NOT-HD-16-034: Notice of Modifications to Research Scope for RFA-HD-17-013 "Contraception Research Centers Program (U54)"

Notice of Modifications to Research Scope for RFA-HD-17-013 "Contraception Research Centers Program (U54)"

Notice Number: NOT-HD-16-034

Key Dates
Release Date: November 16, 2016

Related Announcements
RFA-HD-17-013

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The purpose of this Notice is to clarify the Research Scope of RFA-HD-17-013 "Contraception Research Centers Program (U54)".

The following additions were made to the Research Scope of the contraception development research projects:

Multipurpose contraceptive methods with antibacterial properties are within scope;
Development of female contraceptive methods which act via steroidal cell surface receptors are within scope;
Development of female contraceptive methods which act via classical steroidal mechanisms (nuclear) are within scope, but must address a clear unmet medical need or underserved population.

The following modification was made to the Research Scope of the behavior research projects:

The following bullet describing out of scope research, "Research on attitudes towards hypothetical contraceptive products or contraceptive products that are under development", has been modified to, "Research on attitudes towards hypothetical contraceptive products".

The purpose of this Notice also announces the posting of the frequently asked questions regarding this FOA. They are available for viewing at: https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/active-foa/Pages/FAQ-RFA-HD-17-013-U54.aspx.

The current and modified sections of the Research Scope provided below begin at the first significant change to the Research Scope and continue continuously to the end of the Research Scope.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Scope

Currently reads: Contraception development research projects of high program priority are:

Male contraceptive development based on steroidal or nonsteroidal action
Female contraceptive development based on non-steroidal mechanism of action

Contraception development research projects appropriate for this FOA include, but are not limited to the following:

Small molecule lead discovery for modulation of validated male or female contraceptive targets (e.g., high throughput screening, virtual screening, etc.) and optimization;
Reformulation of previously identified/tested compounds;
Multipurpose products with both contraceptive and antiviral properties
Development of improved contraceptive devices;
Development or improvement of vehicles (implants, transdermal, etc.) for delivery of contraceptive drugs;
Translational research designed to develop a promising target and/or agent into a product suitable for testing in clinical setting;
Clinical trials for safety and efficacy of new agents with promising contraceptive properties.

The following areas of contraception development research projects are not within the scope of this funding announcement and are not responsive to this FOA:

Development of female contraceptive methods based on steroidal mechanisms of action is not within scope unless these methods also have anti-viral properties.
Research Projects may not be dedicated to target identification and/or validation, although this type of research may be supported by the pilot program.

Contraception behavior research projects must be aimed at improving understanding of contraceptive acceptance/use/discontinuation in women and/or men. Examples of research projects include, but are not limited to the following:

Integration of existing research on the needs and expectations of women and men who report having had unwanted, unintended or unplanned pregnancies into the development and improvement of contraceptive research;
Follow-up studies of clinical trials to identify the characteristics and behaviors of study participants who discontinue or are non-compliant with contraceptive methods;
Studies to identify the specific characteristics of contraceptive products e.g. dosing or application processes, texture, or side effects that affect discontinuation or ineffective and/or inconsistent use of contraceptive products and examination whether reactions to specific characteristics of products differs by demographic and socioeconomic status;
Identification of characteristics of contraceptive products that affect the ratio between the actual use Pearl Index and the perfect use or clinical trial Pearl Index; identification of characteristics of contraceptive product users that are associated with low effectiveness in actual use.

The following areas of contraception behavior research are not within the scope of this funding announcement and are not responsive to this FOA.

Re-analyses of extant data sets examining the determinants of contraceptive use in general, or the collection of new data for that purpose;
The use of clinical or convenience samples to examine contraceptive use except when the goal is to examine the use of one specific contraceptive product with the aim of improving the acceptability of that particular product;
Research on attitudes towards hypothetical contraceptive products or contraceptive products that are under development

Modified to read:

Contraception development research projects of high program priority are:

Male contraceptive development based on steroidal or nonsteroidal action
Female contraceptive development based on non-steroidal mechanism of action

Contraception development research projects appropriate for this FOA include, but are not limited to the following:

Small molecule lead discovery for modulation of validated male or female contraceptive targets (e.g., high throughput screening, virtual screening, etc.) and optimization;
Reformulation of previously identified/tested compounds;
Multipurpose methods with contraceptive and antiviral and/or antibacterial properties;
Development of improved contraceptive devices;
Development or improvement of vehicles (implants, transdermal, etc.) for delivery of contraceptive drugs;
Translational research designed to develop a promising target and/or agent into a method suitable for testing in clinical setting;
Clinical trials for safety and efficacy of new agents with promising contraceptive properties:
Development of female contraceptive methods which act via steroidal cell surface receptors:
Development of female contraceptive methods which act via classical steroidal mechanisms (nuclear) are within scope, but must address a clear unmet medical need or underserved population.

The following areas of contraception development research projects are not within the scope of this funding announcement and are not responsive to this FOA:

Research Projects may not be dedicated to target identification and/or validation, although this type of research may be supported by the pilot program.

Integration of existing research on the needs and expectations of women and men who report having had unwanted, unintended or unplanned pregnancies into the development and improvement of contraceptive research;
Follow-up studies of clinical trials to identify the characteristics and behaviors of study participants who discontinue or are non-compliant with contraceptive methods;
Studies to identify the specific characteristics of contraceptive methods (ever marketed or in clinical development) that affect use, non-use/discontinuation of use, and/or ineffective/inconsistent use. Examples of characteristics include, but are not limited to, dosing or application processes, texture, and side effects. Studies are encouraged to address whether reactions to identified method characteristics differ by demographic characteristics and/or socioeconomic status;
Identification of characteristics of contraceptive methods (ever marketed or in clinical development) that affect the ratio between the actual use Pearl Index and the perfect use or clinical trial Pearl Index; identification of characteristics of contraceptive method users that are associated with low effectiveness in actual use.

The following areas of contraception behavior research are not within the scope of this funding announcement and are not responsive to this FOA.

Re-analyses of extant data sets examining the determinants of contraceptive use in general, or the collection of new data for that purpose;
The use of clinical or convenience samples to examine contraceptive use except when the goal is to examine the use of one specific contraceptive method (ever marketed or in clinical development) with the aim of improving the acceptability of that particular method;
Research on attitudes towards hypothetical contraceptive method(s).

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Daniel Johnston, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-4663
Email: [email protected]