Notice Number: NOT-HD-16-017

Key Dates
Release Date: July 11, 2016

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)

Purpose

The purpose of this Notice is to inform potential applicants about changes to the resources available at the NIH Clinical Center for research projects submitted in response to PAR-15-286. Specifically, the good manufacturing practices (GMP) and pharmacy facility for biological or clinical products is no longer available at the Clinical Center, but a clinical biomechanics laboratory has been added to the list of available resources.

Part 2 Section I. Funding Opportunity Description

Purpose

To reflect these changes, the following list of resources is deleted:

Examples of the special resources of the Clinical Center include:

• Large cohorts of patients, including studies of >500 rare diseases;
• A good manufacturing practices (GMP) pharmacy facility for new biological or clinical products;
• Specialized clinical phenotyping facilities (including a metabolic and other units);
• The manufacturing and use of newly designed PET ligands for imaging studies;
• The availability of blood products for special research studies;
• Collaborative opportunities on clinical protocols on unique pharmaceutical agents and/or other
• modes of therapy, or extraordinarily rare diseases with investigators who are known experts;
• A robust training curriculum in clinical research;
• The ability to support long-term clinical studies at minimal cost to patients and their families.
• On-campus amenities (e.g., Family Lodge and Children’s Inn) to assist patients and families in
• supportive, home-like environments as they leave their own homes to participate in clinical
• research; and
• A number of other resources.

This section is replaced by an updated list of resources, as follows:

Examples of the special resources of the Clinical Center include:

• Large cohorts of patients, including studies of >500 rare diseases;
• Specialized clinical phenotyping facilities (including a metabolic unit, clinical biomechanics laboratory, and other units);
• The manufacturing and use of PET ligands for research imaging studies;
• The availability of blood products for special research studies;
• Collaborative opportunities for clinical protocols on first-in-human and early phase agents and/or other modes of therapy, or (deleted extraordinarily) rare diseases with investigators who are known experts;
• A robust training curriculum in clinical research;
• The ability to support long-term clinical studies at minimal cost to patients and their families.
• On-campus amenities (e.g., Family Lodge and Children’s Inn) to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research; and
• A number of other resources.

All other provisions of this Funding Opportunity Announcement are unchanged.

Inquiries

Please direct all inquiries to:

Julie Orlando, MA
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: [email protected]

Pat Piringer, RN, MSN
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: [email protected]

Eugene G. Hayunga, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6856
Email: [email protected]