Determination of Regulatory Review Period for Purposes of Patent Extension; ENHERTU; Correction

CourtFood And Drug Administration
Citation87 FR 1762
Record Number2022-00404
Publication Date12 January 2022
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 non-
grandfathered 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/child-
health/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 evidence-
driven 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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