Title: African Swine Fever; Importation of Live Dogs for Resale from Regions Where ASF Exists or is Reasonably Believed to Exist.

OMB Control Number: 0579-0478.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq. ), the Secretary of the U.S. Department of Agriculture (USDA) is authorized to protect the health of the livestock, poultry, and aquaculture populations in the United States by preventing the introduction and interstate spread of serious diseases and pests of livestock, poultry, and aquaculture, and for eradicating such diseases and pests from the United States, when feasible. Within the USDA, this authority and mission is delegated to the Animal and Plant Health Inspection Service (APHIS).

Within APHIS, part of the mission of Veterinary Services is preventing foreign animal disease outbreaks in the United States, and monitoring, controlling, and eliminating a disease outbreak should one occur. In the past several years, there have been significant worldwide outbreaks of African swine fever (ASF). ASF is a highly contagious and deadly viral disease affecting both domestic and feral (wild) pigs. The disease has not been detected in the United States; however, APHIS is committed to working with State and industry partners to keep the virus out of the country.

An onset of ASF in the United States has the potential to decimate the U.S. swine industry, a $22.5 billion a year sector of the economy. Much of the industry imports to foreign countries, so an impact to it would significantly damage U.S. trade. The disease can be spread among not only swine but also animals that have contact with them (such as dogs) and by items that swine and dogs encounter such as bedding and packaging materials.

The United States has continued to see many dogs (including rescue dogs) imported from regions where ASF has occurred. The number of import permits APHIS has issued has averaged around 3,500 annually. From August 28, 2022, through August 28, 2025, APHIS issued 5,773 permits for commercial dogs originating from ASF-affected countries, accounting for 11,467 dogs entering the United States from these countries. Many of these dogs have contact with affected and potentially affected swine in their home countries.

APHIS has determined that dogs imported from ASF-affected countries for resale purposes, along with their bedding, represent a possible pathway for the introduction of disease. To block this pathway, APHIS issued a Federal Order imposing several restrictions on the importation of dogs for resale from regions where ASF exists or is reasonably believed to exist. Importers need to verify that they have met these restrictions by completing and submitting a Dog Import Record which will record information regarding the dogs' characteristics, ID, origin, and entry into the United States, the disposition of their bedding and packing material, and confirmation of bathing.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years. APHIS has amended this information collection due to a decrease in the number of Respondents reporting; however, the number of Responses and Total Burden Hours reported for the collection has increased.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.5 hours per response.

Respondents: Importers and animal breeders.

Estimated annual number of respondents: 72.

Estimated annual number of responses per respondent: 27.

Estimated annual number of responses: 1,924.

Estimated total annual burden on respondents: 962 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Rangelands in the western United States are vast, diverse ecosystems that include grasslands, shrublands, deserts, and open forests that cover a significant portion of the landscape. Rangeland provides essential habitat for wildlife, forage for livestock, and vital ecosystem services such as maintaining water and air quality. The U.S. Environmental Protection Agency (USEPA) defines rangeland as “lands on which the native vegetation (climax or natural potential plant community) is predominantly grasses, grass-like plants, forbs, or shrubs suitable for grazing or browsing use.”  1 The major differences between rangeland and pastureland are the kind of vegetation and the level of management that each area receives. Rangelands tend to support natural vegetation and introduced plant species without intensive agronomy practices such as cover cropping, irrigation, and tillage. Rangelands are managed by animal grazing, while pastures have forage that is adapted for livestock and managed by seeding and mowing.

Grasshoppers and Mormon crickets are natural components of rangeland ecosystems, serving as food for wildlife and playing an important role in nutrient cycling ( i.e., the process by which essential nutrients are exchanged and recycled between living organisms and the non-living environment). Grasshoppers and Mormon crickets are closely related insects, both belonging to the insect order Orthoptera. Grasshoppers (Family Acrididae) are relatively large insects with distinct appearances and occur throughout the North American continent and around the world. Out of approximately 400 western grasshopper species, only ten to fifteen cause recurrent economic damage to rangeland, grasses, and surrounding crops. Mormon crickets ( Anabrus simplex, Family Tettigoniidae) are a large insect native to western North America found in rangelands dominated by sagebrush and forbs. Grasshoppers and Mormon crickets feed on and damage grasses and other vegetation, including some crops.

Grasshoppers and Mormon crickets (hereinafter referred to collectively as “grasshoppers”) have the potential to occur at high population levels (hereinafter referred to as “outbreaks”). When outbreaks occur, they can reduce the value of rangeland forage, especially during droughts. A rapid and effective response is required when a grasshopper or Mormon cricket outbreak develops and threatens rangeland forage.

Section 417(a) of the Plant Protection Act of 2000, as amended (hereinafter referred to as “Act”), states that APHIS “shall carry out a program to control grasshoppers on all Federal lands to protect rangeland.”  2 Upon request from the land manager, APHIS “shall immediately treat Federal, State, or private lands that are infested with grasshoppers or Mormon crickets at levels of economic infestation, unless the Secretary determines that delaying treatment will not cause greater economic damage to adjacent owners of rangeland.”  3 The Act further specifies that APHIS “shall work in conjunction with other Federal, State, and private prevention, control, or suppression efforts to protect rangeland.”  4 APHIS does not engage in grasshopper suppression efforts unless assistance is specifically requested by an affected landowner or land manager.

APHIS employs Integrated Pest Management (IPM) in the control of grasshopper outbreaks. U.S. Department of Agriculture (USDA) and APHIS have explicitly adopted the statutory definition of IPM from the Food Quality Protection Act of 1996 (FQPA), 5 which defines IPM as “a sustainable approach to managing pests by combining biological, cultural, physical, and chemical tools in a way that minimizes economic, health, and environmental risks.” The FQPA does not define what encompasses “biological, cultural, physical, and chemical tools.” However, APHIS summarizes the respective concepts as follows:

• Biological Control: The use of biological control agents to reduce pest populations. This includes the action of parasites, predators, or pathogens (disease-causing organisms) in maintaining another organism's population density at a lower average than would occur in their absence. 6 Examples include the introduction of birds, predatory insects, parasitic flies, or biological pathogens such as Nosema locustae in grasshopper infested areas.

• Cultural Control: Involves land and habitat management practices that reduce pest survival, reproduction, or spread. These methods involve the practice of moving livestock from field to field in a way that allows the grass or other plants they eat to recover and grow. During the late nineteenth century, several cultural control methods were developed to help remove grasshoppers from agricultural lands. Examples of such methods include grazing management, conservation of game birds, crop rotation, irrigation, vegetation control, removing favorable breeding sites, and maintaining healthy plant cover to reduce bare ground. These strategies appear to offer great potential for reducing the effects of periodic grasshopper outbreaks on cultivated cropland. APHIS does not have the authority to dictate land management practices or other cultural controls on Federal, State, Tribal, or private lands. APHIS believes land management agencies and property owners are the best stewards of their resources to prevent destruction of rangeland vegetation by grasshopper outbreaks. Therefore, land management agencies and property owners are best equipped to implement cultural control methods.

• Physical Control (Mechanical Control): Involves mechanical or physical methods to directly block, remove, or kill pests. These methods do not rely on pesticides or biological agents. Examples of physical control for Mormon crickets are the use of barriers or fences to redirect their movement, trapping, fire, mechanical removal, or altering terrain to limit migration routes. 7 8 Prior to the availability of chemical insecticides, farmers used rangeland fires to destroy grasshopper nymphs. Grasshopper nymphs also were sometimes collected in nets and tar-filled pans dragged behind tractors or horses. Reportedly, rearing turkeys and other wildfowl on cropland reduced grasshopper impacts. Plowing and harrowing soil to destroy grasshopper eggs, particularly where eggs were laid, was also used on cropland. 9 10 APHIS does not have the authority to conduct prescribed burns, raise and manage flocks of wild fowl, or till wide swaths of rangeland to prevent grasshopper outbreaks. Although APHIS uses handheld sweep nets to survey grasshopper species, widespread use of nets to control grasshopper populations would not be economically feasible due to the vast areas of rangeland that would need to be covered, making it extremely labor-intensive and time-consuming. Such methods, to the extent that they may be effective, are best implemented by land management agencies and property owners.

• Chemical Control: The use of USEPA-registered insecticide treatments to rapidly suppress grasshopper populations to a level below that which constitutes an economic infestation. This method is typically used when pest numbers exceed economic or ecological thresholds and other controls are unavailable or insufficient. Examples of chemical controls available to the program include ultra-low volume and bait insecticide formulations applied by all-terrain vehicles and aircraft.

The USDA's Office of Pest Management Policy leads the Federal Integrated Pest Management Coordinating Committee (FIPMCC) to facilitate information exchange among Federal and non-Federal researchers, educators, innovators and IPM practitioners. In 2018, the FIPMCC published a National IPM Road Map “to increase adoption, implementation and efficiency of effective, economical and safe pest management practices, and to develop new practices where needed.”  11 The National IPM Roadmap further states that IPM “uses knowledge of pest and host biology, as well as biological and environmental monitoring, to respond to pest problems with management tactics and technologies.”  12 Building on the priorities outlined in the 2018 Roadmap, the public IPM Enterprise later developed the National IPM Strategic Plan for 2025-2029, which translates the Roadmap's broad goals into more specific strategic objectives, actions and performance measures to guide IPM research, education, and implementation efforts in the coming years. 13

The APHIS grasshopper program implements IPM strategy guided by the principles of the USEPA. The USEPA describes IPM as “an effective and environmentally sensitive approach to pest management that relies on a combination of common-sense practices.”  14 The USEPA further describes IPM as “a series of pest management evaluations, decisions and controls.”  15 Key IPM techniques explicitly recognized by the USEPA, such as surveys, monitoring, population mapping, and treatment avoidance in ecologically sensitive habitats, are essential parts of the APHIS program. 16

IPM first sets an action threshold, a level of infestation at which pest populations or environmental conditions indicate pests will become an economic threat to agricultural producers. For APHIS, this threshold specifically uses the phrase “levels of economic infestation,” a phrase directly from the Plant Protection Act. 17 While the Act itself does not define this phrase, APHIS recognizes that “levels of economic infestation” has been interpreted differently in past documents. For purposes of this PEIS, the phrase “levels of economic infestation” is the threshold at which grasshopper or Mormon cricket populations pose a demonstrable risk of significant economic harm to agricultural resources, rangelands, or other managed lands, based on monitoring data and professional judgment. The ratio of eight adult grasshoppers per square yard has been used as the minimum population at which suppression activities will be considered. This figure was derived by Parker (1939)  18 as the level of infestation at which grasshoppers generally begin to compete with livestock for available forage.

However, recognizing the significant advancements in pest management science and the dynamic nature of rangeland ecosystems since 1939, modern grasshopper and Mormon cricket management, including APHIS' approach, employs a more nuanced and contemporary assessment rather than relying solely on this historical estimate. Current practices focus on dynamic economic thresholds and consider a broader range of factors. Specifically, APHIS uses nymphal grasshopper counts collected during the spring to determine if suppression of a grasshopper population is warranted. Furthermore, other site-specific factors, such as grasshopper and plant species composition, the life-cycle stages of the grasshoppers present, and condition of the range, also affect whether economic injury could be caused by an outbreak. This comprehensive approach ensures decisions are based on current ecological conditions and economic realities.

Normally, suppression activities are not conducted unless the populations are two to three times greater than eight per square yard. However, APHIS is authorized by Congress to take preventive measures at lower levels of infestation to avoid such critical outbreaks. This threshold is not a fixed numeric value but a risk-based management concept that considers site-specific factors such as land use, vegetation, climatic conditions, historical outbreaks patterns, and the potential severity of damage.

When biological, cultural, and physical controls in an IPM-based rangeland management strategy do not prevent development of destructive grasshopper populations, APHIS uses chemical methods in a manner that is economically feasible and minimizes risks to human health, non-target organisms, and the environment. IPM programs monitor pests and seek to identify them accurately; this is done to assist decisionmakers in evaluating the control options available in light of the aforementioned action thresholds. For example, when an agricultural crop is at risk because of a grasshopper outbreak, under IPM, cultural methods, such as rotating between different crops, selecting pest-resistant varieties of crops, and planting pest-free rootstock, may be tried first by land management agencies and property owners. However, once monitoring, identification, and action thresholds indicate that pest control is required, and it has further been determined that the preventive methods already employed by land management agencies and property owners, such as cultural control, are no longer effective or available, IPM programs then evaluate available chemical control methods for effectiveness and risk. For purposes of this PEIS, APHIS will define the program's IPM strategy as the selection, integration, and implementation of pest control tactics in a systems approach based on anticipated economic, environmental, and sociological consequences.

This PEIS focuses on actions taken in response to existing grasshopper outbreaks. It addresses measures used to control an outbreak and prevent it from becoming worse after it has already occurred. It does not include actions intended to prevent outbreaks from occurring in the first place. Preventive measures are already used by land management agencies and property owners as part of normal land management practices and are thus considered part of the environmental baseline for this PEIS. The implementation of such preventive efforts is not a prerequisite for APHIS to provide assistance. This analysis applies when a grasshopper outbreak occurs and assistance from APHIS is requested.

In the PEIS, APHIS will articulate which IPM tools it employs, plans to use, or may recommend land management agencies and property owners use. The PEIS will further examine the environmental effects of several proposed alternatives, described in detail below, involving varying ways in which APHIS may address grasshopper outbreaks. The PEIS will be used for program planning and decision-making and to inform the public about the environmental effects of APHIS' activities to address grasshopper outbreaks. APHIS will not implement site-specific actions as a direct result of the decision that will follow the final PEIS. Instead, APHIS will use the PEIS to provide analysis upon which site-specific environmental documents can rely if new grasshopper infestations are discovered in the affected states.

APHIS is requesting public comments to assist in identifying potential alternatives to address grasshopper outbreaks and environmental issues that should be examined in the PEIS. We are also requesting public comments on relevant information, studies, or analysis with respect to APHIS' proposed action.

APHIS will prepare the PEIS in accordance with the National Environmental Policy Act (NEPA) of 1969, as amended  19 and USDA's NEPA implementing regulations. 20 Additional information regarding this proposal, including updates on the PEIS and Record of Decision, will be available at https://www.aphis.usda.gov/plant-pests-diseases/ghmc.

In 2019, APHIS published a PEIS to assess the potential environmental effects of APHIS' Rangeland Grasshopper and Mormon Cricket Suppression Program. This PEIS will replace the 2019 PEIS.

APHIS developed four proposed program alternatives, two of which do not include use of chemical control ( i.e., insecticides). All four proposed alternatives employ the following IPM principles: surveying grasshopper populations to determine if the level of infestation has reached an action threshold indicating the grasshoppers could cause economic or ecological harm, monitoring, and technical assistance wherein APHIS recommends or provides education on how landowners and land managers can implement cultural control and physical control methods. In evaluating the four proposed alternatives, as part of the environmental baseline, land management agencies and property owners are expected to have administered their rangeland resources to reduce the effects of grasshopper herbivory and are coming to APHIS for assistance because preventive methods were deemed no longer effective or available. This approach maintains the appropriate scope of responding to active outbreaks. The four proposed alternatives are discussed in detail below.

Alternative 1—No Action Alternative. This alternative is the current program as described in the preferred alternative of the 2019 EIS and Record of Decision (Alternative 3—Insecticide Applications at Conventional Rates or Reduced Agent Area Treatments (RAATs) with Adaptive Management Strategy). Under this alternative, based on the results of surveys, monitoring, and habitat assessments, APHIS would continue to address grasshopper outbreaks by using USEPA-registered chemical insecticides, namely, carbaryl, diflubenzuron, chlorantraniliprole, and malathion, at both conventional rates per label instructions and RAATs, applying one of the aforementioned insecticides once per treatment season within a treatment area as needed.

APHIS conducts surveys for grasshoppers to make critical management decisions in accordance with the IPM strategy used under the suppression program. Both nymphal and adult populations of grasshoppers may be surveyed on an annual basis in States where grasshopper outbreaks are common. In States where outbreaks are uncommon, surveys may be required when outbreaks occur. APHIS may conduct surveys on private as well as public rangelands.

When surveys and cooperator observations suggest a grasshopper outbreak is likely to cause economic and ecological harm, APHIS identifies, assesses, and delineates sensitive habitats within the proposed control area. During treatments, APHIS monitors applicators with visual observation and global positioning satellite (GPS)-enabled software to ensure no-spray buffers protect sensitive habitats. Environmental monitoring of chemical residues near and within treatment areas has been conducted under the suppression program for decades. APHIS also conducts post-treatment grasshopper surveys to assess the effectiveness of the control methods.

APHIS also uses population mapping to predict future outbreaks and determine the need for suppression treatments. This involves collecting and analyzing survey data, historical outbreak patterns, and environmental factors using Geographic Information Systems (GIS) to identify areas at high risk for future outbreaks and to guide targeted suppression efforts.

As previously stated, under this proposed alternative, APHIS may apply one of four insecticides—carbaryl, diflubenzuron, chlorantraniliprole, or malathion—to treat grasshopper outbreaks. Carbaryl inhibits the enzyme acetylcholinesterase (AChE), an enzyme that normally breaks down the neurotransmitter acetylcholine, at synaptic junctions in the insect nervous system. Inhibition of AChE results in the accumulation of acetylcholine in the nerve synapses, which leads to continual firing of nerve pulses, causing insect paralysis. Insect paralysis disrupts essential functions such as movement and respiration and leads to death.

Diflubenzuron is an insect growth regulator that kills grasshoppers by disrupting normal insect growth rather than nerve function. Diflubenzuron works by inhibiting the formation of chitin, a molecule necessary to the formation of an insect's exoskeleton. During molting, insects that are exposed to diflubenzuron cannot properly form a new exoskeleton, leading to failed molting, dehydration, physical deformities, and death. Diflubenzuron primarily affects immature stages and does not cause immediate mortality.

Chlorantraniliprole kills insects by disrupting normal muscle function. It affects the nervous system by activating ryanodine receptors in insect muscle cells, causing uncontrolled release of calcium. The uncontrolled release of calcium leads to sustained muscle contraction, paralysis, and an inability to move or feed. Death occurs as essential muscles, including those involved in respiration, can no longer function.

Malathion is an organophosphate insecticide that kills grasshoppers by disrupting their nervous system. It enters the insect through contact or ingestion and interferes with the normal breakdown of the neurotransmitter acetylcholine, which is essential for nerve signal transmission. Acetylcholine builds up at nerve junctions, leading to continuous nerve stimulation, loss of muscle control, paralysis, and death. Grasshoppers typically die shortly after exposure due to failure of normal nerve and muscle function.

In conjunction with determining which insecticide is appropriate to use in a given situation, APHIS will also determine whether the insecticide should be applied at conventional rates or RAATs. Conventional rates refer to the maximum rate as specified on the insecticide label for the individual insecticide. Under the RAATs method, parallel swaths of insecticide-treated rangeland are alternated with untreated swaths. In addition, the rate of insecticide sprayed from the application vehicle is reduced to half the conventional treatment rate. RAAT applications directly suppress the grasshopper population within spray-treated swaths while conserving grasshopper predators and parasites in untreated swaths. The RAATs method reduces exposure of non-target species to insecticides when compared with full-coverage treatments at conventional treatment rates. The suppression rather than elimination of grasshopper populations using the RAATs methodology is in accordance with IPM principles of only applying enough insecticide to reduce pest populations below the economic injury level for that agricultural resource. Because the RAATs application method typically alternates treated and untreated swaths, and the insecticide is sprayed at lower rates, the volume of insecticide applied per protected acre of rangeland is less than half of full coverage at conventional label rate insecticide applications.

The approach of utilizing either conventional rates or RAATs allows APHIS to make site-specific suppression applications using a range of application rates to ensure adequate grasshopper suppression.

Under this alternative, APHIS would employ IPM principles such as surveys, monitoring, and population mapping to determine where and when grasshopper population outbreaks are occurring and what insecticide treatments will be most effective and economical to reduce harm to rangeland resources. APHIS would also continue employing avoidance of treatment in areas with documented occurrences of rare grasshopper species, key pollinator habitat, and other sensitive ecological areas. Additionally, APHIS would provide technical assistance to land management agencies and property owners upon request, consistent with IPM strategies. This assistance would include suggesting and providing education on chemical insecticide application methods and rates as well as non-chemical grasshopper population suppression techniques such as grazing management, rangeland and species monitoring, habitat manipulation, mechanical controls, and treatment avoidance strategies.

The current program also includes adaptive management, which is the addition of other treatments, including biopesticides, that become available for managing grasshoppers. Before APHIS would add other treatment(s) that may become available in the future for managing grasshoppers to currently approved treatments, the treatment must be registered by USEPA for use on grasshoppers and APHIS must make a finding that the treatment poses no greater risks to human health and non-target species than the risks associated with currently approved treatments. In other words, if the potential environmental impacts of the proposed new treatment are similar to or less than those posed by current treatments used under the suppression program, APHIS would add them to its toolbox of available grasshopper suppression methods. For each treatment, APHIS would also provide the environmental analysis in a site-specific NEPA document, as appropriate.

The analysis required to make such a finding is extensive and includes, as appropriate, preparation of a human health and ecological risk assessment (HHERA). We also compare the human health and ecological risks of a new treatment with those of current authorized treatments, publish in the Federal Register the preliminary findings with a 30-day public comment period, and issue a final determination also published in the Federal Register . This process reflects APHIS' established procedures for evaluating new treatments as described in the 2019 EIS. Any proposed new treatment that poses different and significant environmental impacts than those currently used in the program would require supplementation of the PEIS if APHIS wanted to add it to its toolbox of methods.

A lternative 2—Surveys, Monitoring, Population Mapping, and Technical Assistance Only Alternative. Under this alternative, APHIS would not fund or participate in any insecticide treatments to suppress grasshopper outbreaks. APHIS' activities would be limited to surveying, monitoring, and population mapping of grasshopper populations to identify if the level of infestation has reached an action threshold indicating the grasshoppers could cause economic or ecological harm and providing technical assistance. APHIS would carry out these activities as described under Alternative 1. Any grasshopper suppression treatments would be implemented by the applicable land management agencies, private groups, or individual landowners.

Alternative 3—Surveys, Monitoring, Population Mapping, Technical Assistance, and Biopesticides with Adaptive Management Alternative. This alternative would include all aspects of Alternative 2, but with the addition of APHIS application of biopesticide treatments to address grasshopper outbreaks if and when they become available. This alternative would also include treatment avoidance in ecologically sensitive habitats as described under Alternative 1. Biopesticides are naturally occurring substances or microorganisms ( e.g., bacteria, fungi, viruses) that control pests through non-toxic mechanisms like infection or growth disruption. The biopesticides APHIS has studied include fungal ( i.e., Beauveria bassiana, Metarhizium robertsii and Nosema locustae ) and bacterial ( i.e., two species of Pseudomonus bacteria: P. syringae and P. fluorescens ) pathogens for control of rangeland grasshoppers. However, to date, APHIS' experimental studies using the aforementioned biopesticides have not shown them to be economical or effective in suppressing rangeland grasshopper outbreaks in the United States.

Biopesticides are of interest because they infect the target insect pest but are not harmful to humans or livestock. However, some biopesticides may pose risks to certain non-target invertebrates. APHIS cooperators researched a domestic alternative to the nonindigenous Metarhizium acridum, used around the world for management of grasshopper (usually locust) populations, particularly in Australia and sub-Sahelian Africa, but also in Mexico and Brazil. Given the widespread and common nature of Metarhizium in the western United States, potential environmental impacts are expected to be minimal if it was approved for use in the United States. Although entomopathogenic fungi can reduce grasshopper populations, a substantial portion of the treated population are able to resist the infection through thermoregulation. While the experimental results thus far show low efficacy in field trials, using biopesticide-laced insect bait formulations remains a promising area of research.

While additional research, including field testing in the United States, and subsequent approvals would be necessary for any biopesticide to be used to treat grasshoppers in the United States, APHIS has chosen to analyze this alternative in case biopesticides become available for APHIS to consider adopting under its adaptive management strategy as described in Alternative 1. While some are USEPA-registered for grasshoppers, APHIS' widespread program adoption requires further specific field testing, efficacy validation across varied target pests ( e.g., grasshopper species, Mormon crickets) and environments, and comprehensive risk assessment. This ensures they meet program objectives and pose no greater risks than current treatments. APHIS is actively exploring their integration, including considering or conducting field trials.

Alternative 4—Combination of Alternatives 1 and 3 With Modifications—(Preferred Alternative). This alternative is a combination of Alternatives 1 and 3, but with some modifications. Like Alternatives 1 and 3, under this alternative APHIS would employ the IPM principles of surveying grasshopper populations, monitoring, population mapping, treatment avoidance in ecologically sensitive habitats, and technical assistance. Additionally, like Alternative 1, APHIS would continue to address grasshopper outbreaks by using the USEPA-registered chemical insecticides carbaryl, diflubenzuron, and chlorantraniliprole, and would employ adaptive management to add other treatments that become available for managing grasshoppers. However, unlike Alternative 1, APHIS would only use RAATs to apply these insecticides and would no longer use malathion to suppress grasshopper outbreaks. This IPM strategy focuses on targeted and low-risk application methods. By no longer using conventional application rates for grasshopper outbreaks or malathion to address grasshopper outbreaks, APHIS aims to reduce potential risks to human health, non-target organisms, and the environment. Conventional rates are higher than necessary for effective suppression of grasshopper populations and can increase exposure to pollinators, wildlife, and nearby communities. Malathion, while effective, is a broad-spectrum organophosphate insecticide with greater potential for non-target impacts. Advances in IPM, improved application technology, and the availability of reduced-risk pesticide application methods allow APHIS to achieve effective grasshopper suppression using lower application rates and adaptive management. This shift reflects a move toward more targeted, environmentally responsible pest management practices consistent with current science and policy. Finally, like Alternative 3, APHIS would employ application of biopesticide treatments to address grasshopper outbreaks if and when they become available.

APHIS is assessing the potential consequences of implementing each of the action alternatives on the biological, physical, and sociocultural aspects of the affected environment. APHIS may identify additional reasonably foreseeable consequences during the preparation of the PEIS; any other reasonably foreseeable consequences that are identified will receive further examination and discussion in the PEIS. APHIS is requesting that the public comment on the following issues during the scoping period:

• Effects on human health and safety. The rangeland areas where treatments may occur are sparsely populated by isolated ranch units consisting mainly of cattle operations and “ranchettes” (homesteads generally five acres or less). Recreationists may use the rangelands for hiking, camping, bird watching, hunting, or other activities. Ranchers and sheepherders may work on the rangelands daily. Individuals with allergic or hypersensitive reactions to chemicals may live near or may utilize rangelands proposed for treatment with insecticides. Some rural schools and off-grid communities may be in rangeland where insecticide treatments could occur. The PEIS will contain detailed hazard, exposure, and risk characterizations for the chemical formulations available to APHIS, including impacts to program workers and the public through all possible routes of exposure (dermal, oral, inhalation), using parameters designed to overestimate risk. Because the suppression program follows the precautions described on the pesticide labels, APHIS does not expect use of insecticides to affect human health and safety.

While the active ingredients in biopesticides are generally nonpathogenic to humans, immunocompromised and allergen-sensitive individuals could be affected. The PEIS will address the general categories of potential human health effects associated with biopesticide pathogens and their carrier matrices. Future, product-specific analyses would be conducted as part of the adaptive management strategy, once specific formulations are identified for potential program use. Grasshopper surveys, monitoring, population mapping, and treatment avoidance in ecologically sensitive areas are not expected to cause any human health effects because program treatments are specifically avoided in these designated areas. Technical assistance provided to cooperators is not expected to cause human health effects because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods and making recommendations on methods to use. Moreover, APHIS would provide the same guidance that it would employ if it were to implement the method itself and, as such, that guidance already would include standard operating procedures proven to minimize any human health effects.

• Effects on non-target species, including federally listed endangered and threatened species. Rangeland vertebrates include introduced livestock, pets, and native species including carnivores, large and small herbivores, and omnivores. Birds comprise a large portion of the vertebrate species complex, and they also include exotic and native species. Animals living in or passing through a grasshopper suppression program area may be wild, feral, or domesticated. Herbivorous vertebrate species compete with some species of grasshoppers for forage, while omnivorous and predacious species utilize grasshoppers and other insects as an important food source. Insects are the most common rangeland pollinators, but certain non-insects play a significant pollination role in specific ecosystems. Invertebrate pollinators include managed exotic species such as European honeybees and a great diversity of native species including many kinds of solitary and eusocial bees, wasps and ants, flies, hoverflies, bee-mimicking flies, many families of beetles, true bugs, moths, and butterflies, among others. Many species of herbivorous insects, including grasshoppers, contribute to organic material decomposition and nutrient cycling. Predacious invertebrates ( e.g. arachnids, mantids, and dragonflies) help regulate the insect herbivores while also providing food for larger animals. Invertebrates are essential to rangeland ecosystem health and provide the most biodiversity in those ecosystems.

When using insecticides to suppress grasshopper outbreaks, APHIS does not treat near rangeland water resources or other sensitive environments identified by Federal, State or Tribal cooperators. APHIS chooses application methods, insecticides, and formulations to minimize effects on non-target species. The use of biopesticides being considered under the suppression program is not expected to have greater potential to cause significant impacts to non-target species populations because the program will adhere to the habitat avoidance procedures established for chemical insecticides.

Section 7 of the Endangered Species Act (ESA) and its implementing regulations require Federal agencies to ensure their actions are not likely to jeopardize the continued existence of listed threatened or endangered species or result in the destruction or adverse modification of critical habitat. APHIS considers whether listed species, species proposed for listing, experimental populations, or critical habitat are present in proposed suppression areas before selecting a specific treatment method. APHIS completed a programmatic consultation with the Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service (NMFS) for the suppression program (concurrence letter dated (August 12, 2010)). APHIS also completed a programmatic consultation with the U.S Fish and Wildlife Service (USFWS) for the suppression program. USFWS concurred with APHIS' determination that the grasshopper suppression program would have no effect or was not likely to adversely affect listed species and their critical habitat on March 21, 2024. During preparation of the PEIS, APHIS will confer with USFWS and NMFS to determine if re-initiation of consultation is necessary.

Before treatments are conducted, program managers confer with USFWS Field Offices and NMFS (where applicable) to determine if listed species are present in the grasshopper suppression area, and whether mitigations or protection measures beyond those consulted on in the biological assessments must be implemented to protect listed species or critical habitat. Because grasshopper program suppression treatments occur on a minute fraction of the western rangeland annually, do not occur near water resources, and are conducted in accordance with protective measures provided by USFWS, NMFS, and land management agencies, APHIS does not expect its grasshopper suppression activities to significantly impact non-target species populations.

Grasshopper surveys, monitoring, and population mapping are not expected to cause significant non-target species effects because the techniques either do not harm species or occur within such a minute portion of the habitat to be de minimis. Treatment avoidance in ecologically sensitive areas may either have no effect or benefit non-target species because if non-target species are located in ecologically sensitive areas, those areas are less likely to be treated. Treatment avoidance in ecologically sensitive areas would prevent direct chemical impacts to non-target species; however, if severe grasshopper outbreaks lead to significant habitat degradation or reduced food sources in these untreated areas, indirect adverse effects on non-target species could still occur. Technical assistance provided to cooperators is not expected to affect non-target species because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods. Moreover, APHIS would provide guidance the Agency would use if it were to implement the method and that guidance would include standard operating procedures proven to minimize any effects on non-target species.

• Effects on soil, vegetation, air, and water quality. Soil is the basic component of rangeland ecosystems and is associated with nearly all natural processes that occur within the ecosystem. The chemical and physical characteristics of a soil determine its ability to furnish plant nutrients, the rate and depth of water penetration, the amount of water the soil can hold, and its availability to plants. We will assess the potential impacts to soil resources from grasshopper outbreaks and from program use of chemical insecticides and biopesticides to suppress grasshopper populations. Grasshopper surveys, monitoring, and population mapping are not expected to affect rangeland soil because these activities primarily involve visual observation and data collection with minimal to no physical disturbance or chemical application to the soil. Treatment avoidance in ecologically sensitive areas would prevent direct impacts from program activities to soil. However, if severe grasshopper outbreaks lead to excessive plant loss, indirect adverse effects such as soil drying or erosion could result. Treatment avoidance in ecologically sensitive areas may either have no effect or benefit soil because soil in those areas would be less likely to be treated. Technical assistance provided to cooperators is not expected to affect soil because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods. Moreover, APHIS would provide guidance the Agency would use if it were to implement the method and that guidance would include standard operating procedures proven to minimize any effects on rangeland soils.

The suppression of grasshopper populations is expected to reduce the total amount of herbivory and benefit terrestrial plants. Chemical insecticides and biopesticides are expected to have low potential toxicity to aquatic and terrestrial plants. Grasshopper surveys, monitoring, and population mapping are not expected to affect plants. Treatment avoidance in ecologically sensitive areas may either have no effect or benefit terrestrial plants because plants in those areas would be less likely to be treated. Technical assistance provided to cooperators is not expected to affect plants because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods. Moreover, APHIS would provide guidance the Agency would use if it were to implement the method and that guidance would include standard operating procedures proven to minimize any effects on plants.

The effects on air quality resulting from the use of chemical insecticides containing volatile components within and near the treatment areas will also be examined. The analysis will evaluate potential spray drift from applications by aircraft or ground-based vehicles. Air pollution is not likely because the program avoids meteorological conditions that favor drift, and the low volatility of the insecticides used for treatments. Grasshopper surveys, monitoring, and population mapping are not expected to affect air quality because these activities are observational and data-gathering, involving no emissions or physical alterations to the atmosphere. Treatment avoidance in ecologically sensitive areas would prevent direct impacts from program activities to air quality; however, if severe grasshopper outbreaks lead to excessive plant loss and subsequent soil erosion, indirect adverse effects such as increased airborne dust could result. Treatment avoidance in ecologically sensitive areas may either have no effect or benefit air quality because those areas would be less likely to be treated. Technical assistance provided to cooperators is not expected to affect air quality because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods. Moreover, APHIS would provide guidance the Agency would use if it were to implement the method and that guidance would include standard operating procedures proven to minimize any effects on air quality. This means the recommended activities would have air quality impacts similar to those already assessed within the program's scope, thus avoiding new or unanalyzed effects.

The PEIS will examine the potential effects of program-applied chemical insecticides and their degradates on water resources and aquatic environments. These potential effects are not expected to be significant because APHIS observes broad no-spray buffers around streams and other bodies of water. The use of biopesticides being considered by APHIS is not expected to have greater potential to cause effects on water resources because APHIS will adhere to the habitat avoidance procedures established for chemical insecticides. Grasshopper surveys, monitoring, and population mapping are not expected to affect water quality because these activities are observational and data-gathering, involving no discharge into water bodies or physical disturbance of aquatic environments. Treatment avoidance in ecologically sensitive areas would prevent direct impacts from program activities to water quality. However, if severe grasshopper outbreaks lead to excessive plant loss, indirect adverse effects such as increased soil erosion and sedimentation in water resources could occur. Treatment avoidance in ecologically sensitive areas may either have no effect or benefit water quality because APHIS avoids treatments near bodies of water. Technical assistance provided to cooperators is not expected to affect water resources because APHIS would not be implementing any particular method; it would just be providing guidance on how to implement particular methods. Moreover, APHIS would provide guidance the Agency would use if it were to implement the method and that guidance would include standard operating procedures proven to minimize any effect on rangeland water resources.

• Effects on cultural and historic resources. Federal actions must seek to avoid, minimize, and mitigate potential negative impacts to cultural and historic resources in compliance with the National Historic Preservation Act (NHPA). 21 Prior to conducting treatments that may occur near federally registered historic sites, APHIS will consult with State Historic Preservation Officers about grasshopper suppression program activities that may occur. The officers would indicate whether the suppression program's proposed mitigations are sufficient to protect those sites and require additional mitigations if necessary. The NHPA implementing procedures in 36 CFR part 800 require Federal agencies to provide the Advisory Council on Historic Preservation with an opportunity to comment on their findings.

Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments,” calls for agency communication and collaboration with Tribal officials when proposed Federal actions have potential Tribal implications. The Archaeological Resources Protection Act of 1979  22 secures the protection of archaeological resources and sites on public and Tribal lands. In accordance with these directives and 7 CFR 1b.7(d)(2)(i), APHIS is committed to involving Tribal Nations in the development of this PEIS. APHIS will alert Tribal Nations in writing of our plans to begin preparing the PEIS regarding our suppression activities related to grasshopper and Mormon cricket populations in the western United States. More specifically, APHIS will notify Tribes of this NOI, will actively seek their comments on the PEIS, and will otherwise inquire as to their desire for consultation throughout the PEIS development process. Prior to the treatment season, APHIS will notify Tribal land managers of the potential for grasshopper outbreaks on their lands. Prior to conducting treatments on or near Tribal lands, APHIS will consult with local Tribal representatives to fully inform the Tribes of possible actions APHIS may take to protect Tribal lands and rangeland resources from grasshopper outbreaks. Insecticide treatments typically do not occur at cultural sites, and drift from a suppression program treatment at such locations is not expected to adversely affect natural surfaces, such as rock formations and carvings because the chemical insecticides and biopesticides being considered for use are unlikely to stain nor cause increased weathering of the rock surface. APHIS would also confer with the appropriate Tribal authority to ensure that the timing and location of a planned suppression treatment does not coincide or conflict with cultural events or observances on Tribal lands. Because APHIS coordinates with Tribal nations and other historical or cultural site administrators, the agency does not expect to have significant impacts to these resources.

• Effects on economic resources. Rangelands are essential to the livelihoods of western livestock producers, providing forage for a variety of wildlife and domesticated animals. Rangelands are studied by scientists and visited by wilderness tourists. Economic values of rangelands also include energy production sites, both fossil and renewable, and recreation sites. Market and non-market values are associated with goods and services that are physically used (now or in the future), such as forage for livestock or opportunities for outdoor recreation (usually a non-market value, apart from off-road activities like pony trekking or all-terrain sports). Non-use values arise from goods that are never physically used. Non-use values, for example, include the concept of “existence value” ( i.e., the value people place on simply knowing something, such as an unspoiled wilderness area, exists). Non-market and non-use values are difficult to estimate; therefore, most of the economic injury level estimates used by the grasshopper program in accordance with the IPM principles only consider market values and, in most cases, only the single market value for the commodity ( e.g., forage) being damaged. In the case of rangeland, there are a large suite of values, both market and non-market, and use and non-use, that can be affected by pests such as grasshoppers.

Areas with significant cultural value, subsistence resources, or recreational use often have market value and greater scenic and environmental non-market values. These areas might have remote recreational uses, special topographic characteristics, protected archeological sites, or species that are of special concern to land management agencies, Tribal Nations, residents and visitors, or other groups and individuals. If areas designated as Wilderness Areas, National Parks, or Monuments experience grasshopper outbreaks, they are not expected to be sources of requests for assistance from land managers for grasshopper treatments. Wilderness Study Areas typically are excluded from treatment because of ecological priorities of the land administrator or steward, often the Bureau of Land Management, and the grasshopper suppression program standard operating procedures ( i.e., no spray buffers). An additional area designation is Areas of Critical Environmental Concern, which are areas within public lands where special management attention is required to protect and prevent irreparable damage to important historic, cultural, or scenic values, fish and wildlife resources or other natural systems or processes, or to protect life and safety from natural hazards. Such areas or other similar designations from various land management agencies would not be recommended for grasshopper suppression activities, and APHIS will attempt to determine any such special designations with the land manager prior to conducting grasshopper suppression treatments. APHIS believes the grasshopper suppression program activities will not adversely affect the economy in areas where they occur because surveys, monitoring, population mapping, treatment avoidance in ecologically sensitive areas, application of chemical insecticide or biopesticide treatments, and any actions taken by cooperating agencies based on the technical assistance provided by APHIS will occur over short timespans and will have negligible economic effects.

Comments that identify other alternatives or issues that could be considered for examination in the PEIS would be especially helpful. All comments received during the comment period on this NOI will be published on the Federal eRulemaking Portal ( http://www.regulations.gov ) under the docket number in ADDRESSES above and carefully considered in developing the final scope of the PEIS.

Following the review of comments on the NOI and completion of the PEIS, APHIS will issue a Stakeholder Registry notice and will post on its website the PEIS and Record of Decision. In addition, APHIS will provide notification to all agencies or persons consulted and all parties that submitted comments on the NOI, utilizing established communication channels consistent with 7 CFR 1b.8(d). APHIS expects to finalize the PEIS and ROD no later than August 2027 in compliance with 42 U.S.C. 4336a(g) and 7 CFR 1b.7(k).

Pursuant to 42 U.S.C. 4336a(a)(3) and 7 CFR 1b.9(m)(3), in September 2025, the U.S. Department of the Interior's Bureau of Land Management Division of Forestry, Rangeland, and Vegetation Resources and the USDA's U.S. Forest Service were invited to cooperate or participate in the preparation of the PEIS due to their special expertise as land managers of land where grasshopper outbreaks may occur. On January 15, 2026, both agencies agreed to officially serve as cooperating agencies with APHIS on the preparation of the PEIS.

Pursuant to 42 U.S.C. 4336a(c) and7 CFR 1b.7(b)(1)(viii), this NOI requests public comment to help identify potential alternatives or other issues that could be considered, potential effects, and any relevant information, studies, or analyses that APHIS should consider in evaluating the potential impacts of the proposed alternatives on the quality of the human environment. “Human environment” under NEPA “means comprehensively the natural and physical environment and the relationship of present and future generations of Americans with that environment.”  23 “Effect” or “impact” under NEPA “means changes to the human environment from the proposed action or action alternatives that are reasonably foreseeable and have a reasonably close causal relationship to the proposed action or alternatives.”  24 To promote informed NEPA analysis and decision-making, comments should be as specific as possible and explain why the issues raised are important for consideration in the PEIS. Comments should include, where possible, copies of references and data sources supporting the information provided in the comment.

The comments received will be published on the Federal eRulemaking Portal ( http://www.regulations.gov ).

Title: Emergency Conservation Program and Biomass Crop Assistance Program.

OMB Control Number: 0560-0082.

Expiration Date of Approval: December 31, 2026.

Type of Request: Revision of a currently approved information collection.

Abstract: The collection of this information is necessary to allow FSA to:

(1) Effectively administer the regulations under ECP, which are set forth at 7 CFR part 701, so as to provide funding and technical assistance for farmers and ranchers to restore farmland damaged by natural disasters, and for emergency water conservation measures in severe droughts; and

(2) Effectively administer the regulations for BCAP, which are set forth at 7 CFR part 1450, so as to provide financial assistance to owners and operators of agricultural and non-industrial private forest land who wish to establish, produce, and deliver biomass feedstocks.

This information is collected in support of, respectively, sections 401-407 of the Agricultural Credit Act of 1978 (Pub. L. 95-334), as amended, and section 9011 of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), as amended. Activity related to BCAP did not change since the last Office of Management and Budget (OMB) submission due to the lack of BCAP funding. Activity related to ECP requests, approvals, and payments continues to fluctuate due to major storm systems that caused catastrophic damage across the nation, from 2024-2026. Multiple hurricanes, wildfires and flood events all contributed to this activity.

For the following estimated annual burden on respondents, the formula used to calculate the total burden hours is estimated average time per response multiplied by the estimated total annual responses.

Type of Respondents: Owners, operators and other eligible agricultural producers on eligible farmland.

Estimated Number of Respondents: 10,000.

Estimated Number of Responses per Respondent: 10.03.

Estimated Total Annual Responses: 100,300.

Estimated Total Annual Burden on Respondents: 12,427.

We are requesting comments on all aspects of this information collection to help us to:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Evaluate the quality, ability and clarity of information technology; and

(4) Minimize the burden of information collection on those who respond through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information.

All responses to this notice, including names and addresses when provided, will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Climbing is a growing sport in the United States. According to the Outdoor Industry Association's 2022 report on outdoor participation trends, there were nearly 10.3 million climbers in the United States in 2021, of which approximately 2.3 million participated in sport or boulder climbing and approximately 2.4 million participated in traditional ice or mountaineering climbing. The Access Fund, a nonprofit climbing advocacy group, estimates that approximately 30 percent of outdoor climbing in the United States occurs on National Forest System (NFS) lands. In recent years, Forest Service managers have expressed concerns about climbing-related impacts on NFS resources and conflicts among uses on NFS lands.

Current Forest Service directives do not provide guidance for climbing opportunities on NFS lands. Section 122 of the EXPLORE Act (Pub. L. 118-234), 16 U.S.C. 8422, directs the Secretary of Agriculture to issue guidance for recreational climbing activities in wilderness on NFS lands that (1) ensures that recreational climbing activities comply with applicable laws and regulations, (2) recognizes recreational climbing (including the use, placement, and maintenance of fixed anchors) as an appropriate use within components of the National Wilderness Preservation System, (3) describes requirements for the placement and maintenance of fixed anchors for recreational climbing in wilderness, and (4) includes direction for the continued use and maintenance of recreational climbing routes (including fixed anchors along the routes) in existence as of January 4, 2025.

Nothing in section 122 of the EXPLORE Act amends, modifies, or supersedes the Wilderness Act, and this proposal is intended to be implemented consistent with that statute. To implement section 122 of the EXPLORE Act with respect to wilderness—while exercising the Secretary's authority for non-wilderness areas—the Forest Service is proposing revisions to its directives to provide guidance on climbing opportunities on NFS lands.

The proposed directive would provide guidance on climbing opportunities inside and outside wilderness on NFS lands and would provide for climbing opportunities that serve visitor needs; meet land management and recreation policy objectives; emphasize the natural setting of NFS lands; align with natural and cultural resource protection and the Agency's responsibility to Indian Tribes; and are consistent with applicable law, directives, and the applicable land management plan.

The proposed directive would establish a new section, 2355, to Forest Service Manual (FSM) 2300—Recreation, Wilderness, and Related Resource Management, Chapter 2350—Trail, River, and Similar Recreation Opportunities. The new section would provide that recreational climbing (including the use, placement, and maintenance of fixed anchors) is an appropriate use of NFS lands—including in wilderness—when conducted in accordance with applicable law and Forest Service directives and consistent with the applicable land management plan (proposed FSM 2355.03, para. 1); that a climbing management plan should be considered for development where the responsible official determines that planning direction is necessary to address resource conditions, visitor use patterns, use conflict, wilderness character considerations, or public safety concerns, and as funding and resources allow, with priority given to areas with the highest level of need (such as high levels of use, use conflicts, or resource degradation) (proposed FSM 2355.21); and promote stewardship opportunities and collaboration between the Forest Service and climbing organizations (proposed FSM 2355.03, para. 14).

The proposed directive also includes changes from the directive the Forest Service proposed on November 17, 2023 (88 FR 80269), on recreational climbing on NFS lands. The 2023 proposal stated that fixed anchors and fixed equipment were installations for purposes of section 4(c) of the Wilderness Act and would have required a case-specific minimum requirements determination for placement, replacement, or retention of fixed anchors and fixed equipment in wilderness. The Forest Service received public comments on that proposal and, after enactment of section 122 of the EXPLORE Act, reevaluated that approach. In particular, the changes reflect the Secretary's reasoned exercise of discretion in interpreting and administering section 122 of the EXPLORE Act and section 4(c) of the Wilderness Act (16 U.S.C. 1133(c)) in an area where the statutory text does not expressly address how fixed anchors should be treated under section 4(c). For over 30 years, the Forest Service has wrestled with the complex and controversial management topic of fixed anchors in wilderness at site-specific and national levels.

These efforts included establishing the Fixed Anchors in Wilderness Negotiated Rulemaking Advisory Committee in 1999, which failed to reach a consensus on recommendations for rulemaking. The approach proposed here is based on a reasoned interpretation of the applicable statutory text while also considering relevant legislative history, public comments received on the 2023 proposal, intervening enactment of section 122 of the EXPLORE Act, and the Forest Service's management experience. The Forest Service also considered retaining the approach reflected in the 2023 proposal, including requiring a case-specific minimum requirements determination for placement, replacement, or retention of fixed anchors in wilderness, but concluded that the approach proposed here better balances wilderness stewardship, climber safety, administrative practicality, and the direction provided in section 122 of the EXPLORE Act while preserving consistency with the Wilderness Act.

Section 122 of the EXPLORE Act directs the Secretary to recognize that recreational climbing, including the use, placement, and maintenance of fixed anchors, may be an appropriate use within wilderness when undertaken in accordance with the Wilderness Act. The Wilderness Act requires that wilderness areas be administered so as to preserve wilderness character, including their undeveloped condition and outstanding opportunities for solitude or a primitive and unconfined type of recreation, while providing for public recreational use in a manner that leaves the areas unimpaired for future use and enjoyment. The proposed directive implements section 122 of the EXPLORE Act in a manner that preserves this statutory balance. It recognizes recreational climbing as a legitimate wilderness use, while reserving decision space at the local level to evaluate site-specific conditions, long-term impacts, and management needs consistent with preservation of wilderness character and other applicable law.

Specifically, this proposed directive reflects the Forest Service's interpretation that certain fixed anchors, when limited in scope and function and placed consistent with this direction, are distinguishable from other forms of fixed equipment or constructed features for purposes of administering section 4(c) of the Wilderness Act. In administering wilderness areas, the Forest Service generally does not require a minimum requirements analysis for certain limited use of fixed anchors, provided their placement and maintenance are consistent with applicable law, wilderness stewardship principles, and an approved climbing management plan where required. This interpretation is informed by the Agency's management experience and the direction provided in section 122 of the EXPLORE Act.

Nothing in this proposed direction alters the applicability of section 4(c) of the Wilderness Act or the requirement to conduct a minimum requirements analysis where otherwise required by law. Further, nothing in this proposed directive limits the Forest Service's authority to evaluate site-specific circumstances or to determine that particular fixed anchors or related recreational climbing features warrant additional analysis or management action under the Wilderness Act or other applicable law.

To allow for enforcement of restrictions and prohibitions in climbing management plans as needed, the Forest Service will be proposing revisions via a separate Federal Register notice to its regulations at 36 CFR part 261, subpart A General Prohibitions.

On March 23, 2026, the Forest Service distributed a notification of the opportunity to consult, along with a summary of the proposed changes, to all federally recognized Tribes, Alaska Native Corporations, and local Tribal contacts. Formal consultation sessions have not yet occurred; however, early written feedback has highlighted concerns regarding protection of cultural resources and sacred sites, the need to evaluate cumulative effects, the importance of thoughtful climbing management plans, and interest in how route development will be addressed.

All Tribal feedback, both early input and consultation comments, will be incorporated into the Tribal Summary Impact section of the directive. This engagement will continue to guide refinements to the proposed directive to ensure it aligns with Tribal interests, protects cultural resources, and supports the Forest Service's trust responsibilities.

After the comment period closes, the Forest Service will consider timely comments that are within the scope of the proposed directive in the development of the final directive. A notice of the final directive, including a response to comments, will be posted on the Forest Service's web page at https://www.fs.usda.gov/about-agency/regulations-policies.

The full text of the Notice is available on the Agency website at https://www.rd.usda.gov/programs-services/business-programs/intermediary-relending-program.

On August 24, 2017, Commerce published in the Federal Register the antidumping duty (AD) order on finished carbon steel flanges from India. 1 On February 12, 2026, Commerce published the Preliminary Results of the 2023-2024 administrative review and invited interested parties to comment. 2 On March 4, 2026, Norma Group  3 submitted a case brief. 4 No other party submitted case or rebuttal briefs. The deadline for these final results is June 12, 2026.

The merchandise covered by the Order is finished carbon steel flanges. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 5

Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying these final results, see the Issues and Decision Memorandum.

All issues raised by parties in their case brief are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised, and to which we responded in the Issues and Decision Memorandum, is provided in Appendix I to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/frnotices.

Based on our analysis of the comments received, and for the reasons explained in the Issues and Decision Memorandum, Commerce made certain changes to the preliminary weighted-average dumping margin for Norma Group. As a result of these changes, we have also revised the rate applicable to companies not selected for individual examination.

In the past, Commerce has used changed circumstance reviews (CCRs), under section 751(b)(1) of the Act and 19 CFR 351.216, to consider the applicability of cash deposit rates after there have been changes in the name or the structure of a respondent, such as a merger or spinoff (successor-in-interest, or successorship, determinations). While successor-in-interest determinations are often made in the context of distinct CCRs, Commerce has also made successor-in-interest determinations in the context of administrative reviews and investigations. 6

In this review, Munish Forge Limited (MFL) identified that it had made a legal name change from the former company name Munish Forge Private Limited (MFPL) and provided information necessary to evaluate the statements in support of the successorship claim within the context of Commerce's established criteria. 7 In these final results, we determine that, based on the totality of the circumstances and in the absence of any contradictory information on the record, MFL is the successor-in-interest to MFPL, as the change in the company's name was not accompanied by significant changes to its management and operations, production facilities, supplier relationships, and/or customer base. 8 Thus, we have concluded that MFL operates as essentially the same business entity as MFPL, that MFL is the successor-in-interest to MFPL, and that MFL should receive the same AD cash deposit rate and customs number as its predecessor, with respect to subject merchandise.

The Act and Commerce's regulations  9 do not address the establishment of a rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review.

Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any rates that are zero, de minimis, or based entirely on facts available. If the weighted-average dumping margin for each of the individually examined companies is zero, de minimis, or based entirely on facts available, section 735(c)(5)(B) of the Act provides that Commerce may use “any reasonable method to establish the estimated all-others rate for exporters and producers not individually investigated, including averaging the estimated weighted-average dumping margins determined for the exporters and producers individually investigated.”

In this administrative review, we calculated weighted-average dumping margins for Norma Group and R.N. Gupta & Co. Ltd. (RNG) that are not zero, de minimis ( i.e., less than 0.5 percent), or determined entirely on the basis of facts available. Accordingly, Commerce is assigning to the companies not individually examined a margin of 1.94 percent, which is the weighted average of Norma Group's and RNG's margins based on publicly ranged data. The companies not selected for individual examination are listed in Appendix II to this notice.

For these final results, we determine that the following estimated weighted-average dumping margins exist for the period August 1, 2023, through July 31, 2024:

Commerce intends to disclose its calculations and analysis performed for these final results to interested parties 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).

Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.

Because the mandatory respondents' weighted-average dumping margins are not zero or de minimis ( i.e., less than 0.50 percent) in the final results of this review, Commerce calculated an importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales to the total entered value of those sales. Where we do not have entered values for all U.S. sales to a particular importer, we calculated an importer-specific, per-unit assessment rate on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total quantity of those sales. To determine whether an importer-specific, per-unit assessment rate is de minimis, in accordance with 19 CFR 351.106(c)(2), we also calculated an importer-specific ad valorem ratio based on estimated entered values. Where a mandatory respondent's weighted-average dumping margin is zero or de minimis or where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate appropriate entries without regard to antidumping duties. 11

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Norma and RNG which they did not know that the merchandise was destined for the United States, we intend to instruct CBP to liquidate those entries at the all-others rate calculated in the less-than-fair-value (LTFV) investigation if there is no rate for the intermediate companies involved in the transaction. 12

For the companies listed in Appendix II that were not selected for individual review, we will assign an assessment rate based on the review-specific rate, calculated as noted in the “Rate for Non-Individually Examined Companies” section, above.

These final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 13

Commerce intends 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 Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective upon publication in the Federal Register of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for companies subject to this review will be equal to the company-specific weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by a company not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published in the completed segment for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the LTFV investigation, but the producer is, then the cash deposit rate will be the rate established in the most recently completed segment of the proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 8.91 percent, the all-others rate established in the LTFV investigation. 14 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to APO of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

These final results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

In accordance with sections 705(d) and 777(i) of the Tariff Act of 1930 as amended (the Act) on April 24, 2026 Commerce published in the Federal Register its affirmative final determinations in the countervailing duty investigations of certain chassis and subassemblies thereof from Mexico and Thailand. 1 On June 8, 2026, the ITC notified Commerce of its final affirmative determinations pursuant to sections 705(b)(1)(A)(i) and 705(d) of the Act, that an industry in the United States is materially injured by reason of subsidized imports of chassis and subassemblies thereof from Mexico and Thailand. 2

The product covered by these orders is chassis from Mexico and Thailand. For a complete description of the scope of these orders, see the appendix to this notice.

Based on the above-referenced affirmative final determinations by the ITC that an industry in the United States is materially injured by reason of subsidized imports of chassis from Mexico and Thailand, in accordance with sections 705(c)(2) and 706(a) of the Act, Commerce is issuing these CVD orders. Because the ITC determined that imports of chassis from Mexico and Thailand are materially injuring a U.S. industry, unliquidated entries of such merchandise entered, or withdrawn from warehouse, for consumption, are subject to the assessment of countervailing duties.

Therefore, in accordance with section 706(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, countervailing duties on unliquidated entries of chassis from Mexico and Thailand. With the exception of entries occurring after the expiration of the provisional measures period and before the publication of the ITC's final affirmative injury determinations, as further described below, countervailing duties will be assessed on unliquidated entries of chassis from Mexico and Thailand entered, or withdrawn from warehouse, for consumption on or after August 1, 2025, the date of publication of the Preliminary Determinations in the Federal Register . 3

In accordance with section 706 of the Act, Commerce will instruct CBP to reinstitute the suspension of liquidation of chassis from Mexico and Thailand, effective on the date of publication of the ITC's notice of final affirmative injury determination in the Federal Register , and to assess, upon further instruction by Commerce, pursuant to section 706(a)(1) of the Act, countervailing duties on each entry of subject merchandise in an amount based on the net countervailable subsidy rates below. On or after the date of publication of the ITC's final injury determinations in the Federal Register , CBP must require, at the same time as importers would normally deposit estimated duties on this merchandise, a cash deposit equal to the rates noted below. These instructions suspending liquidation will remain in effect until further notice.

The estimated countervailable subsidy rates are as follows; all-others rate applies to all producers or exporters not specifically listed below.

Section 703(d) of the Act states that the suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months. In the underlying investigations, Commerce published the Preliminary Determinations on August 1 2025. 4 Therefore, entries of certain chassis and subassemblies thereof from Mexico and the Kingdom of Thailand made on or after November 29, 2025, and prior to the date of publication of the ITC's final determinations in the Federal Register , are not subject to the assessment of countervailing duties due to Commerce's discontinuation of the suspension of liquidation.

In accordance with section 703(d) of the Act, Commerce instructed CBP to terminate the suspension of liquidation and to liquidate, without regard to countervailing duties, unliquidated entries of chassis from Mexico and Thailand entered, or withdrawn from warehouse, for consumption on or after November 29, 2025, the date on which the provisional CVD measures expired, through the day preceding the date of publication of the ITC final injury determinations in the Federal Register . Suspension of liquidation and the collection of cash deposits will resume on the date of publication of the ITC final injury determinations in the Federal Register .

On September 20, 2021, Commerce published the Final Rule in the Federal Register . 5 On September 27, 2021, Commerce also published the Procedural Guidance in the Federal Register . 6 The Final Rule and Procedural Guidance provide that Commerce will maintain an annual inquiry service list for each order or suspended investigation, and any interested party submitting a scope ruling application or request for circumvention inquiry shall serve a copy of the application or request on the persons on the annual inquiry service list for that order, as well as any companion order covering the same merchandise from the same country of origin. 7

In accordance with the Procedural Guidance, 8 for orders published in the Federal Register after November 4, 2021, Commerce will create an annual inquiry service list segment in Commerce's online e-filing and document management system, Antidumping and Countervailing Duty Electronic Service System (ACCESS), available at https://access.trade.gov, within five business days of publication of the notice of the order. Each annual inquiry service list will be saved in ACCESS, under each case number, and under a specific segment type called “AISL-Annual Inquiry Service List.”  9

Interested parties who wish to be added to the annual inquiry service list for an order must submit an entry of appearance to the annual inquiry service list segment for the order in ACCESS within 30 days after the date of publication of the order. For ease of administration, Commerce requests that law firms with more than one attorney representing interested parties in an order designate a lead attorney to be included on the annual inquiry service list. Commerce will finalize the annual inquiry service list within five business days thereafter. As mentioned in the Procedural Guidance, the new annual inquiry service list will be in place until the following year, when the Opportunity Notice for the anniversary month of the order is published.

Commerce may update an annual inquiry service list at any time as needed based on interested parties' amendments to their entries of appearance to remove or otherwise modify their list of members and representatives, or to update contact information. Any changes or announcements pertaining to these procedures will be posted to the ACCESS website.

In the Final Rule, Commerce stated that, “after an initial request and placement on the annual inquiry service list, both petitioners and foreign governments will automatically be placed on the annual inquiry service list in the years that follow.”  10 Accordingly, as stated above, the petitioners and the Governments of Mexico and Thailand should submit their initial entry of appearance after publication of this notice in order to appear in the first annual inquiry service list for those orders for which they qualify as an interested party. Pursuant to 19 CFR 351.225(n)(3), the petitioners and the Governments of Mexico and the Kingdom of Thailand will not need to resubmit their entry of appearance each year to continue to be included on the annual inquiry service list. However, the petitioners and the Governments of Mexico and the Kingdom of Thailand are responsible for making amendments to their entries of appearance during the annual update to the annual inquiry service list in accordance with the procedures described above.

This notice constitutes the CVD orders with respect to chassis from Mexico and pursuant to section 706(a) of the Act. Interested parties can find a list of CVD orders currently in effect at https://www.trade.gov/data-visualization/adcvd-proceedings.

These CVD orders are published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).

On October 17, 2025, the President issued Proclamation 10984 (Adjusting Imports of Medium- and Heavy-Duty Vehicles, Medium- and Heavy-Duty Vehicle Parts, and Buses Into the United States) (90 FR 48451), finding that imports of medium- and heavy-duty vehicles (MHDVs), medium- and heavy-duty vehicle parts (MHDVPs), and buses threaten to impair the national security of the United States, and determining that it is necessary and appropriate to impose specified tariffs to adjust imports of MHDVs, MHDVPs, and buses so that such imports will not threaten to impair national security pursuant to section 232 of the Trade Expansion Act of 1962, as amended ( 19 U.S.C. 1862 ). In addition, Proclamation 10984 acknowledged the close connections and overlap between part suppliers for the automobile industry and for the MHDV industry, and determined that it is necessary and appropriate to conform certain aspects of the tariff system imposed in Proclamation 10908 of March 26, 2025 (Adjusting Imports of Automobiles and Automobile Parts Into the United States) (90 FR 14705), as amended, with the tariff system imposed in Proclamation 10984 for MHDVs, certain MHDVPs, and buses. Finally, the President found it necessary and appropriate to allow modification of tariffs imposed under Proclamation 9704 of March 8, 2018 (Adjusting Imports of Aluminum Into the United States) (83 FR 11619), as amended, and Proclamation 9705 of March 8, 2018 (Adjusting Imports of Steel Into the United States) (83 FR 11625), as amended, based on commitments to increase production of steel or aluminum products that support U.S. production capacity of key products, including U.S. automobiles and MHDVs.

To enhance the supply chain security and domestic production of U.S. MHDVs and automobiles, Proclamation 10984 authorized the Secretary to reduce tariffs owed under Proclamations 9704 and 9705 by up to half the otherwise applicable rate for aluminum or steel producers that operate production facilities in Canada or Mexico and supply U.S. automobile or MHDV manufacturers. Such adjustments are to be limited to quantities of aluminum or steel equal to newly committed U.S. production capacity, as determined by the Secretary.

Proclamation 10984 provides that the adjusted tariff rate under Proclamations 9704 and 9705 may be no less than 25 percent, and that the adjusted tariff rate is only available for imports of aluminum and steel that qualify for preferential tariff treatment under the U.S.-Mexico-Canada Agreement (USMCA) and that were respectively smelted and cast or melted and poured in Canada or Mexico.

Proclamation 10984 directed the Secretary to administer this program in a manner consistent with the need to address the national security threats the President found in Proclamation 9704, Proclamation 9705, and Proclamation 9888 of May 17, 2019 (Adjusting Imports of Automobiles and Automobile Parts Into the United States) (84 FR 23433). The Secretary has determined that it is necessary to establish a process for firms that operate production facilities in Canada and Mexico to apply for the adjusted tariffs, as authorized in Proclamation 10984, based on the quantities of aluminum or steel equal to newly committed U.S. production capacity. 1 The Secretary has determined that only increased commitments to produce primary steel and primary aluminum should be eligible because these commitments address key bottlenecks and will increase the supply of U.S. steel and aluminum for downstream producers of automobiles and MHDVs. For purposes of these procedures, “primary steel” refers to steel articles that are produced in a basic oxygen furnace, electric arc furnace, or any other steel making furnace in the United States and “primary aluminum” means aluminum articles that are produced in a smelter in the United States.

The Secretary has also determined that, for purposes of these procedures, commitments to increase production capacity of primary steel and primary aluminum that supports U.S. production capacity of key products is limited to commitments to increase capacity of primary steel and primary aluminum that supports U.S. production capacity for automobiles, MHDVs, automobile parts, and MHDV parts (MHDVPs). Proclamation 10984 identifies automobiles and MHDVs as examples of key products. As automobile parts and MHDVPs are critical inputs to MHDVs and automobiles, and as much of the steel and aluminum contained in automobiles and MHDVs is first incorporated into automobile parts and MHDVPs, the Secretary determined that automobile parts and MHDVPs are also “key products” under these procedures, consistent with the purpose of Proclamation 10984.

A Federal Register Notice was published on April 23, 2026, announcing the opportunity for Qualified Companies making Qualifying Commitments to submit documentation, on a project-by-project basis, outlining their proposed investment plan, including the proposed location, production details, proposed capacity, and milestone commitments.

OMB Control Number: 0625-0285.

Form Number(s): None.

Type of Review: Regular submission, extension of a current information collection.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 60.

Estimated Time per Response: 60 hours.

Estimated Total Annual Burden Hours: 3,600.

Estimated Total Annual Cost to Public: $108,684.

Respondent's Obligation: Voluntary.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

On November 18, 2025, Commerce published the Preliminary Results and invited interested parties to comment. 1 Due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by 21 days. 2 On March 12, 2026, we extended the deadline for these final results until May 29, 2026. 3 On April 1, 2026, we issued a Post-Preliminary Analysis wherein we applied an adjustment to reflect an affirmative particular market situation (PMS) determination related to labor in India; we invited interested parties to comment on the Post-Preliminary Analysis. 4 On May 28, 2026, Commerce extended the deadline for the final results by an additional nine days, to June 8, 2026. 5

For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 6 The Issues and Decision Memorandum is a public document and is on file electronically via ACCESS. ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/frnotices.

The product covered by this Order is raw honey from India. For a full description of the scope, see the Issues and Decision Memorandum.

We addressed the issues raised in the case and rebuttal briefs in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is included in Appendix I to this notice.

Based on our review of the record, including comments received from interested parties, we have made changes to the Preliminary Results and Post-Preliminary Analysis margin calculations for Indocan Honey Private Limited (Indocan) and Shakti Apifoods Pvt., Ltd. (Shakti). 8

The Tariff Act of 1930, as amended (the Act), and Commerce's regulations do not address the establishment of a rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “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 de minimis margins, and any margins determined entirely {on the basis of facts available}.”

For these final results, we have calculated weighted-average dumping margins for Indocan and Shakti that are not zero, de minimis, or determined entirely on the basis of facts available. Therefore, Commerce assigned a margin to the companies not selected for individual examination based on the weighted average of the two mandatory respondents' rates, as listed below. 9

Commerce determines that the following weighted-average dumping margins exist for the period June 1, 2023, through May 31, 2024:

Commerce intends to disclose the calculations performed in connection with these final results of review to interested parties within five days after public announcement of the final results or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.

Because the weighted-average dumping margins for Indocan and Shakti are not zero or de minimis ( i.e., less than 0.5 percent), we calculated importer-specific ad valorem assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales. Where an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

Consistent with Commerce's assessment practice, for entries of subject merchandise during the POR produced by Indocan or Shakti for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 11

For the companies that were not selected for individual examination ( see Appendix II), we will assign an assessment rate based on the review-specific average rate, calculated as noted in the “Rate for Non-Selected Respondents” section above.

Commerce intends 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 Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rates for Indocan, Shakti, and the companies not selected for individual examination will be the weighted-average dumping margins established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV)

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h)(1).

In accordance with sections 735(d) and 777(i) of the Tariff Act of 1930, as amended (the Act), on April 23, 2026, Commerce published its affirmative final determinations in the less-than-fair-value (LTFV) investigations of chassis from Mexico, Thailand, and Vietnam. 1

On June 8, 2026, pursuant to section 735(d) of the Act, the ITC notified Commerce of its final affirmative determinations that an industry in the United States is materially injured by reason of LTFV imports of chassis from Mexico, Thailand, and Vietnam within the meaning of section 735(b)(1)(A)(i) of the Act. 2

The merchandise covered by these orders is chassis from Mexico, Thailand, and Vietnam. For a complete description of the scope of the orders, see the appendix to this notice.

As stated above, based on the ITC's affirmative final determinations that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act by reason of LTFV imports of chassis from Mexico, Thailand, and Vietnam, 3 in accordance with section 735(c)(2) of the Act, Commerce is issuing these AD orders. Moreover, because the ITC determined that imports of chassis from Mexico, Thailand, and Vietnam are materially injuring a U.S. industry, unliquidated entries of subject merchandise from Mexico, Thailand, or Vietnam entered, or withdrawn from warehouse, for consumption, are subject to the assessment of antidumping duties.

Therefore, in accordance with section 736(a)(1) of the Act, Commerce intends to direct U.S. Customs and Border Protection (CBP) to assess, upon further instructions by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, on all relevant entries of chassis from Mexico, Thailand, and Vietnam, which are entered, or withdrawn from warehouse, for consumption, on or after September 29, 2025, the date of publication of the Preliminary Determinations, 4 but will not include entries after the expiration of the provisional measures period and before publication of the ITC's final injury determinations under section 735(d) of the Act, as further described in the “Provisional Measures” section of this notice.

Except as noted in the “Provisional Measures” section of this notice, in accordance with section 735(c)(1)(B) of the Act, Commerce intends to instruct CBP to continue to suspend liquidation on all relevant entries of chassis from Mexico, Thailand, and Vietnam. These instructions suspending liquidation will remain in effect until further notice.

Commerce will also instruct CBP to require cash deposits equal to the estimated weighted-average dumping margins indicated in the tables below. Effective on the date of publication in the Federal Register of the notice of the ITC's final affirmative injury determinations, CBP will require, at the same time as importers would normally deposit estimated customs duties on subject merchandise, a cash deposit equal to the rates listed in the table below. The all-others rate applies to all producers or exporters not specifically listed, as appropriate.

The estimated weighted-average dumping margins are as follows:

This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

In accordance with 41 CFR 51-5.3(b), the Committee intends to add the service requirement listed below to the Procurement List as a mandatory purchase only for the contracting activities at the locations listed with the proposed qualified nonprofit agency as the authorized source of supply. Prior to adding the service to the Procurement List, the Committee will consider other pertinent information, including information from Government personnel and relevant comments from interested parties regarding the Committee's intent to geographically limit this services requirement.

The following services(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

The following product(s) are proposed for deletion to the Procurement List:

Background: The Committee for Purchase From People Who Are Blind or Severely Disabled is an independent Federal agency operating as the U.S. AbilityOne Commission. It oversees the AbilityOne Program, which provides employment opportunities through Federal contracts for people who are blind or have significant disabilities in the manufacture and delivery of products and services to the Federal Government. The Javits-Wagner-O'Day Act (41 U.S.C. chapter 85) authorizes the contracts.

Registration: Attendees not requesting speaking time should register not later than July 21, 2026. Attendees requesting speaking time must register not later than July 14, 2026, and use the comment fields in the registration form to specify the intended speaking topic(s). The registration link will be available on the Commission's home page, www.abilityone.gov, under News and Events.

Commission Statement: This regular quarterly public meeting will include updates from the Commission Chairperson, Executive Director, and Acting Inspector General.

Public Participation: The public engagement session will both celebrate the historic milestone of America250 and continue to emphasize “Innovation in AbilityOne Products and Domestic Manufacturing.” In keeping with these themes, speakers are invited to highlight examples of pride and patriotism within—and contributions of—the AbilityOne Program's 88-year history of Federal contracting. In addition, speakers are invited to highlight current domestic manufacturing within the AbilityOne Program including, but not limited to, examples of innovation, efficiency, speed, cost effectiveness, competitiveness, responsiveness to customer needs, reshoring/onshoring materials or components (to use domestic sources), and supply chain management. The Commission looks forward to receiving comments and suggestions on these topics.

During registration, you may choose to submit comments, or you may request speaking time at the meeting. The Commission may invite some attendees who submit advance comments to discuss their comments during the meeting. Comments submitted will be reviewed by staff and the Commission members before the meeting. Comments posted in the chat box during the meeting will be shared with the Commission members after the meeting. The Commission is not subject to the requirements of 5 U.S.C. 552(b); however, the Commission published this notice to encourage the broadest possible participation in its meeting.

Personal Information: Speakers should not include any information that they do not want publicly disclosed.

Deletion

On May 14, 2026 (91 FR 27304), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

After consideration of the relevant matter presented, the Committee has determined that the service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the service(s) deleted from the Procurement List.

Accordingly, the following service(s) are deleted from the Procurement List:

CPSC seeks to renew the following currently approved collection of information:

Title: Standard for the Flammability of Mattresses and Mattress Pads (16 CFR part 1632) and Standard for the Flammability (Open Flame) of Mattresses (16 CFR part 1633).

OMB Number: 3041-0014.

Type of Review: Renewal of collection.

Frequency of Response: On occasion.

Affected Public: Manufacturers and importers of mattresses and mattress pads.

General Description of Collection: The Standard for the Flammability of Mattresses and Mattress Pads, 16 CFR part 1632, was issued and amended under section 4 of the Flammable Fabrics Act (FFA), 15 U.S.C. 1193, to reduce unreasonable risks of burn injuries and deaths from fires associated with mattresses and mattress pads. The standard prescribes requirements to test whether a prototype mattress or mattress pad will resist ignition from a smoldering cigarette. The standard also requires recordkeeping of all prototype test results. Manufacturers and importers must maintain these records for three years. Also, under 16 CFR part 1632, each mattress or mattress pad must be permanently labeled with the month and year of manufacture and the location of the manufacturer. Mattress pads treated with a chemical flame retardant must also be labeled prominently with the letter “T” and instructions on how to protect the pads from agents or treatments that can cause deterioration of their flame resistance.

The Commission promulgated the Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR part 1633, under section 4 of the FFA, to reduce deaths and injuries associated with mattress fires by limiting the size of the fire generated by a mattress set during a thirty minute test. The standard requires manufacturers and importers to maintain certain records to document compliance with the standard, including maintaining records concerning prototype testing, pooling, and confirmation testing, and quality assurance procedures and any associated testing. The required records must be maintained for as long as mattress sets based on the prototype are in production and must be retained for three years thereafter. 16 CFR part 1633 also includes labeling requirements for each mattress set to bear a permanent, conspicuous, and legible label containing specified information. See 16 CFR 1633.2.

Estimated Number of Respondents: CPSC estimates there are 80 respondents annually to part 1632 for mattress pads and 403 respondents for mattresses. For part 1633, CPSC estimates 403 respondents.

Estimated Time per Response: On average, each mattress pad producer will respond for three prototypes annually and each mattress producer will respond for eight prototypes annually for both parts 1632 and 1633. CPSC estimates that each respondent will spend five hours for labeling and recordkeeping per prototype annually.

Total Estimated Annual Burden: Based on each mattress pad producer responding for three prototypes annually and each mattress producer responding for eight prototypes annually, the estimated annual burden for mattress pads subject to part 1632 is 1,200 hours (80 respondents × 3 responses per year × 5 hours per response = 1,200 hours per year), and the estimated annual burden for mattresses subject to 1632 is 16,120 hours (403 respondents × 8 responses per year × 5 hours per response = 16,120). For mattresses subject to part 1633, based on an average of eight different qualified prototypes, the total recordkeeping time is about 16,120 hours annually (403 respondents × 8 responses annually × 5 hours per responses = 16,120 hours).

Total Estimated Annual Cost to Respondents: The hourly compensation for the time required for record keeping for both parts 1632 and 1633 is estimated at $80.04 (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” December 2025, Total compensation of all management, professional, and related occupations in goods-producing industries: https://www.bls.gov/news.release/archives/ecec_03202026.htm ). At this rate, the annualized cost to the respondents would be $2,676,538 (33,440 hours × $80.04 = $2,676,537.60). Therefore, CPSC estimates the total cost of the information collection burden to respondents, for 16 CFR 1632 and 16 CFR 1633, is approximately $2.7 million, annually.

Request for Comments:

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

• whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;

• whether the estimated burden of the proposed collection of information is accurate;

• whether the quality, utility, and clarity of the information to be collected could be enhanced; and

• whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Federal Direct Loan Program Regulations for Forbearance and Loan Rehabilitation.

OMB Control Number: 1845-0119.

Type of Review: A revision of a currently approved ICR.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 1,238,097.

Total Estimated Number of Annual Burden Hours: 4,543,816.

Abstract: The Department of Education (the Department) is seeking emergency processing, in accordance with 5 CFR 1320.13, of the revision of OMB control number 1845-0119 Federal Direct Loan Program Regulations for Forbearance and Loan Rehabilitation.

The One Big Beautiful Bill Act (OBBBA) signed into law by President Trump on July 4, 2025 includes provisions that affect this collection; specifically, 34 CFR 685.211 Miscellaneous repayment provisions. The Final Rule regarding these regulations was published on May 1, 2026 (91 FR 23768). The Department is now updating this collection to comply with the new regulations mentioned above. The Department is also introducing a new, simpler, online portal for borrowers seeking loan rehabilitation.

The (EM SSAB), Paducah meeting previously scheduled for Thursday, June 18, 2026 (91 FR 25872) has been rescheduled for Thursday, July 16, 2026.

Purpose of the Board: At the request of the Assistant Secretary or Field Managers, the Board may provide community-based advice and recommendations concerning any EM program activities, such as clean-up activities and environmental restoration; waste management and disposition; excess facilities; future land use and long-term stewardship; communications; and budget priorities. The Board also provides an avenue to fulfill public participation requirements outlined in the Comprehensive Environmental Response, Compensation, and Liability Act (CERLA), the Resource Conservation and Recovery Act (RCRA), Federal Facility Agreements, Consent Orders, Consent Decrees and Settlement Agreements.

Tentative Agenda: (agenda topics are subject to change; please contact Zachary Boyarski for the most current agenda).

Public Participation: The meeting is open to the public and public comment can be given orally or in writing. Fifteen minutes are allocated during the meeting for public comment and those wishing to make oral comment will be given a minimum of two minutes to speak. Written comments received at least two working days prior to the meeting will be provided to the members and included in the meeting minutes. Written comments received within two working days after the meeting will be included in the minutes. For additional information on public comment and to submit written comment, please contact Zachary Boyarski at Zachary.Boyarski@pppo.gov. The EM SSAB, Paducah, welcomes the attendance of the public at its meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Zachary Boyarski at least seven days in advance of the meeting.

Meeting Conduct: The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Questioning of board members or presenters by the public is not permitted.

Minutes: Minutes will be available at the following website: https://www.energy.gov/pppo/pgdp-cab/listings/meeting-materials.

Signing Authority: This document of the Department of Energy was signed on June 16, 2026, by David Borak, Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

OMB Control Number: 3060-XXXX.

Title: Modernizing Suspension and Debarment Rules.

Form Number: N/A.

Type of Review: New information collection.

Respondents: Business or other for-profit; Individuals or households; State, local, or tribal governments; Not-for-profit institutions.

Number of Respondents and Responses: 75,255 unique respondents; 170,259 unique responses.

Estimated Time per Response: 1-2 hours.

Frequency of Response: Annual, on occasion reporting requirements and third party disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for these information collections are contained in sections 1, 2, 4(i), 4(j), 218, 225, 254, 403, 715, and 719 of the Communications Act of 1934, as amended, and section 904 of Division N, Title IX of the Consolidated Appropriations Act, 2021, Public Law 116-260, 134 Stat. 1182, as amended by section 60502 of Division F, Title V of the Infrastructure Investment and Jobs Act, Public Law 117-58, 135 Stat. 429 (2021), 47 U.S.C. 151, 152, 154, 218, 225, 254, 403, 616, and 620.

Total Annual Burden: 244,185 hours.

Total Annual Cost: No Cost.

Needs and Uses: On March 26, 2026, the Commission adopted the Modernizing Suspension and Debarment Rules Report & Order, adopting a revised suspension and debarment framework that allows the Commission to promptly and efficiently exclude or otherwise limit bad actors' participation in Congressionally-mandated funding programs, such as the Universal Service Fund (USF) and the Telecommunications Relay Services (TRS) program. These programs provide significant funding to close the digital divide and ensure that all Americans have access to communications services.

The Report and Order adopted the governmentwide Office of Management and Budget Governmentwide Guidelines on Debarment and Suspension, as well as supplemental rules tailored to the FCC's programs. To promote transparency and safeguard these critical programs from waste, fraud, and abuse, the Report and Order implements, in pertinent part, several reporting and third-party disclosure requirements consistent with the OMB Guidelines.

These new rules are new information collection requirements which are as follows:

a. Section 6001.335 Disclosures. Pursuant to 2 CFR 180.335 and 2 CFR 6001.335, all program participants must disclose prior misconduct to other participants with whom they are doing or seek to do business, the program administrators, and the Commission. Generally, these disclosures are required at the time program participants enter into covered transactions to ensure that all interested parties are making informed business decisions and conducting business only with participants that are presently responsible. Participants must disclose, under penalty of perjury, if they are presently excluded or disqualified, have been convicted of offenses listed in in section 180.800(a), are presently indicted or otherwise criminally or civilly charged with such offenses, or have had one or more public transactions terminated within the preceding three years for cause or default.

Additionally, pursuant to 2 CFR 180.335 and 2 CFR 6001.335, if no disclosures are required, participants must so certify under penalty of perjury that no disclosures are required under the suspension and debarment rules. We anticipate that these “no response required” certifications will be included on existing forms for each program (as described in subparts (e) through (k) below).

b. Section 6001.120(a) Disclosure. To ensure the Commission's own compliance with the prohibition in 2 CFR 180.400 on entering into covered transactions with people that are currently suspended or debarred, the rules require FCC program participants that are presently excluded on the effective date of these rules to notify the Commission of their status.

c. Section 6001.120(b) Disclosure. Likewise, to the extent that FCC program participants are later suspended or debarred by another federal agency, those excluded participants are required to notify the Commission of such exclusion within 30 days.

d. Section 6001.330(a) Third Party Compliance Certification. Consistent with 2 CFR 180.330, the Report and Order requires program participants to ensure the people with whom they intend to do business (including downstream supply chain participants such as contractors, subcontractors, and consultants) comply with the reporting requirements as well. The participant can do so by collecting a certification or including a term or condition to this effect in the transaction.

To monitor compliance with the suspension and debarment rules, under 2 CFR 6001.435, the Commission may require program participants to provide an assurance or certify their compliance with the rules at the time they apply for funding or request disbursements from Commission programs (as a condition of participation). For the programs listed below, the Commission will require certifications and collect them through existing FCC forms which are already submitted by program participants as described below.

e. Part 6001 Compliance Certification (Lifeline) —As detailed in OMB Control No. 3060-0819, service providers participating in the Lifeline program are required to submit an annual FCC Form 481 (Annual Reporting for High-Cost and Low-Income Universal Service Support Recipients) to report on and certify to program requirements. To monitor compliance under section 6001.435 of the Commission's rules, service providers participating in the Lifeline program will be required to provide an assurance or certify compliance with section 6001.435 when they file their FCC Form 481 each year. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, service providers will be required to certify that no response pursuant to section 6001.335 was required. In addition, service providers will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

f. Part 6001 Compliance Certification (RHC) — Health Care Provider and Consortium Applicant: As detailed in OMB Control No. 3060-0804, applicants are required to submit an annual FCC Form 462 (Request for Funding) or FCC Form 466 (Request for Funding) to request funding for eligible services and equipment in the Rural Health Care program. Applicants must provide certifications along with their FCC Form 462 or 466. To monitor compliance under section 6001.435 of the Commission's rules, applicants will be required to provide an assurance or certify their compliance with section 6001.435 when they file their FCC Form 462 or 466 funding application. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, applicants will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

Consortium Member Applicant: As detailed in OMB Control No. 3060-0804, consortium members in the Rural Health Care program are required to submit a Letter of Agency to their consortium lead to authorize the consortium lead to file forms on their behalf. To monitor compliance under section 6001.435 of the Commission's rules, consortium members will be required to provide an assurance of their compliance with section 6001.435 when they submit their Letter of Agency. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, consortium members will be required to confirm that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

Service Providers: As detailed in OMB Control No. 3060-0804, service providers participating in the Rural Health Care program are required to certify on an FCC Form 463 (Request for Funding Disbursement) or FCC Form 469 (Invoice and Request for Disbursement) that requests for reimbursement are compliant with the Commission's rules. To monitor compliance under section 6001.435 of the Commission's rules, service providers will be required to provide an assurance or certify their compliance with section 6001.435 when they certify an FCC Form 463 or FCC Form 469. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, applicants will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

g. Part 6001 Compliance Certification (E-Rate) — School, Library, and Consortium Applicant: As detailed in OMB Control No. 3060-0806, applicants are required to submit an annual FCC Form 471 (Schools and Libraries Program Services Ordered and Certification Form) to request funding for eligible services and equipment in the E-Rate program. Applicants must provide certifications along with their FCC Form 471. These certifications are required to protect the integrity of the E-Rate program and to ensure compliance with Commission's rules. See 47 CFR 54.504(a)(1). To monitor compliance under section 6001.435 of the Commission's rules, applicants will be required to provide an assurance or certify their compliance with section 6001.435 when they file their FCC Form 471 funding application. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, applicants will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

Consortium Member Applicant: As detailed in OMB Control No. 3060-0853, consortium members in the E-Rate program are required to submit an annual FCC Form 479 (Certification by Administrative Authority to Billed Entity of Compliance with Children's Internet Protection Act (CIPA) Form) to their consortium lead to certify their compliance with CIPA requirements. To monitor compliance under section 6001.435 of the Commission's rules, consortium members will be required to provide an assurance or certify their compliance with section 6001.435 when they submit their FCC Form 479. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, consortium members will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

Service Providers: As detailed in OMB Control No. 3060-0856, service providers participating in the E-Rate program are required to submit an annual FCC Form 474 (Service Provider Annual Certification Form) to certify their requests for reimbursement are compliant with the Commission's rules. These certifications are required to protect the integrity of the E-Rate program and ensure compliance with the Commission's rules. To monitor compliance under section 6001.435 of the Commission's rules, service providers will be required to provide an assurance or certify their compliance with section 6001.435 when they file their FCC Form 474. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, applicants will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

h. Part 6001 Compliance Certification (Cybersecurity Pilot Program)—School, Library, and Consortium Applicant, and Consortium Member Participants: As detailed in OMB Control No. 3060-1323, participants are required to submit an annual amended Pilot FCC Form 484—Cybersecurity (Schools and Libraries Pilot Program Application) to update information provided in the first and second parts of the FCC Form 484 and respond to new annual data reporting requirements ( i.e., the third part of the Pilot FCC Form 484). Participants must provide certifications along with their annual amended Pilot FCC Form 484 (third part)—Cybersecurity. These certifications mirror the certifications in the second part of the Pilot FCC Form 484 and are required to protect the integrity of the Cybersecurity Pilot Program and to ensure compliance with the Commission's rules. See 47 CFR 54.2004(d)(2)(i)-(vii). To monitor compliance under section 6001.435 of the Commission's rules, participants will be required to provide an assurance or certify their compliance with section 6001.435 when they file their Pilot FCC Form 484 (third part)—Cybersecurity annual reporting application. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, participants will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules. Service Providers: As detailed in OMB Control No. 3060-1323, service providers participating in the Cybersecurity Pilot Program are required to submit a Pilot FCC Form(s) 474—Cybersecurity (Schools and Libraries Cybersecurity Pilot Program Request for Reimbursement) to certify their requests for reimbursement are compliant with the Commission's rules. These certifications are required to protect the integrity of the Cybersecurity Pilot Program and ensure compliance with the Commission's rules. To monitor compliance under section 6001.435 of the Commission's rules, service providers will be required to provide an assurance or certify their compliance with section 6001.435 when they file their Pilot FCC Form(s) 474—Cybersecurity. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, service providers will be required to certify that no response pursuant to section 6001.335 was required. In addition, service providers will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

i. Part 6001 Compliance Certification (High-Cost) —As detailed in OMB Control No. 3060-0986, service providers participating in the high-cost programs are required to submit an annual FCC Form 481 (Annual Reporting for High-Cost and Low-Income Universal Service Support Recipients) to report on and certify to program requirements. To monitor compliance under section 6001.435 of the Commission's rules, service providers participating in the high-cost programs will be required to provide an assurance or certify that they complied with section 6001.435 when they file their FCC Form 481 each year. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, service providers will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

j. Part 6001 Compliance Certification (TRS) —As detailed in OMB Control No. 3060-1089 (Structure and Practices of the Video Relay Service Program; Telecommunications Relay Services and Speech-to-Speech Services for Individuals with Hearing and Speech Disabilities, CG Docket Nos. 10-51 & 03-123), the Commission requires applications for State TRS program certification and applications for internet-based TRS provider certification. The applications for State TRS program certification must be submitted in narrative form and clearly describe the state program and the procedures and remedies for enforcing the state program requirements. To certify the State TRS program, the application must establish that the state program meets or exceeds the operational, technical, and functional minimum standards codified in 47 CFR 64.604. Applications for internet-based TRS provider certification must be in narrative form and provide full and detailed information that shows its ability to comply with the Commission's rules. Applications must include a description of the forms of TRS to be provided and a detailed description of how the applicant will meet the minimum standards applicable to each form of TRS offered, including documentary and other evidence; a description of the provider's complaint process; a statement that the provider will file annual compliance reports demonstrating continued compliance; and a certification from the chief executive officer (CEO), chief financial officer (CFO), or other senior executive with first-hand knowledge of the accuracy and completeness of the information provided that all application information required under the Commission's rules and orders has been provided, and that all statements of fact, as well as all documentation contained in the application submission, are true, accurate, and complete.

To monitor compliance under section 6001.435 of the Commission's rules, TRS providers participating in the TRS program will be required to provide an assurance or certify that they complied with section 6001.435 when they file their application each year. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, TRS providers will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

k. Part 6001 Compliance Certification (NDBEDP) —As detailed in OMB Control No. 3060-1225 (National Deaf-Blind Equipment Distribution Program), the Commission certifies a single entity for each state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands—a total of 56 jurisdictions—to receive reimbursement from the TRS Fund for NDBEDP activities. Applications must contain sufficient detail to demonstrate the entity's ability to meet all criteria required for certification and a commitment to comply with all Commission requirements governing the NDBEDP. Applicants for certification must disclose to the Commission certain circumstances that pose an actual or potential conflict of interest and the steps it will take to eliminate the conflict or minimize the associated risks. The Commission determines whether to grant certification based on the ability of a program to meet the criteria required for certification, either directly or in coordination with other programs or entities, as evidenced in the application and any supplemental materials, including letters of recommendation.

To monitor compliance under section 6001.435 of the Commission's rules, NDBEDP providers participating in the NDBEDP program will be required to provide an assurance or certify that they complied with section 6001.435 when they file their application each year. Likewise, unless required to file an affirmative disclosure pursuant to section 6001.335, participants will be required to certify that no response pursuant to section 6001.335 was required. In addition, NDBEDP providers will be required to certify that they have ensured the people they have engaged in business with (including downstream supply chain participants, such as a contractor, subcontractor, or consultant) have complied with the reporting requirements set forth in section 6001.330(a) of the Commission's rules.

For all of the programs discussed above, the information collected by the Commission will be used by agency staff and the program administrators that organize the day-to-day operations of the covered programs under the agency's supervision to monitor compliance with program rules, better detect waste, fraud, and abuse in Commission programs, and ensure bad actors are not able to participate in covered transactions from the outset. Given requirements to disclose information to other primary and lower tier participants, these requirements will also help inform more financially responsible decisions by those participating in Commission programs.

Specifically, under 2 CFR 6001.120, the notification that a program participant is currently or has been previously excluded by another agency will ensure Commission staff responsible for entering into new covered transactions and approving applications will not distribute federal funds to participants that are presently excluded, and therefore, ineligible. Likewise, the disclosure of past misconduct will provide agency staff with pertinent information to consider when evaluating whether to approve or reject new requests for funding. This information is critical to ensuring that the federal government is only conducting business with participants that are presently responsible and do not negatively affect the public interest. Failure to submit accurate disclosures may also be grounds for additional administrative action, including, but not limited to, suspension and debarment.

Similarly, certifications are one of the primary mechanisms for monitoring compliance with the regulatory framework. Compliance with the suspension and debarment rules are conditions of receiving payment from Commission programs. These certifications from program participants allow Commission staff that administer the covered programs and process applications to quickly determine whether participants have satisfied the conditions precedent before distributing federal funds. In turn, the certifications required by program participants of downstream participants will also allow the people who conduct business directly with the government to ensure that their other business relationships are compliant with the suspension and debarment rules.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Health Hazard Evaluations/Technical Assistance and Emerging Problems (OMB Control No. 0920-0260, Exp. 1/31/2027)—Extension—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

In accordance with its mandates under the Occupational Safety and Health Act of 1970 and the Federal Mine Safety and Health Act of 1977, NIOSH responds to requests for Health Hazard Evaluations (HHEs) to identify chemical, biological or physical hazards in workplaces throughout the United States. Each year, NIOSH receives approximately 250 such requests, although that number has been lower in most recent years. Most HHE requests come from workplaces in the following industrial sectors: services, manufacturing, health and social services, transportation, and construction.

A printed HHE request form is available in English and Spanish. The English and Spanish forms are also available on the internet and differ from the printed version only in format and in the fact that they can be submitted directly from the website. The HHE request form is also available online in Arabic, Chinese, Haitian Creole, Mixteco, Tagalog, and Vietnamese. The request form, regardless of language, takes an estimated 12 minutes to complete. The form provides the mechanism for employees, employers, and other authorized representatives to supply the information required by the regulations governing the NIOSH HHE program (42 CFR 85.3-1). NIOSH reviews the HHE request to determine if an on-site evaluation is needed. The primary purpose of an on-site evaluation is to help employers and employees identify and eliminate occupational health hazards. For 25% of the requests received, NIOSH determines an on-site evaluation is needed.

In about 70% of on-site evaluations, employees are interviewed in an informal manner to help further define concerns. Interviews may take approximately 15 minutes per respondent. The interview questions are specific to each workplace and its suspected diseases and hazards. However, interviews are based on standard medical practices. NIOSH estimates that two on-site evaluations (less than 1%) will involve medical tests or the collection of biological samples that would require written informed consent. Informed consent is the process of a participant agreeing to take part in a specific activity of the HHE which includes explaining the purpose of the medical test or biological sample, what medical test or biological sample is being conducted/collected, potential risk and benefits of participating, and collecting contact information if the participant would like their individual results sent directly to them. At the end of the informed consent process, the participant may decline to participate in the activity (no signature or contact information collected) or agree to participate. The estimated time to complete the informed consent process is 30 minutes. If 30 employees are monitored at each of the two work sites, the burden from this activity is 30 hours.

In approximately 30% of on-site evaluations questionnaires are distributed to the employees (averaging about 100 employees per site). Questionnaires may require approximately 30 minutes to complete. The survey questions are specific to each workplace and its suspected diseases and hazards, however, items in the questionnaires are derived from standardized or widely used medical and epidemiologic data collection instruments.

About 70% of the on-site evaluations involve employee exposure monitoring in the workplace. Employees participating in on-site evaluations by wearing a sampler or monitoring device to measure personal workplace exposures are offered the opportunity to get notification of their exposure results. To accept or decline notification, employees complete a contact information post card. Completing the contact card may take five minutes or less. The number of employees monitored for workplace exposures per on-site evaluation is estimated to be 25 per site.

NIOSH distributes interim and final reports of Health Hazard Evaluations, excluding personal identifiers, to requesters, employers, employee representatives, the Department of Labor (Occupational Safety and Health Administration or Mine Safety and Health Administration, as appropriate), state health departments, and, as needed, other state and federal agencies. NIOSH administers a follow back program to assess the effectiveness of its HHE program in reducing workplace hazards. This program entails the mailing of follow back questionnaires to employer and employee representatives at all the workplaces where NIOSH conducted an on-site evaluation. In a small number of instances, a follow back on-site evaluation may be completed. The first follow back questionnaire is sent shortly after the first visit for an on-site evaluation and takes about 10 minutes to complete. A second follow back questionnaire is sent after the final report is completed and requires about 20 minutes to complete. At 12 months, a third follow back questionnaire is sent which takes about 15 minutes to complete. For requests where NIOSH does not conduct an on-site evaluation, the requester receives the first follow back questionnaire after our response letter is sent and a second one 12 months after our response. The first questionnaire takes about 10 minutes to complete, and the second questionnaire takes about 15 minutes to complete.

Due to the number of investigations conducted each year, the need to respond quickly to requests for assistance, the diverse and unpredictable nature of these investigations, and its follow back program to assess evaluation effectiveness, NIOSH requests a consolidated clearance for data collections performed within the domain of its HHE program. A three-year approval is requested, with 1,745 total estimated annual burden hours. There is no cost to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Reporting of the Essentials for Childhood (EfC): Preventing Adverse Childhood Experiences through Data to Action Program (OMB Control No. 0920-1425, Exp. 12/31/2026)—Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

The Centers for Disease Control and Prevention (CDC) seeks OMB approval for this Revision information collection request (ICR) to collect data from recipients funded through CDC's Essentials for Childhood (EfC): Preventing Adverse Childhood Experiences through Data to Action. OMB approval is requested for three years. CDC will collect data from EfC recipients to assess how recipients are improving a surveillance infrastructure, implementing and evaluating prevention strategies to expand efforts to prevent adverse childhood experiences, and using data to inform prevention action.

Adverse childhood experiences (ACEs) are preventable, potentially traumatic events that occur in childhood and adolescence (0-17 years). As the number of ACEs experienced increases, so does the risk for negative health and life outcomes, including health risk behaviors, chronic health conditions, mental health challenges, limited educational and economic opportunity, and early death. Social conditions that affect health and safety like multigenerational poverty, living in under-resourced neighborhoods, or experiencing food insecurity can exacerbate the effects of ACEs. However, ACEs can be prevented. Preventing ACEs has the potential to reduce leading causes of death, mental health challenges, health risk behaviors such as substance use, verified reports of child abuse and neglect, increase productivity and educational attainment, and saves billions of dollars each year. By addressing the conditions that give rise to ACEs and simultaneously addressing the needs of children and parents, communities can take a multigenerational approach to prevent ACEs.

For this Notice of Funding Opportunity (NOFO), funded recipients are expected to leverage multisector partnerships and resources to improve and sustain ACEs and positive childhood experiences (PCEs) surveillance infrastructure that collects, uses, and disseminates data on ACEs and PCEs, including data that contextualize risk factors to inform implementation of ACEs prevention strategies across the state. Funded recipients will work to center and engage communities and improve conditions for health and safety. In addition, the NOFO will require recipients to: (1) Build or improve surveillance infrastructure and capacity; (2) Implement and sustain ACEs prevention strategies; and (3) Utilize ACEs/PCEs data for action.

This NOFO includes base and enhanced funding. EfC recipients who apply for and receive enhanced funding will conduct base and additional activities for the enhanced funding, including: (1) collecting ACEs data using syndromic surveillance approaches; (2) implementing ACEs primary prevention strategies at the local level; and/or (3) linking state and local data on the conditions for health and safety to youth-based ACEs data.

Annually submitted progress, outcomes, performance indicators and related measures will inform the CDC evaluation of the cooperative agreement by capturing program impact as well as inform performance monitoring and continuous program improvement. The purpose of the information collection effort is to collect EfC program recipient data related to surveillance, implementation, program evaluation, and performance monitoring. This data collection is necessary to ensure that programs are progressing toward achievement of their stated goals and objectives, as well as consistently demonstrating efficient and appropriate use of federal funds. CDC will use the information collected to further understand the facilitators, barriers, and critical factors to implementing specific violence prevention strategies and conducting related program evaluation activities. Data collected will also be used to inform CDC's training and technical assistance, program improvement, and the development of future funding opportunities.

CDC requests OMB approval for an estimated 180 annualized burden hours. There is no cost to respondents other than their time to participate.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Public Health Emergency Management Capacity Assessment Tool (PHEM Tool) (OMB Control No. 0920-1417, Exp. 10/31/2026)—Extension—Office of Readiness and Response (ORR), Centers for Disease Control and Prevention (CDC).

The Center for Disease Control and Prevention's (CDC) Global Emergency Management Capacity Development (GEMCD) team strengthens emergency management capacity development globally. It helps countries to prepare for, anticipate, and respond to all forms of public health threats. GEMCD's mission is to build resilient Public Health Emergency Management (PHEM) programs throughout the world.

The GEMCD team's Emergency Management Technical Advisors (EMTAs) use the PHEM Tool to guide an in-person interview with CDC partner countries' Ministry of Health, Public Health Emergency Operations Center (PHEOC) Manager and optional additional staff, to characterize the country's PHEM program and capabilities. EMTAs document responses in an excel based form that will be entered into and maintained in the CDCReady data base. Collected data identifies strengths and weaknesses, capabilities, and gaps in PHEM programs and PHEOCs in partner countries. Findings guide GEMCD team program planning initiatives and determine appropriate technical assistance (TA) for GHSA countries. Data is analyzed to identify the presence or absence of specific PHEM and PHEOC requirements, such as plans, policies, and procedures, etc. Additional analysis will focus upon the status of PHEM and PHEOC plans, policies, and procedures, e.g., date of publication, relevance, etc. The survey is conducted annually to identify progress and document changes from one year to the next in terms of PHEM program and PHEOC capabilities.

CDC requests OMB approval for three years. The estimated annualized burden for this information collection is 72 hours. There is no cost to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Submission of 1135 Waiver Request Automated Process; Use: This is a revision of an information collection request approved under Office of Management and Budget (OMB) control number of 0938-1384 with an expiration date of August 31, 2026. The Acute Hospital Care at Home (AHCAH) program will no longer be included in this package.

Waivers under Section 1135 of the Social Security Act (the Act) and certain flexibilities allow the CMS to relax certain requirements, known as the Conditions of Participation (CoPs) or Conditions of Coverage to promote the health and safety of beneficiaries. Under Section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements to ensure that sufficient health care services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods. These waivers ensure that healthcare entities/caregivers who provide such services in good faith can be reimbursed and exempted from sanctions.

During emergencies, CMS must be able to apply program waivers and flexibilities under section 1135 of the Social Security Act, in a timely manner to respond quickly to unfolding events. In a disaster or emergency, waivers and flexibilities assist health care providers/suppliers in providing timely healthcare and services to people who have been affected and enables states, Federal districts, and U.S. territories to ensure Medicare and/or Medicaid beneficiaries have continued access to care. During disasters and emergencies, it is not uncommon to evacuate patients in health care facilities to other provider settings or across state lines, especially during hurricane, wildfire, and tornado events. CMS must collect relevant information for which a provider is requesting a waiver or flexibility to make proper decisions about approving or denying such requests. Collection of this data aids in the prevention of gaps in access to care and services before, during, and after an emergency. CMS must also respond to inquiries related to a Public Health Emergency (PHE) from providers. CMS is not collecting information from these inquiries; we are merely responding to them.

The collection of the information surrounding 1135 Waiver requests/inquiries is based on a case-by-case basis and not regularly scheduled ( e.g., quarterly, annually, by all providers/suppliers). The collection of information only occurs when the healthcare entity, impacted by an emergency, is requesting waivers/flexibilities under Section 1135 of the Act or inquiring about PHEs. The collection of information is also dependent on provider types; therefore, it is not a collection for all Medicare-participating facilities.

In 2021, we implemented a streamlined, automated process to standardize the 1135 waiver requests and inquiries submitted based on lessons learned during the COVID-19 PHE. Furthermore, the normal operations of a healthcare provider are disrupted by emergencies or disasters occasionally. When this occurs, State Survey Agencies (SA) or Health Care Providers deliver a provider/beneficiary tracking report regarding the status of all affected healthcare providers and their beneficiaries. This report includes demographic information about the beneficiary status, provider, their operational status, anticipated needs and planned resumption of normal operations. This information is provided whether or not a PHE has been declared.

We are enhancing this information collection to better support emergency response by capturing the emergency date, simplifying ongoing status updates for stakeholders, and providing a more comprehensive view of cybersecurity incidents through expanded reporting on patient and operational impacts. This automated process will continue to consist of a public facing web form as well as a process for SAs/Providers to submit data using extracts (CSV or Excel) on emergent events impacting Health Care Facilities via an automated mail handler system. Both processes (public facing web form and extracts via an automated mail handler system) are known as the Health Care Facility (HCF) Operational Status. Form Number: CMS-10752 (OMB control number: 0938-1384); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments; Number of Respondents: 4,829; Total Annual Responses: 4,829; Total Annual Hours: 4,016. (For policy questions regarding this collection, contact Adriane Saunders at 404-562-7484.)

Description: The purpose of PREP is to provide grants to states, tribes and tribal communities, and community organizations to support evidence-based programs to reduce teen pregnancy and sexually transmitted infections. The programs are required to provide education on both abstinence and contraceptive use. The programs also offer information on adulthood preparation subjects such as healthy relationships, adolescent development, financial literacy, parent-child communication, education and employment skills, and healthy life skills.

The PREP project collects performance measures data from PREP grant recipients, program providers, and participants. The data include information on program structure, cost, and support for implementation; program attendance, reach, and dosage; the characteristics of youth involved in programming; youth sexual risk behaviors and behaviors related to adulthood preparation prior to program participation; and youth behavior intentions at program exit. The performance measures help the ACF program office and grant recipients to monitor and report on progress in implementing PREP programs and inform technical assistance. In addition, ACF will use the information to continue fulfilling its reporting requirements to Congress and OMB concerning the PREP initiative.

Some of the performance measures data come from youth participants through surveys PREP grant recipients administer at program entry and exit. There are separate versions of the entry and exit surveys for middle school youth, which exclude some of the more sensitive items that are included in the versions for high school and older youth. There is also a shorter version of the entry survey for participants in the Personal Responsibility Education Innovative Strategies (PREIS) and Tribal PREP (TPREP) programs, to reduce the burden on participants in those programs (who are likely responding to other surveys); youth in these programs complete the same version of the exit survey as other youth.

We are proposing revisions to the current performance measures to address feedback from grant recipients and to ensure the measures meet FYSB data needs. Grant recipients have requested various changes to simplify and clarify the measures, including noting particular questions in the participant surveys that youth have difficulty understanding and responding to. In addition, contractor staff have noted which measures most frequently result in help desk contacts or are prone to data quality issues. Finally, FYSB staff identified measures that are no longer needed or could be obtained from other sources. Types of revisions include re-wording to use simpler language, reducing the number of sub-items or response categories, avoiding patterns in which survey respondents need to skip one or more questions based on their response to an earlier question, and removing some measures entirely. The proposed revisions to the participant surveys were cognitively tested with program participants for clarity and to check burden estimates.

Respondents: State PREP (SPREP), TPREP, Competitive PREP (CPREP), and PREIS grant recipients, their subrecipients, and program participants.

The changes described above reduced the overall length of the surveys and are expected to reduce the burden for completing the participant entry survey from 8 minutes to 5 minutes per response and the participant exit survey from 7 minutes to 5 minutes per response. Additionally, the estimated number of respondents has been adjusted to reflect the estimated number over the next 3 years, which is reduced compared to previous estimates. Overall, we expect a 40 percent reduction in the annual burden hours under this request compared to the previously approved annual burden.

Authority: 42 U.S.C 1310.

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria).

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents (“CBRN”); (B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (i) a CBRN; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces;  1 (C) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a CBRN agent or agents, or a disease or condition that may be attributable to such agent or agents; or (D) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Under section 564(h)(1) of the FD&C Act, revisions to an authorization shall be made available on FDA's website. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use in an actual or potential emergency when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc).

Under section 564(c) of the FD&C Act, FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA  2 concludes: (1) that an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii) of the FD&C Act, that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied. No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.

The Authorizations follow the August 18, 2025, determination by the Secretary of HHS that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared, on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. Notice of the Secretary's determination and declaration was provided in the Federal Register on August 20, 2025 (90 FR 40609). Having concluded that the criteria for the issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has issued two authorizations for the emergency use of animal products. On April 24, 2026, FDA issued an EUA to Health and Hygiene (Pty) Ltd. for the animal product F10 Antiseptic Barrier Ointment with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical ointment), subject to the terms of its Authorization. On April 27, 2026, FDA issued an EUA to Elanco US Inc. for the animal product Negasunt Powder (coumaphos, propoxur, and sulfanilamide topical powder), subject to the terms of its Authorization.

The initial Authorizations, included below in their entirety after section IV of this document (not including the authorized versions of the fact sheets and other written materials), provide explanations of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act. Any subsequent reissuance of the Authorizations can be found on FDA's web page at: https://www.fda.gov/animal-veterinary/safety-health/new-world-screwworm-information-veterinarians.

An electronic version of this document and the full text of the Authorizations are available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization .

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practice for dietary supplements. Section 402(g) of the FD&C Act also stipulates that such regulations will be modeled after current good manufacturing practice (CGMP) regulations for food and may not impose standards for which there are no current, and generally available, analytical methodology. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if “it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.”

Accordingly, we have promulgated regulations in part 111 (21 CFR part 111) establishing minimum CGMP requirements pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality. Included among the requirements is recordkeeping, documenting, planning, control, and improvement processes of a quality control system. Implementation of these processes in a manufacturing operation serves as the backbone to CGMP. The records must show what is being manufactured and whether the controls in place ensure the product's identity, purity, strength, and composition, and that limits on contaminants and measures to prevent adulteration are effective. Further, records must show whether and what deviations from control processes occurred, facilitate evaluation and corrective action concerning these deviations (including, where necessary, whether associated batches of product should be recalled from the marketplace), and enable a manufacturer to assure that the corrective action was effective. We believe the regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling or holding operations.

Specifically, the recordkeeping requirements of the regulations in part 111 include establishing written procedures and maintaining records pertaining to: (1) personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning, and sanitizing equipment and utensils and other contact surfaces; (6) water used that may become a component of the dietary supplement; (7) production and process controls; (8) quality control; (9) components, packaging, labels and product received for packaging and labeling; (10) master manufacturing and batch production; (11) laboratory operations; (12) manufacturing operations; (13) packaging and labeling operations; (14) holding and distributing operations; (15) returned dietary supplements; and (16) product complaints.

Section 111.75(a)(1) (21 CFR 111.75) reflects FDA's determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. Section 111.75(a)(1) provides an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency. Section 111.75(a)(1) also sets forth the information a manufacturer is required to submit for an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the Agency for such an exemption to 100 percent identity testing under 21 CFR 10.30 and the Agency grants such exemption.

Description of Respondents: Respondents to this collection of information include manufacturers, packagers and repackagers, labelers and re-labelers, holders, distributors, warehousers, exporters, importers, large businesses, and small businesses engaged in the dietary supplement industry. Respondents are from the private sector.

In the Federal Register of February 24, 2026 (91 FR 8886), FDA published a 60-day notice requesting public comment on the proposed collection of information. One stakeholder provided multiple comments. Although the commenter supports this collection of information, the commenter has concern that the burden estimate may not fully capture the range of compliance costs across firms of different sizes and operational complexities. Another comment related to enhancing the quality and utility of collected information, further suggesting flexibility in how records are maintained and reported.

We estimate that a substantial proportion of firms subject to the regulations in part 111 are small businesses. We are aware that burden may vary depending on the size and complexity of the operation. We do not provide a burden estimate for various operation types or their various complexities but instead provide an average of the burden estimate.

We believe the regulations in part 111 establish the minimum manufacturing practices necessary to ensure that dietary supplements are manufactured, packaged, labeled, or held in a manner that will ensure the quality of the dietary supplements during manufacturing, packaging, labeling, or holding operations. Regarding flexibility in how records are maintained and reported, the regulations in part 111 do not specifically prescribe the use of automated, electronic, mechanical, or other technological techniques or other forms of information technology as necessary for use by firms. Companies are free to use whatever forms of information technology may best assist them in recordkeeping and reporting.

We estimate the burden of this collection of information as follows:

Based on a review of the information collection since its last OMB approval, we have made no adjustments to our burden estimate.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports implementation of section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351), which governs current good manufacturing practices (CGMPs) for Type A medicated articles and CGMPs for drugs, including medicated feeds.

A Type A medicated article consists of one or more new animal drugs with or without carrier and with or without inactive ingredients. It is intended solely for use in the manufacturing of another Type A medicated article or in the manufacturing of a Type B or Type C medicated feed. See 21 CFR 558.3(b)(2). Under part 226 (21 CFR part 226), manufacturers are required to establish, maintain, and retain records for Type A medicated articles including records to document procedures required under the manufacturing process to ensure that proper quality control is maintained. Type A medicated articles which are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).

Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Under part 225 (21 CFR part 225), a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results ( i.e., batch and stability testing), labels, and product distribution.

This information is needed so that FDA can monitor drug usage and possible mis formulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the CGMP criteria in part 225 to determine whether the systems and procedures used by manufacturers of medicated feeds are adequate to ensure that their feeds meet the requirements of the FD&C Act as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.

A medicated feed mill license is required when the manufacturing process involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required, and the recordkeeping requirements are less demanding, for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control.

The information collection provisions approved under OMB control numbers 0910-0152 and 0910-0154 are similar in that they support FDA's current good manufacturing practices. Thus, with this notice, FDA proposes to consolidate these collections of information into one OMB control number for all reporting associated with CGMPs for Type A medicated articles and CGMPs for medicated feeds. FDA further proposes to consolidate each regulation into a summary. As part of this consolidation FDA has combined the commercial feed mills and the mixer/feeders into a single category, as the requirements for licensed medicated feed mills in 21 CFR part 225 are the same for both facility types. FDA will continue to distinguish between the licensed and the non-licensed feed mills, because non-licensed feed mills are subject to less burdensome recordkeeping requirements than licensed feed mills. As with the licensed facility category, non-licensed commercial feed mills and mixer/feeders have also been combined as the requirements and associated burdens remain the same. The number of non-licensed medicated feed mills have been updated with our current inventory data utilizing production codes to identify manufacturers of medicated feeds. FDA will also continue to maintain a distinct category for Type A medicated article manufacturers subject to the recordkeeping requirements under part 226.

Because we are proposing to combine all reporting associated with CGMPs for Type A medicated articles and CGMPs for medicated feeds into one collection, we are consolidating the burden under OMB control number 0910-0152 and discontinuing OMB control number 0910-0154.

In the Federal Register of February 25, 2026 (91 FR 9285), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received. While the comment did not address the collection of information topics solicited, it did point out an error in the definition of a Type A medicated article.

The commenter is correct, and we have updated the definition in this notice to align with the definition of a Type A medicated article in 21 CFR 558.3(b)(2).

FDA estimates the burden of this collection of information as follows:

Description of Respondents: Respondents to this collection of information are manufacturers of medicated feeds, commercial feed mills, licensed mixer/feeders, and manufacturers of Type A medicated articles.

After review of the information collection, we have adjusted the number of recordkeepers of CGMPs for medicated feeds by 2,722. The reduction accurately reflects the current number of firms that hold a medicated feed mill license and the number of firms that are listed in the FDA database as manufacturing with medicated feeds and meet the definition of a commercial feed manufacturing facility. With this update, we note a corresponding decrease of 13,731,017 records and a decrease of 913,153 hours.

On December 28, 2012, FDA approved ANDA 202608 for Methylphenidate HCl ER tablets, 27 mg, 36 mg, and 54 mg. The reference listed drug (RLD) is CONCERTA (methylphenidate HCl) ER tablets, which are approved under new drug application (NDA) 021121 in strengths of 18 mg, 27 mg, 36 mg, and 54 mg.

At the time of approval, FDA determined that ANDA 202608 included data sufficient to demonstrate the bioequivalence of SpecGx's  1 Methylphenidate HCl ER tablets to CONCERTA. The bioequivalence testing and data submitted in the ANDA conformed to recommendations provided in a draft guidance for industry on “Methylphenidate hydrochloride.” The draft guidance was issued on September 14, 2012 (77 FR 56851) and provided information and recommendations for establishing bioequivalence to CONCERTA that reflected CDER's understanding, at that time, of how to evaluate the pharmacokinetic properties of CONCERTA to support a demonstration of bioequivalence.

Subsequently, FDA received adverse event reports that described insufficient therapeutic effect of SpecGx's Methylphenidate HCl ER tablets, particularly later in the day. After reevaluating the question of what evidence is needed to demonstrate bioequivalence to CONCERTA, CDER concluded that, to ensure therapeutic effect throughout the 12-hour therapeutic time course for which CONCERTA is labeled, an absence of a significant difference in drug exposure between a proposed generic product and CONCERTA must be shown during the entire therapeutic time course, including the latter part of the 12-hour period after drug administration. On November 6, 2014 (79 FR 65978), CDER issued a revised draft guidance for industry on “Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets,” with recommendations for establishing bioequivalence to CONCERTA that reflected CDER's refined understanding of the relationship between the pharmacokinetic profile of CONCERTA and its therapeutic effect.

After continuing to evaluate data and information related to the bioequivalence of SpecGx's Methylphenidate HCl ER tablets to CONCERTA, including the bioequivalence data originally submitted in ANDA 202608 and data from a March 2015 CDER-sponsored study evaluating the bioequivalence of SpecGx's 27 mg product to CONCERTA, CDER determined that SpecGx's Methylphenidate HCl ER tablets had not been shown to be bioequivalent to CONCERTA. Therefore, CDER proposed to withdraw approval of ANDA 202608 under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(a) (21 CFR 314.150(a)).

On October 18, 2016, in Docket No. FDA-2016-N-3118, CDER published a notice of opportunity for hearing (NOOH) on its proposal to withdraw approval of ANDA 202608 for Methylphenidate HCl ER tablets (81 FR 71737). SpecGx submitted a timely request for hearing on November 10, 2016. In February 2026, CDER recommended to FDA's Office of the Commissioner that SpecGx be granted a hearing and submitted to the docket, among other things, CDER's analysis of SpecGx's hearing request. On March 25, 2026, SpecGx and CDER submitted a joint request to pause the proceedings to withdraw approval of ANDA 202608 that are the subject of Docket No. FDA-2016-N-3118. FDA's Office of the Commissioner granted this joint request on April 20, 2026.

FDA is now withdrawing approval of ANDA 202608 under § 314.150(d). For the reasons described in the NOOH and CDER's analysis of SpecGx's hearing request in Docket No. FDA-2016-N-3118, FDA believes the potential problem with respect to the bioequivalence of SpecGx's Methylphenidate HCl ER tablets to CONCERTA is sufficiently serious that the drug should be removed from the market.

On March 12, 2026, at FDA's request, SpecGx submitted a request that FDA withdraw approval of ANDA 202608 for Methylphenidate HCl ER tablets under § 314.150(d) and waived its opportunity for a hearing under § 314.150(a). SpecGx agreed to request withdrawal of approval of ANDA 202608 under § 314.150(d) based on the Agency's position that sufficient bioequivalence data is lacking.

For the reasons discussed above, and in accordance with the applicant's request, approval of ANDA 202608 for Methylphenidate HCl ER tablets, 27 mg, 36 mg, and 54 mg, and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of Methylphenidate HCl ER tablets, 27 mg, 36 mg, and 54 mg, into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d))).

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Science Board to the Food and Drug Administration (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner 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 reviews and evaluates data concerning specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community, and makes appropriate recommendations to the Commissioner.

The Committee shall consist of a core of at least 15 voting members including the Chair. Subject to legal and regulatory requirements, members and the Chair are selected by and serve at the discretion of the Commissioner or designee. Each member, including the Chair, will be selected from among authorities knowledgeable in the fields of food science (safety and nutrition); clinical research; veterinary medicine; pharmacology; toxicology; biostatistics; medical devices; public health and epidemiology; product manufacturing and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products.

Members may be invited to serve for terms of up to four years, or for less time in the discretion of the Commissioner or designee. Non-Federal members of this committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or ExOfficios. The core of voting members may include 1 technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees to serve temporarily as voting members and to designate Special Government Employees to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking.

A quorum for the Committee is a majority of the current voting members present at the time, provided that FDA may specify a quorum that is less than a majority of the current voting members because of the size of the Committee and the variety in the types of issues that it will consider, or other reason determined appropriate in accordance with legal and regulatory requirements. 21 CFR 14.22(d).

If functioning as a medical device panel, an additional non-voting representative member of consumer interests and a non-voting representative member of industry interests will be included in addition to the voting members.

Members appointed to an advisory committee serve for the duration of the committee, or until their terms expire, they resign, or they are removed from membership by the Commissioner or designee. Committee members' terms may be ended prior to their date of expiration, for reasons determined to be good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interferes with the ability to render objective advice, failure to abide by established procedures, or violation of other applicable rules and regulations.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/advisory-committees/science-board-food-and-drug-administration/charter-science-board-food-and-drug-administration or by contacting the Advisory Committee Oversight and Management Staff (see FOR FURTHER INFORMATION CONTACT ). Because the committee's name and description of duties remain unchanged, 21 CFR 14.100 will not be amended.

Renewal Requirements and Justification: The Commissioner has determined that renewal of the Science Board to the Food and Drug Administration is in the public interest. This determination is based on the Committee's essential role in providing independent expert advice concerning specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community, the continued need for specialized expertise in this area, and the Committee's demonstrated value in supporting FDA's regulatory mission. The following information supports this determination in accordance with applicable legal and regulatory requirements.

Public Interest Determination: Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish, or merge a discretionary (agency discretion) advisory committee, an agency must first consult with the General Services Administration's Committee Management Secretariat (the Secretariat) and, as part of the consultation, provide a written public interest determination approved by the head of the agency to the Secretariat with a copy to the Office of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an agency shall follow the same consultation process and document in writing the same determination of need before creating a subcommittee under a discretionary committee that is not made up entirely of members of a parent advisory committee. Information on the following factors for the committee is provided to the Secretariat to demonstrate that renewing the committee is in the public interest:

1. Annual budget: The overall annual budget for this committee is $97,121.

a. Federal personnel on a full-time equivalent (FTE) basis: The estimated person years of Federal staff support required is 0.20 at an estimated annual cost of $51,087.

b. Other Federal internal costs: The anticipated total value in USD of other internal costs, such as cost associated with IT and supplies for meetings, is $16,822

c. Proposed payments to members: The estimated annual payment to members is $11,170.

d. Proposed number of members: The anticipated number of members is 15.

e. Reimbursable costs: The estimated annual reimbursable costs, including travel and related expenses for members is $10,760

2. If applicable, the total dollar value of grants expected to be recommended during the fiscal year: N/A.

3. Criteria for selecting members to ensure the committee has the necessary expertise and fairly balanced membership:

Ensuring Necessary Expertise:

Members must have background, education, and experience commensurate with the committee's function of advising FDA on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Committee will provide advice that supports the Agency in keeping pace with technical and scientific developments, including regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. Members will be selected from among authorities knowledgeable in the fields of food science (safety and nutrition); clinical research; veterinary medicine; pharmacology; toxicology; biostatistics; medical devices; public health and epidemiology; product manufacturing and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products.

Ensuring Fair Balance:

Appointments are made without discrimination. The committee is reviewed in totality for balance, characterized by inclusion of necessary knowledge, insight, and scientific perspective from the relevant community or expertise area. Nominations are sought from all geographic locations within the United States and its territories, and from diverse sources including professional and scientific societies, academia, government agencies, industry and trade associations, consumer and patient organizations, and current Agency staff.

4. List of all other Federal advisory committees of the agency:

FDA maintains the following Federal advisory committees:

5. Justification that the information or advice provided by the Federal advisory committee or subcommittee is not available from another Federal advisory committee, another Federal Government source, or any other more cost-effective and less burdensome source:

The Committee advises and informs the Commissioner or designee(s) in discharging responsibilities as they relate to helping ensure safe and effective drugs and biologic products for human use, and as required, any other product for which the FDA has regulatory responsibility.

The topics considered by the Science Board require specialized expertise in specific complex scientific and technical issues that is not within the primary scope of other FDA advisory committees. As such, these issues cannot be appropriately addressed by another standing committee without diminishing the depth and relevance of the expert input provided to the Agency. The Science Board is currently FDA's only advisory committee that has the requisite expertise to address issues associated with food, cosmetic, or veterinary products, and its continuation is necessary to allow the FDA to receive outside expert scientific advice in those areas.

6. If the consultation is a committee renewal, a summary of the previous accomplishments of the committee and the reasons it needs to continue:

Summary of Previous Accomplishments:

The Science Board serves the public interest by providing scientific support for the regulation of certain products and making appropriate recommendations to the Commissioner.

On October 7, 2024, the Science Board met to receive an update from the New Alternative Methods subcommittee and hear details about the FDA's reorganization scheduled for implementation on October 1, 2024, that included significant updates to the Office of the Chief Scientist and the creation of a unified Human Foods Program.

Impact: This meeting's impact was to transmit formal Science Board recommendations on New Approach Methodologies (NAMs) that later fed into FDA's NAMs roadmap and related guidance activity.

7. Explanation of why the committee/subcommittee is essential to the conduct of agency business:

The Science Board is currently FDA's only advisory committee that has the requisite expertise to address issues associated with food, cosmetic, or veterinary products, and its continuation is necessary to allow the FDA to receive outside expert scientific advice in those areas. The Science Board also has a unique role in providing guidance on complex scientific and regulatory issues, and this role cannot be fulfilled by any other FDA advisory committee.

In conclusion, this public interest determination documents that renewing the committee is in the public interest, essential to the conduct of agency business, and that the information to be obtained is not already available through another advisory committee or source within the Federal Government.

This notice is issued under the Federal Advisory Committee Act as amended (5 U.S.C. 1001 et seq. ). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Food and Drug Administration (FDA, us or we) implementation of section 512 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. Agency regulations in 21 CFR part 530, permit FDA, if we find that there is a reasonable probability that the extralabel use of an animal drug may present a risk to public health, to establish a safe level for a residue from the extralabel use of the drug, and to require the development of an analytical method for the detection of residues above that established safe level. This requirement is codified at 21 CFR 530.22(b). Although to date, we have not established a safe level for a residue from the extralabel use of any new animal drug and, therefore, have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are, therefore, estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State, or Federal and/or State Agencies, academia, or individuals.

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

When submitting comments or requesting information, please include the ICR title for reference.

Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for HRSA —OMB No. 0915-0379— Revision.

Abstract: The purpose of this umbrella ICR is to inform the development of new questions, questionnaires, and tools; pilot/pre-test instruments under development; and identify problems in instruments currently in use by soliciting feedback from members of the public. Using this ICR, individual information collections related to the development or revision of HRSA data collection instruments go through an abbreviated approval process called a “generic” or “fast-track” information collection. This allows program offices to efficiently gather a suitable pool of candidates within the varied time periods available for participant recruitment.

Information collected under this generic clearance will not be used for data collection, reports, or policy documents to be released to the public. It is anticipated that data collection approved under this generic clearance will rely heavily on qualitative techniques and not the collection of numerical data. In general, these activities are not designed to yield results that meet generally accepted standards of statistical rigor but designed to obtain information to develop clearer and more effective and efficient data collection tools that will yield more accurate results and decrease public non-response. The forms submitted under this generic clearance will be voluntary, low-burden, and uncontroversial.

Need and Proposed Use of the Information: HRSA conducts interviews, focus groups, cognitive testing, usability tests, field tests/pilot interviews, and surveys for data collection instrument development and evaluation (including assessment of response errors in data collection instruments). HRSA staff use various techniques to evaluate data collection instruments such as interviewer-administered, self-administered, telephone, Computer Assisted Personal Interviewing, Computer Assisted Self-Interviewing, Audio Computer-Assisted Self-Interviewing, and web-based questionnaires.

Professionally recognized procedures are followed in each information collection activity to ensure collection of high-quality information. Examples of these procedures could include the following:

• Monitoring by supervisory staff of some telephone interviews;

• Conducting interviews using methods including “think-aloud” techniques and debriefings;

• Computerizing data entry from mail or paper-and-pencil surveys using scannable forms or double-key entry ( i.e., two people input the data from mail or paper-and-pencil surveys into an electronic format, and then comparing the two sets of entries for anomalies);

• Monitoring by observers of focus groups and recording ( e.g., video recording, audio recording) of focus group proceedings (subject to participant consent); and

• Employing commonly used statistical validation techniques to ensure accuracy (such as disallowing out-of-range values) of data submitted through on-line surveys.

Each information collection under this ICR will specify the specific testing and evaluation procedures to be used. Participation will be fully voluntary, and non-participation will not affect eligibility for, or receipt of, future HRSA health services research activities or grant awards, recruitment, or participation. Appropriate consent procedures will be customized and used for each information collection activity and any collection of personal, privacy-protected information will be handled in accordance with all applicable federal requirements. If HRSA wishes to record the encounter, the respondent's permission to record will be obtained before beginning the interview. If consent is not provided, the interview will either not be recorded or not be conducted. When screening is used ( e.g., quota sampling), the screening will be as brief as possible, and the screening questionnaire will be provided to OMB for review.

The particular information collection methods used will vary, but may include the following:

• Individual in-depth interviews—In-depth interviews will commonly be used to ensure that the respondent understands the meaning of a questionnaire or strategy. When in-depth interviewing is used, the interview guide will be provided to OMB for review.

• Focus groups—Focus groups will be used to obtain insights into beliefs and understandings of the target audience early in the development of a questionnaire or tool. When focus groups are used, the focus group discussion guide will be provided to OMB for review.

• Expert/Gatekeeper review of tools—In some instances, medical providers or other gatekeepers may review tools to provide feedback on the acceptability and usability of a particular tool. This will usually be in addition to an individual user pretesting the tool.

• Record abstractions—On occasion, the development of a tool or other information collection requires review and interaction with records, rather than individuals.

• “Dress rehearsal” of a specific protocol—In some instances, the proposed pre-testing will constitute a walkthrough of the intended data collection procedure. In these cases, the request will mirror what is expected to occur for the larger scale data collection.

Likely Respondents: HRSA partners are typically state or local governments, health care facilities, health care consortia, health care providers, and researchers. HRSA partners may also include individuals served by HRSA programs and/or funding recipients. Participation in any collections under this clearance will be entirely voluntary, and the privacy of respondents will be preserved to the extent requested by participants and as permitted by law.

Respondents will be recruited by means of advertisements in public venues or through techniques that replicate prospective data collection activities that are the focus of the project. For instance, a survey on physician communication, designed to be administered following an office visit, might be pretested using the same procedure. Each ICR will specify the recruitment procedure to be used.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on: (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

HUD encourages product manufacturers, suppliers, distributors, and other stakeholders to identify products and categories of products that currently are domestically produced, compliant with BABA requirements, and have sufficient domestic availability to support HUD-assisted infrastructure projects, to assist contractors and project sponsors in incorporating compliant products in their projects and to help HUD focus its activities to benefit domestic manufacturers. To assist in gathering this information, HUD seeks input from the public, including domestic manufacturers, labor unions, transportation and trade associations, and other interested parties. HUD seeks information in several categories related to the domestic availability of products commonly used in housing infrastructure projects that are compliant with BABA's Buy America Preference (BAP) requirements.

Please indicate in your written comments the product or category of product you are commenting on and provide specific examples or information to illustrate your comments where possible. You do not need to address all products or categories of products and should focus on those where you have relevant expertise or experience. In all cases, to the extent possible, please cite any public data related to or that support your responses. If data is available, but non-public, describe such data to the extent permissible.

The Build America, Buy America Act was enacted on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (“IIJA”). 1 The Act establishes a domestic content procurement preference, the BAP, for Federal infrastructure programs. Section 70914(a) of the Act establishes that no later than 180 days after the date of enactment, HUD must ensure that none of the funds made available for infrastructure projects may be obligated by the Department unless it has taken steps to ensure that the iron, steel, manufactured products, and construction materials used in a project are produced in the United States.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on September 15, 2025 at 90 FR 44389.

Title of Information Collection: Housing Opportunity Through Modernization Act of 2016 (HOTMA): Public Housing Waiting List Data Collection Tool.

OMB Approval Number: 2577-0302.

Type of Request: Revision of a currently approved collection.

Form Number: None.

Description of the need for the information and proposed use:

This collection of information implements a statutory requirement made by Section 103 of HOTMA, which was signed into law on July 29, 2016 (Pub. L. 114-201, 130 Stat. 782). Section 103 of HOTMA amends section 16(a) of the United States Housing Act of 1937 (42 U.S.C. 1437n(a)) (“1937 Act”).

Section 16 of the 1937 Act now states that after a public housing family has been over-income for two consecutive years, a public housing agency (PHA) must either: (1) charge the over-income family a monthly rent that is the higher of fair market rent section 8(c) for the dwelling unit or the monthly amount of public housing subsidy provided for the dwelling unit; or (2) terminate the tenancy of the over-income family no later than 6 months after the end of the two-year period. Additionally, pursuant to the revised section 16(a), PHAs must submit an annual report on the number of over-income families residing in public housing and the number of families on the public housing waiting lists. Section 16(a) permits HUD to determine the format of these annual reports. HUD has elected to utilize income data already provided, when possible, as this will result in no additional burden to the PHA.

Each PHA with a Public Housing program is required to submit the total number of families on their public housing waiting lists annually (starting with Calendar Year 2023 data) utilizing the electronic Public Housing Waiting List Data Collection Tool. PHAs will be allowed to use income data already provided by Form HUD-50058, under OMB approval number 2577-0083, which is submitted electronically in the Inventory Management System/PIH Information Center to satisfy the requirement to report the annual number of over-income families residing in public housing. Per the requirements of section 16(a) of the 1937 Act, HUD will consolidate the data provided and publish this information annually in a publicly available report.