Notice of a Supplemental Award, Initiated by the Maternal and Child Health Bureau, to the University of Mississippi Medical Center for the Early Childhood Developmental Health System: Implementation in a High Need State Cooperative Agreement, 44307-44308 [2020-15802]
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Federal Register / Vol. 85, No. 141 / Wednesday, July 22, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
accommodate greater participation. FDA
developed this draft guidance in part to
respond to issues and questions raised
in the discussion at that hearing and in
many of the public comments received.
Although the hearing was not
exclusively about cannabidiol (CBD),
this compound was a key discussion
topic. FDA and many stakeholders have
concerns about marketed products that
contain CBD, including concerns about
potential contamination and inaccurate
or misleading labeling. FDA would like
to reiterate that EPIDIOLEX®
(cannabidiol) is the sole FDA-approved 2
product derived from an extract of the
cannabis plant.
Many sponsors initiating clinical
research for drugs containing cannabis
and cannabis-derived compounds may
be unclear regarding, or unfamiliar with,
applicable drug quality expectations. In
general, drugs containing cannabis and
cannabis-derived compounds are
subject to the same authorities and
requirements as drugs containing any
other substance. Drugs intended for
human use are evaluated by FDA’s
Center for Drug Evaluation and Research
(CDER 3) to ensure that drugs marketed
in the United States are safe and
effective for their intended uses and will
be manufactured in a manner that
ensures quality. CDER has published
extensive regulations and guidance
documents regarding the drug
development and review process. In
addition, FDA’s website contains useful
explanations regarding drug research
and development. Finally, CDER’s
Small Business and Industry Assistance
helps small pharmaceutical businesses
and industry navigate the wealth of
information that FDA offers, and assists
in understanding the regulation of
human drug products.
FDA’s support of drug development
extends to drugs containing cannabidiol
and other compounds found in
cannabis. One important element is
encouraging drug developers to meet
with FDA early in their development
programs—ideally, before submitting an
investigational new drug (IND)
application. The pre-IND meeting is an
opportunity to obtain FDA input on
research plans and required content for
an IND submission. The pre-IND
meeting can be valuable in planning a
drug development program, especially if
sponsors’ questions are not fully
answered by guidances and other
2 See Epidiolex drug approval package and
labeling, available at https://
www.accessdata.fda.gov/drugsatfda_docs/nda/
2018/210365Orig1s000TOC.cfm.
3 FDA’s Center for Biologics Evaluation and
Research (CBER) also has regulatory responsibilities
with respect to the review of human drugs.
VerDate Sep<11>2014
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information provided by FDA. Early
interactions with FDA staff through a
pre-IND meeting can answer sponsors’
questions related to a specific drug
development program and provide
information that will assist them in
preparing complete IND applications.
Efficient use of FDA resources can lead
to more efficient drug development.
The FDA web page ‘‘FDA and
Cannabis: Research and Drug Approval
Process’’ (available at https://
www.fda.gov/news-events/publichealth-focus/fda-and-cannabisresearch-and-drug-approval-process)
provides the basic roadmap for
conducting clinical research at FDA
using cannabis and cannabis-derived
compounds. The resources on this page
may be helpful to those interested in
better understanding FDA processes for
conducting clinical trials using cannabis
and cannabis-derived compounds.
Calculating the amount of a substance
in a botanical raw material by dry
weight is a standard procedure.
However, the calculation of dry weight
for an extract or solid oral dosage form
is less familiar to many stakeholders
than the standard calculation for
botanical raw materials. Therefore, the
draft guidance recommends calculating
delta-9 THC by dry weight in
intermediates and drug products by
removing the water content, including
water contained in excipients. We invite
comment from the public on this
recommended approach. In addition,
FDA invites public comment on the
appropriate manufacturing controls over
materials that cross under the 0.3
percent delta-9 THC by dry weight
threshold during the production of a
drug that contains cannabis or cannabis
derived compounds.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Cannabis and Cannabis-Derived
Compounds: Quality Considerations for
Clinical Research.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this draft guidance refers to
previously approved FDA collections of
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information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR parts 312 and
314 for submission and approval of
applications for investigational drugs
and new drugs have been approved
under OMB control numbers 0910–0014
and 0910–0001 respectively; and
current Good Manufacturing Practices
for Finished Pharmaceuticals as
outlined in 21 CFR parts 210 and 211
have been approved under OMB control
number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: July 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15907 Filed 7–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of a Supplemental Award,
Initiated by the Maternal and Child
Health Bureau, to the University of
Mississippi Medical Center for the
Early Childhood Developmental Health
System: Implementation in a High
Need State Cooperative Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a Supplemental
Award.
AGENCY:
HRSA announces the award
of a supplement for $3,500,000 to the
University of Mississippi Medical
Center for the Early Childhood
Developmental Health System:
Implementation in a High Need State
program. The supplement will add
another year of funding to the current
recipient, during the period of
September 30, 2020–September 29,
2021, to continue a study focused on
improving child health through a
statewide system of early childhood
developmental screenings and
interventions.
SUMMARY:
Dina
Lieser, Division of Home Visiting and
Early Childhood Systems, HRSA, 26
Federal Plaza, Room 3337, New York,
FOR FURTHER INFORMATION CONTACT:
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44308
Federal Register / Vol. 85, No. 141 / Wednesday, July 22, 2020 / Notices
NY 10278, Phone: (240) 463–7726 or
Email: dlieser@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award:
University of Mississippi Medical
Center.
Amount of Award: $3,500,000.
Project Period: 09/30/2020–09/29/
2021.
CFDA Number: 93.110.
Authority: Social Security Act, Title V,
§ 501(a)(2), (42 U.S.C. 701(a)(2)).
Justification: The Early Childhood
Developmental Health System:
Implementation in a High Need State
program was first funded in September
Grantee/organization name
Grant No.
University of Mississippi Medical Center ..........
UK2MC31456 ...................................................
Thomas J. Engels,
Administrator.
[FR Doc. 2020–15802 Filed 7–21–20; 8:45 am]
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
BILLING CODE 4165–15–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
2017. At that time, HRSA awarded
$3,500,000 to the University of
Mississippi Medical Center for a 3-year
project period to conduct this program.
After an extensive needs assessment of
children ages 0–5 years and their
families in Mississippi, progress has
been made towards goals articulated in
the Notice of Funding Opportunity: (1)
Increasing the proportion of children
receiving age appropriate
developmental screening and (2)
increasing the number of the state’s
early childhood providers who
demonstrate improved practices around
developmental health promotion.
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FY 2019
authorized
funding level
State
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa-10
et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
2112(b)(2) of the PHS Act, 42 U.S.C.
300aa-12(b)(2), requires that ‘‘[w]ithin
PO 00000
The purpose of the non-competitive
supplement from HRSA is to give the
recipient the opportunity to maximize
the efficiency, reach and impact of the
program and leverage findings that will
be valuable to other states. This
extended year will allow the recipient to
continue efforts to promote systemic
change and support spread, scale, and
sustainability of interventions and
impact. The lessons learned and
progress made in the first 3 years of the
program will help to increase
understanding of facilitators and
barriers to implementation and will
serve as a model for other states.
MS
$3,500,000
FY 2020
proposed
funding level
$3,500,000
30 days after the Secretary receives
service of any petition filed under
section 2111 the Secretary shall publish
notice of such petition in the Federal
Register.’’ Set forth below is a list of
petitions received by HRSA on June 1,
2020, through June 30, 2020. This list
provides the name of petitioner, city
and state of vaccination (if unknown
then city and state of person or attorney
filing claim), and case number. In cases
where the Court has redacted the name
of a petitioner and/or the case number,
the list reflects such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
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]]>Agencies
[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Pages 44307-44308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15802]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of a Supplemental Award, Initiated by the Maternal and
Child Health Bureau, to the University of Mississippi Medical Center
for the Early Childhood Developmental Health System: Implementation in
a High Need State Cooperative Agreement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a Supplemental Award.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplement for $3,500,000 to the
University of Mississippi Medical Center for the Early Childhood
Developmental Health System: Implementation in a High Need State
program. The supplement will add another year of funding to the current
recipient, during the period of September 30, 2020-September 29, 2021,
to continue a study focused on improving child health through a
statewide system of early childhood developmental screenings and
interventions.
FOR FURTHER INFORMATION CONTACT: Dina Lieser, Division of Home Visiting
and Early Childhood Systems, HRSA, 26 Federal Plaza, Room 3337, New
York,
[[Page 44308]]
NY 10278, Phone: (240) 463-7726 or Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award: University of Mississippi Medical
Center.
Amount of Award: $3,500,000.
Project Period: 09/30/2020-09/29/2021.
CFDA Number: 93.110.
Authority: Social Security Act, Title V, Sec. 501(a)(2), (42
U.S.C. 701(a)(2)).
Justification: The Early Childhood Developmental Health System:
Implementation in a High Need State program was first funded in
September 2017. At that time, HRSA awarded $3,500,000 to the University
of Mississippi Medical Center for a 3-year project period to conduct
this program. After an extensive needs assessment of children ages 0-5
years and their families in Mississippi, progress has been made towards
goals articulated in the Notice of Funding Opportunity: (1) Increasing
the proportion of children receiving age appropriate developmental
screening and (2) increasing the number of the state's early childhood
providers who demonstrate improved practices around developmental
health promotion.
The purpose of the non-competitive supplement from HRSA is to give
the recipient the opportunity to maximize the efficiency, reach and
impact of the program and leverage findings that will be valuable to
other states. This extended year will allow the recipient to continue
efforts to promote systemic change and support spread, scale, and
sustainability of interventions and impact. The lessons learned and
progress made in the first 3 years of the program will help to increase
understanding of facilitators and barriers to implementation and will
serve as a model for other states.
----------------------------------------------------------------------------------------------------------------
FY 2019 FY 2020
Grantee/organization name Grant No. State authorized proposed
funding level funding level
----------------------------------------------------------------------------------------------------------------
University of Mississippi Medical UK2MC31456................ MS $3,500,000 $3,500,000
Center.
----------------------------------------------------------------------------------------------------------------
Thomas J. Engels,
Administrator.
[FR Doc. 2020-15802 Filed 7-21-20; 8:45 am]
BILLING CODE 4165-15-P
