Attachment_H.docx

16-223-SOL-00101 Page 2 of 7 Attachment H

FDA Personnel Security Clearance Requirements

1. BACKGROUND

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who shall be working in a DHHS-owned or leased space and/or who shall have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type.

Contractor employees who shall be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL

The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government shall conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office shall be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees shall be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract.

The position risk levels for this contract are Level 5 .

There are two (2) potential position risk levels, which are:

a. Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge shall be required to provide additional security information for a background investigation as specified in Paragraph 4 below.

b. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist shall use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee shall receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The COR for the contract shall provide the name of the appropriate Personnel Security Specialist to the Contractor.

A Contractor’s failure to comply with the e-QIP processing guidelines shall result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

3. BADGING PROCESS

The FDA COR shall sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints shall be submitted in one of two ways, depending on where the contract shall be performed:

a. Contractor employees who shall work in the Washington D.C. metro area shall, at the direction of the FDA COR or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or

b. Contractor employees who shall work in a field office shall submit fingerprints to:

Food and Drug Administration

Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf

An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff.

4. BACKGROUND INVESTIGATIONS

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract.

Required background investigations may include, but not be limited to:

· Review of prior Government/military personnel records;

· Review of FBI records and fingerprint files;

· Searches of credit bureaus;

· Personal interviews; and

· Written inquiries covering the subject's background.

Background investigations shall be conducted by the Office of Personnel Management (OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to:

Food and Drug Administration Badging and Credentialing Office 10903 New Hampshire Avenue, Building 32, Room 1205 Silver Spring, MD 20993

The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names.

The contractor shall advise its prospective employees that all standard forms submitted to the FDA shall be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff shall resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers.

The OPM background investigation shall take approximately 120 days. The Contracting Officer shall notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the contractor shall notify the Contracting Officer, and the Government shall make a determination whether an additional security clearance is required.

In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the COR.

5. NON-PUBLIC DATA PROTECTION

The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure.

CHARTS A & B ARE APPENDED TO THIS CLAUSE

For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided:

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE POSITIONS – LEVEL 1

FORM NAME

OBTAIN

FROM

TO

DATE REQUIRED

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

in contract file Ten (10) calendar days prior to commencement of work

temporary

* Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 301-796-4592 Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 796-4582

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 301-796-4592 Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, contractor shall be notified to respond to the badging office for their building pass.

CHART B

Public Trust Positions - Levels 5 or 6

FORM NAME

OBTAIN

FROM

TO

DATE REQUIRED

SF 85P - Questionnaire for Public Trust Positions

Online via OPM’s e-QIP system

of work

FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only.

Call (301) 827-9527

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 Ten (10) calendar days prior to commencement of work

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

in contract file Ten (10) calendar days prior to commencement of work

Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 32, Room 1205 Silver Spring, MD 20993 Ten (10) calendar days prior to commencement of work

*In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, contractor shall be notified to respond to the badging office for their building pass.