National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 23980-23981 [2020-09197]
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23980
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Type of respondents
Individual ..........................................
Number of
responses per
respondent
15
Average
burden
per response
(in hours)
Total annual
burden hours
1
5/60
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
10/60
10/60
10/60
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
4
10
3
2
5
1
2
5
1
Bench to Bedside: Mental Health Module
Attitude survey pre-test .....................
Module completion ............................
Knowledge check ..............................
Attitude survey post-test ...................
Module evaluation .............................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
25
60
15
Sex as a Biological Variable: A Primer
Attitude survey pre-test .....................
Course completion ............................
Attitude survey post-test ...................
Course evaluation .............................
Total ...........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
Private sector ...................................
Federal government .........................
Individual ..........................................
25
60
15
25
60
15
25
60
15
25
60
15
1
1
1
1
1
1
1
1
1
1
1
1
5/60
5/60
5/60
1
1
1
5/60
5/60
5/60
5/60
5/60
5/60
2
5
1
25
60
15
2
5
1
2
5
1
...........................................................
100
3400
........................
970
Dated: April 22, 2020.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2020–09137 Filed 4–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of Dental &
Craniofacial Research; 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
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18:56 Apr 29, 2020
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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: NIDCR Special Grants
Review Committee.
Date: June 18–19, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
672, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Latarsha J. Carithers,
Scientific Review Officer, Scientific Review
Branch, National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
672, Bethesda, MD 20892, 301–594–4859,
latarsha.carithers@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
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Dated: April 27, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–09245 Filed 4–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
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
E:\FR\FM\30APN1.SGM
30APN1
Federal Register / Vol. 85, No. 84 / Thursday, April 30, 2020 / Notices
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 of
Allergy and Infectious Diseases Special
Emphasis Panel; HIV AIDS CTU Review
Meeting SEP 1.
Date: May 18, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G21,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Robert C. Unfer, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G21, Rockville, MD
20892–9823, 240–669–5035, unferrc@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 24, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–09197 Filed 4–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Best Pharmaceuticals for Children Act
(BPCA) Priority List of Needs in
Pediatric Therapeutics
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institutes of
Health (NIH), Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD) hereby
announces updates to the Best
Pharmaceuticals for Children Act
(BPCA) Program priorities for 2020–
2021. The Best Pharmaceuticals for
Children Act (BPCA) seeks to improve
the level of information on the safe and
effective use of pharmaceuticals used to
treat children. The BPCA requires that
the NIH identify the drugs of highest
priority for study in pediatric
populations, publish a list of drugs/
needs in pediatric therapeutics, and
fund studies in the prioritized areas.
This notice will provide a brief update
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SUMMARY:
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on the current progress of the BPCA
Program and provide the current
Priority List of Needs in Pediatric
Therapeutics.
DATES: The next BPCA stakeholders
meeting will take place on December
14–15, 2020. More information will be
provided on the BPCA website as it
becomes available.
ADDRESSES: The complete Priority List
of Needs in Pediatric Therapeutics
2020–2021 can be found on the BPCA
website at the following address:
https://www.nichd.nih.gov/research/
supported/bpca/activities.
FOR FURTHER INFORMATION CONTACT: Dr.
Perdita Taylor-Zapata via email at
taylorpe@mail.nih.gov; or by phone at
301–496–9584.
SUPPLEMENTARY INFORMATION: The BPCA
requires that the NIH, in consultation
with the Food and Drug Administration
and experts in pediatric research,
identify the drugs and therapeutic areas
of highest priority for study in pediatric
populations. The NIH BPCA Program
has been in existence since 2004 and is
overseen by the Obstetric and Pediatric
Pharmacology and Therapeutics Branch
(OPPTB) of the NICHD. To date, the
BPCA Program has prioritized over onehundred and fifty (150) drugs and
therapeutic areas, funded more than
forty (40) clinical studies, and improved
the labeling to date of eleven (11) drugs
and two (2) devices in the ongoing effort
of advancing the knowledge of dosing,
safety and effectiveness of medicines
used in children. However, despite
these and many other efforts, many gaps
in knowledge still remain regarding the
use of therapeutics in children
including the correct dosage,
appropriate indications, side effects,
and safety concerns in the short- and
long-term. These gaps result in
inadequate labeling and/or wide-spread
off-label use of prescription drugs in
children. Off-label use of a drug
substantially limits the ability to obtain
important clinical information for more
generalized use of a drug product, such
as characterizing changes in drug
metabolic pathways and response
during growth and development,
identifying precision-based treatments
(i.e., impact of genotype and phenotype
of medication responses), and
determining short- and long-term effects
of medications. The mandate of the NIH
BPCA Program is to identify knowledge
gaps that exist in pediatric therapeutics
and to promote an increase in evidencebased data about medications used in
children. Please see the BPCA website
for more information: https://
www.nichd.nih.gov/research/supported/
bpca/about.
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23981
Update on BPCA Prioritization
The BPCA Priority List consists of key
therapeutic needs in the medical
treatment of children and adolescents
identified for further study; it is
organized by therapeutic area, which
can be a group of conditions, a subgroup
of the population, or a setting of care.
The first priority list of off-patent drugs
needing further study under the 2002
BPCA legislation Public Law 107–109,
was published in January 2003 in the
Federal Register (FR Vol. 68, No. 13;
Tuesday, January 21, 2003: 2789–2790).
The most recent priority list has been
published to the BPCA website; more
information on the prioritization
process, all BPCA priority lists, and all
Federal Register Notices can be found
on the BPCA website: https://
www.nichd.nih.gov/research/supported/
bpca/prioritizing-pediatric-therapies.
The BPCA Priority List consists of key
therapeutic needs in the medical
treatment of children and adolescents
identified for further study; it is
organized by therapeutic area, which
can be a group of conditions, a subgroup
of the population, or a setting of care.
The BPCA authorizing legislation
requires the NIH to hold meetings with
stakeholders for input into the
prioritization process and to update the
priority list every three years.
The most recent BPCA stakeholders
meeting was held in Bethesda,
Maryland on March 22, 2019. Please
save the date for December 14–15, 2020
for the next stakeholders meeting. More
information will be provided on the
BPCA website as it becomes available.
All inquiries should be submitted to Dr.
Perdita Taylor-Zapata at the contact
information above. This Notice serves as
an update to the BPCA priority list of
needs in pediatric therapeutics.
Priority List of Needs in Pediatric
Therapeutics 2020–2021
In accordance with the BPCA
legislation, the list outlines priority
needs in pediatric therapeutics for
multiple therapeutic areas listed below.
The complete updated list of
therapeutic areas and drugs that have
been prioritized for study since the
inception of the BPCA, and a summary
of the NICHD’s plans and progress in all
of these areas to date, can be found on
the BPCA website at the following
address: https://www.nichd.nih.gov/
research/supported/bpca/activities.
D Table 1: Infectious Disease Priorities
D Table 2: Cardiovascular Disease
Priorities
D Table 3: Respiratory Disease Priorities
D Table 4: Intensive Care Priorities
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]]>Agencies
[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23980-23981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09197]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious 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
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
[[Page 23981]]
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 of Allergy and Infectious
Diseases Special Emphasis Panel; HIV AIDS CTU Review Meeting SEP 1.
Date: May 18, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G21,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: Robert C. Unfer, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G21,
Rockville, MD 20892-9823, 240-669-5035, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: April 24, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-09197 Filed 4-29-20; 8:45 am]
BILLING CODE 4140-01-P
