Early Hearing Detection and Intervention (EHDI) Program, 35886-35888 [2023-11592]
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ddrumheller on DSK120RN23PROD with NOTICES1
35886
Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices
establishment changes or if there is a
change in the establishment’s U.S.
agent’s name, address, telephone
number, or email address, then
establishments must also amend their
registration within 30 calendar days. Of
note, the regulations make clear that
FDA’s ‘‘acceptance of an establishment
registration and HCT/P listing form does
not constitute a determination that an
establishment is in compliance with
applicable rules and regulations or that
the HCT/P is licensed or approved by
FDA’’ (21 CFR 1271.27(b)).
Registration is performed using
CBER’s eHCTERS. Establishments
electronically submit required
registration and HCT/P listing
information, as well as updates to such
information, through their eHCTERS
account.3 The public can access
eHCTERS to search and review tissue
establishment registration information
(registered, inactive, and pre-registered
establishments) through the eHCTERS
Public Query Application.
Complete, accurate, and up-to-date
establishment registration and HCT/P
listing information is essential to FDA’s
mission. If registration and listing
information is outdated or otherwise
unreliable, the integrity of the HCT/P
registration and listing database is
compromised. Registration information
assists FDA in identifying industry
participants and the scope of HCT/Ps
manufactured. This assists FDA in more
efficiently monitoring industry and
providing new information including
guidances, policies, and requirements.
Establishment registration information
also assists FDA in reacting swiftly to
newly discovered or understood risks by
enabling FDA to quickly alert industry
of our concerns and, when appropriate,
to conduct establishment inspections.
Without this information, FDA would
not be able to effectively monitor
compliance under FDA’s risk-based
surveillance inspection program.
Establishment registration and HCT/P
listing information is also widely used
outside of FDA for various purposes.
The public uses the Public Query
Application of eHCTERS to search for
and locate HCT/P establishments. For
example, certain voluntary healthcare
accreditation organizations require
hospitals or surgical centers to annually
confirm that their tissue suppliers are
registered with FDA. Therefore,
inclusion of inaccurate or outdated
3 Electronic submission of HCT/P establishment
and product listing information may be waived in
certain circumstances as described in 21 CFR
1271.23. Submission of a request for a waiver does
not excuse timely compliance with registration and
listing requirements.
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17:37 May 31, 2023
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information in eHCTERS can negatively
affect public health.
II. Circumstances Under Which HCT/P
Registration and Listing Information
Becomes Inaccurate or Outdated
Establishments that manufacture
HCT/Ps are required to update their
registration annually in December, even
if there are no changes or updates to
their information (§ 1271.21). Every
year, many HCT/P establishments fail to
update their registration information
during the annual update period. In
recent years, 390 of 2671, 379 of 2361,
and 319 of 2431 registered domestic and
foreign establishments failed to submit
their annual registration for 2019, 2020,
and 2021, respectively. Some of the
establishments have not submitted their
annual update for more than 2 years.
After the annual registration period
ends, CBER generates a list of
establishments that have failed to
submit their annual registration update.
From this list, FDA attempts to follow
up with each of these establishments to
rectify their registration status.
However, for a variety of reasons, such
as outdated contact information, FDA is
not able to contact some of these
establishments. The follow-up process,
including sending a reminder email and
contact by phone, requires considerable
additional time and FDA staff resources.
When establishments fail to update
their registration information in
eHCTERS, they are improperly
registered in eHCTERS and improperly
displayed in the Public Query
Application as ‘‘Registered’’. Not only
does this inaccurate and outdated
information compromise the integrity of
eHCTERS, it also hinders the public’s
ability to rely on establishment
registration information.
III. FDA’s Intended Response
To address the above registration and
listing problems, FDA is encouraging
establishments that are required to
register under part 1271 to review their
current registration to ensure its
accuracy. Any registrations that are
outdated should be updated as soon as
possible. Establishments are required to
annually update their registration
pursuant to FDA regulations.
Establishments who do not submit their
annual registration are in violation of
the regulations at part 1271.
Ninety days after publication of this
notice, and every January thereafter,
FDA will inactivate an HCT/P
establishment’s registration when the
establishment fails to submit their
annual registration update during the
previous annual update period between
November 15 to December 31. FDA will
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no longer attempt to follow up with
establishments to rectify their
registration status. The eHCTERS Public
Query Application will display the
establishment registration status as
‘‘inactive’’ and include the last annual
registration year. Email notification of
the inactivation will be sent to the
reporting official of the establishment,
and the reporting official may access the
establishment’s account in eHCTERS to
change or update its registration. If the
email notifying the establishment of the
change in registration status to
‘‘inactive’’ is undeliverable, FDA will
call the phone number of the
establishment to provide notification.
If an establishment changes or
updates its registration in eHCTERS
after its registration has been inactivated
due to failure to annually update
registration information, the eHCTERS
Public Query Application will display
the establishment’s status as
‘‘Registered’’ and the last annual
registration year will be updated to the
current year.
IV. Resources Available To Assist With
Updating Registration and HCT/P
Listings
Access to part 1271 is available at:
https://www.ecfr.gov/current/title-21/
chapter-I/subchapter-L/part-1271?toc=1.
The instructions for using eHCTERS to
complete HCT/P establishment
registration and HCT/P listing and
submitting the annual registration
updates, as well as information on the
eHCTERS Public Query Application, are
available at: https://www.fda.gov/
vaccines-blood-biologics/biologicsestablishment-registration/tissueestablishment-registration. Questions
concerning registration can be emailed
to tissuereg@fda.hhs.gov.
Dated: May 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–11570 Filed 5–31–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Early Hearing Detection and
Intervention (EHDI) Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a HRSA-initiated
competitive supplement for the EHDI
Program.
AGENCY:
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35887
Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices
HRSA will provide
supplemental award funds for up to 20
Early Hearing Detection and
Intervention Program recipients of
$75,000 each with a period of
performance of 12 months to develop
the necessary partnerships, assessments,
evaluations, and other activities at the
state and local levels to ensure that all
children identified as deaf or hard of
hearing (DHH) and their families receive
the services they need to meet language
acquisition and other developmental
milestones by age 3.
FOR FURTHER INFORMATION CONTACT:
Dana Simms, Project Officer, dsimms@
hrsa.gov or 301–443–1623.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award:
Up to 20 EHDI grantees of those listed
in Table 1 who demonstrate readiness as
articulated in review criteria on
methodology, work plan, and budget to
SUMMARY:
address language acquisition and other
developmental milestones at age 3 for
children identified as DHH.
Amount of Competitive Awards: Up to
20 awards at $75,000 ($1.5 million
total).
Project Period: April 1, 2023–March
31, 2024.
Assistance Listing (CFDA) Number:
93.251.
Award Instrument: Supplement.
Authority: Public Health Service Act,
Title III, Section 399M(a) (42 U.S.C.
280g–1(a)).
Purpose/Justification: The
Consolidated Appropriations Act, 2023
(Pub. L. 117–328) provided HRSA’s
Maternal and Child Health Bureau with
an additional $1 million for the EHDI
program. The EHDI program currently
funds 59 states and territories to support
comprehensive systems of care so
families with newborns, infants, and
young children up to 3 years of age
receive appropriate and timely services
including screening, diagnosis, and
early intervention. When children are
identified as DHH early and they are
provided with timely and appropriate
intervention services, they have better
vocabulary development, expressive
language, and social-emotional
development than children identified
later. EHDI programs will use this
supplemental support for 1 year to
develop the necessary partnerships,
assessments, evaluations, and other
activities at the state and local levels to
ensure that all children identified as
DHH and their families receive the
services they need to meet language
acquisition and other developmental
milestones by age 3. By September 2023,
HRSA’s Maternal and Child Health
Bureau intends to provide a 1-year
supplement for $75,000 for up to 20
existing grantees.
TABLE 1—CURRENT EHDI RECIPIENTS
ddrumheller on DSK120RN23PROD with NOTICES1
Grant #
H61MC00015
H61MC00054
H61MC00076
H61MC33903
H61MC30765
H61MC33904
H61MC33905
H61MC00088
H61MC00060
H61MC23639
H61MC00086
H61MC10346
H61MC22706
H61MC24883
H61MC00038
H61MC24884
H61MC26835
H61MC00010
H61MC04498
H61MC23640
H61MC00049
H61MC00033
H61MC00014
H61MC00002
H61MC00081
H61MC30766
H61MC00056
H61MC00035
H61MC00052
H61MC00071
H61MC30523
H61MC00053
H61MC00043
H61MC00028
H61MC00065
H61MC00034
H61MC04397
H61MC23641
H61MC25010
H61MC00005
H61MC00029
H61MC00051
H61MC00057
H61MC24882
H61MC00050
VerDate Sep<11>2014
Award recipient name
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State/territory
Alaska Department of Health and Social Services ....................................................................................
Alabama State Department of Public Health .............................................................................................
Arkansas Department of Health .................................................................................................................
Department of Health American Samoa ....................................................................................................
EAR Foundation of Arizona ........................................................................................................................
NorCal for Deaf and Hard of Hearing ........................................................................................................
State of Colorado Department of Human Services ....................................................................................
State of Connecticut ...................................................................................................................................
District of Columbia Department of Health .................................................................................................
Delaware Department of Health & Social Services ...................................................................................
Florida State Department of Health ............................................................................................................
Federated States of Micronesia .................................................................................................................
Georgia Department of Public Health ........................................................................................................
University of Guam .....................................................................................................................................
State of Hawaii Department of Health ........................................................................................................
University of Hawaii Systems .....................................................................................................................
Iowa Department of Public Health ..............................................................................................................
Idaho State Department of Health and Welfare .........................................................................................
The Illinois Department of Health ...............................................................................................................
Indiana State Department of Health ...........................................................................................................
Kansas State Department of Health and Environment ..............................................................................
Community For Children with Special Healthcare Needs ..........................................................................
Louisiana State Department of Health and Hospitals ................................................................................
Massachusetts Department of Public Health .............................................................................................
Maryland Department of Health and Mental Hygiene ................................................................................
Maine Educational Center for the Deaf & Hard of Hearing .......................................................................
Michigan Department of Community Health ..............................................................................................
Minnesota Department of Health ................................................................................................................
Mississippi State Department of Health .....................................................................................................
Missouri Department of Health ...................................................................................................................
Commonwealth Healthcare Corporation ....................................................................................................
Montana State Department of Public Health and Human Services ...........................................................
North Carolina Department of Health & Human Services .........................................................................
Minot State University .................................................................................................................................
Nebraska State Department of Health .......................................................................................................
New Hampshire Department of Health ......................................................................................................
New Mexico State Department of Health ...................................................................................................
New Jersey Department of Health and Senior Services ...........................................................................
Health and Human Services/Nevada Department of Health .....................................................................
Health Research Inc. ..................................................................................................................................
State of Ohio Department of Health ...........................................................................................................
Oklahoma State Department of Health ......................................................................................................
Oregon State Department of Human Services ..........................................................................................
Commonwealth of Pennsylvania ................................................................................................................
Puerto Rico Department of Health .............................................................................................................
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AK
AL
AR
AS
AZ
CA
CO
CT
DC
DE
FL
FM
GA
GU
HI
HI
IA
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MS
MO
MP
MT
NC
ND
NE
NH
NM
NJ
NV
NY
OH
OK
OR
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PR
35888
Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices
TABLE 1—CURRENT EHDI RECIPIENTS—Continued
Grant #
H61MC05788
H61MC00009
H61MC00040
H61MC33906
H61MC00066
H61MC26836
H61MC00042
H61MC00046
H61MC23642
H61MC09029
H61MC00084
H61MC00024
H61MC23643
H61MC00075
Award recipient name
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
Republic of Palau .......................................................................................................................................
State of Rhode Island Department of Health .............................................................................................
State of South Carolina ..............................................................................................................................
University of South Dakota .........................................................................................................................
Tennessee State Department of Health .....................................................................................................
Texas Department of State Health Services ..............................................................................................
Utah Department of Health .........................................................................................................................
Virginia State Department of Health ...........................................................................................................
U.S. Virgin Islands Department of Health ..................................................................................................
Vermont State Agency for Human Services ..............................................................................................
Washington State Department of Health ....................................................................................................
Wisconsin Department of Health ................................................................................................................
West Virginia Department of Health and Human Resources ....................................................................
Wyoming State Department of Health ........................................................................................................
Carole Johnson,
Administrator.
Public Comments’’ or by using the
search function.
[FR Doc. 2023–11592 Filed 5–31–23; 8:45 am]
To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Ryan White HIV/AIDS Program Part F
Dental Services Report, OMB No. 0915–
0151—Extension.
Abstract: The Dental Reimbursement
Program (DRP) and the Community
Based Dental Partnership Program
(CBDPP) under Part F of the Ryan White
HIV/AIDS Program (RWHAP) offer
funding to accredited dental education
programs to support the education and
training of oral health providers in HIV
oral health care and reimbursement for
the provision of oral health services for
people eligible for the RWHAP.
Institutions eligible for RWHAP DRP
and CBDPP are accredited schools of
dentistry and other accredited dental
education programs, such as dental
hygiene programs or those sponsored by
a school of dentistry, a hospital, or a
public or private institution that offers
postdoctoral training in the specialties
of dentistry, advanced education in
general dentistry, or a dental general
practice residency. The RWHAP DRP
Application for the Notice of Funding
Opportunity includes the Dental
Services Report (DSR) that applicants
use to apply for funding of nonreimbursed costs incurred in providing
oral health care to patients with HIV
and to report annual program data.
Awards are authorized under section
2692(b) of the Public Health Service Act
(42 U.S.C. 300ff–111(b)). The form is
also used by CBDPP recipients to report
on services rendered, patients served,
and partnerships as an annual data
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Ryan White HIV/AIDS
Program Part F Dental Services
Report, OMB No. 0915–0151—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than July 3, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
ddrumheller on DSK120RN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
State/territory
17:37 May 31, 2023
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PW
RI
SC
SD
TN
TX
UT
VA
VI
VT
WA
WI
WV
WY
report. The DSR collects data on
program information, client
demographics, oral health services,
funding, and training. It also requests
applicants to provide narrative
descriptions of their services and
facilities, as well as their linkages and
how they collaborate with communitybased providers of oral health services.
Beginning with the 2022 DSR
submission, the DSR website provided
RWHAP DRP applicants and RWHAP
CBDPP recipients an easily accessible
and secure location to enter and submit
their aggregate DSR data annually. The
web-based platform is accessible by all
users and allows users to easily navigate
the site and enter their data. Users can
see their report submission status and
will no longer email their completed
dataset to HRSA. The implementation of
the DSR website has contributed to the
overall decrease in burden hours. HRSA
proposes two additions to the DSR data
reporting tool. First, HRSA proposes
adding an additional response option to
the HIV/AIDS Status question to record
clients whose HIV status is
indeterminate. Second, HRSA proposes
adding a question that will identify
specific populations such as LGBTQI,
urban/suburban/rural persons, homeless
persons, persons with substance use
disorder, migrant or seasonal workers,
incarcerated/paroled persons, and/or
runaway youth, who were specifically
prioritized to receive services through
community-based partnership programs.
A 60-day notice was published in the
Federal Register on March 8, 2023
(Volume 88, No. 45, pages 14375–76).
There were no public comments in
response to the notice.
Need and Proposed Use of the
Information: The primary purpose of
collecting this information annually is
to verify applicant eligibility and
determine reimbursement amounts for
DRP applicants, as well as to document
the program accomplishments of
E:\FR\FM\01JNN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 105 (Thursday, June 1, 2023)]
[Notices]
[Pages 35886-35888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Early Hearing Detection and Intervention (EHDI) Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a HRSA-initiated competitive supplement for the EHDI
Program.
-----------------------------------------------------------------------
[[Page 35887]]
SUMMARY: HRSA will provide supplemental award funds for up to 20 Early
Hearing Detection and Intervention Program recipients of $75,000 each
with a period of performance of 12 months to develop the necessary
partnerships, assessments, evaluations, and other activities at the
state and local levels to ensure that all children identified as deaf
or hard of hearing (DHH) and their families receive the services they
need to meet language acquisition and other developmental milestones by
age 3.
FOR FURTHER INFORMATION CONTACT: Dana Simms, Project Officer,
[email protected] or 301-443-1623.
SUPPLEMENTARY INFORMATION:
Intended Recipient(s) of the Award: Up to 20 EHDI grantees of those
listed in Table 1 who demonstrate readiness as articulated in review
criteria on methodology, work plan, and budget to address language
acquisition and other developmental milestones at age 3 for children
identified as DHH.
Amount of Competitive Awards: Up to 20 awards at $75,000 ($1.5
million total).
Project Period: April 1, 2023-March 31, 2024.
Assistance Listing (CFDA) Number: 93.251.
Award Instrument: Supplement.
Authority: Public Health Service Act, Title III, Section 399M(a)
(42 U.S.C. 280g-1(a)).
Purpose/Justification: The Consolidated Appropriations Act, 2023
(Pub. L. 117-328) provided HRSA's Maternal and Child Health Bureau with
an additional $1 million for the EHDI program. The EHDI program
currently funds 59 states and territories to support comprehensive
systems of care so families with newborns, infants, and young children
up to 3 years of age receive appropriate and timely services including
screening, diagnosis, and early intervention. When children are
identified as DHH early and they are provided with timely and
appropriate intervention services, they have better vocabulary
development, expressive language, and social-emotional development than
children identified later. EHDI programs will use this supplemental
support for 1 year to develop the necessary partnerships, assessments,
evaluations, and other activities at the state and local levels to
ensure that all children identified as DHH and their families receive
the services they need to meet language acquisition and other
developmental milestones by age 3. By September 2023, HRSA's Maternal
and Child Health Bureau intends to provide a 1-year supplement for
$75,000 for up to 20 existing grantees.
Table 1--Current EHDI Recipients
------------------------------------------------------------------------
Grant # Award recipient name State/territory
------------------------------------------------------------------------
H61MC00015................ Alaska Department of AK
Health and Social
Services.
H61MC00054................ Alabama State AL
Department of Public
Health.
H61MC00076................ Arkansas Department AR
of Health.
H61MC33903................ Department of Health AS
American Samoa.
H61MC30765................ EAR Foundation of AZ
Arizona.
H61MC33904................ NorCal for Deaf and CA
Hard of Hearing.
H61MC33905................ State of Colorado CO
Department of Human
Services.
H61MC00088................ State of Connecticut. CT
H61MC00060................ District of Columbia DC
Department of Health.
H61MC23639................ Delaware Department DE
of Health & Social
Services.
H61MC00086................ Florida State FL
Department of Health.
H61MC10346................ Federated States of FM
Micronesia.
H61MC22706................ Georgia Department of GA
Public Health.
H61MC24883................ University of Guam... GU
H61MC00038................ State of Hawaii HI
Department of Health.
H61MC24884................ University of Hawaii HI
Systems.
H61MC26835................ Iowa Department of IA
Public Health.
H61MC00010................ Idaho State ID
Department of Health
and Welfare.
H61MC04498................ The Illinois IL
Department of Health.
H61MC23640................ Indiana State IN
Department of Health.
H61MC00049................ Kansas State KS
Department of Health
and Environment.
H61MC00033................ Community For KY
Children with
Special Healthcare
Needs.
H61MC00014................ Louisiana State LA
Department of Health
and Hospitals.
H61MC00002................ Massachusetts MA
Department of Public
Health.
H61MC00081................ Maryland Department MD
of Health and Mental
Hygiene.
H61MC30766................ Maine Educational ME
Center for the Deaf
& Hard of Hearing.
H61MC00056................ Michigan Department MI
of Community Health.
H61MC00035................ Minnesota Department MN
of Health.
H61MC00052................ Mississippi State MS
Department of Health.
H61MC00071................ Missouri Department MO
of Health.
H61MC30523................ Commonwealth MP
Healthcare
Corporation.
H61MC00053................ Montana State MT
Department of Public
Health and Human
Services.
H61MC00043................ North Carolina NC
Department of Health
& Human Services.
H61MC00028................ Minot State ND
University.
H61MC00065................ Nebraska State NE
Department of Health.
H61MC00034................ New Hampshire NH
Department of Health.
H61MC04397................ New Mexico State NM
Department of Health.
H61MC23641................ New Jersey Department NJ
of Health and Senior
Services.
H61MC25010................ Health and Human NV
Services/Nevada
Department of Health.
H61MC00005................ Health Research Inc.. NY
H61MC00029................ State of Ohio OH
Department of Health.
H61MC00051................ Oklahoma State OK
Department of Health.
H61MC00057................ Oregon State OR
Department of Human
Services.
H61MC24882................ Commonwealth of PA
Pennsylvania.
H61MC00050................ Puerto Rico PR
Department of Health.
[[Page 35888]]
H61MC05788................ Republic of Palau.... PW
H61MC00009................ State of Rhode Island RI
Department of Health.
H61MC00040................ State of South SC
Carolina.
H61MC33906................ University of South SD
Dakota.
H61MC00066................ Tennessee State TN
Department of Health.
H61MC26836................ Texas Department of TX
State Health
Services.
H61MC00042................ Utah Department of UT
Health.
H61MC00046................ Virginia State VA
Department of Health.
H61MC23642................ U.S. Virgin Islands VI
Department of Health.
H61MC09029................ Vermont State Agency VT
for Human Services.
H61MC00084................ Washington State WA
Department of Health.
H61MC00024................ Wisconsin Department WI
of Health.
H61MC23643................ West Virginia WV
Department of Health
and Human Resources.
H61MC00075................ Wyoming State WY
Department of Health.
------------------------------------------------------------------------
Carole Johnson,
Administrator.
[FR Doc. 2023-11592 Filed 5-31-23; 8:45 am]
BILLING CODE 4165-15-P
