Notice of a Maternal and Child Health Bureau-Initiated Supplemental Award to the Immune Deficiency Foundation for the Severe Combined Immunodeficiency Screening and Education Program, 59534-59535 [2020-20856]
Download as PDF
<![CDATA[
59534
Federal Register / Vol. 85, No. 184 / Tuesday, September 22, 2020 / Notices
and hospitalization as a result of donor
complications or other health related
issues.
Reimbursement for lost wages is
based on the donor providing
appropriate documentation, such as pay
stubs, to the program. Reimbursement of
lost wages is not limited to traditional
wage rate income. Donors may receive
reimbursement for non-traditional or
irregular income through the program if
they provide sufficient documentation
of the expected lost wages.
In order to qualify for reimbursement
of child-care expenses and elder-care
expenses, a donor shall have caretaker
responsibilities for:
(1) A minor child and/or
(2) An elder who requires caretaker
assistance.
Caretaker responsibilities are not
limited to familial relationships
between the donor and/or the
accompanying or assisting person(s),
and the aforementioned individuals.
In considering requests for
reimbursement for child-care expenses
and elder-care expenses, the recipient of
the cooperative agreement is encouraged
to adopt a consistent application of
‘‘child’’ and ‘‘elder.’’ The recipient of
the cooperative agreement may consider
applicable laws within the jurisdiction
in which the caretaker resides in
reviewing requests for reimbursement
for expenses for care of a ‘‘child,’’ and,
in reviewing requests for reimbursement
for elder-care expenses, may consider
‘‘elder’’ to refer to an individual age 60
and older, consistent with the Older
Americans Act, 42 U.S.C. 3002(40).
Requests for reimbursement for the
expenses of persons accompanying or
assisting the donor for travel, housing,
meals, and incidental expenses are
considered under the preference
categories and processed for
reimbursement at the same time as
requests for reimbursement for expenses
incurred by the donor. Requests for
reimbursement for the expenses of
persons accompanying or assisting the
donor for lost wages, child-care
expenses, and elder-care expenses are
considered under the preference
categories and will be processed
separately. Requests for these expenses
will be processed after all requests for
expenses incurred by the donor, and
expenses for persons accompanying or
assisting the donor for qualifying
expenses for travel, housing, meals, and
incidental expenses, have been
processed under all four preference
categories.
The total Federal reimbursement for
all qualifying expenses during the
VerDate Sep<11>2014
18:01 Sep 21, 2020
Jkt 250001
donation process shall not exceed
$6,000.
For donor and recipient pairs
participating in a paired exchange
program, the applicable eligibility
criteria for the originally intended
recipient shall be considered for the
purpose of reimbursement of qualifying
donor expenses even though the final
recipient of the donated organ may not
be the recipient identified in the
original donor-recipient pair.
Given that non-directed donors have
served as catalysts in transplant chains
of multiple recipients, they are
considered donating individuals eligible
to receive reimbursement for qualifying
expenses, if all other relevant program
requirements are satisfied. In applying
the preference categories to nondirected donors, the recipient of the
cooperative agreement will review the
household income of the non-directed
donor against the current income
threshold in effect at the time of the
eligibility determination.
Maximum Number of Prospective
Donors per Recipient
• Kidney: One donor at a time with a
maximum of three donors
• Liver: One donor at a time with a
maximum of five donors
• Lung: Two donors at a time with a
maximum of six donors
Special Provisions
Many factors may prevent the
intended and willing donor from
proceeding with the donation.
Circumstances that would prevent the
transplant or donation from proceeding
include: Present health status of the
intended donor or recipient, perceived
long-term risks to the intended donor,
justified circumstances such as acts of
God (e.g., major storms or hurricanes),
or a circumstance when an intended
donor proceeds toward donation in
good faith, subject to a case-by-case
evaluation by the recipient of the
cooperative agreement, but then elects
not to pursue donation. In such cases,
the intended donor and accompanying
persons may receive reimbursement for
qualifying expenses incurred as if the
donation had been completed. The
recipient of the cooperative agreement
will file a form with the Internal
Revenue Service reporting funds
disbursed as income for expenses not
incurred.
Dated: September 15, 2020.
Thomas J. Engels,
Administrator.
[FR Doc. 2020–20805 Filed 9–18–20; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of a Maternal and Child Health
Bureau-Initiated Supplemental Award
to the Immune Deficiency Foundation
for the Severe Combined
Immunodeficiency Screening and
Education Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a supplemental award.
AGENCY:
HRSA announces the award
of a supplement of approximately
$3,000,000 to the Immune Deficiency
Foundation (IDF) for the Severe
Combined Immunodeficiency (SCID)
Screening and Education program for
fiscal year (FY) 2020. The supplement
will add another year of funding to the
current recipient, during the period of
08/01/2020–07/31/2021, to allow the
recipient to provide increased
implementation, education, and
awareness of newborn screening for
SCID.
FOR FURTHER INFORMATION CONTACT: Debi
Sarkar, Division of Children with
Special Health Needs, Maternal and
Child Health Bureau, HRSA, 5600
Fishers Lane, Room 18W65, Rockville,
MD 20857 Email: DSarkar@hrsa.gov or
Phone: (301) 443–0959
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award: Immune
Deficiency Foundation.
Amount of Non-Competitive Award:
Approximately $3,000,000 for fiscal
year FY 2020.
Period of Supplemental Funding: 08/
01/2020- 07/31/2021.
CFDA Number: 93.110.
Authority: Public Health Service Act,
§ 1109 (42 U.S.C. 300b–8).
Justification: The Explanatory
Statement accompanying the Further
Consolidated Appropriations Act, 2020
indicated that: ‘‘Within the total for the
Heritable Disorders Program, the
agreement includes no less than
$3,000,000 for the third year of a grant
to support implementation, education,
and awareness of newborn screening for
Severe Combined Immunodeficiency
and related disorders.’’ Therefore,
following an objective review, HRSA
awarded $3,000,000 to the Immune
Deficiency Foundation and extended
the 2-year period of performance to a
third year, so that IDF can provide
increased implementation, education,
and awareness of newborn screening for
SCID
SUMMARY:
E:\FR\FM\22SEN1.SGM
22SEN1
Federal Register / Vol. 85, No. 184 / Tuesday, September 22, 2020 / Notices
Although all 50 states have legislation
to screen for SCID, access to pediatric
immunology and infectious disease
specialists for SCID diagnosis and
treatment is mostly found in urban
areas, posing access challenges for
families in rural and other medically
underserved areas. SCID education and
awareness resources that are
linguistically and culturally sensitive
are critical for diverse and medically
underserved families. In addition, longterm follow-up of infants identified
through SCID newborn screening is
critical to obtain clinical outcomes data
and inform future treatment options.
Furthermore, many infants detected
through newborn screening do not have
classical SCID but have one of a number
of other immune deficiency disorders,
so information is needed for families
and providers on other detected
conditions.
Within the scope of the Notice of
Opportunity (HRSA 18–188), proposed
activities include:
• Develop and implement a plan to
engage families and treatment centers to
obtain follow-up information;
• Develop and disseminate
linguistically and culturally appropriate
education and awareness materials
59535
about SCID and other immune
deficiencies that are identified when
screening for SCID;
• Connect families with SCID to
pediatric immunology and infectious
disease specialists, and pediatricians in
urban areas;
• Implement telehealth/telemedicine
outreach to families residing in rural
and medically underserved areas; and
• Support an annual SCID meeting
that includes state newborn screening
staff, pediatricians, immunology and
infectious diseases specialists, and
families.
Grantee/organization name
Grant No.
State
FY 2020
funding
Immune Deficiency Foundation .........................................................................
SC1MC31881
MD ...........................................
$3,000,000
Thomas J. Engels,
Administrator.
www.hrsa.gov/vaccinecompensation/
index.html.
[FR Doc. 2020–20856 Filed 9–21–20; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program) as required, by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
SUMMARY:
VerDate Sep<11>2014
18:01 Sep 21, 2020
Jkt 250001
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
August 1, 2020, through August 31,
2020. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
submit written information relevant to
the issues described above in the case of
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Notices]
[Pages 59534-59535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20856]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of a Maternal and Child Health Bureau-Initiated
Supplemental Award to the Immune Deficiency Foundation for the Severe
Combined Immunodeficiency Screening and Education Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a supplemental award.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplement of approximately
$3,000,000 to the Immune Deficiency Foundation (IDF) for the Severe
Combined Immunodeficiency (SCID) Screening and Education program for
fiscal year (FY) 2020. The supplement will add another year of funding
to the current recipient, during the period of 08/01/2020-07/31/2021,
to allow the recipient to provide increased implementation, education,
and awareness of newborn screening for SCID.
FOR FURTHER INFORMATION CONTACT: Debi Sarkar, Division of Children with
Special Health Needs, Maternal and Child Health Bureau, HRSA, 5600
Fishers Lane, Room 18W65, Rockville, MD 20857 Email: [email protected]
or Phone: (301) 443-0959
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award: Immune Deficiency Foundation.
Amount of Non-Competitive Award: Approximately $3,000,000 for
fiscal year FY 2020.
Period of Supplemental Funding: 08/01/2020- 07/31/2021.
CFDA Number: 93.110.
Authority: Public Health Service Act, Sec. 1109 (42 U.S.C. 300b-
8).
Justification: The Explanatory Statement accompanying the Further
Consolidated Appropriations Act, 2020 indicated that: ``Within the
total for the Heritable Disorders Program, the agreement includes no
less than $3,000,000 for the third year of a grant to support
implementation, education, and awareness of newborn screening for
Severe Combined Immunodeficiency and related disorders.'' Therefore,
following an objective review, HRSA awarded $3,000,000 to the Immune
Deficiency Foundation and extended the 2-year period of performance to
a third year, so that IDF can provide increased implementation,
education, and awareness of newborn screening for SCID
[[Page 59535]]
Although all 50 states have legislation to screen for SCID, access
to pediatric immunology and infectious disease specialists for SCID
diagnosis and treatment is mostly found in urban areas, posing access
challenges for families in rural and other medically underserved areas.
SCID education and awareness resources that are linguistically and
culturally sensitive are critical for diverse and medically underserved
families. In addition, long-term follow-up of infants identified
through SCID newborn screening is critical to obtain clinical outcomes
data and inform future treatment options. Furthermore, many infants
detected through newborn screening do not have classical SCID but have
one of a number of other immune deficiency disorders, so information is
needed for families and providers on other detected conditions.
Within the scope of the Notice of Opportunity (HRSA 18-188),
proposed activities include:
Develop and implement a plan to engage families and
treatment centers to obtain follow-up information;
Develop and disseminate linguistically and culturally
appropriate education and awareness materials about SCID and other
immune deficiencies that are identified when screening for SCID;
Connect families with SCID to pediatric immunology and
infectious disease specialists, and pediatricians in urban areas;
Implement telehealth/telemedicine outreach to families
residing in rural and medically underserved areas; and
Support an annual SCID meeting that includes state newborn
screening staff, pediatricians, immunology and infectious diseases
specialists, and families.
----------------------------------------------------------------------------------------------------------------
Grantee/organization name Grant No. State FY 2020 funding
----------------------------------------------------------------------------------------------------------------
Immune Deficiency Foundation................. SC1MMD............................. $3,000,000
----------------------------------------------------------------------------------------------------------------
Thomas J. Engels,
Administrator.
[FR Doc. 2020-20856 Filed 9-21-20; 8:45 am]
BILLING CODE 4165-15-P
