Privacy Act of 1974; System of Records; Correction, 44990-44991 [2024-11267]
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44990
Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY
DESIGN (PICOTS)—Continued
Element
Inclusion criteria
Outcome ....................................
KQ1:
Newborn size and body composition.
• Birth weight, weight-for-age and percentile or Z-score adjusted for gestational age.
• Low birth weight.
• Small-for-gestational age.
• Large-for-gestational age; fetal macrosomia.
• Birth length, length-for-age and percentile and Z-score adjusted for gestational age.
• Head circumference and percentile and Z-score adjusted
for gestational age.
• BMI, BMI z-score, weight-for-length percentile, and Z-score
• Ponderal index or other composite measures.
• Body composition and distribution (e.g., % fat mass, fat-free
mass, skin fold thicknesses, circumferences).
KQ2:
Gestational weight gain.
• Change in pregnant individual’s body weight from baseline
(before or during 1st trimester of pregnancy) to a later time point
during pregnancy and/or right before delivery.
• Weight gain in relationship to weight gain recommendations, based on pre-pregnancy BMI.
KQ3:
Infant (up to 24 months of age) growth, size, and body composition.
• Weight-for-age and percentile or Z-score adjusted for gestational age.
• Length-for-age and percentile and Z-score adjusted for gestational age.
• Head circumference and percentile and Z-score adjusted
for gestational age.
• BMI, BMI z-score, weight-for-length percentile, and Z-score
• Body composition and distribution (e.g., % fat mass, fat-free
mass, skin fold thicknesses, circumferences).
• Incidence and prevalence of underweight, failure to thrive,
stunting, wasting, healthy weight, overweight, obesity.
• All exposure or intervention durations will be included.
• KQ1 and KQ2: exposure during pregnancy.
• KQ3: exposure from birth to 24 months of age.
• Outpatient; all settings except hospital and acute care will
be included.
• Randomized controlled trials.
• Non-randomized controlled trials, including quasi-experimental and controlled before-and-after studies.
• Prospective cohort studies.
• Nested case-control studies.
Timing ........................................
Setting ........................................
Study Design .............................
Geographic Location .................
Study Size .................................
Language ...................................
Publication Dates .......................
Exclusion criteria
• Locations with food products or dietary supplements widely
available to U.S. and/or Canadian consumers, including those
rated high and very high on the Human Development Index
(HDI)c.
• Studies with N ≥30 participants (for randomized clinical
trials [RCTs]): ≥10 participants analyzed per study arm).
• Articles published in English ..................................................
• Articles published during or after 2000 ..................................
• Hospital and acute care.
•
•
•
•
•
•
•
•
•
•
Narrative reviews.
Systematic reviews.
Meta-analyses.
Scoping reviews.
Umbrella reviews.
Retrospective cohort studies.
Cross-sectional studies.
Case-control studies.
All other study designs.
Locations not rated high or very high on the HDI.
• Studies with N <30 participants (for RCTs: <10 participants
analyzed per study arm), and without power calculation.
• Articles published in languages other than English.
• Articles published prior to 2000.
a Total
dietary digestible carbohydrate intake defined as collective starch and sugar intake; carbohydrate intake not including dietary fiber.
b Dietary supplement is defined as a product intended to supplement the diet that contains one or more dietary ingredients (including vitamins, minerals, herbs or
other botanicals, amino acids, and other substances) intended to be taken by mouth as a pill, capsule, table, or liquid, and that is labeled on the front panel as being
a dietary supplement.
c United Nations Development Programme Human Development Reports, https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
Dated: May 16, 2024.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024–11198 Filed 5–21–24; 8:45 am]
Administration for Children and
Families
BILLING CODE 4160–90–P
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Privacy Act of 1974; System of
Records; Correction
Administration for Children
and Families, Department of Health and
Human Services.
AGENCY:
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ACTION:
Notice; Correction.
The Department of Health and
Human Services (HHS) published a
system of records notice in the Federal
Register on May 16, 2024, for new
system of records ‘‘OCSS Research
Platform’’ maintained by HHS’
Administration for Children and
Families (ACF), Office of Child Support
Services (OCSS). The notice contained
SUMMARY:
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Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Notices
an incorrect system number, 09–80–
0391; the correct number is 09–80–0390.
FOR FURTHER INFORMATION CONTACT: Beth
Kramer, HHS Privacy Act Officer, FOIA/
Privacy Act Division, 200 Independence
Ave. SW—Suite 729H, Washington, DC
20201, or beth.kramer@hhs.gov, (202)
690–6941.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of May 16,
2024, in FR Doc 2024–10776, on page
42881 (third column), correct the system
number to read:
SYSTEM NAME AND NUMBER:
OCSS Research Platform, 09–80–0390.
Dated: May 17, 2024.
Beth Kramer,
HHS Privacy Act Officer, FOIA-Privacy Act
Division, Office of the Assistant Secretary for
Public Affairs.
[FR Doc. 2024–11267 Filed 5–21–24; 8:45 am]
BILLING CODE 4184–42–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2019]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Class II Special
Controls: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Principle
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the collection of
information concerning class II special
controls for an automated blood cell
separator device operating by
centrifugal or filtration separation
principle.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by July
22, 2024.
DATES:
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You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 22, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–2019 for ‘‘Class II Special
Controls: Automated Blood Cell
Separator Device Operating by
Centrifugal or Filtration Separation
Principle.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
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44991
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
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Agencies
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 44990-44991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11267]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Privacy Act of 1974; System of Records; Correction
AGENCY: Administration for Children and Families, Department of Health
and Human Services.
ACTION: Notice; Correction.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) published a
system of records notice in the Federal Register on May 16, 2024, for
new system of records ``OCSS Research Platform'' maintained by HHS'
Administration for Children and Families (ACF), Office of Child Support
Services (OCSS). The notice contained
[[Page 44991]]
an incorrect system number, 09-80-0391; the correct number is 09-80-
0390.
FOR FURTHER INFORMATION CONTACT: Beth Kramer, HHS Privacy Act Officer,
FOIA/Privacy Act Division, 200 Independence Ave. SW--Suite 729H,
Washington, DC 20201, or [email protected], (202) 690-6941.
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of May 16, 2024, in FR Doc 2024-10776, on
page 42881 (third column), correct the system number to read:
SYSTEM NAME AND NUMBER:
OCSS Research Platform, 09-80-0390.
Dated: May 17, 2024.
Beth Kramer,
HHS Privacy Act Officer, FOIA-Privacy Act Division, Office of the
Assistant Secretary for Public Affairs.
[FR Doc. 2024-11267 Filed 5-21-24; 8:45 am]
BILLING CODE 4184-42-P