35810 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

The Maternal, Infant, and Early 

Childhood Home Visiting Program 

Quarterly Performance Report, OMB No. 

0906–0016, Revision 

Abstract: This clearance request is for 

continued approval of the Maternal, 

Infant, and Early Childhood Home 

Visiting (MIECHV) Program Quarterly 

Performance Report. The MIECHV 

Program, administered by HRSA in 

partnership with the Administration for 

Children and Families, supports 

voluntary, evidence-based home visiting 

services during pregnancy and to 

parents with young children up to 

kindergarten entry. States, certain nonprofit organizations, and tribal entities 

are eligible to receive funding from the 

MIECHV Program and have the 

flexibility to tailor the program to serve 

the specific needs of their communities. 

HRSA is revising the data collection 

forms for the MIECHV Program by 

making the following changes: 

• Form 4, reporting guidance: Revise 

reporting instructions to reflect 

updated reporting requirements 

• Form 4, Definition of Key Terms: 

Update definitions for Table A.1 

• Form 4, Definition of Key Terms: Add 

definitions for Table A.2 

HRSA is also requesting approval to 

expand the use of Form 4 in order to 

collect quarterly performance data from 

awardees who receive MIECHV funding 

appropriated by section 9101 of the 

American Rescue Plan Act (Pub. L. 117– 

2). 

Need and Proposed Use of the 

Information: HRSA uses quarterly 

performance information to demonstrate 

program accountability and 

continuously monitor and provide 

oversight to MIECHV Program awardees. 

The information is also used to provide 

quality improvement guidance and 

technical assistance to awardees and 

help inform the development of early 

childhood systems at the national, state, 

and local level. HRSA is seeking to 

revise reporting instructions and 

definitions of key terms and to expand 

the use of Form 4 in order to collect 

distinct quarterly performance data 

related to the use of the American 

Rescue Plan Act funds. This notice is 

subject to the appropriation of funds, 

and is a contingency action taken to 

ensure that, should funds become 

available for this purpose, information 

can be collected in a timely manner. 

Likely Respondents: MIECHV Program 

awardees that are states, territories, and, 

where applicable, nonprofit 

organizations receiving MIECHV 

funding to provide home visiting 

services within states. 

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. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form 

name 

Number 

of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Form 4: Section A—Quarterly Performance Report ............ 56 8 448 24 10,752 

Form 4: Section B Quarterly Benchmark Performance 

Measures .......................................................................... 10 4 40 200 8,000 

Total .............................................................................. * 56 ........................ 488 ........................ 18,752 

* The 10 responses for Section B are a sub-set of 56 total awardees funded through the MIECHV Program. 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–14412 Filed 7–6–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

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: Temporary notice; solicitation 

of comments. 

SUMMARY: The Department of Health and 

Humans Services (HHS) provides notice 

of the extension of the designation 

issued on February 1, 2021, under 

Executive Order 13910 (Executive 

Order) and section 102 of the Defense 

Production Act of 1950 (the Act), as 

amended, 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. These 

designated materials are subject to the 

hoarding prevention measures 

authorized under the Executive Order 

and the Act. 

DATES: This action took effect on July 1, 

2021, and terminates on November 15, 

2021. To be assured consideration, 

comments on this extension and update 

to the list of scarce or threatened 

materials must be received at the 

address provided below by August 6, 

2021. 

ADDRESSES: In commenting, please refer 

to Paige Ezernack: 202–260–0365; 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 35811 

paige.ezernack@hhs.gov. Comments, 

including mass comment submissions, 

must be submitted electronically. You 

may submit electronic comments on this 

regulation to http://

www.regulations.gov. Follow the 

‘‘Submit a comment’’ instructions. 

FOR FURTHER INFORMATION CONTACT: 

Paige Ezernack: 202–260–0365; 

paige.ezernack@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 subject to the 

Administrative Procedure Act (APA). 

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

exemption from the APA). Pursuant to 

50 U.S.C. 4559(b)(2), the Secretary finds 

that, in light of the current pandemic 

and need to ensure Americans have 

access to critical and life-saving health 

resources, urgent and compelling 

circumstances make compliance with 

public comment requirements 

impracticable prior to issuance. This 

temporary Notice is therefore effective 

immediately upon issuance, but the 

Secretary will provide an opportunity 

for 30 days of public comment before 

finalizing. 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, July 30, 

2020, and February 1, 2021 notices, 

through November 15, 2021. The 

Secretary also finds good cause to 

remove the following materials from the 

list because they are no longer scarce or 

threatened materials: 

1. In FR Doc. 2020–06641 of March 

30, 2020 (85 FR 17592), remove the 

following text: 

1. N–95 Filtering Facepiece Respirators, 

including devices that are 

disposable half-face-piece nonpowered 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 an N95 filtration 

efficiency level per 42 CFR 84.181 

3. Elastomeric, air-purifying respirators 

and appropriate particulate filters/ 

cartridges 

4. Powered Air Purifying Respirator 

(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. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
35812 Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices 

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. 

17. Alcohol-based (over 60 percent) 

hand sanitizer and rubs. 

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. Medical gowns or apparel, e.g., 

surgical gowns or isolation gowns 

2. 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 

3. Drug products currently 

recommended by the National Institutes 

of Health COVID–19 Treatment 

Guidelines Panel, including (as of April 

21, 2021) remdesivir and 

dexamethasone 

4. 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. 

Dated: June 30, 2021. 

Xavier Becerra 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–14383 Filed 7–2–21; 4:15 pm] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0001] 

Agency Information Collection 

Request: 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before September 7, 

2021. 

ADDRESSES: Submit your comments 

sagal.musa@hhs.gov or by calling (202) 

205–2634. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 4040–0001– 

Revision–60D and project title for 

reference, to Sagal Musa, email: 

sagal.musa@hhs.gov, or call (202) 205– 

2634 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: SBIR/STTR 

Information. 

Type of Collection: Revision of A 

Currently Approved Collection. 

OMB No.: 4040–0001. 

Abstract: The SBIR (Small Business 

Innovation Research)/STTR (Small 

Business Technology Transfer) program 

is designed to stimulate technological 

innovation in the private sector by 

strengthening the role of small business, 

increasing the commercial application 

of federally supported research results, 

as well as fostering and encouraging 

participation by socially and 

economically disadvantaged and 

women-owned small businesses. This 

form is used by grant applicants to 

apply for SBIR/STTR-related grants. 

Grants.gov seeks to include a question 

regarding the use of SBIR/STTR funds 

for Technical and Business Assistance 

(TABA). 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(If necessary) 

Respondents 

(If necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total 

burden hours 

SBIR/STTR Information .................... Grant Applicants ............................... 6,376 1 1 6,376 

Total ........................................... ........................................................... 6,376 1 1 6,376 


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