82_FR_18729 82 FR 18654 - National Vaccine Injury Compensation Program; List of Petitions Received

82 FR 18654 - National Vaccine Injury Compensation Program; List of Petitions Received

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 82, Issue 75 (April 20, 2017)

Page Range18654-18657
FR Document2017-07989

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.

Federal Register, Volume 82 Issue 75 (Thursday, April 20, 2017)
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18654-18657]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


National Vaccine Injury Compensation Program; List of Petitions 
Received

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

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: http://www.hrsa.gov/vaccinecompensation/index.html.

SUPPLEMENTARY INFORMATION: The program provides a system of no-fault 
compensation for certain individuals who have been injured by specified 
childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 
300aa-10 et seq., provides that those seeking compensation are to file 
a petition with the U.S. Court of Federal Claims and to serve a copy of 
the petition on the Secretary of HHS, who is named as the respondent in 
each proceeding. The Secretary has delegated this responsibility under 
the program to HRSA. The Court is directed by statute to appoint 
special masters who take evidence, conduct hearings as appropriate, and 
make initial decisions as to eligibility for, and amount of, 
compensation.
    A petition may be filed with respect to injuries, disabilities, 
illnesses, conditions, and deaths resulting from vaccines described in 
the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This 
Table lists for each covered childhood vaccine the conditions that may 
lead to compensation and, for each condition, the time period for 
occurrence of the first symptom or manifestation of onset or of 
significant aggravation after vaccine administration. Compensation may 
also be awarded for conditions not listed in the Table and for 
conditions that are manifested outside the time periods specified in 
the Table, but only if the petitioner shows that the condition was 
caused by one of the listed vaccines.
    Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), 
requires that ``[w]ithin 30 days after the Secretary receives service 
of any petition filed under section 2111 the Secretary shall publish 
notice of such petition in the Federal Register.'' Set forth below is a 
list of petitions received by HRSA on 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



                                                    18654                                   Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices

                                                                                                TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
                                                                                                                                                                        Number of                     Total
                                                                                                                                            Number of                                                                        Average burden per                 Total
                                                                               21 CFR section                                                                          records per                   annual
                                                                                                                                          recordkeepers                                                                        recordkeeping                    hours
                                                                                                                                                                      recordkeeper                   records

                                                    111.535, Records for returned dietary supplements ...                                                   110                          4                    440           13.5 ........................           5,940
                                                    111.570, Records regarding product complaints ........                                                  240                        600                144,000           0.5 (30 minutes) .....                 72,000

                                                         Total ......................................................................     ........................   ........................   ........................     ................................     929,140
                                                       1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       The average burden per recordkeeping                                   included those burdens under specific                                         site at: http://www.hrsa.gov/
                                                    estimates in table 1 are based on those                                   provisions for keeping records. For                                           vaccinecompensation/index.html.
                                                    in the June 25, 2007, final rule, which                                   example, § 111.255(a) requires that the                                       SUPPLEMENTARY INFORMATION: The
                                                    were based on our institutional                                           batch production records be prepared                                          program provides a system of no-fault
                                                    experience with other CGMP                                                every time a batch is manufactured, and                                       compensation for certain individuals
                                                    requirements and on data provided by                                      § 111.255(d) requires that batch                                              who have been injured by specified
                                                    Research Triangle Institute in the                                        production records be kept in                                                 childhood vaccines. Subtitle 2 of Title
                                                    ‘‘Survey of Manufacturing Practices in                                    accordance with § 111.605. The                                                XXI of the PHS Act, 42 U.S.C. 300aa–
                                                    the Dietary Supplement Industry’’ cited                                   estimated burdens for both § 111.255(a)                                       10 et seq., provides that those seeking
                                                    in that rule.                                                             and (d) are included under § 111.260,                                         compensation are to file a petition with
                                                       The estimates in table 1 of the number                                 what the batch record must include.                                           the U.S. Court of Federal Claims and to
                                                    of firms affected by each provision of                                      Dated: April 14, 2017.                                                      serve a copy of the petition on the
                                                    part 111 are based on the percentage of                                   Leslie Kux,                                                                   Secretary of HHS, who is named as the
                                                    manufacturers, packagers, labelers,                                       Associate Commissioner for Policy.                                            respondent in each proceeding. The
                                                    holders, distributors, and warehousers                                    [FR Doc. 2017–07965 Filed 4–19–17; 8:45 am]                                   Secretary has delegated this
                                                    that reported in the survey that they                                                                                                                   responsibility under the program to
                                                                                                                              BILLING CODE 4164–01–P
                                                    have not established written SOPs or do                                                                                                                 HRSA. The Court is directed by statute
                                                    not maintain records that were later                                                                                                                    to appoint special masters who take
                                                    required by the June 25, 2007, final rule.                                DEPARTMENT OF HEALTH AND                                                      evidence, conduct hearings as
                                                    Because we do not have survey results                                     HUMAN SERVICES                                                                appropriate, and make initial decisions
                                                    for general warehouses, we entered the                                                                                                                  as to eligibility for, and amount of,
                                                    approximate number of facilities in that                                  Health Resources and Services                                                 compensation.
                                                    category for those provisions covering                                    Administration                                                                   A petition may be filed with respect
                                                    general facilities. For the dietary                                                                                                                     to injuries, disabilities, illnesses,
                                                    supplement industry, the survey                                           National Vaccine Injury Compensation                                          conditions, and deaths resulting from
                                                    estimated that 1,460 firms would be                                       Program; List of Petitions Received                                           vaccines described in the Vaccine Injury
                                                    covered by the final rule, including                                      AGENCY: Health Resources and Services                                         Table (the Table) set forth at 42 CFR
                                                    manufacturers, packagers, labelers,                                       Administration (HRSA), Department of                                          100.3. This Table lists for each covered
                                                    holders, distributors, and warehousers.                                   Health and Human Services (HHS).                                              childhood vaccine the conditions that
                                                    The time estimates include the burden                                                                                                                   may lead to compensation and, for each
                                                                                                                              ACTION: Notice.
                                                    involved in documenting that certain                                                                                                                    condition, the time period for
                                                    requirements are performed and in                                         SUMMARY:    HRSA is publishing this                                           occurrence of the first symptom or
                                                    recordkeeping. We used an estimated                                       notice of petitions received under the                                        manifestation of onset or of significant
                                                    annual batch production of 1,408                                          National Vaccine Injury Compensation                                          aggravation after vaccine
                                                    batches per year to estimate the burden                                   Program (the program), as required by                                         administration. Compensation may also
                                                    of requirements that are related to the                                   the Public Health Service (PHS) Act, as                                       be awarded for conditions not listed in
                                                    number of batches produced annually,                                      amended. While the Secretary of HHS is                                        the Table and for conditions that are
                                                    such as § 111.260, ‘‘What must the batch                                  named as the respondent in all                                                manifested outside the time periods
                                                    production record include?’’ The                                          proceedings brought by the filing of                                          specified in the Table, but only if the
                                                    estimate of 1,408 batches per year is                                     petitions for compensation under the                                          petitioner shows that the condition was
                                                    near the midpoint of the number of                                        program, the United States Court of                                           caused by one of the listed vaccines.
                                                    annual batches reported by survey                                         Federal Claims is charged by statute                                             Section 2112(b)(2) of the PHS Act, 42
                                                    firms.                                                                    with responsibility for considering and                                       U.S.C. 300aa–12(b)(2), requires that
                                                       The length of time that CGMP records                                   acting upon the petitions.                                                    ‘‘[w]ithin 30 days after the Secretary
                                                    must be maintained is set forth in                                        FOR FURTHER INFORMATION CONTACT: For                                          receives service of any petition filed
                                                    § 111.605. Table 1 reflects the estimated                                 information about requirements for                                            under section 2111 the Secretary shall
                                                    burdens for written procedures, record                                    filing petitions, and the program in                                          publish notice of such petition in the
                                                    maintenance, periodically reviewing                                       general, contact the Clerk, United States                                     Federal Register.’’ Set forth below is a
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    records to determine if they may be                                       Court of Federal Claims, 717 Madison                                          list of petitions received by HRSA on
                                                    discarded, and for any associated                                         Place NW., Washington, DC 20005,                                              March 1, 2017, through March 31, 2017.
                                                    documentation for that activity for                                       (202) 357–6400. For information on                                            This list provides the name of
                                                    records that are required under part 111.                                 HRSA’s role in the program, contact the                                       petitioner, city and state of vaccination
                                                    We have not included a separate                                           Director, National Vaccine Injury                                             (if unknown then city and state of
                                                    estimate of burden for those sections                                     Compensation Program, 5600 Fishers                                            person or attorney filing claim), and
                                                    that require maintaining records in                                       Lane, Room 08N146B, Rockville, MD                                             case number. In cases where the Court
                                                    accordance with § 111.605, but have                                       20857; (301) 443–6593, or visit our Web                                       has redacted the name of a petitioner


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                                                                                  Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices                                          18655

                                                    and/or the case number, the list reflects               4. Janee Morris, Atlanta, Georgia, Court                   Indiana, Court of Federal Claims
                                                    such redaction.                                              of Federal Claims No: 17–0291V.                       No: 17–0323V.
                                                      Section 2112(b)(2) also provides that                 5. Carol Bedewi, Denville, New Jersey,                28. Candace Dempsey, Tulsa,
                                                    the special master ‘‘shall afford all                        Court of Federal Claims No: 17–                       Oklahoma, Court of Federal Claims
                                                    interested persons an opportunity to                         0292V.                                                No: 17–0324V.
                                                    submit relevant, written information’’                  6. Lonne Martinec, Houston, Texas,                    29. Sharon LaBounty, Worcester,
                                                    relating to the following:                                   Court of Federal Claims No: 17–                       Massachusetts, Court of Federal
                                                      1. The existence of evidence ‘‘that                        0293V.                                                Claims No: 17–0325V.
                                                    there is not a preponderance of the                     7. The Estate of HS, Deceased, New                    30. Larry Thompson, Oklahoma City,
                                                    evidence that the illness, disability,                       York, New York, Court of Federal                      Oklahoma, Court of Federal Claims
                                                    injury, condition, or death described in                     Claims No: 17–0294V.                                  No: 17–0326V.
                                                    the petition is due to factors unrelated                8. Brenda Faulk on behalf of B. B.,                   31. Skye Robertson on behalf of D. R.-
                                                    to the administration of the vaccine                         Houston, Texas, Court of Federal                      O., Kailua, Hawaii, Court of Federal
                                                    described in the petition,’’ and                             Claims No: 17–0295V.                                  Claims No: 17–0327V.
                                                      2. Any allegation in a petition that the              9. Lyn Geer, Washington, District of                  32. Jerry Ford, Virginia, Minnesota,
                                                    petitioner either:                                           Columbia, Court of Federal Claims                     Court of Federal Claims No: 17–
                                                      a. ‘‘[S]ustained, or had significantly                     No: 17–0296V.                                         0328V.
                                                    aggravated, any illness, disability,                    10. Britton Miller, Cleveland, Ohio,                  33. Mary Caspers, Boston,
                                                    injury, or condition not set forth in the                    Court of Federal Claims No: 17–                       Massachusetts, Court of Federal
                                                    Vaccine Injury Table but which was                           0297V.                                                Claims No: 17–0329V.
                                                    caused by’’ one of the vaccines referred                11. Jackie Crook, Burlington, North                   34. Jennifer Flora Brantley, Houston,
                                                    to in the Table, or                                          Carolina, Court of Federal Claims                     Texas, Court of Federal Claims No:
                                                      b. ‘‘[S]ustained, or had significantly                     No: 17–0298V.                                         17–0330V.
                                                    aggravated, any illness, disability,                    12. Lucy Filipovic, Des Plaines, Illinois,            35. Laurie Andrews, Grand Rapids,
                                                    injury, or condition set forth in the                        Court of Federal Claims No: 17–                       Michigan, Court of Federal Claims
                                                    Vaccine Injury Table the first symptom                       0299V.                                                No: 17–0331V.
                                                    or manifestation of the onset or                        13. Sean Tierney on behalf of R. T.,                  36. Carmen Gonzalez, Dallas, Texas,
                                                    significant aggravation of which did not                     Royal Oak, Michigan, Court of                         Court of Federal Claims No: 17–
                                                    occur within the time period set forth in                    Federal Claims No: 17–0300V.                          0332V.
                                                    the Table but which was caused by a                     14. Corey L. Crockett, Fredericksburg,                37. Leanna Gerritsen-Smith, Buellton,
                                                    vaccine’’ referred to in the Table.                          Virginia, Court of Federal Claims                     California, Court of Federal Claims
                                                      In accordance with Section                                 No: 17–0301V.                                         No: 17–0334V.
                                                    2112(b)(2), all interested persons may                  15. Edwin J. Smith, Layton, Utah, Court               38. Alan Phillips, Hamilton, New York,
                                                    submit written information relevant to                       of Federal Claims No: 17–0302V.                       Court of Federal Claims No: 17–
                                                    the issues described above in the case of               16. Lora Belle Brown, Colorado Springs,
                                                                                                                                                                       0337V.
                                                    the petitions listed below. Any person                       Colorado, Court of Federal Claims
                                                                                                                                                                  39. Ellen Halm, Atlanta, Georgia, Court
                                                    choosing to do so should file an original                    No: 17–0303V.
                                                                                                            17. Lisa Sorrow, Abbeville, South                          of Federal Claims No: 17–0338V.
                                                    and three (3) copies of the information                                                                       40. Maurice Goodgame, Birmingham,
                                                    with the Clerk of the U.S. Court of                          Carolina, Court of Federal Claims
                                                                                                                                                                       Alabama, Court of Federal Claims
                                                    Federal Claims at the address listed                         No: 17–0304V.
                                                                                                            18. Yvonne Shawgo, Butler,                                 No: 17–0339V.
                                                    above (under the heading FOR FURTHER                                                                          41. Alicia Debusca, Fairmont,
                                                    INFORMATION CONTACT), with a copy to                         Pennsylvania, Court of Federal
                                                                                                                 Claims No: 17–0306V.                                  Minnesota, Court of Federal Claims
                                                    HRSA addressed to Director, Division of                                                                            No: 17–0341V.
                                                    Injury Compensation Programs,                           19. Emilie Wolf on behalf of The Estate
                                                                                                                 of Matthew Wolf, Deceased, Boston,               42. Linda King, Bowling Green,
                                                    Healthcare Systems Bureau, 5600                                                                                    Kentucky, Court of Federal Claims
                                                    Fishers Lane, 08N146B, Rockville, MD                         Massachusetts, Court of Federal
                                                                                                                 Claims No: 17–0308V.                                  No: 17–0342V.
                                                    20857. The Court’s caption (Petitioner’s                                                                      43. Laura Brodbeck, Wellesley Hills,
                                                    Name v. Secretary of HHS) and the                       20. Jennifer L. Call, Easton, Maryland,
                                                                                                                 Court of Federal Claims No: 17–                       Massachusetts, Court of Federal
                                                    docket number assigned to the petition                                                                             Claims No: 17–0344V.
                                                    should be used as the caption for the                        0311V.
                                                                                                            21. Lauren Meehan, Newtown,                           44. Billie K. Damet, Olathe, Kansas,
                                                    written submission. Chapter 35 of title                                                                            Court of Federal Claims No: 17–
                                                                                                                 Connecticut, Court of Federal
                                                    44, United States Code, related to                                                                                 0345V.
                                                                                                                 Claims No: 17–0316V.
                                                    paperwork reduction, does not apply to                  22. Douglas T. Lester, Greensboro, North              45. Sheri Hoeger, Folsom, California,
                                                    information required for purposes of                         Carolina, Court of Federal Claims                     Court of Federal Claims No: 17–
                                                    carrying out the program.                                    No: 17–0317V.                                         0346V.
                                                      Dated: April 13, 2017.                                23. Joanne McMaster, Hyannis,                         46. Carole Miller, Gibsonia,
                                                    James Macrae,                                                Massachusetts, Court of Federal                       Pennsylvania, Court of Federal
                                                    Acting Administrator.                                        Claims No: 17–0319V.                                  Claims No: 17–0349V.
                                                                                                            24. Jane Bennett, Steamboat Springs,                  47. Eva S. Reed, Fridley, Minnesota,
                                                    List of Petitions Filed                                      Colorado, Court of Federal Claims                     Court of Federal Claims No: 17–
                                                                                                                                                                       0352V.
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                                                    1. Cooper J. Humphries, Genesco,                             No: 17–0320V.
                                                         Illinois, Court of Federal Claims No:              25. Donna Parker, Germantown,                         48. Nicole Hooper, Wichita Falls, Texas,
                                                         17–0288V.                                               Tennessee, Court of Federal Claims                    Court of Federal Claims No: 17–
                                                    2. Amall Ali, New York, New York,                            No: 17–0321V.                                         0355V.
                                                         Court of Federal Claims No: 17–                    26. Mark Greenberg, Northfield, New                   49. Imogene Haynes-Bleau, Roseville,
                                                         0289V.                                                  Jersey, Court of Federal Claims No:                   California, Court of Federal Claims
                                                    3. Dayna Sotirhos, Floral Park, New                          17–0322V.                                             No: 17–0356V.
                                                         York, Court of Federal Claims No:                  27. James J. Roy and Mary Ann Boger on                50. Anita Jones, Columbus, Ohio, Court
                                                         17–0290V.                                               behalf of Paul E. Roy, Fort Wayne,                    of Federal Claims No: 17–0358V.


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                                                    18656                         Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices

                                                    51. Tommie Humbert, Jr, Washington,                     74. Rigoberto Garza, Jr., Brownsville,                98. Britta Lassmann, Boston,
                                                         District of Columbia, Court of                          Texas, Court of Federal Claims No:                    Massachusetts, Court of Federal
                                                         Federal Claims No: 17–0360V.                            17–0385V.                                             Claims No: 17–0416V.
                                                    52. Sarah D. Murray on behalf of C. E.                  75. Cynthia I. Gomez, Austin, Texas,                  99. Heewon Kim, Staten Island, New
                                                         M., Kennebunk, Maine, Court of                          Court of Federal Claims No: 17–                       York, Court of Federal Claims No:
                                                         Federal Claims No: 17–0361V.                            0386V.                                                17–0418V.
                                                    53. Matthew L. Bonk, Georgetown,                        76. Veronica Vela on behalf of B. V.,                 100. Edward Horne, Rincon, Georgia,
                                                         Texas, Court of Federal Claims No:                      Harlingen, Texas, Court of Federal                    Court of Federal Claims No: 17–
                                                         17–0364V.                                               Claims No: 17–0387V.                                  0419V.
                                                    54. Patricia Lopez, Harlingen, Texas,                   77. Amadeo Tolento, Jr., Harlingen,                   101. James Cox, Valley View,
                                                         Court of Federal Claims No: 17–                         Texas, Court of Federal Claims No:                    Pennsylvania, Court of Federal
                                                         0365V.                                                  17–0388V.                                             Claims No: 17–0420V.
                                                    55. Selina Villafranca on behalf of N. L.               78. John Lowe, Tempe, Arizona, Court                  102. Krystal Alcott, Orlando, Florida,
                                                         V., San Benito, Texas, Court of                         of Federal Claims No: 17–0389V.                       Court of Federal Claims No: 17–
                                                         Federal Claims No: 17–0366V.                       79. Theresa Mullis, Boston,                                0424V.
                                                    56. Leticia Palencia on behalf of C. A.                      Massachusetts, Court of Federal                  103. Brahm Arya, Washington, District
                                                         P., Austin, Texas, Court of Federal                     Claims No: 17–0390V.                                  of Columbia, Court of Federal
                                                         Claims No: 17–0367V.                               80. Suzanne Hulett, Boston,                                Claims No: 17–0425V.
                                                    57. Loren Lynette Machuca on behalf of                       Massachusetts, Court of Federal                  104. Sailaja Peddada, Sacramento,
                                                         J. A. M., Austin, Texas, Court of                       Claims No: 17–0392V.                                  California, Court of Federal Claims
                                                         Federal Claims No: 17–0368V.                       81. Carolyn Green, Chicago, Illinois,                      No: 17–0426V.
                                                    58. Sandra Lopez on behalf of T. Y. D.,                      Court of Federal Claims No: 17–                  105. Gayle Dillenbeck, Hanover Park,
                                                         Austin, Texas, Court of Federal                         0395V.                                                Illinois, Court of Federal Claims No:
                                                         Claims No: 17–0369V.                               82. Jeanne Weber, Exton, Pennsylvania,                     17–0428V.
                                                    59. Guadalupe Gonzalez, Jr., Austin,                         Court of Federal Claims No: 17–                  106. Leanne Knapp, Collegeville,
                                                         Texas, Court of Federal Claims No:                      0396V.                                                Pennsylvania, Court of Federal
                                                         17–0370V.                                          83. James Baumann, Bethel, Maine,                          Claims No: 17–0429V.
                                                    60. Margarita Gonzalez-Monterrey on                          Court of Federal Claims No: 17–                  107. Dennis Ducheneau, Boston,
                                                         behalf of M. N. G., Austin, Texas,                      0397V.                                                Massachusetts, Court of Federal
                                                         Court of Federal Claims No: 17–                    84. Karen Crawford, Montclair, New                         Claims No: 17–0431V.
                                                                                                                 Jersey, Court of Federal Claims No:              108. Marie Curri, Boston,
                                                         0371V.
                                                    61. Sandra Lopez on behalf of J. D., San                     17–0398V.                                             Massachusetts, Court of Federal
                                                         Benito, Texas, Court of Federal                    85. Joanna Weber, Huntersville, North                      Claims No: 17–0432V.
                                                                                                                                                                  109. Lisa A. Lindman, Fort Bragg, North
                                                         Claims No: 17–0372V.                                    Carolina, Court of Federal Claims
                                                                                                                                                                       Carolina, Court of Federal Claims
                                                    62. Joanna Villalobos on behalf of A. D.,                    No: 17–0399V.
                                                                                                                                                                       No: 17–0434V.
                                                         Harlingen, Texas, Court of Federal                 86. Norma Soltys, Austin, Texas, Court
                                                                                                                                                                  110. Jeffrey M. Shur, Rochester, New
                                                         Claims No: 17–0373V.                                    of Federal Claims No: 17–0401V.
                                                                                                                                                                       York, Court of Federal Claims No:
                                                    63. Maria Covarrubias on behalf of M.                   87. Todd Boylan on behalf of L. K. B.,
                                                                                                                                                                       17–0435V.
                                                         M. M., Harlingen, Texas, Court of                       Wayne, Pennsylvania, Court of                    111. Mary Brodie, Athens, Georgia,
                                                         Federal Claims No: 17–0374V.                            Federal Claims No: 17–0402V.                          Court of Federal Claims No: 17–
                                                    64. Marta Saenz on behalf of R. U. S.,                  88. Anna Conte, Beckley, West Virginia,                    0437V.
                                                         Houston, Texas, Court of Federal                        Court of Federal Claims No: 17–                  112. Kathleen Campbell, San Antonio,
                                                         Claims No: 17–0375V.                                    0403V.                                                Texas, Court of Federal Claims No:
                                                    65. Larry Pierce, Austin, Texas, Court of               89. Ashley Loftis, Washington, District                    17–0438V.
                                                         Federal Claims No: 17–0376V.                            of Columbia, Court of Federal                    113. Rosalia Parrea on behalf of M. T.,
                                                    66. Maria Pool on behalf of S. P. P.,                        Claims No: 17–0404V.                                  Edinburgh, Texas, Court of Federal
                                                         Harlingen, Texas, Court of Federal                 90. Alexander Cohen, Millburn, New                         Claims No: 17–0440V.
                                                         Claims No: 17–0377V.                                    Jersey, Court of Federal Claims No:              114. Guadalupe Hernandez on behalf of
                                                    67. Diana C. Villareal, Austin, Texas,                       17–0406V.                                             A. C., Harlingen, Texas, Court of
                                                         Court of Federal Claims No: 17–                    91. Ronald Wagner, Dubois,                                 Federal Claims No: 17–0442V.
                                                         0378V.                                                  Pennsylvania, Court of Federal                   115. Samantha Ledesma on behalf of S.
                                                    68. Maria D. Sanchez, Brownsville,                           Claims No: 17–0407V.                                  L., Pasadena, Texas, Court of
                                                         Texas, Court of Federal Claims No:                 92. Dorothy E. Cooper, Greensboro,                         Federal Claims No: 17–0443V.
                                                         17–0379V.                                               North Carolina, Court of Federal                 116. Kerry Leigh and Benjamin Leigh on
                                                    69. Brelda Segura on behalf of J. A. L.,                     Claims No: 17–0408V.                                  behalf of E. L., Boston,
                                                         Austin, Texas, Court of Federal                    93. Myra Brown, Dover, Delaware, Court                     Massachusetts, Court of Federal
                                                         Claims No: 17–0380V.                                    of Federal Claims No: 17–0409V.                       Claims No: 17–0444V.
                                                    70. Armando Fidencio Orta, Austin,                      94. Zachary Schneider, Atlanta, Georgia,              117. Betty Chally, Fayetteville, Georgia,
                                                         Texas, Court of Federal Claims No:                      Court of Federal Claims No: 17–                       Court of Federal Claims No: 17–
                                                         17–0381V.                                               0410V.                                                0448V.
                                                    71. Leticia Palencia on behalf of A. H.                 95. Rose Johnson, Plymouth, Minnesota,
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                                                                                                                                                                  118. Crystal Moreno on behalf of L. V.,
                                                         P., Harlingen, Texas, Court of                          Court of Federal Claims No: 17–                       Harlingen, Texas, Court of Federal
                                                         Federal Claims No: 17–0382V.                            0411V.                                                Claims No: 17–0450V.
                                                    72. Mario A. Flores, Jr., Harlingen,                    96. Teresa Tinley, Covington, Georgia,                119. Larry Wolford, Grundy, Virginia,
                                                         Texas, Court of Federal Claims No:                      Court of Federal Claims No: 17–                       Court of Federal Claims No: 17–
                                                         17–0383V.                                               0413V.                                                0451V.
                                                    73. Dania Pedraza on behalf of N. Q.,                   97. Jacqueline Deberry, Deerfield,                    120. Billy Watson, Birmingham,
                                                         Brownsville, Texas, Court of                            Illinois, Court of Federal Claims No:                 Alabama, Court of Federal Claims
                                                         Federal Claims No: 17–0384V.                            17–0415V.                                             No: 17–0453V.


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                                                                                  Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices                                                 18657

                                                    121. Dustin Mobley, Washington,                         meeting was originally scheduled to be                   The Thursday meeting will adjourn at
                                                        District of Columbia, Court of                      held March 15–16, but was postponed                   approximately 5:00 p.m.
                                                        Federal Claims No: 17–0454V.                        due to a predicted snow storm.                           The Friday, May 26, meeting will
                                                    122. Gary Schneider, Dana Point,                        ADDRESSES: Fishers Lane Conference                    begin at 8:30 a.m. with
                                                        California, Court of Federal Claims                 Center, Terrace Level, 5635 Fishers                   recommendations from the SOH on the
                                                        No: 17–0456V.                                       Lane, Rockville, Maryland 20852.                      FDA Draft Guidance ‘‘Use of Real-World
                                                    123. Jackie Mills on behalf of L. M.,                                                                         Evidence to Support Regulatory
                                                        Portage, Michigan, Court of Federal                 FOR FURTHER INFORMATION CONTACT: Julia                Decision-Making for Medical Devices,’’
                                                        Claims No: 17–0457V.                                Gorey, J.D., Executive Director,                      issued July 27, 2016. SOH will also
                                                    124. Joseph Charneco, Boca Raton,                       SACHRP; U.S. Department of Health                     present recommendations on the return
                                                        Florida, Court of Federal Claims No:                and Human Services, 1101 Wootton                      of incidental findings to research
                                                        17–0458V.                                           Parkway, Suite 200, Rockville,                        subjects. The SAS will present
                                                    125. Anita Schmitter, Ann Arbor,                        Maryland 20852; telephone: 240–453–                   recommendations surrounding the new
                                                        Michigan, Court of Federal Claims                   8141; fax: 240–453–6909; email address:               Common Rule’s expedited review
                                                        No: 17–0459V.                                       SACHRP@hhs.gov.                                       requirements.
                                                    126. Mariah Corbett on behalf of N. C.,                 SUPPLEMENTARY INFORMATION: Under the                     The meeting will adjourn at 4:30 p.m.
                                                        Deceased, Longs, South Carolina                     authority of 42 U.S.C. 217a, Section 222              May 26, 2017. Time for public comment
                                                        Court of Federal Claims No: 17–                     of the Public Health Service Act, as                  sessions will be allotted both days. Note
                                                        0460V.                                              amended, SACHRP was established to                    that public comment must be relevant to
                                                    127. Hugh Gose, Seymour, Tennessee,                     provide expert advice and                             issues being addressed by the SACHRP.
                                                        Court of Federal Claims No: 17–                     recommendations to the Secretary of                      Public attendance at the meeting is
                                                        0461V.                                              Health and Human Services, through                    limited to space available. Individuals
                                                    128. Jane Elise Delzer, Waukesha,                       the Assistant Secretary for Health, on                who plan to attend and need special
                                                        Wisconsin, Court of Federal Claims                  issues and topics pertaining to or                    assistance, such as sign language
                                                        No: 17–0462V.                                       associated with the protection of human               interpretation or other reasonable
                                                    129. Sharyn Lynn Lobell, Ponchatoula,                   research subjects.                                    accommodations, should notify the
                                                        Louisiana, Court of Federal Claims                     The Subpart A Subcommittee (SAS)                   designated SACHRP point of contact at
                                                        No: 17–0463V.                                       was established by SACHRP in October                  the address/phone number listed above
                                                    130. Sharon Kabelitz, Washington,                       2006 and is charged with developing                   at least one week prior to the meeting.
                                                        District of Columbia, Court of                      recommendations for consideration by                  On-site registration is required for
                                                        Federal Claims No: 17–0466V.                        SACHRP regarding the application of                   participation in the live public comment
                                                    131. Charles Huggins, Watkinsville,                     subpart A of 45 CFR part 46 in the                    session. Individuals who would like to
                                                        Georgia, Court of Federal Claims                    current research environment.                         submit written statements as public
                                                        No: 17–0467V.                                          The Subcommittee on Harmonization                  comment should email or fax their
                                                    132. Barbara Jayne, Washington, District                (SOH) was established by SACHRP at its                comments to SACHRP at SACHRP@
                                                        of Columbia, Court of Federal                       July 2009 meeting and charged with                    hhs.gov at least five business days prior
                                                        Claims No: 17–0469V.                                identifying and prioritizing areas in                 to the meeting.
                                                    [FR Doc. 2017–07989 Filed 4–19–17; 8:45 am]             which regulations and/or guidelines for                 Dated: April 17, 2017.
                                                    BILLING CODE 4165–15–P                                  human subjects research adopted by                    Julia G. Gorey,
                                                                                                            various agencies or offices within HHS                Executive Director, Secretary’s Advisory
                                                                                                            would benefit from harmonization,                     Committee on Human Research Protections.
                                                    DEPARTMENT OF HEALTH AND                                consistency, clarity, simplification and/             [FR Doc. 2017–08017 Filed 4–19–17; 8:45 am]
                                                    HUMAN SERVICES                                          or coordination.                                      BILLING CODE 4150–36–P
                                                                                                               The SACHRP meeting will be open to
                                                    Meeting of the Secretary’s Advisory
                                                                                                            the public at 8:30 a.m., on Thursday,
                                                    Committee on Human Research
                                                                                                            May 25, 2017, followed by opening                     DEPARTMENT OF HEALTH AND
                                                    Protections
                                                                                                            remarks from Dr. Jerry Menikoff,                      HUMAN SERVICES
                                                    AGENCY:  Department of Health and                       Director of OHRP and Executive
                                                    Human Services, Office of the Secretary,                Secretary of SACHRP, and Dr. Stephen                  National Preparedness and Response
                                                    Office of the Assistant Secretary for                   Rosenfeld, SACHRP Chair. Dr. Menikoff                 Science Board; Call for Nominees
                                                    Health.                                                 will then lead a discussion focusing on               AGENCY:  Office of the Secretary,
                                                    ACTION: Notice.                                         selected sections of the new Common                   Department of Health and Human
                                                                                                            Rule, which was published January 19,                 Services.
                                                    SUMMARY:   Pursuant to Section 10(a) of                 2017, with an effective date of January
                                                                                                                                                                  ACTION: Notice.
                                                    the Federal Advisory Committee Act,,                    19, 2018 (see https://www.gpo.gov/
                                                    notice is hereby given that the                         fdsys/pkg/FR-2017-01-19/html/2017-                    SUMMARY:   The Office of the Secretary
                                                    Secretary’s Advisory Committee on                       01058.htm).                                           seeks application submissions from
                                                    Human Research Protections (SACHRP)                        The SOH will present their                         qualified individuals for consideration
                                                    will hold a meeting that will be open to                recommendations for consideration of                  for membership on the National
                                                    the public. Information about SACHRP                    the new Common Rule’s compliance                      Preparedness and Response Science
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    and the full meeting agenda will be                     dates and transition provisions, as well              Board (NPRSB). Terms of eight members
                                                    posted on the SACHRP Web site at:                       as for the interpretation and                         expire December 31, 2017; therefore, the
                                                    http://www.dhhs.gov/ohrp/sachrp-                        implementation of the new broad                       Secretary must appoint eight new voting
                                                    committee/meetings/index.html.                          consent provision.                                    members. Nominees shall represent the
                                                    DATES: The meeting will be held on                         The SAS will discuss their report on               following categories: Industry,
                                                    Thursday, May 25, from 8:30 a.m. until                  the interpretation of the new exemption               academia, health care consumer
                                                    5:00 p.m., and Friday, May 26 from 8:30                 involving benign behavioral                           organizations, and organizations
                                                    a.m. until 4:30 p.m. Please note: this                  interventions.                                        representing other appropriate


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Document Created: 2017-04-20 01:42:30
Document Modified: 2017-04-20 01:42:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFor 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: http://www.hrsa.gov/vaccinecompensation/ index.html.
FR Citation82 FR 18654 

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