(1) The subcontract is awarded to a qualified business;
(2) The contract is for products and the subcontract is for materials not available from another qualified business; or
(3) A waiver is granted.
(End of provision)
As prescribed in 270.X05(b), use the following clause:
(a)
(b)
(1) The subcontract is awarded to a qualified business;
(2) The contract is for products and the subcontract is for materials not available from another qualified business; or
(3) A waiver is granted.
(c)
(1) The number of years the Contractor has been wholly-owned by its employee stock ownership plan.
(2) Challenges the Contractor experienced in attracting and retaining a talented workforce in a competitive market.
(3) Challenges the Contractor experienced that hinder its ability to contract with DoD to scale its technologies and capabilities due to the Contractor's corporate ownership structure.
(4) Challenges the Contractor experienced due to its corporate ownership structure in obtaining capital necessary to bridge funding gaps, for example, between prototype demonstration and full-scale development.
(End of clause)
41 U.S.C. 1303 and 48 CFR chapter 1.
This part has been created to facilitate promulgation of additional DFARS coverage of defense-specific contracting programs that do not properly fall under DFARS subchapter D, Socioeconomic Programs, and neither implement nor supplement existing FAR part 19 or parts 22 through 25.
(a) This subpart implements section 874 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81; 10 U.S.C. 3204 note) and section 872 of the NDAA for FY 2024 (Pub. L. 118-31; 10 U.S.C. 3204 note). Sections 874 and 872 authorize the establishment of a pilot program that allows for the noncompetitive award of certain follow-on contracts to contractors that meet the definition of a qualified business (see 270.X01).
(b) The authority to award contracts under this subpart expires on December 27, 2029.
As used in this subpart—
(a) The contracting officer may only award one sole-source, follow-on contract to the incumbent contractor if—
(1) The contractor has represented that it is a qualified business; and
(2) The contract is for the continued development, production, or provision of products or services that are the same or substantially similar to those procured under the prior contract awarded to the contractor by or for DoD.
(b) The contracting officer shall not begin negotiations for a sole-source, follow-on contract unless the contracting officer justifies the use of a sole-source contract in accordance with FAR 6.303 and 6.304, citing FAR 6.302-5, Authorized or required by statute, as the exception to full and open competition.
(a) Participation in the pilot program is subject to approval by the Under Secretary of Defense (Acquisition and Sustainment), Office of the Principal Director, Defense Pricing and Contracting (Contract Policy). Only a contracting officer may submit an application to participate in the pilot program. See PGI 270.7X04(a).
(b) Contracting officers shall only award—
(1) One sole-source, follow-on contract per predecessor contract to the incumbent contractor unless waived by the head of the contracting activity, delegable to a level no lower than one level above the contracting officer;
(2) Contracts to qualified businesses that have a minimum performance rating of satisfactory for the predecessor contract in the Contractor Performance Assessment Reporting System (see FAR subpart 42.15); and
(3) Contracts to qualified businesses that have certified they will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not qualified businesses, except for subcontracts for materials not available from another qualified business when the contract is for products, unless waived by the head of the contracting activity, delegable to a level no lower than one level above the contracting officer.
See PGI 270.X04 for procedures and information concerning the pilot program.
(a) Use the provision at 252.270-70WW, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Representation, in solicitations, including solicitations using FAR part 12 procedures for the acquisition of commercial products and commercial services, that include the clause at 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses.
(b) Unless waived in accordance with 270.7X03(b)(3), use the provision at 252.270-70XX, Pilot Program to Incentivize Contracting with Employee-Owned Businesses—Subcontracting Certification, in solicitations, including solicitations using FAR part 12 procedures for the acquisition of commercial products and commercial services that include the clause at 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses.
(c) Use the clause at 252.270-70YY, Pilot Program to Incentivize Contracting with Employee-Owned Businesses, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial products and commercial services, for approved pilot program acquisitions.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2024 that modifies certain definitions associated with the Procurement Technical Assistance Program.
Comments on the proposed rule should be submitted in writing to the address shown below on or before July 29, 2024, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2024-D006, using either of the following methods:
○
○
Comments received generally will be posted without change to
Jeanette Snyder, telephone 703-508-7524.
DoD is proposing to revise the DFARS to implement section 853 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2024 (Pub. L. 118-31; 10 U.S.C. 4951). Section 853 amends the definitions of nonprofit organization and business entities at 10 U.S.C. 4951 for the Procurement Technical Assistance Program. DoD implements the requirements at 10 U.S.C. 4951 through its APEX Accelerators (formerly known as Procurement Technical Assistance Centers), which are managed by the DoD Office of Small Business Programs.
DoD is proposing to modify the contract clause at DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders, to implement section 853 of the NDAA for FY 2024. The clause requires contractors to provide cooperative agreement holders, upon request, with a list of the contractor's employees or offices responsible for entering into subcontracts under defense contracts. This proposed rule amends the definition of cooperative agreement holder in the clause by removing “private” from “a private, nonprofit organization” and adding a reference to 10 U.S.C. 4951 to update the definition of business entities. Minor edits are made to align the clause with DFARS drafting conventions.
This proposed rule amends the clause at DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders. However, this proposed rule does not impose any new requirements on contracts at or below the SAT, for commercial products including COTS items, or for commercial services. The clause will continue to not apply to acquisitions at or below the SAT, and will continue to apply to acquisitions of commercial products excluding COTS items, and to acquisitions of commercial services.
This proposed rule, when finalized, is expected to impact DoD contractors whose contracts include the clause at DFARS 252.205-7000. The clause requires contractors to provide cooperative agreement holders under the Procurement Technical Assistance Program, upon request, with a list of the contractor's employees or offices responsible for entering into subcontracts under defense contracts. As a result of the proposed changes, these contractors may be required to provide the list to different entities that are cooperative agreement holders under the Procurement Technical Assistance Program.
The changes in section 853 allow any type of nonprofit organization to be a cooperative agreement holder under the Procurement Technical Assistance Program. In addition, business entities, including corporations, associations, partnerships, limited liability companies, limited liability partnerships, consortia, not-for-profit, or other legal entities will also be able to be a cooperative agreement holder. These changes are reflected in the proposed revisions to the clause at DFARS 252.205-7000. As a result of the section 853 changes to the Procurement Technical Assistance Program, there may be an increase in the number of entities able to become cooperative agreement holders under the Procurement Technical Assistance Program.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, as amended.
DoD does not expect this proposed rule, when finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This proposed rule is necessary to implement section 853 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2024 (Pub. L. 118-31; 10 U.S.C. 4951). Section 853 modifies the definitions of nonprofit organization and business entities at 10 U.S.C. 4951 for the Procurement Technical Assistance Program. This proposed rule implements the revised definitions in the contract clause at DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders. The clause requires contractors to provide cooperative agreement holders under the Procurement Technical Assistance Program, upon request, with a list of the contractor's employees or offices responsible for entering into subcontracts under defense contracts.
The objective of this proposed rule is to implement section 853 of the NDAA for FY 2024, which is the legal basis for the rule.
According to data from the Procurement Business Intelligence Service, in the last three fiscal years, DoD awarded contracts that included the clause at 252.205-7000 to unique small entities as follows: 5,652 in fiscal year 2021, 5,127 in fiscal year 2022, and 5,663 in fiscal year 2023. This averages out to approximately 5,480 per fiscal year. Therefore, DoD estimates that the number of small entities to which this rule will apply is approximately 5,480.
This proposed rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities.
This proposed rule does not duplicate, overlap, or conflict with any other Federal rules.
DoD did not identify any significant alternatives to the proposed rule that would accomplish the stated objectives of the statute. Any impact on small entities is expected to be beneficial.
DoD invites comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this proposed rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2024-D006), in correspondence.
The Paperwork Reduction Act (44 U.S.C. chapter 35) applies to this proposed rule. However, these changes to the DFARS do not impose additional information collection requirements to the paperwork burden previously approved by the Office of Management and Budget (OMB) under OMB Control Number 0704-0286, entitled Defense FAR Supplement (DFARS) Part 205, Publicizing Contract Actions, and DFARS 252.205-7000, Provision of Information to Cooperative Agreement Holders.
Government procurement.
Therefore 48 CFR 252 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As prescribed in 205.470, use the following clause:
(a)
(b) The Contractor shall provide cooperative agreement holders, upon their request, with a list of those appropriate employees or offices responsible for entering into subcontracts under defense contracts. The list shall include the business address, telephone number, and area of responsibility of each employee or office.
(c) The Contractor need not provide the listing to a particular cooperative agreement holder more frequently than once a year.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to designate critical habitat for the Dixie Valley toad (
We will accept comments received or postmarked on or before July 29, 2024. Comments submitted electronically using the Federal eRulemaking Portal (see
You may submit comments by one of the following methods:
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Jodie Mamuscia, Field Supervisor, U.S. Fish and Wildlife Service, Reno Fish and Wildlife Office, 1340 Financial Blvd., Suite 234, Reno, NV 89502; telephone 775-861-6300. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please see Docket No. FWS-R8-ES-2023-0188 on
We intend that any final action resulting from this proposed rule will be based on the best scientific data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:
(1) Specific information on:
(a) The amount and distribution of Dixie Valley toad habitat;
(b) Any additional areas occurring within the range of the species (Churchill County, Nevada) that should be included in the designation because they (i) are occupied at the time of listing and contain the physical or biological features that are essential to the conservation of the species and that may require special management considerations or protection, or (ii) are
(c) Special management considerations or protection that may be needed in critical habitat areas we are proposing, including managing for the potential effects of climate change.
(2) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.
(3) Any probable economic, national security, or other relevant impacts of designating any area that may be included in the final designation, and the related benefits of including or excluding specific areas.
(4) Information on the extent to which the description of probable economic impacts in the draft economic analysis is a reasonable estimate of the likely economic impacts and any additional information regarding probable economic impacts that we should consider.
(5) Whether any specific areas we are proposing for critical habitat designation should be considered for exclusion under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any specific area outweigh the benefits of including that area under section 4(b)(2) of the Act. If you think we should exclude any additional areas, please provide information supporting a benefit of exclusion.
(6) Whether we could improve or modify our approach to designating critical habitat in any way to provide for greater public participation and understanding, or to better accommodate public concerns and comments.
Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific information you include.
Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(2) of the Act directs that the Secretary shall designate critical habitat on the basis of the best scientific data available.
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as new information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), our final designation may not include all areas proposed, may include some additional areas that meet the definition of critical habitat, may exclude some areas if we find the benefits of exclusion outweigh the benefits of inclusion and exclusion will not result in the extinction of the species, or may exempt areas owned or controlled by the Department of Defense if we find the Air Station's integrated natural resources management plan (INRMP) provides a conservation benefit to the species in accordance with 50 CFR 424.12(h). In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.
Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in
On April 7, 2022, we published in the
In accordance with our joint policy on peer review published in the
It is our intent to discuss in this proposed rule only those topics directly relevant to the designation of critical habitat for the Dixie Valley toad. For more information on the taxonomy, life history, habitat, population descriptions, and factors affecting the species, please refer to the April 7, 2022, emergency listing rule (87 FR 20336) and proposed listing rule (87 FR 20374), as well as the December 2, 2022, final listing rule (87 FR 73971).
Critical habitat is defined in section 3 of the Act as:
(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features
(a) Essential to the conservation of the species, and
(b) Which may require special management considerations or protection; and
(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as an area that may generally be delineated around species' occurrences, as determined by the Secretary (
Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.
Critical habitat receives protection under section 7 of the Act through the requirement that each Federal action agency ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of designated critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation also does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Rather, designation requires that, where a landowner requests Federal agency funding or authorization for an action that may affect an area designated as critical habitat, the Federal agency consult with the Service under section 7(a)(2) of the Act. If the action may affect the listed species itself (such as for occupied critical habitat), the Federal agency would have already been required to consult with the Service even absent the designation because of the requirement to ensure that the action is not likely to jeopardize the continued existence of the species. Even if the Service were to conclude after consultation that the proposed activity is likely to result in destruction or adverse modification of the critical habitat, the Federal action agency and the landowner are not required to abandon the proposed activity, or to restore or recover the species; instead, they must implement “reasonable and prudent alternatives” to avoid destruction or adverse modification of critical habitat.
Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat).
Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the
When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information from the SSA report and information developed during the listing process for the species. Additional information sources may include any generalized conservation strategy, criteria, or outline that may have been developed for the species; the recovery plan for the species; articles in peer-reviewed journals; conservation plans developed by States and counties; scientific status surveys and studies; biological assessments; other unpublished materials; or experts' opinions or personal knowledge.
Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act; (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species; and (3) the prohibitions found in section 9 of the Act. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of the species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of those planning efforts calls for a different outcome.
In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12(b), in determining which areas we will designate as critical habitat from within the geographical area occupied by the species at the time of listing, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. The regulations at 50 CFR 424.02 define
In considering whether features are essential to the conservation of the species, we may consider an appropriate quality, quantity, and spatial and temporal arrangement of habitat characteristics in the context of the life-history needs, condition, and status of the species. These characteristics include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing (or development) of offspring; and habitats that are protected from disturbance.
The following is a summary of the key information describing the physical and biological features essential to the conservation of the Dixie Valley toad. More information on species ecology and resource needs is available in chapter 3 of the SSA report (Service 2022, pp. 14-26), which is available on
Dixie Valley toads need enough wetland habitat to maintain population dynamics and life-history functions. Wetland habitat needs to include enough wetted area and have the natural range of variability of water extent to support the vegetation Dixie Valley toads use for brumation (periods of inactivity during cold temperatures) and shelter; open, ephemeral wetted areas for breeding; as well as the prey items the species relies upon.
There is little information on Dixie Valley toad dispersal capacity, besides the fact that they cannot disperse outside of the Dixie Meadows wetlands because they are surrounded by a dry landscape. However, we assume Dixie Valley toads can disperse among the wetlands, via upland corridors, during wet periods or rain. Maintaining the upland dispersal corridors between wetlands is important to maintain genetic diversity within the population and species.
Dixie Meadows contains 122 known spring and seep sources (McGinley and Associates 2021, pp. 1-2) that distribute water across the landscape. Dixie Valley toads are completely reliant on the wetlands produced by the Dixie Meadows springs, as the species is highly aquatic and individuals are rarely found more than 14 meters (m) (46 feet (ft)) away from water (Halstead et al. 2021, pp. 28, 30).
Not only is the water itself necessary for the Dixie Valley toad, but the warm water temperatures produced by the springs are necessary for the species. The Dixie Meadows springs are thermal springs, providing relatively stable, warm temperatures to the wetlands. Dixie Valley toads select areas that are warmer than other surrounding available habitat, particularly in spring, fall, and winter months (Halstead et al. 2021, pp. 30, 33-34). In the spring, Dixie Valley toads select areas with warmer water for breeding (oviposition sites), which allows for faster egg hatching and time to metamorphosis. In the fall, Dixie Valley toads select different areas (closer to thermal springs with dense vegetation) to satisfy their thermal preferences as nighttime temperatures decrease. As they enter winter months, toads find areas with consistent warm temperatures during brumation (periods of inactivity during cold temperatures) so that they do not freeze (Halstead et al. 2021, pp. 30, 33-34). Dixie Valley toads are reliant on warm water temperatures, with Dixie Valley toad tadpoles found most often between 20 °C-28 °C (68 °F-82 °F), in wetland habitat for all life-history stages (Rose et al. 2023, p. 560).
The exact water quality parameters preferred by the Dixie Valley toad are unknown; however, this species has evolved only in Dixie Meadows and is presumed to thrive in the existing complex mix of water emanating from both the basin-fill aquifer and the deep geothermal reservoir. Temperature, dissolved oxygen, pH, salinity and water conductivity, and excessive nutrient concentrations (among others) have all been shown to have direct and indirect impacts to amphibian species when found to be outside of naturally occurring levels for any particular location (Sparling 2010, pp. 105-117). The natural variation of water quality parameters found in Dixie Meadows is considered a need for the species.
There is no published information on the feeding habits of the Dixie Valley toad. It is assumed that adult Dixie Valley toads are opportunistic feeders, similar to other toad species (
Dixie Valley toads need sufficient wetland vegetation to use as shelter. The species uses dense stands of bulrush (
Dixie Valley toad breeding occurs annually from March through May (Forrest et al. 2013, p. 76). Breeding appears protracted due to the thermal nature of the habitat and can last for months, with toads breeding early in the year in habitats closer to the thermal spring sources and then moving downstream into habitats as they warm throughout the spring and early
We derive the specific physical or biological features essential to the conservation of the Dixie Valley toad from studies of the species' habitat, ecology, and life history as described below. Additional information can be found in the SSA report (Service 2022, pp. 14-27; available on
(1) Wetlands within Dixie Valley that are composed of some combination of the following characteristics:
(a) Diverse wetland vegetation that includes, but is not limited to, native phreatophyte (deep-rooted) species found within the Dixie Meadows wetlands (
(b) Dense bulrush stands for brumation and shelter.
(c) Open, ephemerally wetted areas adjacent to vegetated areas for breeding.
(d) The natural range of variability of water temperatures found throughout each wetland.
(e) The natural range of variability of water extent found throughout each wetland.
(f) Water quality necessary to sustain natural physiological processes for normal behavior, growth, and viability of all life stages.
(g) A variety of aquatic and terrestrial invertebrates, detritus, and algae for feeding.
(2) Upland habitat between wetlands through which Dixie Valley toads can disperse when conditions permit.
When designating critical habitat, we assess whether the specific areas within the geographical area occupied by the species at the time of listing contain features which are essential to the conservation of the species and which may require special management considerations or protection. The features essential to the conservation of the Dixie Valley toad may require special management considerations or protection to reduce the following threats: (1) groundwater pumping activities, such as those associated with geothermal energy development and production; and (2) cattle grazing. Geothermal development is considered the primary threat to the Dixie Valley toad. Specifically, the Dixie Meadows Geothermal Utilization Project could have significant, detrimental impacts to the water flow and temperature emanating from the thermal springs the Dixie Valley toad relies on (Service 2022, pp. 39-41, 80-84, 113-119; Tetra Tech 2023a, pp. 3-7; Tetra Tech 2023b, pp. 2-3). A decrease in water flow would reduce habitat in the wetlands, and water temperatures in the wetlands could be reduced to a degree that the species cannot survive through cold winter months. Cattle can step on Dixie Valley toads while grazing, causing direct mortality and grazing may have impacts on water quality due to defecation and urination in the water.
Management activities that could ameliorate these threats include, but are not limited to, development and use of best management practices designed to maintain natural spring flows, spring temperatures, and water quality; use of best management practices designed to control or minimize the level of grazing in order to maintain the desired condition of Dixie Valley toad habitat; and restoration of disturbed features to their pre-disturbance, natural state.
As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b), we review available information pertaining to the habitat requirements of the species and identify specific areas within the geographical area occupied by the species at the time of listing and any specific areas outside the geographical area occupied by the species to be considered for designation as critical habitat. We are not currently proposing to designate any areas outside the geographical area occupied by the species because we have not identified any unoccupied areas that meet the Act's definition of critical habitat. There are no unoccupied areas that have the unique characteristics and physical and biological features necessary to support the Dixie Valley toad.
Sources of data for the Dixie Valley toad and its habitat needs include peer-reviewed articles on the species and related species, satellite imagery analysis done by the U.S. Geological Survey (USGS), and communication with species experts.
To determine which areas to propose as critical habitat, we used the Dixie Meadows wetlands as a starting point. All of the wetlands are considered occupied by the Dixie Valley toad (Rose et al. 2023, entire) and are proposed as critical habitat.
We then used USGS's satellite imagery analysis on the extent of land cover vegetation and soil wetness from October 2015 through January 2022 (Bransky et al. 2023, entire), to determine the upland habitat that could be used by Dixie Valley toads to disperse between wetlands. We delineated all areas of habitat classified by USGS with at least a class two landcover class (apparent moist soil and sparse or short vegetation) at some time during the analysis period, using the Green Normalized Difference Vegetation Index (gNDVI; Gitelson et al. 1996, entire), as suitable upland dispersal habitat for inclusion in the proposed critical habitat. Although upland habitat is not occupied year-round, it is assumed to be used during wet periods each year, playing a vital role in maintaining genetic diversity throughout the single population of the species.
In summary, for areas within the geographic area occupied by the species at the time of listing, we delineated critical habitat unit boundaries using the following criteria:
(1) We identified the wetlands occupied by the Dixie Valley toad.
(2) We then delineated the upland habitat between wetlands that included all areas that could be used for dispersal. Upland habitat was considered dispersal habitat if it has been classified by USGS at some time from October 2015 through January 2022 as at least a gNDVI class two land cover class based on satellite imagery analysis.
When determining proposed critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features necessary for the Dixie Valley toad. The scale of the maps we prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed lands. Any such lands inadvertently left inside critical habitat boundaries shown on the maps of this proposed rule have been excluded by text in the proposed rule and are not proposed for designation as critical habitat.
The proposed critical habitat designation is defined by the map, as modified by any accompanying regulatory text, presented at the end of this document under Proposed Regulation Promulgation. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates or plot points or both on which the map is based available to the public on
We are proposing to designate approximately 930 acres (ac) (376 hectares (ha)) in one unit as critical habitat for the Dixie Valley toad. The critical habitat area we describe below as Dixie Meadows is occupied by the species and constitutes our current best assessment of the area that meets the definition of critical habitat for the Dixie Valley toad. Table 1 shows the land ownership and approximate areas of the proposed critical habitat unit for the Dixie Valley toad.
We present a brief description and map of the proposed unit, and reasons why it meets the definition of critical habitat for the Dixie Valley toad, below.
The Dixie Meadows Unit consists of 930 ac (376 ha) of occupied wetland and upland habitat in Dixie Meadows, Churchill County, Nevada. This unit encompasses the entire range of the Dixie Valley toad and contains all of the physical or biological features essential to the conservation of the species. This unit is essential to the recovery of Dixie Valley toad because it includes all the habitat that is occupied by the species across its range. Special management considerations or protection may be required to protect against impacts from threats that are anticipated: to reduce water flow, temperature, and quality emanating from the springs; and to reduce water quality, water temperature, the amount of wetted area, and vegetation on the landscape. Sources of these threats include geothermal development and production, groundwater pumping activities, and grazing (see Special Management Considerations or Protection, above). Special management considerations related to geothermal development and production, groundwater pumping, and grazing include, but are not limited to: development and use of best management practices designed to maintain natural spring flows, spring temperatures, and water quality; use of best management practices designed to control or minimize the level of grazing in order to maintain the desired condition of Dixie Valley toad habitat; and restoration of disturbed features back to their pre-disturbance, natural state.
Roughly 63 percent (588 ac (238 ha)) of the Unit is part of the Air Station's lands and 37 percent (342 ac (138 ha)) is Bureau of Land Management (BLM) land. The 588 ac (238 ha) of Air Station lands are being considered for exemption from the critical habitat designation (see Exemptions, below).
A map of the proposed unit, showing areas of wetlands, the Air Station's lands, and BLM land appears below. Please note that the BLM lands are those areas within the proposed unit's boundaries that are not labeled as Department of Defense lands:
Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.
Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species (50 CFR 402.02).
Compliance with the requirements of section 7(a)(2) is documented through our issuance of:
(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or
(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.
When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:
(1) Can be implemented in a manner consistent with the intended purpose of the action,
(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,
(3) Are economically and technologically feasible, and
(4) Would, in the Service Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.
Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.
Regulations at 50 CFR 402.16 set forth requirements for Federal agencies to reinitiate consultation. Reinitiation of consultation is required and shall be requested by the Federal agency, where discretionary Federal involvement or control over the action has been retained or is authorized by law and: (1) if the amount or extent of taking specified in the incidental take statement is exceeded; (2) if new information reveals effects of the action that may affect listed species or critical habitat in a manner or to an extent not previously considered; (3) if the identified action is subsequently modified in a manner that causes an effect to the listed species or critical habitat that was not considered in the biological opinion or written concurrence; or (4) if a new species is listed or critical habitat designated that may be affected by the identified action. As provided in 50 CFR 402.16, the requirement to reinitiate consultations for new species listings or critical habitat designation does not apply to certain agency actions (
The key factor related to the destruction or adverse modification determination is whether implementation of the proposed Federal action directly or indirectly alters the designated critical habitat in a way that appreciably diminishes the value of the critical habitat for the conservation of the listed species. As discussed above, the role of critical habitat is to support the physical or biological features essential to the conservation of a listed species and provide for the conservation of the species.
Section 4(b)(8) of the Act requires that our
Section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that the Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the DoD, or designated for its use, that are subject to an integrated natural resources management plan (INRMP) prepared under section 101 of the Sikes Act Improvement Act of 1997 (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.
An INRMP was completed by the Air Station in 2014, prior to the Dixie Valley toad being described as a species and before the toad was listed as an endangered species. The Air Station is in the process of amending its INRMP to incorporate the DoD's National Strategic Plan for amphibian and reptile conservation and management (Lovich et al. 2015, entire), which will include specific management for Dixie Meadows and the Dixie Valley toad (Schofield 2023, in litt.). After we receive the INRMP amendment, we will assess its conservation benefit to the toad under 50 CFR 424.12(h) before the final critical habitat designation. If we determine the Air Station lands qualify for exemption from critical habitat designation, then the 588 ac (238 ha) of Air Station land would be exempted from the final designation, which is 63 percent of the proposed critical habitat designation.
Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from designated critical habitat based on economic impacts, impacts on national security, or any other relevant impacts. Exclusion decisions are governed by the regulations at 50 CFR 424.19 and the Policy Regarding Implementation of Section 4(b)(2) of the Endangered Species Act (hereafter, the “2016 Policy”; 81 FR 7226, February 11, 2016), both of which were developed jointly with the National Marine Fisheries Service (NMFS). We also refer to a 2008 Department of the Interior Solicitor's opinion entitled, “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (M-37016).
In considering whether to exclude a particular area from the designation, we identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, and evaluate whether the benefits of exclusion outweigh the benefits of inclusion. If the analysis indicates that the benefits of exclusion outweigh the benefits of inclusion, the Secretary may exercise discretion to exclude the area only if such exclusion would not result in the extinction of the species. In making the determination to exclude a particular area, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor. In our final rules, we explain any decision to exclude areas, as well as decisions not to exclude, to make clear the rational basis for our decision. We describe below the process that we use for taking into consideration each
Section 4(b)(2) of the Act and its implementing regulations require that we consider the economic impact that may result from a designation of critical habitat. To assess the probable economic impacts of a designation, we must first evaluate specific land uses or activities and projects that may occur in the area of the critical habitat. We then must evaluate the impacts that a specific critical habitat designation may have on restricting or modifying specific land uses or activities for the benefit of the species and its habitat within the areas proposed. We then identify which conservation efforts may be the result of the species being listed under the Act versus those attributed solely to the designation of critical habitat for this particular species. The probable economic impact of a proposed critical habitat designation is analyzed by comparing scenarios both “with critical habitat” and “without critical habitat.”
The “without critical habitat” scenario represents the baseline for the analysis, which includes the existing regulatory and socio-economic burden imposed on landowners, managers, or other resource users potentially affected by the designation of critical habitat (
Executive Orders (E.O.s) 12866 and 13563 direct Federal agencies to assess the costs and benefits of available regulatory alternatives in quantitative (to the extent feasible) and qualitative terms. Executive Order 14094 reaffirms the principles of E.O.s 12866 and 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Consistent with the E.O. regulatory analysis requirements, our effects analysis under the Act may take into consideration impacts to both directly and indirectly affected entities, where practicable and reasonable. If sufficient data are available, we assess to the extent practicable the probable impacts to both directly and indirectly affected entities. Section 3(f) of E.O. 12866 identifies four criteria when a regulation is considered a “significant regulatory action” and requires additional analysis, review, and approval if met. The criterion relevant here is whether the designation of critical habitat may have an economic effect of $200 million or more in any given year (section 3(f)(1), as amended by E.O. 14094). Therefore, our consideration of economic impacts uses a screening analysis to assess whether a designation of critical habitat for the Dixie Valley toad is likely to exceed the economically significant threshold.
For this particular designation, we developed an incremental effects memorandum (IEM) considering the probable incremental economic impacts that may result from this proposed designation of critical habitat. The information contained in our IEM was then used to develop a screening analysis of the probable effects of the designation of critical habitat for the Dixie Valley toad (Industrial Economics (IEc) 2023, entire). We began by conducting a screening analysis of the proposed designation of critical habitat in order to focus our analysis on the key factors that are likely to result in incremental economic impacts. The purpose of the screening analysis is to filter out particular geographical areas of critical habitat that are already subject to such protections and are, therefore, unlikely to incur incremental economic impacts. In particular, the screening analysis considers baseline costs (
Ultimately, the screening analysis allows us to focus our analysis on evaluating the specific areas or sectors that may incur probable incremental economic impacts as a result of the designation. The presence of the listed species in occupied areas of critical habitat means that any destruction or adverse modification of those areas is also likely to jeopardize the continued existence of the species. Therefore, designating occupied areas as critical habitat typically causes little if any incremental impacts above and beyond the impacts of listing the species. As a result, we generally focus the screening analysis on areas of unoccupied critical habitat (unoccupied units or unoccupied areas within occupied units). Overall, the screening analysis assesses whether designation of critical habitat is likely to result in any additional management or conservation efforts that may incur incremental economic impacts. This screening analysis combined with the information contained in our IEM constitute what we consider to be our draft economic analysis (DEA) of the proposed critical habitat designation for the Dixie Valley toad; our DEA is summarized in the narrative below.
As part of our screening analysis, we considered the types of economic activities that are likely to occur within the areas likely affected by the critical habitat designation. In our evaluation of the probable incremental economic impacts that may result from the proposed designation of critical habitat for the Dixie Valley toad, first we identified, in the IEM dated April 10, 2023, probable incremental economic impacts associated with the following categories of activities: (1) geothermal development and production (BLM, DoD); (2) groundwater withdrawal; and (3) grazing (BLM). We considered each industry or category individually. Additionally, we considered whether their activities have any Federal involvement. Critical habitat designation generally will not affect activities that do not have any Federal involvement; under the Act, designation of critical habitat only affects activities conducted, funded, permitted, or authorized by Federal agencies. In the area where the Dixie Valley toad is present, Federal agencies are required to consult with the Service under section 7 of the Act on activities they authorize, fund, or carry out that may affect the species. If we finalize this proposed critical habitat designation, Federal agencies would be required to consider the effects of their actions on the designated habitat, and if the Federal action may affect critical habitat, our consultations would include an evaluation of measures to avoid the
In our IEM, we attempted to clarify the distinction between the effects that result from the species being listed and those attributable to the critical habitat designation (
The proposed critical habitat designation for the Dixie Valley toad includes 930 ac (376 ha) of wetland and upland habitat in one occupied unit. The Air Station manages 588 ac (238 ha), and the BLM manages the remaining 342 ac (138 ha). Any actions that may affect the species or its habitat would also affect designated critical habitat, and it is unlikely that any additional conservation efforts would be recommended to address the adverse modification standard over and above those recommended as necessary to avoid jeopardizing the continued existence of the Dixie Valley toad. Therefore, only administrative costs are expected to result from the proposed critical habitat designation. While this additional analysis will require time and resources by both the Federal action agency and the Service, it is believed that, in most circumstances, these costs would predominantly be administrative in nature and would not be significant.
The probable incremental costs of designating critical habitat for the Dixie Valley toad are likely to be limited to additional administrative efforts to consider adverse modification in section 7 consultations. This limitation is because all of the proposed critical habitat designation is occupied by the Dixie Valley toad. The incremental administrative burden resulting from the designation of critical habitat for the Dixie Valley toad is not anticipated to reach $200 million in any given year based on the anticipated annual number of consultations and associated consultation costs, which are not expected to exceed $7,000 per year (2023 dollars). If Air Station lands are determined to be exempt from the critical habitat designation for the Dixie Valley toad, the anticipated annual consultations costs are not expected to exceed $4,000 per year. The designation is unlikely to trigger additional requirements under State or local regulations. Thus, the annual administrative burden is relatively low.
We are soliciting data and comments from the public on the DEA discussed above. During the development of a final designation, we will consider the information presented in the DEA and any additional information on economic impacts we receive during the public comment period to determine whether any specific areas should be excluded from the final critical habitat designation under the authority of section 4(b)(2) of the Act, our implementing regulations at 50 CFR 424.19, and the 2016 Policy. We may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area, provided the exclusion will not result in the extinction of this species.
Section 4(a)(3)(B)(i) of the Act may not cover all DoD lands or areas that pose potential national-security concerns (
However, we cannot automatically exclude requested areas. When DoD, DHS, or another Federal agency requests exclusion from critical habitat on the basis of national-security or homeland-security impacts, we must conduct an exclusion analysis if the Federal requester provides information, including a reasonably specific justification of an incremental impact on national security that would result from the designation of that specific area as critical habitat. That justification could include demonstration of probable impacts, such as impacts to ongoing border-security patrols and surveillance activities, or a delay in training or facility construction, as a result of compliance with section 7(a)(2) of the Act. If the agency requesting the exclusion does not provide us with a reasonably specific justification, we will contact the agency to recommend that it provide a specific justification or clarification of its concerns relative to the probable incremental impact that could result from the designation. If we conduct an exclusion analysis because the agency provides a reasonably specific justification or because we decide to exercise the discretion to conduct an exclusion analysis, we will defer to the expert judgment of DoD, DHS, or another Federal agency as to: (1) Whether activities on its lands or waters, or its activities on other lands or waters, have national-security or homeland-security implications; (2) the importance of those implications; and (3) the degree to which the cited implications would be adversely affected in the absence of an exclusion. In that circumstance, in conducting a discretionary section 4(b)(2) exclusion analysis, we will give great weight to national-security and homeland-security concerns in analyzing the benefits of exclusion.
Under section 4(b)(2) of the Act, we also consider whether a national security or homeland security impact might exist on lands owned or managed by DoD or DHS. The Air Station may request exclusion on the basis of national-security or homeland-security impacts. The only DoD or DHS lands within the proposed critical habitat designation are the 588 ac (238 ha) of Air Station lands, which is 63 percent of the proposed critical habitat designation, that are being considered for exemption under section 4(a)(3)(B)(i) of the Act (see Exemptions, above). The Air Station has not requested exclusion based on national security impacts.
Under section 4(b)(2) of the Act, we consider any other relevant impacts, in addition to economic impacts and impacts on national security discussed above. To identify other relevant impacts that may affect the exclusion analysis, we consider a number of factors, including whether there are approved and permitted conservation agreements or plans covering the species in the area—such as safe harbor agreements (SHAs), candidate conservation agreements with assurances (CCAAs) or “conservation benefit agreement” or “conservation agreement” (“CBAs”) (CBAs are a new type of agreement replacing SHAs and CCAAs in use after April 2024 (89 FR 26070; April 12, 2024)) or HCPs—or whether there are non-permitted conservation agreements and partnerships that may be impaired by designation of, or exclusion from, critical habitat. In addition, we look at whether Tribal conservation plans or partnerships, Tribal resources, or government-to-government relationships of the United States with Tribal entities may be affected by the designation. We also consider any State, local, social, or other impacts that might occur because of the designation.
In preparing this proposal, we have determined that no HCPs or other management plans for Dixie Valley toad currently exist, and the proposed designation does not include any Tribal lands or trust resources or any lands for which designation would have any economic impacts. We note that this land is a sacred site to the Fallon Paiute-Shoshone Tribe and that they supported the listing of the Dixie Valley toad in their comments on the April 7, 2022, proposed listing rule (87 FR 20374). Therefore, we anticipate no other relevant impacts to Tribal lands, partnerships, or HCPs from this proposed critical habitat designation, and, thus, as described above, we are not considering excluding any particular areas on the basis of the presence of conservation agreements or impacts to trust resources. We will consider exclusion of the Air Station lands if the Air Station requests an exclusion based on national-security impacts.
However, if through the public comment period we receive information that we determine indicates that there are economic, national security, or other relevant impacts from designating particular areas as critical habitat, then as part of developing the final designation of critical habitat, we will evaluate that information and may conduct a discretionary exclusion analysis to determine whether to exclude those areas under authority of section 4(b)(2) of the Act and our implementing regulations at 50 CFR 424.19. If we receive a request for exclusion of a particular area and after evaluation of supporting information we do not exclude, we will fully describe our decision in the final rule for this action. (Please see
We are required by E.O.s 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(1) Be logically organized;
(2) Use the active voice to address readers directly;
(3) Use clear language rather than jargon;
(4) Be divided into short sections and sentences; and
(5) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
Executive Order (E.O.) 12866, as reaffirmed by E.O. 13563 and E.O. 14094, provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 14094 reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601
According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine whether potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.
Under the RFA, as amended, and as understood in light of recent court decisions, Federal agencies are required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself; in other words, the RFA does not require agencies to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried out by the agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7, only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, it is our position that only Federal action agencies would be directly regulated if we adopt the proposed critical habitat designation. The RFA does not require evaluation of the potential impacts to entities not directly regulated. Moreover, Federal agencies are not small entities. Therefore, because no small entities would be directly regulated by this rulemaking, the Service certifies that, if made final as proposed, the proposed critical habitat designation will not have a significant economic impact on a substantial number of small entities.
In summary, we have considered whether the proposed designation would result in a significant economic impact on a substantial number of small entities. For the above reasons and based on currently available information, we certify that, if made final, the proposed critical habitat designation would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.
Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare statements of energy effects “to the extent permitted by law” when undertaking actions identified as significant energy actions (66 FR 28355; May 22, 2001). E.O. 13211 defines a “significant energy action” as an action that (i) is a significant regulatory action under E.O. 12866 (or any successor order, including, most recently, E.O. 14094 (88 FR 21879; April 11, 2023)); and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy. This rule is not a significant regulatory action under E.O. 12866 or 14094. Therefore, this action is not a significant energy action, and there is no requirement to prepare a statement of energy effects for this action.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(1) This proposed rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or Tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and Tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions are not likely to destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.
(2) We do not believe that this rule would significantly or uniquely affect small governments. The lands being proposed for critical habitat designation are owned by the DoD and BLM. Neither of these government entities fit the definition of “small governmental jurisdiction.” Therefore, a Small Government Agency Plan is not required.
In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for the Dixie Valley toad in a takings implications assessment. The Act does not authorize the Service to regulate private actions on private lands or confiscate private property as a result of critical habitat designation. Designation of critical habitat does not affect land ownership, or establish any closures or restrictions on use of or access to the designated areas. Furthermore, the designation of critical habitat does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. However, Federal agencies are prohibited from carrying out, funding, or authorizing actions that would destroy or adversely modify critical habitat. A takings implications assessment has been completed for the proposed designation of critical habitat for the Dixie Valley toad, and it concludes that, if adopted, this designation of critical habitat does not pose significant takings implications for lands within or affected by the designation.
In accordance with E.O. 13132 (Federalism), this proposed rule does not have significant Federalism effects. A federalism summary impact statement is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of this proposed critical habitat designation with, appropriate State resource agencies. From a federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the proposed rule does not have substantial direct effects either on the States, or on the relationship between the Federal Government and the States, or on the distribution of powers and responsibilities among the various levels of government. The proposed designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the species are more clearly defined, and the physical or biological features of the habitat necessary for the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist State and local governments in long-range planning because they no longer have to wait for case-by-case section 7 consultations to occur.
Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) of the Act would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.
In accordance with E.O. 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. We have proposed designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, this proposed rule identifies the physical or biological features essential to the conservation of the species. The proposed area of critical habitat is presented on a map, and the proposed rule provides several options for the interested public to obtain more detailed location information, if desired.
This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes on a government-to-government basis. In accordance with Secretaries' Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We requested information from the Fallon Paiute-Shoshone Tribe during the SSA and proposed listing processes and responded to comments the Tribe made on the proposed listing rule. The Fallon Paiute-Shoshone Tribe commented that they support the listing of the Dixie Valley toad and that the Dixie Meadows hot springs are one of the most sacred sites in their Tribe's culture. The Service met with the Fallon Paiute-Shoshone Tribe for government-to-government consultation in March 2023 at the Tribe's request. During this consultation, the Service emphasized our commitment to incorporating the Tribe's traditional ecological knowledge, to the extent to which the Tribe is comfortable, into the proposed critical habitat designation process, and we stated that we welcome further conversations to facilitate this. We will continue to work with Tribal entities during the development of a final rule for the designation of critical habitat for the Dixie Valley toad.
A complete list of references cited in this rulemaking is available on the internet at
The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Reno Fish and Wildlife Office.
Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.
(h) * * *
(d)
Dixie Valley Toad (
(1) The critical habitat unit for the Dixie Valley toad in Churchill County, Nevada, is depicted on the map in this entry.
(2) Within these areas, the physical or biological features essential to the conservation of the Dixie Valley toad consist of the following components:
(i) Wetlands within Dixie Valley that are composed of some combination of the following characteristics:
(A) Diverse wetland vegetation that includes, but is not limited to, native phreatophyte (deep-rooted) species found within the Dixie Meadows wetlands (
(B) Dense bulrush stands for brumation and shelter.
(C) Open, ephemerally wetted areas adjacent to vegetated areas for breeding.
(D) The natural range of variability of water temperatures found throughout each wetland.
(E) The natural range of variability of water extent found throughout each wetland.
(F) Water quality necessary to sustain natural physiological processes for normal behavior, growth, and viability of all life stages.
(G) A variety of aquatic and terrestrial invertebrates, detritus, and algae for feeding.
(ii) Upland habitat between wetlands through which Dixie Valley toads can disperse when conditions permit.
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the effective date of the final rule.
(4) Data layers defining the map unit were created by the Service, and the critical habitat unit was then mapped using Universal Transverse Mercator Zone 11N coordinates. The map in this entry, as modified by any accompanying regulatory text, establishes the boundaries of the critical habitat designation. The coordinates or plot points or both on which this map is based are available to the public at the Service's internet site at
(5) Dixie Meadows Unit; Churchill County, Nevada.
(i) The unit consists of 930 acres (ac) (376 hectares (ha)) in Churchill County and is composed of Federal lands owned by the Department of Defense (588 ac (238 ha)) and Bureau of Land Management (342 ac (138 ha)).
(ii) Map follows:
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, this notice announces the Office of Partnerships and Public Engagement's intention to request a new information collection titled “
We will consider comments we receive by July 29, 2024.
We invite you to submit comments on this notice.
Kim Okahara, Performance Improvement Officer, 202-720-6350,
The objectives of the 2501 Program are to support socially disadvantaged farmers and ranchers, military veteran farmers and ranchers, and beginning farmers and ranchers with owning and operating successful farms and ranches and participating equitably in the full range of agricultural, forestry, and related programs offered by USDA. The Agriculture Improvement Act of 2018 (2018 Farm Bill) authorizes grants to enhance coordination of the outreach, technical assistance, and education efforts authorized under agriculture programs; and to assist the Secretary in reaching current and prospective socially disadvantaged farmers and ranchers and veteran farmers and ranchers in a linguistically appropriate manner; and improving the participation of those farmers and ranchers in Department programs (7 U.S.C. 2279).
• The recipients of funds made available under the program;
• The activities undertaken and services provided;
• The number of current and prospective socially disadvantaged farmers or ranchers served and outcomes of such service;
• The problems and barriers identified by entities in trying to increase participation by current and prospective socially disadvantaged farmers or ranchers;
• The number of farms or ranches started, maintained, or improved as a result of funds made available under the program; and
• Actions taken by the Secretary in partnership with eligible entities to enhance participation in agricultural programs by veteran farmers or ranchers and socially disadvantaged farmers or ranchers and the effectiveness of those actions.
USDA will use the information collected to:
1. Assess program eligibility and compliance with program requirements;
2. Complete the annual report to Congress as required by 7 U.S.C. 2279(c)(4)(D);
3. Comply with the newly revised guidance on the collection of demographic information, per OMB Statistical Policy Directive No. 15;
4. Comply with the reporting requirements under the Government Performance and Results Modernization Act and Foundations of Evidence-based Policymaking Act; and
5. Assess the progress of grant recipients regarding measurable goals.
Data collected from the grantees will provide a nationwide description of
(A)
(B) A web-based system that collects data from grantees. Grantees report to USDA using a web-based data collection system. The estimated average amount of time required to complete all responses to the data collection instrument is 20 hours per report, or 40 hours annually. We anticipate an additional 10 burden hours for those completing a final report, which is approximately
(C) A follow-up survey that grantees collect from program participants. Many grantees currently ask program participants to complete surveys after attending a program offering or at the completion of a training program to assess the effectiveness and relevance of the training content to the needs of the participant. In this case, we are proposing that OPPE will survey program participants directly in order fulfill reporting requirements to Congress on the success of the program in meeting its performance measures. This information will be used by USDA to measure the program's overall performance from the perspective of program participants. Historical data from grantees regarding burden hours is helpful, but not especially relevant here, as currently grantees create their own feedback surveys that are not consistent across different grantee organizations. We have estimated the number of burden hours for this item based on the number of questions and whether they are multiple choice, short answer, or paragraph responses requested. In this estimate, we also anticipate administering the survey longitudinally by requesting responses from participants at 3 different time intervals.
Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
USDA will consider the comments received and amend the Information Collection Request (ICR) as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, USDA will issue another
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information
Additionally, establishments in the five-year economic census will receive data collection instruments specifically tailored to their industry based on the classification information obtained by the SQ-CLASS Report. Businesses in Support Activities for Crop Production (NAICS 1151) and Support Activities for Animal Production (NAICS 1152) are included in the scope and collection of the Economic Census. To ensure that businesses are properly classified, the scope of the SQ-CLASS Report includes businesses in the Agriculture Sector (NAICS Sector 11) that are not fully classified. This accounts for approximately 600 cases in the SQ-CLASS Report's sample each year.
To keep current with rapid changes in the marketplace caused by new businesses (a.k.a. births) the Census Bureau samples newly assigned Employer Identification Numbers (EINs) obtained from the Internal Revenue Service (IRS). Each EIN can only be selected once for the SQ-CLASS Report. EINs selected for the SQ-CLASS Report sample are asked to provide data about the establishment(s) associated with the new EIN including a more reliable measure of size, consisting of sales in two recent months, company affiliation information, a new or more detailed industry classification code, and other key information needed to maintain proper coverage of the business universe on the Business Register (BR) for the current business surveys.
Based on information collected on the SQ-CLASS Report form, EINs meeting the criteria for inclusion in the Census Bureau's current business surveys are eligible for a second phase of sampling. The retail, wholesale, and services EINs selected in this second sampling are asked to report monthly for the retail and wholesale surveys and quarterly for the services survey.
The Economic Census and the current business surveys represent the primary source of facts about the structure and function of the U.S. economy, providing essential information to government and the business community in making sound decisions. This information helps build the foundation for the calculation of Gross Domestic Product (GDP) and other economic indicators. Crucial to its success are the accuracy and reliability of the BR data, which provides the Economic Census and current business surveys with their establishment lists. Critical to the quality of information housed in the BR is that each of the statistical units has an accurate industry classification, measure of size, activity status, and physical address. The vital information obtained from the SQ-CLASS Report is fed back to the BR to represent changes in industries and confirm coverage between the years of the Economic Census.
We are not proposing any major changes to the collection. Minimal changes are being made to the economic activity descriptions in the primary business activity question on the SQ-CLASS Report. Respondents will continue to choose the economic sector of their business and then select their type of business from a list of business activities based on their response to the economic sector question. If the respondent does not see their business activity listed, then they will provide a brief description of their business activity. This is the same methodology that the Census Bureau uses in the Economic Census to assign industry classification.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
•
•
•
•
•
•
•
•
•
The SDRP encompasses the review of Type 1, Type 2, and Type 3 school districts as defined by the NCES. Type 1 is a local school district that is not a component of a supervisory union. Type 2 is a local school district component of a supervisory union sharing a superintendent and administrative services with other local school districts. Type 3 is an education agency that performs administrative services for more than one school district, providing a common superintendent for participating districts.
Respondents to the SDRP are the mapping coordinators and Title I Coordinators from the fifty states and the District of Columbia. The NCES also anticipates the inclusion of the Commonwealth of Puerto Rico within the next three years. Mapping coordinators are designated by the state departments of education and are tasked with reviewing and providing updates for school district boundaries, federally assigned school district local education agency codes, names, grade ranges, and levels to the Census Bureau. Title I Coordinators are responsible for overseeing the SDRP and reviewing all materials.
There are two phases to the SDRP: the Annotation Phase and Verification Phase. During the Annotation Phase, the Census Bureau provides mapping coordinators with materials containing the latest school district boundaries and school district information that the Census Bureau has on file for their state. Mapping coordinators review the data and submit any changes to the Census Bureau. The Census Bureau reviews and processes the information submitted by the mapping coordinator and updates the Master Address File/Topologically Integrated Geographic Encoding and Referencing (MAF/TIGER) System. During the Verification Phase, mapping coordinators verify that the Census Bureau updated the MAF/TIGER System accurately and completely with updates submitted during the Annotation Phase.
The Census Bureau is adding a feedback component to allow for the solicitation of feedback from respondents to improve the administration of the program and potentially reduce the future burden. Respondents may be asked to provide their feedback on materials, method(s) of data collection, manner of communications, and the usability of program applications and tools.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
On April 5, 2024, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Cleveland Cuyahoga County Port Authority, grantee of FTZ 40, requesting expansion of Subzone 40I subject to the existing activation limit of FTZ 40, on behalf of Swagelok Company, in Wickliffe, Ohio.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Gotion Inc. submitted a notification of proposed production activity to the FTZ Board (the Board) for its facility in Manteno, Illinois within Subzone 22AF. The notification conforming to the requirements of the Board's regulations (15 CFR 400.22) was received on May 22, 2024.
Pursuant to 15 CFR 400.14(b), FTZ production activity would be limited to the specific foreign-status material(s)/component(s) and specific finished product(s) described in the submitted notification (summarized below) and subsequently authorized by the Board. The benefits that may stem from conducting production activity under FTZ procedures are explained in the background section of the Board's website—accessible via
The proposed finished products include high voltage lithium battery systems, high voltage battery system control cabinets, and liquid cooled
The proposed foreign-status materials/components include: structural glue; thermal conductive glue; high voltage warning signs; polyurethane foam strips; glass fiber resin sheets/pads; waterproof blinds; plastic fittings/industrial handles; plug-in panel; wire tie rack; fuse plastic cover; plastic sheath seat; plastic sheath cover; plastic panels; plastic buckles; module brackets; plastic pressure seals/plates; plastic casings; plastic covers; plastic rail fasteners; rubber seals/pads; pan-head screws; hex head combination bolts; hex nuts; steel rivets; electrical switch plates; rail jam (irregular shape); control box body cover/panels; insulating pillar; electrical connectors; copper bars; relief valve; power supply switch; lead acid storage battery; lithium-ion energy storage box/battery; storage battery parts; displays; indicator lights; pre-charge 100 watt resistors; main circuit on/off switches; pre-charge on/off switches; surge protectors; fuses; solenoid valve control modules; isolating switches; power switch buttons; high voltage sockets (positive/negative poles); electrical screw terminals; electrical base control panels; three-level battery management systems; switchgear assemblies; insulated copper winding wire; high voltage wiring harnesses; electricity meters; and electrical current sensors (duty rate ranges from duty-free to 6.6%). The request indicates that certain materials/components may be subject to duties under section 301 of the Trade Act of 1974 (section 301), depending on the country of origin. The applicable section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Online FTZ Information System” section of the Board's website.
For further information, contact Kolade Osho at
Notice of issuance of an amended Export Trade Certificate of Review to United States Surimi Commission (USSC), Application No. 90-9A007.
The Secretary of Commerce, through the Office of Trade and Economic Analysis (OTEA), issued an amended Export Trade Certificate of Review to USSC on May 13, 2024.
Joseph Flynn, Director, OTEA, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4011-21) (the Act) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing title III are found at 15 CFR part 325. OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the
USSC amended its Certificate as follows:
1. Added the following entities as Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
2. Removed the following entities as Members of the Certificate:
The effective date of the amended certificate is February 13, 2024, the date on which USSC's application to amend was deemed submitted.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily finds that frozen warmwater shrimp (shrimp) from Ecuador is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2022,
Applicable May 30, 2024.
Kyle Clahane, Matthew Palmer, or Megan Goins, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5449, (202) 482-1678, and (202) 482-0884, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 21, 2023.
For a complete description of the events that followed the initiation of this investigation,
The product covered by this investigation is shrimp from Ecuador. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section 731 of the Act. Commerce has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination,
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted-average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:
Consistent with section 733(b)(3) of the Act, Commerce disregards
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Because the estimated weighted-average dumping margin for Santa Priscila/Tropack is
Should the final estimated weighted-average dumping margin be zero or
Commerce normally adjusts cash deposits for estimated antidumping duties by the amount of export subsidies countervailed in a companion countervailing duty (CVD) proceeding, when CVD provisional measures are in effect. Accordingly, where Commerce preliminarily made an affirmative determination for countervailable export subsidies, Commerce has offset the estimated weighted-average dumping margin by the appropriate CVD rate. Any such adjusted cash deposit rate may be found in the “Preliminary Determination” section above.
Should provisional measures in the companion CVD investigation expire prior to the expiration of provisional measures in this LTFV investigation, Commerce will direct CBP to begin collecting estimated antidumping duty cash deposits unadjusted for countervailed export subsidies at the time that the provisional CVD measures expire. These suspension of liquidation instructions will remain in effect until further notice.
Commerce intends to disclose to interested parties the calculations performed in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case brief.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(2)(B) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of Commerce's regulations requires that a request by exporters for postponement of the final
On April 17, 2024 and May 20, 2024, pursuant to 19 CFR 351.210(e), American Shrimp Processors Association (ASPA, or the petitioner), and Santa Priscila/Tropack and SONGA, respectively, requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months.
In accordance with section 733(f) of the Act, Commerce will notify the U.S. International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act, and 19 CFR 351.205(c).
The scope of this investigation includes certain frozen warmwater shrimp and prawns whether wild-caught (ocean harvested) or farm-raised (produced by aquaculture), head-on or head-off, shell-on or peeled, tail-on or tail-off, deveined or not deveined, cooked or raw, or otherwise processed in frozen form. “Tails” in this context means the tail fan, which includes the telson and the uropods.
The frozen warmwater shrimp and prawn products included in the scope, regardless of definitions in the Harmonized Tariff Schedule of the United States (HTSUS), are products which are processed from warmwater shrimp and prawns through freezing and which are sold in any count size.
The products described above may be processed from any species of warmwater shrimp and prawns. Warmwater shrimp and prawns are generally classified in, but are not limited to, the Penaeidae family. Some examples of the farmed and wild-caught warmwater species include, but are not limited to, whiteleg shrimp (Penaeus vannemei), banana prawn (Penaeus merguiensis), fleshy prawn (Penaeus chinensis), giant river prawn (Macrobrachium rosenbergii), giant tiger prawn (Penaeus monodon), redspotted shrimp (Penaeus brasiliensis), southern brown shrimp (Penaeus subtilis), southern pink shrimp (Penaeus notialis), southern rough shrimp (Trachypenaeus curvirostris), southern white shrimp (Penaeus schmitti), blue shrimp (Penaeus stylirostris), western white shrimp (Penaeus occidentalis), and Indian white prawn (Penaeus indicus).
Frozen shrimp and prawns that are packed with marinade, spices or sauce are included in the scope. In addition, food preparations, which are not “prepared meals,” that contain more than 20 percent by weight of shrimp or prawn are also included in the scope.
Excluded from the scope are: (1) breaded shrimp and prawns (HTSUS subheading 1605.21.1020); (2) shrimp and prawns generally classified in the Pandalidae family and commonly referred to as coldwater shrimp, in any state of processing; (3) fresh shrimp and prawns whether shell-on or peeled (HTSUS subheadings 0306.36.0020 and 0306.36.0040); (4) shrimp and prawns in prepared meals (HTSUS subheadings 1605.21.0500 and 1605.29.0500); (5) dried shrimp and prawns; (6) canned warmwater shrimp and prawns (HTSUS subheading 1605.29.1040); and (7) certain battered shrimp. Battered shrimp is a shrimp-based product: (1) that is produced from fresh (or thawed-from-frozen) and peeled shrimp; (2) to which a “dusting” layer of rice or wheat flour of at least 95 percent purity has been applied; (3) with the entire surface of the shrimp flesh thoroughly and evenly coated with the flour; (4) with the non-shrimp content of the end product constituting between four and ten percent of the product's total weight after being dusted, but prior to being frozen; and (5) that is subjected to individually quick frozen (IQF) freezing immediately after application of the dusting layer. When dusted in accordance with the definition of dusting above, the battered shrimp product is also coated with a wet viscous layer containing egg and/or milk, and par-fried.
The products covered by the scope are currently classified under the following HTSUS subheadings: 0306.17.0004, 0306.17.0005, 0306.17.0007, 0306.17.0008, 0306.17.0010, 0306.17.0011, 0306.17.0013, 0306.17.0014, 0306.17.0016, 0306.17.0017, 0306.17.0019, 0306.17.0020, 0306.17.0022, 0306.17.0023, 0306.17.0025, 0306.17.0026, 0306.17.0028, 0306.17.0029, 0306.17.0041, 0306.17.0042, 1605.21.1030, and 1605.29.1010. These HTSUS subheadings are provided for convenience and for customs purposes only and are not dispositive, but rather the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable May 30, 2024.
Bob Palmer or Laurel Smalley (Brazil), Peter Shaw (Kazakhstan), and Suresh Maniam (Malaysia), AD/CVD Operations, Offices I, VII, and VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-9068, (202) 482-3456, (202) 482-0697, or (202) 482-1603, respectively.
On April 17, 2024, the U.S. Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations of imports of ferrosilicon from Brazil, Kazakhstan, Malaysia and the Russian Federation (Russia).
Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On May 17, 2024, the petitioners
In accordance with 19 CFR 351.205(e), the petitioners stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations to no later than 130 days after the date on which these investigations were initiated,
This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that frozen warmwater shrimp (shrimp) from Indonesia is being, or likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2022, through September 30, 2023. Interested parties are invited to comment on this preliminary determination.
Applicable May 30, 2024.
Rachel Jennings or Miranda Bourdeau, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1110 or (202) 482-2021, respectively.
This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 21, 2023.
The product covered by this investigation is shrimp from Indonesia. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section
Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and
Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:
In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Because the estimated weighted-average dumping margin for BMS is zero or
Should the final estimated weighted-average dumping margin be zero or
Commerce intends to disclose to interested parties its calculations performed in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this investigation, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of Commerce's regulations requires that a request by exporters for postponement of the final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.
On April 16, and 18, 2024, pursuant to 19 CFR 351.210(e), BMS and First Marine requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months, respectively.
In accordance with section 733(f) of the Act, Commerce will notify the U.S. International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The scope of this investigation includes certain frozen warmwater shrimp and prawns whether wild-caught (ocean harvested) or farm-raised (produced by aquaculture), head-on or head-off, shell-on or peeled, tail-on or tail-off, deveined or not deveined, cooked or raw, or otherwise processed in frozen form. “Tails” in this context means the tail fan, which includes the telson and the uropods.
The frozen warmwater shrimp and prawn products included in the scope, regardless of definitions in the Harmonized Tariff Schedule of the United States (HTSUS), are products which are processed from warmwater shrimp and prawns through freezing and which are sold in any count size.
The products described above may be processed from any species of warmwater shrimp and prawns. Warmwater shrimp and prawns are generally classified in, but are not limited to, the Penaeidae family. Some examples of the farmed and wild-caught warmwater species include, but are not limited to, whiteleg shrimp (Penaeus vannemei), banana prawn (Penaeus merguiensis), fleshy prawn (Penaeus chinensis), giant river prawn (Macrobrachium rosenbergii), giant tiger prawn (Penaeus monodon), redspotted shrimp (Penaeus brasiliensis), southern brown shrimp (Penaeus subtilis), southern pink shrimp (Penaeus notialis), southern rough shrimp (Trachypenaeus curvirostris), southern white shrimp (Penaeus schmitti), blue shrimp (Penaeus stylirostris), western white shrimp (Penaeus occidentalis), and Indian white prawn (Penaeus indicus).
Frozen shrimp and prawns that are packed with marinade, spices or sauce are included in the scope. In addition, food preparations, which are not “prepared meals,” that contain more than 20 percent by weight of shrimp or prawn are also included in the scope.
Excluded from the scope are: (1) breaded shrimp and prawns (HTSUS subheading 1605.21.10.20); (2) shrimp and prawns generally classified in the Pandalidae family and commonly referred to as coldwater shrimp, in any state of processing; (3) fresh shrimp and prawns whether shell-on or peeled (HTSUS subheadings 0306.36.0020 and 0306.36.0040); (4) shrimp and prawns in prepared meals (HTSUS subheading 1605.21.05.00 and 1605.29.05.00); (5) dried shrimp and prawns; (6) canned warmwater shrimp and prawns (HTSUS subheading 1605.29.10.40); and (7) certain battered shrimp. Battered shrimp is a shrimp-based product: (1) that is produced from fresh (or thawed-from-frozen) and peeled shrimp; (2) to which a “dusting” layer of rice or wheat flour of at least 95 percent purity has been applied; (3) with the entire surface of the shrimp flesh thoroughly and evenly coated with the flour; (4) with the non-shrimp content of the end product constituting between four and ten percent of the product's total weight after being dusted, but prior to being frozen; and (5) that is subjected to IQF freezing immediately after application of the dusting layer. When dusted in accordance with the definition of dusting above, the battered shrimp product is also coated with a wet viscous layer containing egg and/or milk, and par-fried.
The products covered by the scope are currently classified under the following HTSUS subheadings: 0306.17.0004, 0306.17.0005, 0306.17.0007, 0306.17.0008, 0306.17.0010, 0306.17.0011, 0306.17.0013, 0306.17.0014, 0306.17.0016, 0306.17.0017, 0306.17.0019, 0306.17.0020, 0306.17.0022, 0306.17.0023, 0306.17.0025, 0306.17.0026, 0306.17.0028, 0306.17.0029, 0306.17.0041, 0306.17.0042, 1605.21.1030, and 1605.29.1010. These HTSUS subheadings are provided for convenience and for customs purposes only and are not dispositive, but rather the written description of the scope is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to certain producers/exporters of organic soybean meal from India. The period of review (POR) is September 3, 2021, through December 31, 2022. Interested parties are invited to comment on these preliminary results.
Applicable May 30, 2024.
Peter Shaw or Tylar Lewis, AD/CVD Operations, Office OVII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0697 or (202) 482-6009, respectively.
On July 12, 2023, Commerce published in the
For a complete description of the events that followed the initiation of this review,
The products covered by this
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. A list of the 35 companies Commerce received timely-filed withdrawal requests from is provided below in Appendix II. Because the withdrawal requests were timely filed and no other parties requested a review of these companies, in accordance with 19 CFR 351.213(d)(1), Commerce is rescinding this review of the
Commerce is conducting this administrative review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found to be countervailable, we preliminarily determine that there is a subsidy,
As a result of this review, we preliminarily determine that for 2021 and 2022, the following estimated countervailable subsidy rates exist:
Commerce intends to disclose its calculations and analysis performed in connection with the preliminary results to interested parties within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs to Commerce no later than 30 days after the publication of these preliminary results of review in the
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. If a request for a hearing is made, Commerce will inform parties of the scheduled date for the hearing.
Pursuant to section 751(a)(2)(C) of the Act, Commerce intends, upon publication of the final results, to instruct U.S. Customs and Border Protection (CBP) to collect cash deposits of estimated countervailing duties in the amounts shown for the year 2022 for Shri Sumati and Shanti, except where the rate calculated in the final results is zero or
In accordance with 19 CFR 351.221(b)(4)(i), we preliminarily assigned subsidy rates in the amounts shown above for the producers/exporters shown above. Consistent with section 751(a)(1) of the Act and 19 CFR 351.212(b)(2), upon issuance of the final results, Commerce shall determine, and CBP shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
For the companies for which this review is rescinded with these preliminary results, we will instruct CBP to assess countervailing duties on all appropriate entries at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period September 3, 2021, through December 31, 2022, in accordance with 19 CFR 351.212(c)(1)(i).
Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(2), Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised by parties in their comments, within 120 days after the date of publication of these preliminary results in the
We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The Board of Overseers of the Malcolm Baldrige National Quality Award (Board of Overseers) will meet in open session on Thursday, June 13, 2024, from 11:00 a.m. to 4:00 p.m. Eastern time. The Board of Overseers, appointed by the Secretary of Commerce, reports the results of the Malcolm Baldrige National Quality Award (Award) activities to the Director of the National Institute of Standards and Technology (NIST) each year, along with its recommendations for the improvement of the Award process. The purpose of this meeting is to discuss and review information received from the National Institute of Standards and Technology. The agenda will include: Baldrige Program Update, Baldrige Foundation Update, Ethics Review, Alliance for Performance Excellence Update, Communities of Excellence Update, and New Business/Public Comment.
The meeting will be held on Thursday, June 13, 2024, from 11:00 a.m. Eastern Time until 4:00 p.m. Eastern Time. The meeting will be open to the public.
The meeting will be virtual via webinar. Please note admittance instructions under the
Robert Fangmeyer, Director, Baldrige Performance Excellence Program, phone: 301-975-2361, email
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. 1000
The purpose of this meeting is to discuss and review information received from NIST. The agenda will include: Baldrige Program Update, Baldrige Foundation Update, Ethics Review, Alliance for Performance Excellence Update, Communities of Excellence Update, and New Business/Public Comment. The agenda may change to accommodate the Board of Overseers business. The final agenda will be posted on the NIST Baldrige Performance Excellence website at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the Board's affairs and/or the Judges Panel's general process are invited to request a place on the agenda. Approximately one-half hour will be reserved in the afternoon for public comments, and speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received but is likely to be about 3 minutes each. The exact time for public comments will be included in the final agenda that will be posted on the Baldrige Performance Excellence Program website at
Pursuant to 41 CFR § 102-3.150(a)(6), Admittance instructions: All participants will be attending virtually via webinar and need to pre-register to be admitted. Please contact Mrs. Robyn Decker by email at
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of solicitation of nominations for membership.
Pursuant to the Promoting Research and Observations of Space Weather to Improve the Forecasting of Tomorrow (PROSWIFT) Act of and the Federal Advisory Committee Act (FACA), the Space Weather Interagency Working Group (interagency working group), requests nominations for membership on the SWAG.
Nominations should be sent to the web address specified below and must be received on or before June 30, 2024.
Nominations and applications should be submitted electronically to the Designated Federal Officer (DFO), SWAG, NOAA, Amy Macpherson via email:
Ms. Amy Macpherson, DFO, SWAG, and Acting National Space Weather Program Manager, National Weather Service, NOAA, at
Establishment of the SWAG implements a statutory requirement of the PROSWIFT Act 2020 (Pub. L. 116-181), 51 U.S.C. 60601
The SWAG shall consist of not more than 15 members, including a chair, of whom: 5 members shall be representatives of the academic community; 5 members shall be representatives of the commercial space weather sector; and 5 members shall be nongovernmental representatives of the space weather end-user community. Members will be chosen to provide an appropriate range of views that represent the span of the space weather community and end-user sectors. Members shall serve in a representative capacity; they are, therefore, not Special Government Employees. As such, members are not subject to the ethics rules applicable to Government employees, except that they must not misuse Government resources or their affiliation with the Committee for personal purposes. All members of the SWAG will be appointed by the interagency working group for a 3-year term, with one member appointed by NOAA as the Chair. Members may not serve on the SWAG for more than two consecutive terms. A member of the SWAG may not serve as the Chair of the SWAG for more than two terms, regardless of whether the terms are consecutive. The SWAG will meet approximately three times each year, which may be conducted in person or by teleconference, webinar, or other means. Additional meetings may be called as appropriate, with approval by the Administrator of NOAA. Members are reimbursed for actual and reasonable travel in accordance with Federal per diem expenses incurred in performing such duties but will not be reimbursed for their time. As a Federal Advisory Committee, the SWAG's membership is required to be balanced in terms of viewpoints represented and the functions to be performed as well as appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, or cultural, religious, or socioeconomic status.
Interested persons may nominate themselves or third parties. An application is required to be considered for SWAG membership, regardless of whether a person is nominated by a third party or self-nominated. The application package must include: (1) the nominee's full name, title, institutional affiliation, and contact information; (2) identification of the nominee's area(s) of industry perspective—academia, commercial service provider, or end-user; (3) a short description of his/her qualifications relative to the kinds of advice being solicited by NOAA in this Notice; and (4) a current resume (maximum length four pages). All nomination information should be provided in a single, complete package, and should be sent to the Designated Federal Officer of the SWAG at the electronic address provided above.
Office of the Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD).
Notice of Federal advisory committee meeting.
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place.
DACOWITS will hold an open to the public meeting—Tuesday, June 25, 2024, from 8:00 a.m. to 2:30 p.m. (EST).
The meeting will take place at the Association of the United States Army Conference Center, located at 2425 Wilson Boulevard, Arlington, Virginia 22201. The meeting will also be streamed virtually. To participate in the meeting, see the Meeting Accessibility section for instructions.
Colonel Samantha Frazier, Designated Federal Officer (DFO), (202) 650-2943 (voice),
This meeting is being held under the provisions of chapter 10 of title 5, United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150.
Defense Advanced Research Projects Agency (DARPA), Department of Defense (DoD).
Notice of adoption of the National Oceanic and Atmospheric Administration (NOAA) categorical exclusion for habitat restoration.
DARPA is adopting the NOAA categorical exclusion C1 for the restoration of coral reefs in south Florida. This notice describes the proposed action for which DARPA intends to use the NOAA categorical exclusion and details the consultation between the agencies.
This action is effective May 30, 2024.
Dr. Catherine Campbell, 703-526-2044 (Voice),
NEPA, 42 U.S.C. 4321-4347 requires all Federal agencies to assess the environmental impacts of their actions. Congress enacted NEPA to encourage productive and enjoyable harmony between humans and the environment, recognizing the profound impact of human activity and the critical importance of restoring and maintaining environmental quality to the overall welfare of humankind. NEPA seeks to ensure agencies consider the environmental effects of their proposed actions in their decision-making processes and inform and involve the public in that process. NEPA created the Council on Environmental Quality (CEQ), which promulgated NEPA implementing regulations, 40 Code of Federal Regulations (CFR) parts 1500 through 1508 (CEQ regulations).
To comply with NEPA, agencies determine the appropriate level of review—an Environmental Impact Statement (EIS), Environmental Assessment (EA), or categorical exclusion. (42 U.S.C. 4336). If a proposed action is likely to have significant environmental effects, the agency must prepare an EIS and document its decision in a record of decision. Id. If the proposed action is not likely to have significant environmental effects or the effects are unknown, the agency may instead prepare an EA, which involves a more concise analysis and process than an EIS. Id.
Following the EA, the agency may conclude the process with a finding of no significant impact if the analysis shows that the action will have no significant effects. If the analysis in the EA finds that the action is likely to have significant effects, however, then an EIS is required.
Under NEPA and the CEQ regulations, a Federal agency may establish in its NEPA implementing procedures categorical exclusions, which are categories of actions the agency has determined normally do not significantly affect the quality of the human environment. (40 CFR 1501.4, 1507.3(e)(2)(ii), 1508.1(d)). If an agency determines that a categorical exclusion covers a proposed action, it then evaluates the proposed action for extraordinary circumstances in which a normally excluded action may have a significant effect. (40 CFR 1501.4(b)). If no extraordinary circumstances are present or if further analysis determines that the extraordinary circumstances do not involve the potential for significant environmental impacts, the agency may apply the categorical exclusion to the proposed action without preparing an EA or EIS. (40 CFR 1501.4). If the extraordinary circumstances have the potential to result in significant effects, the agency is required to prepare an EA or EIS.
Section 109 of NEPA, enacted as part of the Fiscal Responsibility Act of 2023, allows a Federal agency to adopt a categorical exclusion listed in another agency's NEPA procedures for a category of proposed agency actions for which the categorical exclusion was established (42 U.S.C. 4336(c)). To adopt another agency's categorical exclusion under Section 109, an agency must identify the relevant categorical exclusion listed in that agency's (“establishing agency”) NEPA procedures that cover its category of proposed actions or related actions; consult with the establishing agency to ensure that the proposed adoption of the categorical exclusion to a category of actions is appropriate; identify to the public the categorical exclusion that the agency plans to use for its proposed actions; and document adoption of the categorical exclusion.
NOAA's categorical exclusion, C1, for habitat restoration actions is codified in NOAA's procedures for implementing NEPA (
DARPA proposes to deploy and field test ecological engineering and biological adaptation strategies for corals in south Florida that have been tested in laboratory settings. The need to field test these strategies is to determine the best methods for coral translocation that will maximize wave attenuation, promote coral growth, mimic natural reef building and self-repair, increase the adaptive capacity of coral, and provide for long-term resiliency of the artificial reef that will be a part of DARPA's Reefense program in south Florida.
If an agency determines that a categorical exclusion covers a proposed action, the agency must evaluate the proposed action for extraordinary circumstances in which a normally excluded action may have a significant effect. (40 CFR 1501.4(b)). DARPA does not currently have its own NEPA implementing procedures to guide its application of extraordinary circumstances. Until DARPA establishes NEPA implementing procedures, for purposes of considering extraordinary circumstances in connection with the NOAA categorical exclusion discussed in this notice, DARPA has considered whether the proposed action has the potential to result in significant effects. DARPA has assessed extraordinary circumstances and determined they are not present.
DARPA and NOAA consulted on the appropriateness of DARPA's adoption of the categorical exclusion. This consultation included a review of NOAA's experience applying the categorical exclusion and the proposed action for which DARPA plans to utilize it. Following this consultation and review, DARPA has determined that the impacts of the proposed action to deploy and field test ecological engineering and biological adaptation strategies for corals that have been tested in laboratory settings are similar to the impacts, which are not significant, of projects for which NOAA may apply the categorical exclusion. Additionally, DARPA determined that there are no extraordinary circumstances. Therefore, DARPA has determined that its proposed use of NOAA's categorical exclusion C1, as described within this notice, would be appropriate.
This notice documents adoption of the NOAA categorical exclusion listed above and is available for use by DARPA, effective immediately.
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before July 29, 2024.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Andrew Brake, (202) 453-6136.
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on
Federal Student Aid, Department of Education.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Department of Education (Department) publishes this notice of a modified system of records entitled “Aid Awareness and Application Processing” (18-11-21). This system maintains information necessary for the Department to process applications for Federal student financial program assistance under title IV of the Higher Education Act of 1965, as amended (HEA); to perform the responsibilities of the Federal Student Aid (FSA) Ombudsman; to provide Federal student loan repayment relief including under the borrower defense to repayment regulations; to notify aid applicants and aid recipients of aid program opportunities and updates under title IV of the HEA via digital communication channels; and to maintain the
Submit your comments on this modified system of records notice on or before July 1, 2024.
This modified system of records notice will become applicable upon publication in the
Comments must be submitted via the Federal eRulemaking Portal at
•
Rachel Coghlan, Central Processing System (CPS) System Manager, Student Experience and Aid Delivery, Federal Student Aid (FSA), U.S. Department of Education, Union Center Plaza, 830 First Street NE, Washington, DC 20202-5454. Telephone: (202) 377-3205. Email:
Corey Johnson, FAFSA® Processing System (FPS) Information System Owner, Federal Student Aid, U.S. Department of Education, Union Center Plaza, 830 First Street NE, Washington, DC 20202-5454. Telephone: (202) 377-3898. Email:
Bonnie Latreille, Ombudsman/Director, Ombudsman Group, Federal Student Aid (FSA), U.S. Department of Education, Union Center Plaza, 830 First Street NE, Washington, DC 20202-5454. Telephone: (202) 377-3726. Email:
Pardu Ponnapalli, Information System Owner, Technology Directorate, Federal Student Aid, U.S. Department of Education, Union Center Plaza, 830 First Street NE, Washington, DC 20202-5454. Telephone: (240) 382-5825. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
In accordance with the Privacy Act, the Department proposes to modify the system of records notice entitled “Aid Awareness and Application Processing” (18-11-21), which was last published in full in the
The Department is modifying the section entitled “PURPOSE(S) OF THE SYSTEM” for the purposes related to applying for Federal student financial assistance and administering title IV, HEA programs to add purpose (18) to enable institutions of higher education (IHEs) and State higher education agencies to provide aid applicants and aid recipients with information about certain Federal means-tested benefits for which they may qualify and to enable IHEs and State higher education agencies, with the explicit written consent of aid applicants or aid recipients, and parents of dependent aid applicants or aid recipients and spouses of married aid applicants or aid recipients if necessary, to share non-Federal Tax Information (FTI) Free Application for Federal Student Aid (FAFSA) information directly with Federal, State, or local government agencies or tribal organizations to assist such applicants or recipients, in applying for or receiving Federal, State, or local government assistance, or tribal assistance for any component of the applicants' or recipients' cost of attendances that may include financial assistance or non-monetary assistance.
The Department is modifying the second sentence in the first paragraph in the section entitled “CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM” to remove the category of individuals that includes those who are students in attendance at a secondary school or local educational agency for which State grant agencies and other eligible requesting entities submit information to the Department in order for the Department to provide such entities with the student's FAFSA Filing Status Information. The Department is removing this category of individuals because the Department is no longer collecting this information and permits FAFSA filing status to be redisclosed by State higher education agencies to such entities, as described in the modification of routine use 1(p).
The Department is modifying the note in Category (1) in the section entitled “CATEGORIES OF RECORDS IN THE SYSTEM” to clarify that the “FUTURE Act System (FAS)” (18-11-23) system of records notice was published in the
The Department is modifying the section entitled “ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES” as follows:
(i) In the first paragraph, the Department is deleting the last sentence (which reads, “Until June 30, 2024, Section 483(a)(3)(E) of the HEA (20 U.S.C. 1090(a)(3)(E)) restricts the use of the information gathered from the electronic version of the FAFSA to the application, award, and administration of aid awarded under title IV of the HEA, aid awarded by States, aid awarded by eligible institutions, or aid awarded by such entities as the Secretary of Education may designate”) because Section 483(a)(3)(E) of the HEA will not be in effect after June 30, 2024;
(ii) Routine use (1)(p) is modified to revise and limit the entities to which the Department may disclose a student's FAFSA filing status for the purpose of encouraging a student to complete a FAFSA that they started but did not submit and assisting a student with the completion of a FAFSA to a State higher education agency in order for such agency to redisclose such information to a local educational agency; a secondary school where the student is or was enrolled; grantees of the Department; American Indian and Alaska Native educational entities; and nonprofit college access organizations with an established relationship with the student;
(iii) Routine use (1)(q) is modified to remove and replace “Through June 30, 2024, the Department may disclose records from this system to State higher education agencies, eligible IHEs, and other entities that the Secretary of Education has designated under section 483(a)(3)(E) of the HEA (20 U.S.C. 1090(a)(3)(E)) that award and administer aid to students, to determine an applicant's eligibility for the award of aid by State higher education agencies, eligible IHEs, or by other entities the Secretary of Education has designated. (Beginning July 1, 2024, under amendments to the HEA made by the FAFSA Simplification Act and the FAFSA Simplification Technical Corrections Act, the Department will no longer rely on this authority to disclose records from this system to State higher education agencies, eligible IHEs, and other entities that the Secretary of Education has designated under section 483(a)(3)(E) of the HEA (20 U.S.C. 1090(a)(3)(E))” with “The Department may disclose records under Sections 483(a)(2)(D)(i), 483(a)(2)(E)(ii), and 483(a)(3)(B)(i) of the HEA (20 U.S.C. 1090(a)(2)(D)(i), 1090(a)(2)(E)(ii), and 1090(a)(3)(B)(i)) from this system to State higher education agencies, eligible IHEs, and scholarship organizations that were designated prior to the date of enactment (December 19, 2019) of the FUTURE Act (Pub. L. 116-91, 133 Stat. 1189) that award and administer aid to students, to determine an applicant's eligibility for aid awarded by State higher education agencies, eligible IHEs, or designated scholarship organizations, and to administer Federal aid or aid awarded by State higher education agencies, eligible IHEs, or designated scholarship organizations.”; and
(iv) Routine use (1)(s) is added to permit disclosures of records from an applicant's FAFSA to IHEs and State higher education agencies to provide aid applicants and aid recipients with information about certain Federal means-tested benefits for which they may qualify.
You may also access documents of the Department published in the
For the reasons discussed in the preamble, the Chief Operating Officer, Federal Student Aid (FSA) of the U.S. Department of Education (Department) publishes a modified system of records notice to read as follows:
Aid Awareness and Application Processing (18-11-21).
Unclassified.
U.S. Department of Education, 830 First Street NE, Washington, DC 20202.
The following locations are for the Central Processing System (CPS):
Lee's Summit Federal Records Center, National Archives and Records Administration (NARA), 200 Space Center Drive, Lee's Summit, MO 6464-1182 (
General Dynamics Information Technology (GDIT) Image and Data Capture (IDC) Center, 1084 South Laurel Road, Building 1, London, KY 40744 (
Next Generation Data Center (NGDC), 250 Burlington Drive, Clarksville, VA 23927 (
CPS Print Facility, 327 Columbia Pike, Rensselaer, NY 12144 (
The following locations are for the Free Application for Federal Student Aid (FAFSA®) Processing System (FPS):
Perspecta/Peraton, 15052 Conference Center Drive, Chantilly, VA 20151 (
Information Capture Solutions (ICS), 25 Air Park Drive, London, KY 40744 (
iWorks, 1889 Preston White Drive, Suite 100, Reston, VA 20191 (
Red Cedar Consultancy, LLC, 161 Fort Evans Road NE, Suite 200, Leesburg, VA 20176 (
Windsor Group, LLC, 6820 Wisconsin Avenue, Unit 4004, Chevy Chase, MD 20815 (
Jazz Solutions, LLC, 20745 Williamsport Place, Suite 320, Ashburn, VA 20147 (
The following locations are for the Digital and Customer Care (DCC) Information Technology (IT) System:
Salesforce Government Cloud, 415 Mission Street, 3rd Floor, San Francisco, CA 94105 (
Amazon Web Services (AWS) GovCloud (East/West), 410 Terry Avenue, North Seattle, WA 98109-5210 (
Contact Center Fulfillment Center (Senture facility), 4255 W Highway 90, Monticello, KY 42633 (
The following 10 listings are the locations of the Aid Awareness and Application Processing Customer Contact Centers: Jacksonville Contact Center, One Imeson Park Boulevard, Jacksonville, FL 32118; Knoxville, TN Servicing Center, 120 N Seven Oaks Drive, Knoxville, TN 37922; 1600 Osgood Street, Suite 2-120, North Andover, MA 01845; 11499 Chester Road, Suite 101, Sharonville, OH 45246; 100 Domain Drive, Suite 200, Exeter, NH 03833; 221 N Kansas Street, Suite 700, El Paso, TX 79901; 4255 W Highway 90, Monticello, KY 42633; 555 Vandiver Drive, Columbia, MO 65202; 633 Spirit Drive, Chesterfield, MO 63005; and 820 First Street, NE, Washington, DC 20002.
CPS—System Manager, Student Experience and Aid Delivery, FSA, U.S. Department of Education, Union Center Plaza (UCP), 830 First Street NE, Washington, DC 20202-5454.
FPS—Information System Owner, Technology Directorate, Federal Student Aid, U.S. Department of Education, Union Center Plaza, 830 First Street NE, Washington, DC 20202-5454.
Ombudsman, FSA, U.S. Department of Education, UCP, 830 First Street NE, Washington, DC 20202-5454.
DCC—Information System Owner, Technology Directorate, Federal Student Aid, U.S. Department of Education,
The authorities are title IV of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1070
The information contained in this system is maintained for the following purposes related to applying for Federal student financial assistance and administering title IV, HEA programs: (
(1) Assisting with the determination, correction, processing, tracking, and reporting of program eligibility and benefits for the Federal student financial assistance programs authorized by title IV of the HEA, including, but not limited to, discharge of eligible loans under title IV, HEA programs;
(2) Making a loan or grant;
(3) Verifying the identity of the applicant for Federal financial assistance under title IV of the HEA, the spouse of a married applicant, the parent(s) of a dependent applicant, and, until CPS is decommissioned after September 30, 2024, an individual who applies for an FSA ID; and verifying the accuracy of the information in this system;
(4) Reporting the results of the need analysis and Federal Pell Grant eligibility determination to applicants, institutions of higher education (IHEs), third-party servicers, State agencies designated by the applicant, and Departmental and investigative components;
(5) Reporting the results of duly authorized matching programs between the Department and other Federal agencies and between the Department and State or local governments, or agencies thereof, to applicants, IHEs, third-party servicers, State agencies designated by the applicant, and Departmental and investigative components where the Department is required by law to do so or where it would be essential to the conduct of the matching program to report, such as for the imposition of criminal, civil, or administrative sanctions;
(6) Enforcing the terms and conditions of a title IV, HEA loan or grant;
(7) Servicing and collecting a delinquent title IV, HEA loan or grant;
(8) Initiating enforcement action against individuals, IHEs, or other entities involved in program fraud, abuse, or noncompliance;
(9) Locating a debtor or recipient of a grant overpayment;
(10) Maintaining a record of the data supplied by those requesting title IV, HEA program assistance;
(11) Ensuring compliance with and enforcing title IV, HEA programmatic requirements and various consumer protection laws;
(12) Acting as a repository and source for information necessary to fulfill the requirements of title IV of the HEA;
(13) Evaluating title IV, HEA program effectiveness;
(14) Enabling IHEs and State grant agencies designated by the applicant to review and analyze the financial aid data of their applicant population;
(15) Enabling IHEs and State grant agencies to assist applicants with the completion of the application for the Federal student financial assistance programs authorized by title IV of the HEA;
(16) Assisting State agencies, eligible IHEs, and other entities that award aid to students and that are designated by the Secretary of Education with making eligibility determinations for the award of aid and with administering these awards;
(17) Promoting and encouraging applications for title IV, HEA program assistance, State assistance, and aid awarded by eligible IHEs or by other entities designated by the Secretary of Education; and
(18) Enabling IHEs and State higher education agencies to provide aid applicants and aid recipients with information about certain Federal means-tested benefits for which they may qualify and to enable IHEs and State higher education agencies, with the explicit written consent of aid applicants or aid recipients, and parents of dependent aid applicants or aid recipients and spouses of married aid applicants or aid recipients if necessary, to share non-FTI FAFSA information directly with Federal, State, or local government agencies or tribal organizations to assist such applicants or recipients, in applying for or receiving Federal, State, or local government assistance, or tribal assistance for any component of the applicants' or recipients' cost of attendances that may include financial assistance or non-monetary assistance.
The information contained in this system is also maintained for the following purposes related to managing customer engagement:
(1) Carrying out the duties and responsibilities of the FSA Ombudsman, including investigating and resolving complaints, inquiries, and requests for assistance, updating borrower account records, correcting errors, analyzing complaint trends, and making appropriate recommendations pursuant to 20 U.S.C. 1018(f);
(2) Carrying out the duties and responsibilities of the Department to provide Federal student loan repayment relief under Federal law;
(3) Verifying the identity of FSA customers;
(4) Recording complaints, suspicious activities, positive feedback, and comments as provided by customer interactions with contact center support via inbound and outbound channels (phone, chat, webform, email, customer satisfaction survey, fax, physical mail, social media platforms, digital engagement platforms, and controlled correspondence);
(5) Tracking individual cases, including complaints, borrower defense submissions, general inquiries, and chat sessions, through final resolution, reporting trends, and analyzing the data to recommend improvements in Federal student financial assistance programs;
(6) Assisting in the informal resolution of disputes submitted by aid applicants or aid recipients about issues related to title IV, HEA program assistance;
(7) Carrying out the duties and responsibilities of the Department under
(8) Initiating proceedings, where appropriate, to recover liabilities from an IHE for losses incurred as a result of the act or omission of the IHE participating in the Federal student loan programs.
The information contained in this system is also maintained for the following purposes related to assisting aid applicants and recipients with Federal student financial assistance programs authorized by title IV of the HEA, and managing customer relationships for marketing and improving customer service:
(1) Determining employer qualification for borrowers to receive discharge under the PSLF Program;
(2) Collecting, processing, storing, and making available user activity events and user-submitted documentation from across the DCC IT system to provide a complete view of the customer to the Department and its contractors;
(3) Sending aid applicants and aid recipients strategic and real-time, personalized communications via email, and SMS “text messages” via mobile phone communications to inform them of title IV, HEA aid marketing campaigns (such as encouraging completion of their FAFSA), and sending transactional communication to customers (such as confirmation emails when a user completes an action);
(4) Measuring customer satisfaction and analyzing results; and
(5) Promoting and encouraging the repayment of title IV, HEA program loans in a timely manner.
The information in this system is also maintained for the following purposes relating to the Department's administration and oversight of title IV, HEA programs:
(1) To support the investigation of possible fraud and abuse and to detect and prevent fraud and abuse in the title IV, HEA Federal grant and loan programs;
(2) To support compliance with title IV, HEA statutory and regulatory requirements;
(3) To provide an aid recipient's financial aid history, including information about the recipient's title IV, HEA loan defaults, title IV, HEA aid receipt, and title IV, HEA grant program overpayments;
(4) To facilitate receiving and correcting application data, processing Federal Pell Grants and Direct Loans, and reporting Federal Perkins Loan Program expenditures to the Department's processing and reporting systems;
(5) To support pre-claims/supplemental pre-claims assistance;
(6) To assist in locating holders of title IV, HEA loan(s);
(7) To assist in assessing the administration of title IV, HEA program funds by guaranty agencies, lenders and loan holders, IHEs, and third-party servicers;
(8) To initiate or support a limitation, suspension, or termination action, an emergency action, or a debarment or suspension action;
(9) To inform the parent(s) of a dependent applicant of information about the parent(s), or the spouse of a married applicant of information about the spouse, in an application for title IV, HEA funds;
(10) To disclose applicant records to the parent(s) of a dependent applicant applying for a PLUS loan (to be used on behalf of a student), to identify the student as the correct beneficiary of the PLUS loan funds, and to allow the processing of the PLUS loan application and promissory note;
(11) To expedite the application process;
(12) To enable an applicant, at the applicant's written request, to obtain income information about the applicant from the Internal Revenue Service (IRS) using the Data Retrieval Tool, until CPS is decommissioned after September 30, 2024;
(13) To identify, prevent, reduce, and recoup improper payments, prevent fraud, and conduct at-risk campaigns, including protecting customers from Third-Party Debt Relief firms;
(14) To help Federal, State, Tribal, and local government entities exercise their supervisory and administrative powers (including, but not limited to licensure, examination, discipline, regulation, or oversight of educational institutions, Department contractors, guaranty agencies, lenders and loan holders, and third-party servicers) or to respond to individual aid applicant or recipient complaints submitted regarding the practices or processes of the Department and/or the Department's contractors, or to update information or correct errors contained in Department records regarding the aid applicant's or recipient's title IV, HEA program funds;
(15) To provide eligible applicants for title IV, HEA aid, and when necessary, the spouse or parents of an applicant, with information about certain Federal means-tested benefits and services for which they may qualify;
(16) To collect, track, and process Office of Inspector General (OIG) fraud referrals;
(17) To support research, analysis, and development, and the implementation and evaluation of educational policies in relation to title IV, HEA programs; and
(18) To conduct testing, analysis, or take other administrative actions needed to prepare for or execute programs under title IV of the HEA.
This system maintains records on individuals who are, were, or may be participants in any of the Federal student financial assistance programs under title IV of the HEA who request assistance from the Department, directly or through State requestors and legal assistance organizations (“third-party requestors”) who may request that the Secretary of Education form a group of Federal student loan borrowers for borrower defense relief.
This system also maintains records on student and parent applicants (and their third-party preparers), as well as the spouse of a married applicant and the parent(s) of a dependent applicant, who apply for Federal student financial assistance under one of the programs authorized under title IV of the HEA, including, but not limited to the: (1) Federal Pell Grant Program; (2) Federal Perkins Loans Program; (3) Academic Competitiveness Grant (ACG) Program; (4) National Science and Mathematics Access to Retain Talent (National SMART) Grant Program; (5) Teacher Education Assistance for College and Higher Education (TEACH) Grant Program; (6) Iraq and Afghanistan Service Grant (IASG) Program; (7) Direct Loan Program, which includes Federal Direct Stafford/Ford Loans, Federal Direct Unsubsidized Stafford/Ford Loans, Federal Direct PLUS Loans, and Federal Direct Consolidation Loans; (8) Federal Family Education Loan (FFEL) Program; and (9) Federal Insured Student Loan (FISL) Program.
This system also maintains records on individuals who apply for an FSA ID in the Department's Person Authentication Service (PAS) system because the Department uses CPS, which maintains records that are part of this system, as a pass-through to send these individuals' records from the PAS system to the Social Security Administration (SSA) for computer matching in order to assist the Department in verifying their identities. This pass-through will be terminated when CPS is decommissioned after September 30, 2024.
This system maintains records that contain the following information:
(1) Information provided by applicants for title IV, HEA program assistance on an incomplete or completed FAFSA, including, but not limited to, the applicant's name, address, SSN, DOB, telephone number, driver's license number (which will not be collected on the FAFSA for award year 2024-2025 and onward, and will not be collected by FPS), email address, citizenship status, marital status, legal residence, status as a veteran, educational status, and financial information (including asset and income information). (
(2) Information provided about the parent(s) of a dependent applicant, including, but not limited to, the parent's highest level of schooling completed (which will not be collected on the FAFSA starting with award year 2024-2025 and will not be collected by FPS; after which point the Department will instead collect on the FAFSA the parent's college attendance status), marital status, SSN, last name and first initial, DOB, email address, number of people in the household supported by the parent, and asset and income information.
(3) Information about the spouse of a married applicant including, but not limited to: the spouse's name, address, SSN, DOB, telephone number, email address, citizenship status, marital status, legal residence, status as a veteran, and financial information (including asset and income information that is needed for CPS processing until September 30, 2024);
(4) Information provided by IHEs on behalf of student and parent applicants, including, but not limited to, verification results, dependency overrides, and resolution of comment codes or reject codes;
(5) Information calculated by CPS through the 2023-24 award year on the applicant's expected family contribution (EFC);
(6) Information on the applicant's Institutional Student Information Record (ISIR), and Student Aid Report (SAR) or the renamed FAFSA Submission Summary (FSS). The Department uses the ISIR and SAR or FSS to report, among other things, the EFC, or the SAI results that are calculated during FPS processing, to IHEs, State grant agencies, and applicants. The EFC or SAI is available to, and used by, IHEs to determine the applicant's eligibility for Federal and institutional program assistance and the amount of assistance, and State grant agencies to determine the applicant's eligibility for State grants and the amount of grant assistance. The Department notifies the applicant of the results of their application via the SAR or FSS. The Department provides the IHEs identified on the applicant's FAFSA with the ISIR, which indicates whether there are discrepant or insufficient information, school adjustments, or CPS assumptions that affect processing of the FAFSA. Other information in the system includes, but is not limited to: Secondary EFC (an EFC that is calculated from the full EFC formula and is printed in the Financial Aid Administrator's (FAA) Information section of the ISIR), dependency status, Federal Pell Grant eligibility, duplicate SSN (an indicator that is set to alert ISIR recipients that two applications were processed with the same SSN, Incarcerated Student Indicator Flag (an indicator that will be used to identify an aid applicant as an incarcerated student), selection for verification, Simplified Needs Test (SNT) or Automatic Zero EFC (used for extremely low family income), CPS and FPS processing comments, reject codes (explanation for applicant's FAFSA not computing EFC), assumptions made with regard to the student's information due to incomplete or inconsistent FAFSA information, FAA adjustments including dependency status overrides, and CPS and FPS record processing information (application receipt date, transaction number, transaction process date, SAR Serial Number, Compute Number, Data Release Number (DRN), a four-digit number assigned to each application), National Student Loan Database System (NSLDS) match results, a bar code, and transaction source);
(7) Information that identifies aid applicant or aid recipient complaints, positive feedback, reports of suspicious activity, requests for assistance, requests for borrower defense relief, requests for PSLF reconsideration, or other inquiries. Such information includes, but is not limited to: written documentation of an aid applicant or aid recipient's complaint, request for assistance, request for relief under the borrower defense to repayment regulations, case tracking number, case appeal identifier, or other comment or inquiry; and information pertaining to the aid recipient's or the aid recipient's parent's student financial assistance program account(s) under title IV of the HEA, such as the aid recipient's and the aid recipient's parent's names and Federal Student Aid IDs (FSA IDs). Information may include the name, address, and phone numbers of the aid recipient's counsel or representative, IHE(s), lender(s), secondary holder(s) or lender(s), guaranty agency(ies), servicer(s), private collection agency(ies), and third-party requestor(s), as this term is defined in 34 CFR 685.401(a), if applicable, and may contain other loan-level information;
(8) Information provided and generated through customer interactions with contact center support via inbound and outbound channels (phone, chat, webform, email, customer satisfaction survey, fax, physical mail, social media platforms, digital engagement platforms, and controlled correspondence). Information includes, but is not limited to: chat transcripts, email communications, audio recordings of customer calls, and screen recordings of contact center support desktop during customer interactions;
(9) Loan discharge eligibility and verification information for use in determining whether a title IV, HEA debt/loan qualifies for discharge;
(10) Aid recipient's employer information to determine employer qualification for borrowers to receive discharge under PSLF; OIG fraud referral information; and customer support interactions including phone, chat, webform, email, fax, physical mail, and controlled correspondence;
(11) Information for collecting, processing, and storing user activity events from across the DCC IT system: campaign details, delivery details, email/SMS sent timestamp, transaction ID, Federal Account Number (FAN) ID, activity details, activity date, pages/URL accessed, user IP address, user-submitted materials, and user request details;
(12) Information needed to aid in the delivery of strategic and real-time communication to customers, including, but not limited to, first name, last name, DOB, state of residence, email, phone number, mobile device ID, device data, FAFSA transaction data, uniform resource locator (URL), computer-related data, and customer communication preferences and user activity (open or clicks) for email and SMS communications;
(13) Information provided on third-party preparers, including, but not limited to, first name, last name, SSN or employer identification number,
Information maintained in this system of records is obtained from applicants, the parents of dependent applicants, third-party preparers, and the spouse of married applicants for title IV, HEA program assistance, on the paper FAFSA, Portable Document Format (PDF) FAFSA, the online FAFSA form, and FAFSA by phone; the authorized employees or representatives of authorized entities (namely, IHEs, institutional third-party servicers, FFEL Program lenders, FFEL Program guaranty agencies, Federal loan servicers, State grant agencies, other Federal agencies, and research agencies); and from other persons or entities from which information is obtained following a disclosure under the routine uses set forth below.
The Financial Aid Administrators at IHEs designated by the applicant and IHEs' third-party servicers may correct the records in this system as a result of documentation provided by the applicant or by a dependent applicant's parents, such as Federal income return(s) (IRS Form 1040), Social Security card(s), and Department of Homeland Security I-551 Permanent Resident Card.
This system maintains information added during CPS processing and that will be added during FPS processing and information received from other Department systems, including the NSLDS, the COD System, and the SAIG Participation Management System. The results of matching programs with Federal agencies or State or local governments, or agencies thereof, are added to the student's record during CPS processing and will be added to the student's record during FPS processing. The Department's matching programs at the time of the publication of this system of records notice are with the SSA to verify the SSNs of applicants, dependent applicants' parent(s), and spouses of married applicants, as well as of individuals who apply for an FSA ID, and to confirm the U.S. citizenship status of applicants as recorded in SSA records and date of death (if applicable) of applicants, and dependent applicants' parents, pursuant to title IV of the HEA, including sections 428B(f)(2), 483(a)(12) (which under the FAFSA Simplification Act will be section 483(a)(2)(B)), and 484(g) and (p) (which the FAFSA Simplification Act redesignates as section 484(o)) of the HEA (20 U.S.C. 1078-2(f)(2), 1090(a)(12) (which the FAFSA Simplification Act amends to be 1090(a)(2)(B)), and 1091(g) and (p) (which the FAFSA Simplification Act redesignates as 1091(o)); with the Department of Veterans Affairs (VA) to verify the status of applicants who claim to be veterans, pursuant to section 480(c) and (d)(1)(D) of the HEA (20 U.S.C. 1087vv(c) and (d)(1)(D)); with the U.S. Department of Homeland Security (DHS) to confirm the immigration status of applicants for assistance as authorized by section 484(g) of the HEA (20 U.S.C. 1091(g)); with the U.S. Department of Justice (DOJ) to enforce any requirement imposed at the discretion of a court, pursuant to section 5301 of the Anti-Drug Abuse Act of 1988, Public Law 100-690, as amended by section 1002(d) of the Crime Control Act of 1990, Public Law 101-647 (21 U.S.C. 862), denying Federal benefits under the programs established by title IV of the HEA to any individual convicted of a State or Federal offense for the distribution or possession of a controlled substance; and, through award year 2023-2024 following the implementation of the FAFSA Simplification Act on July 1, 2024, with the U.S. Department of Defense (DoD) to identify dependents of U.S. military personnel who died in service in Iraq and Afghanistan after September 11, 2001, to determine if they are eligible for increased amounts of title IV, HEA program assistance, pursuant to sections 420R and 473(b) of the HEA (20 U.S.C. 1070h and 1087mm(b)), which will be replaced by Section 401(c) under the FAFSA Simplification Act.
During CPS and FPS processing, the Department's COD System sends information to these systems for students who have received a Federal Pell Grant. CPS and FPS use this information for verification analysis and for end-of-year reporting. These data elements include, but are not limited to: Verification Selection and Status, Potential Over-award Project (POP) indicator, Institutional Cost of Attendance, Reporting and Attended Campus Pell ID and Enrollment Date, and Federal Pell Grant Program information (Scheduled Federal Pell Grant Award, Origination Award Amount, Total Accepted Disbursement Amount, Number of Disbursements Accepted, Percentage of Eligibility Used At This Attended Campus Institution, and Date of Last Activity from the Origination or Disbursement table).
CPS and FPS also receive applicant information from the Department's NSLDS system each time an application is processed or corrected. This process assesses student aid eligibility, updates financial aid history, and ensures compliance with title IV, HEA regulations. Some of this information appears on the applicant's SAR or FSS and ISIR. Title IV, HEA award information is provided to NSLDS from several different sources. Federal Perkins Loan information and Federal Supplemental Educational Opportunity Grant (FSEOG) overpayment information is sent from IHEs or their third-party servicers; the Department's COD System provides Federal Pell Grant and Direct Loan data; and State and guaranty agencies provide information on FFEL loans received from lending institutions participating in the FFEL programs. Financial aid transcript information reported by NSLDS provides aid recipients, IHEs, and third-party servicers with information about the type(s), amount(s), dates, and overpayment status of prior and current title IV, HEA funds the aid recipient has received. FFEL and William D. Ford Federal Direct Student Loan data information reported by NSLDS includes, but is not limited to: (1) Aggregate Loan Data, such as Subsidized, Unsubsidized; Combined Outstanding Principal Balances; Unallocated Consolidated Outstanding Principal Balances, Subsidized, Unsubsidized; Combined Pending Disbursements, Subsidized, Unsubsidized; Combined Totals; and Unallocated Consolidated Totals; (2) Detailed Loan Data, such as Loan Sequence Number; Loan Type Code; Loan Change Flag; Loan Program Code; Current Status Code and Date; Outstanding Principal Balance and Date; Net Loan Amount; Loan Begin and End Dates; Amount and Date of Last Disbursement; Guaranty Agency Code; School Code; Contact Code; and Institution Type and Grade Level; and (3) system flags for Additional Unsubsidized Loan; Capitalized Interest; Defaulted Loan Change; Discharged Loan Change; Loan Satisfactory Repayment Change; Active Bankruptcy Change; Overpayments Change; Aggregate Loan Change; Defaulted Loan; Discharged Loan; Loan Satisfactory Repayment; Active Bankruptcy; Additional Loans; Direct Loan Master Promissory Note; Direct PLUS Loan Master Promissory Note; Subsidized Loan Limit; and the Combined Loan Limit. Federal Perkins Loan information reported by NSLDS includes, but is not limited to: Cumulative and Current Year Disbursement Amounts; flags for Perkins Loan Change; Defaulted Loan; Discharged Loan; Loan Satisfactory Repayment; Active Bankruptcy; Additional Loans; and Perkins Overpayment Flag and Contact (School or Region). Federal Pell Grant payment information reported includes, but is not limited to: Pell Sequence Number; Pell Attended School Code; Pell Transaction Number; Last Update Date; Scheduled Amount; Award Amount; Amount Paid to Date; Percent Scheduled Award Used; Pell Payment EFC; Flags for Pell Verification; and Pell Payment Change. TEACH Grant Program information includes, but is not limited to: TEACH Grant Overpayment Contact; TEACH Grant Overpayment Flag; TEACH Grant Loan Principal Balance; TEACH Grant Total; and TEACH Grant Change Flag. Iraq and Afghanistan Service Grants information includes, but is not limited to, Total Award Amount. The Department obtains from and exchanges information that is included in this system of records with IHEs, third-party servicers, and State agencies. These eligible entities register with the SAIG system to participate in the information exchanges specified for their business processes.
During FPS processing, this system will receive the SAI information from the Department's FAS. The SAI is calculated using FTI that the IRS will provide directly to the Department under the FUTURE Act that will not be maintained in this system, but instead the system of records entitled “FUTURE Act System (FAS)” (18-11-23).
Additionally, for individuals who request assistance from the Department, directly or through State requestors and legal assistance organizations (“third-party requestors”), as these terms are defined in 34 CFR 685.401(a), who may request that the Secretary of Education form a group of Federal student loan borrowers for borrower defense relief, information is obtained from individuals (
The Department may disclose information maintained in a record in this system of records under the routine uses listed in this system of records notice without the consent of the individual if the disclosure is compatible with the purposes for which the record was collected. These disclosures may be made on a case-by-case basis or pursuant to a computer matching agreement that meets the requirements of the Privacy Act of 1974, as amended (Privacy Act) (5 U.S.C. 552a).
(1)
(a) To verify the identity of the applicant, the spouse of a married applicant, and the parent(s) of a dependent applicant, to verify, until CPS is decommissioned after September 30, 2024, the identities of individuals who apply for a FSA ID, to determine the accuracy of the information contained in the record, to support compliance with title IV, HEA statutory and regulatory requirements, and to assist with the determination, correction, processing, tracking, and reporting of program eligibility and benefits, the Department may disclose records to applicants, guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, local, or Tribal agencies;
(b) To provide an applicant's financial aid history to IHEs, guaranty agencies and State agencies, lenders and loan holders participating in the FFEL Program, and third-party servicers, including information about the applicant's title IV, HEA loan defaults, and title IV, HEA grant program overpayments, the Department may disclose records to IHEs, guaranty agencies and State agencies, lenders and loan holders participating in the FFEL Program, and third-party servicers;
(c) To facilitate receiving and correcting application information, processing Federal Pell Grants and Direct Loans, and reporting Federal Perkins Loan Program expenditures to the Department's processing and reporting systems, the Department may disclose records to IHEs, State agencies, and third-party servicers;
(d) To assist loan holders with the collection and servicing of title IV, HEA loans, to support pre-claims/supplemental pre-claims assistance, to assist in locating borrowers, and to assist in locating students who owe grant overpayments, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, local, and Tribal agencies;
(e) To facilitate assessments of title IV, HEA program compliance, the Department may disclose records to guaranty agencies and IHEs, third-party servicers, and Federal, State, and local agencies;
(f) To assist in locating holders of loans, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, and local agencies;
(g) To assist in assessing the administration of title IV, HEA program funds by guaranty agencies, lenders and loan holders in the FFEL Program, IHEs, and third-party servicers, the Department may disclose records to Federal and State agencies;
(h) To enforce the terms of a loan or grant or to assist in the collection of loan or grant overpayments, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, and local agencies;
(i) To assist borrowers in repayment, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, and local agencies;
(j) To determine the relief that is appropriate if the Secretary of Education grants a borrower defense to repayment discharge application, as well as to pursue the recovery of liabilities of such discharges against the IHE, the
(k) To initiate legal action against an individual or entity involved in an illegal or unauthorized title IV, HEA program expenditure or activity, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, local, and Tribal agencies;
(l) To initiate or support a limitation, suspension, or termination action, an emergency action, or a debarment or suspension action, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, IHEs, third-party servicers, and Federal, State, local, and Tribal agencies;
(m) To investigate and resolve complaints, inquiries, requests for assistance, requests for Federal student loan repayment relief and other relief under the borrower defense to repayment regulations, and to update borrower account records and to correct errors, the Department may disclose records to guaranty agencies, lenders and loan holders participating in the FFEL Program, accreditors, IHEs, third-party requestors, third-party servicers, private collection agencies, and Federal, State, and local agencies;
(n) To inform the parent(s) of a dependent applicant of information about the parent(s), or the spouse of a married applicant of information about the spouse, in an application for title IV, HEA funds, the Department may disclose records to the parent(s), or spouse, respectively;
(o) To identify the student as the correct beneficiary of the PLUS loan funds, and to allow the processing of the PLUS loan application and promissory note, the Department may disclose records to the parent(s) applying for the parent PLUS loan;
(p) To encourage a student to complete a FAFSA that they started but did not submit or to assist a student with the completion of a FAFSA, the Department may disclose a student's FAFSA filing status to a State higher education agency so that the agency may redisclose that information to a local educational agency; a secondary school where the student is or was enrolled; grantees of the Department; American Indian and Alaska Native educational entities; and nonprofit college access organizations with an established relationship with the student;
(q) The Department may disclose records under Sections 483(a)(2)(D)(i), 483(a)(2)(E)(ii), and 483(a)(3)(B)(i) of the HEA (20 U.S.C. 1090(a)(2)(D)(i), 1090(a)(2)(E)(ii), and 1090(a)(3)(B)(i)) from this system to State higher education agencies, eligible IHEs, and scholarship organizations that were designated prior to the date of enactment (December 19, 2019) of the FUTURE Act (Pub. L. 116-91, 133 Stat. 1189) that award and administer aid to students, to determine an applicant's eligibility for aid awarded by State higher education agencies, eligible IHEs, or designated scholarship organizations, and to administer Federal aid or aid awarded by State higher education agencies, eligible IHEs, or designated scholarship organizations.;
(r) To help Federal, State, Tribal, and local government entities exercise their supervisory and administrative powers (including, but not limited to licensure, examination, discipline, regulation, or oversight of IHEs, Department contractors, guaranty agencies, lenders and loan holders, and third-party servicers) or to respond to aid applicant or recipient complaints submitted regarding the practices or processes of the Department and/or the Department's contractors, or to update information or correct errors contained in Department records regarding the aid applicant's or recipient's title IV, HEA program funds, the Department may disclose records to governmental entities at the Federal, State, Tribal, and local levels. These records may include all aspects of loans and grants made under title IV of the HEA to permit these governmental entities to verify compliance with applicable debt collection, consumer protection, financial, and other applicable statutory, regulatory, or local requirements. Before making a disclosure to these Federal, State, local, or Tribal governmental entities, the Department will require them to maintain safeguards consistent with the Privacy Act to protect the security and confidentiality of the disclosed records; and
(s) The Department may disclose records from an applicant's FAFSA to IHEs and State higher education agencies to provide aid applicants and aid recipients with information about certain Federal means-tested benefits for which they may qualify.
(2)
(3)
(a)
(i) The Department or any of its components;
(ii) Any Department employee in their official capacity;
(iii) Any Department employee in their individual capacity where the U.S. Department of Justice (DOJ) agrees to or has been requested to provide or arrange for representation of the employee;
(iv) Any Department employee in their individual capacity where the Department has agreed to represent the employee; and
(v) The United States, where the Department determines that the litigation is likely to affect the Department or any of its components.
(b)
(c)
(d)
(4)
(5)
(6)
(7)
(a)
(b)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
System records are paper-based and stored in locked rooms or electronic and stored on secured computer systems and in the cloud.
Fully processed paper applications and supporting paper documentation that are received on or before June 30, 2024, are stored for applicable periods in standard Federal Records Center boxes in locked storage rooms at the contractor facilities in London, Kentucky. Fully processed paper applications and supporting paper documentation requiring retention and received on or after July 1, 2024, will be stored in a private records storage facility, as applicable. The records storage facilities currently utilized are listed in the “System Location” section above.
Digitized paper applicant records, which include optically imaged documents, are stored on DADS (disks) in a virtual disk library, which is also electronic, in the computer facilities controlled by the Next Generation Data Center (NGDC) in Clarksville, VA.
Records that are collected in this system for applicants of Federal grants or loans are stored in the COD System for individuals who apply under one of the programs authorized under title IV of the HEA, including, but not limited to the: (1) Federal Pell Grant Program; (2) Federal Perkins Loans Program; (3) ACG Program; (4) National SMART Grant Program; (5) TEACH Grant Program; (6) Iraq and Afghanistan Service Grant Program; (7) Direct Loan Program, which includes Federal Direct Stafford/Ford Loans, Federal Direct Unsubsidized Stafford/Ford Loans and Federal Direct PLUS Loans and Federal Direct Consolidation Loans; (8) FFEL Program; and (9) FISL Program.
Records in this system pertaining to a title IV, HEA loan applicant, borrower, or grant recipient are indexed and retrieved by a single data element, or a combination of the following data elements, to include SSN, name, DOB, the award year in which the applicant applied for title IV, HEA program assistance, and case tracking number. These data elements are also used to retrieve information of title IV, HEA program applicants for and recipients of Federal grants or loans from the COD System (applicant information is collected in this system of records and stored in the COD System).
This system also uses a credit appeal identifier to retrieve credit appeal information from the COD System to support the credit appeal process.
Additionally, this system uses a combination of SSN, DOB, and name data elements to retrieve some records from Federal Loan Servicers' systems (covered by the system of records notice entitled “Common Services for Borrowers (CSB)” (18-11-16)) to allow customers to access their payment information, loan information and to make payments on
This system also uses customer identifiers to retrieve customer information data from the EDMAPS system (covered by the system of records noticed entitled “Enterprise Data Management and Analytics Platform Services (EDMAPS) System” (18-11-22)) to allow real-time updates to customer information and communication preferences; and for the Department and its contractors to identify customers who have completed a customer satisfaction survey in the DCC system; who may have potential fraudulent activity from a TPDR company; and who may be at risk for loan default.
Records maintained in this system are primarily retained and disposed of in accordance with the records schedules listed below. The Department has submitted amendments to these records schedules to NARA for its review and approval.
(a) Department Records Schedule 051: FSA National Student Loan Data System (NSLDS) (DAA-0441-2017-0004) (ED 051). (Records covered by ED 051 will not be destroyed until NARA-approved amendments to ED 051 are in effect, as applicable.)
(b) Department Records Schedule 052: Ombudsman Case Files (N1-441-09-21) (ED 052). (Records covered by ED 052 will not be destroyed until NARA-approved amendments to ED 052 are in effect, as applicable.)
(c) Department Records Schedule 072: FSA Application, Origination, and Disbursement Records (DAA-0441-2013-0002) (ED 072). (Records covered by ED 072 will not be destroyed until NARA-approved amendments to ED 072 are in effect, as applicable.)
All users of the system will have a unique user ID with a password. All physical access to the data housed at system locations is controlled and monitored by security personnel who check each individual entering the building for their employee or visitor badge. The IT systems employed by the Department offers a high degree of resistance to tampering and circumvention with firewalls, encryption, and password protection. This security system limits data access to Department and contract staff on a “need-to-know” basis and controls individual users' ability to access and alter records within the system. All interactions by users of the system are recorded.
In accordance with the Federal Information Security Management Act of 2002 (FISMA), as amended by the Federal Information Security Modernization Act of 2014, every Department system must receive a signed Authorization to Operate (ATO) from a designated Department official. The ATO process includes a rigorous assessment of security and privacy controls, a plan of actions and milestones to remediate any identified deficiencies, and a continuous monitoring program.
FISMA controls implemented are comprised of a combination of management, operational, and technical controls, and include the following control families: access control, awareness and training, audit and accountability, security assessment and authorization, configuration management, contingency planning, identification and authentication, incident response, maintenance, media protection, physical and environmental protection, planning, personnel security, privacy, risk assessment, system and services acquisition, system and communications protection, system and information integrity, and program management.
If you wish to gain access to a record in this system, contact the respective system manager at the address listed above. You must provide necessary particulars such as your name, SSN, and any other identifying information requested by the Department while processing the request to distinguish between individuals with the same name.
Alternatively, to gain access to a record in the system, you may make a Privacy Act request through the U.S. Department of Education, FOIA Service
Borrowers are able to access their financial aid history from NSLDS in this system. If you wish to gain access to other records in the NSLDS, please refer to the RECORD ACCESS PROCEDURES section in the system of records notice entitled “National Student Loan Data System (NSLDS)” (18-11-06).
For title IV, HEA program applicants and recipients of Federal grants or loans, if you wish to gain access to such information about you from the COD System, please refer to the RECORD ACCESS PROCEDURES section in the system of records notice entitled “Common Origination and Disbursement (COD) System” (18-11-02).
If you wish to gain access to the EDMAPS system information that is about you and accessible in this system, please refer to the RECORD ACCESS PROCEDURES section in the system of records notice entitled “Enterprise Data Management and Analytics Platform Services (EDMAPS) System” (18-11-22).
If you wish to gain access to the PAS system information about you that is maintained in this system until CPS is decommissioned after September 30, 2024, please refer to the RECORD ACCESS PROCEDURES section in the system of records notice entitled “Person Authentication Service (PAS)” (18-11-12).
If you wish to gain access to the information in the Federal Loan Servicers' IT systems that is about you and accessible in this system, please refer to the RECORD ACCESS PROCEDURES section in the system of records notice entitled “Common Services for Borrowers (CSB)” (18-11-16).
If you wish to contest or change the content of a record about you in the system of records, provide the respective system manager with your name, DOB, SSN, and any other identifying information requested by the Department while processing the request to distinguish between individuals with the same name. Identify the specific items to be changed and provide a written justification for the change.
To contest information submitted or included on a FAFSA application for the current award year, send your request to the FOIA Service Center listed in the Notification Procedures section.
Financial aid history from NSLDS is accessible in this system. To contest name and address records about you, provide the respective system manager with your name, DOB, SSN, and any other identifying information requested by the Department while processing the request to distinguish between individuals with the same name. All other financial aid history records from NSLDS must be contested by following the CONTESTING RECORD PROCEDURES identified in the system of records notice entitled “National Student Loan Data System (NSLDS)” (18-11-06).
For title IV, HEA program applicants and recipients of Federal grants or loans, if you wish to contest such information about you, please refer to the CONTESTING RECORD PROCEDURES section in the system of records notice entitled “Common Origination and Disbursement (COD) System” (18-11-02).
To contest information about you in a Federal Loan Servicer IT system, such as the payment and loan information that is accessible in this system, please refer to the CONTESTING RECORD PROCEDURES section in the system of records notice entitled “Common Services for Borrowers (CSB)” (18-11-16).
To contest the EDMAPS system information that is accessible in this system, please refer to the CONTESTING RECORD PROCEDURES section in the system of records notice entitled “Enterprise Data Management and Analytics Platform Services (EDMAPS) System” (18-11-22).
To contest the PAS system information about you that is maintained in this system until CPS is decommissioned after September 30, 2024, please refer to the CONTESTING RECORD PROCEDURES section in the system of records notice entitled “Person Authentication Service (PAS)” (18-11-12).
Requests to amend a record must meet the requirements of the Department's Privacy Act regulations at 34 CFR 5b.7.
If you wish to determine whether a record exists about you in the system of records, contact the respective system manager at the address listed above. You must provide necessary particulars such as your name, SSN, and any other identifying information requested by the Department while processing the request to distinguish between individuals with the same name.
Alternatively, you may make a Privacy Act request through the U.S. Department of Education, FOIA Service Center at
If you wish to submit a request for notification to determine whether a record exists about you in the COD System as a title IV, HEA program applicant or recipient of a Federal grant or loan, please refer to the NOTIFICATION PROCEDURES section in the system of records notice entitled “Common Origination and Disbursement (COD) System” (18-11-02).
Borrowers are able to access their financial aid history from NSLDS in this system. If you wish to submit a request for notification to determine whether a record exists about you in the NSLDS system of records, please refer to the NOTIFICATION PROCEDURES section in the system of records notice entitled “National Student Loan Data System (NSLDS)” (18-11-06).
If you wish to submit a request for notification to determine whether a record exists about you in a Federal Loan Servicer IT system, please refer to the NOTIFICATION PROCEDURES section in the system of records notice entitled “Common Services for Borrowers (CSB)” (18-11-16).
If you wish to submit a request for notification to determine whether a record exists about you in EDMAPS system, please refer to the NOTIFICATION PROCEDURES section in the system of records notice entitled “Enterprise Data Management and Analytics Platform Services (EDMAPS) System” (18-11-22).
If you wish to submit a request for notification to determine whether a record exists about you in the PAS system, please refer to the NOTIFICATION PROCEDURES section in the system of records notice entitled “Person Authentication Service (PAS)” (18-11-12).
Requests for notification about whether the system of records contains information about an individual must meet the requirements of the Department's Privacy Act regulations at 34 CFR 5b.5, including proof of identity.
None.
The system of records entitled “Aid Awareness and Application Processing” (18-11-21) was last modified and
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for license for the Cross Power Hydroelectric Project, located on the Androscoggin River in Coos County, New Hampshire and has prepared a Draft Environmental Assessment (DEA) for the project. No federal land is occupied by project works or located within the project boundary.
The DEA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
The Commission provides all interested persons with an opportunity to view and/or print the DEA via the internet through the Commission's Home Page (
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
Any questions regarding this notice may be directed to Ryan Hansen at (202) 502-8074 or
On April 23, 2024, Pelzer Hydro Company, LLC (Pelzer Hydro) and Consolidated Hydro Southeast, LLC (Consolidated Hydro) filed an application for partial transfer of licenses of their 3,300-kilowatt Lower Pelzer Hydroelectric Project No. 10253 and the 1,950-kilowatt Upper Pelzer Hydroelectric Project No. 10254. The projects are located on the Saluda River in Anderson and Greenville counties, South Carolina and do not occupy federal land.
Pursuant to 16 U.S.C. 801, the applicants, co-licensees for the projects, seek Commission approval to transfer the licensee interest of Consolidated Hydro to Pelzer Hydro, which would become sole licensee for both projects.
In lieu of electronic filing, you may submit a paper copy. Submissions sent via U.S. Postal Service must be addressed to, Debbie-Anne A. Reese, Acting Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to, Debbie-Anne A. Reese, Acting Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket numbers P-10253-042 and P-10254-039. Comments emailed to Commission staff are not considered part of the Commission record.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes.
For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Notification of Chemical Exports under TSCA Section 12(b) (EPA ICR Number 0795.17, and OMB Control Number 2070-0030) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2024. Public comments were previously requested via the
Comments may be submitted on or before July 1, 2024.
Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2015-0453, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Katherine Sleasman, Office of Program Support (7602M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1206; email address:
This is a proposed extension of the ICR, which is currently approved through May 31, 2024. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
In implementing TSCA section 12(b), EPA described the notification requirements applicable to persons exporting chemicals, including frequency of notification, covered chemicals, and content of the notification. See 40 CFR part 707, subpart D. In summary, the export notice must include five easily ascertainable items: (1) The name and address of the exporter; (2) The name of the chemical; (3) The country of import, (4) The date of export or intended export; and (5) The section of TSCA under which EPA has taken action (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Air Pollution Regulations for Outer Continental Shelf (OCS) Activities (EPA ICR Number 1601.11, OMB Control Number 2060-0249) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2024. Public comments were previously requested via the
Comments may be submitted on or before July 1, 2024.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2011-0742, online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Ben Garwood, Air Quality Policy Division, Office of Air Quality Planning and Standards, C504-03, U.S. Environmental Protection Agency, Post Office Box 12055, Research Triangle Park, NC 27711; telephone number: (919) 541-1358; fax number: (919) 541-4028; email address:
This is a proposed extension of the ICR, which is currently approved through May 31, 2024. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (EPA ICR Number 2434.204, OMB Control Number 2030-0051) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2024. Public comments were previously requested via the
Comments may be submitted on or before July 1, 2024.
Submit your comments, referencing Docket ID Number: EPA-HQ-OMS-2023-0605, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Aaron Jackson, Information Engagement Division (IED), Office of Information Management (OIM), 282T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-0348; email address:
This is a proposed extension of the ICR, which is currently approved through May 31, 2024. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments received are subject to public disclosure. In general, comments received will be made available without change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than July 1, 2024.
1.
Board of Governors of the Federal Reserve System.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Request for supplemental evidence and data submission.
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on
Kelly Carper, Telephone: 301-427-1656 or Email:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (
The entire research protocol is available online at:
This is to notify the public that the EPC Program would find the following information on
A list of completed studies that your organization has sponsored for this topic. In the list, please
Description of whether the above studies constitute
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at:
Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).
Notice.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). The ACD, CDC consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.
The deadline for submission of nominations for membership on the ACD, CDC published May 8, 2024, at 89 FR 38900, is extended. Nominations for membership on the ACD, CDC must be received no later than July 8, 2024. Late nominations will not be considered for membership.
All nominations (cover letters, reference letters, and curriculum vitae/resumes) should be emailed to
Tiffany Brown, J.D., M.P.H., Office of the Chief of Staff, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop H21-10, Atlanta, Georgia 30329-4027. Telephone: (404) 498-6655; Email:
The deadline for nominations for appointment to the Advisory Committee to the Director, Centers for Disease Control and Prevention has been extended from June 7, 2024, to July 8, 2024. The original solicitation of nominations notice was published in the
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Office of Family Violence Prevention and Services; Administration for Children and Families; Department of Health and Human Services.
Request for public comments.
The Family Violence Prevention and Services Act (FVPSA) program within the Office of Family Violence Prevention and Services (OFVPS) plans revised program announcements and minor changes to the previously approved Performance Progress Report for States and Tribes (Office of Management and Budget (OMB) #0970-0280; Expiration Date: May 31, 2024). Minor changes are
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Office of Global Affairs, Department of Health and Human Services.
Notice of public listening session; request for comments.
The listening session will be held on Wednesday, July 24, 2024, from 10 a.m. to 12 p.m. Eastern Daylight Time. This meeting is open to the public but requires RSVP to
The session will be held virtually, with online and dial-in information shared with registered participants.
The Stakeholder Listening Session is designed to seek input from stakeholders and subject matter experts to help inform and prepare for U.S. government engagement with G7 health ministries.
The Group of Seven (G7) is an informal grouping of advanced democracies that meets annually to coordinate global economic policy and address other transnational issues. The Group was established as a platform for economic and financial cooperation in response to the 1973 energy crisis. Over the years G7 has progressively expanded its focus. From an ad-hoc gathering to discuss financial challenges, it has become a more formal, prominent venue to address major global issues.
The G7 is comprised of 7 countries: Canada, France, Germany, Italy, Japan, the United Kingdom, and the U.S. The European Union also participates in the Group as a “nonenumerated” member.
Each year, a different member country holds the presidency of the group and hosts the meetings. The presidency proposes the group's priorities for the year and hosts discussions to work towards consensus positions and actions on those priorities. This year's G7 presidency is Italy, which will be hosting Health Working Group meetings throughout the year, culminating in a Health Ministers' Meeting on in mid-October in Ancona, Italy.
Participation is welcome from stakeholder communities, including:
Registrants must include their full name and organization, if any, and
Requests to participate as a speaker
We look forward to your comments on U.S. engagement in the G7 Health Track.
Office of the Secretary, HHS.
Notice.
Findings of research misconduct have been made against Darrion Nguyen (Respondent), who was formerly a Laboratory Technician, Division of Pediatric Neurology and Developmental Neuroscience, Baylor College of Medicine (BCM). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically Office of the Director (OD), National Institutes of Health (NIH), grant DP5 OD026428-01 and National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant K12 NS098482-01. The questioned research was included in a PHS-funded research project progress report (RPPR), specifically DP5 OD026428-04 submitted to OD, NIH. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on May 14, 2024, and are detailed below.
Sheila Garrity, JD, MPH, MBA, Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 240, Rockville, MD 20852, (240) 453-8200.
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:
ORI found that Respondent engaged in research misconduct by intentionally, knowingly, or recklessly falsifying and/or fabricating experimental data and results that were included in the following one (1) RPPR, one (1) presentation, one (1) poster, six (6) research records, and two (2) figures of a prospective manuscript:
• DP5 OD026428-04, “Illuminating GABAergic Signaling in Neurodevelopmental Disorders,” submitted to OD, NIH, on July 12, 2021 (hereafter referred to as “DP5 OD026428-04”).
• Elucidating the role of EBF3 haploinsufficiency in HADD syndrome pathogenesis. Jan and Dan Duncan Neurological Research Institute Seminar (NRI) Series, January 6, 2020 (hereafter referred to as “NRI Seminar 2020”).
• Elucidating the role of EBF3 haploinsufficiency in 10q26 deletion and HADD syndrome pathogenesis. Poster presentation, Baylor College of Medicine—Texas Children's Hospital Pediatric Research Symposium, March 24, 2020 (hereafter referred to as “Poster 2020”).
• Research Record “2019-5-1_Cerebellar PC Dens_P0.xlsx” (hereafter referred to as “RR1 2019”).
• Research Record “2019-6-27_Cerebellar PC Dens_P0.xlsx” (hereafter referred to as “RR2 2019”).
• Research Record “2019-5-1_P0 Cerebellum Quants.pzfx” (hereafter referred to as “RR3 2019”).
• Research Record “2019-5-21_DN-Cohort5 (Analyzed).xlsx” (hereafter referred to as “RR4 2019”).
• Research Record “2019-8-28_Partition-Cohorts 1, 2, 3, 4, 5, 6.pzfx” (hereafter referred to as “RR5 2019”).
• Research Record “2019-12-11_Dystonia.xlsx” (hereafter referred to as “RR6 2019”).
• “Fig1—GeneratingNullLines.v5.tif” (hereafter referred to as “PM Figure 1”) and “Fig3—Behavior.v6.png” (hereafter referred to as “PM Figure 3”) in a prospective manuscript with working title “Ebf3 haploinsufficiency perturbs cerebellar development and complex behaviors” (hereafter referred to as the “manuscript”).
Specifically, ORI found that Respondent intentionally, knowingly, or recklessly falsified and/or fabricated:
• the Purkinje Cell (PC) density measurements in the cerebellum lobes of newborn (P0) wild-type (WT) and Early B Cell Factor 3 heterozygous (
• the measurements of the distance between the anchor points in the cerebellum lobes of P0 WT and
• the measurements of phosphorylated Histone 3 (PH3) positive neurons in the cerebellum lobes of P0 WT and
• the external granule layer (EGL) thickness measurements in the cerebellum lobes of P0 WT and
• the manual scoring of the social interaction behavior of Cohort 5 mice in a three-chamber assay in RR4 2019 by copying and pasting the manually scored social interaction behavior values from Cohort 4 mice;
• the interaction data of male mice by inserting fabricated and/or falsified values for two (2) mice that had not been collected as part of the experiment in RR5 2019, Slide 44 of NRI Seminar 2020, Figure F in the “Motor Incoordination and Altered Social Behavior” section of Poster 2020, PM Figure 3 of the manuscript, and Figure 6E of DP5 OD026428-04;
• the number of mice used in the Western blot analysis for the expression of Ebf3 protein in
• the hindlimb splay measurements of
Respondent entered into a Voluntary Settlement Agreement (Agreement). Respondent neither admits nor denies ORI's findings of research misconduct. This settlement is not an admission of liability on the part of Respondent. Respondent voluntarily agreed to the following:
(1) Respondent will have his research supervised for a period of three (3) years beginning on May 14, 2024 (the “Supervision Period”). Prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity in PHS-supported research, Respondent will submit a plan for supervision of Respondent's duties to ORI for approval. The supervision plan must be designed to ensure the integrity of Respondent's research. Respondent will not participate in any PHS-supported research until such a supervision plan is approved by ORI. Respondent will comply with the agreed-upon supervision plan.
(2) The requirements for Respondent's supervision plan are as follows:
i. A committee of 2-3 senior faculty members at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for a period of three (3) years from the effective date of the Agreement. The committee will review primary data from Respondent's laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates and Respondent's compliance with appropriate research standards and confirming the integrity of Respondent's research.
ii. The committee will conduct an advance review of each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification to ORI that the data presented in the proposed application, report, manuscript, or abstract are supported by the research record.
(3) During the Supervision Period, Respondent will ensure that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported and not plagiarized in the application, report, manuscript, or abstract.
(4) If no supervision plan is provided to ORI, Respondent will provide certification to ORI at the conclusion of the Supervision Period that his participation was not proposed on a research project for which an application for PHS support was submitted and that he has not participated in any capacity in PHS-supported research.
(5) During the Supervision Period, Respondent will exclude himself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the Interagency Autism Coordinating Committee.
This will be a hybrid meeting held in-person and virtually and will be open to the public as indicated below. Individuals who plan to attend in-person or view the virtual meeting and need special assistance or other accommodations should notify the Contact Person listed below at least seven (7) business days prior to the meeting. The meeting can be accessed from the NIH Videocast website (
A limited number of slots are available for individuals to provide a ~3-minute summary or excerpt of their written comment to the Committee during the meeting either in person or via videoconference. For those interested in that opportunity, please indicate “Interested in providing oral/virtual comment” in your written submission, along with your name, address, email, phone number, and professional/organizational affiliation so that ONAC staff can contact you if a slot is available.
For any given meeting, priority for comment slots will be given to individuals and organizations that have not previously provided comments in the current calendar year. This will help ensure that as many individuals and organizations as possible have an opportunity to share comments. Commenters going over their allotted 3-minute slot may be asked to conclude immediately in order to allow other comments and the rest of the meeting to proceed on schedule.
Public comment submissions received by 5:00 p.m. ET on Monday, June 24, 2024, will be provided to the Committee prior to the meeting for their consideration. Any written comments received after 5:00 p.m. ET, Monday, June 24, 2024, may be provided to the Committee either before or after the meeting, depending on the volume of comments received and the time required to process them in accordance with privacy regulations and other applicable Federal policies. The Committee is not able to respond individually to comments. All public comments become part of the public record. Attachments of copyrighted publications are not permitted, but web links or citations for any copyrighted works cited may be provided. For public comment guidelines, see:
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee.
The meeting will be held as a virtual meeting and will be open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting.
The event is free and open to the public, however, registration is required. Please use this link to register:
Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Amy Williams, Director of the Office of Advocacy Relations (OAR), NCI, NIH, 31 Center Drive, Bldg. 31, Room 10A28, MSC 2580, Bethesda, MD 20892, call non-toll-free number 240-781-3406, or email your request, including your address, to
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency'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 minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 17.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Licensing information may be obtained by emailing the licensing contact Michael Shmilovich, Esq, MS, CLP; 301-435-5019;
This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404. Technology description follows.
Next generation MRI platform Signal Amplification by Reversible Exchange (SABRE) hyperpolarization:
Hyperpolarized magnetic resonance imaging (MRI) is an emerging molecular imaging method for metabolic imaging for detecting cancer, cardiovascular disease, stroke, and traumatic brain injury and monitoring therapy with no Gadolinium or Iron. Available for licensing and commercial development is a patent estate covering a perfluorinated single amplification by reversible exchange (SABRE) catalyst for generating MRI agents that includes a d-block element and a perfluorinated ligand hyperpolarized substrate comprising a
• HHS Reference No. E-035-2022-0 “Preparation Of Isotopically Labeled Ketoglutarates And Methods Of Hyperpolarization Through Signal Amplification By Reversible Exchange (SABRE)”; U.S. Provisional Patent Application No. 63/303,190 filed January 26, 2022; Patent Cooperation Treaty Application PCT/US2023/011640 filed January 26, 2023.
• HHS Reference No. E-036-2022 “Sabre Catalysts Containing Fluorinated Carbon Chains For Delivery Of Metal-Free MRI Contrast Agents”; U.S. Provisional Patent Application 63/328,545 filed April 7, 2022; Patent Cooperation Treaty Application PCT/US2023/017885 filed April 7, 2023, U.S. Patent Application 18/410,773 filed January 11, 2024, Applications also pending in Japan, Canada, Israel, China, and Europe.
• HHS Reference No. E-052-2022 “Infusion device for the preparation and delivery of MRI probes,” U.S. Provisional Patent Application 63/328,556 filed April 7, 2022, Patent Cooperation Treaty Application PCT/US2023/017895 filed April 7, 2023.
• HHS Reference No. E-069-2020 “Real-time Monitoring Of In Vivo Free Radical Scavengers Through Hyperpolarized [1-
• HHS Reference No. E-070-2020 “Isotopes Of Alpha Ketoglutarate And Related Compounds For Hyperpolarized MRI Imaging,” U.S. Provisional Patent Application 62/962,473 filed January 17, 2020, Patent Cooperation Treaty Application PCT/US2021/013658 filed January 15, 2021, European Patent Application 21741941.5 filed January 15, 2021, Israeli Patent Application 294464 filed January 15, 2021, U.S. Patent Application 17/793,089 filed January 15, 2021.
• HHS Reference No. E-039-2022 “Temperature Cycling Method for Hyperpolarization of Target Molecules and Contrast Agents using Parahydrogen,” US Provisional Patent Application 63/203591 filed July 27, 2021. Patent Cooperation Treaty Application PCT/US2022/074122 filed July 26, 2022, U.S. Application 18/291,681.
• Perfluorinated Iridium catalyst for signal amplification by reversible exchange provides metal-free aqueous hyperpolarized [1-
• Monitoring response to a clinically relevant IDH inhibitor in glioma—Hyperpolarized
• Catalyst-Free Aqueous Hyperpolarized
• Rapid
• Order-Unity
• Simple esterification of [1-
• Synthesis of [1-
• Low-cost High-Pressure Clinical-Scale 50% Parahydrogen Generator Using Liquid Nitrogen at 77 K. B. Chapman, B. Joalland, C. Meersman, J. Ettedgui, R. E. Swenson, M. C. Krishna, P. Nikolaou, K.V. Kovtunov, O. G. Salnikov, I. V. Koptyug, M. E. Gemeinhardt, B. M. Goodson, R. V. Shchepin, and E. Y. Chekmenev. Anal. Chem. 2021, 93, 8476-8483.
• Real Time Insight into In Vivo Redox Status utilizing Hyperpolarized [1-
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
60-Day notice and request for comments.
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Comments are encouraged and must be submitted (no later than July 29, 2024) to be assured of consideration.
Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651-0010 in the subject line and the agency name. Please submit written comments and/or suggestions in English. Please use the following method to submit comments:
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number 202-325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Travelers who do not have proof of prior possession in the United States of foreign made articles and who do not want to be assessed duty on these items can register them prior to departing on travel. To register these articles, the traveler completes CBP Form 4457,
CBP Forms 4455 and 4457 are used to provide a convenient means of showing proof of prior possession of a foreign made item taken on a trip abroad and later returned to the United States. This registration is restricted to articles with serial numbers or unique markings. These forms are provided for by 19 CFR 148.1.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection can be sent within 60 days of publication of this notice to
Colette Pollard Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410, Room 8210; telephone (202) 402-3577, (this is not a toll-free number). HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech or communication disabilities. To learn more about how to make an accessible telephone call, please visit
Copies of available documents submitted to OMB may be obtained from [Ms. Pollard].
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(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 those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (HUD).
Notice.
The Department of Housing and Urban Development (HUD) established the Housing Counseling Federal Advisory Committee (HCFAC) on April 14, 2015. This notice invites nominations for appointments to fill vacancies on the HCFAC.
All nominations must be received no later than July 15, 2024.
Nominations must be in writing using form HUD 95000 (Application for Membership on the HCFAC, OMB Approval Number: 2502-0606) and submitted via email to
Virginia F. Holman, Housing Program Specialist, U.S. Department of Housing and Urban Development, Office of Housing Counseling, Office of Outreach and Capacity Building,
The HCFAC is congressionally mandated to provide advice to the Office of Housing Counseling (OHC) (42 U.S.C. 3533(g)(4)). The HCFAC provides the OHC valuable advice regarding its mission to provide individuals and families with the knowledge they need to obtain, sustain, and improve their housing through a strong national network of HUD-approved housing counseling agencies and HUD-certified counselors. The HCFAC, however, does not have any role in reviewing or awarding OHC housing counseling grants and procurement contracts. The HCFAC is subject to the requirements of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C. 1001
By statute, the HCFAC shall consist of not more than 12 individuals appointed by the Secretary (42 U.S.C. 3533(g)(4)(B)). The membership will equally represent the mortgage industry, the real estate industry, consumers, and HUD-approved housing counseling agencies. Each member shall be appointed in his or her individual capacity for a term of up to 3 years.
HUD is seeking nominations for membership on the HCFAC. Nominees shall equally represent the mortgage and real estate industries, including consumers and HUD-approved housing counseling agencies. Nominations may be made by agency officials, members of Congress, the general public, or professional organizations, as well as self-nominations. Nominees must be U.S. citizens and cannot be U.S. Government employees.
All appointed nominees will be serving on the HCFAC in their individual capacity, and not in a representative capacity, therefore, no Federally-registered lobbyists may serve on the HCFAC.
Nominations to the HCFAC must be submitted using a HUD-90005 which is available on the Office of Housing Counseling's Federal Advisory Committee web page at:
Nominations should be submitted via email to
All Nominations must be received no later than July 15, 2024.
HCFAC members will be required to adhere to the conflict-of-interest rules applicable to Special Government Employees as such employees are defined in 18 U.S.C. 202(a). The rules include relevant provisions in 18 U.S.C. related to criminal activity, Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635) and Executive Order 12674 (as modified by E.O. 12731). Therefore, applicants will be required to submit to pre-appointment screenings relating to identity of interest and financial interests that HUD might require. If selected, HCFAC members will also be asked to complete OGE Form 450 (Confidential Financial Disclosure Report).
Members of the HCFAC shall serve without pay but shall receive travel expenses including per diem in lieu of subsistence as authorized by 5 U.S.C. 5703. Regular attendance is essential to the effective operation of the HCFAC.
Please note this notice is not intended to be the exclusive method by which HUD will solicit nominations and expressions of interest to identify qualified candidates; however, all nominees for membership on the HCFAC will be subject to the same application process and evaluation criteria.
Member selections will be made by the Secretary and will be based on the Nominee's qualifications to contribute to the accomplishment of the HCFAC's objectives. Membership on the HCFAC is personal to the appointee and committee members serve at the discretion of the Secretary.
The estimated number of meetings (in-person or virtual) anticipated within a fiscal year is four (4). Additional meetings may be held as needed to render advice to the Deputy Assistant Secretary for the Office of Housing Counseling. The meetings may use electronic communication technologies for attendance.
All meetings will be announced by notice in the
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Milwaukee Electric Tool Corporation and Keter Home and Garden Products Ltd. on May 23, 2024. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain storage containers and toolboxes, organizers, component boxes, coolers, and accessories used therewith. The complaint names as a respondent: Klein Tools, Inc. of Lincolnshire, IL. The complainant requests that the Commission issue a general exclusion order, limited exclusion order, cease and desist orders, and impose a bond upon respondent alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3749”) in a prominent place on the cover page and/or the first page. (
Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
United States International Trade Commission.
June 6, 2024 at 9:30 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701-TA-721 and 731-TA-1689 (Preliminary) (Alkyl Phosphate Esters from China). The Commission currently is scheduled to complete and file its determinations on June 7, 2024; views of the Commission currently are scheduled to be completed and filed on June 14, 2024.
5.
Sharon Bellamy, Supervisory Hearings and Information Officer, 202-205-2000.
The Commission is holding the meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
United States International Trade Commission.
June 7, 2024 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701-TA-722-725 and 731-TA-1690-1693 (Preliminary) (Crystalline Silicon Photovoltaic Products (Solar Panels) from Cambodia, Malaysia, Thailand, and Vietnam). The Commission currently is scheduled to complete and file its determinations on June 10, 2024; views of the Commission currently are scheduled to be completed and filed on June 17, 2024.
5. Commission vote on Inv. Nos. 701-TA-726 and 731-TA-1694 (Preliminary) (High Chrome Cast Iron Grinding Media from India). The Commission currently is scheduled to complete and file its determinations on June 10, 2024; views of the Commission currently are scheduled to be completed and filed on June 17, 2024.
6.
Sharon Bellamy, Supervisory Hearings and Information Officer, 202-205-2000.
The Commission is holding the meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Drug Enforcement Administration, Justice.
Notice of application.
Revvity, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 29, 2024, Revvity, Inc., 120 East Dedham Street, Boston, Massachusetts 02118-2852, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substances for bulk manufacturing into radioactive formulations for sale to its customers for research purposes. Drug code 9333 (Thebaine) will be used to import the Thebaine derivative Diprenorphine. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Almac Clinical Services Incorp (ACSI) has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on May 6, 2024, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, applied to be registered as an importer
The company plans to import the listed controlled substances as finished dosage form units for clinical trials purposes only. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Vici Health Sciences, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 16, 2024, Vici Health Sciences, LLC, 6655 Amberton Drive, Suite O, Elkridge, Maryland 21075-6202, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance for use in clinical trials, research and analytical testing as well as dosage formulation development. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
VA Cooperative Studies Program has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 12, 2024, VA Cooperative Studies Program, 2401 Centre Avenue South East, Albuquerque, New Mexico 87106, applied to be registered as an importer
The company plans to import finished dosage unit products containing the above listed controlled substances for research and clinical trial studies only. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Royal Emerald Pharmaceuticals has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 29, 2024. Such persons may also file a written request for a hearing on the application on or before July 29, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on April 10, 2024, Royal Emerald Pharmaceuticals, 14011 Palm Drive, Building B, Desert Hot Springs, California 92240-6845, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the listed controlled substances to provide Marihuana (Cannabis) as botanical raw material and/or active pharmaceutical ingredients (API) to Drug Enforcement Administration-registered researchers and manufacturers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Quagen Pharmaceuticals LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 16, 2024, Quagen Pharmaceuticals LLC, 37 Fairfield Place, West Caldwell, New Jersey 07006, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance for distribution to its customer. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Veranova, L.P. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 8, 2024, Veranova, L.P., 2003 Nolte Drive, West Deptford, New Jersey 08066-1727, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import Coca Leaves (9040), Opium, raw (9600), and Poppy Straw Concentrate (9670) in order to bulk manufacture Active Pharmaceutical Ingredients (API) for distribution to its customers. The company plans to also import Thebaine (9333), Noroxymorphone (9668), and Fentanyl (9801) to use as analytical reference standards, both internally and to be sold to their customers to support testing of Veranova, L.P. APIs only. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
ANI Pharmaceuticals Inc., applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on April 9, 2024, ANI Pharmaceuticals Inc., 70 Lake Drive, East Windsor, New Jersey 08520-5321, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Psilocybin (7437) will be imported for use in dosage form development leading to use in clinical trials. Levorphanol (9220) will be imported for distribution to customers. Tapentadol (9780) will be used to import small quantities for internal research and reference standards purposes. No other activities for these drug codes are authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-
Drug Enforcement Administration, Justice.
Notice of application.
Chemtos, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 29, 2024. Such persons may also file a written request for a hearing on the application on or before July 29, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on April 10, 2024, Chemtos, LLC, 16713 Picadilly Court, Round Rock, Texas 78664-8544, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the listed controlled substances for sale as reference standards to their customers. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
AMPAC Fine Chemicals Virginia LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 29, 2024. Such persons may also file a written request for a hearing on the application on or before July 29, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.33(a), this is notice that on December 22, 2023, AMPAC Fine Chemicals Virginia LLC, 2820 Normandy Drive, Petersburg, Virginia 23805-2380, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the above listed controlled substances for the internal use as intermediates or for distribution to its customers. No other activities for these
Drug Enforcement Administration, Justice.
Notice of application.
Skalar Pharma, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 1, 2024. Such persons may also file a written request for a hearing on the application on or before July 1, 2024.
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
In accordance with 21 CFR 1301.34(a), this is notice that on March 1, 2024, Skalar Pharma, LLC, SR 53 KM 82 Guayama, Guayama, Puerto Rico 00784, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the listed controlled substance to be used in the manufacturing process for other controlled substances. No other activity for this drug code is authorized for this registration.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
On May 23, 2024, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Ohio in the lawsuit entitled
The proposed Consent Decree settles claims brought by the United States under sections 309 and 311 of the Clean Water Act (“CWA”), 42 U.S.C. 1311 and 1321 and sections 107 and 113 of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), 42 U.S.C. 9607 and 9613, against Norfolk Southern Railway Company and Norfolk Southern Corporation (“Defendants”) related to the February 3, 2023 train derailment in East Palestine, Ohio. The proposed Consent Decree would require Norfolk Southern: (i) to reimburse all CERCLA and CWA section 311 response costs incurred by the United States; (ii) pay a civil penalty of $15 million for violating CWA sections 301 and 311; (iii) establish a $25 million community health program for qualifying members of the public impacted by the derailment; (iv) implement an array of specified rail safety procedures; (v) develop and adopt programs for coordination of rail track restoration and vent and burn procedures; (vi) implement a $6 million local waterways remediation plan; (vii) pay $175,000 for natural resource damages; and (viii) implement compliance and future monitoring requirements in the various work plans approved under EPA's Unilateral Administrative Orders and CWA Order.
The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
Any comments submitted in writing may be filed by the United States in whole or in part on the public court docket without notice to the commenter.
During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department website:
Office of the Chief Information Officer, Department of Justice.
30-Day notice.
The Office of the Chief Information Officer, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until July 1, 2024.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact: Allison Spratlin, Program Manager, 145 N Street NW, Washington, DC 20530; (202)532-5047;
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website
DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
If additional information is required, contact: Darwin Arceo, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michelle Neary by telephone at 202-693-6312, or by email at
Form OWCP-915 is used to claim reimbursement for out-of-pocket covered medical expenses paid by a beneficiary, and must be accompanied by required billing data elements (prepared by the medical provider) and by proof of payment by the beneficiary. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michelle Neary by telephone at 202-693-6312, or by email at
The form, Authorization Request Form and Certification/Letter of Medical Necessity Certification/Letter of Medical Necessity for Opioid Medications (CA-27), requires an injured worker's treating physician to answer a number of questions about the prescribed opioids and certify that they are medically necessary to treat the work-related injury. The responses to the questions on the form is intended to ensure that treating physicians have considered non-opioid drug alternatives, and are only prescribing the most cost effective and medically necessary drugs. The form will also permit OWCP to more easily track the volume, type, and characteristics of opioids authorized by the FECA program. The form will serve as a means for injured workers to continue receiving opioids drugs only where medically necessary and simultaneously give OWCP greater oversight in monitoring their appropriate use and gather additional data about their use. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
The Occupational Exposure to Beryllium Standard in the Construction Industry requires covered employers to establish written exposure control plan, to conduct medical surveillance, and to establish and maintain accurate records of employee exposure to beryllium and beryllium compounds and medical records. These records will be used by employers, workers, physicians and the Government to ensure that construction workers are not being harmed by exposure to beryllium and beryllium compounds. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
Occupational Exposure to Beryllium and Beryllium Compounds Standard in the Shipyard Sector requires covered employers to establish written exposure control plan, to conduct medical surveillance, and to establish and maintain accurate records of employee exposure to beryllium and beryllium compounds and medical records. These records will be used by employers, workers, physicians and the Government to ensure that shipyard workers are not being harmed by
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michael Howell by telephone at 202-693-6782, or by email at
MSHA grantees are required by DOL regulations to submit project and final reports. Grantees are also required to submit final reports no later than 90 days after the end of the grant period.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
Annual Burden Hours: 850 hours.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Office of Workers' Compensation Programs (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with
The OMB will consider all written comments that the agency receives on or before July 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michelle Neary by telephone at 202-693-6312, or by email at
The Office of Workers' Compensation Programs (OWCP) is the primary agency responsible for administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA), 42 U.S.C. 7384
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Office of Federal Procurement Policy, Office of Management and Budget.
Notice of final Office of Management and Budget Circular No. A-137, “Strategic Management of Acquisition Data and Information”.
The Office of Federal Procurement Policy (OFPP) in the Office of Management and Budget (OMB) is issuing a Circular entitled “Strategic Management of Acquisition Data and Information.” This Circular will improve agency access to reliable data and information at the point of need throughout the acquisition lifecycle to ensure successful contracting outcomes without duplicating data, tools, or effort. The Circular establishes a centralized data management strategy to allow for the creation of more comprehensive knowledge and data banks, the development of standard data sharing processes, and improved access to tools and resources for acquisition-related decision-making in a Hi-Definition Intelligent Acquisition Data Environment.
Across the Federal enterprise, there are tens of billions of acquisition data points residing in over 170 contract writing systems (including legacy systems) and over 15 payment processing platforms. Historically, much of this data has been collected and managed at the agency level. Agencies have used their resources to build tools within their agency, harnessing internal data and databases, but this has often led to duplicative tools and efforts and a lack of coordination across agencies. This approach has limited central capacity for analytics, insights, and efficiency gains outside of the System for Award Management and the Federal Procurement Data System, which generally provide aggregate data but very little pricing and best practices information.
To address these challenges, OMB's new Circular establishes a centralized data management policy framework for the creation of a High-Definition Environment (HDE). Through the HDE, which is the technical architecture for the data, users will have access to the right data at the point of need through a single, central access point, better enabling them to buy as an organized entity. Creating the HDE is a critical component of the acquisition community's work to make purchases as an organized enterprise. The HDE will provide agencies with access to the breadth and depth of information needed to support the acquisition needs of the Federal Government—the largest and most sophisticated buyer in the world.
Achieving the HDE will require greater transparency and collaboration in agency data systems planning and investment decisions. This is particularly true with respect to activities that would affect the Government's ability to achieve data interoperability for information that is critical or can otherwise significantly improve acquisition decision-making at
To this end, the Circular: (1) establishes the principle that agencies should no longer view acquisition data as a singular agency asset, but rather an asset critical to supporting the missions of the Government at large, and should be prepared to collect and share the data accordingly; (2) defines agency roles and responsibilities; and (3) supports the design and development of solutions to drive data interoperability, allowing systems to connect and share acquisition data wherever they reside within the Federal Government without duplication.
In response to its November 17, 2023 notice inviting public comment on the proposed Circular, 88 FR 80339, OFPP received public comments from seven respondents, including from several coalitions representing industry interests. Copies of the public comments received are available for review at
Respondents representing industry interests commented on the potential misuse of pre- and post-award pricing data about the scope of the user base. Specifically, concerns were raised about the potential accessibility of proprietary information by the public or by competitors, as well as the management of the data chain of command and the management of Freedom of Information Act (FOIA) requests.
To address these concerns, OFPP added language to section 2 of the Circular to clarify agency responsibilities for securing data shared within the Government and to make clear that any requests for release of information, such as through FOIA, will be handled in accordance with statutes, regulations, and protocols that address the release of contractor information to non-governmental sources. The Circular makes no changes to policies or practices governing the release of contractor data to the public.
Furthermore, OFPP added additional language to define roles and responsibilities that address data security and data sharing. Specifically, OMB will work with the Hi-Def Managing Agency, which is identified as the General Services Administration (GSA), to support the creation of standard data sharing MOU templates that can be tailored on an agency-by-agency basis to document comprehensive data management and security protocols.
The Circular now clearly defines that the role of the Hi-Def Managing Agency (GSA) includes comprehensive data security. GSA is tasked with coordinating with agencies to define an acceptable set of data security standards for the transfer, storage, and use of Hi-Def data through data sharing agreements and properly securing all agency data, based on established data security standards, once transmitted into the HDE.
Finally, the Circular establishes that any Government-wide data products “powered by” data originating from the HDE are subject to an interagency governance process to ensure that the use of the data is aligned with law and policy.
OFPP received comments highlighting the complexity of pricing data, expressing concerns that if prices paid data are used without the relevant context to adjust for contract terms and conditions, supply chain fluctuations, and other time-bound factors, the usefulness of the data is jeopardized for forward decision making and market research.
OFPP agrees. While the final Circular reflects the importance of context surrounding data, it is important to recognize that key elements of the contextualizing data, such as contract terms and conditions, are often stored separately in an unstructured, decentralized manner across the enterprise. The collection of this data is on the Hi-Def roadmap but full implementation will take time and coordination with the agencies.
Through the annual planning process, agency stakeholders will have the opportunity to assess agency data sharing readiness and identify critical acquisition data needs. Agency responses will enable prioritized and orderly data collection efforts to fulfill these needs through small, scalable pilot efforts complete with assessments of the required data context. Data quality issues within existing datasets (for example, low quality data in the Unit of Measure field) will be addressed through both the governance and training processes.
OFPP received a comment asserting that training of the acquisition workforce must be part of the implementation of the Circular and is critical to its success. A second, related comment noted that successfully implementing these initiatives will require significant “human-focused” cultural and process changes within the Government's acquisition and related workforces.
OFPP agrees. The final Circular establishes that OMB, in coordination with the Federal Acquisition Institute, agency working groups, and data experts, will launch a role-based Federal Acquisition Data Training Curriculum that addresses best practices and policies related to data sharing, data use, and the current landscape of Government-wide acquisition tools and resources. The Circular also notes that through the new curriculum and other applicable training paths, agencies are responsible for building data analysis and related skills as a core acquisition workforce capability.
OFPP received comments requesting that the Circular express a position on the impacts to procurement administrative lead time, challenges associated with sub-tier contractor and vendor data, the role of GSA in negotiating prices for GSA Schedules, and the data differences that will arise between best value and lowest price, technically acceptable contracts.
The intention of the Circular is to establish the framework for data sharing to improve enterprise-wide contracting outcomes. Specific use cases may be defined and addressed through the Hi-Def planning process for government-wide, agency-wide, or targeted use, as needed.
The United States Government is the largest buyer of goods and services in the world. However, due to the decentralized nature of Federal acquisition processes and systems, the acquisition workforce is not able to fully utilize the volume of data collected across the Federal enterprise for more informed procurements, resulting in time and cost burdens on both the workforce and industry.
To address this issue, the Office of Management and Budget (OMB) seeks to promote Hi-Definition (Hi-Def) acquisitions where agencies are able to acquire supplies or services using relevant acquisition data that is easily accessed and available when it is needed. Government-wide acquisition initiatives such as Category Management have established that there is significant commonality in the goods and services procured across the enterprise. It follows that the strategy to collect, share, and use procurement data should also extend beyond agency-specific strategies and systems.
Agencies should no longer view acquisition data as a singular agency asset, but rather as an asset that is critical to support the mission of the Government. As such, agencies should be prepared to collect and share the data accordingly.
Important work is already underway in this area through key data modernization efforts resulting from OMB Circular A-130,
Using relevant acquisition data as a strategic asset throughout the acquisition lifecycle facilitates successful contracting outcomes. The Federal Government has taken significant steps to improve the collection and use of data related to contracting transactions, including amounts obligated, information about how contracts are awarded, and the identity of the awardees.
However, other important acquisition-related data and information are not being shared Government-wide. For example, contract line item (CLIN) pricing information
To address these issues and the broader landscape of acquisition data management, OMB is creating a Hi-Def centralized data management policy framework to promote data interoperability, the sharing of acquisition data between agencies, and enterprise-wide data analysis. This framework will be supported and enabled by the HDE, the technical architecture used to consume and make acquisition data collected across the Federal enterprise accessible in a secure and scalable solution. The HDE will:
• serve as a centralized access point and aggregator of acquisition data;
• provide Federal users with a secure entry point to access acquisition data collected by disparate systems and processes across the enterprise; and
• leverage existing architectures, agency offerings, and established governance bodies and processes to the greatest extent possible to avoid duplicative efforts.
Data ingested into the HDE will be phased based on agency data sharing readiness, Hi-Def targeted outcomes, and Government-wide data use cases prioritized through the data governance process.
The data collected and used through the HDE will allow stakeholders
Agencies should regard acquisition data as a Government asset, and should utilize acquisition data management practices that promote collection, interoperability, scalability, sharing, and usability across the Government.
a. Data Collection—agencies shall identify opportunities to improve the collection and sharing of both structured and unstructured acquisition data, including but not limited to prices paid data, contract files, CLIN data, terms and conditions, sub-contracting plans, survey data, purchase card data, and other relevant data sources as identified by OMB.
b. Data Sharing—agencies shall:
i. Continually facilitate adoption of new and emerging technologies to support the ability for cross-agency data sharing, including but not limited to the use of Application Programming Interfaces (APIs), data exchange platforms, and Extract-Transfer-Load tools;
ii. Identify and take steps to update agency-specific policies or operational practices, as necessary, to remove any prohibitions or limitations on the collection and sharing of acquisition data within and among agencies in the Federal Government, consistent with applicable law;
iii. Include clauses, as appropriate and consistent with applicable law, in new contracts to inform contractors that acquisition data included or generated in connection with the contract by either the Government or the contractor may be shared within and among agencies of the Federal Government;
iv. Review and maintain protocols to protect against the unauthorized release of data; and
v. Identify and mitigate data sharing risks as outlined in § 3.c.
c. Data Risk Management—agencies shall:
i. Consistent with OMB Circular A-130,
ii. To the maximum extent possible, align acquisition data sets with data security standards, which shall be determined by the Hi-Def Managing Agency
iii. Regularly review and address risk regarding acquisition processes, people, and technology; and
iv. Practice and share data management best practices relevant to acquisition data.
d. Leadership and Workforce—agencies shall:
i. Ensure that the acquisition workforce has appropriate knowledge and skills to facilitate the data lifecycle, including best practices for acquisition data entry and maintenance;
ii. As aligned with OMB Circular A-130,
iii. Promote the use of the HDE and associated tools to meet agency data requirements, as they become operational.
4.
a.
i.
ii.
iii.
iv.
v.
vi.
vii.
b.
i.
ii.
iii.
iv.
v.
vi.
vii.
c.
i. Managing the technical architecture and planned capabilities for the HDE;
ii. Maintaining a sustainable support function to address the program management elements described in this Circular;
iii. Coordinating with agencies to define an acceptable set of data security standards for the transfer, storage, and use of Hi-Def data through data sharing agreements;
iv. Properly securing all agency data, based on established data security standards, once transmitted into the HDE; and
v. Monitoring use and adoption for the HDE.
d.
5.
6.
7.
a.
i. Identification of the agency's accountable official responsible for Hi-Def activities;
ii. Analysis of the current collection of transactional pricing data (
iii. Acquisition data domains that are defined and managed within the agency enterprise;
iv. Adherence to the existing Federal G-Invoicing Standards;
v. The extent of unstructured acquisition data in contract writing systems that are not in a machine-readable format and would be unable to be transmitted via API (
vi. Existing and planned capabilities to share data centrally within the agency and to share data with other agencies.
b.
c. Within two years of the effective date of this Circular, the Department of Defense and FAI, in coordination with OMB and GSA, will create an outline for the Federal Acquisition Data Literacy training curriculum.
1.
2.
3.
The acquisition ecosystem requires a strong governance structure covering Hi-Def data and the HDE, as well as Government-wide acquisition systems and processes.
Governing bodies and structures may periodically be updated and are subject to change; current charters and other updates will be posted to the Governance and Policies page on the Acquisition Gateway.
1.
a. Hi-Def Data Governance Plan, as referenced in Section 7.b: This plan will be established within one year of this Circular and updated on a regular basis. The plan will, at a minimum, cover the following:
i. Accountability and decision rights;
ii. Transparency and ethics considerations;
iii. Data risk management;
iv. Data security;
v. Business outcomes prioritization;
vi. Product development and dissemination; and
vii. Data domain definition and management.
b. Hi-Def Environment Executive Steering Committee: Technical oversight of the HDE will reside initially with the HDE Executive Steering Committee. This interagency committee will be responsible for establishing the strategic, technical, and change management approaches for building and maintaining the HDE. Oversight of the HDE is subject to change once the comprehensive Hi-Def Data Governance Plan is established.
c. Hi-Def Implementation Groups: On an as-needed basis, OMB may convene working groups composed of agency policy, workforce, or acquisition system experts who are knowledgeable on key topics to support Hi-Def outcomes, including but not limited to: improving machine-readable data; interoperability and system integration (
2.
In addition, agencies will ensure that their current representatives selected for each governance structure or established in support of the goals of the Circular adhere to their respective charters, and possess the necessary skills and abilities to make recommendations and decisions that affect the generation, collection, use, sharing, and improvement of agency data.
This appendix provides illustrative examples of how a future HDE will benefit the acquisition lifecycle, agency planning, and budgeting. Based on agency feedback, the Office of Federal Procurement Policy has identified five initial targeted outcomes:
The table below demonstrates how the impacts of the HDE will map to each stakeholder group, summarizing the impact and noting to which Hi-Def Targeted Outcomes the impact primarily relates.
Data integrity refers to the accuracy, completeness, and reliability of data in its physical location, during transmission, and throughout the stages of generation, collection, use, sharing, and improvement, which support the Federal Data Lifecycle (see Figure 1). Data integrity is maintained through compliance with laws, policies, and standards established by governance. The integrity of the Federal acquisition process, including budgeting for, planning, managing, and closing out contracts that support programs, depends on the quality and availability of data. Innovation leads to ongoing business process improvements, requiring regular assessments of processes and data against established standards. The standardized processes and data will drive strong foundations across the Federal acquisition enterprise, while encouraging and enabling agency innovation and agility in acquisition planning, management, and operations.
This policy builds on the Federal Data Lifecycle by organizing its data roles into the five phases of the acquisition data lifecycle: Generate, Collect, Share, Use, and Improve. In addition, privacy and security are roles that affect every aspect of acquisition data, and agencies should ensure that the most current data protection methodologies are used and that all applicable statutes and regulations are followed.
The governance model identified in Appendix B will support efforts to identify, develop, and implement common business processes, data, and standards. This includes assessing existing standards instituted at an agency level for their potential application to the broader Federal acquisition community. The future HDE will make possible a seamless flow of data from authoritative sources to the point of need. Data will only need to be entered once and will be available for use at any point in the acquisition lifecycle consistent with applicable regulations and policies through implemented machine-readable data, in an open format, and available to computer applications to promote interoperability and system integration such as APIs.
As new regulations or policies are developed, new data may be required. Ongoing processes to review how best to collect this data from new or existing sources should be put into place, including for the review of the quality, security, and integrity of that data. Business process re-engineering may be required to avoid manual or redundant processes, improve quality, and make data available at the time of need. Reporting requirements may need to be adjusted or integrated as a result of increased data availability. Agencies must strategically plan how various Federal-wide and agency specific efforts can be harmonized and used to avoid duplication of effort, costs, and diminished data quality resulting from multiple instances of similar data across an agency.
In collaboration with the Integrated Award Environment governance structures and the Federal Acquisition Regulatory Council, and in consultation with Managing Partners for common technology tools, the PCE will ensure that applicable regulations and policy are reflected in any technologies, processes, systems, and data to reduce agency burden and ensure quality data are available for downstream use.
In addition, the PCE, in coordination with OMB and Integrated Award Environment governance structures, will review, and as needed, update the existing parameters and methods for annual V&V
In the distributed procurement information technology environment, agencies have responsibilities to generate data consistent with procurement policy, as well as standards for business processes, data, and interoperability. Federal agencies must manage data consistent with statutes, regulations, and OMB policies. Agency Chief Acquisition Officers, Senior Procurement Executives, Chief Data Officers, Chief Financial Officers, Chief Information Officers, and Budget Officers must collaborate to:
• Ensure independent V&V processes for data quality in accordance with relevant guidance;
• Assess the feasibility of building and maintaining appropriate and secure APIs to permit sharing and interoperability of procurement data and are developed through the appropriate working group(s) and after the initial data assessment period;
• Promote best business practices of appropriate data hygiene, principles, and standards as developed by the PCE;
• Further innovation and efficiency in the Federal acquisition system by leading or actively participating in the development and implementation of emerging technology tools that align with policy;
• Actively develop professionals with skills in Federal Acquisition Regulation (FAR)-based data analytics for decision-making;
• Assume responsibility for making data-driven decisions and for providing their acquisition workforce with critical information needed to negotiate contracts in the best interest of taxpayers;
• Build security and fraud protection into the management of procurement data to ensure data availability and usability; and
• Practice and share data management best practices through interagency working groups, such as the Chief Data Officers Council.
Strategic and operational planning by agencies, including budget planning, is essential to an interoperable environment where data are shared and available at the point of need. These activities provide opportunities for addressing gaps identified through assessments and innovation in business processes and technology, including lessons learned from pilots or shared activities. As such, agencies must include appropriate analyses of these considerations in agency annual strategic plans, as required by OMB Circular A-11 and any supplementary direction from OMB during the budget process. These plans will be reviewed by OMB to inform and shape actions necessary to support Hi-Def implementation and maintenance.
The Office of Federal Procurement Policy will provide a template with questions and structure for compiling agency Hi-Def strategic plans. The template will include sections for responding to questions related to acquisition data resources and infrastructure, Government-wide priorities established by OMB and governance groups, and agency-specific priorities. The yearly priority areas will be posted with an updated template on the Hi-Def website.
a. Appropriate resource management activities necessary to support innovative practices and alignment of data with statutes, regulations, policies, and standards to support interoperability. The identification of activities should be accomplished in coordination with the appropriate agency leaders directing the acquisition, information, security, data, finance, and human capital functions.
b. Solutions (active, in development, or planned for future development) identified by the agency workforce as the greatest opportunity for improving processes and leveraging technology to support innovation and reduce burden. Such ideas support agency operations and mission success by addressing issues, challenges, and best practices identified by those most impacted on a daily basis by access (or lack thereof) to data and information.
c. Details on how agencies are assuring any new technologies at the agency level are aligned with policy and regulations, and how agency technology supports the interoperability of data in the federated model established through this Circular.
d. Recommendations on any business processes that should be re-engineered to support innovation or just-in-time access to quality information or data. Re-imagining the process before applying emerging technologies or shared tools can lead to a more impactful change. This can be done by seeking workforce input, taking maximum advantage of FAR flexibilities, leveraging data and information technology as strategic assets, consulting with governance on how data is supposed to be used and displayed, and driving changes to agency-specific requirements.
Based on input collected through agency plans and stakeholder use cases, OMB will identify and prioritize datasets to be shared into the HDE.
Once identified, an MOU may be required to share data between the Hi-Def Managing Agency and the originating agency to ensure that data is properly stored, secured, and accessed. OMB is responsible for developing standard MOU templates to cover probable data scenarios, including but not limited to:
1. Exchange of discoverable, non-classified data;
2. Exchange of unstructured, document-based data such as contract terms and conditions; and
3. Exchange of classified or otherwise sensitive data that requires additional security considerations.
Sample elements for a data sharing MOU may include, but are not limited to:
1. Scope of data: Specify the types of data involved and any restrictions on use.
2. Data Ownership: Clarify who owns the data and any rights or responsibilities associated with it.
3. Confidentiality: Outline privacy considerations and measures to protect sensitive information.
4. Security: Detail security protocols required for transmitting, storing, and accessing data
5. Permitted Uses: Specify the authorized uses of the shared data and any limitations (for example, vendor names must be anonymized).
6. Duration of Agreement: Define the start and end dates or conditions for termination.
7. Responsibilities of the Parties: Clearly outline the obligations and responsibilities of each party involved.
8. Data Accuracy and Quality: Address the accuracy and quality standards expected for the shared data.
9. Data Access and Sharing Procedures: Specify how data will be accessed and shared.
10. Dispute Resolution: Establish procedures for resolving disputes or breaches of the agreement.
11. Governing Authorities: Specify the governing authorities that provide for the sharing of this data.
12. Amendments: Outline procedures for making changes to the agreement, as necessary.
HDE Stakeholders fall into four categories: Users, Customer Agencies, Data Providers, and Industry. This list is subject to further refinement, with updates posted to the Hi-Def website.
1. Data Providers will enable and provide access to their acquisition data to improve the capabilities, scope, and value of the HDE.
a. All Federal agencies are expected to ultimately be data providers. However, in the initial phase of the HDE, individual agencies will be consulted by OMB and the Hi-Def Executive Steering Committee about pilot opportunities on a case-by-case basis.
b. Other data providers may include non-Federal Government data sources and commercial data providers, where such data sources significantly enhance Hi-Def capabilities (
2.
a. Customers will be Federal agencies who access select capabilities such as data products, applications, and support services.
b. The customer base and services available are expected to grow and evolve as HDE functionality matures.
3.
a. The Acquisition Workforce (AWF) will primarily engage with various AWF-facing applications, dashboards, and reports that leverage HDE data products, initially those focused on commodity and service prices-paid analysis for market research, monitoring buying patterns, and solicitation development. The AWF can also use their understanding of the data in the HDE to identify more complex acquisition questions that they would like their data analysts to address. AWF users will primarily be agency Contracting Officers, Contract Specialists, and Agency Buyers and Program Managers.
b. Data Analysts from customer agencies will have access to usable agency acquisition data through various HDE components and features. This includes: (1) direct access to the HDE data management layer to perform custom analyses and develop new data products; (2) use of the dashboard and report management application to provide streamlined insights to their AWF in the HDE; and (3) ability to use HDE data products to power functionality developed and hosted by their home agency (
c. Acquisition Executives will primarily engage with various end-user applications that use HDE data products to quickly identify key insights (
4.
Institute of Museum and Library Services (IMLS), National Foundation of the Arts and the Humanities (NFAH).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the National Museum and Library Services Board will meet to advise the Director of the Institute of Museum and Library Services (IMLS) with respect to duties, powers, and authority of IMLS relating to museum, library, and information services, as well as coordination of activities for the improvement of these services.
Katherine Maas, Chief of Staff and Alternate Designated Federal Officer, Institute of Museum and Library Services, Suite 4000, 955 L'Enfant Plaza North SW, Washington, DC 20024; (202) 653-4798;
The National Museum and Library Services Board is meeting pursuant to the National Museum and Library Service Act, 20 U.S.C. 9105a, and the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App.
The 49th Meeting of the National Museum and Library Services Board, which is open to the public, will convene at 1 p.m. Eastern Time on June 24, 2024.
The agenda for the 49th Meeting of the National Museum and Library Services Board will be as follows:
If you wish to attend the meeting, please inform IMLS as soon as possible, but no later than close of business on June 17, 2024, by contacting Katherine Maas at
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the Market Dominant or the Competitive product list, or the modification of an existing product currently appearing on the Market Dominant or the Competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.
1.
2.
3.
4.
5.
This Notice will be published in the
Office of Science and Technology Policy (OSTP).
Request for information (RFI).
Through this Request for information (RFI), the White House Office of Science and Technology Policy (OSTP) seeks input from the public to help inform the development of the Federal Evidence Agenda on Disability Equity. Executive Order 14091 on Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (February 16, 2023) directed the OSTP National Science and Technology Council Subcommittee on Equitable Data (SED) to coordinate implementation of recommendations of the Equitable Data Working Group. To address the recommendations relevant to disability, the SED established the Disability Data Interagency Working Group (DDIWG). The DDIWG is tasked with the development and release of a Federal Evidence Agenda on Disability Equity, in order to improve the Federal government's ability to make data-informed policy decisions that advance equity for the disability community.
Interested persons and organizations are invited to submit comments on or before July 15, 2024.
Interested individuals and organizations should submit comments electronically via the Federal eRulemaking Portal at
Do not include in your submissions any copyrighted material; information of a confidential nature, such as personal or proprietary information; or any information you would not like to be made publicly available. Individuals and organizations who respond to this RFI may be contacted for additional clarification.
OSTP will not respond to individual submissions. A response to this RFI will not be viewed as a binding commitment to develop or pursue the project or ideas discussed. This RFI is not accepting applications for financial assistance or financial incentives.
Responses containing references, studies, research, and other empirical data that are not widely published should include copies of or electronic links to the referenced materials. Responses from minors, or responses containing profanity, vulgarity, threats, or other inappropriate language or content will not be considered.
Comments submitted in response to this notice are subject to the Freedom of Information Act (FOIA). Please note that the United States Government will not pay for response preparation, or for the use of any information contained in a response.
Please email
Executive Order (E.O.) 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021) established the Equitable Data Working Group (EDWG) to study existing Federal data collection policies, programs, and capabilities and provide recommendations for increasing data available for measuring equity and representing the diversity of the American people. Subsequently, E.O. 14091 on Further Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (February 16, 2023) directed the White House Office of Science and Technology Policy (OSTP) National Science and Technology Council Subcommittee on Equitable Data (SED) to coordinate implementation of the recommendations of the EDWG.
To address the recommendations relevant to disability, the SED established the Disability Data Interagency Working Group (DDIWG). The DDIWG is tasked with the development and release of a Federal Evidence Agenda on Disability Equity, in order to improve the Federal Government's ability to make data-informed policy decisions that advance equity for the disability community.
The Federal Evidence Agenda on Disability Equity will:
i. Describe disparities faced by individuals with disabilities that could be better understood through Federal statistics and data collection, such as disparities in health, employment, educational, and other outcomes, or in Federal program participation.
ii. Identify, in coordination with agency staff, Federal data collections where improved disability data collection may be important for advancing the Federal Government's ability to measure disparities facing individuals with disabilities; and
iii. Identify practices for all Federal agencies engaging in disability data collection to follow in order to safeguard privacy, security, and civil rights, including with regard to appropriate and robust practices of consent for the collection of this data and restrictions on its use or transfer.
We invite members of the public to share perspectives on how the DDIWG should address these requirements in the Federal Evidence Agenda on Disability Equity. OSTP seeks responses to one, some, or all of the questions that follow.
In its March 2023 progress report, the Subcommittee on Equitable Data states, “At its core, the principle of equitable data is about disaggregating and analyzing data to identify disparities in federal policies and programs, using levers of the federal government to address those disparities, and then enabling members of the public to hold government accountable.” With this in mind, OSTP seeks response to the following questions:
1. What disparities faced by individuals with disabilities are not well-understood through existing Federal statistics and data collection?
2. What types of community-based or non-Federal statistics or data collections could help inform the creation of the Federal Evidence Agenda on Disability Equity?
3. Community-based research has indicated that individuals with disabilities experience disparities in a broad range of areas. What factors or criteria should the DDIWG consider when considering policy research priorities?
Ultimately, individual agencies decide what data to collect and publish through their surveys and forms, taking into account considerations like informed consent, privacy risk, statistical rigor, intended use of the data, budget, burden to respondents, and more. With that in mind, OSTP seeks response to the following questions:
1. Disability can be defined and measured in multiple ways. Federal surveys and administrative data collections use different definitions of disability and measure it in different ways depending upon the goal(s) of data collection. What frameworks for defining and measuring disability or specific considerations should the DDIWG be aware of?
2. In some instances, there are multiple surveys or data collection tools that could be used to collect data about a particular disparity faced by the disability community. In addition to factors like sample size, timeliness of the data, and geographic specificity of related data products, what other factors should be considered when determining which survey or data collection tool would best generate the relevant data? Which surveys or data collection tools would be uniquely valuable in improving the Federal Government's ability to make data-informed decisions that advance equity for the disability community, and why?
3. Are there any Federal surveys or administrative data collection tools for which you would recommend the Federal Government
4. How can Federal agencies increase public response rates to questions about disability in order to improve sample sizes and population coverage?
5. What barriers may individuals with disabilities face when participating in surveys or filling out administrative forms?
6. Disaggregated data—data about groups separated out by disability, race/ethnicity, gender identity, sexual orientation, geography, income level, veteran status, rural/urban location, and other factors—are essential for identifying and remediating disparities in how the government serves American communities. Which data disaggregated by disability that are currently collected by Federal agencies are useful? Which data disaggregated by disability are not currently collected by Federal agencies and would be useful, and why?
7. How can Federal agencies best raise public awareness about the existence of sources of disability data? How can Federal agencies best communicate with the public about methodological constraints to collecting data or publishing disability statistics?
8. How do individuals and organizations external to the Federal Government utilize data from Federal surveys and administrative data collections? Which practices employed by Federal agencies facilitate access to and use of these data? Are there additional practices that would be beneficial?
The EDWG recommended that “. . . as the federal government expands its use of disaggregated demographic data, it must be intentional about when data are collected and shared, as well as how data are protected so as not to exacerbate the vulnerability of members of underserved communities, many of whom face the heightened risk of harm if their privacy is not protected.” Though previous work by the SED has identified how privacy, confidentiality, and civil rights practices apply to other marginalized groups, OSTP seeks input on privacy, confidentiality, and civil rights considerations that are unique to the disability community and/or are experienced differently by individuals with disabilities. Accordingly, OSTP seeks response to the following questions:
1. What specific privacy and confidentiality considerations should the DDIWG keep in mind when determining promising practices for the Federal collection of data for administrative purposes, such as applications for programs or benefits, compliance forms, and human resources and restrictions on their use or transfer?
2. Unique risks may exist when collecting disability data in the context of both surveys and administrative forms. Please tell us about specific risks Federal agencies should think about when considering whether to collect these data in surveys or administrative contexts.
3. Once disability data have been collected for administrative or statistical purposes, what considerations should Federal agencies be aware of concerning retention of these data? Please tell us how privacy or confidentiality protections could mitigate or change these concerns.
4. Where administrative data are used to enforce civil rights protections, such as in employment, credit applications, healthcare settings, or education settings, what considerations should the DDIWG keep in mind when determining promising practices for the collection of these data and restrictions on its use or transfer?
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Short Term Option Series Program in Supplementary Material .03 of Options 4, Section 5.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the Short Term Option Series Program in Supplementary Material .03 of Options 4, Section 5. Specifically, the Exchange proposes to expand the Short Term Option Series Program to permit the listing of two Monday expirations for options on United States Oil Fund, LP (“USO”), United States Natural Gas Fund, LP (“UNG”), SPDR Gold Shares (“GLD”), iShares Silver Trust (“SLV”), and iShares 20+ Year Treasury Bond ETF (“TLT”) (collectively “Exchange Traded Products” or “ETPs”).
Currently, as set forth in Supplementary Material .03 to Options 4, Section 5, after an option class has been approved for listing and trading on the Exchange as a Short Term Option Series pursuant to Options 1, Section 1(a)(49),
Additionally, the Exchange may open for trading series of options on the symbols provided in Table 1 of Supplementary Material .03 to Options 4, Section 5 that expire at the close of business on each of the next two Mondays, Tuesdays, Wednesdays, and Thursdays, respectively, that are business days beyond the current week and are not business days in which standard expiration options series, Monthly Options Series, or Quarterly Options Series expire (“Short Term Option Daily Expirations”).
At this time, the Exchange proposes to expand the Short Term Option Daily Expirations to permit the listing and trading of options on USO, UNG, GLD, SLV, and TLT expiring on Mondays. The Exchange proposes to permit two Short Term Option Expiration Dates beyond the current week for each Monday expiration at one time, and would update Table 1 in Supplementary Material .03 to Options 4, Section 5 for each of those symbols accordingly.
The proposed Monday USO, UNG, GLD, SLV, and TLT expirations will be similar to the current Monday SPY, QQQ, and IWM Short Term Option Daily Expirations set forth in Supplementary Material .03 to Options 4, Section 5, such that the Exchange may open for trading on any Friday or Monday that is a business day (beyond the current week) series of options on USO, UNG, GLD, SLV, and TLT to expire on any Monday of the month that is a business day and is not a Monday in which standard expiration options series, Monthly Options Series, or Quarterly Options Series expire, provided that Monday expirations that are listed on a Friday must be listed at least one business week and one business day prior to the expiration (“Monday USO Expirations,” “Monday UNG Expirations,” “Monday GLD Expirations,” “Monday SLV Expirations,” and “Monday TLT Expirations”) (collectively, “Monday ETP Expirations”).
The interval between strike prices for the proposed Monday ETP Expirations will be the same as those currently applicable for SPY, QQQ, and IWM Monday expirations in the Short Term Option Series Program.
Pursuant to Options 1, Section 1(a)(49), with respect to the Short Term Option Series Program, if a Monday is not a business day, the series shall expire on the first business day immediately following that Monday.
Currently, for each option class eligible for participation in the Short Term Option Series Program, the Exchange is limited to opening thirty (30) series for each expiration date for the specific class.
With this proposal, Monday ETP Expirations would be treated similarly to existing Monday SPY, QQQ, and IWM Expirations. With respect to standard expiration option series, Short Term Option Daily Expirations will be permitted to expire in the same week in which standard expiration option series on the same class expire.
Further, as with Monday SPY, QQQ, and IWM Expirations, the Exchange would not permit Monday ETP Expirations to expire on a business day in which standard expiration option series, Monthly Options Series, or Quarterly Options Series expire.
The Exchange does not believe that any market disruptions will be encountered with the introduction of Monday ETP Expirations. The Exchange currently trades P.M.-settled Short Term Option Series that expire Monday for SPY, QQQ and IWM and has not experienced any market disruptions nor issues with capacity. In addition, the Exchange has not experienced any market disruptions or issues with capacity in expanding the five ETPs to the Wednesday expirations.
The Exchange notes that listings in the Short Term Option Series Program comprise a significant part of the standard listings in options markets. The below diagram demonstrates the percentage of weekly listings in the options industry compared to monthly, quarterly, and Long-Term Option Series for a twelve-month period ending on February 22, 2024.
While the Exchange is expanding the Short Term Option Series Program to permit USO, UNG, GLD, SLV, and TLT Monday Expirations, the Exchange anticipates that it would overall add a small number of weekly expiration dates because the Exchange will limit the number of Short Term Option Daily Expirations for these ETPs to two Monday expirations. Expanding the Short Term Option Series Program in the foregoing manner will account for the addition of 4% (GLD), 8% (SLV), and 4% (TLT), 16% (UNG), and 9% (USO) of strikes for the respective symbol.
Further, as shown below, weeklies comprise 48% of the total volume of
In addition, the Exchange looked at the average daily contracts traded in SPY and QQQ five months before and five months after the introduction of Tuesday and Thursday expirations on those two symbols to assess whether there was new interest from adding alternative expirations (as opposed to existing interest being cannibalized).
The Exchange believes there is general demand for alternative expirations in GLD, SLV, TLT, UNG, and USO based on similar analysis. In particular, the Exchange looked at the average daily contracts traded in GLD, SLV, TLT, UNG, and USO five months before and five months after the introduction of Wednesday expirations to similarly assess whether there was new interest from adding these alternative expirations.
The Exchange also looked at the lifecycle volume of GLD, SLV, TLT, UNG, and USO in terms of average daily contracts traded, going from 50 days before expiration to the expiration date, to see how that lifecycle volume changed before and after the introduction of Wednesday expirations. As shown below, there is a notable increase in volume in terms of average daily contracts traded as the expiration date approaches. This is consistent across all five symbols as well as before and after the addition of Wednesday expirations.
In addition, the below chart shows post-close movements between 4:00-5:30 p.m. Eastern Time, and indicates that GLD, SLV, TLT, UNG, and USO are generally less volatile (strike-wise) than SPY, QQQ, and IWM, where alternative expirations exist today.
Furthermore, the below chart shows that GLD, SLV, TLT, UNG, and USO are generally less volatile in the last 30 minutes of trading than SPY, QQQ, and IWM, which have alternative expirations today.
Because the Exchange proposes to limit the number of Monday Expirations for options on USO, UNG, GLD, SLV, and TLT to two expirations beyond the current week, the Exchange believes that the addition of these Monday ETP Expirations should encourage Market Makers to continue to deploy capital more efficiently and improve displayed market quality.
Similar to SPY, QQQ and IWM Monday Expirations, the introduction of Monday ETP Expirations will, among other things, expand hedging tools available to market participants and allow for a reduced premium cost of buying portfolio protection. The Exchange believes that Monday ETP Expirations will allow market participants to hedge their portfolios with options on commodities (oil, natural gas, gold, and silver) as well as treasury securities, and tailor their investment and hedging needs more effectively.
The Exchange proposes to implement this rule change within 30 days after Commission approval. The Exchange will issue an Options Trader Alert to notify Members of the implementation date.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
Similar to Monday expirations in SPY, QQQ, and IWM, the proposal to permit Monday ETP Expirations, subject to the proposed limitation of two expirations beyond the current week, would protect investors and the public interest by providing the investing public and other market participants more choice and flexibility to closely tailor their investment and hedging decisions in these options and allow for a reduced premium cost of buying portfolio protection, thus allowing them to better manage their risk exposure. The Exchange believes that there is general demand for alternative expirations based on the analysis discussed above, notably comparing the average daily contracts traded in options overlying SPY, QQQ, and the five ETPs five months before and after the introduction of alternative expirations on those symbols. As shown above, the Exchange saw a volume increase in SPY and QQQ in the five-month period following the introduction of Tuesday and Thursday expirations, which suggests there is indeed genuine new interest in these alternative expirations (as opposed to existing interest being cannibalized). The Exchange also saw a volume increase in the majority of the five ETPs in the five-month period following the introduction of Wednesday expirations, likewise indicating the existence of general demand for alternative expirations in these symbols.
ISE represents that it has an adequate surveillance program in place to detect manipulative trading in the proposed option expirations, in the same way that it monitors trading in the current Short Term Option Series for Monday SPY, QQQ and IWM expirations. The Exchange also represents that it has the necessary system capacity to support the new expirations. Finally, the Exchange does not believe that any market disruptions will be encountered with the introduction of these option expirations. As discussed above, the Exchange believes that its proposal is a modest expansion of weekly expiration dates for GLD, SLV, USO, UNG, and TLT given that it will be limited to two Monday expirations beyond the current week. Furthermore, the above charts show less volatility in these five products (both in terms of post-close and during the last 30 minutes of trading) compared to SPY, QQQ, and IWM, which have alternative expirations (including Monday expirations) today.
The Exchange believes that the proposal is consistent with the Act as
Similar to Monday SPY, QQQ, and IWM expirations, the introduction of Monday ETP Expirations is consistent with the Act as it will, among other things, expand hedging tools available to market participants and allow for a reduced premium cost of buying portfolio protection. The Exchange believes that Monday ETP Expirations will allow market participants to purchase options on USO, UNG, GLD, SLV, and TLT based on their timing as needed and allow them to tailor their investment and hedging needs more effectively, thus allowing them to better manage their risk exposure. Today, ISE lists Monday SPY, QQQ, and IWM Expirations.
In particular, the Exchange believes the Short Term Option Series Program has been successful to date and that Monday ETP Expirations should simply expand the ability of investors to hedge risk against market movements stemming from economic releases or market events that occur throughout the month in the same way that the Short Term Option Series Program has expanded the landscape of hedging.
There are no material differences in the treatment of Monday SPY, QQQ and IWM expirations compared to the proposed Monday ETP Expirations. Given the similarities between Monday SPY, QQQ and IWM expirations and the proposed Monday ETP Expirations, the Exchange believes that applying the provisions in Supplementary Material .03 to Options 4, Section 5 that currently apply to Monday SPY, QQQ and IWM expirations is justified. For example, the Exchange believes that allowing Monday ETP Expirations and monthly Exchange Traded Product expirations in the same week will benefit investors and minimize investor confusion by providing Monday ETP Expirations in a continuous and uniform manner.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
While the proposal will expand the Short Term Options Expirations to allow Monday ETP Expirations to be listed on ISE,
Similar to Monday SPY, QQQ and IWM expirations, the introduction of Monday ETP Expirations does not impose an undue burden on competition. The Exchange believes that it will, among other things, expand hedging tools available to market participants and allow for a reduced premium cost of buying portfolio protection. The Exchange believes that Monday ETP Expirations will allow market participants to purchase options on USO, UNG, GLD, SLV, and TLT based on their timing as needed and allow them to tailor their investment and hedging needs more effectively.
The Exchange does not believe the proposal will impose any burden on inter-market competition, as nothing prevents the other options exchanges from proposing similar rules to list and trade Monday ETP Expirations.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
Each of the foregoing proposed rule changes, as modified by their respective amendments, is referred to herein as a “Proposal” and collectively as the “Proposals.” Each trust (or series of a trust) described in a Proposal is referred to herein as a “Trust” and collectively as the “Trusts.” As described in more detail in the Proposals' respective amended filings,
After careful review, the Commission finds that the Proposals are consistent with the Exchange Act and rules and regulations thereunder applicable to a national securities exchange.
When considering proposals to list bitcoin-based commodity trusts and bitcoin-based trust issued receipts, the Commission has explained that one way an exchange that lists bitcoin-based ETPs can meet the obligation under Exchange Act Section 6(b)(5) that its rules be designed to prevent fraudulent and manipulative acts and practices is by demonstrating that the exchange has a comprehensive surveillance-sharing agreement with a regulated market of significant size related to the underlying or reference assets.
The Commission has also consistently recognized, however, that this is not the
Each Exchange has a comprehensive surveillance-sharing agreement with the Chicago Mercantile Exchange (“CME”) via their common membership in the Intermarket Surveillance Group.
In the Spot Bitcoin ETP Approval Order, the Commission concluded that having a comprehensive surveillance-sharing agreement with a U.S.-regulated market that, based on evidence from robust correlation analysis, is consistently highly correlated with the ETPs' underlying assets (spot bitcoin) constituted “other means” sufficient to satisfy the Exchange Act Section 6(b)(5) standard.
Several of the Proposals and some commenters offered correlation analyses in the ether context. Some Proposals provided correlation results that used data at a daily frequency. For example, the ARK Amendment finds a correlation between the daily returns of CME ether futures and daily returns on certain spot ether trading platforms of more than 99.89%;
The Fidelity Amendment performed rolling 90-day correlations between daily returns of CME ether futures and six spot ether trading platforms and found correlations ranged between 94% and 99.8%.
The use of hourly data, however, provides no indication of how prices move at finer increments. For example, the results provide no indication of whether price movements—including price manipulations—in ether spot markets that persist for only a few minutes or less are likely to be reflected in CME ether futures prices. While the Fidelity Amendment's results may suggest a high degree of similarity in price movements between the CME ether futures market and the spot ether platforms “
Two commenters and one Proposal examined correlation between the CME ether futures market and spot ether trading platforms at hourly, five-minute, and one-minute intervals. The Coinbase Letter used price returns data from March 1, 2021, through January 31, 2024, for the CME ether futures market and the Coinbase platform.
The CF Benchmarks Letters used price returns data from February 2, 2022, through February 2, 2024, for the CME ether futures market and the Coinbase, Kraken, and LMAX Digital platforms.
The Bitwise Amendment used price returns data from August 1, 2021, through March 20, 2024, for the CME ether futures market and the Coinbase and Kraken platforms.
The Commission undertook to verify the Bitwise Amendment's and these two commenters' correlation results for certain spot ether markets. For robust
The results of the Commission's analysis confirm that the CME ether futures market has been consistently highly correlated with this subset of the spot ether market throughout the past 2.5 years. The correlation between the CME ether futures market and this subset of spot ether platforms for the full sample period is no less than 96.2 percent using data at an hourly interval, 85.7 percent using data at a five-minute interval, and 67.1 percent using data at a one-minute interval. The rolling three-month correlation results range between 86.4 and 98.4 percent using data at an hourly interval, 75.8 and 90.2 percent using data at a five-minute interval, and 58.6 and 75.9 percent using data at a one-minute interval.
The Commission further examined correlation between the CME ether futures market and the Coinbase and Kraken spot ether trading platforms at hourly, five-minute, and one-minute intervals in a recent month, March 2024, sourcing CME ether futures market data from Refinitiv.
The results of the Commission's robust correlation analysis
Each Proposal sets forth aspects of its proposed ETP, including the availability of pricing information, transparency of portfolio holdings, and types of surveillance procedures, that are consistent with other ETPs that the Commission has approved.
The Commission therefore finds that the Proposals, as with other ETPs that the Commission has approved,
One commenter asserts that the Commission should approve the Proposals because CME ether futures exchange-traded funds (“ETFs”) registered under the Investment Company Act of 1940 (“1940 Act”) are already trading on national securities exchanges “and possess much more potential for manipulation of the underlying asset.”
The Commission has considered and, for the reasons described above, is approving the Proposals on their own merits and under the standards applicable to them; namely, the standards provided by Section 6(b)(5) and Section 11A(a)(1)(C)(iii) of the Exchange Act.
Some commenters state that the Commission should approve the Proposals for a variety of investor protection reasons, including that spot ether ETPs would be a less costly and more efficient,
Another commenter disagrees that the ETP investment vehicle would protect investors, stating that the value of an investment in a spot ether ETP would be subject to the same risks of fraud and manipulation in the spot ether market as holding ether directly, and that ETPs are not subject to the Commission's examination authority, custody requirements, or conflicts of interest rules of ETFs registered under the 1940 Act.
This commenter also states that the price volatility of ether means that spot ether ETPs would threaten retail investors by exposing them to an unstable asset.
The Commission has considered these potential benefits and concerns in the broader context of whether the Proposals meet the applicable requirements of the Exchange Act,
The Commission also finds that the Proposals are consistent with the Section 6(b)(5) requirement that the Exchanges' rules be designed to protect investors and the public interest because, in addition to the factors discussed in Section II.A and II.B above, existing rules and standards of conduct would apply to recommending and advising investments in the shares of the Trusts. For example, when broker-dealers recommend ETPs to retail customers, Regulation Best Interest (“Reg BI”) would apply.
Some commenters contend that the Commission should disapprove the Proposals because the nature of ether and the Ethereum Network makes them inherently susceptible to fraud and manipulation.
Commenters also address, among other things: investor demand for spot ether ETPs;
The Commission finds good cause to approve the Proposals prior to the 30th day after the date of publication of notice of the Exchanges' amended filings
This approval order is based on all of the Exchanges' representations and descriptions in their respective amended filings, which the Commission has carefully evaluated as discussed
It is therefore ordered, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested member of the public an additional 30 days to provide comments on the proposed collection of information.
Submit comments on or before July 1, 2024.
Written comments and recommendations for this information collection request should be sent within 30 days of publication of this notice to
You may obtain a copy of the information collection and supporting documents from the Agency Clearance Office at
For SBA financial assistance programs, SBA Form 413 Personal Financial Statement (PFS) collects information regarding the assets and liabilities of certain owners, officers and guarantors of the small business applicant benefiting from such assistance and is used when analyzing the applicant's repayment abilities or creditworthiness. SBA's Surety Bond Guaranty Program uses the Form 413 PFS information during the claim recovery process. The information is also collected from applicants and participants in SBA's 8(a) Business Development (BD) and Women-Owned Small Business (WOSB) Program certification process to determine whether they meet the economic disadvantage requirements of the program.
All program offices use the same Form 413. SBA plans to revise and clarify the instructions for the Form 413 to ensure the public will be aware of the specific submission process for each program office. SBA will update the Form 413 to include recent rule and policy updates related to its thresholds for inflation. Lastly, the Form 413 may undergo additional formatting changes to make it easier to address mandatory Federal government 508 accessibility compliance.
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of indiana dated 05/23/2024.
Issued on 05/23/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be submitted online using the MySBA Loan Portal
The following areas have been determined to be adversely affected by the disaster:
The number assigned to this disaster for physical damage is 20349C and for economic injury is 203500.
The States which received an EIDL Declaration are Indiana, Ohio.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
SSA submitted the information collections below to OMB for clearance. Your comments regarding these information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than July 1, 2024. Individuals can obtain copies of these OMB clearance packages by writing to the
SSA established the eCBSV service in response to section 215 of the Economic Growth, Regulatory Relief, and Consumer Protection Act of 2018 (Banking Bill), Public Law 115-174. Permitted entities are able to submit the SSN, name, and DOB of the number holder in connection with a credit transaction, or any circumstances described in section 604 of the Fair Credit Reporting Act to SSA for verification via an application programming interface. eCBSV allows SSA to verify permitted entities who submit SSN, name, and DOB matches, or does not match, the data contained in SSA's records. After obtaining number holders' consents, a permitted entity submits the names, DOBs, and SSNs of number holders to the eCBSV service. SSA matches the information against our Master File, using SSN, name, and DOB. The eCBSV service responds in real time with a match, or no match indicator (and an indicator if our records show that the number holder died). SSA does not provide specific information on what data elements did not match, nor does SSA provide any SSNs or other identifiable information. The verification does not authenticate the identity of the number holders or conclusively prove the number holders we verify are who they are claiming to be.
Under the eCBSV process, the permitted entities do not submit the number holder's consent forms to SSA. SSA requires each permitted entity to retain a valid consent for each SSN verification request submitted for a period of 5 years. SSA allows the permitted entities to retain the consent in an electronic format, and SSA requires a wet or electronic signature on the consent. Permitted entities may request verification of a number holder's SSN on behalf of a financial institution pursuant to the terms of the Banking Bill; the user agreement between SSA and the PE; and the SSN Holder's consent. The permitted entity ensures the financial institution agrees to the terms in the user agreement to only use the SSN verification for the purpose stated in the consent, and prohibits public entities from further using or disclosing the SSN verification. This relationship is subject to the terms in the user agreement between SSA and the PE.
SSA requires each permitted entity to undergo compliance reviews which an SSA approved certified public accountant (CPA) conducts. The compliance reviews ensure the permitted entities meet all terms and conditions of the user agreement, including obtaining valid consent from number holders. The permitted entities pay all compliance review costs through the eCBSV fees. In general, SSA requests annual reviews with additional reviews
Initially, SSA only allowed 10 permitted entities access to use the service, with an estimated 307,000,000 requests. Now, with the open enrollment, eCBSV is available to all interested permitted entities, as defined in section 215 of the Banking Bill with an estimated annual 77,000,000 requests, and 20 participating public entities. The respondents are permitted entities; members of the public who consent to SSN verifications; and CPAs who provide compliance review services.
The public cost burden depends on the number of permitted entities using the service and the annual transaction volume. SSA based the current tier fee schedule below on 20 participating public entities in fiscal year (FY) 2023 submitting an anticipated annual volume of 65 million transactions. For FY 2024, we are maintaining the current tier structure, based our analysis, which estimated 20 participating public entities with an anticipated annual volume of 52 million. Since our analysis and initial estimate, one permitted entity noted the potential for a significant increase in volume in FY 2024. The total cost for developing and operating the service is $62 million through FY 2023. Of this amount, $37 million remains unrecovered/unreimbursed. The current subscription tier structure and associated fees intend to recover these costs over a four-year period, assuming projected enrollments and transaction volumes meet these projections. SSA uses the fee to allocate for forecasted systems and operational expenses; agency oversight; and overhead necessary to sustain the service.
SSA calculates fees based on forecasted systems and operational expenses, agency oversight, overhead, and Certified Public Accountant audit contract costs.
Section 215(h)(1)(B) of the Banking Bill requires that the Commissioner shall “periodically adjust” the price paid by users to ensure that amounts collected are sufficient to fully offset the costs of administering the eCBSV system. SSA will monitor costs incurred to provide eCBSV services on at least and annual basis, and will revise the tier fee schedule accordingly. SSA will notify permitted entities of the tier fee schedule in effect at the renewal of the eCBSV user agreements; when a permitted entity begins a new 365-day agreement period; and via notice in the
Office of the United States Trade Representative (USTR).
Notice.
In prior notices, the U.S. Trade Representative modified the actions in the section 301 investigation of China's acts, policies, and practices related to technology transfer, intellectual property, and innovation by excluding from additional duties certain products of China. The current 429 product specific exclusions (352 previously reinstated exclusions and 77 COVID-related exclusions) are scheduled to expire on May 31, 2024. This notice announces the U.S. Trade Representative's determination to provide a 14-day transition period for all current exclusions, extending them through June 14, 2024, and to extend certain exclusions through May 31, 2025.
To provide a transition period, this notice extends all exclusions scheduled to expire on May 31, 2024, through June 14, 2024. Those exclusions receiving further extension are listed in Annex C to this notice and are extended through May 31, 2025.
For general questions about this notice, contact Senior Associate General Counsel Philip Butler or Assistant General Counsel Edward Marcus at (202) 395-5725. For specific questions on customs classification or implementation of the product exclusions, contact
In the course of this investigation, the U.S. Trade Representative has imposed additional duties on products of China in four tranches.
For each tranche of additional duties, the U.S. Trade Representative established a process by which interested persons could request the temporary exclusion of particular products subject to the action. These exclusions were granted for a limited time and, with few exceptions, most expired in 2019 and 2020.
On October 8, 2021, the U.S. Trade Representative invited the public to submit comments on whether to temporarily reinstate certain exclusions previously granted and extended.
On March 25, 2020, USTR requested public comments on proposed modifications to exclude from additional duties certain medical-care products related to the U.S. response to COVID.
In accordance with section 307(c)(3) of the Trade Act of 1974 (19 U.S.C. 2417(c)(3)), on September 8, 2022, USTR announced that it would be conducting a review of the July 6, 2018 and August 23, 2018 actions, as modified.
To allow for consideration under the statutory review, on September 11, 2023, the U.S. Trade Representative determined to extend all current exclusions through December 31, 2023.
In light of public comments submitted in the four-year review, on December 29, 2023, USTR invited public comments on whether to further extend any of the current exclusions and announced an interim extension of the exclusions through May 31, 2024.
The December 29 notice provided that, in considering possible extensions, USTR would evaluate each exclusion on a case-by-case basis, with the focus of the evaluation on the availability of products covered by the exclusion from sources outside of China, efforts undertaken to source products covered by the exclusion from the United States or third countries, and whether further extension of a particular exclusion would aid in shifting sourcing outside of China.
USTR opened a 30-day docket on January 22, 2024, and requested that commenters address the availability of products covered by the exclusion outside of China, plans to shift their sourcing outside of China in 2024, efforts undertaken to source products from the United States or third countries, and why additional time is needed to shift sourcing out of China and the timeline, if any, expected for sourcing to shift outside of China.
Based on evaluation of the factors set out in the December 29 notice, and pursuant to sections 301(b), 301(c), and 307(a) of the Trade Act of 1974, as amended, the U.S. Trade Representative has determined to further modify the action to extend the exclusions listed in Annex C to this notice through May 31, 2025. The U.S. Trade Representative has found that extending these exclusions will support efforts to shift sourcing out of China, or provide additional time where, despite efforts to source products from alternative sources, availability of the product outside of China remains limited.
The U.S. Trade Representative has determined not to extend the remaining exclusions beyond the 14-day transition period. These exclusions are listed in
For example, the U.S. Trade Representative has declined to further extend exclusions where comments indicated that importers had no plans to shift sourcing out of China in 2024 (or at all). Similarly, the U.S. Trade Representative has declined to further extend exclusions where, despite more than four years of temporary exclusion, commenters reported that they had taken few or no steps to shift sourcing out of China. This includes comments that, without further explanation, asserted that they were considering alternative sources, or reported plans to shift sourcing, but failed to adequately explain efforts undertaken or why additional time was needed.
The U.S. Trade Representative also declined to further extend exclusions where opposing comments indicated availability from domestic sources or third country sources. This includes opposing comments from domestic producers reporting available capacity and opposing comments from importers who previously benefitted from the exclusion reporting successful efforts to shift to alternative sources. Extending these exclusions may undercut those efforts, including recent investments in domestic capacity.
The U.S. Trade Representative also declined to extend exclusions where claims of unavailability were based on the product being unavailable at the price of Chinese sources. In many instances, comments simply asserted that products were unavailable because China remained the lowest cost source. Extending those exclusions would likely delay the commenters' efforts to find alternative sourcing and continue their dependence on Chinese suppliers and products, which undermines the goal of obtaining the elimination of China's acts, policies, and practices covered in the investigation.
Similarly, many comments asserted that a product was unavailable outside of China due to costs associated with finding alternative sources or based on the limited availability of certain product specifications or comparable quality outside of China. Without additional explanation of efforts undertaken or how further extending the exclusion would aid efforts to shift sourcing, the U.S. Trade Representative declined to extend these exclusions.
The U.S. Trade Representative's consideration to extend certain exclusions takes into account public comments submitted in response to the December 29 notice, public comments submitted in the four-year review, confidential import data provided by U.S. Customs and Border Protection, the advice of advisory committees, and the advice of the interagency section 301 Committee.
As stated above, to provide a transition period for the expiring exclusions, the U.S. Trade Representative has determined to extend all current exclusions through June 14, 2024.
The extensions announced in the notice are available for any product that meets the description in the product exclusion. Further, the scope of each exclusion and modification is governed by the scope of the ten-digit Harmonized Tariff Schedule of the United States (HTSUS) subheadings and product descriptions in the Annexes of this notice. U.S. Customs and Border Protection will issue instructions on entry guidance and implementation.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of public meetings.
The FAA announces multiple meetings of the Aviation Rulemaking Advisory Committee (ARAC). This notice announces the date, time, and location of these meetings. The meetings will be “open to the public” meeting notice requirements. The purpose of ARAC is to provide information, advice, and recommendations to the Secretary of Transportation, through the FAA Administrator, concerning rulemaking activities, such as aircraft operations, airman and air agency certification, airworthiness standards and certification, airports, maintenance, noise, and training.
The ARAC will host two public meetings, the first will take place June 13, 2024, from 2:00 p.m. to 4:00 p.m. Eastern Time. The second public meeting will be held on September 12, 2024, from 1:00 p.m. to 4:00 p.m. Eastern Time. The FAA must receive requests to attend the meeting at least two weeks in advance of the meeting.
Each meeting will be held at the Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, and virtually on Zoom. However, if the FAA is unable to hold the meeting in person due to circumstances outside of its control, the FAA will hold a virtual meeting, notifying registrants of the meeting details and posting any updates on the FAA Committee website. Members of the public who wish to observe the meeting must RSVP by emailing
Aliah Duckett, Federal Aviation Administration, Office of Rulemaking, 800 Independence Avenue SW, Washington, DC 20591,
ARAC was established on January 22, 1991, under the Federal Advisory Committee Act (FACA) and pursuant to Title 5 of the United States Code (5 U.S.C. 1001
The agendas for the June 13 and September 12, 2024, meetings will include the following:
Detailed agenda information will be posted on the FAA Committee website address listed in the
The meeting will be open to the public for virtual or in-person attendance on a first-come, first-served basis, as there is limited space. Please confirm your attendance with the person listed in the
The DOT is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, such as sign language, interpretation, or other ancillary aids, please contact the person listed in the
The FAA is not accepting oral presentations at the meetings due to time constraints. Members of the public may present written statements to ARAC by providing a copy to the Designated Federal Officer via the email listed in the
Federal Aviation Administration, Department of Transportation.
Cancellation notice of Advanced Aviation Advisory Committee (AAAC) meetings.
The Federal Aviation Administration published a notice in the
Gary Kolb, Advanced Aviation Advisory Committee Manager, Federal Aviation Administration, U.S. Department of Transportation, at
Issued in Washington, DC.
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for a new information collection, which is summarized below under
Please submit comments by July 29, 2024.
You may submit comments identified by DOT Docket ID Number FHWA-2024-0043 by any of the following methods:
Ms. Tashia J. Clemons, Office of Infrastructure, 202-493-0551,
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of application for renewal of exemption; request for comments.
FMCSA announces that it has received an application from the National School Transportation Association (NSTA) to renew its exemption that permits all commercial driver's license (CDL) applicants seeking a school bus endorsement to forgo the engine compartment portion of the pre-trip vehicle inspection skills testing requirement, known informally as the “under-the-hood” testing requirement. Drivers issued CDLs pursuant to the requested exemption are restricted to intrastate operation of school buses only. The current exemption is effective from November 28, 2022, through November 28, 2024, and NSTA has requested a three-year extension of the exemption. FMCSA requests public comment on NSTA's request for exemption.
Comments must be received on or before July 1, 2024.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2022-0148 using any of the following methods:
•
•
•
•
Each submission must include the Agency name and the docket number for this notice (FMCSA-2022-0148). Note that DOT posts all comments received without change to
Mr. Richard Clemente, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; 202-366-2722;
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2022-0148), indicate the specific section of this document to which the comment applies, and provide a reason for your suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305(a)). The Agency must publish its decision in the
FMCSA's CDL regulations in 49 CFR 383.113(a) require that applicants for a CDL possess basic pre-trip vehicle inspection skills for the vehicle class that they operate or expect to operate. Applicants must be able to identify each safety-related part on the test vehicle and explain what needs to be inspected to ensure a safe operating condition of each part.
On January 3, 2022, in response to a request from NSTA, FMCSA issued a three-month waiver from 49 CFR 383.113(a)(1)(i), which requires CDL applicants to demonstrate familiarity with the engine compartment, the so-called “under-the-hood” requirement. The waiver responded to the unique circumstances resulting from the school bus driver shortage, which was exacerbated by the COVID-19 pandemic. FMCSA issued two subsequent three-month waivers, on March 28, 2022, and June 30, 2022.
FMCSA published notice of NSTA's application for a longer-term exemption from the “under-the-hood” skills testing requirement on August 11, 2022 (87 FR 49646). The Agency analyzed the application and public comments and determined that granting it was likely to achieve a level of safety equivalent to or greater than the level of safety that would be achieved in the absence of the exemption. On October 27, 2022, FMCSA granted a two-year “under-the-hood” exemption which will expire on November 27, 2024 (87 FR 65114). The exemption applies to CDL applicants seeking the school bus (S) and passenger (P) endorsements and the intrastate only (K) restriction. Consequently, drivers issued a CDL pursuant to the exemption are restricted to the intrastate operation of school buses only.
NSTA applied for renewal of the exemption on February 28, 2024. NSTA is a membership organization for school bus contract-operators engaged primarily in transporting students to and from school and school-related activities. Its members range from small family businesses serving one school district, to large corporations operating tens of thousands of buses across multiple states all with a stated commitment to the safe, efficient, and economical transportation of students. According to NSTA, private school bus contractors account for 38 percent of the nation's pupil transportation services and employ more than 250,000 individuals as bus drivers, mechanics, maintenance workers, dispatch workers, and office workers. School transportation represents the largest form of mass transportation in the United States, and daily almost 26 million K-12 students are transported by an estimated 480,000 yellow school buses.
NSTA requests renewal of the exemption for a three-year period because NSTA claims it has aided in the successful recruitment of school bus drivers who otherwise may not have obtained a CDL. According to NSTA, the industry's CDL training resources are limited, and the exemption helps ensure that the limited resources are used to train school bus drivers, rather than operators of other kinds of CMVs. NSTA indicates that the current exemption has had a demonstrably positive impact on student transportation thus far, and notably with no negative impact on safety.
In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on NSTA's application for the renewal of the exemption from the requirement in 49 CFR 383.133(a)(1)(i) that requires CDL applicants seeking a school bus endorsement, to perform the engine compartment portion of the pre-trip vehicle inspection skills testing requirement. All comments received before the close of business on the comment closing date indicated at the beginning of this notice will be considered and will be available for examination in the docket at the location listed under the Addresses section of this notice. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable. In addition to late comments, FMCSA will also continue to file, in the public docket, relevant information that becomes available after the comment closing date. Interested persons should continue to examine the public docket for new material.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of correction.
FMCSA corrects the notice published in the
Ms. Pearlie Robinson, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; (202) 366-4225; or
The original notice of application and request for comments, published on May 23, 2024, at 89 FR 45732, contains on page 45733 the following two sentences “On an annual basis, it hires approximately 1,200 new drivers each year through driver training schools. Covenant Logistics estimates that approximately 2,000 drivers annually would operate CMVs under the requested exemption.” FMCSA is correcting these sentences to read: “On an annual basis, it hires approximately 2,400 new drivers each year through driver training schools. Covenant Logistics estimates that approximately 4,000 drivers annually would operate CMVs under the requested exemption.”
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of application for exemptions; request for comments.
FMCSA announces that it has received an application from the American Pyrotechnics Association (APA) requesting extension of its current exemptions from the Agency's hours-of-service (HOS) regulations for 12 additional member companies. The request would allow drivers employed by the 12 member carriers to exclude off-duty and sleeper-berth time of any length from the calculation of the 14-hour limit. It would also to allow these drivers to use paper records of duty status (RODS) in lieu of an electronic logging device (ELD) during the designated Independence Day periods.
Comments must be received on or before July 1, 2024.
You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2021-0052 by any of the following methods:
•
•
•
•
Each submission must include the Agency name and the docket number (FMCSA-2021-0052) for this notice. Note that DOT posts all comments received without change to
Ms. Pearlie Robinson, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; 1200 New Jersey Avenue SE, Washington, DC 20590-0001; (202) 366-4225;
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2022-0122), indicate the specific section of this document to which the comment applies, and provide a reason for your suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely maintain a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305(a)). The Agency must publish its decision in the
The APA is a trade association representing the domestic fireworks industry. In 2022, FMCSA granted the APA exemptions from the requirements of 49 CFR 395.3(a)(2) and 395.8(a)(1)(i) for 32 of its member companies through the annual Independence Day periods ending on July 8, 2024 [87 FR 79935, December 28, 2022]. One of the 32 APA member companies, Dominion Fireworks Inc., DOT # 540485, no longer requires the exemptions, leaving the total number of companies currently covered by the exemptions at 31. APA has requested exemptions for 12 additional member companies, which would increase the total to 43 if the exemption request is granted. The 12 additional companies consist of three new member companies that have not operated under the exemptions, and nine member companies that previously held such exemptions. If granted, the exemptions would expire on July 8, 2024. The 12 additional companies, like the 31 current companies, would be subject to all of the terms and conditions of the exemptions set forth in the December 28, 2022, decision (87 FR 79935, 79937). The 12 companies combined are listed in the appendix table of this notice, including the three new companies, which are identified by asterisks.
APA member companies have held waivers or exemptions during Independence Day periods each year since 2005. Copies of the initial request for an exemption, subsequent renewal requests, and all public comments received may be reviewed at
A copy of the APA's application for exemptions is available for review in the docket for this notice.
In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on APA's application for exemptions from 49 CFR 395.3(a)(2) and 395.8(a)(1)(i). All comments received before the close of business on the comment closing date indicated at the beginning of this notice will be considered and will be available for examination in the docket at the location listed under the Addresses section of this notice. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable. In addition to late comments, FMCSA will also continue to file, in the public docket, relevant information that becomes available after the comment closing date. Interested persons should continue to examine the public docket for new material.
Departmental Offices, Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Comments should be received on or before July 1, 2024 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Melody Braswell by emailing
Form 1098-Q is used to comply with the reporting requirements under TD 9673. Any person who issues a contract intended to be a QLAC that is purchased or held under any plan, annuity, or account described in section 401(a), 403(a), 403(b), 408 (other than a Roth IRA) or eligible governmental plan under section 457(b), must file Form 1098-Q.
U.S.-China Economic and Security Review Commission.
Notice of open public hearing.
Notice is hereby given of the following hearing of the U.S.-China Economic and Security Review Commission. The Commission is mandated by Congress to investigate, assess, and report to Congress annually on “the national security implications of the economic relationship between the United States and the People's Republic of China.” Pursuant to this mandate, the Commission will hold a public hearing
The hearing is scheduled for Thursday, June 13, 2024 at 9:30 a.m.
Members of the public will be able to attend in person at a location TBD or view a live webcast via the Commission's website at
Any member of the public seeking further information concerning the hearing should contact Jameson Cunningham, 444 North Capitol Street NW, Suite 602, Washington, DC 20001; telephone: 202-624-1496, or via email at
The hearing will be co-chaired by Commissioners Carte P. Goodwin and Cliff Sims. Any interested party may file a written statement by June 13, 2024 by transmitting it to the contact above. A portion of the hearing will include a question and answer period between the Commissioners and the witnesses.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice by clicking on the following link
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Comments and recommendations for the proposed
VA PRA information: Maribel Aponte, 202-461-8900,
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Comments must be received on or before July 29, 2024.
Comments must be submitted through
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (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 or the use of other forms of information technology.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice by clicking on the following link
VA PRA information: Maribel Aponte, 202-461-8900,
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
Department of Veterans Affairs.
Notice.
VA intends to implement a new law that prohibits the collection of copayments for the first three mental health care outpatient visits of a Veteran in a calendar year for which the Veteran would otherwise be required to pay a copayment. VA's current regulations regarding copayments do not include an exemption for this purpose, but VA will revise them soon to align with the law. In April 2024, VA was able to modify its systems and processes to comply with the law for qualifying appointments that occurred on or after June 27, 2023. By law, the exemption will expire on December 29, 2027.
Implementation will be applicable upon publication in the
Ms. Tamara Wagner, Office of Finance, Revenue Operations, (104RO2), Veterans Health Administration, Department of Veterans Affairs, 128 Bingham Road, Suite 1000, Asheville, NC 28806; 970-242-0731, extension 2219. (This is not a toll-free number.)
The primary purpose of this notice is to inform the public of VA's intent to modify its systems and processes to comply with new statutory requirements while rulemaking proceeds to modify existing regulations. On December 29, 2022, the Joseph Maxwell Cleland and Robert Joseph Dole Memorial Veterans Benefits and Health Care Improvement Act of 2022 (the Act; Pub. L. 117-328, Division U), added a new section 1722C to title 38, U.S.C., that generally prohibits VA from imposing or collecting a copayment for the first three mental health care outpatient visits of a Veteran in a calendar year for which the Veteran would otherwise be required to pay a copayment to VA. The Act defines a mental health care outpatient visit to mean an outpatient visit with a qualified mental health professional for the primary purpose of seeking either mental health care, or treatment for substance abuse disorder. The copayment exemption for the first three outpatient mental health care visits includes appointments completed in VA clinics as well as those conducted by community care providers.
VA will modify its regulations regarding copayments for outpatient mental health care, set forth at 38 CFR 17.108, to reflect this authority. Mental health care outpatient visits are defined in law to mean an outpatient visit with a qualified mental health professional for the primary purpose of seeking either mental health care or treatment for substance abuse disorder.
The determination of the first three mental health visits is expected to be complex due to a variety of issues, including the need to consider whether care is service-connected or otherwise exempt, how to handle Veterans with multiple appointments in the same day, and administrative requirements (such as establishing a tool to count the number of appointments a Veteran has had in a calendar year). To ensure the most effective application of this benefit and exempt copayments as applicable under the statute, VA will determine if a visit qualifies for a copayment exemption using the following process.
First, VA will evaluate the clinic where the appointment occurred. If the clinic is a mental health, psychiatry, psychology, or substance abuse clinic, VA will exempt the copayment, if applicable, if the appointment is one of the first three qualifying visits in a calendar year. Second, if the visit was not performed in such a clinic, VA will review what provider completed the appointment to determine if the visit applies for a copayment exemption. If the provider is a psychiatrist, psychologist, licensed professional mental health counselor, marriage or family therapist, or social worker, and if the medical service provided is classified as an evaluation and management visit, mental health visit, group therapy visit, or psychiatric diagnostic assessment, VA will exempt the copayment, if applicable, provided the appointment is one of the first three qualifying visits in a calendar year. Veterans that are otherwise copayment exempt based on Priority Group or service connection should see no difference in their copayment status as the copayment would already be exempt for other reasons. If a Veteran has multiple appointments in one day, including a visit that would qualify for
Section 1722C, by prohibiting the imposition or collection of copayments “for the first three mental health care outpatient visits of a Veteran in a calendar year
Section 193A(b) of the Act provided that the new 38 U.S.C. 1722C shall apply with respect to mental health care outpatient visits occurring on or after the date that is 180 days after the date of the enactment of this Act. The Act
While this process is expected to identify the vast majority of qualifying mental health care outpatient visits, Veterans who believe a copayment was applied in error may contact VA to review its determination and correct the copayment, if applicable. Information on disputing VA copayments can be found on the VA website at
Denis McDonough, Secretary of Veterans Affairs, approved and signed this document on May 6, 2024, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
Environmental Protection Agency (EPA).
Proposed rule.
The U.S. Environmental Protection Agency (EPA or the agency) is proposing a regulatory framework for states and public water systems (PWSs) to identify and assess restructuring alternatives to ensure that every community receives safe, affordable, and reliable drinking water. The proposed regulations would: establish a new mandatory restructuring assessment authority for states; require states with primary enforcement authority (primacy) to develop mandatory restructuring assessment programs and submit primacy revisions for EPA review and approval; establish requirements for states and PWSs that implement system-specific mandatory restructuring assessments; and establish eligibility requirements and limitations for restructuring incentives under state-approved restructuring plans. This proposed rulemaking is required under amendments to the Safe Drinking Water Act (SDWA). By taking this action, the EPA intends to strengthen the ongoing efforts of states and PWSs to protect public health.
Comments must be received on or before July 29, 2024. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before July 1, 2024.
You may send comments, identified by Docket ID No. EPA-HQ-OW-2022-0678, by any of the following methods:
•
•
•
•
Will Bowman, Drinking Water Capacity & Compliance Assistance Division, Office of Ground Water and Drinking Water (MC-4606M) Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 564-3782; email address:
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2022-0678 at
This proposed rulemaking would apply to all states with primary enforcement responsibility, to a PWS that is the subject of a mandatory restructuring assessment where the state has mandated such assessment, and to a PWS that submits a restructuring plan to the state for purposes of enforcement relief or liability protection. Consistent with the SDWA, a PWS is subject to a mandatory assessment if the state finds that: (1) the PWS has repeatedly violated one or more National Primary Drinking Water Regulations (NPDWRs) and such violations are likely to adversely affect human health; (2) the PWS is unable or unwilling to implement restructuring activities, or already has attempted to implement such activities but has not achieved compliance; (3) restructuring of the PWS, including a form of consolidation or a transfer of ownership, is feasible; and (4) restructuring of the PWS could result in greater compliance with drinking water standards. Although the mandatory assessment requirements would not apply to a PWS that does not meet these four SDWA criteria, such PWSs may develop and submit restructuring plans eligible for restructuring incentives. This description of the applicability of this proposed regulation is not intended to be exhaustive, but rather provides a guide for readers regarding entities intended to be regulated by this action. To determine whether a particular entity or state would be regulated by this action, the reader should carefully examine the definitions of “primary enforcement responsibility,” “public water system” or “PWS,” “supplier of water,” and “state” found in the Code of Federal Regulations (CFR) at 40 CFR 142.2 entitled “Definitions” and in 40 CFR 142.3 entitled “Scope.” The reader also should review the paragraph entitled “Applicability” in the proposed 40 CFR 142.90 of this document. For any questions regarding the applicability of this action to a particular entity, the reader should consult the person listed in the
The proposed Water System Restructuring Assessment Rule (WSRAR) would create a framework for states and PWSs to evaluate and implement restructuring alternatives for systems in chronic noncompliance. Assessments may identify a broad array of alternatives that may include sharing resources (
In some cases, consolidation or transfer of ownership could be the most feasible alternative to ensure a community receives safe drinking water in a sustainable manner, particularly if a PWS already has attempted to build technical or managerial capacity, to invest in infrastructure improvements, or to implement other restructuring actions, yet public health remains at risk due to persistent noncompliance with drinking water standards. For example, consolidation can reduce costs per household by spreading the cost of service across a larger customer base (US Water Alliance and UNC Environmental Finance Center 2019). As described in section IV of this preamble, the proposed rule distinguishes consolidation from privatization, which can occur under a transfer of PWS ownership from a public entity to a private entity. A common form of consolidation by small water utilities is referred to as regionalization, in which neighboring water utilities facing similar challenges choose to consolidate administratively or physically. The EPA recognizes that forms of consolidation or transfers of ownership, particularly those that would result in privatization, might raise community concerns. These concerns include affordable water rates, the need for transparency and community involvement in decision making, and ensuring accountability for utility management and operations (Zhang, et. al, 2022). A recently published case study on privatization provides an example that highlights these concerns. The case study found that, due to lack of consumer protections and utility mismanagement under private control, residents and community organizers demanded public ownership and management of the water system, more equitable water rates, and greater accountability and transparency in governance (Rivas and Schroering, 2021). To address these concerns, the proposed rule would establish several “tailoring” requirements to ensure that the assessment identifies feasible restructuring alternatives based on the physical and socio-economic characteristics of the water system, which can limit its capacity to restructure without technical and financial assistance. These characteristics include not only those cited in the SDWA (population served, water system type), but also the following: source water type; the technical, managerial, and financial (TMF) capacity of the water system; whether the community it serves is disadvantaged or underserved; as well as other characteristics. In addition, the proposed rule would require the mandatory assessment to describe how restructuring would ensure that the service community would sustainably receive safe, affordable drinking water. To ensure that the local community can raise concerns, ask questions, and provide input to the state and to the water utility, the proposed rule also would require the state to hold a public meeting before approving either a mandatory assessment or a restructuring plan that would result in consolidation or transfer of ownership. Finally, the proposed rule would require the state to make electronic and physical copies of state-approved assessment reports or restructuring plans available to the public. In addition to the assessment
The SDWA also establishes enforcement relief and liability protection incentives for state-approved restructuring plans. The enforcement relief incentive would prohibit enforcement action for up to two years for specific violations identified in the plan. The liability protection incentive would protect a compliant water system from liability for violations at an assessed water system until it has acquired an assessed water system through transfer of ownership or has completed physical or administrative consolidation with the assessed water system. The SDWA limits these incentives to plans for managerial or physical consolidation, transfer of ownership, or contracts for managing or administering the water system to resolve violations. As described in sections IV.E and IV.F of this preamble, the proposed rule also would establish additional eligibility requirements and limitations for both incentives, which would apply only to violations that the PWS identified in a state-approved plan.
Finally, the proposed rule would revise existing primacy regulations to require states to develop programs with the authority to mandate restructuring assessments and to review and approve restructuring plans. To obtain this authority, states would submit primacy revision applications for the EPA's approval. To assist the agency with oversight of state mandatory assessment programs, the revised primacy regulations would establish new reporting and recordkeeping requirements for states.
The EPA proposes this regulation as mandated by SDWA section 1414(h)(6), 42 U.S.C. 300g-3(h)(6) and pursuant to SDWA sections 1413, 42 U.S.C. 300(g)-2 and 1450(a), 42 U.S.C. 300j-9.
The proposed rule, if finalized, would impose direct costs on states that are required under the SDWA to establish mandatory assessment programs, and, when a state mandates an assessment, would impose indirect costs on both states and assessed PWSs to ensure that the proposed assessment requirements are satisfied. The EPA estimated that the annualized direct costs to states of implementing the requirements of this proposed WSRAR, if finalized, would be within $0.8 million to $1.0 million at a 2 percent discount rate. The estimated benefits of this proposed rulemaking would be reduced risks to public health at assessed water systems that return to compliance through restructuring, and reduced enforcement costs for states.
In 2019, the EPA met with the Association of State Drinking Water Administrators (ASDWA) on the restructuring-related amendments to SDWA sections 1413 and 1414(h). The purpose of the consultations was to determine how the EPA should communicate with states regarding each set of amendments and their implications for states, especially the mandatory primacy revisions. Following these initial conversations, in August 2019, the EPA participated in a national webinar on water system consolidation hosted by ASDWA. During the webinar, the EPA presented a detailed summary of the America's Water Infrastructure Act (AWIA) amendments to SDWA sections 1413 and 1414(h), described several policy issues that the agency might consider as part of WSRAR development, and explained the likely effects of the amendments on state programs.
Consistent with Paperwork Reduction Act (PRA) requirements, following the national webinar, from September through November 2019, the EPA conducted telephone interviews with drinking water program staff and managers in the States of California, Connecticut, Indiana, Nebraska, Nevada, Pennsylvania, Virginia, and Washington. The EPA selected these eight states as representative of state Public Water System Supervision (PWSS) programs based on total population served, sizes of PWS inventory, geographic region, and features of their capacity development programs as documented in the EPA's 2017 compendium of state partnership programs (EPA 2017). The interviews allowed the EPA to develop a clearer understanding of states' perspectives on how these new SDWA primacy requirements and the proposed mandatory assessment authority could affect their PWSS programs. In addition, the interviews helped the EPA understand how these states currently conduct four types of water system assessments: sanitary surveys; Revised Total Coliform Rule (RTCR) Level 1 and 2 assessments; technical, managerial, and financial (TMF) capacity assessments; and feasibility studies. Collectively, these four types of assessment, which include the identification of system vulnerabilities, evaluations of water system performance, or financial capacity assessments, are closely related to the proposed elements of mandatory restructuring assessments under the WSRAR. As a result of the state interviews, the EPA obtained, for each of the assessment types, state costs of establishing an assessment program, including training staff, developing training materials for water systems, preparing databases, and conducting assessment activities. The interviews also yielded data from each state that the EPA used to calculate the cost estimates for the proposed WSRAR discussed in section VI of this preamble.
In 2019 and 2020, the EPA conducted webinars and held informational meetings with national associations that represent large and small drinking water utilities, or that provide direct technical assistance to PWSs, to discuss water system partnerships, including forms of consolidation, transfers of ownership, and other types of restructuring. These organizations included: The Rural Community Assistance Partnership (RCAP), the Rural Community Assistance Corporation (RCAC), the Association of Metropolitan Water Agencies (AMWA), the National Rural Water Association (NRWA), and the American Water Works Association (AWWA). During these meetings, the EPA provided stakeholders with an overview of the AWIA amendments to SDWA sections 1413 and 1414(h), and described potential provisions of interest, including those that require the EPA to establish implementing regulations in the WSRAR. For large water utilities, the discussion centered on the statutory requirements for liability protection as an incentive to consolidate with assessed water systems. Small water utilities focused on the SDWA tailoring provision that requires assessment of restructuring options to be based on the characteristics of each water system, and on enforcement relief as a restructuring incentive. The EPA outlined these SDWA requirements to ensure that stakeholders were aware of how these provisions might affect them. During these discussions, utility stakeholders also identified restructuring barriers and incentives and provided case studies for the EPA to consider when developing the proposed WSRAR. This feedback informed our rulemaking process. The
In October 2022, the EPA conducted an informational meeting with the Natural Resources Defense Council (NRDC) and community-based organizations from Michigan and California. The meeting provided the agency an opportunity to listen to concerns about: the importance of community involvement in restructuring decisions; community impacts when restructuring alternatives are evaluated and implemented; and the potential impacts of consolidation or transfer of ownership on community access to safe, affordable drinking water. Of particular concern were the potential impacts of water system privatization that could result in unaffordable water rate increases or water shut offs, particularly in disadvantaged or underserved communities. This feedback also informed the agency's rulemaking process.
Congress has long been concerned about PWSs that struggle to comply with drinking water standards, particularly small PWSs.
There are three regulatory components of the proposed rule: (1) requirements for state primacy revisions to establish a mandatory assessment program with the authority to mandate assessments and to approve assessors; (2) requirements for mandatory assessments to evaluate restructuring alternatives based on water system characteristics, content requirements for assessment reports, and an assessment schedule that includes holding a public meeting prior to state approval of an assessment that identifies ownership transfer or consolidation as a feasible restructuring option; and, (3) requirements for restructuring plans, including content requirements to determine eligibility for enforcement relief or liability protection, and public meeting requirements. These regulatory components are based on the America's Water Infrastructure Act of 2018 (AWIA) amendments to SDWA sections 1413 (Primary Enforcement Responsibility) and 1414(h) (Consolidation Incentive). Through this action, the EPA proposes implementing regulations for both the section 1413 amendments that modify 40 CFR part 142 subpart B and the section 1414(h) amendments under new 40 CFR part 142 subpart J. The proposed WSRAR would give states the authority, as part of their approved SDWA primacy programs, to mandate restructuring assessments and to approve restructuring plans eligible for enforcement relief or liability protection. The implementing framework for the three regulatory components, and the guiding principles of water system restructuring, are summarized in the following section.
SDWA section 1413 describes requirements for states with primary enforcement responsibility (primacy). The proposed revisions would require states to establish procedures to identify and notify PWSs that meet the statutory preconditions for a mandatory assessment; review and approve eligible assessors; review and approve mandatory assessments; review restructuring plans to determine water system eligibility for enforcement relief or liability protection; and enforce mandatory assessment requirements. The WSRAR would establish implementing regulations for these new primacy requirements under revised 40 CFR 142.10 and 142.11. To support the EPA's oversight of state mandatory assessment programs, the proposed WSRAR would establish new reporting and recordkeeping requirements, codified under revised 40 CFR 142.14 and 142.15.
The primary objective of a mandatory restructuring assessment under SDWA section 1414(h) is to identify feasible restructuring activities expected to help the assessed water system comply with NPDWRs. Consistent with the SDWA, the proposed rule requires a state to find that a PWS meets the following conditions before mandating an assessment: the PWS has repeatedly violated NPDWRs; the PWS is unwilling or unable to implement feasible and affordable restructuring activities to comply, or already has attempted to take
A mandatory restructuring assessment process would include:
a. Notifying the public water system that it is the subject of a mandatory restructuring assessment;
b. Performing an evaluation to identify feasible restructuring alternatives for a water system based on its geographical, managerial, financial, socio-economic, and physical characteristics;
c. Preparing an assessment report that: identifies the unresolved violations at the assessed PWS and their underlying causes; identifies at least one feasible alternative to return the PWS to compliance while ensuring its long-term TMF capacity based on its socio-economic, physical and other characteristics; describes how feasible alternatives were identified, including an explanation if consolidation or ownership transfer are infeasible, based on documented procedures, data and data sources; and, describes how any alternative would ensure that the community achieves access to safe, affordable drinking water;
d. Holding a public meeting with community leaders,
e. Making physical and electronic copies of the assessment report publicly available; and,
f. Consulting with the assessed PWS and community leaders during the assessment and any next steps, which might include applying for Federal or state funding to voluntarily carry out restructuring activities that the PWS and community decide to implement.
SDWA section 1414(h) establishes enforcement relief and liability protection incentives for struggling water systems to restructure. Under SDWA section 1414(h)(2), if a state approves a restructuring plan for administrative or managerial consolidation, physical consolidation, or transfer of ownership, then for a period of no more than two years from the date of state approval, the PWS that submitted the plan would be eligible for enforcement relief (as discussed further in section IV of this preamble). During this enforcement relief period, the state could not take further enforcement action for a specific violation identified in the approved plan, although the PWS that received enforcement relief would remain subject to existing enforcement orders to ensure it takes short-term corrective actions to protect public health.
Under SDWA section 1414(h)(5), a non-responsible PWS that either has assumed ownership of, or has completed administrative or physical consolidation with, an assessed PWS would not be liable for the specific violations identified in the plan. However, the non-responsible PWS must use any liquid assets of the assessed PWS to pay any outstanding fines or penalties for those violations. The proposed rule clarifies that a non-responsible PWS would not be liable for violations not identified in the approved plan, such as those that occur during restructuring, until the non-responsible system became the owner of the restructured water system. As described in more detail in section IV of this preamble, under the proposed rule a state may determine eligibility for either enforcement relief or liability protection, or for both incentives under the same restructuring plan. The proposed WSRAR also would establish implementing regulations for this statutory provision, with clarifications regarding eligibility requirements, as described in section IV of this preamble.
The proposed WSRAR, if finalized, would establish implementing regulations for statutory provisions that give states the authority to mandate restructuring assessments and to approve restructuring plans that are eligible for enforcement relief or liability protection. These new authorities complement other Federal and state programs and policies that are collectively intended to increase sustainable access to safe and affordable drinking water supplies in all communities served by PWSs. To achieve these goals, in addition to regulatory requirements, the EPA proposes three guiding principles of restructuring to help ensure that mandatory assessments and restructuring plans are the result of collaborative efforts between states, local authorities, water utilities and community leaders (US Water Alliance 2022; 2019a, 2019b). These guiding principles are applicable not only to assessed water systems, but also to compliant water systems that are considering restructuring to ensure a sustainable capacity to provide access to safe, affordable drinking water.
States should consider restructuring alternatives that take into consideration community culture, needs and interests to ensure that the planned restructuring leads to access to safe, affordable drinking water for all consumers served by the PWS. This principle is consistent with the EPA's Water Technical Assistance (WaterTA) initiative, which focuses directly on the status and needs of recipients and on developing locally driven approaches to identifying and implementing public health solutions to ensure equitable access to water infrastructure funding (EPA Office of Water 2023). For example, when a large water utility consolidates with a smaller utility that serves a disadvantaged community, the restructuring could result in less affordable drinking water. As a result, the proposed WSRAR would require any identified restructuring alternative, including consolidation, to describe how it will ensure that the community served by the assessed PWS will achieve access to safe, affordable drinking water. Feasible alternatives for PWSs struggling with long-term compliance challenges should reflect the socio-economic conditions of the communities they serve, including disadvantaged or underserved status, or other barriers to water equity such as historical disinvestment in water infrastructure. Therefore, when identifying solutions for a restructuring water system, the assessor must consider not only geographical and technical factors, but also water affordability and socio-economic conditions of the community. States should proactively engage with local governments and community leaders that would be affected by restructuring to fully understand the range of technical, managerial, financial, and socio-economic factors that create long-term compliance challenges. Public water systems that might have attempted to restructure but remain persistently noncompliant have demonstrated they do not have the sustainable capacity to provide safe, affordable drinking water. To address the significant public health risks to the
States and water utilities should directly engage with community leaders when making restructuring decisions. This approach is essential to ensure successful collaboration between state and local authorities, community leaders, and drinking water utilities. Direct engagement is particularly important if the water system is considering consolidation or transfer of ownership, which can raise community concerns about the affordability of safe drinking water and which involve complicated technical and financial terms and concepts. States should work with utilities, trained facilitators, and technical assistance providers to clearly communicate the costs and benefits of restructuring alternatives to community leaders and consumers and should ensure frequent opportunities for public input. In addition, the management structure determines the authority to establish water rates and rate structures, to apply for state and Federal funding, and to operate the water system. Therefore, states should provide comprehensive information that describes alternative management structures and water system ownership types to the affected communities. Providing information to support community involvement in decision making includes, for example, access to state data, and to mapping and planning tools. The EPA can assist in this process by providing guidance and tools to support community-level engagements in workshops, public meetings, and information sharing, including the agency's partnerships implementation tools and resources. More information about these implementation tools and resources is available at the agency's website for water system partnerships.
Under SDWA section 1414(h), a water system may be a candidate for a mandatory assessment even if it has attempted to obtain technical or financial assistance through the Drinking Water State Revolving Fund (DWSRF). Under the proposed WSRAR, states and drinking water utilities would benefit from the availability of an unprecedented level of Federal investment in grant programs that focus on small, disadvantaged, and underserved communities. These programs can help PWSs achieve and maintain the long-term capacity to provide safe drinking water through the implementation of a wide range of eligible restructuring activities, including consolidation or transfer of ownership. The 2021 Infrastructure Investment and Jobs Act, also known as the Bipartisan Infrastructure Law (BIL), is set to provide $16.6 billion in additional investment in the DWSRF over the next three years. A key priority of the BIL is to increase investment in disadvantaged communities, including those with environmental justice concerns. Nearly half (49 percent) of this investment is designated for disadvantaged communities either as loan forgiveness or as grants to water systems that meet a state's disadvantaged community criteria as described in SDWA section 1452(d). These resources may be used to: identify restructuring alternatives that address the underlying causes of noncompliance; provide technical support for communities applying for funding; design and implement restructuring plans; and build and maintain water systems with the long-term capacity to provide affordable access to safe drinking water. The EPA will continue to work with states to implement program administration flexibilities under the DWSRF that are designed to help disadvantaged communities overcome barriers in applying for and receiving DWSRF funds. In addition, the EPA's Small, Underserved and Disadvantaged Community (SUDC) grant program can help communities establish and maintain access to safe, affordable drinking water by funding eligible restructuring activities. These activities include physical infrastructure improvements related to treatment, distribution, and storage; development of new sources; and assistance to increase technical, managerial, and financial (TMF) capacity, physical interconnection, water system consolidation or purchase of a water system. For more information on how SUDC grants may be used to support water system restructuring, please refer to the EPA's website.
The three regulatory components previously described—state primacy revisions, mandatory assessment requirements, and restructuring plan eligibility requirements and limitations for enforcement relief and liability protection—comprise the framework of the proposed rule. This section of the preamble describes the proposed rule sections that govern mandatory restructuring assessments and restructuring plans.
The agency seeks public comment on whether the rule appropriately balances meeting the statutory requirements of the SDWA while considering the impacts of the proposed requirements on our state and Tribal co-regulators, large and small water utilities, and the communities they serve. The EPA also has identified in this preamble specific topics for which the agency seeks public comment.
SDWA section 1413 and its implementing regulations under 40 CFR part 142 subpart B set forth the requirements for a state to obtain primacy for EPA regulations under 40 CFR parts 141 and 142, and for EPA review and approval of state applications for primacy or for revisions to primacy. Because AWIA directly amended the criteria for primacy under SDWA section 1413(a), every state with primacy for the PWSS program must submit to the EPA an application for a primacy revision that demonstrates that the state has adopted, and is prepared to implement, the requirements of the proposed WSRAR. The proposed WSRAR, if finalized, would amend 40 CFR 142.10 and 142.11 to describe the basis on which the EPA would determine whether to authorize state
Where an EPA Region has primacy for the WSRAR, the Regional Administrator would have the authority, fully equivalent to that of a state, to mandate restructuring assessments, to perform assessments, to review and approve restructuring plans, and to determine PWS eligibility for restructuring incentives. This equivalent authority also would include EPA enforcement actions for noncompliance with the WSRAR and use of its independent enforcement authority under SDWA section 1414. Accordingly, the term “state” as it appears throughout this preamble, also refers to the EPA exercising its authority to implement the WSRAR. In addition, states with primacy for the WSRAR could, at their discretion, request that the EPA Region mandate an assessment of a PWS or assist the state with the implementation and enforcement of WSRAR requirements.
The proposed requirements of the WSRAR would apply to all states for which the EPA has approved primacy for the WSRAR, and to PWSs for which an approved state has mandated a restructuring assessment. Additional proposed WSRAR requirements would apply to PWSs that submit plans to states seeking enforcement relief or liability protection.
The EPA proposes the following terms and definitions for the WSRAR:
The EPA proposes this term to refer to a PWS that meets all four preconditions for a state to use its mandatory assessment authority described in SDWA section 1414(h)(3)(A), and that is the subject of a mandatory restructuring assessment as required by the state pursuant to proposed 40 CFR 142.92.
The EPA proposes this term to refer to the incentive described in SDWA section 1414(h)(2). Enforcement relief would apply to an eligible PWS as specified in proposed sections 40 CFR 142.93 and 142.94. A PWS would be eligible for enforcement relief if the state approved a restructuring plan that met the proposed requirements and that would result in physical or administrative consolidation; transfer of ownership to improve water quality; or a contractual agreement to carry out the administrative or managerial functions of a water system. Enforcement relief would mean that if a state approved a restructuring plan, the state could not take enforcement action under SDWA for specific violations identified in the plan for up to two years from the date of state approval. If the eligible water system were to complete its planned restructuring earlier, the enforcement relief period would end on the date of completion.
The EPA proposes this term to refer to the incentive described in SDWA section 1414(h)(5). This incentive applies to a non-responsible (compliant) water system that seeks liability protection when it restructures with an assessed (non-compliant) water system. Under the proposed rule, a non-responsible water system would be eligible for liability protection once restructuring has been completed under a state-approved restructuring plan for physical or administrative consolidation; transfer of ownership to improve water quality; or a contractual agreement to carry out the administrative or managerial functions of a water system. Liability protection would mean that, after using available assets of the assessed water system to pay any liabilities for specific violations identified in the approved plan, the non-responsible water system would have no remaining liability under SDWA for those specific violations. Liability protection would continue for SDWA violations at the assessed system that occur during restructuring, but that protection would end after the state determined that the non-responsible system had become the owner of the newly restructured water system.
The EPA proposes this term to refer to a mandatory evaluation of restructuring alternatives at an assessed water system as described in SDWA section 1414(h)(3) and that is performed consistent with the requirements of proposed 40 CFR 142.92. For rule implementation purposes, the term “restructuring” means any planned change in water system operations, management, or infrastructure.
The EPA proposes this term to refer to a compliant PWS that restructures with an assessed water system under a state-approved plan that is based on a completed mandatory restructuring assessment. The non-responsible system is the PWS that intends to benefit from liability protection because it did not commit the violations identified in the approved restructuring plan. Under the proposed rule, if the state determined that all requirements for liability protection in proposed 40 CFR 142.95 had been met, then the non-responsible system would not be liable for assessed water system violations identified in the plan, but it would be required to use any acquired liquid assets of the assessed water system to compensate the state for any fines or penalties associated with the identified violations. Under the proposed rule, a non-responsible system would continue to receive liability protection for violations at the assessed system that occurred during restructuring but would become liable for violations after it became the owner of the newly restructured water system.
The EPA proposes this term to refer to the four restructuring plan types cited in SDWA section 1414(h)(1): physical consolidation of a water system with one or more other water systems; the consolidation of significant management or administrative functions of a water system with one or more other water systems; the transfer of ownership of a water system to another water system for purposes of improving drinking water quality; and a contractual agreement for significant management or administrative functions of a water system. Although other restructuring plan types are possible, they are outside the scope of this proposed rulemaking. A PWS that voluntarily develops and submits a plan to potentially benefit from the SDWA incentives should only incur burden when there is an incentive to do so. Unlike a mandatory restructuring assessment, a restructuring plan would be optional for a water system to submit. Consistent with SDWA, under the proposed 40 CFR 142.93, a submitted restructuring plan must include a schedule for restructuring activities and measures of progress. In addition, to be eligible for enforcement relief or liability
The proposed WSRAR, if finalized, would establish requirements for the EPA, the state, or a state-approved assessor to implement a mandatory restructuring assessment according to an established schedule, and to produce an assessment report that satisfies the proposed content and tailoring requirements of the WSRAR. The specific elements of the proposed mandatory assessment requirements are outlined in the following sections.
SDWA section 1414(h)(3)(A) describes four preconditions that a state would be required to find are applicable to a PWS before it could mandate a restructuring assessment. The proposed WSRAR restates these four preconditions to provide additional clarifications. A state with primacy for the proposed WSRAR may mandate a restructuring assessment if it finds that: (1) the PWS has repeatedly violated one or more NPDWRs and such violations are likely to adversely affect human health; (2) the PWS is unable or unwilling to implement restructuring activities, or already has attempted to implement such activities but has not achieved compliance; (3) restructuring of the water system, including a form of consolidation or a transfer of ownership, is feasible; and (4) restructuring of the water system could result in greater compliance with drinking water standards. Consistent with the SDWA, under the proposed rule each state has the discretion to determine whether a PWS meets all four preconditions and, if so, whether to mandate a restructuring assessment as a result. When exercising its mandatory assessment authority, a state would be required to provide written notification to the assessed system. This “state notification date” would determine the milestones and dates in the required assessment schedule.
Recurring monitoring violations might conceal repeated health-based violations at PWSs. Although recurring monitoring violations are not a regulatory precondition for a mandatory assessment, states should ensure there are no underlying health-based violations by investigating possible causes of the monitoring violations.
If a state finds that a public water system meets the four preconditions and mandates a restructuring assessment, the state would be required to notify the assessed system in writing.
SDWA section 1414(h)(3)(A) requires a mandatory assessment to identify restructuring options that are expected to help the water system achieve compliance and that are feasible for the water system to implement. A wide range of water system restructuring alternatives are possible. These alternatives range from temporary, informal agreements between neighboring water systems to permanent, formal types of restructuring, such as physical consolidation. The EPA expects that an assessor would evaluate and compare restructuring alternatives from within this range, such as changes in rate structure and associated impacts, installation of treatment technology, operator training, or access to alternative water supplies. SDWA section 1414(h)(3)(B) states that the requirements of a mandatory restructuring assessment must be tailored to the size, type, and other characteristics of the assessed water system. Therefore, consistent with these two SDWA provisions, and with the proposed principles of restructuring, the proposed rule requires the assessor to “tailor” the feasibility of restructuring options based on the following geographical, socio-economic, and physical criteria. The information would ensure that a feasible restructuring alternative is technically, managerially, and financially feasible in the long term for the assessed PWS to implement.
The population served by the assessed water system. This criterion is required by the SDWA.
The classification of the assessed system as a community water system or a noncommunity water system. This criterion is required by the SDWA.
The extent to which the assessed system uses ground water, surface water, or both ground and surface water as a drinking water supply, and the extent to which the drinking water supply is purchased from another supplier of water.
The technical, financial, and managerial capacity of the assessed system, using the state definition of each term as part of its capacity development strategy under SDWA section 1420(c).
A determination whether the service area of an assessed water system meets the state definition of a disadvantaged community pursuant to the requirements of SDWA section 1452(d) or SDWA section 1459A(c)(2), or whether a community is underserved pursuant to SDWA section 1459A(a)(2). Disadvantaged or underserved status is a critical socio-economic factor that determines feasibility of the restructuring options both in terms of the affordability of the restructuring and the impacts of the restructuring on the community served by the assessed water system.
The extent to which proximity to neighboring water systems, changes in elevation, or other geographic factors affect the available restructuring alternatives.
The potential or known interactions between surface activities, such as agriculture, and the ground water or surface water sources of water used by the assessed system. This criterion includes naturally occurring levels of contaminants in the geologic formation surrounding a ground water source.
State or local laws or regulations can determine the permissible legal authorities and types of restructuring at assessed water systems.
Under the proposed WSRAR, a mandatory restructuring assessment would identify feasible restructuring alternatives that must be documented in a report that meets five minimum content requirements. These requirements would establish a minimum standard that requires a focus
First, to address immediate health risks, the proposed rule would require the assessment report to describe all unresolved violations, their underlying causes, their enforcement status, and how restructuring would return the system to compliance as soon as practicable. Underlying causes can be technical, such as inadequate treatment technologies, or financial or managerial issues such as those related to being a disadvantaged or underserved community.
Second, to achieve a sustainable capacity to provide safe drinking water, the proposed rule would require the assessment report to identify at least one feasible restructuring alternative for the assessed water system that will return the PWS to compliance as soon as possible, while also improving its technical, managerial, and financial (TMF) capacity. For purposes of implementing these proposed requirements, the term “TMF capacity” generally means the capability of a public water system to achieve and maintain compliance with NPDWRs, including ensuring sufficient resources for sustainable fiscal planning and management. Technical capacity improvements may include greater access to higher quality source water; sharing, upgrading, or building new infrastructure; or implementing more effective treatment technologies. Managerial capacity improvements may include increasing expertise in water system planning and operations, or enhancing systems' financial, accounting, and asset management practices. Financial capacity improvements may include reducing costs, achieving greater economies of scale through shared services, or increasing a system's sustainable access to funding through new partnerships (EPA Office of Water 2017).
Third, the assessment report would be required to describe how the assessor has used the tailoring criteria to take a holistic approach to identifying feasible and affordable alternatives based on a broad range of technical, managerial, financial, and socio-economic factors. The report also must describe how the proposed alternatives ensure that the communities served by the assessed water system sustainably achieve or maintain access to safe, affordable drinking water. As part of its primacy revision for the rule, a state may propose using affordability criteria in addition to those already identified by the state as required under SDWA section 1452(d)(3). This requirement helps to ensure that the assessment considers the long-term affordability impacts of restructuring alternatives, particularly at water systems that serve disadvantaged or underserved communities.
Fourth, because SDWA section 1414(h) establishes incentives for consolidation or transfer of ownership at struggling water systems, the proposed rule would require the mandatory assessment report to provide an explanation if these alternatives are considered infeasible.
Finally, to help the state or EPA ensure the assessment is valid, the proposed rule would require that the assessment report include a description of the data, data sources, information, procedures, and techniques used to identify the feasible restructuring alternatives for the assessed water system. This documentation requirement helps ensure that the state or EPA could independently determine the quality of the evidence used as the basis for an evaluation of alternatives.
SDWA section 1414(h)(3)(D) describes a sense of Congress that a mandatory restructuring assessment should not be “overly burdensome” on the assessed system. Under the proposed WSRAR, the mandatory assessment would involve collecting data; identifying and evaluating feasible alternatives using the tailoring criteria; and preparing an assessment report. Although the EPA expects that the assessment burden would vary by individual water system, the WSRAR's minimum content and tailoring requirements have been designed to minimize the burden. In addition, as described in the economic impact analysis of the proposed WSRAR, due to the technical expertise necessary to meet the WSRAR's proposed requirements and the proposed principles of restructuring, the EPA anticipates that states would perform nearly all mandatory restructuring assessments (EPA Office of Water 2022). Therefore, a mandatory assessment conducted according to the proposed requirements would not be overly burdensome on the assessed system.
Consistent with the meaning and intent of the statute, the EPA's proposed rule restates SDWA section 1414(h)(3)(C) while providing additional clarifications. The assessor would be responsible for ensuring that the assessment report aligns with the proposed restructuring principles, meets all content requirements, is submitted on time, and that the restructuring alternatives identified during the assessment are feasible in the long term based on the tailoring requirements. A state or a third-party assessor may perform the assessment. A third-party assessor could be a technical assistance provider or another individual whom the state deems to be qualified to perform the mandatory assessment on behalf of either the water system or the state. A third-party assessor that performed an assessment on behalf of the state would be acting as “the state” for purposes of performing the evaluation of alternatives and preparing the assessment report. Alternatively, the assessed water system could conduct a self-assessment if approved by the state. To ensure that an assessor is qualified, as part of its primacy revision each state would be required to establish and implement procedures and qualifications for reviewing and approving eligible assessors.
The following proposed assessment schedule requirements apply to a state, to a PWS performing a self-assessment, and to a third-party assessor retained by the assessed water system. These requirements would begin as of the date the state notifies the water system in writing. Within 30 days of the state notification date, the water system could request in writing that the state approve either a self-assessment or a third-party assessor retained by the water system. The state would have 30 days from receipt of the system's request to approve or reject the request. If the state rejected the request, or if the system did not request a self- assessment within 30 days, the state could decide to perform the assessment instead. In such cases, the system also would be required to provide relevant information requested by the state, such as an asset inventory, accounting records to demonstrate financial capacity, or monitoring results, to help the state perform the assessment.
If the state approved the request for a self-assessment or third-party assessor, the assessment report would be due on the submittal date established by the state. The EPA expects that the submittal date would be based on the anticipated complexity of the mandatory assessment. During the assessment, either the assessed system or the state could propose a different
If the mandatory restructuring assessment identified a form of consolidation or transfer of ownership as a feasible alternative for the immediate and long-term needs of the community, the state would be required to notify the community that it will hold a public meeting. The state would hold this meeting as soon as practicable after receiving the assessment report from the assessed water system. If the state performed the assessment, it would be required to hold the meeting before approving the mandatory assessment report.
Consistent with the principles of restructuring, the required public meeting would allow community-based organizations and residents served by the system to be directly involved in decision-making to ensure that the proposed consolidation or transfer of ownership would meet immediate and long-term community needs. The state and the water utility would provide specific details from the assessment report to the local community, including the anticipated costs and benefits, to ensure transparency into how the assessment was based on a holistic approach to identify consolidation or transfer of ownership as a sustainable, feasible and affordable alternative. To ensure meaningful opportunity for community participation, the public meeting would be required to comply with the EPA's notice, location, and time requirements under 40 CFR 25.6, as well as any state-specific-regulations for public meetings. The EPA expects that the state would consider community feedback received during the public meeting, and the potential impacts of restructuring on the community, before it determines whether to approve the report. The EPA also strongly encourages states to make publicly available a written summary of its responses to comments received during the public meeting. The public meeting requirements are intended to provide transparency into, and accountability for, the mandatory assessment decision-making process.
Following the public meeting, the state would determine whether the report complied with tailoring and content requirements. Once the state determined that the submitted assessment met all requirements and was developed consistent with the proposed restructuring principles, it would approve the assessment, and notify the assessed water system in writing. If the state determined that the submitted assessment report did not meet all proposed requirements, it could choose to consult with the assessed system to determine a schedule and a method for completing a revised assessment report.
Within 30 days of approval, the state would be required to make electronic copies of the report publicly available on the state website, and physical copies available in one or more public libraries within, or as near as possible to, the communities served by the assessed water system. Requiring both electronic and physical copies would help ensure that that the approved assessment is widely available to the local community, including to individuals without internet service. The EPA expects that states will take additional steps to ensure that approved assessment reports are publicly available in an alternative format, and that translation services are provided, in communities where English is not the primary language.
In addition to making the approved report publicly available, the state would be required to meet with the assessed water system to discuss the restructuring alternatives. The state consultation is intended to ensure that the assessed water system understands proposed alternatives and their potential benefits, as well as available sources of state and Federal funding for restructuring. Additionally, consistent with the principles of restructuring, the EPA strongly encourages states to either create a Citizen's Advisory Committee (CAC) or to identify an existing organization, such as the local water utility board, a town committee, or a local environmental justice group, that would serve as a community point-of-contact to perform three essential roles during the assessment. First, it would collaborate with the state and assessed PWS to ensure a shared understanding of the purpose, schedule, and objectives of the assessment. Second, it would consult with the state and assessed PWS as restructuring alternatives are identified, to help ensure that the tailoring requirements are met. Third, it would assist the state and assessed water system in the development of a restructuring plan, after the assessment is complete.
Periodic engagement with the broader community also is important because although not every member of the affected community is able to collaborate regularly with the state and assessed PWS, all members of the community should be fully informed about the purpose, objectives, and schedule of the assessment, and about the potential impacts of restructuring on each household's ability to maintain or achieve access to safe, affordable drinking water. To ensure periodic engagement with the broader community, the EPA would require a state to describe in its mandatory primacy revisions how it would implement the WSRAR principles of restructuring at three key stages of the mandatory restructuring assessment: when the assessment is mandated, to provide information to the community about the purpose, objectives and schedule; when restructuring alternatives are identified, to explain what kinds of changes the state and water utility are considering; and, when the assessment is complete, to explain what kind of restructuring the state has approved, when it will be completed, and how community access to safe, affordable drinking water will be maintained or achieved.
In addition, the EPA seeks public comment on how best to ensure transparency into restructuring decisions, and accountability for the impacts of restructuring, in communities where English is not the primary language.
SDWA section 1414(h)(1) identifies four types of restructuring plans that are eligible for enforcement relief under SDWA section 1414(h)(2) or for liability protection under section 1414(h)(5): physical consolidation between water systems; management or administrative consolidation; transfer of ownership to improve drinking water quality; and a contractual agreement for significant management or administrative functions of a water system to correct violations identified in the plan. In addition, SDWA section 1414 (h)(1) requires a restructuring plan to identify the violations at the restructuring water system(s) and include an implementation schedule and measures of restructuring progress. Consistent with the meaning and intent of the SDWA, the proposed WSRAR reaffirms and clarifies these SDWA section 1414(h)(1) requirements while providing additional clarifications.
In preparing this proposed rulemaking, the EPA conducted a literature review that identified several published reports and case studies on public water system restructuring (RCAP 2020; Water Research Foundation 2020; UNC Environmental Finance Center 2019b; Water Research Foundation 2018; RCAC 2016a; RCAC 2016b; AWWA 2012; AWWARF 2008). These reports and studies collectively refer to a typology of restructuring that generally defines physical consolidation as two or more water systems joining physically and managerially; administrative consolidation as the merger of decision-making and management authority of two or more water systems under one governance structure; and transfer of ownership as one water system acquiring the assets and liabilities of another water system. The reports and studies also showed that plans for physical consolidation, administrative consolidation, or transfers of ownership can vary based on several factors. These factors include extent of physical interconnection; type of governance (decision-making) structure; full or partial ownership transfer; ownership type; whether a new legal entity is created; and state laws governing restructuring (AWWARF 2008). Because of this variability, the EPA proposes to define each of the four eligible plan types in general terms, instead of through formal regulation, to assist states as they implement the rule. Further, a restructuring plan that is eligible for incentives may combine aspects of more than one type,
The first eligible type would be a plan for administrative or managerial consolidation.
The second eligible type would be a plan for full physical consolidation. The EPA's proposed rule would distinguish physical consolidation from physical interconnection because a consecutive water system can be physically interconnected to purchase water while remaining administratively and managerially independent.
The third eligible type would be a plan for the transfer of ownership to improve drinking water quality. In a transfer of ownership, a merged water system no longer exists as an independent entity because another water system has acquired its assets and liabilities. In practice, a transfer of ownership is often, but not necessarily, combined with administrative consolidation (Water Research Foundation 2020; UNC Environmental Finance Center 2019a; RCAC 2016a). Transfers of ownership generally involve:
• Direct acquisition, in which one water system directly acquires another water system in its entirety;
• Joint merger, in which two existing water systems combine to create a new, jointly owned and jointly managed water system or water system facility; or,
• Balanced merger, in which one water system acquires another water system but the acquired water system
The fourth eligible plan type would be a contract for administrative or managerial functions of a PWS to correct the violations identified in the restructuring plan. Under this plan type, a technical assistance provider would contract with a water system to perform some or all administrative functions of the water system, while the water system owner would retain ownership of the PWS's assets and liabilities (AWWARF 2008). A technical assistance provider could be a non-governmental organization, a private company, or another water system. Like the other plan types, to be eligible the restructuring plan would be required to identify the violations to be resolved and to include an implementation schedule with measures of progress. Unlike plans for permanent forms of restructuring such as consolidation or transfer of ownership, however, the schedule and duration of this plan type would be limited to the contract terms.
Consistent with SDWA, this proposed WSRAR, if finalized, would not mandate any type of restructuring plan, including plans for consolidation, transfer of ownership, or contracts for administrative or managerial functions.
The proposed WSRAR, if finalized, would require each state to determine plan eligibility for restructuring incentives in two steps. First, the state must determine within 60 days whether a submitted plan is an eligible type and notify the submitting water system(s) in writing. Second, after this initial determination the state would determine within 12 months whether the submitted plan is eligible for enforcement relief, or, it would determine within 18 months whether the plan is eligible for liability protection. Because under the proposed rule the eligibility requirements for liability protection incorporate the requirements for enforcement relief, a plan for liability protection may include enforcement relief for the assessed PWS. If a state determined that a plan was an eligible type that did not satisfy the minimum requirements, the state could consult with the submitting system(s) to decide when and how to submit a revised plan.
The EPA recognizes that due to such challenges as unforeseen project delays or increases in project costs, either the planned restructuring or the implementation schedule could become infeasible. As a result, either revisions to an existing restructuring plan, or a new plan entirely, could be necessary to protect public health. To account for such cases, the EPA proposes to allow a restructuring water system to submit a new or revised plan to the state for approval. As with the original submitted restructuring plan, the state would be required to evaluate the new or revised plan against the same minimum eligibility requirements and any applicable requirements for enforcement relief or for liability protection as established under the proposed WSRAR.
Under the proposed WSRAR, if finalized, the state first would determine whether the submitted restructuring plan is eligible. Then the state would determine whether the plan satisfies the minimum requirements for enforcement relief. Unlike the SDWA eligibility requirements for liability protection, a plan could be eligible for enforcement relief even if it were not based on a mandatory restructuring assessment. As a result, under the proposed rule, the first minimum requirement is to identify each violation that the restructuring plan is intended to resolve. Second, because the identified violations indicate a public health risk, the restructuring plan would be required to describe how the proposed restructuring activities would return the system to compliance as soon as practicable by addressing the underlying causes of noncompliance. Third, as stated in SDWA section 1414(h)(1), the restructuring plan would be required to include an implementation schedule and measures of progress. The schedule and measures would allow the state to monitor restructuring progress to determine that the plan is on schedule and that the proposed restructuring activities remain feasible. Fourth, the plan would be required to describe how restructuring would improve the technical, managerial, and financial capacity of the restructuring system. This requirement is intended to ensure that an approved restructuring plan focuses not only on corrective actions for the violations identified in the plan, but also on strengthening water system capacity to sustainably maintain compliance over time. Fifth, the plan would be required to ensure that all consumers served by the restructuring water system continuously achieve access to safe, affordable drinking water. This requirement is intended both to prevent communities from losing access to safe drinking water because of restructuring, and to ensure consumers who live in disadvantaged or underserved communities receive sustainable, safe, and affordable drinking water. Finally, the restructuring plan would be required to include a request for enforcement relief for the noncompliant water system(s) subject to the plan.
The restructuring plan would be required to incorporate state-approved quantitative and qualitative types of information that describe how restructuring would protect public health in the short term while also improving the long-term TMF capacity of the restructuring PWS. States would have the discretion to determine whether the submitted documentation or data are acceptable for this purpose. Although the proposed rule does not prescribe specific forms of acceptable data or documentation, examples could include engineering plans, feasibility studies, performance specifications for treatment technologies, proposed changes to water system operations, state-approved water system operator certification, or sample results from alternative water supplies.
In addition to the minimum eligibility requirements for enforcement relief, the proposed WSRAR, if finalized, would require the submitted restructuring plan to meet additional requirements under three sets of conditions. First, a restructuring plan that involves a transfer of ownership to improve drinking water quality would be required to describe the date on which ownership is expected to change and to identify the new water system owner. These conditional requirements would ensure that the state could determine when the new owner becomes legally liable for compliance at the restructured water system. Second, conditional requirements would apply if the restructuring plan were to establish a new or revised governance structure. Water system governance structures can vary based on state law and on the approach to administrative or physical consolidation. In some cases, a merged public water system no longer participates in the decision making for the newly consolidated water utility. As
The EPA expects that the time frame for developing and submitting a restructuring plan would vary widely based on several factors, including the specific characteristics of the restructuring water system, the number and type of restructuring activities planned, the nature and extent of the violations to be corrected, and applicable state or local laws and regulations. As a result, states are in the best position to determine, on a case-by-case basis, whether the proposed measures of progress and the implementation schedule are acceptable for each restructuring plan.
Consistent with SDWA section 1414(h)(2), under the proposed WSRAR a PWS would be eligible for enforcement relief from specific violations under SDWA that were identified in the submitted restructuring plan, subject to state approval. The restructuring plan should identify each violation by its identification number, type, and the date of notification.
As soon as practicable after determining a submitted plan is eligible for enforcement or liability protection, a state would be required to notify the service community and to conduct a public meeting. Like the requirements for a mandatory restructuring assessment, the purpose of the public meeting would be to ensure that the impacted communities are aware of how the draft restructuring plan, subject to public input and available before and during the meeting, would be implemented to ensure their sustainable access to safe, affordable drinking water. For example, a restructuring plan could include potential changes in water rates or rate structures, or terms of service. The public meeting would need to comply with the EPA's requirements in 40 CFR 25.6, as well as any state-specific-regulations. The EPA expects that state would incorporate community feedback received during the public meeting when determining whether the proposed restructuring plan is feasible in terms of the immediate and long-term needs of the community, particularly for plans that would result in consolidation or transfer of ownership.
No later than 12 months from the date it determines that a restructuring plan is an eligible type, the state would be required to determine whether a plan meets all minimum and applicable conditional eligibility requirements. If the plan meets all rule requirements, and the public meeting has been held, the plan would be considered approved, and the state would be required to notify the supplier of water in writing.
Within 30 days of approving a restructuring plan, the state would be required to make electronic copies of the plan publicly available on the state website, and physical copies available in one or more public libraries within, or as near as possible to, the communities served by the assessed water system. Requiring both electronic and physical copies ensures that that the approved assessment is widely available to the local community, including to individuals without internet service. The EPA also expects that states will take additional steps to ensure that approved restructuring plans are publicly available in an alternative format, and that translation services are provided, in communities where English is not the primary language.
On the date the state determines that the submitted plan met all requirements, the plan would be approved and an enforcement relief period of up to two years would begin. During this enforcement relief period,
The proposed rulemaking contains limitations on enforcement relief. These limitations clarify that enforcement relief would apply only to violations identified in a restructuring plan. In addition, under the proposed rule a water system eligible for enforcement relief would be required to:
a. Implement any corrective actions that are required under existing enforcement orders or agreements that were established prior to the state's approval of the restructuring plan. This limitation ensures that steps are taken to protect public health by resolving existing noncompliance as soon as practicable. Although the corrective actions under existing enforcement orders must be taken, the EPA recommends that states consider ways to align such orders with proposed restructuring plans. For example, the implementation schedule for corrective actions under an existing enforcement order could be incorporated within a state-approved restructuring plan as part of the SDWA-required measures and schedule of restructuring activities.
b. Comply with any applicable requirements of the SDWA or its implementing regulations, including EPA directives stemming from the use of its SDWA section 1431 authority. These requirements including monitoring, reporting sample results, and notifying and informing consumers regarding their drinking water quality.
c. Comply with any enforcement actions for new violations that occur after the date on which the state approves the plan. Only violations identified in the approved restructuring plan would be eligible for statutory enforcement relief. Therefore, new violations at the restructuring water system would be ineligible.
The EPA considers the proposed measures and schedule required for each approved restructuring plan to be critical elements of state oversight of water system restructuring. The EPA expects that during the enforcement relief period, each state would use the required measures and schedules to conduct oversight and to consult with the restructuring water system as needed. As a result of its oversight, a state might determine that a noncompliant water system is unwilling or unable to restructure according to the approved plan. In such cases, if the state determines that enforcement relief is no longer applicable to the water system, the state would be required to inform the supplier of water in writing as soon as practicable.
The EPA recognizes that restructuring activities, the project schedule, or both could become infeasible due to unanticipated project delays or increases in project costs. The EPA also recognizes that a water system that would benefit from enforcement relief is likely to incur additional violations as it restructures. Because SDWA section 1414(h)(2) establishes a two-year time frame for enforcement relief under an approved restructuring plan, pursuant to the proposed 40 CFR 142.94(h), the EPA proposes that a water system would not be eligible for additional Federal enforcement relief under an approved revised restructuring plan. Under a revised plan, states could instead provide state-level enforcement relief granted through system-specific enforcement agreements. Such enforcement agreements could identify additional compliance options for a noncompliant water system, thereby providing additional relief for the duration of the restructuring beyond the initial two years.
The proposed eligibility requirements for liability protection build on the eligibility requirements for enforcement relief. Under the proposed rule the state would be required to determine whether the plan is an eligible type and meets the minimum and conditional requirements for enforcement relief. After this initial determination, the state would then determine whether the plan also satisfied the proposed requirements for liability protection.
Consistent with the language and intent of the statute, the proposed WSRAR restates the SDWA section 1414(h)(5) requirements for liability protection while providing additional clarifications. The proposed WSRAR, if finalized, would ensure that only a non-responsible system is potentially eligible for liability protection. To meet the proposed eligibility requirements, the non-responsible water system would be required to submit to the state a restructuring plan that:
a. Is based on a mandatory restructuring assessment that the state has approved. To meet this requirement, the EPA expects that the submitted plan would describe how the non-responsible water system plans to implement the feasible restructuring alternatives identified in the approved mandatory assessment report.
b. Identifies the non-responsible water system(s) and assessed water system(s) that are subject to the restructuring plan, to allow the state to determine the extent of any liability protection.
c. Identifies and describes, using data and other forms of documentation that the state finds acceptable for purposes of calculating liability, any potential and existing liability for violations that are identified in the restructuring plan. SDWA section 1414(h) does not describe or define potential or existing liability. The EPA proposes that states and suppliers of water would consider an “existing liability” to be a known obligation or responsibility for penalties and damages that the state has assessed for a violation identified in the plan. The submitted plan could identify these existing liabilities as the amounts of penalties or fines that would be cited in formal state notices of violation or
d. Identifies and describes, using data and other forms of documentation acceptable to the state, the available funds or other liquid assets of the assessed water system as of the date of plan submittal. The EPA expects that as part of its submitted restructuring plan a non-responsible water system would conduct an asset inventory of the assessed system. The asset inventory could identify and document recoverable assets that could be used to pay the liability for the identified violations.
e. Requests liability protection of the non-responsible system for the violations identified in the submitted plan.
Consistent with SDWA section 1414(h)(5), a non-responsible water system would be eligible for liability protection from specific violations under the SDWA if the violations were identified in the submitted restructuring plan, subject to state approval. The restructuring plan should identify each violation by its identification number, type, and the date of notification.
The EPA proposes that either an assessed water system, or a water system that otherwise meets the four statutory preconditions for a mandatory restructuring assessment, would be ineligible for liability protection. Under the SDWA, such water systems have repeatedly violated health-based standards and therefore cannot be considered “non-responsible” water systems.
As under the proposed enforcement relief requirements, before approving a restructuring plan that is eligible for liability protection, the state would be required to notify the community that would be affected by the restructuring plan and to hold a public meeting. The primary purposes of the meeting are to provide the community served by the restructuring water system(s) a meaningful opportunity to understand how the restructuring would ensure their continuous access to safe, affordable drinking water, and how the restructuring plan would be implemented, including potential changes in water rates or rate structures, or terms of service. The state would be required to hold the meeting as soon as possible after it determines that a plan is an eligible type. The public meeting would need to comply with the EPA's notice, location, and time requirements for public meetings under 40 CFR 25.6, as well as any state-specific-regulations. The EPA also expects that the state would consider the outcomes of the public meeting when determining whether the proposed restructuring plan is feasible for both the immediate and long-term needs of the community, particularly for plans that would result in consolidation or transfer of ownership.
The EPA proposes to require the state to determine that the plan meets the rule eligibility requirements for liability protection, and to notify the non-responsible water system, no more than 18 months from the date on which the state determines plan type eligibility. The proposed time frame would include the time necessary for the state to review and verify the required documentation of existing and potential liabilities and assets before making its determination. If the state determined that the submitted plan met all requirements, the submitted plan would be approved. As under the proposed requirements for enforcement relief, if the submitted plan did not meet all requirements, the state could consult with the non-responsible water system regarding a time frame for submitting a corrected plan.
Unlike the enforcement relief incentive, a non-responsible water system would not be eligible as of the date of state approval of a plan that meets eligibility requirements. Instead, as required by SDWA section 1414(h)(5), under the proposed rule all restructuring must be completed before the non-responsible system is eligible for liability protection. As a result, the EPA expects that restructuring would begin as soon as practicable after the state determined that the plan met eligibility requirements. During restructuring, the state should consult with the non-responsible water system and apply the required measures and schedules of the restructuring plan to track progress. Once the state determined that all restructuring activities in the plan were complete, the state would be required to notify the non-responsible system in writing within 30 days.
Under the proposed rule, the state's notification must explain that, as of the date of state notification, the non-responsible water system is eligible for liability protection. To determine the extent of liability protection, the state would be required to calculate the difference between the total value of all liabilities and assets of the assessed (noncompliant) water system. To enable the state to perform this calculation, the submitted plan would be required to identify all assets and liabilities of the assessed water system. Although the non-responsible system would not be liable for penalties or fines that exceed the value of the identified liquid assets, the non-responsible water system would be required to transfer to the state any identified liquid assets or funds of the assessed system up to the amount necessary to pay the outstanding penalties or fines. The state's notification also would be required to explain that the non-responsible water system must consult with the state to determine when and how it would transfer the funds or other identified assets of the assessed system(s) to the state. Based on stakeholder consultation, the EPA acknowledges that an assessed system could have no liquid financial assets that could be used to pay liabilities. In such cases, to obtain liability protection, the non-responsible water system would be required to submit data or other forms of documentation acceptable to the state that demonstrate that the assessed system had no liquid financial assets.
In addition, although the eligibility requirements for each SDWA restructuring incentive are separate, a state may approve a restructuring plan that provides both enforcement relief for a noncompliant system and liability protection for a compliant system. For example, under an approved plan for transfer of ownership, enforcement relief would begin on the date the state approves the plan and end up to two years later. If the transfer of ownership were completed in fewer than two years, the enforcement relief would end on the date of completion. Under the same restructuring plan, liability protection for the non-responsible system would begin on the date that the transfer of ownership is completed. Within 30 days of this date, the non-responsible water system would consult with the state to determine if there were any acquired
As with the proposed requirements for enforcement relief, within 30 days of approving a restructuring plan eligible for liability protection, the state would be required to make the approved plan publicly available. The state would need to provide electronic copies on the state website, and physical copies in one or more public libraries within, or as near as possible to, the communities served by the assessed water system. Requiring both electronic and physical copies would ensure that that the approved assessment is widely available to the local community, including to individuals without internet service. The EPA also expects that states will take additional steps to ensure that approved restructuring plans are publicly available in an alternative format, and that translation services are provided in communities where English is not the primary language.
The EPA's proposal would not establish any liability protection that exceeds the extent of protection that the state calculates as required under the rule. The non-responsible water system also would be required to comply with all other applicable requirements of SDWA and its implementing regulations.
Under proposed 40 CFR 142.94(b)(1), if the non-responsible water system intended to take ownership of the restructured water system, then the restructuring plan would be required to identify the planned date of the change in ownership. This date should appear in the schedule of restructuring activities as would be required of any eligible plan. As part of its determination that all restructuring activities were completed, the state would be required to identify the date on which the non-responsible water system took ownership of the restructured water system, and to provide notice. Until this notification date, the non-responsible water system would not be liable for any violations that occurred during restructuring.
As with plans seeking enforcement relief, the EPA recognizes that there could be circumstances under which an approved restructuring plan should be revised. The proposed WSRAR, if finalized, would allow a non-responsible water system to remain eligible for liability protection under a revised restructuring plan under three conditions. First, the non-responsible water system would need to provide a justification to the state, using data and other forms of documentation that the state found acceptable, that a revised plan is necessary to ensure that the restructuring objectives are achieved as soon as practicable. Second, the state would need to confirm that any violations identified in the revised restructuring plan did not occur at the non-responsible system. Third, the state would need to approve the revised restructuring plan consistent with the proposed rule's plan requirements for liability protection. As a result, the state would have 18 months from submittal of the revised plan to determine whether it met the eligibility requirements.
As provided under SDWA section 1414(h)(4), a PWS that has completed a mandatory restructuring assessment would be eligible for a DWSRF loan to support restructuring. The EPA believes that the language of SDWA section 1414(h)(4) is consistent with statutory language regarding DWSRF loan eligibility under SDWA section 1452(a)(3). As a result, under existing regulations states and assessed water systems should consider a completed mandatory restructuring assessment to be a means of identifying restructuring activities that are eligible for DWSRF loans. As a result, the agency does not propose to amend existing DWSRF regulations in 40 CFR part 35 to implement this provision under the WSRAR.
Under the proposed rule, a reporting violation would occur if the assessed water system, or an approved third party on behalf of the assessed water system:
1. Failed to submit the assessment report as mandated by the state;
2. Submitted an assessment report to the state after the submittal date that the supplier of water and the state had established through previous consultation;
3. Submitted an assessment report to the state that does not address all minimum elements; or
4. Submitted an assessment that does not include the required certification statement.
Pursuant to the Administrative Procedure Act (APA) at 5 U.S.C. 553(d), the EPA is proposing that the WSRAR would be effective 60 days from the date of publication in the
As of the date of this proposed rulemaking, the EPA has approved PWSS primacy for 49 states, Puerto Rico, American Samoa, Commonwealth of the Northern Mariana Islands, Virgin Islands, Guam, and the Navajo Nation. Primacy for the PWSS program is established under SDWA section 1413. The EPA may approve primacy for the PWSS program for states, territories, and federally recognized Tribes. To obtain initial primacy from the EPA, a state must meet the EPA's regulatory requirements under 40 CFR 142.10, including that it: has adopted drinking water regulations that are no less stringent than the NPDWRs established under SDWA section 1412; has adopted and is implementing adequate procedures for enforcement of the regulations; and, is keeping records and making reports as required by SDWA section 1413.
Under 40 CFR 142.11, a state's primacy application must contain several elements including:
• The text of the state's PWSS statutes and administrative regulations.
• Documentation of the primacy agency's procedures for enforcement of its drinking water regulations including a description of the state's procedures to maintain its PWS inventory and conduct sanitary surveys, identification of certified laboratories, a brief description of the state's program to ensure that new or substantially modified PWSs will be capable of complying with the state's drinking water regulations, copies of state statutory and regulatory provisions authorizing adoption and enforcement of state primary drinking water regulations.
• A brief description of state procedures for administrative or judicial action against noncompliant PWSs.
• A statement that the state will satisfy reporting and recordkeeping requirements.
• Text of the state's statutory and regulatory provisions concerning variances and exemptions (if allowed by the state).
• A description of the state's plan for ensuring safe drinking water under emergency conditions.
• Copies of state statutory and regulatory provisions authorizing the state executive branch to impose administrative penalties.
• An Attorney General's statement certifying that the laws and regulations were duly adopted and are enforceable.
The 2018 AWIA amended SDWA section 1413 to require, as a condition of primacy, the adoption and implementation of procedures for requiring public water systems to assess options or consolidation or transfer of ownership or other actions in accordance with regulations issued by the EPA under SDWA section 1414(h)(6). As a result, the proposed WSRAR would revise the implementing regulations under 40 CFR part 142 subpart B to include a description of the state's procedures for an assessment to be completed with respect to options for consolidation, transfer of ownership, or other restructuring actions in accordance with WSRAR requirements.
The proposed primacy requirements are intended to ensure that states would adequately describe how they would implement mandatory assessment programs and determine eligibility for enforcement relief or liability protection. The requirements would apply both to a state seeking an initial determination of primacy under 40 CFR 142.11 and to existing primacy agencies that seek a revision under 40 CFR 142.12. The EPA may not grant interim primacy for WSRAR under 40 CFR 142.12(e) because the proposed rule is not a NPDWR.
As described in proposed requirements under 40 CFR 142.10(i), the EPA would approve a state primacy application for the WSRAR if the agency were able to determine that, consistent with state legal authority, the state had adopted and is implementing procedures for conducting or approving mandatory restructuring assessments, and review of restructuring plans, as would be required under 40 CFR part 142 subpart J. To obtain primacy for the WSRAR, an applicant would be required to show that is has adopted and is implementing procedures to, among other activities: find that a PWS has satisfied the SDWA preconditions for a mandatory restructuring assessment; review and approve eligible assessors; ensure assessed water system compliance with the requirements for conducting a mandatory assessment, including public meetings; and, review restructuring plans to determine water system eligibility for enforcement relief or liability protection and the extent of liability protection, as applicable, based on rule requirements.
Pursuant to the proposed requirements under 40 CFR 142.11(a)(8), a state primacy application would be required to demonstrate to the EPA that it has adequate authority to satisfy all the proposed new WSRAR primacy requirements under 40 CFR 142.10(i), and the proposed new WSRAR reporting and recordkeeping requirements for mandatory assessments and approved restructuring plans under 40 CFR 142.14 and 142.15. The submitted application would serve as the basis for the EPA's initial primacy determinations for the WSRAR.
Pursuant to 40 CFR 142.12(c), an entity that already has primacy would be required to submit to the EPA a primacy revision application that includes: the documentation required by proposed new WSRAR primacy requirements under sections 142.10(i) and 142.11(a)(8); any primacy elements that would not change under a proposed program revision; and, a certification statement from the state's Attorney General or independent counsel, or the attorney representing the Indian Tribe, that its laws and regulations to carry out the requested program revisions were duly adopted and are enforceable.
The proposed WSRAR, if finalized, also would establish new reporting and recordkeeping requirements that are intended to ensure that mandatory assessments satisfy scheduling, content, and tailoring requirements, and that states determine water system eligibility for statutory incentives consistent with WSRAR requirements for restructuring plans.
Existing regulations in 40 CFR 142.15 establish reporting requirements for states with primary enforcement responsibility. The proposed WSRAR would establish new requirements under 142.15(c)(8) for states to report to the EPA annually, using a format and on a schedule that the agency will have established, the name and identification number of each PWS for each of the following notifications or determinations, as applicable:
a. Candidates for a mandatory restructuring assessment. This proposed reporting element would refer to each PWS that the state has determined to be a candidate for a mandatory assessment, having met the four statutory preconditions in the proposed WSRAR, including the date of determination;
b. Mandatory assessment notifications. This proposed reporting element would refer to each identified PWS that the state has notified as the subject of a mandatory assessment, including the date of notification;
c. Mandatory assessments completed. This proposed reporting element would refer to each PWS that the state has notified as the subject of a mandatory restructuring assessment and has completed the assessment as required, including the date of completion;
d. Violations of mandatory assessment requirements. This proposed reporting element would refer to each PWS that the state has determined to be in violation of the WSRAR mandatory restructuring assessment requirements, by violation type and violation date; or
e. Eligibility for restructuring incentives. This proposed reporting element would refer to each PWS that the state has determined to be eligible for either enforcement relief or liability protection based on an approved restructuring plan, including the type of eligibility and the date of plan approval.
Existing regulations in 40 CFR 142.14 establish recordkeeping requirements for states with primary enforcement responsibility. To enable the EPA to
The following section summarizes the EPA's analysis to estimate the economic impact of the proposed WSRAR on states with primacy, including the Navajo Nation and U.S. territories, and EPA Regions, to develop and maintain mandatory assessment programs. Because the EPA is required to propose the WSRAR pursuant to 42 U.S.C. 300g-3(h)(6), and the scope of the proposed WSRAR is defined by 42 U.S.C. 300g-3(h), the agency did not consider regulatory alternatives. In addition, because the proposed WSRAR does not mandate restructuring plans, the EPA also did not estimate the costs to PWSs of developing restructuring plans, or the costs to states of reviewing restructuring plans to make eligibility determinations. The full economic impact analysis (EIA)
SDWA section 1413 requires states to develop mandatory assessment programs as a condition of primacy. In addition, consistent with SDWA section 1414(h)each state would have discretion to decide whether a PWS meets the statutory preconditions and whether to mandate a restructuring assessment. As a result, states would incur direct costs of the mandatory primacy revision under the proposed WSRAR, even if they elected not to use their mandatory assessment authority. To estimate the indirect costs of the proposed rule requirements on states and PWSs where a state chooses to exercise its mandatory assessment authority, the EPA also conducted a supplementary analysis, which is provided in Appendix A of the EIA for the proposed rule.
The direct costs of the proposed rule requirements would comprise both program development costs and program administration costs. States would incur program development costs to establish state programs to implement the proposed WSRAR. These costs would include reading and understanding the WSRAR, developing policies and procedures, preparing a primacy revision package, updating data systems, preliminary data analysis, outreach to PWS, and the education and training of staff. States would incur program administration costs to maintain established mandatory assessment programs. These costs would include maintaining program staffing and funding, collecting, and reviewing data to identify PWSs that meet the assessment preconditions, and reporting and recordkeeping.
Because the proposed rule would impose direct costs only on states, the EIA focused primarily on the program development and program administration costs of the mandatory primacy revision. Additionally, the EPA expects that to protect public health, states with primacy for the WSRAR would exercise their mandatory assessment authority. As a result, the EPA also conducted a supplementary analysis of the indirect costs of the proposed rule requirements on states and PWSs. The indirect cost estimates were based on different approaches to estimating the number of mandatory restructuring assessments that would be conducted over a 25-year period after promulgation of the rule. The indirect costs of the proposed WSRAR would include performing mandatory restructuring assessments; reviewing assessment reports to ensure they satisfy the content and tailoring requirements; and enforcement of assessment reporting violations. Details of the supplementary analysis are available in Appendix A of the EIA for the proposed WSRAR.
For each direct cost, the EPA developed high and low estimates. The EPA derived the high estimates from a cost model that assumed no prior experience conducting water system assessments. The EPA derived the low estimates based on available information about each primacy agency's baseline capacity to implement the WSRAR. The primary source of data for these estimates was interviews conducted with staff and managers from eight state PWSS programs. The EPA used data from these interviews to estimate the level-of-effort (LOE, in hours) to develop, administer and implement a mandatory assessment program. Following the interviews, states provided assessment forms, report examples, procedural documents, and spreadsheets showing the LOE for various assessments. The EPA used this information to better characterize the LOE estimates provided during the interviews. The EPA supplemented the interview information with details available on primacy agency websites, as well as documents provided by interview states that included assessment forms, report examples, state procedures and spreadsheets. The agency also used published EPA and state reports on state programs and state resource needs.
Based on these assumptions and data sources, the EPA estimated the costs of program development using two approaches. Under the first approach, the EPA assumed a constant uniform distribution between the high and low burden estimate. This approach permitted the EPA to estimate a theoretical upper bound program development burden of the proposed rule. The EPA refers to estimates based on this approach as “full program development” burden. The “full program development” burden is designed to show that, even under the constraint that prior experience conducting similar activities would not lower the burden of developing a mandatory assessment program, the estimated costs of the proposed WSRAR would not exceed any statutory or executive order thresholds (see section VII of this preamble).
Under the second approach, while the EPA assumed that all states need experience and technical expertise to implement mandatory assessment programs, each will start from a different baseline. Using the interview data, publicly available information on state websites, and published reports, the EPA established three categories of state baseline capacity, based on the assumed experience of each state in establishing and implementing
Of the two approaches, the EPA assumes the differential program development estimates, shown in Table VI-1 of this preamble, more accurately represent the cost of the EPA's proposal if finalized. Estimates in Table VI-1 of this preamble represent aggregate average development costs for primacy agencies during the three years after promulgation of the final rule, because the EPA assumes the LOE will vary by state based on factors other than program experience, such as program efficiencies in implementing procedures or policies, etc. As a result, some primacy agencies costs would exceed the highest estimate while others would be below the lowest estimate.
After adopting a new rule, states incur direct costs on an ongoing basis to administer the rule. For the proposed WSRAR, each state would incur direct program administration costs related to updating mandatory assessment guidance, forms, resources, and materials; training inexperienced staff; collecting and reviewing data to identify candidates for a mandatory assessment; and maintaining required records. Unlike the program development cost estimates, the EPA assumed that program administration costs would not vary based on past program experience conducting similar activities. Based on the results of state interviews, the EPA assumed that to identify candidates for mandatory assessments, states would collect and review data annually using one-third the amount of time required to conduct the preliminary data analysis. Like the program development cost estimates, the EPA also assumed that some primacy agencies would incur a higher level of effort (LOE) and some primacy agencies would incur a lower LOE to maintain their programs based on factors other than experience, such as program efficiencies in implementing procedures or policies. Therefore, the EPA calculated the average per primacy agency of the high and low estimates to develop the estimate for each program administration activity as shown in Table VI-2.
As a result of its analysis, the EPA estimated that the annualized total direct (development and administrative) costs to states of implementing the requirements of this proposed WSRAR, if finalized, would lie within a 95 percent confidence interval of $0.8 to $1.0 million at the 2 percent discount rate. As shown in Table VI-3 of this preamble, in either the differential or full implementation burden scenarios, the estimated annualized total direct cost over a 25-year period is not more than $1 million. For more information about how the EPA estimated the annualized direct costs, please refer to section VI of the EIA.
When preparing the EIA, the EPA also accounted for uncertainty in estimating the differences in the states' baseline capacity to conduct mandatory restructuring assessments, and in the estimated level of effort needed to complete program development and administrative tasks. The uncertainty in the estimates stems from the limited amount of data that could be used to estimate direct costs for all state programs and is inherent to the data sources available to populate the cost model. Therefore, the EPA used a three-pronged approach to address uncertainty in its estimate of the total (direct and indirect) cost of the proposed rule, including estimating the cost under four different cost scenarios based on two sets of assumptions about the number of assessments that primacy agencies could mandate and the cost of program development. Each scenario reflects a combination of one of two alternative assumptions about the number of assessments primacy agencies will mandate and one of two approaches for estimating primacy agencies' program development costs.
Scenario 1a assumes primacy agencies will mandate a low number of assessments and have a differential program development burden. Scenario 2a assumes primacy agencies will mandate a low number of assessments and have a full program development burden. Scenario 1b assumes primacy agencies will mandate a high number of assessments and have a differential program development burden. Scenario 2b assumes primacy agencies will mandate a high number of assessments and a have a full program development burden. Table VI-4 summarizes the four scenarios for which the EPA evaluated total costs of the proposed rule.
Consistent with the provisions of SDWA section 1414(h), states have the discretion to mandate restructuring assessments that require assessed PWSs to undertake the restructuring alternatives identified in mandatory restructuring assessments, including forms of consolidation or transfer of ownership. To quantify the potential costs of these activities, the EPA estimated the number of restructuring assessments that states would mandate under different scenarios. For the potential benefits of the proposed WSRAR, the EPA conducted qualitative analysis that included the types of benefits likely to result from implementation of the proposed rule, as there is no reasonable basis for quantifying the effects of future restructuring activities on compliance rates. The EPA could not quantitatively estimate how the proposed WSRAR would affect water system capacity to comply with health-based standards, or what reductions in morbidity or mortality could result from water systems that return to compliance. The primary nonquantifiable benefit of mandatory restructuring assessments under the proposed WSRAR would be returning assessed PWSs to compliance. The EPA also estimates that the proposed WSRAR would generate two potential long-term benefits. First, the enforcement relief and liability protection incentives increase the likelihood that assessed public water systems will restructure and return to compliance with health-based standards. As a result, public health risks would be reduced in communities where the assessed water system restructures. Second, states that utilize the mandatory assessment authority will be able reduce the administrative costs of enforcement against water systems that otherwise would remain persistently noncompliant.
This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.
The information collection activities in this proposed rulemaking have been submitted for approval to the OMB under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2736.01. You can find a copy of the ICR in the docket for this rulemaking, and it is briefly summarized here.
Because the AWIA directly revised primacy requirements under SDWA section 1413, all primacy agencies must submit to the EPA a primacy revision application for the proposed WSRAR. Primacy agencies include each of the 49 states (all U.S. states except Wyoming), Puerto Rico, American Samoa, Commonwealth of the Northern Mariana Islands, Guam, Virgin Islands, and Navajo Nation, for a total of 56 primacy agencies. The ICR for the proposed WSRAR describes costs and burden for all 56 primacy agencies to conduct the following activities: adopt the proposed WSRAR by developing primacy agency programs and submitting primacy revision packages to the EPA for review and approval; update data systems; analyze data on water systems that are potential candidates for a mandatory restructuring assessment; develop PWS outreach and education materials about the WSRAR; and train staff for adoption and implementation of the WSRAR (USEPA 2024b).
The burden estimate is derived from the economic impact analysis of the proposed WSRAR (USEPA 2024a). The EPA estimated the potential cost of the proposed WSRAR under alternative scenarios to account for uncertainty regarding how primacy agencies will develop their programs and implement the WSRAR. For the proposed ICR, the EPA used the estimated burden hours and costs from the highest cost scenario. Under this scenario, the EPA assumed the full program development cost for every primacy agency, regardless of existing program capacity to implement the proposed WSRAR requirements. This approach established an upper bound on the estimated burden and cost of the proposed WSRAR.
The ICR for the proposed WSRAR presents the total time, effort, and financial resources required of primacy agencies to generate, maintain, retain, disclose, and/or provide information to the EPA during the first three years following WSRAR promulgation. Existing regulations under 40 CFR 142.12(b), promulgated pursuant to 42 U.S.C. 300g-2(b)(1), allow primacy agencies up to two years to request approval of primacy revisions to adopt regulations that are no less stringent than those that the EPA promulgates, with an extension of up to two years if the EPA Administrator determines the extension is necessary and justified. Once approved, primacy agencies may exercise this authority to require a PWS to assess options for system restructuring, including forms of consolidation or the transfer of ownership to improve drinking water quality. The proposed WSRAR imposes no direct reporting requirements on PWSs.
The EPA will use the information collected during the first three years after promulgation of the WSRAR to review each submitting primacy agency's application and to determine whether the submitting primacy agency has met the proposed revised requirements under 40 CFR 142.10 and 142.11.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. The proposed WSRAR mandate applies only to state or Tribal government agencies with primary enforcement responsibility (primacy). The EPA expects states that elect to exercise their mandatory assessment authority will conduct nearly all mandatory restructuring assessments. Finally, this action does not require small entities to implement any restructuring activities identified in a mandatory assessment (USEPA 2024a). Small entities may voluntarily submit restructuring plans that must meet the eligibility requirements established by SDWA and any additional requirements of the proposed WSRAR.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The proposed WSRAR requirements to establish a mandatory assessment program and to submit a primacy revision to the EPA apply only to state or Tribal government agencies with primary enforcement authority under 42 U.S.C. 300(g)-2 and not to small governments as defined by UMRA.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The proposed WSRAR, if finalized, mandates primacy agencies to adopt and develop mandatory assessment programs, including new recordkeeping requirements, and to submit primacy applications to the EPA for review. The
This action does not have Tribal implications as specified in Executive Order 13175. The proposed WSRAR does not uniquely affect the communities of Tribal governments, nor does it impose substantial direct compliance costs on those communities. The direct compliance costs of the primacy requirements of the proposed WSRAR would apply uniformly to primacy agencies. Thus, Executive Order 13175 does not apply to this action. Consistent with the EPA's
During the webinars, the EPA requested input from Tribal governments on three aspects of WSRAR development: first, factors that EPA should consider for mandatory assessments of Tribal PWSs; second, whether and how the amended SDWA provisions to obtain enforcement relief from primacy agencies might affect the number of restructuring plans submitted by Tribal PWSs; and third, whether and how the amended SDWA provisions to obtain liability protection for compliant (non-responsible) water systems that are consolidating with, or acquiring, assessed PWSs might affect the number of restructuring plans submitted by Tribal PWSs. In addition, on October 9, 2019, the EPA participated in informational meetings upon request with the Region 1 Tribal Operations Committee (RTOC) and National Tribal Water Council (NTWC) to discuss the AWIA amendments to SDWA. During these informational meetings, the EPA encouraged broad participation in both national webinars to ensure that the agency could explain the policy implications of the SDWA-required provisions of the WSRAR to Tribal PWSs and could hear Tribal perspectives before drafting this proposal. Tribes did not provide written comments or further requests for consultation or outreach by the end of the consultation period. This discussion under Executive Order 13175 serves as a summary of EPA's Tribal consultation efforts for this proposed rulemaking.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that the human health or environmental conditions that exist prior to this action may result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns. The EPA has identified several recent studies that support this Executive Order review which indicate disparities in access to safe drinking water based on racial or socioeconomic status in the United States (Zhang, et al. 2022; Martinez-Morata et al. 2022;
The EPA believes that it is not practicable to assess whether this action is likely to change existing disproportionate and adverse effects on communities with environmental justice concerns. Consistent with SDWA 1414(h), the proposed rule requires states to establish mandatory assessment programs and provides states with the discretion to use the mandatory assessment authority for persistently noncompliant PWSs, including those that serve communities with environmental justice concerns. The rule does not require a PWS or a community to implement any restructuring actions identified in a mandatory restructuring assessment. Instead, the rule establishes eligibility criteria for SDWA incentives under which PWSs would voluntarily submit restructuring plans. As a result, it is difficult to quantify the potential impacts of this rulemaking on communities with environmental justice concerns.
The EPA proposes in this rule several requirements that are intended to ensure that mandatory assessments and restructuring plans are carried out in a transparent manner with the direct involvement of, and engagement with, impacted communities:
• States would be required to hold a public meeting before approving an assessment report or proposed restructuring plan. The public meeting would be subject to notice, location, and time requirements to ensure it is well publicized and accessible to all interested and affected parties.
• States would be required to make drafts of mandatory assessment reports available before and during public meetings, and physical and electronic copies of state-approved mandatory assessment reports and restructuring plans publicly available within 30 days of approval. This requirement increases transparency of drinking water utility decision making for potentially impacted communities.
• Assessments would be required to meet minimum tailoring requirements that expressly require the assessor to determine whether the assessed water system meets the state definition of a disadvantaged community pursuant to the requirements of SDWA section 1452(d) or to 42 U.S.C 300j-19(c)(2)(B), or whether the consumers served by assessed system are underserved pursuant to 42 U.S.C. 300j-19a. This requirement would benefit underserved or disadvantaged populations because it ensures that the assessment identifies affordable restructuring options in the communities served by the assessed water system.
• Assessments and restructuring plans would be required to describe how restructuring would ensure that the community served by the assessed water system would achieve access to safe, affordable drinking water.
• States would be required to consult with the assessed water system to discuss the results of the assessment. This consultation is intended to ensure that the assessed water system understands the restructuring options, the potential benefits of restructuring, and available funding sources.
In addition to these proposed requirements, in section IV of this preamble the agency specifically requests public comment on additional requirements to ensure that communities are directly involved and engaged in mandatory restructuring assessments.
Environmental protection, Administrative practice and procedure, Chemicals, Indian lands, Radiation protection, Reporting and recordkeeping requirements, Water supply.
For the reasons set forth in the preamble, the EPA proposes to amend 40 CFR part 142 as follows:
42 U.S.C. 300f, 42 U.S.C. 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, and 42 U.S.C. 300j-4, 300j-9, and 300j-11.
(i) Has adopted and is implementing procedures for requiring that an assessment be completed with respect to alternatives for consolidation, transfer of ownership, or other restructuring actions in accordance with 40 CFR part 142 subpart J, including procedures to:
(1) Establish that a public water system has satisfied the statutory preconditions for a mandatory restructuring assessment pursuant to § 142.92(a) and to notify the assessed public water system pursuant to § 142.92(b);
(2) Ensure that an assessment meets the minimum assessment tailoring criteria of § 142.92(c) and the minimum report content requirements of § 142.92(d);
(3) Review and approve eligible assessors pursuant to § 142.92(e);
(4) Ensure that the assessment is conducted according to a schedule pursuant to § 142.92(f);
(5) Determine whether a restructuring plan is eligible for restructuring incentives pursuant to § 142.93;
(6) Review restructuring plans pursuant to § 142.94 to determine public water system eligibility for enforcement relief;
(7) Review restructuring plans pursuant to § 142.95 to determine non-responsible public water system eligibility for liability protection, and the extent of liability protection, as applicable;
(8) Enforce mandatory assessment requirements pursuant to § 142.97; and
(9) Implement the reporting and recordkeeping requirements related to mandatory assessments and approved restructuring plans pursuant to §§ 142.14(h) and 142.15(c)(8).
(a) * * *
(8) A description of the State's procedures for requiring that an assessment be completed with respect to alternatives for consolidation, transfer of ownership, or other restructuring actions in accordance with 40 CFR part 142 subpart J, including procedures to:
(i) Establish that a public water system has satisfied the statutory preconditions for a mandatory restructuring assessment pursuant to § 142.92(a) and to notify the assessed public water system pursuant to § 142.92(b);
(ii) Ensure that an assessment meets the minimum assessment tailoring criteria of § 142.92(c) and the minimum report content requirements of § 142.92(d);
(iii) Review and approve eligible assessors pursuant to § 142.92(e);
(iv) Ensure that the assessment is conducted according to a schedule pursuant to § 142.92(f);
(v) Determine whether a restructuring plan is eligible for restructuring pursuant to § 142.93;
(vi) Review restructuring plans pursuant to § 142.94 to determine public water system eligibility for enforcement relief;
(vii) Review restructuring plans pursuant to § 142.95 to determine non-responsible water system eligibility for liability protection, and the extent of liability protection, as applicable;
(viii) Enforce mandatory assessment requirements pursuant to § 142.97; and
(ix) Implement the reporting and recordkeeping requirements related to mandatory assessments and to approved restructuring plans pursuant to §§ 142.14(h) and 142.15(c)(8).
(h) Pursuant to 40 CFR part 142 subpart J, each State that has primary enforcement responsibility shall retain, and provide to the Administrator upon request, records of any plans submitted by a public water system for consolidation, transfer of ownership, or other restructuring actions, and of any mandatory assessment reports approved by the State as follows:
(1) From the date of plan approval until one year following the completion of all activities in an approved restructuring plan that meets the requirements for enforcement relief pursuant to § 142.94, a copy of the approved restructuring plan and, if conducted, a copy of the approved assessment report on which the approved plan may be based.
(2) From the date of plan approval until one year following the completion of all activities in an approved restructuring plan that meets the requirements for liability protection of a non-responsible public water system pursuant to § 142.95, a copy of the approved plan and a copy of the approved assessment report on which the plan must be based.
(3) For five years from the date of approval of a mandatory restructuring assessment pursuant to § 142.92(f), a copy of the assessment report, notwithstanding the assessment retention requirements of paragraphs (h)(1) and (2) of this section.
(c) *-*-*
(8)
(i) That has satisfied the preconditions for a mandatory restructuring assessment as required pursuant to § 142.92(a), including the date on which the State made its finding;
(ii) That the State has identified pursuant to paragraph (c)(8)(i) of this section, and has notified as the subject of a mandatory restructuring assessment pursuant to a schedule as described in § 142.92(f) including the date of notification;
(iii) That the State has notified pursuant to paragraph (c)(8)(ii) of this section, and that has completed a mandatory restructuring assessment pursuant to § 142.92 as determined by the State, including the date of determination.
(iv) That is in violation of the mandatory restructuring assessment requirements pursuant to § 142.97, by violation type and violation date; or
(v) That the State has determined to be eligible for enforcement relief pursuant to § 142.94 or liability protection pursuant to § 142.95, including the type of eligibility and the date of plan approval.
(a)
(b)
(c)
The following definitions apply to terms used in this subpart:
(1) Two years from the date on which the primacy agency approves the restructuring plan; or
(2) The date on which all restructuring activities identified in the schedule of the approved plan have been completed.
(1) Physical consolidation of the public water system with one or more other public water systems;
(2) The consolidation of significant management or administrative functions of the public water system with one or more other public water systems; the transfer of ownership of the public water system to another public water system for purposes of improving drinking water quality; or
(3) Entering into a contractual agreement for significant management or administrative functions of the public water system to correct violations identified in the plan.
(a)
(1) The water system has repeatedly violated one or more national primary drinking water regulations, and such repeated violations are likely to adversely affect human health;
(2) The supplier of water is unable or unwilling to take feasible and affordable actions, as determined by the State, that will result in the public water system complying with the national primary drinking water regulations, or has already undertaken such actions, including accessing technical assistance or financial assistance from the State, without achieving compliance;
(3) Physical, administrative, or managerial consolidation, transfer of ownership, or another type of restructuring is feasible for the water system; and
(4) Physical, administrative, or managerial consolidation, transfer of ownership, or another type of restructuring of the water system could result in greater compliance with national primary drinking water regulations.
(b)
(c)
(1) System size based on the number of people served by the assessed water system;
(2) Whether the assessed water system is a community or noncommunity water system;
(3) The source(s) of water used by the assessed water system;
(4) The technical, managerial, and financial (TMF) capacity of the assessed water system;
(5) Whether the service area of the assessed water system is disadvantaged pursuant to the State's definition under 42 U.S.C. 300j-12(d)(3) or to 42 U.S.C 300j-19(c)(2)(B), or is underserved pursuant to 42 U.S.C. 300j-19a;
(6) Geographic factors;
(7) Hydrogeologic or geologic factors; and
(8) State or local statutory or regulatory requirements.
(d)
(1) Identifies all unresolved violations at the assessed water system, the underlying causes of the violations, and the enforcement status of each violation;
(2) Identifies at least one feasible restructuring alternative, and describes how the alternative(s) will:
(i) Return the system to compliance as soon as practicable; and (ii) Help ensure the technical, financial, and managerial capacity of the assessed water system to provide safe drinking water;
(3) Describes how the assessor has determined the feasibility of the identified alternative(s) pursuant to paragraph (c) of this section, including how alternative(s) will ensure that a community served by the assessed water system receives safe and affordable drinking water;
(4) Explains, if a type of consolidation or a transfer of ownership is not identified as a feasible restructuring alternative, why such alternative is not feasible; and
(5) Describes the processes, procedures, data, data sources, and other information used to identify feasible restructuring alternatives for the assessed water system.
(e)
(f)
(1) Within 30 days of the date of State notification that a mandatory restructuring assessment is required, the supplier of water may request in writing State approval of either a self-assessment or a third-party assessor on its behalf; otherwise, the State may conduct the mandatory restructuring assessment.
(2) Within 30 days of the date of request by the supplier of water pursuant to paragraph (f)(1) of this section, the State shall determine whether to approve a third-party assessor or a self-assessment and notify the supplier of water.
(i) If the State approves a self-assessment or a third-party assessor to conduct the mandatory restructuring assessment, the supplier of water must submit an assessment report on a date that is determined by the State. At any time during the implementation of the mandatory restructuring assessment, either the supplier of water or the State may consult with the other party to determine whether to revise the assessment report submittal date. The State may determine whether to revise the submittal date based on documentation or other information acceptable to the State.
(ii) If the State does not approve a third-party assessor or a self-assessment, the State may conduct the mandatory restructuring assessment and develop the assessment report. In such cases, the supplier of water shall provide as soon as practicable any information deemed necessary by the State to complete a mandatory restructuring assessment pursuant to the requirements of this section.
(3) When submitting the assessment report to the State, the supplier of water or a third-party assessor must provide a certification statement to affirm:
(i) The authority of the assessor to verify the results of the mandatory restructuring assessment;
(ii) That the information included in the assessment report is true, accurate and complete; and
(iii) That the assessor understands that there are penalties for submitting false information to the State.
(4) If the assessment report identifies a form of consolidation or transfer of ownership during the mandatory assessment, the State shall hold at least one public meeting in the community served by the assessed water system. The public meeting shall satisfy EPA public meeting requirements under 40 CFR 25.6 and any applicable provisions of State law (as determined by the State). Otherwise, as soon as practicable following the date of submission, the State shall review the assessment pursuant to paragraph (f)(5)(i) or ((ii) of this section.
(i) If the supplier of water performs the mandatory assessment, the State shall hold the public meeting as soon as practicable from the date of submission.
(ii) If the State performs the mandatory assessment, the State shall hold the public meeting before completing its assessment report.
(5) As soon as practicable following the date of a public meeting pursuant to paragraph (f)(4) of this section, the State shall review the assessment report to determine whether it satisfies the requirements of this section.
(i) If the supplier of water has prepared the assessment report and the State determines it satisfies the requirements of this section, then the assessment is approved and the State shall notify the supplier of water in writing within 7 business days of its determination. Otherwise, the State may consult with the supplier of water to determine a schedule and a method by which a revised assessment report must be completed pursuant to the requirements of this section.
(ii) If the State has prepared the assessment report, the State shall ensure that the report satisfies the requirements of this section and is otherwise complete. Upon such completion, the State shall notify the supplier of water in writing within 7 business days of its determination.
(6) Within 30 days of the State's approval of an assessment report submitted by the supplier of water or of the State's completion of an assessment report, the State shall make available to the public a copy of the approved assessment report in an electronic format on an appropriate State website and shall transmit physical copies of the restructuring plan to one or more public libraries in the closest possible proximity to the community served by the restructuring supplier of water.
(7) If the State has notified the supplier of water that the assessment report is approved or that the State assessment report is complete, the State shall consult with the supplier of water as soon as practicable to discuss the results of the mandatory restructuring assessment.
(a)
(1) Physical consolidation of the water system with one or more other water systems;
(2) The consolidation of significant management or administrative functions of the water system with one or more other water systems;
(3) The transfer of ownership of the water system to another water system for purposes of improving drinking water quality; or
(4) Entering into a contractual agreement for significant management or administrative functions of the system to correct violations identified in the plan.
(b)
(i) If the State determines that the plan is eligible pursuant to paragraph (a) of this section, then pursuant to § 142.94 or § 142.95, the State shall determine whether the plan also satisfies the applicable requirements for enforcement relief or liability protection.
(ii) If the State determines that the plan is not eligible pursuant to paragraph (a) of this section, then the State may consult with the supplier of water that submitted the ineligible plan to determine a schedule and a method by which a corrected plan may be submitted.
(c)
(a)
(1) Identifies each specific violation that the restructuring plan is intended to correct;
(2) Describes, using data and other forms of documentation acceptable to the State, how the activities in the restructuring plan will protect public health as soon as practicable by addressing the underlying causes of the identified violations;
(3) Proposes a schedule for implementing and completing each of the restructuring activities identified in the plan, including corrective actions to resolve identified violations and measures by which the State can assess progress for each restructuring activity;
(4) Describes, using data and other forms of documentation acceptable to the State, how the restructuring plan will improve, as applicable, the technical capacity, managerial capacity, or financial capacity of the restructuring system to achieve compliance with national primary drinking water regulations;
(5) Describes how the proposed restructuring plan will ensure that the community served by the restructured water system receives safe and affordable drinking water; and
(6) Requests enforcement relief from the violations identified in the plan for the noncompliant water system(s) subject to the plan.
(b)
(1) If the restructuring plan will result in a change in the supplier of water at the restructured water system, the submitted plan must identify both the date on which the change is planned to occur, and the identity of the new supplier of water at the restructured water system.;
(2) If the restructuring plan will require one or more suppliers of water to establish a new or revised governance structure, the plan must describe the new governance structure and how it will help achieve the objectives of the plan; and
(3) If the restructuring plan includes the temporary provision of an alternative source or supply of water, the plan must include an implementation schedule and measures, supported by data and other forms of documentation acceptable to the State, that describe how the water served will comply with applicable Federal or state regulations and identify when the temporary alternative source will no longer be needed.
(c)
(d)
(e)
(f)
(g)
(h)
(1) Implement any corrective actions as required under existing enforcement orders or agreements;
(2) Comply with all other applicable requirements of the SDWA and its implementing regulations, including any EPA actions pursuant to 42 U.S.C. 300i; and
(3) Comply with any enforcement actions for violations that occur after the date of plan approval.
(i)
(j)
(a)
(1) Satisfies the minimum eligibility requirements for enforcement relief pursuant to § 142.94(a);
(2) Satisfies any conditional requirements pursuant to § 142.94(b), as applicable;
(3) Is based on a mandatory restructuring assessment approved or completed by the State pursuant to § 142.92;
(4) Identifies the non-responsible water system(s) and assessed water system(s) subject to the plan;
(5) Identifies and describes, using data and other forms of documentation that the State finds acceptable, any potential and existing liability for penalties and damages associated with each specific violation identified in the plan;
(6) Identifies and describes, using data and other forms of documentation that the State finds acceptable, any funds or other assets of the assessed system(s) available as of the date of submission; and
(7) Requests liability protection of the non-responsible water system for the violations identified in the plan.
(b)
(c)
(d)
(e)
(f)
(1) As of the date of State notification, the non-responsible water system is not liable under the SDWA for penalties or damages associated with the violations identified in the plan that exceed the total amount of the identified funds and the value of other identified assets of the assessed system(s); and
(2) Within 30 days of the date of State notification, the non-responsible supplier of water shall consult with the State to determine a method and a schedule by which any identified funds, and the value of the identified assets of the assessed system(s), shall be transferred to the State to satisfy the liability for violations at the assessed system(s). If the non-responsible supplier of water finds that it cannot identify funds or assets to satisfy the liability of the identified violations, it shall support its finding pursuant to the requirements of § 142.95(a)(6).
(g)
(h)
(i)
(j)
(1) The non-responsible supplier of water has provided a justification, using data and other forms of documentation that the State finds acceptable, that a revised plan is necessary to ensure that the objectives of the restructuring plan are achieved as soon as practicable;
(2) The non-responsible water system is not the water system that incurred the violations identified in the revised restructuring plan; and
(3) The State has determined that the revised restructuring plan meets the requirements of this section and has approved the revised plan.
Notwithstanding 42 U.S.C. 300j-12(a)(3) and its implementing regulations, a public water system undertaking consolidation, transfer of ownership for purposes of improving drinking water quality, or other restructuring activities pursuant to a mandatory assessment that meets the requirements of § 142.92 may receive a loan described in 42 U.S.C. 300j-12(a)(2)(A) to implement such consolidation, transfer of ownership, or
An assessed water system is in violation of this subpart if the supplier of water that performs a self-assessment, or an approved third party performing the assessment on behalf of the supplier of water:
(a) Fails to submit an assessment report to the State as mandated under § 142.92;
(b) Submits an assessment report after the submittal date that was determined by the State as required under § 142.92(f)(2);
(c) Submits an assessment report that does not meet the minimum content requirements of § 142.92(c); or
(d) Submits an assessment report without the certification statement required under § 142.92(f)(3).
Federal Trade Commission.
Final rule.
The Federal Trade Commission (“FTC” or “Commission”) is amending the Commission's Health Breach Notification Rule (the “HBN Rule” or the “Rule”). The HBN Rule requires vendors of personal health records (“PHRs”) and related entities that are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) to notify individuals, the FTC, and, in some cases, the media of a breach of unsecured personally identifiable health data.
The amendments are effective July 29, 2024.
Relevant portions of the record of this proceeding, including this document, are available at
Ryan Mehm, (202) 326-2918,
The amendments: (1) clarify the Rule's scope, including its coverage of developers of many health applications (“apps”); (2) clarify what it means for a vendor of personal health records to draw PHR identifiable health information from multiple sources; (3) revise the definition of breach of security to clarify that a breach of security includes data security breaches and unauthorized disclosures; (4) revise the definition of PHR related entity; (5) modernize the method of notice; (6) expand the content of the notice; (7) alter the Rule's timing requirement for notifying the FTC of a breach of security; and (8) improve the Rule's readability by clarifying cross-references and adding statutory citations, consolidating notice and timing requirements, articulating the penalties for non-compliance, and incorporating a small number of non-substantive changes.
Congress enacted the American Recovery and Reinvestment Act of 2009 (“Recovery Act” or “the Act”),
Specifically, section 13407 of the Recovery Act created certain protections for “personal health records” or “PHRs,”
The Rule the Commission issued in 2009 (“2009 Rule”) requires vendors of personal health records and PHR related entities to provide: (1) notice to consumers whose unsecured PHR identifiable health information has been breached; (2) notice to the Commission; and (3) notice to prominent media outlets
The 2009 Rule requires notice to individuals “without unreasonable delay and in no case later than 60 calendar days” after discovery of a data breach.
The 2009 Rule applies only to breaches of “unsecured” health information, which the Rule defines as health information that is not secured through technologies or methodologies specified by the Department of Health and Human Services (“HHS”). The Rule does not apply to businesses or organizations covered by HIPAA.
Since the Rule's issuance, apps and other direct-to-consumer health technologies, such as fitness trackers and wearable blood pressure monitors, have become commonplace.
In May 2020, the Commission announced its regular, ten-year review of the Rule and requested public comment about potential Rule changes.
Many of the commenters in 2020 encouraged the Commission to clarify that the Rule applies to apps and similar technologies.
On September 15, 2021, the Commission issued a Policy Statement providing guidance on the scope of the Rule. The Policy Statement clarified that the Rule covers most health apps and similar technologies that are not covered by HIPAA.
The Commission explained that PHR identifiable health information includes individually identifiable health information created or received by a health care provider,
The Policy Statement further explained that the statute directing the FTC to promulgate the Rule requires that a “personal health record” be an electronic record that can be drawn from multiple sources.
In 2023, the Commission brought its first enforcement actions under the Rule against vendors of personal health records. In February 2023, the Commission brought an enforcement action alleging a violation of the Rule against GoodRx Holdings, Inc. (“GoodRx”), a digital health company that sells health-related products and services directly to consumers, including prescription medication discount products and telehealth services through its website and mobile applications.
In its complaint, the Commission alleged that between 2017 and 2020, GoodRx, as a vendor of personal health records, disclosed more than 500 consumers' unsecured PHR identifiable health information to third party advertising platforms like Facebook and Google, without the authorization of those consumers. As charged in the complaint, these disclosures violated explicit privacy promises the company made to its users about its data sharing practices (including about its sharing of PHR identifiable health information). The Commission alleged GoodRx broke these promises and disclosed its users' prescription medications and personal health conditions, personal contact information, and unique advertising and persistent identifiers. The Commission charged GoodRx with violating the Rule by failing to provide the required notifications, as prescribed by the Rule, to (1) individuals whose unsecured PHR identifiable health information was acquired by an unauthorized person, (2) the Federal Trade Commission, and (3) media outlets. 16 CFR 318.3 through 318.6. The Commission entered into a settlement that imposed injunctive relief and required GoodRx to pay a $1.5 million civil penalty for its alleged violation of the Rule.
Similarly, on May 17, 2023, the Commission brought its second enforcement action under the Rule against Easy Healthcare Corporation (“Easy Healthcare”), a company that publishes an ovulation and period tracking mobile application called Premom, which allows its users to input and track various types of health and other sensitive data. Similar to the conduct alleged against GoodRx, Easy Healthcare disclosed PHR identifiable health information to third party companies such as Google and AppsFlyer, contrary to its privacy promises, and did not comply with the Rule's notification requirements. The Commission entered into a settlement that imposed injunctive relief and required Easy Healthcare to pay a $100,000 civil penalty for its alleged violation of the Rule.
Having considered the public comments on the regulatory review notification and its Policy Statement, on June 9, 2023, the Commission issued a notice of proposed rulemaking (“NPRM”)
• First, the Commission proposed to revise several definitions in order to clarify the Rule and better explain its application to health apps and similar technologies not covered by HIPAA. Consistent with this objective, the NPRM modified the definition of “PHR identifiable health information” and added two new definitions (“health care provider” and “health care services or supplies”). These proposed changes were consistent with a number of public comments supporting the Rule's coverage of these technologies.
• Second, the Commission proposed to revise the definition of “breach of security” to clarify that a breach of security includes an unauthorized acquisition of PHR identifiable health information in a personal health record that occurs as a result of a data security breach or an unauthorized disclosure.
• Third, the Commission proposed to revise the definition of “PHR related entity” in two ways. Consistent with its proposal to clarify that the Rule applies to health apps, the Commission first proposed clarifying the definition of “PHR related entity” to make clear that the Rule covers entities that offer products and services through the online services, including mobile applications, of vendors of personal health records. In addition, the Commission proposed revising the definition of “PHR related entity” to provide that entities that access or send unsecured PHR identifiable health information to a personal health record—rather than entities that access or send
• Fourth, the Commission proposed to clarify what it means for a personal health record to draw PHR identifiable health information from multiple sources.
• Fifth, in response to public comments expressing concern that mailed notice is costly and not consistent with how consumers interact with online technologies like health apps, the Commission proposed to revise the Rule to authorize electronic notice in additional circumstances. Specifically, the proposed Rule adjusted the language in the “method of notice section” and added a new definition of the term “electronic mail.” The proposed Rule also required that any notice delivered by electronic mail be “clear and conspicuous,” a newly defined term, which aligns closely with the definition of “clear and conspicuous” codified in the FTC's Financial Privacy Rule.
• Sixth, the Commission proposed to expand the required content of the notice to individuals, to require that consumers whose unsecured PHR identifiable health information has been breached receive additional important information, including information regarding the potential for harm from the breach and protections that the notifying entity is making available to affected consumers. In addition, the proposed Rule included exemplar notices, which entities subject to the Rule could use to notify consumers in terms that are easy to understand.
• Seventh, in response to public comments, the Commission proposed to make a number of changes to improve the Rule's readability. Specifically, the Commission proposed to include explanatory parentheticals for internal cross-references, add statutory citations in relevant places, consolidate notice and timing requirements in single sections, respectively, of the Rule, and add a new section that plainly states the penalties for non-compliance.
The NPRM also included a section discussing several alternatives the
The Commission received approximately 120 comments in response to the NPRM from a wide spectrum of stakeholders, including consumers, consumer groups, trade associations, think tanks, policy organizations, private sector entities, and members of Congress.
The Commission believes the amendments are consistent with the language and intent of the Recovery Act, address the concerns raised by the public comments in response to the NPRM, and will ensure the Rule remains current in the face of changing business practices and technological developments.
The following discussion analyzes the amendments to the Rule.
The Commission proposed changes to several definitions in § 318.2 to clarify the Rule's application to health apps and similar technologies not covered by HIPAA. First, the proposed Rule revised the definition of “PHR identifiable health information” to remove a cross-reference and instead import language from section 1171(6) of the Social Security Act, 42 U.S.C. 1320d(6), which is also referenced directly in section 13407 of the Recovery Act. The proposed Rule defined “PHR identifiable health information” as information (1) that is provided by or on behalf of the individual; (2) that identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual; (3) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual; and (4) is created or received by a health care provider, health plan (as defined in 42 U.S.C. 1320d(5)), employer, or health care clearinghouse (as defined in 42 U.S.C. 1320d(2)).
The Commission explained that this proposed definition covers traditional health information (such as diagnoses or medications), health information derived from consumers' interactions with apps and other online services (such as health information generated from tracking technologies employed on websites or mobile applications or from customized records of website or mobile application interactions), as well as emergent health data (such as health information inferred from non-health-related data points, such as location and recent purchases). The Commission sought comment as to whether any further amendment of the definition was needed to clarify the scope of data covered.
Second, the NPRM proposed to define the term “health care provider” that appears in the proposed definition of “PHR identifiable health information” (“is created or received by a health care provider”). The Commission proposed to define this term in a manner similar to the definition of “health care provider” found in 42 U.S.C. 1320d(3) (and referenced in 42 U.S.C. 1320d(6), which is directly referenced in section 13407 of the Recovery Act), to mean a provider of services (as defined in 42 U.S.C. 1395x(u)), a provider of medical or other health services (as defined in 42 U.S.C. 1395x(s)), or any other entity furnishing health care services or supplies. The Commission observed that this proposed definition, which is consistent with the statutory scheme, differs from, but does not contradict, the definitions or interpretations adopted by HHS. The Commission sought comment on defining this term more broadly than the term is used in other contexts.
Third, the NPRM proposed to define “health care services or supplies” (the final term in the definition of “health care provider”) to include any online service, such as a website, mobile application, or internet-connected device that provides mechanisms to track diseases, health conditions, diagnoses or diagnostic testing, treatment, medications, vital signs, symptoms, bodily functions, fitness, fertility, sexual health, sleep, mental health, genetic information, diet, or that provides other health-related services or tools. The Commission explained that this change clarified that the Rule applies generally to online services, including websites, apps, and internet-connected devices that provide health care services or supplies, and clarified that the Rule covers online services related not only to medical issues (by including in the definition terms such as “diseases, diagnoses, treatment, medications”) but also wellness issues (by including in the definition terms such as “fitness, sleep, and diet”).
The Commission explained that these proposed changes to the definitions clarified that developers of health apps and similar technologies providing “health care services or supplies” qualify as “health care providers,” such that any individually identifiable health information these products collect or use would constitute “PHR identifiable health information” covered by the Rule. The Commission explained that these proposed changes further clarified that a mobile health application can be a “personal health record” covered by the Rule and the developers of such applications can be “vendors of personal health records.”
The Commission received numerous comments on the application of the Rule to health apps and similar technologies. A substantial number of commenters supported the Rule's application to health apps and similar technologies not covered by HIPAA as necessary in light of the explosion of health apps and the associated dangers to the privacy and security of consumers' health information.
Although many commenters expressed support for the proposed changes, several business coalitions, industry associations and individual firms opposed the changes, which, they argued, are inconsistent with Congress's intent in the Recovery Act to address a narrow subset of “personal health records” and therefore exceed the FTC's statutory authority.
Some commenters opposed to the changes also argued that the revised definitions would reduce choice and access in the marketplace,
Some commenters specifically addressed the proposed changes to the definitions of “PHR identifiable health information” and the new definitions of “health care provider” and “health care services or supplies.” First, a number of comments addressed the scope of “PHR identifiable health information.” Some commenters urged greater breadth, arguing, for example, that the definition of “PHR identifiable health information” should be expanded to include other types of data, such as data
Relatedly, some commenters urged the Commission to create a definition of or standard for “identifiable data,” “de-identification” or “de-identified
Second, many commenters specifically addressed the Commission's proposed new definition of “health care provider.” One commenter applauded the Commission's revised definition of “health care provider,” arguing that taking a crabbed view of that or related terms would lead to further fragmentation of health data, which is already fragmented by HIPAA's limited purview.
Other commenters, however, raised concerns that the proposed definition of “health care provider” is confusing in its departure from HIPAA's terminology or is otherwise overbroad.
Several comments also expressed concern with the final phrase of the definition of “health care provider” (“any other entity furnishing health care services or supplies”), as overly broad and confusing. Commenters argued its breadth (and the breadth of the accompanying definition of “health care services or supplies”) would have perverse results, turning retailers of tennis shoes, shampoo, or vitamins into entities covered by the Rule, which is not what Congress intended.
Several commenters urged the Commission to address this problem by dropping the phrase “any other entity furnishing health care services or supplies” entirely—or at least excising the word “supplies”—from the definition of “health care provider.”
Third, some commenters addressed the proposed definition of “health care services or supplies.”
After considering the comments received, the Commission adopts the proposed changes to the Rule (with only non-substantive, organizational improvements noted below) to clarify that the Rule applies to mobile health applications and similar technologies. The Commission agrees with the substantial number of comments, from many different types of entities and individuals, who argued that such clarification is necessary in light of changing technology (
The Commission is not persuaded that applying the Rule to health apps and similar technologies will have deleterious consequences for individual firms or competition or result in over-notification of consumers. Importantly, the only obligation the Rule imposes is to notify the Commission, consumers, and, in some cases, the media of a breach of unsecured PHR identifiable health information. As noted in the NPRM, many State laws already impose similar, or significantly broader, data breach obligations.
The Commission carefully considered the arguments commenters raised that the definitional changes depart from the language or spirit of the Recovery Act. The Commission does not agree. The definitions hew closely to the language of the Recovery Act and to the definitions directly referenced by the Recovery Act in section 1171(6) of the Social Security Act, 42 U.S.C. 1320d(6). As many commenters noted, while health apps did not exist when Congress passed the Recovery Act, they function in a similar manner to the personal health records that existed at the time.
For these reasons, the Commission is adopting the proposed definitions, with minor clarifications. First, the Commission has retained the definition of “PHR identifiable health information” as set out in the NPRM, with non-substantive organizational changes noted below. In response to comments that the definition of “PHR identifiable health information” should be broader, the Commission notes the definition, which closely follows the statutory language, already encompasses most of the categories of data that commenters identified. For example, unique, persistent identifiers (such as unique device and mobile advertising identifiers), when combined with health information, constitute “PHR identifiable health information,” if these identifiers can be used to identify or re-identify an individual. Moreover, “PHR identifiable health information” encompasses information about sexual health and substance abuse disorders, because the information “relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.” The Recovery Act states PHR identifiable health information is information provided “by or on behalf of the individual,” so the Commission declines to change this phrase to “about,” as one commenter suggested.
The Commission does not agree with commenters who sought to narrow the definition of PHR identifiable health information out of concern for the Rule's overall breadth. The Commission notes that liability under the Rule does not arise from a single definition. While data used for public health research, for example, may, in some instances, meet the definition of “PHR identifiable health information,” the firm using that data is subject to the Rule only if other conditions are met (
The Commission declines to create a new definition of “de-identified data” or another similar term, because the definition of de-identification is already embedded in the second part of the definition of PHR identifiable health information (“that identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual”). Where there is no “reasonable basis to believe that the information can be used to identify the individual,” the information is not identifiable; rather, it is de-identified. If data has been de-identified according to standards set forth by HHS, then there is not a “reasonable basis to believe that the information can be used to identify the individual,” as the definition of PHR identifiable health information requires. Because the Commission's standard is consistent with HHS's, the Commission's Rule poses no impediment to health-related research or other flows of de-identified data. The Commission does not view the existing language as a subjective standard that turns on a company's knowledge, as one commenter suggested; by requiring a “reasonable basis to believe” that the information is not identifiable, the Rule creates an objective standard. Whether such reasonable basis exists will depend on whether the data can reasonably be linked to an individual consumer. There is no need for a supplemental notice of proposed rulemaking on this issue, as the Commission is not changing this aspect of the Rule, which closely follows the statute.
Second, the Commission is modifying the proposed definition of “health care provider” to “covered health care provider” to distinguish that term from interpretations of the term “health care provider” in other contexts, which may be more limited in scope. As commenters requested, the Commission affirms its definition of “covered health care provider” is unique to the Rule; it does not bear on the meaning of “health care provider” as used in other regulations enforced by other government agencies. The Commission adopts this change merely to dispel confusion in terminology; the Commission is not making any substantive change from the definition as proposed. The Commission does not need to state expressly, either in this definition or elsewhere, that the Rule's notification requirements do not apply to HIPAA-covered entities and their business associates, as § 318.1 of the
Third, the Commission is adopting the proposed definition of “health care services or supplies,” with one minor modification: the Commission has substituted the word “means” for “includes” to avoid implying greater breadth than the Commission intends. The Commission adopts this change merely to dispel confusion about undue breadth; the Commission does not intend any substantive change from the definition proposed. The Commission otherwise affirms the proposed definition without change. The Commission believes the term “online service” in the definition of “health care services or supplies” is sufficiently clear because of the examples of “online services” given within the definition itself: website, mobile application, or internet-connected device. Providing an exhaustive list of what constitutes an online service would prevent the definition from being sufficiently flexible to account for future innovation in types of online services. The Commission also retains the catch-all “or that provides other health-related services or tools” for the same reason: to ensure the Rule's language can accommodate future changes in technology. There is no undue breadth, because that phrase's meaning is in the context of the preceding phrase (“provides mechanisms to track diseases, health conditions, diagnoses or diagnostic testing, treatment, medications, vital signs, symptoms, bodily functions, fitness, fertility, sexual health, sleep, mental health, genetic information, diet”).
In response to some commenters' concerns that the proposed Rule's definition of “health care provider” and “health care services or supplies” would impermissibly cause the Rule to cover retailers of general-purpose items like tennis shoes, shampoo, or vitamins, the Commission disagrees this would necessarily be the case. A threshold inquiry under the Rule is whether an entity is a “vendor of personal health records,” which the Recovery Act defines as “an entity . . . that offers or maintains a personal health record.”
The Commission notes a general retailer (one that sells food products, children's toys, garden supplies, healthcare products (such as pregnancy tests), or apparel (such as maternity clothes)) offering consumers an app to purchase and access purchases of these products—by itself—would not make the retailer a vendor of personal health records. In this scenario, purchase information relating to certain items—such as a pregnancy test or maternity clothes from a retailer—may reveal information about that person's health. While this purchase information may be PHR identifiable health information, the retailer in this scenario is not a vendor of personal health records because the app is only tangentially related to health. The Commission notes, however, there may be scenarios where a general-purpose retailer described above may become a vendor of personal health records under the Rule, such as where the retailer offers an app with features or functionalities that are sold, marketed, or promoted as more than tangentially relating to health.
In addition, the Commission reiterates a personal health record must be an electronic record of PHR identifiable health information on an individual, must have the technical capacity to draw information from multiple sources, and must be managed, shared, and controlled by or primarily for the individual. The Commission also notes that purchases of items at a brick and mortar retailer where there is no app, website, or online service to access or track that purchase information electronically is not a personal health record, because there is no electronic record at issue. Contrary to the assertions of some commenters, these definitions do not result in undue breadth, because they do not function in isolation. The Commission provides the following examples to illustrate the interplay of these definitions with the definition of “personal health record”:
•
•
•
•
Whether a health app or other electronic record constitutes a personal health record (and is therefore subject to the Rule) is a fact-intensive inquiry whose outcome depends not only on the nature of the information contained in that record, but also on numerous other factors, such as its “technical capacity,” its source(s) of information, and its relationship to the individual.
Finally, the Commission notes a non-substantive, organizational change relating to the definition of “PHR identifiable health information.” In the 2023 NPRM, the Commission proposed revising “PHR identifiable health information” by importing language from section 1171(6) of the Social Security Act, 42 U.S.C. 1320d(6), which is referenced directly in section 13407 of the Recovery Act. To hew more closely to the organization of the Recovery Act, and to preserve the word “includes” in the phrase “includes information that is provided by or on behalf of the individual,” the Commission revised slightly the order of the elements in the definition of “PHR identifiable health information.”
The Commission proposed amending the definition of the term “personal health record” to clarify what it means for a personal health record to draw information from multiple sources. Under the 2009 Rule, a personal health record is defined as an electronic record of PHR identifiable health information that can be drawn from multiple sources and that is managed, shared, and controlled by or primarily for the individual. Under the Commission's proposed definition, a “personal health record” would be defined as an electronic record of PHR identifiable health information on an individual that has the technical capacity to draw information from multiple sources and that is managed, shared, and controlled by or primarily for the individual.
Changing the phrase “that can be drawn from multiple sources” to “has the technical capacity to draw information from multiple sources” serves several purposes. First, it clarifies a product is a personal health record if it can draw information from multiple sources, even if the consumer elects to limit information to a single source only, in a particular instance. For example, a depression management app that accepts consumer inputs of mental health states and has the technical capacity to sync with a wearable sleep monitor is a personal health record, even if some customers choose not to sync a sleep monitor with the app. Thus, whether an app qualifies as a personal health record would not depend on the prevalence of consumers' use of a particular app feature, like sleep monitor-syncing. Instead, the analysis of the Rule's application would be straightforward: either the app has the technical means (
The Commission sought public comment as to whether this revised language sufficiently clarifies the Rule's application to developers and purveyors of products that have the technical capacity to draw information from more than one source. The Commission invited comment on its interpretation that an app is a personal health record because it has the technical capacity to draw information from multiple sources, even if particular users of the app choose not to enable the syncing features. The Commission also requested comment about whether an app (or other product) should be considered a personal health record even if it only draws health information from one place (in addition to non-health information drawn elsewhere); or only draws identifiable health information from one place (in addition to non-identifiable health information drawn elsewhere). The Commission further requested comment about whether the Commission's bright-line rule (apps with the “technical capacity to draw information” are covered) should be adjusted to take into account consumer use, such as where no consumers (or only a de minimis number) use a feature, and about the likelihood of such scenarios. For example, the Commission offered an example of an app that might have the technical capacity to draw information from multiple sources, but its API is entirely or mostly unused, either because it remains a Beta feature, has not been publicized, or is not popular.
Many commenters supported the Commission's proposal amending the definition of a “personal health record.”
Other commenters opposed this proposal.
Another commenter expressed concern the proposed change could sweep in services that draw any information from multiple sources, regardless of whether that information is identifiable health information.
After considering the comments received, the Commission adopts the proposed amendment without change. This amendment will help clarify the types of entities covered by the Rule. The definition does not create undue breadth or deviate from Congressional intent; rather, the changes are consistent with the language of the Recovery Act, and only serve to give meaning to the phrase “can be drawn” in the Recovery Act in a way that is consistent with the current state of technology. They are also necessary to keep pace with technological change, which has enabled firms to offer consumers mobile electronic records of their health information that contain numerous integrations. To illustrate the intended meaning of the proposed revisions to the term “personal health record,” the Commission reiterates examples from the 2023 NPRM of two non-HIPAA covered diet and fitness apps available for consumer download in an app store. Under the amended Rule, each is a personal health record.
•
•
As these examples make clear, and in response to one commenter's concern that the changes would sweep in services that do not draw any health information,
The Commission declines to make other requested changes to the definition of personal health record. First, the Commission declines to include an express exemption for HIPAA-covered entities within the definition of personal health record because § 318.1 of the Rule already specifically exempts businesses or organizations covered by HIPAA.
Further, and importantly, the Rule is triggered only by breaches of unsecured PHR identifiable health information and does not apply to information that is protected or “secured” through the use of a technology or methodology specified by the Secretary of Health and Human Services in the guidance issued under section 13402(h)(2) of the American Reinvestment and Recovery Act of 2009, 42 U.S.C. 17932(h)(2).
Third, the Commission declines, as one commenter requested,
In addition, the Commission declines to remove from the definition of personal health record the requirement that it be “managed, shared, and controlled by or primarily for the individual.” This language mirrors the Recovery Act's statutory definition of personal health record.
Generally, a personal health record is an electronic record of an individual's health information by which the individual maintains access to the information and may have, for example, the ability to manage, track, control, or participate in his or her own health care. If these elements are not present, the website or app may not be “managed, shared, and controlled by or primarily for the individual,” and would not, therefore, constitute a personal health record.
The Commission proposed a definitional change to clarify that a breach of security under the Rule encompasses unauthorized acquisitions that occur as a result of a data breach
Accordingly, consistent with the Recovery Act definition, the Policy Statement, FTC enforcement actions under the Rule, and public comments received, the Commission proposed amending the definition of “breach of security” in § 318.2 by adding the following sentence to the end of the existing definition: “[a] breach of security includes an unauthorized acquisition of unsecured PHR identifiable health information in a personal health record that occurs as a result of a data breach or an unauthorized disclosure.” The change was intended to make clear to the marketplace that a breach includes an unauthorized acquisition of identifiable health information that occurs as a result of a data breach or an unauthorized disclosure, such as a voluntary disclosure made by the PHR vendor or PHR related entity where such disclosure was not authorized by the consumer.
The NPRM, like the 2009 Rule, continued to include a rebuttable presumption for unauthorized access to an individual's data; it stated when there is unauthorized access to data, unauthorized acquisition will be presumed unless the entity that experienced the breach “has reliable evidence showing that there has not been, or could not reasonably have been, unauthorized acquisition of such information.”
In the 2023 NPRM, the Commission stated it had considered defining the term “authorization,” which appears in § 318.2's definition of “breach of security,” but did not propose any such change in the NPRM.
The Commission considered defining “authorization” to mean the affirmative express consent of the individual and then defining “affirmative express consent” consistent with State laws that define consent, such as the California Consumer Privacy Rights Act, Cal. Civ. Code 1798.140(h).
The Commission did not, however, propose to define “authorization” because (1) the 2009 Rule Commentary already provided guidance on the types of disclosures the Commission considers to be “unauthorized”;
The Commission sought public comment about:
• Whether the commentary above and FTC enforcement actions under the Rule provide sufficient guidance to put companies on notice about their obligations for obtaining consumer authorization for disclosures, or whether defining the term “authorization” would better inform companies of their compliance obligations.
• To the extent that including such definitions would be appropriate, the definitions of “authorization” and “affirmative express consent,” as described above, and the extent to which such definitions are consistent with the language and purpose of the Recovery Act.
• What constitutes an acceptable method of authorization, particularly when unauthorized sharing is occurring.
• Whether there are certain types of sharing for which authorization by consumers is implied because such sharing is expected and/or necessary to provide a service to consumers.
Many commenters supported the Commission's proposed amendment to the definition of “breach of security.”
Some commenters supported expanding or changing the definition further. Specifically, some commenters urged the Commission to amend the definition to encompass (1) exceeding authorized access or use of PHR identifiable health information, such as where a company collects data for one purpose, but later uses or discloses that data for a second, undisclosed purpose;
Some commenters, however, urged the Commission to not amend the definition at all. These commenters expressed concern the amendment would cause the Rule to exceed what Congress intended in the Recovery Act and transform the Rule into an opt-in notice and consent privacy regime.
Some commenters also urged that the Commission adopt carve-outs so that certain conduct would not be deemed breaches of security under the Rule. Commenters requested exemptions consistent with or found in HIPAA or
Commenters were divided as to whether the Commission should define “authorization.” Some commenters supported defining “authorization” to provide greater guidance to companies, to promote transparency, and to discourage buried or inconspicuous disclosures relating to health information, or approaches to consent that are not meaningful because they are confusing or coercive.
By contrast, some commenters opposed defining the term—or opposed a requirement under the Rule that entities be required to get authorization before disclosing PHR identifiable health information.
Some commenters endorsed other approaches that would exempt from any requirement of affirmative express consent certain types of disclosures of PHR identifiable health information, such as to service providers, data processors, and entities that assist with combatting fraud and promoting safety.
After carefully considering the public comments, the Commission adopts the proposed amendment without change. The final rule definition is consistent with the statutory definition in the Recovery Act, the Policy Statement,
The Commission declines to adopt any specific exemptions or safe harbors to the definition of breach of security. Unlike the section of the Recovery Act that governs breach notifications under HIPAA,
After carefully considering the public comments, the Commission declines to define “authorization,” as that term appears in § 318.2's definition of “breach of security.” The Commission finds persuasive the public comments suggesting that imposing an affirmative express consent requirement would not be appropriate or warranted in all cases.
The Commission believes whether a disclosure is authorized under the Rule is a fact-specific inquiry that will depend on the context of the interactions between the consumer and the company; the nature, recipients, and purposes of those disclosures; the company's representations to consumers; and other applicable laws. The Commission reiterates the 2009 Rule Commentary, which states a use of data is “authorized” only where it is consistent with a company's disclosures and consumers' reasonable expectations and where there is meaningful choice in consenting to sharing—buried disclosures do not suffice.
The Commission's recent enforcement actions alleging violations of the Rule against GoodRx and Easy Healthcare further highlight that disclosures of PHR identifiable health information inconsistent with a company's privacy promises constitute an unauthorized disclosure. These recent Commission orders also make clear that the use of “dark patterns,” which have the effect of manipulating or deceiving consumers, including through use of user interfaces designed with the substantial effect of subverting or impairing user autonomy and decision-making, undercut an entity's assertion that consumers exercised “meaningful choice.”
In response to public comments seeking more guidance on what constitutes an unauthorized disclosure under the Rule,
•
• By contrast, disclosures of PHR identifiable health information by the app in Example 1 would be authorized if made to service providers in the following circumstances: (1) the service providers assist with functions that are necessary to the operation and functioning of the medication app, or with services the consumer requested; (2) the service providers are contractually prohibited from using, sharing, or disclosing the PHR identifiable health information for any purpose beyond providing services to the medication app; and (3) the medication app's privacy notice clearly and conspicuously discloses the specific purposes for which it shares users' PHR identifiable health information with these service providers. Such authorized disclosures could include those to cloud storage providers that host user data in the health record in a secure fashion; payment processors who process user payments to the app; vendors that facilitate refill reminders or other communications from the app developer that directly relate to the provision of the personal health record or services the consumer requested; analytics providers that assist with tracking analytics relating to the app's functionality;
•
•
Examples 1 and 3 provide guidance about scenarios in which limited disclosures of PHR identifiable health information are permitted without opt-in consent because it is necessary to provide a personal health record to a consumer, is consistent with consumer expectations, the sharing is disclosed to consumers, and (in the case of Example 1) the sharing is subject to protections like service provider agreements that limit the use of the data only for the purpose of providing that service to the consumer. Examples 1 and 3 are also consistent with HIPAA and State health privacy laws.
The Commission notes “breach of security” could cover more than just an unauthorized disclosure to a third party. For example, depending on the facts and scope of the authorizations, such as in the company's promises and disclosures to consumers, a “breach of security” could include unauthorized
Finally, the Commission notes unauthorized access or use of derived PHR identifiable health information may also constitute a breach of security. The Commission noted in its 2023 NPRM that PHR identifiable health information includes “health
The NPRM proposed to revise the definition of “PHR related entity” in two ways. Consistent with its clarification that the Rule applies to health apps, the Commission proposed amending the definition of “PHR related entity” to make clear the Rule covers entities that offer products and services through the online services, including mobile applications, of vendors of personal health records. In addition, the Commission proposed revising the definition of “PHR related entity” to provide that entities that access or send unsecured PHR identifiable health information to a personal health record—rather than entities that access or send any information to a personal health record—are PHR related entities.
The Commission explained the first change (to cover online services) was necessary as websites are no longer the only means through which consumers access health information online. The Commission explained the second change—narrowing the scope of “PHR related entities” to entities that access or send unsecured PHR identifiable health information—was intended to eliminate potential confusion about the Rule's breadth and promote compliance by narrowing the scope of entities that qualify as PHR related entities.
The proposed Rule also revised § 318.3(b) by adding language establishing that a third party service provider is not rendered a PHR related entity when it accesses unsecured PHR identifiable health information in the course of providing services. The Commission explained it did not intend for any entity (such as a firm performing attribution and analytics services for a health app) to be considered both a PHR related entity (to the extent it accesses unsecured PHR identifiable health information in a personal health record) and a third party service provider, which could create competing notice obligations and confuse consumers with notice from an unfamiliar company. The Commission explained it considers such firms to be third party service providers that must notify the health app developers for whom they provide services, who in turn would notify affected individuals.
The Commission explained that distinguishing between third party service providers and PHR related entities would create incentives for responsible data stewardship and for de-identification because a firm would only become an entity covered by the Rule in relation to unsecured PHR identifiable health information. To the extent that firms must deal with unsecured PHR identifiable health information, PHR vendors would have incentives to select and retain service providers capable of treating data responsibly (
The Commission observed in most cases, third party service providers are likely to be non-consumer facing. The Commission noted examples of PHR related entities would include, as noted above, makers of fitness trackers and health monitors when consumers sync their devices with a mobile health app. The Commission noted further examples of third party service providers would include entities that provide support or administrative functions to vendors of personal health records and PHR related entities.
The Commission received numerous public comments about the changes to the definition of PHR related entity. Most commenters supported the Commission's approach.
A few commenters proposed changes to the definition of “third party service provider” to further distinguish the term from “PHR related entity.” One commenter recommended defining “third party service provider” as an
Some commenters raised concerns that the Commission's approach did not provide sufficient clarity for companies trying to understand their obligations as either a third party service provider or PHR related entity.
In response to the Commission's request for comment on whether an analytics firm would be a third party service provider, many commenters responded that an analytics firm should fall within that definition
After considering the comments received, the Commission adopts the proposed changes regarding “PHR related entity” without further change. The Commission affirms that (1) PHR related entities include entities offering products and services not only through the websites of vendors of personal health records, but also through any online service, including mobile applications; (2) PHR related entities encompass only entities that access or send unsecured PHR identifiable health information to a personal health record; and (3) while some third party service providers may access unsecured PHR identifiable health information in the course of providing services, this does not render the third party service provider a PHR related entity.
In response to commenters who expressed concern that certain data recipients will not be able to understand their obligations under the Rule because they are unaware of the content of the data transmissions they receive, the Commission highlights § 318.3(b), which states: “For purposes of ensuring implementation of this requirement, vendors of personal health records and PHR related entities shall notify third party service providers of their status as vendors of personal health records or PHR related entities subject to this Part.” This requirement puts data recipients on notice about the potential content of the data transmissions they receive.
Firms may also facilitate compliance by stipulating by contract whether transmissions of data will contain unsecured PHR identifiable health information. Both the sender and recipient of the data can monitor for compliance with those contractual agreements through the use of automated tools, internal auditing, external auditing, or other mechanisms, as appropriate to the size and sophistication of the firms and the sensitivity of the data. For example, a large advertising platform that has routinely received unsecured PHR identifiable health information, notwithstanding partners' promises not to send this information, may have different obligations to monitor the data it receives than small firms that do not engage in high-risk activities where the contract precludes sending such data and there is no history of such transmissions.
The Commission believes this approach—notice to service providers pursuant to § 318.3(b) coupled with contracts and oversight—is more appropriate than creating a safe harbor in the Rule that exempts firms that enter into contracts, as there is evidence from FTC cases that firms do not always abide by contractual obligations to safeguard data.
The Commission declines to change the definition of “third party service provider” to distinguish it further from a “PHR related entity,” for two reasons. First, the Commission notes the current definitions of “third party service provider” and “PHR related entity” align closely with the language prescribed by section 13407 and section 13424(b)(1)(A) of the Recovery Act. Jettisoning the current language entirely, as some commenters suggested, would not be consistent with the Recovery Act's requirements. Second, the Commission believes the current language, in conjunction with the examples provided below, will provide sufficient guidance to the market as to which types of firms fit within each definition.
In response to comments that requested examples of the types of firms that fall into the category of “third party service provider” or “PHR related entity,” the Commission provides the following examples. The Commission believes these examples, in conjunction with the language in § 318.3(b), will provide sufficient clarity about the obligations of third party service providers and PHR related entities to promote compliance, avoid overlapping notice, and prevent loopholes.
•
•
•
•
The Commission proposed to authorize expanded use of email and other electronic means of providing clear and effective notice of a breach to consumers. In furtherance of this objective, the Commission proposed to update § 318.5 to specify that vendors of personal health records or PHR related entities that discover a breach of security must provide written notice at the last known contact information of the individual. Such written notice may be sent by electronic mail, if an individual has specified electronic mail as the primary contact method, or by first-class mail. The Commission proposed defining “electronic mail” in § 318.2 to mean email in combination with one or more of the following: text message, within-application messaging, or electronic banner. The Commission further specified that any notification delivered via electronic mail should be clear and conspicuous, and the proposed Rule defined “clear and conspicuous.” To assist entities that are required to provide notice to individuals under the Rule, the Commission developed a model notice for entities to use to notify individuals.
Nearly every comment submitted on this proposed change supported the Commission's efforts to update the Rule to allow for greater electronic notice.
However, not all commenters agreed with the Commission's proposal and some commenters offered other suggestions. Some objected to defining “electronic mail” to mean anything more than “email,” stating that electronic mail is commonly understood to mean email and nothing else.
Many commenters endorsed the Commission's proposal that any notification delivered via electronic mail should be “clear and conspicuous,” a newly defined term in the Rule.
Regarding the model notice, nearly all who commented on this topic urged the Commission to make the model notice voluntary.
The Commission adopts without change the modifications regarding § 318.5 involving electronic notice and adopts without change the definition of “electronic mail” in § 318.2. The Commission declines to make the other changes commenters requested. First, the Commission believes it is critical, especially given how consumers are accessing information today, to modernize the methods of notice to facilitate greater opportunities for electronic notice. The Commission believes the changes to § 318.5 and the new definition of “electronic mail”
In response to concerns raised about the two-part electronic notice, the Commission agrees with commenters who stated it increases the likelihood that individuals will encounter such notices.
The Commission also declines, in response to public comments,
Nor does the Commission believe, as some commenters argued, the two-part electronic notification will result in additional collections of information by notifying entities. The Commission agrees with commenters who stated entities are generally already collecting the information needed for notice via “electronic mail” and a data minimization issue does not exist.
In response to the commenter who suggested the FTC consider adding a provision allowing an individual to request a copy of the notice in other accessible formats, such as for hearing- or vision-impaired people, or in non-English languages,
The Commission also adopts without modification the definition of “clear and conspicuous.” The Commission agrees with the commenter who indicated it is imperative that a breach notice be reasonably understandable and call attention to the significance of the information that is included in the notice.
Turning to the model notice,
The Commission declines to adopt the position that use of the model notice provides a safe harbor, although the Commission would take into consideration in an enforcement action an entity who follows the model notice. Further, the Commission notes an entity who follows the model notice can nevertheless violate the Rule in other ways. For example, an entity could follow the model notice but fail to provide timely notice. In such instances, providing a safe harbor because the entity utilized the model notice would be inappropriate.
The Commission proposed five changes to the content of the notice. First, in § 318.6(a), as part of relaying what happened regarding the breach, the Commission proposed the notice to individuals also include a brief description of the potential harm that may result from the breach, such as medical or other identity theft. Second, the Commission proposed to amend the requirements for the notice under § 318.6(a) to include the full name, website, and contact information (such as a public email address or phone number) of any third parties that acquired unsecured PHR identifiable health information as a result of a breach of security, if this information is known to the vendor of personal health records or PHR related entity (such as where the breach resulted from disclosures of users' sensitive health information without authorization). Third, the Commission proposed modifications to § 318.6(b), which requires that the notice include a description of the types of unsecured PHR identifiable health information that were involved in the breach. The Commission proposed this exemplar list be expanded to include additional types of PHR identifiable health information, such as health diagnosis or condition, lab results, medications, other treatment information, the individual's use of a health-related mobile application, and device identifier. Fourth, the Commission proposed revising § 318.6(d) of the Rule to require the notice to individuals include additional information providing a brief description of what the entity that experienced the breach is doing to protect affected individuals, such as offering credit monitoring or other services. Fifth, the Commission proposed modifying § 318.6(e) so the contact procedures specified by the notifying entity must include two or more of the following: toll-free telephone number; email address; website; within-application; or postal address.
The Commission's proposal to modify § 318.6(a) to include in the notice to individuals a brief description of the potential harm that may result from a breach drew a wide range of comments. On the one hand, many commenters supported the Commission's proposal.
On the other hand, many commenters criticized this proposal.
Next, the Commission proposed to amend the requirements for the notice under § 318.6(a) to include the full name, website, and contact information (such as a public email address or phone number) of any third parties that acquired unsecured PHR identifiable health information as a result of a breach of security. Although several commenters supported this proposal,
Third, the Commission proposed modifications to § 318.6(b), which requires the notice to individuals include a description of the types of unsecured PHR identifiable health information that were involved in the breach. The Commission proposed this exemplar list be expanded to include additional types of PHR identifiable health information, such as health diagnosis or condition, lab results, medications, other treatment information, the individual's use of a health-related mobile application, and device identifier. Several commenters supported this proposal.
Fourth, the Commission proposed revising § 318.6(d) of the Rule to require that the notice to individuals include additional information providing a brief description of what the entity that experienced the breach is doing to protect affected individuals, such as offering credit monitoring or other services. This proposal attracted support from multiple commenters.
Some commenters, however, raised concerns about this proposal. For instance, one commenter believed the Rule already encompasses this requirement and therefore the Commission's proposal could result in duplicative information being provided in the notice.
Fifth, the Commission proposed amendments to § 318.6(e) so the contact procedures specified by the notifying entity in its breach notification must include two or more of the following: toll-free telephone number; email address; website; within-application; or postal address. Many commenters expressed support for this proposal.
The Commission believes, in light of the public comments, that the downsides of requiring in the notice a description of the potential harms that may result from a breach outweigh the upsides. The Commission is concerned about requiring a consumer notice to include possible harms that may never materialize. In such cases, consumers may experience needless anxiety and take actions that are not necessary, leading to consumer frustration. The Commission also is concerned this proposal may result in entities describing potential harms so generically that the description provides minimal value to consumers, or, alternatively, that entities will provide a laundry list of potential harms, making such a list meaningless to consumers. The Commission also agrees with one commenter who noted this proposal might lead consumers to believe the harms listed in the notice are the only possible harms from a breach, when in fact consumers may suffer other harms not disclosed in the notice.
Accordingly, the Commission declines to adopt this proposal.
In light of the public comments, the Commission is modifying § 318.6(a) to require notifying entities to provide the full name or identity (or where providing name or identity would pose a risk to individuals or the entity providing notice, a description) of the third parties that acquired the PHR identifiable health information as a result of a breach of security.
Accordingly, this revised provision is intended to still provide individuals with information about who acquired their health information. Under § 318.6(a), notifying entities are required to provide the full name or identity of the third parties that acquired the PHR identifiable health information as a result of a breach of security, except where providing the full name or identity of the third parties would pose a risk to affected individuals or the entity providing notice. In cases where providing the name or identity of the third parties that acquired the PHR identifiable health information as a result of a breach of security would pose a risk to affected individuals or the entity providing notice (
The Commission agrees with the many public comments supporting this proposal.
Several commenters supported the Commission proposal that the notice to individuals include a description of what the notifying entity is doing to protect affected individuals.
In response to the one commenter who noted the 2009 Rule already includes this proposed requirement,
In response to the commenter who argued the Commission needs to help consumers understand post-breach remedies,
The Commission adopts proposed § 318.6(d) without modification.
In response to the comment that providing two or more contact
The Commission notes multiple commenters supported this proposal.
Although the Commission did not propose any timing changes in the NPRM, the Commission requested comments on several issues related to timing, including the timing of the notification to the FTC. Regarding the notification timeline to the FTC, the Commission sought comment on whether it should extend the timeline to give entities more time to investigate breaches and better ascertain the number of affected individuals or whether an extension would simply facilitate dilatory action and minimize the opportunity for an important dialogue with Commission staff during the fact-gathering stage immediately following a breach.
Several commenters expressed support for extending the notification timeline to the FTC.
Several commenters urged the FTC to align the timeframe to notify the FTC with the timing requirement under HIPAA's Health Breach Notification Rule,
Having considered the public comments, the Commission agrees with commenters who recommended that the notification timeline to the FTC for breaches of security involving 500 or more individuals should be adjusted. The Commission agrees that in certain incidents, especially large, complex breaches, it can be challenging for entities to fully understand the scope of a breach in ten business days, leading to the possibility of incomplete breach notices.
Accordingly, the Commission is revising § 318.4(b) to read: “All notifications required under § 318.5(c) involving the unsecured PHR identifiable health information of 500 or more individuals shall be provided contemporaneously with the notice required by paragraph (a) of this section.” This change requires entities, for breaches involving 500 or more individuals, to notify the FTC consistent with the notice required by § 318.4(a)—
As a result of this change, the Commission anticipates entities will have sufficient time to provide complete and fulsome notifications to the Commission. The Commission emphasizes, however, that notice to the FTC should occur “without unreasonable delay,” with 60 days serving as the outer limit.
Finally, a small number of commenters addressed other issues related to timing, such as the timeline for providing notice to consumers or the media. The Commission believes, for the reasons stated in the commentary accompanying the 2009 NPRM and the 2009 Rule Commentary, the current timelines are appropriate to give consumers and the media timely notice without overburdening notifying firms.
The Commission proposed several changes to improve the Rule's readability. Specifically, the Commission proposed to include explanatory parentheticals for internal cross-references, add statutory citations in relevant places, consolidate notice and timing requirements in single sections, and revise the Enforcement section to state more plainly the penalties for non-compliance.
Commenters supported the Commission's proposed changes to improve the Rule's readability and promote comprehension by including explanatory parentheticals and statutory citations.
In light of support from commenters and the Commission's belief that these proposed changes improve readability, the Commission adopts these changes without modification.
The Paperwork Reduction Act (“PRA”), 44 U.S.C. chapter 35, requires Federal agencies to seek and obtain Office of Management and Budget (“OMB”) approval before undertaking a collection of information directed to ten or more persons.
FTC staff estimates the amendments to 16 CFR part 318 will likely result in more reportable breaches by covered entities to the FTC. In the event of a breach of security, the covered firms will be required to investigate and, if certain conditions are met, notify consumers, the Commission, and, in some cases, the media.
Based on industry reports, FTC staff estimates the amendments will cover approximately 193,000 entities, which, in the event they experience a breach, may be required to notify consumers, the Commission, and, in some cases, the media. While there are approximately 1.8 million apps in the Apple App Store
The Commission received three comments in response to the NPRM arguing the Rule's scope is broader than apps categorized as “Health and Fitness” and the NPRM's PRA analysis therefore underestimated the number of covered entities and the resulting number of reportable breaches.
FTC staff estimates these entities will, cumulatively, experience 82 breaches per year for which notification may be required. With the proviso that there is insufficient data at this time about the number and incidence rate of breaches at entities covered by the amendments (due to underreporting prior to issuance of the Policy Statement), FTC staff determined the number of estimated breaches by calculating the breach incidence rate for HIPAA-covered entities, and then applied this rate to the estimated total number of entities that will be subject to the amendments.
Specifically, HHS's OCR reported 715 breaches in 2021, 719 breaches in 2022, and 733 breaches in 2023,
To determine the costs for purposes of this analysis, FTC staff has developed estimates for two categories of potential costs: (1) the estimated annual burden hours and labor cost of determining what information has been breached, identifying the affected customers, preparing the breach notice, and making the required report to the Commission; and (2) the estimated capital and other non-labor costs associated with notifying consumers.
First, to determine what information has been breached, identify the affected customers, prepare the breach notice, and make the required report to the Commission, FTC staff estimates covered firms will require per breach, on average, 150 hours of employee labor at a cost of $10,770.
The capital and non-labor costs associated with breach notifications depend upon the number of consumers contacted and whether covered firms are likely to retain the services of a forensic expert. For breaches affecting large numbers of consumers, covered firms are likely to retain the services of a forensic expert. FTC staff estimates, for each breach requiring the services of forensic experts, forensic experts will spend approximately 40 hours to assist in the response to the cybersecurity intrusion, at an estimated cost of $20,000.
Using the data on HIPAA-covered breach notices available from HHS for the years 2018-2023, FTC staff estimates the average number of individuals affected per breach is 93,497.
Based on a recent study of data breach costs, FTC staff estimates the cost of providing notice to consumers to be $11.87 per breached record.
FTC staff notes these estimates likely overstate the costs imposed by the amendments because FTC staff made conservative assumptions in developing many of the underlying estimates. Moreover, many entities covered by the amendments already have similar notification obligations under State data breach laws.
The Regulatory Flexibility Act (RFA)
In this document, the Commission largely adopts the amendments proposed in its NPRM. The Commission believes the amendments will not have a significant economic impact upon small entities, although they may affect a substantial number of small businesses. Among other things, the amendments clarify certain definitions, revise the disclosures that must accompany notice of a breach under the Rule, and modernize the methods of notice to allow additional use of electronic notice such as email by entities affected by a breach. In addition, the amendments improve the Rule's readability by clarifying cross-references and adding statutory citations. The Commission does not anticipate that these changes will add significant additional costs for entities covered by the Rule, and by authorizing electronic notice in additional circumstances, the amendments may reduce costs for many entities covered by the Rule. Therefore, the Commission certifies that the amendments will not have a significant economic impact on a substantial number of small entities. Although the Commission certifies under the RFA that the Rule will not have a significant impact on a substantial number of small entities, and hereby provides notice of that certification to the Small Business Administration (“SBA”), the Commission has determined, nonetheless, that it is appropriate to publish an FRFA to inquire into the impact of the proposed amendments on small entities.
The objective of the amendments is to clarify existing notice obligations for entities covered by the Rule. The legal basis for the amendments is section 13407 of the Recovery Act.
Although the Commission received several comments that argued that the amendments would be burdensome for businesses, none argued specifically that smaller businesses in particular would be subject to special burdens. The Commission did not receive any comments filed by the Chief Counsel for Advocacy of the SBA.
The amendments, like the current Rule, will apply to vendors of personal health records, PHR related entities, and third party service providers, including developers and purveyors of health apps, connected health devices, and similar technologies. As discussed in the Commission's PRA estimates above, FTC staff estimates the amendments will apply to approximately 193,000 covered entities. The Commission estimates that a substantial number of these entities likely qualify as small businesses. According to the Statistics on Small Businesses Census data, approximately 94% of “Software Publishers” (the category to which health and fitness apps belong) are small businesses.
The Recovery Act and the amendments contain certain reporting requirements. The amendments will clarify which entities are subject to those reporting requirements. Specifically, the Act and amendments require vendors of personal health records and PHR related entities to provide notice to consumers, the Commission, and in some cases the media in the event of a breach of unsecured PHR identifiable health information. The Act and amendments also require third party service providers to provide notice to vendors of personal health records and PHR related entities in the event of such a breach. If a breach occurs, each entity covered by the Act and amendments will expend costs to determine the extent of the breach and the individuals affected. If the entity is a vendor of personal health records or a PHR related entity, additional costs will include the costs of preparing a breach notice, notifying the Commission, compiling a list of consumers to whom a breach notice must be sent, and sending a breach notice. Such entities may incur additional costs in locating consumers who cannot be reached, and in certain cases, posting a breach notice on a website, notifying consumers through media advertisements, or sending breach notices through press releases to media outlets.
In-house costs may include technical costs to determine the extent of breaches; investigative costs of conducting interviews and gathering information; administrative costs of compiling address lists; professional/legal costs of drafting the notice; and potentially, costs for postage, web posting, and/or advertising. Costs may also include the purchase of services of a forensic expert. As discussed in the context of the PRA, FTC staff estimates that compliance with these requirements will likely result in $883,148 in labor costs and $91,984,370 in capital and other non-labor costs. The estimated cost per covered entity is $481 (the total labor, capital, and non-labor costs of $92,867,518 divided by 193,000 covered entities). The SBA categorizes Software Publishers with annual receipts under $41.5 million as a small business; the per entity cost of $481 represents 0.0001% of this annual receipts threshold.
In drafting the Rule, the Commission has made every effort to avoid unduly burdensome requirements for entities. In particular, the Commission believes that the changes to facilitate electronic notice will assist small entities by significantly reducing the costs of sending breach notices. In addition, the Commission is making available exemplar notices that entities covered by the Rule may use, in their discretion, to notify individuals. The Commission anticipates these exemplar notices will further reduce the burden on entities that are required to provide notice under the Rule. The Commission is not aware of alternative methods of compliance that will reduce the impact of the amendments on small entities, while also comporting with the Recovery Act. The statutory requirements are specific as to the timing, method, and content of notice.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Breach, Consumer protection, Health, Privacy, Reporting and recordkeeping requirements, Trade practices.
42 U.S.C. 17937 and 17953.
(a) This part, which shall be called the “Health Breach Notification Rule,” implements section 13407 of the American Recovery and Reinvestment Act of 2009, 42 U.S.C. 17937. This part applies to foreign and domestic vendors of personal health records, PHR related entities, and third party service providers, irrespective of any jurisdictional tests in the Federal Trade Commission (FTC) Act, that maintain information of U.S. citizens or residents. This part does not apply to HIPAA-covered entities, or to any other entity to the extent that it engages in activities as a business associate of a HIPAA-covered entity.
(b) This part preempts State law as set forth in section 13421 of the American Recovery and Reinvestment Act of 2009, 42 U.S.C 17951.
(1)
(i) Present the information in the notice in clear, concise sentences, paragraphs, and sections;
(ii) Use short explanatory sentences or bullet lists whenever possible;
(iii) Use definite, concrete, everyday words and active voice whenever possible;
(iv) Avoid multiple negatives;
(v) Avoid legal and highly technical business terminology whenever possible; and
(vi) Avoid explanations that are imprecise and readily subject to different interpretations.
(2)
(i) Use a plain-language heading to call attention to the notice;
(ii) Use a typeface and type size that are easy to read;
(iii) Provide wide margins and ample line spacing;
(iv) Use boldface or italics for key words; and
(v) In a form that combines your notice with other information, use distinctive type size, style, and graphic devices, such as shading or sidebars, when you combine your notice with other information. The notice should stand out from any accompanying text or other visual elements so that it is easily noticed, read, and understood.
(3)
(i) Place the notice on a screen that consumers frequently access, such as a page on which transactions are conducted; or
(ii) Place a link on a screen that consumers frequently access, such as a page on which transactions are conducted, that connects directly to the notice and is labeled appropriately to convey the importance, nature and relevance of the notice.
(1) Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual; and
(i) Identifies the individual; or
(ii) With respect to which there is a reasonable basis to believe that the information can be used to identify the individual; and
(2) Is created or received by a:
(i) Covered health care provider;
(ii) Health plan (as defined in 42 U.S.C. 1320d(5));
(iii) Employer; or
(iv) Health care clearinghouse (as defined in 42 U.S.C. 1320d(2)); and
(3) With respect to an individual, includes information that is provided by or on behalf of the individual.
(1) Offers products or services through the website, including any online service, of a vendor of personal health records;
(2) Offers products or services through the websites, including any online service, of HIPAA-covered entities that offer individuals personal health records; or
(3) Accesses unsecured PHR identifiable health information in a personal health record or sends unsecured PHR identifiable health information to a personal health record.
(1) Provides services to a vendor of personal health records in connection with the offering or maintenance of a personal health record or to a PHR related entity in connection with a product or service offered by that entity; and
(2) Accesses, maintains, retains, modifies, records, stores, destroys, or otherwise holds, uses, or discloses unsecured PHR identifiable health information as a result of such services.
(a)
(1) Notify each individual who is a citizen or resident of the United States whose unsecured PHR identifiable health information was acquired by an unauthorized person as a result of such breach of security;
(2) Notify the Federal Trade Commission; and
(3) Notify prominent media outlets serving a State or jurisdiction, following the discovery of a breach of security, if the unsecured PHR identifiable health information of 500 or more residents of such State or jurisdiction is, or is reasonably believed to have been, acquired during such breach.
(b)
(c)
(a)
(b)
(c)
(d)
(a)
(1) Written notice at the last known address of the individual. Written notice may be sent by electronic mail if the individual has specified electronic mail as the primary method of communication. Any written notice sent by electronic mail must be Clear and Conspicuous. Where notice via electronic mail is not available or the individual has not specified electronic mail as the primary method of communication, a vendor of personal health records or PHR related entity may provide notice by first-class mail at the last known address of the individual. If the individual is deceased, the vendor of personal health records or PHR related entity that discovered the breach must provide such notice to the next of kin of the individual if the individual had provided contact information for his or her next of kin, along with authorization to contact them. The notice may be provided in one or more mailings as information is available.
(2) If, after making reasonable efforts to contact all individuals to whom notice is required under § 318.3(a), through the means provided in paragraph (a)(1) of this section, the vendor of personal health records or PHR related entity finds that contact information for ten or more individuals is insufficient or out-of-date, the vendor of personal health records or PHR related entity shall provide substitute notice, which shall be reasonably calculated to reach the individuals affected by the breach, in the following form:
(i) Through a conspicuous posting for a period of 90 days on the home page of its website; or
(ii) In major print or broadcast media, including major media in geographic areas where the individuals affected by the breach likely reside. Such a notice in media or web posting shall include a toll-free phone number, which shall remain active for at least 90 days, where an individual can learn if the individual's unsecured PHR identifiable health information may have been included in the breach.
(3) In any case deemed by the vendor of personal health records or PHR related entity to require urgency because of possible imminent misuse of unsecured PHR identifiable health information, that entity may provide information to individuals by telephone or other means, as appropriate, in addition to notice provided under paragraph (a)(1) of this section.
(b)
(c)
Regardless of the method by which notice is provided to individuals under § 318.5 (regarding methods of notice), notice of a breach of security shall be in plain language and include, to the extent possible, the following:
(a) A brief description of what happened, including: the date of the breach and the date of the discovery of the breach, if known; and the full name or identity (or, where providing the full name or identity would pose a risk to individuals or the entity providing notice, a description) of any third parties that acquired unsecured PHR identifiable health information as a result of a breach of security, if this information is known to the vendor of
(b) A description of the types of unsecured PHR identifiable health information that were involved in the breach (such as but not limited to full name, Social Security number, date of birth, home address, account number, health diagnosis or condition, lab results, medications, other treatment information, the individual's use of a health-related mobile application, or device identifier (in combination with another data element));
(c) Steps individuals should take to protect themselves from potential harm resulting from the breach;
(d) A brief description of what the entity that experienced the breach is doing to investigate the breach, to mitigate harm, to protect against any further breaches, and to protect affected individuals, such as offering credit monitoring or other services; and
(e) Contact procedures for individuals to ask questions or learn additional information, which must include two or more of the following: toll-free telephone number; email address; website; within-application; or postal address.
Any violation of this part shall be treated as a violation of a rule promulgated under section 18 of the Federal Trade Commission Act, 15 U.S.C. 57a, regarding unfair or deceptive acts or practices, and thus subject to civil penalties (as adjusted for inflation pursuant to § 1.98 of this chapter), and the Commission will enforce this part in the same manner, by the same means, and with the same jurisdiction, powers, and duties as are available to it pursuant to the Federal Trade Commission Act, 15 U.S.C. 41
This part shall apply to breaches of security that are discovered on or after September 24, 2009.
If new legislation is enacted establishing requirements for notification in the case of a breach of security that apply to entities covered by this part, the provisions of this part shall not apply to breaches of security discovered on or after the effective date of regulations implementing such legislation.
By direction of the Commission, Commissioners Holyoak and Ferguson dissenting.
The following appendices will not appear in the Code of Federal Regulations.
The notices below are intended to be examples of notifications that entities may use, in their discretion, to notify individuals of a breach of security pursuant to the Health Breach Notification Rule. The examples below are for illustrative purposes only. You should tailor any notices to the particular facts and circumstances of your breach. While your notice must comply with the Health Breach Notification Rule, you are not required to use the notices below.
Due to a security breach on our system,
You shared health information with us when you used [product name].
Due to a security breach on our system,
You shared health information with us when you used [product name].
Due to a security breach on our system,
•
You shared health information with us when you used [product name].
•
We are contacting you because an attacker recently gained unauthorized access to our system and stole health information about our customers, including you.
On [March 1, 2024], we learned that an attacker had accessed a file containing our customers' health information on [February 28, 2024]. The file included your name, the name of your health insurance company, your date of birth, and your group or policy number.
You can take steps now to reduce the risk of identity theft.
1.
Also review the Explanation of Benefits statement your insurer sends you when it pays for medical care.
Some criminals wait before using stolen information so keep monitoring your benefits and bills.
2.
3.
4.
A fraud alert will make it harder for someone to open a new credit account in your name. It tells creditors to contact you before they open any new accounts in your name or change your accounts. A fraud alert lasts for one year. After a year, you can renew it.
To freeze your credit report, contact
To place a fraud alert, contact
Learn more about how credit report freezes and fraud alerts can protect you from identity theft or prevent further misuse of your personal information at
We hired security experts to secure our system. We are working with law enforcement to find the attacker. And we are investigating whether we made mistakes that made it possible for the attackers to get in.
Go to [URL] to learn more about what happened and what you can do to protect yourself. If we have any updates, we will post them there.
If you have questions or concerns, call us at [telephone number], email us at [address], or go to [URL].
We are contacting you because you use our company's app [name of app]. When you downloaded our app, we promised to keep your personal health information private. Instead, we disclosed health information about you without your approval.
We told [insert Company name, identity, or, where providing full name or identity would pose a risk to individuals or the entity providing notice, a description of type of company] that you use our app, and between [January 10, 2024] and [March 1, 2024], we gave them your name and your email address.
We gave [insert Company name, identity, or where providing full name or identity would pose a risk to individuals or the entity providing notice, a description of type of company] this information so they could use it for advertising and marketing purposes. For example, to target you for ads for cancer drugs.
We will stop selling or sharing your health information with other companies. We will stop using your health information for advertising or marketing purposes. We have asked Company XYZ to delete your health information, but it's possible they could continue to use it for advertising and marketing.
We made important changes to our app to fix this problem. Download the latest updates to our app then review your privacy settings. You can also contact Company XYZ to request that it delete your data.
Learn more about our privacy and security practices at [URL]. If we have any updates, we will post them there.
If you have any questions or concerns, call us at [telephone number] or email us at [address].
We are contacting you about a breach of your health information collected through the [product], a device sold by our company, [Company].
On [March 1, 2024], we discovered that our employee had accidentally posted a database online on [February 28, 2024]. That database included your name, your credit or debit card information, and your blood pressure readings. We don't know if anyone else found the database and saw your information. If someone found the database, they could use personal information to steal your identity or make unauthorized charges in your name.
You can take steps now to reduce the risk of identity theft.
1.
2.
A fraud alert will make it harder for someone to open a new credit account in your name. It tells creditors to contact you before they open any new accounts in your name or change your accounts. A fraud alert lasts for one year. After a year, you can renew it.
To freeze your credit report, contact
To place a fraud alert, contact
Learn more about how credit report freezes and fraud alerts can protect you from identity theft or prevent further misuse of your personal information at
3.
We are investigating our mistakes. We know the database shouldn't have been online and it should have been encrypted. We are making changes to prevent this from happening again.
We are working with experts to secure our system. We are reviewing our databases to make sure we store health information securely.
Go to [URL] to learn more about what happened and what you can do to protect yourself. If we have any updates, we will post them there.
If you have questions or concerns, call us at [telephone number], email us at [address], or go to [URL].
Today, the FTC finalizes an update to the Health Breach Notification Rule (“the Final Rule”) that ensures its protections keep pace with the rapid proliferation of digital health records. We do so to fulfill a clear statutory directive given to us by Congress.
In 2009, as part of the American Recovery and Reinvestment Act (“ARRA”), Congress passed the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”).
The dissent argues that the Commission's action “exceeds the Commission's statutory authority.”
In the HITECH Act, Congress directed the FTC to issue rules requiring vendors of personal health records (“PHR”) to notify consumers and the FTC following “a breach of security of unsecured PHR identifiable health information.”
The term “health care services or supplies,” undefined in the statute, is defined in the Final Rule as follows:
Health care services or supplies means any online service such as a website, mobile application, or internet-connected device that provides mechanisms to track diseases, health conditions, diagnoses or diagnostic testing, treatment, medications, vital signs, symptoms, bodily functions, fitness, fertility, sexual health, sleep, mental health, genetic information, diet, or that provides other health-related services or tools.
The dissent argues that this definition violates certain canons of statutory construction.
The dissent's approach also fails to give meaning to other textual differences between the second and third category. The second category in the definition of “health care provider” discusses a “provider” and “medical” services.
The dissent also notes that the Department of Health and Human Services (“HHS”) “has never interpreted the term `health care provider' to reach the expansive, creative conclusion that the Commission does today.”
Notably, in its 1999 Notice of Proposed Rulemaking for the HIPAA Privacy Rule, HHS originally had proposed to define the term “health care” as constituting “the provision of care, services, or supplies. . . .”
The dissent also claims that changing the phrase “can be drawn” to “has the technical capacity to draw” violates the surplusage canon because it renders the limitation meaningless as to health apps, because “virtually every app has the technical capacity to draw some information from more than one source.”
The practical ramifications of the dissent's legal shortcomings are significant.
Just last year, the Commission brought an action against Easy Healthcare Corporation, alleging privacy violations by its fertility tracking application Premom.
Under the dissent's analysis of health care services or supplies, the developer of the Premom application—Easy Healthcare—would not be covered by the Health Breach Notification Rule. This reading would mean that when companies like Easy Healthcare suffer a breach that may divulge health information to companies located in China, the Health Breach Notification Rule would not require them to disclose the breach to its users. It would also mean that when Easy Healthcare broadcasts women's sensitive health data across the vast commercial surveillance network propped up by SDKs and ad networks, the Health Breach Notification Rule would not require Easy Healthcare to alert women. Today's Final Rule rejects this atextual and cramped reading of the law, ensuring that businesses that hold themselves out as health care services companies—like Easy Healthcare—
Lastly, the dissent claims that the Final Rule introduces ambiguity where previous there was none. But
We are deeply grateful to the Division of Privacy and Identity Protection for leading the Commission's work to activate the Health Breach Notification Rule and for finalizing this Rule update. In an environment rife with new and evolving threats to Americans' health data, ensuring we are faithfully harnessing all of our statutory tools to protect people from data breaches is paramount.
The Health Breach Notification Rule (“Final Rule”) that the Commission adopts today exceeds the Commission's statutory authority, puts companies at risk of perpetual non-compliance, and opens the Commission to legal challenge that could undermine its institutional integrity. I share the majority's goal of protecting the privacy and security of consumers' identifiable health information,
The American Recovery and Reinvestment Act of 2009 (“Recovery Act”)
I am encouraged that today the Commission is acting by rulemaking, as authorized by statute and following a period of notice and comment that elicited a range of views, rather than acting by fiat in a policy statement, as the Commission did in 2021.
Setting aside this troubling history, I turn to the Final Rule itself, which, unfortunately, I find equally troubling in its extension beyond the parameters established by Congress.
Some background first. Under the Recovery Act, PHR identifiable health information means “individually identifiable health information,” as defined by the Social Security Act, 42 U.S.C. 1320d(6).
The Commission takes liberties with the final category in that definition (“any other person furnishing health care services or supplies”) to adopt a new, capacious definition of “covered health care provider” and a new, similarly capacious definition of “health care services and supplies,” whose joint effect is to sweep a large swath of apps and app developers under the purview of the Final Rule. These expansive definitions are not consistent with the statute. Under longstanding principles of statutory interpretation, the final category of provider (“any other person . . .”) must be understood in relation to the first two categories (“provider of services” and “provider of medical or other health services”).
The first two categories of health care provider incorporate the definitions of sections 1395x(u) and 1395x(s) of the Social Security Act, respectively.
The final category, addressing “any other person furnishing health care services or supplies,” must therefore only include persons that are “similar in nature” to these first two categories.
The Final Rule's definition of “covered health care provider” is not remotely similar, because it incorporates a new, astonishingly broad definition of “health care services or supplies,” which means “any online service such as a website, mobile application, or internet-connected device that provides mechanisms to track diseases, health conditions, diagnoses or diagnostic testing, treatment, medications, vital signs, symptoms, bodily functions, fitness, fertility, sexual health, sleep, mental health, genetic information, diet, or that provides other health-related services or tools.”
Notably, even though the Department of Health and Human Services (“HHS”) interprets this same provision of the Social Security Act, HHS has—notwithstanding the majority's assertion to the contrary
(1) Preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual or that affects the structure or function of the body; and
(2) Sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.
The Majority Statement repeatedly says that HHS defines “health care” broadly,
Aware of this incongruency, the Commission seeks to differentiate its use of “health care provider” from that of “other government agencies.”
The Commission also takes troubling liberties with the statute's definition of “personal health record,” which are evident from a side-by-side comparison of the statute and the Final Rule:
Under the
The Commission's expansive definitions of “covered health care provider,” “health care services and supplies,” and “personal health record” have a profound effect on the scope of the Rule: Most companies that offer or disseminate health-related apps or similar products would be treated as “covered health care providers” that therefore hold “PHR identifiable health information” in their apps (
Remarkably, the Commission imposes no limit on this extraordinary breadth in the Rule itself. Rather, in a post-NPRM attempt to check the scope, the Commission fashions a limiting principle: Apps are covered only if they are “more than tangentially relating to health.”
First, if the majority were correct, from where would it draw the authority to impose this “more than tangentially relating to health” limitation? If Congress in fact commanded us to cover all the apps the majority claims, this extra-textual limitation would be beyond our power to impose.
The second problem is substantive: What does this language mean? When does an app cross the line between tangentially related to health and more than tangentially related? If a gas station with a loyalty app sells Advil, is the app only tangentially related to health and outside the Final Rule's purview? If the gas station adds Robitussin and pregnancy tests to its inventory, does it cross the line to more than tangentially related to health? If a clothing store with an e-commerce app sells a handful of maternity shirts, is the app only tangentially related to health? If the store adds more maternity clothes, nursing bras, and some anti-nausea ginger tea to its in-app offerings, is the app more than tangentially related to health? If vitamins, over-the-counter medicines, acne creams, bandages, and similar items comprise 0.1% or 1% or 10% of a superstore's inventory, when is the retailer's e-commerce app more than tangentially related to health? I see no clear answers to any of these hypotheticals in today's Final Rule, which suggests that the marketplace will see no clear answers either.
The third problem is procedural. The Commission did not propose this ambiguous but impactful limitation in a Notice of Proposed Rulemaking—likely because there is no statutory basis for this newly-created language. Rather, it introduces this crucial concept for the first time in a Statement of Basis and Purpose (a purely interpretive document) as a
The final problem is that this
Perhaps the breath of the Final Rule would be more of a theoretical than practical concern to businesses, if they could adopt practices sufficient to avoid any breach that would trigger notice obligations under the Final Rule, or, in the event of a breach, err on the side of notification. But § 318.3(b) of the Final Rule imposes affirmative obligations on companies to notify their service providers if they are covered by the Final Rule, regardless of whether they experience a breach.
I find the majority's liberties with the statute particularly troubling because they are unnecessary to reach health apps. Indeed, the Commission's own recent enforcement action against digital healthcare platform GoodRx makes that clear. Only last year, a bipartisan Commission applied the 2009 Rule to GoodRx's online platform and app because the company received identifiable health information on prescription medications (among other things) from pharmacy benefit managers and pharmacies, among other sources, so that consumers could manage their information.
The FTC is a venerable institution that does vital work to protect consumers and promote competition, thanks to its hardworking and devoted career staff. I commend the staff attorneys, economists, and technologists who worked on the rule for their careful and thoughtful consideration of difficult issues. Ultimately, while I am sympathetic to the majority's goal, I fear that adopting a Final Rule that is irreconcilable with the statute and that puts companies in an untenable position puts the Commission at risk. Legal challenges may undermine the Commission's institutional integrity, and Congress may be reluctant to trust the Commission with other authority—even the much-needed authority to protect the privacy of consumers' sensitive personal information. I therefore respectfully dissent.