Attachment_2-Sec_Req.pdf

ATTACHMENT 2- PERSONNEL SECURITY REQUIREMENTS

Personnel security requirements and risk level determinations will be established at the task order level. Additionally, the Personnel Security Requirements contained herein apply to all Task Orders.

Access to and Dissemination of Non-Public Information All persons authorized by FDA to work under this Contract, and all employees of the Contractor or any subcontractor who are directly involved in the inspection program under this Contract or who have access to any non-public information gathered under or related to this Contract, must sign a Commitment to Protect Non-Public Information Agreement (FDA Form 3398). FDA Form 3398 prohibits the release, publication, or disclosure of non-public information, except under specific circumstances.

The Contractor shall obtain signed copies of FDA Form 3398 for all Contractor and subcontractor personnel covered by this requirement, and shall provide a copy of each signed Form 3398 to FDA within 21 calendar days of award or ten (10) business days prior to commencement of any work under this Contract, whichever occurs first. Any new person assigned to this Contract shall sign the Form 3398 Agreement and shall submit it to the Contracting Officer and COR prior to commencement of work or access to non-public information under this Contract. If a person who has signed the Form 3398 Agreement resigns, is dismissed, or is otherwise no longer working on this Contract, the Contractor shall notify the COR and Contracting Officer within ten (10) business days of the departure of such person. No person working under this Contract shall be provided or possess non-public information in any form unless written approval and a facility clearance have been granted by the Contracting Officer. Disclosure of any confidential information in violation of the Form 3398 Agreement may subject that individual to civil or criminal sanctions.

The Contractor and its employees shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this contract which has not been made public, except in the course of their duties or by written authorization of the Contracting Officer. The Contractor shall include the substance of this provision in all contracts for employment and in all subcontracts hereunder.

Inspectors must be commissioned and receive FDA credentials prior to accessing any FDA training materials. Non-inspectors must have signed an FDA Form 3398 (or, in the case of subcontractors, a substantially similar non-disclosure agreement with the prime contractor) and successfully cleared the FDA background investigation prior to accessing training materials.

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

Contractor employees who will be in DHHS-owned or leased 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.

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

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 will 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 will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. However, in the event that work must commence before security badges can be issued, contractor employees will 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 order.

The position risk levels for this contract is Level 5. There are two (2) potential position risk levels, which are:

1. 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 will be required to provide additional security information for a background investigation as specified below.

2. 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 will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an e-mail 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 order will provide the name of the appropriate Personnel Security Specialist to the Contractor. A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

Commissioning and Credentials A FDA commission is a delegated authority from the Commissioner of Food and Drugs to an individual to act on his/her behalf. A health, food, or drug officer or employee of any State, Territory, or political subdivision thereof (herein referred to as "state and local officials") may be commissioned to conduct examinations and investigations on FDA’s behalf for the purposes of the Act. For example, a commissioned official may work on behalf of the FDA under contract, partnership, or for the purposes of other work-sharing agreements. It may be necessary for state or local officials to carry pocket credentials in cases where they are conducting assignments under FDA authority, such as conducting examinations, inspections, investigations or collecting samples, and copying and verifying records. In other cases, it may be necessary for them to only be commissioned with certificate to receive and review information.

All Contractor or subcontractor personnel who will be conducting inspection activities under this Contract (“inspectors”) must obtain an FDA Commission and credentials prior to conducting any inspections.

FDA commissions enable the commissioned official to conduct inspections and collect evidence and samples under an FDA contract, operate under the authority of the Federal Food, Drug and Cosmetic Act, and obtain access to certain FDA information normally considered confidential and not releasable to the public. Commissions are granted pursuant to Section 702(a) of the Federal Food, Drug, and Cosmetic Act and other applicable Federal laws, regulations, and policies. Only certain officers or employees of a State, Territory, or political subdivision thereof can be commissioned as an officer of the Food and Drug Administration.

Guidance on the requirements and procedures for commissioning and obtaining FDA credentials can be found in Chapter 3 of FDA’s Regulatory Procedures Manual, available at http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176712.htm

FDA has an established procedure to commission contractor and subcontractor employees to perform certain functions pursuant to the FD&C Act. The commissioning process begins with a background investigation, including a fingerprint check, credit check, and childcare check facilitated by FDA. Several parties within the U.S. Department of Health and Human Services (HHS) may be involved in the process, with oversight provided by FDA’s Center for Tobacco Products (CTP). Any of these parties may contact the Contractor for additional information to facilitate the process. Upon clearance of the fingerprint check, a person may be commissioned while the background investigation continues.

Within 21 calendar days of contract award, the Contractor shall provide all required information for employees and subcontractor personnel to be commissioned and receive background investigations. The Contractor shall provide FDA with each such person’s name, work address, work phone number or cell phone number, and email address. The Contractor shall notify FDA if any of the employee information above changes. Throughout the term of the Contract, the http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176712.htm

Contractor shall immediately notify FDA and provide all required information when it identifies additional Contractor or subcontractor personnel it wishes to have commissioned.

Receiving a commission signifies that the employee has accepted a position of public trust and must comply with all applicable Federal laws and ethical standards. Each FDA commission is issued for a period of five years. Contractor and subcontractor employees are responsible for immediately notifying the key personnel of any event or occurrence that could affect or change their status. The status of a background investigation may be continuously monitored by the Contractor and by FDA.

The issuance of a commission is discretionary, and FDA may revoke a commission at any time.

Reasons for revocation may include, but are not limited to:

• The abuse or misuse of the commission;

• The transmittal of confidential information from a commissioned officer to individuals who are not employees or commissioned officers of HHS;

• A conflict of interest;

• Change in criminal or credit history;

• Substance abuse; or

• Behavior that may discredit FDA.

Upon separation of a commissioned employee of the Contractor or a subcontractor, the Contractor shall immediately notify the COR and shall ensure all commissioning credentials and certificates and all Government-furnished equipment provided to that individual are returned to FDA within ten (10) business days.

Background Investigations All Contractor and subcontractor personnel under this Contract who do not conduct inspections, including but not limited key personnel and administrative personnel, will be subject to a background investigation.

The Contractor shall submit contact information for the person(s) or entity most familiar with their organization’s background investigation procedure (if any) as well as that of any subcontractor(s). FDA will discuss the Contractor’s or subcontractor’s background clearance requirements with the respective security contact to assess whether the entity’s existing background investigation is equivalent to the FDA’s requirement which is a Federal Level 5 Minimum Background Investigation (MBI), Public Trust Background Investigation.

Additionally, FDA will evaluate the clearances currently held by each individual required to have a background check under the Contract. If FDA determines that any additional element or information is needed to complete the required clearances, FDA will facilitate this process.

The Government shall conduct an additional background investigation for those individuals named to risk Levels 5 and 6 work under this contract. Required background investigations may include:

• Review of prior Government/military personnel records

• Review of FBI records and fingerprint files

• Searches of credit bureaus

• Personal interviews

• Written inquiries covering the subject's background

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

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

The Contractor shall submit a cover letter, the information required for eQIP access, and other requisite forms for the risk level(s) specified.

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 will be forwarded for scheduling background investigations. Personnel Security Staff will resolve with the order employee 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 order, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA COR and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will 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 will 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.

Badging Process All Contractor or subcontractor employees using FDA-furnished equipment (handheld devices or laptop computers) must obtain a FDA Security Access Card (“PIV Badge”, or “Badge”).Where task orders require Contractor access to FDA systems using FDA provided laptops or access to FDA Document Control Centers and Mailrooms, all contractor personnel utilizing those systems shall complete and sign the equip85, eArrive, and HHS 745 forms in order to be badged and gain systems access. The Contractor shall ensure the completion of these forms. Badging may take 21-31 business days and the Contractor shall reflect that in the timeline for a task order.

The COR will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain an FDA Security Access Card, a Contractor or subcontractor 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 will be submitted in one of two ways, depending on where the Contract will be performed:

1. Contractor and subcontractor employees located in the Washington D.C. metropolitan area will contact FDA’s Personnel Security Branch—in accordance with FDA guidance— to schedule an in-person fingerprinting appointment at FDA offices in Silver Spring, MD. FDA will provide more details and applicable contact information upon issuance of each task order. For purposes of this section, “Washington D.C. metropolitan area” generally refers to the area within a 50 mile radius of the FDA campus at 10903 New Hampshire Ave, Silver Spring, MD 20993.

2. Contractor and subcontractor employees located outside the Washington, D.C.

metropolitan area will submit fingerprints to:

Food and Drug Administration Fingerprinting and Personnel Security Office 10903 New Hampshire Avenue, Building 1, Room 1201 Silver Spring, MD 20993

For each Contractor and subcontractor employee located outside the Washington, D.C.

metro area, FDA will provide a security packet to the Contractor, and the Contractor is responsible for distributing the packet to the applicable employee. Fingerprinting must be completed in accordance with the instructions in the packet—which includes the requirement that it be conducted at particular types of facilities (including any police station)—and then shipped to FDA.

Upon the receipt of a "favorable" fingerprint return, the Contractor will be notified to respond to the badging office for their building pass, and each Contractor and subcontractor 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.

Personnel Security Charts The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure. For clarification purposes and to facilitate the flow of all required security forms, the matrix below is provided.

CHART A-NON-SENSITIVE POSITIONS - LEVEL 1

FORM NAME OBTAIN FROM WHEN

REQUIRED

SUBMIT TO DATE

REQUIRED

FDA Form 3391 - FDA Security Card Access Request

COR.

Sponsorship must be provided by COR.

All positions on

DHHS

property or leased space

Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement form

Contracting Officer All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release

Contractor generated All positions, including intermittent, per diem or temporary

*Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4592

Ten (10) calendar days prior to commencement of work

SF 85 - Questionnaire for Non- Sensitive Positions

Online via OPM’s e- QIP system

Non-Sensitive Positions - Level 1 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days upon request of the Contracting Officer

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

Call (301) 827-9527

Contracting Officer

Non-Sensitive Positions - Level 1 Clearance

*Food and Drug Administration Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4607

Ten (10) calendar days prior to commencement of work

CHART B- Public Trust Positions - Levels 5 or 6

FORM NAME OBTAIN

FROM

WHEN REQUIRED SUBMIT TO DATE

REQUIRED

SF 85P -

Questionnaire for Public Trust Positions

Online via OPM’s e- QIP system

Public Trust Positions - Level 5 or 6 Clearance

*Submit to OPM online via the e-QIP system

Ten (10) calendar days prior to commencement of work

FD 258 - Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only.

Call (301) 827-9527

Contracting Officer

Public Trust Positions - Level 5 or 6 Clearance

*Food and Drug Administration Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4607

Ten (10) calendar days prior to commencement of work

FDA Form 3391 - FDA Security Card Access Request

COR.

Sponsorship must be provided by

COR.

All positions on

DHHS

property or leased space

Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement form

Contracting Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release

Contractor generated

All positions, including intermittent, per diem or temporary

*Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

Ten (10) calendar days prior to commencement of work