Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29793 

DATES: Fax written comments on the 

collection of information by July 26, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0718. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Assessing User 

Fees Under the Biosimilar User Fee 

Amendments of 2017 

OMB Control Number 0910–0718— 

Revision 

This information collection supports 

the above captioned Agency guidance 

and implementation of the Biosimilar 

User Fee Amendments of 2017 (BsUFA 

II). Under BsUFA II, FDA’s authority is 

extended to collect user fees from fiscal 

years 2018–2022 and includes a number 

of technical revisions that affect what 

fees and how fees are collected. Fees 

authorized by this legislation help fund 

the review process for biosimilar 

biological product applications and play 

an important role in expediting the 

review and approval process. 

We have developed the guidance 

document entitled ‘‘Assessing User Fees 

Under the Biosimilar User Fee 

Amendments of 2017’’ to assist industry 

in understanding when these fees are 

incurred and the process by which 

applicants can submit payments. The 

guidance also provides information on 

the consequences of failing to pay 

BsUFA II fees, as well as processes for 

submitting reconsideration and appeal 

requests. The guidance document is 

available on our website at: https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM584984.pdf. 

In the Federal Register of November 

16, 2017 (82 FR 53505), we published a 

notice announcing availability of the 

subject guidance document, including a 

60-day notice requesting public 

comment on the information collection. 

One comment was received in response 

to the notice from a trade organization 

indicating that interested persons ‘‘have 

reviewed the draft guidance and 

appreciate(s) FDA applying the user fee 

provisions consistent with the BsUFA II 

negotiations and Commitment Letter.’’ 

In addition, and upon our own review, 

we believe it is appropriate to include 

the guidance document under the 

existing information collection 

‘‘Biosimilar User Fee Cover Sheet’’ 

currently approved under OMB control 

number 0910–0718 rather than to 

establish a new collection. FDA is 

preparing to renew OMB control 

number 0910–0718 and will include the 

guidance document accordingly. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Request for discontinuation from biological product development 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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

* 30 minutes. 

Our estimate is based on the number 

of Biosimilars User Fee submissions we 

have received since establishing the 

program. 

Dated: June 21, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–13688 Filed 6–25–18; 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 


sradovich on DSK3GMQ082PROD with NOTICES
29794 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 

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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 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 


sradovich on DSK3GMQ082PROD with NOTICES
29796 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Proposed Standards for the Children’s 

Hospitals Graduate Medical Education 

Payment Program’s Quality Bonus 

System 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Final response. 

SUMMARY: HRSA published a notice in 

the Federal Register on October 11, 

2017, soliciting feedback on the 

establishment of the Children’s 

Hospitals Graduate Medical Education 

Payment (CHGME) Program’s Quality 

Bonus System (QBS). In particular, 

HRSA requested feedback on the Fiscal 

Year (FY) 2019 and beyond multi-step 

implementation of the system, including 

demonstration of engagement in state or 

regional-level initiatives, 

documentation, and payment structure. 

This notice summarizes and responds to 

the comments received during the 60- 

day comment period. 

ADDRESSES: Additional information 

about the CHGME is available at https:// 

bhw.hrsa.gov/grants/medicine/chgme. 

FOR FURTHER INFORMATION CONTACT: 

Malena Crawford, Project Officer, 

Children’s Hospitals Graduate Medical 

Education Payment Program, Division of 

Medicine and Dentistry, HRSA at 

MCrawford@hrsa.gov or (301) 443–7334. 

SUPPLEMENTARY INFORMATION: The 

CHGME statute was amended in 2013. 

The amendments permit up to 25 

percent of the total amount appropriated 

annually in excess of $245 million, but 

not to exceed $7,000,000, to provide 

payments to newly qualified hospitals, 

as defined in section 340E(h) of the 

Public Health Service Act. The statute 

additionally states that the Secretary 

may establish a quality bonus system for 

CHGME hospitals using any remaining 

funds after payments are made to newly 

qualified hospitals. In FY 2018, 

Congress appropriated $315 million to 

the CHGME Program. Of this, 

approximately $4 million in payments 

were made to newly qualified hospitals. 

If funding levels and mechanisms 

remain constant in FY 2019, it is 

estimated that approximately $3 million 

may be available annually for the 

CHGME QBS. 

On October 16, 2017, through a 

Federal Register Notice (FRN), HRSA 

announced a 60-day public comment 

period to solicit input on the CHGME 

QBS proposed standards. HRSA 

proposed a multi-step implementation 

beginning in FY 2019 that initially will 

recognize high-level engagement of 

CHGME hospitals in state and regional 

health care transformation, as well as 

engagement of resident trainees in these 

activities. HRSA sought public comment 

on the timeline, eligibility, standards, 

documentation, and payment structure 

as described in the FRN. HRSA also 

requested comment on proposed QBS 

measures, potential data sources, and 

tiering of QBS payments for FY 2020 

and beyond. HRSA received feedback 

on the following program components 

in response to the FRN: 

• QBS Goals 

• Qualifying Initiatives for the FY 2019 

QBS 

• Measures and Metrics 

• Payment Structure 

• Documentation, Reporting 

Requirements and Reducing 

Reporting Burden 

• Implementation Timeline for FY 2020 

and Beyond 

HRSA carefully reviewed the 

comments received and used them to 

guide the development of the FY 2019 

CHGME QBS and to inform future 

iterations of the CHGME QBS. Final 

guidance for the FY 2019 CHGME QBS 

will be published in the FY 2019 

CHGME Notice of Funding Opportunity 

(NOFO). 

Comments on the Proposed Standards 

of the Quality Bonus System 

HRSA received 17 responses to the 

request for comments. Thirteen 

commenters are current CHGME 

hospitals and four are state/national 

associations. Comments are summarized 

below. 

QBS Goals 

Summary of Comments 

Nearly all commenters supported 

establishing the CHGME QBS to 

recognize and reward quality training 

programs for residents supported by the 

CHGME program and agreed with the 

approach to recognize engagement in 

initiatives geared towards transforming 

pediatric health care to improve access, 

quality, and cost effectiveness. 

However, many commenters questioned 

whether there was enough information 

about these initiatives to establish a 

baseline, draw comparisons between 

children’s hospitals, and make 

judgements about relative performance. 

Several suggested the proposed 

approach could be enhanced by starting 

with documentation of transformation 

activities in which residents are 

involved. Specifically, one commenter 

recommended ‘‘that HRSA work to 

identify current residents’ engagement 

in quality initiatives and how residents 

can further engage on broader based 

initiatives before transitioning the 

Quality Bonus Program to other criteria 

in FY 2020 and beyond.’’ A few 

commenters also requested that HRSA 

offer more clear and specific goals for 

the multi-step implementation of the 

QBS. 

Response 

After considering feedback from 

stakeholders, the revised goal of the 

QBS will be to recognize hospitals for 

quality improvement & GME 

transformation efforts in high priority 

focus areas and build standards to 

increase engagement and involvement 

of residents in broader initiatives. HRSA 

will implement a baseline phase for 

CHGME QBS in FY 2019. Information 

collected during this baseline phase will 

be used to establish QBS standards for 

implementation in FY 2021. In order to 

qualify for the QBS payment, CHGME 

awardees must submit documentation 

in the FY 2019 reconciliation 

application describing the hospital’s 

initiatives, resident curriculum, and 

direct resident involvement in the 

following areas: Integrated care models, 

telehealth/HIT, population health, 

social determinants of health, and 

additional initiatives to improve access 


sradovich on DSK3GMQ082PROD with NOTICES