National Vaccine Injury Compensation Program; List of Petitions Received, 18654-18657 [2017-07989]
Download as PDF
<![CDATA[
18654
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total
annual
records
Average burden per
recordkeeping
Total
hours
111.535, Records for returned dietary supplements ...
111.570, Records regarding product complaints ........
110
240
4
600
440
144,000
13.5 ........................
0.5 (30 minutes) .....
5,940
72,000
Total ......................................................................
........................
........................
........................
................................
929,140
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 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 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
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
included those burdens under 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: April 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–07965 Filed 4–19–17; 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 HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the program in
general, contact 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
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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
March 1, 2017, through March 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
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: April 13, 2017.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Cooper J. Humphries, Genesco,
Illinois, Court of Federal Claims No:
17–0288V.
2. Amall Ali, New York, New York,
Court of Federal Claims No: 17–
0289V.
3. Dayna Sotirhos, Floral Park, New
York, Court of Federal Claims No:
17–0290V.
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
4. Janee Morris, Atlanta, Georgia, Court
of Federal Claims No: 17–0291V.
5. Carol Bedewi, Denville, New Jersey,
Court of Federal Claims No: 17–
0292V.
6. Lonne Martinec, Houston, Texas,
Court of Federal Claims No: 17–
0293V.
7. The Estate of HS, Deceased, New
York, New York, Court of Federal
Claims No: 17–0294V.
8. Brenda Faulk on behalf of B. B.,
Houston, Texas, Court of Federal
Claims No: 17–0295V.
9. Lyn Geer, Washington, District of
Columbia, Court of Federal Claims
No: 17–0296V.
10. Britton Miller, Cleveland, Ohio,
Court of Federal Claims No: 17–
0297V.
11. Jackie Crook, Burlington, North
Carolina, Court of Federal Claims
No: 17–0298V.
12. Lucy Filipovic, Des Plaines, Illinois,
Court of Federal Claims No: 17–
0299V.
13. Sean Tierney on behalf of R. T.,
Royal Oak, Michigan, Court of
Federal Claims No: 17–0300V.
14. Corey L. Crockett, Fredericksburg,
Virginia, Court of Federal Claims
No: 17–0301V.
15. Edwin J. Smith, Layton, Utah, Court
of Federal Claims No: 17–0302V.
16. Lora Belle Brown, Colorado Springs,
Colorado, Court of Federal Claims
No: 17–0303V.
17. Lisa Sorrow, Abbeville, South
Carolina, Court of Federal Claims
No: 17–0304V.
18. Yvonne Shawgo, Butler,
Pennsylvania, Court of Federal
Claims No: 17–0306V.
19. Emilie Wolf on behalf of The Estate
of Matthew Wolf, Deceased, Boston,
Massachusetts, Court of Federal
Claims No: 17–0308V.
20. Jennifer L. Call, Easton, Maryland,
Court of Federal Claims No: 17–
0311V.
21. Lauren Meehan, Newtown,
Connecticut, Court of Federal
Claims No: 17–0316V.
22. Douglas T. Lester, Greensboro, North
Carolina, Court of Federal Claims
No: 17–0317V.
23. Joanne McMaster, Hyannis,
Massachusetts, Court of Federal
Claims No: 17–0319V.
24. Jane Bennett, Steamboat Springs,
Colorado, Court of Federal Claims
No: 17–0320V.
25. Donna Parker, Germantown,
Tennessee, Court of Federal Claims
No: 17–0321V.
26. Mark Greenberg, Northfield, New
Jersey, Court of Federal Claims No:
17–0322V.
27. James J. Roy and Mary Ann Boger on
behalf of Paul E. Roy, Fort Wayne,
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
18655
Indiana, Court of Federal Claims
No: 17–0323V.
28. Candace Dempsey, Tulsa,
Oklahoma, Court of Federal Claims
No: 17–0324V.
29. Sharon LaBounty, Worcester,
Massachusetts, Court of Federal
Claims No: 17–0325V.
30. Larry Thompson, Oklahoma City,
Oklahoma, Court of Federal Claims
No: 17–0326V.
31. Skye Robertson on behalf of D. R.O., Kailua, Hawaii, Court of Federal
Claims No: 17–0327V.
32. Jerry Ford, Virginia, Minnesota,
Court of Federal Claims No: 17–
0328V.
33. Mary Caspers, Boston,
Massachusetts, Court of Federal
Claims No: 17–0329V.
34. Jennifer Flora Brantley, Houston,
Texas, Court of Federal Claims No:
17–0330V.
35. Laurie Andrews, Grand Rapids,
Michigan, Court of Federal Claims
No: 17–0331V.
36. Carmen Gonzalez, Dallas, Texas,
Court of Federal Claims No: 17–
0332V.
37. Leanna Gerritsen-Smith, Buellton,
California, Court of Federal Claims
No: 17–0334V.
38. Alan Phillips, Hamilton, New York,
Court of Federal Claims No: 17–
0337V.
39. Ellen Halm, Atlanta, Georgia, Court
of Federal Claims No: 17–0338V.
40. Maurice Goodgame, Birmingham,
Alabama, Court of Federal Claims
No: 17–0339V.
41. Alicia Debusca, Fairmont,
Minnesota, Court of Federal Claims
No: 17–0341V.
42. Linda King, Bowling Green,
Kentucky, Court of Federal Claims
No: 17–0342V.
43. Laura Brodbeck, Wellesley Hills,
Massachusetts, Court of Federal
Claims No: 17–0344V.
44. Billie K. Damet, Olathe, Kansas,
Court of Federal Claims No: 17–
0345V.
45. Sheri Hoeger, Folsom, California,
Court of Federal Claims No: 17–
0346V.
46. Carole Miller, Gibsonia,
Pennsylvania, Court of Federal
Claims No: 17–0349V.
47. Eva S. Reed, Fridley, Minnesota,
Court of Federal Claims No: 17–
0352V.
48. Nicole Hooper, Wichita Falls, Texas,
Court of Federal Claims No: 17–
0355V.
49. Imogene Haynes-Bleau, Roseville,
California, Court of Federal Claims
No: 17–0356V.
50. Anita Jones, Columbus, Ohio, Court
of Federal Claims No: 17–0358V.
E:\FR\FM\20APN1.SGM
20APN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
18656
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
51. Tommie Humbert, Jr, Washington,
District of Columbia, Court of
Federal Claims No: 17–0360V.
52. Sarah D. Murray on behalf of C. E.
M., Kennebunk, Maine, Court of
Federal Claims No: 17–0361V.
53. Matthew L. Bonk, Georgetown,
Texas, Court of Federal Claims No:
17–0364V.
54. Patricia Lopez, Harlingen, Texas,
Court of Federal Claims No: 17–
0365V.
55. Selina Villafranca on behalf of N. L.
V., San Benito, Texas, Court of
Federal Claims No: 17–0366V.
56. Leticia Palencia on behalf of C. A.
P., Austin, Texas, Court of Federal
Claims No: 17–0367V.
57. Loren Lynette Machuca on behalf of
J. A. M., Austin, Texas, Court of
Federal Claims No: 17–0368V.
58. Sandra Lopez on behalf of T. Y. D.,
Austin, Texas, Court of Federal
Claims No: 17–0369V.
59. Guadalupe Gonzalez, Jr., Austin,
Texas, Court of Federal Claims No:
17–0370V.
60. Margarita Gonzalez-Monterrey on
behalf of M. N. G., Austin, Texas,
Court of Federal Claims No: 17–
0371V.
61. Sandra Lopez on behalf of J. D., San
Benito, Texas, Court of Federal
Claims No: 17–0372V.
62. Joanna Villalobos on behalf of A. D.,
Harlingen, Texas, Court of Federal
Claims No: 17–0373V.
63. Maria Covarrubias on behalf of M.
M. M., Harlingen, Texas, Court of
Federal Claims No: 17–0374V.
64. Marta Saenz on behalf of R. U. S.,
Houston, Texas, Court of Federal
Claims No: 17–0375V.
65. Larry Pierce, Austin, Texas, Court of
Federal Claims No: 17–0376V.
66. Maria Pool on behalf of S. P. P.,
Harlingen, Texas, Court of Federal
Claims No: 17–0377V.
67. Diana C. Villareal, Austin, Texas,
Court of Federal Claims No: 17–
0378V.
68. Maria D. Sanchez, Brownsville,
Texas, Court of Federal Claims No:
17–0379V.
69. Brelda Segura on behalf of J. A. L.,
Austin, Texas, Court of Federal
Claims No: 17–0380V.
70. Armando Fidencio Orta, Austin,
Texas, Court of Federal Claims No:
17–0381V.
71. Leticia Palencia on behalf of A. H.
P., Harlingen, Texas, Court of
Federal Claims No: 17–0382V.
72. Mario A. Flores, Jr., Harlingen,
Texas, Court of Federal Claims No:
17–0383V.
73. Dania Pedraza on behalf of N. Q.,
Brownsville, Texas, Court of
Federal Claims No: 17–0384V.
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
74. Rigoberto Garza, Jr., Brownsville,
Texas, Court of Federal Claims No:
17–0385V.
75. Cynthia I. Gomez, Austin, Texas,
Court of Federal Claims No: 17–
0386V.
76. Veronica Vela on behalf of B. V.,
Harlingen, Texas, Court of Federal
Claims No: 17–0387V.
77. Amadeo Tolento, Jr., Harlingen,
Texas, Court of Federal Claims No:
17–0388V.
78. John Lowe, Tempe, Arizona, Court
of Federal Claims No: 17–0389V.
79. Theresa Mullis, Boston,
Massachusetts, Court of Federal
Claims No: 17–0390V.
80. Suzanne Hulett, Boston,
Massachusetts, Court of Federal
Claims No: 17–0392V.
81. Carolyn Green, Chicago, Illinois,
Court of Federal Claims No: 17–
0395V.
82. Jeanne Weber, Exton, Pennsylvania,
Court of Federal Claims No: 17–
0396V.
83. James Baumann, Bethel, Maine,
Court of Federal Claims No: 17–
0397V.
84. Karen Crawford, Montclair, New
Jersey, Court of Federal Claims No:
17–0398V.
85. Joanna Weber, Huntersville, North
Carolina, Court of Federal Claims
No: 17–0399V.
86. Norma Soltys, Austin, Texas, Court
of Federal Claims No: 17–0401V.
87. Todd Boylan on behalf of L. K. B.,
Wayne, Pennsylvania, Court of
Federal Claims No: 17–0402V.
88. Anna Conte, Beckley, West Virginia,
Court of Federal Claims No: 17–
0403V.
89. Ashley Loftis, Washington, District
of Columbia, Court of Federal
Claims No: 17–0404V.
90. Alexander Cohen, Millburn, New
Jersey, Court of Federal Claims No:
17–0406V.
91. Ronald Wagner, Dubois,
Pennsylvania, Court of Federal
Claims No: 17–0407V.
92. Dorothy E. Cooper, Greensboro,
North Carolina, Court of Federal
Claims No: 17–0408V.
93. Myra Brown, Dover, Delaware, Court
of Federal Claims No: 17–0409V.
94. Zachary Schneider, Atlanta, Georgia,
Court of Federal Claims No: 17–
0410V.
95. Rose Johnson, Plymouth, Minnesota,
Court of Federal Claims No: 17–
0411V.
96. Teresa Tinley, Covington, Georgia,
Court of Federal Claims No: 17–
0413V.
97. Jacqueline Deberry, Deerfield,
Illinois, Court of Federal Claims No:
17–0415V.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
98. Britta Lassmann, Boston,
Massachusetts, Court of Federal
Claims No: 17–0416V.
99. Heewon Kim, Staten Island, New
York, Court of Federal Claims No:
17–0418V.
100. Edward Horne, Rincon, Georgia,
Court of Federal Claims No: 17–
0419V.
101. James Cox, Valley View,
Pennsylvania, Court of Federal
Claims No: 17–0420V.
102. Krystal Alcott, Orlando, Florida,
Court of Federal Claims No: 17–
0424V.
103. Brahm Arya, Washington, District
of Columbia, Court of Federal
Claims No: 17–0425V.
104. Sailaja Peddada, Sacramento,
California, Court of Federal Claims
No: 17–0426V.
105. Gayle Dillenbeck, Hanover Park,
Illinois, Court of Federal Claims No:
17–0428V.
106. Leanne Knapp, Collegeville,
Pennsylvania, Court of Federal
Claims No: 17–0429V.
107. Dennis Ducheneau, Boston,
Massachusetts, Court of Federal
Claims No: 17–0431V.
108. Marie Curri, Boston,
Massachusetts, Court of Federal
Claims No: 17–0432V.
109. Lisa A. Lindman, Fort Bragg, North
Carolina, Court of Federal Claims
No: 17–0434V.
110. Jeffrey M. Shur, Rochester, New
York, Court of Federal Claims No:
17–0435V.
111. Mary Brodie, Athens, Georgia,
Court of Federal Claims No: 17–
0437V.
112. Kathleen Campbell, San Antonio,
Texas, Court of Federal Claims No:
17–0438V.
113. Rosalia Parrea on behalf of M. T.,
Edinburgh, Texas, Court of Federal
Claims No: 17–0440V.
114. Guadalupe Hernandez on behalf of
A. C., Harlingen, Texas, Court of
Federal Claims No: 17–0442V.
115. Samantha Ledesma on behalf of S.
L., Pasadena, Texas, Court of
Federal Claims No: 17–0443V.
116. Kerry Leigh and Benjamin Leigh on
behalf of E. L., Boston,
Massachusetts, Court of Federal
Claims No: 17–0444V.
117. Betty Chally, Fayetteville, Georgia,
Court of Federal Claims No: 17–
0448V.
118. Crystal Moreno on behalf of L. V.,
Harlingen, Texas, Court of Federal
Claims No: 17–0450V.
119. Larry Wolford, Grundy, Virginia,
Court of Federal Claims No: 17–
0451V.
120. Billy Watson, Birmingham,
Alabama, Court of Federal Claims
No: 17–0453V.
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
121. Dustin Mobley, Washington,
District of Columbia, Court of
Federal Claims No: 17–0454V.
122. Gary Schneider, Dana Point,
California, Court of Federal Claims
No: 17–0456V.
123. Jackie Mills on behalf of L. M.,
Portage, Michigan, Court of Federal
Claims No: 17–0457V.
124. Joseph Charneco, Boca Raton,
Florida, Court of Federal Claims No:
17–0458V.
125. Anita Schmitter, Ann Arbor,
Michigan, Court of Federal Claims
No: 17–0459V.
126. Mariah Corbett on behalf of N. C.,
Deceased, Longs, South Carolina
Court of Federal Claims No: 17–
0460V.
127. Hugh Gose, Seymour, Tennessee,
Court of Federal Claims No: 17–
0461V.
128. Jane Elise Delzer, Waukesha,
Wisconsin, Court of Federal Claims
No: 17–0462V.
129. Sharyn Lynn Lobell, Ponchatoula,
Louisiana, Court of Federal Claims
No: 17–0463V.
130. Sharon Kabelitz, Washington,
District of Columbia, Court of
Federal Claims No: 17–0466V.
131. Charles Huggins, Watkinsville,
Georgia, Court of Federal Claims
No: 17–0467V.
132. Barbara Jayne, Washington, District
of Columbia, Court of Federal
Claims No: 17–0469V.
[FR Doc. 2017–07989 Filed 4–19–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,,
notice is hereby given that the
Secretary’s Advisory Committee on
Human Research Protections (SACHRP)
will hold a meeting that will be open to
the public. Information about SACHRP
and the full meeting agenda will be
posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
DATES: The meeting will be held on
Thursday, May 25, from 8:30 a.m. until
5:00 p.m., and Friday, May 26 from 8:30
a.m. until 4:30 p.m. Please note: this
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
meeting was originally scheduled to be
held March 15–16, but was postponed
due to a predicted snow storm.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will be open to
the public at 8:30 a.m., on Thursday,
May 25, 2017, followed by opening
remarks from Dr. Jerry Menikoff,
Director of OHRP and Executive
Secretary of SACHRP, and Dr. Stephen
Rosenfeld, SACHRP Chair. Dr. Menikoff
will then lead a discussion focusing on
selected sections of the new Common
Rule, which was published January 19,
2017, with an effective date of January
19, 2018 (see https://www.gpo.gov/
fdsys/pkg/FR-2017-01-19/html/201701058.htm).
The SOH will present their
recommendations for consideration of
the new Common Rule’s compliance
dates and transition provisions, as well
as for the interpretation and
implementation of the new broad
consent provision.
The SAS will discuss their report on
the interpretation of the new exemption
involving benign behavioral
interventions.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
18657
The Thursday meeting will adjourn at
approximately 5:00 p.m.
The Friday, May 26, meeting will
begin at 8:30 a.m. with
recommendations from the SOH on the
FDA Draft Guidance ‘‘Use of Real-World
Evidence to Support Regulatory
Decision-Making for Medical Devices,’’
issued July 27, 2016. SOH will also
present recommendations on the return
of incidental findings to research
subjects. The SAS will present
recommendations surrounding the new
Common Rule’s expedited review
requirements.
The meeting will adjourn at 4:30 p.m.
May 26, 2017. Time for public comment
sessions will be allotted both days. Note
that public comment must be relevant to
issues being addressed by the SACHRP.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated SACHRP point of contact at
the address/phone number listed above
at least one week prior to the meeting.
On-site registration is required for
participation in the live public comment
session. Individuals who would like to
submit written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Dated: April 17, 2017.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2017–08017 Filed 4–19–17; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Preparedness and Response
Science Board; Call for Nominees
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Office of the Secretary
seeks application submissions from
qualified individuals for consideration
for membership on the National
Preparedness and Response Science
Board (NPRSB). Terms of eight members
expire December 31, 2017; therefore, the
Secretary must appoint eight new voting
members. Nominees shall represent the
following categories: Industry,
academia, health care consumer
organizations, and organizations
representing other appropriate
SUMMARY:
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18654-18657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07989]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Vaccine Injury Compensation Program; List of Petitions
Received
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HRSA is publishing this notice of petitions received under the
National Vaccine Injury Compensation Program (the program), as required
by the Public Health Service (PHS) Act, as amended. While the Secretary
of HHS is named as the respondent in all proceedings brought by the
filing of petitions for compensation under the program, the United
States Court of Federal Claims is charged by statute with
responsibility for considering and acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For information about requirements for
filing petitions, and the program in general, contact 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 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 March 1, 2017, through March 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
[[Page 18655]]
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: April 13, 2017.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Cooper J. Humphries, Genesco, Illinois, Court of Federal Claims No:
17-0288V.
2. Amall Ali, New York, New York, Court of Federal Claims No: 17-0289V.
3. Dayna Sotirhos, Floral Park, New York, Court of Federal Claims No:
17-0290V.
4. Janee Morris, Atlanta, Georgia, Court of Federal Claims No: 17-
0291V.
5. Carol Bedewi, Denville, New Jersey, Court of Federal Claims No: 17-
0292V.
6. Lonne Martinec, Houston, Texas, Court of Federal Claims No: 17-
0293V.
7. The Estate of HS, Deceased, New York, New York, Court of Federal
Claims No: 17-0294V.
8. Brenda Faulk on behalf of B. B., Houston, Texas, Court of Federal
Claims No: 17-0295V.
9. Lyn Geer, Washington, District of Columbia, Court of Federal Claims
No: 17-0296V.
10. Britton Miller, Cleveland, Ohio, Court of Federal Claims No: 17-
0297V.
11. Jackie Crook, Burlington, North Carolina, Court of Federal Claims
No: 17-0298V.
12. Lucy Filipovic, Des Plaines, Illinois, Court of Federal Claims No:
17-0299V.
13. Sean Tierney on behalf of R. T., Royal Oak, Michigan, Court of
Federal Claims No: 17-0300V.
14. Corey L. Crockett, Fredericksburg, Virginia, Court of Federal
Claims No: 17-0301V.
15. Edwin J. Smith, Layton, Utah, Court of Federal Claims No: 17-0302V.
16. Lora Belle Brown, Colorado Springs, Colorado, Court of Federal
Claims No: 17-0303V.
17. Lisa Sorrow, Abbeville, South Carolina, Court of Federal Claims No:
17-0304V.
18. Yvonne Shawgo, Butler, Pennsylvania, Court of Federal Claims No:
17-0306V.
19. Emilie Wolf on behalf of The Estate of Matthew Wolf, Deceased,
Boston, Massachusetts, Court of Federal Claims No: 17-0308V.
20. Jennifer L. Call, Easton, Maryland, Court of Federal Claims No: 17-
0311V.
21. Lauren Meehan, Newtown, Connecticut, Court of Federal Claims No:
17-0316V.
22. Douglas T. Lester, Greensboro, North Carolina, Court of Federal
Claims No: 17-0317V.
23. Joanne McMaster, Hyannis, Massachusetts, Court of Federal Claims
No: 17-0319V.
24. Jane Bennett, Steamboat Springs, Colorado, Court of Federal Claims
No: 17-0320V.
25. Donna Parker, Germantown, Tennessee, Court of Federal Claims No:
17-0321V.
26. Mark Greenberg, Northfield, New Jersey, Court of Federal Claims No:
17-0322V.
27. James J. Roy and Mary Ann Boger on behalf of Paul E. Roy, Fort
Wayne, Indiana, Court of Federal Claims No: 17-0323V.
28. Candace Dempsey, Tulsa, Oklahoma, Court of Federal Claims No: 17-
0324V.
29. Sharon LaBounty, Worcester, Massachusetts, Court of Federal Claims
No: 17-0325V.
30. Larry Thompson, Oklahoma City, Oklahoma, Court of Federal Claims
No: 17-0326V.
31. Skye Robertson on behalf of D. R.-O., Kailua, Hawaii, Court of
Federal Claims No: 17-0327V.
32. Jerry Ford, Virginia, Minnesota, Court of Federal Claims No: 17-
0328V.
33. Mary Caspers, Boston, Massachusetts, Court of Federal Claims No:
17-0329V.
34. Jennifer Flora Brantley, Houston, Texas, Court of Federal Claims
No: 17-0330V.
35. Laurie Andrews, Grand Rapids, Michigan, Court of Federal Claims No:
17-0331V.
36. Carmen Gonzalez, Dallas, Texas, Court of Federal Claims No: 17-
0332V.
37. Leanna Gerritsen-Smith, Buellton, California, Court of Federal
Claims No: 17-0334V.
38. Alan Phillips, Hamilton, New York, Court of Federal Claims No: 17-
0337V.
39. Ellen Halm, Atlanta, Georgia, Court of Federal Claims No: 17-0338V.
40. Maurice Goodgame, Birmingham, Alabama, Court of Federal Claims No:
17-0339V.
41. Alicia Debusca, Fairmont, Minnesota, Court of Federal Claims No:
17-0341V.
42. Linda King, Bowling Green, Kentucky, Court of Federal Claims No:
17-0342V.
43. Laura Brodbeck, Wellesley Hills, Massachusetts, Court of Federal
Claims No: 17-0344V.
44. Billie K. Damet, Olathe, Kansas, Court of Federal Claims No: 17-
0345V.
45. Sheri Hoeger, Folsom, California, Court of Federal Claims No: 17-
0346V.
46. Carole Miller, Gibsonia, Pennsylvania, Court of Federal Claims No:
17-0349V.
47. Eva S. Reed, Fridley, Minnesota, Court of Federal Claims No: 17-
0352V.
48. Nicole Hooper, Wichita Falls, Texas, Court of Federal Claims No:
17-0355V.
49. Imogene Haynes-Bleau, Roseville, California, Court of Federal
Claims No: 17-0356V.
50. Anita Jones, Columbus, Ohio, Court of Federal Claims No: 17-0358V.
[[Page 18656]]
51. Tommie Humbert, Jr, Washington, District of Columbia, Court of
Federal Claims No: 17-0360V.
52. Sarah D. Murray on behalf of C. E. M., Kennebunk, Maine, Court of
Federal Claims No: 17-0361V.
53. Matthew L. Bonk, Georgetown, Texas, Court of Federal Claims No: 17-
0364V.
54. Patricia Lopez, Harlingen, Texas, Court of Federal Claims No: 17-
0365V.
55. Selina Villafranca on behalf of N. L. V., San Benito, Texas, Court
of Federal Claims No: 17-0366V.
56. Leticia Palencia on behalf of C. A. P., Austin, Texas, Court of
Federal Claims No: 17-0367V.
57. Loren Lynette Machuca on behalf of J. A. M., Austin, Texas, Court
of Federal Claims No: 17-0368V.
58. Sandra Lopez on behalf of T. Y. D., Austin, Texas, Court of Federal
Claims No: 17-0369V.
59. Guadalupe Gonzalez, Jr., Austin, Texas, Court of Federal Claims No:
17-0370V.
60. Margarita Gonzalez-Monterrey on behalf of M. N. G., Austin, Texas,
Court of Federal Claims No: 17-0371V.
61. Sandra Lopez on behalf of J. D., San Benito, Texas, Court of
Federal Claims No: 17-0372V.
62. Joanna Villalobos on behalf of A. D., Harlingen, Texas, Court of
Federal Claims No: 17-0373V.
63. Maria Covarrubias on behalf of M. M. M., Harlingen, Texas, Court of
Federal Claims No: 17-0374V.
64. Marta Saenz on behalf of R. U. S., Houston, Texas, Court of Federal
Claims No: 17-0375V.
65. Larry Pierce, Austin, Texas, Court of Federal Claims No: 17-0376V.
66. Maria Pool on behalf of S. P. P., Harlingen, Texas, Court of
Federal Claims No: 17-0377V.
67. Diana C. Villareal, Austin, Texas, Court of Federal Claims No: 17-
0378V.
68. Maria D. Sanchez, Brownsville, Texas, Court of Federal Claims No:
17-0379V.
69. Brelda Segura on behalf of J. A. L., Austin, Texas, Court of
Federal Claims No: 17-0380V.
70. Armando Fidencio Orta, Austin, Texas, Court of Federal Claims No:
17-0381V.
71. Leticia Palencia on behalf of A. H. P., Harlingen, Texas, Court of
Federal Claims No: 17-0382V.
72. Mario A. Flores, Jr., Harlingen, Texas, Court of Federal Claims No:
17-0383V.
73. Dania Pedraza on behalf of N. Q., Brownsville, Texas, Court of
Federal Claims No: 17-0384V.
74. Rigoberto Garza, Jr., Brownsville, Texas, Court of Federal Claims
No: 17-0385V.
75. Cynthia I. Gomez, Austin, Texas, Court of Federal Claims No: 17-
0386V.
76. Veronica Vela on behalf of B. V., Harlingen, Texas, Court of
Federal Claims No: 17-0387V.
77. Amadeo Tolento, Jr., Harlingen, Texas, Court of Federal Claims No:
17-0388V.
78. John Lowe, Tempe, Arizona, Court of Federal Claims No: 17-0389V.
79. Theresa Mullis, Boston, Massachusetts, Court of Federal Claims No:
17-0390V.
80. Suzanne Hulett, Boston, Massachusetts, Court of Federal Claims No:
17-0392V.
81. Carolyn Green, Chicago, Illinois, Court of Federal Claims No: 17-
0395V.
82. Jeanne Weber, Exton, Pennsylvania, Court of Federal Claims No: 17-
0396V.
83. James Baumann, Bethel, Maine, Court of Federal Claims No: 17-0397V.
84. Karen Crawford, Montclair, New Jersey, Court of Federal Claims No:
17-0398V.
85. Joanna Weber, Huntersville, North Carolina, Court of Federal Claims
No: 17-0399V.
86. Norma Soltys, Austin, Texas, Court of Federal Claims No: 17-0401V.
87. Todd Boylan on behalf of L. K. B., Wayne, Pennsylvania, Court of
Federal Claims No: 17-0402V.
88. Anna Conte, Beckley, West Virginia, Court of Federal Claims No: 17-
0403V.
89. Ashley Loftis, Washington, District of Columbia, Court of Federal
Claims No: 17-0404V.
90. Alexander Cohen, Millburn, New Jersey, Court of Federal Claims No:
17-0406V.
91. Ronald Wagner, Dubois, Pennsylvania, Court of Federal Claims No:
17-0407V.
92. Dorothy E. Cooper, Greensboro, North Carolina, Court of Federal
Claims No: 17-0408V.
93. Myra Brown, Dover, Delaware, Court of Federal Claims No: 17-0409V.
94. Zachary Schneider, Atlanta, Georgia, Court of Federal Claims No:
17-0410V.
95. Rose Johnson, Plymouth, Minnesota, Court of Federal Claims No: 17-
0411V.
96. Teresa Tinley, Covington, Georgia, Court of Federal Claims No: 17-
0413V.
97. Jacqueline Deberry, Deerfield, Illinois, Court of Federal Claims
No: 17-0415V.
98. Britta Lassmann, Boston, Massachusetts, Court of Federal Claims No:
17-0416V.
99. Heewon Kim, Staten Island, New York, Court of Federal Claims No:
17-0418V.
100. Edward Horne, Rincon, Georgia, Court of Federal Claims No: 17-
0419V.
101. James Cox, Valley View, Pennsylvania, Court of Federal Claims No:
17-0420V.
102. Krystal Alcott, Orlando, Florida, Court of Federal Claims No: 17-
0424V.
103. Brahm Arya, Washington, District of Columbia, Court of Federal
Claims No: 17-0425V.
104. Sailaja Peddada, Sacramento, California, Court of Federal Claims
No: 17-0426V.
105. Gayle Dillenbeck, Hanover Park, Illinois, Court of Federal Claims
No: 17-0428V.
106. Leanne Knapp, Collegeville, Pennsylvania, Court of Federal Claims
No: 17-0429V.
107. Dennis Ducheneau, Boston, Massachusetts, Court of Federal Claims
No: 17-0431V.
108. Marie Curri, Boston, Massachusetts, Court of Federal Claims No:
17-0432V.
109. Lisa A. Lindman, Fort Bragg, North Carolina, Court of Federal
Claims No: 17-0434V.
110. Jeffrey M. Shur, Rochester, New York, Court of Federal Claims No:
17-0435V.
111. Mary Brodie, Athens, Georgia, Court of Federal Claims No: 17-
0437V.
112. Kathleen Campbell, San Antonio, Texas, Court of Federal Claims No:
17-0438V.
113. Rosalia Parrea on behalf of M. T., Edinburgh, Texas, Court of
Federal Claims No: 17-0440V.
114. Guadalupe Hernandez on behalf of A. C., Harlingen, Texas, Court of
Federal Claims No: 17-0442V.
115. Samantha Ledesma on behalf of S. L., Pasadena, Texas, Court of
Federal Claims No: 17-0443V.
116. Kerry Leigh and Benjamin Leigh on behalf of E. L., Boston,
Massachusetts, Court of Federal Claims No: 17-0444V.
117. Betty Chally, Fayetteville, Georgia, Court of Federal Claims No:
17-0448V.
118. Crystal Moreno on behalf of L. V., Harlingen, Texas, Court of
Federal Claims No: 17-0450V.
119. Larry Wolford, Grundy, Virginia, Court of Federal Claims No: 17-
0451V.
120. Billy Watson, Birmingham, Alabama, Court of Federal Claims No: 17-
0453V.
[[Page 18657]]
121. Dustin Mobley, Washington, District of Columbia, Court of Federal
Claims No: 17-0454V.
122. Gary Schneider, Dana Point, California, Court of Federal Claims
No: 17-0456V.
123. Jackie Mills on behalf of L. M., Portage, Michigan, Court of
Federal Claims No: 17-0457V.
124. Joseph Charneco, Boca Raton, Florida, Court of Federal Claims No:
17-0458V.
125. Anita Schmitter, Ann Arbor, Michigan, Court of Federal Claims No:
17-0459V.
126. Mariah Corbett on behalf of N. C., Deceased, Longs, South Carolina
Court of Federal Claims No: 17-0460V.
127. Hugh Gose, Seymour, Tennessee, Court of Federal Claims No: 17-
0461V.
128. Jane Elise Delzer, Waukesha, Wisconsin, Court of Federal Claims
No: 17-0462V.
129. Sharyn Lynn Lobell, Ponchatoula, Louisiana, Court of Federal
Claims No: 17-0463V.
130. Sharon Kabelitz, Washington, District of Columbia, Court of
Federal Claims No: 17-0466V.
131. Charles Huggins, Watkinsville, Georgia, Court of Federal Claims
No: 17-0467V.
132. Barbara Jayne, Washington, District of Columbia, Court of Federal
Claims No: 17-0469V.
[FR Doc. 2017-07989 Filed 4-19-17; 8:45 am]
BILLING CODE 4165-15-P
