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 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: http:// 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]


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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.

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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