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Combine Solicitation - Scientific and Technical Consulting Services

September 4, 2014

Notice Type: Combine Solicitation

Posted Date: 03-SEP-14

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001

Subject: Scientific and Technical Consulting Services

Classification Code: R - Professional, administrative, and management support services

Solicitation Number: FDA-1138444

Contact: ZetherineGore , Contract Specialist, Phone (240) 402-7583, Fax 301-827-7106, Email

Setaside: Total Small BusinessTotal Small Business

Place of Performance (address): Food and Drug Administration10903 New Hampshire Avenue Silver Spring, MD

Place of Performance (zipcode): 20993

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12 Commercial Items acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-76. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code, 541690 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary.

The Food and Drug Administration (FDA) intends to award a purchase order for Scientific and Technical Consulting Services. This solicitation is issued as Request for Quote (RFQ) No. 1138444.


Contract Title: Scientific and Technical Consulting Services for the Office of Orphan Products Development

Background: The mission of the Office of Orphan Products (OOPD) is to facilitate development of FDA regulated orphan products that may be useful for treating rare diseases and disorders when a lack of commitment exists on the part of a commercial sector to market the products. To facilitate this mission, the OOPD designates eligible orphan products and has a grants program to stimulate clinical research of potential orphan products.

Purpose of Contract: A contractor is needed to provide scientific and technical consulting services to the OOPD for the review of grant applications and grant program activities, the preparation of grant summary statements, for a quality assurance review of the OOPD database, and for assistance, writing and preparation with outreach activities.

Location: Most work shall be conducted at the contractor's site using an FDA-provided computer. Some work, such as occasional grant application review meetings or on-site research, shall require the contractor to travel to FDA'sWhite Oak campus.


The government will provide the contractor (subject to obtaining a security approval):

a) An FDA laptop computer b) Appropriate accounts to access OOPD data c) Identification badge to enter White Oak Campus d) Office location to work when visiting OOPD offices.


The contractor shall provide the following scientific and technical consulting services:

1. Provide grants administrative services including (a) expert professional scientific evaluation and recommendation about the qualifications of orphan product grant applications; (b) preparation of grant application documents for review by the National Institutes of Health Council, (c) assist with improvements for the program such as review process, summary statements, workshops, roadshows, tools for applicants to apply, and (d) review and close out of expired grants. The level of effort is estimated to be 120 hours.

2. Prepare and review/edit seventy-five (75) summary statements, which summarize in writing the discussion among non-Federal subject matter experts who are members of a panel to review and score individual orphan grant applications. The level of effort is estimated to be 375 hours.

3. Provide a quality check on the data and other information in the OOPD database and new database being developed for OOPD. The contractor shall review, modify, and correct data and other information in the database in accordance with quality assurance criteria. The level of effort is estimated to be 120 hours.

4. Respond to and assist with outreach activities with regards to the office including but not limited to the following: publications, outside group correspondences, participate in guidance/regulation writing, preparation of presentations for the Director or others as needed, preparation for conferences and workshops the office coordinates, serve as a liaison between investigator and various elements of FDA, etc. The level of effort is estimated to be 250 hours.


The contractor must have the following qualifications:

a) Have a current medical license from a US jurisdiction and MD or DO degree from an accredited U.S. medical school.

b) Have medical genetic expertise and orphan products development expertise.

c) Have a general understanding of clinical trials and grants administration; understands the health science and statistics needed to evaluate applications for orphan grants; knowledge of FDA orphan drug regulations and grants project administration.

d) Have good scientific writing skills.

e) Have good communication skills for medical and nonmedical audiences.

f) Not have any contractual or employment relationships that could be a conflict of interest (e.g., employed by a pharmaceutical company).

g) Knowledge of clinical trials with a specialty in rare diseases and the ability to review grant applications against a set of qualifying eligibility criteria; knowledge of grants project administration; knowledgeable and experienced in conducting medical literature research to substantiate or repudiate claims about medical products, rare diseases, and clinical trials.

h) Knowledge of clinical trials and understanding of medical terminology.

i) Ability to work with databases and an understanding of disease statistics, medical terminology, and clinical trials.

j) Knowledge of rare diseases, most current evidence and science available; knowledge of FDA's policies and the potential public health impact functions of the office, and ability to correspond with all types of inquiries from multiple levels of knowledgeable sources.


The contractor shall be required to provide deliverables by the following schedules:

a) Orphan product grant application reviews within 15 calendar days. b) Orphan grants Summary Statements within 15 calendar days. c) OOPD grant closeouts and database reviews - ongoing. d) Outreach activities - ongoing.


One Year: anticipated period of performance is from September 22, 2014 through September 21, 2015


It is estimated that the level of effort will be 865 hours for one year. Proposed pricing should be the entire period of performance, and detail the number of labor hours proposed and the price per hour. Labor hours should be fully loaded.


A. BEST VALUE CRITERIA - BASIS FOR AWARD The Offeror should demonstrate the statement of work is understood and offer a logical approach to its achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Relevant Past Experience as described below. Technical, Past Performance, and Price are of equal importance. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a purchase order on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint. B. EVALUATION CRITERIA The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the Statement of Work as set forth in the RFQ. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their proposals based on the criteria listed below.

TECHNICAL EVALUATION Offerors shall provide information to substantiate experience and knowledge of each of the Contractor Responsibilities and Contractor Qualifications stated above. RELEVANT PAST PERFORMANCE FDA will evaluate the offeror's relevant past performance in the conduct of similar tasks and their relevance to this acquisition.

PRICE FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered).

7. PAYMENT SCHEDULE The contractor shall invoice no more than once a month for hours worked.

8. SAM Vendors must be registered in the System for Award Management (SAM) prior to the award of a purchase order. You may register by going to You will need your Dun & Bradstreet number and banking information.

9. QUESTIONS DEADLINE: All questions are to be submitted via email to no later than 2:00 P.M. on September 5, 201412:00 p.m. Eastern time.

10. OFFERS DUE: Proposals must be delivered no later than 12:00 p.m. Eastern time on September 10th, 2014. Offerors shall submit resume/curriculum vitae. Proposal submissions are restricted to a limit of ten (10) pages, excluding resume/curriculum vitae. Proposal must be submitted electronically via e-mail to

11. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.232-33, and FAR 52.232.40. Clauses and provisions are incorporated by reference and apply to this acquisition. No telephone calls will be accepted.


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Source: FedBizOpps

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