Request for Information: Nomination and Evidence-Based Review Process of the Advisory Committee on Heritable Disorders in Newborns and Children, 15876-15878 [2024-04618]
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15876
Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices
stimuli and one on cigarette-focused
stimuli) will be fielded as appropriate,
but not within the same month.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use by minors, FDA requests
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
OMB approval to collect information to
evaluate CTP’s public education
campaign ‘‘The Real Cost’’ through the
MIA.
In the Federal Register of April 27,
2023 (88 FR 25660), FDA published a
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Total
responses
Parent Screener ..........................................................
Parent Permission .......................................................
Invitation Emails (Respondents ages 18–20) .............
Youth Assent ...............................................................
Young Adult Consent ..................................................
Online Survey ..............................................................
Reminder Emails .........................................................
2,338,560
1,753,920
54,096
27,936
20,064
48,000
48,000
1
1
1
1
1
1
1
2,338,560
1,753,920
54,096
27,936
20,064
48,000
48,000
Total ......................................................................
........................
........................
........................
1 There
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Average burden per
response
0.05
0.05
0.02
0.05
0.05
0.42
0.20
Total hours
(3 minutes) .....
(3 minutes) .....
(1 minute) ......
(3 minutes) .....
(3 minutes) .....
(25 minutes) ..
(12 minutes) ..
116,928
87,696
1,082
1,397
1,003
20,160
9,600
................................
237,866
are no capital costs or operating and maintenance costs associated with this collection of information.
Data collection for the MIA will
consist of administering a monthly
survey to participants ages 12–20 over
the course of 2 years (24 months). We
expect the screening process (3 minutes
per response) to yield an approximate
2.3 to 1 ratio of eligible participants. We
will need to screen approximately
97,440 potential parents each month
(resulting in 2,338,560 screeners) over
the study period. Since the eligible age
for data collection is 12 to 20 years old,
we intend to screen parents of eligible
youth and young adults. Parents of the
youth participants determined to be
eligible through the screener will
provide parent permission (3 minutes
per response). We estimate that
1,753,920 of the parents who complete
the screener will provide their
permission for their youth to complete
the online survey (approximately 75
percent of the 2,338,560 screened). In
addition to recruiting respondents
through parents, we will send direct
invitations to young adult panel
members (18 to 20 years old). We
anticipate that 50 percent of young
adults will agree to participate. We will
send 508 direct invitations a month to
young adult panel members (18 to 20
years old). Eligible youth (1,753,920)
will provide their assent (3 minutes per
response) to participate in the online
survey (25 minutes per response).
Participants who are 18 to 20 years old
(19 to 20 years old in Alabama and
Nebraska in accordance with state law)
will provide their consent (3 minutes
per response) to participate in the
online survey. We estimate that
approximately 42 percent of the 48,000
completed surveys will come from
VerDate Sep<11>2014
16:50 Mar 04, 2024
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young adults aged 18 to 20 (aged 19 to
20 in Alabama and Nebraska).
Over the course of the study period,
we intend to survey approximately
2,000 teens ages 12–20 per month for 24
months. From completed screeners, we
estimate that we will obtain data from
approximately 27,936 youth and 20,064
young adults. This will give us a total
of 48,000 participants for the study. The
survey will be repeated with a new
cross-sectional sample approximately
every month over a period of 24 months;
however, some participants will
complete more than one wave. These
48,000 respondents will receive an
invitation email with a link to take the
survey (4 minutes), 6 reminder emails (3
minutes each), and a thank you email (3
minutes) upon completion of the study
for a total of 25 minutes for respondents
to read and respond to the emails.
Several changes have been made to
this information collection request since
the 60-day notice was published in the
Federal Register. These changes include
(a) editing to clarify that the ad
campaign is intended for ‘‘teens’’ not
just ‘‘youth;’’ (b) removing the focus on
video ads since the campaign may use
other forms of communication to deliver
its message and replacing the term ‘‘ad’’
with ‘‘stimuli;’’ (c) removing the youth
screener from the burden table because
parents determine the eligibility of their
youth aged 12–17 (18–20 in Alabama
and Nebraska in accordance with state
law); (d) removing the young adult
screener from the burden table, which
will not be needed because young adult
panel members (18–20 years old) will
only receive an email invitation to
complete the survey; (e) updating the
burden table to reflect that we will send
PO 00000
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direct invitations to young adult panel
members (18–20 years old); (f) updating
the permission, assent, and consents
because of updated information on the
expected sample breakdown from the
sample vendor for the distribution of the
sample who are 12–17 years old and 18–
20 years old; and (g) removing the thank
you email since that will not be a part
of the data collection procedures. In
addition to the implementation
evaluation described above, we will also
assess perceptions to proposed stimuli
and potential unintended consequences
in order to inform the development of
future messaging.
Dated: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04526 Filed 3–4–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Request for Information: Nomination
and Evidence-Based Review Process
of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of request for public
comment.
AGENCY:
At the request of the Advisory
Committee on Heritable Disorders in
Newborns and Children (ACHDNC or
SUMMARY:
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Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices
Committee), HRSA is requesting input
from the public on the process used by
the Committee for nomination and
evidence-based review of conditions
that are considered for inclusion in the
Recommended Uniform Screening Panel
(RUSP). As an entity that advises the
Secretary of Health and Human Services
(Secretary) based on evidence-based
information, ACHDNC periodically
considers and evaluates its processes.
During the November 2023 meeting,
ACHDNC hosted listening sessions to
learn more from stakeholders regarding
their views on the process used by
ACHDNC for nomination and evidencebased review of conditions. In support
of this work, HRSA is seeking public
input on a series of questions that will
help inform the nomination and review
processes.
DATES: Comments on this FRN should
be received no later than April 4, 2024.
ADDRESSES: Responses must be
submitted electronically as email
attachments to CDR Leticia Manning,
MPH, ACHDNC’s Designated Federal
Officer, at: ACHDNC@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: CDR
Leticia Manning, MPH, Designated
Federal Officer, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–8335; or ACHDNC@hrsa.gov. A
copy of the ACHDNC charter may be
obtained by accessing the ACHDNC
website at: https://www.hrsa.gov/
advisory-committees/heritabledisorders.
SUPPLEMENTARY INFORMATION: ACHDNC
was established in 2003 and provides
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,
recommends improvements in the
national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening on
the RUSP, following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in comprehensive guidelines supported
by HRSA pursuant to section 2713 of
the Public Health Service Act (42 U.S.C.
300gg–13), for which certain health
insurance plans and issuers are required
to provide coverage without costsharing. The ACHDNC meets four times
VerDate Sep<11>2014
16:50 Mar 04, 2024
Jkt 262001
each calendar year or at the discretion
of the Designated Federal Officer in
consultation with the Chair.
Responses
HRSA is seeking responses on the
following questions. Responses to all
questions are voluntary, and a response
to each question is not required.
Nomination Process: The current
nomination process can be found here:
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
condition-nomination. The Committee
has already received feedback from
newborn screening stakeholders on the
current nomination process, and based
on this feedback, the Committee is
requesting that HRSA publish this
notice to obtain additional public
feedback on the proposed revisions to
the questions addressed within the
nomination package.
Please provide feedback in response
to the questions on the proposed
elements below (i.e., the condition,
newborn screening, and benefits and
harms of newborn screening), including:
(1) Whether these questions add
clarity to what is required for a
condition nomination package?
(2) Whether appropriate language is
used to describe the required
information for each section?
(3) Whether this question-based
format makes clearer the requirements
for a nomination? If not, please propose
edits and/or changes to what is
provided.
Please cite any available information
that you may have to support your
responses.
Section I: The Condition
(1) What is the specific condition to
be screened for (‘‘target condition’’) and
how is it defined?
(2) How is the condition diagnosed as
part of usual clinical care? Why is the
current clinical diagnostic approach
inadequate?
(3) What is the reported birth
prevalence of the condition in the
United States (or comparable newborn
population)? Is the condition more
common in certain populations?
(4) Describe the severity of the
condition when detected as part of
usual clinical care.
Section II: Newborn Screening
(1) What testing approach(es) are you
suggesting for newborn screening?
Please be specific regarding the
approach to screening (e.g., dried-blood
spot, point-of-care screening, what
specimen or test). Is there one or more
tiers of testing that should occur before
a diagnostic referral to a clinical
specialist?
PO 00000
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15877
(2) How is the condition diagnosed
after an at-risk child is identified
through newborn screening? (i.e., How
does a clinical specialist confirm that an
infant has the condition after referral
from the newborn screening program?)
(3) What other conditions could be
identified through newborn screening
for the target condition as nominated?
This includes phenotypes of the target
condition that are not being nominated
for newborn screening (e.g., late-onset,
mild variants). Will screening for the
target condition identify carriers?
(4) What examples are there of
screening and diagnosis for the
condition at a prospective population
level (e.g., through state newborn
screening (NBS) program or pilot
studies)? Has at least one case of the
condition been identified, diagnosed,
and treated through a prospective
population-based approach?
(5) Based on at least one example of
a prospective population level study
from question #4, please describe the
epidemiologic elements a–e below.
(Include a peer-reviewed study, if
available.):
(a) The birth prevalence of the target
condition.
(b) The birth prevalence of the other
conditions that could be identified by
screening.
(c) The percentage of newborns with
the target condition who had a positive
screen (sensitivity of NBS test).
(d) The percentage of newborns with
one of the other conditions who were
identified through newborn screening
with the target condition.
(e) The percentage of newborns
without the target condition who had a
negative screen (specificity of NBS test).
Section III: Benefits and Harms of
Newborn Screening
(1) What is the expected benefit to
infants and/or families for detection of
the condition through newborn
screening compared to clinical care
identification?
(2) What is the expected harm to
infants and/or families for detection of
the condition through newborn
screening compared to clinical care
identification?
(3) Are there other benefits or harms
that may result from implementing a
state newborn screening program? (e.g.,
false positive or negative results, infants
identified with other conditions, or
opportunity costs to a state public
health system)
(4) What treatment and management
protocols are available for newborns
identified with the condition through
newborn screening?
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Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices
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(5) What plan for longitudinal followup of newborns identified through
newborn screening is available? For
example, will there be a patient registry
available for use by clinical providers or
by individuals/families? For how many
years would infants with the condition
be followed?
Evidence-based Review Process: The
current criteria for ACHDNC to
recommend inclusion of a condition on
the RUSP to the Secretary is based
primarily on peer-reviewed evidence
regarding the certainty that benefits of
universal screening outweigh harms
(‘‘net benefit’’). These criteria have been
largely applied to focus on the benefits
and harms to the individual child, with
much less consideration of benefits and
harms to the family, states, or to the
public health system. Financial and
opportunity costs have received less
attention by ACHDNC, in part because
of the lack of published evidence
regarding such topics.
Below is an example of what
published evidence should be
considered by the Committee when
conducting a condition evidence
review. The Committee requests
feedback regarding the example below.
When weighing certainty and net
benefit of screening for a condition, the
Committee should consider the full
range of relevant, published, peerreviewed evidence. Although such
evidence in relation to benefits and
harms to the individual child remain
paramount, the Committee should also
consider benefits and harms to the
family and to society at large, including
disproportionate impacts or disparities
related to specific conditions or
screening. For example, the Committee
could consider evidence demonstrating
benefits for the family regarding future
planning (e.g., finances, geographic
proximity to services, home design,
etc.), earlier access to early intervention
programs, or opportunity costs to the
public health system. Ideally, potential
harms and benefits should be supported
by evidence directly relevant to the
condition under review. When such
evidence is lacking, Committee
members could consider peer-reviewed
evidence from other disorders to the
extent that such evidence is considered
potentially relevant to the condition
under consideration.
Special Note to Commenters
The information obtained through this
request for information (RFI) may help
inform ACHDNC processes. Per the
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ACHDNC Charter, the Committee has
the responsibility to decide the
processes for nomination, evidence
review, and making recommendations
regarding the RUSP. How Committee
members ultimately vote on
recommending a condition for inclusion
on the RUSP will continue to reflect
their judgment on the certainty of net
benefit to the entire population of
infants born in the United States.
This RFI is issued solely for
information and planning purposes; it
does not constitute a Request for
Proposal, applications, proposal
abstracts, or quotations. This RFI does
not commit the U.S. government to
contract for any supplies or services or
make a grant or cooperative agreement
award. Further, HRSA is not seeking
proposals through this RFI and will not
accept unsolicited proposals. HRSA will
not respond to questions about the
policy issues raised in this RFI.
Responders are advised that the U.S.
government will not pay for any
information or administrative costs
incurred in response to this RFI; all
costs associated with responding to this
RFI will be solely at the interested
party’s expense.
Authority: ACHDNC is authorized by
section 1111(g) of the Public Health
Service Act, 42 U.S.C. 300b–10(g), and
the Federal Advisory Committee Act, 5
U.S.C. chapter 10.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–04618 Filed 3–4–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0955–0018]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before April 4, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
SUMMARY:
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information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0955–0018–30D
and project title for reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: 21st Century
Cures Act: Interoperability, Information
Blocking, and the ONC Health IT
Certification Program.
Type of Collection: Reinstatement
without change.
OMB No: 0955–0018.
Abstract: The Department of Health
and Human Services, Office of the
Secretary, Office of the National
Coordinator for Health IT Office of
Policy, is requesting an approval by
OMB for reinstatement without change
which pertains to a records and
information retention requirement
found at 45 CFR 170.402(b)(1). The
purpose and use of this records and
information retention requirement is to
verify, as necessary, health IT developer
compliance with the ONC Health IT
Certification Program (Program)
requirements, including certification
criteria and Conditions and
Maintenance of Certification.
Specifically, a health IT developer must,
for a period of 10 years beginning from
the date each of a developer’s health IT
is first certified under the Program,
retain all records and information
necessary that demonstrate initial and
ongoing compliance with the
requirements of the Program.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05MRN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 44 (Tuesday, March 5, 2024)]
[Notices]
[Pages 15876-15878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Request for Information: Nomination and Evidence-Based Review
Process of the Advisory Committee on Heritable Disorders in Newborns
and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of request for public comment.
-----------------------------------------------------------------------
SUMMARY: At the request of the Advisory Committee on Heritable
Disorders in Newborns and Children (ACHDNC or
[[Page 15877]]
Committee), HRSA is requesting input from the public on the process
used by the Committee for nomination and evidence-based review of
conditions that are considered for inclusion in the Recommended Uniform
Screening Panel (RUSP). As an entity that advises the Secretary of
Health and Human Services (Secretary) based on evidence-based
information, ACHDNC periodically considers and evaluates its processes.
During the November 2023 meeting, ACHDNC hosted listening sessions to
learn more from stakeholders regarding their views on the process used
by ACHDNC for nomination and evidence-based review of conditions. In
support of this work, HRSA is seeking public input on a series of
questions that will help inform the nomination and review processes.
DATES: Comments on this FRN should be received no later than April 4,
2024.
ADDRESSES: Responses must be submitted electronically as email
attachments to CDR Leticia Manning, MPH, ACHDNC's Designated Federal
Officer, at: [email protected].
FOR FURTHER INFORMATION CONTACT: CDR Leticia Manning, MPH, Designated
Federal Officer, Maternal and Child Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301-443-8335; or [email protected]. A
copy of the ACHDNC charter may be obtained by accessing the ACHDNC
website at: https://www.hrsa.gov/advisory-committees/heritable-disorders.
SUPPLEMENTARY INFORMATION: ACHDNC was established in 2003 and provides
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, recommends improvements in the national newborn and
childhood screening programs, and fulfills requirements stated in the
authorizing legislation. In addition, ACHDNC's recommendations
regarding inclusion of additional conditions for screening on the RUSP,
following adoption by the Secretary, are evidence-informed preventive
health services provided for in comprehensive guidelines supported by
HRSA pursuant to section 2713 of the Public Health Service Act (42
U.S.C. 300gg-13), for which certain health insurance plans and issuers
are required to provide coverage without cost-sharing. The ACHDNC meets
four times each calendar year or at the discretion of the Designated
Federal Officer in consultation with the Chair.
Responses
HRSA is seeking responses on the following questions. Responses to
all questions are voluntary, and a response to each question is not
required.
Nomination Process: The current nomination process can be found
here: https://www.hrsa.gov/advisory-committees/heritable-disorders/condition-nomination. The Committee has already received feedback from
newborn screening stakeholders on the current nomination process, and
based on this feedback, the Committee is requesting that HRSA publish
this notice to obtain additional public feedback on the proposed
revisions to the questions addressed within the nomination package.
Please provide feedback in response to the questions on the
proposed elements below (i.e., the condition, newborn screening, and
benefits and harms of newborn screening), including:
(1) Whether these questions add clarity to what is required for a
condition nomination package?
(2) Whether appropriate language is used to describe the required
information for each section?
(3) Whether this question-based format makes clearer the
requirements for a nomination? If not, please propose edits and/or
changes to what is provided.
Please cite any available information that you may have to support
your responses.
Section I: The Condition
(1) What is the specific condition to be screened for (``target
condition'') and how is it defined?
(2) How is the condition diagnosed as part of usual clinical care?
Why is the current clinical diagnostic approach inadequate?
(3) What is the reported birth prevalence of the condition in the
United States (or comparable newborn population)? Is the condition more
common in certain populations?
(4) Describe the severity of the condition when detected as part of
usual clinical care.
Section II: Newborn Screening
(1) What testing approach(es) are you suggesting for newborn
screening? Please be specific regarding the approach to screening
(e.g., dried-blood spot, point-of-care screening, what specimen or
test). Is there one or more tiers of testing that should occur before a
diagnostic referral to a clinical specialist?
(2) How is the condition diagnosed after an at-risk child is
identified through newborn screening? (i.e., How does a clinical
specialist confirm that an infant has the condition after referral from
the newborn screening program?)
(3) What other conditions could be identified through newborn
screening for the target condition as nominated? This includes
phenotypes of the target condition that are not being nominated for
newborn screening (e.g., late-onset, mild variants). Will screening for
the target condition identify carriers?
(4) What examples are there of screening and diagnosis for the
condition at a prospective population level (e.g., through state
newborn screening (NBS) program or pilot studies)? Has at least one
case of the condition been identified, diagnosed, and treated through a
prospective population-based approach?
(5) Based on at least one example of a prospective population level
study from question #4, please describe the epidemiologic elements a-e
below. (Include a peer-reviewed study, if available.):
(a) The birth prevalence of the target condition.
(b) The birth prevalence of the other conditions that could be
identified by screening.
(c) The percentage of newborns with the target condition who had a
positive screen (sensitivity of NBS test).
(d) The percentage of newborns with one of the other conditions who
were identified through newborn screening with the target condition.
(e) The percentage of newborns without the target condition who had
a negative screen (specificity of NBS test).
Section III: Benefits and Harms of Newborn Screening
(1) What is the expected benefit to infants and/or families for
detection of the condition through newborn screening compared to
clinical care identification?
(2) What is the expected harm to infants and/or families for
detection of the condition through newborn screening compared to
clinical care identification?
(3) Are there other benefits or harms that may result from
implementing a state newborn screening program? (e.g., false positive
or negative results, infants identified with other conditions, or
opportunity costs to a state public health system)
(4) What treatment and management protocols are available for
newborns identified with the condition through newborn screening?
[[Page 15878]]
(5) What plan for longitudinal follow-up of newborns identified
through newborn screening is available? For example, will there be a
patient registry available for use by clinical providers or by
individuals/families? For how many years would infants with the
condition be followed?
Evidence-based Review Process: The current criteria for ACHDNC to
recommend inclusion of a condition on the RUSP to the Secretary is
based primarily on peer-reviewed evidence regarding the certainty that
benefits of universal screening outweigh harms (``net benefit''). These
criteria have been largely applied to focus on the benefits and harms
to the individual child, with much less consideration of benefits and
harms to the family, states, or to the public health system. Financial
and opportunity costs have received less attention by ACHDNC, in part
because of the lack of published evidence regarding such topics.
Below is an example of what published evidence should be considered
by the Committee when conducting a condition evidence review. The
Committee requests feedback regarding the example below.
When weighing certainty and net benefit of screening for a
condition, the Committee should consider the full range of relevant,
published, peer-reviewed evidence. Although such evidence in relation
to benefits and harms to the individual child remain paramount, the
Committee should also consider benefits and harms to the family and to
society at large, including disproportionate impacts or disparities
related to specific conditions or screening. For example, the Committee
could consider evidence demonstrating benefits for the family regarding
future planning (e.g., finances, geographic proximity to services, home
design, etc.), earlier access to early intervention programs, or
opportunity costs to the public health system. Ideally, potential harms
and benefits should be supported by evidence directly relevant to the
condition under review. When such evidence is lacking, Committee
members could consider peer-reviewed evidence from other disorders to
the extent that such evidence is considered potentially relevant to the
condition under consideration.
Special Note to Commenters
The information obtained through this request for information (RFI)
may help inform ACHDNC processes. Per the ACHDNC Charter, the Committee
has the responsibility to decide the processes for nomination, evidence
review, and making recommendations regarding the RUSP. How Committee
members ultimately vote on recommending a condition for inclusion on
the RUSP will continue to reflect their judgment on the certainty of
net benefit to the entire population of infants born in the United
States.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal, applications, proposal
abstracts, or quotations. This RFI does not commit the U.S. government
to contract for any supplies or services or make a grant or cooperative
agreement award. Further, HRSA is not seeking proposals through this
RFI and will not accept unsolicited proposals. HRSA will not respond to
questions about the policy issues raised in this RFI. Responders are
advised that the U.S. government will not pay for any information or
administrative costs incurred in response to this RFI; all costs
associated with responding to this RFI will be solely at the interested
party's expense.
Authority: ACHDNC is authorized by section 1111(g) of the Public
Health Service Act, 42 U.S.C. 300b-10(g), and the Federal Advisory
Committee Act, 5 U.S.C. chapter 10.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-04618 Filed 3-4-24; 8:45 am]
BILLING CODE 4165-15-P
