List of Drugs for Which Pediatric Studies Are Needed, 3937 [05-1495]
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Federal Register / Vol. 70, No. 17 / Thursday, January 27, 2005 / Notices
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Dated: January 21, 2005.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–1494 Filed 1–26–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
List of Drugs for Which Pediatric
Studies Are Needed
ACTION:
Notice.
The National Institutes of
Health (NIH) is providing notice of a
‘‘List of Drugs for Which Pediatric
Studies Are Needed.’’ The NIH
developed 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 adds to the
previously published lists prioritizing
drugs most in need of study for use by
children to ensure the safety and
efficacy of their medication. 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.
Tamar Lasky, National Institute of Child
Health and Human Development
(NICHD), 6100 Executive Boulevard,
Suite 5C01G, Bethesda, MD 20892–
7510, e-mail
BestPharmaceuticals@mail.nih.gov,
telephone (301) 594–8670 (not a toll-free
number).
SUPPLEMENTARY INFORMATION: The NIH
is providing notice of a ‘‘List of Drugs
for Which Pediatric Studies Are
Needed,’’ as authorized under Section 3,
Pub. L. 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
SUMMARY:
VerDate jul<14>2003
17:20 Jan 26, 2005
Jkt 205001
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
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.
In developing this list, the NIH
consulted with the FDA, the American
Academy of Pediatrics, and other
experts in pediatric research and
practice. A preliminary list of drugs was
drafted and categorized as a function of
indication and use. The drugs were then
prioritized based on frequency of use in
the pediatric population, severity of the
condition being treated, and potential
for providing a health benefit in the
pediatric population.
The following off-patent drugs were
reviewed by expert consultants at an
October 25 and 26, 2004, scientific
meeting at NICHD and recommended
for further study: Ivermectin for scabies;
hydrocortisone valerate ointment and
cream for dermatitis;
hydrochlorothiazide for hypertension;
ethambutol for tuberculosis;
griseofulvin for tinea capitis; methadone
for opiate addicted neonates;
hydroxychloroquine for connective
tissue disorders.
The following off-patent drugs were
recommended for re-labeling based on
evidence available in the literature:
Acyclovir for herpetic infections.
The following off-patent drugs were
recommended for systematic literature
review and/or further consultation with
scientific community to finalize
scientific questions in need of study:
Cyclosporine for heart transplant
patients; clonidine for autism, attention
deficit disorder; flecainide for life
threatening ventricular arrhythmias.
The following on-patent drugs were
referred to the NICHD by the
Foundation for NIH, reviewed by expert
consultants at the October 25 and 26,
2004, scientific meeting, and
recommended for further study:
Sevelamer for renal failure; morphine
for analgesia.
PO 00000
Frm 00035
Fmt 4703
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3937
The following on-patent drugs were
recommended for systematic literature
review and/or further consultation with
the scientific community to finalize
scientific questions in need of study:
Bupropion for depression.
Dated: January 19, 2005.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 05–1495 Filed 1–26–05; 8:45 am]
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2004 at 69 FR 61033–61034, allowing
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E:\FR\FM\27JAN1.SGM
27JAN1
]]>Agencies
[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Notices]
[Page 3937]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1495]
-----------------------------------------------------------------------
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
a ``List of Drugs for Which Pediatric Studies Are Needed.'' The NIH
developed 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 adds to the previously
published lists prioritizing drugs most in need of study for use by
children to ensure the safety and efficacy of their medication. 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. Tamar Lasky, National Institute of
Child Health and Human Development (NICHD), 6100 Executive Boulevard,
Suite 5C01G, Bethesda, MD 20892-7510, e-mail
BestPharmaceuticals@mail.nih.gov, telephone (301) 594-8670 (not a toll-
free number).
SUPPLEMENTARY INFORMATION: The NIH is providing notice of a ``List of
Drugs for Which Pediatric Studies Are Needed,'' as authorized under
Section 3, Pub. L. 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 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. In developing this list, the NIH consulted with the FDA, the
American Academy of Pediatrics, and other experts in pediatric research
and practice. A preliminary list of drugs was drafted and categorized
as a function of indication and use. The drugs were then prioritized
based on frequency of use in the pediatric population, severity of the
condition being treated, and potential for providing a health benefit
in the pediatric population.
The following off-patent drugs were reviewed by expert consultants
at an October 25 and 26, 2004, scientific meeting at NICHD and
recommended for further study: Ivermectin for scabies; hydrocortisone
valerate ointment and cream for dermatitis; hydrochlorothiazide for
hypertension; ethambutol for tuberculosis; griseofulvin for tinea
capitis; methadone for opiate addicted neonates; hydroxychloroquine for
connective tissue disorders.
The following off-patent drugs were recommended for re-labeling
based on evidence available in the literature: Acyclovir for herpetic
infections.
The following off-patent drugs were recommended for systematic
literature review and/or further consultation with scientific community
to finalize scientific questions in need of study: Cyclosporine for
heart transplant patients; clonidine for autism, attention deficit
disorder; flecainide for life threatening ventricular arrhythmias.
The following on-patent drugs were referred to the NICHD by the
Foundation for NIH, reviewed by expert consultants at the October 25
and 26, 2004, scientific meeting, and recommended for further study:
Sevelamer for renal failure; morphine for analgesia.
The following on-patent drugs were recommended for systematic
literature review and/or further consultation with the scientific
community to finalize scientific questions in need of study: Bupropion
for depression.
Dated: January 19, 2005.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 05-1495 Filed 1-26-05; 8:45 am]
BILLING CODE 4140-01-P
