Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics, 16872-16874 [2019-08167]
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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total number
of respondents
Instrument
HPOG 2.0 National Evaluation descriptive study second
round telephone interview protocol ..................................
HPOG 2.0 National Evaluation descriptive study program
operator interview guide ...................................................
HPOG 2.0 National Evaluation descriptive study partner
interview guide .................................................................
HPOG 2.0 National Evaluation descriptive study participant in-depth interview guide ...........................................
Intermediate follow-up survey for the HPOG 2.0 National
Evaluation impact study ...................................................
HPOG 2.0 National Evaluation impact study instrument for
a Pilot Study of Phone-Based Skills Assessment ...........
HPOG 2.0 National Evaluation program cost survey ..........
Number of
responses per
respondent
Authority: Section 2008 of the Social
Security Act as enacted by Section 5507 of
the Affordable Care Act.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–08163 Filed 4–22–19; 8:45 am]
BILLING CODE 4184–72–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission for OMB Review; State
Access and Visitation Grant
Application (OMB #0970–0482)
Office of Child Support
Enforcement, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Child Support
Enforcement is requesting a three-year
Annual burden
hours
63
1
1.25
79
16
5
1
1.25
6
112
37
1
1
37
140
47
1
1.33
63
4,000
1,333
1
1
1,333
300
38
100
13
1
1
.75
7
75
91
Written comments and
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Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
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Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
ADDRESSES:
Administration for Children and
Families
Average
burden
hours per
response
190
extension of the application form titled,
Child Access and Visitation Grant
Application Form, expiration 8/31/
2019. There are no changes requested to
the form.
DATES: Comments due within 30 days of
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Estimated Total Annual Burden
Hours: 1,691.
SUMMARY:
Annual
number of
respondents
Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
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Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Annual
burden hours
Child Access and Visitation Grant Application Form ...........
54
1
10
540
180
Estimated Total Annual Burden
Hours: 180.
jbell on DSK3GLQ082PROD with NOTICES
Authority: Sec. 469B. [42 U.S.C.669b].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–08109 Filed 4–22–19; 8:45 am]
BILLING CODE 4184–41–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.
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ACTION:
Notice.
The National Institutes of
Health (NIH), Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD) hereby
announces the renewal of the Best
Pharmaceuticals for Children Act
(BPCA) Program. The Best
Pharmaceuticals for Children Act
(BPCA) seeks to improve the level of
SUMMARY:
E:\FR\FM\23APN1.SGM
23APN1
jbell on DSK3GLQ082PROD with NOTICES
Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
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
summary of recent changes in the
legislation, a brief update on the current
progress of the BPCA Program and
provide the current Priority List of
Needs in Pediatric Therapeutics.
ADDRESSES: The complete Priority List
of Needs in Pediatric Therapeutics
2018–2019 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 150
drugs and therapeutic areas, funded
more than 25 clinical studies, and
improved the labeling to date of eight
drugs and one device 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 our knowledge still
remain regarding the use of therapeutics
in children including the correct dosage,
appropriate indications, side effects,
and safety concerns of pharmaceuticals
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
metabolism and response during growth
and development, identifying precisionbased responses (i.e., impact of
genotype and phenotype of medication
responses, the impact of obesity on
dosing), and determining short- and
long-term effects. The mandate of the
NIH BPCA Program is to fill knowledge
gaps that exist in pediatric therapeutics
and to promote an increase in evidencebased data about medications used in
VerDate Sep<11>2014
17:49 Apr 22, 2019
Jkt 247001
children. Please see the BPCA website
for more information: https://
www.nichd.nih.gov/research/supported/
bpca/about.
Update on the BPCA Legislation
First authorized in 2002, the Best
Pharmaceuticals for Children Act
(BPCA) has been reauthorized as part of
larger Food and Drug Administration
(FDA) user fee legislation three
additional times: 2007, 2012, and now
2017. The overall mandate for the
implementation of the research program
at NIH has remained the same
throughout, but with clarifications each
time: To prioritize testing of pediatric
therapeutics that do not have labeling
for pediatric use, to sponsor clinical
trials and other research to provide the
necessary data, and to submit those data
to the FDA to begin the process of
obtaining label changes and provide
clinicians with the appropriate
information on appropriate pediatric
use and dosing. In August of 2017, the
BPCA legislation was reauthorized by
Congress, which renewed the NIH BPCA
Program for five years (the FDA portion
of the program is permanently
authorized). The new legislation also
permits the NIH to prioritize research on
the identification of biomarkers for
pediatric diseases and conditions. In
addition, a new provision specifically
allows the NIH to post the data from the
pediatric studies it funded on its public
website when it submits the report to
the FDA, as required for potential label
changes.
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 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-pediatrictherapies. The BPCA authorizing
legislation requires the NIH to update
the priority list every three years. This
Notice serves as an update to the BPCA
priority list of needs in pediatric
therapeutics.
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16873
Each year, the NICHD revisits the
current list of needs in pediatric
therapeutics and seeks input from
experts in pediatric research and
medicine to determine if previous needs
still exist and if new areas of needs have
developed.
Below is an 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. In 2017, the NIH
BPCA Program focused on the following
areas: Treatment options in Pediatric
Hypertension, Biomarkers in Pediatric
Research (various subspecialties), and
Treatment strategies in several neonatal
conditions (including Neonatal Opioid
Withdrawal Syndrome, also known as
Neonatal Abstinence Syndrome).
Meeting minutes for workshops and
lectures on the above topics can be
found on the BPCA website https://
www.nichd.nih.gov/research/supported/
bpca/research-initiatives-collaborations.
For 2018, the NIH BPCA Program’s
priorities have included: Heart failure in
children, Kidney diseases, and Lactation
(in particular, neonatal and infant
medication exposure). The NICHD
welcomes input from the pediatric
medical community on additional gaps
in pediatric therapeutics for future
consideration. The most recent BPCA
stakeholders meeting was held in
Bethesda, Maryland on March 22, 2019.
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.
Priority List of Needs in Pediatric
Therapeutics 2018–2019
In accordance with the BPCA
legislation, the list outlines priority
needs in pediatric therapeutics for
multiple therapeutic areas listed below.
The complete list 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
D Table 5: Bio-defense Research
Priorities
D Table 6: Pediatric Cancer Priorities
D Table 7: Psychiatric Disorder
Priorities
D Table 8: Neurological Disease
Priorities
D Table 9: Neonatal Research Priorities
D Table 10: Adolescent Research
Priorities
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16874
Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
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D Table 11: Hematologic Disease
Priorities
D Table 12: Endocrine Disease Priorities
and Diseases with Limited Alternative
Therapies
D Table 13: Dermatologic Disease
Priorities
D Table 14: Gastrointestinal Disease
Priorities
D Table 15: Renal Disease Priorities
D Table 16: Rheumatologic Disease
Priorities
D Table 17: Special Considerations.
accompanying list of waivers that have
been granted in the fourth quarter of
calendar year 2018.
SUPPLEMENTARY INFORMATION: Section
106 of the HUD Reform Act added a
new section 7(q) to the Department of
Housing and Urban Development Act
(42 U.S.C. 3535(q)), which provides
that:
1. Any waiver of a regulation must be
in writing and must specify the grounds
for approving the waiver;
2. Authority to approve a waiver of a
regulation may be delegated by the
Dated: April 17, 2019.
Secretary only to an individual of
Francis S. Collins,
Assistant Secretary or equivalent rank,
Director, National Institutes of Health.
and the person to whom authority to
[FR Doc. 2019–08167 Filed 4–22–19; 8:45 am]
waive is delegated must also have
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regulation to be waived;
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covering the period since the most
Notice of Regulatory Waiver Requests
recent previous notification) shall:
Granted for the Fourth Quarter of
a. Identify the project, activity, or
Calendar Year 2018
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HUD.
waived and the designation of the
ACTION: Notice.
provision;
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SUMMARY: Section 106 of the Department
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Federal Register notices of all
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this notice is to comply with the
that are not relevant to the purpose of
requirements of section 106 of the HUD
this notice.
Reform Act. This notice contains a list
This notice follows procedures
of regulatory waivers granted by HUD
provided in HUD’s Statement of Policy
during the period beginning on October on Waiver of Regulations and Directives
1, 2018 and ending on December 31,
issued on April 22, 1991 (56 FR 16337).
2018.
In accordance with those procedures
and with the requirements of section
FOR FURTHER INFORMATION CONTACT: For
106 of the HUD Reform Act, waivers of
general information about this notice,
contact Ariel Pereira, Associate General regulations are granted by the Assistant
Counsel for Legislation and Regulations, Secretary with jurisdiction over the
regulations for which a waiver was
Department of Housing and Urban
requested. In those cases in which a
Development, 451 Seventh Street SW,
General Deputy Assistant Secretary
Room 10282, Washington, DC 20410–
granted the waiver, the General Deputy
0500, telephone 202–708–3055 (this is
Assistant Secretary was serving in the
not a toll-free number). Persons with
absence of the Assistant Secretary in
hearing- or speech-impairments may
accordance with the office’s Order of
access this number through TTY by
Succession.
calling the toll-free Federal Relay
This notice covers waivers of
Service at 800–877–8339.
regulations granted by HUD from
For information concerning a
October 1, 2018 through December 31,
particular waiver that was granted and
2018. For ease of reference, the waivers
for which public notice is provided in
granted by HUD are listed by HUD
this document, contact the person
program office (for example, the Office
whose name and address follow the
of Community Planning and
description of the waiver granted in the
VerDate Sep<11>2014
17:49 Apr 22, 2019
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Development, the Office of Fair Housing
and Equal Opportunity, the Office of
Housing, and the Office of Public and
Indian Housing, etc.). Within each
program office grouping, the waivers are
listed sequentially by the regulatory
section of title 24 of the Code of Federal
Regulations (CFR) that is being waived.
For example, a waiver of a provision in
24 CFR part 58 would be listed before
a waiver of a provision in 24 CFR part
570.
Where more than one regulatory
provision is involved in the grant of a
particular waiver request, the action is
listed under the section number of the
first regulatory requirement that appears
in 24 CFR and that is being waived. For
example, a waiver of both § 58.73 and
§ 58.74 would appear sequentially in the
listing under § 58.73.
Waiver of regulations that involve the
same initial regulatory citation are in
time sequence beginning with the
earliest-dated regulatory waiver.
Should HUD receive additional
information about waivers granted
during the period covered by this report
(the fourth quarter of calendar year
2018) before the next report is published
(the first quarter of calendar year 2019),
HUD will include any additional
waivers granted for the fourth quarter in
the next report.
Accordingly, information about
approved waiver requests pertaining to
HUD regulations is provided in the
Appendix that follows this notice.
Dated: April 16, 2019.
J. Paul Compton, Jr.,
General Counsel.
Appendix—Listing of Waivers of
Regulatory Requirements Granted by
Offices of the Department of Housing
and Urban Development October 1,
2018 Through December 31, 2018
Note to Reader: More information about
the granting of these waivers, including a
copy of the waiver request and approval, may
be obtained by contacting the person whose
name is listed as the contact person directly
after each set of regulatory waivers granted.
The regulatory waivers granted appear in the
following order:
I. Regulatory waivers granted by the Office of
Community Planning and Development.
II. Regulatory waivers granted by the Office
of Housing.
III. Regulatory waivers granted by the Office
of Public and Indian Housing.
I. Regulatory Waivers Granted by the Office
of Community Planning and Development
For further information about the following
regulatory waivers, please see the name of
the contact person that immediately follows
the description of the waiver granted.
• Regulation: 24 CFR 92.252(d)(1) Utility
Allowance Requirements.
E:\FR\FM\23APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16872-16874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08167]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH), Eunice Kennedy
Shriver National Institute of Child Health and Human Development
(NICHD) hereby announces the renewal of the Best Pharmaceuticals for
Children Act (BPCA) Program. The Best Pharmaceuticals for Children Act
(BPCA) seeks to improve the level of
[[Page 16873]]
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 summary of recent
changes in the legislation, a brief update on the current progress of
the BPCA Program and provide the current Priority List of Needs in
Pediatric Therapeutics.
ADDRESSES: The complete Priority List of Needs in Pediatric
Therapeutics 2018-2019 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
[email protected]; 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 150 drugs and therapeutic
areas, funded more than 25 clinical studies, and improved the labeling
to date of eight drugs and one device 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 our knowledge still remain regarding the use of
therapeutics in children including the correct dosage, appropriate
indications, side effects, and safety concerns of pharmaceuticals 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 metabolism and response
during growth and development, identifying precision-based responses
(i.e., impact of genotype and phenotype of medication responses, the
impact of obesity on dosing), and determining short- and long-term
effects. The mandate of the NIH BPCA Program is to fill knowledge gaps
that exist in pediatric therapeutics and to promote an increase in
evidence-based data about medications used in children. Please see the
BPCA website for more information: https://www.nichd.nih.gov/research/supported/bpca/about.
Update on the BPCA Legislation
First authorized in 2002, the Best Pharmaceuticals for Children Act
(BPCA) has been reauthorized as part of larger Food and Drug
Administration (FDA) user fee legislation three additional times: 2007,
2012, and now 2017. The overall mandate for the implementation of the
research program at NIH has remained the same throughout, but with
clarifications each time: To prioritize testing of pediatric
therapeutics that do not have labeling for pediatric use, to sponsor
clinical trials and other research to provide the necessary data, and
to submit those data to the FDA to begin the process of obtaining label
changes and provide clinicians with the appropriate information on
appropriate pediatric use and dosing. In August of 2017, the BPCA
legislation was reauthorized by Congress, which renewed the NIH BPCA
Program for five years (the FDA portion of the program is permanently
authorized). The new legislation also permits the NIH to prioritize
research on the identification of biomarkers for pediatric diseases and
conditions. In addition, a new provision specifically allows the NIH to
post the data from the pediatric studies it funded on its public
website when it submits the report to the FDA, as required for
potential label changes.
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 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 authorizing legislation
requires the NIH to update the priority list every three years. This
Notice serves as an update to the BPCA priority list of needs in
pediatric therapeutics.
Each year, the NICHD revisits the current list of needs in
pediatric therapeutics and seeks input from experts in pediatric
research and medicine to determine if previous needs still exist and if
new areas of needs have developed.
Below is an 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. In 2017, the NIH BPCA Program focused on the following areas:
Treatment options in Pediatric Hypertension, Biomarkers in Pediatric
Research (various subspecialties), and Treatment strategies in several
neonatal conditions (including Neonatal Opioid Withdrawal Syndrome,
also known as Neonatal Abstinence Syndrome). Meeting minutes for
workshops and lectures on the above topics can be found on the BPCA
website https://www.nichd.nih.gov/research/supported/bpca/research-initiatives-collaborations.
For 2018, the NIH BPCA Program's priorities have included: Heart
failure in children, Kidney diseases, and Lactation (in particular,
neonatal and infant medication exposure). The NICHD welcomes input from
the pediatric medical community on additional gaps in pediatric
therapeutics for future consideration. The most recent BPCA
stakeholders meeting was held in Bethesda, Maryland on March 22, 2019.
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.
Priority List of Needs in Pediatric Therapeutics 2018-2019
In accordance with the BPCA legislation, the list outlines priority
needs in pediatric therapeutics for multiple therapeutic areas listed
below. The complete list can be found on the BPCA website at the
following address: https://www.nichd.nih.gov/research/supported/bpca/activities.
[ssquf] Table 1: Infectious Disease Priorities
[ssquf] Table 2: Cardiovascular Disease Priorities
[ssquf] Table 3: Respiratory Disease Priorities
[ssquf] Table 4: Intensive Care Priorities
[ssquf] Table 5: Bio-defense Research Priorities
[ssquf] Table 6: Pediatric Cancer Priorities
[ssquf] Table 7: Psychiatric Disorder Priorities
[ssquf] Table 8: Neurological Disease Priorities
[ssquf] Table 9: Neonatal Research Priorities
[ssquf] Table 10: Adolescent Research Priorities
[[Page 16874]]
[ssquf] Table 11: Hematologic Disease Priorities
[ssquf] Table 12: Endocrine Disease Priorities and Diseases with
Limited Alternative Therapies
[ssquf] Table 13: Dermatologic Disease Priorities
[ssquf] Table 14: Gastrointestinal Disease Priorities
[ssquf] Table 15: Renal Disease Priorities
[ssquf] Table 16: Rheumatologic Disease Priorities
[ssquf] Table 17: Special Considerations.
Dated: April 17, 2019.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2019-08167 Filed 4-22-19; 8:45 am]
BILLING CODE 4140-01-P
