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 


jspears on DSK121TN23PROD with NOTICES1
17308 Federal Register / Vol. 87, No. 59 / Monday, March 28, 2022 / Notices 

after the date that is 1 year from the 

Secretary’s adoption of the condition. 

ACHDNC also provides advice and 

recommendations to the Secretary 

concerning grants, projects and 

technical information to develop 

policies and priorities for grants, 

including those that will enhance the 

ability of the state and local health 

agencies to provide for newborn and 

child screening, counseling, and health 

care services for newborns and children 

having or at risk for heritable disorders. 

ACHDNC meets four times each 

calendar year, or at the discretion of the 

DFO in consultation with the Chair. 

Nominations: The Committee may 

invite organizations to designate 

individuals to serve as non-voting 

liaisons. Organizations should 

demonstrate wide-ranging newborn 

screening and heritable disorders 

interests. In addition, the organization’s 

work should inform the activities of the 

Committee. Eligible organizations must 

represent national public health 

constituencies, medical professional 

societies, or organizations with large, 

broad constituencies and broad interest 

or involvement in newborn screening. 

Organizations that represent narrow 

interests (e.g., interest in a single disease 

treatment) or smaller constituencies are 

not eligible. Organizational 

representatives attend Committee 

meetings to provide relevant expertise 

and perspectives to Committee members 

during their deliberations and 

discussions, but they do not vote and 

are not official members of the 

Committee. 

Applications must contain a cover 

letter and statement. The cover letter 

should include the organization name 

and mission statement; contact 

information for the designated 

representative, including point of 

contact name, address, email, telephone 

number; and website of the 

organization. The statement should 

include the perspective and expertise 

provided by the organization and its 

relevance to the Committee; description 

of how the Committee’s work affects 

and impacts the organization and its 

constituency; a list of organizational 

projects, programs, and products that 

are of relevance to the Committee’s 

work; an affirmation of the 

organization’s commitment to identify a 

representative with expertise who can 

attend Committee meetings in person 

(when applicable) and provide input to 

the Committee at the discretion of the 

Chair; an affirmation of the 

organization’s commitment to 

financially support (e.g., cover travel 

expenses) a representative to attend any 

in-person Committee meetings held in 

Rockville, Maryland; an affirmation of 

the organization’s commitment to 

ensure active contribution to and 

dissemination of Committee activities 

and recommendations to its 

constituencies; affirmation the 

designated representative is able to 

serve as the liaison; and an affirmation 

that the organization has no conflict of 

interest that would preclude informing 

the Committee in a fair and balanced 

manner. If there are potential conflicts 

of interest, please detail the information 

concerning any potential conflicts of 

interest relative to both the organization 

and the proposed organizational 

representative (e.g., current or 

anticipated employment, consultancies, 

research grants, or contracts), as well as 

how the organization proposes to 

address the potential conflict. 

Organizations are eligible to send a 

representative as long as the 

organization’s subject area of expertise 

and mission is relevant to the 

Committee’s purpose, objective, scope 

of activities and duties, and as long as 

the organization actively participates in 

Committee activities. Every 3 years, the 

Chair and DFO will re-assess the 

organization’s mission, relevancy, and 

benefit as it relates to the Committee’s 

purpose, objective, scope of activities 

and duties. Every 3 years, current 

organizations will be asked to reaffirm 

their commitment to support an 

organizational representative. 

The selection of eligible organizations 

is based on a review of the 

organization’s subject area of expertise, 

mission, relevancy, and benefit as it 

relates to the Committee’s purpose. 

Authority: Section 1111(g) of the 

Public Health Service Act, 42 U.S.C. 

300b–10(g), Section 222 of the Public 

Health Service Act, 42 U.S.C. 217a, and 

the Federal Advisory Committee Act, 5 

U.S.C. App. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–06368 Filed 3–25–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Solicitation of Nominations for 

Membership To Serve on 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 

of qualified candidates for consideration 

for appointment as members of the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(ACHDNC or Committee). ACHDNC 

provides advice, recommendations, and 

technical information about aspects of 

heritable disorders and newborn and 

childhood screening to the Secretary of 

HHS (Secretary). HRSA is seeking 

nominations of qualified candidates for 

appointment to two positions on the 

Committee beginning in 2023, each 

serving a term of up-to 4 years. 

DATES: Written nominations for 

membership on the Committee must be 

received on or before April 11, 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 the 

current membership is available on the 

Committee’s website at https://

www.hrsa.gov/advisory-committees/ 

heritable-disorders/about/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 


jspears on DSK121TN23PROD with NOTICES1