PR20666_MDA_2018_JOFOC_FBO.pdf

“Source Selection Information – FAR 2.101 and 3.104”

ALS MDA Outreach and Education Activities to Support the National ALS Registry

000HJAAN-2018-20666

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. Agency for Toxic Substances and

Disease Registry (ATSDR)

b. Sponsoring organization.

Centers for Disease Control and Prevention (CDC)

Agency for Toxic Substances and Disease Registry (ATSDR)

Division of Toxicology and Human Health Sciences

c. Project Officer Information.

Project Officer name Darlene Brady

Mailing address Division of Toxicology and Human Health Sciences

Office of the Director

4770 Buford Highway NE, MS F-57

Atlanta, GA 30341

E-mail address zct8@cdc.gov

Telephone number (770) 488-0889

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this contract is to promote the

National Amyotrophic Lateral Sclerosis (ALS) Registry to increase enrollment numbers through the Muscular Dystrophy Association’s (MDA) extensive nationwide network of offices, clinics, and Centers of Excellence so that the agency can fulfill the congressional mandate under the ALS Registry Act, Public Law No. 110-373.

Justification for Other than Full and Open Competition

b. Project background. The Centers for Disease Control and Prevention

(CDC)/ATSDR, within the U.S. Department of Health and Human Services, have been directed by Congress to gather data for a nationwide ALS registry. A bill to amend the Public Health Service Act to provide for the establishment of an ALS

Registry, S. 1382: ALS Registry Act, was signed into law on October 10, 2008 by

President Bush and became Law No: 110-373. The purpose of the registry as described in the bill, is to: (1) better describe the incidence and prevalence of ALS in the United States; (2) examine appropriate factors, such as environmental and occupational, that might be associated with the disease; (3) better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and (4) better examine the connection between ALS and other motor neuron disorders

(MND) that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. The Muscular Dystrophy Association's (MDA) Strategies & Activities to

Support the National ALS Registry

b. Project description. Please see attached Statement of Work (SOW).

In response to the enactment of Public Law 100-373, ATSDR launched the National

ALS Registry in October 2010. While ATSDR has been actively promoting the ALS

Registry via key national and international neurological conferences, social media, and its partners since then, significant numbers of patients with ALS in the United

States have not been registered in the registry. ATSDR believes that the most direct way to reach these patients is to conduct outreach in the clinics and centers where these ALS patients are being supported.

MDA is one of the worlds most well-respected and trusted non-profit health organizations dedicated to the treatment and cure of muscular dystrophy, ALS and related diseases. MDA provides comprehensive health care and support services, advocacy and education to ALS patients and their families throughout its nationwide network of clinics, offices, and Centers of Excellence. MDA's patient cohort and its partners in the local ALS community include a large concentration of the ALS patients who are eligible for registration in the National ALS Registry. Therefore, MDA is in a unique position to provide ATSDR with substantial assistance in promoting the National ALS Registry to MDA's constituents (e.g., ALS patients, their family members and caregivers, and ALSA clinical staff) as well as the entire ALS

Community so that the purposes and objectives of the ALS Registry Act can be met with a statistically significant data set of ALS patients registered throughout the

United States.

Requirement type.

Research & Development (R&D)

R & D support services

X Support services (non-R&D)

Supplies/equipment

Information technology (IT)

Construction

Architect-engineer (A & E) services

Design-build

Other (specify):_______________

Type of action.

X New requirement

Follow-on

Other (specify):_______________

Proposed contract/order type.

X Firm-fixed price

Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): ______________

Cost-plus-fixed-fee

Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ________________

Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ____________

Other (specify): ______________

Completion Form

Term form

Acquisition identification number. PR # 000HJAAN-2018-20666

Total estimated dollar value and performance/delivery period. The total estimated dollar value of this contract is $3,815,184, which includes a base year and four optional years to be funded as follows:

4. Identification of the statutory authority permitting other than full and open competition.

X The acquisition is conducted under the authority of 41 United States Code

(U.S.C.) 253 (c) (__) as set forth in Federal Acquisition Regulation (FAR) 6.302-

1(a) (2).

This acquisition is conducted under the authority of section 4202 of the Clinger-

Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition

Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Muscular Dystrophy Association (MDA)

USA National Office

222 S. Riverside Plaza, Suite 1500

Chicago, IL 60606

(800) 572-1717

Year 1

Base Year

Year 2

Option Yr 1

Year 3

Option Yr 2

Year 4

Option Yr 3

Year 5

Option Yr 4

Total

Base and 4 Option Yrs

July 1, through

June 30, 2019

July l, 2019 through

June 30, 2020

July 1, 2020 through

June 30, 2021

July 1, through

June 30, 2022

July 1, 2022 through

June 30, 2023

July l , 2018 through June 30, 2023

12 Months 12 Months 12 Months 12 Months 12 Months 60 Months (Cumulative of Base + 4

Option

Years)

$781,523 $799,108 $817,088 $835,472 $854,270 $4,087,463

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

ATSDR believes that the most direct way to reach ALS patients is to conduct outreach in the clinics, centers, and offices where ALS patients are being treated and supported. As a leading healthcare provider of ALS treatment, support, advocacy and education in the United States, MDA's nationwide network of clinics, offices, and

Centers of Excellence offers assistance to a large number of ALS patients and their families.

MDA's very large and unique ALS patient cohort located throughout the United

States provides MDA with sole and exclusive proprietary access to these patients, their medical records and their contact information. This information is protected by medical privilege and not commercially available in the marketplace, so only MDA has access to its specific nationwide client base of ALS patients. MDA's established relationship of trust and confidence with its ALS patients and their families places

MDA in a unique position to provide AT SDR with substantial assistance in promoting the National ALS Registry to their constituents (e.g., ALS patients, their family members and caregivers, and ALSA clinical staff). MDA is the sole source to access the MDA-ALS patient/family cohort and no other contractor can provide this service to meet the agency's requirements.

MDA's stellar work and efforts in the treatment, cure, advocacy and education related to ALS have earned it tremendous respect and credibility in the field of ALS throughout the entire ALS Community. MDA has thus cultivated, fostered and developed an extensive network of professional relationships and partnerships with others in the general ALS community over the years. MDA, thus, has important links to the ALS clinical community, regularly engaging ALS physicians and other ALS health professionals and MDA clinics throughout the country. These links provide outreach, education, support, and assistance to ALS patients, their families, and the local ALS clinical community beyond the MDA patient cohort.

MDA provides ATSDR with the relationships, links, knowledge, experience, patients and community support needed to fulfill ATSDR's congressional mandate to build the

National ALS Registry as provided for in the ALS Registry Act, Public Law No.

110373. Without the access to MDA's patients and community network, ATSDR will have incomplete gaps in the data registered in the National ALS Registry, thus preventing the objectives of this national public health ALS initiative from being met.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR

5.202 applies.

During 2002-2011, ATSDR completed an extensive nationwide search for organizations to be considered for comprehensive promotion and outreach activities to support its National ALS Registry efforts. MDA was identified from those efforts.

As required by FAR 5.202, a pre-solicitation Intent to Sole Source notice will be placed on FedBizOpps with a response due date allowing for no less than 15 days response. This will allow any other potential contractors to challenge this determination.

7. Determination by the Contracting Officer that the anticipated cost/price to the

Government will be fair and reasonable.

A formal cost proposal will be obtained from the proposed contractor which will be certified in accordance with FAR 15.406-2. The Contracting Officer will conduct a thorough review of the proposal, and the cost realism analysis will be performed.

There is sufficient data from historical data of comparable work of this kind to evaluate the cost reasonableness of the proposal.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

During 2002-2011, ATSDR conducted extensive nationwide search for organizations to be considered for comprehensive promotion and outreach activities to support its

ALS Registry efforts. ATSDR's market research revealed that MDA, as a national leader in ALS research, treatment, advocacy and education, currently has direct and proprietary access to a high percentage of ALS patients in the United States. Serving a very large and unique ALS patient cohort located throughout the United States, MDA has sole and exclusive proprietary access to these patients, their medical records and their contact information. This information is protected by medical privilege and not commercially available in the marketplace, so only MDA has access to its specific nationwide client base of ALS patients.

ATSDR's market research also revealed that MDA currently has an extensive network of professional relationships and partnerships with the general ALS community. This network can be leverage to reach other ALS patients and their families.

The results of the market research established that MDA is the sole source for leveraging MDA's large ALS patient database and its general community partnerships in the ALS community to build a nationwide ALS patient registration database. No other contractor can provide this type of service to meet the agency requirements with respect to the MDA database and community partnerships.

9. Any other facts supporting the use of other than full and open competition.

None

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Market Research (FAR Part 10) was conducted for this acquisition via the Federal Business

Opportunities website at www.fedbizopps.gov on March 1, 2018 under NAICS 541990, All

Other Professional, Scientific and Technical Services, with a size standard of $15M.

CDC posted a Sources Sought Notice synopsis (HHS-CDC-ATSDR-SS-18-001-BV) on March

1, 2018:

a) Interested Sources: 10 responses received under the Source Sought Notice:

b) Assessment of Small and Large businesses capabilities:

No. NAME ADDRESS Business Size

NAICS Code

541990

Capable of

Meeting the

Agency’s need

1 Little Communications

Group

100 South 4th Street

St. Louis, MO 63102

8(a) Minority Owned

Small Business

No

2 Brunet-Garcia

Advertising

25 N Market Street

Jacksonville, FL 32202

Small, Minority-

Owned 8(a) Business

No

3 Hendall, Inc. 1803 Research Blvd., #517

Rockville, MD 20850

Small Business No

4 Deloitte 1919 North Lynn Street

Arlington, VA 22209

Large Business No

5 Karna 2970 Clairmont Road, #720

Atlanta, GA 30329

Large Business No

6 Ripple Effect

Communications

2400 Research Blvd, # 305

Rockville, MD 20850

Woman-owned

Small Business

No

7 BioCentric, Inc. 5008 Lake Circle West

Columbia, MD 21044

Small Woman

Owned Business

No

8 Chenega Corporation 3395 Northeast Expressway

NE, #300,

Atlanta, GA 30341

Certified 8(a) Small

Disadvantaged

Business

No

9 CSR, Inc. 4250 N. Fairfax Drive, #500

Arlington, VA 22203

Small Business No

10 Cygnus Corporation, Inc. 5640 Nicholson Lane, #227

Rockville, MD 20852

Women-Owned

Small Business

(WOSB)

No http://www.fedbizopps.gov/

c. Capability statement /information sought:

The respondents were responsible for providing their professional answers or insights to the synopsis. The responses may be found in OAS File, TAB B.9.

d. Below is a summary of the review:

The government requirement focuses on the need to directly reach the MDA’s network of offices, clinics, Centers of Excellence to obtain an ALS patient cohort (e.g. direct contact with patients and family members serviced by or volunteering with the MDA or who are patients at the partnering clinics, etc.). This information is protected by medical privilege, Health Insurance

Portability and Accountability Act (HIPAA), and not commercially available in the marketplace, so only MDA has access to its specific nationwide client base of ALS patients.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to completion before any subsequent acquisition for the required supplies or services.

There are no future plans to acquire the same type of services, e.g., further extensions or renewals by competition or any other means. The barriers to competition cannot be overcome by ATSDR because MDA has direct and proprietary access to a high percentage of ALS patients in the US, including ALS patient databases and mailing lists. However, if plans are revised, the agency will consider all reasonable sources who can provide the services and work required to assist ATSDR in fulfilling its' congressionally mandated responsibilities.

12. Program office certification.

The is to certify that the portions of the this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full open competition, are accurate and complete.

Official

Name & Title Signature Date

Project Officer

Darlene Brady

Management and Program

Analyst

Project Officer’s

Immediate

Supervisor

Janathan Jackson

Acting Deputy Director for

Management and Operations

Head of the

Sponsoring

Program Office

William Cibulas

Acting Division Director

ATSDR, DTHHS, OD

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting

Officer

Vallerie M. Redd

Contracting Officer

Branch II, Team 1

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Chief of the

Contracting Office

Christine Godfrey, Branch Chief, Acquisition Branch

II

Head of the

Contracting Activity

Jeffrey L. Napier

Director Of Office

Of Acquisition

Services (OAS)

15. Competition Advocate signature.

Competition

Advocate

Sherry Smallwood, Competition

Advocate

16. HHS Senior Procurement Executive signature.

HHS Senior

Procurement

Executive