Notice Number: NOT-HD-16-022
Key Dates
Release Date: July 21, 2016
PAR-16-262
Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
Purpose
The purpose of this Notice is to inform potential applicants that the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will participate, effective immediately, in PAR-16-262 "Sustained Release of Antivirals for Treatment or Prevention of HIV (SRATP) (R01)".
The following changes and updates are made to PAR-16-262 to reflect the participation of NICHD in this FOA and our priority research areas:
Part 1. Overview Information
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.855, 93.856; 93.242; 93.865
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Specific Areas of Research Interest
NICHD
NICHD's Maternal and Pediatric Infectious Disease Branch (MPIDB) is particularly interested efforts targeting infants, children, adolescents and young adults and/or pregnant women.
- Development of sustained release formulations for HIV treatment in formulations and/or drug platforms that are appropriate for administration to infants and children, particularly formulations that do not require a cold chain, are not liquids with solid and are palatable (e.g. incorporating effective taste masking technologies) and parenteral dosage forms scaled for the age of the individual, i.e. smaller size or lower volume, respectively.
- Evaluation of sustained release formulations in pregnant animals, including toxicity studies for mother/fetus as well as assessments for teratogenicity.
- Studies in animals that investigate the pharmacology of the proposed formulations to determine transplacental passage, concentration in amniotic fluid, and passage into breast milk.
- Studies involving the investigation of pharmacologic properties of proposed formulations in animal models to understand the interaction of the formulation with endocrine, physiologic and other biochemical changes experienced among children, adolescent and young adult populations (e.g. effects on reproductive organs, growth, changes in volume of distribution [e.g. due to potential portioning in fat], hormonal effects, potential for unique toxicities [e.g. bone, CNS]).
- Studies to evaluate key pharmacologic interactions of sustained release formulations with agents commonly used by and behaviors typically practiced among adolescent and young adult populations (e.g. contraceptives, alcohol, smoking, illicit substances, erratic eating behaviors).
Special Note: Consultation with NICHD staff prior to submission of an application is strongly encouraged.
Part 2. Section VII. Agency Contacts
Scientific/Research Contact(s)
Bill G. Kapogiannis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0698
Email: kapogiannisb@mail.nih.gov
Financial/Grants Management Contact(s)
Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clark1@mail.nih.gov
All other sections of this FOA remain the same.
Inquiries
Please direct all inquiries to:
Bill G. Kapogiannis, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0698
Email: kapogiannisb@mail.nih.gov
and Human Services (HHS)
