17300 Federal Register / Vol. 87, No. 59 / Monday, March 28, 2022 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over request period) 

Number of 

responses per 

respondent 

(total over request period) 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

Construction Worker Survey .................... 4,200 1 1 0.5 2,100 1,050 

Estimated Total Annual Burden 

Hours: 1,050. 

Authority: Section 105(d)(2) of the 

Trafficking Victims Protection Act of 

2000 (Pub. L. 106–386) [22 U.S.C. 7103]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–06415 Filed 3–25–22; 8:45 am] 

BILLING CODE 4184–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0709] 

Prescription Drug User Fee Rates for 

Fiscal Year 2022; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Prescription Drug User 

Fee Rates for Fiscal Year 2022’’ that 

appeared in the Federal Register of 

August 16, 2021. The document 

announced the Fiscal Year 2022 fee 

rates for the Prescription Drug User Fee 

Act. The document published with 

errors. The errors did not have an 

impact on the previously published user 

fee rates but are corrected in this 

document for clarity. 

FOR FURTHER INFORMATION CONTACT: 

Misbah Tareen, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61077A, Beltsville, MD 20705– 

4304, 301–796–3997. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 16, 2021 (86 

FR 45732), appearing on page 45736 in 

FR Doc. 2021–17505, the following 

corrections are made: 

1. In the second column, in the last 

sentence of the third paragraph under 

‘‘D. FY 2022 Statutory Fee Revenue 

Adjustments for Operating Reserve’’, 

‘‘both user fee funds available for 

obligation $126,873,636 and funds that 

are considered unavailable due to a lack 

of appropriations $98,850,995’’ is 

corrected to read ‘‘user fee funds 

considered unavailable due to a lack of 

appropriations $78,850,995, additional 

fee funds that are available for 

obligation but set aside for future year 

refunds as a matter of prudent 

operations $20,000,000, and carryover 

net of unavailable funds and the setaside $126,873,636.’’ 

2. The fourth footnote is corrected by 

removing the text and replacing it with: 

‘‘In recent PDUFA Annual Financial 

Reports, the category ‘‘unavailable for 

use’’ has been used to refer both to (1) 

fee funds that are considered 

unappropriated and (2) appropriated fee 

funds the Agency has maintained to 

provide for any refunds. FDA intends to 

discontinue use of the category 

‘‘unavailable for use’’ in forthcoming 

reports to better reflect the difference 

between these line items and improve 

the clarity of its reporting. Although 

certain amounts have been maintained 

for future refunds as a matter of prudent 

operations, these amounts are 

considered appropriated and are 

available for obligation.’’ 

3. In the second column, in the fifth 

paragraph under ‘‘D. FY 2022, Statutory 

Fee Revenue Adjustments for Operating 

Reserve’’, sentences 4 through 7 are 

corrected by removing the text and 

replacing it with ‘‘FDA has decided to 

make an available operating reserve 

adjustment that is intended to increase 

the amount of available funds to 

approximately 8 weeks by the end of FY 

2022, representing the low end of the 8- 

to 10-week range while mitigating the 

impact on fee amounts. FDA estimates 

the cost of operations per week is 

$22,144,672. Before the operating 

adjustment, the estimated end of year 

FY 2022 available operating reserve is 

$145,677,240, which equates to about 

61⁄2 weeks of available operating 

reserves. Adding the FY 2022 operating 

reserve adjustment of $39,402,923 to 

this amount is expected to provide 

approximately 8 weeks of available 

operating reserve, or $185,080,162 

(including $20,000,000 in available fee 

funds maintained for any future 

refunds), and a total carryover of 

operating reserves (including 

unavailable funds) of $263,931,157.’’ 

Dated: March 21, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06427 Filed 3–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0336] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Quantitative 

Research on a Voluntary Symbol 

Depicting the Nutrient Content Claim 

‘‘Healthy’’ on Packaged Foods 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by April 27, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is 

‘‘Quantitative Research on a Voluntary 

Symbol Depicting the Nutrient Content 

Claim ‘Healthy’ on Packaged Foods.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 


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Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Quantitative Research on a Voluntary 

Symbol Depicting the Nutrient Content 

Claim ‘‘Healthy’’ on Packaged Foods 

OMB Control Number 0910–NEW 

I. Background 

Section 403(r)(1)(A) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 343(r)(1)(A)) permits the 

use of label and labeling claims that 

characterize the level of a nutrient in a 

food when the claims are made in 

accordance with FDA’s regulations. 

Such claims are referred to as ‘‘nutrient 

content claims.’’ We have issued 

regulations under section 403(r)(1)(A) of 

the FD&C Act describing ‘‘implied 

nutrient content claims’’ as those that, 

among other things, suggest that a food, 

because of its nutrient content, may 

help consumers maintain healthy 

dietary practices (21 CFR 101.65(d)(1)(i). 

The rule finalizing these claims also 

describes implied claims, in part, as 

those that imply that a food, because of 

its nutrient content, may be useful in 

achieving a total diet that conforms to 

current dietary recommendations 

(‘‘Food Labeling: Nutrient Content 

Claims, General Principles, Petitions, 

Definition of Terms,’’ 58 FR 2302 at 

2374, January 6, 1993)). We have 

determined that a claim that a food, 

because of its nutrient content, may be 

useful in maintaining healthy dietary 

practices is clearly a claim that 

characterizes the level of nutrients in 

that food. The claim is essentially 

saying that the level of nutrients in the 

food is such that the food will 

contribute to good health (58 FR 2302 at 

2375). In 1994, we issued a definition of 

‘‘healthy’’ as an implied nutrient 

content claim (59 FR 24232, May 10, 

1994); the regulation is codified at 21 

CFR 101.65(d)(2). 

FDA seeks to improve dietary patterns 

in the United States to help reduce the 

burden of diet-related chronic diseases 

and advance health equity. We are 

committed to accomplishing this by, in 

part, empowering consumers with 

information to make more informed 

dietary choices. To help advance these 

goals, we are exploring the development 

of a graphic symbol to help companies 

communicate and consumers identify 

packaged food products that meet FDA’s 

definition of ‘‘healthy.’’ The symbol 

would be a graphic representation of the 

nutrient content claim ‘‘healthy’’ and, 

like the implied nutrient content claim 

‘‘healthy’’ itself, would be voluntary for 

packaged food companies. Companies 

could voluntarily use the symbol on 

food products that meet FDA’s 

definition of ‘‘healthy.’’ 

In 2019 and 2020, FDA conducted a 

review of the literature on front-ofpackage (FOP) nutrition-related symbols 

and conducted a series of focus groups 

to test symbol concepts and draft FOP 

symbols (see Docket No. FDA–2021–N– 

0336 for the literature review and a table 

of draft FOP symbols). 

As part of our efforts to promote 

public health, we intend to conduct two 

consecutive quantitative research 

studies—a survey (Study 1) and an 

experimental study (Study 2) to explore 

consumer responses to the draft FOP 

symbols that companies could 

voluntarily use on a food product as a 

graphic representation of the nutrient 

content claim ‘‘healthy.’’ If research 

results suggest the need, the symbols 

will be fine-tuned following the survey 

and again following the experimental 

study. Study 1 will use non-probability 

survey methods, using a web-based 

panel to draw a sample of 2,000 U.S. 

adults ages 18 and older who selfidentify as primary food shoppers. The 

sample will be balanced to the 

demographics of the U.S. population. 

The survey instrument will focus on 

clarity, relevance, and appeal of a set of 

symbols. 

Study 2 will be a controlled, 

randomized experiment that will use a 

15-minute web-based questionnaire to 

collect information from 5,000 U.S. 

adult members of an online consumer 

panel. Conditions for Study 2 will be: 

(1) A set of draft FOP symbols, 

including ‘‘no-symbol’’ controls; (2) 

three types of mock food products (i.e., 

a breakfast cereal, a frozen meal, and a 

canned soup); (3) a ‘‘no-information’’ 

condition where no explanation of the 

symbol is provided; and; (4) a Uniform 

Resource Locator (URL) condition, in 

which a URL is tested alongside the 

symbol. Each participant in Study 2 will 

be randomly assigned to a condition, 

which will include viewing a label 

image and responding to various 

measures of the symbol’s effectiveness. 

Measures of response in the experiment 

will include product perceptions (e.g., 

healthfulness and contribution to a 

healthy diet), label perceptions (e.g., 

believability, trustworthiness, message 

effects), and purchase/choice questions. 

The instrument will also collect 

information from participants about 

their history of purchasing or 

consuming similar products; nutrition 

knowledge; dietary interests; motivation 

regarding label use; health status; and 

demographic characteristics. 

The studies are part of our continuing 

effort to enable consumers to make 

informed dietary choices and construct 

healthful diets. We intend to use the 

results to inform our continued 

exploration of a symbol manufacturers 

could voluntarily use to represent the 

nutrient content claim ‘‘healthy’’ on the 

food label. We will not use the results 

to develop population estimates. 

Description of Respondents: 

Respondents to this collection of 

information include members of the 

general public. 

In the Federal Register of May 7, 2021 

(86 FR 24629), FDA published a 60-day 

notice requesting public comment on 

the proposed collection of information 

(‘‘60-day notice’’). We received 43 

comments, 27 of which were PRArelated. The remaining comments were 

non-responsive to the four PRA topics, 

and so we will not address them in this 

document. 

A. Comments Regarding the Necessity 

and Practical Utility of the Information 

Being Collected and FDA Response 

Several comments addressed the 

necessity and practical utility of 

collecting information on a voluntary 

symbol depicting the nutrient content 

claim ‘‘healthy’’ on packaged foods. 

(Comment 1) Some comments 

supported FDA’s proposed collection of 

information through the three proposed 

quantitative consumer research studies. 

Some comments expressly supported 

FDA’s end research goal of enabling 

consumers to make informed dietary 

choices and construct healthful diets. 

Some supported FDA’s intention to 

understand consumer responses to draft 

FOP symbols and gather data and other 

information to inform our thinking on a 

‘‘healthy’’ symbol. Many comments 

indicated the importance of conducting 

this research before taking regulatory 

action on any symbol. Some comments 

supported conducting the research in 

conjunction with development of a 

proposed rule that would update the 

definition of ‘‘healthy’’ on food 

packages. 

Other comments opposed FDA 

research on a ‘‘healthy’’ symbol. Some 

of these comments suggested the 

research is unnecessary, claiming that a 

single food is not ‘‘healthy’’ or 

‘‘unhealthy,’’ that overall diet matters 

more than individual foods, or that 

symbols are industry marketing. A few 

comments suggested a ‘‘healthy’’ symbol 

could be particularly misleading to, or 

misinterpreted by, people who are 


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experiencing eating disorders. Some 

comments also questioned whether a 

‘‘healthy’’ symbol would: (1) Have a 

positive and meaningful impact on 

improving health or (2) lead consumers 

to overconsume foods bearing the 

symbol. 

(Response 1) We intend to conduct 

this research now, in conjunction with 

further work on updating our definition 

of the claim ‘‘healthy’’ and before taking 

regulatory action on any symbol. Our 

intended research will help us better 

understand how consumers might 

respond to and use a graphic symbol to 

identify packaged food products that 

meet our definition of ‘‘healthy.’’ This 

research will help address many points 

raised in the comments, such as how 

consumers might react to and 

understand a ‘‘healthy’’ symbol and 

misinterpretations they may have. 

While we agree that there are some 

symbols that may be used exclusively 

for industry marketing, companies 

could use any FDA ‘‘healthy’’ symbol 

we develop and finalize only when the 

product displaying the symbol meets 

FDA’s regulatory definition of 

‘‘healthy.’’ This could help consumers 

make more informed dietary choices 

and construct healthful diets. The 

comments claiming that a single food is 

not ‘‘healthy’’ or ‘‘unhealthy’’ and that 

overall diet matters more than 

individual foods are commenting on the 

‘‘healthy’’ claim itself, which we do not 

intend to test in this research. Rather, 

we intend to test consumer reactions to 

symbols that could be a graphic 

representation of the claim. 

Nonetheless, we note that a ‘‘healthy’’ 

symbol, such as the ones FDA is 

exploring in our research, could help 

consumers choose food products, as 

part of their overall diet, that meet 

FDA’s regulatory definition of 

‘‘healthy.’’ The research is not designed 

to study long-term health effects or 

consumer consumption patterns. We 

reiterate that this research is about 

graphical representations of the nutrient 

content claim ‘‘healthy’’—in other 

words, we intend to study only the 

symbol, not the claim itself. Depending 

on the results of this data collection, we 

may decide to test additional symbols or 

revise our current symbols. 

(Comment 2) Many comments 

expressed a preference for conducting 

the research after we revise our 

regulatory definition of ‘‘healthy,’’ as 

they wondered whether the definition of 

the claim could influence both the 

design and consumer understanding of 

the symbol. Some expressed concern 

that testing a symbol without clearly 

communicating what the symbol means 

could lead to ambiguous results. One 

comment expressed concern that, by 

conducting testing only on the symbols 

in the notice, we would not consider 

testing any other symbols in the future. 

A few comments contended that FDA’s 

testing would be invalid if the mock 

products used in testing do not meet 

FDA’s updated ‘‘healthy’’ definition. 

(Response 2) FDA has an existing 

definition for the claim ‘‘healthy,’’ and 

in the Federal Register of September 28, 

2016, we announced our intent to 

exercise enforcement discretion around 

some criteria for the claim (see ‘‘Use of 

the Term ‘Healthy’ in the Labeling of 

Human Food Products: Guidance for 

Industry,’’ 81 FR 66527). However, as 

part of this data collection, we have 

included experimental conditions in 

which participants will read general 

information outlining the use of the 

claim ‘‘healthy’’ only for purposes of 

this study. This will help us better 

understand how consumers might 

respond to the symbols we are 

proposing to test if participants 

understand a ‘‘healthy’’ definition, even 

if not necessarily an updated definition. 

While the symbol is intended to 

represent the nutrient content claim 

‘‘healthy,’’ our research on the symbol is 

not dependent on specific criteria for 

‘‘healthy.’’ We are researching general 

consumer perceptions and impressions 

of the symbols themselves, not the 

definition that may underly those 

symbols, and as such, we do not need 

to wait until we have a final, updated 

regulatory definition of ‘‘healthy’’ before 

conducting this research. Moreover, the 

symbols being tested would not need to 

be modified with a changing definition 

of ‘‘healthy;’’ the symbol would remain 

a simple graphic representation of the 

‘‘healthy’’ claim. 

Regarding the claim that our testing 

would be invalid if the mock products 

used in testing do not meet FDA’s 

updated ‘‘healthy’’ definition, our mock 

products represent broad and basic food 

categories. They include foods such as 

vegetables and whole grains with 

limited nutrients of concern (e.g., 

sodium or saturated fat) that would 

meet our current definition of ‘‘healthy’’ 

and would help consumers build a diet 

consistent with the Dietary Guidelines 

for Americans, 2020–2025. 

B. Comments Regarding the Accuracy of 

Our Burden Estimates, Including the 

Validity of the Methodology and 

Assumptions Used, and FDA Response 

Many comments discussed the 

accuracy of FDA’s estimate of the 

burden for this information collection, 

including the validity of FDA’s 

methodology and the assumptions used. 

(Comment 3) Several comments 

alleged that we provided limited details 

about our proposed research studies and 

encouraged us to publish additional 

information on the proposed scope and 

methodology of our consumer research 

to allow for more comprehensive input 

from experts in the field of consumer 

research. One comment suggested we 

‘‘pre-register’’ details of the proposed 

studies on AsPredicted.org or 

ClinicalTrials.gov so that stakeholders 

could better understand the primary 

outcome of the research, hypotheses, 

analytic plan, and power analysis used. 

(Response 3) We described the 

research in the 60-day notice, providing 

information on research design, 

measures, sampling, and sample size. 

Many comments substantively 

addressed these issues, and so we 

believe there was enough information 

about the studies in the 60-day notice 

for the public—including consumer 

researchers—to comment on the 

research. 

We specified in the 60-day notice that 

we intend to use the results to inform 

our continued exploration of a symbol 

manufacturers could voluntarily use to 

represent the nutrient content claim 

‘‘healthy’’ on the food label (86 FR 

24629 at 24631). The comment did not 

provide sufficient information regarding 

additional details that it believed 

necessary for stakeholders to better 

understand this primary outcome, 

hypotheses, analytic plan, and power 

analysis used, and it did not explain 

what additional details might be 

available via pre-registration that would 

not be available in our Federal Register 

notices. Therefore, we are unable to 

provide those details here, and we also 

decline to pre-register our studies. 

(Comment 4) One comment 

questioned the ordering of the 

quantitative research, asking why the 

experimental studies come before the 

surveys. Other comments suggested we 

use the two surveys to test draft symbols 

first to narrow down options and test 

the ‘‘final’’ symbols in the experiment, 

or to conduct preliminary research to 

narrow the options for the experiment. 

(Response 4) We conducted several 

phases of qualitative research to solicit 

input from consumers, allowing us to 

evaluate symbol prototypes and design 

elements to learn what resonated with 

consumers. Through that process we 

narrowed our draft symbol options. 

After considering public comments, we 

have reconsidered the order of the 

research, and plan to conduct one 

survey with a larger sample size (instead 

of two surveys with smaller sample 

sizes each) before the experimental 

study. In other words, we will reorder 


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the studies and combine the two 

surveys into one, which will allow us to 

test all symbols in a single survey. 

While our proposed information 

collection is intended to help us better 

understand how consumers might 

respond to and use a graphic symbol 

that indicates packaged food products 

meet FDA’s definition of ‘‘healthy,’’ and 

all the draft symbols we proposed to test 

would allow us to do that, we expect 

conducting a single survey first will 

help us further revise and narrow down 

the set of symbols. 

(Comment 5) One comment suggested 

we use a more naturalistic study 

environment, such as an online store 

setting, instead of using images. 

(Response 5) Online store settings and 

other naturalistic study environments 

have been successfully employed in 

some studies on food labeling effects. 

One advantage of employing such 

naturalistic study environments is that 

they more closely reflect participants’ 

actual shopping experience. However, 

there are substantial additional costs 

associated with using such research 

settings, and results in these settings 

generally do not differ appreciably from 

results garnered through the simple 

random-assignment-to-condition design 

that we proposed. Therefore, we decline 

to change our study environment. 

(Comment 6) One comment suggested 

that FDA separate different aspects of 

the symbols to isolate consumer 

perceptions of the word ‘‘healthy,’’ the 

graphic itself, and the graphic 

accompanied by the word ‘‘FDA.’’ One 

comment suggested that FDA should 

test each symbol with and without 

‘‘FDA.’’ 

(Response 6) Separating each aspect 

of the symbols for our testing would 

increase the number of conditions 

exponentially, making the design 

impractical. We instead elected to use a 

full factorial design with simple random 

assignment to condition, to give us 

results on the performance of the 

various symbol designs. Using random 

assignment to condition, we may be able 

to eliminate some symbols without 

needing to test particular attributes in 

any one symbol. We may consider 

alternate study designs when we have a 

narrower set of symbols. 

One finding of our literature review 

was that institutional endorsement may 

be related to greater confidence in the 

symbol. Our focus group research 

affirmed that participants regarded 

symbols with ‘‘FDA’’ as more 

trustworthy than symbols without 

‘‘FDA.’’ Therefore, for the intended 

research, we are testing draft symbols 

with ‘‘FDA.’’ We may consider 

additional research on this point 

depending on the results. 

(Comment 7) One comment 

recommended using images of real food 

products in the experimental studies 

instead of using mock product images. 

(Response 7) FDA does not agree with 

the recommendation to use images of 

real products in the experimental 

studies. Mock images remove the 

potential for brand biases, a source of 

response error that has been 

demonstrated to affect the way 

individuals answer survey questions. 

Mock food product labels 

psychologically remove the salience of 

branded product informational cues 

present in the retrieval stage of the 

response process (Refs. 1 and 2). 

Additionally, the mock product labels 

we designed are visually similar to 

labels consumers could expect to see in 

stores for each given product category. 

We confirmed this assertion in our 

qualitative testing by noting that 

participants perceived the mock product 

labels as ones with which they were 

unfamiliar, but which were plausible for 

the food product depicted. 

(Comment 8) One comment suggested 

that we should assess ‘‘multi-tier 

symbols’’ in addition to the symbols we 

intend to test. The comment suggested 

that multi-tier symbols are those that 

use, for example, an increasing number 

of stars to indicate to the consumer that 

a choice is ‘‘good,’’ ‘‘better,’’ or ‘‘best.’’ 

The comment argued that a multi-tiered 

approach could encourage consumers to 

make incremental improvements in 

their diets, enable manufacturers to 

reformulate products to meet the initial 

tier of the system, and increase the 

number of foods with at least some 

healthful benefits that could carry a 

symbol. 

Another comment suggested that FDA 

consider a symbol that warns consumers 

about high levels of unhealthy nutrients. 

Another comment asserted that we 

should also test what it suggested were 

more neutral FOP labels, such as traffic 

lights, nutrition scoring symbols, and 

warning symbols, to better assist 

consumers in making healthy choices 

and motivate manufacturers to make 

healthier foods. 

(Response 8) For the purpose of this 

study, we are testing only symbols that 

would be a graphic representation of the 

nutrient content claim ‘‘healthy’’—a 

food that could bear that claim could 

also bear the symbol. FDA’s systematic 

literature review suggested that a 

summary indicator—the type we are 

proposing to test—would have the 

greatest utility to depict the ‘‘healthy’’ 

claim to a broad array of consumers, 

especially those with lower education or 

lower health literacy. As such, we 

disagree that we should test other kinds 

of symbols to depict the nutrient 

content claim ‘‘healthy.’’ We are testing 

different draft symbol designs based on 

our literature review and the feedback 

we collected through our focus group 

research. Our current study plans are 

limited to testing summary symbols 

depicting the nutrient content claim 

‘‘healthy’’ to get reactions to design 

elements and to reduce the current 

number of symbols under consideration. 

Because there are no ‘‘healthy’’ tiers in 

the nutrient content claim, we decline 

to test a tiered symbol. 

(Comment 9) One comment 

encouraged us to consider testing the 

‘‘healthy’’ symbol alongside other 

current voluntary FOP labels—rather 

than as the only symbol on a package— 

to determine the effect of other FOP 

labels on the efficacy of the ‘‘healthy’’ 

symbol. 

(Response 9) Our studies are designed 

to test general consumer responses to 

the symbols presented. Testing 

additional variables, such as the effect 

of other packaging elements on the 

symbols, is outside the scope of this 

research. We may decide to test 

‘‘healthy’’ symbols alongside other FOP 

symbols in later research depending on 

the results from this data collection. 

(Comment 10) One comment 

recommended randomizing participants 

to see subgroups of symbols, claiming it 

would be an efficient use of resources. 

(Response 10) FDA agrees with the 

recommendation that participants be 

randomly assigned; however, we 

disagree with the recommendation to 

have participants view subgroups of 

symbols. We plan to randomly assign 

participants to see a single symbol 

condition, including product type, 

information on the definition of healthy, 

URL/no-URL, and set of symbols. 

Viewing a single symbol condition 

precludes the effects of biases that may 

result from having viewed and 

responded to questions about one 

symbol affecting responses about 

another symbol (Ref. 1). Therefore, even 

if we might use fewer resources by 

assigning participants to see subgroups 

of symbols, the practice would 

introduce biases and confounds that 

could make interpreting the results very 

difficult. 

(Comment 11) One comment 

recommended incorporating time limits 

for a choice task to better mimic real-life 

scenarios where consumers have only 

limited time to shop. 

(Response 11) The current 

experimental study design is random 

assignment to condition with no 

‘‘choice task.’’ While time-constraint 


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studies can be useful to test certain 

variables, our research goal is for the 

participants to provide thoughtful 

responses, unaffected by the stress that 

a time limit could impose. 

(Comment 12) A few comments 

recommended that the studies be 

adequately powered to enable FDA to 

do appropriate statistical analysis. 

(Response 12) Our studies are 

designed to have the appropriate 

statistical power to conduct all 

necessary statistical analysis. We will 

test hypotheses related to between-label 

differences. We will impose no a priori 

direction of differences, if any (i.e., we 

assume all tests are two-tailed). The 

target sample size (5,000 for the 

experimental study and 2,000 for the 

survey) will yield enough observations 

to provide adequate power to identify 4- 

way interactions of a medium size (Ref. 

3). 

(Comment 13) One comment 

recommended that we test the draft 

‘‘healthy’’ symbols in the context of 

restaurants. 

(Response 13) Our research plans 

include testing symbols solely on 

packaged foods. Testing ‘‘healthy’’ on a 

packaged food label versus in a 

restaurant minimizes the many 

confounding factors inherent in 

studying claims in a restaurant 

environment, such as the enormous 

variance in size and content of materials 

used to sell restaurant food. Keeping the 

studies limited to packaged food labels 

allows FDA to better isolate various 

effects of the symbols to strictly test 

consumer perceptions about the 

symbols. Additionally, as we noted in 

response to another comment, we have 

no reason to believe that adding 

additional test product categories would 

change the study outcomes given our 

goal of testing consumer responses to 

the symbols. 

(Comment 14) Some comments 

recommended that FDA include more 

than three mock product types in the 

experimental studies because of the 

potential that consumer perceptions of a 

‘‘healthy’’ symbol might be different on 

different products. One comment 

suggested including a variety of food 

categories in the studies, while a few 

other comments recommended 

including specific product categories, 

including beverages and fresh produce, 

so FDA could assess consumer reactions 

to, or preferences for placement of, a 

symbol on those products. 

(Response 14) FDA disagrees with the 

recommendation to add more product 

types to the studies. We are proposing 

to test ‘‘healthy’’ symbols on a set of 

mock products that belong to large food 

categories, with many product types 

within each category. The broad product 

categories for those mock products are 

likely to contain multiple products that 

currently meet FDA’s regulatory 

definition of ‘‘healthy.’’ 

For our research, we chose three 

packaged foods that are commonly 

consumed and that are clearly distinct 

food types. The selected products will 

give us sufficient information on general 

consumer responses to the symbols to 

continue development of a proposed 

‘‘healthy’’ symbol. We also note that 

adding any products would increase the 

scope and cost of the studies while 

providing limited new information and 

that the comments provided no 

evidence that additional test products 

from other food categories would impact 

our study outcome. 

We decline to include a beverage as 

one of the mock products. While 

beverages that meet FDA’s definition of 

‘‘healthy’’ could bear any ‘‘healthy’’ 

symbol we finalize, the same is true of 

any packaged food, and as we explained 

above, we have no reason to believe that 

adding additional test product 

categories would change the study 

outcomes. We decline to add fresh 

produce to the studies for the same 

reasons. 

(Comment 15) A few comments 

recommend comparing foods with a 

‘‘healthy’’ symbol and foods that may 

have healthful attributes but do not 

meet the regulatory definition of 

‘‘healthy,’’ to evaluate whether use of 

the symbol might result in discouraging 

purchase of foods that have important 

nutrients but that do not meet the 

definition of ‘‘healthy.’’ Another 

comment suggested testing a variety of 

products (‘‘healthier’’ and ‘‘less 

healthy’’) for each food product category 

included in the studies. 

(Response 15) The studies are not 

designed to test purchasing behavior, 

and so we decline to add mock products 

for that purpose. Rather, this research is 

designed to test general consumer 

responses to the symbols themselves. 

Additionally, a product could only bear 

the symbol if it qualified to bear the 

‘‘healthy’’ claim itself—the symbol is a 

graphic representation of the claim— 

and we are not testing the claim 

definition or its effects here. 

One of the study assumptions is that, 

like the nutrient content claim 

‘‘healthy,’’ any food bearing a ‘‘healthy’’ 

symbol on its label must meet the 

regulatory definition of ‘‘healthy.’’ 

Therefore, to test consumer responses to 

the symbols, we do not need to test the 

ancillary effects of a ‘‘healthy’’ symbol 

on foods that do not bear the claim. 

Moreover, FDA intends to test ‘‘healthy’’ 

symbols on a set of mock products 

whose product categories are likely to 

contain multiple products that currently 

meet FDA’s regulatory definition of 

‘‘healthy’’—we are making no claims 

about the relative healthfulness of any 

product. Using these mock products in 

our research will provide us with 

sufficient information to understand 

how consumers might respond to a 

‘‘healthy’’ symbol on food packaging, 

and that information is our goal with 

these studies. Testing the selected 

products will give us sufficient 

information to continue development of 

a proposed ‘‘healthy’’ symbol. 

The comment did not provide an 

explanation for its recommendation to 

test ‘‘healthier’’ and ‘‘less healthy’’ 

products for each food product category. 

We are not testing ‘‘healthier’’ and ‘‘less 

healthy’’ versions of a given product in 

this research effort, as the goal of the 

research is to gauge participants’ 

reactions to a symbol. Additionally, we 

are working on updating our definition 

of ‘‘healthy’’ and will describe our 

proposed updated definition in any 

related rulemaking. It would be 

inappropriate to assign relative 

‘‘healthfulness’’ to comparator products. 

Products bearing the ‘‘healthy’’ symbol, 

which would be a graphic version of the 

nutrient content claim ‘‘healthy,’’ would 

have to meet the criteria for using the 

claim. 

(Comment 16) One comment noted a 

symbol with the term ‘‘FDA’’ may cause 

confusion if that symbol is used on any 

products regulated by the U.S. 

Department of Agriculture (USDA) and 

urged us to consider the potential for 

such confusion in our research. Another 

suggested that we engage with the Food 

Safety and Inspection Service during 

our proposed consumer research on the 

‘‘healthy’’ symbol to develop a symbol 

that could apply to all products that 

meet the ‘‘healthy’’ claim criteria. 

(Response 16) We cannot comment on 

whether or how USDA might allow an 

FDA ‘‘healthy’’ symbol on the products 

it regulates that meet FDA’s definition 

of ‘‘healthy.’’ However, we intend to 

coordinate with our federal partners, 

including USDA, as appropriate, as we 

continue our work on a ‘‘healthy’’ 

symbol. 

(Comment 17) A few comments 

asserted it was important to consider the 

symbols’ placement on packaging and 

noted that food packaging size, type, 

and appearance vary, suggesting that 

FDA should study how consumers may 

respond to a ‘‘healthy’’ symbol on a 

wider variety of packaging formats than 

are currently proposed for the studies. 

One comment suggested testing the 

symbol on different locations on the 

package and with varying prominence. 


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Another encouraged flexibility in 

specified requirements (e.g., placement, 

type size, color format, scannable 

images) surrounding the FOP symbol. 

(Response 17) We anticipate that any 

‘‘healthy’’ symbol we propose would be 

standardized in certain ways. However, 

the purpose of this research is to gauge 

consumer responses to the symbols we 

are testing, not to decide on a single 

symbol, its potential placement on 

packaging, or what aspects we would 

require, should a company choose to 

use the symbol. 

(Comment 18) A few comments 

suggested we include questions or 

conduct additional research to assess 

the potential for consumer 

misunderstanding of the symbols. Some 

comments suggested that we investigate 

whether consumer perceptions of some 

symbols might imply messages other 

than ‘‘healthy’’ (such as ‘‘organic,’’ 

‘‘natural,’’ ‘‘plant-based,’’ and 

‘‘minimally processed’’) or whether the 

symbols we are testing may appear 

similar to other existing or abandoned 

symbols (such as the USDA Organic 

Seal, Smart Choices, or any of USDA’s 

bioengineered food symbols). One 

comment claimed that a lack of 

legibility of the text in the symbol could 

cause consumer confusion. Another 

comment recommended that FDA avoid 

leaf or nature imagery in the symbol 

because it could imply that the product 

is plant-based, ‘‘natural,’’ or 

unprocessed. One comment encouraged 

us to examine how appealing the 

symbols are to consumers, and another 

comment described the proposed 

symbols as too simplistic. 

(Response 18) We have selected study 

designs and draft symbols that we 

expect, when used together, will reveal 

how consumers will react when they see 

such symbols on a food label. We 

included questions in our studies on 

what the symbols lead participants to 

believe about the products bearing 

them. We also expect to hear from 

participants whether the symbols we are 

testing are perceived as too complex, too 

simplistic, or invoke concepts other 

than ‘‘healthy.’’ 

We agree that any symbol we propose 

should be legible and minimize imagery 

that our research indicates could widely 

lead consumers to think the symbol 

means something unintended. As such, 

we will add an open-ended question to 

the experimental study asking what the 

symbol brings to mind to help 

determine if any symbols should be 

removed from consideration or revised 

on this basis. Moreover, we agree that 

the FDA symbol design for ‘‘healthy’’ 

should not be easily confused with 

other existing symbols and should be 

viewed as professional and credible by 

consumers. We expect to get some data 

on these points through this round of 

testing and may undertake further 

research before we make any formal 

regulatory decision on a symbol. 

(Comment 19) One comment 

suggested that FDA test other terms 

besides ‘‘healthy,’’ such as ‘‘nourishing’’ 

or ‘‘nutrient-dense.’’ 

(Response 19) We are not testing the 

nutrient content claim ‘‘healthy;’’ rather, 

we are testing consumer responses to 

graphic representations of the claim. We 

similarly do not intend to test other 

terms. 

(Comment 20) Several comments 

supported conducting research on the 

use of an accompanying URL with the 

‘‘healthy’’ symbol; however, others 

stated the purpose for including a URL 

was unclear, and one comment 

expressed concern that a URL would not 

work as well in a brick-and-mortar retail 

setting. Another comment stated that 

future labeling could include the use of 

other technologies, such as a quick 

response (QR) code or digital 

watermark, to provide consumers access 

to all the labeling information included 

on the package and suggested that we 

incorporate digital disclosure flexibility 

into our labeling regulations because 

technology continues to evolve. Other 

comments suggested that consumers 

may not have internet access in stores 

or may not know how to use QR codes, 

while another comment suggested that 

researchers could develop unique QR 

codes for each condition and track 

participant use. 

(Response 20) Our research efforts on 

the ‘‘healthy’’ symbol are intended to 

collect sufficient data for the 

development and finalization of a 

‘‘healthy’’ symbol. We are studying 

several dimensions of a proposed 

symbol, including the inclusion of a 

URL as part of the symbol. This research 

will help us better understand study 

participants’ reactions to and 

understanding of those different 

elements. 

Our preliminary research indicated 

that participants are interested in 

learning more about the symbols, and a 

URL can serve as a representation to 

participants that more information is 

available. The current study design 

proposes to test a URL alongside some 

of the symbols to gauge the ability of the 

URL to indicate that information about 

the symbol is available and to assess the 

degree to which a URL improves 

confidence and trust in the symbol. We 

are not studying participants’ actual 

ability to access the URL in stores or 

elsewhere. We are also not considering 

inclusion of other technologies, such as 

a QR code or digital watermark, in this 

information collection because a URL 

will help us gauge whether participants 

want a way to access additional 

information about the symbol. Further, 

a QR code or digital watermark would 

not indicate government involvement in 

the way a URL ending ‘‘.gov’’ may, and 

we are interested in how participants 

will respond to a ‘‘.gov’’ URL. 

While we agree that technology 

changes over time, we are only studying 

consumer responses to the symbols in 

this research. It would be premature to 

comment on any requirements 

surrounding any symbol we might 

propose. However, we could consider 

other digital elements, such as QR codes 

or digital watermarks, in future research 

depending on our future research goals. 

(Comment 21) Some comments raised 

concerns that the use of FDA’s name as 

part of the ‘‘healthy’’ symbol. The 

comments said that the use of FDA’s 

name could create the appearance of an 

FDA endorsement of a given food. 

(Response 21) We are testing draft 

symbols with ‘‘FDA.’’ We note that we 

are studying several dimensions of a 

proposed symbol to help us better 

understand study participants’ reactions 

to and understanding of those different 

elements, including any impression of 

an FDA endorsement. 

(Comment 22) A few comments 

expressed uncertainty as to whether 

FDA research participants would come 

from a nationally representative sample 

and recommended paying particular 

attention to or using quota samples 

similar to the demographic breakdown 

of the U.S. population regarding sex, 

age, race/ethnicity, income, and 

education. Some comments also stated 

that FDA should consider oversampling 

from certain groups at highest risk for 

dietary-related disparities, asserting that 

it is important to ensure that any 

proposed healthy symbol works well 

among all populations. One comment 

noted this is especially important for 

lower-education groups who, the 

comment asserted, may be less likely to 

use or understand the package’s 

nutrition label. Some comments also 

requested that FDA screen participants 

to ensure a sample large enough to 

collect responses from food-allergic 

individuals, caregivers to food-allergic 

individuals, and parents. 

(Response 22) We designed our 

studies to test consumer responses to 

draft symbols in a randomized 

controlled setting, with participants 

drawn from a general population. Our 

research collection is not intended to 

produce population estimates. However, 

we intend to select the samples in each 

study to be reflective of the general U.S. 


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population (e.g., sex, race/ethnicity). We 

believe our approach is reasonable 

because any ‘‘healthy’’ symbol we 

finalize will be available to the general 

U.S. population. 

(Comment 23) One comment 

suggested that we test a Spanish 

language version of the symbol and 

consider whether including ‘‘FDA’’ as 

part of the symbol would resonate with 

consumers of products sold in other 

countries. 

(Response 23) Our regulations, at 21 

CFR 101.15(c), generally require that the 

labeling of all food offered for sale in the 

United States be in English, and outline 

requirements for manufacturers that also 

choose to label their products in 

additional languages. Because we 

generally require only English labeling, 

and manufacturers may choose whether 

to use or include foreign-language 

labeling, we are testing only an Englishlanguage version of the symbol in this 

set of studies. 

As for products sold in other 

countries, the nutrient content claim 

‘‘healthy,’’ and any related symbol we 

finalize, are specifically for products 

marketed and sold in the United States. 

We decline to comment on marketing 

and sales in, or the food labeling 

requirements of, other countries. 

(Comment 24) One comment argued 

that we should not generalize the results 

from this study to all FOP label systems. 

(Response 24) We agree that findings 

from this research should not be 

generalized to all FOP label systems. 

C. Comments Regarding Ways To 

Enhance the Quality, Utility, and Clarity 

of the Information To Be Collected, and 

FDA Response 

Several comments suggested ways to 

enhance the quality, utility, and clarity 

of the information about ‘‘healthy’’ 

symbols to be collected. 

(Comment 25) Some comments stated 

FDA should conduct thorough research 

regarding the development and 

finalization of a symbol for ‘‘healthy,’’ 

and should collect comprehensive data 

so that FDA’s final decision promotes 

health. 

(Response 25) FDA agrees with the 

comments. Our research goal is to 

explore consumer responses to draft 

symbols that could represent the 

nutrient content claim ‘‘healthy.’’ The 

goal of the symbol is to help consumers 

make more informed dietary choices. 

(Comment 26) Several comments 

recommended we change certain 

aspects of the questions we include in 

the experimental study. Some 

comments suggested that we select 

specific outcome measures, such as 

purchase intent, sales data, ability of the 

symbols to attract consumer attention, 

long-term behavior change, consumer 

perceptions of the taste and cost of 

products bearing the ‘‘healthy’’ symbol, 

the healthfulness of the products 

consumers purchased, the number of 

‘‘healthier’’ products purchased in a 

shopping setting, and any unintended 

consequences of the symbol. 

One comment recommended adding 

covariates, such as health status, 

particularly for conditions that are 

related to nutrition, such as diabetes, 

weight status, and hypertension, to help 

us understand responses. Regarding the 

interpretation of measurements, one 

comment suggested we avoid 

‘‘believability’’ or ‘‘trustworthiness’’ as 

indicators of which symbol can help 

people make more informed dietary 

choices, claiming that these are not 

strong predictors of behavior. The 

comment cited a study on cigarette pack 

warning messages that found that 

measures on the effects of the warning 

message resulted more in intended 

behavior change than did measures on 

attitude perceptions (Ref. 4). 

Another comment recommended FDA 

provide an option for open-ended 

responses to gauge consumers’ 

perceptions of ‘‘healthy.’’ 

(Response 26) The intended studies 

cover the key measurements and 

covariates that will help us understand 

consumer perceptions of the symbols. 

The comments did not provide, and we 

are not aware of, evidence that adding 

covariates or measurements would 

enhance the quality, utility, or clarity of 

the information we intend to collect. We 

will evaluate our draft symbols based on 

our analysis of all—not just a subset— 

of these measurements. We 

acknowledge that there are 

measurements we are not including in 

this research effort (e.g., long-term 

behavior changes). These studies are 

designed to explore consumer responses 

to the draft symbols, and inclusion of 

variables such as long-term behavior 

changes would be premature. 

We plan to use a variety of measures 

to help understand the potential impact 

of a voluntary FOP symbol for 

‘‘healthy,’’ and intend to use 

‘‘believability’’ and ‘‘trustworthiness’’ as 

outcome measures because wellestablished scientific literature has 

shown that consumers’ attitudes and 

perceptions affect their behavior (Refs. 5 

to 7). Additionally, we note that the 

cigarette-pack study one comment cited 

qualified its findings as unsure if the 

same would be found in other message 

or product scenarios (Ref. 4). Because 

the published literature does not 

indicate that ‘‘effects perception 

measures’’ have been tested in the food 

label domain, we will add some 

questions to the experimental study to 

evaluate their use as outcome measures 

compared to ‘‘message effects 

measures.’’ 

We disagree with the suggestion to 

query consumers on their perception of 

‘‘healthy.’’ Our research is designed to 

test consumer responses to the draft 

symbols, not determine consumer 

perceptions of ‘‘healthy.’’ 

D. Comment Regarding Ways To 

Minimize the Burden of the Collection 

of Information on Respondents, 

Including Through the Use of 

Automated Collection Techniques, 

When Appropriate, and Other Forms of 

Information Technology, and FDA 

Response 

One comment discussed minimizing 

the information collection burden on 

respondents to our proposed ‘‘healthy’’ 

symbol research. 

(Comment 27) One comment 

supported the proposed research and 

noted that the use of online surveys will 

help alleviate participant and 

administrative burden while ensuring 

that the research reaches sufficient 

participants. 

(Response 27) We agree with the 

comment for the purposes of this 

research. 

E. Nonresponsive Comments to the PRA 

Some comments addressed aspects of 

‘‘healthy’’ symbols that are outside the 

scope of this information collection or 

addressed issues other than the 

‘‘healthy’’ symbol research. These 

discussed, for example, the definition of 

‘‘healthy,’’ potential impacts of the 

‘‘healthy’’ nutrient content claim 

generally, whether the symbols should 

be voluntary or mandatory, and whether 

we should develop an accompanying 

consumer education campaign. These 

are outside the scope of this information 

collection, and we will not address 

them here. Interested parties will have 

an opportunity to comment on any 

‘‘healthy’’ symbol we propose and any 

proposed updated definition of the 

nutrient content claim ‘‘healthy’’ in 

response to their respective Federal 

Register notices. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 87, No. 59 / Monday, March 28, 2022 / Notices 17307 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Study 1 (Survey) Cognitive interview screener ........... 75 1 75 0.083 (5 minutes) .. 6 

Study 2 (Experiment) Cognitive interview screener 2 .. 75 1 75 0.083 (5 minutes) .. 6 

Study 1 (Survey) Cognitive interview .......................... 5 1 5 1 ............................. 5 

Study 2 (Experiment) Cognitive interview ................... 9 1 9 1 ............................. 9 

Study 1 (Survey) Pretest ............................................. 60 1 60 0.17 (10 minutes) ... 10 

Study 2 (Experiment) Pretest ...................................... 180 1 180 0.25 (15 minutes) ... 45 

Study 1 (Survey) .......................................................... 2,000 1 2,000 0.17 (10 minutes) .. 340 

Study 2 (Experiment) ................................................... 5,000 1 5,000 0.25 (15 minutes) .. 1,250 

Total ...................................................................... ........................ ........................ ........................ ................................ 1,671 

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

2Since Study 3 is identical to Study 2, only one set of cognitive interviews and pre-tests are needed. 

II. References 

The following references are on 

display with 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; these are not available 

electronically at https://

www.regulations.gov as these references 

are copyright protected. Some may be 

available at the website address, if 

listed. FDA has verified the website 

addresses, as of the date this document 

publishes in the Federal Register, but 

websites are subject to change over time. 

1. Odsakoff, P.M., S.B. MacKenzie, N.P. 

Podsakoff, 2012. ‘‘Sources of Method 

Biases in Social Science Research and 

Recommendations on How to Control 

It.’’ Annual Review of Psychology, 63, 

pp. 539–569. 

2. Sheff, J.N., 2011. ‘‘Biasing Brands.’’ 

Cardozo Law Review, 32(4), pp. 1245– 

1314. 

3. Cohen, J., 1992. ‘‘A Power Primer.’’ 

Psychology Bulletin, 112(1), pp. 155–159. 

4. Baig, S.A., S.M. Noar, N.C. Gottfredson, et 

al., 2021. ‘‘Incremental Criterion Validity 

of Message Perceptions and Effects 

Perceptions in the Context of Antismoking Messages.’’ Journal of 

Behavioral Medicine, 44, pp. 74–83. 

5. Azjen, I., 2011. ‘‘The Theory of Planned 

Behaviour: Reactions and Reflections.’’ 

Psychology and Health, 26(9), pp. 1113– 

1127. 

6. Azjen, I., 2014. ‘‘The Theory of Planned 

Behaviour is Alive and Well, and Not 

Ready to Retire: A Commentary on 

Sniehotta, Presseau, and Araujo-Soares.’’ 

Healthy Psychology Review, 9(2), pp. 

131–137. 

7. Ajzen, I., 2016. ‘‘Consumer Attitudes and 

Behavior: The Theory of Planned 

Behavior Applied to Food Consumption 

Decisions.’’ Italian Review of 

Agricultural Economics, 70(2), pp. 121– 

138. 

Dated: March 21, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06419 Filed 3–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Solicitation of Nominations for 

Organizational Representatives to the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Request for nominations. 

SUMMARY: HRSA is seeking nominations 

from organizations to send 

representatives to be a liaison to the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(ACHDNC or Committee). Selections 

will be based on a review of the 

organization’s subject area of expertise, 

mission, relevancy, and benefit 

provided relative to the Committee’s 

purpose. The organizational 

representatives are non-voting liaisons. 

The Committee provides advice, 

recommendations, and technical 

information about aspects of heritable 

disorders and newborn and childhood 

screening to the Secretary of HHS. 

DATES: Written nominations for 

organizational representatives to the 

ACHDNC must be received on or before 

May 2, 2022. 

ADDRESSES: Nomination packages must 

be submitted electronically as email 

attachments to Soohyun Kim, MPH, 

CPH, Acting Designated Federal Officer 

(DFO) at ACHDNC@hrsa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Acting DFO Soohyun Kim, MPH, CPH; 

Maternal and Child Health Bureau, 

HRSA, 5600 Fishers Lane, Room 18–N– 

38A, Rockville, MD 20857; 301–594– 

4202; or ACHDNC@hrsa.gov. A copy of 

the Committee charter and list of 

current membership is available on the 

Committee’s website: https://

www.hrsa.gov/advisory-committees/ 

heritable-disorders/index.html. 

SUPPLEMENTARY INFORMATION: ACHDNC 

was established in 2003 to provide 

advice and recommendations to the 

Secretary on the development of 

newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices for 

heritable disorders, recommends 

improvements in the national newborn 

and childhood heritable screening 

programs, recommends conditions for 

inclusion in the Recommended Uniform 

Screening Panel (RUSP), and fulfills 

requirements stated in the authorizing 

legislation. ACHDNC’s 

recommendations regarding inclusion of 

additional conditions/inherited 

disorders for screening that, when 

adopted by the Secretary, are included 

in the RUSP, and constitute part of the 

evidence-informed comprehensive 

preventive health services guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and group and individual 

health insurance issuers are required to 

provide coverage without cost-sharing (a 

co-payment, co-insurance, or 

deductible) for preventive services for 

plan years (i.e., in the individual 

market, policy years) beginning on or 


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