83_FR_29916 83 FR 29793 - National Vaccine Injury Compensation Program; List of Petitions Received

83 FR 29793 - National Vaccine Injury Compensation Program; List of Petitions Received

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 123 (June 26, 2018)

Page Range29793-29796
FR Document2018-13593

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 83 Issue 123 (Tuesday, June 26, 2018) 
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29793-29796]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13593]


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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.

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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 Lisa L. Reyes, 
Clerk of Court, United States Court of Federal

[[Page 29794]]

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 website 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 United States 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 May 1, 2018, through May 31, 
2018. This list provides the name of petitioner, city and state of 
vaccination (if unknown then city and state of person or attorney 
filing claim), and case number. In cases where the Court has redacted 
the name of a petitioner and/or the case number, the list reflects such 
redaction.
    Section 2112(b)(2) also provides that the special master ``shall 
afford all interested persons an opportunity to submit relevant, 
written information'' relating to the following:
    1. The existence of evidence ``that there is not a preponderance of 
the evidence that the illness, disability, injury, condition, or death 
described in the petition is due to factors unrelated to the 
administration of the vaccine described in the petition,'' and
    2. Any allegation in a petition that the petitioner either:
    a. ``[S]ustained, or had significantly aggravated, any illness, 
disability, injury, or condition not set forth in the Vaccine Injury 
Table but which was caused by'' one of the vaccines referred to in the 
table, or
    b. ``[S]ustained, or had significantly aggravated, any illness, 
disability, injury, or condition set forth in the Vaccine Injury Table 
the first symptom or manifestation of the onset or significant 
aggravation of which did not occur within the time period set forth in 
the table but which was caused by a vaccine'' referred to in the table.
    In accordance with Section 2112(b)(2), all interested persons may 
submit written information relevant to the issues described above in 
the case of the petitions listed below. Any person choosing to do so 
should file an original and three (3) copies of the information with 
the Clerk of the U.S. Court of Federal Claims at the address listed 
above (under the heading FOR FURTHER INFORMATION CONTACT), with a copy 
to HRSA addressed to Director, Division of Injury Compensation 
Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, 
Rockville, MD 20857. The Court's caption (Petitioner's Name v. 
Secretary of HHS) and the docket number assigned to the petition should 
be used as the caption for the written submission. Chapter 35 of title 
44, United States Code, related to paperwork reduction, does not apply 
to information required for purposes of carrying out the Program.

    Dated: June 19, 2018.
George Sigounas,
Administrator.

List of Petitions Filed

1. Emily Jahn, Millbury, Massachusetts, Court of Federal Claims No: 18-
0613V
2. Kathy Macaluso, Naples, Florida, Court of Federal Claims No: 18-
0614V
3. Jason Fey and Heather Fey on behalf of E.P.F., Hudson, Wisconsin, 
Court of Federal Claims No: 18-0615V
4. Jeanne Rudzki, Jefferson, Louisiana, Court of Federal Claims No: 18-
0617V
5. Michael Schwarz, Walla Walla, Washington, Court of Federal Claims 
No: 18-0619V
6. Ernest Perkins, Salt Lake City, Utah, Court of Federal Claims No: 
18-0620V
7. Sally Musulin, Cranberry, Pennsylvania, Court of Federal Claims No: 
18-0621V
8. Katherine L. Alberino, Medford, Massachusetts, Court of Federal 
Claims No: 18-0622V
9. Timothy W. Massa, La Grange, Georgia, Court of Federal Claims No: 
18-0623V
10. Joseph Davis, Auburn, California, Court of Federal Claims No: 18-
0624V
11. Tesalia Lyons on behalf of G.L., Douglasville, Georgia, Court of 
Federal Claims No: 18-0625V
12. Matthew T. Manley, Greensboro, North Carolina, Court of Federal 
Claims No: 18-0626V
13. Sherri Paige, Willimantic, Connecticut, Court of Federal Claims No: 
18-0627V
14. Marie Aagotnes, New York, New York, Court of Federal Claims No: 18-
0631V
15. Arthur Renfro, Cheyenne, Wyoming, Court of Federal Claims No: 18-
0632V
16. Thomas D. Taylor, Purcellville, Virginia, Court of Federal Claims 
No: 18-0633V
17. Alia J. Stone, Columbus, Ohio, Court of Federal Claims No: 18-0634V
18. Carrine Paulen, Big Rapids, Michigan, Court of Federal Claims No: 
18-0635V
19. Lovely Varughese, Des Plaines, Illinois, Court of Federal Claims 
No: 18-0637V
20. Melissa K. Woinarowicz, Karlstad, Minnesota, Court of Federal 
Claims No: 18-0639V
21. Adam Crispo, Jersey City, New Jersey, Court of Federal Claims No: 
18-0640V
22. Cynthia Peterson, Bronx, New York, Court of Federal Claims No: 18-
0641V
23. Debra Juno, Yardley, Pennsylvania, Court of Federal Claims No: 18-
0643V
24. Fawne Adams, Frederick, Maryland, Court of Federal Claims No: 18-
0644V
25. Juliet Ley, Canonsburg, Pennsylvania, Court of Federal Claims No: 
18-0645V
26. Keria Edwards, Toledo, Ohio, Court of Federal Claims No: 18-0646V
27. Frankie Reese, Hickory, North Carolina, Court of Federal Claims No: 
18-0647V
28. Dana Ochsner, Olympia, Washington, Court of Federal Claims No: 18-
0648V

[[Page 29795]]

29. Kimberly J. Little, Rochester, New York, Court of Federal Claims 
No: 18-0649V
30. Mary Stewart, Hattiesburg, Mississippi, Court of Federal Claims No: 
18-0650V
31. Ida E. Sondy, Mountain Home, Arkansas, Court of Federal Claims No: 
18-0651V
32. Jill Corsiglia, Aptos, California, Court of Federal Claims No: 18-
0652V
33. Helen Kearns, Clinton, North Carolina, Court of Federal Claims No: 
18-0654V
34. Beverly Schick-Cowell, Sylvania, Ohio, Court of Federal Claims No: 
18-0656V
35. Sue Ann Chamberlain, Pleasant Grove, Utah, Court of Federal Claims 
No: 18-0658V
36. Judy Welch, Lapeer, Michigan, Court of Federal Claims No: 18-0660V
37. Brent Pyles, Georgetown, Kentucky, Court of Federal Claims No: 18-
0662V
38. Kristina Link, Grand Rapids, Michigan, Court of Federal Claims No: 
18-0663V
39. Brooke Konsky, Newark, Delaware, Court of Federal Claims No: 18-
0666V
40. Heather Sheehan, Madison, Wisconsin, Court of Federal Claims No: 
18-0668V
41. Linda Serra, Springfield, Illinois, Court of Federal Claims No: 18-
0672V
42. Paula Rosselet, Spokane, Washington, Court of Federal Claims No: 
18-0674V
43. Bradley Haag, Pickering, Ohio, Court of Federal Claims No: 18-0675V
44. Marian Williams, Jacksonville, Florida, Court of Federal Claims No: 
18-0676V
45. Douglas Billing, Wichita Falls, Texas, Court of Federal Claims No: 
18-0679V
46. Cecelia Keller, Upland, Pennsylvania, Court of Federal Claims No: 
18-0680V
47. David Christian Kunz, Nibley, Utah, Court of Federal Claims No: 18-
0681V
48. Merrick Brunker, Ventura, California, Court of Federal Claims No: 
18-0683V
49. Bonnie Mahayni, Midlothian, Virginia, Court of Federal Claims No: 
18-0684V
50. Elizabeth Tregillus, Washington, District of Columbia, Court of 
Federal Claims No: 18-0688V
51. Jeffrey Strain, Sacramento, California, Court of Federal Claims No: 
18-0689V
52. Maria Turkson, Harrisburg, Pennsylvania, Court of Federal Claims 
No: 18-0690V
53. Laura Guerrie, Tujunga, California, Court of Federal Claims No: 18-
0692V
54. Flint Allen, Hill City, Kansas, Court of Federal Claims No: 18-
0693V
55. Chad Sheller on behalf of Daniel E. Sheller, Deceased, Santa Maria, 
California, Court of Federal Claims No: 18-0696V
56. Lari Talbert, Shreveport, Louisiana, Court of Federal Claims No: 
18-0699V
57. Robert G. Baker, Rock Hill, North Carolina, Court of Federal Claims 
No: 18-0701V
58. Randy Leblanc, Salt Lake City, Utah, Court of Federal Claims No: 
18-0702V
59. Jill Longworth, St. Louis, Missouri, Court of Federal Claims No: 
18-0703V
60. Kevin Radford, Alpharetta, Georgia, Court of Federal Claims No: 18-
0704V
61. Judith Bohnenkamp, O'Fallon, Missouri, Court of Federal Claims No: 
18-0709V
62. Gerard L. Muensterman on behalf of Cletus J. Muensterman, Deceased, 
Evansville, Indiana, Court of Federal Claims No: 18-0714V
63. Claudette Guerrero, Edinburg, Texas, Court of Federal Claims No: 
18-0716V
64. Sheila Chille, Niagara Falls, New York, Court of Federal Claims No: 
18-0718V
65. Alice Lawler, Oak Harbor, Washington, Court of Federal Claims No: 
18-0719V
66. Patricia Wright, La Marque, Texas, Court of Federal Claims No: 18-
0720V
67. Gerald Jansen, Newport, Pennsylvania, Court of Federal Claims No: 
18-0722V
68. Bethanne Hull, Titusville, Florida, Court of Federal Claims No: 18-
0723V
69. Sheena Schmacht on behalf of H.S., Silvis, Illinois, Court of 
Federal Claims No: 18-0724V
70. David M. Roberts, Sioux City, Iowa, Court of Federal Claims No: 18-
0725V
71. Judith A. Bridges, St. Charles, Missouri, Court of Federal Claims 
No: 18-0726V
72. Barbara Murray, Orlando, Florida, Court of Federal Claims No: 18-
0728V
73. Vicki Havel, Rockwall, Texas, Court of Federal Claims No: 18-0729V
74. Silvia Hernandez, Washington, District of Columbia, Court of 
Federal Claims No: 18-0731V
75. Charles Williams, Oroville, California, Court of Federal Claims No: 
18-0732V
76. James Seylaz, Bridgewater, New Jersey, Court of Federal Claims No: 
18-0733V
77. Laurel Ostiguy, Marlborough, Massachusetts, Court of Federal Claims 
No: 18-0736V
78. Kathleen Spain, Las Vegas, Nevada, Court of Federal Claims No: 18-
0737V
79. Staci McTeigue, Alpharetta, Georgia, Court of Federal Claims No: 
18-0740V
80. Jackie Johns, Marshfield, Missouri, Court of Federal Claims No: 18-
0741V
81. Erica Schofield, Missoula, Montana, Court of Federal Claims No: 18-
0742V
82. Rocco E. Moat, Milwaukee, Wisconsin, Court of Federal Claims No: 
18-0743V
83. Raymond Spornhauer, Lufkin, Texas, Court of Federal Claims No: 18-
0744V
84. Janice Hodgett, Kewanee, Illinois, Court of Federal Claims No: 18-
0745V
85. Carol D'Angelo, Philadelphia, Pennsylvania, Court of Federal Claims 
No: 18-0747V
86. Cami Perry, Aurora, Colorado, Court of Federal Claims No: 18-0748V
87. Carol Vorwerck, Towson, Maryland, Court of Federal Claims No: 18-
0749V
88. Georgia Derr on behalf of M.D., Harrisburg, North Carolina, Court 
of Federal Claims No: 18-0751V
89. Sheri Henning, Owasso, Oklahoma, Court of Federal Claims No: 18-
0752V
90. Patricia Gauthier, Tonasket, Washington, Court of Federal Claims 
No: 18-0753V
91. Roderick Sanders, Conyers, Georgia, Court of Federal Claims No: 18-
0754V
92. Derek Grace, Dayton, Ohio, Court of Federal Claims No: 18-0757V
93. Sarah Flores and Ryan C. Flores on behalf of M.F., Houston, Texas, 
Court of Federal Claims No: 18-0759V
94. David Daniel, Houston, Texas, Court of Federal Claims No: 18-0760V
95. Raymond Bielak, St. George, Utah, Court of Federal Claims No: 18-
0761V
96. Tori Dreyer, Topeka, Kansas, Court of Federal Claims No: 18-0764V
97. Mark D. Scarlette, Greensboro, North Carolina, Court of Federal 
Claims No: 18-0766V
98. James Louis, Lisbon, Connecticut, Court of Federal Claims No: 18-
0767V
99. Dayane Penderis, Pasadena, California, Court of Federal Claims No: 
18-0768V

[[Page 29796]]

100. Kathleen Cooper-Loher, Marshfield, Wisconsin, Court of Federal 
Claims No: 18-0769V
101. Kerstina Alexander on behalf of M.A., Deceased, Woodbridge, 
Illinois, Court of Federal Claims No: 18-0770V
102. Henry Milligan, Jr., Orlando, Florida, Court of Federal Claims No: 
18-0771V
103. Cheryl Thompson, South Bend, Indiana, Court of Federal Claims No: 
18-0772V
104. Olivia Gallegos, Fresno, California, Court of Federal Claims No: 
18-0773V
105. Jacie Albanez and Mario Albanez on behalf of N.A., San Diego, 
California, Court of Federal Claims No: 18-0774V
106. Scott Kelbick, Avondale, Arizona, Court of Federal Claims No: 18-
0775V
107. Elizabeth Phenneger, Spokane, Washington, Court of Federal Claims 
No: 18-0776V

[FR Doc. 2018-13593 Filed 6-25-18; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29793 DATES: Fax written comments on the Guidance for Industry: Assessing User available on our website at: https:// collection of information by July 26, Fees Under the Biosimilar User Fee www.fda.gov/downloads/Drugs/ 2018. Amendments of 2017 GuidanceComplianceRegulatory Information/Guidances/ ADDRESSES: To ensure that comments on OMB Control Number 0910–0718— UCM584984.pdf. the information collection are received, Revision In the Federal Register of November OMB recommends that written This information collection supports 16, 2017 (82 FR 53505), we published a comments be faxed to the Office of the above captioned Agency guidance notice announcing availability of the Information and Regulatory Affairs, and implementation of the Biosimilar subject guidance document, including a OMB, Attn: FDA Desk Officer, Fax: 202– User Fee Amendments of 2017 (BsUFA 60-day notice requesting public 395–7285, or emailed to oira_ II). Under BsUFA II, FDA’s authority is comment on the information collection. submission@omb.eop.gov. All extended to collect user fees from fiscal One comment was received in response comments should be identified with the years 2018–2022 and includes a number to the notice from a trade organization of technical revisions that affect what OMB control number 0910–0718. Also indicating that interested persons ‘‘have fees and how fees are collected. Fees include the FDA docket number found reviewed the draft guidance and authorized by this legislation help fund in brackets in the heading of this the review process for biosimilar appreciate(s) FDA applying the user fee document. biological product applications and play provisions consistent with the BsUFA II an important role in expediting the negotiations and Commitment Letter.’’ FOR FURTHER INFORMATION CONTACT: In addition, and upon our own review, Domini Bean, Office of Operations, review and approval process. We have developed the guidance we believe it is appropriate to include Food and Drug Administration, Three the guidance document under the document entitled ‘‘Assessing User Fees White Flint North, 10A–12M, 11601 Under the Biosimilar User Fee existing information collection Landsdown St., North Bethesda, MD Amendments of 2017’’ to assist industry ‘‘Biosimilar User Fee Cover Sheet’’ 20852, 301–796–5733, PRAStaff@ in understanding when these fees are currently approved under OMB control fda.hhs.gov. incurred and the process by which number 0910–0718 rather than to applicants can submit payments. The establish a new collection. FDA is SUPPLEMENTARY INFORMATION: In preparing to renew OMB control guidance also provides information on compliance with 44 U.S.C. 3507, FDA number 0910–0718 and will include the the consequences of failing to pay has submitted the following proposed guidance document accordingly. BsUFA II fees, as well as processes for collection of information to OMB for submitting reconsideration and appeal We estimate the burden of the review and clearance. requests. The guidance document is information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Average Number of Number of Total annual burden per Activity responses per Total hours respondents responses response respondent (hours) Request for discontinuation from biological product devel- opment program ............................................................... 2 1 2 1 2 Request to move products to discontinued section of the biosimilar list ..................................................................... 5 1 5 * 0.5 2.5 Small business waiver of the BsUFA application fee .......... 1 1 1 16 16 Small business waiver reconsiderations .............................. 1 1 1 24 24 Small business waiver appeals ........................................... 1 1 1 12 12 Annual Fee Determination Survey ....................................... 35 1 35 1 35 Annual BsUFA Fees Correspondence ................................ 35 1 35 2 70 Total .............................................................................. ........................ ........................ ........................ ........................ 161.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. * 30 minutes. Our estimate is based on the number DEPARTMENT OF HEALTH AND Program (the Program), as required by of Biosimilars User Fee submissions we HUMAN SERVICES the Public Health Service (PHS) Act, as have received since establishing the amended. While the Secretary of HHS is program. Health Resources and Services named as the respondent in all Administration proceedings brought by the filing of Dated: June 21, 2018. petitions for compensation under the Leslie Kux, National Vaccine Injury Compensation Program, the United States Court of Associate Commissioner for Policy. Program; List of Petitions Received Federal Claims is charged by statute sradovich on DSK3GMQ082PROD with NOTICES [FR Doc. 2018–13688 Filed 6–25–18; 8:45 am] AGENCY: Health Resources and Services with responsibility for considering and BILLING CODE 4164–01–P Administration (HRSA), Department of acting upon the petitions. Health and Human Services (HHS). FOR FURTHER INFORMATION CONTACT: For ACTION: Notice. information about requirements for SUMMARY: HRSA is publishing this filing petitions and the Program in notice of petitions received under the general, contact Lisa L. Reyes, Clerk of National Vaccine Injury Compensation Court, United States Court of Federal VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1

29794 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices Claims, 717 Madison Place NW, interested persons an opportunity to 5. Michael Schwarz, Walla Walla, Washington, DC 20005, (202) 357–6400. submit relevant, written information’’ Washington, Court of Federal For information on HRSA’s role in the relating to the following: Claims No: 18–0619V Program, contact the Director, National 1. The existence of evidence ‘‘that 6. Ernest Perkins, Salt Lake City, Utah, Vaccine Injury Compensation Program, there is not a preponderance of the Court of Federal Claims No: 18– 5600 Fishers Lane, Room 08N146B, evidence that the illness, disability, 0620V Rockville, MD 20857; (301) 443–6593, injury, condition, or death described in 7. Sally Musulin, Cranberry, or visit our website at: http:// the petition is due to factors unrelated Pennsylvania, Court of Federal www.hrsa.gov/vaccinecompensation/ to the administration of the vaccine Claims No: 18–0621V index.html. described in the petition,’’ and 8. Katherine L. Alberino, Medford, 2. Any allegation in a petition that the Massachusetts, Court of Federal SUPPLEMENTARY INFORMATION: The Claims No: 18–0622V Program provides a system of no-fault petitioner either: a. ‘‘[S]ustained, or had significantly 9. Timothy W. Massa, La Grange, compensation for certain individuals Georgia, Court of Federal Claims who have been injured by specified aggravated, any illness, disability, injury, or condition not set forth in the No: 18–0623V childhood vaccines. Subtitle 2 of Title 10. Joseph Davis, Auburn, California, XXI of the PHS Act, 42 U.S.C. 300aa– Vaccine Injury Table but which was caused by’’ one of the vaccines referred Court of Federal Claims No: 18– 10 et seq., provides that those seeking 0624V compensation are to file a petition with to in the table, or b. ‘‘[S]ustained, or had significantly 11. Tesalia Lyons on behalf of G.L., the United States Court of Federal Douglasville, Georgia, Court of aggravated, any illness, disability, Claims and to serve a copy of the Federal Claims No: 18–0625V injury, or condition set forth in the petition on the Secretary of HHS, who 12. Matthew T. Manley, Greensboro, Vaccine Injury Table the first symptom is named as the respondent in each North Carolina, Court of Federal or manifestation of the onset or proceeding. The Secretary has delegated Claims No: 18–0626V significant aggravation of which did not this responsibility under the Program to 13. Sherri Paige, Willimantic, occur within the time period set forth in HRSA. The Court is directed by statute Connecticut, Court of Federal the table but which was caused by a to appoint special masters who take Claims No: 18–0627V vaccine’’ referred to in the table. 14. Marie Aagotnes, New York, New evidence, conduct hearings as In accordance with Section York, Court of Federal Claims No: appropriate, and make initial decisions 2112(b)(2), all interested persons may 18–0631V as to eligibility for, and amount of, submit written information relevant to 15. Arthur Renfro, Cheyenne, Wyoming, compensation. A petition may be filed with respect the issues described above in the case of Court of Federal Claims No: 18– to injuries, disabilities, illnesses, the petitions listed below. Any person 0632V conditions, and deaths resulting from choosing to do so should file an original 16. Thomas D. Taylor, Purcellville, vaccines described in the Vaccine Injury and three (3) copies of the information Virginia, Court of Federal Claims Table (the table) set forth at 42 CFR with the Clerk of the U.S. Court of No: 18–0633V 100.3. This table lists for each covered Federal Claims at the address listed 17. Alia J. Stone, Columbus, Ohio, Court childhood vaccine the conditions that above (under the heading FOR FURTHER of Federal Claims No: 18–0634V INFORMATION CONTACT), with a copy to 18. Carrine Paulen, Big Rapids, may lead to compensation and, for each condition, the time period for HRSA addressed to Director, Division of Michigan, Court of Federal Claims occurrence of the first symptom or Injury Compensation Programs, No: 18–0635V manifestation of onset or of significant Healthcare Systems Bureau, 5600 19. Lovely Varughese, Des Plaines, aggravation after vaccine Fishers Lane, 08N146B, Rockville, MD Illinois, Court of Federal Claims No: administration. Compensation may also 20857. The Court’s caption (Petitioner’s 18–0637V Name v. Secretary of HHS) and the 20. Melissa K. Woinarowicz, Karlstad, be awarded for conditions not listed in docket number assigned to the petition Minnesota, Court of Federal Claims the table and for conditions that are should be used as the caption for the No: 18–0639V manifested outside the time periods 21. Adam Crispo, Jersey City, New specified in the table, but only if the written submission. Chapter 35 of title 44, United States Code, related to Jersey, Court of Federal Claims No: petitioner shows that the condition was 18–0640V caused by one of the listed vaccines. paperwork reduction, does not apply to information required for purposes of 22. Cynthia Peterson, Bronx, New York, Section 2112(b)(2) of the PHS Act, 42 Court of Federal Claims No: 18– U.S.C. 300aa–12(b)(2), requires that carrying out the Program. 0641V ‘‘[w]ithin 30 days after the Secretary Dated: June 19, 2018. 23. Debra Juno, Yardley, Pennsylvania, receives service of any petition filed George Sigounas, Court of Federal Claims No: 18– under section 2111 the Secretary shall Administrator. 0643V publish notice of such petition in the 24. Fawne Adams, Frederick, Maryland, Federal Register.’’ Set forth below is a List of Petitions Filed Court of Federal Claims No: 18– list of petitions received by HRSA on 1. Emily Jahn, Millbury, Massachusetts, 0644V May 1, 2018, through May 31, 2018. Court of Federal Claims No: 18– 25. Juliet Ley, Canonsburg, This list provides the name of 0613V Pennsylvania, Court of Federal petitioner, city and state of vaccination 2. Kathy Macaluso, Naples, Florida, Claims No: 18–0645V sradovich on DSK3GMQ082PROD with NOTICES (if unknown then city and state of Court of Federal Claims No: 18– 26. Keria Edwards, Toledo, Ohio, Court person or attorney filing claim), and 0614V of Federal Claims No: 18–0646V case number. In cases where the Court 3. Jason Fey and Heather Fey on behalf 27. Frankie Reese, Hickory, North has redacted the name of a petitioner of E.P.F., Hudson, Wisconsin, Court Carolina, Court of Federal Claims and/or the case number, the list reflects of Federal Claims No: 18–0615V No: 18–0647V such redaction. 4. Jeanne Rudzki, Jefferson, Louisiana, 28. Dana Ochsner, Olympia, Section 2112(b)(2) also provides that Court of Federal Claims No: 18– Washington, Court of Federal the special master ‘‘shall afford all 0617V Claims No: 18–0648V VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1

Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29795 29. Kimberly J. Little, Rochester, New 53. Laura Guerrie, Tujunga, California, 76. James Seylaz, Bridgewater, New York, Court of Federal Claims No: Court of Federal Claims No: 18– Jersey, Court of Federal Claims No: 18–0649V 0692V 18–0733V 30. Mary Stewart, Hattiesburg, 54. Flint Allen, Hill City, Kansas, Court 77. Laurel Ostiguy, Marlborough, Mississippi, Court of Federal of Federal Claims No: 18–0693V Massachusetts, Court of Federal Claims No: 18–0650V 55. Chad Sheller on behalf of Daniel E. Claims No: 18–0736V 31. Ida E. Sondy, Mountain Home, Sheller, Deceased, Santa Maria, 78. Kathleen Spain, Las Vegas, Nevada, Arkansas, Court of Federal Claims California, Court of Federal Claims Court of Federal Claims No: 18– No: 18–0651V No: 18–0696V 0737V 32. Jill Corsiglia, Aptos, California, 56. Lari Talbert, Shreveport, Louisiana, 79. Staci McTeigue, Alpharetta, Georgia, Court of Federal Claims No: 18– Court of Federal Claims No: 18– Court of Federal Claims No: 18– 0652V 0699V 0740V 33. Helen Kearns, Clinton, North 57. Robert G. Baker, Rock Hill, North 80. Jackie Johns, Marshfield, Missouri, Carolina, Court of Federal Claims Carolina, Court of Federal Claims Court of Federal Claims No: 18– No: 18–0654V No: 18–0701V 0741V 34. Beverly Schick-Cowell, Sylvania, 58. Randy Leblanc, Salt Lake City, Utah, 81. Erica Schofield, Missoula, Montana, Ohio, Court of Federal Claims No: Court of Federal Claims No: 18– Court of Federal Claims No: 18– 18–0656V 0702V 0742V 35. Sue Ann Chamberlain, Pleasant 59. Jill Longworth, St. Louis, Missouri, 82. Rocco E. Moat, Milwaukee, Grove, Utah, Court of Federal Court of Federal Claims No: 18– Wisconsin, Court of Federal Claims Claims No: 18–0658V 0703V No: 18–0743V 36. Judy Welch, Lapeer, Michigan, Court 60. Kevin Radford, Alpharetta, Georgia, 83. Raymond Spornhauer, Lufkin, of Federal Claims No: 18–0660V Court of Federal Claims No: 18– Texas, Court of Federal Claims No: 37. Brent Pyles, Georgetown, Kentucky, 0704V 18–0744V Court of Federal Claims No: 18– 61. Judith Bohnenkamp, O’Fallon, 84. Janice Hodgett, Kewanee, Illinois, 0662V Missouri, Court of Federal Claims Court of Federal Claims No: 18– 38. Kristina Link, Grand Rapids, No: 18–0709V 0745V Michigan, Court of Federal Claims 62. Gerard L. Muensterman on behalf of 85. Carol D’Angelo, Philadelphia, No: 18–0663V Cletus J. Muensterman, Deceased, Pennsylvania, Court of Federal 39. Brooke Konsky, Newark, Delaware, Evansville, Indiana, Court of Claims No: 18–0747V Court of Federal Claims No: 18– Federal Claims No: 18–0714V 86. Cami Perry, Aurora, Colorado, Court 0666V 63. Claudette Guerrero, Edinburg, Texas, of Federal Claims No: 18–0748V 40. Heather Sheehan, Madison, 87. Carol Vorwerck, Towson, Maryland, Court of Federal Claims No: 18– Wisconsin, Court of Federal Claims Court of Federal Claims No: 18– 0716V No: 18–0668V 64. Sheila Chille, Niagara Falls, New 0749V 41. Linda Serra, Springfield, Illinois, York, Court of Federal Claims No: 88. Georgia Derr on behalf of M.D., Court of Federal Claims No: 18– 18–0718V Harrisburg, North Carolina, Court of 0672V 42. Paula Rosselet, Spokane, 65. Alice Lawler, Oak Harbor, Federal Claims No: 18–0751V Washington, Court of Federal 89. Sheri Henning, Owasso, Oklahoma, Washington, Court of Federal Claims No: 18–0719V Court of Federal Claims No: 18– Claims No: 18–0674V 43. Bradley Haag, Pickering, Ohio, Court 66. Patricia Wright, La Marque, Texas, 0752V of Federal Claims No: 18–0675V Court of Federal Claims No: 18– 90. Patricia Gauthier, Tonasket, 44. Marian Williams, Jacksonville, 0720V Washington, Court of Federal Florida, Court of Federal Claims No: 67. Gerald Jansen, Newport, Claims No: 18–0753V 18–0676V Pennsylvania, Court of Federal 91. Roderick Sanders, Conyers, Georgia, 45. Douglas Billing, Wichita Falls, Claims No: 18–0722V Court of Federal Claims No: 18– Texas, Court of Federal Claims No: 68. Bethanne Hull, Titusville, Florida, 0754V 18–0679V Court of Federal Claims No: 18– 92. Derek Grace, Dayton, Ohio, Court of 46. Cecelia Keller, Upland, 0723V Federal Claims No: 18–0757V Pennsylvania, Court of Federal 69. Sheena Schmacht on behalf of H.S., 93. Sarah Flores and Ryan C. Flores on Claims No: 18–0680V Silvis, Illinois, Court of Federal behalf of M.F., Houston, Texas, 47. David Christian Kunz, Nibley, Utah, Claims No: 18–0724V Court of Federal Claims No: 18– Court of Federal Claims No: 18– 70. David M. Roberts, Sioux City, Iowa, 0759V 0681V Court of Federal Claims No: 18– 94. David Daniel, Houston, Texas, Court 48. Merrick Brunker, Ventura, 0725V of Federal Claims No: 18–0760V California, Court of Federal Claims 71. Judith A. Bridges, St. Charles, 95. Raymond Bielak, St. George, Utah, No: 18–0683V Missouri, Court of Federal Claims Court of Federal Claims No: 18– 49. Bonnie Mahayni, Midlothian, No: 18–0726V 0761V Virginia, Court of Federal Claims 72. Barbara Murray, Orlando, Florida, 96. Tori Dreyer, Topeka, Kansas, Court No: 18–0684V Court of Federal Claims No: 18– of Federal Claims No: 18–0764V 50. Elizabeth Tregillus, Washington, 0728V 97. Mark D. Scarlette, Greensboro, North sradovich on DSK3GMQ082PROD with NOTICES District of Columbia, Court of 73. Vicki Havel, Rockwall, Texas, Court Carolina, Court of Federal Claims Federal Claims No: 18–0688V of Federal Claims No: 18–0729V No: 18–0766V 51. Jeffrey Strain, Sacramento, 74. Silvia Hernandez, Washington, 98. James Louis, Lisbon, Connecticut, California, Court of Federal Claims District of Columbia, Court of Court of Federal Claims No: 18– No: 18–0689V Federal Claims No: 18–0731V 0767V 52. Maria Turkson, Harrisburg, 75. Charles Williams, Oroville, 99. Dayane Penderis, Pasadena, Pennsylvania, Court of Federal California, Court of Federal Claims California, Court of Federal Claims Claims No: 18–0690V No: 18–0732V No: 18–0768V VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1

29796 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 100. Kathleen Cooper-Loher, Medicine and Dentistry, HRSA at Comments on the Proposed Standards Marshfield, Wisconsin, Court of MCrawford@hrsa.gov or (301) 443–7334. of the Quality Bonus System Federal Claims No: 18–0769V SUPPLEMENTARY INFORMATION: The HRSA received 17 responses to the 101. Kerstina Alexander on behalf of CHGME statute was amended in 2013. request for comments. Thirteen M.A., Deceased, Woodbridge, The amendments permit up to 25 commenters are current CHGME Illinois, Court of Federal Claims No: percent of the total amount appropriated hospitals and four are state/national 18–0770V 102. Henry Milligan, Jr., Orlando, annually in excess of $245 million, but associations. Comments are summarized Florida, Court of Federal Claims No: not to exceed $7,000,000, to provide below. 18–0771V payments to newly qualified hospitals, as defined in section 340E(h) of the QBS Goals 103. Cheryl Thompson, South Bend, Indiana, Court of Federal Claims Public Health Service Act. The statute Summary of Comments No: 18–0772V additionally states that the Secretary may establish a quality bonus system for Nearly all commenters supported 104. Olivia Gallegos, Fresno, California, establishing the CHGME QBS to Court of Federal Claims No: 18– CHGME hospitals using any remaining funds after payments are made to newly recognize and reward quality training 0773V programs for residents supported by the 105. Jacie Albanez and Mario Albanez qualified hospitals. In FY 2018, Congress appropriated $315 million to CHGME program and agreed with the on behalf of N.A., San Diego, approach to recognize engagement in California, Court of Federal Claims the CHGME Program. Of this, approximately $4 million in payments initiatives geared towards transforming No: 18–0774V pediatric health care to improve access, 106. Scott Kelbick, Avondale, Arizona, were made to newly qualified hospitals. If funding levels and mechanisms quality, and cost effectiveness. Court of Federal Claims No: 18– However, many commenters questioned 0775V remain constant in FY 2019, it is estimated that approximately $3 million whether there was enough information 107. Elizabeth Phenneger, Spokane, about these initiatives to establish a Washington, Court of Federal may be available annually for the CHGME QBS. baseline, draw comparisons between Claims No: 18–0776V children’s hospitals, and make [FR Doc. 2018–13593 Filed 6–25–18; 8:45 am] On October 16, 2017, through a judgements about relative performance. BILLING CODE 4165–15–P Federal Register Notice (FRN), HRSA Several suggested the proposed announced a 60-day public comment approach could be enhanced by starting period to solicit input on the CHGME with documentation of transformation DEPARTMENT OF HEALTH AND QBS proposed standards. HRSA activities in which residents are HUMAN SERVICES proposed a multi-step implementation involved. Specifically, one commenter beginning in FY 2019 that initially will recommended ‘‘that HRSA work to Health Resources and Services recognize high-level engagement of identify current residents’ engagement Administration CHGME hospitals in state and regional in quality initiatives and how residents health care transformation, as well as can further engage on broader based Proposed Standards for the Children’s engagement of resident trainees in these Hospitals Graduate Medical Education initiatives before transitioning the activities. HRSA sought public comment Quality Bonus Program to other criteria Payment Program’s Quality Bonus on the timeline, eligibility, standards, System in FY 2020 and beyond.’’ A few documentation, and payment structure commenters also requested that HRSA AGENCY: Health Resources and Services as described in the FRN. HRSA also offer more clear and specific goals for Administration (HRSA), Department of requested comment on proposed QBS the multi-step implementation of the Health and Human Services. measures, potential data sources, and QBS. ACTION: Final response. tiering of QBS payments for FY 2020 and beyond. HRSA received feedback Response SUMMARY: HRSA published a notice in on the following program components After considering feedback from the Federal Register on October 11, in response to the FRN: stakeholders, the revised goal of the 2017, soliciting feedback on the • QBS Goals QBS will be to recognize hospitals for establishment of the Children’s quality improvement & GME Hospitals Graduate Medical Education • Qualifying Initiatives for the FY 2019 QBS transformation efforts in high priority Payment (CHGME) Program’s Quality focus areas and build standards to Bonus System (QBS). In particular, • Measures and Metrics increase engagement and involvement HRSA requested feedback on the Fiscal • Payment Structure of residents in broader initiatives. HRSA Year (FY) 2019 and beyond multi-step implementation of the system, including • Documentation, Reporting will implement a baseline phase for Requirements and Reducing CHGME QBS in FY 2019. Information demonstration of engagement in state or collected during this baseline phase will regional-level initiatives, Reporting Burden be used to establish QBS standards for documentation, and payment structure. • Implementation Timeline for FY 2020 implementation in FY 2021. In order to This notice summarizes and responds to and Beyond qualify for the QBS payment, CHGME the comments received during the 60- HRSA carefully reviewed the awardees must submit documentation day comment period. comments received and used them to in the FY 2019 reconciliation sradovich on DSK3GMQ082PROD with NOTICES ADDRESSES: Additional information guide the development of the FY 2019 application describing the hospital’s about the CHGME is available at https:// CHGME QBS and to inform future initiatives, resident curriculum, and bhw.hrsa.gov/grants/medicine/chgme. iterations of the CHGME QBS. Final direct resident involvement in the FOR FURTHER INFORMATION CONTACT: guidance for the FY 2019 CHGME QBS following areas: Integrated care models, Malena Crawford, Project Officer, will be published in the FY 2019 telehealth/HIT, population health, Children’s Hospitals Graduate Medical CHGME Notice of Funding Opportunity social determinants of health, and Education Payment Program, Division of (NOFO). additional initiatives to improve access VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1


Document Created: 2018-06-26 00:52:51
Document Modified: 2018-06-26 00:52:51
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 Lisa L. Reyes, Clerk of Court, 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 website at: http://www.hrsa.gov/vaccinecompensation/index.html.
FR Citation83 FR 29793 
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