Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Notices 78093 

event before, test your connection at 

https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit http://www.adobe.com/

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Comments: FDA is holding this public 

workshop to obtain feedback from the 

community on the questions in the 

discussion paper. In order to permit the 

widest possible opportunity to obtain 

public comment, FDA is soliciting 

either electronic or written comments 

on all aspects of the public workshop 

topics. The deadline for submitting 

comments related to this public 

workshop is March 20, 2015. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section II, please identify 

the question you are addressing. 

Received comments may be seen in the 

Division of Dockets Management 

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

through Friday, and will be posted to 

the docket at http://

www.regulations.gov. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available 

approximately 45 days after the public 

workshop on the Internet at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this public 

workshop from the posted events list). 

I. Background 

In vitro diagnostic devices, including 

laboratory-developed tests that utilize 

NGS technology to generate information 

on an individual’s genome, are rapidly 

transforming healthcare. Because NGS 

tests generate large amounts of data and 

consequently may have relatively broad 

or undefined intended uses or 

indications, these tests pose certain 

challenges during review of premarket 

submissions. At the same time, this 

large amount of data provides 

opportunities for novel approaches to 

assure the analytical and clinical 

validity of NGS tests. FDA is committed 

to providing efficient and effective 

oversight for NGS tests to assure their 

safety and effectiveness. By doing so, 

FDA will promote innovation and 

advance precision medicine. The 

Agency is therefore requesting public 

input on the regulatory strategy for NGS 

tests that produce results on variation in 

the human genome. Further details of 

current and new approaches that may be 

considered in the workshop are outlined 

in the discussion paper entitled 

‘‘Optimizing FDA’s Regulatory 

Oversight of Next Generation 

Sequencing Diagnostic Tests’’ available 

at http://www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this public 

workshop from the posted events list). 

II. Topics for Discussion at the Public 

Workshop 

The workshop discussion will focus 

on regulatory strategies to assure the 

analytical and clinical validity of NGS 

tests. Specific topics to be discussed at 

the workshop are outlined in the 

discussion paper entitled ‘‘Optimizing 

FDA’s Regulatory Oversight of Next 

Generation Sequencing Diagnostic 

Tests’’ available at http://www.fda.gov/

MedicalDevices/NewsEvents/

WorkshopsConferences/default.htm. 

(Select this public workshop from the 

posted events list). A detailed agenda 

will be posted on this Web site in 

advance of the workshop. 

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30308 Filed 12–22–14; 4:15 pm] 

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, 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 


tkelley on DSK3SPTVN1PROD with NOTICES
78094 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Notices 

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 

November 1, 2014, through November 

30, 2014. 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) ‘‘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: December 17, 2014. 

Mary K. Wakefield, 

Administrator. 

List of Petitions Filed 

1. Candi Gonzalez on behalf of Marley 

Alecia-Sapphire Morales, Linwood, 

New Jersey, Court of Federal Claims 

No: 14–1072V. 

2. Rosemary West, Walnut Creek, 

California, Court of Federal Claims 

No: 14–1073V. 

3. Michael Smith, Kalispell, Montana, 

Court of Federal Claims No: 14– 

1074V. 

4. Karen Comeiro, Boston, 

Massachusetts, Court of Federal 

Claims No: 14–1075V. 

5. Louis Mansolillo, Providence, Rhode 

Island, Court of Federal Claims No: 

14–1080V. 

6. Donald Weiss, Rossford, Ohio, Court 

of Federal Claims No: 14–1081V. 

7. Lynn Henderson, Lafayette, Indiana, 

Court of Federal Claims No: 14– 

1082V. 

8. Marilyn Witbrodt, Palm Harbor, 

Florida, Court of Federal Claims No: 

14–1086V. 

9. Martha Scrantom, Hillsborough, 

North Carolina, Court of Federal 

Claims No: 14–1087V. 

10. Stephanie Stout on behalf of Z. S., 

Louisville, Kentucky, Court of 

Federal Claims No: 14–1088V. 

11. Howard McCosh, Provo, Utah, Court 

of Federal Claims No: 14–1089V. 

12. Virgil Kim, Bothell, Washington, 

Court of Federal Claims No: 14– 

1090V. 

13. Natalee Hessell, Troy, Michigan, 

Court of Federal Claims No: 14– 

1091V. 

14. Jasmine Morgan on behalf of C. S., 

Deceased, Roanoke, Virginia, Court 

of Federal Claims No: 14–1094V. 

15. Kristen Walter, Mt. Holly, New 

Jersey, Court of Federal Claims No: 

14–1095V. 

16. Milford B. Reiman, Wellesley Hills, 

Massachusetts, Court of Federal 

Claims No: 14–1096V. 

17. Janice Steinkamp, Lincoln, 

Nebraska, Court of Federal Claims 

No: 14–1097V. 

18. Jeffrey Edgar, Marblehead, 

Massachusetts, Court of Federal 

Claims No: 14–1098V. 

19. Nicholas J. Xanthopoulos, St. Paul, 

Minnesota, Court of Federal Claims 

No: 14–1101V. 

20. Kayla Nichols and Jason Nichols on 

behalf of Noah Nichols, Phoenix, 

Arizona, Court of Federal Claims 

No: 14–1103V. 

21. Kristina Ries on behalf of Nickolas 

Ries, Deceased, Phoenix, Arizona, 

Court of Federal Claims No: 14– 

1104V. 

22. Noemi Frette on behalf of N. F., 

Scottsdale, Arizona, Court of 

Federal Claims No: 14–1105V. 

23. Kathi Aho, St. Cloud, Minnesota, 

Court of Federal Claims No: 14– 

1106V. 

24. Matthew Smith and Michelle Smith 

on behalf of M. S., Chicago, Illinois, 

Court of Federal Claims No: 14– 

1107V. 

25. Suzanne Fuhri on behalf of Thomas 

Fic, Chicago, Illinois, Court of 

Federal Claims No: 14–1108V. 

26. Purvi Desai-Leyva, Albany, New 

York, Court of Federal Claims No: 

14–1109V. 

27. Olga Molina, San Antonio, Texas, 

Court of Federal Claims No: 14– 

1110V. 

28. Eula Jane Matthews, Cleburne, 

Texas, Court of Federal Claims No: 

14–1111V. 

29. Ashley Puroll on behalf of P. H., 

Muskegon, Michigan, Court of 

Federal Claims No: 14–1112V. 

30. Paul Judge, Glen Rock, New Jersey, 

Court of Federal Claims No: 14– 

1113V. 

31. Antoinette McCormick, College 

Station, Texas, Court of Federal 

Claims No: 14–1114V. 

32. Daniel E. McKinney, Berkeley 

Heights, New Jersey, Court of 

Federal Claims No: 14–1116V. 

33. Robin McCarthy-Stancavage on 

behalf of A. S., Severna Park, 

Maryland, Court of Federal Claims 

No: 14–1117V. 

34. Cornell Yellen, Souderton, 

Pennsylvania, Court of Federal 

Claims No: 14–1118V. 

35. Eva Cruz and Omar Lopez Jiminez 

on behalf of L. J. L., Deceased, Las 

Vegas, Nevada, Court of Federal 

Claims No: 14–1119V. 

36. Elmer D. McKercher, Duluth, 

Minnesota, Court of Federal Claims 

No: 14–1124V. 

37. Barbara Goforth, Farmville, Virginia, 

Court of Federal Claims No: 14– 

1128V. 

38. Teresa Bray, Green Bay, Wisconsin, 

Court of Federal Claims No: 14– 

1131V. 

39. Judith Rosenfield, Sherman Oaks, 

California, Court of Federal Claims 

No: 14–1132V. 

40. Jose Guadalupe Garcia, II, Pasadena, 

Texas, Court of Federal Claims No: 

14–1136V. 

41. Robert Handeyside, Saginaw, 

Michigan, Court of Federal Claims 

No: 14–1137V. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Notices 78095 

42. Marlie Dulaurier, M.D., Columbus, 

Ohio, Court of Federal Claims No: 

14–1138V. 

43. Larry Thompson, Lynchburg, 

Virginia, Court of Federal Claims 

No: 14–1139V. 

44. Richard Greenslade, Ann Arbor, 

Michigan, Court of Federal Claims 

No: 14–1140V. 

45. Navid Nourani, Tempe, Arizona, 

Court of Federal Claims No: 14– 

1142V. 

46. Andrew Funk, Tempe, Arizona, 

Court of Federal Claims No: 14– 

1143V. 

47. Duke Duquette, Uxbridge, 

Massachusetts, Court of Federal 

Claims No: 14–1144V. 

48. Candace Johnson, Portland, Oregon, 

Court of Federal Claims No: 14– 

1145V. 

49. Thalia Monsha Stallworth Lewis on 

behalf of Alton Jerome Lewis, 

Deceased, Birmingham, Alabama, 

Court of Federal Claims No: 14– 

1147V. 

50. Billy Whitchurch, Dallas, Texas, 

Court of Federal Claims No: 14– 

1148V. 

51. Andrea Gasaway, Dallas, Tennessee, 

Court of Federal Claims No: 14– 

1149V. 

52. Barbara Budgake, Rahway, New 

Jersey, Court of Federal Claims No: 

14–1150V. 

53. Douglas A. Dinunzio, Charlotte, 

North Carolina, Court of Federal 

Claims No: 14–1151V. 

54. Imogene B. Fowler, Tuscaloosa, 

Alabama, Court of Federal Claims 

No: 14–1152V. 

55. Mary Daniels, Boston, 

Massachusetts, Court of Federal 

Claims No: 14–1153V. 

56. Amy Junker, Frederick, Maryland, 

Court of Federal Claims No: 14– 

1155V. 

57. Paula Pasquinelli, Carnegie, 

Pennsylvania, Court of Federal 

Claims No: 14–1156V. 

[FR Doc. 2014–30402 Filed 12–24–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings 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: Cell Biology 

Integrated Review Group; Nuclear and 

Cytoplasmic Structure/Function and 

Dynamics Study Section. 

Date: January 29–30, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW., 

Washington, DC 20015. 

Contact Person: David Balasundaram, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5189, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1022, balasundaramd@csr.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group; 

Psychosocial Risk and Disease Prevention 

Study Section. 

Date: January 29–30, 2015. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Villa Florence Hotel, 225 Powell 

Street, San Francisco, CA 94102, 

Contact Person: Stacey FitzSimmons, 

Ph.D., MPH, Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7808, Bethesda, MD 20892, (301) 451– 

9956, fitzsimmonss@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Psychosocial Risk and Disease Prevention. 

Date: January 29, 2015. 

Time: 10:30 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Villa Florence Hotel, 225 Powell 

Street, San Francisco, CA 94102. 

Contact Person: Kristen Prentice, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3112, 

MSC 7808, Bethesda, MD 20892, (301) 496– 

0726, prenticekj@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR 13–374 

Modeling of Social Behavior. 

Date: January 29, 2015. 

Time: 12:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Jacinta Bronte-Tinkew, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3164, 

MSC 7770, Bethesda, MD 20892, (301) 806– 

0009, brontetinkewjm@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846-93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: December 19, 2014. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–30257 Filed 12–24–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Correction for National 

Institute of Neurological Disorders and 

Stroke, Interagency Pain Research 

Coordinating Committee Call for 

Committee Membership Nominations 

The National Institutes of Health 

(NIH) is correcting a notice previously 

published in the Federal Register on 

December 15, 2014 (79 FR 74102) and 

titled ‘‘National Institute of Neurological 

Disorders and Stroke, Interagency Pain 

Research Coordinating Committee Call 

for Committee Membership 

Nominations.’’ The notice announced 

that The Department of Health and 

Human Services (HHS) is seeking 

nominations for the Interagency Pain 

Research Coordinating Committee. 

NIH is amending the due date for 

nominations from January 5, 2015, as 

stated toward the end of the notice, to 

January 12, 2015. For further 

information about the meeting, please 

contact Linda Porter, Ph.D., porterl@ 

ninds.nih.gov. 

Dated: December 16, 2014. 

Walter J. Koroshetz, 

Acting Director, National Institute of 

Neurological Disorders and Stroke, National 

Institutes of Health. 

[FR Doc. 2014–30387 Filed 12–24–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

35). To request a copy of these 


tkelley on DSK3SPTVN1PROD with NOTICES