1760 Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices 

that captures a core set of individual 

level data relevant for determining the 

range of necessary LTSS. 

The Federal vision for the NWD 

System gives states flexibility in 

determining how best to organize, 

structure and operate the various 

functions of their NWD System. States 

continue to integrate, in some cases 

restructure, and over time strengthen 

their existing programs in order to 

realize the joint ACL/CMS/VHA vision 

for a fully coordinated and integrated 

system of access. These efforts are 

supported by a variety of initiatives, 

including the VHA’s Veteran Directed 

Care (VDC) program, an evidence-based 

self-directed program where personcentered counselors from aging and 

disability network agencies within a 

state’s NWD System provide facilitated 

assessment and care planning, arrange 

fiscal management services, and provide 

ongoing counseling and support to 

Veterans, their families, and caregivers. 

The NWD System Management Tool 

(NWD MT) provides a platform for data 

collection necessary to evaluate the four 

primary functions of a NWD System: 

State Governance and Administration, 

Public Outreach and Coordination with 

Key Referral Sources, Person Centered 

Counseling, and Streamlined Access to 

Public LTSS Programs. In addition, this 

tool will include data collection for the 

VDC program to collect qualitative and 

quantitative data elements necessary to 

evaluate the impact of the VDC program. 

The VDC Tool will track key 

performance measures and identify best 

practices and technical assistance 

needs. 

The NWD MT and the VDC Tool will 

enable ACL and its partners to collect 

and analyze data elements necessary to 

assess the progress of the NWD System 

model, track performance measures, and 

identify gaps and best practices. These 

tools have been designed in close 

collaboration with states and are 

intended to simplify grant reporting 

requirements to reduce burden on local 

and state entities and will provide a 

consistent, streamlined and coordinated 

statewide approach to help states govern 

their NWD System and manage their 

programs efficiently. 

The proposed data collection tools 

may be found on the ACL website for 

review at: https://www.acl.gov/aboutacl/public-input. 

Estimated Program Burden: ACL 

estimates the burden of this collection 

of information as follows: 

Fifty-six lead NWD System state and 

territorial agencies will respond to the 

NWD MT bi-annually and it will take 

approximately half an hour to collect 

the data and an additional half hour to 

input the data into a web-based system. 

Additionally, an estimated 900 local 

agencies will take approximately two 

hours to collect and submit the data to 

their lead NWD System state agency. 

There may be several lead NWD System 

state and territorial agencies who will be 

submitting on behalf of their local 

agencies. Therefore, the approximate 

burden for the local level agencies may 

be thirty minutes less than anticipated. 

If all state and local agencies respond biannually, the national burden estimate 

for the NWD MT would be a total of 

3,712 hours annually. This burden 

estimate is calculated based upon a 

sample of ADRC/NWD grantees. Each 

state entity submitting data will receive 

local-level data from designated NWD 

System entities. The estimated response 

burden includes time to review the 

instructions, gather existing 

information, and complete and review 

the data entries in a web-based system. 

An estimated 275 VDC program 

entities will respond to the VDC Tool on 

a monthly-basis, all of which are also 

NWD local-level entities, for an annual 

burden of 1,650 hours. This burden 

estimate is calculated based upon 

information provided by current VDC 

program providers testing an 

abbreviated version of the VDC Tool. 

The NWD MT and the VDC Tool have 

been developed to increase ease and 

uniformity of reporting and improve the 

ability of ACL to manage and analyze 

data. 

Respondent/data collection activity Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Annual 

burden hours 

NWD Management Tool data collection and entry—State Level .................... 56 2 1.0 112 

NWD Management Tool data collection and entry—Local Level ................... 900 2 2.0 3,600 

Veteran Directed Care Tool ............................................................................. 275 12 0.5 1,650 

Total .......................................................................................................... 1,231 ........................ ........................ 5,362 

Dated: January 6, 2022. 

Alison Barkoff, 

Principal Deputy Administrator. 

[FR Doc. 2022–00399 Filed 1–11–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Availability of Program Application 

Instructions for Subtitle C of the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000, 

Protection and Advocacy Systems To 

Expand the Public Health Workforce 

Title: Expanding the Public Health 

Workforce within the Disability 

Networks: Protection and Advocacy 

Systems. 

Announcement Type: Initial. 

Statutory Authority: The statutory 

authority for grants under this program 

announcement is Section 2501 of the 

American Rescue Plan Act of 2021 (Pub. 

L. 117–2) and awards authorized under 

Subtitle C of the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000 (42 U.S.C 15041 et seq.), 

Protection and Advocacy Systems, shall 

be provided funding under this 

opportunity. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.630. 

DATES: The deadline date for the 

submission of the Expanding the Public 

Health Workforce within Disability 

Networks: Protection and Advocacy 

Systems is 11:59 p.m. Eastern Time 

February 11, 2022. 

I. Funding Opportunity Description 

The Administration for Community 

Living (ACL) announced a new funding 

opportunity to expand the public health 

workforce within the disability 

networks. Public health promotes and 

protects the health of people and the 

communities where they live, learn, 

work, and play. The disability networks 

funded by the Administration for 

Community Living (ACL) play an 

essential role in that work. The 

disability networks consist of trusted 

organizations and programs that reach 

and provide services and supports to 

people with disabilities in every 

community throughout the nation, 

including those related to public health 


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Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices 1761 

1American Rescue Plan Act of 2021, Public Law 

117–2, 135 Stat 4 (Mar. 11, 2021). 

such as health and wellness education 

and information, counseling, case 

management and guidance related to 

health and social needs, as well as how 

to access those supports. These 

networks have over 50 years of 

community experience and possess 

intimate knowledge of the public health 

and other resources available and the 

needs of people with disabilities in their 

direct area. 

As part of its ongoing COVID–19 

response efforts, the Biden-Harris 

Administration is investing federal 

funds through the American Rescue 

Plan Act of 2021 (ARPA) 1 to recruit, 

hire, and train public health workers to 

respond to the pandemic and prepare 

for future public health challenges. 

Specifically, the Secretary of the U.S. 

Department of Health and Human 

Services (HHS) will ‘‘carry out activities 

related to establishing, expanding, and 

sustaining a public health workforce 

. . . ,’’ ARPA § 2501(a), and funds may 

be used to support costs, including 

wages and benefits, of a range of public 

health professionals including but not 

limited to social support professionals, 

community health workers, 

communication and policy experts and 

‘‘. . . other positions as may be required 

to prevent, prepare for, and respond to 

COVID–19 . . . ,’’ ARPA § 2501(b)(1). 

To help advance these efforts, ACL 

has created the Expanding the Public 

Health Workforce within Disability 

Networks program. This program aims 

to increase through the support of wages 

and benefits the number of public 

health professionals within the 

disability networks to address the 

unique needs of individuals with 

disabilities. Public health professionals 

supported through this program may 

provide a wide range of public health 

services and supports, including 

provision of culturally affirmative and 

linguistically accessible information, 

access assistance for vaccines and 

boosters, transition and diversion from 

high-risk congregate settings to 

community living, provision and 

connections to health and wellness 

programs, activities that address social 

isolation and social determinants of 

health, and other activities that support 

the public health and wellbeing of 

people with disabilities. 

Protection and Advocacy Systems 

(P&As) under the Developmental 

Disabilities Assistance and Bill of Rights 

Act (DD Act)—the eligible entities for 

this opportunity—shall be provided 

funding to support new staff or increase 

the full-time equivalent (FTE) of 

existing staff under this opportunity to 

carry out public health services and 

supports. Although not required for 

funding, grantees are encouraged to 

explore options for funding to sustain 

the new FTE after the end of the grant. 

There is no cost sharing or matching 

requirement for this funding. 

Award recipients will be required to 

submit annual progress reports in the 

form of a written summary on the 

number of full-time equivalents (FTEs) 

funded, type of public health 

professional(s) hired, and the activities 

they are engaged in to advance public 

health. To be eligible to receive this 

grant, the P&As must submit a Letter of 

Assurance to ACL containing all the 

assurances required, (see below, 

‘‘Section III. Eligibility Criteria and 

Other Requirements’’ and ‘‘Section IV. 

Submission Information’’). P&As that do 

not submit a Letter of Assurance or 

otherwise indicate no desire to receive 

funds, will be excluded from receiving 

funds. 

ACL may extend deadlines based on 

the need of the COVID–19 response, 

e.g., to meet unanticipated issues related 

to COVID–19 and/or to allow impacted 

P&As that missed the cut-off date to 

submit a letter of assurance for 

consideration. ACL intends to issue 

notices of award as soon as possible 

with an estimated start date of March 1, 

2022. However, the actual award may be 

released earlier or later than that date. 

Because the total amount awarded to 

each grantee is contingent upon the total 

number of grantees applying for 

funding, grant awards will be issued 

after ACL receives responses from all 

eligible P&As. Regardless of the date of 

award, the funding will be available 

until September 30, 2024. Grantees may 

use the funds over any period of time 

before this date but are encouraged to 

use the funding as soon as possible to 

have the greatest impact. 

II. Award Information 

1. Funding Instrument Type 

These awards will be made in the 

form of new grants, evenly distributed 

to eligible entities. 

2. Anticipated Total Funding per Budget 

Period 

Awards made under this 

announcement will have an estimated 

start date of March 1, 2022 and an end 

date of September 30, 2024. 

The total available funding for this 

opportunity is $6,384,000. 

Eligible entities who do not complete 

assurance requirements below, or 

otherwise indicate no desire to receive 

funds will be excluded from receiving 

funds. This will have the effect of 

increasing the amount of funds available 

for eventual recipients. 

ACL will distribute the $6,384,000 

evenly to all eligible entities to ensure 

a sufficient level of funding to provide 

substantive support for the public 

health workforce, which equates to a 

minimum award of $112,000. This 

figure is based on the current number of 

eligible entities and would rise if some 

eligible entities refuse or are deemed 

ineligible. 

III. Eligibility Criteria and Other 

Requirements 

1. Eligible Entities 

The eligible entity for these awards is 

designated by ACL as Protection and 

Advocacy Systems authorized under 

Subtitle C of the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000. 

2. Match 

Cost Sharing or Matching is not 

required. 

3. Other Requirements 

A. Letter of Assurance 

A Letter of Assurance is required to be 

submitted by the eligible entity in order 

to receive an award. The Letter of 

Assurance must include the following: 

1. Assurance that the award recipient 

is the agency or entity designated as the 

Protection and Advocacy System in the 

state or territory under section 143 of 

the DD Act (42 U.S.C. 15042). 

2. Assurance that funds will be spent 

in ways consistent with the purpose of 

the funding to support the cost of wages 

and benefits for public health 

professionals, directly or through 

contract such as: 

• Case investigator, 

• Contact tracer, 

• Social support specialist, 

• Community health worker, 

• Public health nurse, 

• Disease intervention specialist, 

• Epidemiologist, 

• Program manager, 

• Laboratory personnel, 

• Informaticians, 

• Communication and policy experts, 

• Other positions as may be required 

to prevent, prepare for, and respond to 

COVID–19. 

3. Assurance to provide semi-annual 

federal financial reports and annual 

program reports that include the 

number and type of full-time 

equivalents hired, and activities 

performed to advance public health. 

B. DUNS Number 

All grant applicants must obtain and 

keep current a D–U–N–S number from 


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1762 Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices 

Dun and Bradstreet. It is a nine-digit 

identification number, which provides 

unique identifiers of single business 

entities. The D–U–N–S number can be 

obtained from: https://iupdate.dnb.com/ 

iUpdate/viewiUpdateHome.htm. 

C. Intergovernmental Review 

Executive Order 12372, 

Intergovernmental Review of Federal 

Programs, is not applicable to these 

grant applications. 

IV. Submission Information 

1. Letter of Assurance 

To receive funding, eligible entities 

must provide a Letter of Assurance 

containing all the information outlined 

in Section III above. 

Letters of Assurance should be 

addressed to: Jennifer Johnson, Deputy 

Commissioner, Administration on 

Disabilities, Administration for 

Community Living. 

Letters of Assurance should be 

submitted electronically via email to 

PHWF@acl.hhs.gov. 

2. Submission Dates and Times 

To receive consideration, Letters of 

Assurance must be submitted by 11:59 

p.m. Eastern Time on February 11, 2022. 

Letters of Assurance should be 

submitted electronically via email and 

have an electronic time stamp 

indicating the date/time submitted. 

VII. Agency Contacts 

1. Programmatic and Submission Issues 

Direct programmatic and submission 

inquiries to PHWF@acl.hhs.gov. 

Dated: January 6, 2022. 

Alison Barkoff, 

Principal Deputy Administrator. 

[FR Doc. 2022–00401 Filed 1–11–22; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–1817, FDA– 

2020–E–1818, and FDA–2020–E–1820] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENHERTU; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 

published a notice in the Federal 

Register of November 1, 2021, for the 

determination of a regulatory review 

period for purposes of patent extension 

for the human biological product, 

ENHERTU. This document corrects that 

notice by adjusting the applicable 

regulatory review period for the testing 

phase and approval phase of the 

product, ENHERTU. 

DATES: All due dates for submission of 

comments, redetermination requests, 

and submission of petitions for due 

diligence as well as the dates used to 

determine the regulatory review periods 

for the products noted above remain the 

same as originally published. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: On 

November 1, 2021, the Food and Drug 

Administration (FDA or the Agency) 

published a notice in the Federal 

Register determining the regulatory 

review period for the human biological 

product ENHERTU. This correction to 

the notice adjusts the applicable 

regulatory review period of the product 

with the number of days occurring 

during the testing phase and the 

approval phase of the product 

ENHERTU. 

Correction 

In the Federal Register of November 

1, 2021 (86 FR 60252), in FR Doc. 2021– 

23725, appearing on page 60253, in the 

third column, in section II., 

‘‘Determination of Regulatory Review 

Period,’’ in the first two sentences, the 

following correction is made: 

FDA has determined that the 

applicable regulatory review period for 

ENHERTU is 1,395 days. Of this time, 

114 days occurred during the testing 

phase of the regulatory review period, 

while 1,281 days occurred during the 

approval phase. 

Dated: January 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00404 Filed 1–11–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Updates to the Bright Futures 

Periodicity Schedule 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: Effective December 30, 2021, 

HRSA accepted recommended updates 

to the Bright Futures Periodicity 

Schedule, a HRSA-supported guideline 

for infants, children and adolescents for 

purposes of ensuring that nongrandfathered group and individual 

health insurance issuers provide 

coverage without cost sharing under the 

Public Health Service Act. The updates 

to the Bright Futures Periodicity 

Schedule are: A new category for 

sudden cardiac arrest and sudden 

cardiac death risk assessment, a new 

category for hepatitis B virus infection 

risk assessment, addition of suicide risk 

as an element of universal depression 

screening for children ages 12–21, and 

updated category title from 

‘‘Psychosocial/Behavioral Assessment’’ 

to ‘‘Behavioral/Social/Emotional 

Screening,’’ with no revision to the ages 

in which the screening occurs (newborn 

to 21 years). Finally, two clarifying 

references related to dental fluoride 

varnish and fluoride supplementation 

have been added, with no associated 

recommended changes to clinical 

practice or health insurance coverage. 

Please see https://mchb.hrsa.gov/ 

maternal-child-health-topics/childhealth/bright-futures.html for additional 

information. 

FOR FURTHER INFORMATION CONTACT: 

Savannah Kidd, M.S. MFT, HRSA/ 

Maternal and Child Health Bureau by 

calling 301–287–2601 or by emailing at 

SKidd@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The Bright 

Futures program has been funded by 

HRSA since 1990. A primary focus of 

this program is for the funding recipient 

to maintain and recommend updates to 

the Bright Futures Guidelines for Health 

Supervision of Infants, Children and 

Adolescents, a set of materials and tools 

that provide theory-based and evidencedriven guidance for all preventive care 

screenings and well-child visits. One 

component of these tools is the Bright 

Futures Periodicity Schedule, a chart 

that identifies the recommended 

screenings, assessments, physical 

examinations, and procedures to be 

delivered within preventive checkups at 

each age milestone. Over the program’s 

existence, the Bright Futures Periodicity 

Schedule has become the accepted 

schedule within the United States for 

preventive health services through the 

course of a child’s development. 

Section 2713 of the Public Health 

Service Act (42 U.S.C. 300gg–13), added 

by the Patient Protection and Affordable 

Care Act (Pub. L. 111–148), requires that 

non-grandfathered group health plans 

and health insurance issuers offering 


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