# Presentation: 623972

## Director’s Report to the

**Director’s Report to the**
**National Advisory Council**
**on Drug Abuse**

**     ****February 16, 2005**

## Budget Update

**Budget Update**

**Recent NIDA Activities**
** ****& Events**

**Policy Issues**

## Slide 3

## NIDA  BUDGET

**(Thousands)**

**Increase Over**** Prior Year**

**AIDS**

**TOTAL**

**NonAIDS**

## Slide 5

## Sets out broad prohibitions regarding...

**	****	****	****Outside activities**
**	****	****	****Holdings**
**	****	****	****Awards**

**         ****NEW Supplemental Ethics Regulation**
**        ****That Affects ALL NIH Employees **

## NIH Policy on Enhancing Public Access

**to Archived Publications **
**Resulting from NIH-Funded Research**

**  ****NIH Public Access Policy**** released February 3, 2005**
***  ******Requests***** NIH-funded investigators to release**
**    ****manuscripts as soon as possible and ****within 12 months**
**    ****of final publication**
**  ****These peer-reviewed publication will be available in a**
**    ****Web-based archive**** to be managed by the National**
**    ****Library of Medicine (NLM) **
**  ****Provides the public with better access to research**
**    ****publications**

## NACDA Bioethics Taskforce 

**NACDA Bioethics Taskforce **
**Immunotherapy Recommendations**

**STAGE I**

** ****Continued development**
**   ****of these promising**
**   ****medications **
** ****Research that results in**
**   ****clinical trials**
** ****Preclinical studies of **
**   ****vulnerable populations**
** ****Research  on  **
**   ****behavioral consequences**

** ****Foster and establish**
**   ****partnerships**
** ****Research to integrate**
**   ****vaccines with psychosocial **
**   ****services**
** ****Develop combination **
**   ****therapies**
** ****Preclinical  studies in**
**   ****adolescents to ascertain**
**   ****prophylactic use**

** ****Clinical trials in **
**   ****adolescents**
** ****Research on pre-**
**   ****marketing testing**
** ****Evaluate impact on **
**   ****perceived risks, **
**   ****illicit  drug market **
**   ****dynamics, off label use**

**STAGE II**

**STAGE III**

**Develop/Establish Safe**
**& Effective **
**Immunotherapeutic**
**& Depot Medication **
**Approaches**

**Translate to the Clinic/**
**Evaluate Prophylactic Potential**

**Implement/**
**Ascertain Impact**

## NIDA Immunotherapy Program

**NIDA Immunotherapy Program**

**Develop/Establish Safe**
**& Effective **
**Immunotherapeutic**
**& Depot Medication **
**Approaches**

**Translate to the Clinic/**
**Evaluate Prophylactic Potential**

**Implement/**
**Ascertain Impact**

**PRESENT**
**ACTIONS**

**FUTURE (LONG-TERM)**
**ACTIONS**

**FUTURE (LONGER-TERM)**
**ACTIONS**

** ****Vaccines and/or**
**   ****monoclonal antibodies**
**   ****for cocaine, nicotine, PCP,**
**   ****methamphetamine &**
**   ****MDMA**
**Preclinical S/E studies in**
**   ****adults, pregnant women **
**   ****and fetuses including**
**   ****evaluation of behavioral **
**   ****consequences**

** ****Clinical assessment **
**   ****through CTN, IRP and others**
** ****Use SBIR/STTR mechanisms**
**   ****to encourage development of **
**   ****adjuvant-mediated optimization**
** ****Involve constituencies & **
**   ****professional associations in **
**   ****preparing field for **
**   ****adoption/deployment**
** ****Preclinical studies to evaluate**
**   ****prophylactic potential**
** ****Preclinical S/E studies **
**   ****in adolescent primates**
** ****Consider possible develop of**
**   ****vaccine cocktails**

** ****Research on ethical, financial,**
**   ****legal, medical consequences**
**   ****of immunotherapies for drug **
**   ****abuse prevention**
** ****Clinical trials-deploy strategy**
**Monitoring  strategies (MTF,**
**  ****CEWG, DAWN) to assess attitude**
**  ****change due to new technology for **
**  ****drug abuse prevention & tx**
** ****Involve SAMHSA, state health **
**  ****depts. & relevant professional **
**  ****societies to ensure safe adoption**
** ****Collaborate with SAMHSA,**
**   ****FDA and DOJ to develop policy**
**   ****guidelines and monitor societal**
**   ****impact**

## Recent NIDA Activities

**Recent NIDA Activities**
**& Events**

## NIDA RFAs Just Issued

**Lapse or Relapse to Drug Abuse and Other**
**    ****Chronic Conditions (RFA-DA-05-004) **
**Neurobiology of Behavioral Treatment:**
**    ****Recovery of Brain Structure and Function**
**    ****(RFA-DA-05-006)**
**HIV and Drug Abuse Interventions among **
**    ****Pregnant Women in Drug Abuse Treatment **
**    ****(RFA-DA-05-008)**

**NIDA RFAs Just Issued**

## 8 New PAs and 8 New RFAs

**Foci include:**
**Co-morbidity**
**HIV/AIDS**
**Behavior**
**Brain Development**

**PAs and RFAs Recently Issued With**
**Other NIH Components/Agencies**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**HIV/AIDS Research**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**Dr. Jacques Normand**

## Office of AIDS Research 

**  ****HIV/AIDS Treatment Issues Related to Drug Abuse**
**    ****and Addiction**
**  ****Epidemiology, Etiology, and Natural History of **
**    ****Drug Abuse-Related HIV/AIDS and its Consequences**
**  ****International Studies on HIV/AIDS and Other **
**    ****Infections in Drug-Using Populations **

**Office of AIDS Research **
**FY 2006 President’s Budget**
**NIDA Approved Initiatives**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**Special Population/**
**Health Disparities**

## NIDA’s African American Initiative

**Conducted a ****preliminary portfolio analysis**** **
**of NIDA grants **
**Scientific meeting  of experts**** held in October 2004  **
**Articles will be published in the J Health Care Poor Underserved, Fall 2005**
**Administrative Supplements**** for Research on the intersection of**
**Drug Use and Criminal Justice Consequences in AA Population released February 10, 2005; Applications**
**due May 1, 2005: Awards will be made by September 30, 2005. **
**“****Drugs, African Americans, HIV, and Criminalization: **
**Breaking the Cycle?” ****Symposium at APA**** in August 2005**
**RFA planned for FY 2006**

## Other Special Populations Activities

**Second National Conference on Health Disparities**
**October 24-26, 2005 in Atlanta, GA**
**Minority Institutions Drug Abuse Research Program **
**(MIDARP) Program Announcement soon to be reissued**
**Summer Research with NIDA Program**
**Provides mentored summer research experiences to minority**
**high school and undergraduate students; significant increase**
**in PI applicants in 2005—87 placements**
**Minority Supplement Program – new name for the PA**
**“****Research Supplements to Promote Diversity in **
**Health-Related Research”**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DBNBR**

## Impact of Diseases of the Nervous System

**  ****Account for 6 of the top 10 causes**
**    ****of death* **

**          ****academic performance**
**          ****workplace productivity**
**          ****social functioning**
**          ****quality of life **

***Sources: * CDC; ** SfN Fact Page***

**  ****Affect 1 in 3 Americans**

**  ****Exact an economic cost of **
**    ****over $500 billion per year****

**  ****Have a major impact on:**

## Integration of Knowledge

**genome**

**protein expression**

**neuronal circuits**

**Understand Disease**
**Optimize Health**

**social**

**behavior**

**Integration of Knowledge**

## Blueprint

**Blueprint**

**Project Team                 ****	****Lead IC**
**GENSAT expansion ****	****  ****	****NINDS**
**Neurobiology of Disease**
**  ****Training Supplements    ****	****NIMH**
**Neuroscience Inventory   ****	****NIDA**

**FY 2005 (****Tap =  0.15%)****       **

** ****Neuroimaging Training**
** ****Computational Neuroscience**
** ****Neurobiology of Disease**

**FY 2006**** (****Tap =  0.30%)****       **

**Project Team              Lead IC**
**Core Grants****	**** ****	**** NINDS**
**Neuromouse****	****	**** NIMH**
**Training    ****	****	**** NIDA**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DPMCDA**

## Progress in Medication Development Program 

**Progress in Medication Development Program **

**Medications Development Workgroup Report**
** ****Has Been Completed **

***NIDA Response to Recommendations***
***will be discussed at May 2005 Council Meeting***

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DCNDBT**

## NIH MRI Study of Normal Brain Development

**Brain Development Cooperative Group**

## Problems with previous studies

**Sample sizes too small to detect subtle signals**
**Heterogeneity of subject population**
**Little longitudinal data**
**Lack of demographic representativeness**
**Limited behavioral data for brain-behavior correlation**
**Limited MRI data (typically T1 only)**
**Usually limited analysis techniques**

##        MRI Study of Normal Brain Development(N=500)

**Create a ****database**** of behavioral and brain MRI development data for 0-18 years**
**Analyze ****structural-behavioural relationships**
**Develop technique for ****dissemination**** of results**

## MRI Objectives

**Objective 1: Anatomical **
**    ****MRI/Behavior (5-18)**
**Objective 2: Anatomical **
**    ****MRI/Behavior (0-4)**
**Ancillary A: MR Spectroscopy**
**    ****(Single Voxel and MRSI)**
**Ancillary B: Diffusion Tensor Imaging,**
**    ****Relaxometry**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**CCTN**

## The National Drug Abuse Treatment

**Application Receipt Date: October 14, 2004**
**Applications Received = 15         **
**Anticipated Award Date: July 2005**

**The National Drug Abuse Treatment**
**Clinical Trials Network**
**(RFA-DA-05-001)**
***Issued July 7, 2004***

## Completed CTN Trials

**CTN-0001: Buprenorphine/Naloxone Detox (Inpatient)**
**CTN-0002: Buprenorphine/Naloxone Detox (Outpatient)**
**CTN-0004: Motivational Enhancement Therapy**
**CTN-0005: Motivational Interviewing**
**CTN-0006: Motivational Incentives (Drug-Free Clinics)**
**CTN-0007: Motivational Incentives (Methadone Clinics)**
**CTN-0011: Telephone Follow-Up Post-Discharge**
**Other Completed Studies**
**CTN-0008: Baseline Survey**
**CTN-0012: Perceptions of Infections in SA Tx Program**
**CTN-0016: Patient Feedback**

**Completed CTN Trials**

## Selected Research Findings   

**High acceptability; many drug free clinics have already adopted**
**Motivational Interviewing**
**Improved retention for stimulant abusers entering treatment**

**Selected Research Findings   **

**Motivational Incentives for Enhanced Drug Abuse Recovery (MIEDAR)**
**Low cost incentives are effective in promoting treatment retention and abstinence, successfully introduced into community**
**TELE**
**Higher rate of attendance in post residential treatment with intensive telephone follow-up**
**Higher rate of abstinence**

## Future Research Plans  

**Randomized control trials of Bup/Nx in assessing liver function in opioid dependence treatment**
**Randomized control trial of OROS MPH in ADHD adolescent with Substance Abuse disorders**
**Randomized control trial of OROS MPH in ADHD adult smokers**
**Prescription Opioid Addiction Treatment (POAT)**

**Future Research Plans  **

## NIDA Funding of ATTC “Research/Practice Liaisons” to Forge Linkages with CTN

**NIDA Funding of ATTC “Research/Practice Liaisons” to Forge Linkages with CTN**

**CTN Sites**

- Puerto Rico

***Enhancing Linkages to ***
***Ensure Research is Used***

**Notes:**
Modified 1/11/01 – 14 Sites

## Dissemination

**Dissemination**
**Products**

**Research **
**Findings**

**Create the charge for the Blending Team, **
**based on results of the protocol, and how it**
**can address critical needs in the treatment field**

**Led by 3 ATTC members **
**& 3 NIDA members**

**Hand-Off **
**Meeting**

**Blending**
** ****Team**

## CTN Research Findings – Blending Teams

**  ****Motivational Interviewing**
**  ****Motivational Incentives for Enhanced**
**      ****Drug Abuse Recovery (MIEDAR) **

**CTN Research Findings – Blending Teams**

**Buprenorphine Treatment –  Product **
**     ****released November 2004**
**Addiction Severity Index (ASI) – Product released December 2004**

## NIDA

**NIDA**

**National Institute ****on**** Drug Abuse**

**Special Populations Office**

**Division of **
**Basic Neurosciences**
**& Behavior Research**

**Office of**
**Extramural **
**Affairs**

**Office of Planning**
**& Resource**
** ****Management**

**Office of **
**Science Policy & **
**Communications**

** ****Intramural **
**Research**
**Program**

**Division of**
**Epidemiology, **
**Services & **
**Prevention Research **

**Division of**
**Pharmacotherapies &**
**Medical Consequences**
**of Drug Abuse**

**Center for the**
**Clinical Trials **
**Network**

**Teresa Levitin, PhD**

**Laura Rosenthal**

**Timothy Condon, PhD**

**Betty Tai, PhD**

**David Shurtleff, PhD**

**Frank Vocci, PhD**

**Wilson Compton, MD, MPE**

**Barry Hoffer, MD, PhD**

**Office of the Director**

**Nora D. Volkow, MD**

** ****Director**

**Timothy P. Condon, Ph.D.**

**Deputy Director**

**Laura S. Rosenthal**

**Associate Director**
**for Management**

** ****Division of Clinical**
**Neuroscience, **
**Development &**
**Behavioral**
**Treatment**

**Joseph Frascella, PhD**

**Director, AIDS Research**

**DESPR**

## Update on the Blue Ribbon Task Force Report 

**1.  Define drug abuse services research at NIDA:  *****Achieved*****  **** **
**2.  Fund more research on organization, management, and economics:  *****Progress made, effort ongoing****** ***
**3.  Develop standards for evidence-based practice:  *****Progress made, effort ongoing***
**4.  Develop collaborative research:  *****Achieved,***** *****effort ongoing***
**Fund research to understand widely used common practices that have not been studied:  *****Progress made, effort ongoing****** ***
**Encourage use of research designs that permit causal inferences: *****Progress made, effort ongoing****** ***

**NIDA has addressed all 6 goals and 24 recommendations of the Blue Ribbon Task Force.**

## Services Research at NIDA:Enhancing Adoption of Evidence-Based Practices 

**CTN as a platform for service studies**
**Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) (SAMHSA co-fund) **
**Primary Care Initiative (SAMHSA co-fund) **
**RFA in FY 2005 on Enhancing State Capacity to Foster Adoption of Science-Based Practices (SAMHSA co-fund)**
**Funding research within the SAMHSA Strategic Prevention Framework program using state epidemiology systems**

## reach large numbers of people

be broadly adopted by different settings

be consistently implemented by staff with 
      moderate training/expertise

produce replicable and long-lasting effects 
       at a reasonable cost

**be **_**broadly adopted**_** by different settings**
**be **_**consistently implemented**_** by staff with **
**      ****moderate training/expertise**
**produce **_**replicable and long-lasting effects**_** **
**       ****at a **_**reasonable cost**_

***What are the characteristics of interventions that can:******                    ***

**Future Directions:****Key Research Questions **

## Thrombospondins Promote CNS Synaptogenesis

***Source: Christopherson, KS et al., Cell 120, 421-433, February 11, 2005. ***

**Thrombospondins Promote CNS Synaptogenesis**

**`**

## Routine HIV Screening in Health Care Settings

***Source: Sanders, GD et al., NEJM 352(6), February 10, 2005.***

**Routine HIV Screening in Health Care Settings**
**Can Provide Important Health & Survival Benefits...**

**And Can Be As Cost-Effective As Screening for Such**
**Other Conditions As Breast Cancer & Hypertension**

**Increase in Life Expectancy **
**Due to Screening (Yr)**

** ****2.0**
**1.8**
**1.6**
**1.4**
**1.2**
**1.0**
**0.8**
**0.6**
**0.4**
**0.2**
**0.0**

**30           40            50           60          70           80           90**

**Life expectancy**

**Quality-adjusted**
**life expectancy**

**AGE (Yr)**

**0.0   0.1   0.2   0.3   0.4   0.5   0.6   0.7   0.8   0.9   1.0**

**200,000**
**180,000**
**160,000**
**140,000**
**120,000**
**100,000**
**80,000**
**60,000**
**40,000**
**20,000**
**0**

**Incremental Cost-Effectiveness of Screening**
**($/quality-adjusted life year)**

**Costs and benefits to partners excluded**

**Costs and benefits to partners included**

**Prevalence of Unidentified HIV (%)**

## NIDA-Sponsored/Chaired Symposia at the

**NIDA-Sponsored/Chaired Symposia at the**
**Annual Meeting of the **
**American College of Neuropsychopharmacology**

**  ****Substance Abuse in the 21****st**** Century: What Problems **
**    ****Lie Ahead for the Baby Boomers?**
**  ****The Neurobiology of Obesity: Relations to Addiction**
**  ****Glia and Astrocytes as Modulators of Synaptic Function**
**  ****Molecular Genetics of Addiction Vulnerability **
**    ****and Treatment **
**  ****Predictors of Treatment Response and Relapse: **
**    ****Neurobiological Markers**

## Slide 45

## Prohibited Outside Activities – 5 C.F.R. §5501.109 

**in Interim Final Rule**
**Prohibited Outside Activities – 5 C.F.R. ****§5501.109**** **

***What activities are not allowed?***
**For all NIH employees – ****compensated or uncompensated employment****, including consulting & advisory or other board service, & compensated teaching, speaking, writing, or editing is now prohibited with or for:**
**         ****substantially affected organizations (defined to include biotechnology, **
**         ****pharmaceutical, medical device companies, and others with similar interests)**
**         ****hospitals, clinics, health maintenance organizations, or other health care providers**
**         ****health insurers**
**         ****health, science, or health research-related trade organizations, professional **
**         ****associations, or consumer or advocacy groups**
**         ****educational institutions or non-profit independent research institutes that are**
**          ****or recently were NIH funding applicants, grantees, contractors, or CRADA partners**
**Employees are also prohibited from engaging in ****self-employment activities that involve the sale or promotion of the services or products**** of the above entities.**

## Prohibited Outside Activities – 5 C.F.R. §5501.109 

**    ****established curriculum of a university or college**
**  ****Teaching, speaking, or writing performed as part of a continuing professional **
**     ****education program**
**  ****Employment with political, religious, social, fraternal, or recreational**
**    ****organizations**
**  ****Clinical, medical, or health-related professional practice involving provision of **
**    ****care to individual patients**
**  ****Clerical or similar services**
**   ****Authorship of articles, chapters or textbooks that are subject to a peer review**
**     ****or substantially equivalent editorial review process**

**Summary of NIH-Specific Provisions**
**in Interim Final Rule**
**Prohibited Outside Activities – 5 C.F.R. ****§5501.109**** **

***What is allowed?***
**In general, if otherwise approvable under existing regulations, the                following activities are allowed:**

## Holdings – 5 C.F.R. §5501.110 

**financial disclosure reports are prohibited from acquiring or holding**
**financial interests, such as stock, in biotechnology, pharmaceutical, and **
**medical device companies and others involved in the research, **
**development, or manufacture of medical devices, equipment, **
**preparations, treatments, or products.**
**All other employees (that is, those who do not file either of these **
**reports) are subject to a $15,000 cap on holdings in such companies.**
**There is an exception from both rules for a financial interest, such as a **
**pension or other employee benefit, arising from employment with a **
**substantially affected organization and widely diversified, publicly**
**traded mutual funds.**

**Summary of NIH-Specific Provisions**
**in Interim Final Rule**
**Holdings – 5 C.F.R. ****§5501.110**** **

## Awards – 5 C.F.R. §5501.111 

**Employees, generally, may receive awards from outside sources that are nothing more than plaques or trophies of little intrinsic value and free attendance and food at the event in which employee is honored.**
**There is an exception to the ban that may permit the acceptance of gifts with a aggregate market value of more than $200 that are associated with the most prestigious awards that confer an exceptionally high honor in the fields of medicine or scientific research, e.g., Nobel, Lasker, if the award is otherwise approvable.**

**Summary of NIH-Specific Provisions**
**in Interim Final Rule**
**Awards – 5 C.F.R. ****§5501.111**** **