To the contrary, the inverse core-shell structure is characterized by an iron oxide coating of nonmagnetic functional material. High-quality diagnostic information was provided by the MRI examination. Iron oxide nanoparticles with a high level of monodispersity and size control were obtained by high-temperature decomposition of iron organic precursors, such as Fe(Cup)3, Fe(CO)5, or iron(III) acetylacenonate [Fe(acac)3], using organic solvents and surfactants (Hyeon etal., 2001). However, the reduction in the platelet counts may reflect tissue lesions triggered by NPs (Comnescu et al., 2015). to the courts under 44 U.S.C. on From the NHANES data, Colorcon determined that 2 dietary supplements are consumed in a 24-hour period at the mean, and 4 at the 90th percentile. are not part of the published document itself. developer tools pages. 2018-23863 Filed 10-31-18; 8:45 am], updated on 4:15 PM on Friday, July 29, 2022, updated on 8:45 AM on Friday, July 29, 2022. documents in the last year, by the Forest Service Please note that late, untimely filed objections will not be considered. Iron interacts with various aqueous dissolved compounds, and humic substances may coprecipitate with iron-oxide particles. documents in the last year, 678 For these characteristics, they have been investigated for liver imaging, macrophage imaging or blood pool agents. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows: 1. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see Written/Paper Submissions and Instructions). 2). FDA's color additive regulations in 21 CFR 70.3(i) define safe to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. ScienceDirect is a registered trademark of Elsevier B.V. ScienceDirect is a registered trademark of Elsevier B.V. Superparamagnetic Iron Oxide Nanoparticle, Meyler's Side Effects of Drugs (Sixteenth Edition), Ultrasmall superparamagnetic particles of, Ferumoxtran-10 (Combidex, Advanced Magnetics, Cambridge, MA) is an ultrasmall superparamagnetic, Handbook of Cosmeceutical Excipients and their Safeties, Synthesis of Magnetic Iron Oxide Nanoparticles, Nanocarriers in Different Preclinical and Clinical Stages, Nanomedicine in Central Nervous System Injury and Repair, A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Breathing Manganese and Iron: Solid-State Respiration, Balistrieri and Murray, 1982, 1984; Tessier, Handbook on the Toxicology of Metals (Fourth Edition), Miyata etal., 1978; Sharrock and Bodnar, 1985; Vissokov and Pirgov, 1996; Choo and Kang, 2003, Raj and Moskovitz, 1990; Hfeli etal., 1997; Schutt etal., 1997; Denizli and Say 2001, Laurent etal., 2009; Veiseh etal., 2009, Hamm etal., 1994; Reimer and Balzer 2003, Laurent etal., 2009; Kunzmann etal., 2011b, Sun etal., 2004; Park etal., 2004; Redl etal., 2004; OBrien etal., 2001, Deng etal., 2005; Del Monte etal., 1997; Kim and Kim, 2006; Yu etal., 2006; Qin etal., 2007, Interactions of Dissolved Organic Matter and Humic Substances in Freshwater Systems, Reference Module in Earth Systems and Environmental Sciences. There are various types of iron oxides that include iron(II) oxide, wstite (FeO), magnetite (Fe3O4), iron(III) oxide (Fe2O3), alpha phase, hematite (-Fe2O3), beta phase, (-Fe2O3), gamma phase, maghemite (-Fe2O3), epsilon phase, (-Fe2O3). Fe(II) is oxidized into Fe(III) by photochemically produced H2O2 and the redox cycling (Fenton's reaction) is thereby complete. This is suggested to be due to products of photolysis, including reactive oxygen species, which transform DOM into less soluble forms. In the final rule approving the use of synthetic iron oxides for use in candy, mints, and chewing gum (80 FR 14839, March 20, 2015), FDA discussed that elemental iron from synthetic iron oxides is not readily bioavailable and is poorly absorbed by the human gastrointestinal tract (80 FR 14839 at 14840). This information is not part of the official Federal Register document. rendition of the daily Federal Register on FederalRegister.gov does not In addition, light and iron interactively promote particle formation from dissolved humic substances. See section X for further information on the filing of objections. documents in the last year, 913 the Federal Register. Hanna L. Karlsson, Bengt Fadeel, in Handbook on the Toxicology of Metals (Fourth Edition), 2015. The diagnostic efficacy and safety of SHU 555 A has been investigated in 19 patients aged 4389 years who had been referred for investigation of hepatocellular carcinoma (eight patients), liver metastases (four patients), liver hemangioma (four patients), cholangiocarcinoma (two patients), and focal nodular hyperplasia (one patient) [6]. None of the 19 patients reported any pain or discomfort at the injection site. Synthetic iron oxides and their hydrated forms are currently approved as color additives for use in human foods and drugs: (1) In sausage casings intended for human consumption in an amount not to exceed 0.10 percent by weight of the finished food (73.200); (2) in soft and hard candy, mints, and chewing gum at levels consistent with good manufacturing practice (GMP), except that they may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Kenneth H. Nealson, Brenda Little, in Advances in Applied Microbiology, 1997. documents in the last year, 81 documents in the last year, by the Maritime Administration documents in the last year, 889 For biomedical applications, it is crucial that SPIONs have a well-defined shape, are monodispersed, and exhibit a high magnetization capacity (Laurent etal., 2009; Kunzmann etal., 2011b). This site displays a prototype of a Web 2.0 version of the daily We further conclude that the color additive will achieve its intended technical effect and is suitable for the petitioned use. 2. This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. 1). Memorandum from T. Thurmond, Toxicology Team, Division of Petition Review, OFAS, CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, September 17, 2018. FDA-2017-C-6238 for Listing of Color Additives Exempt from Certification; Synthetic Iron Oxide. Received objections, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https://www.regulations.gov or with the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Results revealed that NPs have perhaps caused an induction of a local inflammation and subsequent employment of the peripheral lymphocytes. headings within the legal text of Federal Register documents. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Federal Register. Synthetic iron oxides also are approved for use as color additives in cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with GMP (21 CFR 73.2250). Tranvik, E. von Wachenfeldt, in Reference Module in Earth Systems and Environmental Sciences, 2014. A Rule by the Food and Drug Administration on 11/01/2018. on 3). The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 3, 2018. 07/29/2022, 329 This prototype edition of the In the report, IOM determined dietary reference intakes and upper limits (ULs) for iron of 40 mg/d for children (2-13 years of age) and 45 mg/d for adolescents and adults (14 years and older) (Ref. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. oxides, hydroxides, and oxy-hydroxides are known to date. *1. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e. About the Federal Register 2). The UL is determined using a risk assessment model developed specifically for nutrients and may consider intake from such sources as food, water, nutrient supplements, and pharmacological agents (Ref. on the bloodbrain barrier (BBB) permeability, edema formation, and neuronal or glial changes within 424h after administration was examined in normal rats and after a focal spinal cord injury (SCI). FDA reviewed the data and information in the petition and other available relevant material and determined the petitioned use of synthetic iron oxides in dietary supplement tablets and capsules is safe. The authority citation for part 73 continues to read as follows: Authority: As provided in 71.15, we will delete from the documents any materials that are not available for public disclosure.Start Printed Page 54872. In estimating exposure, we presumed that: (1) Each dietary supplement could contain up to 5 mg elemental iron for labeled dosages from the use of synthetic iron oxides, resulting in an exposure to elemental iron of 10 milligrams per person per day (mg/p/d) at the mean and 25 mg/p/d at the 90th percentile; (2) all dietary supplements would contain added synthetic iron oxides; and (3) the added synthetic iron oxides would contain a maximum amount (72 percent) of elemental iron; therefore, the use level of 5 mg elemental iron per labeled dosage of dietary supplement would result in a use level of 6.9 mg synthetic iron oxides per labeled dosage of dietary supplement (Ref. The exposure to elemental iron from the petitioned use of synthetic iron oxides is estimated to be 10 mg/p/d at the mean and 25 mg/p/d at the 90th percentile. We stated that we had determined, under 21 CFR 25.32(k), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment such that neither an environmental assessment nor an environmental impact statement is required. The reference without an asterisk is not on public display at https://www.regulations.gov because it has copyright restriction but is available at the website address. 1). Our review of this petition was limited to section 721 of the FD&C Act. In 2001, the Institute of Medicine (IOM) published a report on dietary reference intakes for vitamins and minerals (Ref. Influence of iron oxide magnetic nanoparticles (IOMNPs, 10nm in diameter, 0.25 or 0.50mg/mL in 100L, i.v.) 3). 1). Under section 721(b)(4) of the FD&C Act (21 U.S.C. L.J. These contrast agents are well tolerated, with no serious adverse effects. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in our consideration of comments. MRI iron oxide causes loss of signal intensity, especially on T1 and T2 weighted images, and the contrast between the lesions and the surrounding tissues is increased owing to loss of signal in the healthy tissues. documents in the last year, 53 After intravenous injection it is sequestered by the reticuloendothelial system, mostly in the liver and spleen. As a consequence, when iron or manganese oxide reduction occurs in municipal water systems, not only is the water fouled by excess soluble manganese and/or iron, but trace components bound to the metal oxides may also be released (Francis and Dodge, 1990). These markup elements allow the user to see how the document follows the of the issuing agency. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. Taking into account the bioavailability of iron from synthetic iron oxides, the exposure to elemental iron from the petitioned use of synthetic iron oxides for the U.S. population aged 2 years and older is estimated to be 0.10 mg/p/d at the mean and 0.25 mg/p/d at the 90th percentile (Ref 1). The reference without an asterisk is available for viewing only at the Dockets Management Staff. For example, section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. You may submit objections and requests for a hearing as follows. 2). for better understanding how a document is structured but Furthermore, effect of cerebrolysin, a balanced composition of several neurotrophic factors, and active peptide fragments was also evaluated on IOMNP-induced changes in central nervous system (CNS) pathology. The incidence of adverse reactions is higher with these particulate iron oxide agents than with gadolinium chelates. on This PDF is was given either 30min before IOMNP injection in the 4-h SCI group or 4h after injury in the 24-h survival groups. Five patients had 10 adverse events, including rectal pain, diarrhea, edema, a phobic reaction, nausea, and a rash; all recovered without further therapy. We previously estimated the cumulative exposure to bioavailable elemental iron for the U.S. population to be 3.48 mg/p/d at the mean (Ref. documents in the last year, 75 Regarding exposure to elemental iron resulting from the proposed use of synthetic iron oxides in printing inks applied on tablets and capsules, we estimated that the amount of elemental iron from the use of synthetic iron oxides in inks for use on tablets and capsules is no more than 5.4 micrograms (g) per tablet or capsule, which corresponds to 10.8 g elemental iron/p/d at the mean (2 tablets or capsules) and 27 g elemental iron/p/d at the 90th percentile level (5 tablets or capsules) (Ref. Iron and manganese oxides are regarded as the scavengers of the sea (Goldberg, 1954) because of their ability to adsorb other metals and trace components. 2). documents in the last year, 108 431) (FD&C Act), unless the use of the added color is authorized by such standards (73.200); and (3) in ingested or topically applied drugs with a limit for ingested drugs of 5 mg, calculated as elemental iron, per day for labeled or prescribed dosages (21 CFR 73.1200). We use cookies to help provide and enhance our service and tailor content and ads. Use the PDF linked in the document sidebar for the official electronic format. Therefore, considering the exposure of 0.10 mg/p/d for elemental iron from the proposed use of synthetic iron oxides, the updated cumulative exposure to bioavailable iron from the current and proposed sources for the U.S. population aged 2 years and older is estimated to be 3.6 mg/p/d at the mean and 7.2 mg/p/d at the pseudo-90th percentile (Ref. Iron oxides, either Fe3O4 or -Fe2O3, can be prepared from aqueous Fe2+/Fe3+ salt solutions by the addition of a base under an inert atmosphere at room temperature or at elevated temperature (Bee etal., 1995). When the Fe(III)DOM complex is exposed to UV light, the complex is broken, resulting in colloids of DOC and Fe(II). The petitioner requested that the proposed uses be permitted at a maximum use level of 5 milligrams (mg), calculated as elemental iron, per day for labeled dosages. Preeti K. Menon, Hari S. Sharma, in International Review of Neurobiology, 2017. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. To support the safety of the proposed use of synthetic iron oxides, Colorcon proposed a maximum use level of the color additive in dietary supplements such that the total amount of elemental iron consumed shall not exceed 5 mg per day for labeled dosages. For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions., Confidential SubmissionsTo submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. 07/29/2022, 210 Section 73.200 is amended by revising paragraph (c)(1) to read as follows: (1) Synthetic iron oxide may be safely used for human food use subject to the following restrictions: (i) In sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food. Using more recent NHANES data (2011-2014), FDA determined that the U.S. population aged 2 years and older consumes 2 dietary supplements per day at the mean and 5 supplements per day at the 90th percentile (Ref. The Public Inspection page may also (iii) In dietary supplement tablets and capsules, including coatings and printing inks, such that the total amount of elemental iron per day for labeled dosages does not exceed 5 milligrams. Each document posted on the site includes a link to the The dose of iron was 6.011.7mol/kg. Several phase transfer strategies have been applied to hydrophobic magnetic nanoparticles to obtain the aqueous dispersion necessary for biomedical applications (Deng etal., 2005; Del Monte etal., 1997; Kim and Kim, 2006; Yu etal., 2006; Qin etal., 2007). An example is a study that was carried out for the preclinical investigation of the biocompatibility of a new iron oxide-based nanoparticle coated with L-DOPA to improve its dispersion in biological media. 3). Such reactions may account for the distribution of trace metals (Francis and Dodge, 1990; Rose et al., 1993; Tessier et al., 1996) and radionuclides like uranium in sediments (McKee et al., 1987) and anoxic water columns (McKee and Todd, 1993). They are taken up by the reticuloendothelial system. Synthetic iron oxides and their hydrated forms include red iron oxide (synthetic hematite), yellow iron oxide (synthetic geoethite), black iron oxide (synthetic magnetite), and brown iron oxide, which is a blend of various iron oxides. The authors concluded that ferumoxtran-10 is safe and well tolerated. It is not an official legal edition of the Federal documents in the last year, by the Indian Affairs Bureau 07/29/2022, 250 Ferumoxtran-10 (Combidex, Advanced Magnetics, Cambridge, MA) is an ultrasmall superparamagnetic iron oxide agent. After injection, the particles accumulate in the reticuloendothelial system. informational resource until the Administrative Committee of the Federal This final rule contains no collection of information. Magnetic nanoparticles are a widely studied class of nanoparticles because they offer great possibilities in a number of diagnostic applications and therapies (Laurent etal., 2009; Veiseh etal., 2009). documents in the last year, 12 High quality, monodisperse, as well as biocompatible DMSA-coated SPIONs have been attained by a thermal decomposition followed by ligand exchange reaction. This exposure is negligible compared to that for use of elemental iron as a color additive in tablets and capsules and in coatings applied to dietary supplements. Iron oxides are compounds that are basically composed of iron and oxygen. A thermal decomposition method has been developed as an effective way to synthesize high-quality semiconductor and oxide nanoparticles with a controlled size and shape. The iron oxide core is encapsulated in an inorganic or organic coating, which serves for particle stabilization and biocompatibility. One had a diffuse erythematous rash associated with a feeling of pressure in the thorax, which lasted for 30 minutes. on If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection. For complete information about, and access to, our official publications This indicated that cerebrolysin might be used as adjunct therapy during IOMNP administration in disease conditions, not reported earlier. Other methods, including microemulsion, hydrothermal, and sol-gel, have also been investigated for the synthesis of magnetic nanoparticles. They also have a greater T1 shortening effect than SPIO contrast agents. 1). provide legal notice to the public or judicial notice to the courts. 07/29/2022, 841 This table of contents is a navigational tool, processed from the The high-viscosity formulation (70g of granules/l) was better than the low-viscosity formulation in tumor staging, but the iron concentration (30 or 59 micrograms/ml) of the contrast agent was less important. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act, PART 73LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION, https://www.federalregister.gov/d/2018-23863, MODS: Government Publishing Office metadata, https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf, https://www.ncbi.nlm.nih.gov/books/NBK222310/pdf/Bookshelf_NBK222310.pdf. There were no serious adverse events during the 48-hour observation period and no changes in vital signs, physical examination, or laboratory parameters. The ultra-small superparamagnetic iron oxide (USPIO) contrast agents have a longer plasma circulation time and have greater uptake into marrow and lymph nodes. 2). 1503 & 1507. There were also minimal changes in the results of blood tests, which were not of clinical importance. Electronic objections must be submitted on or before December 3, 2018. Register, and does not replace the official print version or the official If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. Using 2-day food consumption data from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) food consumption database, Colorcon estimated exposure to elemental iron from the proposed use in dietary supplements. These observations are the first to show that IOMNPs are safe for the CNS and cerebrolysin treatment prevented CNS pathology following a combination of trauma and IOMNP injection. In a document published in the Federal Register on November 9, 2017 (82 FR 52037), we announced that we filed a color additive petition (CAP 7C0308) submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville, PA 19438. the material on FederalRegister.gov is accurately displayed, consistent with documents in the last year. edition of the Federal Register. This action is in response to a color additive petition (CAP) filed by Colorcon, Inc. daily Federal Register on FederalRegister.gov will remain an unofficial The EDI is determined by projections based on the amount of the color additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the color additive. Only official editions of the Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 1061, Rockville, MD 20852. Iron can catalyze the photodegradation of humic substances and colored dissolved organic matter (CDOM). New Documents Federal Register provide legal notice to the public and judicial notice Considering this, FDA has estimated exposure to elemental iron resulting from the petitioned use of synthetic iron oxides in dietary supplements as described below. We note that these values could represent 2 or 4 different dietary supplements, respectively, with each supplement containing up to 5 mg elemental iron. Consequently, we are amending the color additive regulations in 21 CFR part 73 as set forth in this document. Safety of Petitioned Use of Color Additive, IX. Learn more here. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and an uncertainty factor (Ref. Liver tumors have few or no reticuloendothelial cells and so there is a contrast between normal liver and tumor. by the Alcohol and Tobacco Tax and Trade Bureau The President of the United States manages the operations of the Executive branch of Government through Executive orders. We estimated an upper-bound exposure to synthetic iron oxides from its use as a color additive in dietary supplement tablets and capsules and in coatings applied to dietary supplement tablets and capsules, but excluding its use in printing inks applied on tablets and capsules, to be 13.8 mg/p/d at the mean and 34.5 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older (Ref. This rule is effective December 4, 2018. These changes were not considered to be of clinical importance. Listing of Color Additives Exempt From Certification; 3)-CAP 7C0308_Toxicology Review Memo_Finalized_Redacted, 2)-CAP 7C0308_Chemistry Memo_Finalized_Redacted, 1)-FDA-2017-C-6238_List of References_CAP 7C0308, IV. on FederalRegister.gov In this method, organometallic compounds as precursors are decomposed in high-boiling nonaqueous media containing stabilizing surfactants (Sun etal., 2004; Park etal., 2004; Redl etal., 2004; OBrien etal., 2001). *3. Copyright 2022 Elsevier B.V. or its licensors or contributors. NC100150 shows promise for myocardial perfusion analysis. You should submit two copies total. Document Drafting Handbook They consist of non-stoichiometric microcrystalline iron oxide cores, which are coated with dextrans (in ferumoxides) or siloxanes (in ferumoxsils). 10/31/2018 at 8:45 am. Open for Comment, Proposed Addition of American Single Malt Whisky to the Standards of Identity for Distilled Spirits, Economic Sanctions & Foreign Assets Control, Vessel Repair Duties for Vessels Entering U.S. To establish with reasonable certainty that a color additive intended for use in foods is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the color additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. Ultrasmall superparamagnetic particles of iron oxide (USPIOs) of median diameter no less than 50nm have been studied as blood-pool agents and are given intravenously to enhance liver imaging in patients with cirrhosis and to visualize lymph nodes. In this Issue, Documents better and aid in comparing the online edition to the print edition. Iron oxide-containing contrast agents consist of suspended colloids of iron oxide nanoparticles, which reduce T2 MRI signals. documents in the last year, 1385 Moreover, oxic water iron (III) forms a complex with DOM which stays in solution. Because the 90th percentile exposure estimate to bioavailable elemental iron from all dietary sources, including the proposed use of synthetic iron oxides to color dietary supplement tablets and capsules, is significantly below the UL determined by IOM, we conclude that there is a reasonable certainty of no harm from the proposed use of synthetic iron oxide as a color additive in dietary supplement tablets and capsules (Ref. Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies. The use of SPION-based MRI contrast agents is well established and a number of SPIONs have been approved by the U.S. Food and Drug Administration (FDA) (Hamm etal., 1994; Reimer and Balzer 2003). If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. documents in the last year, 22 This document has been published in the Federal Register. The most common form of iron oxide used is magnetite, which is a mixture of Fe2O3 and FeO; a mixture of Fe2O3 and Fe3O4 can be used instead.
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