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