Federal Register / Vol. 89, No. 213 / Monday, November 4, 2024 / Notices 87591 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0367] 

Sec. 540.525 Scombrotoxin 

(Histamine)-Forming Fish and Fishery 

Products—Decomposition and 

Histamine (CPG 7108.24) Compliance 

Policy Guide; Guidance for Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for FDA staff entitled 

‘‘Sec. 540.525 Scombrotoxin 

(Histamine)-forming Fish and Fishery 

Products—Decomposition and 

Histamine (CPG 7108.24) Compliance 

Policy Guide.’’ This compliance policy 

guide (CPG) is intended to provide FDA 

staff guidance on adulteration 

associated with decomposition and/or 

histamine identified during surveillance 

sampling and testing of fish and fishery 

products susceptible to histamine 

formation. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 4, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–D–0367 for ‘‘Sec. 540.525 

Scombrotoxin (Histamine)-forming Fish 

and Fishery Products—Decomposition 

and Histamine (CPG 7108.24) 

Compliance Policy Guide.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

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

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to Division of 

Seafood Safety, Office of Dairy and 

Seafood Safety, Office of 

Microbiological Food Safety, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Steven Bloodgood, Division of Seafood 

Safety, Office of Dairy and Seafood 

Safety, Office of Microbiological Food 

Safety, Human Foods Program, Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

5316; or Jessica Ritsick, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a CPG for FDA Staff entitled ‘‘Sec. 

540.525 Scombrotoxin (Histamine)- 

forming Fish and Fishery Products— 

Decomposition and Histamine (CPG 

7108.24).’’ We are issuing this guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

This CPG is intended to provide FDA 

staff guidance on adulteration 

associated with decomposition and/or 

histamine identified during surveillance 

sampling and testing of fish and fishery 

products susceptible to histamine 

formation. This finalized CPG 

supersedes FDA’s existing CPG on this 

topic. 

In the Federal Register of December 

27, 2021 (86 FR 73295), we made 


lotter on DSK11XQN23PROD with NOTICES1
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 


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