87380 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

This leads to administrative burdens 

and financial inefficiencies for the 

Agency and can be confusing for 

manufacturers that participate in other 

user fee programs. To address this issue, 

FDA is proposing that Congress shift the 

facility fee due date to October and 

change the liability period for annual 

facility fees to be the 12 months 

immediately preceding the start of the 

fiscal year for which the fees are due. 

The proposal also includes an option for 

the facility to be paid in two 

installments in the transition year to 

ease the burden on fee-paying 

companies. 

To ensure that FDA is adequately 

resourced with OMUFA fees, FDA is 

also proposing that Congress authorize a 

one-time adjustment in calculating 

annual target revenue if the average 

number of fee-liable facilities exceeds a 

particular number in certain years of 

OMUFA II. This would help 

accommodate the additional work 

required to oversee these facilities. If 

this adjustment is made, FDA is 

proposing it would be part of the base 

revenue going forward. Additionally, 

FDA is proposing that Congress reset the 

starting base revenue for OMUFA II to 

include the additional direct cost 

adjustment from the final year of 

OMUFA I, which reflects funding to 

support information technology 

operations and maintenance activities. 

H. Impact of OMUFA II Enhancements 

on User Fee Revenue 

To implement the proposed 

enhancements for OMUFA II, user fee 

funding for a cumulative total of 11 fulltime equivalent staff is proposed to be 

phased in by Congress over the course 

of OMUFA II. The proposed new 

funding will be phased in as follows, as 

an additional dollar amount in annual 

fee setting: 

• $2,373,000 for FY 2026. 

• $1,233,000 for FY 2027. 

• $854,000 for FY 2028. 

In addition, to support the other 

additional direct costs associated with 

the OMUFA II enhancements, the 

following amounts are proposed to be 

added as an additional direct cost 

adjustment: 

• $135,000 for FY 2026. 

• $300,000 for FY 2027. 

• $55,000 for FY 2028. 

• $30,000 for FY 2030. 

IV. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The public meeting will include a 

presentation by FDA and a series of 

invited panels representing different 

interested parties. For members of the 

public who would like to make verbal 

comments on the proposed 

enhancements and other 

recommendations (see instructions 

below), there will be a public comment 

period at the end of the meeting. 

Individuals can also submit written 

comments to the docket [LINK] before 

and after the meeting until December 

20, 2024. 

B. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting must 

register online by 11:59 p.m. Eastern 

Time on November 19, 2024, at https:// 

fda.zoomgov.com/webinar/register/WN_

aW5YWtFfQiyOSzkABY3G4A#/ 

registration. Provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone. 

Opportunity for Public Comment: 

Those who register online by November 

13, 2024, will have the opportunity to 

participate in the public comment 

session of the meeting. If you wish to 

speak during the public comment 

session, respond ‘‘yes’’ to that question 

in the registration form. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

those who wish to make a public 

comment during the meeting must be 

registered by November 13, 2024, at 

11:59 p.m. Eastern Time. We will 

determine the amount of time allotted to 

each commenter, the approximate time 

each comment is to begin, and will 

select and notify participants by 

November 18, 2024. No commercial or 

promotional material will be permitted 

to be presented at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. You will be asked to 

indicate in your registration if you plan 

to attend in person or via the webcast. 

The webcast for this public meeting is 

available at https://fda.zoomgov.com/ 

webinar/register/WN_

aW5YWtFfQiyOSzkABY3G4A#/ 

registration. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/drugs/ 

news-events-human-drugs/publicmeeting-recommendations-overcounter-monograph-drug-user-feeprogram-omufa-reauthorization. 

Dated: October 28, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25458 Filed 10–31–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Data System 

for Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than December 31, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland, 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Data System for Organ Procurement and 

Transplantation Network, OMB No. 

0915–0157—Revision. 

Abstract: Section 372 of the Public 

Health Service Act requires that the 

Secretary of Health and Human 

Services, by awards, provide for the 

establishment and operation of the 

Organ Procurement and Transplantation 

Network (OPTN), which, under HRSA’s 


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Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 87381 

oversight, operates the U.S. organ 

procurement and transplantation 

system. HRSA, in alignment with the 

Paperwork Reduction Act of 1995, 

submits OPTN Board of Directors 

(BOD)-approved data elements for 

collection to OMB for official Federal 

approval. 

Need and Proposed Use of the 

Information: HRSA and the OPTN BOD 

use data to develop transplant, 

procurement, and allocation policies; to 

determine whether institutional 

members are complying with policy; to 

determine member-specific 

performance; to ensure patient safety; 

and to fulfill the requirements of the 

OPTN Final Rule. In addition, the 

regulatory authority in 42 CFR 121.11 of 

the OPTN Final Rule requires the OPTN 

data to be made available, consistent 

with applicable laws, for use by OPTN 

members, the Scientific Registry of 

Transplant Recipients, the Department 

of Health and Human Services, and 

members of the public for evaluation, 

research, patient information, and other 

important purposes. 

This is a request to revise the current 

OPTN data collection which includes 

time-sensitive, life-critical data on 

transplant candidates and potential 

organ donors, the organ matching 

process, histocompatibility results, 

organ labeling and packaging, and preand post-transplantation data on 

recipients and donors. This revision 

includes OPTN BOD-approved changes 

to the existing OMB data collection 

forms. The OPTN collects these specific 

data elements from transplant hospitals, 

organ procurement organizations, and 

histocompatibility laboratories. 

HRSA and the OPTN use this 

information to (1) facilitate organ 

placement and match donor organs with 

recipients; (2) monitor compliance of 

member organizations with Federal laws 

and regulations and with OPTN 

requirements; (3) review and report 

periodically to the public on the status 

of organ donation, procurement, and 

transplantation in the United States; (4) 

provide data to researchers and 

government agencies to study the 

scientific and clinical status of organ 

transplantation; and (5) perform 

transplantation-related public health 

surveillance, including the possible 

transmission of donor disease. 

HRSA is requesting to make the 

following changes to improve the OPTN 

organ matching and allocation process 

and improve OPTN member compliance 

with OPTN requirements: 

(1) Adding data collection forms for 

candidates listed in the OPTN organ 

transplant waiting list to the existing 

OMB-approved information collection. 

These forms allow a transplant center to 

add, change, or remove candidates from 

the OPTN waiting list after a transplant 

center completes the patient evaluation. 

These forms contain information which 

the OPTN electronic organ matching 

system uses to match potential organ 

recipients with available deceased 

donor organs. There are 83 new data 

collection forms: candidate listing 

registration forms of all organs, 

candidate status justification forms of 

all applicable organs, Model for EndState Liver Disease or Pediatric EndStage Liver Disease (MELD/PELD) score 

exception and extension forms, and 

other forms. 

(2) OPTN BOD-approved revisions to 

existing data collection forms to 

improve organ matching, allocation, and 

OPTN policy compliance. 

Likely Respondents: Transplant 

Centers, Organ Procurement 

Organizations (OPOs), and 

Histocompatibility Laboratories. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

The estimated burden hours for this 

collection increased by 203,937.21 

hours from the currently approved ICR 

package. This increase included 

96,148.84 hours due to the addition of 

83 new data collection forms for the 

OPTN waiting list and 107,788.37 hours 

due to OPTN BOD-approved data 

collection changes to existing forms and 

changes in the number of respondents. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form # Form name Number of 

respondents 

Number of 

responses per 

respondent **** 

Total 

responses 

Average 

burden 

per 

response 

(in hours) 

Total 

burden 

hours 

1 ....................... Deceased Donor Registration .......................................................... 56 414.71 23,224 0.48 11,147.40 

2 ....................... Living Donor Registration ................................................................. 207 33.42 6,918 2.19 15,150.29 

3 ....................... Living Donor Follow-up .................................................................... 207 94.86 19,636 1.52 29,846.75 

4 ....................... Donor Histocompatibility .................................................................. 138 173.31 23,917 0.20 4,783.36 

5 ....................... Recipient Histocompatibility ............................................................. 138 307.09 42,378 0.40 16,951.37 

6 ....................... Heart Transplant Candidate Registration ........................................ 149 38.50 5,737 0.90 5,162.85 

7 ....................... Heart Transplant Recipient Registration .......................................... 149 30.50 4,545 1.96 8,907.22 

8 ....................... Heart Transplant Recipient Follow Up (6 Month) ............................ 149 27.79 4,141 0.40 1,656.28

9 ....................... Heart Transplant Recipient Follow Up (1–5 Year) ........................... 149 109.21 16,272 0.90 14,645.06 

10 ..................... Heart Transplant Recipient Follow Up (Post 5 Year) ...................... 149 183.73 27,376 0.50 13,687.89

11 ..................... Heart Post-Transplant Malignancy Form ......................................... 149 12.21 1,819 0.90 1,637.36 

12 ..................... Lung Transplant Candidate Registration ......................................... 74 45.36 3,357 0.95 3,188.81 

13 ..................... Lung Transplant Recipient Registration ........................................... 74 40.85 3,023 1.14 3,446.11 

14 ..................... Lung Transplant Recipient Follow Up (6 Month) ............................. 74 35.96 2,661 0.50 1,330.52 

15 ..................... Lung Transplant Recipient Follow Up (1–5 Year) ........................... 74 135.61 10,035 1.10 11,038.65

16 ..................... Lung Transplant Recipient Follow Up (Post 5 Year) ....................... 74 148.09 10,959 0.60 6,575.20 

17 ..................... Lung Post-Transplant Malignancy Form .......................................... 74 18.39 1,361 0.40 544.34

18 ..................... Heart/Lung Transplant Candidate Registration ............................... 72 1.03 74 1.16 86.03 

19 ..................... Heart/Lung Transplant Recipient Registration ................................. 72 0.75 54 2.09 112.86 

20 ..................... Heart/Lung Transplant Recipient Follow Up (6 Month) ................... 72 0.64 46 0.80 36.86 

21 ..................... Heart/Lung Transplant Recipient Follow Up (1–5 Year) ................. 72 2.46 177 1.10 194.83 

22 ..................... Heart/Lung Transplant Recipient Follow Up (Post 5 Year) ............. 72 3.35 241 0.60 144.72 

23 ..................... Heart/Lung Post-Transplant Malignancy Form ................................ 72 0.22 16 0.40 6.34 

24 ..................... Liver Transplant Candidate Registration ......................................... 142 103.39 14,681 0.80 11,745.10 

25 ..................... Liver Transplant Recipient Registration ........................................... 142 75.08 10,661 1.20 12,793.63 


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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form # Form name Number of 

respondents 

Number of 

responses per 

respondent   

Total 

responses 

Average 

burden 

per 

response 

(in hours) 

Total 

burden 

hours 

26 ..................... Liver Transplant Recipient Follow Up (6 Month–5 Year) ................ 142 344.55 48,926 1.00 48,926.10 

27 ..................... Liver Transplant Recipient Follow Up (Post 5 Year) ....................... 142 427.56 60,714 0.50 30,356.76 

28 ..................... Liver Recipient Explant Pathology Form ......................................... 142 7.17 1,018 0.60 610.88 

29 ..................... Liver Post-Transplant Malignancy Form .......................................... 142 21.21 3,012 0.80 2,409.46 

30 ..................... Intestine Transplant Candidate Registration .................................... 18 7.50 135 1.30 175.50 

31 ..................... Intestine Transplant Recipient Registration ..................................... 18 5.28 95 1.80 171.07 

32 ..................... Intestine Transplant Recipient Follow Up (6 Month–5 Year) ........... 18 21.50 387 1.50 580.50 

33 ..................... Intestine Transplant Recipient Follow Up (Post 5 Year) ................. 18 49.61 893 0.40 357.19 

34 ..................... Intestine Post-Transplant Malignancy Form .................................... 18 0.94 17 1.00 16.92 

35 ..................... Kidney Transplant Candidate Registration ...................................... 228 203.12 46,311 0.80 37,049.09 

36 ..................... Kidney Transplant Recipient Registration ........................................ 228 119.89 27,335 1.20 32,801.90 

37 ..................... Kidney Transplant Recipient Follow Up (6 Month–5 Year) ............. 228 571.22 130,238 0.90 117,214.34 

38 ..................... Kidney Transplant Recipient Follow Up (Post 5 Year) .................... 228 565.59 128,955 0.50 64,477.26

39 ..................... Kidney Post-Transplant Malignancy Form ....................................... 228 25.60 5,837 0.80 4,669.44 

40 ..................... Pancreas Transplant Candidate Registration .................................. 123 2.63 323 0.60 194.09 

41 ..................... Pancreas Transplant Recipient Registration ................................... 123 0.84 103 1.20 123.98 

42 ..................... Pancreas Transplant Recipient Follow Up (6 Month–5 Year) ......... 123 5.05 621 0.50 310.58 

43 ..................... Pancreas Transplant Recipient Follow Up (Post 5 Year) ................ 123 17.11 2,105 0.50 1,052.27 

44 ..................... Pancreas Post-Transplant Malignancy Form ................................... 123 0.76 93 0.60 56.09 

45 ..................... Kidney/Pancreas Transplant Candidate Registration ...................... 123 12.94 1,592 0.60 954.97 

46 ..................... Kidney/Pancreas Transplant Recipient Registration ....................... 123 6.59 811 1.20 972.68 

47 ..................... Kidney/Pancreas Transplant Recipient Follow Up (6 Month–5 

Year).

123 38.12 4,689 0.50 2,344.38 

48 ..................... Kidney/Pancreas Transplant Recipient Follow Up (Post 5 Year) .... 123 66.63 8,195 0.60 4,917.29 

49 ..................... Kidney/Pancreas Post-Transplant Malignancy Form ....................... 123 2.24 276 0.40 110.21 

50 ..................... VCA Transplant Candidate Registration .......................................... 23 1.00 23 0.40 9.20 

51 ..................... VCA Transplant Recipient Registration ........................................... 23 0.39 9 1.36 12.20 

52 ..................... VCA Transplant Recipient Follow Up .............................................. 23 2.30 53 1.31 69.30 

53 ..................... Organ Labeling and Packaging ....................................................... 56 298.27 16,703 0.18 3,006.56 

54 ..................... Organ Tracking and Validating ........................................................ 304 20.36 6,189 0.08 495.16 

55 ..................... Kidney Paired Donation Candidate Registration ............................. 156 0.34 53 0.26 13.79 

56 ..................... Kidney Paired Donation Donor Registration .................................... 156 0.99 154 1.08 166.80 

57 ..................... Kidney Paired Donation Match Offer Management ......................... 156 0.59 92 0.67 61.67 

58 ..................... Disease Transmission Event ........................................................... 304 2.33 708 0.60 424.99 

59 ..................... Living Donor Event ........................................................................... 207 0.15 31 0.56 17.39 

60 ..................... Safety Situation ................................................................................ 442 0.93 411 0.24 98.65 

61 ..................... Potential Disease Transmission Report ........................................... 56 11.09 621 1.27 788.72

62 ..................... Request to Unlock Form .................................................................. 442 174.67 77,204 0.02 1,544.08 

63 ..................... Initial Donor Registration .................................................................. 56 414.71 23,224 4.61 107,061.53 

64 ..................... OPO Notification Limit Administration .............................................. 56 9.52 533 0.17 90.63 

65 ..................... Potential Transplant Recipient ......................................................... 304 6,017.74 1,829,393 0.05 91,469.65 

66 ..................... Death Notification Registration **  ..................................................... 56 289.70 16,223 0.42 6,813.74 

67 ..................... Deceased Donor Death Referral ** .................................................. 56 58.11 3,254 0.50 1,627.08 

68 ..................... Donor Hospital Registration ............................................................. 56 0.04 2 0.08 0.18 

69 ..................... Donor Organ Disposition .................................................................. 56 414.71 23,224 0.17 3,948.04 

70 ..................... Transplant Center Contact Management ......................................... 248 808.10 200,409 0.06 12,024.53 

71 ..................... Adult Kidney Candidate Listing Registration *** ............................... 228 204.93 46,724 0.52 24,296.50 

72 ..................... Pediatric Kidney Candidate Listing Registration *** ......................... 101 11.66 1,178 0.47 553.50 

73 ..................... Adult Kidney Pancreas Candidate Listing Registration *** .............. 123 12.93 1,590 0.37 588.44 

74 ..................... Pediatric Kidney Pancreas Candidate Listing Registration *** ........ 29 0.07 2 0.30 0.61 

75 ..................... Adult Pancreas Candidate Listing Registration *** .......................... 123 15.29 1,881 0.38 714.65 

76 ..................... Pediatric Pancreas Candidate Listing Registration *** ..................... 30 1.13 34 0.38 12.88 

77 ..................... Adult Pancreas Islet Listing Registration ......................................... 16 2.06 33 0.38 12.52 

78 ..................... Pediatric Pancreas Islet Listing Registration *** .............................. 16 0.00 0 0.33 0.00 

79 ..................... Adult Liver Candidate Listing Registration *** .................................. 142 98.43 13,977 0.32 4,472.66 

80 ..................... Pediatric Liver Candidate Listing Registration *** ............................ 57 12.37 705 0.40 282.04 

81 ..................... Adult Intestine Candidate Listing Registration *** ............................ 18 4.94 89 0.38 33.79 

82 ..................... Pediatric Intestine Candidate Listing Registration *** ...................... 18 2.56 46 0.43 19.81 

83 ..................... Adult Heart Candidate Listing Registration *** ................................. 149 33.58 5,003 0.83 4,152.84 

84 ..................... Pediatric Heart Candidate Listing Registration *** ........................... 64 11.47 734 0.58 425.77 

85 ..................... Adult HeartLung Candidate Listing Registration *** ......................... 72 0.97 70 0.85 59.36 

86 ..................... Pediatric HeartLung Candidate Listing Registration *** ................... 27 0.15 4 0.93 3.77 

87 ..................... Adult Lung Candidate Listing Registration *** .................................. 74 44.85 3,319 1.00 3,318.90 

88 ..................... Pediatric Lung Candidate Listing Registration *** ............................ 45 0.84 38 0.83 31.37 

89 ..................... Candidate Registration Listing Removal *** ..................................... 248 289.27 71,739 0.18 12,913.01 

90 ..................... VCA Abdominal Wall Candidate Listing Registration *** ................. 8 0.38 3 0.33 1.00 

91 ..................... VCA External Male Genitalia Candidate Listing Registration *** ..... 2 0.00 0 0.33 0.00 

92 ..................... VCA Head and Neck Candidate Listing Registration *** ................. 10 0.50 5 0.33 1.65 

93 ..................... VCA Lower Limb Candidate Listing Registration *** ........................ 4 0.00 0 0.33 0.00 

94 ..................... VCA Musculoskeletal Composite Graft Segment Candidate Listing 

Registration ***.

2 0.00 0 0.33 0.00 

95 ..................... VCA Other Genitourinary Organ Candidate Listing Registration *** 3 0.00 0 0.33 0.00 

96 ..................... VCA Spleen Candidate Listing Registration *** ............................... 0 0.00 0 0.33 0.00 

97 ..................... VCA Upper Limb Candidate Listing Registration *** ........................ 11 0.27 3 0.33 0.98 

98 ..................... VCA Uterus Candidate Listing Registration *** ................................ 6 2.00 12 0.33 3.96 

99 ..................... VCA Vascularized Gland Candidate Listing Registration *** ........... 8 0.00 0 0.33 0.00 

100 ................... Organ Export Verification Form *** .................................................. 56 0.46 26 0.03 0.77 

101 ................... OPTN Waiting Time Transfer Form *** ............................................ 248 5.54 1,374 0.23 316.00 


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TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form # Form name Number of 

respondents 

Number of 

responses per 

respondent   

Total 

responses 

Average 

burden 

per 

response 

(in hours) 

Total 

burden 

hours 

102 ................... OPTN Waiting Time Modification Form ** * ...................................... 248 59.40 14,731 0.22 3,240.86 

103 ................... OPTN Renal Waiting Time Reinstatement Form *** ........................ 228 1.21 276 0.27 74.49 

104 ................... OPTN Pancreas Waiting Time Reinstatement Form *** .................. 123 0.03 4 0.20 0.74 

105 ................... Intestinal Waiting Time Reinstatement Form *** .............................. 18 0.00 0 0.25 0.00 

106 ................... Prior Living Donor Priority *** ........................................................... 228 0.25 57 0.27 15.39 

107 ................... Kidney Minimum Acceptance Criteria *** ......................................... 228 0.47 107 0.30 32.15 

108 ................... Adult Liver Status 1A Initial Justification and Extension Form *** ... 142 2.31 328 0.57 186.97 

109 ................... Pediatric Liver Status 1A Initial Justification and Extension 

Form ***.

57 2.30 131 0.57 74.73 

110 ................... Pediatric Liver Status 1B Initial Justification and Extension 

Form ***.

57 5.61 320 0.47 150.29 

111 ................... Liver Cholangiocarcinoma (CCA) Initial MELD/PELD Score Exception Form ***.142 0.42 60 0.43 25.65 

112 ................... Liver Cholangiocarcinoma (CCA) MELD/PELD Score Exception 

Extension Form ***.

142 0.34 48 0.32 15.45 

113 ................... Liver Cystic Fibrosis (CF) Initial MELD/PELD Score Exception and 

Extension Form ***.

142 0.10 14 0.33 4.69 

114 ................... Liver Familial Amyloid Polyneuropathy (FAP) Initial MELD/PELD 

Score Exception Form ***.

142 0.04 6 0.40 2.27 

115 ................... Liver Familial Amyloid Polyneuropathy (FAP) MELD/PELD Score 

Exception Extension Form ***.

142 0.05 7 0.30 2.13 

116 ................... Liver Hepatic Artery Thrombosis (HAT) Initial MELD/PELD Score 

Exception and Extension Form ***.

142 0.69 98 0.35 34.29 

117 ................... Liver Hepatocellular Carcinoma (HCC) Initial MELD/PELD Score 

Exception Form ***.

142 23.30 3,309 0.47 1,555.04 

118 ................... Liver Hepatocellular Carcinoma (HCC) MELD/PELD Score Exception Extension Form ***.142 33.21 4,716 0.35 1,650.54 

119 ................... Liver Hepatopulmonary Syndrome (HPS) Initial MELD/PELD 

Score Exception Form ***.

142 1.39 197 0.32 63.16 

120 ................... Liver Hepatopulmonary Syndrome (HPS) MELD/PELD Score Exception Extension Form ***.142 0.99 141 0.25 35.15 

121 ................... Liver Metabolic Disease Initial MELD/PELD Score Exception and 

Extension Form ***.

142 0.77 109 0.28 30.62 

122 ................... Liver Portopulmonary Hypertension Initial MELD/PELD Score Exception Form ***.142 0.51 72 0.42 30.42 

123 ................... Liver Portopulmonary Hypertension MELD/PELD Score Exception 

Extension Form ***.

142 0.36 51 0.33 16.87 

124 ................... Liver Primary Hyperoxaluria Initial MELD/PELD Score Exception 

and Extension Form ***.

142 0.13 18 0.35 6.46 

125 ................... Liver Other Diagnosis Initial MELD/PELD Score Exception and 

Extension Form ***.

142 12.03 1,708 0.35 597.89 

126 ................... Pediatric Heart and HeartLung Status 1A Initial Justification 

Form ***.

64 16.06 1,028 0.52 534.48 

127 ................... Pediatric Heart and HeartLung Status 1A Extension and Appeal 

Justification Forms ***.

64 54.61 3,495 0.47 1,642.67 

128 ................... Pediatric Heart and HeartLung Status 1B Initial Justification 

Form ***.

64 7.31 468 0.42 196.49 

129 ................... Adult Heart and HeartLung Status 1–6 Justification Form Demographic Data ***.149 135.78 20,231 0.32 6,473.99 

130 ................... Adult Heart and HeartLung Status 1–6 Justification Form Risk 

Stratification Data ***.

149 135.78 20,231 0.72 14,566.48 

131 ................... Adult Heart and HeartLung Status 1 Initial Justification Form Medical Urgency Data ***.149 5.69 848 0.58 491.73 

132 ................... Adult Heart and HeartLung Status 1 Exception Extension Justification Form Medical Urgency Data ***.149 0.46 69 0.33 22.62 

133 ................... Adult Heart and HeartLung Status 1 Criteria 1 Extension Justification Form Medical Urgency Data ***.149 0.43 64 0.53 33.96 

134 ................... Adult Heart and HeartLung Status 2 Initial Justification Form Medical Urgency Data ***.149 25.91 3,861 0.80 3,088.47 

135 ................... Adult Heart and HeartLung Status 2 Exception Extension Justification Form Medical Urgency Data ***.149 9.87 1,471 0.33 485.31 

136 ................... Adult Heart and HeartLung Status 2 Criteria 1 Extension Justification Form Medical Urgency Data ***.149 0.03 4 0.42 1.88 

137 ................... Adult Heart and HeartLung Status 2 Criteria 4 Extension Justification Form Medical Urgency Data ***.149 3.05 454 0.63 286.30 

138 ................... Adult Heart and HeartLung Status 2 Criteria 5 Extension Justification Form Medical Urgency Data ***.149 1.70 253 0.60 151.98 

139 ................... Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data ***.149 11.91 1,775 0.63 1,117.99 

140 ................... Adult Heart and HeartLung Status 3 Exception Extension Justification Form Medical Urgency Data ***.149 6.88 1,025 0.33 338.29 

141 ................... Adult Heart and HeartLung Status 3 Criteria 2 Extension Justification Form Medical Urgency Data ***.149 0.64 95 0.32 30.52 

142 ................... Adult Heart and HeartLung Status 3 Criteria 5 Extension Justification Form Medical Urgency Data ***.149 0.11 16 0.48 7.87 

143 ................... Adult Heart and HeartLung Status 4 Initial Justification Form Medical Urgency Data ***.149 23.51 3,503 0.50 1,751.50 


khammond on DSKJM1Z7X2PROD with NOTICES
87384 Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form # Form name Number of 

respondents 

Number of 

responses per 

respondent   

Total 

responses 

Average 

burden 

per 

response 

(in hours) 

Total 

burden 

hours 

144 ................... Adult Heart and HeartLung Status 4 Exception Extension Justification Form Medical Urgency Data ** *.149 1.73 258 0.25 64.44 

145 ................... Adult Heart and HeartLung Status 4 Criteria 2 Extension Justification Form Medical Urgency Data ***.149 0.56 83 0.40 33.38 

146 ................... Adult and Pediatric Lung and HeartLung Goal Exception Form *** 149 3.72 554 0.75 415.71 

147 ................... Pediatric Lung Priority 1 Status Justification Form *** ..................... 45 1.16 52 0.33 17.23 

148 ................... Review Board Voter Form *** ........................................................... 248 22.46 5,570 0.23 1,281.12 

149 ................... Living Donor Feedback Form *** ...................................................... 207 37.73 7,810 0.13 1,015.31 

150 ................... Extra Vessels Reporting Form *** .................................................... 248 53.71 13,320 0.03 399.60 

151 ................... Non-US Transplants Reporting Form *** ......................................... 228 0.00 0 0.03 0.00 

152 ................... Discrepant HLA Typings Reporting Form *** ................................... 138 0.78 108 5.17 556.50 

153 ................... Interim Event Reporting Form *** ..................................................... 248 72.58 18,000 0.06 1,079.99 

Total .......................................................................................... 18,697 .............................. 3,184,246 .................... 851,565.51 

* The numbers of respondents and the numbers of total responses in the burden table were updated with 2023 OPTN data and reflect increases in the number of 

organ transplants and changes in the number of respondents (Transplant Centers, OPOs, and Histocompatibility Labs). 

** These two forms will not be used once the OPTN Process Data OMB package is approved and implemented. The OPTN Process Data OMB package is new 

and will be considered separate from this package. We are including these forms in this collection to avoid any lapse in approval of these forms while the OPTN 

Process Data package is being approved. 

*** These are new forms. 

**** If a form has 0.00 under average number of responses, this is an indicator that there were no submissions in calendar year 2023. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Amy P. McNulty, 

Deputy Director, Executive Secretariat. 

[FR Doc. 2024–25506 Filed 10–31–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory Child 

Health and Human Development 

Council. The meeting will be held as a 

virtual meeting and will be open to the 

public as indicated below. Individuals 

who plan to view the virtual meeting 

and need special assistance or other 

reasonable accommodations to view the 

meeting, should notify the Contact 

Person listed below in advance of the 

meeting. The meeting can be accessed 

from the NIH Videocast at the following 

link: https://videocast.nih.gov/. 

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: National Advisory 

Child Health and Human Development 

Council. 

Date: January 13–14, 2025. 

Open: January 13, 2025, 12:00 p.m. to 5:00 

p.m. 

Agenda: NICHD Director’s Report and 

other Council Business. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Closed: January 14, 2025, 9:00 a.m. to 12:15 

p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Rebekah S. Rasooly, Ph.D., 

Director, Division of Extramural Activities, 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development, 

National Institute of Health, 6710B Rockledge 

Drive, Room: 2316, Bethesda, MD 20817. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Persons listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nichd.nih.gov/about/advisory/council, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 28, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–25420 Filed 10–31–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, NIDDK. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 


khammond on DSKJM1Z7X2PROD with NOTICES