Federal Register / Vol. 86, No. 19 / Monday, February 1, 2021 / Notices 7731 

issues related to the Commission’s 

charge. There will be an opportunity for 

limited oral comments (each no more 

than 3 minutes in length) at this virtual 

meeting. Virtual attendees who plan to 

provide oral comments at the 

Commission meeting during a 

designated time must register prior to 

the meeting at: https://

kauffmaninc.adobeconnect.com/nccc_

feb_2021/event/event_info.html. 

Written comments are welcome 

throughout the entire development 

process of the Commission’s work and 

may be emailed to OHQ@hhs.gov. 

Written comments should not exceed 

three pages in length. 

Individuals who need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate the 

special accommodation when 

registering online or by notifying 

Jennifer Gillissen at jennifer.gillissen@

kauffmaninc.com by February 8, 2021. 

Authority: The National Clinical Care 

Commission is authorized by the 

National Clinical Care Commission Act 

(Pub. L. 115–80). The Commission is 

governed by provisions of the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463, as amended (5 U.S.C., 

App.) which sets forth standards for the 

formation and use of federal advisory 

committees. 

Dated: January 25, 2021. 

Dorothy A. Fink, 

Deputy Assistant Secretary for Women’s 

Health, Office of the Assistant Secretary for 

Health. 

[FR Doc. 2021–02037 Filed 1–29–21; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Extension of Designation of Scarce 

Materials or Threatened Materials 

Subject to COVID–19 Hoarding 

Prevention Measures; Extension of 

Effective Date With Modifications 

AGENCY: Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) provides notice 

of the extension of the designation 

issued on July 30, 2020 designating 

health and medical resources necessary 

to respond to the spread of the virus 

associated with Coronavirus Disease 

2019 (COVID–19) that are scarce or the 

supply of which would be threatened by 

excessive accumulation by people or 

entities not needing the excess supplies. 

This notice extends the designation and 

updates the list of scarce or threatened 

materials to include certain classes and 

sizes of hypodermic needles and 

syringes. 

DATES: This action took effect February 

1, 2021 and terminates on June 30, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Paige Ezernack: 202–260–0365; 

PaigeEzernack@hhs.gov. 

SUPPLEMENTARY INFORMATION: On March 

23, 2020, and in response to the spread 

of the virus associated with COVID–19, 

President Trump signed Executive 

Order 13910 (Executive Order) to 

prevent hoarding of health and medical 

resources necessary to respond to the 

spread of COVID–19 within the United 

States. As provided in the Executive 

Order, it is the policy of the United 

States that health and medical resources 

needed to respond to the spread of 

COVID–19, such as personal protective 

equipment and sanitizing and 

disinfecting products, are appropriately 

distributed. This policy furthers the goal 

of protecting the Nation’s healthcare 

systems from undue strain. 

Through the Executive Order, the 

President delegated, to the Secretary of 

Health and Human Services (the 

Secretary), his authority under section 

102 of the Defense Production Act of 

1950, 50 U.S.C. 4512, as amended (the 

Act), to prevent hoarding of health and 

medical resources necessary to respond 

to the spread of COVID–19 within the 

United States, and his authority to 

implement the Act in subsection III of 

chapter 55 of title 50, United States 

Code (50 U.S.C. 4554, 4555, 4556, and 

4560). Under this delegation and the 

Act, the Secretary may designate such 

resources as scarce materials or 

materials the supply of which would be 

threatened by such accumulation 

(threatened materials). The Secretary 

may also prescribe conditions with 

respect to accumulation of such 

materials in excess of the reasonable 

demands of business, personal, or home 

consumption. The Act prohibits any 

person or entity from accumulating 

designated materials (1) in excess of the 

reasonable demands of business, 

personal, or home consumption, or (2) 

for the purpose of resale at prices in 

excess of prevailing market prices. 

The March 25 Designation Notice 

issued by HHS designates scarce 

materials or threatened materials that 

are subject to the hoarding prevention 

measures authorized under the 

Executive Order and the Act. See 85 FR 

17592. (Mar. 30, 2020). Under 50 U.S.C. 

4552(13), the term ‘‘materials’’ includes: 

‘‘(A) any raw materials (including 

minerals, metals, and advanced 

processed materials), commodities, 

articles, components (including critical 

components), products, and items of 

supply; and (B) any technical 

information or services ancillary to the 

use of any such materials, commodities, 

articles, components, products, or 

items.’’ For purposes of the March 25 

Designation Notice, the term ‘‘scarce 

materials or threatened materials’’ 

means health or medical resources, or 

any of their essential components, 

determined by the Secretary to be 

needed to respond to the spread of 

COVID–19 and which are, or are likely 

to be, in short supply or the supply of 

which would be threatened by hoarding. 

85 FR at 17592. Designated scarce 

materials or threatened materials are 

subject to periodic review by the 

Secretary. 

The designation is not a ‘‘regulation’’ 

under the Administrative Procedure Act 

(APA). See 50 U.S.C. 4559 (providing an 

exemption from the APA). To the extent 

that it is, the Secretary finds that, in 

light of the current pandemic, urgent 

and compelling circumstances make 

compliance with public comment 

requirements impracticable. See Id. 

The March 25 Designation Notice was 

scheduled to terminate 120 days from 

the date of publication, unless 

superseded by a subsequent notice. 

Given the ongoing pandemic, the 

Secretary finds good cause to extend the 

March 25 Designation Notice, as 

modified by the June 30, 2020 and July 

30, 2020 notices, through June 30, 2021. 

The Secretary also finds good cause to 

include the following modifications and 

additions to the list of scarce or 

threatened materials: 

1. In FR Doc. 2020–06641 of March 

30, 2020 (85 FR 17592), add the 

following text: 

(i) On page 17593, first column, (7) 

Sterilization services, add ‘‘or are 

authorized by FDA under section 564 of 

the FD&C Act for purposes of 

decontamination’’ 

(ii) On page 17593, first column, (11) 

Face masks, remove ‘‘PPE’’ 

(iii) On page 17593, first column, (12) 

Surgical masks, remove ‘‘PPE’’ 

2. Add ‘‘Syringes and hypodermic 

needles (whether distributed separately 

or attached together) generally used in 

the 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 7886–1:2017 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 

7732 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 106–430, 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 HHS’s 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 COVID–19 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 COVID–19) as 

scarce materials or threatened materials: 

1. N–95 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 user’s 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 201(h) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and sterilizers as defined in 

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 user’s nose and mouth 

and may or may not meet fluid barrier 

or filtration efficiency levels 

11. Surgical masks, including masks 

that covers the user’s 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 FDA’s 

March 2020 Enforcement Policy for 

Ventilators and Accessories and Other 

Respiratory Devices During the 

Coronavirus Disease 2019 (COVID–19) 

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 COVID–19 

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 

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 7886–1:2017 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 106–430, 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. 

[FR Doc. 2021–02102 Filed 1–29–21; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Annual Update of the HHS Poverty 

Guidelines 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: This notice provides an 

update of the Department of Health and 

Human Services (HHS) poverty 

guidelines to account for last calendar 

year’s 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.