Amendment 2 - BAA-NIAAA-09-07.pdf

OMB NO. 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

Amendment 02

3. EFFECTIVE DATE

April 30, 2009

4. REQUISITION/PURCHASE REQ. NO

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

Eunice Kennedy Shriver National Institute of Child Health and Human Development Office of Acquisitions, NIAAA Contracts Management Branch 5635 Fishers Lane, Room 3016, MSC 9304 Bethesda, MD 20892-9304

(X)

9A. AMENDMENT OF SOLICITATION NO.

BAA-NIAAA-09-07

9B. DATED (SEE ITEM 13)

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

Recipients of BAA-NIAAA-09-07 Title: Mechanisms of Behavior Change Initiation (MOBCI) for Drinking Behavior

10A. MODIFICATION OF CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

(X) The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers is extended, (X) is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning _1___ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor _X is not, is required to sign this document and return ____ copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

1) The purpose of this amendment is to provide responses to questions received from potential offerors; 2) and to provide potential offerors with supplemental information as examples. Supplemental information includes Definition of Terms and Examples of Available Data Sets.

DATE OF ISSURANCE: April 30, 2009

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Gwennifer Epps, Contracting Officer NIAAA Contracts Management Branch, OA, NICHD

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY Gwennifer Epps ___ ______ (Signature of Contracting Officer)

16C. DATE SIGNED

04/30/2009

NSN 7540-01-152-8070 STANDARD FORM 30 (REV 10-83)

PREVIOUS EDITION NOT USABLE Prescribed by GSA

FAR (48 CFR) 53.243

Solicitation Questions & Answers

QUESTION 1: I have been thinking about developing a series of iphone/blackberry/smartphone applications that will provide mini brief alcohol interventions, based on a dynamic model of individual's relapse risk factors in the moment (i.e., Momentary Assessment, Momentary Intervention). Other than theory and data from a few smoking studies I have no preliminary data to back this idea up. Do you think it could still fly under this mechanism? I've been thinking it would be a good business opportunity and I could easily collaborate with one of many tech firms in Seattle on the development.

ANSWER: Although we encourage the use of new technology, the focus is NOT in intervention studies.

Rather, results of this program are proof-of-principle models that demonstrate the potential to evolve into a more scientifically based understanding of drinking behavior change initiation. Proposals should describe a cohesive project resulting in proof-of-concept approaches that demonstrate strong potential to enable objective a priori analysis and design of mechanism-based strategies for inducing positive drinking behavior change. See Attachment 3, Page 4, Envisioned Technology Developments and Innovative Concepts.

QUESTION 2: May we talk about the solicitation & discuss deadlines?

ANSWER: The Broad Agency Announcement was posted on April 10, 2009 on the Federal Business Opportunities website. Proposals are due no later than May26, 2009; questions must be submitted no later than April 27, 2009. Please contact Ms. Kesha Williams or Ms. Gwennifer Epps for answers to questions specific to this solicitation. Per page 33 of the solicitation, section e. communications prior to contract award: Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this RFP. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement.

QUESTION 3: I am trying to determine an approximate anticipated price range for the contracts. Most often this is indicated by informing applicants of ceiling amounts such as total amount (e.g. Challenge Grants were a ceiling of $1,000,000 for 2 years or a total pool of funded available (eg TR01 was listed as a total of $26 million) or an estimated amount plus the anticipated number of grants to be funded (e.g., most RFA will give an amount such as $4 million and an estimated number of 6-8 grants). Having as much guidance regarding the anticipated range of costs is vital in preparing proposals, especially given the Technical Proposal requirements here. To state this more concretely, it is hard to know how ambitious and comprehensive a plan to create without knowing whether the expectation is that contracts should come in under $1 million dollars over 3 years or under $10 million. Right now, my group could write a proposal for either sum. I hope I have made that point clear.

ANSWER: The anticipated budget for both for both Category A and Category B combined could range from $250,000 to $500,000 total cost per year. NIAAA expects to fund 4 - 8 projects.

QUESTION 4: Will NIAAA accept a proposal from a group of geographically distant investigators, specifically ones whose labs are not in the same institution or city. In my specific situation, I have worked with Drs. Bates (Rutgers) and Breiter (Harvard) on prior MOBCI projects including a U13 grant in which we collaborated with NIAAA (Drs. Willenbring and Huebner). We are wondering if NIAAA will 1) ACCEPT a proposal from a geographically separated group as long as the work plan is feasible and 2) WOULD PREFER to see local collaboratives (within universities or cities). The latter is how other NIAAA multi-site treatment study contracts were organized, i.e. each site for the contract organized within one city (e.g., New Haven) or even within one university community (Yale). There are advantages and disadvantages to each approach. The advantages of local collaboratives are a) it is easier to design discreet experimental work (recruiting, experiments) and communication, collaboration may be easier.

The disadvantage is that finding the right individuals across disciplines is also important. Someone in your institution may or may not be a good fit for this project, even given their complimentary expertise.

Investigators in other locations may have greater shared interested, comparability, and history of collaboration. Composition of new teams may be especially challenging given the rapid response required coupled with the unusual load of work scientists face now in responding to other NIH Stimulus RFAs.

ANSWER: Yes, NIAAA encourages transdisciplinary research engaging a team with suitable multidisciplinary experts, as well as a plan for enabling the necessary cross-disciplinary discussion, coordination, and sharing of results among the team members. It is anticipated that a successful project will require, in addition to significant alcohol research expertise, a broad subset of theoretical, experimental, analytical, and application expertise from disciplines spanning the behavioral, biological, clinical, cognitive, medical, computational, engineering, imaging, mathematical, social, and statistical sciences. See Attachment 3, Page 8 Envisioned Project Structure.

QUESTION 5: We are rather confused and hope you can help us understand the recent information about the Mechanisms of Behavior Change Initiation (MOBCI) for Drinking Behavior solicitation. We had thought that what would be released would be a BAA for which grant proposals (i.e., RO1’s) could be submitted. However, the information that downloads from the web appears to be a description for a business contract arrangement that requires a technical proposal and a business proposal. Even the preparation of a notice of intent to apply seems to involve procedures that are entirely unfamiliar to us (e.g., Representations and Certifications) and there is no mention of forms to be used, review group processes and so on. Is the notice that you sent a request for grant proposals, or is it some other sort of solicitation? In particular, is it something that we would be eligible to apply to from the University.

ANSWER: This is a solicitation for a contract, not a grant. Please note: Grants are mechanisms used by the NIAAA to extend financial assistance to organizations or individuals involved in programs related to the work of the Institute. Under a grant, the specific approach, the protocol, and in most instances, the subject matter of the grant originates with the applicant who maintains overall responsibility. Grants are awarded based upon considerations of scientific merit and relevance to the Institute’s program objectives.

Grants may result from a Request for Applications (RFA), in response to Program Announcements, or most often from investigator-initiated applications. A contract is a mutually binding legal relationship in which the seller or “Contractor” is obligated to furnish supplies or services and the buyer, or “NIAAA” as used in this document, must pay for them. The contract is usually a written document that carefully outlines the supplies or services to be provided as well as acceptance requirements, payment provisions, and other rights and responsibilities applicable to the Contractor and the NIAAA. Contracts can be used to acquire research and development programs as well as products or services to meet a predetermined program need. New contracts are usually awarded on a competitive basis via a Request for Proposals (RFP) solicitation document, which contain a Statement of Work (SOW), specifically identifying the Government’s requirement. Contracts may also be awarded via a Broad Agency Announcement (BAA), which is very similar to an RFP, except that it contains no SOW. A BAA is general in nature and identifies areas of research interest and includes proposal selection criteria, and solicits the participation of all offerors capable of satisfying the Government’s needs. The SOW to be included in the contract is proposed by the offeror, not the Government, and in this respect a BAA is similar to a grant. Both contracts and grants can be awarded based upon considerations of scientific merit and relevance to the Institute’s program objectives.

Also, please see page 26, section “Business Proposal Attachments” No 8, 9, 10, 11, 12, 13. Pay special attention to Attachment 10, Breakdown of Proposed Estimated Costs w/Excel Spreadsheet.

QUESTION 6: Will projects include 1) theoretical projects exploring and explaining why aspects of current methodology are guaranteed to limit progress and 2) exploring what needs to be done to create a more positive methodology?

ANSWER: Yes. Envisioned research may entail strategies that integrate application knowledge, theory, modeling, computation, analysis, and experiment will be required. Any theoretical or experimental MOBCI breakthrough will have strong implications for behavior change research in these other fields, including the potential for clarifying relationships among mechanisms of behavior change for individuals with multiple maladaptive behaviors. Methods and insights from other fields may well have import to the objectives of MOBCI.

DEFINITION OF TERMS

Behavior: Overt, observable actions, determined by underlying psychological processes.

and to biobehavioral interactions.

Broad Agency Announcement (BAA): A mechanism used to solicit contract proposals to fulfill requirements for scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding. Typically, a BAA is used for High Risk and High Payoff Projects. Proposals are evaluated in accordance with evaluation criteria specified through a peer review process. Proposals are not evaluated against a specific Government need, as in the case of a conventional Request for Proposals (RFP), as they are not submitted in accordance with a common work statement.

See Federal Acquisition Regulation (FAR) subchapter 2.101(b) and 6.102(d)(2) for further information about BAA’s.

Drinking behavior control system (DBCS): A bio-psycho-social feedback system that regulates the drinking behavior. A key purpose of MOBCI is to better define this.

DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. A manual published by the American Psychiatric Association and covers all mental health disorders for both children and adults. It also lists known causes of these disorders, statistics in terms of gender, age at onset, and prognosis as well as some research concerning the optimal treatment approaches.

Interpersonal Factors: An individual’s immediate social ecology (e.g. family, friends).

Intrapersonal Factors: An individual’s intrapersonal factors such as cognition, affect and behavior.

Interdisciplinarity/Cross-disiplinarity: an interactive process in which researchers work jointly, each drawing from his or her own discipline specific perspective, to address a common research problem.

Example: A pharmacologist, health psychologist, and neuroscientist conduct a collaborative study to examine the interrelations among patterns of nicotine consumption, brain chemistry, caloric intake, and physical activity levels. Their research design incorporates conceptual and methodologic approaches drawn from each of their respective fields.

Maladaptive Drinking Behavior: Behavior that results from any disruption in the bio-psycho-social feedback system resulting in an inability to regulate the drinking behavior. An individual can be thought to have maladaptive versus a healthful drinking behavior, but there are clearly intermediate gradations between these two extremes.

Multidisciplinarity: a sequential process whereby researchers in different disciplines work independently, each from his or her own discipline-specific perspective, with a goal of eventually combining efforts to address a common research problem. Example: A pharmacologist, health psychologist, and neuroscientist each contribute sections to a multi-authored manuscript that reviews research in their respective fields pertaining to the links between nicotine consumption, changes in brain chemistry and caloric intake induced by nicotine, and physical activity levels.

Neurophysiologic Factors: An individual’s neurophysiology and relevant biology.

Spontaneous Recovery: Recovery from maladaptive drinking behavior, seen after the passage of time, with no active intervention.

Transdisciplinarity: an integrative process in which researchers work jointly to develop and use a shared conceptual framework that synthesizes and extends discipline-specific theories, concepts, methods, or all three to create new models and language to address a common research problem. Example: A pharmacologist, health psychologist, and neuroscientist conduct a collaborative study to examine the interrelations among nicotine consumption, brain chemistry, caloric intake, and physical activity levels.

Based on their findings, they develop a neurobehavioral model of the links among tobacco consumption, brain chemistry, insulin metabolism, physical activity, and obesity that integrates and extends the concepts and methods drawn from their respective fields.

EXAMPLES OF AVAILABLE DATA SETS

I. ALCOHOL EPIDEMIOLOGIC DATA DIRECTORY

This Alcohol Epidemiologic Data Directory is compiled and updated by the Alcohol Epidemiologic Data System (AEDS), operated by CSR, Incorporated under contract for the National Institute on Alcohol Abuse and Alcoholism (NIAAA). AEDS’ task is to identify, acquire, maintain, and analyze alcohol-related epidemiologic data under the direction of NIAAA’s Division of Epidemiology and Prevention Research. This Directory is a current listing of surveys and other relevant data suitable for epidemiologic research on alcohol. Some surveys included in the Directory are designed specifically to answer alcohol-related questions. Other surveys may address other issues but still contain alcohol-related data.

The first section of the Directory includes data sets that are representative of the overall U.S.

population, although many use different age categories in the sample design. The second section includes data sets on special populations (e.g., adolescents, prison inmates, military personnel, older Americans, and specific racial/ethnic groups). A final section describes publications and other research products available from AEDS.

It is important to note that this Directory is not a comprehensive listing of all data sets that are available to alcoholism professionals. Many small-scale surveys, such as single-state surveys and local attitudinal surveys, are excluded, as are data sets that are not available to the public.

Website: http://pubs.niaaa.nih.gov/publications/datasys.htm

Examples of data sets referenced in the AEDS include the following:

• National Epidemiologic Survey on Alcohol and Related Conditions (NESARC)—2001–02 and its follow up studies.

• National Health Interview Survey (NHIS) and the NHIS Alcohol Sections—1983 and 1988.

• National Longitudinal Alcohol Epidemiologic Survey (NLAES)—1992

• National Survey of Alcohol, Drug, and Mental Health Problems [Healthcare for

Communities] (HCC)—1997–98, and 2000–01.

Website: http://pubs.niaaa.nih.gov/publications/datasys.htm

II. NHANES: National Health and Nutrition Examination Survey

In 1970, the National Nutritional Surveillance System was combined with the National Health Examination Survey to form NHANES. This was done to initiate a series of surveys to collect information about health and diet of people in the U.S. Major goals of NHANES are to (1) estimate the number and percent of persons in the U.S. population and designated subgroups with selected disease and risk factors; (2) monitor trends in the prevalence, awareness, treatment, and control of selected diseases; (3) monitor trends in risk behaviors and environmental exposures; (4) analyze risk factors for selected diseases; (5) study the relationship between diet, nutrition, and health; (6) explore emerging public health issues and new technologies; and (7) establish a national probability sample of genetic material for future genetic testing (NHANES III and beyond). NHANES I represents the first cycle of the NHANES studies.

Website: http://www.cdc.gov/nchs/nhanes.htm

III. Project MATCH - Matching Alcoholism Treatments to Client Heterogeneity

This multi-site clinical trial of alcohol treatment was conducted based on the premise that no single treatment approach is effective for all persons with alcohol problems. A more promising strategy involves assigning patients to alternative treatments based on specific needs and characteristics of patients. Project MATCH was a multisite clinical trial designed to test a series of a priori hypotheses on how patient-treatment interactions relate to outcome. Two independent matching studies were conducted in parallel, one with clients recruited from outpatient settings and the other with patients receiving aftercare treatment following inpatient care. Patients were randomly assigned to 12-Step Facilitation, Cognitive-Behavioral Coping Skills, or Motivational Enhancement Therapy. Subjects were followed at 3-month intervals for one year following completion of the 12-week treatment period and were evaluated for changes in drinking patterns, functional status/quality of life, and treatment services utilization. Interaction effects with selected patient characteristics were studied.

http://pubs.niaaa.nih.gov/publications/datasys.htm http://www.cdc.gov/nchs/nhanes.htm

The Project MATCH Public Data Set is being released in three waves. Wave I includes the major variables used to test the trial's hypotheses (e.g., client matching attributes, treatment outcomes) and additional summary scale scores derived from the assessment instruments used in the trial.

Data files are organized by content domain. Wave I of the Public Data Set is currently available.

Wave II files currently contain item-level (raw) data, also organized in terms of content domain.

Wave III will consist primarily of data from the 3-year follow-up evaluation of clients in the trial's Outpatient arm. Wave II and Wave III data files will also include additional measures developed by trial investigators that were not available earlier.

Waves II and III of the Public Data Set are not yet fully available, however, members of the Project MATCH Public Data Set User Group who demonstrate a strong and detailed rationale for use of specific data may submit a request to the Coordinating Center.

Websites: http://www.commed.uchc.edu/match/ http://www.commed.uchc.edu/match/dataset/default.htm

IV. COMBINE - Combining Medications and Behavioral Interventions

This multi-center, randomized, controlled clinical trial is sponsored by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Under investigation is whether combinations of pharmacologic and behavioral therapies are superior to mono therapies in the treatment of alcohol dependence. The trial will include eleven clinical centers and approximately 1,400 patients.

The two medications are Naltrexone and Acamprosate. Neither drug has been found to be addictive. Naltrexone is a medication that has been used in this country for a number of years and has been found to reduce alcohol craving. Acamprosate, a drug that has been prescribed in Europe for over 14 years but is not yet approved in the U.S., has been shown to help increase abstinence and reduce the likelihood of relapse to drinking.

Behavioral therapies will focus on medication issues, general health issues, and drinking. As part of this treatment, participants will be encouraged to attend self-help groups such as Alcoholics Anonymous or SMART Recovery. A second type of behavioral treatment includes additional components designed to help people to: (1) increase their motivation to manage their alcohol problems, (2) participate in self help groups, and (3) learn new skills to cope with problems and avoid drinking.

Website: The procedure for applying to receive the data base and other background information is described on the NIAAA website, on the following link http://www.niaaa.nih.gov/Resources/DatabaseResources/combinedataset.htm

V. COGA: COLLABORATIVE STUDIES ON GENETICS OF ALCOHOLISM

http://www.commed.uchc.edu/match/ http://www.commed.uchc.edu/match/dataset/default.htm http://www.niaaa.nih.gov/Resources/DatabaseResources/combinedataset.htm

Since 1989, NIAAA has funded the Collaborative Studies on Genetics of Alcoholism (COGA) in response to overwhelming evidence from twin, family, and adoption studies of a major genetic influence on vulnerability to alcoholism. The overall goal was to identify the specific genes underlying this vulnerability. The COGA investigators, in the course of carrying out their own genetic linkage studies of alcoholism, have assembled a collection of more than 300 extended families densely affected by alcoholism, consisting collectively of over 3000 individuals. They have collected extensive clinical, neuropsychological, electrophysiological, biochemical, and genetic data, and established a repository of immortalized cell lines from these individuals, to serve as a permanent source of DNA for genetic studies. In order to promote the most rapid possible progress in identifying genes influencing vulnerability to alcoholism, NIAAA is supporting COGA's distribution of these data and biomaterials to qualified investigators in the broader scientific community. Recipients of data and biomaterials will be responsible for defraying the cost of their distribution, as described below, under Access to Data and Biomaterials.

Website:

http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/projcoga.

htm - Biomaterials

VI. NESARC: NATIONAL EPIDEMIOLOGIC SURVEY ON ALCOHOL AND RELATED

CONDITIONS

NESARC was designed to be a longitudinal survey. Wave I and Wave II interviews were conducted in 2001-2002 and 2004-2005, respectively. NESARC was a representative sample of the United States population and 43,093 Americans participated in the Wave I of the survey.

During Wave II, 34,653 of those respondents interviewed in Wave 1 were interviewed. The target population of the NESARC is the non-institutionalized household population, 18 years and older, residing in the United States including the District of Columbia, Alaska, and Hawaii.

Additionally the following non-institutional group quarters housing units were included as part of the NESARC sample: boarding houses, rooming houses, non-transient hotels and motels, shelters, facilities for housing workers, college quarters, and group homes. The Wave I and Wave II NESARC data provide detailed information on topics related to alcohol and drug use, abuse and dependence and their associated psychiatric and medical disabilities.

The NESARC includes extensive questions on patterns of alcohol consumption, as well as items designed to provide psychiatric classification of alcohol and other substance use disorders, mood and anxiety disorders, and personality and conduct disorders. In addition, the survey contains a variety of questions on family history of alcoholism, alcohol treatment utilization, medical conditions, and sociodemographic information.

NESARC is the primary source for information and data on the U.S. population aged 18 and older for:

alcohol and drug use, alcohol and drug abuse and dependence, and associated psychiatric and other medical comorbidity.

http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/projcoga.htm#Biomaterials http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/projcoga.htm#Biomaterials http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/projcoga.htm#Biomaterials http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/SharedResources/projcoga.htm#Biomaterials

Information on obtaining the public use data file for NIAAA's 1991-1992 National Longitudinal Alcohol Epidemiologic Survey (NLAES), a cross-sectional survey of the U.S. population aged 18 and older, is also available on the NESARC website.

Website: http://www.nesarc.niaaa.nih.gov/

VII. NATIONAL CENTER FOR HEALTH STATISTICS

Some NCHS data systems and surveys are ongoing annual systems while others are conducted periodically. NCHS has two major types of data systems: systems based on populations, containing data collected through personal interviews or examinations; and systems based on records, containing data collected from vital and medical records.

Website: http://www.cdc.gov/nchs/Default.htm Summary: http://www.cdc.gov/nchs/data/NCHS_Survey_Matrix.pdf http://www.nesarc.niaaa.nih.gov/ http://www.cdc.gov/nchs/Default.htm http://www.cdc.gov/nchs/data/NCHS_Survey_Matrix.pdf

Bethesda, MD 20892-9304