National Vaccine Injury Compensation Program; List of Petitions Received, 66970-66972 [2016-23585]
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Federal Register / Vol. 81, No. 189 / Thursday, September 29, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
111.570, Records regarding product complaints ..............
240
600
144,000
0.5 (30 minutes)
72,000
Total ...........................................................................
........................
........................
........................
...........................
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The average burden per recordkeeping
estimates in Table 1 of this document
are based on those in the June 25, 2007,
final rule, which were based on our
institutional experience with other
CGMP requirements and on data
provided by Research Triangle Institute
in the ‘‘Survey of Manufacturing
Practices in the Dietary Supplement
Industry’’ cited in that rule.
The estimates in table 1 of the number
of firms affected by each provision of
part 111 are based on the percentage of
manufacturers, packagers, labelers,
holders, distributors, and warehousers
that reported in the survey that they
have not established written SOPs or do
not maintain records that were later
required by the June 25, 2007, final rule.
Because we do not have survey results
for general warehouses, we entered the
approximate number of facilities in that
category for those provisions covering
general facilities. For the dietary
supplement industry, the survey
estimated that 1,460 firms would be
covered by the final rule, including
manufacturers, packagers, labelers,
holders, distributors, and warehousers.
The time estimates include the burden
involved in documenting that certain
requirements are performed and in
recordkeeping. We used an estimated
annual batch production of 1,408
batches per year to estimate the burden
of requirements that are related to the
number of batches produced annually,
such as § 111.260, ‘‘What must the batch
production record include?’’ The
estimate of 1,408 batches per year is
near the midpoint of the number of
annual batches reported by survey
firms.
The length of time that CGMP records
must be maintained is set forth in
§ 111.605. Table 1 of this document
reflects the estimated burdens for
written procedures, record maintenance,
periodically reviewing records to
determine if they may be discarded, and
for any associated documentation for
that activity for records that are required
under part 111. We have not included
a separate estimate of burden for those
sections that require maintaining
records in accordance with § 111.605,
but have included those burdens under
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specific provisions for keeping records.
For example, § 111.255(a) requires that
the batch production records be
prepared every time a batch is
manufactured, and § 111.255(d) requires
that batch production records be kept in
accordance with § 111.605. The
estimated burdens for both § 111.255(a)
and (d) are included under § 111.260,
what the batch record must include.
Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23521 Filed 9–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3326]
Biosimilar User Fee Act; Public
Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
PO 00000
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Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23523 Filed 9–28–16; 8:45 am]
The Food and Drug
Administration is correcting a notice
entitled ‘‘Biosimilar User Fee Act;
Public Meeting’’ that appeared in the
Federal Register of September 19, 2016
(81 FR 64171). The document
announced a public meeting to discuss
proposed recommendations for the
reauthorization of the Biosimilar User
Fee Act (BsUFA) for fiscal years (FYs)
2018 through 2022. The document was
published with the incorrect date of the
closure of the docket and incorrect
transcript information. This document
corrects those errors.
FOR FURTHER INFORMATION CONTACT: Lisa
Granger, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 3330, Silver Spring, MD 20993–
0002, 301–796–9115, lisa.granger@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Monday, September
19, 2016, in FR Doc. 2016–22442, the
following corrections are made:
1. On page 64172, in the first column,
in the third sentence of the DATES
SUMMARY:
section, ‘‘October 19, 2016’’ is corrected
to read ‘‘October 28, 2016.’’
2. On page 64175, in the third
column, the section ‘‘Transcripts: As
soon as a transcript is available, FDA
will post it at https://www.fda.gov/
ForIndustry/UserFees/BiosimilarUser
FeeActBsUFA/ucm461774.htm.’’ is
corrected to read ‘‘Transcripts: Please be
advised that as soon as a transcript is
available, it will be accessible at https://
www.regulations.gov and https://
www.fda.gov/ForIndustry/UserFees/
BiosimilarUserFeeActBsUFA/
ucm461774.htm. It may be viewed at the
Division of Dockets Management, Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. The Freedom of Information
office address is available on the
Agency’s Web site at https://
www.fda.gov.’’
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
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS (the Secretary) 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
SUMMARY:
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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 the 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
serve a copy of the petition on the
Secretary of Health and Human
Services, 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
August 1, 2016, through August 31,
2016. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
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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 Health and Human
Services) 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: September 22, 2016.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Victoria Cohen, Norwood, Massachusetts,
Court of Federal Claims No: 16–0910V.
2. Cheryl Stephens, Portland, Texas, Court of
Federal Claims No: 16–0913V.
3. John Greider, Plano, Texas, Court of
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Federal Claims No: 16–0915V.
4. Jessie M. Holloway, Houston, Texas, Court
of Federal Claims No: 16–0919V.
5. Stephanie Digerolamo, Cedar Brook, New
Jersey, Court of Federal Claims No: 16–
0920V.
6. Melinda Holgate, Syracuse, New York,
Court of Federal Claims No: 16–0921V.
7. Michele Baxter on behalf of L.R.,
Fayetteville, Tennessee, Court of Federal
Claims No: 16–0922V.
8. Stephanie Nwala and Emmanuel Nwala on
behalf of C.N., Aberdeen, South Dakota,
Court of Federal Claims No: 16–0923V.
9. Susan Cobbina, Spencerport, New York,
Court of Federal Claims No: 16–0924V.
10. Patrice Moczek on behalf of K.H.,
Shadyside, Ohio, Court of Federal
Claims No: 16–0930V.
11. Wanda Hughs on behalf of A.E.H.,
Meridian, Mississippi, Court of Federal
Claims No: 16–0934V.
12. Michael Anderson and Hasani Taylor on
behalf of K.A., Valhalla, New York, Court
of Federal Claims No: 16–0935V.
13. George M. Gavin, Pittsburgh,
Pennsylvania, Court of Federal Claims
No: 16–0936V.
14. Greg Averitt, Perryton, Texas, Court of
Federal Claims No: 16–0938V.
15. William Lance Ferguson, Corpus Christi,
Texas, Court of Federal Claims No: 16–
0939V.
16. Paulette Stuart, Valley Stream, New York,
Court of Federal Claims No: 16–0940V.
17. Danny Pasawongse and Kristy M. Suh on
behalf of I.Y.P., San Mateo, California,
Court of Federal Claims No: 16–0944V.
18. Armicka S. Miller on behalf of The Estate
of Arnold Lee Miller, Deceased,
Hampton, Virginia, Court of Federal
Claims No: 16–0946V.
19. Peter Matte, Houston, Texas, Court of
Federal Claims No: 16–0949V.
20. Helga Matthews, Glendale, Arizona,
Court of Federal Claims No: 16–0951V.
21. Melissa Bianconi on behalf of S.L.,
Seattle, Washington, Court of Federal
Claims No: 16–0952V.
22. Donald Jackson, Lexington, Kentucky,
Court of Federal Claims No: 16–0955V.
23. Leonard Sean Thompson, Hoboken, New
Jersey, Court of Federal Claims No: 16–
0956V.
24. Flora Adler, Russiaville, Indiana, Court of
Federal Claims No: 16–0960V.
25. Marilyn Smith, Dallas, Texas, Court of
Federal Claims No: 16–0961V.
26. Niki Delson, Saugerties, New York, Court
of Federal Claims No: 16–0962V.
27. Barbara Sease, Chambersburg,
Pennsylvania, Court of Federal Claims
No: 16–0964V.
28. David Fenster, Princeton, New Jersey,
Court of Federal Claims No: 16–0965V.
29. Tamara Frye, Topeka, Kansas, Court of
Federal Claims No: 16–0966V.
30. Horace Mungin, Goose Creek, South
Carolina, Court of Federal Claims No:
16–0968V.
31. Ann Meril, Yonkers, New York, Court of
Federal Claims No: 16–0969V.
32. Abdolrahim Noorani, Levittown,
Pennsylvania, Court of Federal Claims
No: 16–0970V.
33. William Dye, Portland, Maine, Court of
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Federal Claims No: 16–0971V.
34. Donnie Jordan, Springfield, Virginia,
Court of Federal Claims No: 16–0972V.
35. David Davis, Lumberton, North Carolina,
Court of Federal Claims No: 16–0974V.
36. Mary Germano, Washington, District of
Columbia, Court of Federal Claims No:
16–0976V.
37. David Hanson, New Hope, Minnesota,
Court of Federal Claims No: 16–0977V.
38. Kathleen A. Seko, Kitty Hawk, North
Carolina, Court of Federal Claims No:
16–0978V.
39. Jacklyn Hallead, Bay City, Michigan,
Court of Federal Claims No: 16–0979V.
40. Jean Gentile, Saint Louis Park, Minnesota,
Court of Federal Claims No: 16–0980V.
41. Pam Mecagni, Collinsville, Illinois, Court
of Federal Claims No: 16–0981V.
42. Sara Faley, Dixon, Illinois, Court of
Federal Claims No: 16–0982V.
43. Brady Scott, Westminster, Colorado,
Court of Federal Claims No: 16–0983V.
44. Linda Multer, Somerville, Massachusetts,
Court of Federal Claims No: 16–0985V.
45. Rhonda Larson, Woodbridge, Virginia,
Court of Federal Claims No: 16–0986V.
46. Holly Dlouhy, Houston, Texas, Court of
Federal Claims No: 16–0987V.
47. Kimberly Daniel, New York, New York,
Court of Federal Claims No: 16–0988V.
48. Kameshwar Rao S. Ayyasolla, Lake
Success, New York, Court of Federal
Claims No: 16–0989V.
49. Paul Schachter, Fort Wright, Kentucky,
Court of Federal Claims No: 16–0990V.
50. Denise Procida, Atlanta, Georgia, Court of
Federal Claims No: 16–0991V.
51. Nicola Winkel, Phoenix, Arizona, Court
of Federal Claims No: 16–0992V.
52. Gary Hausdorf, Minneapolis, Minnesota,
Court of Federal Claims No: 16–0993V.
53. Nicholas Zumwalt on behalf of L.Z.,
Broken Arrow, Oklahoma, Court of
Federal Claims No: 16–0994V.
54. Marie Campbell on behalf of Andrew J.
Campbell, Whippany, New Jersey, Court
of Federal Claims No: 16–0996V.
55. Anna Perekotiy on behalf of S.K.,
Scottsdale, Arizona, Court of Federal
Claims No: 16–0997V.
56. Artha Timothy, Hope Mills, North
Carolina, Court of Federal Claims No:
16–0998V.
57. Donald Butts, Jr., Middletown, Ohio,
Court of Federal Claims No: 16–1002V.
58. Gerald Sather, Port Orchard, Washington,
Court of Federal Claims No: 16–1004V.
59. Peter A. Voss, Menomonee Falls,
Wisconsin, Court of Federal Claims No:
16–1005V.
60. Jane Rocha-DeMelo, Swansea,
Massachusetts, Court of Federal Claims
No: 16–1007V.
61. Mee Lee on behalf of Maiyer Lee,
Milwaukee, Wisconsin, Court of Federal
Claims No: 16–1008V.
62. Fred Booth, Birmingham, Alabama, Court
of Federal Claims No: 16–1012V.
63. Patrick C. Richardson, Waianae, Hawaii,
Court of Federal Claims No: 16–1013V.
64. Anita Romero, Huntington Valley,
Pennsylvania, Court of Federal Claims
No: 16–1014V.
65. Daniel Soper, Boston, Massachusetts,
Court of Federal Claims No: 16–1016V.
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66. Norman Larsen, Staten Island, New York,
Court of Federal Claims No: 16–1018V.
67. Valerie Silver on behalf of R.S., Nyak,
New York, Court of Federal Claims No:
16–1019V.
68. Michael Rochotte, New Brunswick, New
Jersey, Court of Federal Claims No: 16–
1024V.
69. Mark P. Calnan, Lexington,
Massachusetts, Court of Federal Claims
No: 16–1025V.
70. John Belt, Lakewood, Colorado, Court of
Federal Claims No: 16–1026V.
71. Crystal Butler on behalf of S.B., Phoenix,
Arizona, Court of Federal Claims No: 16–
1027V.
72. Turmak Davis, Wilmington, North
Carolina, Court of Federal Claims No:
16–1028V.
73. Daniel McNeal, Indianapolis, Indiana,
Court of Federal Claims No: 16–1029V.
74. Jessica Roberts, Woodbury, Minnesota,
Court of Federal Claims No: 16–1030V.
75. Beverly Massey, Sister Bay, Wisconsin,
Court of Federal Claims No: 16–1032V.
76. Sharlee Funai, Honolulu, Hawaii, Court
of Federal Claims No: 16–1033V.
77. Alexis Obers, Solvang, California, Court
of Federal Claims No: 16–1034V.
78. Regina O. Fletcher, Nesconset, New York,
Court of Federal Claims No: 16–1037V.
79. Deborah Chrowl, Salem, Oregon, Court of
Federal Claims No: 16–1040V.
80. Michael Bates, Rock Hill, South Carolina,
Court of Federal Claims No: 16–1041V.
81. Brandon Hood, Kingwood, Texas, Court
of Federal Claims No: 16–1042V.
82. Lanesia Shea on behalf of A.S., Las
Cruces, New Mexico, Court of Federal
Claims No: 16–1043V.
83. Aprises Phillips and Ivan Phillips, Sr. on
behalf of Ivana Phillips, Birmingham,
Alabama, Court of Federal Claims No:
16–1044V.
84. Aprises Phillips and Ivan Phillips, Sr. on
behalf of Ivanka Phillips, Birmingham,
Alabama, Court of Federal Claims No:
16–1045V.
85. Aprises Phillips and Ivan Phillips, Sr. on
behalf of Ivan Phillips, Birmingham,
Alabama, Court of Federal Claims No:
16–1046V.
86. Ursula Rehfeld, Berlin, Germany, Court of
Federal Claims No: 16–1048V.
87. Kelsey Hanstead, Mt. Vernon,
Washington, Court of Federal Claims No:
16–1050V.
88. Shannon Jablonski, Washington, District
of Columbia, Court of Federal Claims No:
16–1051V.
89. Fabrizio Cianni on behalf of Carmella
Cianni, Deceased, Vienna, Virginia,
Court of Federal Claims No: 16–1052V.
90. James Lagle, Huntingdon, Pennsylvania,
Court of Federal Claims No: 16–1053V.
91. Diana Malick, Swarthmore, Pennsylvania,
Court of Federal Claims No: 16–1054V.
92. Rachel McCarron, Groton, Massachusetts,
Court of Federal Claims No: 16–1055V.
93. Robert Manuel, Bakersfield, California,
Court of Federal Claims No: 16–1057V.
94. Luis Trigueros, Boston, Massachusetts,
Court of Federal Claims No: 16–1058V.
95. Linda Hubbard on behalf of Leslie
McKnight, Deceased, Boulder, Colorado,
Court of Federal Claims No: 16–1059V.
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96. Jenifer Twiford, San Francisco,
California, Court of Federal Claims No:
16–1060V.
97. William Staak, Jr., Jonesboro, Georgia,
Court of Federal Claims No: 16–1061V.
98. Claydene Benson, Beverly Hills,
California, Court of Federal Claims No:
16–1062V.
99. Kim Manget, Beverly Hills, California,
Court of Federal Claims No: 16–1064V.
100. John Strowger, Largo, Florida, Court of
Federal Claims No: 16–1065V.
101. Vickie L. Dern on behalf of David J.
Dern, Deceased, Birmingham, Alabama,
Court of Federal Claims No: 16–1066V.
102. Kim LaFountaine, Longview,
Washington, Court of Federal Claims No:
16–1067V.
103. Linda Hagans, Villa Rica, Georgia, Court
of Federal Claims No: 16–1068V.
104. George Easton, Hazelton, Pennsylvania,
Court of Federal Claims No: 16–1069V.
105. Cathy Deshler, Salt Lake City, Utah,
Court of Federal Claims No: 16–1070V.
106. Ala Mohamad, Denver, Colorado, Court
of Federal Claims No: 16–1075V.
107. Bonnie Stratton, Brea, California, Court
of Federal Claims No: 16–1076V.
108. Minh Le, Bristol, Pennsylvania, Court of
Federal Claims No: 16–1078V.
109. Jean de Bary, Boston, Massachusetts,
Court of Federal Claims No: 16–1080V.
110. Chiyoko Miller, Washington, District of
Columbia, Court of Federal Claims No:
16–1081V.
111. Jeffrey Heise and Meghan Heise on
behalf of L.D.H., Wausau, Wisconsin,
Court of Federal Claims No: 16–1082V.
112. Julia Sullivan, Phoenix, Arizona, Court
of Federal Claims No: 16–1083V.
113. Richard Waters, Phoenix, Arizona, Court
of Federal Claims No: 16–1084V.
114. Carol Katora, York, Pennsylvania, Court
of Federal Claims No: 16–1086V.
115. Teresa Shuart, Syracuse, New York,
Court of Federal Claims No: 16–1087V.
116. Pauline Zand, Greenbrae, California,
Court of Federal Claims No: 16–1088V.
117. Heather Sturtze, Worcester,
Massachusetts, Court of Federal Claims
No: 16–1089V.
[FR Doc. 2016–23585 Filed 9–28–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Announcement of Requirements and
Registration for ‘‘The Simple
Extensible Sampling Tool Challenge’’
Office of Inspector General
(OIG), HHS.
ACTION: Notice.
AGENCY:
The Simple Extensible
Sampling Tool Challenge (Challenge) is
an HHS/OIG Challenge under the
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SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 66970-66972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23585]
-----------------------------------------------------------------------
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 Section 2112(b)(2) of the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS (the Secretary) 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
[[Page 66971]]
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 the 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 serve a copy of
the petition on the Secretary of Health and Human Services, 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 August 1, 2016, through August
31, 2016. 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 Health and Human Services) 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: September 22, 2016.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Victoria Cohen, Norwood, Massachusetts, Court of Federal Claims
No: 16-0910V.
2. Cheryl Stephens, Portland, Texas, Court of Federal Claims No: 16-
0913V.
3. John Greider, Plano, Texas, Court of Federal Claims No: 16-0915V.
4. Jessie M. Holloway, Houston, Texas, Court of Federal Claims No:
16-0919V.
5. Stephanie Digerolamo, Cedar Brook, New Jersey, Court of Federal
Claims No: 16-0920V.
6. Melinda Holgate, Syracuse, New York, Court of Federal Claims No:
16-0921V.
7. Michele Baxter on behalf of L.R., Fayetteville, Tennessee, Court
of Federal Claims No: 16-0922V.
8. Stephanie Nwala and Emmanuel Nwala on behalf of C.N., Aberdeen,
South Dakota, Court of Federal Claims No: 16-0923V.
9. Susan Cobbina, Spencerport, New York, Court of Federal Claims No:
16-0924V.
10. Patrice Moczek on behalf of K.H., Shadyside, Ohio, Court of
Federal Claims No: 16-0930V.
11. Wanda Hughs on behalf of A.E.H., Meridian, Mississippi, Court of
Federal Claims No: 16-0934V.
12. Michael Anderson and Hasani Taylor on behalf of K.A., Valhalla,
New York, Court of Federal Claims No: 16-0935V.
13. George M. Gavin, Pittsburgh, Pennsylvania, Court of Federal
Claims No: 16-0936V.
14. Greg Averitt, Perryton, Texas, Court of Federal Claims No: 16-
0938V.
15. William Lance Ferguson, Corpus Christi, Texas, Court of Federal
Claims No: 16-0939V.
16. Paulette Stuart, Valley Stream, New York, Court of Federal
Claims No: 16-0940V.
17. Danny Pasawongse and Kristy M. Suh on behalf of I.Y.P., San
Mateo, California, Court of Federal Claims No: 16-0944V.
18. Armicka S. Miller on behalf of The Estate of Arnold Lee Miller,
Deceased, Hampton, Virginia, Court of Federal Claims No: 16-0946V.
19. Peter Matte, Houston, Texas, Court of Federal Claims No: 16-
0949V.
20. Helga Matthews, Glendale, Arizona, Court of Federal Claims No:
16-0951V.
21. Melissa Bianconi on behalf of S.L., Seattle, Washington, Court
of Federal Claims No: 16-0952V.
22. Donald Jackson, Lexington, Kentucky, Court of Federal Claims No:
16-0955V.
23. Leonard Sean Thompson, Hoboken, New Jersey, Court of Federal
Claims No: 16-0956V.
24. Flora Adler, Russiaville, Indiana, Court of Federal Claims No:
16-0960V.
25. Marilyn Smith, Dallas, Texas, Court of Federal Claims No: 16-
0961V.
26. Niki Delson, Saugerties, New York, Court of Federal Claims No:
16-0962V.
27. Barbara Sease, Chambersburg, Pennsylvania, Court of Federal
Claims No: 16-0964V.
28. David Fenster, Princeton, New Jersey, Court of Federal Claims
No: 16-0965V.
29. Tamara Frye, Topeka, Kansas, Court of Federal Claims No: 16-
0966V.
30. Horace Mungin, Goose Creek, South Carolina, Court of Federal
Claims No: 16-0968V.
31. Ann Meril, Yonkers, New York, Court of Federal Claims No: 16-
0969V.
32. Abdolrahim Noorani, Levittown, Pennsylvania, Court of Federal
Claims No: 16-0970V.
33. William Dye, Portland, Maine, Court of
[[Page 66972]]
Federal Claims No: 16-0971V.
34. Donnie Jordan, Springfield, Virginia, Court of Federal Claims
No: 16-0972V.
35. David Davis, Lumberton, North Carolina, Court of Federal Claims
No: 16-0974V.
36. Mary Germano, Washington, District of Columbia, Court of Federal
Claims No: 16-0976V.
37. David Hanson, New Hope, Minnesota, Court of Federal Claims No:
16-0977V.
38. Kathleen A. Seko, Kitty Hawk, North Carolina, Court of Federal
Claims No: 16-0978V.
39. Jacklyn Hallead, Bay City, Michigan, Court of Federal Claims No:
16-0979V.
40. Jean Gentile, Saint Louis Park, Minnesota, Court of Federal
Claims No: 16-0980V.
41. Pam Mecagni, Collinsville, Illinois, Court of Federal Claims No:
16-0981V.
42. Sara Faley, Dixon, Illinois, Court of Federal Claims No: 16-
0982V.
43. Brady Scott, Westminster, Colorado, Court of Federal Claims No:
16-0983V.
44. Linda Multer, Somerville, Massachusetts, Court of Federal Claims
No: 16-0985V.
45. Rhonda Larson, Woodbridge, Virginia, Court of Federal Claims No:
16-0986V.
46. Holly Dlouhy, Houston, Texas, Court of Federal Claims No: 16-
0987V.
47. Kimberly Daniel, New York, New York, Court of Federal Claims No:
16-0988V.
48. Kameshwar Rao S. Ayyasolla, Lake Success, New York, Court of
Federal Claims No: 16-0989V.
49. Paul Schachter, Fort Wright, Kentucky, Court of Federal Claims
No: 16-0990V.
50. Denise Procida, Atlanta, Georgia, Court of Federal Claims No:
16-0991V.
51. Nicola Winkel, Phoenix, Arizona, Court of Federal Claims No: 16-
0992V.
52. Gary Hausdorf, Minneapolis, Minnesota, Court of Federal Claims
No: 16-0993V.
53. Nicholas Zumwalt on behalf of L.Z., Broken Arrow, Oklahoma,
Court of Federal Claims No: 16-0994V.
54. Marie Campbell on behalf of Andrew J. Campbell, Whippany, New
Jersey, Court of Federal Claims No: 16-0996V.
55. Anna Perekotiy on behalf of S.K., Scottsdale, Arizona, Court of
Federal Claims No: 16-0997V.
56. Artha Timothy, Hope Mills, North Carolina, Court of Federal
Claims No: 16-0998V.
57. Donald Butts, Jr., Middletown, Ohio, Court of Federal Claims No:
16-1002V.
58. Gerald Sather, Port Orchard, Washington, Court of Federal Claims
No: 16-1004V.
59. Peter A. Voss, Menomonee Falls, Wisconsin, Court of Federal
Claims No: 16-1005V.
60. Jane Rocha-DeMelo, Swansea, Massachusetts, Court of Federal
Claims No: 16-1007V.
61. Mee Lee on behalf of Maiyer Lee, Milwaukee, Wisconsin, Court of
Federal Claims No: 16-1008V.
62. Fred Booth, Birmingham, Alabama, Court of Federal Claims No: 16-
1012V.
63. Patrick C. Richardson, Waianae, Hawaii, Court of Federal Claims
No: 16-1013V.
64. Anita Romero, Huntington Valley, Pennsylvania, Court of Federal
Claims No: 16-1014V.
65. Daniel Soper, Boston, Massachusetts, Court of Federal Claims No:
16-1016V.
66. Norman Larsen, Staten Island, New York, Court of Federal Claims
No: 16-1018V.
67. Valerie Silver on behalf of R.S., Nyak, New York, Court of
Federal Claims No: 16-1019V.
68. Michael Rochotte, New Brunswick, New Jersey, Court of Federal
Claims No: 16-1024V.
69. Mark P. Calnan, Lexington, Massachusetts, Court of Federal
Claims No: 16-1025V.
70. John Belt, Lakewood, Colorado, Court of Federal Claims No: 16-
1026V.
71. Crystal Butler on behalf of S.B., Phoenix, Arizona, Court of
Federal Claims No: 16-1027V.
72. Turmak Davis, Wilmington, North Carolina, Court of Federal
Claims No: 16-1028V.
73. Daniel McNeal, Indianapolis, Indiana, Court of Federal Claims
No: 16-1029V.
74. Jessica Roberts, Woodbury, Minnesota, Court of Federal Claims
No: 16-1030V.
75. Beverly Massey, Sister Bay, Wisconsin, Court of Federal Claims
No: 16-1032V.
76. Sharlee Funai, Honolulu, Hawaii, Court of Federal Claims No: 16-
1033V.
77. Alexis Obers, Solvang, California, Court of Federal Claims No:
16-1034V.
78. Regina O. Fletcher, Nesconset, New York, Court of Federal Claims
No: 16-1037V.
79. Deborah Chrowl, Salem, Oregon, Court of Federal Claims No: 16-
1040V.
80. Michael Bates, Rock Hill, South Carolina, Court of Federal
Claims No: 16-1041V.
81. Brandon Hood, Kingwood, Texas, Court of Federal Claims No: 16-
1042V.
82. Lanesia Shea on behalf of A.S., Las Cruces, New Mexico, Court of
Federal Claims No: 16-1043V.
83. Aprises Phillips and Ivan Phillips, Sr. on behalf of Ivana
Phillips, Birmingham, Alabama, Court of Federal Claims No: 16-1044V.
84. Aprises Phillips and Ivan Phillips, Sr. on behalf of Ivanka
Phillips, Birmingham, Alabama, Court of Federal Claims No: 16-1045V.
85. Aprises Phillips and Ivan Phillips, Sr. on behalf of Ivan
Phillips, Birmingham, Alabama, Court of Federal Claims No: 16-1046V.
86. Ursula Rehfeld, Berlin, Germany, Court of Federal Claims No: 16-
1048V.
87. Kelsey Hanstead, Mt. Vernon, Washington, Court of Federal Claims
No: 16-1050V.
88. Shannon Jablonski, Washington, District of Columbia, Court of
Federal Claims No: 16-1051V.
89. Fabrizio Cianni on behalf of Carmella Cianni, Deceased, Vienna,
Virginia, Court of Federal Claims No: 16-1052V.
90. James Lagle, Huntingdon, Pennsylvania, Court of Federal Claims
No: 16-1053V.
91. Diana Malick, Swarthmore, Pennsylvania, Court of Federal Claims
No: 16-1054V.
92. Rachel McCarron, Groton, Massachusetts, Court of Federal Claims
No: 16-1055V.
93. Robert Manuel, Bakersfield, California, Court of Federal Claims
No: 16-1057V.
94. Luis Trigueros, Boston, Massachusetts, Court of Federal Claims
No: 16-1058V.
95. Linda Hubbard on behalf of Leslie McKnight, Deceased, Boulder,
Colorado, Court of Federal Claims No: 16-1059V.
96. Jenifer Twiford, San Francisco, California, Court of Federal
Claims No: 16-1060V.
97. William Staak, Jr., Jonesboro, Georgia, Court of Federal Claims
No: 16-1061V.
98. Claydene Benson, Beverly Hills, California, Court of Federal
Claims No: 16-1062V.
99. Kim Manget, Beverly Hills, California, Court of Federal Claims
No: 16-1064V.
100. John Strowger, Largo, Florida, Court of Federal Claims No: 16-
1065V.
101. Vickie L. Dern on behalf of David J. Dern, Deceased,
Birmingham, Alabama, Court of Federal Claims No: 16-1066V.
102. Kim LaFountaine, Longview, Washington, Court of Federal Claims
No: 16-1067V.
103. Linda Hagans, Villa Rica, Georgia, Court of Federal Claims No:
16-1068V.
104. George Easton, Hazelton, Pennsylvania, Court of Federal Claims
No: 16-1069V.
105. Cathy Deshler, Salt Lake City, Utah, Court of Federal Claims
No: 16-1070V.
106. Ala Mohamad, Denver, Colorado, Court of Federal Claims No: 16-
1075V.
107. Bonnie Stratton, Brea, California, Court of Federal Claims No:
16-1076V.
108. Minh Le, Bristol, Pennsylvania, Court of Federal Claims No: 16-
1078V.
109. Jean de Bary, Boston, Massachusetts, Court of Federal Claims
No: 16-1080V.
110. Chiyoko Miller, Washington, District of Columbia, Court of
Federal Claims No: 16-1081V.
111. Jeffrey Heise and Meghan Heise on behalf of L.D.H., Wausau,
Wisconsin, Court of Federal Claims No: 16-1082V.
112. Julia Sullivan, Phoenix, Arizona, Court of Federal Claims No:
16-1083V.
113. Richard Waters, Phoenix, Arizona, Court of Federal Claims No:
16-1084V.
114. Carol Katora, York, Pennsylvania, Court of Federal Claims No:
16-1086V.
115. Teresa Shuart, Syracuse, New York, Court of Federal Claims No:
16-1087V.
116. Pauline Zand, Greenbrae, California, Court of Federal Claims
No: 16-1088V.
117. Heather Sturtze, Worcester, Massachusetts, Court of Federal
Claims No: 16-1089V.
[FR Doc. 2016-23585 Filed 9-28-16; 8:45 am]
BILLING CODE 4165-15-P
