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Federal Register / Vol. 86, No. 19 / Monday, February 1, 2021 / Notices
that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Public Law 106430, 114 Stat. 1901
Nov. 6, 2000 and Occupational Safety and Health Administration OSHA
standard 29 CFR 1910.1030, Bloodborne Pathogens.
A copy of the Notice of the March 25
Designation, including the above modifications and those included in the June 30, 2020 and July 30, 2020 notices is provided below and also can be found on HHSs website.
Notice of Designation of Scarce Materials or Threatened Materials Health or medical resources, or any of their essential components, determined by the Secretary of HHS to be needed to respond to the spread of COVID19 and which are, or are likely to be, in short supply scarce materials or the supply of which would be threatened by hoarding threatened materials.
Designated scarce materials or threatened materials are subject to periodic review by the Secretary.
The following materials are designated pursuant to section 102 of the Defense Production Act 50 U.S.C.
4512 and Executive Order 13190 of March 23, 2020 Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID19 as scarce materials or threatened materials:
1. N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates 2. Other Filtering Facepiece Respirators e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100, including single-use, disposable half-mask respiratory protective devices that cover the users airway nose and mouth and offer protection from particulate materials at or greater than an N95 filtration efficiency level per 42
CFR 84.181.
3. Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges 4. Powered Air Purifying Respirators PAPR
5. Portable Ventilators, including portable devices intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas 6. Sterilization services for any device as defined in section 201h of the Federal Food, Drug, and Cosmetic Act FD&C Act and sterilizers as defined in
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21 CFR 880.6860, 880.6870, and 880.6880, including devices that already have FDA marketing authorization and those that do not have FDA marketing authorization but are intended for the same uses, or are authorized by FDA
under section 564 of the FD&C Act for purposes of decontamination 7. Disinfecting devices intended to kill pathogens and other kinds of microorganisms by chemical means or physical means, including those defined in 21 CFR 876.1500, 880.6992, and 892.1570 and other sanitizing and disinfecting products suitable for use in a clinical setting 8. Medical gowns or apparel, e.g., surgical gowns or isolation gowns 9. Personal protective equipment PPE coveralls, e.g., Tyvek Suits 10. Face masks, including any masks that cover the users nose and mouth and may or may not meet fluid barrier or filtration efficiency levels 11. Surgical masks, including masks that covers the users nose and mouth and provides a physical barrier to fluids and particulate materials 12. PPE face shields, including those defined at 21 CFR 878.4040 and those intended for the same purpose 13. PPE gloves or surgical gloves, including those defined at 21 CFR
880.6250 exam gloves and 878.4460
surgical gloves and such gloves intended for the same purposes 14. Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators collectively referred to as ventilators, ventilator tubing connectors, and ventilator accessories as those terms are described in FDAs March 2020 Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 COVID19
Public Health Emergency located at https www.fda.gov/media/136318/
download.
15. Laboratory reagents and materials used for isolation of viral genetic material and testing, such as transport media, collection swabs, test kits and reagents specific to those kits, and consumables such as plastic pipette tips and plastic tubes 16. Drug products currently recommended by the NIH COVID19
Treatment Guidelines Panel, including as of July 30, 2020 remdesivir and dexamethasone 17. Alcohol-based over 60 percent hand sanitizer and rubs.
18. Syringes and hypodermic needles whether distributed separately or attached together generally used in the
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United States for vaccinations that are either:
i Piston syringes in 1 ml or 3 ml sizes that allow for the controlled and precise flow of liquid as described by 21
CFR 880.5860, that are compliant with ISO 78861:2017 and use only Current Good Manufacturing Practices CGMP
processes; or ii Hypodermic single lumen needles between 1 and 1.5 and 22 to 25 gauge between 1 and 1.5 and 22 to 25 gauge that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Public Law 106430, 114 Stat. 1901
Nov. 6, 2000 and OSHA standard 29
CFR 1910.1030, Bloodborne Pathogens.
Authority: The authority for this Notice is Executive Order 13910 and section 102 of the Defense Production Act of 1950, 50 U.S.C.
4512, as amended.
Norris Cochran, Acting Secretary, Department of Health and Human Services.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary Annual Update of the HHS Poverty Guidelines Department of Health and Human Services.
ACTION: Notice.
AGENCY:

This notice provides an update of the Department of Health and Human Services HHS poverty guidelines to account for last calendar years increase in prices as measured by the Consumer Price Index.
DATES: Applicable: January 13, 2021
unless an office administering a program using the guidelines specifies a different effective date for that particular program.
ADDRESSES: Office of the Assistant Secretary for Planning and Evaluation, Room 404E, Humphrey Building, Department of Health and Human Services, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: For information about how the guidelines are used or how income is defined in a particular program, contact the Federal, state, or local office that is responsible for that program. For information about poverty figures for immigration forms, the Hill-Burton Uncompensated Services Program, and the number of people in poverty, use the specific telephone numbers and addresses given below.
SUMMARY:

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