United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2004_register
executive
2010-09-23
article
Request for Public Comment on a Written Request Issued by the Food and Drug Administration on the Use of Oral Azithromycin for the Treatment or Prevention of Pneumonia or Conjunctivitis Caused by Chlamydia Trachomatis in Infants
Notices
D09002ee1bde5ff23
D09002ee1bde5ffe2
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
National Institutes of Health
originator
org
United States Government Agency or Subagency
The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as required by the BPCA. The Written Request was developed following formulation of an NIH-generated priority list, which prioritizes certain drugs most in need of study for use by children. The priority list was produced in consultation with the FDA, other NIH Institutes and Centers, and pediatric experts, as mandated by the BPCA. The studies that are described in the Written Request are intended to characterize the safety, efficacy, and pharmacokinetics of the drug for optimum use in pediatric patients.
69 FR 62065
https://www.govinfo.gov/app/details/FR-2004-10-22/04-23724
04-23724
fr22oc04-79
4167-01-P
https://www.govinfo.gov/app/details/FR-2004-10-22/04-23724
https://www.govinfo.gov/content/pkg/FR-2004-10-22/html/04-23724.htm
https://www.govinfo.gov/content/pkg/FR-2004-10-22/pdf/04-23724.pdf
4 p.
62065
62068
69 FR 62065
Request for Public Comment on a Written Request Issued by the Food and Drug Administration on the Use of Oral Azithromycin for the Treatment or Prevention of Pneumonia or Conjunctivitis Caused by Chlamydia Trachomatis in Infants; Federal Register Vol. 69, Issue
NOTICE
04-23724
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
4167-01-P
04-23724
Notice.
The National Institutes of Health (NIH) is requesting public comment on the following Written Request issued by the Food and Drug Administration (FDA) for off-patent drugs as defined in the Best Pharmaceuticals for Children Act (BPCA). The Written Request was referred to the NIH by the FDA as required by the BPCA. The Written Request was developed following formulation of an NIH-generated priority list, which prioritizes certain drugs most in need of study for use by children. The priority list was produced in consultation with the FDA, other NIH Institutes and Centers, and pediatric experts, as mandated by the BPCA. The studies that are described in the Written Request are intended to characterize the safety, efficacy, and pharmacokinetics of the drug for optimum use in pediatric patients.
Comments are requested within 45 days of publication of this notice.
Anne Zajicek, M.D., Pharm.D., National Institute of Child Health and Human Development (NICHD), 6100 Executive Boulevard, Suite 4B-09, Bethesda, MD 20892-7510, telephone 301-435-6865 (not a toll-free number), e-mail <BestPharmaceuticals@mail.nih.gov>.
Reports and guidance documents; availability, etc.:
Azithromycin; oral use for the treatment or prevention of pneumonia or conjunctivitis caused by Chlamydia trachomatis in infants,
BestPharmaceuticals@mail.nih.gov
Federal Register
Vol. 69, no. 204
Office of the Federal Register, National Archives and Records Administration
2004-10-22
continuing
daily
deposited
born digital
196 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2004-10-22
P0b002ee18097d07f
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr22oc04
https://www.govinfo.gov/app/details/FR-2004-10-22
https://www.govinfo.gov/content/pkg/FR-2004-10-22/pdf/FR-2004-10-22.pdf
https://www.govinfo.gov/content/pkg/FR-2004-10-22/xml/FR-2004-10-22.xml
fdlp
61991
62174
DGPO
2010-09-23
2023-05-03
FR-2004-10-22
machine generated
eng
FR
FR-2004-10-22
69
204