Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children, 17307-17308 [2022-06368]

Download as PDF Federal Register / Vol. 87, No. 59 / Monday, March 28, 2022 / Notices 17307 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Study Study Study Study Study Study Study Study 1 2 1 2 1 2 1 2 Number of responses per respondent Total annual responses Average burden per response Total hours (Survey) Cognitive interview screener ........... (Experiment) Cognitive interview screener 2 .. (Survey) Cognitive interview .......................... (Experiment) Cognitive interview ................... (Survey) Pretest ............................................. (Experiment) Pretest ...................................... (Survey) .......................................................... (Experiment) ................................................... 75 75 5 9 60 180 2,000 5,000 1 1 1 1 1 1 1 1 75 75 5 9 60 180 2,000 5,000 0.083 (5 minutes) .. 0.083 (5 minutes) .. 1 ............................. 1 ............................. 0.17 (10 minutes) ... 0.25 (15 minutes) ... 0.17 (10 minutes) .. 0.25 (15 minutes) .. 6 6 5 9 10 45 340 1,250 Total ...................................................................... ........................ ........................ ........................ ................................ 1,671 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Since Study 3 is identical to Study 2, only one set of cognitive interviews and pre-tests are needed. II. References jspears on DSK121TN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:30 Mar 25, 2022 Jkt 256001 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for nominations. AGENCY: 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. SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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/. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\28MRN1.SGM 28MRN1 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 VerDate Sep<11>2014 17:30 Mar 25, 2022 Jkt 256001 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). AGENCY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 ACTION: Request for nominations. 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/. 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 SUMMARY: E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 87, Number 59 (Monday, March 28, 2022)]
[Notices]
[Pages 17307-17308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06368]


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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 [email protected].

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 [email protected]. 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/.

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

[[Page 17308]]

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