Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 39103 

effectiveness and to support claims in 

approved medical labeling. 

The collections of information in 21 

CFR 314.50, 314.126, and 601.2 are 

submitted to FDA to support the 

medical product’s effectiveness and to 

support claims in approved medical 

product labeling. The collections of 

information have been approved under 

OMB control numbers 0910–0001 and 

0910–0338. The collections of 

information in 21 CFR 312.23 regarding 

investigational new drug applications, 

including clinical trial design and study 

protocols, have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

parts 50 and 56 regarding institutional 

review boards and the protection of 

human subjects have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 11 regarding electronic records 

and signatures have been approved 

under OMB control number 0910–0303. 

The collections of information described 

in FDA’s guidance entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’‘ (https://www.fda.gov/media/ 

109951/download) have been approved 

under OMB control number 0910–0429. 

III. Additional Information 

Section 3002 of Title III, Subtitle A, of 

the 21st Century Cures Act (Pub. L. 114– 

255) directs FDA to develop patientfocused drug development guidance to 

address a number of areas, including 

under section 3002(c)(2): 

Methodological approaches that may be 

used to develop and identify what is 

important to patients with respect to 

burden of disease, burden of treatment, 

and the benefits and risks in the 

management of the patient’s disease. 

In addition, FDA committed to meet 

certain performance goals under the 

sixth authorization of the Prescription 

Drug User Fee Act. These goal 

commitments were developed in 

consultation with patient and consumer 

advocates, healthcare professionals, and 

other public stakeholders, as part of 

negotiations with regulated industry. 

Section J.1 of the commitment letter, 

‘‘Enhancing the Incorporation of the 

Patient’s Voice in Drug Development 

and Decision-Making’’ (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf) outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and use robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision-making. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at 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 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13952 Filed 6–29–22; 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 

April 1, 2022, through April 30, 2022. 

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 


jspears on DSK121TN23PROD with NOTICES1
39104 Federal Register / Vol. 87, No. 125 / Thursday, June 30, 2022 / Notices 

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, Health 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. 

Carole Johnson, 

Administrator. 

List of Petitions Filed 

1. Sherrie Grabp on behalf of Judith Grabp, 

Deceased, Buffalo, New York, Court of 

Federal Claims No: 22–0375V 

2. Douglas Berman, Boston, Massachusetts, 

Court of Federal Claims No: 22–0380V 

3. Tommy E. Martin, Charlotte, North 

Carolina, Court of Federal Claims No: 

22–0384V 

4. Katelin Whiddon, Conway, Arkansas, 

Court of Federal Claims No: 22–0385V 

5. Bridgette Melvin, Oswego, New York, 

Court of Federal Claims No: 22–0386V 

6. Rasheedah Smith, Atlanta, Georgia, Court 

of Federal Claims No: 22–0387V 

7. Sheila Porter, Goodyear, Arizona, Court of 

Federal Claims No: 22–0389V 

8. Mark Humpfer, Schererville, Indiana, 

Court of Federal Claims No: 22–0390V 

9. Darla Wilson, Bloomington, Indiana, Court 

of Federal Claims No: 22–0393V 

10. Maria Schory, Grand Island, New York, 

Court of Federal Claims No: 22–0394V 

11. Josie Ransom, Athens, Georgia, Court of 

Federal Claims No: 22–0395V 

12. Deborah Precil, Maple Shade, New Jersey, 

Court of Federal Claims No: 22–0396V 

13. Rodney Moore, Columbia, Maryland, 

Court of Federal Claims No: 22–0397V 

14. Xania Murray, Denton, Texas, Court of 

Federal Claims No: 22–0398V 

15. Amanda Seigel, Perry, Michigan, Court of 

Federal Claims No: 22–0399V 

16. Jason Brose, Chester Springs, 

Pennsylvania, Court of Federal Claims 

No: 22–0401V 

17. Krzysztof Kosmicki, Cheyenne, Wyoming, 

Court of Federal Claims No: 22–0402V 

18. Donna Nemuras, Hancock, Maryland, 

Court of Federal Claims No: 22–0403V 

19. Marie Sroka, Walton, New York, Court of 

Federal Claims No: 22–0405V 

20. Brigette Klish, Urbana, Illinois, Court of 

Federal Claims No: 22–0408V 

21. Arlene Weiss, Delray Beach, Florida, 

Court of Federal Claims No: 22–0409V 

22. Ryan Mehm on behalf of C. M., 

Gaithersburg, Maryland, Court of Federal 

Claims No: 22–0413V 

23. Homer Stine, Ponte Vedra, Florida, Court 

of Federal Claims No: 22–0415V 

24. Mary Flatt, Des Moines, Iowa, Court of 

Federal Claims No: 22–0416V 

25. Shelly Vera, Houston, Texas, Court of 

Federal Claims No: 22–0421V 

26. Sherri Smilow, Robbinsville, New Jersey, 

Court of Federal Claims No: 22–0425V 

27. Doris Clark, Madisonville, Kentucky, 

Court of Federal Claims No: 22–0427V 

28. Kelsey Jaranilla and Ryan Jaranilla on 

behalf of B. J., Salem, Oregon, Court of 

Federal Claims No: 22–0428V 

29. Steven Koruan, Boston, Massachusetts, 

Court of Federal Claims No: 22–0430V 

30. Amy Scarfpin, Westerville, Ohio, Court of 

Federal Claims No: 22–0431V 

31. Antoinette Harris, Heath Springs, South 

Carolina, Court of Federal Claims No: 

22–0432V 

32. Christine Madden, Chicago, Illinois, 

Court of Federal Claims No: 22–0433V 

33. Brenda McGaha, Farmington, New 

Mexico, Court of Federal Claims No: 22– 

0436V 

34. Tammy Beaver, Houston, Texas, Court of 

Federal Claims No: 22–0439V 

35. Emily Cafarella, Phoenix, Arizona, Court 

of Federal Claims No: 22–0444V 

36. Kristen Linton on behalf of C. K., 

Phoenix, Arizona, Court of Federal 

Claims No: 22–0445V 

37. Beverly Padratzik, Chicago, Illinois, Court 

of Federal Claims No: 22–0448V 

38. Natalie Lawrence, Columbia, South 

Carolina, Court of Federal Claims No: 

22–0450V 

39. Katie Pendleton, Dayton, Ohio, Court of 

Federal Claims No: 22–0454V 

40. Margarita Galvan, Houston, Texas, Court 

of Federal Claims No: 22–0455V 

41. Eric Daniel and Chris Daniel on behalf of 

M. D., Phoenix, Arizona, Court of 

Federal Claims No: 22–0456V 

42. Hanah Hilton on behalf of J. G., Phoenix, 

Arizona, Court of Federal Claims No: 22– 

0459V 

43. Jason Craigle, Langhorne, Pennsylvania, 

Court of Federal Claims No: 22–0461V 

44. Steven Hillstrom, Hancock, Michigan, 

Court of Federal Claims No: 22–0462V 

45. Christopher James, Reston, Virginia, 

Court of Federal Claims No: 22–0463V 

46. Angel Isai Rivera Gonzalez, San Juan, 

Puerto Rico, Court of Federal Claims No: 

22–0464V 

47. Corinne Fenn on behalf of R. F., Monroe, 

North Carolina, Court of Federal Claims 

No: 22–0465V 

48. Larissa Aidone, Islip, New York, Court of 

Federal Claims No: 22–0467V 

49. Lessie Williams, Greensboro, North 

Carolina, Court of Federal Claims No: 

22–0469V 

50. Nicholas J. Gauthier, Fort Hood, Texas, 

Court of Federal Claims No: 22–0470V 

51. Gina Crete, Glens Falls, New York, Court 

of Federal Claims No: 22–0472V 

52. Janet Solorio, Sacramento, California, 

Court of Federal Claims No: 22–0473V 

53. John Giangiulio, Devon, Pennsylvania, 

Court of Federal Claims No: 22–0474V 

54. Lisa Ortiz, Ocoee, Florida, Court of 

Federal Claims No: 22–0475V 

55. Patricia Stewart-Robinson, Rego Park, 

New York, Court of Federal Claims No: 

22–0477V 

56. Royann Matsel on behalf of the Estate of 

David Matsel, Kansas City, Missouri, 

Court of Federal Claims No: 22–0478V 

57. Amy Collins on behalf of H. C., Phoenix, 

Arizona, Court of Federal Claims No: 22– 

0479V 

58. Yul Bernard, Boston, Massachusetts, 

Court of Federal Claims No: 22–0480V 

59. Robert Long, El Cajon, California, Court 

of Federal Claims No: 22–0481V 

60. Claudia Praetel on behalf of M. P., 

Phoenix, Arizona, Court of Federal 

Claims No: 22–0482V 

61. Abby Vaughn, Barron, Wisconsin, Court 

of Federal Claims No: 22–0483V 

62. Weiwei Dong and Xiangli Kong on behalf 

of V. K., Fairbanks, Alaska, Court of 

Federal Claims No: 22–0486V 

63. Sharon Scott on behalf of S. S., Phoenix, 

Arizona, Court of Federal Claims No: 22– 

0487V 

[FR Doc. 2022–14038 Filed 6–29–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Office of Research 

Infrastructure Programs Special Emphasis 

Panel; Member Conflicts: Scientific and 

Technical Review Board on Biomedical and 

Behavioral Research Facilities (STOD). 

Date: July 28, 2022. 

Time: 1:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


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