Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33315 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 15, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13388 Filed 6–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

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 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, Maryland 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 to 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, 2021, through May 31, 2021. 

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 United States 

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, 

Maryland 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. 

Diana Espinosa, 

Acting Administrator. 

List of Petitions Filed 

1. Kelly Hannon, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1304V 

2. Margaret Hoyt, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1305V 

3. Sarah Lopez, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1306V 

4. Lydia M. Goode, Greensboro, North 

Carolina, Court of Federal Claims No: 

21–1307V 

5. Jonathan Jarog, Chicago, Illinois, Court of 

Federal Claims No: 21–1308V 


khammond on DSKJM1Z7X2PROD with NOTICES
33316 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 

6. Chad Adaway, Birmingham, Alabama, 

Court of Federal Claims No: 21–1311V 

7. John Buen, Boston, Massachusetts, Court 

of Federal Claims No: 21–1314V 

8. Robert Ben, Colorado Springs, Colorado, 

Court of Federal Claims No: 21–1315V 

9. David Plaut, Fort Collins, Colorado, Court 

of Federal Claims No: 21–1316V 

10. Ciara Johnson, Durango, Colorado, Court 

of Federal Claims No: 21–1317V 

11. Lindsay Walker on behalf of R.W., 

Aurora, Colorado, Court of Federal 

Claims No: 21–1318V 

12. Dana Hilden, Phoenix, Arizona, Court of 

Federal Claims No: 21–1321V 

13. Debbie L. Tice, Jackson, Mississippi, 

Court of Federal Claims No: 21–1322V 

14. Rhonda Boyd, Huntsville, Alabama, Court 

of Federal Claims No: 21–1323V 

15. Janice Walker, Ventura, California, Court 

of Federal Claims No: 21–1325V 

16. Mary Patricia Turner, Washington, 

District of Columbia, Court of Federal 

Claims No: 21–1327V 

17. Kara Mahuron, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1328V 

18. Estate of James Leroy Doebler, Deceased, 

Pascagoula, Mississippi, Court of Federal 

Claims No: 21–1331V 

19. Marlena Lloyd and Jeffrey Lloyd on 

behalf of C.L., Boston, Massachusetts, 

Court of Federal Claims No: 21–1332V 

20. Keith Montague, Boston, Massachusetts, 

Court of Federal Claims No: 21–1333V 

21. Daniel Murphy, Philadelphia, 

Pennsylvania, Court of Federal Claims 

No: 21–1334V 

22. Jennifer Huch and Lucas Huch on behalf 

of L.L.L.H., Bedford, Texas, Court of 

Federal Claims No: 21–1335V 

23. Michelle Gill on behalf of A.G., Phoenix, 

Arizona, Court of Federal Claims No: 21– 

1336V 

24. Thomas Burbank, Plainville, Connecticut, 

Court of Federal Claims No: 21–1337V 

25. Clifton Foley and Kelli Foley on behalf 

of N.F., Deceased, Burlington, North 

Carolina, Court of Federal Claims No: 

21–1338V 

26. Juanita Artman, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1340V 

27. Ramon K. Jusino and Ann M. Jusino on 

behalf of W.J. Staten Island, New York, 

Court of Federal Claims No: 21–1342V 

28. Nardia Thompson Harris, Nanuet, New 

York, Court of Federal Claims No: 21– 

1345V 

29. Michael Williamson, Murfreesboro, 

Tennessee, Court of Federal Claims No: 

21–1346V 

30. John Allain, Sulphur, Louisiana, Court of 

Federal Claims No: 21–1349V 

31. Jennifer Clark, Chattanooga, Tennessee, 

Court of Federal Claims No: 21–1350V 

32. Robert Silver, Shelby, North Carolina, 

Court of Federal Claims No: 21–1351V 

33. Kelsey Hamonds, Edgewood, Kentucky, 

Court of Federal Claims No: 21–1352V 

34. Mindy Schuehrer, Marie, Michigan, Court 

of Federal Claims No: 21–1353V 

35. Hortencia Torres, Annandale, Virginia, 

Court of Federal Claims No: 21–1356V 

36. Laurel Bennett, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1357V 

37. Marie Tully, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1358V 

38. Donna Fulbright, Washington, District of 

Columbia, Court of Federal Claims No: 

21–1359V 

39. Jovonna Beyer, New York, New York, 

Court of Federal Claims No: 21–1362V 

40. Richard Munoz, Plant City, Florida, Court 

of Federal Claims No: 21–1369V 

41. Josephine Feitel, Georgetown, Texas, 

Court of Federal Claims No: 21–1370V 

42. Austin Reid, Louisville, Kentucky, Court 

of Federal Claims No: 21–1374V 

43. Elizabeth Fellows, Kansas City, Missouri, 

Court of Federal Claims No: 21–1378V 

44. Stephen R. Hunt, Athens, Ohio, Court of 

Federal Claims No: 21–1379V 

45. Raymond Milligan, Jr., Sulphur Springs, 

Texas, Court of Federal Claims No: 21– 

1382V 

46. Tina Paxson, Bloomington, Indiana, Court 

of Federal Claims No: 21–1383V 

47. Rashawnda L. Benton, Greensboro, North 

Carolina, Court of Federal Claims No: 

21–1384V 

48. Jerome Dacurawat, Alexandria, Virginia, 

Court of Federal Claims No: 21–1389V 

49. Krystal Kilgore, Morristown, Tennessee, 

Court of Federal Claims No: 21–1390V 

50. Jeffrey A. Ridenour, Lima, Ohio, Court of 

Federal Claims No: 21–1392V 

51. Lori Kathleen Ogden Erickson, Milton, 

Washington, Court of Federal Claims No: 

21–1395V 

52. Angela Saporito, Nutley, New Jersey, 

Court of Federal Claims No: 21–1398V 

53. Shawn Wilson-Blount, White Plains, New 

York, Court of Federal Claims No: 21– 

1400V 

54. Geeta Karra, Philadelphia, Pennsylvania, 

Court of Federal Claims No: 21–1402V 

55. Jonathan Charter, Manchester, 

Connecticut, Court of Federal Claims No: 

21–1404V 

56. Tammy Walden on behalf of J.F., 

Phoenix, Arizona, Court of Federal 

Claims No: 21–1406V 

57. Bruce A. Ades, Denver, Colorado, Court 

of Federal Claims No: 21–1407V 

58. Wendy O’Neil, Englewood, New Jersey, 

Court of Federal Claims No: 21–1410V 

[FR Doc. 2021–13312 Filed 6–23–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP, the full 

meeting agenda, and instructions for 

linking to public access will be posted 

on the SACHRP website at https://

www.hhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Wednesday, July 21, from 11:00 a.m. 

until 4:30 p.m., and Thursday, July 22, 

2021, from 11:00 a.m. until 4:30 p.m. 

(times are tentative and subject to 

change). The confirmed times and 

agenda will be posted on the SACHRP 

website when this information becomes 

available. 

ADDRESSES: This meeting will be held 

via webcast. Members of the public may 

also attend the meeting via webcast. 

Instructions for attending via webcast 

will be posted one week prior to the 

meeting at https://www.hhs.gov/ohrp/ 

sachrp-committee/meetings/index.html. 

FOR FURTHER INFORMATION CONTACT: Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The Subpart A Subcommittee (SAS) 

was established by SACHRP in October 

2006 and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

The Subcommittee on Harmonization 

(SOH) was established by SACHRP at its 

July 2009 meeting and charged with 

identifying and prioritizing areas in 

which regulations and/or guidelines for 

human subjects research adopted by 

various agencies or offices within HHS 

would benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. 

The SACHRP meeting will open to the 

public at 11:00 a.m., on Wednesday, 

July 21, followed by opening remarks 

from Dr. Jerry Menikoff, Director of 

OHRP and Dr. Douglas Diekema, 

SACHRP Chair. The meeting will begin 

with presentation of recommendations 

on justice as an ethical concept in 45 


khammond on DSKJM1Z7X2PROD with NOTICES