Statement of Organization, Functions, and Delegations of Authority, 67464 [2019-26494]
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67464
Federal Register / Vol. 84, No. 237 / Tuesday, December 10, 2019 / Notices
TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/
EXCLUSION CRITERIA—Continued
PICOTS
Inclusion
Exclusion
Æ Harms specific to pregnancy and breastfeeding (infertility,
miscarriage,
abruption,
preterm
labor/preterm
birth,
preeclampsia, gestational hypertensive disorders, glucose intolerance/gestational diabetes mellitus, reduced milk production in breastfeeding/undesired weaning).
Æ Danger to self or infant.
Æ Misuse of prescription medication.
Æ Serious adverse events related to treatment.
Æ Death.
• Fetal/infant/child harms.
Æ Preterm birth/small for gestational age or large for gestational
age.
Æ Congenital anomalies.
Æ Perinatal complications (low APGAR, withdrawal, respiratory
distress, neonatal intensive care unit time, persistent pulmonary hypertension).
Æ Poor infant attachment/bonding *†.
Æ Delayed social, emotional, and cognitive development *.
Æ Death.
Time frame ...
Followup .......................................................................................................
KQ 1, KQ 2: From conception up to 1 year postpartum for maternal outcomes.
KQ 3, KQ 4: All ............................................................................................
Followup
• KQ 1, KQ 2: More than 12 weeks preconception for maternal preconception outcomes, more than 1 year for maternal postpartum outcomes
• KQ 3, KQ 4: None.
Settings § .....
Clinical setting ..............................................................................................
All settings ....................................................................................................
Clinical setting
None.
Study design
• RCTs, CCTs, case-control studies, cohort studies with comparison
arms.
• Reference lists of relevant systematic reviews published in 2013 or
later will be used to ensure our search strategies captured all relevant
studies.
All other designs and studies using included designs that do not meet the
sample size criterion.
Language .....
Studies published in English ........................................................................
Studies published in languages other than English.
* We will limit included outcomes to those using validated measures. Another potential exclusion, depending on volume of yield, includes studies that fail to control
for confounding.
† Drugs such as brexanolone that are awaiting FDA approval will be included in the review once they are approved
‡ We will focus strength of evidence (SOE) grades on outcomes prioritized by the Technical Expert Panel (TEP).
§ Depending on volume, we may limit the primary analysis to studies from geographic settings with resources comparable or applicable to the United States.
Dated: December 4, 2019.
Virginia Mackay-Smith,
Associate Director.
[FR Doc. 2019–26510 Filed 12–9–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
jbell on DSKJLSW7X2PROD with NOTICES
Statement of Organization, Functions,
and Delegations of Authority
Part J (Agency for Toxic Substances
and Disease Registry) of the Statement
of Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (50 FR 25129–25130, dated
June 17, 1985, as amended most
recently at 82 FR 42555, dated
September 8, 2017) is amended to
reflect the Order of Succession for the
Agency for Toxic Substances and
Disease Registry.
Section J–C, Order of Succession:
VerDate Sep<11>2014
17:49 Dec 09, 2019
Jkt 250001
Delete in its entirety the Section J–C,
Order of Succession, and insert the
following:
During the absence or disability of the
Administrator, Agency for Toxic
Substances and Disease Registry
(ATSDR), or in the event of a vacancy
in that office, the first official listed
below who is available shall act as
Administrator, except during a planned
period of absence, the Administrator
may specify a different order of
succession:
1. Assistant Administrator, ATSDR
2. Deputy Director for Non-Infectious
Diseases
3. Principal Deputy Director
4. Chief Medical Officer
5. Director, Center for Preparedness and
Response
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2019–26494 Filed 12–9–19; 8:45 am]
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AGENCY:
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SUMMARY:
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[Federal Register Volume 84, Number 237 (Tuesday, December 10, 2019)]
[Notices]
[Page 67464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26494]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Statement of Organization, Functions, and Delegations of
Authority
Part J (Agency for Toxic Substances and Disease Registry) of the
Statement of Organization, Functions, and Delegations of Authority of
the Department of Health and Human Services (50 FR 25129-25130, dated
June 17, 1985, as amended most recently at 82 FR 42555, dated September
8, 2017) is amended to reflect the Order of Succession for the Agency
for Toxic Substances and Disease Registry.
Section J-C, Order of Succession:
Delete in its entirety the Section J-C, Order of Succession, and
insert the following:
During the absence or disability of the Administrator, Agency for
Toxic Substances and Disease Registry (ATSDR), or in the event of a
vacancy in that office, the first official listed below who is
available shall act as Administrator, except during a planned period of
absence, the Administrator may specify a different order of succession:
1. Assistant Administrator, ATSDR
2. Deputy Director for Non-Infectious Diseases
3. Principal Deputy Director
4. Chief Medical Officer
5. Director, Center for Preparedness and Response
Sherri A. Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2019-26494 Filed 12-9-19; 8:45 am]
BILLING CODE 4163-70-P