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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