List of Drugs for Which Pediatric Studies Are Needed, 14588-14589 [E7-5673]
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sroberts on PROD1PC70 with NOTICES
14588
Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices
print and online materials, outreach
activities, and messages to maximize
their impact and usefulness.
OCPL wishes to continue to carry out
formative research to further understand
the knowledge, attitudes, and behaviors
of its core constituent groups: members
of the general public, researchers, and
providers of both conventional and
CAM health care. In addition, it seeks to
test newly formulated messages and
identify barriers and impediments to the
effective communication of those
messages. With this audience research,
OCPL will carry out pretesting of
audience responses to NCCAM’s fact
sheets, Web content, and other materials
and messages.
Clearance is also requested to
continue to carry out evaluative
research on existing materials and
messages, as part of OCPL’s ongoing
effort to develop a comprehensive
program of testing and evaluation of all
of its communications strategies. This
evaluative research will include pilot
testing of recently developed messages
and information products such as fact
sheets and brochures. It will also
address the need to evaluate the
processes by which new materials and
messages were developed, the
effectiveness of an outreach or the
extent to which behaviors were changed
by the message, and the impact of a
message on health knowledge and
behaviors.
The tools to collect this information
have been selected to minimize burden
on NCCAM’s audiences, produce or
refine messages that have the greatest
potential to influence target audience
attitudes and behavior in a positive
manner, and to use Government
resources efficiently. They may include
individual in-depth interviews, focus
group interviews, intercept interviews,
self-administered questionnaires,
gatekeeper reviews, and omnibus
surveys.
The data will enhance OCPL’s
understanding of (1) the unique
information needs and distinct healthinformation-seeking behaviors of its
core constituencies, and (2) the
segments within these constituencies
with special information needs (for
example, among the general public
these segments include cancer patients,
the chronically ill, minority and ethnic
populations, the elderly, users of dietary
supplements, and patients integrating
complementary therapies with
conventional medical treatments).
Frequency of Response: On occasion.
Affected Public: Individuals and
households; non-profit institutions;
Federal Government; State, Local, or
Tribal Government.
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Type of Respondents: Adult patients;
members of the public; health care
professionals; organizational
representations. The annual reporting
burden is as follows.
Estimated Number of Respondents:
2,440;
Estimated Number of Responses per
Respondent: 1;
Average Burden Hours per Response:
0.29; and
Estimated Total Burden Hours
Requested: 2,137.5 for the 3-year
clearance period (approximately 712.5
hours annually). The annualized cost to
respondents is estimated at $21,333.
There are no Capital Costs, Operating
Costs, or Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on the following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumption used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Christy Thomsen,
Director, Office of Communications and
Public Liaison, NCCAM, 31 Center
Drive, Room 2B11, Bethesda, MD 20892,
or fax your request to 301–402–4741, or
e-mail thomsenc@mail.nih.gov. Ms.
Thomsen can be contacted by telephone
at 301–451–8876.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: March 20, 2007.
Christy Thomsen,
Director, Office of Communications and
Public Liaison, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
[FR Doc. E7–5671 Filed 3–27–07; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
List of Drugs for Which Pediatric
Studies Are Needed
ACTION:
Notice.
SUMMARY: The National Institutes of
Health (NIH) is providing notice of the
‘‘Priority List of Drugs for Which
Pediatric Studies Are Needed.’’ The NIH
develops the list in consultation with
the Food and Drug Administration
(FDA) and pediatric experts, as
mandated by the Best Pharmaceuticals
for Children Act. This list prioritizes
certain drugs that are most in need of
study for use by children to ensure their
safety and efficacy. The NIH will update
the list at least annually until the Act
expires on October 1, 2007.
DATES: The list is effective upon
publication.
FOR FURTHER INFORMATION CONTACT: Dr.
Perdita Taylor-Zapata, National Institute
of Child Health and Human
Development (NICHD), 6100 Executive
Boulevard, Suite 4A–01, Bethesda, MD
20892–7510, e-mail
taylorpe@mail.nih.gov or
BestPharmaceuticals@mail.nih.gov,
telephone 301–496–9584 (not a toll-free
number).
SUPPLEMENTARY INFORMATION: The NIH
is providing notice of the ‘‘List of Drugs
for Which Pediatric Studies Are
Needed,’’ as authorized under Section 3,
Public Law 107–109 (42 U.S.C. 409I).
On January 4, 2002, President Bush
signed into law the Best
Pharmaceuticals for Children Act
(BPCA). The BPCA mandates that not
later than one year after the date of
enactment, the NIH in consultation with
the FDA and experts in pediatric
research shall develop, prioritize, and
publish an annual list of certain
approved drugs for which pediatric
studies are needed. For inclusion on the
list, an approved drug must meet the
following criteria: (1) There is an
approved application under section
505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)); (2) there
is a submitted application that could be
approved under the criteria of section
505(j) of the Federal Food, Drug, and
Cosmetic Act; (3) there is no patent
protection or market exclusivity
protection under the Federal Food,
Drug, and Cosmetic Act; or (4) there is
a referral for inclusion on the list under
section 505A(d)(4)(c); and additional
studies are needed to assess the safety
and effectiveness of the use of the drug
in the pediatric population. The BPCA
E:\FR\FM\28MRN1.SGM
28MRN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 59 / Wednesday, March 28, 2007 / Notices
further stipulates that in developing and
prioritizing the list, the NIH shall
consider for each drug on the list: (1)
The availability of information
concerning the safe and effective use of
the drug in the pediatric population; (2)
whether additional information is
needed; (3) whether new pediatric
studies concerning the drug may
produce health benefits in the pediatric
population; and (4) whether
reformulation of the drug is necessary.
For this year, we are providing an
update and a summary of the progress
made by the prioritization working
group from last year’s notice until now,
as well as a summary of the annual
scientific prioritization meeting held
with pediatric experts on December 5–
6, 2006.
We have updated the complete list of
drugs, listed previously in the April
2006 Federal Register notice, and post
it on the BPCA Web site https://
bpca.nichd.nih.gov/index.cfm. We will
continue to reevaluate this list
throughout the year and will provide
updates as required, based upon the
reauthorization of the BPCA.
In 2005, and with the suggestion of
pediatric experts, NIH changed the
listing system from a focus on
individual off-patent drugs to a
therapeutic class-based approach.
Pediatric experts indicated that this
approach will allow us to compare
drugs within a therapeutic class (on and
off patent) and give a broader
description of the use of these drugs in
children. This approach will also allow
us to obtain focused expertise in
therapeutic areas that will subsequently
give us more insight into scientific gaps
in treatments of the proposed
conditions, as well as feasibility and
study designs. Based on expert opinion
obtained throughout the year as part of
our regular outreach program, a
preliminary list of conditions and
suggested drugs was drafted and
categorized for the 2007 prioritization
based on this approach.
The following are the conditions and
the drugs discussed in our December 5–
6, 2006 scientific meeting with experts
in pediatric research: Infectious
Diseases, with a focus on Methicillinresistant Staphylococcus aureus (MRSA)
infections; Pediatric Cancer, specifically
Neuroblastoma; Neonatal Pain; and
Asthma. The gaps in scientific
knowledge as well as specific drugs
thought to be effective for treatment in
each of these conditions were then
discussed based on off-patent status,
gaps in pediatric labeling, and the
potential for providing a health benefit
in the general pediatric population. We
also provided updates on our current
VerDate Aug<31>2005
18:07 Mar 27, 2007
Jkt 211001
work in the areas of Pediatric
Hypertension, Sickle Cell Anemia, and
Attention Deficit Hyperactivity Disorder
during this meeting. There was also a
brief discussion on future areas of
consideration, pending the
reauthorization of the BPCA, that
include topics such as childhood
obesity, counter-terrorism research, and
Fragile X Syndrome.
Following below are the conditions
and drugs we discussed in the
December 5–6, 2006, scientific meeting
with experts in pediatric research. We
will add these conditions and drugs,
and their indications for use, to the
Priority List for 2007 for which pediatric
studies are most urgently needed.
Treatment of Pediatric Cancers: 13-CisRetinoic Acid
There is a need for information
regarding the pharmacokinetics, safety,
and efficacy of 13-Cis-Retinoic Acid in
the treatment of neuroblastoma.
Treatment of Pediatric MRSA:
Clindamycin, Tetracycline, Doxycycline
and Trimethoprim-Sulfamethoxazole
There is a need for further
pharmacokinetic and safety data in the
use of these drugs to treat children with
MRSA infections.
In addition to the above conditions
and their associated drugs for
consideration, the following are
conditions that have been identified as
needing improvements in the treatment
strategies and/or assessments in
pediatrics.
Pediatric Hypertension
Data from the medical literature,
clinical trials, and experience were
presented and discussed by experts in
the field of Pediatric Hypertension.
Gaps in knowledge in this field include
standardization of blood pressure
measurements in children as well as the
sequence of drugs for hypertension
treatment in children.
Asthma
14589
advances in neonatal research. Such
gaps in research include areas such as
determining feasibility of studying
specific drugs in low-birth-weight
infants based on current use; the
development of novel study designs that
take into account the small number of
patients available due to either ethical
limitations and/or feasibility issues; and
the performance of clinical studies in
areas such as the treatment of pain,
neonatal seizures, and
bronchopulmonary dysplasia, based on
templates that are being developed by
experts in research such as the working
groups of the Newborn Drug
Development Initiative.
For the coming year, NICHD is
planning a series of discussions with
experts in the fields listed above and
plans to identify and work with experts
in these respective fields along with our
continuing discussions with the other
NIH Institutes and Centers. The goal of
all of these discussions will be to
specifically identify current gaps in
scientific knowledge regarding research
and treatment of these various pediatric
conditions with the ultimate goal of
determining future approved drugs for
which pediatric studies are needed.
Dated: March 15, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7–5673 Filed 3–27–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
Data from the medical literature,
clinical trials, and experience were
presented and discussed by experts in
the field of Pediatric Asthma. Gaps in
knowledge in this field include gaps in
measuring efficacy and safety of
treatments and drug delivery systems,
especially in young children. There is
also a need for the development of new
tools to identify symptom measures,
pulmonary function tests, biomarkers,
and genetics.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Neonatal Research
ADDRESSES:
There are many areas in the field of
neonatal medicine that can benefit from
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Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
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]]>Agencies
[Federal Register Volume 72, Number 59 (Wednesday, March 28, 2007)]
[Notices]
[Pages 14588-14589]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
List of Drugs for Which Pediatric Studies Are Needed
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) is providing notice of
the ``Priority List of Drugs for Which Pediatric Studies Are Needed.''
The NIH develops the list in consultation with the Food and Drug
Administration (FDA) and pediatric experts, as mandated by the Best
Pharmaceuticals for Children Act. This list prioritizes certain drugs
that are most in need of study for use by children to ensure their
safety and efficacy. The NIH will update the list at least annually
until the Act expires on October 1, 2007.
DATES: The list is effective upon publication.
FOR FURTHER INFORMATION CONTACT: Dr. Perdita Taylor-Zapata, National
Institute of Child Health and Human Development (NICHD), 6100 Executive
Boulevard, Suite 4A-01, Bethesda, MD 20892-7510, e-mail
taylorpe@mail.nih.gov or BestPharmaceuticals@mail.nih.gov, telephone
301-496-9584 (not a toll-free number).
SUPPLEMENTARY INFORMATION: The NIH is providing notice of the ``List of
Drugs for Which Pediatric Studies Are Needed,'' as authorized under
Section 3, Public Law 107-109 (42 U.S.C. 409I). On January 4, 2002,
President Bush signed into law the Best Pharmaceuticals for Children
Act (BPCA). The BPCA mandates that not later than one year after the
date of enactment, the NIH in consultation with the FDA and experts in
pediatric research shall develop, prioritize, and publish an annual
list of certain approved drugs for which pediatric studies are needed.
For inclusion on the list, an approved drug must meet the following
criteria: (1) There is an approved application under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)); (2) there
is a submitted application that could be approved under the criteria of
section 505(j) of the Federal Food, Drug, and Cosmetic Act; (3) there
is no patent protection or market exclusivity protection under the
Federal Food, Drug, and Cosmetic Act; or (4) there is a referral for
inclusion on the list under section 505A(d)(4)(c); and additional
studies are needed to assess the safety and effectiveness of the use of
the drug in the pediatric population. The BPCA
[[Page 14589]]
further stipulates that in developing and prioritizing the list, the
NIH shall consider for each drug on the list: (1) The availability of
information concerning the safe and effective use of the drug in the
pediatric population; (2) whether additional information is needed; (3)
whether new pediatric studies concerning the drug may produce health
benefits in the pediatric population; and (4) whether reformulation of
the drug is necessary. For this year, we are providing an update and a
summary of the progress made by the prioritization working group from
last year's notice until now, as well as a summary of the annual
scientific prioritization meeting held with pediatric experts on
December 5-6, 2006.
We have updated the complete list of drugs, listed previously in
the April 2006 Federal Register notice, and post it on the BPCA Web
site https://bpca.nichd.nih.gov/index.cfm. We will continue to
reevaluate this list throughout the year and will provide updates as
required, based upon the reauthorization of the BPCA.
In 2005, and with the suggestion of pediatric experts, NIH changed
the listing system from a focus on individual off-patent drugs to a
therapeutic class-based approach. Pediatric experts indicated that this
approach will allow us to compare drugs within a therapeutic class (on
and off patent) and give a broader description of the use of these
drugs in children. This approach will also allow us to obtain focused
expertise in therapeutic areas that will subsequently give us more
insight into scientific gaps in treatments of the proposed conditions,
as well as feasibility and study designs. Based on expert opinion
obtained throughout the year as part of our regular outreach program, a
preliminary list of conditions and suggested drugs was drafted and
categorized for the 2007 prioritization based on this approach.
The following are the conditions and the drugs discussed in our
December 5-6, 2006 scientific meeting with experts in pediatric
research: Infectious Diseases, with a focus on Methicillin-resistant
Staphylococcus aureus (MRSA) infections; Pediatric Cancer, specifically
Neuroblastoma; Neonatal Pain; and Asthma. The gaps in scientific
knowledge as well as specific drugs thought to be effective for
treatment in each of these conditions were then discussed based on off-
patent status, gaps in pediatric labeling, and the potential for
providing a health benefit in the general pediatric population. We also
provided updates on our current work in the areas of Pediatric
Hypertension, Sickle Cell Anemia, and Attention Deficit Hyperactivity
Disorder during this meeting. There was also a brief discussion on
future areas of consideration, pending the reauthorization of the BPCA,
that include topics such as childhood obesity, counter-terrorism
research, and Fragile X Syndrome.
Following below are the conditions and drugs we discussed in the
December 5-6, 2006, scientific meeting with experts in pediatric
research. We will add these conditions and drugs, and their indications
for use, to the Priority List for 2007 for which pediatric studies are
most urgently needed.
Treatment of Pediatric Cancers: 13-Cis-Retinoic Acid
There is a need for information regarding the pharmacokinetics,
safety, and efficacy of 13-Cis-Retinoic Acid in the treatment of
neuroblastoma.
Treatment of Pediatric MRSA: Clindamycin, Tetracycline, Doxycycline and
Trimethoprim-Sulfamethoxazole
There is a need for further pharmacokinetic and safety data in the
use of these drugs to treat children with MRSA infections.
In addition to the above conditions and their associated drugs for
consideration, the following are conditions that have been identified
as needing improvements in the treatment strategies and/or assessments
in pediatrics.
Pediatric Hypertension
Data from the medical literature, clinical trials, and experience
were presented and discussed by experts in the field of Pediatric
Hypertension. Gaps in knowledge in this field include standardization
of blood pressure measurements in children as well as the sequence of
drugs for hypertension treatment in children.
Asthma
Data from the medical literature, clinical trials, and experience
were presented and discussed by experts in the field of Pediatric
Asthma. Gaps in knowledge in this field include gaps in measuring
efficacy and safety of treatments and drug delivery systems, especially
in young children. There is also a need for the development of new
tools to identify symptom measures, pulmonary function tests,
biomarkers, and genetics.
Neonatal Research
There are many areas in the field of neonatal medicine that can
benefit from advances in neonatal research. Such gaps in research
include areas such as determining feasibility of studying specific
drugs in low-birth-weight infants based on current use; the development
of novel study designs that take into account the small number of
patients available due to either ethical limitations and/or feasibility
issues; and the performance of clinical studies in areas such as the
treatment of pain, neonatal seizures, and bronchopulmonary dysplasia,
based on templates that are being developed by experts in research such
as the working groups of the Newborn Drug Development Initiative.
For the coming year, NICHD is planning a series of discussions with
experts in the fields listed above and plans to identify and work with
experts in these respective fields along with our continuing
discussions with the other NIH Institutes and Centers. The goal of all
of these discussions will be to specifically identify current gaps in
scientific knowledge regarding research and treatment of these various
pediatric conditions with the ultimate goal of determining future
approved drugs for which pediatric studies are needed.
Dated: March 15, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7-5673 Filed 3-27-07; 8:45 am]
BILLING CODE 4140-01-P
