Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children, 47766-47767 [2022-16654]
Download as PDF
<![CDATA[
47766
Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Notices
led to a subsequent 2020 study
conducted and published by Jones et al.,
which found that analysis of pooled
samples was not equivalent to that of
single samples. In environmental
samples, the level of background
microflora plays a role in the ability to
detect SE, if present. When samples are
pooled, the amount of background
microflora is amplified, potentially
causing the inability to detect SE by
masking its presence. This is further
exacerbated based on the number of
pooled samples (e.g., two vs. four
samples per collection bag) and could
result in false negative test results. After
consideration of the science, FDA
determined that at this time, there is not
sufficient data to consider pooled
samples equivalent to single samples, as
required by the reference methods cited
in § 118.8. While we understand cost
considerations are important, the
primary concern should always be the
ability to detect SE if it is present.
The comment also suggested adjusting
the egg testing protocol to two 1,000-egg
samples instead of four 1,000-egg
samples. Testing four 1,000-egg samples
over an 8-week period results in
approximately a 95 percent probability
that a positive egg will be detected from
a flock that is producing SEcontaminated eggs with a prevalence of
1 in 1,400. Testing fewer than 4,000 eggs
over a period of 8 weeks, as required by
§ 118.7, would result in less than a 95
percent probability that a positive egg
would be detected from a flock that is
producing SE-contaminated eggs at that
rate.
We find that the required testing
established under 21 CFR 118.7 and
118.8 best protects the public health and
that relaxing the current testing
requirements, whether or not in an
effort to reduce costs, would not provide
the same level of protection necessary to
ensure the public health.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers 2
Activity; 21 CFR section
Refrigeration Records; § 118.10(a)(3)(iv) .......................
Testing, Diversion, and Treatment Records;
§ 118.10(a)(3)(v) through (viii) (positive) 3.
Egg Testing; § 118.10(a)(3)(vii) ......................................
Environmental Testing; § 118.10(a)(3)(v) 3 .....................
Testing, Diversion, and Treatment Records;
§ 118.10(a)(3)(v) through (viii) (negative) 3.
Prevention Plan Review and Modifications;
§ 118.10(a)(4).
Chick and Pullet Procurement Records; § 118.10(a)(2)
Rodent and Other Pest Control; § 118.10(a)(3)(ii), and
Biosecurity Records, § 118.10(a)(3)(i).
Prevention Plan Design; § 118.10(a)(1) .........................
Cleaning and Disinfection Records; § 118.10(a)(3)(iii) ...
Total .........................................................................
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total
hours
2,600
343
52
52
135,200
17,836
0.5 (30 minutes) .......
0.5 (30 minutes) .......
67,600
8,918
331
6,308
5,965
7
23
1
2,317
145,084
5,965
8.3 .............................
0.25 (15 minutes) .....
0.5 (30 minutes) .......
19,231
36,271
2,983
331
1
331
10 ..............................
3,310
4,731
9,462
1
52
4,731
492,024
0.5 (30 minutes) .......
0.5 (30 minutes) .......
2,366
246,012
350
331
1
1
350
331
20 ..............................
0.5 (30 minutes) .......
7,000
166
........................
........................
........................
...................................
393,857
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
records are kept on a by-farm basis and others are kept on a by-house basis.
3 Calculations include requirements for pullet and layer houses.
2 Some
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
Activity; 21 CFR section
Form
Registrations or Updates; § 118.11 .......
Cancellations; § 118.11 ..........................
FDA 3733 2 ............
FDA 3733 ..............
350
30
1
1
350
30
2.3
1
805
30
Total ................................................
................................
........................
........................
........................
........................
835
1 There
jspears on DSK121TN23PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at https://www.access.fda.gov per § 118.11(b)(1).
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimates for the recordkeeping burden
and the reporting burden are based on
our experience with similar
recordkeeping activities and the number
of registrations and cancellations
received in the past 3 years.
VerDate Sep<11>2014
17:25 Aug 03, 2022
Jkt 256001
Dated: July 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–16686 Filed 8–3–22; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
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).
AGENCY:
Frm 00078
Fmt 4703
Sfmt 4703
E:\FR\FM\04AUN1.SGM
04AUN1
Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Notices
ACTION:
Notice.
In accordance with the
Federal Advisory Committee Act and
the Public Health Service Act, this
notice announces a public meeting of
the Advisory Committee on Heritable
Disorders in Newborns and Children
(ACHDNC or Committee). 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/.
DATES: Tuesday, August 30, 2022, from
10:00 a.m. to 2:00 p.m. Eastern Time
(ET) and Wednesday, August 31, 2022,
from 10:00 a.m. to 1:00 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 29, 2022. 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
Lane, Room 18W66, 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. 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 Recommended Uniform Screening
Panel, following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive 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 health insurance
issuers offering non-grandfathered
group or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Aug 03, 2022
Jkt 256001
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
During the August 30–31, 2022,
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) A presentation on phase one of the
Krabbe disease evidence review;
(2) A presentation and Committee
discussion on the infant formula
shortage;
(3) A presentation and Committee
discussion on advancing the newborn
screening system;
(4) A presentation on the Long-term
Follow-up for Severe Combined
Immunodeficiency and Other Newborn
Screening Conditions Program; and
(5) Workgroup updates.
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 will hear presentation on
evidence review of Krabbe disease,
which may lead to such a
recommendation at a future time.
Agenda items are subject to change as
priorities dictate. Information about
ACHDNC, including a roster of members
and past meeting summaries, is also
available on the ACHDNC website.
Members of the public also will have
the opportunity to provide comments.
Public participants may request to
provide general oral comments and may
submit written statements in advance of
the scheduled meeting. The Committee
will honor oral comments in the order
they are requested and may be limited
as time allows. Participants who wish to
provide a written statement or make oral
comments to ACHDNC must submit
their request via the registration website
by 12:00 p.m. ET on Wednesday, August
24, 2022.
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. 2022–16654 Filed 8–3–22; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
47767
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel Role of FSH—
II.
Date: August 30, 2022.
Time: 12:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: NIJAGUNA PRASAD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
7201 Wisconsin Avenue, Gateway Bldg, Suite
2W200, Bethesda, MD 20892, (301) 496–
9667, prasadnb@nia.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.nia.nih.gov/, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 1, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–16716 Filed 8–3–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47766-47767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16654]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Advisory Committee on Heritable Disorders in
Newborns and Children
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
[[Page 47767]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act and the
Public Health Service Act, this notice announces a public meeting of
the Advisory Committee on Heritable Disorders in Newborns and Children
(ACHDNC or Committee). 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/.
DATES: Tuesday, August 30, 2022, from 10:00 a.m. to 2:00 p.m. Eastern
Time (ET) and Wednesday, August 31, 2022, from 10:00 a.m. to 1:00 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 29, 2022.
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 Lane, Room 18W66, Rockville, Maryland
20857; 301-443-0721; or [email protected].
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. 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 Recommended Uniform
Screening Panel, following adoption by the Secretary, are evidence-
informed preventive health services provided for in the comprehensive
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 health insurance issuers offering
non-grandfathered 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 30-31, 2022, 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) A presentation on phase one of the Krabbe disease evidence
review;
(2) A presentation and Committee discussion on the infant formula
shortage;
(3) A presentation and Committee discussion on advancing the
newborn screening system;
(4) A presentation on the Long-term Follow-up for Severe Combined
Immunodeficiency and Other Newborn Screening Conditions Program; and
(5) Workgroup updates.
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 will hear
presentation on evidence review of Krabbe disease, which may lead to
such a recommendation at a future time.
Agenda items are subject to change as priorities dictate.
Information about ACHDNC, including a roster of members and past
meeting summaries, is also available on the ACHDNC website.
Members of the public also will have the opportunity to provide
comments. Public participants may request to provide general oral
comments and may submit written statements in advance of the scheduled
meeting. The Committee will honor oral comments in the order they are
requested and may be limited as time allows. Participants who wish to
provide a written statement or make oral comments to ACHDNC must submit
their request via the registration website by 12:00 p.m. ET on
Wednesday, August 24, 2022.
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. 2022-16654 Filed 8-3-22; 8:45 am]
BILLING CODE 4165-15-P
