87592 Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices 

available a draft guidance for FDA staff 

entitled ‘‘Sec. 540.525 Scombrotoxin 

(Histamine)-forming Fish and Fishery 

Products—Decomposition and 

Histamine (CPG 7108.24)’’ and gave 

interested parties an opportunity to 

submit comments by February 25, 2022, 

for us to consider before beginning work 

on the final version of the guidance. In 

the Federal Register of March 15, 2022 

(87 FR 14538), in response to a request 

from stakeholders, we reopened the 

comment period until April 14, 2022. 

We received comments on the draft 

guidance and have modified the final 

guidance where appropriate. Changes to 

the guidance include the addition of a 

detailed explanation for our revisions to 

the histamine levels set forth in the 

guidance. The guidance announced in 

this notice finalizes the draft guidance 

dated December 2021. 

II. Paperwork Reduction Act of 1995 

This guidance contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/FoodGuidances or https:// 

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: October 22, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25315 Filed 11–1–24; 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: Process Data 

for Organ Procurement and 

Transplantation Network 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

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 

and any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than January 3, 2025. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, MD 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 

information collection request title for 

reference. 

Information Collection Request Title: 

Process Data for Organ Procurement and 

Transplantation Network, OMB No. 

0906–xxxx—New. 

Abstract: Section 372 of the Public 

Health Service Act requires that the 

Secretary of HHS, by awards, provide 

for the establishment and operation of 

the Organ Procurement and 

Transplantation Network (OPTN), 

which, under oversight of the HRSA, 

operates the U.S. procurement and 

transplantation system. The Secretary 

and/or HRSA may direct the collection 

of data in accordance with the 

regulatory authority in 42 CFR 121.11 of 

the OPTN Final Rule. HRSA, in 

alignment with the Paperwork 

Reduction Act of 1995, submits data 

elements for collection to OMB for 

official federal approval. 

Need and Proposed Use of the 

Information: HRSA and the OPTN 

Board of Directors use data to develop 

transplant, procurement, and allocation 

policies; to determine whether 

institutional members are complying 

with policy; to determine memberspecific performance; to ensure patient 

safety, and to fulfill the requirements of 

the OPTN Final Rule. The regulatory 

authority in 42 CFR 121.11 of the OPTN 

Final Rule allows the Secretary of HHS 

to prescribe data collection. This 

regulatory authority requires OPTN data 

to be made available, consistent with 

applicable laws, for use by OPTN 

members, the Scientific Registry of 

Transplant Recipients, and members of 

the public for evaluation, research, 

patient information, and other purposes. 

This is a request to expand the current 

OPTN data collection, approved under 

OMB No. 0915–0157. HRSA is 

submitting this new data collection, 

separate from OMB No. 0915–0157, 

since it includes new forms developed 

in response to an HHS Secretarial Data 

Directive that are not in use by OPTN. 

HRSA believes that separating these 

data collections will minimize 

confusion, increase clarity among OPTN 

members and stakeholders, and enable 

more direct feedback on the new forms. 

Both data collections include timesensitive, life-critical data on transplant 

candidates and potential organ donor 

patients, the organ matching process, 

histocompatibility results, organ 

labeling and packaging, and pre-and 

post-transplantation data on recipients 

and donors. The OPTN collects these 

specific data elements from transplant 

centers. 

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. 

This new collection consists of three 

new data forms as directed by the HHS 

Secretary, which were developed to 

improve the OPTN organ matching and 

allocation process and OPTN member 

compliance with OPTN requirements: 

• One new form will collect data from 

the point of referral of a patient to an 

organ procurement organization (OPO) 

for potential deceased organ donation. 

These data will provide a more objective 

source of information on procurement 

practices, the management of donor 

patients, and how these practices inform 

the supply of deceased donor organs 

available for transplant. These data may 

also help to improve monitoring of OPO 

performance and would facilitate 

quality assurance and performance 

improvement efforts to reduce the 

variation in the quality-of-care OPOs 

provide to donors and donor families. 

• Two new forms will expand data 

collection from the point of patient 

registration, referral, and evaluation at 

transplant centers. These data will 

enable collection of data from the point 

of referral. Pre-waitlisting data will 

provide insight into who gets referred 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices 87593 

and by whom, who gets evaluated, and 

who gets placed on the organ 

transplantation waiting list. These data 

will also facilitate the OPTN’s ability to 

address disparities in processes of care, 

improve access to organ transplantation, 

and assess overall system performance. 

Once this collection is approved, 

HRSA will cease the use of the Death 

Notification Registration and the 

Deceased Donor Death Referral forms 

that are included within the existing 

OMB-approved Data System for Organ 

Procurement and Transplantation 

Network OMB No. 0915–0157. This 

decision was made to avoid unnecessary 

burden and redundancy in the data 

collected by this package and the 

existing OMB data collection 

instrument. 

Likely Respondents: Transplant 

Centers, 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. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form No. Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

1 ..................... Pre-Waitlist Transplant Referral Form ............. 248 1,164.68 288,840.64 0.35 101,094.22 

2 ..................... Pre-Waitlist Transplant Evaluation Form ......... 248 594.22 147,366.56 0.40 58,946.62 

3 ..................... Ventilated Patient Form ................................... 56 3,292.00 184,352.00 0.50 92,176.00 

Total ........ .......................................................................... 552 ........................ 620,559.20 .................... 252,216.84 

The average burden estimates of both 

new pre-waitlist forms are based on the 

2023 burden estimates of existing OMBapproved Transplant Candidate 

Registration forms, approved under 

0915–0157. The average burden 

estimate of the Ventilated Patient Form 

is based on the average burden estimate 

of the 2024 burden estimates of existing 

OMB-approved Death Notification 

Registration form with an additional 

0.08 hour per collected form burden to 

reflect an increase in total data fields. 

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. 2024–25522 Filed 11–1–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Advisory Committee to 

the Director, National Institutes of 

Health. 

This will be a hybrid meeting held inperson and virtually and will be open to 

the public as indicated below. Given the 

capacity constraints of the venue, the 

public is strongly encouraged to attend 

virtually via NIH videocast. Individuals 

who plan to attend in-person or view 

the virtual meeting and need special 

assistance or other reasonable 

accommodations, 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/. 

Name of Committee: Advisory Committee 

to the Director, National Institutes of Health. 

Date: December 12, 2024. 

Time: 9:00 a.m. to 5:45 p.m. 

Agenda: NIH Director’s Report; Budget 

Update; Legislative Update; RECOVER 2.0 

Early Career Intramural Investigator 

Highlight; ACD Working Group on Diversity 

Update; Accessibility, Disability Inclusion, 

and Disability Research at NIH; NExTRAC 

ENGAGE Update; Scientific Management 

Review Board. Other Business of the 

Committee. 

Date: December 13, 2024. 

Time: 9:00 a.m. to 12:15 p.m. 

Agenda: Cancer Moonshot Update; ABCD 

Update; Alzheimer’s Update; AMP Update 

Other Business of the Committee. 

Place: National Institutes of Health, 

Building 1, Wilson Hall, One Center Drive, 

Bethesda, MD 20892. 

Contact Person: Cyndi Burrus-Shaw, Staff 

Assistant, National Institutes of Health, 

Office of the Director, One Center Drive, 

Building 1, Room 126, Bethesda, MD 20892, 

301–496–2433, email: shawcy@od.nih.gov. 

Any interested person may file 

written comments with the committee 

by forwarding the statement to the 

Contact Person 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. 

In the interest of security, NIH has 

procedures at https://www.nih.gov/ 

about-nih/visitor-information/campusaccess-security for entrance into oncampus and off-campus facilities. All 

visitor vehicles, including taxicabs, 

hotel, and airport shuttles will be 

inspected before being allowed on 

campus. Visitors attending a meeting on 

campus or at an off-campus federal 

facility will be asked to show one form 

of identification (for example, a 

government-issued photo ID, driver’s 

license, or passport) and to state the 

purpose of their visit. 

Information is also available on the 

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

acd.od.nih.gov, where an agenda and 

any additional information for the 

meeting will be posted when available. 


lotter on DSK11XQN23PROD with NOTICES1