12016 Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 

1See United States v. Park, 421 U.S. 658, 673– 

74 (1975) (holding that a high-level manager within 

a business entity bears a responsibility to prevent 

and correct violations of the FD&C Act). 

order the TRI-toxin and substitute it for 

BOTOX, and the proposal to debar 

specifically finds that another physician 

authorized a nurse to place that order. 

However, Dr. Lynch, as a principal of 

TPSG, was responsible for failing to 

ensure that there were controls and 

procedures in place to prevent other 

physicians or a nurse from ordering 

unapproved drugs for administration to 

patients. His own admitted inaction on 

that front warrants treating his 

management participation as an 

unfavorable factor.1

Consistent with the proposal to debar, 

the record establishes that the medical 

practice of which Dr. Lynch was a part 

ultimately took voluntary steps to 

mitigate the effect on the public health 

from its unlawful conduct (see section 

306(c)(3)(C) of the FD&C Act). 

Furthermore, it is undisputed that Dr. 

Lynch had no previous criminal 

convictions related to matters within the 

jurisdiction of FDA (see section 

306(c)(3)(F) of the FD&C Act). Therefore, 

these will be treated as favorable factors. 

In light of the foregoing four 

considerations, one of which weighs 

against Dr. Lynch, debarment for 2 years 

is appropriate. 

III. Findings and Order 

Therefore, the Chief Scientist, under 

section 306(b)(2)(B)(i)(I) of the FD&C 

Act and under authority delegated to 

him, finds that Dr. Lynch has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating to the 

regulation of a drug product under the 

FD&C Act and that the conduct 

underlying the conviction undermines 

the regulation of drugs. FDA has 

considered the relevant factors listed in 

section 306(c)(3) of the FD&C Act and 

determined that a debarment of 2 years 

is appropriate. 

As a result of the foregoing findings, 

Dr. Lynch is debarred for 2 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), effective (see 

DATES) (see 21 U.S.C. 335a(c)(1)(B) and 

(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 

Any person with an approved, or 

pending, drug product application, who 

knowingly uses the services of Dr. 

Lynch, in any capacity during his 

period of debarment, will be subject to 

civil money penalties. If Dr. Lynch, 

during his period of debarment, 

provides services in any capacity to a 

person with an approved or pending 

drug product application he will be 

subject to civil money penalties. In 

addition, FDA will not accept or review 

any abbreviated new drug applications 

submitted by or with the assistance of 

Dr. Lynch during his period of 

debarment. 

Any application by Dr. Lynch for 

termination of debarment under section 

306(d) of the FD&C Act should be 

identified with Docket No. FDA–2010– 

N–0301 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). Publicly 

available submissions may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. Persons with access to 

the Internet may obtain documents in 

the Docket at http://

www.regulations.gov/. 

Dated: February 24, 2015. 

Stephen Ostroff, 

Director, Office of the Chief Scientist. 

[FR Doc. 2015–05044 Filed 3–4–15; 8:45 am] 

BILLING CODE 4164–01P 

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, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

publishing this notice of petitions 

received under the National Vaccine 

Injury Compensation Program (the 

Program), as required by Section 

2112(b)(2) of the Public Health Service 

(PHS) Act, as amended. While the 

Secretary of Health and Human Services 

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 11C–26, Rockville, MD 

20857; (301) 443–6593. 

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 Health and Human 

Services, 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 Section 

2114 of the PHS Act or as set forth at 

42 CFR 100.3, as applicable. This Table 

lists for each covered childhood vaccine 

the conditions which 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 

January 1, 2015, through January 31, 

2015. 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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12017 

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. ‘‘Sustained, 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. ‘‘Sustained, 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, Room 11C–26, Rockville, 

MD 20857. The Court’s caption 

(Petitioner’s Name v. Secretary of Health 

and Human Services) 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: February 25, 2015. 

Mary K. Wakefield, 

Administrator. 

List of Petitions Filed 

1. Jason Chevalier, Wakefield, Rhode Island, 

Court of Federal Claims No: 15–0001V 

2. Juan Alvarado, Rockaway Park, New York, 

Court of Federal Claims No: 15–0002V 

3. Kimberly Durgala, Johnson City, New 

York, Court of Federal Claims No: 15– 

0003V 

4. Leanell Jones, Fairfield, California, Court 

of Federal Claims No: 15–0004V 

5. Marion Eugene Hayward, Wellesley Hills, 

Massachusetts, Court of Federal Claims 

No: 15–0005V 

6. Kathleen Konen on behalf of Joseph 

Konen, Lexington, Michigan, Court of 

Federal Claims No: 15–0006V 

7. Deborah Valles, Oak Lawn, Illinois, Court 

of Federal Claims No: 15–0007V 

8. William Davis and Nicole Davis on behalf 

of Z.D., Lexington, North Carolina, Court 

of Federal Claims No: 15–0008V 

9. Wyatt Tanner, Columbus, Ohio, Court of 

Federal Claims No: 15–0011V 

10. John Ford, Charleston, South Carolina, 

Court of Federal Claims No: 15–0012V 

11. Martin Crowley, Parris Island, North 

Carolina, Court of Federal Claims No: 

15–0015V 

12. Candie Decker on behalf of A.D., Great 

Neck, New York, Court of Federal Claims 

No: 15–0017V 

13. Norman Reed, Bridgewater, 

Massachusetts, Court of Federal Claims 

No: 15–0018V 

14. Erica Vancleave, Mill Creek, Washington, 

Court of Federal Claims No: 15–0019V 

15. Linda Schorel, Hudson, Florida, Court of 

Federal Claims No: 15–0021V 

16. Oscar A. Dighero, Garden Grove, 

California, Court of Federal Claims No: 

15–0022V 

17. Brandie Terry, Brazoria, Texas, Court of 

Federal Claims No: 15–0023V 

18. Randall Ho, Chicago, Illinois, Court of 

Federal Claims No: 15–0025V 

19. Elaine Stout, Centreville, Virginia, Court 

of Federal Claims No: 15–0026V 

20. Rachael Hanna, Boston, Massachusetts, 

Court of Federal Claims No: 15–0031V 

21. Julie Reiling, Phoenix, Arizona, Court of 

Federal Claims No: 15–0032V 

22. Sherry Smith, Sarasota, Florida, Court of 

Federal Claims No: 15–0033V 

23. Rachel Faucher, Berlin, New Hampshire, 

Court of Federal Claims No: 15–0034V 

24. Cynthia Kuhn, Boston, Massachusetts, 

Court of Federal Claims No: 15–0035V 

25. Wahib Mashini, Irvine, California, Court 

of Federal Claims No: 15–0036V 

26. Patricia Lynne Spilman, Towson, 

Maryland, Court of Federal Claims No: 

15–0037V 

27. Linda Roche, Boston, Massachusetts, 

Court of Federal Claims No: 15–0038V 

28. Audra Najera, San Diego, California, 

Court of Federal Claims No: 15–0039V 

29. Jamie Emerson, Boston, Massachusetts, 

Court of Federal Claims No: 15–0042V 

30. Todd Carlson and Carrie Carlson on 

behalf of E.C., Vienna, Virginia, Court of 

Federal Claims No: 15–0043V 

31. Willard First, Langhorne, Pennsylvania, 

Court of Federal Claims No: 15–0047V 

32. Louis Danni, Niagara Falls, New York, 

Court of Federal Claims No: 15–0048V 

33. Violet Wilson, Auburn, California, Court 

of Federal Claims No: 15–0049V 

34. Douglas Tullio, Washington, District of 

Columbia, Court of Federal Claims No: 

15–0051V 

35. Timothy Kelly, Jackson, Michigan, Court 

of Federal Claims No: 15–0052V 

36. Craig Richardson, Princeton, New Jersey, 

Court of Federal Claims No: 15–0053V 

37. Thomas Steffens on behalf of William K. 

Woll, Deceased, Venice, Florida, Court of 

Federal Claims No: 15–0059V 

38. Rebeca Vega Henchys, Aguadilla, Puerto 

Rico, Court of Federal Claims No: 15– 

0060V 

39. Finnettia Garner, Houston, Texas, Court 

of Federal Claims No: 15–0063V 

40. Margaret Carpenter, Easton, 

Pennsylvania, Court of Federal Claims 

No: 15–0064V 

41. Leah Hawkins Bennett on behalf of 

Varnadora McNeal Hawkins, Deceased, 

Winter Haven, Florida, Court of Federal 

Claims No: 15–0065V 

42. Jillaine Burghardt, Lake Success, New 

York, Court of Federal Claims No: 15– 

0067V 

43. David Hoskins, Jr. on behalf of Annabelle 

Hoskins, Deceased, Huber Heights, Ohio, 

Court of Federal Claims No: 15–0071V 

44. Leslie Hammond, Ephraim, Utah, Court 

of Federal Claims No: 15–0072V 

45. Jose De La Cruz Herrera, Birmingham, 

Alabama, Court of Federal Claims No: 

15–0076V 

46. Laura Williams, Farmville, Virginia, 

Court of Federal Claims No: 15–0080V 

47. Phyllis Webb, Millsboro, Delaware, Court 

of Federal Claims No: 15–0081V 

48. Gail A. Clements on behalf of Ronald 

Clements, Deceased, Murrieta, 

California, Court of Federal Claims No: 

15–0083V 

49. Angelika Belgrade, Wilmington, 

Delaware, Court of Federal Claims No: 

15–0084V 

50. Sevela DePlush and Mykelle D’Tiole on 

behalf of M.J.D., Bayside, California, 

Court of Federal Claims No: 15–0085V 

51. Michelle Schneider on behalf of R.S., 

Leander, Texas, Court of Federal Claims 

No: 15–0086V 

52. Jacqueline Haim, Weston, Florida, Court 

of Federal Claims No: 15–0089V 

53. James Moore, Weston, Florida, Court of 

Federal Claims No: 15–0090V 

54. James Bojan on behalf of J.D.B., Baraboo, 

Wisconsin, Court of Federal Claims No: 

15–0091V 

55. Laurie Dart, St. Petersburg, Florida, Court 

of Federal Claims No: 15–0092V 

56. Colleen Dotson, El Cajon, California, 

Court of Federal Claims No: 15–0093V 

57. Gloria Massey Chinea, Irvine, California, 

Court of Federal Claims No: 15–0095V 

58. Anthony Forziati, Belmont, 

Massachusetts, Court of Federal Claims 

No: 15–0096V 

[FR Doc. 2015–05089 Filed 3–4–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering (NIBIB) 

Announcement of Requirements and 

Registration for the 2015 Design by 

Biomedical Undergraduate Teams 

(DEBUT) Challenge 

Authority: 15 U.S.C. 3719. 

SUMMARY: The National Institute of 

Biomedical Imaging and Bioengineering 

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