National Vaccine Injury Compensation Program; List of Petitions Received, 29793-29796 [2018-13593]
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29793
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
DATES:
Fax written comments on the
collection of information by July 26,
2018.
Guidance for Industry: Assessing User
Fees Under the Biosimilar User Fee
Amendments of 2017
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0718. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0718—
Revision
This information collection supports
the above captioned Agency guidance
and implementation of the Biosimilar
User Fee Amendments of 2017 (BsUFA
II). Under BsUFA II, FDA’s authority is
extended to collect user fees from fiscal
years 2018–2022 and includes a number
of technical revisions that affect what
fees and how fees are collected. Fees
authorized by this legislation help fund
the review process for biosimilar
biological product applications and play
an important role in expediting the
review and approval process.
We have developed the guidance
document entitled ‘‘Assessing User Fees
Under the Biosimilar User Fee
Amendments of 2017’’ to assist industry
in understanding when these fees are
incurred and the process by which
applicants can submit payments. The
guidance also provides information on
the consequences of failing to pay
BsUFA II fees, as well as processes for
submitting reconsideration and appeal
requests. The guidance document is
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
available on our website at: https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM584984.pdf.
In the Federal Register of November
16, 2017 (82 FR 53505), we published a
notice announcing availability of the
subject guidance document, including a
60-day notice requesting public
comment on the information collection.
One comment was received in response
to the notice from a trade organization
indicating that interested persons ‘‘have
reviewed the draft guidance and
appreciate(s) FDA applying the user fee
provisions consistent with the BsUFA II
negotiations and Commitment Letter.’’
In addition, and upon our own review,
we believe it is appropriate to include
the guidance document under the
existing information collection
‘‘Biosimilar User Fee Cover Sheet’’
currently approved under OMB control
number 0910–0718 rather than to
establish a new collection. FDA is
preparing to renew OMB control
number 0910–0718 and will include the
guidance document accordingly.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
(hours)
Total annual
responses
Total hours
Request for discontinuation from biological product development program ...............................................................
Request to move products to discontinued section of the
biosimilar list .....................................................................
Small business waiver of the BsUFA application fee ..........
Small business waiver reconsiderations ..............................
Small business waiver appeals ...........................................
Annual Fee Determination Survey .......................................
Annual BsUFA Fees Correspondence ................................
2
1
2
1
2
5
1
1
1
35
35
1
1
1
1
1
1
5
1
1
1
35
35
* 0.5
16
24
12
1
2
2.5
16
24
12
35
70
Total ..............................................................................
........................
........................
........................
........................
161.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Our estimate is based on the number
of Biosimilars User Fee submissions we
have received since establishing the
program.
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Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13688 Filed 6–25–18; 8:45 am]
BILLING CODE 4164–01–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
SUMMARY:
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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
information about requirements for
filing petitions and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
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, MD 20857; (301) 443–6593,
or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
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 on 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
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
May 1, 2018, through May 31, 2018.
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
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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 U.S. 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,
Healthcare Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville, MD
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.
Dated: June 19, 2018.
George Sigounas,
Administrator.
List of Petitions Filed
1. Emily Jahn, Millbury, Massachusetts,
Court of Federal Claims No: 18–
0613V
2. Kathy Macaluso, Naples, Florida,
Court of Federal Claims No: 18–
0614V
3. Jason Fey and Heather Fey on behalf
of E.P.F., Hudson, Wisconsin, Court
of Federal Claims No: 18–0615V
4. Jeanne Rudzki, Jefferson, Louisiana,
Court of Federal Claims No: 18–
0617V
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5. Michael Schwarz, Walla Walla,
Washington, Court of Federal
Claims No: 18–0619V
6. Ernest Perkins, Salt Lake City, Utah,
Court of Federal Claims No: 18–
0620V
7. Sally Musulin, Cranberry,
Pennsylvania, Court of Federal
Claims No: 18–0621V
8. Katherine L. Alberino, Medford,
Massachusetts, Court of Federal
Claims No: 18–0622V
9. Timothy W. Massa, La Grange,
Georgia, Court of Federal Claims
No: 18–0623V
10. Joseph Davis, Auburn, California,
Court of Federal Claims No: 18–
0624V
11. Tesalia Lyons on behalf of G.L.,
Douglasville, Georgia, Court of
Federal Claims No: 18–0625V
12. Matthew T. Manley, Greensboro,
North Carolina, Court of Federal
Claims No: 18–0626V
13. Sherri Paige, Willimantic,
Connecticut, Court of Federal
Claims No: 18–0627V
14. Marie Aagotnes, New York, New
York, Court of Federal Claims No:
18–0631V
15. Arthur Renfro, Cheyenne, Wyoming,
Court of Federal Claims No: 18–
0632V
16. Thomas D. Taylor, Purcellville,
Virginia, Court of Federal Claims
No: 18–0633V
17. Alia J. Stone, Columbus, Ohio, Court
of Federal Claims No: 18–0634V
18. Carrine Paulen, Big Rapids,
Michigan, Court of Federal Claims
No: 18–0635V
19. Lovely Varughese, Des Plaines,
Illinois, Court of Federal Claims No:
18–0637V
20. Melissa K. Woinarowicz, Karlstad,
Minnesota, Court of Federal Claims
No: 18–0639V
21. Adam Crispo, Jersey City, New
Jersey, Court of Federal Claims No:
18–0640V
22. Cynthia Peterson, Bronx, New York,
Court of Federal Claims No: 18–
0641V
23. Debra Juno, Yardley, Pennsylvania,
Court of Federal Claims No: 18–
0643V
24. Fawne Adams, Frederick, Maryland,
Court of Federal Claims No: 18–
0644V
25. Juliet Ley, Canonsburg,
Pennsylvania, Court of Federal
Claims No: 18–0645V
26. Keria Edwards, Toledo, Ohio, Court
of Federal Claims No: 18–0646V
27. Frankie Reese, Hickory, North
Carolina, Court of Federal Claims
No: 18–0647V
28. Dana Ochsner, Olympia,
Washington, Court of Federal
Claims No: 18–0648V
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29. Kimberly J. Little, Rochester, New
York, Court of Federal Claims No:
18–0649V
30. Mary Stewart, Hattiesburg,
Mississippi, Court of Federal
Claims No: 18–0650V
31. Ida E. Sondy, Mountain Home,
Arkansas, Court of Federal Claims
No: 18–0651V
32. Jill Corsiglia, Aptos, California,
Court of Federal Claims No: 18–
0652V
33. Helen Kearns, Clinton, North
Carolina, Court of Federal Claims
No: 18–0654V
34. Beverly Schick-Cowell, Sylvania,
Ohio, Court of Federal Claims No:
18–0656V
35. Sue Ann Chamberlain, Pleasant
Grove, Utah, Court of Federal
Claims No: 18–0658V
36. Judy Welch, Lapeer, Michigan, Court
of Federal Claims No: 18–0660V
37. Brent Pyles, Georgetown, Kentucky,
Court of Federal Claims No: 18–
0662V
38. Kristina Link, Grand Rapids,
Michigan, Court of Federal Claims
No: 18–0663V
39. Brooke Konsky, Newark, Delaware,
Court of Federal Claims No: 18–
0666V
40. Heather Sheehan, Madison,
Wisconsin, Court of Federal Claims
No: 18–0668V
41. Linda Serra, Springfield, Illinois,
Court of Federal Claims No: 18–
0672V
42. Paula Rosselet, Spokane,
Washington, Court of Federal
Claims No: 18–0674V
43. Bradley Haag, Pickering, Ohio, Court
of Federal Claims No: 18–0675V
44. Marian Williams, Jacksonville,
Florida, Court of Federal Claims No:
18–0676V
45. Douglas Billing, Wichita Falls,
Texas, Court of Federal Claims No:
18–0679V
46. Cecelia Keller, Upland,
Pennsylvania, Court of Federal
Claims No: 18–0680V
47. David Christian Kunz, Nibley, Utah,
Court of Federal Claims No: 18–
0681V
48. Merrick Brunker, Ventura,
California, Court of Federal Claims
No: 18–0683V
49. Bonnie Mahayni, Midlothian,
Virginia, Court of Federal Claims
No: 18–0684V
50. Elizabeth Tregillus, Washington,
District of Columbia, Court of
Federal Claims No: 18–0688V
51. Jeffrey Strain, Sacramento,
California, Court of Federal Claims
No: 18–0689V
52. Maria Turkson, Harrisburg,
Pennsylvania, Court of Federal
Claims No: 18–0690V
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53. Laura Guerrie, Tujunga, California,
Court of Federal Claims No: 18–
0692V
54. Flint Allen, Hill City, Kansas, Court
of Federal Claims No: 18–0693V
55. Chad Sheller on behalf of Daniel E.
Sheller, Deceased, Santa Maria,
California, Court of Federal Claims
No: 18–0696V
56. Lari Talbert, Shreveport, Louisiana,
Court of Federal Claims No: 18–
0699V
57. Robert G. Baker, Rock Hill, North
Carolina, Court of Federal Claims
No: 18–0701V
58. Randy Leblanc, Salt Lake City, Utah,
Court of Federal Claims No: 18–
0702V
59. Jill Longworth, St. Louis, Missouri,
Court of Federal Claims No: 18–
0703V
60. Kevin Radford, Alpharetta, Georgia,
Court of Federal Claims No: 18–
0704V
61. Judith Bohnenkamp, O’Fallon,
Missouri, Court of Federal Claims
No: 18–0709V
62. Gerard L. Muensterman on behalf of
Cletus J. Muensterman, Deceased,
Evansville, Indiana, Court of
Federal Claims No: 18–0714V
63. Claudette Guerrero, Edinburg, Texas,
Court of Federal Claims No: 18–
0716V
64. Sheila Chille, Niagara Falls, New
York, Court of Federal Claims No:
18–0718V
65. Alice Lawler, Oak Harbor,
Washington, Court of Federal
Claims No: 18–0719V
66. Patricia Wright, La Marque, Texas,
Court of Federal Claims No: 18–
0720V
67. Gerald Jansen, Newport,
Pennsylvania, Court of Federal
Claims No: 18–0722V
68. Bethanne Hull, Titusville, Florida,
Court of Federal Claims No: 18–
0723V
69. Sheena Schmacht on behalf of H.S.,
Silvis, Illinois, Court of Federal
Claims No: 18–0724V
70. David M. Roberts, Sioux City, Iowa,
Court of Federal Claims No: 18–
0725V
71. Judith A. Bridges, St. Charles,
Missouri, Court of Federal Claims
No: 18–0726V
72. Barbara Murray, Orlando, Florida,
Court of Federal Claims No: 18–
0728V
73. Vicki Havel, Rockwall, Texas, Court
of Federal Claims No: 18–0729V
74. Silvia Hernandez, Washington,
District of Columbia, Court of
Federal Claims No: 18–0731V
75. Charles Williams, Oroville,
California, Court of Federal Claims
No: 18–0732V
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29795
76. James Seylaz, Bridgewater, New
Jersey, Court of Federal Claims No:
18–0733V
77. Laurel Ostiguy, Marlborough,
Massachusetts, Court of Federal
Claims No: 18–0736V
78. Kathleen Spain, Las Vegas, Nevada,
Court of Federal Claims No: 18–
0737V
79. Staci McTeigue, Alpharetta, Georgia,
Court of Federal Claims No: 18–
0740V
80. Jackie Johns, Marshfield, Missouri,
Court of Federal Claims No: 18–
0741V
81. Erica Schofield, Missoula, Montana,
Court of Federal Claims No: 18–
0742V
82. Rocco E. Moat, Milwaukee,
Wisconsin, Court of Federal Claims
No: 18–0743V
83. Raymond Spornhauer, Lufkin,
Texas, Court of Federal Claims No:
18–0744V
84. Janice Hodgett, Kewanee, Illinois,
Court of Federal Claims No: 18–
0745V
85. Carol D’Angelo, Philadelphia,
Pennsylvania, Court of Federal
Claims No: 18–0747V
86. Cami Perry, Aurora, Colorado, Court
of Federal Claims No: 18–0748V
87. Carol Vorwerck, Towson, Maryland,
Court of Federal Claims No: 18–
0749V
88. Georgia Derr on behalf of M.D.,
Harrisburg, North Carolina, Court of
Federal Claims No: 18–0751V
89. Sheri Henning, Owasso, Oklahoma,
Court of Federal Claims No: 18–
0752V
90. Patricia Gauthier, Tonasket,
Washington, Court of Federal
Claims No: 18–0753V
91. Roderick Sanders, Conyers, Georgia,
Court of Federal Claims No: 18–
0754V
92. Derek Grace, Dayton, Ohio, Court of
Federal Claims No: 18–0757V
93. Sarah Flores and Ryan C. Flores on
behalf of M.F., Houston, Texas,
Court of Federal Claims No: 18–
0759V
94. David Daniel, Houston, Texas, Court
of Federal Claims No: 18–0760V
95. Raymond Bielak, St. George, Utah,
Court of Federal Claims No: 18–
0761V
96. Tori Dreyer, Topeka, Kansas, Court
of Federal Claims No: 18–0764V
97. Mark D. Scarlette, Greensboro, North
Carolina, Court of Federal Claims
No: 18–0766V
98. James Louis, Lisbon, Connecticut,
Court of Federal Claims No: 18–
0767V
99. Dayane Penderis, Pasadena,
California, Court of Federal Claims
No: 18–0768V
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100. Kathleen Cooper-Loher,
Marshfield, Wisconsin, Court of
Federal Claims No: 18–0769V
101. Kerstina Alexander on behalf of
M.A., Deceased, Woodbridge,
Illinois, Court of Federal Claims No:
18–0770V
102. Henry Milligan, Jr., Orlando,
Florida, Court of Federal Claims No:
18–0771V
103. Cheryl Thompson, South Bend,
Indiana, Court of Federal Claims
No: 18–0772V
104. Olivia Gallegos, Fresno, California,
Court of Federal Claims No: 18–
0773V
105. Jacie Albanez and Mario Albanez
on behalf of N.A., San Diego,
California, Court of Federal Claims
No: 18–0774V
106. Scott Kelbick, Avondale, Arizona,
Court of Federal Claims No: 18–
0775V
107. Elizabeth Phenneger, Spokane,
Washington, Court of Federal
Claims No: 18–0776V
[FR Doc. 2018–13593 Filed 6–25–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Standards for the Children’s
Hospitals Graduate Medical Education
Payment Program’s Quality Bonus
System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Final response.
AGENCY:
HRSA published a notice in
the Federal Register on October 11,
2017, soliciting feedback on the
establishment of the Children’s
Hospitals Graduate Medical Education
Payment (CHGME) Program’s Quality
Bonus System (QBS). In particular,
HRSA requested feedback on the Fiscal
Year (FY) 2019 and beyond multi-step
implementation of the system, including
demonstration of engagement in state or
regional-level initiatives,
documentation, and payment structure.
This notice summarizes and responds to
the comments received during the 60day comment period.
ADDRESSES: Additional information
about the CHGME is available at https://
bhw.hrsa.gov/grants/medicine/chgme.
FOR FURTHER INFORMATION CONTACT:
Malena Crawford, Project Officer,
Children’s Hospitals Graduate Medical
Education Payment Program, Division of
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Medicine and Dentistry, HRSA at
MCrawford@hrsa.gov or (301) 443–7334.
Comments on the Proposed Standards
of the Quality Bonus System
The
CHGME statute was amended in 2013.
The amendments permit up to 25
percent of the total amount appropriated
annually in excess of $245 million, but
not to exceed $7,000,000, to provide
payments to newly qualified hospitals,
as defined in section 340E(h) of the
Public Health Service Act. The statute
additionally states that the Secretary
may establish a quality bonus system for
CHGME hospitals using any remaining
funds after payments are made to newly
qualified hospitals. In FY 2018,
Congress appropriated $315 million to
the CHGME Program. Of this,
approximately $4 million in payments
were made to newly qualified hospitals.
If funding levels and mechanisms
remain constant in FY 2019, it is
estimated that approximately $3 million
may be available annually for the
CHGME QBS.
On October 16, 2017, through a
Federal Register Notice (FRN), HRSA
announced a 60-day public comment
period to solicit input on the CHGME
QBS proposed standards. HRSA
proposed a multi-step implementation
beginning in FY 2019 that initially will
recognize high-level engagement of
CHGME hospitals in state and regional
health care transformation, as well as
engagement of resident trainees in these
activities. HRSA sought public comment
on the timeline, eligibility, standards,
documentation, and payment structure
as described in the FRN. HRSA also
requested comment on proposed QBS
measures, potential data sources, and
tiering of QBS payments for FY 2020
and beyond. HRSA received feedback
on the following program components
in response to the FRN:
HRSA received 17 responses to the
request for comments. Thirteen
commenters are current CHGME
hospitals and four are state/national
associations. Comments are summarized
below.
SUPPLEMENTARY INFORMATION:
• QBS Goals
• Qualifying Initiatives for the FY 2019
QBS
• Measures and Metrics
• Payment Structure
• Documentation, Reporting
Requirements and Reducing
Reporting Burden
• Implementation Timeline for FY 2020
and Beyond
HRSA carefully reviewed the
comments received and used them to
guide the development of the FY 2019
CHGME QBS and to inform future
iterations of the CHGME QBS. Final
guidance for the FY 2019 CHGME QBS
will be published in the FY 2019
CHGME Notice of Funding Opportunity
(NOFO).
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QBS Goals
Summary of Comments
Nearly all commenters supported
establishing the CHGME QBS to
recognize and reward quality training
programs for residents supported by the
CHGME program and agreed with the
approach to recognize engagement in
initiatives geared towards transforming
pediatric health care to improve access,
quality, and cost effectiveness.
However, many commenters questioned
whether there was enough information
about these initiatives to establish a
baseline, draw comparisons between
children’s hospitals, and make
judgements about relative performance.
Several suggested the proposed
approach could be enhanced by starting
with documentation of transformation
activities in which residents are
involved. Specifically, one commenter
recommended ‘‘that HRSA work to
identify current residents’ engagement
in quality initiatives and how residents
can further engage on broader based
initiatives before transitioning the
Quality Bonus Program to other criteria
in FY 2020 and beyond.’’ A few
commenters also requested that HRSA
offer more clear and specific goals for
the multi-step implementation of the
QBS.
Response
After considering feedback from
stakeholders, the revised goal of the
QBS will be to recognize hospitals for
quality improvement & GME
transformation efforts in high priority
focus areas and build standards to
increase engagement and involvement
of residents in broader initiatives. HRSA
will implement a baseline phase for
CHGME QBS in FY 2019. Information
collected during this baseline phase will
be used to establish QBS standards for
implementation in FY 2021. In order to
qualify for the QBS payment, CHGME
awardees must submit documentation
in the FY 2019 reconciliation
application describing the hospital’s
initiatives, resident curriculum, and
direct resident involvement in the
following areas: Integrated care models,
telehealth/HIT, population health,
social determinants of health, and
additional initiatives to improve access
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]]>Agencies
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29793-29796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13593]
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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.
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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
[[Page 29794]]
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, MD 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 on 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 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 May 1, 2018, through May 31,
2018. 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 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 U.S. 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, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B,
Rockville, MD 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.
Dated: June 19, 2018.
George Sigounas,
Administrator.
List of Petitions Filed
1. Emily Jahn, Millbury, Massachusetts, Court of Federal Claims No: 18-
0613V
2. Kathy Macaluso, Naples, Florida, Court of Federal Claims No: 18-
0614V
3. Jason Fey and Heather Fey on behalf of E.P.F., Hudson, Wisconsin,
Court of Federal Claims No: 18-0615V
4. Jeanne Rudzki, Jefferson, Louisiana, Court of Federal Claims No: 18-
0617V
5. Michael Schwarz, Walla Walla, Washington, Court of Federal Claims
No: 18-0619V
6. Ernest Perkins, Salt Lake City, Utah, Court of Federal Claims No:
18-0620V
7. Sally Musulin, Cranberry, Pennsylvania, Court of Federal Claims No:
18-0621V
8. Katherine L. Alberino, Medford, Massachusetts, Court of Federal
Claims No: 18-0622V
9. Timothy W. Massa, La Grange, Georgia, Court of Federal Claims No:
18-0623V
10. Joseph Davis, Auburn, California, Court of Federal Claims No: 18-
0624V
11. Tesalia Lyons on behalf of G.L., Douglasville, Georgia, Court of
Federal Claims No: 18-0625V
12. Matthew T. Manley, Greensboro, North Carolina, Court of Federal
Claims No: 18-0626V
13. Sherri Paige, Willimantic, Connecticut, Court of Federal Claims No:
18-0627V
14. Marie Aagotnes, New York, New York, Court of Federal Claims No: 18-
0631V
15. Arthur Renfro, Cheyenne, Wyoming, Court of Federal Claims No: 18-
0632V
16. Thomas D. Taylor, Purcellville, Virginia, Court of Federal Claims
No: 18-0633V
17. Alia J. Stone, Columbus, Ohio, Court of Federal Claims No: 18-0634V
18. Carrine Paulen, Big Rapids, Michigan, Court of Federal Claims No:
18-0635V
19. Lovely Varughese, Des Plaines, Illinois, Court of Federal Claims
No: 18-0637V
20. Melissa K. Woinarowicz, Karlstad, Minnesota, Court of Federal
Claims No: 18-0639V
21. Adam Crispo, Jersey City, New Jersey, Court of Federal Claims No:
18-0640V
22. Cynthia Peterson, Bronx, New York, Court of Federal Claims No: 18-
0641V
23. Debra Juno, Yardley, Pennsylvania, Court of Federal Claims No: 18-
0643V
24. Fawne Adams, Frederick, Maryland, Court of Federal Claims No: 18-
0644V
25. Juliet Ley, Canonsburg, Pennsylvania, Court of Federal Claims No:
18-0645V
26. Keria Edwards, Toledo, Ohio, Court of Federal Claims No: 18-0646V
27. Frankie Reese, Hickory, North Carolina, Court of Federal Claims No:
18-0647V
28. Dana Ochsner, Olympia, Washington, Court of Federal Claims No: 18-
0648V
[[Page 29795]]
29. Kimberly J. Little, Rochester, New York, Court of Federal Claims
No: 18-0649V
30. Mary Stewart, Hattiesburg, Mississippi, Court of Federal Claims No:
18-0650V
31. Ida E. Sondy, Mountain Home, Arkansas, Court of Federal Claims No:
18-0651V
32. Jill Corsiglia, Aptos, California, Court of Federal Claims No: 18-
0652V
33. Helen Kearns, Clinton, North Carolina, Court of Federal Claims No:
18-0654V
34. Beverly Schick-Cowell, Sylvania, Ohio, Court of Federal Claims No:
18-0656V
35. Sue Ann Chamberlain, Pleasant Grove, Utah, Court of Federal Claims
No: 18-0658V
36. Judy Welch, Lapeer, Michigan, Court of Federal Claims No: 18-0660V
37. Brent Pyles, Georgetown, Kentucky, Court of Federal Claims No: 18-
0662V
38. Kristina Link, Grand Rapids, Michigan, Court of Federal Claims No:
18-0663V
39. Brooke Konsky, Newark, Delaware, Court of Federal Claims No: 18-
0666V
40. Heather Sheehan, Madison, Wisconsin, Court of Federal Claims No:
18-0668V
41. Linda Serra, Springfield, Illinois, Court of Federal Claims No: 18-
0672V
42. Paula Rosselet, Spokane, Washington, Court of Federal Claims No:
18-0674V
43. Bradley Haag, Pickering, Ohio, Court of Federal Claims No: 18-0675V
44. Marian Williams, Jacksonville, Florida, Court of Federal Claims No:
18-0676V
45. Douglas Billing, Wichita Falls, Texas, Court of Federal Claims No:
18-0679V
46. Cecelia Keller, Upland, Pennsylvania, Court of Federal Claims No:
18-0680V
47. David Christian Kunz, Nibley, Utah, Court of Federal Claims No: 18-
0681V
48. Merrick Brunker, Ventura, California, Court of Federal Claims No:
18-0683V
49. Bonnie Mahayni, Midlothian, Virginia, Court of Federal Claims No:
18-0684V
50. Elizabeth Tregillus, Washington, District of Columbia, Court of
Federal Claims No: 18-0688V
51. Jeffrey Strain, Sacramento, California, Court of Federal Claims No:
18-0689V
52. Maria Turkson, Harrisburg, Pennsylvania, Court of Federal Claims
No: 18-0690V
53. Laura Guerrie, Tujunga, California, Court of Federal Claims No: 18-
0692V
54. Flint Allen, Hill City, Kansas, Court of Federal Claims No: 18-
0693V
55. Chad Sheller on behalf of Daniel E. Sheller, Deceased, Santa Maria,
California, Court of Federal Claims No: 18-0696V
56. Lari Talbert, Shreveport, Louisiana, Court of Federal Claims No:
18-0699V
57. Robert G. Baker, Rock Hill, North Carolina, Court of Federal Claims
No: 18-0701V
58. Randy Leblanc, Salt Lake City, Utah, Court of Federal Claims No:
18-0702V
59. Jill Longworth, St. Louis, Missouri, Court of Federal Claims No:
18-0703V
60. Kevin Radford, Alpharetta, Georgia, Court of Federal Claims No: 18-
0704V
61. Judith Bohnenkamp, O'Fallon, Missouri, Court of Federal Claims No:
18-0709V
62. Gerard L. Muensterman on behalf of Cletus J. Muensterman, Deceased,
Evansville, Indiana, Court of Federal Claims No: 18-0714V
63. Claudette Guerrero, Edinburg, Texas, Court of Federal Claims No:
18-0716V
64. Sheila Chille, Niagara Falls, New York, Court of Federal Claims No:
18-0718V
65. Alice Lawler, Oak Harbor, Washington, Court of Federal Claims No:
18-0719V
66. Patricia Wright, La Marque, Texas, Court of Federal Claims No: 18-
0720V
67. Gerald Jansen, Newport, Pennsylvania, Court of Federal Claims No:
18-0722V
68. Bethanne Hull, Titusville, Florida, Court of Federal Claims No: 18-
0723V
69. Sheena Schmacht on behalf of H.S., Silvis, Illinois, Court of
Federal Claims No: 18-0724V
70. David M. Roberts, Sioux City, Iowa, Court of Federal Claims No: 18-
0725V
71. Judith A. Bridges, St. Charles, Missouri, Court of Federal Claims
No: 18-0726V
72. Barbara Murray, Orlando, Florida, Court of Federal Claims No: 18-
0728V
73. Vicki Havel, Rockwall, Texas, Court of Federal Claims No: 18-0729V
74. Silvia Hernandez, Washington, District of Columbia, Court of
Federal Claims No: 18-0731V
75. Charles Williams, Oroville, California, Court of Federal Claims No:
18-0732V
76. James Seylaz, Bridgewater, New Jersey, Court of Federal Claims No:
18-0733V
77. Laurel Ostiguy, Marlborough, Massachusetts, Court of Federal Claims
No: 18-0736V
78. Kathleen Spain, Las Vegas, Nevada, Court of Federal Claims No: 18-
0737V
79. Staci McTeigue, Alpharetta, Georgia, Court of Federal Claims No:
18-0740V
80. Jackie Johns, Marshfield, Missouri, Court of Federal Claims No: 18-
0741V
81. Erica Schofield, Missoula, Montana, Court of Federal Claims No: 18-
0742V
82. Rocco E. Moat, Milwaukee, Wisconsin, Court of Federal Claims No:
18-0743V
83. Raymond Spornhauer, Lufkin, Texas, Court of Federal Claims No: 18-
0744V
84. Janice Hodgett, Kewanee, Illinois, Court of Federal Claims No: 18-
0745V
85. Carol D'Angelo, Philadelphia, Pennsylvania, Court of Federal Claims
No: 18-0747V
86. Cami Perry, Aurora, Colorado, Court of Federal Claims No: 18-0748V
87. Carol Vorwerck, Towson, Maryland, Court of Federal Claims No: 18-
0749V
88. Georgia Derr on behalf of M.D., Harrisburg, North Carolina, Court
of Federal Claims No: 18-0751V
89. Sheri Henning, Owasso, Oklahoma, Court of Federal Claims No: 18-
0752V
90. Patricia Gauthier, Tonasket, Washington, Court of Federal Claims
No: 18-0753V
91. Roderick Sanders, Conyers, Georgia, Court of Federal Claims No: 18-
0754V
92. Derek Grace, Dayton, Ohio, Court of Federal Claims No: 18-0757V
93. Sarah Flores and Ryan C. Flores on behalf of M.F., Houston, Texas,
Court of Federal Claims No: 18-0759V
94. David Daniel, Houston, Texas, Court of Federal Claims No: 18-0760V
95. Raymond Bielak, St. George, Utah, Court of Federal Claims No: 18-
0761V
96. Tori Dreyer, Topeka, Kansas, Court of Federal Claims No: 18-0764V
97. Mark D. Scarlette, Greensboro, North Carolina, Court of Federal
Claims No: 18-0766V
98. James Louis, Lisbon, Connecticut, Court of Federal Claims No: 18-
0767V
99. Dayane Penderis, Pasadena, California, Court of Federal Claims No:
18-0768V
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100. Kathleen Cooper-Loher, Marshfield, Wisconsin, Court of Federal
Claims No: 18-0769V
101. Kerstina Alexander on behalf of M.A., Deceased, Woodbridge,
Illinois, Court of Federal Claims No: 18-0770V
102. Henry Milligan, Jr., Orlando, Florida, Court of Federal Claims No:
18-0771V
103. Cheryl Thompson, South Bend, Indiana, Court of Federal Claims No:
18-0772V
104. Olivia Gallegos, Fresno, California, Court of Federal Claims No:
18-0773V
105. Jacie Albanez and Mario Albanez on behalf of N.A., San Diego,
California, Court of Federal Claims No: 18-0774V
106. Scott Kelbick, Avondale, Arizona, Court of Federal Claims No: 18-
0775V
107. Elizabeth Phenneger, Spokane, Washington, Court of Federal Claims
No: 18-0776V
[FR Doc. 2018-13593 Filed 6-25-18; 8:45 am]
BILLING CODE 4165-15-P
