List of Drugs for Which Pediatric Studies Are Needed, 3937 [05-1495]

Download as PDF 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 Sfmt 4703 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] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Office for Civil Rights and Civil Liberties [DHS–2005–0001] Submission for New Information Collection, DHS Individual Complaint of Employment Discrimination Form (DHS 3090–1) Office for Civil Rights and Civil Liberties, DHS. ACTION: Notice; 30-day notice request for comments. AGENCY: SUMMARY: The Department of Homeland Security, Office for Civil Rights and Civil Liberties has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on October 14, 2004 at 69 FR 61033–61034, allowing for a 60-day public comment period. No comments were received by DHS on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. DATES: Comments are encouraged and will be accepted until February 28, 2005. This process is conducted in accordance with 5 CFR 1320.10 ADDRESSES: Submitting comments: You may submit comments either electronically, or by mail or courier, or you may hand deliver in person. When submitting comments please only choose one of the methods listed below. It is not necessary to submit duplicate sets of comments by using more than one method of submission (i.e., if you submit electronic comments then it is not necessary to submit comments by mail). When submitting electronic comments you must include Docket No. DHS–2005–0001, and the Agency name, in the subject box. When submitting comments by mail or courier, or hand delivery, you must 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
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