Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 91765 

TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued 

Active ingredient(s) 

Dexamethasone; Neomycin sulfate; Polymyxin b sulfate. 

Enfuvirtide. 

Eplontersen sodium. 

Estrogens, conjugated. 

Icatibant acetate. 

Macitentan; Tadalafil. 

Magnesium sulfate; Polyethylene glycol 

3350; Potassium chloride; Sodium chloride; 

Sodium sulfate. 

Memantine hydrochloride. 

Mitomycin. 

Paclitaxel. 

Palovarotene. 

Pemetrexed disodium. 

Phentolamine mesylate. 

Phytonadione (multiple reference listed 

drugs). 

Quizartinib dihydrochloride. 

Risperidone. 

Ritlecitinib tosylate. 

Treprostinil. 

III. Drug Products for Which Revised 

Draft Product-Specific Guidances Are 

Available 

FDA is announcing the availability of 

revised draft product-specific guidances 

for industry for drug products 

containing the following active 

ingredients: 

TABLE 2.—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS

Active Ingredient(s). 

Allopurinol. 

Azelaic acid. 

Bictegravir sodium; Emtricitabine; Tenofovir 

alafenamide fumarate. 

Budesonide; Formoterol fumarate dihydrate. 

Enzalutamide. 

Ferric carboxymaltose. 

Ferumoxytol. 

Fluticasone propionate. 

Fluticasone propionate; Salmeterol xinafoate. 

Formoterol fumarate. 

Formoterol fumarate; Mometasone furoate. 

Labetalol hydrochloride. 

Lenvatinib mesylate. 

Levonorgestrel. 

Liraglutide. 

Losartan potassium. 

Mometasone furoate. 

Nepafenac (multiple reference listed drugs). 

Nitroglycerin. 

Olaparib. 

Phytonadione (multiple reference listed 

drugs). 

Primidone. 

Rasagiline mesylate. 

Ruxolitinib phosphate. 

Salmeterol xinafoate. 

Tacrolimus. 

Tazarotene. 

TABLE 2.—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG

PRODUCTS—Continued 

Active Ingredient(s). 

Tiotropium bromide. 

Tramadol hydrochloride. 

For a complete history of previously 

published Federal Register notices 

related to product-specific guidances, go 

to https://www.regulations.gov and 

enter Docket No. FDA–2007–D–0369. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the current 

thinking of FDA on, among other things, 

the product-specific design of BE 

studies to support ANDAs. They do not 

establish any rights for any person and 

are not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

IV. Paperwork Reduction Act of 1995 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information. The previously 

approved collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3521). The collections 

of information in 21 CFR part 312 for 

investigational new drugs have been 

approved under 0910–0014. The 

collections of information in 21 CFR 

part 314 for applications for FDA 

approval to market a new drug and in 

21 CFR part 320 for bioavailability and 

bioequivalence requirements have been 

approved under OMB control number 

0910–0001. 

V. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27048 Filed 11–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4604] 

Per- and Polyfluoroalkyl Substances in 

Seafood; Request for Information 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

requesting information to help fill data 

gaps that remain regarding per- and 

polyfluoroalkyl substances (PFAS) in 

seafood. The purpose of this request is 

to help increase our understanding of 

the potential for PFAS exposure from 

seafood. We intend to use the 

information submitted in response to 

this request to help inform future 

activities to reduce dietary exposure to 

PFAS that may pose a health concern. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by February 18, 2025. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 18, 2025. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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 


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91766 Federal Register / Vol. 89, No. 224 / Wednesday, November 20, 2024 / Notices 

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– 

2024–N–4604 for ‘‘Per- and 

Polyfluoroalkyl Substances in Seafood; 

Request for Information.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Stacey Wiggins, Office of Dairy and 

Seafood Safety, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–1470; or Alexandra Beliveau 

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 

A. PFAS in Food, Generally 

PFAS are a diverse group of 

thousands of synthetic chemicals— 

including perfluorooctanoic acid 

(PFOA), perfluorooctane sulfonic acid, 

perfluorononanoic acid, 

perfluorohexane sulfonic acid, and 

perfluorodecanoic acid—that are used 

in a wide range of consumer and 

industrial products. PFAS do not easily 

break down, and some types have been 

shown to accumulate in the 

environment and in our bodies. 

Exposure to certain types of PFAS has 

been linked to serious health effects, 

including hepatic, cardiovascular, 

immune, and developmental effects 

(Refs. 1 through 4). 

FDA has developed validated 

methods for testing for certain PFAS at 

very low levels (i.e., in the parts per 

trillion) in increasingly diverse types of 

foods (Ref. 5). We select specific PFAS 

for testing based on, for example, 

information from the scientific 

literature, the expected PFAS uptake in 

foods, and the availability of chemical 

standards to accurately detect and 

identify the presence of PFAS. 

As with other chemical contaminants 

for which there are no established 

action levels or tolerances, FDA 

evaluates PFAS in food on a case-bycase basis. When we detect PFAS in 

food, we may conduct a human health 

assessment to evaluate whether the 

levels detected present a possible 

human health concern. We consider the 

level of the contaminant in the specific 

food, consumption patterns for that 

specific food in various sectors of the 

population (by age), and current 

toxicological data for the PFAS 

chemical(s) detected to determine 

whether the concentration of PFAS 

found in the food poses a health 

concern (see Ref. 5 for additional 

information on our approach to human 

health assessments, generally). 

Addressing potential effects of 

Americans’ PFAS exposure is a national 

priority and is coordinated across 

several Federal Agencies. Through these 

interagency collaborations, we are 

working to identify routes of PFAS 

exposure, understand associated health 

risks, and reduce the public’s dietary 

exposure to PFAS that may pose health 

concern. FDA is a part of the Council on 

Environmental Quality-led Interagency 

Policy Committee on PFAS, which is 

tasked with coordinating the Federal 

response to PFAS contamination in the 

environment and in products. 

Additionally, FDA also participates in 

an interagency Strategy Team on PFAS, 

focused on research and development. 

B. PFAS in Seafood 

For purposes of this document, we 

use the term ‘‘seafood’’ to refer to fresh 

or saltwater finfish, crustaceans, other 

forms of aquatic animal life (e.g., 

alligator) other than birds or mammals, 

and all mollusks, where such animal life 

is intended for human consumption, 

which is consistent with our definition 

of ‘‘fish’’ under 21 CFR 123.3(d). Since 

2019, we have been utilizing samples 

collected from the Total Diet Study 

(TDS) to evaluate the presence of PFAS 

in foods, including seafood. The 

analysis of TDS samples was a 

preliminary step in determining 

whether more targeted or larger surveys 

of PFAS in foods may be needed. To 

date, we have analyzed 810 TDS food 

samples, including samples from 7 

regional collections and 1 national 

collection. PFAS were detected at 

relatively low levels in 23 out of 810 

TDS food samples. Of those 23 food 

samples with PFAS detected, 19 were 

seafood samples (Ref. 6). Using human 

health assessments, we determined that 

none of the TDS seafood samples had 

levels of PFAS that would be considered 

a human health concern. However, 

FDA’s testing indicates that seafood may 

be at higher risk for environmental 

PFAS contamination compared to other 

types of food. This request for 

information is one way we are working 

to better understand PFAS 

contamination in commercial seafood to 

reduce dietary exposure to PFAS that 

may pose a health concern. 

To expand on the results from the 

TDS samples and evaluate potential 

exposure to PFAS from other seafood 


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types, we collected additional seafood 

samples for PFAS analysis in 2021 and 

2022. The survey targeted the most 

commonly consumed seafood in the 

United States and consisted of 81 

samples comprised of clams, cod, crab, 

pollock, salmon, shrimp, tilapia, and 

canned tuna—most of which were 

imported to the United States. This 

work advances our efforts to understand 

PFAS levels in commercial seafood and 

is also a part of our comprehensive 

approach to help ensure the safety of 

imported seafood, as outlined in the 

‘‘Activities for the Safety of Imported 

Seafood’’ report released in March 2023 

(Ref. 7). Based on the PFOA 

concentrations found in canned clams, 

we concluded that consumption of the 

canned clams sampled from China were 

likely a human health concern. Two 

voluntary recalls of processed clams 

from China have occurred due to these 

findings (Refs. 8 and 9). 

Because many potential hazards can 

be introduced at the source—in growing 

areas, in aquaculture farms, and on 

fishing vessels—seafood presents a 

unique challenge and opportunity to 

prevent contamination. This request for 

information is an opportunity for 

interested entities (including the 

seafood industry, academia, and state 

and other Federal Agencies) (you) to 

provide information to address the data 

gaps that exist. This request is 

consistent with FDA’s efforts to increase 

our understanding of the potential for 

PFAS exposure from seafood and to 

reduce dietary exposure to PFAS that 

may pose a health concern. The 

information submitted in response to 

this request for information will help 

enhance FDA’s knowledge about the 

types of seafood prone to accumulate 

PFAS and harvest locations with PFAS 

contamination, improve our 

comprehensive understanding of the 

sources of PFAS in seafood, prioritize 

our sampling strategies and seafood 

targets for testing, and inform potential 

mitigation strategies. Additional 

information about existing data and 

information on PFAS in seafood will 

help us advance our public health 

mission and further support the current 

Administration’s comprehensive 

approach to addressing PFAS and 

advancing clean air, water, and food 

(Refs. 10 through 12). 

II. Request for Information 

This request focuses on PFAS in 

seafood. We request data and 

information in response to specific 

questions presented below that fall 

under the following categories: (1) PFAS 

concentrations in seafood; (2) PFAS 

concentrations in the environment; (3) 

PFAS concentrations in processing 

water; and (4) mitigation strategies for 

PFAS in seafood. When responding, 

please identify the question by its 

number (e.g., ‘‘1.1’’) so that we can 

associate your response with a specific 

question. Please be as detailed as 

possible in your response. 

It is important to know whether 

samples were found to contain 

detectable PFAS. Information about 

samples where no PFAS was detected is 

just as important as samples where 

PFAS was detected. This information 

helps identify where PFAS was 

observed and lets us know that it was 

undetected, as opposed to simply not 

sampled. 

When reporting PFAS concentrations 

detected (Questions 1–3), please include 

information about sample preparations 

(e.g., individual samples versus 

composites of subsamples) and 

analytical methods (e.g., the analytical 

method(s) used and associated limits of 

detection, limit of quantitation, and 

method detection limit (MDL)). Such 

information provides context and helps 

enable better interpretation of data (e.g., 

determining which datasets can be 

compared to other datasets and what 

conclusions may be drawn). For 

example, if analytical methods with 

high MDLs were used and reported nondetectable concentrations, it is possible 

that the concentrations may have been 

detectable if a more sensitive method 

had been used. 

While the questions presented below 

are aimed at gathering data and 

information on PFAS in seafood that is 

most pertinent, we welcome any 

additional data and information 

regarding PFAS in seafood that may 

improve our understanding and advance 

our public health mission. 

1. PFAS Concentrations in Seafood 

FDA is interested in identifying 

which specific seafood types are more 

prone to PFAS accumulation, as this 

could help inform future seafood 

sampling plans. We have been analyzing 

the most commonly consumed seafood 

in the United States for PFAS; however, 

there are many other seafood types for 

which data are limited. Additionally, 

we are interested in the harvest 

locations where the seafood samples 

were collected. Information about 

geographical PFAS contamination and 

harvest areas where seafood may be 

contaminated with PFAS will help 

inform potential mitigation strategies. 

For each item below, please provide 

the PFAS concentrations for each type 

of PFAS detected (including samples 

where no PFAS was detected), as well 

as any relevant data (e.g., sample 

collection date), evidence, or other 

information to support your response. 

1.1 Which types of seafood (e.g., 

scientific name, acceptable market 

name, common name) have you tested 

for PFAS? Please describe the sample 

(e.g., individual or composite) and 

provide the number of subsamples used 

for composite samples. Please answer 

the following questions for each type of 

seafood tested, providing any data and 

evidence to support your response. 

1.1.1 Was the seafood sample a 

commercial seafood product (i.e., was 

the seafood in or intended for interstate 

commerce whether collected from 

harvest areas, processing stages, or at 

retail)? Or was the seafood sample 

collected a non-commercial seafood 

product? 

1.1.2 Was the seafood sample 

harvested from fresh water or salt water? 

What else is known about the harvest 

location of the seafood sample? Please 

provide latitude and longitude of 

harvest location, if known. 

1.1.3 Was the seafood sample raw or 

processed? If raw, was the sample fresh 

or frozen? If processed, was the sample 

frozen, canned, pouched, or other? Was 

the processed sample cooked, 

eviscerated, smoked, dried, or other? 

1.1.4 Was the seafood sample wildcaught or raised via aquaculture? 

1.1.5 If the sample was a commercial 

seafood product, what was the country 

of origin on the seafood label? The 

country of origin label indicates the 

country where the last substantial 

transformation to the seafood product 

was made, which may not be the 

country where the seafood was 

harvested (19 U.S.C. 1304(a) and 19 CFR 

part 134; see also Ref. 13). 

1.2 Knowing whether the seafood 

sample (for commercial or noncommercial seafood) has been tested 

whole or separated into parts is 

valuable, particularly for informing 

potential mitigation strategies (e.g., 

anatomical parts demonstrated to have 

higher PFAS concentrations may be 

removed as a mitigation strategy for the 

remaining parts to be sold for 

consumption). For each question below, 

please provide any relevant data, 

evidence, or other information to 

support your response. 

1.2.1 How would you characterize 

the seafood sample that was tested (e.g., 

whole, muscle, roe, viscera)? 

1.2.2 If the seafood was separated 

into different tissues, which specific 

tissues were used to measure PFAS 

concentrations? Why were those 

specific tissues chosen for testing? 


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2. PFAS Concentrations in the 

Environment (e.g., Water and Sediment 

in Seafood Harvest Areas) 

PFAS can enter seafood through 

environmental contamination. FDA is 

interested in understanding PFAS 

sources and concentrations in the 

environment that impact seafood. Such 

information can aid in the identification 

of harvest areas to avoid. Examples of 

PFAS sources in the environment 

include water and sediment. 

For each item below, please provide 

the PFAS concentrations for each type 

of PFAS detected (including samples 

where no PFAS was detected), as well 

as any relevant data (e.g., sample 

collection date), evidence, or other 

information to support your response. 

2.1 In conjunction with testing 

PFAS concentrations in seafood, please 

describe any environmental samples 

(e.g., volume or amount of matrix, 

individual or composite) you have 

tested from locations where seafood was 

grown or harvested, including the 

number of subsamples used for 

composite samples. Please provide 

latitude and longitude of sample 

location, if known. 

2.1.1 What type of environmental 

sample was collected and analyzed for 

PFAS (i.e., water, sediment, or another 

type of sample (e.g., soil, biosolids))? 

Please provide the date of sample 

collection, if known. 

2.1.2 If water, was the sample fresh 

water or salt water? What was the depth 

at which the water sample was 

collected? What was the salinity of the 

salt water? 

2.1.3 If sediment, was the sample 

mud, sand, or clay? What was the depth 

at which the sediment was collected? 

2.1.4 If another type of sample, 

please provide additional information 

about the sample matrix (e.g., whether 

the samples were biosolids or soils near 

the coast). 

2.2 If known, please provide any 

historical data you have about PFAS 

sources in the sampling locale and any 

information showing a relationship 

between PFAS in the environmental 

samples and PFAS in the seafood 

samples. Such historical information 

can help identify whether there are 

patterns or trends in PFAS 

contamination that may be useful in 

predicting potential PFAS 

contamination in seafood, which could 

inform mitigation efforts. 

2.2.1 Are there any factors specific 

to this geographic location that play a 

role in PFAS accumulation? If yes, 

please elaborate. 

2.2.2 Is the PFAS contamination in 

the geographic location persistent? 

Please provide the rationale for this 

conclusion. 

2.2.3 What, if anything, has the data 

shown about the source of the PFAS 

contamination? 

3. PFAS Concentration in Processing 

Water 

PFAS can enter processed seafood 

through the use of contaminated 

processing water. FDA would like to 

know about the occurrence of PFAS 

contamination in processing water 

intended for use with seafood. 

Identification of the source of 

contaminated water that was intended 

for use as processing water will help 

FDA better understand potential and 

likely routes of PFAS contamination, 

and may help inform mitigation 

strategies, such as the need to find 

alternative source water for food 

processing. It is also helpful to know if 

water that was intended for use as 

processing water was tested but not 

found to contain detectable 

concentrations of PFAS. 

For each item below, please provide 

the PFAS concentrations for each type 

of PFAS detected (including samples 

where no PFAS was detected), as well 

as any relevant data (e.g., sample 

collection date), evidence, or other 

information to support your response. 

3.1 What processing water samples 

have been tested for PFAS? At what 

stage of processing was the process 

water used or intended to be used? 

Please describe the sample (e.g., 

individual or composite, volume) and 

provide the number of subsamples used 

for composite samples. 

3.2 What is the source of the 

processing water (e.g., municipal, 

private, well)? If known, please provide 

any historical data you have about PFAS 

sources in the sampling locale of the 

processing water, and any information 

showing a relationship between PFAS 

in the processing water samples and 

seafood samples. Such information can 

help identify whether patterns or trends 

are available to aid in mitigation efforts. 

4. Mitigation Strategies for PFAS in 

Seafood 

As PFAS are known to accumulate 

and persist in the environment, it is 

important to develop mitigation 

strategies for reducing PFAS 

contamination in seafood. Examples of 

mitigation strategies include changing 

or closing seafood harvest locations if an 

area is contaminated with PFAS or 

processing certain tissues of seafood 

that have been determined to not 

accumulate PFAS. Understanding the 

rates of PFAS accumulation and 

elimination from seafood can help to 

determine whether natural or controlled 

reduction strategies may be effective at 

removing PFAS. FDA is interested to 

learn about additional mitigation 

strategies that may be used to reduce or 

prevent PFAS contamination of seafood. 

For each item below, please provide any 

relevant data, evidence, or other 

information to support your response. 

4.1 Please describe the PFAS 

mitigation strategies that you have used 

or of which you are aware to reduce 

PFAS in seafood, including any 

industry-wide practices. Please provide 

details regarding, as applicable, testing 

seafood products and/or processing 

water for PFAS, changing seafood 

harvest areas and/or processing water 

sources based on PFAS concentrations, 

eviscerating seafood and/or processing 

different tissues for consumption, or 

depurating (i.e., storing in controlled 

conditions to allow for elimination of 

impurities) PFAS from seafood. 

4.1.1 Which mitigation strategies 

have you determined to be successful at 

reducing PFAS in seafood? Please 

provide details about the strategy, 

including your criteria for determining 

success and the level to which PFAS 

was reduced. 

4.1.2 What challenges have you 

encountered regarding mitigation 

strategies for reducing PFAS 

contamination in seafood? 

4.2 If any seafood growing areas or 

harvest areas have been found to be 

contaminated with PFAS, please 

describe whether the area has been 

placed in a closed or prohibited status, 

you have been impacted by growing or 

harvest areas being placed in a closed 

status, or you have avoided harvesting 

in the area. Please describe the 

contamination event in as much detail 

as possible (e.g., PFAS concentration, 

location with latitude and longitude if 

known, length of closure or avoidance). 

4.3 To what degree is PFAS in 

seafood testing being incorporated into 

Seafood Hazard Analysis Critical 

Control Point (HACCP) plans? If PFAS 

was detected in seafood or processing 

water, was PFAS added to HACCP 

plans? Please provide details, such as 

what critical limit is being considered. 

III. References 

The following references are on 

display at the Dockets Management Staff 

(see ADDRESSES) and are available for 

viewing by interested persons between 

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

Friday; they are also available 

electronically at https://

www.regulations.gov. Although FDA 

verified the website addresses in this 

document, please note that websites are 

subject to change over time. 


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1. Agency for Toxic Substances and Disease 

Registry, ‘‘Toxicological Profile for 

Perfluoroalkyls.’’ Accessed June 14, 

2024. Available at: https://

www.atsdr.cdc.gov/toxprofiles/ 

tp200.pdf. 

2. U.S. Environmental Protection Agency, 

‘‘Human Health Toxicity Assessment for 

PFBS.’’ Accessed June 14, 2024. 

Available at: https://www.epa.gov/ 

chemical-research/learn-about-humanhealth-toxicity-assessment-pfbs. 

3. U.S. Environmental Protection Agency, 

‘‘Human Health Toxicity Assessments 

for GenX Chemicals.’’ Accessed June 14, 

2024. Available at: https://www.epa.gov/ 

chemical-research/human-healthtoxicity-assessments-genx-chemicals. 

4. U.S. Environmental Protection Agency, 

‘‘Final IRIS Assessment of 

Perfluorobutanoic Acid (PFBA) and 

Related Salts.’’ Accessed June 14, 2024. 

Available at: https://www.epa.gov/ 

newsreleases/epa-publishes-irishandbook-and-final-iris-assessmentperfluorobutanoic-acid-pfba-and. 

5. U.S. Food and Drug Administration, 

‘‘Testing Food for PFAS and Assessing 

Dietary Exposure.’’ Accessed June 14, 

2024. Available at: https://www.fda.gov/ 

food/process-contaminants-food/testingfood-pfas-and-assessing-dietaryexposure. 

6. U.S. Food and Drug Administration, 

‘‘Analytical Results of Testing Food for 

PFAS from Environmental 

Contamination.’’ Accessed June 14, 2024. 

Available at: https://www.fda.gov/food/ 

process-contaminants-food/analyticalresults-testing-food-pfas-environmentalcontamination. 

7. U.S. Food and Drug Administration, 

‘‘Activities for the Safety of Imported 

Seafood, February 2023.’’ Accessed June 

14, 2024. Available at: https://

www.fda.gov/media/165447/download. 

8. U.S. Food and Drug Administration, ‘‘FDA 

Shares Results on PFAS Testing in 

Seafood, July 15, 2022.’’ Accessed June 

14, 2024. Available at: https://

www.fda.gov/food/cfsan-constituentupdates/fda-shares-results-pfas-testingseafood. 

9. U.S. Food and Drug Administration, 

‘‘Crown Prince, Inc. Issues Voluntary 

Recall of Smoked Baby Clams in Olive 

Oil Due to the Presence of Detectable 

Levels of PFAS Chemicals.’’ Accessed 

June 14, 2024. Available at: https://

www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/crown-princeinc-issues-voluntary-recall-smoked-babyclams-olive-oil-due-presence-detectablelevels. 

10. The White House, ‘‘Fact Sheet: BidenHarris Administration Launches Plan to 

Combat PFAS Pollution, October 2021.’’ 

Accessed June 14, 2024. Available at: 

https://www.whitehouse.gov/briefingroom/statements-releases/2021/10/18/ 

fact-sheet-biden-harris-administrationlaunches-plan-to-combat-pfas-pollution/ 

. 

11. The White House, ‘‘Fact Sheet: BidenHarris Administration Combatting PFAS 

Pollution to Safeguard Clean Drinking 

Water for All Americans, June 2022.’’ 

Accessed June 14, 2024. Available at: 

https://www.whitehouse.gov/briefingroom/statements-releases/2022/06/15/ 

fact-sheet-biden-harris-administrationcombatting-pfas-pollution-to-safeguardclean-drinking-water-for-all-americans/. 

12. The White House, ‘‘Fact Sheet: BidenHarris Administration Takes New Action 

to Protect Communities from PFAS 

Pollution, March 2023.’’ Accessed June 

14, 2024. Available at: https://

www.whitehouse.gov/briefing-room/ 

statements-releases/2023/03/14/factsheet-biden-harris-administration-takesnew-action-to-protect-communities-frompfas-pollution/. 

13. U.S. Food and Drug Administration, 

‘‘CPG Sec. 560.200 Country of Origin 

Labeling.’’ Accessed June 14, 2024. 

Available at: https://www.fda.gov/media/ 

71994/download. 

Dated: November 12, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–27070 Filed 11–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Office of the 

Commissioner (OC), Office of Digital 

Transformation (ODT) has modified 

their organizational structure. The new 

organizational structure was approved 

by the Secretary of Health and Human 

Services on September 20, 2024. 

FOR FURTHER INFORMATION CONTACT: 

William Tootle, Director, Office of 

Budget; 10903 New Hampshire Avenue, 

WO–2, #3313, Silver Spring, MD 20990. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect FDA, OC’s ODT. 

The changes to ODT’s organizational 

structure consolidate similar functions 

and resources across multiple areas and 

align the organizational structure with 

federal and industry standards. This 

will create a more agile organization, 

improve resource management, enhance 

customer service, and better align the 

name of organizational components 

with current functions. The 

reorganization will maintain a 

reasonable span of control and clear and 

appropriate lines of authority and 

responsibilities between organizations. 

This will also ensure optimal resource 

utilization and leveraging of existing 

staff talent and will allow ODT more 

efficiency and effectiveness in the 

advancement of continuous 

improvement efforts. 

DCAD. ORGANIZATION: ODT is 

headed by the Chief Information Officer 

and includes: 

Office of Digital Transformation (DCAD) 

Office of Information Management and 

Technology (DCADA) 

Enterprise Architecture Staff (DCADA2) 

Office of Technology and Delivery 

(DCADAA) 

Division of Infrastructure Services 

(DCADAAA) 

Network Services Support Staff 

(DCADAAA10) 

Systems Operations Support Staff 

(DCADAAA11) 

Operations and Planning Staff 

(DCADAAA12) 

Data Center Facilities Branch 

(DCADAAA13) 

Quality Assurance Branch (DCADAAA14) 

Network Communications Branch 

(DCADAAA15) 

Server Operations Services Branch 

(DCADAAA16) 

Enterprise Management Operations Branch 

(DCADAAA17) 

Cloud Operations Branch (DCADAAA18) 

Division of Application Services 

(DCADAAB) 

Operations Support Staff (DCADAAB10) 

Enterprise Business and Post-Market Staff 

(DCADAAB11) 

Scientific Support Staff (DCADAAB12) 

Human Food Support Branch 

(DCADAAB13) 

Regulatory Science Support Branch 

(DCADAAB14) 

Compliance and Enforcement Branch 

(DCADAAB15) 

Application Services Support Branch 

(DCADAAB16) 

Platform Management Support Branch 

(DCADAAB17) 

Digital Solutions Partners Branch 

(DCADAAB18) 

Business Intelligence Data Branch 

(DCADAAB19) 

Products Review and Approval Branch 

(DCADAAB20) 

Digital Solution Delivery Branch 

(DCADAAB21) 

Registration Listing Services Branch 

(DCADAAB22) 

User Fee Support Branch (DCADAAB23) 

Division of Engineering (DCADAAD) 


khammond on DSK9W7S144PROD with NOTICES