Attachment C 60 day FRN ACHDNC 0906-0014

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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices

providing clinical services (currently 7,
previously 8) related to Healthy People
2020 and;
(7) removal of the outdated project
specific Health Improvement Special
Project measure (1 measure removed).
In total, the proposed changes reflect
the addition of 43 measures and the
removal of 5 measures for an increase in
measures by a total of 38 measures. Of
these measures, 17 are required and 26
are optional. All additional measures
proposed are project specific (only
applicable to anticipated total ranging
from 15–16 out of 61 awardees). All

measures will not be applicable to all 61
respondents. Project specific measures
will remain applicable only to Outreach
Awardees focusing on the respective
project specific topic.
Likely Respondents: The respondents
would be award recipients of the Rural
Health Care Services Outreach Program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
Number of
respondents

Form name

Rural Health Care Services Outreach PIMS .......................

HRSA specifically requests comments
on the: (1) Necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–15607 Filed 7–21–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
System Assessment Surveys, OMB No.
0906–0014, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
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AGENCY:

In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the

SUMMARY:

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Number of
responses per
respondent

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Fmt 4703

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

61

1

61

3.5

213.5

61

........................

61

........................

213.5

Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 20,
2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Advisory Committee on Heritable
Disorders in Newborns and Children’s
Public Health System Assessment
Surveys, OMB No. 0906–0014—
Revision.
Abstract: The purpose of the Public
Health System Assessment Surveys is to
inform the Advisory Committee on
Heritable Disorders in Newborns and
Children (Committee) on states’ ability
to add newborn screening for particular
conditions, including the feasibility,
readiness, and overall capacity to screen
for a new condition.
The Committee was established under
the Public Health Service Act, 42 U.S.C.

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and systems for the purpose of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; train
personnel and to be able to respond to
a collection of information; to search
data sources; complete and review the
collection of information; and transmit
or otherwise disclose the information.
The total annual burden hours
estimated for this ICR are summarized
in the table below.
Total Estimated Annualized Burden
Hours:

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217a: Advisory councils or committees,
and Title XI § 1111 (42 U.S.C. 300b-10).
The purpose of the Committee is to
provide the Secretary with
recommendations, advice, and technical
information regarding the most
appropriate application of technologies,
policies, guidelines, and standards for:
(a) Effectively reducing morbidity and
mortality in newborns and children
having, or at risk for, heritable
disorders; and (b) enhancing the ability
of 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. Specifically, the Committee
makes systematic evidence-based
recommendations on newborn screening
for conditions that have the potential to
change the health outcomes for
newborns.
The Committee tasks an external
workgroup to conduct systematic
evidence-based reviews for conditions
being considered for addition to the
Recommended Uniform Screening
Panel, and their corresponding newborn
screening test(s), confirmatory test(s),
and treatment(s). Reviews also include
an analysis of the benefits and harms of
newborn screening for a selected
condition at a population level and an
assessment of state public health
newborn screening programs’ ability to
implement the screening of a new
condition.
Need and Proposed Use of the
Information: The Committee’s Evidence
Review Group administers the surveys
to collect data from state newborn
screening programs in the United States.

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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices
The surveys have been developed to
capture the following: (1) Readiness of
state public health newborn screening
programs to expand newborn screening
to include the target condition, (2)
specific requirements of screening for a
condition that could hinder or facilitate
implementation in each state, and (3)
estimated timeframes needed for each
state to complete major milestones
toward full implementation of newborn
screening for the condition.
The following is a summary of
proposed changes to the Committee’s
Public Health System Assessment
Surveys:
Proposed changes to the ‘‘INITIAL
Survey of the Secretary’s Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
System Assessment:’’
• Survey title:
Æ Current title: ‘‘INITIAL Survey of
the Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children’s Public Health System
Assessment’’
Æ Proposed change: (strike
‘‘Secretary’s’’) ‘‘INITIAL Survey of the
Advisory Committee on Heritable
Disorders in Newborns and Children’s
Public Health System Assessment’’
Æ Rationale: Per the charter signed on
November 10, 2020, the Advisory
Committee on Heritable Disorders in
Newborns and Children is the correct
name for the Committee.
• Introductory paragraph:
Æ Current introductory paragraph:
‘‘The purpose of this survey is to inform
the Secretary of Health and Human
Services Advisory Committee on
Heritable Disorders in Newborns and
Children (Committee) about states’
ability to add newborn screening (NBS)
for [condition x] using information
gathered from most of the state and
territorial NBS programs in the U.S.
. . .’’
Æ Proposed change: (strike ‘‘Secretary
of Health and Human Services’’) ‘‘The
purpose of this survey is to inform the

Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee) about states’ ability to add
newborn screening (NBS) for [condition
x] using information gathered from most
of the state and territorial NBS programs
in the U.S. . . .’’
Æ Rationale: Per the charter signed
November 10, 2020, the Advisory
Committee on Heritable Disorders in
Newborns and Children is the correct
name of the Committee.
• Instructions for question 3
(grammatical edit):
Æ Current instructions: ‘‘. . . The
following question asks you to consider,
in general, how much the following
factors would be an issue in considering
adding [condition x] to your NBS
panel.’’
Æ Proposed change: (strike ‘‘in’’ and
replace with ‘‘when’’) ‘‘. . . The
following question asks you to consider,
in general, how much the following
factors would be an issue when
considering adding [condition x] to your
NBS panel.’’
Æ Rationale: Change made to correct
a grammatical error.
Proposed changes to the ‘‘FOLLOW–
UP Survey of the Secretary’s Advisory
Committee on Heritable Disorders in
Newborns and Children’s Public Health
System Assessment’’
• Survey title:
Æ Current title: ‘‘INITIAL Survey of
the Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children’s Public Health System
Assessment’’
Æ Proposed change: (strike
‘‘Secretary’s’’) ‘‘INITIAL Survey of the
Advisory Committee on Heritable
Disorders in Newborns and Children’s
Pub.
Æ Rationale: Per the charter signed
November 10, 2020, the Advisory
Committee on Heritable Disorders in
Newborns and Children is the correct
name of the Committee.
• Question 9 (grammatical edits):
Æ Current question: ‘‘Have you
developed a follow up protocol and/or

educational materials for [condition x]?
If so please describe the steps for shortterm follow and how the plan was
developed.’’
Æ Proposed change: (insert hyphen in
‘‘follow-up’’ and insert ‘‘-up’’ in the
phrase ‘‘short-term follow’’) ‘‘Have you
developed a follow-up protocol and/or
educational materials for [condition x]?
If so, please describe the steps for shortterm follow-up and how the plan was
developed.
Æ Rationale: Change made to correct
grammatical errors.
The data gathered informs the
Committee on the following: (1)
Feasibility of implementing populationbased screening for the target condition,
(2) readiness of state newborn screening
programs to adopt screening for the
condition, (3) gaps or limitations related
to the feasibility or readiness of states to
screen for a condition, and (4) areas of
technical assistance and resources
needed to facilitate screening for
conditions with low feasibility or
readiness.
Likely Respondents: The respondents
to the survey will be state and territorial
newborn screening programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

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Form name

Number of
responses per
respondent

1 59

32

118

10.0

1,180

2 30

32

60

2.0

120

89

........................

178

........................

1,300

INITIAL Survey of the Advisory Committee on Heritable
Disorders in Newborns and Children’s Public Health
System Assessment .........................................................
FOLLOW–UP Survey of the Advisory Committee on Heritable Disorders in Newborns and Children’s Public
Health System Assessment .............................................
Total ..............................................................................

Total
responses

* It is anticipated that the proposed revisions will not impact the estimated annualized burden hours.
1 The respondents to the survey will be state and territorial newborn screening programs.

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Average
burden per
response
(in hours)

Number
of respondents

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Total burden
hours

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3 Up

Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices

to 30 states and/or territories will be asked to complete a follow-up survey.
to two conditions may be reviewed per year.

HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–15598 Filed 7–21–21; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

In accordance with the Public
Health Service Act and the Federal
Advisory Committee Act, this notice
announces that the Advisory Committee
on Heritable Disorders in Newborns and
Children (ACHDNC or Committee) has
scheduled a public meeting to be held
on Thursday, August 12, 2021, and
Friday, August 13, 2021. Information
about the ACHDNC and the agenda for
this meeting can be found on the
ACHDNC website at https://
www.hrsa.gov/advisory-committees/
heritable-disorders/index.html.
DATES: Thursday, August 12, 2021, from
10:00 a.m. to 2:15 p.m. Eastern Time
(ET) and Friday, August 13, 2021, from
10:00 a.m. to 2:00 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
required.
Please register online at https://
www.achdncmeetings.org/registration/
by the deadline of 12:00 p.m. ET on
August 11, 2021. Instructions on how to
access the meeting via webcast will be
provided upon registration.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau, HRSA, 5600 Fishers

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SUMMARY:

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Lane, Rockville, Maryland 20857; 301–
443–0721; or ACHDNC@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of HHS (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. The 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,
following adoption by the Secretary, are
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel 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 health insurance
issuers offering group or individual
health insurance are required to provide
insurance coverage without cost-sharing
(a co-payment, co-insurance, or
deductible) for preventive services for
plan years (i.e., policy years) beginning
on or after the date that is one year from
the Secretary’s adoption of the
condition for screening.
During the August 12–13, 2021,
meeting, ACHDNC will hear from
experts in the fields of public health,
medicine, heritable disorders, rare
disorders, and newborn screening.
Agenda items include the following:
(1) Overview of the Committee’s
review of its evidence-review processes
and proposed updates,
(2) A presentation on phase one of the
mucopolysaccharidosis type II evidence
review,
(3) Guanidinoacetate
methyltransferase (GAMT) deficiency
nomination summary,
(4) Possible Committee vote on
whether to move GAMT deficiency
forward to a full evidence review,
(5) Committee discussion on emerging
issues for newborn screening,
(6) A panel presentation on national
registries followed by Committee
discussion,
(7) A panel presentation on emerging
issues facing the newborn screening

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workforce followed by Committee
discussion, and
(8) Public comments on any newborn
screening related topic.
The public is also encouraged to
provide public comment on the
proposed updates to the Committee’s
evidence review processes. For
reference, a summary of questions for
public consideration is on the ACHDNC
website. We request that public
participants providing oral comments
on the review of the Committee’s
evidence review process also submit a
written version of their remarks.
The agenda for this meeting does not
include any vote or decision to
recommend a condition for inclusion in
the Recommended Uniform Screening
Panel. As noted in the agenda items, the
Committee may hold a vote on whether
or not to recommend a nominated
condition (GAMT deficiency) to full
evidence review, which may lead to
such a recommendation at a future time.
Agenda items are subject to change as
priorities dictate. Information about the
ACHDNC, including a roster of members
and past meeting summaries, is
available on the ACHDNC website listed
above.
As previously noted, members of the
public will have the opportunity to
provide comments. Public participants
providing general oral comments may
submit written statements in advance of
the scheduled meeting. Oral comments
will be honored in the order they are
requested and may be limited as time
allows. Requests to provide a written
statement or make oral comments to the
ACHDNC must be submitted via the
registration website by 10:00 a.m. ET on
Monday, August 9, 2021.
Individuals who need special
assistance or another reasonable
accommodation should notify Alaina
Harris at the address and phone number
listed above at least 10 business days
prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–15569 Filed 7–21–21; 8:45 am]
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