National Vaccine Injury Compensation Program; List of Petitions Received, 23036-23038 [2015-09602]
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Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product KYNAMRO
(mipomersen sodium). KYNAMRO is
indicated as an adjunct to lipidlowering medications and diet to reduce
low density lipoprotein-cholesterol,
apolipoprotein B, total cholesterol, and
non-high density lipoprotein-cholesterol
in patients with homozygous familial
hypercholesterolemia. Subsequent to
this approval, the USPTO received a
patent term restoration application for
KYNAMRO (U.S. Patent No. 7,511,131)
from Genzyme Corporation, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 27, 2014, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
KYNAMRO represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
FDA has determined that the
applicable regulatory review period for
KYNAMRO is 2,601 days. Of this time,
2,294 days occurred during the testing
phase of the regulatory review period,
while 307 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355(i)) became effective:
December 18, 2005. FDA has verified
the applicant’s claim that the date the
investigational new drug application
became effective was on December 18,
2005.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: March 29, 2012.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
KYNAMRO (NDA 203568) was
submitted on March 29, 2012.
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3. The date the application was
approved: January 29, 2013. FDA has
verified the applicant’s claim that NDA
203568 was approved on January 29,
2013.
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 application for patent extension,
this applicant seeks 853 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 23, 2015.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
October 21, 2015. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09522 Filed 4–23–15; 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, HHS.
AGENCY:
PO 00000
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ACTION:
Notice.
The Health Resources and
Services Administration (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 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.
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 11C–26, Rockville, MD
20857; (301) 443–6593.
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 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 Section
2114 of the PHS Act or as set forth at
42 CFR 100.3, as applicable. 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
SUMMARY:
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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
March 1, 2015, through March 31, 2015.
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. ‘‘Sustained, 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. ‘‘Sustained, 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, Room 11C–26, 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
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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: April 17, 2015.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Leanna Babb, Yuma, Arizona, Court of
Federal Claims No: 15–0195V
2. Avery Kranz and Alyssa Kranz on behalf
of M. K., Millburn, New Jersey, Court of
Federal Claims No: 15–0196V
3. Avery Kranz, Millburn, New Jersey, Court
of Federal Claims No: 15–0197V
4. Carol Williams, Morgantown, West
Virginia, Court of Federal Claims No: 15–
0198V
5. Thomas Holland, Cataumet,
Massachusetts, Court of Federal Claims
No: 15–0199V
6. Mario Caruso, Clovis, California, Court of
Federal Claims No: 15–0200V
7. Marilyn Akyuz, Brooklyn, New York,
Court of Federal Claims No: 15–0201V
8. Andrew Bussa, Boston, Massachusetts,
Court of Federal Claims No: 15–0202V
9. Peggy Lafon, Crowley, Texas, Court of
Federal Claims No: 15–0203V
10. Rosemary St. George, Boston,
Massachusetts, Court of Federal Claims
No: 15–0204V
11. David G. Smith, Billerica, Massachusetts,
Court of Federal Claims No: 15–0205V
12. Carin Ing-Marie Malkin, Sarasota, Florida,
Court of Federal Claims No: 15–0206V
13. Tamie Blesi, Minneapolis, Minnesota,
Court of Federal Claims No: 15–0208V
14. Tamie Blesi, Minneapolis, Minnesota,
Court of Federal Claims No: 15–0209V
15. James Collins, Jr., Concord, North
Carolina, Court of Federal Claims No:
15–0210V
16. Annabella Chin, Pembroke, Florida, Court
of Federal Claims No: 15–0214V
17. Tisia Green, Cheektowaga, New York,
Court of Federal Claims No: 15–0218V
18. Tate Takahashi, Honolulu, Hawaii, Court
of Federal Claims No: 15–0219V
19. Dorothy Keegan, Rochester, New York,
Court of Federal Claims No: 15–0220V
20. Brandene LaPorte, Philadelphia,
Pennsylvania, Court of Federal Claims
No: 15–0221V
21. Melvin Keith Castle, New Bern, North
Carolina, Court of Federal Claims No:
15–0222V
22. Sarah Yoon on behalf of N.Y., Valencia,
California, Court of Federal Claims No:
15–0224V
23. Bernard Halverson on behalf of Susan
Halverson, Deceased, Somers Point, New
Jersey, Court of Federal Claims No: 15–
0227V
24. Jean L. Buck, Las Vegas, Nevada, Court
of Federal Claims No: 15–0231V
25. Joseph Bourche, Boulder, Colorado, Court
of Federal Claims No: 15–0232V
26. Keith Saunders, Onawa, Iowa, Court of
Federal Claims No: 15–0233V
27. Mary Axelson on behalf of A. A.,
Phoenix, Arizona, Court of Federal
Claims No: 15–0234V
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28. Kristen Silverio on behalf of G. L.,
Phoenix, Arizona, Court of Federal
Claims No: 15–0235V
29. Phyllis Phipps, Bluffton, Indiana, Court
of Federal Claims No: 15–0238V
30. Travis Morgan, Franklin, Tennessee,
Court of Federal Claims No: 15–0239V
31. Carl S. Fish, Folsom, California, Court of
Federal Claims No: 15–0244V
32. Rami Hatter, Dale City, California, Court
of Federal Claims No: 15–0245V
33. Tarah Gramza on behalf of J. G., Mesa,
Arizona, Court of Federal Claims No: 15–
0247V
34. Angela Bogue, Louisburg, North Carolina,
Court of Federal Claims No: 15–0250V
35. Joseph Willett, Wake Forest, North
Carolina, Court of Federal Claims No:
15–0252V
36. Scott Siciliano and Kathleen Siciliano on
behalf of E. S., Smithtown, New York,
Court of Federal Claims No: 15–0253V
37. Janet Florence, Glassboro, New Jersey,
Court of Federal Claims No: 15–0255V
38. Allison Boman on behalf of R. B., Rock
Springs, Wyoming, Court of Federal
Claims No: 15–0256V
39. Jordan Holtz, Sussex, Wisconsin, Court of
Federal Claims No: 15–0257V
40. Robert Richie, Atoka, Oklahoma, Court of
Federal Claims No: 15–0258V
41. Sandra E. Horvath, San Jose, California,
Court of Federal Claims No: 15–0260V
42. Lawrence Marra, Jr., Bethlehem,
Pennsylvania, Court of Federal Claims
No: 15–0261V
43. Ameena Jaafar on behalf of A. M.,
Windsor, Connecticut, Court of Federal
Claims No: 15–0267V
44. Brian Badger, Owensboro, Kentucky,
Court of Federal Claims No: 15–0273V
45. John Harbrucker, Kansas City, Kansas,
Court of Federal Claims No: 15–0274V
46. Maureen McGrath, Sturgeon Bay,
Wisconsin, Court of Federal Claims No:
15–0275V
47. Jane Privitera, Baldwin, New York, Court
of Federal Claims No: 15–0276V
48. Raquel Davis on behalf of M. D., Boston,
Massachusetts, Court of Federal Claims
No: 15–0277V
49. Janice Schroeder, Austin, Texas, Court of
Federal Claims No: 15–0278V
50. Brittany Stallings Benoit and Arsene
Benoit on behalf of Gabriel Cash Benoit,
Deceased, Quitman, Mississippi, Court of
Federal Claims No: 15–0279V
51. Annette Dominguez and Lydia Fazekas
on behalf of Rebecca C. Arana, Deceased,
Beverly Hills, California, Court of
Federal Claims No: 15–0280V
52. Rita Glynn, St. Paul, Minnesota, Court of
Federal Claims No: 15–0283V
53. Malissa Ajeti, Gilroy, California, Court of
Federal Claims No: 15–0284V
54. Shawn Orgel-Olson, Boston,
Massachusetts, Court of Federal Claims
No: 15–0285V
55. George Swaiss, Santa Clara, California,
Court of Federal Claims No: 15–0286V
56. Ann Wyborski, Vienna, Virginia, Court of
Federal Claims No: 15–0295V
57. Nadara Shives, Boston, Massachusetts,
Court of Federal Claims No: 15–0296V
58. Joseph Sullivan, Sarasota, Florida, Court
of Federal Claims No: 15–0300V
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59. Robert VanOsdol, Dallas, Texas, Court of
Federal Claims No: 15–0303V
60. Melissa Intini on behalf of Vanni Mae
Intini, Fort Bragg, North Carolina, Court
of Federal Claims No: 15–0304V
61. Erich Micheal Gram, Huntersville, North
Carolina, Court of Federal Claims No:
15–0305V
62. Edward M. Haney, San Pablo, California,
Court of Federal Claims No: 15–0310V
63. Charles Rohrer, Cedar Rapids, Iowa,
Court of Federal Claims No: 15–0311V
64. Jovan Ragia, Dallas, Texas, Court of
Federal Claims No: 15–0312V
65. Karen Ryf, Oshkosh, Wisconsin, Court of
Federal Claims No: 15–0313V
66. Jaymeeni Patel, Atlanta, Georgia, Court of
Federal Claims No: 15–0318V
67. Angela Waters, Seneca, South Carolina,
Court of Federal Claims No: 15–0320V
68. Beatrice Thomure, Boston,
Massachusetts, Court of Federal Claims
No: 15–0322V
69. Annmarie Auer, Boston, Massachusetts,
Court of Federal Claims No: 15–0323V
70. Sara Olivia Cain, Raleigh, North Carolina,
Court of Federal Claims No: 15–0325V
71. Nicholas Reinking and Hilary Katherine
Reinking on behalf of M. R., Phoenix,
Arizona, Court of Federal Claims No: 15–
0326V
72. Philip Power and April Power on behalf
of C. P., Cary, North Carolina, Court of
Federal Claims No: 15–0327V
[FR Doc. 2015–09602 Filed 4–23–15; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
tkelley on DSK3SPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Epigenetics,
Heparins, and Neurologic Disorders.
Date: May 1, 2015.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
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Contact Person: Suzan Nadi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–12–
138: NHLBI Systems Biology Collaborations.
Date: May 18–19, 2015.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Ai-Ping Zou, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9497, zouai@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–12–
138: NHLBI Systems Biology Collaborations.
Date: May 18–19, 2015.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Katherine M Malinda,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140,
MSC 7814, Bethesda, MD 20892, 301–435–
0912, Katherine_Malinda@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel LRP.
Date: June 2–3, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Barbara J. Nelson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences (NCATS), National
Institutes of Health, 6701 Democracy Blvd.,
Democracy 1, Room 1080, Bethesda, MD
20892–4874, 301–435–0806, nelsonbj@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: April 20, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–09502 Filed 4–23–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 20, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
[FR Doc. 2015–09500 Filed 4–23–15; 8:45 am]
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
PO 00000
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National Human Genome Research
Institute; Notice of Closed Meetings
Name of Committee: Center for Inherited
Disease Research Access Committee.
Date: May 7, 2015.
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[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 23036-23038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09602]
-----------------------------------------------------------------------
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, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (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 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.
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 11C-26, Rockville, MD 20857; (301) 443-6593.
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 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 Section 2114 of the
PHS Act or as set forth at 42 CFR 100.3, as applicable. 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
[[Page 23037]]
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 March 1, 2015, through March 31,
2015. 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. ``Sustained, 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. ``Sustained, 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, Room 11C-26,
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: April 17, 2015.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Leanna Babb, Yuma, Arizona, Court of Federal Claims No: 15-0195V
2. Avery Kranz and Alyssa Kranz on behalf of M. K., Millburn, New
Jersey, Court of Federal Claims No: 15-0196V
3. Avery Kranz, Millburn, New Jersey, Court of Federal Claims No:
15-0197V
4. Carol Williams, Morgantown, West Virginia, Court of Federal
Claims No: 15-0198V
5. Thomas Holland, Cataumet, Massachusetts, Court of Federal Claims
No: 15-0199V
6. Mario Caruso, Clovis, California, Court of Federal Claims No: 15-
0200V
7. Marilyn Akyuz, Brooklyn, New York, Court of Federal Claims No:
15-0201V
8. Andrew Bussa, Boston, Massachusetts, Court of Federal Claims No:
15-0202V
9. Peggy Lafon, Crowley, Texas, Court of Federal Claims No: 15-0203V
10. Rosemary St. George, Boston, Massachusetts, Court of Federal
Claims No: 15-0204V
11. David G. Smith, Billerica, Massachusetts, Court of Federal
Claims No: 15-0205V
12. Carin Ing-Marie Malkin, Sarasota, Florida, Court of Federal
Claims No: 15-0206V
13. Tamie Blesi, Minneapolis, Minnesota, Court of Federal Claims No:
15-0208V
14. Tamie Blesi, Minneapolis, Minnesota, Court of Federal Claims No:
15-0209V
15. James Collins, Jr., Concord, North Carolina, Court of Federal
Claims No: 15-0210V
16. Annabella Chin, Pembroke, Florida, Court of Federal Claims No:
15-0214V
17. Tisia Green, Cheektowaga, New York, Court of Federal Claims No:
15-0218V
18. Tate Takahashi, Honolulu, Hawaii, Court of Federal Claims No:
15-0219V
19. Dorothy Keegan, Rochester, New York, Court of Federal Claims No:
15-0220V
20. Brandene LaPorte, Philadelphia, Pennsylvania, Court of Federal
Claims No: 15-0221V
21. Melvin Keith Castle, New Bern, North Carolina, Court of Federal
Claims No: 15-0222V
22. Sarah Yoon on behalf of N.Y., Valencia, California, Court of
Federal Claims No: 15-0224V
23. Bernard Halverson on behalf of Susan Halverson, Deceased, Somers
Point, New Jersey, Court of Federal Claims No: 15-0227V
24. Jean L. Buck, Las Vegas, Nevada, Court of Federal Claims No: 15-
0231V
25. Joseph Bourche, Boulder, Colorado, Court of Federal Claims No:
15-0232V
26. Keith Saunders, Onawa, Iowa, Court of Federal Claims No: 15-
0233V
27. Mary Axelson on behalf of A. A., Phoenix, Arizona, Court of
Federal Claims No: 15-0234V
28. Kristen Silverio on behalf of G. L., Phoenix, Arizona, Court of
Federal Claims No: 15-0235V
29. Phyllis Phipps, Bluffton, Indiana, Court of Federal Claims No:
15-0238V
30. Travis Morgan, Franklin, Tennessee, Court of Federal Claims No:
15-0239V
31. Carl S. Fish, Folsom, California, Court of Federal Claims No:
15-0244V
32. Rami Hatter, Dale City, California, Court of Federal Claims No:
15-0245V
33. Tarah Gramza on behalf of J. G., Mesa, Arizona, Court of Federal
Claims No: 15-0247V
34. Angela Bogue, Louisburg, North Carolina, Court of Federal Claims
No: 15-0250V
35. Joseph Willett, Wake Forest, North Carolina, Court of Federal
Claims No: 15-0252V
36. Scott Siciliano and Kathleen Siciliano on behalf of E. S.,
Smithtown, New York, Court of Federal Claims No: 15-0253V
37. Janet Florence, Glassboro, New Jersey, Court of Federal Claims
No: 15-0255V
38. Allison Boman on behalf of R. B., Rock Springs, Wyoming, Court
of Federal Claims No: 15-0256V
39. Jordan Holtz, Sussex, Wisconsin, Court of Federal Claims No: 15-
0257V
40. Robert Richie, Atoka, Oklahoma, Court of Federal Claims No: 15-
0258V
41. Sandra E. Horvath, San Jose, California, Court of Federal Claims
No: 15-0260V
42. Lawrence Marra, Jr., Bethlehem, Pennsylvania, Court of Federal
Claims No: 15-0261V
43. Ameena Jaafar on behalf of A. M., Windsor, Connecticut, Court of
Federal Claims No: 15-0267V
44. Brian Badger, Owensboro, Kentucky, Court of Federal Claims No:
15-0273V
45. John Harbrucker, Kansas City, Kansas, Court of Federal Claims
No: 15-0274V
46. Maureen McGrath, Sturgeon Bay, Wisconsin, Court of Federal
Claims No: 15-0275V
47. Jane Privitera, Baldwin, New York, Court of Federal Claims No:
15-0276V
48. Raquel Davis on behalf of M. D., Boston, Massachusetts, Court of
Federal Claims No: 15-0277V
49. Janice Schroeder, Austin, Texas, Court of Federal Claims No: 15-
0278V
50. Brittany Stallings Benoit and Arsene Benoit on behalf of Gabriel
Cash Benoit, Deceased, Quitman, Mississippi, Court of Federal Claims
No: 15-0279V
51. Annette Dominguez and Lydia Fazekas on behalf of Rebecca C.
Arana, Deceased, Beverly Hills, California, Court of Federal Claims
No: 15-0280V
52. Rita Glynn, St. Paul, Minnesota, Court of Federal Claims No: 15-
0283V
53. Malissa Ajeti, Gilroy, California, Court of Federal Claims No:
15-0284V
54. Shawn Orgel-Olson, Boston, Massachusetts, Court of Federal
Claims No: 15-0285V
55. George Swaiss, Santa Clara, California, Court of Federal Claims
No: 15-0286V
56. Ann Wyborski, Vienna, Virginia, Court of Federal Claims No: 15-
0295V
57. Nadara Shives, Boston, Massachusetts, Court of Federal Claims
No: 15-0296V
58. Joseph Sullivan, Sarasota, Florida, Court of Federal Claims No:
15-0300V
[[Page 23038]]
59. Robert VanOsdol, Dallas, Texas, Court of Federal Claims No: 15-
0303V
60. Melissa Intini on behalf of Vanni Mae Intini, Fort Bragg, North
Carolina, Court of Federal Claims No: 15-0304V
61. Erich Micheal Gram, Huntersville, North Carolina, Court of
Federal Claims No: 15-0305V
62. Edward M. Haney, San Pablo, California, Court of Federal Claims
No: 15-0310V
63. Charles Rohrer, Cedar Rapids, Iowa, Court of Federal Claims No:
15-0311V
64. Jovan Ragia, Dallas, Texas, Court of Federal Claims No: 15-0312V
65. Karen Ryf, Oshkosh, Wisconsin, Court of Federal Claims No: 15-
0313V
66. Jaymeeni Patel, Atlanta, Georgia, Court of Federal Claims No:
15-0318V
67. Angela Waters, Seneca, South Carolina, Court of Federal Claims
No: 15-0320V
68. Beatrice Thomure, Boston, Massachusetts, Court of Federal Claims
No: 15-0322V
69. Annmarie Auer, Boston, Massachusetts, Court of Federal Claims
No: 15-0323V
70. Sara Olivia Cain, Raleigh, North Carolina, Court of Federal
Claims No: 15-0325V
71. Nicholas Reinking and Hilary Katherine Reinking on behalf of M.
R., Phoenix, Arizona, Court of Federal Claims No: 15-0326V
72. Philip Power and April Power on behalf of C. P., Cary, North
Carolina, Court of Federal Claims No: 15-0327V
[FR Doc. 2015-09602 Filed 4-23-15; 8:45 am]
BILLING CODE 4165-15-P
