National Vaccine Injury Compensation Program; List of Petitions Received, 56829-56832 [2017-25817]
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animal drug product, medical device,
food additive, or color additive) was
subject to regulatory review by FDA
before the item was marketed. Under
these acts, a product’s regulatory review
period forms the basis for determining
the amount of extension an applicant
may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For food and color
additive products, the testing phase
begins on the date a major health or
environmental effects test is begun and
runs until the approval phase begins.
The approval phase begins on the date
a petition relying on the major health or
environmental effects test and
requesting the issuance of a regulation
for use of the additive under section 409
or 721 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) is initially
submitted to FDA and ends upon
whichever of the following occurs last:
(i) The regulation for the additive
becomes effective; or (ii) objections filed
against the regulation that result in a
stay of effectiveness are resolved and
commercial marketing is permitted; or
(iii) proceedings resulting from
objections to the regulation, after
commercial marketing has been
permitted and later stayed pending
resolution of the proceedings, are finally
resolved and commercial marketing is
permitted.
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 food and color additive will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(2)(B).
FDA has approved for marketing the
food additive ADVANTAME.
ADVANTAME may be safely used as a
sweetening agent and flavor enhancer in
foods generally, except in meat and
poultry, in accordance with current
good manufacturing practice, in an
amount not to exceed that reasonably
required to achieve the intended
technical effect, in foods for which
standards of identity established under
section 401 of the FD&C Act do not
preclude such use. Subsequent to this
approval, the USPTO received patent
term restoration applications for
ADVANTAME (U.S. Patent Nos.
6,548,096 and 7,141,263) from
Ajinomoto Co., Inc., and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
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patent term restoration. In a letter dated
October 30, 2015, FDA advised the
USPTO that this food and color additive
had undergone a regulatory review
period and that the approval of
ADVANTAME 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
ADVANTAME is 4,967 days. Of this
time, 3,091 days occurred during the
testing phase of the regulatory review
period, while 1,876 days occurred
during the approval phase. These
periods of time were derived from the
following dates:
1. The date a major health or
environmental effects test on the food
additive was initiated: October 16, 2000.
FDA has verified the Ajinomoto Co.,
Inc. claim that October 16, 2000, is the
date the major health or environmental
effects test was begun.
2. The date a petition relying on the
major health or environmental effects
test and requesting the issuance of a
regulation for use of the additive under
section 409 or 721 of the Federal Food
Drug, and Cosmetic Act is initially
submitted to FDA: April 2, 2009. The
applicant claims that the food additive
petition (FAP) for ADVANTAME (FAP
9A4778) was submitted on March 30,
2009. However, according to FDA
records, FAP 9A4778 was submitted on
April 2, 2009, when a complete
application was received.
3. The date the regulation for the
additive becomes effective or the date
objections filed against the regulation
that result in a stay of effectiveness are
resolved and commercial marketing is
permitted, or the date proceedings
resulting from objections to the
regulation after commercial marketing
has been permitted and later stayed
pending resolution of the proceedings,
are finally resolved and commercial
marketing is permitted: May 21, 2014.
FDA has verified the applicant’s claim
that FAP 9A4778 became effective on
May 21, 2014.
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 5 years of patent
term extension.
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56829
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 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: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25780 Filed 11–29–17; 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
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of Health
and Human Services 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.
SUMMARY:
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Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Notices
For
information about requirements for
filing petitions, and the program in
general, contact Lisa L. Reyes, Acting
Clerk, 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, MD 20857; (301) 443–6593,
or visit our Web site 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 U.S. 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
October 1, 2017, through October 31,
2017. 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
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FOR FURTHER INFORMATION CONTACT:
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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: November 21, 2017.
George Sigounas,
Administrator.
List of Petitions Filed
1. Connie Fong, San Mateo, California,
Court of Federal Claims No: 17–
1400V
2. Matthew McDermott, Babylon, New
York, Court of Federal Claims No:
17–1401V
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3. Marcella Boettcher, Pittsburg, Kansas,
Court of Federal Claims No: 17–
1402V
4. Alice Rhee, San Antonio, Texas,
Court of Federal Claims No: 17–
1403V
5. Julie K. Beyers, Indianapolis, Indiana,
Court of Federal Claims No: 17–
1406V
6. Deborah Kay Tomlin, Richmond,
Virginia, Court of Federal Claims
No: 17–1410V
7. Debra Sepulveda, Portland, Maine,
Court of Federal Claims No: 17–
1412V
8. Cynthia Levin, Orange, Virginia,
Court of Federal Claims No: 17–
1413V
9. Charles Thompson, North Fort Myers,
Florida, Court of Federal Claims No:
17–1414V
10. Samuel Kazery, Fayetteville,
Arkansas, Court of Federal Claims
No: 17–1415V
11. Julie Nicholson, Lynchburg,
Virginia, Court of Federal Claims
No: 17–1416V
12. Keith Noe and Carol Langley on
behalf of J. J. N., Brockton,
Massachusetts, Court of Federal
Claims No: 17–1418V
13. Mitchell Godfrey, Bozeman,
Montana, Court of Federal Claims
No: 17–1419V
14. Audrea Dale, Raleigh, North
Carolina, Court of Federal Claims
No: 17–1420V
15. Amy Capesius, Broomfield,
Colorado, Court of Federal Claims
No: 17–1421V
16. Wanda E. Evin, Fargo, North Dakota,
Court of Federal Claims No: 17–
1422V
17. Cindy Kissler, Milwaukee,
Wisconsin, Court of Federal Claims
No: 17–1425V
18. Lindsey Lally, San Francisco,
California, Court of Federal Claims
No: 17–1426V
19. Virginie Bridges, Charlotte, North
Carolina, Court of Federal Claims
No: 17–1429V
20. Scott A. Youngmark, Waupun,
Wisconsin, Court of Federal Claims
No: 17–1431V
21. Mary Tennesen, St. Louis, Missouri,
Court of Federal Claims No: 17–
1441V
22. Bita Fotuhi, Baltimore, Maryland,
Court of Federal Claims No: 17–
1442V
23. Samuel J. LaBine, St. Cloud,
Minnesota, Court of Federal Claims
No: 17–1443V
24. Michael Pollio, Staten Island, New
York, Court of Federal Claims No:
17–1444V
25. Paul Gallagher on behalf of R. G.,
South Hadley, Massachusetts, Court
of Federal Claims No: 17–1445V
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26. Kyle Anderson, Killeen, Texas,
Court of Federal Claims No: 17–
1452V
27. Ginger Pahos, Minneapolis,
Minnesota, Court of Federal Claims
No: 17–1455V
28. April J. Barr, Nashville, Indiana,
Court of Federal Claims No: 17–
1462V
29. Genevieve Mergen-Barret, Coconut
Creek, Florida, Court of Federal
Claims No: 17–1463V
30. Robert Nemmer, Salt Lake City,
Utah, Court of Federal Claims No:
17–1464V
31. Bangone Thirakul, San Diego,
California, Court of Federal Claims
No: 17–1465V
32. Sandra Sneathen, Charlevoix,
Michigan, Court of Federal Claims
No: 17–1466V
33. Leslee Moran, Fremont, New
Hampshire, Court of Federal Claims
No: 17–1467V
34. Purna Kami, Columbus, Ohio, Court
of Federal Claims No: 17–1468V
35. Ramon Cuevas, Boston,
Massachusetts, Court of Federal
Claims No: 17–1469V
36. Rebecca Eugley, Oxford, Maine,
Court of Federal Claims No: 17–
1470V
37. Patricia Piazza, Brick, New Jersey,
Court of Federal Claims No: 17–
1471V
38. Olwen Dowling, Florence,
Massachusetts, Court of Federal
Claims No: 17–1472V
39. Kay Lynne Klotz, Martinsburg,
Pennsylvania, Court of Federal
Claims No: 17–1473V
40. Lucita Singleton, Shelbyville,
Tennessee, Court of Federal Claims
No: 17–1474V
41. Katherine Kelly, Celebration,
Florida, Court of Federal Claims No:
17–1475V
42. Deborah Miller on behalf of A. M.,
Ithaca, New York, Court of Federal
Claims No: 17–1476V
43. Kathleen Mosley, Oklahoma City,
Oklahoma, Court of Federal Claims
No: 17–1477V
44. Sean McLoughlin on behalf of John
McLoughlin, Summit, New Jersey,
Court of Federal Claims No: 17–
1478V
45. Angelina Cavallo and Matthew
Polanco on behalf of M. P.,
Paterson, New Jersey, Court of
Federal Claims No: 17–1479V
46. Frances MacCormack, Somerset,
New Jersey, Court of Federal Claims
No: 17–1482V
47. Bryan Kitt, West Bend, Wisconsin,
Court of Federal Claims No: 17–
1483V
48. Ann Pelelo on behalf of T. P.,
Dubuque, Iowa, Court of Federal
Claims No: 17–1485V
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49. Linda Jones, Springfield, Missouri,
Court of Federal Claims No: 17–
1486V
50. Hector Baez, Baxley, Georgia, Court
of Federal Claims No: 17–1488V
51. Elmer J. George on behalf of James
C. McMurtry, Lebanon, Kentucky,
Court of Federal Claims No: 17–
1489V
52. Damaris Shaffer Miltenberger,
Carbondale, Illinois, Court of
Federal Claims No: 17–1491V
53. Angela B. Cooper, Pittsburgh,
Pennsylvania, Court of Federal
Claims No: 17–1493V
54. Jessica Watts, Indianapolis, Indiana,
Court of Federal Claims No: 17–
1494V
55. Kevin R. Danchik, Pittsburgh,
Pennsylvania, Court of Federal
Claims No: 17–1495V
56. Jan Skugstad, Minneapolis,
Minnesota, Court of Federal Claims
No: 17–1497V
57. Laurie Ann Minns, Corvallis,
Montana, Court of Federal Claims
No: 17–1499V
58. Marlena Carrillo on behalf of K. C.,
Phoenix, Arizona, Court of Federal
Claims No: 17–1500V
59. Gary Foster, Conway, Arkansas,
Court of Federal Claims No: 17–
1502V
60. Clifford Schneider, Naples, Florida,
Court of Federal Claims No: 17–
1504V
61. Melba L. Callaway, Pittsburgh,
Pennsylvania, Court of Federal
Claims No: 17–1506V
62. Donald Jackson, Stafford, Virginia,
Court of Federal Claims No: 17–
1508V
63. Stephanie Walker, Poplar Bluff,
Missouri, Court of Federal Claims
No: 17–1509V
64. Karen Falconio, Langhorne,
Pennsylvania, Court of Federal
Claims No: 17–1510V
65. Robin Lara Camacho Keja,
Harrisburg, Pennsylvania, Court of
Federal Claims No: 17–1511V
66. Rafael D. Leal, Houston, Texas,
Court of Federal Claims No: 17–
1513V
67. Tawnya Montano, Murray, Utah,
Court of Federal Claims No: 17–
1526V
68. Ruth Nortey, Tulsa, Oklahoma,
Court of Federal Claims No: 17–
1527V
69. Ryan Thompson, Washington,
District of Columbia, Court of
Federal Claims No: 17–1529V
70. Ryan M. Schmidt, Ooltewah,
Tennessee, Court of Federal Claims
No: 17–1530V
71. Donna Wissbaum, Montello,
Wisconsin, Court of Federal Claims
No: 17–1531V
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72. Latoya Christie on behalf of P. A.,
Wellesley Hills, Massachusetts,
Court of Federal Claims No: 17–
1532V
73. Connie Rainbolt, Torrington,
Wyoming, Court of Federal Claims
No: 17–1533V
74. John G. Rima, North Bend,
Washington, Court of Federal
Claims No: 17–1534V
75. Samantha Rivera and Timur Rivera
on behalf of S. R., Beverly Hills,
California, Court of Federal Claims
No: 17–1535V
76. Stacy Hendrick, Hampton, Virginia,
Court of Federal Claims No: 17–
1536V
77. Sheila Harshaw, Van Nuys,
California, Court of Federal Claims
No: 17–1537V
78. Quinton Kapper, Greenwich, New
York, Court of Federal Claims No:
17–1538V
79. Melani DePetro, Boston,
Massachusetts, Court of Federal
Claims No: 17–1539V
80. Paul L. Cooper, Arlington, Virginia,
Court of Federal Claims No: 17–
1541V
81. Shannon Mercer, Springboro, Ohio,
Court of Federal Claims No: 17–
1544V
82. Timothy Biery, Goodlettsville,
Tennessee, Court of Federal Claims
No: 17–1546V
83. Melanie Machado, Tacoma,
Washington, Court of Federal
Claims No: 17–1547V
84. Joyce Lineberger, Matthews, North
Carolina, Court of Federal Claims
No: 17–1548V
85. Suzanne Schaffer, San Diego,
California, Court of Federal Claims
No: 17–1550V
86. Robert David Dupach-Carron and
Elizabeth Joanna Carron on behalf
of A. R. D-C., Nassau, Bahamas,
Court of Federal Claims No: 17–
1551V
87. Audrey Walton, Bozeman, Montana,
Court of Federal Claims No: 17–
1552V
88. Clark Elaine, Salem, New
Hampshire, Court of Federal Claims
No: 17–1553V
89. Frances Labonte, Boston,
Massachusetts, Court of Federal
Claims No: 17–1554V
90. Robin Cooley, Louisville, Colorado,
Court of Federal Claims No: 17–
1556V
91. Cheyenne Whitesell on behalf of M.
W., Deceased, Piermont, New York,
Court of Federal Claims No: 17–
1557V
92. Sarah D. Geschwindner, Concord,
New Hampshire, Court of Federal
Claims No: 17–1558V
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93. Timothy Werner Boothe, San Jose,
California, Court of Federal Claims
No: 17–1560V
94. Louise Gartner on behalf of Anthony
J. Gartner, Jr., Deceased, St. Peters,
Missouri, Court of Federal Claims
No: 17–1561V
95. Rosalie Helen Pedersen, Pine Bush,
New York, Court of Federal Claims
No: 17–1562V
96. Patricia Richards, Loganville,
Georgia, Court of Federal Claims
No: 17–1563V
97. Peggy W. Vice on behalf of Michael
Louie Vice, Deceased, Southside,
Alabama, Court of Federal Claims
No: 17–1568V
98. James Gudaitis, San Mateo,
California, Court of Federal Claims
No: 17–1570V
99. Michael Braun on behalf of Heath
Braun, Dover, New Jersey, Court of
Federal Claims No: 17–1571V
100. Deanne A. Graf, Rice Lake,
Wisconsin, Court of Federal Claims
No: 17–1572V
101. Gary L. Larson, Portland, Oregon,
Court of Federal Claims No: 17–
1573V
102. Ibironke Akintaju, Clinton,
Maryland, Court of Federal Claims
No: 17–1574V
103. Kathleen Smith, Norwalk,
Connecticut, Court of Federal
Claims No: 17–1575V
104. Joseph Spataro, Fairfield,
Connecticut, Court of Federal
Claims No: 17–1576V
105. Gayle Randall, Armuchee, Georgia,
Court of Federal Claims No: 17–
1579V
106. Jessica Harding, Corvallis, Oregon,
Court of Federal Claims No: 17–
1580V
107. Jose Monsalvez, Houston, Texas,
Court of Federal Claims No: 17–
1583V
108. Minnie Bullock, Bowling Green,
Kentucky, Court of Federal Claims
No: 17–1584V
109. Susan Pierce, Seattle, Washington,
Court of Federal Claims No: 17–
1585V
110. Anthony Rucker, Winter Haven,
Florida, Court of Federal Claims No:
17–1586V
111. Janice Berkow, Lenoir, North
Carolina, Court of Federal Claims
No: 17–1587V
112. Melinda Porter, Oklahoma City,
Oklahoma, Court of Federal Claims
No: 17–1589V
113. Kurt Rhodes, Grand Rapids,
Michigan, Court of Federal Claims
No: 17–1590V
114. Bruchy Schik, Brooklyn, New York,
Court of Federal Claims No: 17–
1591V
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115. Barbara Van Esler, St. Louis,
Missouri, Court of Federal Claims
No: 17–1592V
116. Mary Guler, North Myrtle Beach,
South Carolina, Court of Federal
Claims No: 17–1593V
117. Robert Robinson, Fort Pierce,
Florida, Court of Federal Claims No:
17–1594V
118. Rachael Anne Witherspoon, New
Orleans, Louisiana, Court of Federal
Claims No: 17–1595V
119. Richard Hirsch, Delray Beach,
Florida, Court of Federal Claims No:
17–1596V
120. Judith Tucker, Tarrytown, New
York, Court of Federal Claims No:
17–1597V
121. Carrie Gregory, South Kingstown,
Rhode Island, Court of Federal
Claims No: 17–1599V
122. Mark Ferrara, Fayetteville, Georgia,
Court of Federal Claims No: 17–
1601V
123. Sandra Sundlov, Jamestown, New
York, Court of Federal Claims No:
17–1603V
124. Terri E. Scarbro, Great Falls,
Montana, Court of Federal Claims
No: 17–1604V
125. Robin Hamlin, Holly Hill, Florida,
Court of Federal Claims No: 17–
1606V
126. Donna Martin, St. Petersburg,
Pennsylvania, Court of Federal
Claims No: 17–1607V
127. Gayle Kligis, Aurora, Illinois, Court
of Federal Claims No: 17–1608V
128. Joan Creech, Zebulon, North
Carolina, Court of Federal Claims
No: 17–1609V
129. Georgiana McKenzie, Dorchester,
Massachusetts, Court of Federal
Claims No: 17–1610V
130. Sheree Garrett, Dallas, Texas, Court
of Federal Claims No: 17–1611V
131. Ninnart Changkiendee, South
Jordan, Utah, Court of Federal
Claims No: 17–1612V
132. Richard Denham, Franklin,
Tennessee, Court of Federal Claims
No: 17–1613V
133. Margaret Parsons, Faribault,
Minnesota, Court of Federal Claims
No: 17–1615V
134. Stacy James-Cornelius on behalf of
E. J., Phoenix, Arizona, Court of
Federal Claims No: 17–1616V
135. Joyce Carter, Bethel Park,
Pennsylvania, Court of Federal
Claims No: 17–1617V
136. Erica Livingston, Englewood, New
Jersey, Court of Federal Claims No:
17–1619V
137. Walter C. Jones, Jr., Mukilteo,
Washington, Court of Federal
Claims No: 17–1620V
138. Antonio Katz, Ocean City, New
Jersey, Court of Federal Claims No:
17–1621V
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139. Lisa Guerrero, Boston,
Massachusetts, Court of Federal
Claims No: 17–1624V
140. Timothy A. Thatcher, Boise, Idaho,
Court of Federal Claims No: 17–
1628V
141. Kenneth Niemczyk, West Lebanon,
New Hampshire, Court of Federal
Claims No: 17–1629V
142. Lisa Laimer, Moreno Valley,
California, Court of Federal Claims
No: 17–1630V
143. Cheryl Gibbs, New Orleans,
Louisiana, Court of Federal Claims
No: 17–1632V
144. Rhonda Meade, Kingsport,
Tennessee, Court of Federal Claims
No: 17–1633V
145. Marina Vidal, Annandale, Virginia,
Court of Federal Claims No: 17–
1635V
146. Bassam Al Saddawi, Laguna Nigel,
California, Court of Federal Claims
No: 17–1640V
147. Rosemary Morgan-Lee, Dresher,
Pennsylvania, Court of Federal
Claims No: 17–1641V
148. Tonya Hood, Rocky Mount, North
Carolina, Court of Federal Claims
No: 17–1642V
149. Darlene Lopez, Englewood, New
Jersey, Court of Federal Claims No:
17–1643V
150. Cynthia Quinn, Hammond,
Louisiana, Court of Federal Claims
No: 17–1644V
[FR Doc. 2017–25817 Filed 11–29–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day
Proposed Information Collection:
Indian Health Service Information
Security Ticketing and Incident
Reporting
Indian Health Service, HHS.
Notice and request for
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995,
which requires 60 days for public
comment on proposed information
collection projects, the Indian Health
Service (IHS) invites the general public
to take this opportunity to comment on
the information collection Office of
Management and Budget (OMB) Control
Number 0917–XXXX, titled, Information
Security Ticketing and Incident
Reporting. The purpose of this notice is
to allow 60 days for public comment to
be submitted directly to OMB. A copy
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56829-56832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25817]
-----------------------------------------------------------------------
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 Health and Human Services 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.
[[Page 56830]]
FOR FURTHER INFORMATION CONTACT: For information about requirements for
filing petitions, and the program in general, contact Lisa L. Reyes,
Acting Clerk, 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, MD
20857; (301) 443-6593, or visit our Web site 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 U.S. 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 October 1, 2017, through October
31, 2017. 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: November 21, 2017.
George Sigounas,
Administrator.
List of Petitions Filed
1. Connie Fong, San Mateo, California, Court of Federal Claims No: 17-
1400V
2. Matthew McDermott, Babylon, New York, Court of Federal Claims No:
17-1401V
3. Marcella Boettcher, Pittsburg, Kansas, Court of Federal Claims No:
17-1402V
4. Alice Rhee, San Antonio, Texas, Court of Federal Claims No: 17-1403V
5. Julie K. Beyers, Indianapolis, Indiana, Court of Federal Claims No:
17-1406V
6. Deborah Kay Tomlin, Richmond, Virginia, Court of Federal Claims No:
17-1410V
7. Debra Sepulveda, Portland, Maine, Court of Federal Claims No: 17-
1412V
8. Cynthia Levin, Orange, Virginia, Court of Federal Claims No: 17-
1413V
9. Charles Thompson, North Fort Myers, Florida, Court of Federal Claims
No: 17-1414V
10. Samuel Kazery, Fayetteville, Arkansas, Court of Federal Claims No:
17-1415V
11. Julie Nicholson, Lynchburg, Virginia, Court of Federal Claims No:
17-1416V
12. Keith Noe and Carol Langley on behalf of J. J. N., Brockton,
Massachusetts, Court of Federal Claims No: 17-1418V
13. Mitchell Godfrey, Bozeman, Montana, Court of Federal Claims No: 17-
1419V
14. Audrea Dale, Raleigh, North Carolina, Court of Federal Claims No:
17-1420V
15. Amy Capesius, Broomfield, Colorado, Court of Federal Claims No: 17-
1421V
16. Wanda E. Evin, Fargo, North Dakota, Court of Federal Claims No: 17-
1422V
17. Cindy Kissler, Milwaukee, Wisconsin, Court of Federal Claims No:
17-1425V
18. Lindsey Lally, San Francisco, California, Court of Federal Claims
No: 17-1426V
19. Virginie Bridges, Charlotte, North Carolina, Court of Federal
Claims No: 17-1429V
20. Scott A. Youngmark, Waupun, Wisconsin, Court of Federal Claims No:
17-1431V
21. Mary Tennesen, St. Louis, Missouri, Court of Federal Claims No: 17-
1441V
22. Bita Fotuhi, Baltimore, Maryland, Court of Federal Claims No: 17-
1442V
23. Samuel J. LaBine, St. Cloud, Minnesota, Court of Federal Claims No:
17-1443V
24. Michael Pollio, Staten Island, New York, Court of Federal Claims
No: 17-1444V
25. Paul Gallagher on behalf of R. G., South Hadley, Massachusetts,
Court of Federal Claims No: 17-1445V
[[Page 56831]]
26. Kyle Anderson, Killeen, Texas, Court of Federal Claims No: 17-1452V
27. Ginger Pahos, Minneapolis, Minnesota, Court of Federal Claims No:
17-1455V
28. April J. Barr, Nashville, Indiana, Court of Federal Claims No: 17-
1462V
29. Genevieve Mergen-Barret, Coconut Creek, Florida, Court of Federal
Claims No: 17-1463V
30. Robert Nemmer, Salt Lake City, Utah, Court of Federal Claims No:
17-1464V
31. Bangone Thirakul, San Diego, California, Court of Federal Claims
No: 17-1465V
32. Sandra Sneathen, Charlevoix, Michigan, Court of Federal Claims No:
17-1466V
33. Leslee Moran, Fremont, New Hampshire, Court of Federal Claims No:
17-1467V
34. Purna Kami, Columbus, Ohio, Court of Federal Claims No: 17-1468V
35. Ramon Cuevas, Boston, Massachusetts, Court of Federal Claims No:
17-1469V
36. Rebecca Eugley, Oxford, Maine, Court of Federal Claims No: 17-1470V
37. Patricia Piazza, Brick, New Jersey, Court of Federal Claims No: 17-
1471V
38. Olwen Dowling, Florence, Massachusetts, Court of Federal Claims No:
17-1472V
39. Kay Lynne Klotz, Martinsburg, Pennsylvania, Court of Federal Claims
No: 17-1473V
40. Lucita Singleton, Shelbyville, Tennessee, Court of Federal Claims
No: 17-1474V
41. Katherine Kelly, Celebration, Florida, Court of Federal Claims No:
17-1475V
42. Deborah Miller on behalf of A. M., Ithaca, New York, Court of
Federal Claims No: 17-1476V
43. Kathleen Mosley, Oklahoma City, Oklahoma, Court of Federal Claims
No: 17-1477V
44. Sean McLoughlin on behalf of John McLoughlin, Summit, New Jersey,
Court of Federal Claims No: 17-1478V
45. Angelina Cavallo and Matthew Polanco on behalf of M. P., Paterson,
New Jersey, Court of Federal Claims No: 17-1479V
46. Frances MacCormack, Somerset, New Jersey, Court of Federal Claims
No: 17-1482V
47. Bryan Kitt, West Bend, Wisconsin, Court of Federal Claims No: 17-
1483V
48. Ann Pelelo on behalf of T. P., Dubuque, Iowa, Court of Federal
Claims No: 17-1485V
49. Linda Jones, Springfield, Missouri, Court of Federal Claims No: 17-
1486V
50. Hector Baez, Baxley, Georgia, Court of Federal Claims No: 17-1488V
51. Elmer J. George on behalf of James C. McMurtry, Lebanon, Kentucky,
Court of Federal Claims No: 17-1489V
52. Damaris Shaffer Miltenberger, Carbondale, Illinois, Court of
Federal Claims No: 17-1491V
53. Angela B. Cooper, Pittsburgh, Pennsylvania, Court of Federal Claims
No: 17-1493V
54. Jessica Watts, Indianapolis, Indiana, Court of Federal Claims No:
17-1494V
55. Kevin R. Danchik, Pittsburgh, Pennsylvania, Court of Federal Claims
No: 17-1495V
56. Jan Skugstad, Minneapolis, Minnesota, Court of Federal Claims No:
17-1497V
57. Laurie Ann Minns, Corvallis, Montana, Court of Federal Claims No:
17-1499V
58. Marlena Carrillo on behalf of K. C., Phoenix, Arizona, Court of
Federal Claims No: 17-1500V
59. Gary Foster, Conway, Arkansas, Court of Federal Claims No: 17-1502V
60. Clifford Schneider, Naples, Florida, Court of Federal Claims No:
17-1504V
61. Melba L. Callaway, Pittsburgh, Pennsylvania, Court of Federal
Claims No: 17-1506V
62. Donald Jackson, Stafford, Virginia, Court of Federal Claims No: 17-
1508V
63. Stephanie Walker, Poplar Bluff, Missouri, Court of Federal Claims
No: 17-1509V
64. Karen Falconio, Langhorne, Pennsylvania, Court of Federal Claims
No: 17-1510V
65. Robin Lara Camacho Keja, Harrisburg, Pennsylvania, Court of Federal
Claims No: 17-1511V
66. Rafael D. Leal, Houston, Texas, Court of Federal Claims No: 17-
1513V
67. Tawnya Montano, Murray, Utah, Court of Federal Claims No: 17-1526V
68. Ruth Nortey, Tulsa, Oklahoma, Court of Federal Claims No: 17-1527V
69. Ryan Thompson, Washington, District of Columbia, Court of Federal
Claims No: 17-1529V
70. Ryan M. Schmidt, Ooltewah, Tennessee, Court of Federal Claims No:
17-1530V
71. Donna Wissbaum, Montello, Wisconsin, Court of Federal Claims No:
17-1531V
72. Latoya Christie on behalf of P. A., Wellesley Hills, Massachusetts,
Court of Federal Claims No: 17-1532V
73. Connie Rainbolt, Torrington, Wyoming, Court of Federal Claims No:
17-1533V
74. John G. Rima, North Bend, Washington, Court of Federal Claims No:
17-1534V
75. Samantha Rivera and Timur Rivera on behalf of S. R., Beverly Hills,
California, Court of Federal Claims No: 17-1535V
76. Stacy Hendrick, Hampton, Virginia, Court of Federal Claims No: 17-
1536V
77. Sheila Harshaw, Van Nuys, California, Court of Federal Claims No:
17-1537V
78. Quinton Kapper, Greenwich, New York, Court of Federal Claims No:
17-1538V
79. Melani DePetro, Boston, Massachusetts, Court of Federal Claims No:
17-1539V
80. Paul L. Cooper, Arlington, Virginia, Court of Federal Claims No:
17-1541V
81. Shannon Mercer, Springboro, Ohio, Court of Federal Claims No: 17-
1544V
82. Timothy Biery, Goodlettsville, Tennessee, Court of Federal Claims
No: 17-1546V
83. Melanie Machado, Tacoma, Washington, Court of Federal Claims No:
17-1547V
84. Joyce Lineberger, Matthews, North Carolina, Court of Federal Claims
No: 17-1548V
85. Suzanne Schaffer, San Diego, California, Court of Federal Claims
No: 17-1550V
86. Robert David Dupach-Carron and Elizabeth Joanna Carron on behalf of
A. R. D-C., Nassau, Bahamas, Court of Federal Claims No: 17-1551V
87. Audrey Walton, Bozeman, Montana, Court of Federal Claims No: 17-
1552V
88. Clark Elaine, Salem, New Hampshire, Court of Federal Claims No: 17-
1553V
89. Frances Labonte, Boston, Massachusetts, Court of Federal Claims No:
17-1554V
90. Robin Cooley, Louisville, Colorado, Court of Federal Claims No: 17-
1556V
91. Cheyenne Whitesell on behalf of M. W., Deceased, Piermont, New
York, Court of Federal Claims No: 17-1557V
92. Sarah D. Geschwindner, Concord, New Hampshire, Court of Federal
Claims No: 17-1558V
[[Page 56832]]
93. Timothy Werner Boothe, San Jose, California, Court of Federal
Claims No: 17-1560V
94. Louise Gartner on behalf of Anthony J. Gartner, Jr., Deceased, St.
Peters, Missouri, Court of Federal Claims No: 17-1561V
95. Rosalie Helen Pedersen, Pine Bush, New York, Court of Federal
Claims No: 17-1562V
96. Patricia Richards, Loganville, Georgia, Court of Federal Claims No:
17-1563V
97. Peggy W. Vice on behalf of Michael Louie Vice, Deceased, Southside,
Alabama, Court of Federal Claims No: 17-1568V
98. James Gudaitis, San Mateo, California, Court of Federal Claims No:
17-1570V
99. Michael Braun on behalf of Heath Braun, Dover, New Jersey, Court of
Federal Claims No: 17-1571V
100. Deanne A. Graf, Rice Lake, Wisconsin, Court of Federal Claims No:
17-1572V
101. Gary L. Larson, Portland, Oregon, Court of Federal Claims No: 17-
1573V
102. Ibironke Akintaju, Clinton, Maryland, Court of Federal Claims No:
17-1574V
103. Kathleen Smith, Norwalk, Connecticut, Court of Federal Claims No:
17-1575V
104. Joseph Spataro, Fairfield, Connecticut, Court of Federal Claims
No: 17-1576V
105. Gayle Randall, Armuchee, Georgia, Court of Federal Claims No: 17-
1579V
106. Jessica Harding, Corvallis, Oregon, Court of Federal Claims No:
17-1580V
107. Jose Monsalvez, Houston, Texas, Court of Federal Claims No: 17-
1583V
108. Minnie Bullock, Bowling Green, Kentucky, Court of Federal Claims
No: 17-1584V
109. Susan Pierce, Seattle, Washington, Court of Federal Claims No: 17-
1585V
110. Anthony Rucker, Winter Haven, Florida, Court of Federal Claims No:
17-1586V
111. Janice Berkow, Lenoir, North Carolina, Court of Federal Claims No:
17-1587V
112. Melinda Porter, Oklahoma City, Oklahoma, Court of Federal Claims
No: 17-1589V
113. Kurt Rhodes, Grand Rapids, Michigan, Court of Federal Claims No:
17-1590V
114. Bruchy Schik, Brooklyn, New York, Court of Federal Claims No: 17-
1591V
115. Barbara Van Esler, St. Louis, Missouri, Court of Federal Claims
No: 17-1592V
116. Mary Guler, North Myrtle Beach, South Carolina, Court of Federal
Claims No: 17-1593V
117. Robert Robinson, Fort Pierce, Florida, Court of Federal Claims No:
17-1594V
118. Rachael Anne Witherspoon, New Orleans, Louisiana, Court of Federal
Claims No: 17-1595V
119. Richard Hirsch, Delray Beach, Florida, Court of Federal Claims No:
17-1596V
120. Judith Tucker, Tarrytown, New York, Court of Federal Claims No:
17-1597V
121. Carrie Gregory, South Kingstown, Rhode Island, Court of Federal
Claims No: 17-1599V
122. Mark Ferrara, Fayetteville, Georgia, Court of Federal Claims No:
17-1601V
123. Sandra Sundlov, Jamestown, New York, Court of Federal Claims No:
17-1603V
124. Terri E. Scarbro, Great Falls, Montana, Court of Federal Claims
No: 17-1604V
125. Robin Hamlin, Holly Hill, Florida, Court of Federal Claims No: 17-
1606V
126. Donna Martin, St. Petersburg, Pennsylvania, Court of Federal
Claims No: 17-1607V
127. Gayle Kligis, Aurora, Illinois, Court of Federal Claims No: 17-
1608V
128. Joan Creech, Zebulon, North Carolina, Court of Federal Claims No:
17-1609V
129. Georgiana McKenzie, Dorchester, Massachusetts, Court of Federal
Claims No: 17-1610V
130. Sheree Garrett, Dallas, Texas, Court of Federal Claims No: 17-
1611V
131. Ninnart Changkiendee, South Jordan, Utah, Court of Federal Claims
No: 17-1612V
132. Richard Denham, Franklin, Tennessee, Court of Federal Claims No:
17-1613V
133. Margaret Parsons, Faribault, Minnesota, Court of Federal Claims
No: 17-1615V
134. Stacy James-Cornelius on behalf of E. J., Phoenix, Arizona, Court
of Federal Claims No: 17-1616V
135. Joyce Carter, Bethel Park, Pennsylvania, Court of Federal Claims
No: 17-1617V
136. Erica Livingston, Englewood, New Jersey, Court of Federal Claims
No: 17-1619V
137. Walter C. Jones, Jr., Mukilteo, Washington, Court of Federal
Claims No: 17-1620V
138. Antonio Katz, Ocean City, New Jersey, Court of Federal Claims No:
17-1621V
139. Lisa Guerrero, Boston, Massachusetts, Court of Federal Claims No:
17-1624V
140. Timothy A. Thatcher, Boise, Idaho, Court of Federal Claims No: 17-
1628V
141. Kenneth Niemczyk, West Lebanon, New Hampshire, Court of Federal
Claims No: 17-1629V
142. Lisa Laimer, Moreno Valley, California, Court of Federal Claims
No: 17-1630V
143. Cheryl Gibbs, New Orleans, Louisiana, Court of Federal Claims No:
17-1632V
144. Rhonda Meade, Kingsport, Tennessee, Court of Federal Claims No:
17-1633V
145. Marina Vidal, Annandale, Virginia, Court of Federal Claims No: 17-
1635V
146. Bassam Al Saddawi, Laguna Nigel, California, Court of Federal
Claims No: 17-1640V
147. Rosemary Morgan-Lee, Dresher, Pennsylvania, Court of Federal
Claims No: 17-1641V
148. Tonya Hood, Rocky Mount, North Carolina, Court of Federal Claims
No: 17-1642V
149. Darlene Lopez, Englewood, New Jersey, Court of Federal Claims No:
17-1643V
150. Cynthia Quinn, Hammond, Louisiana, Court of Federal Claims No: 17-
1644V
[FR Doc. 2017-25817 Filed 11-29-17; 8:45 am]
BILLING CODE 4165-15-P
