National Vaccine Injury Compensation Program; List of Petitions Received, 17236-17238 [2023-05851]
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Federal Register / Vol. 88, No. 55 / Wednesday, March 22, 2023 / Notices
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A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, GALAFOLD
(migalastat) indicated for the treatment
of adults with a confirmed diagnosis of
Fabry Disease and an amenable
galactosidase alpha gene variant based
on in vitro assay data. This indication
is approved under accelerated approval
based on reduction in kidney interstitial
capillary cell globotriaosylceramide
substrate. Continued approval for this
indication may be contingent upon
verification and description of clinical
benefit in confirmatory trials.
Subsequent to this approval, the USPTO
received patent term restoration
applications for GALAFOLD (U.S.
Patent Nos. 8,592,362 and 9,000,011)
from Amicus Therapeutics, Inc. and the
USPTO requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
October 29, 2019, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
GALAFOLD represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
GALAFOLD is 5,132 days. Of this time,
4,891 days occurred during the testing
phase of the regulatory review period,
while 241 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
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355(i)) became effective: July 24, 2004.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on July 24, 2004.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 13, 2017.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
GALAFOLD (NDA 208623) was initially
submitted on December 13, 2017.
3. The date the application was
approved: August 10, 2018. FDA has
verified the applicant’s claim that NDA
208623 was approved on August 10,
2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 732 days or 980
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: March 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05897 Filed 3–21–23; 8:45 am]
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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://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: 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
SUMMARY:
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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
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
February 1, 2023, through February 28,
2023. This list provides the name of the
petitioner, city, and state of vaccination
(if unknown then the city and state of
the person or attorney filing the 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
the petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the United States
Court of Federal Claims at the address
listed above (under the heading FOR
FURTHER INFORMATION CONTACT), with a
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copy to HRSA addressed to Director,
Division of Injury Compensation
Programs, Health Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville,
Maryland 20857. The Court’s caption
(Petitioner’s Name v. Secretary of HHS)
and the docket number assigned to the
petition should be used as the caption
for the written submission. Chapter 35
of title 44, United States Code, related
to paperwork reduction, does not apply
to information required for purposes of
carrying out the Program.
Carole Johnson,
Administrator.
List of Petitions Filed
1. Thomas Fiumara, Medford, Massachusetts,
Court of Federal Claims No: 23–0138V
2. Darren J. Bunton, Indianapolis, Indiana,
Court of Federal Claims No: 23–0139V
3. Christina Orton, Phoenix, Arizona, Court
of Federal Claims No: 23–0140V
4. Teagan Grabish, Lynden, Washington,
Court of Federal Claims No: 23–0141V
5. Samantha Seager, Phoenix, Arizona, Court
of Federal Claims No: 23–0142V
6. Sonya Davee, Mattoon, Illinois, Court of
Federal Claims No: 23–0148V
7. Ariane Yango on behalf of N.Y., San Jose,
California, Court of Federal Claims No:
23–0150V
8. Anthony Blei, Phoenix, Arizona, Court of
Federal Claims No: 23–0151V
9. Melinda Adams, Portsmouth, Ohio, Court
of Federal Claims No: 23–0153V
10. Barbara Bennett, Hudson, New York,
Court of Federal Claims No: 23–0154V,
11. Huda Ahmed, Elmhurst, Illinois, Court of
Federal Claims No: 23–0155V
12. Kristine Zuggi on behalf of I.Z., Deceased,
Phoenix, Arizona, Court of Federal
Claims No: 23–0161V
13. John Jennings, Boston, Massachusetts,
Court of Federal Claims No: 23–0162V
14. Matthew J. Koehler, Rochester, New York,
Court of Federal Claims No: 23–0163V
15. Ralph Devito, Manchester, New Jersey,
Court of Federal Claims No: 23–0164V
16. Emily Mercer, Phoenix, Arizona, Court of
Federal Claims No: 23–0168V
17. Haley Phillippi, Phoenix, Arizona, Court
of Federal Claims No: 23–0169V
18. Edward Ladwig, Boston, Massachusetts,
Court of Federal Claims No: 23–0170V
19. Charles Lindsey, Lawrenceville, Georgia,
Court of Federal Claims No: 23–0171V
20. Claire Paul, Atlanta, Georgia, Court of
Federal Claims No: 23–0172V
21. Aaron Ford, Phoenix, Arizona, Court of
Federal Claims No: 23–0177V
22. Cristina Frank, Pennsville, New Jersey,
Court of Federal Claims No: 23–0178V
23. Hyun Lee, Kernersville, North Carolina,
Court of Federal Claims No: 23–0179V
24. Karen McLaughlin, East Ridge,
Tennessee, Court of Federal Claims No:
23–0180V
25. Amy Vanus, Dresher, Pennsylvania, Court
of Federal Claims No: 23–0181V
26. Aiman Al-Hiyari, Rochester, New York,
Court of Federal Claims No: 23–0183V
27. Oneil Walker, New Haven, Connecticut,
Court of Federal Claims No: 23–0184V
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28. Patricia Corcoran, Brewster, New York,
Court of Federal Claims No: 23–0186V
29. Molly McBride, Columbia, Missouri,
Court of Federal Claims No: 23–0190V
30. Amie Luk, Katy, Texas, Court of Federal
Claims No: 23–0191V
31. Dale McCormick, Bryan, Ohio, Court of
Federal Claims No: 23–0193V
32. Joseph Meier, Walnut Creek, California,
Court of Federal Claims No: 23–0195V
33. Ann Tonjes, Westmont, Illinois, Court of
Federal Claims No: 23–0196V
34. Krystel Hannon, Spartanburg, South
Carolina, Court of Federal Claims No:
23–0197V
35. Ashlee M. Hong, Thousand Oaks,
California, Court of Federal Claims No:
23–0198V
36. James McGinnis, Waynesboro, Virginia,
Court of Federal Claims No: 23–0199V
37. Lindsay Anderson on behalf of A.B.,
Indianapolis, Indiana, Court of Federal
Claims No: 23–0200V
38. Michele Plucinsky, Plantation, Florida,
Court of Federal Claims No: 23–0201V
39. Patricia Baumann, Dunkirk, Maryland,
Court of Federal Claims No: 23–0204V
40. Erny Pope, Leesburg, Virginia, Court of
Federal Claims No: 23–0205V
41. Julie Johnson, Rochester, Minnesota,
Court of Federal Claims No: 23–0206V
42. Tracy Chapman, Jacksonville, Florida,
Court of Federal Claims No: 23–0207V
43. Julia Hill, Lakewood, Washington, Court
of Federal Claims No: 23–0208V
44. Lewis von Almen, Addison, Illinois,
Court of Federal Claims No: 23–0212V
45. Melanie Hoard on behalf of R.H.,
Phoenix, Arizona, Court of Federal
Claims No: 23–0213V
46. Jamie Walton, Houston, Texas, Court of
Federal Claims No: 23–0214V
47. Jean Francois Daneault, Westfield, New
Jersey, Court of Federal Claims No: 23–
0215V
48. Anson K. Au, Sacramento, California,
Court of Federal Claims No: 23–0216V
49. Christy Allen on behalf of E.A., Phoenix,
Arizona, Court of Federal Claims No: 23–
0219V
50. Annalise Gratovich, Phoenix, Arizona,
Court of Federal Claims No: 23–0220V
51. Tricia Unrath on behalf of A.U., Phoenix,
Arizona, Court of Federal Claims No: 23–
0221V
52. Taryn Keeshan on behalf of L.K.,
Phoenix, Arizona, Court of Federal
Claims No: 23–0223V
53. Ronald Havens, Arcadia, California, Court
of Federal Claims No: 23–0225V
54. Samantha Dotson, Cynthiana, Kentucky,
Court of Federal Claims No: 23–0227V
55. Jennifer Barrios and Michael Barrios on
behalf of B.H.B., Long Beach, California,
Court of Federal Claims No: 23–0230V
56. Aklilu Keflezighi, La Mesa, California,
Court of Federal Claims No: 23–0233V
57. Rivkalaia Rokeach, Brooklyn, New York,
Court of Federal Claims No: 23–0234V
58. Debbie Nease Bohannon on behalf of
Braydon Bohannon, Oakdale, California,
Court of Federal Claims No: 23–0235V
59. Antonia Dejesus, Englewood, New Jersey,
Court of Federal Claims No: 23–0236V
60. Lisa Kurdziel, Hoboken, New Jersey,
Court of Federal Claims No: 23–0237V
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61. Lee Yuill, Huntsville, Alabama, Court of
Federal Claims No: 23–0238V
62. Jose Garcia, Dinuba, California, Court of
Federal Claims No: 23–0240V
63. Nicholas Watkins, Rockford, Michigan,
Court of Federal Claims No: 23–0241V
64. Timothy Alexander, Albuquerque, New
Mexico, Court of Federal Claims No: 23–
0242V
65. Barry Griffiths, Manahawkin, New Jersey,
Court of Federal Claims No: 23–0243V
66. Karol Schaeffer, York, Pennsylvania,
Court of Federal Claims No: 23–0244V
67. Dreama Cleaver, Bellefontaine, Ohio,
Court of Federal Claims No: 23–0245V
68. Kristen McCafferty, Phoenix, Arizona,
Court of Federal Claims No: 23–0246V
69. Jennifer M. Cangas, Davenport, Iowa,
Court of Federal Claims No: 23–0248V
70. Don Chambers, Abilene, Texas, Court of
Federal Claims No: 23–0249V
71. Velinda Baker, Dayton, Ohio, Court of
Federal Claims No: 23–0250V
72. Alvin Moody, Farmington, Connecticut,
Court of Federal Claims No: 23–0251V
73. Benjamin Kane, Newburyport,
Massachusetts, Court of Federal Claims
No: 23–0252V
74. Peggy Evans, Dacula, Georgia, Court of
Federal Claims No: 23–0254V
75. Richa Sharma, Reno, Nevada, Court of
Federal Claims No: 23–0255V
76. Mary Ann Locke, Rochester, New York,
Court of Federal Claims No: 23–0256V
77. Joseph Hernandez, West Bend,
Wisconsin, Court of Federal Claims No:
23–0257V
78. Michael Erhart, Ottawa, Illinois, Court of
Federal Claims No: 23–0258V
79. Andrea Walker, Washington, District of
Columbia, Court of Federal Claims No:
23–0259V
80. Janice Caraballo, Waterbury, Connecticut,
Court of Federal Claims No: 23–0260V
81. Nadia Noel, Phoenix, Arizona, Court of
Federal Claims No: 23–0261V
82. Kristilee Maiella, Phoenix, Arizona, Court
of Federal Claims No: 23–0262V
83. Vernon Scott, Rochester Hills, Michigan,
Court of Federal Claims No: 23–0264V
84. Aaron Labelle, Marquette, Michigan,
Court of Federal Claims No: 23–0265V
85. Shiloh Williams, Phoenix, Arizona, Court
of Federal Claims No: 23–0266V
86. Andrea Leathers, Phoenix, Arizona, Court
of Federal Claims No: 23–0268V
87. Dari Matilsky, Pomona, New York, Court
of Federal Claims No: 23–0269V
88. Oana Repede, Raleigh, North Carolina,
Court of Federal Claims No: 23–0270V
89. Wendy Newton, Boston, Massachusetts,
Court of Federal Claims No: 23–0271V
90. Steele Campbell, Gilbert, Arizona, Court
of Federal Claims No: 23–0272V
91. Doris Sawyers, Waynesboro, Mississippi,
Court of Federal Claims No: 23–0273V
92. Debra Inman, Farmington, Illinois, Court
of Federal Claims No: 23–0274V
93. Michael Edson, Pasadena, California,
Court of Federal Claims No: 23–0275V
94. Kristen Hamlin, Greensboro, North
Carolina, Court of Federal Claims No:
23–0278V
95. Eugene Lorenzo Wilson, New Lisbon,
Wisconsin, Court of Federal Claims No:
23–0279V
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96. Ryland Beutz, St. Cloud, Minnesota,
Court of Federal Claims No: 23–0283V
97. Michael Ibarra, Houston, Texas, Court of
Federal Claims No: 23–0284V
98. Srilatha Rachan, Mount Royal, New
Jersey, Court of Federal Claims No: 23–
0286V
99. Spencer Thornton, Castle Rock, Colorado,
Court of Federal Claims No: 23–0287V
100. Thomas Worrell, Houston, Texas, Court
of Federal Claims No: 23–0289V
101. Cathy Burgard, Mukilteo, Washington,
Court of Federal Claims No: 23–0290V
102. Jordan Riccardi and Kiley Riccardi on
behalf of G.R., Lakewood Ranch, Florida,
Court of Federal Claims No: 23–0291V
103. Demonta L. Hambright. Milwaukee,
Wisconsin, Court of Federal Claims No:
23–0292V
104. Samuel Smith and Jessica Smith on
behalf of J.S., Sarasota, Florida, Court of
Federal Claims No: 23–0293V
105. Annette Joseph-Gabriel and Steeve
Joseph-Gabriel on behalf of A.J.G.,
Sarasota, Florida, Court of Federal
Claims No: 23–0297V
106. Jon Eric Jensen, Chicago, Illinois, Court
of Federal Claims No: 23–0299V
[FR Doc. 2023–05851 Filed 3–21–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
‘‘Low-Income Levels’’ Used for Various
Health Professions and Nursing
Programs Authorized in the Public
Health Service Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is updating income
levels used to identify a ‘‘low-income
family’’ for the purpose of determining
eligibility for programs that provide
health professions and nursing training
to individuals from disadvantaged
backgrounds. These various programs
are authorized in the Public Health
Service Act. HHS periodically publishes
in the Federal Register, low-income
levels to be used by institutions
receiving grants or cooperative
agreement awards to determine
eligibility for programs providing
training for disadvantaged individuals,
individuals from disadvantaged
backgrounds, or individuals from lowincome families.
SUPPLEMENTARY INFORMATION: Many
health professions and nursing grant
and cooperative agreement awardees
use the low-income levels to determine
whether potential program participants
are from economically disadvantaged
SUMMARY:
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backgrounds and would be eligible to
participate in the program, as well as to
determine the amount of funding
individuals receive. Awards are
generally made to accredited schools of
medicine, osteopathic medicine, public
health, dentistry, pharmacy, allied
health, and nursing; public or private
nonprofit schools which offer graduate
programs in behavioral health and
mental health practice; and other public
or private nonprofit health or
educational entities to assist individuals
from disadvantaged backgrounds and
disadvantaged students to enter and
graduate from health professions and
nursing schools. Some programs
provide for the repayment of health
professions or nursing education loans
for students from disadvantaged
backgrounds and disadvantaged
students.
A ‘‘low-income family/household’’ for
programs included in titles III, VII, and
VIII of the Public Health Service Act is
defined as having an annual income that
does not exceed 200 percent of HHS’s
poverty guidelines. A family is a group
of two or more individuals related by
birth, marriage, or adoption who live
together.
Most HRSA programs use the income
of a student’s parent(s) to compute lowincome status. However, a ‘‘household’’
may potentially be only one person.
Other HRSA programs, depending upon
the legislative intent of the program, the
programmatic purpose related to income
level, as well as the age and
circumstances of the participant, will
apply these low-income standards to the
individual student to determine
eligibility, if the student is not listed as
a dependent on the tax form of their
parent(s). Each program includes the
rationale and methodology for
determining low-income levels in
program funding opportunities or
applications.
Low-income levels are adjusted
annually based on HHS’s poverty
guidelines. HHS’s poverty guidelines
are based on poverty thresholds
published by the U.S. Census Bureau,
adjusted annually for changes in the
Consumer Price Index. The income
figures below have been updated to
reflect HHS’s 2023 poverty guidelines as
published in the Federal Register at 88
FR 3424. See https://www.govinfo.gov/
content/pkg/FR-2023-01-19/pdf/202300885.pdf.
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[Federal Register Volume 88, Number 55 (Wednesday, March 22, 2023)]
[Notices]
[Pages 17236-17238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05851]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program; List of Petitions
Received
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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://www.hrsa.gov/vaccinecompensation/.
SUPPLEMENTARY INFORMATION: 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
[[Page 17237]]
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 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 February 1, 2023, through
February 28, 2023. This list provides the name of the petitioner, city,
and state of vaccination (if unknown then the city and state of the
person or attorney filing the 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 the petitions listed below. Any person choosing to do so
should file an original and three (3) copies of the information with
the Clerk of the United States Court of Federal Claims at the address
listed above (under the heading For Further Information Contact), with
a copy to HRSA addressed to Director, Division of Injury Compensation
Programs, Health Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville,
Maryland 20857. The Court's caption (Petitioner's Name v. Secretary of
HHS) and the docket number assigned to the petition should be used as
the caption for the written submission. Chapter 35 of title 44, United
States Code, related to paperwork reduction, does not apply to
information required for purposes of carrying out the Program.
Carole Johnson,
Administrator.
List of Petitions Filed
1. Thomas Fiumara, Medford, Massachusetts, Court of Federal Claims
No: 23-0138V
2. Darren J. Bunton, Indianapolis, Indiana, Court of Federal Claims
No: 23-0139V
3. Christina Orton, Phoenix, Arizona, Court of Federal Claims No:
23-0140V
4. Teagan Grabish, Lynden, Washington, Court of Federal Claims No:
23-0141V
5. Samantha Seager, Phoenix, Arizona, Court of Federal Claims No:
23-0142V
6. Sonya Davee, Mattoon, Illinois, Court of Federal Claims No: 23-
0148V
7. Ariane Yango on behalf of N.Y., San Jose, California, Court of
Federal Claims No: 23-0150V
8. Anthony Blei, Phoenix, Arizona, Court of Federal Claims No: 23-
0151V
9. Melinda Adams, Portsmouth, Ohio, Court of Federal Claims No: 23-
0153V
10. Barbara Bennett, Hudson, New York, Court of Federal Claims No:
23-0154V,
11. Huda Ahmed, Elmhurst, Illinois, Court of Federal Claims No: 23-
0155V
12. Kristine Zuggi on behalf of I.Z., Deceased, Phoenix, Arizona,
Court of Federal Claims No: 23-0161V
13. John Jennings, Boston, Massachusetts, Court of Federal Claims
No: 23-0162V
14. Matthew J. Koehler, Rochester, New York, Court of Federal Claims
No: 23-0163V
15. Ralph Devito, Manchester, New Jersey, Court of Federal Claims
No: 23-0164V
16. Emily Mercer, Phoenix, Arizona, Court of Federal Claims No: 23-
0168V
17. Haley Phillippi, Phoenix, Arizona, Court of Federal Claims No:
23-0169V
18. Edward Ladwig, Boston, Massachusetts, Court of Federal Claims
No: 23-0170V
19. Charles Lindsey, Lawrenceville, Georgia, Court of Federal Claims
No: 23-0171V
20. Claire Paul, Atlanta, Georgia, Court of Federal Claims No: 23-
0172V
21. Aaron Ford, Phoenix, Arizona, Court of Federal Claims No: 23-
0177V
22. Cristina Frank, Pennsville, New Jersey, Court of Federal Claims
No: 23-0178V
23. Hyun Lee, Kernersville, North Carolina, Court of Federal Claims
No: 23-0179V
24. Karen McLaughlin, East Ridge, Tennessee, Court of Federal Claims
No: 23-0180V
25. Amy Vanus, Dresher, Pennsylvania, Court of Federal Claims No:
23-0181V
26. Aiman Al-Hiyari, Rochester, New York, Court of Federal Claims
No: 23-0183V
27. Oneil Walker, New Haven, Connecticut, Court of Federal Claims
No: 23-0184V
28. Patricia Corcoran, Brewster, New York, Court of Federal Claims
No: 23-0186V
29. Molly McBride, Columbia, Missouri, Court of Federal Claims No:
23-0190V
30. Amie Luk, Katy, Texas, Court of Federal Claims No: 23-0191V
31. Dale McCormick, Bryan, Ohio, Court of Federal Claims No: 23-
0193V
32. Joseph Meier, Walnut Creek, California, Court of Federal Claims
No: 23-0195V
33. Ann Tonjes, Westmont, Illinois, Court of Federal Claims No: 23-
0196V
34. Krystel Hannon, Spartanburg, South Carolina, Court of Federal
Claims No: 23-0197V
35. Ashlee M. Hong, Thousand Oaks, California, Court of Federal
Claims No: 23-0198V
36. James McGinnis, Waynesboro, Virginia, Court of Federal Claims
No: 23-0199V
37. Lindsay Anderson on behalf of A.B., Indianapolis, Indiana, Court
of Federal Claims No: 23-0200V
38. Michele Plucinsky, Plantation, Florida, Court of Federal Claims
No: 23-0201V
39. Patricia Baumann, Dunkirk, Maryland, Court of Federal Claims No:
23-0204V
40. Erny Pope, Leesburg, Virginia, Court of Federal Claims No: 23-
0205V
41. Julie Johnson, Rochester, Minnesota, Court of Federal Claims No:
23-0206V
42. Tracy Chapman, Jacksonville, Florida, Court of Federal Claims
No: 23-0207V
43. Julia Hill, Lakewood, Washington, Court of Federal Claims No:
23-0208V
44. Lewis von Almen, Addison, Illinois, Court of Federal Claims No:
23-0212V
45. Melanie Hoard on behalf of R.H., Phoenix, Arizona, Court of
Federal Claims No: 23-0213V
46. Jamie Walton, Houston, Texas, Court of Federal Claims No: 23-
0214V
47. Jean Francois Daneault, Westfield, New Jersey, Court of Federal
Claims No: 23-0215V
48. Anson K. Au, Sacramento, California, Court of Federal Claims No:
23-0216V
49. Christy Allen on behalf of E.A., Phoenix, Arizona, Court of
Federal Claims No: 23-0219V
50. Annalise Gratovich, Phoenix, Arizona, Court of Federal Claims
No: 23-0220V
51. Tricia Unrath on behalf of A.U., Phoenix, Arizona, Court of
Federal Claims No: 23-0221V
52. Taryn Keeshan on behalf of L.K., Phoenix, Arizona, Court of
Federal Claims No: 23-0223V
53. Ronald Havens, Arcadia, California, Court of Federal Claims No:
23-0225V
54. Samantha Dotson, Cynthiana, Kentucky, Court of Federal Claims
No: 23-0227V
55. Jennifer Barrios and Michael Barrios on behalf of B.H.B., Long
Beach, California, Court of Federal Claims No: 23-0230V
56. Aklilu Keflezighi, La Mesa, California, Court of Federal Claims
No: 23-0233V
57. Rivkalaia Rokeach, Brooklyn, New York, Court of Federal Claims
No: 23-0234V
58. Debbie Nease Bohannon on behalf of Braydon Bohannon, Oakdale,
California, Court of Federal Claims No: 23-0235V
59. Antonia Dejesus, Englewood, New Jersey, Court of Federal Claims
No: 23-0236V
60. Lisa Kurdziel, Hoboken, New Jersey, Court of Federal Claims No:
23-0237V
[[Page 17238]]
61. Lee Yuill, Huntsville, Alabama, Court of Federal Claims No: 23-
0238V
62. Jose Garcia, Dinuba, California, Court of Federal Claims No: 23-
0240V
63. Nicholas Watkins, Rockford, Michigan, Court of Federal Claims
No: 23-0241V
64. Timothy Alexander, Albuquerque, New Mexico, Court of Federal
Claims No: 23-0242V
65. Barry Griffiths, Manahawkin, New Jersey, Court of Federal Claims
No: 23-0243V
66. Karol Schaeffer, York, Pennsylvania, Court of Federal Claims No:
23-0244V
67. Dreama Cleaver, Bellefontaine, Ohio, Court of Federal Claims No:
23-0245V
68. Kristen McCafferty, Phoenix, Arizona, Court of Federal Claims
No: 23-0246V
69. Jennifer M. Cangas, Davenport, Iowa, Court of Federal Claims No:
23-0248V
70. Don Chambers, Abilene, Texas, Court of Federal Claims No: 23-
0249V
71. Velinda Baker, Dayton, Ohio, Court of Federal Claims No: 23-
0250V
72. Alvin Moody, Farmington, Connecticut, Court of Federal Claims
No: 23-0251V
73. Benjamin Kane, Newburyport, Massachusetts, Court of Federal
Claims No: 23-0252V
74. Peggy Evans, Dacula, Georgia, Court of Federal Claims No: 23-
0254V
75. Richa Sharma, Reno, Nevada, Court of Federal Claims No: 23-0255V
76. Mary Ann Locke, Rochester, New York, Court of Federal Claims No:
23-0256V
77. Joseph Hernandez, West Bend, Wisconsin, Court of Federal Claims
No: 23-0257V
78. Michael Erhart, Ottawa, Illinois, Court of Federal Claims No:
23-0258V
79. Andrea Walker, Washington, District of Columbia, Court of
Federal Claims No: 23-0259V
80. Janice Caraballo, Waterbury, Connecticut, Court of Federal
Claims No: 23-0260V
81. Nadia Noel, Phoenix, Arizona, Court of Federal Claims No: 23-
0261V
82. Kristilee Maiella, Phoenix, Arizona, Court of Federal Claims No:
23-0262V
83. Vernon Scott, Rochester Hills, Michigan, Court of Federal Claims
No: 23-0264V
84. Aaron Labelle, Marquette, Michigan, Court of Federal Claims No:
23-0265V
85. Shiloh Williams, Phoenix, Arizona, Court of Federal Claims No:
23-0266V
86. Andrea Leathers, Phoenix, Arizona, Court of Federal Claims No:
23-0268V
87. Dari Matilsky, Pomona, New York, Court of Federal Claims No: 23-
0269V
88. Oana Repede, Raleigh, North Carolina, Court of Federal Claims
No: 23-0270V
89. Wendy Newton, Boston, Massachusetts, Court of Federal Claims No:
23-0271V
90. Steele Campbell, Gilbert, Arizona, Court of Federal Claims No:
23-0272V
91. Doris Sawyers, Waynesboro, Mississippi, Court of Federal Claims
No: 23-0273V
92. Debra Inman, Farmington, Illinois, Court of Federal Claims No:
23-0274V
93. Michael Edson, Pasadena, California, Court of Federal Claims No:
23-0275V
94. Kristen Hamlin, Greensboro, North Carolina, Court of Federal
Claims No: 23-0278V
95. Eugene Lorenzo Wilson, New Lisbon, Wisconsin, Court of Federal
Claims No: 23-0279V
96. Ryland Beutz, St. Cloud, Minnesota, Court of Federal Claims No:
23-0283V
97. Michael Ibarra, Houston, Texas, Court of Federal Claims No: 23-
0284V
98. Srilatha Rachan, Mount Royal, New Jersey, Court of Federal
Claims No: 23-0286V
99. Spencer Thornton, Castle Rock, Colorado, Court of Federal Claims
No: 23-0287V
100. Thomas Worrell, Houston, Texas, Court of Federal Claims No: 23-
0289V
101. Cathy Burgard, Mukilteo, Washington, Court of Federal Claims
No: 23-0290V
102. Jordan Riccardi and Kiley Riccardi on behalf of G.R., Lakewood
Ranch, Florida, Court of Federal Claims No: 23-0291V
103. Demonta L. Hambright. Milwaukee, Wisconsin, Court of Federal
Claims No: 23-0292V
104. Samuel Smith and Jessica Smith on behalf of J.S., Sarasota,
Florida, Court of Federal Claims No: 23-0293V
105. Annette Joseph-Gabriel and Steeve Joseph-Gabriel on behalf of
A.J.G., Sarasota, Florida, Court of Federal Claims No: 23-0297V
106. Jon Eric Jensen, Chicago, Illinois, Court of Federal Claims No:
23-0299V
[FR Doc. 2023-05851 Filed 3-21-23; 8:45 am]
BILLING CODE 4165-15-P
