Form 1 BPCA Framework survey

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form
OVERVIEW
As part of the BPCA mandate, six public assemblies have been convened to develop a generic framework to
provide an overall structure to enable pediatric drug development studies. The goal is to develop -- in
collaboration with subject matter experts (SMEs) in pediatric care and research -- an annotated, selective,
curated collection of resources that will assist drug developers, researchers, and clinicians conducting
pediatric drug development research. As part of this process, assembly participants are asked to submit
references for best practice and guidance documents for inclusion in the final framework. This online form has
been created to streamline this process.
BPCA Framework to Enable Pediatric Drug Development Resource Submission Form
OMB# 0925-0766 Exp Date: 4/2023
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden
estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648). Do not return the
completed form to this address.

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form

All submissions must be available in the public domain. All submissions will be compiled and
shared with assembly participants for eventual inclusion in the final framework.
Multiple submissions are welcome but you must submit them individually. You may complete
this form as many times as you'd like.
* Which category best applies to your framework submission?
General/Overview
Advancing Clinical Trials
Biomarkers
Systems Pharmacology
Pediatric-Friendly Formulations
Pharmacoepidemiology
PK Modeling to Inform Dosing

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form
Skip Logic Note: This question is only shown if General/Overview is selected for the first question.

* Which sub-category does your GENERAL DRUG DEVELOPMENT submission fall under?
General Drug Development Overview (principles that apply across all populations)
Pediatric Drug Development Overview (including extrapolation, iPSPs)

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form
Skip Logic Note: This question is only shown if Advancing Clinical Trials is selected for the first question.

* Which sub-category does your CLINICAL TRIALS submission fall under?
Clinical Trial Design (Vanilla designs, adaptive designs, platform trials, small and difficult to reach populations)
Clinical Trial Conduct (GCP, implementation of GCP, working with networks, decentralized / remote trials)

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form
Skip Logic Note: This question is only shown if Systems Pharmacology is selected for the first question.

* Which sub-category does your SYSTEMS PHARMACOLOGY submission fall under?
Pre-clinical/drug discovery
Dosing

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form
Skip Logic Note: This question is only shown if Pharmacoepidemiology is selected for the first question.

* What sub-category does your PHARMACOEPIDEMIOLOGY submission fall under?
Pharmacoepidemiology studies including post-authorization
Real-world data

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form

* The final framework will include resources in the areas below. Which option best applies to your
submission?
Read this First (single document 10 - 20 pages that give an overview)
This is a Helpful Explanation
U.S. Guidance
Non-U.S. Guidance

Please list the title and reference of your submission below, along with your name,
email address, and any comments you may have. REMINDER: All submissions must
be available in the public domain.
* Title/Description

* Weblink/Reference

Name

Email Address

Comments

Best Pharmaceuticals for Children Act (BPCA)
Framework to Enable Pediatric Drug Development
Resource Submission Form

Thank you for your submission! If you would like to submit another reference, please click
here.
Questions? Contact [email protected].