[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Rules and Regulations]
[Pages 62396-62472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26948]



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Part II





Department of Health and Human Services





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48 CFR Chapter 3



Health and Human Services Acquisition Regulation; Final Rule

Federal Register / Vol. 74 , No. 227 / Friday, November 27, 2009 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

48 CFR Chapter 3


Health and Human Services Acquisition Regulation

AGENCY: Department of Health and Human Services.

ACTION: Issuance of direct final rule and opportunity for comment.

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SUMMARY: The Department of Health and Human Services (HHS) is revising 
its Federal Acquisition Regulation (FAR) Supplement--the HHS 
Acquisition Regulation (HHSAR) in its entirety to reflect statutory, 
FAR, and government-wide and HHS policy changes since the last revision 
to the HHSAR in December 2006.

DATES: Comments are due on or before December 28, 2009. If HHS does not 
receive adverse comments, this direct final rule will be effective on 
January 26, 2010.

ADDRESSES: You may submit comments, identified by docket number or RIN 
number and title, by any of the following four methods:
     Access the Federal eRulemaking Portal: [http://www.regulations.gov], and follow the instructions;
     Mail them to: Cheryl Howe, Procurement Analyst, U.S. 
Department of Health and Human Services, Office of the Assistant 
Secretary for Financial Resources, Office of Grants and Acquisition 
Policy and Accountability, Division of Acquisition, Room 336-E, Hubert 
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201;
     E-mail them to cheryl.howe@hhs.gov; or
     Via facsimile to 202-690-8772.

Due to potential delays in receipt and processing of mail sent through 
the U.S. Postal Service, respondents are encouraged to submit comments 
electronically to ensure timely receipt. HHS cannot guarantee that 
comments mailed will be received before the comment closing date.
    If providing comments via e-mail, please include ``HHS Acquisition 
Regulation'' in the subject line of your e-mail message. Also, please 
include the full body of your comments in the text of the electronic 
message, as well as in an attachment, and include your name, title, 
organization, postal address, telephone number, and e-mail address in 
the text of the message.
    Instructions: All comments or submissions must include the agency 
name and docket number or Regulatory Information Number (RIN) for this 
Federal Register document. The policy is to make comments and other 
submissions available for public viewing on the Internet at http://regulations.gov. These submissions are published just as they are 
received without changes or deletions of information, including any 
personal identifiers or contact information.

FOR FURTHER INFORMATION CONTACT: Cheryl Howe, Procurement Analyst, U.S. 
Department of Health and Human Services, Office of the Assistant 
Secretary for Financial Resources, Office of Grants and Acquisition 
Policy and Accountability, Division of Acquisition, telephone (202) 
690-5552.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Department of Health and Human Services (HHS) is revising the 
entire HHSAR (48 CFR chapter 3, parts 301 through 370) to reflect 
changes since the last revision was published in the Federal Register 
in December 2006. The decision to revise the document in its entirety 
is based on the number of changes rather than their collective 
substance.
    The amendments generally fall into several categories: (1) Changes 
to make the document easier to read; (2) changes to reflect internal 
procedural matters which are administrative in nature and which will 
not have a major effect on the general public or on contractors or 
offerors supporting HHS acquisition programs; (3) changes which HHS 
previously issued on an interim basis (and posted on its publicly 
available Web site), following coordination with the HHS Operating 
Divisions' (OPDIVs) Heads of Contracting Activity; (4) changes that 
involve implementation of statutes or government-wide mandates enacted 
or issued since December 2006; (5) necessary conforming changes, such 
as addition of new or revised definitions; and (6) deletion of outdated 
material.
    The majority of the HHSAR revisions fall into the first category, 
i.e., they are editorial and include (1) using plain English, such as 
using active rather than passive voice; (2) standardizing terminology 
usage and formatting; (3) making minor adjustments to reflect current 
internal coordination procedures among departmental organizations; (4) 
citing current titles for various acquisition officials and 
organizations; and (5) providing a table that specifies the 
abbreviations and acronyms commonly used throughout the HHSAR.

II. Summary of Key Changes

    The following summarizes changes that involve implementation of 
statutes or government-wide mandates enacted or issued since December 
2006. The editorial changes are not individually summarized.

A. Federal-Wide and HHS Acquisition Certification Programs

    The HHSAR coverage in Subpart 301.6 of requirements for training 
and certification of acquisition officials, as well appointment of 
Contracting Officers, has been rewritten to reflect the HHS 
implementation of the Federal Acquisition Certification Programs for 
contracting staff (FAC-C) (based on guidance provided by the Office of 
Federal Procurement Policy (OFPP) in April, 2005); Contracting 
Officer's Technical Representatives (FAC-COTR) (based on the 
government-wide COTR certification standards established by OFPP in 
November, 2007), and Program/Project Managers (FAC-P/PM) (in response 
to the Services Acquisition Reform Act of 2003 (SARA), Public Law 108-
136, and the requirements established by OFPP in April, 2007).
    Implementation of the FAC-COTR program also has resulted in HHS 
changing the terminology it uses to describe the official who 
represents the requiring office after award. Where previously, HHS used 
only one term--Project Officer--to signify the person responsible for 
the pre-award and post-award responsibilities of the requiring office, 
the HHSAR now distinguishes between the pre-award responsibilities of 
the Project Officer and the post-award responsibilities of the COTR, 
even if the same individual performs both sets of responsibilities.
    These certification programs establish prerequisites for those who 
seek certification, as well as for others involved in the acquisition 
process. For example, HHS added a new section 301.605, Contracting 
Officer designation of Contracting Officer Technical Representative, to 
specify Contracting Officer responsibilities for designation of a COTR, 
including documenting that a proposed COTR meets certification 
requirements.
    Subpart 301 also addresses the HHS-unique simplified acquisition 
certification program (SAC-C); HHS-specific training requirements, 
including those for purchase card holders; and prerequisites and 
authorities for issuance of Contracting Officer warrants.

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B. Improvements in the Quality of Contract Data

    Consistent with the statutory requirements of the Federal Funding 
and Transparency Act of 2006 (Pub. L. 109-282) and the American 
Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) and OFPP's 
initiative to improve the quality and timeliness of the award 
information stored in the Federal Procurement Data System--Next 
Generation, HHS is making efforts to improve the quality and timeliness 
of its contract data as reported in FPDS-NG, USA.Spending.gov, and 
Recovery.gov. To accomplish this, in Subpart 304.6, HHS has established 
clear lines of responsibility and accountability for the quality and 
timeliness of contract data.

C. Internal Initiatives To Provide Common Formats and Templates

    A new HHSAR Subpart--302.71--lists the areas where HHS has 
developed standards for documentation or approaches that provide 
consistency across the HHS OPDIVs. These internal business standards 
encompass: Acquisition planning, competition reporting, the 
organization and content of contract files, and market research 
notices.

D. Homeland Security Presidential Directive-12 (HSPD-12)

    A new Subpart 304.13, Personal Identity Verification, and section 
304.1300, Policy, have been added to implement HSPD-12 in HHS. The HHS 
implementation includes applicable solicitation provisions and contract 
clauses and (1) reflects the implementing guidance established by 
Office of Management and Budget Memoranda M-05-24 and M-06-18, Federal 
Information Processing Standard (FIPS) Publication 201, and Federal 
Acquisition Regulation (FAR) 4.13; and (2) provides a consistent and 
systematic approach to ensure the security of HHS facilities and 
information systems.

E. Competition and Acquisition Planning

    Consistent with government-wide efforts to increase competition, in 
Parts 306, 307, and 308, as applicable, HHS included HHSAR coverage 
concerning (1) appropriate use of sources sought notices (Research and 
development (R&D) and non-R&D and small businesses) and requests for 
information (2) content requirements for Justifications for Other Than 
Full and Open Competition (JOFOCs) and Limited Source Justifications 
(LSJs), (3) the requirement to use a standard JOFOC and LSJ format, and 
(4) the Contracting Officer's approval authority for JOFOCs and LSJs 
for acquisitions exceeding $100,000.
    HHS also--
--Specified that each HHS OPDIV competition advocate must prepare an 
annual Competition Advocate Report; and provided a standard format for 
the report's preparation.
--Updated the requirements for preparing an Annual Acquisition Plan and 
provided a standard template for the plan's preparation.
--Established a standard format for development of an Acquisition Plan; 
and provided procedures for the plan's review, coordination, and 
approval.
--Addressed preparation and approval of a LSJ for acquisitions awarded 
under the General Services Administration multiple award schedule 
program; and provided a standard format for preparing an LSJ.
--Addressed preparation and approval of an acquisition strategy for 
major information technology capital investments and, as applicable, 
other major investments.

F. Section 508 Electronic Information Technology Accessibility 
Standards

    In a new Subpart 315.70, HHS added coverage for acquisition of 
electronic information technology (EIT) products and services to 
implement the requirements of Section 508 of the Rehabilitation Act of 
1973 [29 U.S.C. 794(d)], as amended by the Workforce Investment Act of 
1998. In that subpart and, as a result of conforming changes in other 
parts of the HHSAR, HHS established a policy preference for 
commercially available products; indicated what must be addressed in 
solicitations, contracts, and orders, and added documentation and 
contract administration requirements that relate to the Section 508 
accessibility standards and requirements.

G. Multi-Year Contracting and Awards Made During a Continuing 
Resolution

    HHS added a new Subpart 317.1 to address its policy on multi-year 
contracting and amended Subpart 332.7 to provide coverage regarding 
awards made during a continuing resolution.

H. Multi-Agency and Intra-Agency Contracts

    HHS added a new subpart 317.70 to address its expectations 
regarding the use of intra-agency and multi-agency contracts. Such 
contracting has been the subject of audit scrutiny and has been 
addressed by OFPP. As a result, to avoid possible misuse, HHS is 
stating the conditions for use of such vehicles within HHS.

I. Green Purchasing Requirements

    HHS added a new subpart 323.71 to establish its requirements for 
green purchasing.

J. Earned Value Management

    HHS added a new Subpart 334.2 to implement the FAR coverage of 
earned value management (EVM), including: Use of full and partial EVM; 
use of solicitation provisions and contract clauses addressing 
documentation offerors must provide to demonstrate compliance with EVM 
system requirements; and criteria for use of pre-award or post-award 
integrated baseline reviews.

K. Other Changes

    Under section 331.101-70, Salary Rate Limitation, HHS provided a 
revised prescription for use of, and made minor revisions to, the 
Salary Rate Limitation clause in 352.231-70.
    HHS added the following coverage in Part 339 for information 
technology-related acquisition:
--A new subpart, 339.70, to address the use of General Services 
Administration Blanket Purchase Agreements for the acquisition of 
independent risk analysis services, and
--A new subpart 339.1 that provides standards for security 
configuration, encryption, and information security.

HHS revised the coverage in Part 333 related to internal handling of 
protests to specify revised legal review, concurrence, and approval 
procedures related to protests to HHS and the Government Accountability 
Office before and after award.
    HHS added language in section 319.270-1 concerning use of the 
mentor-protege program in HHS.
    HHS added a new subpart 322.8 to provide a contract clause 
regarding contractor cooperation in equal employment opportunity 
investigations.
    HHS added a new subpart 370.6 to provide guidance, including a 
contract clause, concerning conference funding, sponsorship, and 
disclaimers.
    HHS added a new subpart 370.7 to provide a solicitation provision 
and a contract clause to be used (i) in connection with the 
implementation of HIV/AIDS programs under the President's Emergency 
Plan for AIDS Relief; or (ii) when the contractor will receive funding 
under the United States Leadership Against HIV/AIDS, Tuberculosis and 
Malaria Act of 2003.

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III. Procedural Review Requirements

A. Executive Order 12866, Regulatory Planning and Review

    It has been determined that this revision of the HHSAR is not a 
significant regulatory action. The rule does not--
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect, in a material way, the economy; a section of the 
economy; productivity; competition; jobs; the environment; public 
health or safety; or State, local, or Tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another Agency;
    (3) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
Executive Order 12866.

B. Unfunded Mandates Reform Act [2 U.S.C. 1501(7)]

    It has been certified that this revision of the HHSAR does not 
contain a Federal mandate that may result in the expenditure by State, 
local, and Tribal governments, in aggregate, or by the private sector, 
of $100 million or more in any one year.

C. Regulatory Flexibility Act (5 U.S.C. 601)

    The Regulatory Flexibility Act requires that a Federal agency 
prepare a regulatory flexibility analysis for any rule for which the 
agency is required to publish a general notice of rulemaking. This rule 
consists of a general statement of policies and procedures and amends 
HHS regulations for contracts. Each part of today's direct final rule 
is exempt from the requirement to publish a general notice of proposed 
rulemaking under the Administrative Procedure Act, 5 U.S.C. 553(a)(2). 
Therefore, the Regulatory Flexibility Act does not apply to this 
rulemaking.

D. Paperwork Reduction Act (44 U.S.C. 35)

    It has been determined that this rule does not impose any reporting 
or recordkeeping requirements under the Paperwork Reduction Act beyond 
those provided in the FAR.

E. Small Business Regulatory Enforcement Fairness Act

    As required by the Small Business Regulatory Enforcement Fairness 
Act, 5 U.S.C. 801, HHS has determined that this rule is not a major 
rule under 5 U.S.C. 801(2).

F. Executive Order 12988, Civil Justice Reform

    Each agency promulgating new regulations shall adhere to the 
following requirements: The agency's proposed regulations shall (1) be 
reviewed by the agency to eliminate drafting errors and ambiguity; (2) 
be written to minimize litigation; (3) provide a clear legal standard 
for affected conduct rather than a general standard, and (4) promote 
simplification and burden reduction. HHS determined that this rule 
meets these standards.

List of Subjects in 48 CFR Chapter 3, Parts 301-370

    Government procurement.

0
For the reasons stated in the preamble, HHS revises 48 CFR Chapter 3, 
parts 301 through 370, to read as follows:

Title 48--Federal Acquisition Regulations System

CHAPTER 3--HEALTH AND HUMAN SERVICES

SUBCHAPTER A--GENERAL

PART 301--HHS ACQUISITION REGULATION SYSTEM
PART 302--DEFINITIONS OF WORDS AND TERMS
PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTEREST
PART 304--ADMINISTRATIVE MATTERS

SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING

PART 305--PUBLICIZING CONTRACT ACTIONS
PART 306--COMPETITION REQUIREMENTS
PART 307--ACQUISITION PLANNING
PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES
PART 309--CONTRACTOR QUALIFICATIONS
PART 310--MARKET RESEARCH
PART 311--DESCRIBING AGENCY NEEDS
PART 312--ACQUISITION OF COMMERCIAL ITEMS

SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES

PART 313--SIMPLIFIED ACQUISITION PROCEDURES
PART 314--SEALED BIDDING
PART 315--CONTRACTING BY NEGOTIATION
PART 316--TYPES OF CONTRACTS
PART 317--SPECIAL CONTRACTING METHODS

SUBCHAPTER D--SOCIOECONOMIC PROGRAMS

PART 319--SMALL BUSINESS PROGRAMS
PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS
PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY 
TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE
PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS

PART 327--PATENTS, DATA, AND COPYRIGHTS
PART 328--BONDS AND INSURANCE
PART 330--COST ACCOUNTING STANDARDS
PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES
PART 332--CONTRACT FINANCING
PART 333--PROTESTS, DISPUTES, AND APPEALS

SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING

PART 334--MAJOR SYSTEM ACQUISITION
PART 335--RESEARCH AND DEVELOPMENT CONTRACTING
PART 337--SERVICE CONTRACTING--GENERAL
PART 339--ACQUISITION OF INFORMATION TECHNOLOGY

SUBCHAPTER G--CONTRACT MANAGEMENT

PART 342--CONTRACT ADMINISTRATION

SUBCHAPTER H--CLAUSES AND FORMS

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
PART 353--FORMS

SUBCHAPTERS I, J, K AND L ARE RESERVED

SUBCHAPTER M--HHS SUPPLEMENTATIONS

PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION

SUBCHAPTER A--GENERAL

PART 301--HHS ACQUISITION REGULATION SYSTEM

Subpart 301.1--Purpose, Authority, and Issuance
Sec.
301.101 Purpose.
301.103 Authority.
301.106 Office of Management and Budget Approval under the Paperwork 
Reduction Act.

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Subpart 301.2--Administration
301.270 Executive Committee for Acquisition.
Subpart 301.4--Deviations From the FAR
301.403 Individual deviations.
301.404 Class deviations.
301.470 Procedure.
Subpart 301.6--Career Development, Contracting Authority, and 
Responsibilities
301.602 Contracting Officers.
301.602-3 Ratification of unauthorized commitments.
301.603 Selection, appointment, and termination of appointment of 
Contracting Officers.
301.603-1 General.
301.603-2 Selection and appointment.
301.603-3 Interim appointments.
301.603-4 Termination of appointments.
301.603-70 Delegation of Contracting Officer responsibilities.
301.603-71 Waivers to warrant standards.
301.603-72 FAC-C and HHS SAC certification requirements.
301.603-73 Additional HHS training requirements.
301.603-74 Requirement for retention of FAC-C and HHS SAC 
certification.
301.604 Training and certification of Contracting Officers' 
Technical Representatives.
301.604-70 General.
301.604-71 HCA authorities and responsibilities.
301.604-72 Requirements for certification maintenance.
301.604-73 Certification policy exception.
301.604-74 Additional COTR training requirements.
301.605 Contracting Officer designation of Contracting Officer 
Technical Representative.
301.606 Training requirements for Project Officers.
301.606-70 General.
301.606-71 Project Officer training.
301.606-72 Delegation of authority to HCAs.
301.606-73 Training policy exception.
301.606-74 Additional Project Officer training requirements.
301.607 Certification of Program and Project Managers.
301.607-70 General.
301.607-71 FAC-P/PM levels and requirements.
301.607-72 Applicability.
301.607-73 Certification waivers.
301.607-74 Certification transfers.
301.607-75 Maintenance of FAC-P/PM certification.
301.607-76 FAC-P/PM application process.
301.607-77 Input and maintenance of FAC-P/PM information.
301.607-78 Governance.
301.607-79 Contracting Officer designation of a Program/Project 
Manager as the Contracting Officer's Technical Representative.
301.608 Training Requirements for Purchase Cardholders, Approving 
Officials, and Agency/Organization Program Coordinators.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 301.1--Purpose, Authority, and Issuance


301.101  Purpose.

    (a) The Department of Health and Human Services (HHS) Acquisition 
Regulation (HHSAR) establishes uniform HHS acquisition policies and 
procedures that conform to the Federal Acquisition Regulation (FAR) 
System.
    (b) The HHSAR implements FAR policies and procedures and provides 
additional policies and procedures that supplement the FAR.
    (c) The HHSAR contains HHS policies and procedures that govern the 
acquisition process or otherwise control acquisition relationships 
between HHS' contracting activities and contractors.


301.103  Authority.

    (b) The Assistant Secretary for Financial Resources (ASFR) 
prescribes the HHSAR under the authority of 5 U.S.C. 301 and section 
205(c) of the Federal Property and Administrative Services Act of 1949, 
as amended (40 U.S.C. 486(c), as delegated by the Secretary.
    (c) The HHSAR is issued in the Code of Federal Regulations (CFR) as 
Chapter 3 of Title 48, Department of Health and Human Services 
Acquisition Regulation. It may be referenced as ``48 CFR Chapter 3.''


301.106  Office of Management and Budget approval under the Paperwork 
Reduction Act.

    (a) The Paperwork Reduction Act of 1980 (44 U.S.C 3501 et seq.) 
imposes a requirement on Federal agencies to obtain approval from the 
Office of Management and Budget (OMB) before collecting the same 
information from 10 or more members of the public.
    (b) The following OMB control numbers apply to the information 
collection and recordkeeping requirements contained in this chapter:

------------------------------------------------------------------------
                                                             OMB control
                     HHSAR segment No.                           No.
------------------------------------------------------------------------
315.4......................................................    0990-0139
342.7101...................................................    0990-0131
352.233-70.................................................    0990-0133
352.270-1..................................................    0990-0129
352.270-2..................................................    0990-0129
352.270-3..................................................    0990-0129
352.270-5..................................................    0990-0130
352.270-8..................................................    0990-0128
352.270-9..................................................    0990-0128
370.1......................................................    0990-0129
370.2......................................................    0990-0129
------------------------------------------------------------------------

    (c) The Contracting Officer shall insert the clause in 352.201-70, 
Paperwork Reduction Act, in solicitations, contracts, and orders that 
include a requirement to collect the same information from 10 or more 
persons.

Subpart 301.2--Administration


301.270  Executive Committee for Acquisition.

    (a) The Associate Deputy Assistant Secretary for Acquisition 
(Associate DAS for Acquisition) has established the Executive Committee 
for Acquisition (ECA) to facilitate the planning, development, and 
implementation of HHS acquisition policies and procedures and to share 
successful acquisition practices.
    (b) The ECA consists of members and alternates from the following 
organizations:
    (1) ASFR/Office of Grants and Acquisition Policy and Accountability
    (OGAPA)/Division of Acquisition (DA).
    (2) Agency for Healthcare Research and Quality (AHRQ).
    (3) Biomedical Advanced Research and Development Authority (BARDA).
    (4) Centers for Disease Control and Prevention (CDC).
    (5) Centers for Medicare and Medicaid Services (CMS).
    (6) Food and Drug Administration (FDA).
    (7) Health Resources and Services Administration (HRSA).
    (8) Indian Health Service (IHS).
    (9) National Institutes of Health (NIH).
    (10) Program Support Center (PSC).
    (11) Substance Abuse and Mental Health Services Administration 
(SAMHSA).
    (c) The Associate DAS for Acquisition is the Chair of the ECA. The 
Chair will call all meetings and direct all ECA activities.

Subpart 301.4--Deviations From the FAR


301.403  Individual deviations.

    Contracting activities shall prepare requests for individual 
deviations to either the FAR or HHSAR in accordance with 301.470.


301.404  Class deviations.

    Contracting activities shall prepare requests for class deviations 
to either the FAR or HHSAR in accordance with 301.470.


301.470  Procedure.

    (a) Contracting activities shall prepare deviation requests in 
memorandum form and forward them through the Head of the Contracting 
Activity (HCA) to the Associate DAS for Acquisition. The Associate DAS 
for Acquisition (non-delegable) is the official authorized to approve 
all deviation requests.

[[Page 62400]]

Contracting activities may request a deviation telephonically or by e-
mail in an exigent situation, but shall confirm the request by 
memorandum as soon as possible.
    (b) A deviation request shall clearly set forth the--
    (1) Nature of the deviation, including what contract(s)/
contractor(s) is involved;
    (2) Identification of the FAR or HHSAR citation from which the 
deviation is needed;
    (3) Circumstances under which the deviation will be used;
    (4) Intended effect of the deviation;
    (5) Period of applicability;
    (6) Rationale for the deviation (Note: The Contracting Officer 
shall include a copy of pertinent background papers, such as a 
contractor's request, as part of the deviation request.); and
    (7) Suggested wording for the deviation, if applicable.

Subpart 301.6--Career Development, Contracting Authority, and 
Responsibilities


301.602  Contracting Officers.


301.602-3  Ratification of unauthorized commitments.

    (b) Policy.
    (1) The Government is not bound by agreements with, or contractual 
commitments made to, prospective contractors by individuals who do not 
have delegated contracting authority. However, an authorized official 
may later ratify and execute otherwise proper contracts that were made 
by individuals without contracting authority or by Contracting Officers 
in excess of their delegated authority. The ratification shall be in 
the form of a written document that clearly states that ratification of 
a previously unauthorized act is intended.
    (2) The HCA is the official authorized to ratify an unauthorized 
commitment--but see paragraph (b)(3) of this section.
    (3) The HCA may redelegate ratification authority for actions up to 
$100,000 to the Chief of the Contracting Office (CCO). No other 
redelegations are authorized.
    (c) Limitations.
    (5) The concurrence of legal counsel concerning an unauthorized 
commitment is optional. If a contracting activity determines that a 
legal review is necessary, the HCA or CCO shall coordinate the request 
for ratification with the Office of General Counsel (OGC), General Law 
Division (GLD).
    (e) Procedures.
    (1) The individual who is responsible for the unauthorized 
commitment shall provide the reviewing Contracting Officer all records 
and documents concerning the commitment and a complete written 
statement of facts, including a description of the requirement; the 
estimated or agreed upon price; the funds citation; an explanation of 
why the contracting office was not used and why the proposed contractor 
was selected; a list of other sources considered; and a statement as to 
whether the contractor has commenced work or an item has been 
delivered.
    (2) The Contracting Officer shall review the submitted material 
and, if the Contracting Officer determines that the ratification 
request has merit, prepare it for ratification. The Contracting Officer 
shall forward the ratification document and related materials to the 
HCA or CCO, as appropriate, with any comments or information which the 
approving official should consider in evaluating the ratification 
request.
    (3) If the HCA or CCO approves the ratification request, the 
Contracting Officer shall issue a purchase order or contract, as 
appropriate, upon return of the approved ratification document and 
file.


301.603  Selection, appointment, and termination of appointment of 
Contracting Officers.


301.603-1  General.

    (a) The HCA (non-delegable) shall select, appoint, and terminate 
the appointment of Contracting Officers--i.e., those individuals who 
are authorized to obligate the Government to the expenditure of funds 
for contracts and orders with dollar values that exceed (or are 
expected to exceed) the micro-purchase threshold. The procedures for 
selecting and appointing Contracting Officers apply to HHS employees. 
HCAs may not issue HHS Contracting Officer warrants to contractor 
personnel. OPDIVs shall follow local procedures in the event that the 
signature of another authorized official, in addition to that of the 
HCA, is required to appoint or terminate the appointment of Contracting 
Officers.
    (b) The HCA shall use Standard Form (SF) 1402, ``Certificate of 
Appointment,'' (also known as a warrant) to appoint personnel, whether 
in the General Schedule (GS) 1102 series or other series, as 
Contracting Officers. The SF 1402 shall indicate the Contracting 
Officer's warrant level--i.e., maximum dollar signature authority 
(e.g., $1 million or ``unlimited'') and any other limitations or 
restrictions. The HCA shall make changes to a Contracting Officer 
appointment (other than a termination of an appointment as provided in 
301.603-4) by issuing a revised SF 1402. FAR 1.603-1 prescribes the 
requirements for preparing and maintaining Contracting Officer 
warrants.
    (c) Before an HCA may appoint an individual as a Contracting 
Officer, the individual must be certified in accordance with either the 
Federal Acquisition Certification in Contracting (FAC-C) program or the 
HHS Simplified Acquisition Certification (SAC) program, as appropriate, 
at the level required for the warrant authority requested. See 301.603-
72 and the HHS Contracting Workforce Training and Certification 
Handbook.
    (d) The dollar amount of an individual transaction determines 
whether a Contracting Officer has the authority to sign it in 
accordance with the delegated authority specified on the SF 1402. For 
new or follow-on awards, the dollar amount of an individual transaction 
is the amount obligated at the time of contract or order award plus any 
potential option amounts or future funding amounts established by the 
transaction. However, under an existing contract or order, when an 
option is subsequently exercised or a contact or order is otherwise 
modified to add funding, the dollar amount of the modification 
(individual transaction) determines whether a Contracting Officer has 
the necessary delegated authority to sign it.
    (e) For individuals that will exercise acquisition authorities 
(other than solely purchase card authorities) at or below the micro-
purchase threshold, the HCA may--
    (1) Use a document other than the SF 1402, such as a memorandum, 
that indicates a maximum dollar signature authority for individual 
transactions; and
    (2) Determine training requirements for individuals who will 
exercise acquisition authorities at dollar levels below the micro-
purchase threshold level.


301.603-2  Selection and appointment.

    Contracting activities shall provide nominations for appointment of 
Contracting Officers through appropriate acquisition channels to the 
HCA for review. The HCA shall appoint an individual as a Contracting 
Officer only when a valid organizational need is demonstrated and after 
considering such factors as volume of actions, complexity of work, and 
structure of the requesting organization. The HCA shall also ensure 
that a Contracting Officer candidate meets the FAC-C or HHS SAC 
certification requirements, as

[[Page 62401]]

appropriate. Consistent with FAR 1.603-2, the HCA shall determine the 
documentation required when the requested appointment and authority 
will not exceed the micro-purchase threshold.


301.603-3  Interim appointments.

    If it is essential to appoint an individual as a Contracting 
Officer who does not yet fully meet the FAC-C or HHS SAC certification 
requirements for the signature authority sought, the HCA (non-
delegable) may make an interim appointment for up to 2 years. If an 
extension of time has been granted, but the individual does not 
complete the certification requirements by the extended date, the HCA's 
approval for the interim appointment will automatically terminate on 
that date.


301.603-4  Termination of appointments.

    The HCA shall terminate or revoke Contracting Officer appointments 
in accordance with FAR 1.603-4.


301.603-70  Delegation of Contracting Officer responsibilities.

    (a) Contracting Officers may re-delegate their acquisition 
responsibilities that do not involve the obligation or deobligation of 
funds, but involve the expenditure of previously obligated funds (such 
as approval of contractor scientific meeting travel and subcontract 
consent) to acquisition staff (for example, those in the GS-1100 
series) by means of a written memorandum that clearly delineates the 
delegation and its limits. See 301.604 for responsibilities that 
Contracting Officers may delegate to technical personnel.
    (b) Contracting Officers may designate individuals as ordering or 
approving officials to make purchases or place/approve orders under 
blanket purchase agreements (BPAs), indefinite-delivery, indefinite 
quantity (IDIQ) contracts, or other pre-established mechanisms. 
Ordering officials are not Contracting Officers.


301.603-71  Waivers to warrant standards.

    There may be an unusual circumstance that requires issuance of a 
warrant to an individual who does not fully meet the FAC-C or HHS SAC 
certification program requirements. Contracting activities shall 
provide any request for a waiver of the FAC-C program requirements and 
policies in writing to the Senior Procurement Executive (SPE), through 
the HCA, for review and approval. The SPE (non-delegable) will either 
approve or disapprove in writing the request for waiver. The HCA (non-
delegable) may approve or disapprove a waiver of the HHS SAC program 
requirements.


301.603-72  FAC-C and HHS SAC certification requirements.

    (a) The FAC-C certification program is available to all acquisition 
staff who are/will be involved as Contracting Officers or Contract 
Specialists in acquisitions exceeding the simplified acquisition 
threshold. Personnel who, as part of prior certification programs, have 
completed some or all of the required training or have attained 
certification thereunder are not required to re-take training courses, 
but shall follow FAC-C training requirements when considering 
additional or required core training, if needed. See 301.603-74 for 
information regarding retention of certification, including the 
requirement to earn continuous learning points (CLPs). FAC-C 
certification also does not apply to--
    (1) The SPE;
    (2) Senior level officials responsible for delegating acquisition 
authority;
    (3) Personnel who are not in the GS-1102 series whose warrants are 
used to acquire emergency goods and services; or
    (4) Personnel who are not in the GS-1102 series whose warrants are 
so limited as to be outside the scope of this program, as determined by 
the Chief Acquisition Officer (CAO). (Note: The HHS CAO has determined 
that individuals with warrants which are limited to simplified 
acquisitions are deemed to be outside the scope of the FAC-C program.)
    (b) HHS does not require personnel with Contracting Officer 
warrants issued prior to January 1, 2007 to be FAC-C certified unless 
they are seeking a change in authority on or after that date. 
Individuals applying for a new Contracting Officer warrant or an 
increase in warrant authority on or after January 1, 2007, regardless 
of GS series, must be FAC-C certified at the level appropriate for the 
warrant authority sought. To obtain an unlimited warrant, FAC-C Level 
III certification is required. (Note: New Contracting Officer warrants 
are defined in the Office of Federal Procurement Policy's (OFPP's) FAC-
C memorandum, dated January 20, 2006, as warrants issued to employees 
for the first time at a department or agency.)
    (c) The FAC-C certification is based on three sets of requirements: 
Education, training, and experience, and the requirements are 
cumulative--i.e., an individual must meet the requirements of each 
previous certification level before attaining a higher level 
certification. The FAC-C certification requirements, including 
additional HHS-specific training requirements for certain types of 
acquisitions, are specified in the HHS Contracting Workforce Training 
and Certification Handbook.
    (d) HHS SAC certification is based on three sets of requirements: 
Training, experience, and satisfactory performance rating. Personnel 
who are involved in the award of simplified acquisitions must meet the 
appropriate HHS SAC certification requirements. (Note: While personnel 
who are FAC-C certified are not required to obtain HHS SAC 
certification in order to award simplified acquisitions, they should 
obtain appropriate training before doing so.) The HHS SAC certification 
requirements, including additional HHS-specific training requirements 
for certain types of acquisitions, are specified in the HHS Contracting 
Workforce Training and Certification Handbook.


301.603-73  Additional HHS training requirements.

    HHS acquisition personnel are required to complete, as applicable, 
the additional training requirements specified below. These courses may 
be used as electives for the purpose of satisfying FAC-C requirements 
or as continuous learning for maintenance of FAC-C or SAC 
certifications.
    (a) Earned value management training. Effective January 1, 2010, 
all personnel in the GS-1102 series who are responsible for, or may 
become responsible for, the award or administration of any contract to 
which earned value management (EVM) is applied pursuant to 334.201(a) 
or (b) must successfully complete an EVM training course before they 
commence administration of the contract or are authorized to award the 
contract. After completion of the initial course, a refresher course is 
required every 2 years. This course is in addition to the training 
requirements for FAC-C certification at the specified levels. 
Determination of course suitability shall be made by the Operating 
Division (OPDIV) HCA, in conjunction with HHS' Office of the Chief 
Information Officer (OCIO) or Office of Facilities Management and 
Policy (OFMP), as appropriate. To be eligible, the basic and refresher 
courses must each be 8 hours or more in length.
    (b) Performance based acquisition training. Effective January 1, 
2010, all GS-1102s, who award or administer service contracts, are 
required to complete a Performance-Based Acquisition (PBA) course prior 
to assuming such responsibilities. Refresher training in PBA is 
required

[[Page 62402]]

every 4 years. To be eligible, a course must be 8 hours or more in 
length. Determination of course suitability shall be made by the HCA.
    (c) Federal appropriations law training. Effective January 1, 2010, 
all GS-1102s and GS-1105s are required to complete both HHS 
University's classroom-based and on-line Federal appropriations law 
course, by January 1, 2011 (for current employees) and within 1 year of 
entering on duty (for new employees). Employees are required to take 
the HHS University on-line course as refresher training every year. 
Determination of course equivalency shall be made by the HCA.
    (d) Green purchasing training. Effective January 1, 2010, all GS-
1102s and GS-1105s are required to complete green purchasing training 
by January 1, 2011 (for current employees) and within 1 year of 
entering on duty (for new employees). Refresher training is required 
every 2 years. To be eligible, a course must be 4 hours or more in 
length. Determination of course suitability shall be made by the HCA.
    (e) Section 508 training. Effective January 1, 2010 (or when the 
HHS Office on Disability so requires), all GS-1102s, GS-1105s, and GS-
1106s who award or administer acquisitions that exceed the micro-
purchase threshold and involve electronic information technology (EIT) 
products or services (subject to Section 508 of the Rehabilitation Act 
of 1973 and pertinent HHSAR provisions), must complete all applicable 
training courses sponsored by the HHS Office on Disability. For 
information on frequency, timing, and duration of the training 
requirement, personnel shall consult with the HHS Office on Disability.
    (f) Training policy exceptions.
    (1) EVM training. In the event that there is an urgent requirement 
for a Contracting Officer/Contract Specialist to award or administer a 
project to which EVM will be applied, and the individual has not yet 
met the EVM training requirement, the HCA (non-delegable) may authorize 
the individual to perform the position duties, provided that the 
individual meets the training requirement within 9 months from the date 
of assignment to the contract. If the individual does not complete the 
training requirement within 9 months, the HCA's approval for the 
individual's assignment to the contract will automatically terminate on 
that date. The Contract Specialist is not required to take the class as 
long as the Contract Specialist is working under the direction of a 
Contracting Officer who has taken an EVM course.
    (2) Other additional HHS training. The HCA (non-delegable) may 
grant a time extension of up to 9 months to an individual to complete 
the PBA, Federal appropriations law, green purchasing, and Section 508 
training requirements, including completion of refresher training. If 
the individual does not complete the training requirement within the 
extension period, the HCA's approval will automatically terminate on 
that date.


301.603-74  Requirement for retention of FAC-C and HHS SAC 
certification.

    To maintain FAC-C certification, all warranted Contracting 
Officers, regardless of series, as well as Contract Specialists, must 
earn 80 CLPs every 2 years. To maintain HHS SAC certification, all 
individuals with delegated Contracting Officer authority, including 
those in the GS-1102, GS-1105, GS-1106, and non-1100 series, must earn 
a minimum of 40 hours (CLPs) every 2 years after completing all 
mandatory training requirements. FAC-C and HHS SAC certification will 
expire if the CLPs are not earned every 2 years (from the date of 
initial certification or re-certification) and, if applicable, may 
result in a loss of warrant authority. (Note: The certification 
programs' continuous learning requirement applies to all applicable 
personnel, including those who were certified under prior certification 
programs.)


301.604  Training and certification of Contracting Officers' Technical 
Representatives.


301.604-70  General.

    In accordance with the Federal Acquisition Certification for 
Contracting Officers' Technical Representatives (FAC-COTR) program, HHS 
has established a training program for certification and designation of 
personnel as COTRs--see HHS' Federal Acquisition Certification for 
Contracting Officers' Technical Representative Program Handbook, dated 
January 2009, for information on the methods for earning FAC-COTR 
certification. See also 302.101(c) for further information regarding 
the definition of a COTR and when designation of a COTR is appropriate. 
All references to COTRs also apply to their alternates.


301.604-71  HCA authorities and responsibilities.

    (a) HCAs are authorized to determine (1) equivalencies for the 
Basic Contracting Officer's Technical Representative Course; (2) course 
prerequisites; and (3) approve completion of CLP continuous learning 
activities, education, and training for maintenance of COTR 
certification. This authority does not apply to EVM training--see 
301.603-73. Course equivalencies must meet the Federal Acquisition 
Institute's (FAI's) required COTR competencies. HCAs may re-delegate 
the authorities in (1) and (2) to OPDIV Acquisition Career Managers 
(ACMs) or other comparable officials.
    (b) In addition to the authorities specified in 301.604-71(a), HCAs 
or their designees (except where the authority is shown as non-
delegable) are responsible for--
    (1) Reviewing a candidate's qualifications to be a COTR;
    (2) Granting, suspending, denying, and revoking COTR certifications 
and their continuance;
    (3) Authorizing (non-delegable) an individual to perform COTR 
duties on an interim basis for up to 90 days--see 301.604-73; and
    (4) Determining (non-delegable) on a case-by-case basis whether to 
postpone (for up to 90 days) withdrawal of any interim COTR delegation 
for failure of a candidate to qualify for certification--see 301.604-
73.


301.604-72  Requirements for certification maintenance.

    Maintaining HHS FAC-COTR certification requires at least 40 
relevant CLPs every 2 years. See Appendix A of OFPP's FAC-COTR 
memorandum, dated November 26, 2007, and HHS' Federal Acquisition 
Certification for Contracting Officers' Technical Representative 
Program Handbook, dated January 2009, for information on CLPs.


301.604-73  Certification policy exception.

    (a) In the event that an individual who is not currently certified 
under HHS' FAC-COTR program is urgently required to serve as a COTR, 
the head of the sponsoring program office (Program Manager) or designee 
(e.g., the immediate supervisor) may request, and the HCA (non-
delegable) may authorize, the individual to perform the designated 
duties on an interim basis for up to 6 months, provided that--
    (1) The individual agrees to become certified during that period 
and provides evidence of training course registration; and
    (2) Prior to assignment to the contract, the individual meets with 
the cognizant Contracting Officer to discuss the role and specific 
responsibilities of a COTR and the interrelationships, as applicable, 
among the Project Officer, Contracting Officer, Program/Project 
Manager, and COTR functions.
    (b) If an extension has been granted, but the individual does not 
complete

[[Page 62403]]

the training by the extended date, the HCA's approval for the 
individual's assignment to the contract will automatically terminate on 
that date.


301.604-74  Additional COTR training requirements.

    HHS COTRs are required to complete, as applicable, the training 
requirements specified below.
    (a) Earned value management training. Effective January 1, 2010, 
all COTRs assigned to any contract to which EVM is applied pursuant to 
334.201(a) or (b) must successfully complete an EVM training course 
before assuming their COTR duties. In conjunction with ASFR/OGAPA/DA, 
HHS' OCIO [for information technology (IT)] and OFMP (for construction/
facilities), are authorized to designate appropriate EVM courses. At 
least 8 hours of EVM training is required every 2 years.
    (b) Performance-based acquisition training. Effective January 1, 
2010, all COTRs assigned to a service contract are required to 
successfully complete a PBA course. To be eligible, a course must be 8 
hours or more in length. Determination of course suitability shall be 
made by the HCA or designee. At least 8 hours of refresher training in 
PBA is required every 4 years.
    (c) Federal appropriations law training. Effective January 1, 2010, 
all COTRs are required to successfully complete HHS University's 
classroom-based or on-line Federal appropriations law course within 3 
years after an initial certification is issued. COTRs are required to 
take the HHS University on-line appropriations law course as refresher 
training every 4 years.
    (d) Green purchasing training. Effective January 1, 2010, all COTRs 
are required to complete green purchasing training within the first 
certification period. The individual's immediate supervisor shall make 
the determination of course suitability. At least 4 hours of refresher 
training is required every 4 years.
    (e) Training policy exceptions.
    (1) EVM training. In the event that there is an urgent requirement 
for a COTR to administer a contract to which EVM will be applied, and 
the individual has not yet met the EVM training requirement, the HCA 
(non-delegable) may authorize the individual to perform the position 
duties, provided that the individual meets the training requirement 
within 9 months from the date of assignment to the contract. If the 
individual does not complete the training requirement within 9 months, 
the HCA's approval for the individual's assignment to the contract will 
automatically terminate on that date. In addition, during any extension 
period, the COTR must work under the direction of a COTR, or Program/
Project Manager who has taken an EVM course.
    (2) Other additional HHS training. The HCA (non-delegable) may 
grant a time extension of up to 9 months to a COTR to complete the PBA, 
Federal appropriations law, and green purchasing training requirements, 
including completion of refresher training. If the individual does not 
complete the training requirement within the extension period, the 
HCA's approval will automatically terminate on that date.


301.605  Contracting Officer designation of Contracting Officer 
Technical Representative.

    The Contracting Officer shall ensure that a COTR candidate is 
currently certified under HHS' FAC-COTR program before delegating 
authority to that individual to act as a COTR. Even if an individual is 
FAC-COTR-certified, a candidate becomes a COTR only when a Contracting 
Officer provides in writing the authorities the individual may exercise 
for a specified contract or order. Authority for such designations 
rests solely with the Contracting Officer. The Contracting Officer 
shall retain in the contract or order file the individual's active FAC-
COTR certificate. In the event that the HCA has granted an exception--
see 301.604-73, the Contracting Officer shall include the HCA's 
approval in the file.


301.606  Training requirements for Project Officers.


301.606-70  General.

    HHS has established a program for training personnel for 
certification and designation as Project Officers. See 302.101(g) for 
further information regarding the definition of a Project Officer and 
when designation of a Project Officer is appropriate. All references to 
Project Officers also apply to their alternates. Program Managers or 
their designees are authorized to designate individuals to serve as 
Project Officers. (Note: If an individual will also serve as the COTR 
for a proposed project, the individual shall comply with the training 
certification requirements for COTRs--see 301.604.)


301.606-71  Project Officer training.

    Before an individual may perform the duties of a Project Officer, 
including development of an Acquisition Plan (AP) or other acquisition 
request documentation--see 307.71, for a proposed project, the Program 
Manager or designee shall designate an individual as a Project Officer 
in writing by means of a memorandum to the Project Officer candidate 
with a copy to the cognizant Contracting Officer. A Project Officer 
must successfully complete HHS University's Basic Contracting Officer's 
Technical Representative Course or equivalent and any OPDIV-specific 
course prerequisites. The Project Officer must provide a course 
completion certificate to the Contracting Officer with any AP or other 
acquisition request documentation submitted. See HHS guidance on the 
training requirement for technical proposal evaluators in 
315.305(a)(3)(ii).


301.606-72  Delegation of authority to HCAs.

    HCAs are authorized to determine equivalencies for the Basic 
Contracting Officer's Technical Representative Course and any OPDIV-
specific course prerequisites. This authority may be re-delegated to 
OPDIV acquisition ACMs or other comparable officials.


301.606-73  Training policy exception.

    (a) In the event that an individual who has not successfully 
completed the required training course is urgently required to serve as 
a Project Officer, the Program Manager or designee may authorize the 
individual to perform the designated duties on an interim basis for up 
to 6 months, provided that--
    (1) The individual agrees to take the Basic Contracting Officer's 
Technical Representative course during that period and provides 
evidence of course registration; and
    (2) The individual meets, prior to assignment to the project, with 
the cognizant Contracting Officer to discuss the specific role and 
responsibilities of a Project Officer and the interrelationships, as 
applicable, among the Project Officer, Contracting Officer, Program/
Project Manager, and COTR functions.
    (b) If an extension of time has been granted, but the individual 
fails to complete the training by the extended date, the Program 
Manager's or designee's approval for the individual's assignment to the 
project will automatically terminate on that date.


301.606-74  Additional Project Officer training requirements.

    HHS Project Officers are required to complete, as applicable, the 
training requirements specified below.
    (a) Earned value management training. All Project Officers assigned 
to any contract project to which EVM is applied pursuant to 334.201(a) 
or (b) must successfully complete an EVM

[[Page 62404]]

training course before assuming their Project Officer duties. In 
conjunction with ASFR/OGAPA/DA, HHS' OCIO (for IT) and OFMP (for 
construction/facilities) are authorized to designate appropriate EVM 
courses.
    (b) Performance-based acquisition training. Effective January 1, 
2010, all Project Officers assigned to a service contract are required 
to successfully complete a PBA course. To be eligible, a course must be 
8 hours or more in length. Determination of course suitability shall be 
made by the HCA or designee. At least 8 hours of refresher training in 
PBA is required every 4 years.
    (c) Federal appropriations law training. Effective January 1, 2010, 
all Project Officers are required to successfully complete HHS 
University's classroom-based or on-line Federal appropriations law 
course. Project Officers are required to take the HHS University on-
line appropriations law course as refresher training every 4 years.
    (d) Green purchasing training. Effective January 1, 2010, all 
Project Officers are required to complete green purchasing training. 
The individual's immediate supervisor shall make the determination of 
course suitability. At least 4 hours of refresher training is required 
every 4 years.
    (e) Training policy exceptions.
    (1) EVM training. In the event that there is an urgent requirement 
to assign a Project Officer to a contract project to which EVM will be 
applied, and the individual has not yet met the EVM training 
requirement, the HCA (non-delegable) may authorize the individual to 
perform the position duties, provided that the individual meets the 
training requirement within 3 months from the date of submission of the 
AP or other acquisition request documentation to the contracting 
office. If the individual does not complete the training requirement 
within the extension period, the HCA's approval for the individual's 
assignment to the project will automatically terminate on that date. In 
addition, during any extension period, the Project Officer must work 
under the direction of a Project Officer, COTR, or Program/Project 
Manager who has taken an EVM course.
    (2) Other additional HHS training. The HCA (non-delegable) may 
grant a time extension of up to 9 months to a Project Officer to 
complete the PBA, Federal appropriations law, and green purchasing 
training requirements, including completion of refresher training. If 
the individual does not complete the training requirement within the 
extension period, the HCA's approval will automatically terminate on 
that date.


301.607   Certification of Program and Project Managers.


301.607-70   General.

    In accordance with the Federal Acquisition Certification--Program 
and Project Managers (FAC-P/PM) program, HHS has established a 
certification program for Program or Project Managers. See HHS' Federal 
Acquisition Certification--Program and Project Managers Handbook (P/PM 
Handbook) for information on the methods for earning FAC-P/PM 
certification.


301.607-71   FAC-P/PM levels and requirements.

    (a)(1) The FAC-P/PM certification program specifies three different 
levels of certification, depending on the core competency, training, 
and experience required to manage different types of acquisitions--
    (i) Entry/Apprentice--Level I;
    (ii) Mid-level/Journeyman--Level II; and
    (iii) Senior/Expert--Level III.
    (2) Each FAC-P/PM certification level is independent of the 
others--i.e., applicants for the Senior/Expert level need not have been 
certified at the Mid-level/Journeyman or Entry/Apprentice levels. 
General and specific core competencies, training, and required 
experience vary by certification level. (Note: Individuals certified 
under the FAC-P/PM program meet the general competency and experience 
standards for P/PM certification. However, IT Program and Project 
Managers should attain/demonstrate IT-specific P/PM requirements. See 
Appendix C, Federal Acquisition Certification--Program and Project 
Managers--Information Technology Technical Competencies, in the P/PM 
Handbook for additional information.
    (b)(1) Competencies. An applicant can satisfy the competency 
requirements through:
    (i) Successful completion of training;
    (ii) Completion of comparable education or certification programs;
    (iii) Demonstration of knowledge, skills, and abilities; or
    (iv) Any combination of these three.
    (2) The FAI describes the following three sets of general core 
competencies on its Web site:
    (3) General Business Competencies: Includes decision-making, 
interpersonal skills, oral communication, team-building, and writing.
    (4) Technical Competencies: Includes contracting, financial 
management, quality assurance, and risk management.
    (5) Essential Competencies and Proficiencies: Includes management 
processes, systems engineering, test and evaluation, contracting, and 
business.
    (6) Specific core competencies also apply to the three 
certification levels. See Chapter 2, Federal Acquisition 
Certification--Program and Project Managers--Requirements and 
Performance Accountability, in the P/PM Handbook for additional 
information.
    (c) Training. (1) Suggested training includes coursework, varying 
from 16-24 hours in duration, in:
    (i) Acquisition;
    (ii) Project management;
    (iii) leadership and interpersonal skills;
    (iv) Government-specific training; and
    (v) Earned value management and cost estimating.
    (2) The depth of the training for each course required may vary by 
certification level.
    (d) Experience. Experience requirements vary by certification 
level. For example, for certification at the Entry/Apprentice--Level I, 
at least 1 year of project management experience within the last 5 
years is required. The Mid-level/Journeyman--Level II requires at least 
2 years of program or project management experience within the last 5 
years. The Senior/Expert--Level III requires at least 4 years of 
program and project management experience on Federal projects within 
the last 5 years.
    (e) Additional OPDIV guidance. OPDIVs may issue supplemental 
guidance and requirements for selection and assignment of Program and 
Project Managers and require additional skills and competencies to meet 
organizational or mission needs. However, OPDIVs may not reduce the 
requirements specified in the P/PM Handbook.


301.607-72   Applicability.

    (a) The FAC-P/PM certification prerequisites and continuous 
learning requirements apply to all HHS employees who seek to obtain a 
FAC-P/PM certification. Although obtaining a FAC-P/PM certification 
qualifies employees to serve as a Program or Project Manager, it does 
not ensure their selection or designation as such. (Note: Contractors 
and their employees are not eligible to be certified or to serve as 
Program or Project Managers.)
    (b) Mandatory certification is limited to major and non-major IT 
and construction capital investment acquisitions. Consistent with OFPP 
guidance, HHS requires FAC-P/PM Level III certification for Program and

[[Page 62405]]

Project Managers responsible for major IT and construction capital 
investments--i.e., those requiring preparation of an OMB Exhibit 300, 
HHS Form 300, or equivalent. An individual must obtain FAC-P/PM Level 
III certification within 1 year from the date of being assigned to such 
a major capital investment. Also, HHS requires that an individual 
obtain FAC-P/PM Level II or I certification for non-major IT and 
construction--i.e., tactical or supporting, capital investments, 
respectively, within 2 years from the date of being assigned to such a 
non-major capital investment. See Appendix A, Federal Acquisition 
Certification--Program and Project Managers--HHS Projects and Programs 
with Associated Certification Levels, in the P/PM Handbook for 
additional information regarding major and non-major IT and 
construction capital investments. FAC-P/PM certification for other 
types of investments [e.g., advanced research and development (R & D)] 
is encouraged, but is not mandatory.


301.607-73   Certification waivers.

    (a) Waivers to certification requirements may be approved in 
certain situations. Waivers for additional time to complete 
certification requirements are not necessary for the first year 
following an assignment to a major IT or construction capital 
investment and for 2 years following an assignment to a non-major 
capital investment. For waivers beyond those periods (for up to 1 
additional year), the HHS Chief Information Officer (CIO) (for IT 
programs and projects) and the Deputy Assistant Secretary for 
Facilities Management and Policy (DASFMP) (for construction programs 
and projects) are delegated authority to approve waiver requests. The 
HHS CAO is the only individual authorized to approve waiver requests 
for additional time beyond the initial 1-year waiver period.
    (b) Approval of a waiver request does not relieve an individual 
from meeting the certification requirements. Also, unlike FAC-P/PM 
certifications, waivers issued by other Federal departments and 
agencies do not transfer to HHS, since a waiver is agency-specific.


301.607-74   Certification transfers.

    (a) HHS recognizes and accepts FAC-P/PM certifications issued by 
other Federal departments and agencies. In addition, HHS complies with 
FAI determinations as to which certifications by organizations outside 
the Federal government are eligible for full or partial consideration 
under FAC-P/PM. See FAI's Web site, and Chapter 3, Federal Acquisition 
Certification--Program and Project Managers--Application and 
Certification Procedures, in the P/PM Handbook for additional 
information.
    (b) A certification transfer should not be initiated when an 
individual, who holds a current FAC-P/PM certification from another 
Federal department or agency, becomes an HHS employee. Instead, the 
individual must apply for recertification (which will result in 
issuance of an HHS certification) at the time the candidate's immediate 
supervisor performs the bi-annual assessment to determine whether the 
individual has met the HHS FAC-P/PM CLP requirements.


301.607-75   Maintenance of FAC-P/PM certification.

    (a) FAC-P/PM certification lasts for 2 years. To maintain FAC-P/PM 
certification, HHS Program and Project Managers are required to earn 80 
CLPs of skills currency every 2 years, starting from the date of their 
initial certification or recertification, and document completion of 
all training. If the required CLPs are not earned within each 2-year 
period, a FAC-P/PM certification will lapse. Lapsed certifications may 
be reinstated when 80 CLPs have been accumulated.
    (b) Continuous learning activities related to FAC-P/PM include, but 
are not limited to--
    (1) Training activities, such as teaching, self-directed study, and 
mentoring;
    (2) Courses completed to achieve certification at the next higher 
level;
    (3) Professional activities, such as attending/speaking/presenting 
at professional seminars/symposia/conferences, publishing papers, and 
attending workshops;
    (4) Educational activities, such as formal training and formal 
academic programs; and
    (5) Experience, such as developmental or rotational assignments.
    See Appendix F, Federal Acquisition Certification--Program and 
Project Managers--Guidance on Meeting Requirements for Continuous 
Learning Points, in the P/PM Handbook for additional information.


301.607-76  FAC-P/PM application process.

    The P/PM Handbook contains application procedures and forms to be 
completed for basic certification; certification transfer; 
certification through fulfillment; recertification; and certification 
waiver. Applicants for HHS FAC-P/PM certification actions shall comply 
with the requirements and procedures specified in the P/PM Handbook and 
refer any questions to their OPDIV ACM for resolution.


301.607-77   Input and maintenance of FAC-P/PM information.

    FAI's Acquisition Career Management Information System (ACMIS) is 
HHS' system of record for the FAC-P/PM program. Program and Project 
Manager candidates and certified Program and Project Managers are 
responsible for entering, maintaining, and updating their FAC-P/PM 
training and CLP data in ACMIS. OPDIV ACMs shall periodically review 
ACMIS records for quality assurance purposes.


301.607-78   Governance.

    The Departmental ACM, in ASFR/OGAPA/DA, serves as the Departmental 
FAC-P/PM Program Manager and is responsible for administering the 
program. To support the overall management of the FAC-P/PM 
certification program at the OPDIV level, Executive Officers and their 
HCAs may either use their existing ACM or designate an additional ACM, 
whose professional background includes program and project management. 
See Appendix B, Federal Acquisition Certification--Program and Project 
Managers--Roles and Responsibilities, in the P/PM Handbook for 
additional information.


301.607-79   Contracting Officer designation of a Program/Project 
Manager as the Contracting Officer's Technical Representative.

    Personnel who are FAC-P/PM certified, at any level, meet the 
requirements for FAC-COTR certification and are, therefore, not 
required to obtain FAC-COTR certification to serve as a COTR for an HHS 
acquisition. However, for those individuals serving as a Program or 
Project Manager under a FAC-P/PM certification waiver--see 301.607-73, 
the Contracting Officer shall ensure that the individual meets the 
requirements of HHS' FAC-COTR program before delegating authority to 
that individual to act as a COTR. See 301.605 for additional 
information regarding the Contracting Officer's designation of a COTR.


301.608  Training Requirements for Purchase Cardholders, Approving 
Officials, and Agency/Organization Program Coordinators.

    Training requirements for purchase cardholders, Approving 
Officials, and Agency/Organization Program Coordinators are listed in 
the following table:

[[Page 62406]]



         HHS Purchase Card Training Program, by Authority Level
------------------------------------------------------------------------
                                                      Required training
        Authority \a\          Program participant           \b\
------------------------------------------------------------------------
Up to $3,000................  Prospective/newly     Basic purchase card
                               appointed purchase    training (HHS
                               cardholders and       University course
                               Approving Officials.  or an OPDIV
                                                     equivalent course).
                              Purchase card         Yearly refresher
                               holders and           purchase card
                               Approving Officials.  training.
$3,001 to $25,000...........  Prospective/newly      Basic
                               appointed purchase    purchase card
                               cardholders and       training (HHS
                               Approving Officials.  University course
                                                     or an equivalent).
                                                     Basic
                                                     simplified
                                                     acquisition
                                                     procedures (e.g.,
                                                     DAU's CON 237).
                                                     Advanced
                                                     simplified
                                                     acquisition
                                                     procedures or
                                                     Appropriations law.
                              Purchase card         Yearly refresher
                               holders and           purchase card
                               Approving Officials.  training.
$25,001 to $100,000.........  Prospective/newly      Basic
                               appointed purchase    purchase card
                               cardholders and       training (HHS
                               Approving Officials.  University course
                                                     or an OPDIV
                                                     equivalent course).
                                                     Basic
                                                     simplified
                                                     acquisition
                                                     procedures (e.g.,
                                                     DAU's CON 237).
                                                     Advanced
                                                     simplified
                                                     acquisition
                                                     procedures or
                                                     Appropriations law.
                                                     CON 100
                                                     (Shaping Smart
                                                     Business
                                                     Arrangements).
                                                     CON 110
                                                     (Mission Support
                                                     Planning).
                              Purchase cardholders  Yearly refresher
                               and Approving         purchase card
                               Officials.            training.
Not applicable..............  Prospective/newly      Basic
                               appointed Agency/     purchase card
                               Organization          training (HHS
                               Program               University course
                               Coordinators.         or an OPDIV
                                                     equivalent course).
                                                     Basic
                                                     simplified
                                                     acquisition
                                                     procedures or DAU's
                                                     CON 237.
                                                     Advanced
                                                     simplified
                                                     acquisition
                                                     procedures or
                                                     appropriations law.
                                                     CON 100
                                                     (Shaping Smart
                                                     Business
                                                     Arrangements).
                                                     CON 110
                                                     (Mission Support
                                                     Planning).
                              Agency/Organization   Yearly refresher
                               Program               purchase card
                               Coordinators.         training
                                                     (attendance at
                                                     GSA's annual
                                                     training conference
                                                     satisfies refresher
                                                     training).
------------------------------------------------------------------------
\a\ Cardholders and Approving Officials with authorized increases in
  delegation of procurement authority (DPA) have up to 3 months to
  complete the training requirements for the new DPA.
\b\ CON 237, CON 100, and CON 110 are available at the DAU Web site at
  http://www.dau.mil/registrar/enroll.asp. CON 100 is also offered
  through HHS University (see Web site at: http://learning.hhs.gov).

PART 302--DEFINITIONS OF WORDS AND TERMS

Subpart 302.1--Definitions
Sec.
302.101 Definitions.
Subpart 302.2--Definitions Clause
302.201 Contract clause.
Subpart 302.70--Common HHSAR Acronyms and Abbreviations
302.7000 Common HHSAR acronyms and abbreviations.
Subpart 302.71--HHS Standard Templates and Formats
302.7100 HHS standard templates and formats.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 302.1--Definitions


302.101   Definitions.

    (a) Agency head or head of the Agency, unless otherwise stated, 
means the head of the OPDIV for: AHRQ; CDC; CMS; FDA; HRSA; IHS; NIH; 
SAMHSA; and ASFR for the Office of the Secretary (OS), including PSC. 
The Assistant Secretary for Preparedness and Response (ASPR) is the 
head of the agency for BARDA contracting functions.
    (b) Chief of the Contracting Office is typically a mid-level 
management official, usually an office director, division director, or 
branch chief, who manages and monitors the daily contract operations of 
an OPDIV or major component of an OPDIV. The CCO is subordinate to the 
HCA, except where the same individual is the HCA and CCO.
    (c) Contracting Officer's Technical Representative is a Federal 
employee whom a Contracting Officer has designated in writing to act as 
the Contracting Officer's representative in monitoring and 
administering specified aspects of contractor performance after award 
of a contract or order that exceeds the simplified acquisition 
threshold. (Note: In accordance with local procedures, OPDIVs may 
designate COTRs for contracts or orders estimated to be less than the 
simplified acquisition threshold.) These activities may include 
verifying that:
    (1) The contractor's performance meets the standards set forth in 
the contract;
    (2) The contractor meets the contract/order's technical 
requirements by the specified delivery date(s) or within the period of 
performance; and
    (3) The contractor performs within the fixed price or cost ceiling 
stated in the contract or order. COTRs must meet the training and 
certification requirements specified in 301.604.
    (d) Head of the contracting activity is an official who has overall 
responsibility for managing a contracting activity--i.e., the 
organization within an OPDIV or other HHS organization which has been 
delegated broad authority regarding the conduct of acquisition 
functions.
    (1) The HHS HCAs are as follows:

AHRQ: Director, Division of Contracts Management
BARDA: Director, Acquisition Management System
CDC: Director, Procurement and Grants Office
CMS: Director, Office of Acquisition and Grants Management
FDA: Director, Office of Acquisitions and Grant Services
HRSA: Director, Office of Acquisition Management and Policy
IHS: Director, Division of Acquisition Policy
NIH: Director, Office of Acquisition and Logistics Management
PSC: Director, Strategic Acquisition Service
SAMHSA: Director, Division of Contracts Management


[[Page 62407]]


    (2) Each HCA shall conduct an effective and efficient acquisition 
program; establish adequate controls to ensure compliance with 
applicable laws, regulations, procedures, and the dictates of good 
management practices; and conduct periodic reviews to evaluate and 
determine the extent of adherence to prescribed policies and 
regulations and the need for guidance and training.
    (3) HCAs may redelegate their authorities to the extent that 
redelegation is not prohibited by the terms of their respective 
delegations of authority, by law, by the FAR, by the HHSAR, or by other 
regulations. To ensure proper control of redelegated acquisition 
authorities, HCAs shall maintain a file containing successive 
delegations of HCA authority through the Contracting Officer level.
    (e) Program Manager is a Federal employee whom an OPDIV official or 
designee one level above the head of the sponsoring program office has 
designated in writing to act as a Program Manager for a group of 
related major or non-major IT or construction capital investments--see 
HHS FAC-P/PM Program Handbook. See also Appendix D, Relationship 
between Program Management and Project Management, of OFFP memorandum 
entitled ``The Federal Acquisition Certification for Program and 
Project Managers,'' dated April 25, 2007. Program Managers must meet 
the FAC-P/PM certification requirements in 301.607. A Program Manager 
may also be delegated authority to act as the COTR for a major or non-
major IT or construction capital investment--see 301.604.
    (f) Project Manager is a Federal employee whom a head of the 
sponsoring program office (Program Manager) or designee has designated 
in writing to act as a Project Manager for a major or non-major IT or 
construction capital investment--see HHS FAC-P/PM Program Handbook. See 
also Appendix D, Relationship between Program Management and Project 
Management, of OFFP memorandum entitled ``The Federal Acquisition 
Certification for Program and Project Managers,'' dated April 25, 2007. 
Project Managers must meet the FAC-P/PM certification requirements in 
301.607. A Project Manager may also be delegated authority to act as 
the COTR for a major or non-major IT or construction capital 
investment--see 301.604.
    (g) Project Officer is a Federal employee whom a head of the 
sponsoring program office (Program Manager) or designee has designated 
in writing to act as a Project Officer and provide guidance, 
information, and assistance to the Contracting Officer for all 
technical aspects of a proposed project before award of a contract or 
order that is estimated to exceed the simplified acquisition threshold. 
(Note: In accordance with local procedures, OPDIVs may designate 
Project Officers for contracts or orders estimated to be less than the 
simplified acquisition threshold.) Project Officers must meet the 
training requirements in 301.606. Project Officers are often delegated 
authority to also act as the COTR on a contract or order--see 301.604.

Subpart 302.2--Definitions Clause


302.201   Contract clause.

    The Contracting Officer shall insert the clause in FAR 52.202-1, 
Definitions, in solicitations and contracts, except as cited below. 
This is an authorized FAR deviation.
    (a) In accordance with FAR 52.202-1(a)(1), the Contracting Officer 
shall insert paragraph (a) in 352.202-1 in place of paragraph (a) of 
the FAR clause.
    (b) In accordance with FAR 52.202-1(a)(1), the Contracting Officer 
shall insert paragraph (b), or its alternate in 352.202-1, to the end 
of the FAR clause. The Contracting Officer shall insert paragraph (b) 
when a fixed-priced contract is contemplated and the alternate to 
paragraph (b) when a cost-reimbursement contract is contemplated.

Subpart 302.70--Common HHSAR Acronyms and Abbreviations


302.7000   Common HHSAR acronyms and abbreviations.

    (a) The HHSAR cites numerous acquisition-related and organizational 
acronyms and abbreviations. Each of these is established where first 
cited in the text, following the use of the unabbreviated term, and are 
used in subsequent subparts of that part or any other part of the 
HHSAR.
    (b) The table below cites, for reference purposes, the most 
commonly used acronyms and abbreviations--i.e., those that have 
applicability to multiple parts of the HHSAR, and where they are first 
cited. They are listed alphabetically. The HHSAR also contains other 
acronyms and abbreviations, which because they are cited only in one 
HHSAR part, subpart, section, or in reference to a particular topic, 
are not listed in the table. An example is DCIS (Departmental Contracts 
Information System) cited in subpart 304.602.

----------------------------------------------------------------------------------------------------------------
          Acronym/abbreviation                          Term                   Where first cited in the HHSAR
----------------------------------------------------------------------------------------------------------------
A & E...................................  Architect and engineer            304.803-70(b).
                                           (contracts).
AHRQ....................................  Agency for Healthcare Research    301.270(b).
                                           and Quality.
AP......................................  Acquisition Plan................  301.606-71.
ASFR....................................  Assistant Secretary for           301.103(b).
                                           Financial Resources (in OS).
Associate DAS for Acquisition...........  Associate Deputy Assistant        301.270(a).
                                           Secretary for Acquisition (in
                                           OS/ASFR/OGAPA/DA).
BARDA...................................  Biomedical Advanced Research and  301.270(b).
                                           Development Authority.
BPA or BPAs.............................  Blanket Purchase Agreement(s)...  301.603-70(b).
CA......................................  Competition Advocate............  306.202(a).
CAO.....................................  Chief Acquisition Officer (for    301.603-72(a)(4).
                                           HHS).
CCO.....................................  Chief of the Contracting Office.  301.602-3(b)(3).
CDC.....................................  Centers for Disease Control and   301.270(b).
                                           Prevention.
CFR.....................................  Code of Federal Regulations.....  301.103(c).
CIO.....................................  Chief Information Officer (for    301.607-73(a).
                                           HHS).
CMS.....................................  Centers for Medicare and          301.270(b).
                                           Medicaid Services.
COTR....................................  Contracting Officer's Technical   301.604-70.
                                           Representative.
D&F.....................................  Determination and Findings......  306.202(b)(1).
DA......................................  Division of Acquisition (in       301.270(b).
                                           ASFR) in OS.
DASFMP..................................  Deputy Assistant Secretary for    301.607-73(a).
                                           Facilities Management and
                                           Policy.
DAS/GAPA................................  Deputy Assistant Secretary for    309.403.
                                           Grants and Acquisition Policy
                                           and Accountability.
EIT.....................................  Electronic information            301.603-73(e).
                                           technology.
EVM.....................................  Earned value management.........  301.603-73(a).

[[Page 62408]]

 
FAR.....................................  Federal Acquisition Regulation..  301.101(a).
FDA.....................................  Food and Drug Administration....  301.270(b).
FedBizOpps..............................  Federal Business Opportunities..  305.205(a).
FSS.....................................  Federal Supply Schedule.........  304.803-70(b).
GLD.....................................  General Law Division (typically   301.602-3(c)(5).
                                           referred to with ``OGC'').
GSA.....................................  General Services Administration.  304.803-70(b).
GWAC....................................  Government-wide acquisition       304.803-70(b).
                                           contract.
HCA.....................................  Head of the Contracting Activity  301.470(a).
HHS.....................................  (Department of) Health and Human  301.101(a).
                                           Services.
HHSAR...................................  Health and Human Services         301.101(a).
                                           Acquisition Regulation.
HRSA....................................  Health Resources and Services     301.270(b).
                                           Administration.
HUBZone.................................  Historically Underutilized        305.205(a)(2).
                                           Business Zone.
IDIQ....................................  indefinite-delivery, indefinite-  301.603-70(b).
                                           quantity (contract type).
IHS.....................................  Indian Health Service...........  301.270(b).
IT......................................  information technology..........  301.604-74(a).
JOFOC...................................  Justification for Other than      306.303-1(b)(1).
                                           Full and Open Competition.
NIH.....................................  National Institutes of Health...  301.270(b).
OCIO....................................  Office of the Chief Information   301.603-73(a).
                                           Officer (for HHS).
OFMP....................................  Office of Facilities Management   301.603-73(a).
                                           and Policy (for HHS).
OGAPA...................................  Office of Grants and Acquisition  301.270(b).
                                           Policy and Accountability.
OGC.....................................  Office of the General Counsel...  301.602-3(c)(5).
OIG.....................................  Office of the Inspector General.  303.104-7(a)(2)(i).
OMB.....................................  Office of Management and Budget.  301.106.
OPDIV...................................  Operating Division..............  301.603-73(a).
OS......................................  Office of the Secretary.........  302.101(a).
OSDBU...................................  Office of Small and               307.104(a)(4).
                                           Disadvantaged Business
                                           Utilization (in OS).
Pub. L..................................  Public Law......................  304.604.
PWS.....................................  performance work statement        304.1300(c).
                                           (typically cited with SOW).
PSC.....................................  Program Support Center (in OS)..  301.270(b).
R&D.....................................  research and development........  301.607-72(b).
RFI.....................................  Request for Information.........  305.205(a).
SAMHSA..................................  Substance Abuse and Mental        301.270(b).
                                           Health Services Administration.
SBS.....................................  Small Business Specialist (in     307.104(a)(4).
                                           OSDBU).
SF......................................  Standard Form...................  301.603-1(b).
SOW.....................................  statement of work [inclusive of   304.1300(c).
                                           specification(s)] and typically
                                           cited with PWS.
SPE.....................................  Senior Procurement Executive--    301.603-71.
                                           i.e., Associate DAS for
                                           Acquisition.
STAFFDIV................................  Staff Division (in OS)..........  311.7001(b).
----------------------------------------------------------------------------------------------------------------

Subpart 302.71--HHS Standard Templates and Formats


302.7100  HHS standard templates and formats.

    HHS has developed standard templates and formats for preparation of 
various acquisition documents, reports, and plans. The templates and 
formats, which contain instructions for their completion, may be 
accessed on the ASFR/OGAPA/DA Internet Web site. A complete listing of 
the standard templates and formats and where they are referenced in the 
text are cited in the table below:

------------------------------------------------------------------------
       Title of template/format                  HHSAR reference
------------------------------------------------------------------------
Acquisition Plan......................  307.7103.
Acquisition Plan Waiver Request.......  307.7101(b)(2).
Acquisition Strategy..................  307.104-70.
Annual Acquisition Plan...............  307.104(a)(5).
Competition Advocate Report...........  306.502(b).
Contract File Checklists..............  304.803-70.
FedBizOpps R & D Sources Sought Notice  305.205(a)(3).
FedBizOpps Request for Information....  315.201(e)(4).
FedBizOpps Small Business Sources       319.202-2(a)(3).
 Sought Notice.
FedBizOpps Sources Sought Notice......  310.001(a)(3)(iv).
Justification for Other than Full and   306.303-1(b)(1).
 Open Competition.
Limited Source Justification..........  308.405-6(g)(1)(i).
Request for Information...............  315.201(e)(4).
------------------------------------------------------------------------

PART 303--IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF 
INTEREST

Subpart 303.1--Safeguards
Sec.
303.101 Standards of conduct.
303.101-3 Agency regulations.
303.1047-7 Violations or possible violations of the Procurement 
Integrity Act.
303.1003 Requirements.
Subpart 303.2--Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause.

[[Page 62409]]

Subpart 303.3--Reports of Suspected Antitrust Violations
303.303 Reporting suspected antitrust violations.
Subpart 303.4--Contingent Fees
303.405 Misrepresentations or violations of the Covenant Against 
Contingent Fees clause.
Subpart 303.6--Contracts With Government Employees or Organizations 
Owned or Controlled by Them
303.602 Exceptions.
Subpart 303.7--Voiding and Rescinding Contracts
303.704 Policy.
Subpart 303.8--Limitation on the Payment of Funds to Influence Federal 
Transactions
303.808-70 Solicitation provision and contract clause.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 303.1--Safeguards


303.101  Standards of conduct.


303.101-3  Agency regulations.

    (a)(3) The HHS Standards of Conduct are prescribed in 45 CFR part 
73.


303.104-7  Violations or possible violations of the Procurement 
Integrity Act.

    (a)(1) The Contracting Officer shall submit to the HCA for review 
and approval the determination (along with supporting documentation) 
that a reported violation or possible violation of the statutory 
prohibitions has no impact on the pending award or selection of a 
contractor for award.
    (2) The Contracting Officer shall refer the determination that a 
reported violation or possible violation of the statutory prohibitions 
has an impact on the pending award or selection of a contractor, along 
with all related information available, to the HCA, if the HCA is in 
the Senior Executive Service (SES), or to another SES official 
designated by the OPDIV. That individual shall--
    (i) Refer the matter immediately to the Associate DAS for 
Acquisition for review, who may consult with OGC-GLD and the Office of 
the Inspector General (OIG), as appropriate; and
    (ii) Determine the necessary action in accordance with FAR 3.104-
7(c) and (d). The HCA shall obtain the approval or concurrence of the 
Associate DAS for Acquisition before proceeding with an action.
    (b) The HCA (non-delegable) shall act with respect to actions taken 
under the FAR clause 52.203-10, Price or Fee Adjustment for Illegal or 
Improper Authority.


303.1003  Requirements.

    (b) The Contracting Officer, when notified of a possible contractor 
violation of Federal criminal law, in accordance with FAR 3.1003(b), 
shall--
    (1) Notify the OIG at http://www.oig.hhs.gov/fraud/hotline, 1-800-
HHS-TIPS (1-800-447-8477), or HHSTips@oig.hhs.gov;
    (2) Notify the HCA; and
    (3) Cooperate with any investigation by the OIG; and in 
coordination with the HCA, OIG, OGC and the affected program office, 
pursue appropriate remedies.
    (c)(2) The Contracting Officer shall specify the title of HHS' 
hotline poster (``Report Fraud'') and the Web site where the poster can 
be obtained (http://oig.hhs.gov/fraud/hotline/OIG_Hotline_Poster.pdf) 
in subparagraph (b)(3) of the clause at FAR 52.203-14.

Subpart 303.2--Contractor Gratuities to Government Personnel


303.203  Reporting suspected violations of the Gratuities clause.

    HHS personnel shall report suspected violations of the Gratuities 
clause to the Contracting Officer, who will in turn report the matter 
to the OGC Ethics Division for disposition. The OGC Ethics Division 
shall identify, and notify the Contracting Officer of, the form and 
content of the required report.

Subpart 303.3--Reports of Suspected Antitrust Violations


303.303  Reporting suspected antitrust violations.

    (h) The HCA shall provide a copy of the draft OPDIV report of 
suspected antitrust violations to the SPE. If the SPE concurs with the 
draft report, the SPE will provide it to the OGC-GLD for its review. If 
the OGD-GLD concurs with the draft report, the SPE will provide the 
signed OGC-approved report to the Attorney General.

Subpart 303.4--Contingent Fees


303.405  Misrepresentations or violations of the Covenant Against 
Contingent Fees clause.

    (a) HHS personnel shall promptly report suspected 
misrepresentations or violations of the Covenant Against Contingent 
Fees clause to the Contracting Officer.
    (b)(4) The HCA shall provide a copy of the draft OPDIV report of 
suspected covenant against contingency fees misrepresentations or 
violations to the SPE. If the SPE concurs with the draft report, the 
SPE will provide it to the OGC-GLD for its review. If the OGD-GLD 
concurs with the draft report, the SPE will provide the signed OGC-
approved report to the Attorney General.

Subpart 303.6--Contracts With Government Employees or Organizations 
Owned or Controlled by Them


303.602  Exceptions.

    The HCA (non-delegable) is the official authorized to approve an 
exception to the policy stated in FAR 3.601.

Subpart 303.7--Voiding and Rescinding Contracts


303.704  Policy.

    (a) For purposes of implementing FAR subpart 3.7, the HCA (non-
delegable) shall exercise the authorities granted to the ``agency head 
or designee.''

Subpart 303.8--Limitation on the Payment of Funds to Influence 
Federal Transactions


303.808-70  Solicitation provision and contract clause.

    The Contracting Officer shall insert the clause in 352.203-70, 
Anti-lobbying, in solicitations and contracts that exceed the 
simplified acquisition threshold.

PART 304--ADMINISTRATIVE MATTERS

Subpart 304.6--Contracting Reporting
Subpart 304.8--Government Contract Files
Sec.
304.602 General.
304.604 Responsibilities.
304.803-70 Contract/order file organization and use of checklists.
304.804-70 Contract closeout audits.
Subpart 304.13--Personal Identity Verification
304.1300 Policy.
Subpart 304.70--Acquisition Instrument Identification Numbering System
304.7000 Scope of subpart.
304.7001 Numbering acquisitions.
Subpart 304.71--Review and Approval of Proposed Contract Awards
304.7100 Policy.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 304.6--Contract Reporting


304.602  General.

    HHS' Departmental Contracts Information System (DCIS) captures and 
stores HHS' Individual Contract Award Reports (ICARs) and forwards 
copies of them to the Federal Procurement Data System--Next Generation 
(FPDS-NG).

[[Page 62410]]

All HHS contracting activities shall use the DCIS, in accordance with 
the most current version of the ``User Manual for the Enhanced 
Departmental Contracts Information System,'' (DCIS Users' Manual) 
available at http://dcis.hhs.gov. For the purposes of this policy, 
reporting shall include inputting and submitting report data through 
DCIS into FPDS-NG.


304.604  Responsibilities.

    In order for HHS to meet its reporting requirements and ensure 
compliance with the Federal Funding Accountability and Transparency Act 
(Transparency Act), Public Law (Pub. L.) 109-282, HHS acquisition 
officials and staff must report their contract information accurately 
and timely. Ensuring accuracy and timeliness also requires effective 
and efficient data verification and validation at the time of and 
following reporting.
    Following are descriptions of the organizational roles and 
responsibilities associated with contract reporting, including data 
input, oversight, and quality control; training of acquisition staff on 
reporting responsibilities; and operating, managing, and maintaining 
DCIS.
    (a) ASFR/OGAPA/DA. The ASFR/OGAPA/DA shall do the following:
    (1) Oversee and provide policy guidance for OPDIV contract 
reporting by--
    (i) Establishing and implementing an effective HHS-wide ICAR data 
verification and validation program; and
    (ii) Identifying cross-cutting trends through periodic testing of 
selected ICAR data, including Transparency Act data fields.
    (2) Ensure that DCIS is properly managed and maintained, 
including--
    (i) Verifying that data included therein meets FPDS-NG and 
Transparency Act accuracy and timeliness standards;
    (ii) Updating the DCIS Users' Manual periodically; and
    (iii) Prescribing standard HHS-wide DCIS training.
    (3) Certify annually that HHS ICAR information is complete and 
accurate.
    (b) HCA. Each HCA (non-delegable) shall--
    (1) Ensure that all reportable ICAR information is collected, 
submitted, and received within the time frames and under the 
circumstances specified in FAR Subpart 4.6.

    Note: Each CCO shall prepare and submit accurate ICAR data in 
accordance with HCA guidance.;

    (2) Provide continuing oversight, including implementing an OPDIV-
level data verification and validation program, to ensure ICAR data 
quality and timeliness;
    (3) Establish a continuous training program for acquisition staff 
to ensure the quality and timeliness of ICAR data; and
    (4) Certify annually to HHS' SPE that OPDIV ICAR information is 
complete and accurate.
    (c) Contracting Officer. As part of a normal file review, required 
under 304.7101, the Contracting Officer shall--
    (1) Ensure that all reportable contracts and orders, including BPA 
orders and modifications thereto, are reported;
    (2) Review and approve proposed ICAR data for completeness and 
accuracy prior to signing contracts/orders and modifications; and
    (3) Correct all DCIS data discrepancies before signing the 
associated contract, order, or modification.
    (d) OPDIV DCIS coordinator/focal point. The OPDIV DCIS coordinator/
focal point shall--
    (1) Identify data errors and ensure their timely correction as part 
of the DCIS quality control process;
    (2) Conduct remedial staff training, as appropriate, to improve 
data accuracy and timeliness; and
    (3) Represent the OPDIV as a member of the DCIS Configuration 
Committee.
    (e) DCIS Configuration Committee. The DCIS Configuration Committee 
is composed of the HHS DCIS manager, other ASFR/OGAPA/DA acquisition 
management staff, as required; and each OPDIV's DCIS coordinator/focal 
point. The Committee shall ensure that the DCIS is properly maintained 
and shall evaluate and recommend changes to DCIS to improve its 
functionality, features, and quality control, as appropriate.

Subpart 304.8--Government Contract Files


304.803-70  Contract/order file organization and use of checklists.

    (a) To provide a consistent approach to the organization and 
content of HHS contract and order files, OPDIVs shall use the folder 
filing system and accompanying file checklists specified in 304.803-
70(b), in accordance with the guidance therein and the instructions 
specified as ``Contract and Order File Folders, Checklists, and 
Instructions. The checklists are available on the ASFR/OGAPA/DA 
Internet.
    (b) The checklist requirements apply to files for (i) negotiated, 
sealed-bid, and Architect-Engineer (A & E) acquisitions; (ii) orders 
awarded and BPAs established under General Services Administration 
(GSA) Federal Supply Schedule (FSS) contracts; (iii) orders placed 
under all types of indefinite-delivery contracts, including task orders 
under Government-wide Acquisition Contracts (GWACs); and (iv) 
modifications under the types of acquisitions specified in (i), (ii), 
and (iii). Simplified acquisitions, including those for commercial 
items, are exempt from these checklist requirements. However, HHS 
contracting activities shall adhere to the simplified acquisition file 
documentation and retention requirements of FAR 13.106-3(b). For 
commercial item acquisitions using the negotiated or sealed bid 
methods, HHS contracting activities shall use the applicable checklist.
    (1) A complete contract or order file may consist of the following 
folders that are titled as indicated below for the specified 
acquisition methods:

----------------------------------------------------------------------------------------------------------------
       Acquisition method            Folder title        Folder title        Folder title        Folder title
----------------------------------------------------------------------------------------------------------------
Negotiated......................  Presolicitation to  Unsuccessful        Administration and  Reports and
                                   Award.              Proposals.          Closeout.           Deliverables.
Sealed-bid......................  Presolicitation to  Unsuccessful Bids.  Administration and  N/A.
                                   Award.                                  Closeout.
A & E...........................  Preannouncement to  Unsuccessful        Administration and  Reports and
                                   Award.              Qualifications      Closeout.           Deliverables.
                                                       Statements.
Task orders.....................  Presolicitation to  Unsuccessful        Administration and  Reports and
                                   Award.              Proposals.          Closeout.           Deliverables.
GSA FSS.........................  Presolicitation to  Unsuccessful        Administration and  N/A.
                                   Award.              Quotations/Oral     Closeout.
                                                       Presentations.
----------------------------------------------------------------------------------------------------------------


[[Page 62411]]

     (2) Although the use of the checklists is mandatory, each OPDIV 
contracting office is permitted to make certain checklist changes or 
additions as specified in ``Use and modification of checklists'' under 
``File checklists and tab dividers'' in the instructions.
    (3) OPDIVs using or planning to use electronic filing capabilities 
shall adhere to the folder and tab nomenclature requirements identified 
herein to the maximum extent practicable.


304.804-70  Contract closeout audits.

    (a) Contracting Officers shall rely, to the maximum extent 
possible, on single audits to close physically completed cost-
reimbursement contracts with colleges and universities, hospitals, non-
profit organizations, and State and local governments. In addition, 
where appropriate, a sample of these contracts or an individual 
contract may be selected for audit, in accordance with paragraph (b) of 
this section.
    (b) Contracting Officers shall request contract closeout audits on 
physically completed, cost-reimbursement, contracts with for-profit 
organizations in accordance with the following:
    (1) The OIG and the Associate DAS for Acquisition, in conjunction 
with the OPDIV's cost advisory/audit focal point, determine which 
contracts or contractors will be audited, which audit agency will 
perform the audit, and the type and scope of closeout audit to be 
performed. These decisions are based on the needs of the customer, risk 
analysis, return on investment, and the availability of audit 
resources. When an audit is warranted prior to closing a contract, the 
Contracting Officer shall submit the audit request to the OIG's Office 
of Audit Services, through the OPDIV's cost advisory/audit focal point.
    (2) Except where a Contracting Officer suspects misrepresentation 
or fraud, the Contracting Officer shall not request contract closeout 
field audits, if the cost of performance is likely to exceed the 
potential cost recovery. Contracting Officers may close contracts that 
are not selected for a field audit on the basis of a desk review, 
subject to any later on-site audit findings. In those situations, the 
release executed by the contractor shall contain the following 
statement: ``The Contractor agrees, pursuant to the clause in this 
contract entitled ``Allowable Cost'' or ``Allowable Cost and Fixed 
Fee,'' as appropriate, that it will refund to the Government the amount 
of any sustained audit exceptions resulting from any audit made after 
final payment.''

Subpart 304.13--Personal Identity Verification


304.1300  Policy.

    (a) Definitions. The following definitions apply to this subpart:
    (1) Access: ``Physical'' entry to and/or exit from a facility/area 
of a facility (such as a building or room in a building) or ``logical'' 
entry into an information system, such as a researcher up-loading data/
information through a secure Web site or a contractor accessing an HHS-
controlled information system from its own facility. It does not 
include access to a public Web site, whether by an HHS contractor or 
member of the public, because such Web sites do not require permission 
to access. In the case of sensitive data/information that exists in 
hard copy, ``access'' means providing a contractor the right to view or 
use written/typed data or information for the purpose described in a 
contract.
    (2) Long-term: Greater than 6 months in duration.
    (3) Routine: On a regular, non-intermittent basis, which is at 
least once per week during the contract or order period of performance.
    (4) Sensitive data/information: As defined by the Computer Security 
Act of 1987, any data/information, ``the loss, misuse, or unauthorized 
access to or modification of which, could adversely affect the national 
interest or the conduct of Federal programs, or the privacy to which 
individuals are entitled under section 552a of the Title 5 of U.S.C. 
(the Privacy Act), but which has not been specifically authorized under 
criteria established by an Executive order or an act of Congress to be 
kept secret in the interest of national defense or foreign policy.'' 
Examples include individuals' social security numbers; other personal 
identification information, such as individuals' health, medical, or 
psychological information; proprietary research data; and confidential 
legal data.
    (5) Short-term: Six (6) months or less in duration.
    (b) Homeland Security Presidential Directive (HSPD-12), entitled, 
``Policy for a Common Identification Standard for Federal Employees and 
Contractors,'' was issued on August 27, 2004, to enhance security and 
reduce identity fraud related to contractor physical access to 
Federally-controlled facilities and/or logical access to Federally-
controlled information systems.
    (1) The HSPD-12 requirements related to routine, long-term physical 
access to HHS-controlled facilities and logical access to HHS-
controlled information systems, including contractor personnel 
background checks/investigations (termed herein as ``more stringent'' 
access procedures), apply to all solicitations and new contracts or 
orders for services, including services incidental to supply contracts/
orders, regardless of dollar amount, where the contractor will require 
such access (FAR 4.1303). In addition, HHS has determined that, when a 
contractor has routine, long-term access to sensitive data/information, 
whether it exists in an HHS-controlled information system or in hard 
copy, that data/information must also be protected and controlled in 
accordance with HSPD-12's more stringent access procedures--see 
304.1300(e).
    (2) When a contractor's access to HHS-controlled facilities, 
information systems, and/or sensitive data/information is of routine 
but short-term duration, an OPDIV shall use the applicable guidance 
cited in OMB memorandum M-05-24 related to ``short-term'' access to 
determine appropriate protections and limit/control contractor access--
see 304.1300(f)]. However, if the Project Officer determines greater 
access controls are necessary, an OPDIV may protect and control 
facilities, information systems, and/or sensitive data information in 
accordance with HSPD-12's more stringent access procedures.
    (3) When a contractor's access to HHS-controlled facilities, 
information systems, and/or sensitive data/information is not routine, 
regardless of duration, HHS has determined that OPDIVs shall use the 
applicable guidance cited in OMB memorandum M-05-24 related to 
``occasional visitors'' to determine appropriate protections and limit/
control contractor access--see 304.1300(g).
    (4) Summary table of contractor access circumstances and HSPD-12 
requirements.

[[Page 62412]]



------------------------------------------------------------------------
                                                       HSPD-12 security
                                    HSPD-12 access    notice required in
         Type of access               procedures         solicitation/
                                       required        contract SOW/PWS?
                                                       [see 304.1300(e)]
------------------------------------------------------------------------
Routine, long-term, physical      More stringent      YES.
 access to HHS-controlled          access procedures
 facilities.                       apply.
Routine, long-term logical        More stringent      YES.
 access to an HHS-controlled       access procedures
 information system that does      apply.
 not contain sensitive HHS data/
 information.
Routine, long-term access to      More stringent      YES.
 sensitive HHS data/information,   access procedures
 whether it exists in an HHS-      apply.
 controlled information system
 (logical access) or in hard
 copy.
Routine, short-term access to     If greater access   YES.
 HHS-controlled facilities,        controls are
 information systems, and/or       deemed necessary,
 sensitive HHS data/information.   more stringent
                                   access procedures
                                   apply.
If greater access controls are    NO, but contractor
 not deemed necessary,             staff must be
 applicable guidance cited in      provided with the
 OMB memorandum M-05-24 related    OPDIV
 to ``short-term'' access to       documentation on
 determine appropriate             the rules of
 protections and limit/control     behavior and
 contractor access.                consequences for
                                   violation [see
                                   304.1300(f)].
Non-routine access, regardless    Applicable          NO, but contractor
 of duration, to HHS-controlled    guidance cited in   staff must be
 facilities, information           OMB memorandum M-   provided with the
 systems, and/or sensitive HHS     05-24 related to    OPDIV
 data/information.                 ``occasional        ``occasional
                                   visitors'' to       visitor'' policy
                                   determine           and procedures
                                   appropriate         [see
                                   protections and     304.1300(g)].
                                   limit/control
                                   contractor access.
------------------------------------------------------------------------

     (c) As part of the acquisition planning process, the Project 
Officer shall determine whether, based on the nature of the 
requirement, contractor personnel may require access to HHS-controlled 
facilities and/or information systems, including sensitive data/
information, in order to perform the contract/order Statement of Work 
(SOW)/Performance Work Statement (PWS). If contractor access is 
required, the Project Officer must assess, based on information 
available at that point in the process, the type, frequency, and 
duration of such access. Following that determination, the Project 
Officer shall consult with OPDIV and/or local building and IT security 
officials/staff, and officials/staff involved with personnel security, 
including the designated personnel security representative, to 
determine appropriate security requirements and, as necessary, adjust 
project requirements to minimize security and access issues. The 
Project Officer shall comply with HSPD-12 and the following 
implementing guidance in making these judgments and determinations:
    (1) OMB memorandum M-05-24, Implementation of Homeland Security 
Presidential Directive (HSPD) 12--Policy for a Common Identification 
Standard for Federal Employees and Contractors, dated August 5, 2005.
    (2) National Institutes of Standards and Technology Federal 
Information Processing Standard Publication (FIPS PUB) 201), dated 
February 25, 2005, which can be accessed at: http://csrc.nist.gov/publications/.
    (3) FAR (FAR 4.13 and 52.204-9).
    (4) Any HHS and OPDIV implementation thereof.
    (d) If, as part of the acquisition planning process, the Project 
Officer determines that contractor access will not be required, the 
Project Officer should so state in the AP (or other acquisition request 
document)--see 307.7101. If an AP does not address access issues or 
indicates contractor access is not required, and it appears an 
acquisition may involve access requirements, the Contracting Officer 
shall request that the Project Officer address or reconsider the 
initial access determination. The Project Officer's determination shall 
be final.
    (e) If HSPD-12's more stringent access procedures are expected to 
apply, because access will be routine and of long-term duration, or is 
routine and of short-term duration, but greater access controls are 
deemed necessary, the Project Officer shall include the following 
``HHS-Controlled Facilities and Information Systems Security'' notice 
in a separate, clearly designated ``Security'' section of the SOW/PWS. 
(Note: The Contracting Officer is responsible for tailoring the 
language in the solicitation and contract/order in accordance with the 
instructions provided below.)

    ``XXX Security.

HHS-Controlled Facilities and Information Systems Security

    (a) To perform the work specified herein, Contractor personnel 
are expected to have routine (1) physical access to an HHS-
controlled facility; (2) logical access to an HHS-controlled 
information system; (3) access to sensitive HHS data or information, 
whether in an HHS-controlled information system or in hard copy; or 
(4) any combination of circumstances (1) through (3). (b) To gain 
routine physical access to an HHS facility, logical access to an 
HHS-controlled information system, and/or access to sensitive data 
or information, the Contractor and its employees shall comply with 
Homeland Security Presidential Directive (HSPD)-12, Policy for a 
Common Identification Standard for Federal Employees and 
Contractors; Office of Management and Budget memorandum (M-05-24); 
and Federal Information Processing Standards Publication (FIPS PUB) 
Number 201; and with the personal identity verification and 
investigation procedures contained in the following documents:
    (1) HHS Information Security Program Policy.
    (2) HHS Office of Security and Drug Testing, Personnel Security/
Suitability Handbook, dated February 1, 2005.
    (3) HHS HSPD-12 Policy Document, v. 2.0.
    (4)

    Note: Based upon information provided by the Project Officer, 
the Contracting Officer shall insert references to OPDIV and/or 
local procedural guideline(s), if any; indicate if they are readily 
accessible to the public; and, if so, specify where they may be 
found. If they are not readily accessible, the Contracting Officer 
shall attach a copy to the solicitation and contract and reference 
the guideline(s) here.

    (c) This contract/order will entail the following position 
sensitivity level(s): --------------------.

    Note: At the time of solicitation, based upon information 
provided by the Project Officer, the Contracting Officer shall 
specify all known levels. If the position sensitivity levels are not 
known at that time, the Contracting Officer shall insert the words 
``To Be Determined at the Time of Award.'' However, the Contracting 
Officer must include the definitive position sensitivity levels in 
the awarded contract/order.

    (d) The personnel investigation procedures for Contractor 
personnel require that the Contractor prepare and submit background 
check/investigation forms based on the type

[[Page 62413]]

of investigation required. The minimum Government investigation for 
a non-sensitive position is a National Agency Check and Inquiries 
(NACI) with fingerprinting. More restricted positions--i.e., those 
above non-sensitive, require more extensive documentation and 
investigation.

    Note: The Contracting Officer shall include the following 
sentence in each solicitation as the concluding sentence in 
paragraph (d)): ``As part of its proposal, and if the anticipated 
position sensitivity levels are specified in paragraph (c) above, 
the Offeror shall notify the Contracting Officer of (1) its proposed 
personnel who will be subject to a background check/investigation 
and (2) whether any of its proposed personnel who will work under 
the contract have previously been the subject of national agency 
checks or background investigations.''

    (The Contracting Officer shall include the following sentence in 
each contract/order as the concluding sentence in paragraph (d) in 
lieu of the solicitation language: ``The Contractor shall notify the 
Contracting Officer in advance when any new personnel, who are 
subject to a background check/investigation, will work under the 
contract and if they have previously been the subject of national 
agency checks or background investigations.'')
    (e) Investigations are expensive and may delay performance, 
regardless of the outcome of the investigation. Delays associated 
with rejections and consequent re-investigations may not be 
excusable in accordance with the FAR clause, Excusable Delays--see 
FAR 52.249-14.

    Note: The Contracting Officer shall include the following 
sentence in each solicitation as the concluding sentence in 
paragraph (e): ``Accordingly, if position sensitivity levels are 
specified in paragraph (c), the Offeror shall ensure that the 
employees it proposes for work under this contract have a reasonable 
chance for approval.'' The Contracting Officer shall include the 
following sentence in each contract/order as the concluding sentence 
in paragraph (e) in lieu of the solicitation language: 
``Accordingly, the Contractor shall ensure that any additional 
employees whose names it submits for work under this contract have a 
reasonable chance for approval.''

    (f) Typically, the Government investigates personnel at no cost 
to the Contractor. However, multiple investigations for the same 
position may, at the Contracting Officer's discretion, justify 
reduction(s) in the contract price of no more than the cost of the 
additional investigation(s).
    (g) The Contractor shall include language similar to this ``HHS-
Controlled Facilities and Information Systems Security'' language in 
all subcontracts that require subcontractor personnel to have the 
same frequency and duration of (1) physical access to an HHS-
controlled facility; (2) logical access to an HHS-controlled 
information system; (3) access to sensitive HHS data/information, 
whether in an HHS-controlled information system or in hard copy; or 
(4) any combination of circumstances (1) through (3).
    (h) The Contractor shall direct inquiries, including requests 
for forms and assistance, to the Contracting Officer or designee.
    (i) Within 7 calendar days after the Government's final 
acceptance of the work under this contract, or upon termination of 
the contract, the Contractor shall return all identification badges 
to the Contracting Officer or designee.''

    (f) When a contractor's access to HHS-controlled facilities, 
information systems, and/or sensitive data/information is of routine, 
but short-term duration, and greater access controls are not deemed 
necessary, the Contracting Officer and Project Officer shall use the 
applicable guidance cited in OMB memorandum M-05-24, dated August 5, 
2005, specifically Attachment A, ``HSPD-12 Implementation Guidance for 
Federal Departments and Agencies,'' to ensure that--
    (1) Adequate OPDIV access controls are applied, and a contractor is 
granted only limited/controlled access to facilities, systems, and/or 
sensitive data/information, consistent with the requirements of the 
acquisition;
    (2) Contractor staff are provided with clear OPDIV documentation on 
the rules of behavior and consequences of their violation before being 
granted access to facilities, systems, and/or sensitive data/
information;
    (3) Contractor security violations are documented and reported to 
the appropriate OPDIV authority within 24 hours of their occurrence; 
and
    (4) Identity credentials issued to contractor staff are visually 
and electronically distinguishable from credentials issued to 
individuals to whom the more stringent HSPD-12 access procedures apply.

    Note to paragraph (f): However, as indicated in 304.1300(e), if 
the Project Officer determines greater access controls are 
necessary, an OPDIV may protect and control facilities, information 
systems, and/or sensitive data information in accordance with HSPD-
12's more stringent access procedures.

    (g) When a contractor's access to HHS-controlled facilities, 
information systems, and/or sensitive data/information is not routine, 
regardless of duration, the Contracting Officer and Project Officer 
shall use the applicable guidance cited in OMB memorandum M-05-24, 
dated August 5, 2005, specifically Attachment A, ``HSPD-12 
Implementation Guidance for Federal Departments and Agencies,'' related 
to ``occasional visitors'' to determine appropriate protections and 
limit/control contractor access to ensure that--
    (1) Adequate OPDIV access controls are applied, and the contractor 
is granted only limited/controlled access to facilities, systems, and/
or sensitive data/information, consistent with the requirements of the 
acquisition; and
    (2) OPDIV visitor policies, including contractor personnel identity 
badging requirements, are enforced and are provided to the contractor.

Subpart 304.70--Acquisition Instrument Identification Numbering 
System


304.7000  Scope of subpart.

    This subpart prescribes policy and procedures for assigning 
identification numbers to contracts and related instruments, including 
solicitation documents, purchase orders, and delivery orders. The HCA 
(non-delegable) shall establish a numbering system within an OPDIV.


304.7001  Numbering acquisitions.

    (a) Acquisitions which require numbering. Contracting activities 
shall number the following acquisitions and related instruments in 
accordance with the system prescribed in paragraphs (b), (c) and (d) of 
this section:
    (1) Contracts, including letter contracts, that exceed the micro-
purchase threshold or the acquisition of personal property or 
nonpersonal services. (Note: The Contracting Officer shall also assign 
the letter contract number to the superseding definitized contract.)
    (2) Basic ordering agreements (BOAs) and BPAs.
    (3) Requests for proposals and invitations for bids.
    (4) Requests for quotations.
    (b) Numbering system for contracts. The Contracting Officer shall 
assign a number consisting of the following to all contracts which 
require numbering (paragraph (a)(1) of this section):
    (1) The three-digit identification code (HHS) of the Department.
    (2) A one-digit alphabetic identification code of the servicing 
agency.

AHRQ: A
BARDA: O
CDC: D
CMS: M
FDA: F
HRSA: H
IHS: I
NIH: N
PSC: P
SAMHSA: S

    (3) The three-digit numeric identification code assigned by ASFR/
OGAPA/DA to the contracting office within the servicing agency.
    (4) A four-digit fiscal year designation (e.g., 2009, 2010).
    (5) A five-digit alphanumeric tracking number, the content of which 
is

[[Page 62414]]

determined by the contracting office within the servicing agency.
    (6) A one-digit code describing the type of contract action. For 
example, the National Cancer Institute, NIH, may number its first 
contract for fiscal year 2009 as HHSN261200900001C. (Note: When more 
than one code may apply in a specific situation, or for additional 
codes, refer to the DCIS Users' Manual or consult with the cognizant 
DCIS coordinator/focal point for guidance on which code governs.):

A Commercial Item Acquisitions (including purchases using simplified 
acquisition procedures in accordance with the FAR subpart 13.5 Test 
program)
C New Definitive Contract
P Purchases using simplified acquisition procedures (other than 
commercial items)
I IDC
O BOA
B BPA
F Facilities Contract
U Contracts placed with or through other Government departments, GSA 
contracts, or against mandatory source contracts such as AbilityOne 
and Federal Prison Industries (UNICOR)
L Lease Agreement
W Government-wide Acquisition Contract (GWAC)
E Letter Contract
G Federal Supply Schedule
M Micro-purchase
Q Multi-agency contract

    (c) Numbering system for orders. The Contracting Officer shall 
assign order numbers (e.g., task order numbers) to orders issued under 
contracts. The order number shall be up to a seventeen-digit number 
consisting of the following:
    (1) The three-digit identification code (HHS) of the Department.
    (2) A one-digit numeric identification code of the servicing 
agency:

AHRQ: A
BARDA: O
CDC: D
CMS: M
FDA: F
HRSA: H
IHS: I
NIH: N
PSC: P
SAMHSA: S

    (3) The three-digit numeric identification code assigned by ASFR/
OGAPA/DA to the contracting office within the servicing agency.
    (4) An alphanumeric tracking number, up to ten characters, the 
content of which is determined by the contracting office within the 
servicing agency.
    (d) Numbering system for solicitations. The HCA is responsible for 
developing a numbering system for solicitations listed in paragraphs 
(a)(3) and (a)(4) of this section.
    (e) Assignment of identification codes. ASFR/OGAPA/DA shall assign 
each contracting office a three-digit identification code. HCAs shall 
request from ASFR/OGAPA/DA the assignment of codes for newly 
established contracting offices. A listing of the contracting office 
identification codes currently in use is contained in the DCIS Users' 
Manual, available at http://dcis.hhs.gov.

Subpart 304.71--Review and Approval of Proposed Contract Actions


304.7100  Policy.

    (a) The HCA (non-delegable) shall establish review and approval 
procedures for proposed contract actions to ensure that--
    (1) Contractual documents are in conformance with law, established 
policies and procedures, and sound business practices;
    (2) Contract awards properly reflect the mutual understanding of 
the parties; and
    (3) The Contracting Officer is informed of deficiencies and items 
of questionable acceptability, and takes corrective action.
    (b) The HCA shall designate acquisition officials to serve as 
reviewers. Each HCA shall establish the criteria for determining which 
contracts to review.
    (c) Officials assigned responsibility for review and approval of 
contract actions shall possess qualifications in the field of 
acquisition commensurate with the level of review performed. However, 
if an official is to serve as the Contracting Officer and sign the 
contractual document, an appropriate official at least one level above 
the Contracting Officer shall perform the review and approval function.
    (d) The Contracting Officer shall review all contractual documents, 
regardless of dollar value, prior to award to ensure the requirements 
of paragraph (a) of this section are met.

SUBCHAPTER B--COMPETITION AND ACQUISITION PLANNING

PART 305--PUBLICIZING CONTRACT ACTIONS

Subpart 305.2--Synopsis of Proposed Contract Actions
Sec.
305.202 Exceptions.
305.205 Special situations.
Subpart 305.3--Synopses of Contract Awards
305.303 Announcement of contract awards.
Subpart 305.5--Paid Advertisements
305.502 Authority.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 305.2--Synopsis of Proposed Contract Actions


305.202  Exceptions.

    (b) When the Contracting Officer deems an advance notice is not 
appropriate or reasonable, the Contracting Officer shall prepare a 
memorandum citing all pertinent facts and details and send it through 
appropriate acquisition channels, including the HCA, to Associate DAS 
for Acquisition requesting an exception to synopsizing. The Associate 
DAS for Acquisition shall review the request and decide whether an 
exception is appropriate and reasonable. If it is, the Associate DAS 
for Acquisition shall take the necessary coordinating actions required 
by FAR 5.202(b). ASFR/OGAPA/DA shall promptly notify the contracting 
office of the Associate DAS for Acquisition's determination on the 
request.


305.205  Special situations.

    (a) An OPDIV may issue an advance notice, entitled ``Research and 
Development Sources Sought,'' in Federal Business Opportunities 
(FedBizOpps), in accordance with the requirements of FAR 5.205(a). The 
primary purpose of an R & D Sources Sought notice is to identify all 
potential sources, regardless of organizational type and size 
classification, and determine their capabilities to fulfill a potential 
Government requirement. The notice is not intended to solicit 
technical, scientific, or business information for project planning 
purposes regarding existing or possible solutions. In the latter 
instance, a Request for Information (RFI) may be used--see FAR 
15.201(e) and 315.201(e).
    (1) When using an R & D Sources Sought notice, an OPDIV shall not 
request that potential sources provide more than the minimum 
information necessary--see FAR 10.001(b), to determine whether they 
have the apparent capability to perform a requirement and, therefore, 
whether they should be included in any future competition. The notice 
and the information received shall not be used to determine how well 
respondents can perform a requirement, which can only be evaluated in 
response to a solicitation. Accordingly, the notice shall not be used 
to--
    (i) Obtain capability statements that are evaluated and determined 
acceptable or unacceptable;
    (ii) Require cost/price proposals or detailed technical solutions;
    (iii) Identify a prospective sole source; or

[[Page 62415]]

    (iv) Exclude small business concerns.
    (2) While not the primary intent of an R & D Sources Sought notice, 
in addition to seeking information regarding all potential qualified R 
& D sources, the notice may request that respondents provide 
information regarding their organizational size classification. For 
example, the notice may ask respondents to identify whether they are 
small businesses; Historically Underutilized Business (HUB) Zone small 
businesses; service-disabled, veteran-owned small businesses; 8(a) 
small businesses; veteran-owned small businesses; woman-owned small 
businesses; or small disadvantaged businesses in order to determine the 
appropriate acquisition method, including whether a set-aside is 
possible. However, such a notice shall not be used solely to determine 
the size classification of respondents for a proposed R & D 
acquisition. In such instances, a ``Small Business Sources Sought'' 
notice may be used (see 319.202-2), in lieu of the procedures in this 
section.
    (3) OPDIVs shall follow the standard HHS instructions for 
completing an R & D Sources Sought notice. The template for the notice 
is available on the ASFR/OGAPA/DA Internet Web site. The Contracting 
Officer shall post the notice in FedBizOpps by selecting and completing 
a Sources Sought notice, accessible on the FedBizOpps ``Notices'' page 
at: http://www.fedbizopps.gov. Additional information may be included 
in the notice in accordance with OPDIV procedures. The Contracting 
Officer shall document, in the form of a memorandum to the file, the 
results of the review by technical personnel of information submitted 
in response to the notice, including whether each respondent appears to 
be capable of performing the requirement. The Contracting Officer shall 
attach a copy of the analysis provided by the technical personnel to 
the memorandum.
    (4) In instances where a sufficient number of sources has not been 
identified to compete for a non-R & D project, an OPDIV may use the 
procedures specified in 310.001, including the issuance of a ``Sources 
Sought'' notice, as appropriate, in lieu of the procedures in this 
section.

Subpart 305.3--Synopses of Contract Awards


305.303  Announcement of contract awards.

    (a) Public Announcement. The Contracting Officer shall report 
awards over $3.5 million, not otherwise exempt under FAR 5.303, to the 
Office of the Assistant Secretary for Legislation (OASL) (Congressional 
Liaison). The Contracting Officer shall provide a copy of the contract 
or award document face page to the referenced office prior to the day 
of award or in sufficient time to allow OASL to make an announcement by 
5 p.m. Washington, DC time on the day of award. The Contracting Officer 
may also provide notification by e-mail or facsimile.

Subpart 305.5--Paid Advertisements


305.502  Authority.

    The Contracting Officer may advertise or place notices in 
newspapers and periodicals to announce that the contracting office is 
seeking proposals, quotations, or bids, as appropriate.

PART 306--COMPETITION REQUIREMENTS

Subpart 306.2--Full and Open Competition after Exclusion of Sources
Sec.
306.202 Establishing or maintaining alternative sources.
Subpart 306.3--Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open 
competition.
306.302-1 Only one responsible source and no other supplies or 
services will satisfy agency requirements.
306.302-7 Public interest.
306.303 Justifications.
306.303-1 Requirements.
306.304 Approval of the justification.
Subpart 306.5--Competition Advocates
306.501 Requirement.
306.502 Duties and responsibilities.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 306.2--Full and Open Competition after Exclusion of Sources


306.202  Establishing or maintaining alternative sources.

    (a) The reference to the agency head in FAR 6.202 (a) shall mean 
the appropriate Competition Advocate (CA) cited in 306.501.
    (b)(1) The Contracting Officer shall prepare the required 
determination and findings (D & F) based on the data provided by 
program personnel. The appropriate CA (non-delegable) shall sign the D 
& F.

Subpart 306.3--Other Than Full and Open Competition


306.302  Circumstances permitting other than full and open competition.


306.302-1  Only one responsible source and no other supplies or 
services will satisfy agency requirements.

    (a)(2)(iv) Follow-on contracts for the continuation of R & D 
studies on long-term social and health programs, research studies, or 
clinical trials may be deemed to be available only from the original 
source when it is likely that award to any other source would result in 
unacceptable delays in fulfilling HHS' or the OPDIV's requirements.
    (b) Application.
    (5) when the head of the sponsoring program office has determined 
that the activity must acquire only specified makes or models of 
technical equipment or parts to meet the activity's program 
responsibility to test and evaluate certain kinds and types of 
products, and only one source is available. (Note: This criterion is 
limited to testing and evaluation purposes only and not for initial 
outfitting or repetitive acquisitions. Project Officers shall support 
the use of this criterion with citations from their agency's 
legislation and the technical rationale for the item of equipment 
required.)


306.302-7  Public interest.

    (a) Authority.
    (2) Agency head, in this instance, means the Secretary.
    (c) Limitations. The Contracting Officer shall prepare a written 
request for approval and provide it through appropriate acquisition 
channels, including the HCA and Associate DAS for Acquisition, to the 
Secretary. The request shall include a D & F for the Secretary's 
signature that contains all pertinent information to support the 
justification for exercising the exemption to competition and a letter 
for the Secretary's signature notifying Congress of the determination 
to award a contract under the authority of 41 U.S.C. 253(c)(7).


306.303  Justifications.


306.303-1  Requirements.

    (b) The responsible Program Office must provide a written 
justification whenever it requests that goods or services be acquired 
without obtaining full and open competition. The justification must be 
submitted with the AP or other acquisition request document--see 
Subpart 307.71. The Project Officer has responsibility for preparing 
the justification with

[[Page 62416]]

assistance, as necessary, from the Contracting Officer.
    (1) Justifications for acquisitions at or below the simplified 
acquisition threshold may be in the form of a paragraph or paragraphs 
contained in the requisition or other acquisition request document. 
Justifications for acquisitions in excess of the simplified acquisition 
threshold shall be in the form of a separate, self-contained document, 
prepared in accordance with FAR 6.303 and 306.303, and titled 
``Justification for Other Than Full and Open Competition'' (JOFOC). HHS 
requires use of a standard format for a JOFOC. The template for the 
justification is available on the ASFR/OGAPA/DA Internet Web site. 
Additional information may be included in the JOFOC template in 
accordance with OPDIV procedures.
    (2) Regardless of the dollar amount of the acquisition, 
justifications shall--
    (i) Fully describe what is to be acquired;
    (ii) Provide a specific explanation of why it is not feasible to 
obtain full and open competition;
    (iii) Be supported by verifiable facts, rather than untested or 
unsubstantiated opinions or conclusions; and
    (iv) Be written in a manner to permit an individual without 
technical knowledge of the requirement to understand the supporting 
rationale.
    (3) Preliminary arrangements with, or verbal or written commitments 
to, a proposed sole-source contractor shall be avoided given the 
statutory requirement to obtain full and open competition to the 
maximum extent practicable.
    (4) Justifications for orders to be placed under FSS contracts that 
limit consideration of contractors shall comply with FAR 8.405-6 and 
308.405-6.


306.304  Approval of the justification.

    Certification, concurrence, and approval requirements. The Project 
Officer, the Project Officer's immediate supervisor, the head of the 
sponsoring program office, and the Contracting Officer shall certify 
that the justification is accurate and complete by signing the JOFOC. 
For acquisitions in the dollar amount cited in FAR 6.304(a)(2) through 
(a)(4), the CCO, if applicable, and the HCA shall indicate their review 
of, and concurrence with, the justification by signing the JOFOC.
    (a) The approving officials for JOFOCs are as follows:
    (1) The Contracting Officer shall exercise this approval authority 
unless a higher approval level is required by OPDIV procedures.
    (2) The CAs are listed in 306.501. This approval authority is not 
delegable.
    (3) The CA shall exercise this approval authority, except where the 
individual designated as the CA does not meet the requirements of FAR 
6.304 (a)(3)(ii). This approval authority is not delegable.
    (4) HHS' SPE is the Associate DAS for Acquisition.
    (c) A class justification shall be processed in the same manner as 
an individual justification. A class justification may consist of 
contracts/orders for the same or related supplies and services or other 
contract/order actions that require essentially identical 
justifications.

Subpart 306.5--Competition Advocates


306.501  Requirement.

    The HHS CA is the Director, Strategic Acquisition Service, PSC. The 
CAs for each of HHS' contracting activities are as follows:

AHRQ: Director, Office of Performance Accountability, Resources and 
Technology
BARDA: Chief of Mission Support and Acquisition Policy
CDC: Chief Information Officer
CMS: Chief Operating Officer
FDA: Deputy Commissioner for Administration
HRSA: Associate Administrator, Office of Operations
IHS: Director, Office of Management Services
NIH: Senior Scientific Advisor for Extramural Research, Office of 
Extramural Research (R&D) and Senior Advisor to the Director (other 
than R&D)
    PSC: Director, Strategic Acquisition Service
    SAMHSA: Executive Officer


306.502  Duties and responsibilities.

    (a) Each OPDIV CA shall prepare an annual Competition Advocate 
Report (CAR), covering the prior fiscal year, in accordance with the 
requirements of FAR 6.502(b)(2) and 306.502(b), and provide it to the 
HHS CA not later than November 16 of each year or the next business 
day, if the due date falls on a non-business day. NIH's two CAs shall 
prepare and sign a joint report covering their respective areas of 
responsibility.
    (b) HHS requires that each CAR be prepared in a standard format. 
The template for the report is available on the ASFR/OGAPA/DA Internet 
Web site. As long as the standard headings are included and required 
information is addressed, the OPDIV may include additional information 
in accordance with OPDIV procedures.
    (1) The CAR shall be based on information and data for all 
acquisitions that exceed the micro-purchase threshold for the 
applicable fiscal year, unless otherwise noted in the standard format.
    (2) Each OPDIV CA shall obtain the information and data needed for 
preparation of the CAR from the responsible HCA and/or the CCO, as 
appropriate, who shall assist the CA in preparing the CAR.
    (3) Prior to forwarding the CAR to the HHS CA, each OPDIV CA shall 
provide the CAR to the responsible HCA, who shall review and approve it 
for accuracy and completeness.
    (c) The HHS CA shall consolidate all OPDIV CARs and provide an HHS-
wide CAR that addresses all requirements of FAR 6.502(b) to the HHS SPE 
and the CAO by December 20 of each year or the next business day, if 
the due date falls on a non-business day.

PART 307--ACQUISITION PLANNING

Subpart 307.1--Acquisition Planning
Sec.
307.104 General procedures.
307.104-70 Acquisition strategy.
307.104-71 Purpose and timing.
307.105 Contents of written acquisition plans.
307.108-70 Telecommuting of contractor employees.
Subpart 307.70--Considerations in Selecting an Award Instrument.
307.7000 Scope of subpart.
307.7001 Distinction between acquisition and assistance.
307.7002 Procedures.
Subpart 307.71--Acquisition Plan.
307.7100 Scope of subpart.
307.7101 Policy.
307.7102 Content.
307.7103 Format.
307.7104 Review and certification.
307.7105 Transmittal.
307.7106 Acquisition milestones.
307.7107 Responsibilities.
307.7108 Statement of work.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 307.1--Acquisition Planning


307.104  General procedures.

    (a) Each contracting activity shall prepare an Annual Acquisition 
Plan (AAP) as far in advance of each fiscal year as possible, in 
accordance with the following:
    (1) The AAP shall contain all anticipated acquisition actions for 
the coming fiscal year that exceed the simplified acquisition 
threshold, including new acquisitions and contract/order modifications. 
The AAP must include--
    (i) The aggregate dollars planned for simplified acquisitions by 
quarter;
    (ii) Any long lead-time acquisitions that will be awarded in future 
fiscal years (see paragraph (c) below); and

[[Page 62417]]

    (iii) Proposed multi-agency and intra-agency contracts--see 317.70.
    (2) The HCA or the CCO, as appropriate, shall prepare the AAP and 
obtain the information needed for its preparation from the responsible 
program planning/budget office and/or the program offices.
    (3) Contracting activities shall use the AAP for reporting purposes 
and workload scheduling and monitoring.
    (4) The HCA/CCO and Small Business Specialist (SBS) in the Office 
of Small and Disadvantaged Business Utilization (OSDBU) shall review 
the AAP at least quarterly, with input from the cognizant program 
office, and modify it, as appropriate, during the fiscal year, with 
updated information, particularly regarding the specific acquisition 
method the contracting activity plans to use.
    (5) HHS requires use of a standard format for an AAP. The template 
for the plan is available on the ASFR/OGAPA/DA Internet Web site. For 
the data elements specified in the AAP format, the HCA/CCO may include 
information in addition to that required by the standard instructions 
accompanying the format.
    (b) As early as possible following completion of the AAP, the 
Contracting Officer shall initiate discussions with the assigned 
Project Officer, in consultation with the OSDBU SBS, for each action 
that exceeds the simplified acquisition threshold. As appropriate, the 
discussions shall include--
    (1) Determining the intended acquisition strategy and contract/
order type, including the use of options;
    (2) Reviewing the SOW, if available, for adequacy and ensuring that 
a PWS is used for services, where practicable;
    (3) Evaluating the potential for, and maximizing the use of, 
competitive procedures;
    (4) Performing market research, identifying potential sources, and 
determining set-aside potential and small business subcontracting 
opportunities;
    (5) Assessing the availability of commercial items;
    (6) Determining required clearances/approvals and supporting 
documentation; and
    (7) Preparing an acquisition milestone schedule;
    (8) Determining the best multi- or intra-agency contracting 
activity to assist in awarding a contract on the requiring 
organization's behalf, if applicable; and
    (9) Determining in the case of direct ordering that the chosen 
acquisition vehicle is the best way to obtain the required product or 
service, if a vehicle other than those listed in 317.7002(b) is 
proposed.
    (c) The HCA or designee (not lower than the CCO) shall establish 
standard lead-times for processing various types of acquisitions and 
applicable fiscal year deadlines for receipt of requirements to allow 
for well-planned and timely awards. The Project Officer shall initiate 
planning, to the extent possible, for certain requirements, such as 
major capital IT investments, major capital construction investments, 
and R & D projects that require peer review, at least 24 months before 
planned award, given the clearance/approval requirements and lead-time 
required for such complex acquisitions.
    (d) The outcome of the discussions referenced in paragraph (b) 
above shall be an agreement concerning the acquisition approach and 
documentation required. For those actions that require development of a 
written AP--see 307.7101, for which the Project Officer has ultimate 
responsibility, these discussions shall also result in an agreement 
concerning--
    (1) Which elements of the AP the Contracting Officer will assist 
the Project Officer in preparing; and
    (2) The date (as specified in the milestone schedule) the Project 
Officer will provide the AP to the CCO or designee.


307.104-70  Acquisition strategy.

    Program and Project Managers responsible for major IT capital 
investments (and for any other investments designated by the HHS CIO, 
DASFMP, the CAO, or the cognizant HCA) shall prepare an acquisition 
strategy using the HHS acquisition strategy template. The template for 
the acquisition strategy is available on the ASFR/OGAPA/DA Internet Web 
site. Program and Project Managers must initiate the acquisition 
strategy for major IT capital investments as part of the planned 
investment's business case, usually during the Enterprise Performance 
Life Cycle concept phase.


307.104-71  Purpose and timing.

    (a) The purpose of an acquisition strategy is to describe the 
overall approach for acquiring capabilities needed to fulfill 
investment/programmatic objectives. Acquisition strategy development 
requires identification of issues and risks that might impact an 
acquisition(s) to allow early action to eliminate or mitigate the 
issues and risks.
    (b) An acquisition strategy differs from an AP with respect to the 
timing of its development and the level of detail required.
    (1) An acquisition strategy is established at the inception 
(concept phase) of an investment/acquisition to support the business 
case, identify and mitigate risks, and begin the acquisition planning 
process. An acquisition strategy addresses the major issues surrounding 
business objectives, competitive forces, and various risks that need to 
be considered.
    (2) An acquisition strategy is a living document used throughout 
the investment's life-cycle. It should be continuously updated with the 
active involvement of the Program or Project Manager and the 
Contracting Officer at appropriate points, as plans for the investment/
acquisition mature. An acquisition strategy ultimately will result in 
an AP--see 307.71.
    (3) An AP, which is required to support proposed acquisitions 
expected to exceed $500,000 (inclusive of options, with certain 
exceptions)--see 307.7101, is developed closer to the time of 
solicitation. The AP addresses not only those issues in the acquisition 
strategy, but also the tactical details of how the acquisition will be 
executed.


307.105  Contents of written acquisition plans.

    FAR 7.105 specifies the content requirements of a written AP. 
Subpart 307.71 incorporates and supplements those requirements.


307.108-70  Telecommuting of contractor employees.

    (a) SOWs/PWSs shall permit offerors or contractors to specify their 
own place(s) of performance (hence authorize their employees to 
telecommute), except as follows:
    (1) The Project Officer may restrict place of performance (hence 
restrict an offeror's or contractor's telecommuting) for any part of an 
SOW/PWS, after determining that the work or any portion thereof must be 
performed at a specified place of performance; or security would be 
compromised. The Project Officer must document this determination in 
writing and send a copy of the determination, along with the SOW/PWS, 
to the Contracting Officer. The Project Officer must also address in an 
HHS AP (or other acquisition request document) any performance 
requirements or security considerations that restrict place of 
performance--see 307.71.
    (2) In accordance with FAR 7.108(a), if the Contracting Officer 
concurs with the Project Officer's determination in (a)(1) above, then 
the Contracting Officer must sign the Project Officer's

[[Page 62418]]

determination; include it in the official contract file; and specify 
any prohibition against telecommuting in the solicitation and resultant 
contract.
    (3) In accordance with FAR 7.108(a), if the Contracting Officer 
decides to restrict a place of performance that the Project Officer did 
not restrict, then the Contracting Officer must document in writing the 
determination to preclude telecommuting in part or in whole; include 
the determination in the official contract file; and specify any 
prohibition against telecommuting in the solicitation and resultant 
contract.
    (b) If the Contracting Officer disagrees with the Project Officer's 
determination in (a)(1) above, then the Contracting Officer shall 
return both the SOW/PWS and determination to the Project Officer for 
further consideration.
    (c) The Contracting Officer shall ensure that authorized 
telecommuting of contractor employees does not result in increased cost 
or price to the Government.

Subpart 307.70--Considerations in Selecting an Award Instrument


307.7000  Scope of subpart.

    This subpart provides guidance on the appropriate selection of 
award instruments to fulfill program needs consistent with 31 U.S.C. 
6301-6308. This subpart explains the use of the contract as the award 
instrument for acquisition relationships and a grant or cooperative 
agreement as instruments for financial assistance relationships.


307.7001  Distinction between acquisition and assistance.

    (a) 31 U.S.C. 6301-6308 requires the use of contracts to acquire 
property or services for the direct benefit or use of the Government 
and grants or cooperative agreements to transfer money, property, 
services, or anything of value to eligible entities to accomplish a 
public purpose of support or stimulation authorized by Federal statute.
    (b) OPDIVs shall use a contract as the legal instrument to reflect 
a relationship between the Government and an entity whenever the--
    (1) Principal purpose of the instrument is the acquisition, by 
purchase, lease, or barter, of property or services for the direct 
benefit or use of the Government; or
    (2) Government determines in a certain situation that specific 
needs can be satisfied best by using the acquisition process. However, 
this authority does not permit circumventing the criteria for use of 
acquisition or assistance instruments. Use of this authority is 
restricted to extraordinary circumstances and requires the Associate 
DAS for Acquisition's prior approval.
    (c) OPDIVs shall use a grant or cooperative agreement as the legal 
instrument to reflect a relationship between the Government and an 
entity whenever the principal purpose of the relationship is the 
transfer of money, property, services, or anything of value to 
accomplish a public purpose of support or stimulation authorized by 
Federal statute.
    (1) OPDIVs shall use a grant when no substantial programmatic 
involvement is anticipated between the Government and the recipient 
during performance of the contemplated activity.
    (2) OPDIVs shall use a cooperative agreement when substantial 
programmatic involvement is anticipated between the Government and the 
recipient during performance of the contemplated activity.
    (d) As a general rule, OPDIVs shall use contracts for the following 
purposes:
    (1) Evaluation (including research of an evaluative nature) of the 
performance of Government programs or projects or grantee activity 
initiated by the funding agency for its direct benefit or use.
    (2) Technical assistance rendered to the Government, or on behalf 
of the Government, to any third party, including those receiving grants 
or cooperative agreements.
    (3) Surveys, studies, and research which provide specific 
information desired by the Government for its direct activities, or for 
dissemination to the public.
    (4) Consulting services or professional services of all kinds if 
provided to the Government or, on behalf of the Government, to any 
third party.
    (5) Training projects where the Government selects the individuals 
or specific groups whose members are to be trained or specifies the 
content of the curriculum (not applicable to fellowship awards).
    (6) Production of publications or audiovisual materials the 
Government requires primarily for the conduct of its direct operations.
    (7) Design or development of items for Government use or pursuant 
to agency definition or specifications.
    (8) Conferences conducted on the Government's behalf.
    (9) Generation of management information or other data for 
Government use.


307.7002  Procedures.

    (a) OPDIV program officials shall use existing budget and program 
planning procedures to propose new activities and major changes in 
ongoing programs. OPDIV program officials shall meet with the HCA and 
the Chief Grants Management Officer, or their designees, as necessary, 
to determine whether award is to be made through the acquisition or 
assistance process. This determination shall normally occur prior to 
the time when the AAP is reviewed and approved so that the AAP will 
reflect all known proposed contract actions. The HCA shall fully 
document a shift from one award instrument to another in the 
appropriate files to show a fundamental change in program purpose that 
unequivocally justifies the rationale for the shift.
    (b) The Contracting Officer shall confirm the appropriateness of 
the use of the contract instrument when reviewing the AP or other 
acquisition request document.
    (c) OPDIVs shall ensure that the choice of instrument is in 
accordance with 31 U.S.C. 6301-6308 and applicable HHS policies. If, 
however, there are major individual transactions or programs which 
contain elements of both acquisition and assistance in such a way that 
they cannot be characterized as having a principal purpose of one or 
the other instrument, OPDIVs shall obtain guidance from ASFR/OGAPA/DA, 
through appropriate acquisition channels, including the HCA, before 
proceeding with a determination.
    (d) Any public notice, program announcement, solicitation, or 
request for applications or proposals, or request for quotations shall 
indicate whether the intended relationship will be one of acquisition 
or financial assistance and specify the award instrument the OPDIV will 
use.

Subpart 307.71--Acquisition Plan


307.7100  Scope of subpart.

    FAR 7.102 requires acquisition planning for all acquisitions. This 
subpart establishes: (a) when a written AP is required; (b) its 
contents and format; and (c) the need for review of the AP to certify 
that it is accurate, complete, and in the proper format. This subpart 
also establishes the documentation requirements for those acquisitions 
not requiring an AP.


307.7101  Policy.

    (a) An AP is required for all acquisitions, to be placed by an HHS 
contracting office, expected to exceed $500,000 (inclusive of options) 
with the following exceptions:
    (1) Letter contracts.
    (2) Unsolicited proposals.
    (3) Regulated utility services available from only one source.

[[Page 62419]]

    (4) Proposals under the Small Business Innovative Research (SBIR) 
and Small Business Technology Transfer (STTR) programs.
    (5) Acquisition of commercial items/services--see FAR 2.101, 
including orders placed under FSS contracts meeting the definition of a 
commercial item/service, and not exceeding $5.5 million [$11 million 
for acquisitions as described in FAR 13.500(e)].
    (6) Task orders or delivery orders of any dollar amount placed 
under--
    (i) An IDIQ contract, other than a GWAC; or
    (ii) A BPA, provided there is an approved acquisition planning 
document for the original action, and there is no significant deviation 
from that plan.
    (7) Orders of any dollar amount placed under HHS-wide strategic 
sourcing vehicles.
    (8) Contract/order modifications that--
    (i) Exercise options;
    (ii) Only provide additional funding; or
    (iii) Make changes authorized by the Changes clause.
    (9) Assisted acquisitions processed pursuant to an interagency 
agreement. However, the OPDIV must comply with the requirements 
specified in 317.5 Interagency Agreements under the Economy Act and 
317.70, Multi-agency and Intra-agency Contracts.
    (b) In urgent or other justifiable cases, such as an emergency 
acquisition--see FAR Part 18, the HCA may waive, in writing, the 
requirement for completion of an AP. An HCA shall not approve a waiver 
request based on the lack of advance planning.
    (1) The Project Officer, the Project Officer's immediate 
supervisor, the head of the sponsoring program office, the Contracting 
Officer, and other signatories shall sign the waiver request in 
accordance with OPDIV policies. In OPDIVs where a CCO(s) is designated, 
as defined in 302.101, the cognizant CCO also shall sign the waiver 
request.
    (2) HHS has established a standard format for preparing an AP 
waiver request. The template for the waiver request is available on the 
ASFR/OGAPA/DA Internet Web site. Contracting activities shall use this 
format when requesting a waiver.
    (3) The OPDIV shall provide ASFR/OGAPA/DA a copy of any approved 
waiver request within 5 business days after HCA approval.
    (c) For those acquisitions not requiring an AP, other than assisted 
acquisitions processed pursuant to an interagency agreement--see 317.5 
and 317.70, the Project Officer shall provide an acquisition request 
document (e.g., memorandum, requisition, or other form of transmittal) 
to the CCO or designee, requesting completion of the required action. 
The request must include, as applicable: a SOW/PWS (including 
deliverables and reporting requirements); a certified funding document; 
source selection strategy and criteria; necessary clearances, 
approvals, and justifications (e.g., a JOFOC); a milestone schedule; 
and an independent Government cost estimate.) In addition, OPDIVs shall 
use the content requirements of the AP as a reference in determining 
what other information and documentation is necessary to support the 
intended acquisition. Alternatively, OPDIVs may prescribe use of an AP 
for acquisitions excepted under 307.7101(a)(i) through (a)(viii).


307.7102  Content.

    In accordance with 307.105, the FAR, HHSAR, and other Federal 
requirements that OPDIVs must consider in developing an AP, as well as 
its format, are stipulated in 307.7103. An AP shall address each 
applicable element. As indicated in the instructions, elements that are 
not applicable to an individual acquisition shall be marked ``N/A.'' 
The scope and depth of an AP may vary depending on the nature, 
complexity, and estimated cost of the proposed acquisition. As a result 
of new or revised FAR requirements or other Federal directives, the--
    (a) HCA or designee may make any needed interim changes to the AP;
    (b) HCA or designee shall notify ASFR/OGAPA/DA of the need for 
revision(s) to the acquisition; and
    (c) ASFR/OGAPA/DA shall update the AP, which would supersede any 
interim HCA (or designee) changes made to the acquisition plan for 
future acquisitions.


307.7103  Format.

    (a) HHS has established a standard format for preparing an AP. The 
template for the AP is available on the ASFR/OGAPA/DA Internet Web 
site.
    (b) OPDIVs may use the prescribed format without modification or 
use it as a guideline, as long as the format used by the OPDIV complies 
with the requirements specified in subparagraphs (c) and (d) below.
    (c) An AP must consist of seven (7) parts with standard headings, 
as follows:

Part I Transmittal and Approval Form.
Part II Summary Sheet.
Part III Project Considerations and Information.
Part IV Clearance/Approval Checklist.
Part V Acquisition Milestone Schedule.
Part VI Independent Government Cost Estimate.
Part VII Attachments.

    (d) Within each of the seven parts, there are required components 
that an OPDIV cannot modify and specific areas where OPDIVs can make 
changes. The table in the Requirements and Responsibilities section of 
the AP cites the titles, paragraph/subparagraph headings, narrative, 
and other requirements that must appear in each part of an AP in the 
specified format, as well as permissible modifications.


307.7104  Review and certification.

    Before the Project Officer transmits the AP to the CCO or 
designee--see 307.7105, the head of the sponsoring program office 
(typically a Division Director or equivalent), Project Officer, Funds 
Certification Official, Contracting Officer, and other signatories in 
accordance with OPDIV policies, shall review the AP and certify that it 
provides all required information in the prescribed format and the 
following:
    (a) Vague and ambiguous language has been eliminated.
    (b) A thorough technical review of the SOW/PWS has been completed.
    (c) The project is structured by phases or tasks, as appropriate.
    (d) Methods are available to assess the contractor's performance.
    (e) The acquisition mechanism is appropriate--i.e., the principal 
purpose of the project is to acquire supplies or services for the 
direct benefit or use of the Government.
    (f) The planned obligation of appropriated funds for the project 
satisfies a bona fide need of the requiring office arising in the 
fiscal year for which the appropriation was made.


307.7105  Transmittal.

    The Project Officer shall convey the signed AP to the CCO or 
designee by providing a completed Part I--Transmittal and Approval 
Form, with other parts of the AP attached, no later than the date 
agreed to in the acquisition milestone schedule, unless the officials 
establish a different date by mutual agreement.


307.7106  Acquisition milestones.

    The Contracting Officer shall retain the acquisition milestone 
schedule in the contract file and update/revise it to track progress of 
the acquisition. The milestone schedule signatories (see the 
Requirements and Responsibilities section of the AP--Part V of the 
table) shall mutually agree to any revisions to the milestone dates 
that will impact meeting the scheduled award date. Milestone schedule 
signatories shall

[[Page 62420]]

report a failure to meet established milestones to a higher level 
official in accordance with OPDIV procedures.


307.7107  Responsibilities.

    The following table summarizes the responsibilities of the various 
organizations and officials for acquisition planning:

------------------------------------------------------------------------
                                      Responsible
     Acquisition planning        organization/official   HHSAR reference
------------------------------------------------------------------------
Make necessary interim changes  OPDIV HCA or designee.  307.7102.
 to the AP and notify ASFR/
 OGAPA/DA of changes needed.
Update the AP to reflect new    ASFR/OGAPA/DA.........  307.7102.
 or revised FAR and other
 Federal directives.
Prepare the AAP and update it   OPDIV-HCA/CCO.........  307.104,
 quarterly, as appropriate.                              subparagraph
                                                         (a).
Establish standard acquisition  OPDIV-HCA/CCO.........  307.104,
 lead-times and deadlines for                            subparagraph
 receipt of requirements for                             (d).
 award in an applicable fiscal
 year.
Identify and plan               OPDIV-Project Officer.  307.104,
 requirements, particularly                              subparagraph
 complex, long lead-time                                 (d).
 acquisitions, well in advance
 of the fiscal year in which
 they are to be awarded.
(i) Participate in acquisition  OPDIV-Project Officer.  (i) 307.104,
 planning; (ii) prepare the                              subparagraph
 AP; and (iii) provide the AP                            (c);
 to the Contracting Officer.                            (ii) 307.104,
                                                         subparagraph
                                                         (e); and (iii)
                                                         307.7105.
(i) Participate in acquisition  OPDIV-Contracting       (i) 307.104,
 planning; and (ii) assist the   Officer.                subparagraph
 Project Officer in AP                                   (c);
 preparation.                                           (ii) 307.104,
                                                         subparagraph
                                                         (e).
Waive requirement for           OPDIV-HCA.............  307.7101,
 development of an AP when                               subparagraph
 justified.                                              (b).
Review and certify that an AP   OPDIV-Head of the       307.7104
 is complete, accurate, and in   Sponsoring Program
 the proper format.              Office, Project
                                 Officer, Funds
                                 Certification
                                 Official, Contracting
                                 Officer, and other
                                 signatories in
                                 accordance with OPDIV
                                 policies.
Meet established acquisition    OPDIV-Project Officer   307.7106.
 milestone dates.                and Contracting
                                 Officer.
------------------------------------------------------------------------

307.7108  Statement of work.

    (a) General. An SOW describes the work or services a contractor is 
to perform in reaching an end result without describing the method that 
the contractor shall use, unless the method of performance is critical 
or required in order to obtain successful performance. An SOW shall be 
clear and concise; completely define the responsibilities of both the 
contractor and the Government; and be worded to make misinterpretation 
virtually impossible.
    (b) Term (level of effort)form and completion form SOWs. Term-form 
(level of effort) SOWs essentially require the furnishing of technical 
effort, which may include a report thereof, while completion-form SOWs 
require development of tangible items designed to meet specific 
performance and/or design characteristics--see FAR 16.306(d) for this 
distinction.
    (1) Term (or level of effort). A term or level of effort-form SOW 
is appropriate for research where the objective is to discover the 
feasibility of later development or to gather general information. A 
term or level of effort-form SOW specifies that some number of labor 
hours be expended on a particular course of research or that a certain 
number of tests be run, without reference to any intended conclusion.
    (2) Completion. A completion-form SOW is appropriate for 
development work where the feasibility of producing an end item is 
already known. A completion-form SOW may describe what is to be 
achieved through the contracted effort, such as development of new 
methods, new end items, or other tangible results.
    (c) Phasing. Individual research, development, or demonstration 
projects frequently lie well beyond the present state of the art and 
entail procedures and techniques of great complexity and difficulty. 
Under these circumstances, a contractor, no matter how carefully 
selected, may be unable to deliver the desired result. Moreover, the 
job of evaluating the contractor's progress is often difficult. Such a 
contract is frequently phased and often divided into stages of 
accomplishment, each of which the contractor must complete and the 
Contracting Officer approve before the contractor may proceed to the 
next phase or stage. Phasing makes it necessary to develop methods and 
controls, including reporting requirements for each phase of the 
contract and criteria for evaluation of the report submitted, that will 
provide, at the earliest possible time, appropriate data for making 
decisions relative to future phases. A phased contract, such as one for 
an R & D or demonstration project, may include stages of 
accomplishment. Within each phase, there may be a number of tasks that 
the SOW should include. When phases of work can be identified, the SOW 
shall provide for phasing and the solicitation shall require offerors 
to submit proposed costs by phases. The resultant contract shall 
reflect costs by phases, require the contractor to identify incurred 
costs by phases, establish delivery schedules by phase, and require the 
written acceptance of each phase. The Contracting Officer shall not 
allow contractors to incur costs for phases that are dependent upon 
successful completion of earlier phases until the Contracting Officer 
provides written acceptance of the prior work.
    (d) Elements of the SOW. The elements of the SOW may vary with the 
objective, complexity, size, and nature of the acquisition. In general, 
the SOW shall include the following:
    (1) Purpose of the project. This includes a general description of 
the objectives of the project and the desired results.
    (2) Background information. This includes a brief history of the 
project and the importance of the project to the overall program 
objectives.
    (3) A detailed description of the technical requirements. The SOW 
shall provide sufficient detail to accurately reflect the Government's 
requirement. It shall state what is to be accomplished without 
prescribing the method the contractor is to use and shall include 
performance standards, if applicable. See 307.104(b)(2) and FAR 37.602 
for guidance on preparation of a PWS. An SOW may include tasks and 
subtasks. The degree of breakout depends on the size and complexity of 
the project. An

[[Page 62421]]

SOW shall indicate whether the tasks are sequential or concurrent.
    (4) Reference material. This includes an explanation of all 
reference material a contractor needs to carry out the project; the 
applicability of the reference material; and a statement as to where 
potential offerors can obtain the material.
    (5) Level of effort. When a level of effort is necessary, the SOW 
shall specify the number and type of personnel required, if known, and 
the type and degree of expertise.
    (6) Special requirements (as applicable). This includes providing, 
in a separate section, any unusual or special contractual requirements 
that may affect performance. For example, the SOW shall specify 
separately the work requirements to implement information security 
management requirements--see 339.71 for additional information.
    (7) Deliverables and reporting requirements. This includes clearly 
and completely describing all deliverables and reports, including the 
time frame for completion, the format, and the required number of 
copies.

PART 308--REQUIRED SOURCES OF SUPPLIES AND SERVICES

Subpart 308.4--Federal Supply Schedules
Sec.
308.404 Use of Federal Supply Schedules.
308.405-6 Limited source justification and approval.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 308.4--Federal Supply Schedules


308.404  Use of Federal Supply Schedule.

    (f) Technical Evaluation. When conducting a technical evaluation of 
quotations or proposals received under FAR Part 8, the provisions of 
315.305(a)(3) apply.


308.405-6  Limited source justification and approval.

    (g) (1) As required by FAR 8.405-1 or 8.405-2, the responsible 
program office must provide a written justification whenever it 
requests an acquisition under the FSS program that restricts 
consideration of the number of schedule contractors or to an item 
peculiar to one manufacturer. The justification must be submitted with 
the AP or other acquisition request document--see 307.71. The Project 
Officer has responsibility for preparing the justification with 
assistance, as necessary, from the Contracting Officer.
    (i) Justifications for orders at or below the simplified 
acquisition threshold may be in the form of a paragraph or paragraphs 
contained in the requisition or other acquisition request document. 
Justifications for orders in excess of the simplified acquisition 
threshold shall be in the form of a separate, self-contained document, 
prepared in accordance with FAR 8.405-6(g) and 308.405-6(g), and titled 
``Limited Source Justification'' (LSJ). HHS requires use of a standard 
format for an LSJ. The template for the justification is available on 
the ASFR/OGAPA/DA Internet Web site. Additional information may be 
included in the LSJ template in accordance with OPDIV procedures.
    (ii) Regardless of dollar amount of the acquisition, justifications 
shall--
    (A) Fully describe what is to be acquired;
    (B) Cite specific reasons that explain why it is necessary to 
restrict consideration of sources;
    (C) Be supported by verifiable facts rather than untested or 
unsubstantiated opinions or conclusions; and
    (D) Be written in a manner to permit an individual without 
technical knowledge of the requirement to understand the supporting 
rationale.
    (iii) Preliminary arrangements with, or verbal or written 
commitments to, a proposed contractor shall be avoided given the 
requirement to obtain competition for FSS orders using the procedures 
in FAR Subpart 8.4--see also FAR 6.102(d)(3).
    (iv) Justifications for non-FSS orders to be awarded without full 
and open competition shall comply with FAR 6.303 and 306.303.
    (h) Justification approvals.
    Certification, concurrence, and approval requirements. The Project 
Officer, the Project Officer's immediate supervisor, the head of the 
sponsoring program office, and the Contracting Officer shall certify 
that the justification is accurate and complete by signing the LSJ. For 
acquisitions in the dollar amount cited in FAR 8.405-6(h)(2) through 
(h)(4), the CCO, if applicable, and the HCA shall indicate their review 
of, and concurrence with, the justification by signing the LSJ. The 
approving officials for LSJs are as follows:
    (1) The Contracting Officer shall exercise this approval authority 
unless a higher approval level is required by OPDIV procedures.
    (2) The CAs are listed in 306.501. This approval authority is not 
delegable.
    (3) The CA shall exercise this approval authority, except where the 
individual designated as the competition advocate does not meet the 
requirements of FAR 8.405-6(h)(3)(ii). This approval authority is not 
delegable.
    (4) The HHS SPE is the Associate DAS for Acquisition.

PART 309--CONTRACTOR QUALIFICATIONS

Subpart 309.4--Debarment, Suspension, and Ineligibility
Sec.
309.403 Definitions.
309.404 List of parties excluded from Federal procurement and non-
procurement programs.
309.405 Effect of listing.
309.406 Debarment.
309.406-3 Procedures.
309.407 Suspension.
309.407-3 Procedures.
309.470 Reporting of suspected causes for debarment or suspension or 
the taking of evasive actions.
309.470-1 Situations where reports are required.
309.470-2 Contents of reports.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 309.4--Debarment, Suspension, and Ineligibility


309.403  Definitions.

    Acquiring agency's head or designee, as used in the FAR, means, 
unless otherwise stated in this subpart, the HCA. The HCA may make the 
required justifications or determinations and take the necessary 
actions specified in FAR 9.405, 9.406 and 9.407, only after obtaining 
the written approval of the debarring or suspending official, as 
appropriate.
    Debarring official means the Deputy Assistant Secretary for Grants 
and Acquisition Policy and Accountability (DAS/GAPA).
    Initiating official means the Contracting Officer, the HCA, the 
Associate DAS for Acquisition, or the Inspector General (IG).
    Suspending official means the DAS/GAPA.


309.404  List of parties excluded from Federal procurement and non-
procurement programs.

    (c) The ASFR/OGAPA/DA shall perform the actions required by FAR 
9.404(c).
    (4) The ASFR/OGAPA/DA shall maintain all documentation the 
initiating official submits to recommend the debarment or suspension 
action and all correspondence and other pertinent documentation 
generated during the review.


309.405  Effect of listing.

    (a) The HCA (non-delegable) may, with the written concurrence of 
the debarring or suspending official, make the determinations 
referenced in FAR 9.405(a) regarding contracts.

[[Page 62422]]

    (1) If a Contracting Officer considers it necessary to award a 
contract, or consent to a subcontract with a debarred or suspended 
contractor, the Contracting Officer shall prepare a determination, 
including all pertinent documentation, and submit it through 
appropriate acquisition channels to the HCA. The documentation shall 
include the date by which approval is required and a compelling reason 
for the proposed action. Compelling reasons for award of a contract or 
consent to a subcontract with a debarred or suspended contractor 
include the following:
    (i) Only the cited contractor can provide the property or services.
    (ii) The urgency of the requirement dictates that HHS conduct 
business with the cited contractor.
    (2) If the HCA decides to approve the requested action, the HCA 
shall request the concurrence of the debarring or suspending official 
and, if given, shall inform the Contracting Officer in writing of the 
decision within the required time period.


309.406  Debarment.


309.406-3  Procedures.

    (a) Investigation and referral. When an apparent cause for 
debarment becomes known, the initiating official shall prepare a report 
containing the information required by 309.470-2, along with a written 
recommendation, and forward it through appropriate acquisition 
channels, including the HCA, to the Associate DAS for Acquisition in 
accordance with 309.470-1. The debarring official shall initiate an 
investigation.
    (b) Decision making process. The debarring official shall review 
the results of the investigation, if any, and make a written 
determination whether or not debarment procedures shall commence. The 
ASFR/OGAPA/DA shall promptly send a copy of the determination through 
appropriate acquisition channels to the initiating official and the 
Contracting Officer. If the debarring official determines that 
debarment procedures shall commence, the debarring official shall 
consult with OGC-GLD and then notify the contractor in accordance with 
FAR 9.406-3(c). If the proposed action is not based on a conviction or 
judgment and the contractor's submission in response to the notice 
raises a genuine dispute over facts material to the proposed debarment, 
the debarring official shall arrange for fact-finding hearings and take 
the necessary action specified in FAR 9.406-3(b)(2). The debarring 
official shall also ensure that written findings of facts are prepared 
and shall base the debarment decisions on the facts as found, after 
considering information and argument submitted by the contractor and 
any other information in the administrative record. The OGC-GLD shall 
represent HHS at any fact-finding hearing and may present witnesses for 
HHS and question any witnesses presented by the contractor.


309.407  Suspension.


309.407-3  Procedures.

    (a) Investigation and referral. When an apparent cause for 
suspension becomes known, the initiating official shall prepare a 
report containing the information required by 309.470-2 along with a 
written recommendation and forward it through appropriate acquisition 
channels, including the HCA, to the suspending official in accordance 
with 309.470-1. The suspending official shall initiate an 
investigation.
    (b) Decision making process. The suspending official shall review 
the results of the investigation, if any, and make a written 
determination whether or not suspension shall occur. ASFR/OGAPA/DA 
shall send a copy of the determination through appropriate acquisition 
channels to the initiating official and the Contracting Officer. If the 
suspending official determines that suspension is necessary, the 
suspending official shall consult with OGC-GLD and then notify the 
contractor in accordance with FAR 9.407-3(c). If the action is not 
based on an indictment, and, subject to the provisions of FAR 9.407-
3(b) (2), the contractor's submission in response to the notice raises 
a genuine dispute over facts material to the suspension, the suspending 
official shall, after imposing the suspension, arrange for fact-finding 
hearings and take the necessary actions specified in FAR 9.407-3(b)(2).


309.470   Reporting of suspected causes for debarment or suspension or 
the taking of evasive actions.


309.470-1   Situations where reports are required.

    The Contracting Officer shall forward a report, incorporating the 
information required by 309.470-2, through appropriate acquisition 
channels, including the HCA, to the Associate DAS for Acquisition 
whenever a contractor--
    (a) Has committed, or is suspected of having committed, any of the 
acts described in FAR 9.406-2 or FAR 9.407-2; or
    (b) Is suspected of attempting to evade the prohibitions of 
debarment or suspension imposed under this subject, or any other 
comparable regulation, by changes of address, multiple addresses, 
formation of new companies, or by other devices.


309.470-2   Contents of reports.

    The Contracting Officer shall coordinate each report prepared under 
309.470-1 with OGC-GLD and include the following information, when 
available:
    (a) Contractor name and address.
    (b) Name of the principal officers, partners, owners, or managers.
    (c) All known affiliates, subsidiaries, or parent firms, and the 
nature of the affiliation.
    (d) Description of the contract or contracts concerned, including 
the contract number and office identifying numbers or symbols; the 
amount of each contract; the amount paid to the contractor and the 
amount still due; and the percentage of work completed and to be 
completed.
    (e) The status of vouchers.
    (f) Whether contract funds have been assigned pursuant to the 
Assignment of Claims Act, as amended, (31 U.S.C. 3727, 41 U.S.C. 15), 
and, if so assigned, the name and address of the assignee and a copy of 
the assignment.
    (g) Whether any other contracts are outstanding with the contractor 
or any affiliates, and, if so, the amount of the contracts, whether 
these funds have been assigned pursuant to the Assignment of Claims 
Act, as amended, (31 U.S.C. 3727, 41 U.S.C. 15), and the amounts paid 
or due on the contracts.
    (h) A complete summary of all available pertinent evidence.
    (i) A recommendation as to the continuation of current contracts.
    (j) An estimate of damages, if any, sustained by the Government as 
a result of the contractor's action, including an explanation of the 
method used in making the estimate.
    (k) The comments and recommendations of the Contracting Officer and 
statements indicating whether the contractor should be suspended or 
debarred, whether any limitations are necessary, and the period of any 
proposed debarment.
    (l) As an enclosure, a copy of the contract(s) or pertinent 
excerpts therefrom, appropriate exhibits, testimony or statements of 
witnesses, copies of assignments, and other relevant documentation or a 
written summary of any information for which documentation is not 
available.

[[Page 62423]]

PART 310--MARKET RESEARCH

Sec.
 310.001 Policy.


    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

310.001 Policy.

    (a) OPDIVs are encouraged to conduct market research, to the 
maximum extent practicable, consistent with the urgency, complexity, 
and dollar value of a proposed acquisition, as well as their past 
experience with the same or similar requirements.
    (3) (i) An OPDIV may issue an advance notice, entitled ``Sources 
Sought'' in FedBizOpps in accordance with the requirements of FAR Part 
5, whenever a sufficient number of sources has not been identified to 
obtain adequate competition for a non-R & D project. The primary 
purpose of a Sources Sought notice is to identify all potential 
sources, regardless of organizational type and size classification, and 
determine their capabilities to fulfill a potential Government 
requirement. The notice is not intended to solicit technical, 
scientific, or business information for project planning purposes 
regarding existing or potential solutions. In the latter instance, an 
RFI may be used--see FAR 15.201(e) and 315.201(e).
    (ii) When using a Sources Sought notice, an OPDIV shall not request 
that potential sources provide more than the minimum information 
necessary--see FAR 10.001(b), to determine whether they have the 
apparent capability to perform a requirement and, therefore, whether 
they should be included in any future competition. The notice and the 
information received shall not be used to determine how well 
respondents can perform a requirement, which can only be evaluated in 
response to a solicitation. Accordingly, the notice shall not be used 
to--
    (A) Obtain capability statements that are evaluated and determined 
acceptable or unacceptable;
    (B) Require cost/price proposals or detailed technical solutions;
    (C) Identify a prospective sole source; or
    (D) Exclude small business concerns.
    (iii) While not the primary intent of a Sources Sought notice, in 
addition to seeking information regarding all potential qualified 
sources, the notice may request that respondents provide information 
regarding their organizational size classification. For example, the 
notice may ask respondents to identify whether they are small 
businesses; HUBZone small businesses; service-disabled, veteran-owned 
small businesses; 8(a) small businesses; veteran-owned small 
businesses; woman-owned small businesses; or small disadvantaged 
businesses in order to determine the appropriate acquisition method, 
including whether a set-aside is possible. However, such a notice shall 
not be used solely to determine the size classification of respondents 
for a proposed non-R & D acquisition. In such instances, a ``Small 
Business Sources Sought'' notice may be used--see 319.202-2, in lieu of 
the procedures in this section.
    (iv) OPDIVs shall follow the standard HHS instructions for 
completing a Sources Sought notice. The Contracting Officer shall post 
the notice in FedBizOpps by selecting and completing a Sources Sought 
notice. The template for the notice is available on the ASFR/OGAPA/DA 
Internet Web site. Additional information may be included in the notice 
in accordance with OPDIV procedures. The Contracting Officer shall 
document, in the form of a memorandum to the file, the results of the 
review by technical personnel of information submitted in response to 
the notice, including whether each respondent appears to be capable of 
performing the requirement. The Contracting Officer shall attach a copy 
of the analysis provided by the technical personnel to the memorandum.
    (v) In instances where a sufficient number of sources has not been 
identified to compete for an R & D project, OPDIVs may use the 
procedures specified in 305.205, including the issuance of an ``R & D 
Sources Sought'' notice, as appropriate, in lieu of the procedures in 
this section.

PART 311--DESCRIBING AGENCY NEEDS

Subpart 311.70--Section 508 Accessibility Standards
Sec.
311.7000 Defining electronic information technology requirements.
311.7001 Section 508 accessibility standards for HHS Web site 
content and communication materials.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 311.70--Section 508 Accessibility Standards


311.7000  Defining electronic information technology requirements.

    HHS staff that define agency needs for EIT products and services, 
including EIT deliverables such as electronic documents and reports, 
and perform market research to meet those needs, shall document EIT 
requirements, identify the applicable Section 508 accessibility 
standards, and document the market research. OPDIVs may develop 
procedures for these activities, based on the level of agency 
investment and risk, and shall ensure any procedures developed are in 
conformance with FAR Part 10. Procedures for defining EIT requirements 
may, but are not required to, include the use of the Buy Accessible 
Wizard (http://www.buyaccessible.gov), managed by GSA, or other Federal 
agency tools.


311.7001  Section 508 accessibility standards for HHS Web site content 
and communications materials.

    (a) Section 508 of the Rehabilitation Act of 1973 [29 U.S.C. 
794(d)], as amended by the Workforce Investment Act of 1998, (Section 
508) specifies the accessibility standards that apply to all new 
solicitations and new or existing contracts or orders, regardless of 
dollar amount, for communications products and services that require a 
contractor or consultant to produce content in any format that is 
specifically intended for publication on, or delivery via, an HHS-owned 
or -funded Web site.
    (b) Accordingly, before forwarding a request to the contracting/
ordering office for the acquisition of communications products and 
services, including content in any format, such as reports, documents, 
charts, posters, presentations (such as Microsoft PowerPoint), or video 
material that is specifically intended for publication on, or delivery 
via, an HHS-owned or -funded Web site, the Project Officer shall 
consult with the OPDIV/STAFF Division (DIV) Section 508 Official or 
Coordinator, as necessary, to determine the applicability of Section 
508, identify applicable Section 508 accessibility standards, and 
resolve any related issues.
    (c) Based on those discussions, the Project Officer shall provide a 
statement in the AP (or other acquisition request document)--see 
307.7101, as to the applicability of Section 508. If Section 508 
applies to an acquisition, the Project Officer shall include the 
following ``HHS Section 508 Accessibility Standards Notice'' language 
in a separate, clearly designated section of the SOW/PWS, and any 
additional information applicable to the acquisition's Section 508 
accessibility standards [e.g., the list of applicable accessibility 
standards of the Architectural and Transportation Barriers Compliance 
Board (Access Board) Final Rule (36 CFR Part 1194)]. If an AP does not 
address these issues, and it appears an acquisition involves

[[Page 62424]]

Section 508, or if the discussion of Section 508 applicability to the 
acquisition is inadequate or incomplete, the Contracting Officer shall 
request that the Project Officer modify the AP accordingly.

HHS Section 508 Accessibility Standards Notice (September 2009)

    This contract is subject to Section 508 of the Rehabilitation Act 
(the Act) of 1973 (29 U.S.C. 794d), as amended by the Workforce 
Investment Act of 1998, and the Architectural and Transportation 
Barriers Compliance Board (Access Board) Electronic and Information 
Accessibility Provisions (36 CFR Part 1194). Section 508 of the Act 
requires that, unless an exception applies, all communications products 
and services that require a contractor or consultant to produce content 
in any format that is specifically intended for publication on, or 
delivery via, a Federally owned or Federally funded Web site permit the 
following:
    (1) Federal employees with disabilities to have access to and use 
information and data that is comparable to the access and use of 
information and data by Federal employees who are not individuals with 
disabilities.
    (2) Members of the public with disabilities seeking information or 
services from a Federal agency to have access to and use of information 
and data that is comparable to the access and use of information and 
data by members of the public who are not individuals with 
disabilities.

    Note: Information about Section 508 of the Act is available at 
http://www.section508.gov/. The complete text of Section 508 can be 
accessed at http://www.access-board.gov/sec508/provisions.htm.

    Accordingly, regardless of format, all Web content or 
communications materials specifically produced for publication on, or 
delivery via, HHS Web sites, including text, audio, or video, under 
this contract shall conform to applicable Section 508 accessibility 
standards. Remediation of any materials that do not comply with the 
applicable accessibility standards of 36 CFR Part 1194 as set forth 
herein shall be the responsibility of the Contractor.
    The following Section 508 accessibility standards apply to the 
content or communications material identified in this SOW or PWS:

    Note: The Project Officer shall list the applicable 
accessibility standards of the Access Board Final Rule (36 CFR Part 
1194) (e.g., ``36 CFR 1194.21(a)-(j).'' Most Web-based text and 
communication must meet the accessibility standards in 36 CFR 
1194.22, ``Web-based intranet and Internet information and 
applications.'' Additionally, 36 CFR 1194.41, ``Information, 
documentation and support,'' and 36 CFR 1194.24 ``Video and 
multimedia products'' apply to all written, graphical, or broadcast 
video materials or products produced for HHS, including training. 36 
CFR 1194.41(c) specifies that support services for products shall 
accommodate the communication needs of end-users with disabilities.

PART 312--ACQUISITION OF COMMERCIAL ITEMS

Subpart 312.1--Acquisition of Commercial Items--General
Sec.
312.101 Policy
Subpart 312.2--Special Requirements for the Acquisition of Commercial 
Items.
312.202(d) Market research and description of agency need.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 312.1--Acquisition of Commercial Items--General


312.101  Policy.

    (a) It is HHS policy to leverage its buying power, reduce 
acquisition administrative costs, and develop long-term, mutually 
beneficial partnerships with best-in-class providers of products and 
services. Accordingly, HHS has implemented a Strategic Sourcing Program 
through which it awards BPAs or other contract vehicles to achieve 
savings for commercial items and services across HHS and make the 
acquisition process more efficient. OPDIVs shall use HHS' strategic 
sourcing vehicles to the maximum extent possible--see the HHS strategic 
sourcing portion of the ASFR/OGAPA/DA intranet site for further 
information.

Subpart 312.2--Special Requirements for the Acquisition of 
Commercial Items


312.202(d)  Market research and description of agency need.

    Whenever an OPDIV/STAFFDIV requires EIT products and services 
subject to Section 508 of the Rehabilitation Act of 1973, as amended, 
commercially available products and services shall be acquired to the 
maximum extent possible while ensuring Section 508 compliance. 
Consistent with paragraph 4.3.1 of the HHS Section 508 policy--see 
Section 508 policy on the HHS Office on Disability Web site, if 
products and services are commercially available that meet some but not 
all of the applicable Section 508 accessibility standards, and no 
commercially available products or services meet all of the applicable 
Section 508 accessibility standards, an OPDIV/STAFFDIV shall acquire 
the products and services that best meet the applicable Section 508 
accessibility standards. Commercial nonavailability exception 
determinations for EIT products and services that do not meet some or 
all of the applicable Section 508 accessibility standards shall be 
processed in accordance with 339.203.

SUBCHAPTER C--CONTRACTING METHODS AND CONTRACT TYPES

PART 313--SIMPLIFIED ACQUISITION PROCEDURES

Sec.
313.003 Policy.
Subpart 313.1--Procedures.
313.106-2 Evaluation of quotations or offers.
Subpart 313.3--Simplified Acquisition Methods
313.301 Government-wide commercial purchase card.
313.303 Blanket purchase agreements.
313.303-5 Purchases under blanket purchase agreements.
Subpart 313.5--Test Program for Certain Commercial Items
313.501 Special documentation requirements.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).


313.003  Policy.

    EIT products and services, including EIT deliverables such as 
electronic documents and reports, acquired pursuant to FAR Part 13 
shall comply with Section 508 of the Rehabilitation Act of 1973, as 
amended. Consistent with paragraph 4.3.1 of the HHS Section 508 
policy--see Section 508 policy on HHS Office on Disability Web site, if 
products and services, including commercially available items, meet 
some but not all of the applicable Section 508 accessibility standards, 
and no commercially available products or services meet all of the 
applicable Section 508 accessibility standards, an OPDIV/STAFFDIV shall 
acquire the products and services that best meet the applicable Section 
508 accessibility standards. Commercial nonavailability exception 
determinations for EIT products and services that do not meet some or 
all of the applicable Section 508 accessibility standards shall be 
processed in accordance with 339.203.

Subpart 313.1--Procedures


313.106-2  Evaluation of quotations or offers.

    (b)(5) Technical Evaluation. When conducting a technical evaluation 
of quotations or proposals received under FAR Part 13, the provisions 
of 315.305(a)(3) apply.

[[Page 62425]]

Subpart 313.3--Simplified Acquisition Methods


313.301  Government-wide commercial purchase card.

    (b) HHS' procedures for the use and control of the Government-wide 
commercial purchase card may be found in the HHS Purchase Card Program 
Guide, available on the ASFR/OGAPA/DA Web site.
    (1) ASFR/OGAPA/DA has overall responsibility for monitoring the 
OPDIVs' implementation of the HHS purchase card program to foster 
compliance with FAR 13.301; OMB Circular A-123, Appendix B, ``Improving 
the Management of Government Charge Card Programs;'' GSA's SmartPay 
Program guidance; and HHS Purchase Card program standards.
    (2) The OPDIVs, through their designated Agency/Organization 
Program Coordinators, are responsible for establishing the necessary 
local procedures and appropriate training requirements to ensure 
effective implementation of the HHS purchase card program.
    (3) OPDIVs shall refer to 313.003 and the HHS Purchase Card Program 
Guide for information regarding acquiring EIT products and services 
subject to Section 508 of the Rehabilitation Act of 1973, as amended.


313.303   Blanket purchase agreements.


313.303-5   Purchases under blanket purchase agreements.

    (e)(5) HHS personnel that sign delivery documents, invoices, etc., 
verifying the receipt of an item or service shall forward such 
documents to the fiscal office or other paying office that the OPDIV 
designates. The fiscal or other paying officer shall use the signed 
document, invoice, etc., as the basis for payment. Alternatively, 
OPDIVs may use electronic methods to document, and transmit to the 
paying office, the receipt, inspection, and acceptance of items or 
services for payment purposes, provided such methods are authorized in 
local fiscal procedures. Contracting offices shall establish procedures 
to ensure that funds are available prior to placement of orders.

Subpart 313.5--Test Program for Certain Commercial Items


313.501  Special documentation requirements.

    (a) (1)
    (i) The justification requirements of 306.303-1(b) and 306.303-
1(b)(1) through (b)(4) apply to proposed noncompetitive acquisitions 
placed under FAR Subpart 13.5.
    (ii) The HHS standard format for JOFOCs cited in 306.303-1(b)(1) 
shall be used to support noncompetitive acquisitions in excess of the 
simplified acquisition threshold placed under FAR Subpart 13.5.
    (iii) The certification, concurrence, and approval requirements 
cited in 306.304 for JOFOCs apply to applicable noncompetitive 
acquisitions placed under FAR Subpart 13.5.
    (2)
    (i) The Contracting Officer shall exercise this approval authority 
unless a higher approval level is required by OPDIV procedures.
    (ii) The CAs are listed in 306.501. This approval authority is not 
delegable.
    (iii) The CA shall exercise this approval authority, except where 
the individual designated as the competition advocate does not meet the 
requirements of FAR 6.304(a)(3)(ii). This approval authority is not 
delegable.
    (iv) The HHS SPE is the Associate DAS for Acquisition.

PART 314--SEALED BIDDING

Subpart 314.1--Use of Sealed Bidding
Sec.
314.103 Policy.
Subpart 314.2--Solicitation of Bids
314.202 General rules for solicitation of bids.
314.202-7 Facsimile bids.
Subpart 314.4--Opening of Bids and Award of Contract
314.404 Rejection of bids.
314.404-1 Cancellation of invitations after opening.
314.407 Mistakes in bids.
314.407-3 Other mistakes disclosed before award.
314.407-4 Mistakes after award.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 314.1--Use of Sealed Bidding


314.103  Policy.

    EIT products and services, including EIT deliverables such as 
electronic documents and reports, acquired using sealed-bid procedures 
shall comply with Section 508 of the Rehabilitation Act of 1973, as 
amended. Consistent with paragraph 4.3.1 of the HHS Section 508 
policy--see Section 508 policy on HHS Office of Disability Web site, if 
products and services, including commercially available items, meet 
some but not all of the applicable Section 508 accessibility standards, 
and no commercially available products or services meet all of the 
applicable Section 508 accessibility standards, an OPDIV/STAFFDIV shall 
acquire the products and services that best meet the applicable Section 
508 accessibility standards. Commercial nonavailability exception 
determinations for EIT products and services that do not meet some or 
all of the applicable Section 508 accessibility standards shall be 
processed in accordance with 339.203.

Subpart 314.2--Solicitation of Bids


314.202  General rules for solicitation of bids.


314.202-7  Facsimile bids.

    (c) If the HCA (non-delegable) determines that the contracting 
activity will allow use of facsimile bids and proposals, the HCA shall 
prescribe internal procedures, in accordance with the FAR 14.202-7, to 
ensure uniform processing and control.

Subpart 314.4--Opening of Bids and Award of Contract


314.404  Rejection of bids.


314.404-1  Cancellation of invitations after opening.

    (c) The HCA or CCO (non-delegable) shall make the agency head 
determinations specified in FAR 14.404-1.


314.407   Mistakes in bids.


314.407-3   Other mistakes disclosed before award.

    (e) The CCO (non-delegable) has the authority to make 
determinations under paragraphs (a), (b), (c), and (d) of FAR 14.407-3.
    (f) OGC-GLD shall concur in each proposed determination.
    (i) The CCO shall submit directly to OGC-GLD cases in which the 
evidence is not clear and convincing or is otherwise doubtful.


314.407-4  Mistakes after award.

    (c) The HCA or the CCO (non-delegable), in consultation with OGC-
GLD, has the authority to make administrative determinations in 
connection with mistakes in bid alleged after award.
    (d) OGC-GLD shall concur in each proposed determination.

PART 315--CONTRACTING BY NEGOTIATION

Subpart 315.2--Solicitation and Receipt of Proposals and Information
Sec.
315.201 Exchanges with industry before receipt of proposals.
315.204-5 Part IV--Representations and instructions.
315.208 Submission, modification, revision, and withdrawal of 
proposals.
315.209 Solicitation provisions and contract clauses.

[[Page 62426]]

Subpart 315.3--Source Selection.
315.303-70 Policy.
315.304 Evaluation factors and significant subfactors.
315.305 Proposal evaluation.
315.306 Exchanges with offerors after receipt of proposals.
315.307 Proposal revisions.
315.370 Finalization of details with the selected source.
315.371 Contract preparation and award.
315.372 Preparation of negotiation memorandum.
Subpart 315.4--Contract Pricing
315.404 Proposal analysis.
315.404-2 Information to support proposal analysis.
315.404-4 Profit.
Subpart 315.6--Unsolicited Proposals
315.605 Content of unsolicited proposals.
315.606 Agency procedures.
315.606-1 Receipt and initial review.
315.609 Limited use of data.
Subpart 315.70--Acquisition of Electronic Information Technology
315.7000 Section 508 accessibility standards.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 315.2--Solicitation and Receipt of Proposals and 
Information


315.201  Exchanges with industry before receipt of proposals.

    (e)(1) An OPDIV may issue an advance notice, entitled ``Request for 
Information,'' in accordance with the requirements of FAR 15.201(e), 
whenever it requires technical, scientific, and/or business information 
and input from the marketplace for project planning purposes regarding 
the availability of existing or potential solutions. An RFI may be used 
for any type of requirement, but is particularly appropriate for 
complex projects involving R & D, IT, construction, and other highly 
technical requirements. An RFI may also be issued to identify issues 
about the Government's requirements and the planned acquisition 
strategy. Use of an RFI generally is appropriate under the following 
conditions:
    (i) It is not clear whether the purpose and performance 
requirements of a potential or planned project are feasible, 
achievable, and complete.
    (ii) It is not certain that a solution, technical approach, or 
product needed to accomplish a potential or planned project exists or 
can be developed, particularly in the case of a new, highly 
specialized/unique Government program mandate.
    (iii) It is necessary to test the marketplace to determine if there 
are questions or concerns regarding the use of a new or innovative 
acquisition strategy or instrument previously untried to accomplish a 
potential or planned project.
    (iv) It is necessary to determine the general effort or time 
(estimate or rough order of magnitude) that may be required to 
accomplish a potential or planned project.

    Note: This type of information may be requested, only if it is 
necessary, broad in scope, and required for planning purposes. 
Detailed estimates must not be requested.

    (v) It is necessary to ensure that unduly restrictive technical or 
business/acquisition requirements are not made part of any resultant 
solicitation so that maximum competition is generated.
    (2) When using an RFI, an OPDIV shall not request that potential 
sources provide more than the minimum information necessary--see FAR 
10.001(b), to obtain the input required. The notice and the information 
received shall not be used to determine how well respondents can 
perform a requirement, which can only be evaluated in response to a 
solicitation. Accordingly, the notice shall not be used to--
    (i) Obtain capability statements that are evaluated and determined 
acceptable or unacceptable;
    (ii) Require cost/price proposals or detailed technical solutions;
    (iii) Identify a prospective sole source; or
    (iv) Exclude small business concerns.
    (3) While not the primary intent of an RFI, an OPDIV may 
additionally request that respondents provide information regarding 
their organizational size classification and capabilities when the 
OPDIV is uncertain whether any organization, acting individually or in 
partnership with others, can satisfy the requirement. For example, the 
notice may ask respondents to identify whether they are small 
businesses; HUBZone small businesses; service-disabled, veteran-owned 
small businesses; 8(a) small businesses; veteran-owned small 
businesses; woman-owned small businesses; or a small disadvantaged 
businesses. However, an RFI shall not be used solely to determine the 
availability of qualified sources for a proposed project or to 
determine their size classification. In such instances, as applicable, 
an R & D Sources Sought notice, Sources Sought notice, or Small 
Business Sources Sought notice may be used--see HHSAR 305.205, 310.001, 
and 319.202-2.
    (4) OPDIVs shall follow the standard HHS instructions for 
completing an RFI. The template for an RFI is available on the ASFR/
OGAPA/DA Internet Web site. The Contracting Officer shall post the 
notice in FedBizOpps by selecting and completing a Special Notice, 
accessible on the FedBizOpps ``Notices'' page at: http://www.fedbizopps.gov. RFIs must be published, at a minimum, in 
FedBizOpps--see FAR 10.002(b)(2)(iii) and 15.201(d). Additional 
information may be included in an RFI in accordance with OPDIV 
procedures. The Contracting Officer shall document, in the form of a 
memorandum to the file, the results of the review by technical 
personnel of information submitted in response to the notice, including 
whether each respondent appears to be capable of performing the 
requirement. The Contracting Officer shall attach a copy of the 
analysis provided by the technical personnel to the memorandum.


 315.204-5  Part IV--Representations and instructions.

    (c) Section M, Evaluation factors for award.
    (1) General.
    (i) The Project Officer shall develop technical evaluation factors 
and submit them to the Contracting Officer as part of the acquisition 
plan or other acquisition request documentation for inclusion in a 
solicitation. The Project Officer shall indicate the relative 
importance or weight of the evaluation factors based on the 
requirements of an individual acquisition. Since the evaluation factors 
will serve as the standard for proposal evaluation, they require 
careful selection.
    (ii) Only a formal amendment to a solicitation can change the 
evaluation factors. Evaluation of proposals shall include only those 
factors set forth in a solicitation.
    (2) Review of evaluation factors.
    (i) The Contracting Officer shall review evaluation factors to 
ensure they are consistent with the SOW/PWS. This review is not 
intended to dictate technical requirements to the program office or 
Project Officer, but rather to ensure that the evaluation factors are 
clear, concise, and fair, so that all potential offerors are fully 
aware of the bases for proposal evaluation and are given an equal 
opportunity to compete.
    (ii) The Project Officer and the Contracting Officer shall review 
the evaluation factors to ascertain the following:
    (A) The factors address the key programmatic concerns which the 
offerors must be aware of in preparing proposals.
    (B) The factors are specifically applicable to the current 
acquisition and are not restatements of factors from previous 
acquisitions which are not relevant.

[[Page 62427]]

    (C) The factors represent only the significant areas of importance, 
rather than a multitude of factors. (Note: All factors tend to lose 
importance, if too many are included; and using too many factors may 
prove as detrimental as using too few.)
    (3) Examples of topics that form a basis for evaluation factors. 
Typical examples of topics that form a basis for the development of 
evaluation factors are listed in the following paragraphs. These 
examples may assist in the development of actual evaluation factors for 
a specific acquisition, as appropriate.
    (i) Understanding of the SOW/PWS.
    (ii) Method of accomplishing the objectives and intent of the SOW/
PWS.
    (iii) Soundness of the scientific or technical approach for 
executing the requirements of the SOW/PWS, including, when applicable, 
preliminary layouts, sketches, diagrams, other graphic representations, 
calculations, curves, and other data necessary for presentation, 
substantiation, justification, or understanding of the approach.
    (iv) Special technical factors, such as experience or pertinent 
novel ideas in the specific branch of science or technology involved.
    (v) Feasibility or practicality of successfully accomplishing the 
requirements (including a statement and discussion of anticipated major 
difficulties and problem areas, and recommended approaches for their 
resolution).
    (vi) Availability of required special research, test, and other 
equipment or facilities.
    (vii) Managerial capability (ability to achieve delivery or 
performance requirements as demonstrated by the proposed use of 
management and other personnel resources, and to successfully manage 
the project, including subcontractor and/or consultant efforts, if 
applicable, as evidenced by the management plan and demonstrated by 
previous experience).
    (viii) Availability, qualifications, experience, education, and 
competence of professional, technical, and other personnel, including 
proposed subcontractors and consultants (as evidenced by resumes, 
endorsements, and explanations of previous efforts).
    (ix) Soundness of the proposed staff time or labor hours, propriety 
of personnel classifications (professional, technical, others), 
necessity for type and quantity of material and facilities proposed, 
validity of proposed subcontracting, and necessity of proposed travel.
    (x) Quality of offeror's past performance on recent projects of 
similar size and scope.
    (xi) Extent of proposed participation of small disadvantaged 
business concerns in performance of the contract.


315.208  Submission, modification, revision, and withdrawal of 
proposals.

    (b) In addition to the provision in FAR 52.215-1, Instructions to 
Offerors--Competitive Acquisition, if an HCA determines that certain 
classes of biomedical or behavioral R & D acquisitions are subject to 
conditions other than those specified in FAR 52.215-1(c)(3), the HCA 
may authorize for use in competitive solicitations for R & D, valued at 
more than the simplified acquisition threshold, the use of the 
provision in 352.215-70, Late Proposals and Revisions. This is an 
authorized FAR deviation.
    (2) When the provision at 352.215-70 is included in the 
solicitation and a proposal is received after the exact time specified 
for receipt, the Contracting Officer, with the assistance of cost and 
technical personnel, shall make a written determination as to whether 
the proposal meets the requirements of the provision at 352.215-70 and, 
therefore, can be considered.


315.209  Solicitation provisions and contract clauses.

    (a) The Contracting Officer shall insert paragraph (e) in 352.215-1 
in place of paragraph (e) in the provision in FAR 52.215-1, 
Instructions to Offerors--Competitive Acquisition, in solicitations for 
competitive, negotiated acquisitions valued at more than the simplified 
acquisition threshold. This is an authorized FAR deviation.

Subpart 315.3--Source Selection


315.303-70  Policy.

    (a) If an OPDIV is required by statute to use peer review for 
technical review of specified contracts, the requirements of those 
statutes, any implementing regulatory requirements, the Federal 
Advisory Committee Act, and as applicable, any approved HHSAR 
deviation(s) from this subpart take precedence over the otherwise 
applicable requirements of this subpart.
    (1) The statutes that require such review and implementing 
regulations are as follows: NIH--42 U.S.C. 289a and 42 CFR Part 52h; 
SAMHSA--42 U.S.C. 290aa-3, and AHRQ--42 U.S.C. 299c-1.


315.304  Evaluation factors and significant subfactors.

    (a) A solicitation for EIT products and services, including EIT 
deliverables such as electronic documents and reports, shall include a 
separate technical evaluation factor (which may be in the form of a 
technical evaluation criterion or a mandatory qualification criterion, 
as appropriate) developed by the Contracting Officer, Project Officer, 
and the OPDIV Section 508 Coordinator to determine vendor compliance 
with applicable Section 508 accessibility standards. The technical 
evaluation panel's assessment of Section 508 accessibility standards 
conformance shall be based on the Section 508 Product Assessment 
Template--see Section 508 policy on Office of Disability Web site for 
the template, and on any other pertinent information that offerors 
provide in response to a solicitation. The HHS Office on Disability is 
responsible for providing technical assistance in Section 508 
evaluation factor development.
    (b) Before conducting negotiations or making an award, the 
Contracting Officer shall provide a summary of the technical evaluation 
panel's assessment of vendor responses to the solicitation's Section 
508 evaluation factor for review by the Section 508 Official or 
designee. The Section 508 Official or designee shall indicate approval/
disapproval of the evaluation panel's assessment. The Contracting 
Officer shall coordinate the resolution of any issues raised by the 
Section 508 Official or designee with the chair of the technical 
evaluation panel or Project Officer, as appropriate. The acquisition 
process shall not proceed unless and until the Section 508 Official or 
designee has approved the technical evaluation panel's assessment. The 
Contracting Officer shall include the assessment in the official 
contract file. See 339.203 regarding processing exception determination 
requests.


315.305  Proposal evaluation.

    (a)(1) Cost or price evaluation.
    (i) The Contracting Officer shall evaluate proposals in accordance 
with the FAR 15.404. The extent of cost or price analysis in each case 
depends on the availability of competition, contract type, the proposed 
amount, and technical complexity.
    (A) For competitive firm-fixed-price and fixed price with economic 
price adjustment contracts, price analysis should be sufficient to 
determine price fairness and reasonableness.
    (B) When competition is not adequate for the above contract types, 
and for cost-reimbursement and time and materials contracts, cost 
analysis may be required. In such cases, the Contracting Officer shall 
request the Project Officer's assistance in analyzing the following 
cost elements, if applicable, to

[[Page 62428]]

determine if the proposed amounts are necessary and reasonable for 
efficient contract performance:
    (1) The number and mix of proposed labor hours relative to the 
technical requirements.
    (2) Types, numbers and hours/days of proposed consultants.
    (3) The kinds and quantities of material, equipment, supplies, and 
services.
    (4) Kinds and quantities of IT.
    (5) Logic of proposed subcontracting.
    (6) Travel proposed, including number of trips, locations, purpose, 
and travelers.
    (7) Other direct costs not specified above.
    (ii) The Project Officer shall provide written comments, including 
the rationale for any exceptions to the cost elements. The Contracting 
Officer shall consider the Project Officer's comments for negotiations 
or to support award without discussions. The Contracting Officer shall 
also request assistance of a cost/price analyst, when necessary.
    (2) Past performance evaluation. When evaluating past performance, 
the Contracting Officer shall check references to obtain information 
concerning the performance history of offerors in compliance with FAR 
42.1502. The Contracting Officer may require the assistance of the 
Project Officer as well as other Government technical personnel in 
performing this function.
    (3) Technical evaluation.
    (i) Technical evaluation plan.
    (A) The Contracting Officer shall require a technical evaluation 
plan if the proposed acquisition either requires preparation of an AP--
see 307.71 or is otherwise sufficiently complex.
    (B) The technical evaluation plan shall include, at a minimum, the 
following elements:
    (1) A list of recommended technical evaluation panel members, their 
organizations, a list of their major consulting clients (if 
applicable), their qualifications, and curricula vitae (if applicable).
    (2) A statement that the technical evaluation panel will include 
non-Federal technical proposal evaluators, if applicable, and a 
determination that sufficient Federal technical proposal evaluators are 
unavailable--see FAR 37.204. A determination to use non-Federal 
proposal evaluators shall be signed at a level no lower than the HCA. A 
determination is not required, however, if non-Federal evaluators will 
be used in accordance with 315.303-70(a).
    (3) A statement that there is no apparent or actual conflict of 
interest regarding any recommended panel member.
    (4) A copy of each rating sheet, approved by the Contracting 
Officer, to ensure consistency with the evaluation criteria.
    (5) A brief description of the general evaluation approach.
    (6) A description of the methodology for evaluating key elements in 
the technical evaluation plan, including any solicitation evaluation 
factor involving the acquisition of EIT products and services subject 
to Section 508.
    (C) Except as provided in OPDIV procedures, a program office 
official at least one level above the Project Officer shall approve the 
technical evaluation plan.
    (D) The Project Officer shall provide the technical evaluation plan 
to the Contracting Officer for review and approval before the 
solicitation is issued. The Contracting Officer shall ensure that the 
evaluation criteria reflect the significant factors and subfactors 
relating to the evaluation when conducting the review of the plan.
    (ii) Technical evaluation panel.
    (A) General.
    (1) A technical evaluation panel is required for all acquisitions 
subject to this subpart that require preparation of an AP. The 
Contracting Officer may require a technical evaluation panel for 
acquisitions that do not require preparation of an AP, based on the 
complexity of the acquisition and the role that the technical 
evaluation will have in the award decision.
    (2) The technical evaluation process requires careful consideration 
regarding the size, composition, expertise, and function of the 
technical evaluation panel. The panel's efforts will influence the 
success or failure of the acquisition.
    (3) At least 50 percent of the HHS personnel on a technical 
evaluation panel shall have successfully completed HHS University's 
``Basic Contracting Officer's Technical Representative'' course or an 
equivalent course before assuming their designated role. This training 
requirement applies to evaluators performing the initial technical 
evaluation and any subsequent technical evaluations. However, this 
training requirement does not apply to peer review panel members.
    (B) Role of the Project Officer.
    (1) The Project Officer provides guidance, information, and 
assistance to the Contracting Officer on all technical aspects of a 
proposed acquisition--see 302.101. The Project Officer may be a voting 
member of the technical evaluation panel and may serve as the 
chairperson of the panel unless prohibited by law or contracting 
activity procedures.
    (2) The Project Officer shall recommend panel members who have 
sufficient expertise in the technical aspects of the acquisition to be 
able to evaluate strengths and weaknesses in proposals.
    (3) The Project Officer shall ensure that persons possessing 
expertise and experience in addressing issues relative to sex, race, 
national origin, and disability are included as panel members for 
acquisitions to which such issues apply.
    (4) The Project Officer shall submit a list of recommended panel 
members to a program office official at least one level higher than 
him/herself. This official shall review the list and select the 
chairperson.
    (5) The Project Officer shall arrange for adequate and secure 
working space for the panel.
    (C) Role of the Contracting Officer.
    (1) The term ``Contracting Officer,'' as used in this subpart, may 
be the Contracting Officer or a Contract Specialist possessing an 
appropriate FAC-C certification.
    (2) The Contracting Officer shall not serve as a member of the 
technical evaluation panel, but shall--
    (i) Address the initial meeting of the technical evaluation panel;
    (ii) Provide assistance to the evaluators as required; and
    (iii) Ensure that the scores adequately reflect the written 
technical report comments.
    (D) Conflict of interest.
    (1) If a panel member has an actual or apparent conflict of 
interest related to a proposal under evaluation, the individual cannot 
serve on the panel. If a suitable replacement is not available, the 
panel shall perform the review without a replacement.
    (2) For the purposes of this subpart, conflicts of interest are 
defined in the Standards of Ethical Conduct for Employees of the 
Executive Branch (5 CFR part 2635), Supplemental Standards of Ethical 
Conduct for Employees of the Department of Health and Human Services (5 
CFR part 5501), and the Procurement Integrity Act. For outside 
evaluators serving on the technical evaluation panel, see paragraph 
(a)(3)(ii)(F) of this section.
    (E) Continuity of evaluation process.
    (1) The technical evaluation panel shall evaluate all original 
proposals; make recommendations to the chairperson regarding strengths 
and weaknesses of proposals; if required by the Contracting Officer, 
assist the Contracting Officer during communications and discussions; 
and

[[Page 62429]]

review supplemental, revised or final proposal revisions. To the extent 
possible, the same evaluators shall be available throughout the entire 
evaluation and selection process to ensure continuity and consistency 
in the treatment of proposals. The following are examples of 
circumstances when it would not be necessary for the technical 
evaluation panel to evaluate revised proposals submitted during the 
acquisition:
    (i) The answers to questions do not have a substantial impact on 
the proposal.
    (ii) Final proposal revisions are not materially different from the 
original proposals.
    (iii) Revisions to the proposals are relatively minor and do not 
affect the rankings of the offerors.
    (2) The Contracting Officer, with the written concurrence of the 
technical evaluation panel chairperson, may decide not to have the 
panel evaluate the revised proposals. The Contracting Officer shall 
fully document such a decision in the contract file.
    (3) When the Contracting Officer considers technical evaluation 
panel meetings necessary, the attendance of evaluators is mandatory. 
When the chairperson determines that an evaluator's failure to attend 
the meetings is prejudicial to the evaluation, the chairperson shall 
remove or replace the individual after discussing the situation with 
the Contracting Officer and obtaining the Contracting Officer's 
concurrence and the approval of the official responsible for appointing 
the panel members.
    (4) When continuity of the evaluation process is not possible, and 
new evaluators are selected or the size of the evaluation panel is 
reduced, each panel member shall review all proposals at the current 
stage of the acquisition--i.e., initial proposal, final proposal 
revisions, etc. Also, the Contracting Officer shall provide guidance 
concerning what steps to take if an unusually large number of proposals 
is received, including how to determine what constitutes an unusually 
large number of proposals.
    (F) Use of outside evaluators.
    (1) Except when peer review is required by statute as provided in 
315.303-70(a), decisions to disclose proposals to evaluators outside of 
the Government shall be made by the official responsible for appointing 
panel members in accordance with OPDIV procedures. The avoidance of 
organization conflict of interest and competitive relationships must be 
taken into consideration when making the decision to use outside 
evaluators.
    (2) When a solicited proposal will be disclosed outside the 
Government for evaluation purposes, the following or similar conditions 
shall be part of the written agreement with the evaluator(s) prior to 
disclosure:

Conditions for Evaluating Proposals

    The evaluator agrees to use the data (trade secrets, business 
data, and technical data) contained in the proposal for evaluation 
purposes only. The foregoing requirement does not apply to data 
obtained from another source without restriction. Any notice or 
legend placed on the proposal by either HHS or the submitter of the 
proposal shall be applied to any reproduction or abstract provided 
to the evaluator or made by the evaluator. Upon completion of the 
evaluation, the evaluator shall return to the Government the 
furnished copy of the proposal or abstract, and all copies thereof, 
to the HHS office which initially furnished the proposal for 
evaluation. Unless authorized by the HHS initiating office, the 
evaluator shall not contact the submitter of the proposal concerning 
any aspects of its contents. The evaluator's employees and 
subcontractors shall abide by these conditions.

    (iii) Receipt of proposals.
    (A) After the closing date for the receipt of proposals set in the 
solicitation, the Contracting Officer shall forward the technical 
proposals, by memorandum, to the Project Officer or chairperson for 
evaluation. The Contracting Officer shall retain the business proposals 
for evaluation.
    (B) The transmittal memorandum shall include at least the following 
elements:
    (1) A list of the names of the organizations submitting proposals.
    (2) A reference to the need to preserve the integrity of the source 
selection process.
    (3) A statement that only the Contracting Officer is authorized to 
conduct discussions.
    (4) A requirement for a technical evaluation report in accordance 
with paragraph (a)(3)(vi) of this section.
    (5) The establishment of a date for receipt of the technical 
evaluation report.
    (iv) Convening the technical evaluation panel.
    (A) Normally, the technical evaluation panel convenes to evaluate 
proposals. However, there may be situations when the panel chairperson 
determines that it is not feasible for the panel to convene. Whenever 
the panel does not convene, the panel chairperson shall closely monitor 
the technical review to produce acceptable results.
    (B) When a panel convenes, the chairperson shall control the 
technical proposals provided by the Contracting Officer for use during 
the evaluation process. The chairperson normally distributes the 
technical proposals prior to the initial panel meeting and establishes 
procedures for securing the proposals whenever they are not being 
evaluated to ensure their confidentiality. After an evaluation is 
completed, the chairperson shall return all proposals to the 
Contracting Officer.
    (C) The Contracting Officer shall address the initial meeting of 
the panel and state the basic rules for conducting the evaluation. The 
Contracting Officer shall provide written guidance to the panel, if the 
Contracting Officer cannot attend the initial panel meeting. The 
guidance shall include the following elements:
    (1) An explanation of the evaluation process and the role of 
evaluators throughout the process.
    (2) The need for evaluators to read and understand the 
solicitation, especially the SOW/PWS and evaluation criteria, prior to 
reading the proposals.
    (3) The need for evaluators to restrict the review to only the SOW/
PWS, the evaluation criteria, and the contents of the technical 
proposals.
    (4) The need for each evaluator to review all of the proposals.
    (5) The need for evaluators to identify ambiguities, 
inconsistencies, errors, and deficiencies.
    (6) The need for the evaluators to provide complete written 
documentation of the individual strengths and weaknesses for each 
proposal.
    (7) An instruction specifying that, until an award is made, they 
may not disclose information concerning the acquisition to any person 
not directly involved in the evaluation process.
    (8) An explanation of conflicts of interest.
    (v) Rating and ranking of proposals. The evaluators shall 
individually read each proposal, describe tentative strengths and 
weaknesses, and independently assign preliminary scores in relation to 
each evaluation factor set forth in the solicitation. The evaluators 
may then discuss in detail the individual strengths and weakness 
described by each evaluator and, if possible, arrive at a common 
understanding of the major strengths and weaknesses and the potential 
for correcting each offeror's weakness(es). Each evaluator shall assign 
a final score to each proposal, and the technical evaluation panel 
shall collectively rank the proposals. Normally, ranking is the result 
of adding the numerical scores assigned to the evaluation factors and 
determining the average for each offeror. The evaluators shall then 
identify

[[Page 62430]]

whether each proposal is acceptable or unacceptable. The technical 
evaluation panel shall not employ predetermined cutoff scores.
    (vi) Technical evaluation report. The chairperson shall prepare a 
technical evaluation report and provide it to the Contracting Officer, 
who shall maintain it as a permanent record in the contract file. The 
report shall reflect the ranking of the proposals and identify each 
proposal as acceptable or unacceptable. The report shall also include a 
narrative evaluation specifying the strengths and weaknesses of each 
proposal, and any reservations, qualifications, or areas to be 
addressed that might bear upon the selection of sources for negotiation 
and award. The report shall include concrete technical reasons 
supporting any determination of unacceptability of a proposal and, for 
acceptable proposals, include specific points and questions for 
discussions or negotiations. The technical evaluation report shall also 
include a copy of each signed rating sheet, unless the Contracting 
Officer determines, in accordance with FAR 15.305(a)(3)(ii), and 
315.305(a)(3)(vi), that the technical evaluation report includes 
appropriate and sufficiently detailed supporting narrative (with 
specific references to particular portions of offerors' proposals) to 
(1) fully and reasonably explain the basis for the technical evaluation 
panel's assessments of each proposal, including an evaluation rating of 
``acceptable'' or ``unacceptable; and (2) support any recommendation to 
include or not include a proposal in the competitive range. However, 
when peer review of proposals is required as provided in 315.303-70(a), 
OPDIVs shall follow applicable peer review guidelines and practices 
regarding the submission, maintenance, and disposal of reviewer rating 
sheets.


315.306  Exchanges with offerors after receipt of proposals.

    (d) Exchanges with offerors after establishment of the competitive 
range. The Project Officer or technical evaluation panel shall develop 
technical questions as part of the technical evaluation report. The 
questions shall disclose the ambiguities, weaknesses, and deficiencies 
of offeror(s)' proposals. The Contracting Officer, with the assistance 
of the Project Officer or panel as required, shall prepare the 
management, past performance, and cost or price questions. The method 
of requesting offerors in the competitive range to submit additional 
information may vary depending on the complexity of the questions, the 
extent of additional information necessary, the time needed to analyze 
the responses, and the time frame for making the award. However, to the 
extent practicable, all questions and answers shall be in writing. The 
Contracting Officer shall give each offeror in the competitive range an 
equitable period of time for preparation of responses to questions to 
the extent practicable.


315.307  Proposal revisions.

    (b) Final proposal revisions are subject to--
    (1) A final evaluation of price or cost and other salient factors 
by the Contracting Officer and Project Officer, with assistance from a 
cost/price analyst, as appropriate; and
    (2) An evaluation of technical factors by the technical evaluation 
panel, as necessary.
    The technical evaluation panel may rescore and re-rank technical 
proposals in the competitive range and prepare a technical evaluation 
report. To the extent practicable, the same evaluators who reviewed the 
original proposals shall perform the evaluation. The Contracting 
Officer and Project Officer shall conduct a final evaluation of past 
performance. The technical evaluation panel may be involved in the 
final evaluation of past performance, if the panel is comprised solely 
of Government personnel.


315.370  Finalization of details with the selected source.

    (a) After selection of the successful proposal, the Contracting 
Officer may finalize details with the selected offeror, if necessary. 
However, the Contracting Officer shall not introduce any factor that 
could have an effect on the selection process after the common cutoff 
date for receipt of final proposal revisions, nor shall the 
finalization process in any way prejudice the competitive interest or 
rights of the unsuccessful offerors. The Contracting Officer shall 
restrict finalization of details with the selected offeror to 
definitizing the final agreement on terms and conditions, assuming none 
of these factors were involved in the selection process.
    (b) Whenever a change occurs in the requirements, the Contracting 
Officer shall reopen the competition, and provide all offerors 
submitting final proposal revisions an opportunity to resubmit 
proposals based on the revised requirements. If there is a question as 
to whether a change is material and would require the initiation of a 
new competition, the Contracting Officer shall obtain the advice of 
technical personnel and OGC-GLD before proceeding. Significant changes 
in the offeror's cost proposal may also necessitate a reopening of a 
competition, if the changes alter the factors involved in the original 
selection process.
    (c) Upon finalization of details, the Contracting Officer shall 
obtain a confirmation letter from the successful offeror which includes 
any revisions to its technical proposal, the agreed upon price or cost, 
and, as applicable, a certificate of current cost or pricing data.


315.371  Contract preparation and award.

    (a) After completing any activities that may be necessary to 
finalize details with the selected offeror, the Contracting Officer 
shall--
    (1) Prepare the negotiation memorandum in accordance with 315.372;
    (2) Prepare the contract containing all agreed to terms and 
conditions and clauses required by law or regulation;
    (3) Include in the contract file the pertinent documents referenced 
in FAR 4.803; and
    (4) Obtain the appropriate approval of the proposed contract 
award(s) in accordance with subpart 304.71 and contracting activity 
procedures.
    (b) After receiving the required approvals, the Contracting Officer 
shall--
    (1) Transmit the contract to the prospective contractor for 
signature; and
    (2) Inform the prospective contractor that the contract is not 
effective until the Contracting Officer transmits the fully executed 
contract to the contractor.
    (c) The Contracting Officer shall not sign or issue the contract 
until the finance office certifies that the funds are available for 
obligation.


315.372  Preparation of negotiation memorandum.

    The Contracting Officer shall prepare a negotiation memorandum, or 
summary of negotiations, to document all actions leading to award of a 
contract and support the source selection decision discussed in FAR 
15.308. The memorandum also satisfies the requirement for preparation 
of a ``cost/price negotiation memorandum'' required by FAR 15.406-3. 
The memorandum shall be in sufficient detail to explain and support the 
rationale, judgments, and authorities upon which all actions were 
predicated. The memorandum shall document the negotiation process and 
reflect the negotiator's actions and judgments in concluding a 
satisfactory agreement for the Government. The memorandum shall address 
each item listed below. If an item is not applicable, the

[[Page 62431]]

memorandum shall so state. The Contracting Officer may reference 
information already contained in the contract file rather than 
reiterate it.
    (a) Description of articles and services and period of performance. 
Provide a description of the articles or services, quantity, unit 
price, total contract amount, and period of contract performance.
    (b) Acquisition planning. Summarize or reference any acquisition 
planning activities that have taken place.
    (c) Synopsis of acquisition. Provide a statement as to whether the 
acquisition has or has not been publicized in accordance with FAR 
Subpart 5.2. Include a brief statement referencing the specific basis 
for exemption under the FAR, if applicable.
    (d) Contract type. Provide sufficient detail to support the type of 
contractual instrument recommended for the acquisition. If the contract 
is a cost-sharing type, explain the essential cost-sharing features.
    (e) Extent of competition. Discuss the extent to which full and 
open competition was solicited and obtained. Include the date of 
solicitation, sources solicited, and solicitation results. If a late 
proposal was received, discuss whether or not the late proposal was 
evaluated and the rationale for the decision.
    (f) Technical evaluation. Summarize or reference the results 
presented in the technical evaluation report.
    (g) Business evaluation. Summarize or reference results presented 
in the business report.
    (h) Past performance. Summarize or reference results of both the 
past performance evaluation and reference checks.
    (i) Competitive range (if applicable). Describe how the competitive 
range was determined, and indicate the offerors that were included in 
and excluded from the competitive range.
    (j) Cost breakdown and analysis. Include a complete cost breakdown 
together with the Contracting Officer's analysis of the estimated cost 
by individual cost elements. The analysis shall discuss the items 
specified in FAR 15.406-3 and other cost factors, such as--
    (1) A comparison of cost factors proposed for the current 
requirement with actual factors used in earlier contracts, using the 
same cost centers of the same supplier or cost centers of other sources 
having recent contracts for the same or similar item;
    (2) Any pertinent Government-conducted audit of the proposed 
contractor's record or any pertinent cost advisory report;
    (3) Any pertinent technical evaluation inputs as to necessity, 
allocability and reasonableness of labor, material and other direct 
expenses;
    (4) Any other pertinent information to fully support the basis for 
the cost analysis;
    (5) If the contract is an incentive type, a discussion of all 
elements of profit and fee structure; and
    (6) A justification of the reasonableness of the contractor's 
proposed profit or fixed fee considering the requirements of FAR 
15.404-4 and 315.404-4.
    (k) Cost realism. Describe the cost realism analysis performed on 
proposals.
    (l) Government-furnished property and facilities. With respect to 
Government-furnished facilities, equipment, tooling, or other property, 
include the following:
    (1) If the Government will not provide property, a statement to 
that effect.
    (2) If the Government will provide property, a full description of 
it, its estimated dollar value, the basis of price comparison with 
competitors, and the basis of rental charge, if rental is involved.
    (3) If a decision to furnish property has not been made, a detailed 
explanation.
    (m) Negotiations. Include a statement as to the date and place of 
negotiations, and identify members of both the Government and 
contractor negotiating teams by area of responsibility. Include 
negotiation details relative to the SOW/PWS, terms and conditions, and 
special provisions. The results of cost or price negotiations shall 
include the information required by FAR 31.109 and 15.406-3. In 
addition, if the potential contractor provided cost or pricing data, 
specify the extent to which the Contracting Officer relied upon the 
factual cost or pricing data submitted and used it in negotiating the 
cost or price.
    (n) Other considerations. Include coverage of areas such as the 
following:
    (1) Financial data with respect to a contractor's capacity and 
stability.
    (2) Determination of contractor responsibility.
    (3) Details as to why the method of payment, such as progress 
payments, advance payments, etc., is necessary and cite any required D 
& F's.
    (4) Information with respect to obtaining a certificate of current 
cost or pricing data.
    (5) Other required special approvals.
    (6) If the contract represents an extension of previous work, the 
status of funds and performance under the prior contract(s). Also, the 
Project Officer shall provide sufficient information for the 
Contracting Officer to determine that the Government has obtained 
enough actual or potential value from the work previously performed to 
warrant continuation with the same contractor.
    (7) A statement that the Contracting Officer has explained the 
equal opportunity provisions of the proposed contract to the 
contractor, and the contractor is aware of its responsibilities. Also, 
state whether or not an Equal Employment Opportunity (EEO) clearance is 
required.
    (8) If the contract is for services, a statement, in accordance 
with FAR 37.103, that the services are nonpersonal in nature.
    (o) Terms and conditions. Identify the general and special clauses 
and conditions that are contained in the contract, such as option 
arrangements, multi-year contracting, anticipatory costs, deviations 
from standard clauses, etc. The Contracting Officer shall state the 
rationale for inclusion of any special terms and conditions and, where 
applicable, identify the document which granted approval for their use.
    (p) Recommendation. Briefly state the basis (or bases) for 
recommending award.
    (q) Signature. The Contracting Officer and the individual who 
prepared the negotiation memorandum must sign the document.

Subpart 315.4--Contract Pricing


315.404  Proposal analysis.


315.404-2  Information to support proposal analysis.

    (a)(2) When some or all information sufficient to determine the 
reasonableness of the proposed cost or price is already available or 
can be obtained by phone from the cognizant audit agency, the 
Contracting Officer may request less-than-complete field pricing 
support (specifying in the request the information needed) or may waive 
in writing the requirement for audit and field pricing support by 
documenting the file to indicate what information will be used instead 
of the audit report and the field pricing report.
    (3) When initiating audit and field pricing support, the 
Contracting Officer shall do so by sending a request to the cognizant 
Administrative Contracting Officer, with an information copy to the 
cognizant audit office. When field pricing support is not available, 
the Contracting Officer shall initiate an audit by sending, in 
accordance with agency procedures, two (2) copies of the request to the 
OIG Office of Audit Services, Regional Inspector General. In

[[Page 62432]]

both cases, the Contracting Officer shall, in the request--
    (i) Prescribe the extent of the support needed;
    (ii) State the specific areas for which input is required;
    (iii) Include the information necessary to perform the review, such 
as the offeror's proposal and the applicable portions of the 
solicitation, particularly those describing requirements and delivery 
schedules;
    (iv) Provide the complete address of the location of the offeror's 
financial records that support the proposal;
    (v) Identify the office having audit responsibility, if other than 
the HHS Regional Audit Office; and
    (vi) Specify a due date for receipt of a verbal report and the 
written audit report. If the time available is not adequate to permit 
satisfactory coverage of the proposal, the auditor shall so advise the 
Contracting Officer and indicate the additional time needed. The 
Contracting Officer shall submit one copy of the audit request letter 
provided to the Office of Audit Services, Regional Inspector General 
and a complete copy of the contract price proposal to OIG Office of 
Audit Services. Whenever the Office of Audit Services has conducted an 
audit review, the Contracting Officer shall forward two (2) copies of 
the memorandum of negotiation to OIG Office of Audit Services.


315.404-4  Profit.

    (b) Policy.
    (1) The structured approach for determining profit provides a 
technique for establishing a profit objective for negotiation. A profit 
objective is that part of the estimated contract price objective or 
value which, in the judgment of the Contracting Officer, constitutes an 
appropriate amount of profit for the acquisition being considered. This 
technique allows for consideration of the profit factors described in 
paragraph (d) of this section. The Contracting Officer's analysis of 
these factors shall be based on available information, such as 
proposals, audit data, assessment reports, and pre-award surveys. The 
structured approach provides a basis for documenting the profit 
objective. The Contracting Officer shall explain any significant 
departure from this objective. The amount of documentation depends on 
the dollar value and complexity of the proposed acquisition. The profit 
objective is a part of the overall negotiation objective and is 
directly related to the cost objective and any proposed sharing 
arrangement. The profit objective shall exclude factors considered 
inapplicable to the acquisition.
    (ii) The Contracting Officer shall negotiate the profit objective 
at the same time as the other cost items and as a whole rather than as 
individual profit factors. The profit factor breakdown shall be part of 
the documentation. The Contracting Officer shall use the profit 
analysis factors in FAR 15.404-4(d) in lieu of the structured approach 
in the following circumstances:
    (A) Contracts not expected to exceed $100,000.
    (B) A & E contracts.
    (C) Management contracts for operations or maintenance of 
Government facilities.
    (D) Construction contracts.
    (E) Contracts primarily requiring delivery of material supplies by 
subcontractors
    (F) Termination settlements.
    (G) Cost-plus-award-fee contracts.
    However, the Contracting Officer may perform a structured profit 
analysis as an aid in arriving at an appropriate fee arrangement. The 
Contracting Officer may make other exceptions in the negotiation of 
contracts having unusual pricing situations, but shall justify in 
writing those situations where the structured approach is determined to 
be unsuitable.
    (c) Contracting Officer responsibilities. The Contracting Officer 
shall develop the profit objective, which shall realistically reflect 
the total overall effort of the contractor. The Contracting Officer 
shall not begin to develop the profit objective until he or she has 
completed a thorough review of the proposed contract work; conducted a 
review of all available knowledge regarding the contractor pursuant to 
FAR subpart 9.1, including audit data, pre-award survey reports and 
financial statements, as appropriate; and completed an analysis of the 
contractor's cost estimate and comparison with the Government's 
estimate or projection of cost.
    (d) Profit-analysis factors.
    (1) Common factors. The Contracting Officer shall consider the 
following factors in all cases in which profit is negotiated and shall 
use the weight ranges listed after each factor in all instances where 
the structured approach is used.

------------------------------------------------------------------------
              Profit factors                      Weight ranges (%)
------------------------------------------------------------------------
Contractor Effort:
    Material acquisition..................  1 to 5.
  Direct labor............................  4 to 15.
  Overhead................................  4 to 9.
  General & Administrative (G & A)........  4 to 8.
  Other costs.............................  1 to 5.
Other Factors:
  Cost risk...............................  0 to 7.
  Investment..............................  -2 to +2.
  Performance.............................  -1 to +1.
  Socioeconomic programs..................  -.5 to +.5.
  Special situations
------------------------------------------------------------------------

    (i) The Contracting Officer shall measure ``Contractor Effort'' by 
assigning a profit percentage within the designated weight range to 
each element of contract cost. The categories listed are for reference 
purposes only, but are broad and basic enough to provide guidance for 
other elements of cost. The Contracting Officer shall not include 
facilities capital cost of money. ``Contractor Effort'' shall include a 
computed total dollar profit.
    (ii) The Contracting Officer shall use the total dollar profit for 
the ``Contractor Effort'' to calculate specific profit dollars for 
``Other Factors''--cost risk, investment, performance, socioeconomic 
programs, and special situations. The Contracting Officer shall 
multiply the total dollar profit for the ``Contractor Effort'' by the 
weight assigned to each of the elements in the ``Other Factors'' 
category. Facilities capital cost of money is not included. Form HHS 
674, Structured Approach Profit/Fee Objective, shall be used.
    (iii) In making a judgment of the value of each factor, the 
Contracting Officer shall consider the definition, description, and 
purpose of the factors together with considerations for evaluating 
them.
    (iv) The structured approach was designed for arriving at profit 
objectives for other than nonprofit organizations. However, the 
Contracting Officer shall use the modified structured approach in 
paragraph (d)(1)(iv)(B) of this section to establish fee objectives for 
nonprofit organizations.
    (A) For purposes of this section, nonprofit organizations are 
defined as those business entities organized and operated exclusively 
for charitable, scientific, or educational purposes, no part of the net 
earnings of which inure to the benefit of any private shareholder or 
individual, and which are exempt from Federal income taxation under 
Section 501(c)(3) of the Internal Revenue Code.
    (B) For contracts with nonprofit organizations where fee is 
involved, the Contracting Officer shall subtract up to three percentage 
points from the total ``profit'' objective percentage. In determining 
the amount of this adjustment, the Contracting Officer shall consider 
the following factors:

[[Page 62433]]

    (1) Tax position benefits.
    (2) Granting of financing through advance payments.
    (3) Other pertinent factors which may work to either the advantage 
or disadvantage of the contractor in its position as a nonprofit 
organization.
    (2) Contractor effort. Contractor effort is a measure of how much 
the contractor is expected to contribute to the overall effort 
necessary to meet the contract performance requirement in an efficient 
manner. This factor, which is apart from the contractor's 
responsibility for contract performance, takes into account what 
resources are necessary and what steps the contractor must take to 
accomplish a conversion of ideas and material into the final service or 
product called for in the contract. This is a recognition that within a 
given performance output, or within a given sales dollar figure, 
necessary efforts on the part of individual contractors can vary widely 
in both value and quantity, and that the profit objective shall reflect 
the extent and nature of the contractor's contribution to total 
performance. A major consideration, particularly in connection with 
experimental or R & D work, is the difficulty or complexity of the work 
to be performed, and the unusual demands of the contract, such as 
whether the project involves a new approach unrelated to existing 
technology or equipment or only refinements to these items. The 
evaluation of this factor requires an analysis of the cost content of 
the proposed contract as follows:
    (i) Material acquisition (subcontracted items, purchased parts, and 
other material). Analysis of these cost items shall include an 
evaluation of the managerial and technical effort necessary to obtain 
the required subcontracted items, purchased parts, material or 
services. The Contracting Officer shall determine whether the 
contractor will obtain the items or services by routine order from 
readily available sources or by detailed subcontracts for which the 
prime contractor must develop complex specifications. The Contracting 
Officer shall also consider the managerial and technical efforts 
necessary for the prime contractor to select subcontractors and to 
perform subcontract administration functions, which may be substantial. 
Normally, the lowest unadjusted weight for direct material is two 
percent. A weighting of less than two percent may be appropriate only 
in unusual circumstances when there is a minimal contribution by the 
contractor.
    (ii) Direct labor (professional, service, manufacturing and other 
labor). Analysis of the various labor categories of the cost content of 
the contract shall include evaluation of the comparative quality and 
quantity of professional and semiprofessional talents, manufacturing 
and service skills, and experience to be employed. In evaluating 
professional and semiprofessional labor for the purpose of assigning 
profit dollars, the Contracting Officer shall consider the amount of 
notable scientific talent or unusual or scarce talent needed in 
contrast to nonprofessional effort, including the contribution this 
talent will provide toward the achievement of contract objectives. 
Since nonprofessional labor is relatively plentiful and the contractor 
may easily obtain it, it is less critical to the successful performance 
of contract objectives. Therefore, the Contracting Officer cannot 
weight it nearly as high as professional or semiprofessional labor. The 
Contracting Officer shall evaluate service contract labor in a like 
manner by assigning higher weights to engineering or professional type 
skills required for contract performance and considering the variety of 
manufacturing and other categories of labor skills required and the 
contractor's personnel resources for meeting those requirements. For 
purposes of evaluation, the Contracting Officer may separately 
categorize, as appropriate, certain types of labor (e.g., quality 
control, receiving and inspection), that do not fall within the 
definition of professional, service or manufacturing labor; but shall 
apply the same evaluation considerations as outlined in this paragraph.
    (iii) Overhead and G & A expense.
    (A) Analysis of these overhead items of cost shall include the 
evaluation of the makeup of these expenses and how much they contribute 
to contract performance. To the extent practicable, analysis shall 
include a determination of the amount of labor within these overhead 
pools and how this labor would be treated if it were considered direct 
labor under the contract. The Contracting Officer shall give the 
allocable labor elements the same profit considerations that they would 
receive if they were treated as direct labor. The other elements of 
these overhead pools require analysis to determine whether they are 
routine expenses, such as utilities and maintenance, and hence given 
lesser profit consideration, or whether they are significant 
contributing elements. The composite of the individual determinations 
in relation to the elements of the overhead pools shall be the profit 
consideration given the pools as a whole. The procedure for assigning 
relative values to these overhead expenses differs from the method used 
in assigning values of the direct labor. The upper and lower limits 
assignable to the direct labor are absolute. In the case of overhead 
expenses, individual expenses may be assigned values outside the range 
as long as the composite ratio is within the range.
    (B) It is not necessary that the contractor's accounting system 
break down overhead expenses within the classifications of research 
overhead, other overhead pools, and general administrative expenses, 
unless dictated otherwise by Cost Accounting Standards (CAS). The 
contractor whose accounting system reflects only one overhead rate on 
all direct labor need not change its system, if CAS exempt, to 
correspond with these classifications. The Contracting Officer, in an 
evaluation of such a contractor's overhead rate, may break out the 
applicable sections of the composite rate which could be classified as 
research overhead, other overhead pools, and general and administrative 
expenses, and follow the appropriate evaluation technique.
    (C) The Contracting Officer shall consider management problems that 
may surface in varying degrees and the management expertise exercised 
to solve them as an element of profit. For example, a contract for a 
new R & D program or an item which is on the cutting edge may cause 
more problems and require more managerial time and abilities of a 
higher order than a follow-on contract. If new contracts create more 
problems and require a higher profit weight, the Contracting Officer 
shall adjust follow-ons downward because many of the problems should 
have been solved. In any event, the evaluation shall consider the 
underlying managerial effort involved on a case-by-case basis.
    (D) It may not be necessary for the Contracting Officer to make a 
separate profit evaluation of overhead expenses, in connection with 
each acquisition action for substantially the same project with the 
same contractor. Where the Contracting Officer has made an analysis of 
the profit weight to be assigned to the overhead pool, the weight 
assigned may apply to future acquisitions with the same contractor 
unless there is a change in the cost composition of the overhead pool 
or contract circumstances, or unless the factors discussed in paragraph 
(d)(2)(iii)(C) of this section are involved.
    (iv) Other costs. Analysis of this factor shall include all other 
direct costs associated with contractor performance (e.g., travel and 
relocation, direct support, and consultants). Analysis of these items 
of cost shall include the

[[Page 62434]]

significance of the cost of contract performance, nature of the cost, 
and how much they contribute to contract performance. Normally, travel 
costs require minimal administrative effort by the contractor and, 
therefore, usually receive a weight no greater than one percent. Also, 
the contractor may designate individuals as ``consultants,'' but in 
reality the contractor may obtain these individuals to supplement its 
workforce in the performance of routine duties required by contract. 
These costs would normally receive a minimum weight. However, there may 
be instances when contract performance may require the contractor to 
obtain the services of consultants having expertise in fields such as 
medicine or human services. In these instances, the contractor may 
expend greater managerial and technical effort to obtain these services 
and, consequently, the costs shall receive a much greater weight.
    (3) Other factors:
    (i) Contract cost risk. The contract type employed basically 
determines the degree of cost risk assumed by the contractor. For 
example, where a portion of the risk has been shifted to the Government 
through cost-reimbursement provisions, unusual contingency provisions, 
or other risk-reducing measures, the amount of profit shall be less 
than where the contractor assumes all the risk.
    (A) In developing the prenegotiation profit objective, the 
Contracting Officer shall consider the type of contract anticipated and 
the contractor risk associated therewith, when selecting the position 
in the weight range for profit that is appropriate for the risk the 
contractor will bear. This factor is one of the most important in 
arriving at the prenegotiation profit objective. Evaluation of this 
risk requires a determination of: The degree of cost responsibility 
assumed by the contractor; the reliability of the cost estimates in 
relation to the tasks assumed by the contractor; and the complexity of 
the tasks assumed by the contractor. This factor is specifically 
limited to the risk of contract costs. Risks associated with a 
contractor's reputation, a contractor's potential loss of a commercial 
market, or a contractor's loss of potential profits in other fields, 
are not within the scope of this factor.
    (B) The first and basic determination of the degree of cost 
responsibility assumed by the contractor is related to the sharing of 
total risk of contract cost by the Government and the contractor 
through the selection of contract type. The extremes are a cost-plus-
fixed-fee contract requiring the contractor to use its best efforts to 
perform a task and a firm fixed-price contract for a service or a 
complex item. A cost-plus-fixed-fee contract would reflect a minimum 
assumption of cost responsibility, whereas a firm-fixed-price contract 
would reflect a complete assumption of cost responsibility. The 
determination of risk by contract type usually falls into the following 
percentage ranges:

------------------------------------------------------------------------
                                                                Percent
------------------------------------------------------------------------
Cost-reimbursement type contracts..........................          0-3
Fixed-price type contracts.................................          2-7
------------------------------------------------------------------------

    (C) The second determination is that of the reliability of the cost 
estimates. Sound price negotiation requires well-defined contract 
objectives and reliable cost estimates. Prior experience assists the 
contractor in preparing reliable cost estimates on new acquisitions for 
similar efforts. An excessive cost estimate reduces the likelihood that 
the cost of performance will exceed the contract price, thereby 
reducing the contractor's assumption of contract cost risk.
    (D) The third determination is that of the difficulty of the 
contractor's task. The contractor's task can be difficult or easy, 
regardless of the type of contract.
    (E) Contractors are likely to assume greater cost risk only if 
Contracting Officers objectively analyze the risk associated with 
proposed contracts and are willing to compensate contractors for it. 
Generally, a cost-plus-fixed fee contract will not justify a reward for 
risk in excess of 0.5 percent, nor will a firm fixed-price contract 
justify a reward of less than the minimum in the structured approach. 
The reward for risk, by contract type, will usually fall into the 
following percentage ranges:
    (1) Type of contract and percentage ranges for profit objectives 
based on structured approach for R & D and manufacturing contracts:

------------------------------------------------------------------------
                                                       Percent
------------------------------------------------------------------------
Cost-plus-fixed-fee.......................  0 to 0.5.
Cost-plus-incentive-fee: With cost          1 to 2.
 incentive only.
With multiple incentives..................  1.5 to 3.
Fixed-price-incentive: With cost incentive  2 to 4.
 only.
With multiple incentives..................  3 to 5.
Prospective price redetermination.........  3 to 5.
Firm-fixed-price..........................  5 to 7.
------------------------------------------------------------------------

    (2) Type of contract and percentage ranges for profit objectives 
based on the structured approach for service contracts:

------------------------------------------------------------------------
                                                       Percent
------------------------------------------------------------------------
Cost-plus-fixed-fee.......................  0 to 0.5.
Cost-plus-incentive-fee...................  1 to 2.
Fixed-price incentive.....................  2 to 3.
Firm-fixed-price..........................  3 to 4.
------------------------------------------------------------------------

    (F) These ranges may not be appropriate for all acquisitions. For 
instance, a fixed-price incentive contract with a low ceiling price and 
high incentive share may be tantamount to a firm fixed-price contract. 
In this situation, the Contracting Officer may determine that a basis 
exists for high confidence in the reasonableness of the estimate and 
that little opportunity exists for cost reduction without extraordinary 
efforts. On the other hand, a contract with a high ceiling and low 
incentive formula can be considered to contain cost-plus-incentive-fee 
contract features. In this situation, the Contracting Officer may 
determine that the Government is retaining much of the contract cost 
responsibility and that the risk the contractor assumes is minimal. 
Similarly, if a cost-plus-incentive-fee contract includes an unlimited 
downward (negative) fee adjustment on cost control, it could be 
comparable to a fixed-price-incentive contract. In such a pricing 
environment, the Contracting Officer may determine that the Government 
has transferred a greater amount of cost responsibility to the 
contractor than is typical under a normal cost-plus-incentive-fee 
contract.
    (G) The contractor's subcontracting program may have a significant 
impact on the contractor's acceptance of risk. It could cause risk to 
increase or decrease in terms of both cost and performance. This 
consideration shall be a part of the Contracting Officer's overall 
evaluation in selecting a factor to apply to cost risk. The Contracting 
Officer may determine, for instance, that the prime contractor has 
effectively transferred real cost risk to a subcontractor and the 
contract cost risk evaluation may, as a result, be below the range 
which would otherwise apply for the contract type being proposed. 
However, without any substantial transfer of cost risk from the prime 
contractor to a subcontractor, the Contracting Officer shall not lower 
the contract cost risk evaluation merely because a substantial portion 
of the contract costs represents subcontracts.
    (H) In making a contract cost risk evaluation for an acquisition 
that involves definitization of a letter contract, unpriced change 
orders, and unpriced orders under basic ordering agreements, the 
Contracting Officer shall consider the effect on total contract cost 
risk of partial performance before definitization. Under some

[[Page 62435]]

circumstances, the total amount of cost risk may have been effectively 
reduced. Under other circumstances it may be apparent that the 
contractor's cost risk remains substantially unchanged. To be 
equitable, the Contracting Officer shall make the determination of 
profit weight for all recognized costs, both incurred and yet to be 
expended, considering all attendant circumstances--not merely the 
portion of costs incurred or percentage of work completed prior to 
definitization.
    (I) The Contracting Officer shall consider time-and-materials and 
labor-hour contracts to be cost-plus-fixed-fee contracts for the 
purpose of establishing profit weights in the evaluation of the 
contractor's assumption of contract cost risk, unless otherwise exempt 
from use of the structured approach under paragraph (b)(1)(ii) of this 
section.
    (ii) Investment. HHS encourages its contractors to perform their 
contracts with the minimum of financial, facilities, or other 
assistance from the Government. As such, it is the purpose of this 
factor to encourage the contractor to acquire and use its own resources 
to the maximum extent possible. The evaluation of this factor shall 
include an analysis of the following:
    (A) Facilities (including equipment). Evaluating how this factor 
contributes to the profit objective requires knowledge of the level of 
facilities utilization needed for contract performance, the source and 
financing of the required facilities, and the overall cost-
effectiveness of the facilities offered. The Contracting Officer shall 
provide contractors with additional profit, if they furnish their own 
facilities and such contractor-furnished facilities contribute 
significantly to lower total contract costs. On the other hand, 
contractors that rely on the Government to provide or finance needed 
facilities shall receive a corresponding reduction in profit. Between 
these extremes, the Contracting Officer shall evaluate cases on their 
merits and make positive or negative adjustments in profit, as 
appropriate. When applicable, the contractor's computation of 
facilities capital cost of money under CAS 414 can help the Contracting 
Officer identify the level of facilities investment the contractor will 
employ in contract performance.
    (B) Payments. In analyzing this factor, the Contracting Officer 
shall consider the frequency of payments by the Government to the 
contractor. The key to this weighting is to give proper consideration 
to the impact the contract will have on the contractor's cash flow. 
Generally, negative consideration applies to advance payments and 
payments more frequent than monthly, with the Contracting Officer 
making a maximum reduction as the contractor's working capital 
approaches zero. The Contracting Officer shall generally give positive 
consideration for payments less frequent than monthly and for a capital 
turn-over rate on the contract less than the contractor's or the 
industry's normal capital turn-over rate.
    (iii) Performance (cost control and other past accomplishments). 
The Contracting Officer shall evaluate the contractor's past 
performance in areas such as: quality of services or products, meeting 
performance schedules, efficiency in cost control (including need for 
and reasonableness of costs incurred), accuracy and reliability of 
previous cost estimates, degree of cooperation (both business and 
technical), compliance with previous contract requirements, and 
management of subcontract programs. Where a contractor has consistently 
achieved excellent results in these areas in comparison with other 
contractors in similar circumstances, this performance merits a 
proportionately greater opportunity for profit. Conversely, a poor 
record in this regard warrants less profit.
    (iv) Federal socioeconomic programs. This factor, which may apply 
to special circumstances or particular acquisitions, relates to the 
extent of a contractor's successful participation in Government 
sponsored programs involving: Small businesses; HUBZone small 
businesses; service-disabled, veteran-owned small businesses; 8(a) 
small businesses; women-owned small businesses; small disadvantaged 
businesses; sheltered workshops for the disabled; mentor-
prot[eacute]g[eacute]; energy conservation, etc. The Contracting 
Officer shall give positive consideration for the contractor's policies 
and practices that support Federal socioeconomic programs and 
contribute to successful results. Conversely, the Contracting Officer 
shall view failure or unwillingness on the part of the contractor to 
support Federal socioeconomic programs as evidence of poor performance 
for the purpose of establishing a profit objective.
    (v) Special situations.
    (A) Inventive and developmental contributions. The Contracting 
Officer shall consider the extent and nature of contractor-initiated 
and contractor-financed independent development in formulating the 
profit objective, provided that the Contracting Officer has made a 
determination that the effort will benefit the contract. Examples of 
profit weighting factors include contribution of the independent 
development to health and human service-related missions; the 
initiative demonstrated by the contractor in pursuing the independent 
development; the extent of the contractor's cost risk; and whether the 
independent development cost was recovered directly or indirectly from 
Government sources.
    (B) Unusual pricing agreements. Occasionally, unusual contract 
pricing arrangements are made with the contractor wherein it agrees to 
cost ceilings (e.g., a ceiling on overhead rates for conditions other 
than those discussed at FAR 42.707). In these circumstances, the 
Contracting Officer shall give the contractor favorable consideration 
in developing a profit objective.
    (C) Negative factors. Special situations need not be limited to 
those which only increase profit levels. A negative consideration may 
be appropriate when the contractor is expected to obtain spin-off-
benefits as a direct result of the contract (e.g., products or services 
with commercial application).
    (4) Facilities capital cost of money. When facilities capital cost 
of money (cost of capital committed to facilities) is included as an 
item of cost in the contractor's proposal, the Contracting Officer 
shall reduce the profit objective in an amount equal to the amount of 
facilities capital cost of money allowed in accordance with the 
Facilities Capital Cost-of-Money cost principle. If the contractor does 
not propose this cost, the Contracting Officer shall insert a provision 
in the contract that makes facilities capital cost of money an 
unallowable cost.

Subpart 315.6--Unsolicited Proposals


315.605  Content of unsolicited proposals.

    (d) Certification by offeror. To ensure against contacts between 
HHS personnel and prospective offerors that would exceed the limits of 
advance guidance set forth in FAR 15.604 and potentially result in an 
unfair advantage to an offeror, the Contracting Officer shall: Furnish 
the following certification template to any prospective offeror of an 
unsolicited proposal; and require that the executed certification be 
included in any resultant unsolicited proposal:

Unsolicited Proposal

Certification by Offeror

    This is to certify, to the best of my knowledge and belief, 
that--
    (a) This proposal has not been prepared under Government 
supervision;
    (b) The methods and approaches stated in the proposal were 
developed by this offeror;

[[Page 62436]]

    (c) Any contact with Department of Health and Human Services 
(HHS) personnel has been within the limits of appropriate advance 
guidance set forth in FAR 15.604; and
    (d) No prior commitments were received from HHS personnel 
regarding acceptance of this proposal.

Date:------------------------------------------------------------------
Organization-----------------------------------------------------------
Name-------------------------------------------------------------------
Title------------------------------------------------------------------

    (This certification shall be signed by a responsible management 
official of the proposing organization or by a person authorized to 
contractually obligate the organization.)


315.606  Agency procedures.

    (a) The HCA is responsible for establishing procedures to comply 
with FAR 15.606(a).
    (b) The HCA or designee shall be the point of contact for 
coordinating the receipt and processing of unsolicited proposals.

315.606-1 Receipt and initial review.

    (d) OPDIVs shall not refuse consideration of an unsolicited 
proposal because an organization initially submitted it as a grant 
application. However, OPDIVs shall not award contracts based on 
unsolicited proposals that have been rejected for grant awards due to 
lack of scientific merit.


315.609  Limited use of data.

    An offeror shall use the legend, Use and Disclosure of Data, 
prescribed in FAR 15.609(a), to restrict the use of data for evaluation 
purposes only. However, data contained within the unsolicited proposal 
may need to be disclosed as a result of a request submitted pursuant to 
the Freedom of Information Act. Because of this possibility, the 
Contracting Officer shall provide the following notice to all 
prospective offerors of unsolicited proposals:

    ``The Government will attempt to comply with the ``Use and 
Disclosure of Data'' legend. However, the Government may not be able 
to withhold a record (data, document, etc.) or deny access to a 
record requested by an individual (the public) when an obligation is 
imposed on the Government under the Freedom of Information Act, 5 
U.S.C. 552, as amended. The Government determination to withhold or 
disclose a record will be based upon the particular circumstances 
surrounding the record and on whether the record is exempt from 
disclosure under the Freedom of Information Act. Per FAR 15.609(e), 
the offeror should identify any records that it considers to be 
trade secrets, commercial or financial information, and privileged 
or confidential information.''

Subpart 315.70--Acquisition of Electronic Information Technology


315.7000  Section 508 accessibility standards.

    EIT products and services, including EIT deliverables such as 
electronic documents and reports, acquired using negotiated procedures 
shall comply with Section 508 of the Rehabilitation Act of 1973, as 
amended. Consistent with paragraph 4.3.1 of the HHS Section 508 
policy--see Section 508 policy on HHS Office on Disability Web site, if 
products and services, including commercially available items, meet 
some but not all of the applicable Section 508 accessibility standards, 
and no commercially available products or services meet all of the 
applicable Section 508 accessibility standards, an OPDIV/STAFFDIV shall 
acquire the products and services that best meet the applicable Section 
508 accessibility standards. Commercial nonavailability exception 
determinations for EIT products and services that do not meet some or 
all of the applicable Section 508 accessibility standards shall be 
processed in accordance with 339.203.

PART 316--TYPES OF CONTRACTS

Subpart 316.3--Cost-reimbursement Contracts
Sec.
316.307 Contract clauses.
Subpart 316.5--Indefinite-Delivery Contracts
316.505 Ordering.
Subpart 316.6--Time-and-Materials, Labor-Hour, and Letter Contracts
316.603 Letter contracts.
316.603-3 Limitations.
316.603-70 Procedure for requesting authority to issue a letter 
contract.
316.603-71 Approval for modifications to letter contracts.
Subpart 316.7--Agreements
316.770 Unauthorized types of agreements.
316.770-2 Memoranda of understanding.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 316.3--Cost-reimbursement Contracts


316.307  Contract clauses.

    (a) If a contract for R & D is with a hospital (profit or 
nonprofit), the Contracting Officer shall modify the ``Allowable Cost 
and Payment'' clause at FAR 52.216-7 by deleting from paragraph (a) the 
words ``Subpart 31.2 of the Federal Acquisition Regulation (FAR)'' and 
substituting ``45 CFR Part 74 Appendix E.''
    (j) The Contracting Officer shall insert the clause in 352.216-70, 
Additional Cost Principles, in solicitations and contracts when a cost-
reimbursement contract is contemplated.

Subpart 316.5--Indefinite-Delivery Contracts


316.505  Ordering.

    (b)(5) The HHS task-order and delivery-order ombudsman is the 
Director, Strategic Acquisition Service, PSC. The task-order and 
delivery-order ombudsmen for each of the HHS contracting activities are 
as follows:

AHRQ: Director, Office of Performance Accountability, Resources and 
Technology
BARDA: Chief of Mission Support and Acquisition Policy
CDC: Chief Information Officer
CMS: Chief Operating Officer
FDA: Director, Office of Acquisitions and Grants Services
HRSA: Associate Administrator, Office of Operations
IHS: Director, Office of Management Services
NIH: Senior Scientific Advisor for Extramural Research, Office of 
Extramural Research (R & D) and Senior Advisor to the Director 
(Other than R & D)
PSC: Director, Strategic Acquisition Service
SAMHSA: Executive Officer

Subpart 316.6--Time-and-Materials, Labor-Hour, and Letter Contracts


316.603  Letter contracts.


316.603-3  Limitations.

    An official one level above the Contracting Officer shall make the 
written determination that no other contract type is suitable.


316.603-70  Procedure for requesting authority to issue a letter 
contract.

    The Contracting Officer shall include the following information in 
a memorandum requesting approval to award a letter contract:
    (a) Name and address of proposed contractor.
    (b) Location where contract is to be performed.
    (c) Contract number, including modification number, if possible.
    (d) Brief description of work and services to be performed.
    (e) Proposed performance or delivery schedule.
    (f) Amount of letter contract.
    (g) Estimated total amount of definitized contract.
    (h) Type of definitive contract to be executed (fixed price, cost-
reimbursement, etc.).
    (i) Statement of the necessity and advantage to the Government of 
the use of the proposed letter contract.
    (j) Statement of percentage of the estimated cost that the 
obligation of funds represents (in rare instances where the obligation 
represents 50

[[Page 62437]]

percent or more of the proposed estimated cost of the acquisition, the 
Contracting Officer shall include a justification for that obligation 
(e.g., the contractor requires a large initial outlay of funds for 
major subcontract awards or an extensive purchase of materials to meet 
an urgent delivery requirement)). In every case, documentation shall 
demonstrate that the amount to be obligated is not in excess of an 
amount reasonably required to perform the work.
    (k) Period of effectiveness of a proposed letter contract. (If more 
than 180 days, the Contracting Officer shall provide a detailed 
justification).
    (l) A statement of any substantive matters that need to be 
resolved.


316.603-71  Approval for modifications to letter contracts.

    An official one level above the Contracting Officer shall approve 
all letter contract modifications. Contracting activities shall process 
requests for authority to issue letter contract modifications in the 
same manner as requests for authority to issue letter contracts. A 
request shall include the following:
    (a) Name and address of the contractor.
    (b) Description of work and services.
    (c) Date original request was approved and name/title of approving 
official.
    (d) Letter contract number and date issued.
    (e) Detailed justification as to why the letter contract cannot 
currently be definitized.
    (f) Detailed justification as to why the level of funding must be 
increased.
    (g) Detailed justification as to why the period of effectiveness 
must be increased beyond 180 days, if applicable.
    (h) If the funding of the letter contract is to be increased to 
more than 50 percent of the estimated cost of the acquisition, the 
Contracting Officer shall include the information required by 316.603-
70(j).

Subpart 316.7--Agreements


316.770  Unauthorized types of agreements.


316.770-2  Memorandum of understanding.

    Use of a ``memorandum of understanding,'' which purports to modify 
mandatory FAR and HHSAR provisions to make them acceptable to a 
prospective contractor, is not authorized because it may address 
matters contrary to the language of the solicitation or prospective 
contract. A memorandum of understanding does not bind the Government 
under the contract. The Contracting Officer shall make a change in a 
solicitation or contract only by amendment or modification, 
respectively. When a change to a prescribed contract clause is 
considered necessary, the Contracting Officer shall request a 
deviation.

PART 317--SPECIAL CONTRACTING METHODS

Subpart 317.1--Multi-year Contracting
Sec.
317.104 General.
317.105 Policy.
317.105-1 Uses.
317.107 Options.
317.108 Congressional notification.
Subpart 317.2--Options
317.204 Contracts.
317.207 Exercise of options.
Subpart 317.5--Interagency Acquisitions Under the Economy Act
317.503 Determination and findings requirements.
Subpart 317.70--Multi-agency and Intra-agency contracts
317.7000 Scope of subpart.
317.7001 Definitions.
317.7002 Potential multi-agency and intra-agency sources.
317.7003 Documentation for multi-agency contracts.
317.7004 Documentation for intra-agency contracts.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 317.1--Multi-year Contracting


317.104  General.

    (b) The Senior Procurement Executive is the agency head for the 
purpose of FAR 17.104(b).


317.105  Policy.


317.105-1  Uses.

    (a) Each HCA determination to use multi-year contracting, as 
defined in FAR 17.103, is limited to individual acquisitions where the 
cancellation ceiling obligated in the first year does not exceed 20 
percent of the contract value over the full multi-year term or $11.5 
million, whichever is less. Cancellation ceiling provisions shall 
conform to the requirements of FAR 17.106-1(c). The determination is 
not delegable and shall address the issues in FAR 17.105-1(a) and the 
following:
    (1) The amount of, and basis for, the proposed cancellation 
ceiling.
    (2) Identification and assignment of a Contracting Officer holding 
a FAC-C Level III certification or, alternatively, one familiar with 
the application of this contracting method.
    (3) Availability of appropriations to fund the obligation of total 
contract costs for the first year of performance plus the estimated 
amount of the full cancellation ceiling.
    (4) Reasonable expectation that, throughout the contemplated 
contract performance period, the OPDIV, through its annual budget 
request, will seek funding for the contract at the level necessary to 
avoid contract cancellation; and
    (5) Program requirements are reasonably stable and the associated 
technical risks are not excessive--i.e., not of the nature or level to 
jeopardize contract completion or result in its cancellation.
    Upon SPE request, the HCA shall provide a copy of each 
determination (other than those specified in 317.105-1(b) below).
    (b) SPE approval is required for--
    (1) Any individual determination to use multi-year contracting with 
a cancellation ceiling in excess of the limits in 317.105-1(a); and
    (2) Any class determination (see FAR Subpart 1.7).
    HCA determinations involving a cancellation ceiling in excess of 
the limits in 317.105-1(a) shall also include a compelling rationale 
why this approach is in the best interests of the Government and a 
draft congressional notification letter pursuant to FAR 17.108 and 
317.108.


317.107  Options.

    When used as part of a multi-year contract, options shall not be 
used to extend the performance of non-severable services beyond 5 
years. Options may serve as a means to acquire related severable 
services and, upon being exercised, shall be funded from the then-
current fiscal year's appropriation.


317.108  Congressional notification.

    (a) The SPE is the agency head for the purposes of FAR 17.108(a). 
Upon SPE approval of the determination required by 317.105-1(b)(1), the 
SPE will finalize and sign the congressional notification letter and 
provide it to the appropriate House and Senate committees.

Subpart 317.2--Options


317.204  Contracts.

    (e) The total of the basic and option periods shall not exceed 10 
years in the case of services and the total of the basic and option 
quantities shall not exceed the requirement for 5 years in the case of 
supplies. These limitations do not apply to IT and R & D contracts. 
However, statutes applicable to various classes of contracts may place 
additional restrictions on the length of contracts.

[[Page 62438]]

317.207  Exercise of options.

    (h) Before exercising an option for a subsequent performance 
period/additional quantity under a multiple-year contract/order--see 
339.201-70(c), which involves the acquisition of EIT products and 
services, including EIT deliverables such as electronic documents and 
reports, subject to Section 508 of the Rehabilitation Act of 1973, as 
amended, the Contracting Officer shall ensure that the contractor has 
provided to the Contracting Officer and Project Officer a properly 
completed HHS Section 508 Annual Report--see Section 508 policy on HHS 
Office on Disability Web site. The Contracting Officer shall request 
that the contractor provide the report in sufficient time for its 
review and approval by the Contracting Officer, Project Officer, and 
the Section 508 Official or designee, prior to exercise of an option. 
The Contracting Officer shall ensure that the report and all related 
approvals are made a part of the official contract/order file.

Subpart 317.5--Interagency Acquisitions Under the Economy Act


317.503  Determination and findings requirements.

    (a) In addition to the D & F contents specified in FAR 17.503(a)(1) 
and (2), each Assisted Contracting D & F shall address--
    (3) The servicing organization(s) contemplated (the assigned HHS 
contracting office shall be one of the servicing organizations 
contemplated);
    (4) For each organization and alternative approach contemplated, 
the anticipated benefits to the OPDIV; the anticipated costs, including 
associated fees or other compensation; and the contract/order placement 
timeframe;
    (5) The tradeoffs (cost, schedule, performance) among the 
approaches considered;
    (6) The recommended multi-agency or intra-agency contracting 
approach; and
    (7) The conclusion that the contract to be awarded by the selected 
servicing organization is the most advantageous alternative to the 
Government, notwithstanding fees and the increased risk associated with 
assisted contracting.

Subpart 317.70--Multi-agency and Intra-agency Contracts


317.7000  Scope of subpart.

    (a) This subpart prescribes policies for HHS' use of multi-agency 
and intra-agency contracting under all authorities. It does not apply 
when HHS transfers funds to another agency under an interagency 
agreement whose primary purpose is other than contracting on HHS' 
behalf.
    (b) For multi-agency contracts under the authority of the Economy 
Act, see FAR Subpart 17.5 and 317.503.
    (c) Multi-agency contracting authorities other than the Economy Act 
include but are not limited to the Clinger-Cohen Act [40 U.S.C. 
11302(e)]; the Government Management Reform Act (Pub. L. 103-356); 
Title III of the Federal Property and Administrative Services Act of 
1949 (41 U.S.C. 251, et seq.); and 40 U.S.C. 501, Services for 
Executive Agencies.


317.7001  Definitions.

    As used in this subpart:
    Multi-agency contracting describes a procedure in which a Federal 
agency needing supplies or services obtains them using another Federal 
agency's contract (direct ordering), the contracting assistance of 
another Federal agency (assisted contracting), or both. In some cases, 
more than one servicing organization may be involved in assisted 
contracting.
    Intra-agency contracting describes a procedure in which an HHS 
OPDIV/STAFFDIV needing supplies or services obtains them by issuing an 
order under another HHS OPDIV/STAFFDIV's contract or agreement (e.g., a 
BPA--direct ordering); or using the contracting assistance of another 
OPDIV/STAFFDIV (assisted contracting); or both.
    Assisted contracting is a subset of multi-agency/intra-agency 
contracting in which a servicing contracting office other than the 
requesting organization's assigned contracting office contracts on 
behalf of the requesting organization.
    Direct ordering is a subset of multi-/intra-agency contracting in 
which a contracting or ordering officer issues an order under another 
OPDIV's or Federal agency's indefinite delivery vehicle (e.g., a GSA 
FSS schedule or a GWAC).
    Requesting organization refers to the organization with the 
requirement for a multi- or intra-agency contract.
    Servicing organization refers to an organization that assists a 
requesting organization by awarding a contract or order on its behalf. 
In the context of multi-agency contracting, the servicing organization 
and requesting organization must be in different Federal agencies. For 
intra-agency contracting, the servicing and requesting organizations 
must both be HHS organizations.


317.7002  Potential multi-agency and intra-agency sources.

    (a) Prior to deciding to use multi-agency or intra-agency 
contracting, the requesting organization must perform sufficient market 
research to consider the relative merits and costs of available 
contracts and contracting offices for meeting the requesting 
organization's need.
    (b) Direct ordering conducted by HHS contracting officers using GSA 
vehicles, GWACs, and vehicles established under the Federal Strategic 
Sourcing Initiative does not require justification. HHS contracting 
officers should be cautious about using unfamiliar contract vehicles. 
When using vehicles other than those listed above, the Contracting 
Officer shall include in the contract file a D & F, which is prepared 
in consultation with the SBS, and which concludes that the chosen 
vehicle is the best way to obtain the required product or service.
    (c) With the exception of assisted contracts and direct order 
acquisitions to be placed pursuant to the authority of the Economy Act, 
which always require preparation of a supporting D & F--see FAR 17.503, 
proposed assisted contracts approved as part of an annual or updated 
acquisition plan require no additional documentation or approvals.
    (d) For proposed assisted contracts not approved as part of an 
annual or update acquisition plan, the requiring organization shall 
identify the potential servicing organization(s); summarize the 
services each source provides; and describe the compensation 
arrangement(s). The assigned contracting office shall be one of the 
alternatives considered. For multi-agency contract actions, this 
information shall be included in the Assisted Contracting D & F 
required in 317.7003(b).


317.7003  Documentation for multi-agency contracts.

    (a) In the case of proposed direct ordering using vehicles other 
than those listed in 317.7002(b), the HHS contracting officer shall 
comply with the D & F requirement in 317.7003(b).
    (b) If a proposed assisted contract, using a servicing organization 
outside HHS, was not approved during preparation and review of the 
annual acquisition plan, including updates, then the program/project 
office or other requiring activity shall prepare an Assisted 
Contracting D & F, similar to the D & F specified in FAR 17.503, but 
augmented with the information specified in 317.503. The Project 
Officer or other requiring official shall be responsible for preparing 
and staffing this Assisted Contracting D & F.
    (1) For assisted contracts greater than or equal to $500,000 
(including the value of the base contract and all

[[Page 62439]]

options and, for indefinite delivery vehicles, the value of the vehicle 
and all potential orders), the assigned HHS Contracting Officer shall 
review and approve or reject the Assisted Contracting D & F, annotated 
with the SBS' recommendation. The Contracting Officer's signature on 
the Assisted Contracting D&F signifies his/her concurrence that 
assisted contracting through the proposed servicing contracting office 
is in the best interest of the government. The Project Officer must 
retain a copy of the approved Assisted Contracting D & F.
    (2) For assisted contracts less than $500,000, the HCA may delegate 
authority to the Project Officer or other requiring official to approve 
the required Assisted Contracting D & F. The $500,000 threshold 
includes the value of the base contract and all options and, for 
indefinite delivery vehicles, the value of the vehicle and all 
potential orders.
    (3) During a declared (Presidential or HHS Secretarial) emergency, 
funding and requirements documentation may be transferred to a 
servicing organization without an Assisted Contracting D & F. The 
Project Officer shall document his/her file, explaining the exigent 
circumstances.
    (c) Assisted contracts require supporting interagency agreements, 
as described in OFPP's memorandum, ``Interagency Acquisitions,'' dated 
June 2008. Note that Part A of an interagency agreement can support 
multiple assisted contracts. Each interagency agreement shall address 
all the elements identified in OFPP's model interagency agreement 
(Appendix 2 of OFPP's ``Interagency Acquisitions''). The level of 
detail in HHS interagency agreements should be commensurate with the 
dollar value and complexity of the assisted contract. HHS requesting 
organizations shall not forward funding or requirements documentation 
outside HHS without a properly executed interagency agreement; and 
servicing activities within HHS (e.g., PSC and the NIH Information 
Technology Acquisition and Assessment Center), shall not contract on 
behalf of non-HHS requesting organizations without properly executed 
interagency agreements.


317.7004  Documentation for intra-agency contracts.

    (a) In the case of proposed direct ordering, using vehicles other 
than those listed in 317.7002(b), the HHS contracting officer shall 
comply with the D & F requirement in 317.7003(b).
    (b) With the exception of assisted contracts and direct order 
acquisitions to be placed pursuant to the authority of the Economy Act, 
which always require preparation of a supporting D & F--see FAR 17.503, 
proposed assisted contracts approved as part of an annual or updated 
acquisition plan require no additional documentation or approvals.
    (c) For proposed assisted contracts not approved as part of an 
annual or updated acquisition plan, the requiring organization shall 
identify the potential servicing organization(s); summarize the 
services the source(s) provide(s); and describe the compensation 
arrangement(s). The assigned contracting office shall be one of the 
alternatives considered.
    (d) Assisted intra-agency contracts may require supporting intra-
agency agreements or other documentation as prescribed by OPDIV 
procedures.

SUBCHAPTER D--SOCIOECONOMIC PROGRAMS

PART 319--SMALL BUSINESS PROGRAMS

Subpart 319.2--Policies
Sec.
319.201 General policy.
319.202-2 Locating small business sources.
319.270-1 Solicitation provision and contract clause.
Subpart 319.5--Set-Asides for Small Business
319.501 General.
319.506 Withdrawing or modifying set-asides.
Subpart 319.7--Subcontracting with Small Business, Small Disadvantaged 
Business, and Women-Owned Small Business Concerns
319.705 Responsibilities of the Contracting Officer under the 
subcontracting assistance program.
319.705-5 Awards involving subcontracting plans.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 319.2--Policies


319.201  General policy.

    (d) The functional management responsibilities for HHS' small 
business program (i.e., small businesses; veteran-owned small 
businesses; service-disabled, veteran-owned small businesses; HUBZone 
small businesses; small disadvantaged businesses; and women-owned small 
businesses) are delegated to the OSDBU Director. See the HHS Small 
Business Program manual for information on the HHS small business 
program, including SBS and Small Business Administration (SBA) 
Procurement Center Representative (PCR) acquisition review timeframes.
    (e) (1) One or more qualified SBSs will implement the HHS small 
business program and shall be co-located within the following OPDIVs: 
AHRQ; BARDA; CDC; CMS; FDA; HRSA; IHS; NIH; PSC; and SAMHSA. The OSDBU 
Director shall exercise full management authority over SBSs.
    (2) Within IHS, the primary SBS will be responsible for IHS' 
overall implementation of the HHS small business program; however, each 
IHS contracting office will have a small business technical advisor 
(SBTA) to carry out those functions and responsibilities to implement 
the small business program. The primary IHS SBS shall assist and 
provide guidance to respective SBTAs.


319.202-2  Locating small business sources.

    (a) OPDIVs shall foster, to the extent practicable, maximum 
participation by small businesses in HHS acquisitions. Prior to issuing 
a solicitation, the Contracting Officer shall make every reasonable 
effort to find small business concerns that can compete for the 
proposed requirement--see FAR 19.202, 10.001(2)(v), and 
10.002(b)(1)(vii).
    (1) If it cannot be determined in advance (through market research 
under FAR Part 10, discussions between the Contracting Officer and the 
SBS, or other means--see FAR 15.201, whether a solicitation in excess 
of the simplified acquisition threshold can be set aside exclusively 
for small business participation [whether for small businesses; HUBZone 
small businesses; service-disabled, veteran-owned small businesses; or 
8(a) small business(es)], the Contracting Officer may publish a notice 
entitled ``Small Business Sources Sought'' in FedBizOpps. The purpose 
of a Small Business Sources Sought notice is to identify the 
availability and capability of qualified small business sources; and 
their size classification relative to the appropriate North American 
Industry Classification System (NAICs) code. This will assist the 
Government in determining the appropriate acquisition method, including 
whether a set-aside is possible. However, to solicit technical, 
scientific, or business information for project planning purposes, an 
RFI may be used--see 315.201(e).
    (2) When using a Small Business Sought notice, an OPDIV shall not 
request that potential sources provide more than the minimum 
information necessary--see FAR 10.001(b), to determine whether they 
have the apparent capability to perform a requirement and, therefore, 
whether they should be included in any future

[[Page 62440]]

competition. The notice and the information received shall not be used 
to determine how well respondents can perform a requirement, which can 
only be evaluated in response to a solicitation. Accordingly, the 
notice shall not be used to--
    (i) Obtain capability statements that are evaluated and determined 
acceptable or unacceptable;
    (ii) Require cost/price proposals or detailed technical solutions;
    (iii) Identify a prospective sole source; or
    (iv) Exclude small business concerns.
    (3) OPDIVs shall follow the standard HHS instructions for 
completing a ``Small Business Sources Sought'' notice.'' The template 
for the notice is available on the ASFR/OGAPA/DA Internet Web site. The 
Contracting Officer shall post the notice in FedBizOpps by selecting 
and completing a Sources Sought notice, accessible on the FedBizOpps 
``Notices'' page at: http://www.fedbizopps.gov. Additional information 
may be included in the notice in accordance with OPDIV procedures. The 
Contracting Officer shall document, in the form of a memorandum to the 
file, the results of the review by technical personnel of information 
submitted in response to the notice, including whether each respondent 
appears to be capable of performing the requirement. The Contracting 
Officer shall attach a copy of the analysis provided by the technical 
personnel to the memorandum.


319.270-1  Solicitation provision and contract clause.

    (a) The Contacting Officer shall insert the provision in 352.219-
70, Mentor-Prot[eacute]g[eacute] Program, in solicitations that include 
the clause in FAR 52.219-9, Small Business Subcontracting Plan. The 
provision requires that offerors provide the Contracting Officer a copy 
of their HHS Office of Small and Disadvantaged Business Utilization 
(OSDBU)-approved mentor-prot[eacute]g[eacute] agreement in response to 
a solicitation. (b) The Contacting Officer shall insert the clause in 
352.219-71, Mentor-Prot[eacute]g[eacute] Program Reporting 
Requirements, in contracts that include the clause in FAR 52.219-9, 
Small Business Subcontracting Plan, and which are awarded to a 
contractor with an HHS OSDBU-approved mentor-prot[eacute]g[eacute] 
agreement.

Subpart 319.5--Set-Asides for Small Business


319.501  General.

    (e) Subsequent to the Contracting Officer's recommendation on Form 
HHS 653, HHS Small Business Review Form, the SBS shall review each 
proposed acquisition strategy and either concur or not concur with the 
Contracting Officer's recommendation. The PCR shall also review the 
acquisition strategy and either concur or not concur with the 
Contracting Officer's recommendation. If the Contracting Officer 
disapproves the SBS's or the PCR's set-aside recommendation, the 
Contracting Officer shall document the reasons on Form HHS 653 and 
place the form in the contract file. The Contracting Officer shall make 
the final determination as to whether the proposed acquisition will be 
set-aside or not.


319.506  Withdrawing or modifying set-asides.

    (d) Immediately upon notice from the Contracting Officer, the SBS 
shall provide notification of all set-aside withdrawals to the OSDBU 
Director by both telephone and e-mail.

Subpart 319.7--Subcontracting With Small Business, Small 
Disadvantaged Business, and Women-Owned Small Business Concerns


319.705  Responsibilities of the Contracting Officer under the 
subcontracting assistance program.


319.705-5  Awards involving subcontracting plans.

    (a) (3) The Contracting Officer shall provide the PCR a period of 1 
to 5 working days to review the contract award package, depending upon 
the circumstances and complexity of the individual acquisition.

PART 322--APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS

Subpart 322.8--Equal Employment Opportunity
Sec.
322.810 Solicitation provisions and contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 322.8--Equal Employment Opportunity


322.810  Solicitation provisions and contract clauses.

    (h) The Contracting Officer shall insert the clause in 352.222-70, 
Contractor Cooperation in Equal Employment Opportunity Investigations, 
in solicitations, contracts, and orders that include the clause in FAR 
52.222-26, Equal Opportunity.

PART 323--ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE 
ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE

Subpart 323.70--Safety and Health
Sec.
323.7000 Scope of subpart.
323.7001 Policy.
323.7002 Actions required.
Subpart 323.71--Green Purchasing Requirements
323.7100 Policy.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 323.70--Safety and Health


323.7000  Scope of subpart.

    This subpart prescribes the use of a safety and health clause in 
contracts involving hazardous materials or operations, and provides 
procedures for administering safety and health provisions.


323.7001  Policy.

    Various statutes and regulations (e.g., the Walsh-Healy Act and 
Service Contract Act), require adherence to minimum safety and health 
standards by contractors engaged in potentially hazardous work. FAR 
subpart 23.3 serves as the primary reference regarding hazardous 
materials. The Contracting Officer shall follow the guidance in this 
subpart when the guidance in the FAR is not sufficient or does not meet 
the safety and health situation for an acquisition.


323.7002  Actions required.

    (a) Contracting activities. The Contracting Officer shall insert 
the clause in 352.223-70, Safety and Health, or a clause substantially 
the same, in solicitations and contracts that involve hazardous 
materials or operations for the following types of requirements:
    (1) Services or products.
    (2) Research, development, or test projects.
    (3) Transportation of hazardous materials.
    (4) Construction, including construction of facilities on the 
contractor's premises.
    (b) Safety officers. OPDIV safety officers shall advise and assist 
initiators of acquisition requests and Contracting Officers in--
    (1) Determining whether safety and health provisions shall be part 
of a prospective contract;
    (2) Evaluating a prospective contractor's safety and health 
programs; and

[[Page 62441]]

    (3) Conducting post-award reviews and surveillance to the extent 
deemed necessary.
    (c) Initiators. Initiators of acquisition requests for items 
described in paragraph (a) of this section shall--
    (1) During the preparation of an acquisition plan or other 
acquisition request documentation, and in the solicitation, ensure that 
hazardous materials and operations to be used in the performance of the 
contract are clearly identified; and
    (2) During the period of performance--
    (i) Apprise the Contracting Officer of any noncompliance with 
safety and health provisions identified in the contract; and
    (ii) Cooperate with the safety officer in conducting review and 
surveillance activities.

Subpart 323.71--Green Purchasing Requirements


323.7100  Policy.

    (a) The HHS guidelines and procedures for ``green purchasing'' may 
be found in the HHS Affirmative Procurement Plan (APP), ``Purchasing 
Environmentally Preferable Products and Services at the U.S. Department 
of Health and Human Services.'' The APP encompasses the acquisition and 
use of designated recycled content, and Energy Star[supreg], Electronic 
Product Environmental Assessment Tool (EPEAT)-registered, energy-
efficient, bio-based, and environmentally preferable products.
    (1) ASFR/OGAPA/DA has overall responsibility for monitoring the 
OPDIVs' implementation of HHS' APP to ensure compliance with Executive 
Order 13423, ``Strengthening Federal Environmental, Energy, and 
Transportation Management;'' the White House Council on Environmental 
Quality's Implementing Instructions for Executive Order 13423; Section 
6002 of the Resource Conservation and Recovery Act of 1976; Section 104 
of the Energy Policy Act of 2005; Section 9002 of the Farm Security and 
Rural Investment Act of 2002; Section 612 of the Clean Air Act of 1990; 
and FAR Part 23.
    (2) The OPDIVs, through their designated APP Program Managers, are 
responsible for establishing the necessary local procedures and 
appropriate training requirements to ensure effective implementation of 
the HHS APP.

PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

Subpart 324.1--Protection of Individual Privacy
Sec.
324.000 Scope of subpart.
324.102 General.
324.103 Procedures.
Subpart 324.2--Freedom of Information Act
324.203 Policy.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 324.1--Protection of Individual Privacy


324.000  Scope of subpart.

    This part prescribes policies and procedures that apply 
requirements of the Privacy Act of 1974 (5 U.S.C. 552a) and OMB 
Circular A-130, Revised, November 30, 2000, to HHS contracts and cites 
the Freedom of Information Act (5 U.S.C. 552, as amended).


324.102  General.

    (a) It is HHS policy to protect the privacy of individuals to the 
maximum possible extent, while permitting the exchange of records 
required to fulfill HHS administrative and program responsibilities and 
its responsibilities for disclosing records to which the general public 
is entitled under the Freedom of Information Act (5 U.S.C. 552). The 
Privacy Act of 1974 and the HHS implementation under 45 CFR Part 5b 
apply ``when an agency provides by a contract for the operation by or 
on behalf of the agency of a system of records to accomplish any agency 
function * * *.'' The key factor is whether an HHS function is 
involved. Therefore, the Privacy Act requirements apply to an HHS 
contract when, under the contract, the contractor must maintain or 
operate a system of records to accomplish an HHS function.
    (e) The Project Officer, and, as necessary, the official designated 
as the OPDIV's Privacy Act Coordinator and OGC-GLD, shall determine the 
applicability of the Privacy Act to each proposed acquisition. The 
Project Officer is required to include a statement in the AP or other 
acquisition request document indicating whether the Privacy Act is or 
is not applicable to a proposed acquisition.
    (f) Whenever a Contracting Officer is informed that the Privacy Act 
is not applicable, but the resultant contract will involve the 
collection of individually identifiable personal data by the 
contractor, the Contracting Officer shall include provisions to protect 
the confidentiality of the records and the privacy of individuals 
identified in the records--see 324.70.


324.103  Procedures.

    (a) The Contracting Officer shall review all acquisition request 
documentation to determine whether the Privacy Act requirements are 
applicable. The Privacy Act requirements apply when a contract or order 
will require the contractor to design, develop, or operate any Privacy 
Act system of records on individuals to accomplish an agency function. 
When applicable, the Contracting Officer shall include the two Privacy 
Act clauses required by FAR 24.104 in the solicitation and contract or 
order. In addition, the Contracting Officer shall include the two FAR 
Privacy Act clauses, and other pertinent information specified in this 
subpart, in any modification which results in the Privacy Act 
requirements becoming applicable to a contract or order.
    (b)(1) The Contracting Officer shall identify in the SOW/PWS the 
system(s) of records to which the Privacy Act and the implementing 
regulations are applicable.
    (2) The Contracting Officer shall include the clause specified in 
352.224-70, Privacy Act, in solicitations, contracts, and orders that 
involve Privacy Act requirements to notify the contractor that it and 
its employees are subject to criminal penalties for violations of the 
Privacy Act (5 U.S.C. 552a(i)) to the same extent as HHS employees. The 
clause also requires the contractor to ensure that each of its 
employees knows the prescribed rules of conduct and each contractor 
employee is aware that he/she is subject to criminal penalties for 
violations of the Privacy Act. These requirements also apply to all 
subcontracts awarded under the contract or order that require the 
design, development, or operation of a system of records. The 
Contracting Officer shall send the contractor a copy of 45 CFR Part 5b, 
which includes the rules of conduct and other Privacy Act requirements.
    (c) The Contracting Officer shall specify in the contract SOW/PWS 
the disposition to be made of the system(s) of records upon completion 
of contract performance. The contract SOW/PWS may require the 
contractor to destroy the records, remove personal identifiers, or turn 
the records over to the Contracting Officer. If there is a legitimate 
need for a contractor to keep copies of the records after completion of 
a contract, the contractor must take measures, as approved by the 
Contracting Officer, to keep the records confidential and protect the 
individuals' privacy.
    (d) For any acquisition subject to Privacy Act requirements, the 
Project

[[Page 62442]]

Officer, prior to award, or the COTR, after award, shall prepare and 
have published in the Federal Register a ``system notice,'' describing 
HHS' intent to establish a new system of records on individuals, to 
make modifications to an existing system, or to disclose information in 
regard to an existing system. The Project Officer shall attach a copy 
of the system notice to the acquisition plan or other acquisition 
request documentation. If a system notice is not attached, the 
Contracting Officer shall inquire about its status and shall obtain a 
copy from the Project Officer for inclusion in the contract file. If a 
system notice has not been published in the Federal Register, the 
Contracting Officer may proceed with the acquisition but shall not 
award the contract until the system notice is published and the 
Contracting Officer verifies its publication.

Subpart 324.2--Freedom of Information Act


324.203  Policy.

    (a) The HHS regulation implementing the Freedom of Information Act 
(FOIA), 5 U.S.C. 552, as amended, is set forth in 45 CFR Part 5.
    (b) The Contracting Officer, upon receiving a FOIA request, shall 
follow HHS and OPDIV procedures. As necessary, the Contracting Officer 
shall coordinate all actions with the cognizant Freedom of Information 
(FOI) Officer and the OGC-GLD. Only the FOI Officer is authorized to 
release or deny release of records. The Contracting Officer shall be 
familiar with the entire FOIA regulation in 45 CFR Part 5.

SUBCHAPTER E--GENERAL CONTRACTING REQUIREMENTS

PART 327--PATENTS, DATA, AND COPYRIGHTS

Subpart 327.4--Rights in Data and Copyrights
Sec.
327.404-70 Solicitation provision and contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 327.4--Rights in Data and Copyrights


327.404-70  Solicitation provision and contract clause.

    The Contracting Officer shall insert the clause in 352.227-70, 
Publications and Publicity, in solicitations, contracts, and orders 
that involve requirements which could lead to the contractor's 
publishing the results of the award.

PART 328--BONDS AND INSURANCE

Subpart 328.3--Insurance
Sec.
328.301 Policy.
328.311 Solicitation provision and contract clause on liability 
insurance under cost-reimbursement contracts.
328.311-2 Agency solicitation provisions and contract clauses.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 328.3--Insurance


328.301  Policy.

    It is HHS policy to limit the Government's reimbursement, of its 
contractors' liability to third persons for claims not covered by 
insurance in cost-reimbursement contracts, to the Limitation of Funds 
or Limitation of Cost clause of the contract. In addition, the amount 
of the Government's reimbursement cannot exceed the final judgments or 
settlements approved in writing by the Government.


328.311  Solicitation provision and contract clause on liability 
insurance under cost-reimbursement contracts.


328.311-2  Agency solicitation provisions and contract clauses.

    The Contracting Officer shall insert the clause in 352.228-7, 
Insurance--Liability to Third Persons, in lieu of the clause in FAR 
52.228-7, Insurance--Liability to Third Persons, in solicitations and 
contracts when a cost-reimbursement contract is contemplated. The 
Contracting Officer shall insert Alternate I or II based on the 
conditions specified therein. This is an authorized FAR deviation.

PART 330--COST ACCOUNTING STANDARDS

Subpart 330.2--CAS Program Requirements
Sec.
330.201 Contract requirements.
330.201-5 Waiver.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 330.2--CAS Program Requirements


330.201  Contract requirements.


330.201-5  Waiver.

    (a) OPDIVs shall forward waiver requests through appropriate 
acquisition channels, including the HCA, to the Associate DAS for 
Acquisition (non-delegable) for review. Associate DAS for Acquisition 
shall exercise the waiver authority under FAR 30.201-5(a)(2).

PART 331--CONTRACT COST PRINCIPLES AND PROCEDURES

Subpart 331.1--Applicability
Sec.
331.101-70 Salary rate limitation.
331.102-70 Pricing of adjustments.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 331.1--Applicability


331.101-70  Salary rate limitation.

    (a) Beginning in fiscal year 1990, Congress has stipulated in HHS 
appropriations acts and continuing resolutions that, under applicable 
NIH, SAMHSA, and AHRQ contracts, appropriated funds cannot be used to 
pay the direct salary of an individual at a rate in excess of the 
Federal Executive Schedule Level I.
    (b) The Contracting Officer shall insert the clause in 352.231-70, 
Salary Rate Limitation, in NIH, SAMHSA, and AHRQ solicitations and 
contracts that exceed the simplified acquisition threshold when a cost-
reimbursement, fixed-price level-of-effort, time-and-materials, or 
labor-hour contract is contemplated, including modifications of 
contracts of those types for projects that support extramural program 
activities. For purposes of this clause, for NIH: Projects that support 
extramural program activities are basic and applied research projects; 
and for SAMHSA and AHRQ: Projects that support extramural program 
activities are mission-related projects, exclusive of contracts for 
general support services.


331.102-70  Pricing of adjustments.

    The Contracting Officer shall insert the clause in 352.231-71, 
Pricing of Adjustments, in solicitations and contracts when a fixed-
price contract is contemplated.

PART 332--CONTRACT FINANCING

Subpart 332.4--Advance Payments for Non-Commercial Items
Sec.
332.402 General.
332.403 Applicability.
332.407 Interest.
332.409 Contracting Officer action.
332.409-1 Recommendation for approval.
Subpart 332.5--Progress Payments Based on Cost
332.501 General.
332.501-2 Unusual progress payments.
Subpart 332.7--Contract Funding
332.703-70 Funding contracts during a continuing resolution.
332.704 Limitation of cost or funds.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

[[Page 62443]]

Subpart 332.4--Advance Payments for Non-Commercial Items


332.402   General.

    (e) The HCA (non-delegable) shall determine whether an advance 
payment is in the public interest in accordance with FAR 
32.402(c)(1)(iii)(A).


332.403   Applicability.

    All R&D contracts with educational institutions located in the 
United States shall provide for financing by use of advance payments, 
in reasonable amounts, unless otherwise prohibited by law.


332.407   Interest.

    (d) The HCA (non-delegable) shall make the determinations in FAR 
32.407(d). The HCA may also approve interest-free advance payments for 
educational institutions and other nonprofit organizations, whether 
public or private, performing work under nonprofit contracts (without 
fee) involving health services, educational programs, or social service 
programs, such as the following:
    (1) Community health representative services for an Indian Tribe.
    (2) Narcotic addict rehabilitative services.
    (3) Comprehensive health care services for Model Neighborhood 
programs.
    (4) Planning and development of health maintenance organizations.
    (5) Dissemination of information derived from educational research.
    (6) Surveys or demonstrations in the field of education.
    (7) Producing or distributing educational media for disabled 
persons including captioned films for the hearing impaired.
    (8) Operation of language or area centers.
    (9) Biomedical research and support services.
    (10) Research surveys or demonstrations involving the training and 
placement of health personnel and health professionals, and 
dissemination of related information.
    (11) Surveys or demonstrations in the field of social service.


332.409   Contracting Officer action.


332.409-1   Recommendation for approval.

    The Contracting Officer shall transmit the information in FAR 
32.409-1 (or FAR 32.409-2) to the HCA by memorandum.

Subpart 332.5--Progress Payments Based on Cost


332.501   General.


332.501-2   Unusual progress payments.

    (a)(3) The HCA (non-delegable) shall approve an unusual progress 
payment.

Subpart 332.7--Contract Funding


332.703-70   Funding contracts during a continuing resolution.

    (a) Continuing resolutions. A continuing resolution (CR) is a 
legislative measure enacted to keep existing Federal programs 
functioning, generally at minimal levels, after the expiration of prior 
fiscal year budget authority and until passage of regular appropriation 
acts by Congress.
    (b) Operating guidance. Because the terms of CRs may vary, for each 
CR, specific operating guidance will be issued by the Office of the 
Assistant Secretary for Resources and Technology (ASRT). This guidance 
will--
    (1) Establish the availability of funds for existing and new 
projects or activities (consistent with the language of the CR);
    (2) Identify any specific limits or constraints imposed; and
    (3) Establish the authorized level and timing of obligations 
permitted.
    (c) Contracting activities, in concert with program, budget and 
finance personnel, must carefully assess contract funding decisions 
to--
    (1) Ensure compliance with HHS guidance regarding the specific 
terms of a CR;
    (2) Maintain essential operations and activities; and
    (3) Guard against violations of the Anti-Deficiency Act--see FAR 
32.702.


332.704   Limitation of cost or funds.

    See subpart 342.71, ``Administrative Actions for Cost Overruns,'' 
for procedures for handling anticipated cost overruns.

PART 333--PROTESTS, DISPUTES, AND APPEALS

Subpart 333.1--Protests
Sec.
333.102 General.
333.103 Protests to the agency.
333.104 Protests to GAO.
Subpart 333.2--Disputes and Appeals
333.203 Applicability.
333.209 Suspected fraudulent claims.
333.211 Contracting Officer's decision.
333.212 Contracting Officer's duties upon appeal.
333.212-70 Formats.
333.213 Obligation to continue performance.
333.215-70 Contract clauses.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 333.1--Protests


333.102   General.

    (g)(1) The OGC-GLD serves as the liaison for protests lodged with 
the Government Accountability Office (GAO); is designated as the office 
responsible for all protests within HHS; and serves as the notification 
point with GAO for all protests.
    (2) Each contracting activity shall designate a protest control 
officer to serve as an advisor to the Contracting Officer and to 
monitor protests from the time of initial notification until the 
protest has been resolved. Contracting activities shall forward a copy 
of each appointment and termination of appointment of protest control 
officers through appropriate acquisition channels, including the HCA, 
to ASFR/OGAPA/DA and the Deputy Associate General Counsel, OGC-GLD.


333.103   Protests to the agency.

    (f)(1) The Contracting Officer is authorized to make the 
determination, using the criteria in FAR 33.104(b), to award a contract 
notwithstanding the protest after obtaining the concurrence of the 
contracting activity's protest control officer and the OGC-GLD. If a 
protest has been lodged with the Secretary, is addressed to the 
Secretary, or requests referral to the Secretary, the Contracting 
Officer shall also obtain approval from Associate DAS for Acquisition 
and OGC-GLD before making the award.
    (2) The Contracting Officer shall require written confirmation of 
any oral protest. To be considered timely, the protester must file a 
written confirmation in accordance with the applicable provisions in 
FAR 33.102(d)(2) and (e). In the following cases, the Contracting 
Officer shall forward written protests received before award through 
appropriate acquisition channels, including the HCA, to OGC-GLD for 
processing:
    (i) The protester requests referral to the Secretary of HHS.
    (ii) The protest is known to have been lodged with GAO or the 
Secretary or is addressed to either.
    (iii) The Contracting Officer entertains some doubt as to the 
proper action regarding the protest or believes it to be in the best 
interest of the Government that the Secretary or GAO consider the 
protest. Otherwise, the Contracting Officer may answer protests 
addressed to the Contracting Officer with the concurrence of the 
contracting activity's protest control officer and OGC-GLD.
    The Contracting Officer shall submit files concerning these 
protests in

[[Page 62444]]

duplicate, or as otherwise specified by OGC-GLD, within 5 calendar days 
after protest receipt; mark the files ``IMMEDIATE ACTION--PROTEST 
BEFORE AWARD;'' and include any documents relevant to issues raised in 
the protest.
    (3) The Contracting Officer shall treat protests received after 
award as indicated in FAR 33.103(f)(3).


333.104   Protests to GAO.

    (a) General procedures.
    (3)(ii) OGC-GLD shall process protests filed with GAO, whether pre- 
or post- award. The Contracting Officer shall prepare protest files as 
follows: assemble them in a secure binder, fastened at the left side 
with a fastener that will permit the full page to be read; include a 
numerical document index, with the first two positions reserved for the 
Contracting Officer's Statement of Facts and Circumstances and the 
second for OGC-GLD's Memorandum of Law, that is paginated and, as 
necessary for sizable files, divided into two or more volumes; and the 
cover of the report shall identify it as the protest file and include 
the solicitation number and the GAO Bid Protest file number--i.e., ``B- 
number.'' In addition, the Contracting Officer shall fold drawings and 
place them in an envelope in the binder and the solicitation/contract 
shall constitute a separate exhibit, if it is voluminous in size. The 
Contracting Officer shall distribute protest files as follows: four 
copies to OGC-GLD and one copy to the contracting activity's protest 
control officer. In addition to the items listed in FAR 
33.104(a)(3)(ii)(A) through (G), the protest file shall include the 
following documents:
    (H) The current status of award. (Note: When award has been made, 
this shall include whether performance has commenced, shipment or 
delivery has been made, or a stop work order has been issued.)
    (I) A copy of any mutual agreement to suspend work on a no-cost 
basis, when appropriate--see FAR 33.104(c)(4).
    (J) Copies of the notice of protest given offerors and other 
parties when the notice is appropriate--see FAR 33.104(a)(2).
    (K) A copy of the negotiation memorandum, when applicable.
    (L) The name and telephone number of the person in the contracting 
office who may be contacted for information relevant to the protest.
    (M) A copy of the competitive range determination.
    (N) The acquisition plan, source selection plan, and the source 
selection decision document.
    (O) The Contracting Officer's statement of facts and circumstances, 
including numbered findings of fact prepared with complete 
documentation, and all the facts and rationale, both favorable and 
unfavorable, to the Contracting Officer's position.
    (4) OGC-GLD shall make the necessary distributions referenced in 
FAR 33.104(a)(4).
    (5) Unless an alternative arrangement is reached with OGC-GLD, the 
Contracting Officer shall furnish one copy of the protest file 
containing the documentation specified in paragraph (a)(3)(ii) of this 
section (with the exception of the Contracting Officer statement of 
facts and circumstances) and FAR 33.104(a)(3)(ii)(A) through (G) to 
OGC-GLD within 5 calendar days from receipt of the protest. In 
addition, the Contracting Officer shall also accommodate any other OGC-
GLD requests for documents which may be needed prior to the 
aforementioned 5-day time period. The Contracting Officer shall submit 
the Contracting Officer's statement of facts and circumstances and the 
additional copies of documentation within 14 calendar days from receipt 
of the protest. Since the statute allows only a short time period in 
which to respond to protests lodged with GAO, the Contracting Officer 
shall handle each protest on a priority basis. OGC-GLD shall submit 
copies of the protest file to GAO, the protestor, and any intervenors 
in accordance with FAR 33.104(a)(4)(i).
    (6) Since OGC-GLD will furnish the protest file to GAO, the 
protestor, and any intervenors, comments on the file from the protestor 
and any intervenors will be sent to OGC-GLD.
    (7) OGC-GLD shall serve as the GAO point of contact for protests 
lodged with GAO.
    (b) Protests before award.
    (1) To make an award notwithstanding a protest, the Contracting 
Officer shall prepare a finding using the criteria in FAR 33.104(b)(1), 
have it executed by the HCA (non-delegable), and forward it, along with 
a written request for approval to make the award (addressed to the 
Associate DAS for Acquisition through OGC-GLD). Should OGC-GLD concur, 
it shall forward the request to the Associate DAS for Acquisition for 
final approval. The written request for approval shall contain all 
relevant documentation as attachments to the request, so that the 
information may be considered by Associate DAS for Acquisition.
    (2) If the request to make an award notwithstanding the protest is 
approved by the Associate DAS for Acquisition, OGC-GLD shall notify 
GAO. Whether the request is approved or not, OGC-GLD shall 
telephonically notify the contracting activity's protest control 
officer of the Associate DAS for Acquisition decision, and the 
contracting activity's protest control officer shall immediately notify 
the Contracting Officer. Should the Associate DAS for Acquisition 
approve the request, ASFR/OGAPA/DA shall send a copy of that written 
approval to the contracting activity's protest control officer.
    (c) Protests after award.
    (2) If the Contracting Officer believes performance should be 
allowed to continue notwithstanding a protest, the Contracting Officer 
shall prepare a written finding using the criteria in FAR 33.104(c)(2). 
The HCA (non-delegable) shall execute the written finding, which the 
contracting office shall forward pursuant to the procedures described 
in paragraph (b)(1) of this section. The notification procedures stated 
in paragraph (b)(2) of this section shall apply to protests after 
award.
    (d) Findings and notice. The Contracting Officer shall prepare the 
written notice required by FAR 33.104(d) and provide a copy to OGC-GLD. 
OGC-GLD shall provide copies to GAO, the protester, and any 
intervenors.
    (g) Notice to GAO. FAR 33.104(g) requires the agency to notify GAO, 
if the agency has not followed any of GAO's recommendations (other than 
costs) within 60 days after its decision. By the end of the 60-day 
period, the Contracting Officer shall notify OGC-GLD of the status of 
implementing the recommendations and reasons for any non-compliance. 
OGC-GLD shall serve as the designated official to comply with the 
requirements of FAR 33.104(g).
    (i) Express option. When GAO invokes the express option, the 
Contracting Officer shall prepare the complete protest file as 
described in paragraph (a)(3) of this section, to include the item in 
paragraph (a)(3)(i), and deliver it (hand-carry, if necessary) to OGC-
GLD in time to meet the submittal date GAO established. OGC-GLD shall 
notify the Contracting Officer of the submittal date after GAO has 
finalized its requirements. If the Contracting Officer is not notified 
about a changed schedule, the timelines for a regular bid protest 
outlined in FAR 33.104(a)(3)(i) shall apply.

Subpart 333.2--Disputes and Appeals


333.203  Applicability.

    (c) The Secretary has designated the Civilian Board of Contract 
Appeals (CBCA) as the authorized ``Board'' to

[[Page 62445]]

hear and determine disputes for the Department.


333.209  Suspected fraudulent claims.

    The Contracting Officer shall submit any instance of a contractor's 
suspected fraudulent claim to the OIG for investigation.


333.211  Contracting Officer's decision.

    (a)(2) The Contracting Officer shall refer a proposed final 
decision to OGC-GLD, for advice as to the legal sufficiency and format 
before sending the final decision to the contractor. The Contracting 
Officer shall provide OGC-GLD with the pertinent documents with the 
submission of each proposed final decision.
    (4)(v) When using the paragraph in FAR 33.211 (a)(4)(v), the 
Contracting Officer shall insert the words ``Civilian'' before each 
mention of the term ``Board of Contract Appeals.''
    (h) At any time within the period of appeal, the Contracting 
Officer may modify or withdraw the final decision. If a contractor has 
appealed the final decision to the CBCA, the Contracting Officer shall 
forward the recommended action to OGC-GLD with a supplement to the 
contract file that supports the recommended correction or amendment.


333.212  Contracting Officer's duties upon appeal.

    (a) The rules set forth in the ``Rules of the Civilian Board of 
Contract Appeals,'' or the rules established by the U.S. Court of 
Federal Claims, as appropriate, shall govern appeals.
    (b) The OGC-GLD is designated as the Government Trial Attorney to 
represent the Government in the defense of appeals before the CBCA. 
OGC-GLD shall provide the decision by CBCA to the appropriate 
Contracting Officer for compliance in accordance with the CBCA's 
decision.
    (c) If an appeal is filed with the CBCA, the Contracting Officer 
shall assemble a file, within 30 days of receipt of an appeal or 
notification that an appeal has been filed, that consists of all 
documents pertinent to the appeal, including the following:
    (1) The decision and findings of fact from which the appeal is 
taken.
    (2) The contract, including specifications and pertinent 
modifications, plans and drawings.
    (3) All correspondence between the parties pertinent to the appeal, 
including the letter or letters of claim in response to which the 
decision was issued.
    (4) Transcripts of any testimony taken during the course of 
proceedings, and affidavits or statements of any witness on the matter 
in dispute made prior to the filing of the notice of appeal with the 
CBCA.
    (5) Any additional information considered pertinent. The 
Contracting Officer shall furnish the appeal file to the Government 
Trial Attorney for review and approval. After approval, the Contracting 
Officer shall prepare four copies of the file--i.e., one for the CBCA, 
one for the appellant, one for the Government Trial Attorney, and one 
for the contracting office.
    (d) At all times after the filing of an appeal, the Contracting 
Officer shall render whatever assistance is requested by the Government 
Trial Attorney. When an appeal is set for hearing, the Contracting 
Officer shall provide Government witnesses and specified physical and 
documentary evidence to the Trial Attorney. The Trial Attorney shall 
ensure the presence of all witnesses and documentary evidence at both 
the prehearing conference and hearing.
    (e) If a contractor, which has filed an appeal with the CBCA, 
elects to accept fully the decision from which the appeal was taken, or 
any modification to it, and gives written notification of acceptance to 
the Government Trial Attorney or the concerned Contracting Officer, the 
Government Trial Attorney shall notify the CBCA of the disposition of 
the dispute in accordance with Rule 27 of the CBCA.
    (f) If the contractor has elected to appeal to the U.S. Court of 
Federal Claims, the U.S. Department of Justice will represent HHS. 
However, the Contracting Officer shall coordinate all actions through 
OGC-GLD.


333.212-70  Formats.

    (a) Contracting activities shall use the following format in 
transmitting appeal files to CBCA:

Your reference:

(Docket No.)

(insert name)

Clerk of the Board, Civilian Board of Contract Appeals
1800 F. Street, Washington, DC 20405 (for regular mail delivery)
1800 M Street, 6th floor, Washington, DC 20036 [for overnight and 
physical (hand-carry) delivery]

Dear (insert name):

Transmitted herewith are documents relative to the appeal under 
Contract No. ---- with the ------------ (insert name of contractor) in 
accordance with the procedures under Rule 4. The Government Trial 
Attorney for this case is ------------ (insert General Law Division, 
Office of General Counsel, Department of Health and Human Services, 330 
Independence Avenue, SW., Washington, DC 20201).

The request for payment of charges resulting from the processing of 
this appeal shall be addressed to: ------------ (insert name and 
address of cognizant finance office.)

     Sincerely yours,

     Contracting Officer


Enclosures

    (b) Contracting activities shall use the following format in 
notifying the appellant that the appeal file was submitted to CBCA:
-----------------------------------------------------------------------

-----------------------------------------------------------------------

-----------------------------------------------------------------------

(insert contractor name and address)
Dear ------------: (insert name)

An appeal file has been compiled relative to the appeal under Contract 
No. ------ (insert number), and has been submitted to the Civilian 
Board of Contract Appeals (CBCA). The enclosed duplicate of the appeal 
file is identical to that submitted to CBCA, except for contract 
documents which you already have been provided. You may furnish or 
suggest any additional information deemed pertinent to the appeal to 
CBCA according to their rules.

The CBCA will provide you with further information concerning this 
appeal.

     Sincerely yours,

     Contracting Officer


Enclosure


333.213  Obligation to continue performance.

    (a) The Contracting Officer shall use the Disputes clause at FAR 
52.233-1 without the use of Alternate I. However, if the Contracting 
Officer determines that the Government's interest would be better 
served by use of paragraph (i) in Alternate I, the HCA or CCO shall 
approve its use.


333.215-70  Contract clauses.

    (a) The Contracting Officer shall insert the clause in 352.233-70, 
Choice of Law (Overseas), in solicitations and contracts when 
performance will be outside the United States, its possessions, and 
Puerto Rico, except as otherwise provided in a government-to-government 
agreement.
    (b) The Contracting Officer shall insert the clause in 352.233-71, 
Litigation and Claims, in solicitations and contracts when a cost-
reimbursement, time-and-materials, or labor-hour contract is 
contemplated

[[Page 62446]]

(other than a contract for a commercial item.)

SUBCHAPTER F--SPECIAL CATEGORIES OF CONTRACTING

PART 334--MAJOR SYSTEM ACQUISITION

Subpart 334.2--Earned Value Management System
Sec.
334.200 Definitions.
334.201 Policy.
334.202 Integrated Baseline Reviews (IBRs).
334.203 Solicitation provisions and contract clauses.
334.203-70 HHS solicitation provisions and contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 334.2--Earned Value Management System


334.200  Definitions.

    As used in this subpart, the following definitions shall apply:
    Full EVMS means tracking and reporting of both the cost and 
schedule aspects of a contract using the principles and guidelines 
described in ANSI/EIA Standard-748, Earned Value Management Systems 
(using the version of the Standard that is in effect at the time of the 
solicitation).
    Partial EVMS means tracking and reporting of only the schedule 
aspects of a contract using the principles and guidelines described in 
ANSI/EIA Standard-748, Earned Value Management Systems (using the 
version of the Standard that is in effect at the time of the 
solicitation).


334.201  Policy.

    (a) For acquisitions for development designated as major in 
accordance with both OMB Circular A-11 and HHS policy on major 
acquisitions; for acquisitions that involve substantial development, 
modification or enhancement; or for acquisitions that involve 
significant upgrade of operational or steady state systems or programs, 
use of an Earned Value Management System (EVMS) is required as follows:
    (1) For individual cost-reimbursement or fixed-price-incentive 
contracts (with incentive based on cost) valued at $10 million to $25 
million, including options, full EVMS (as defined in 334.200) is 
required and the contractor's EVMS shall comply with the guidelines in 
ANSI/EIA Standard-748.
    (2) For individual firm-fixed-price, term form (level-of-effort) of 
any type, time-and-materials, or labor-hour contracts valued at $10 
million to $25 million, including options, partial EVMS (as defined in 
334.200) is required and the contractor's EVMS shall comply with the 
guidelines in ANSI/EIA Standard-748.
    (3) For individual cost-reimbursement or fixed-price-incentive 
contracts (with incentive based on cost) valued at more than $25 
million, including options, full EVMS (as defined in 334.200) is 
required and the contractor's EVMS must be formally validated and 
accepted by the Government--i.e., the contractor's Cognizant Federal 
Agency (CFA), as defined in FAR 2.101 and described in FAR 42.003).
    (4) For individual firm-fixed-price, term form (level-of-effort) of 
any type, time-and-materials, or labor-hour contracts valued at more 
than $25 million, including options, partial EVMS (as defined in 
334.200) is required and the contractor's EVMS must be formally 
validated and accepted by the Government--i.e., the contractor's CFA.
    (5) For individual contracts of any type valued at less than $10 
million, including options, full or partial EVM application, as 
appropriate to the contract type involved, is optional. The 
recommendation to use EVM should be based upon a risk analysis by the 
Program Manager/Project Officer. A decision to use EVM at this level 
requires the prior approval of the cognizant HCA.
    (b) EVM is not required, but may be applied with prior written 
approval of the HCA, on contracts of any dollar amount meeting either 
of the following criteria:
    (1) The acquisition is for non-developmental support services 
(e.g., program office support, Independent Verification & Validation 
services), steady state operations, basic and applied research, and 
routine services (e.g., building maintenance, help-desk services, 
landscaping services).
    (2) The contract is for a commercial item(s) under FAR Part 12.
    (c) When full EVM is required on a prime contract, it applies to 
subcontracts issued there under if those subcontracts have a value and 
are of a type and subject matter that would have required the use of 
full EVM had they been prime contracts. However, if the prime contract 
requires the use of only partial EVM, any subcontracts to which EVM is 
made applicable, because of dollar value, contract type or subject 
matter, shall require only partial EVM.
    (d) When offerors are required to provide an EVMS plan as part of 
their proposals, the Contracting Officer shall request the assistance 
of the Project Officer (and/or an appropriate HHS-designated third 
party) in determining the adequacy of such proposed EVMS plans.
    (e) The selection or use of a particular contract type, if done 
only or primarily to avoid the application of full EVM to the 
acquisition is prohibited.


334.202  Integrated Baseline Reviews (IBRs).

    (a) An IBR normally should be conducted as a post-award activity. A 
pre-award IBR may be conducted only if--
    (1) The AP contains documentation that demonstrates the need and 
rationale for a pre-award IBR, including an assessment of the impact on 
the source selection schedule and the expected benefits;
    (2) The use of a pre-award IBR is approved in writing by the HCA 
prior to the issuance of the solicitation;
    (3) The source selection plan specifically addresses how the 
results of a pre-award IBR will be used during source selection, 
including any weight to be given to it in source evaluation, and that 
same or similar rationale is clearly set forth in the solicitation; 
and,
    (4) Specific arrangements are made, and budget authority is 
provided, to compensate all offerors who prepare for or participate in 
a pre-award IBR; and the solicitation informs prospective offerors of 
the means for and conditions of such compensation.


334.203  Solicitation provisions and contract clauses.

    The FAR EVMS solicitation provisions and contract clause shall not 
be used in HHS contracts. See 334.203-70 for the HHS solicitation 
provisions and contract clauses.


334.203-70  HHS solicitation provisions and contract clauses.

    As provided in 334.201(a) and 334.202, the Contracting Officer 
shall insert the following:
    (a) The provision in 352.234-1, Notice of Earned Value Management 
System--Pre-Award IBR, in solicitations that will require the 
contractor to use an EVMS, whether full or partial, when the Government 
requires an IBR prior to award.
    (b) The provision in 352.234-2, Notice of Earned Value Management 
System--Post-Award IBR, in solicitations that will require the 
contractor to use an EVMS, whether full or partial, when the Government 
requires an IBR after contract award.
    (c) The clause in 352.234-3, Full Earned Value Management System, 
in solicitations and contracts, valued at, or greater than, $25 
million, when a cost-reimbursement or fixed-price-incentive contract 
(where the incentive is based

[[Page 62447]]

on cost) is contemplated, and which require a contractor to use full 
EVMS. The Contracting Officer shall use the clause with its Alternate I 
when the contract value is equal to or greater than $10 million, but 
less than $25 million.
    (d) The clause in 352.234-4, Partial Earned Value Management 
System, in solicitations and contracts, valued at, or greater than, $25 
million, when a firm-fixed-price, time-and-materials, labor-hour, or 
term-form cost-plus-fixed-fee contract is contemplated, and which 
require a contractor to use partial EVMS. The Contracting Officer shall 
use the clause with its Alternate I when the contract value, is equal 
to or greater than $10 million, but less than $25 million.

PART 335--RESEARCH AND DEVELOPMENT CONTRACTING

Sec.
335.070 Cost sharing.
335.070-1 Policy.
335.070-2 Amount of cost sharing.
335.070-3 Method of cost sharing.
335.070-4 Contract award.
335.071 Special determinations and findings affecting research and 
development contracting.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).


335.070  Cost-sharing.


335.070-1  Policy.

    (a) Contracting activities shall encourage performing organizations 
to contribute to the cost of performing R & D, through the use of cost-
sharing contracts, where there is a probability that the contractor 
will receive present or future benefits from participation, such as 
increased technical know-how, training for employees, acquisition of 
equipment, and use of background knowledge in future contracts. Cost-
sharing is intended to serve the mutual interests of the Government and 
the performing organization by helping to ensure efficient utilization 
of the resources available for the conduct of R & D projects and by 
promoting sound planning and prudent fiscal policies of the performing 
organization. The Contracting Officer shall use a cost-sharing 
contract, unless the Contracting Officer determines that a request for 
cost-sharing would not be appropriate because of the following 
circumstances:
    (1) The particular R & D objective or scope of effort for the 
project is specified by the Government rather than proposed by the 
performing organization. This would usually include any formal 
Government solicitation for a specific project.
    (2) The R & D effort has only minor relevance to the non-Federal 
activities of the performing organization, and the organization is 
proposing to undertake the R & D primarily as a service to the 
Government.
    (3) The organization has little or no non-Federal sources or funds 
from which to make a cost contribution. Organizations which are 
predominantly engaged in R & D and have little or no production or 
other service activities may not be in a favorable position to make a 
cost contribution. Accordingly, the Contracting Officer shall normally 
not request cost-sharing, if cost-sharing would require the Government 
to provide funds through some other means (such as fees) to enable the 
organization to cost-share.
    (b) The Contracting Officer has the responsibility for negotiating 
cost-sharing. Each R & D contract file shall indicate whether the 
Contracting Officer considered cost-sharing appropriate for that 
particular contract and in what amount. If cost sharing was not 
appropriate, the file must include a statement and factual basis for 
that decision (e.g., ``Because the contractor will derive no benefits 
from this award that can be applied to its commercial activities, cost-
sharing is not considered appropriate.'') The Contracting Officer shall 
coordinate with the Project Officer before documenting this decision.
    (c) If the Contracting Officer considers cost-sharing appropriate 
for an R & D contract and the contractor refuses to accept this type of 
contract, the Contracting Officer may make an award without cost-
sharing, if the Contracting Officer concludes that payment of the full 
cost of the R & D effort is necessary to obtain the services of that 
particular contractor.


335.070-2  Amount of cost sharing.

    When cost-sharing is appropriate, the Contracting Officer shall use 
the following guidelines to determine the amount of cost participation 
by the contractor:
    (a) The amount of cost participation depends on the extent to which 
the R & D effort or results are likely to enhance the performing 
organization's capability, expertise, or competitive position, and the 
value of this enhancement to the performing organization. Therefore, 
contractor cost participation could reasonably range from as little as 
one percent or less of the total project cost to more than 50 percent 
of the total project cost. Ultimately, cost-sharing is a negotiable 
item. As such, the amount of cost-sharing shall be proportional to the 
anticipated value of the contractor's gain.
    (b) If the performing organization will not acquire title to, or 
the right to use, inventions, patents, or technical information 
resulting from the R & D project, it is normally appropriate to obtain 
less cost-sharing than in cases in which the performer acquires these 
rights.
    (c) A fee or profit is not normally paid to the performing 
organization, if the organization is to contribute to the cost of the R 
& D effort, but the amount of cost-sharing may be reduced to reflect 
the fact that the organization is foregoing its normal fee or profit in 
the research. However, if the R & D is expected to be of only minor 
value to the performing organization, and if a statute does not require 
cost-sharing, it may be appropriate for the performer to make a 
contribution in the form of a reduced fee or profit rather than sharing 
costs of the project.
    (d) The organization's participation may be considered over the 
total term of the project, so that a relatively high contribution in 
one year may be offset by a relatively low contribution in another.
    (e) A relatively low degree of cost-sharing may be appropriate, if 
an area of R & D requires special stimulus in the national interest.


335.070-3  Method of cost sharing.

    Cost-sharing on individual contracts may be accomplished either by 
a contribution of part or all of one or more elements of allowable cost 
of the work being performed or by a fixed amount or stated percentage 
of the total allowable costs of the project. Contractors shall not 
charge costs contributed to the Government under any other instrument 
(e.g., grant or contract), including allocations to other instruments 
as part of any independent R & D program.


335.070-4  Contract award.

    Consistent with HHS' objectives of competition and support of the 
small business program, Contracting Officers shall not award contracts 
solely on the basis of an organization's ability or willingness to 
cost-share. Contracting Officers shall make awards primarily on the 
contractor's competence and only after adequate competition has been 
obtained among large and small business organizations, whenever 
possible. An offeror's willingness to share costs is not a technical 
evaluation consideration, but a business consideration, which is 
secondary to selecting the best qualified source.


335.071  Special determinations and findings affecting research and 
development contracting.

    OPDIV heads shall sign individual and class D & Fs for--

[[Page 62448]]

    (a) Acquisition or construction of equipment or facilities on 
property not owned by the United States pursuant to 42 U.S.C. 
241(a)(7); and
    (b) Use of an indemnification provision in an R & D contract 
pursuant to 42 U.S.C. 241(a)(7).

PART 337--SERVICE CONTRACTING--GENERAL

Subpart 337.1--Service Contracts--General
Sec.
337.103-70 Solicitation provisions and contract clauses.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 337.1--Service Contracts--General


337.103-70  Solicitation provisions and contract clauses.

    (a) The Contracting Officer shall insert the clause in 352.237-70, 
Pro-Children Act, in solicitations, contracts, and orders that involve 
(a) kindergarten, elementary, or secondary education or library 
services or (b) health or daycare services that are provided to 
children under the age of 18 on a routine or regular basis pursuant to 
the Pro-Children Act of 1994.
    (b) The Contracting Officer shall insert the clause in 352.237-71, 
Crime Control Act--Reporting of Child Abuse, in solicitations, 
contracts, and orders that require performance on Federal land or in a 
Federally operated (or contracted) facility and involve the 
professions/activities performed by persons specified in the Crime 
Control Act of 1990, including, but not limited to, physicians, nurses, 
dentists, health care practitioners, optometrists, psychologists, 
emergency medical technicians, alcohol or drug treatment personnel, 
child care workers and administrators, emergency medical technicians 
and ambulance drivers.
    (c) The Contracting Officer shall insert the clause in 352.237-72, 
Crime Control Act--Requirement for Background Checks, in solicitations, 
contracts, and orders that involve providing child care services to 
children under the age of 18, including social services, health and 
mental health care, child- (day) care, education (whether or not 
directly involved in teaching), and rehabilitative programs covered 
under the Crime Control Act of 1990 (Act).

PART 339--ACQUISITION OF INFORMATION TECHNOLOGY

Subpart 339.1--General
Sec.
339.101 Policy.
Subpart 339.2--Electronic and Information Technology
339.201 Clarification.
339.201-70 Required provision and contract clause.
339.203 Approval of exceptions.
Subpart 339.70--Use of General Services Administration Blanket Purchase 
Agreements for Independent Risk Analysis Services
339.7000 Policy.
339.7001 Request for approval to make an award to other than a GSA 
BPA holder.
339.7002 Notice of intended award.
Subpart 339.71--Information Security Management
339.7100 Definitions.
339.7101 Policy.
339.7102 Applicability.
339.7103 Solicitation and contract clause.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 339.1--General


339.101  Policy.

    (d)(1) The Contracting Officer shall insert the clause in 352.239-
70, Standard for Security Configurations, in solicitations, contracts, 
and orders that involve the operation or acquisition of an information 
technology system (for definition of the latter term, see http://www.hhs.gov/ocio/policy.)
    An HHS information security policy waiver, the template for which 
is available at: http://intranet.hhs.gov/infosec/policies_memos.html, 
must be approved in order to deviate from HHS OCIO Standard 2009-
0001.001S, HHS Standard for Security Configurations Language in HHS 
Contracts, dated January 30, 2009. A copy of the approved waiver shall 
be forwarded to the Contracting Officer who, in turn, shall request a 
comparable deviation for the clause in 352.239-70.
    (2) The Contracting Officer shall insert the clause in 352.239-71, 
Standard for Encryption Language, in solicitations, contracts, and 
orders that involve the acquisition or lease of, or the requirement to 
use, desktop or laptop computers, mobile devices, or portable media to 
store or process HHS sensitive information that the Project Officer 
categorizes as moderate or high under Federal Information Processing 
Standard (FIPS) 199, Standards for Security Categorization of Federal 
Information and Information Systems, dated February 2004. An HHS 
information security policy waiver, the template for which is available 
at: http://intranet.hhs.gov/infosec/policies_memos.html, must be 
approved in order to deviate from HHS OCIO Standard 2009-0002.001S, HHS 
Standard for Encryption Language in HHS Contracts, dated January 30, 
2009. A copy of the approved waiver shall be forwarded to the 
Contracting Officer who, in turn, shall request a comparable deviation 
for the clause in 352.239-71.

Subpart 339.2--Electronic and Information Technology


339.201  Clarification.

    FAR Subpart 39.2, Electronic and Information Technology, requires 
Federal agencies to ensure that, when acquiring EIT, Federal employees 
with disabilities and members of the public with disabilities have 
access to and use of information and data that is comparable to 
individuals without disabilities. This EIT access requirement does not 
apply to a contractor's internal workplaces. EIT that is neither used 
nor accessed by Federal employees or members of the public is not 
subject to the Access Board accessibility standards. Contractors in 
their professional capacity are not members of the public for purposes 
of Section 508.


339.201-70  Required provision and contract clause.

    (a) The Contracting Officer shall insert the provision in 352.239-
73(a), Electronic and Information Technology Accessibility, in 
solicitations valued at more than the micro-purchase threshold that 
involve the development, acquisition, maintenance, or use of EIT 
products and services subject to Section 508 of the Rehabilitation Act 
of 1973, as amended, including EIT deliverables such as electronic 
documents and reports. (Note: Exceptions to this requirement can be 
found in FAR 39.204.) After approval of the Section 508 Official or 
designee, the Contracting Officer may waive the requirement for 
offerors to provide an HHS Section 508 Product Assessment Template, if 
Section 508 EIT conformance can be determined conclusively through 
other less formal methods. The Contracting Officer shall document in 
the award file any waiver for submission of the Product Assessment 
Template. The approval of a waiver by the Section 508 Official does 
not, however, eliminate the requirement for product assessment against 
Section 508 accessibility standards.
    (b) The Contracting Officer shall insert the clause in 352.239-
73(b), Electronic and Information Technology Accessibility, in 
contracts and orders that involve the development, acquisition, 
maintenance, or use of EIT products and services, including EIT 
deliverables such as electronic documents and reports, subject to 
Section 508 of the Rehabilitation Act of

[[Page 62449]]

1973, as amended, unless the EIT products and services are incidental 
to the project. (Note: Other exceptions to this requirement can be 
found at FAR 39.204.)
    (c) When acquiring EIT products and services subject to Section 508 
of the Rehabilitation Act of 1973, as amended, in the following 
circumstances, the Contracting Officer shall insert the paragraph in 
352.239-73(c), Schedule for Contractor Submission of Section 508 Annual 
Report, which requires a contractor to provide an HHS Section 508 
Annual Report, at the end of the clause in 352.239-73(b) and cite the 
schedule for report submission, where indicated:
    (1) New multiple-year contracts.
    (2) Existing multiple-year contracts, with a performance period of 
1 year or more remaining as of January 16, 2008 (the effective date of 
HHS' interim acquisition guidance).
    (3) New multiple-year task and delivery orders exceeding $100,000 
awarded under IDIQ or FSS contracts.
    (4) Existing multiple-year task and delivery orders exceeding 
$100,000 awarded under IDIQ or FSS contracts, with a task/delivery 
order performance period of 1 year or more remaining as of January 16, 
2008.
    (5) New multiple-year BPA orders that exceed $100,000.
    (6) Existing multiple-year BPA orders with a performance period of 
1 year or more remaining as of January 16, 2008.
    (7) New multiple-year contracts with option periods/quantities.
    (8) Existing multiple-year contracts with option periods/quantities 
remaining as of January 16, 2008.
    (d) Before adding funds to a multiple-year contract or order--see 
339.201-70(c), that involves the acquisition of EIT products and 
services, including EIT deliverables such as electronic documents and 
reports, subject to Section 508 of the Rehabilitation Act of 1973, as 
amended, the Contracting Officer shall ensure that the contractor has 
provided to the Contracting Officer and COTR a properly completed HHS 
Section 508 Annual Report--see Section 508 policy on HHS Office on 
Disability Web site. The Contracting Officer shall request that the 
contractor provide the report in sufficient time for its review and 
approval by the Contracting Officer, COTR, and the Section 508 Official 
or designee, prior to funding performance beyond the currently funded 
contract performance period. The Contracting Officer shall ensure that 
the report and all related approvals are made a part of the official 
contract/order file. The Section 508 Official or designee shall monitor 
the Annual Reports, direct corrective measures to improve their 
submission and quality, and report improvement actions taken to the HHS 
Office on Disability.


339.203  Approval of exceptions.

    (a) Procedures to document exception and determination requests are 
set forth in the OPDIV/STAFFDIV Section 508 Implementation Plans 
required by paragraph 4.1 of the HHS Section 508 policy.
    (b) In the development of an AP or other acquisition request 
document, the Contracting Officer shall ensure that all Section 508 
commercial non-availability or undue burden exception determination 
requests for applicable EIT requirements are: (1) Documented and 
certified in accordance with the requirements of paragraph 4.3, Section 
508 Compliance Exceptions, of the HHS Section 508 policy; (2) signed by 
the Project Officer; (3) approved by the OPDIV Section 508 Official or 
designee; and (4) included in the AP or other acquisition request 
document provided by the Project Officer to the contracting office.
    (c) In instances where a technical evaluation has been performed, 
and no organization's proposed products or services meet some or all of 
Section 508 accessibility standards, in order to proceed with the 
acquisition, the Contracting Officer shall provide an exception 
determination request along with the technical evaluation panel's 
assessment of the Section 508 evaluation factor to the designated 
Section 508 Official or designee for review and approval/disapproval. 
See 315.304 regarding obtaining approval of technical evaluation panel 
assessments by the Section 508 Official or designee. The Contracting 
Officer shall include the Section 508 Official's or designee's 
approval/disapproval of the exception determination request in the 
official contract file and reference it, as appropriate, in all source 
selection documents. For further information, see paragraphs 4.3, 
Section 508 Compliance Exceptions, and paragraph 11, Appendix A, of HHS 
Section 508 policy--see Section 508 policy on HHS Office on Disability 
Web site.

Subpart 339.70--Use of General Services Administration Blanket 
Purchase Agreements for Independent Risk Analysis Services


339.7000  Policy.

    GSA has established government-wide BPAs for independent risk 
analysis services, including verification and validation of in-house 
risk assessments. For information on ordering procedures, see the 
attachment to OMB memorandum (M-08-10), Use of Commercial Independent 
Risk Analysis Services Blanket Purchase Agreements (BPA), dated 
February 4, 2008, available on the OMB Web site. HHS policy is for 
contracting activities to use the GSA BPA sources to the maximum 
practicable extent.


339.7001  Request for approval to make an award to other than a GSA BPA 
holder.

    The Contracting Officer, in conjunction with the OPDIV/STAFFDIV 
Chief Information Security Officer (CISO), may determine, as part of 
conducting market research for independent risk analysis services 
expected to exceed the micro-purchase threshold, that obtaining the 
required services from a source other than a GSA BPA holder will result 
in the best value to the Government. In that event, the Contracting 
Officer shall prepare a request for approval at least 15 business days 
prior to the planned date of the contract or order award and forward it 
through the HCA and the OPDIV/STAFFDIV CISO for concurrence, to the 
SPE. The SPE shall coordinate the processing of the request with the 
CAO and the HHS CIO. The request for approval shall briefly describe 
the services required, indicate the intended source's pricing and other 
terms and conditions, and provide the rationale for award to the 
intended source rather than the GSA BPA holders. The request may 
include additional supporting rationale to document the best value 
decision, as appropriate.


339.7002  Notice of intended award.

    The CAO, or designee, in conjunction with the HHS CIO, will review 
the Contracting Officer's request for approval to make an award to 
other than a GSA BPA holder for independent risk analysis services and 
either approve or disapprove the request in writing. If the CAO, or 
designee, approves the request, upon approval, the CAO, or designee, 
shall send a notice of intended award to the designated GSA BPA 
Contracting Officer, with a copy to OMB's E-Government and Information 
Technology Administrator, at least 10 business days prior to the date 
of the proposed award explaining how it provides the best value to the 
Government. In the event of unusual and compelling urgency, the CAO, or 
designee, shall provide the notice of intended award to GSA as soon as 
practicable.

[[Page 62450]]

Subpart 339.71--Information Security Management


339.7100  Definitions.

    As used in this subpart, the following definitions shall apply:
    Adequate security means, in accordance with OMB Circular A-130, 
Management of Federal Information Resources, Appendix 3 (Security of 
Federal Automated Information Resources), security commensurate with 
the risk and magnitude of harm resulting from the loss, misuse, or 
unauthorized access to or modification of information.
    Federal information means, in accordance with OMB Circular A-130, 
Management of Federal Information Resources, Appendix 3 (Security of 
Federal Automated Information Resources), information created, 
collected, processed, disseminated, or disposed of by or for the 
Federal Government.
    Federal information system means an information system used or 
operated by an executive agency, by a contractor of an executive 
agency, or by another organization on behalf of an executive agency.
    Information means, in accordance with OMB Circular A-130, 
Management of Federal Information Resources, Appendix 3 (Security of 
Federal Automated Information Resources), any communication or 
representation of knowledge such as facts, data, or opinions in any 
medium or form, including textual, numerical, graphic, cartographic, 
narrative, or audiovisual forms.
    Information infrastructure means the underlying framework that 
information systems and assets rely on in processing, transmitting, 
receiving, or storing information electronically.
    Information security means protecting information and information 
systems from unauthorized access, use, disclosure, disruption, 
modification or destruction in order to provide--
    (1) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information non-
repudiation and authenticity;
    (2) Confidentiality, which means preserving authorized restrictions 
on access and disclosure, including means of protecting personal 
privacy and proprietary information;
    (3) Availability, which means ensuring timely and reliable access 
to and use of information; and
    (4) Privacy, which means regulating the appropriate collection, 
maintenance, use, and dissemination of personal information by Federal 
executive branch agencies. It essentially prohibits disclosure without 
consent.
    Information system means a discrete set of information resources 
organized for the collection, processing, maintenance, transmission, 
and dissemination of information, in accordance with defined 
procedures, whether automated or manual.
    Information technology includes computers, ancillary equipment 
(including imaging peripherals, input, output, and storage devices 
necessary for security and surveillance), peripheral equipment designed 
to be controlled by the central processing unit of a computer, 
software, firmware and similar procedures, services (including support 
services) and related resources.


339.7101  Policy.

    HHS is responsible for implementing an information security program 
to ensure that its information systems and associated facilities, as 
well as those of its contractors, provide a level of security 
commensurate with the risk and magnitude of harm that could result from 
the loss, misuse, disclosure, or modification of the information 
contained in those systems. Each system's level of security shall 
protect the integrity, confidentiality, and availability of the 
information and comply with all security and privacy-related laws and 
regulations.


339.7102  Applicability.

    Contracting Officers are responsible for ensuring that all 
information technology acquisitions comply with the Federal Information 
Security Management Act (FISMA), the HHS-OCIO Information Systems 
Security and Privacy Policy, and FISMA-related FAR and HHSAR 
requirements. This policy does not apply to national security systems 
as defined in FISMA.


339.7103  Solicitation and contract clause.

    The Contracting Officer shall insert the clause in 352.239-72, 
Security Requirements for Federal Information Technology Resources, in 
solicitations and contracts that involve contractor access to Federal 
information or Federal information systems.

SUBCHAPTER G--CONTRACT MANAGEMENT

PART 342--CONTRACT ADMINISTRATION

Subpart 342.3--Contract Administration Office Functions
Sec.
 342.302 Contract administration functions.
Subpart 342.7--Indirect Cost Rates
342.705 Final indirect cost rates.
Subpart 342.70--Contract Monitoring
342.7000 Purpose.
342.7001 Contract monitoring responsibilities.
342.7002 Procedures to be followed when a contractor fails to 
perform.
342.7003 Withholding of contract payments.
342.7003-1 Solicitation provisions and contract clauses.
342.7003-2 Procedures to be followed when withholding payments.
Subpart 342.71--Administrative Actions for Cost Overruns
342.7100 Scope of subpart.
342.7101 Contract administration.
342.7101-1 General.
342.7101-2 Procedures.
342.7102 Contract modifications.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 342.3--Contract Administration Office Functions


342.302  Contract administration functions.

    (c)
    (1) In multiple-year contracts or orders, the OPDIV's Section 508 
Official or designee, as well as the Contracting Officer and COTR, 
shall review and approve all Section 508 Annual Reports before the 
Contracting Officer makes final payment or any option is exercised 
under any applicable contract/order. In contracts/orders of 1 year or 
less in duration, the aforementioned officials shall review and approve 
the Section 508 conformance certification before final payment is made. 
The Contracting Officer also shall ensure that the report and all 
related approvals are made a part of the official contract/order file.
    (2) The Contracting Officer shall insert the clause in 352.242-70, 
Key Personnel, in solicitations and contracts when the Contracting 
Officer will designate contractor key personnel. See FAR 35.015 for 
additional information regarding key personnel when contracting for R & 
D.
    (3) The Contracting Officer shall insert the clause in 352.242-71, 
Tobacco-free Facilities, in solicitations, contracts, and orders when 
some or all of the contractor's performance (including construction 
services), will take place on HHS-owned or controlled properties. The 
clause shall not be included if performance requires only that 
contractor staff attend occasional meetings on HHS properties. In that 
case, contractor employees are considered ``visitors.'' Further, for 
any proposed or existing construction contract or order, the 
Contracting Officer shall coordinate any exceptions to the policy, 
raised by an incumbent or potential contractor based on union or 
collective bargaining agreements, with the designated OPDIV tobacco-
free

[[Page 62451]]

policy contact point for final disposition.
    (4) The Contracting Officer shall insert the clause in 352.242-72, 
Native American Graves Protection and Repatriation Act, in 
solicitations, contracts, and orders that require performance on Tribal 
lands or are for construction on Federal or Tribal lands.

Subpart 342.7--Indirect Cost Rates


342.705  Final indirect cost rates.

    (a) The Division of Cost Allocation, PSC, shall establish indirect 
cost rates, research patient care rates, and, as necessary, fringe 
benefit, computer, and other special costing rates for use in contracts 
awarded to State and local governments, colleges and universities, 
hospitals, and other nonprofit organizations.
    (b) The Division of Financial Advisory Services, NIH, shall 
establish indirect cost rates, fringe benefit rates, and similar rates 
for use in contracts awarded to commercial organizations.

Subpart 342.70--Contract Monitoring


342.7000  Purpose.

    Contract monitoring is an essential element of contract 
administration that the Contracting Officer and the COTR perform 
jointly. This subpart describes HHS' operating concepts.


342.7001  Contract monitoring responsibilities.

    (a) The contract establishes the obligations of both the Government 
and the contractor. The Contracting Officer is the only person 
authorized to modify the contract and shall confirm all modifications 
in writing.
    (b) The Contracting Officer shall ensure the contractor's 
compliance with all the terms and conditions of the contract. The 
Contracting Officer shall inform the contractor by letter (if not 
already stipulated in the contract) of the authorities and 
responsibilities of the Government personnel involved with the 
contract.
    (c) The Contracting Officer shall use program, technical, and other 
personnel for assistance and advice in monitoring the contractor's 
performance and in other areas of post-award administration. The 
Contracting Officer shall ensure that these individuals understand and 
carry out their assigned responsibilities. The individual roles and 
corresponding responsibilities typically involve, but are not limited 
to, the following:
    (1) The role of program and technical personnel in monitoring the 
contract is to assist and advise the Contracting Officer, and act as 
the COTR when so designated by the Contracting Officer. COTR activities 
include--
    (i) Providing technical monitoring during contract performance and 
advising the Contracting Officer relating to delivery, acceptance, or 
rejection of deliverables in accordance with the terms of the contract;
    (ii) Assessing contractor performance;
    (iii) Recommending necessary changes to the schedule of work and 
period of performance to accomplish the objectives of the contract (The 
COTR shall provide the Contracting Officer a written request along with 
an appropriate justification and a funding document, if additional 
funds are needed.);
    (iv) Reviewing invoices/vouchers and recommending approval/
disapproval by the Contracting Officer, including providing comments 
regarding anything unusual discovered in the review (Note: If a 
contract contains the Salary Rate Limitation clause specified in 
352.231-70, the Contracting Officer, in conjunction with the COTR, 
shall monitor the contractor's invoices to ensure that the contractor 
is billing salaries, including those of subcontractors, at rates no 
higher than the Federal Executive Schedule salary rate limitation in 
effect on the date(s) the expense(s) was/were incurred.);
    (v) Reviewing and recommending approval or disapproval of 
subcontractors, overtime, travel, and key personnel changes; and
    (vi) Participating, as necessary, in various phases of the contract 
closeout process.
    (2) The roles of the contract administrator, auditor, cost analyst, 
and property administrator are to assist or advise the Contracting 
Officer in post-award administration. Such activities include--
    (i) Evaluating contractor systems and procedures, including 
accounting policies and procedures, purchasing policies and practices, 
property accounting and control, wage and salary plans and rate 
structures, personnel policies and practices, etc.;
    (ii) Processing disputes under the Disputes clause and any 
resultant appeals;
    (iii) Modifying or terminating the contract; and
    (iv) Determining the allowability of: costs charged in incentive or 
cost- reimbursement type contracts, and progress payments under fixed-
price contracts. This is important for awards to new organizations or 
those with financial weaknesses.
    (d) The Contracting Officer shall ensure that contractor 
performance and contract monitoring conform with contract terms and 
conditions. If performance is not satisfactory or if problems are 
anticipated, the Contracting Officer shall take immediate action to 
protect the Government's rights under the contract. The Contracting 
Officer shall notify appropriate officials of problems that cannot be 
resolved within contract limitations and whenever the contractor is not 
meeting contract or program objectives. The notification shall include 
a statement of corrective actions that the Contracting Officer is 
taking.


342.7002  Procedures to be followed when a contractor fails to perform.

    (a) The Contracting Officer shall initiate immediate action to 
protect the Government's rights whenever the contractor fails to comply 
with either the delivery or reporting terms of the contract. Compliance 
with the reporting terms includes those reports the contractor is 
required to submit directly to the payment office. The payment office 
shall notify the Contracting Officer promptly when the contractor does 
not submit such a report on time.
    (b) When the contract contains a termination for default clause, 
the contractor's failure to submit any report, perform services, or 
deliver work when required by the contract is considered a default in 
performance. The Contracting Officer shall immediately issue a formal 
10-day cure notice pursuant to FAR 49.607. The notice shall include a 
statement to the effect that payments will be withheld if the default 
is not cured within the time period specified in the notice or if the 
default is not determined to be excusable.
    (1) If the default is cured or is determined to be excusable, the 
Contracting Officer shall not initiate the withholding action.
    (2) If the default is not determined to be excusable or a response 
is not received within the allotted time, the Contracting Officer shall 
initiate withholding action on all contract payments and shall 
determine whether termination for default or other action would be in 
the best interest of the Government.
    (c) When the contract does not contain a termination for default 
clause, the Contracting Officer shall consider a contractor's failure 
to submit any required report, perform services, or deliver work when 
required by the contract a failure to perform. The Contracting Officer 
shall immediately issue a written notice to the contractor that: 
specifies the failure, and provides a 10-day period (or longer period 
if the Contracting Officer deems it necessary) within which the 
contractor shall either

[[Page 62452]]

cure the failure or provide reasons for an excusable delay. The notice 
shall include a statement to the effect that payments will be withheld, 
if the default is not cured within the time period specified in the 
notice or if the default is not determined to be excusable.
    (1) If the contractor cures the failure or the Contracting Officer 
determines it to be excusable, the Contracting Officer shall not 
initiate the withholding action.
    (2) If the Contracting Officer does not determine the failure 
excusable or the contractor does not provide a response within the 
allotted time, the Contracting Officer shall initiate withholding 
action on all contract payments and shall determine whether termination 
for convenience or other action would be in the best interest of the 
Government.
    (d) The Contracting Officer shall consult FAR subpart 49.4 for 
further guidance before taking any of the actions described in this 
section.


342.7003  Withholding of contract payments.


342.7003-1  Solicitation provisions and contract clauses.

    (a) The Contracting Officer shall insert the clause in 352.242-73, 
Withholding of Contract Payments, and the clause in FAR 52.249-14, 
Excusable Delays, in solicitations and contracts when a cost-
reimbursement, time-and-materials, or labor-hour contract is 
contemplated.
    (b) The Contracting Officer shall insert the clause in 352.242-74, 
Final Decisions on Audit Findings, in solicitations and contracts when 
a cost-reimbursement contract is contemplated, except for those 
contracts with:
    (1) A foreign government or agency of that government; or
    (2) An international organization or a subsidiary body of that 
organization that the HCA determines would not be appropriate.


342.7003-2  Procedures to be followed when withholding payments.

    (a) When appropriate, the Contracting Officer shall withhold any 
contract payment when a required report is overdue or the contractor 
fails to perform or deliver required work or services. When making the 
determination to withhold contract payments in accordance with the 
Withholding of Contract Payments clause, the Contracting Officer shall 
immediately notify the servicing finance office in writing of the 
determination to withhold payments. The notice of suspension shall 
contain all information necessary for the finance office to identify 
the contract--i.e., contract number, task/delivery order number, and 
contractor name and address.
    (b) The Contracting Officer shall immediately notify the contractor 
in writing that payments have been suspended until the default or 
failure is cured.
    (c) When the contractor cures the default or failure, the 
Contracting Officer shall immediately notify, in writing, all 
recipients of the notice of withholding that the withholding is to be 
lifted and contract payments are to be resumed.
    (d) When taking any actions regarding the withholding of payments, 
the Contracting Officer shall not waive any of the Government's rights 
when corresponding with the contractor.

Subpart 342.71--Administrative Actions for Cost Overruns


342.7100  Scope of subpart.

    This subpart sets forth the procedures to follow when a cost 
overrun is anticipated. A cost overrun occurs when the allowable actual 
cost of performing a cost-reimbursement type contract exceeds the total 
estimated cost specified in the contract.


342.7101  Contract administration.


342.7101-1  General.

    Upon receipt of information that a contractor's accumulated cost 
and projected expenditures will exceed the limit of funds obligated by 
the contract, the Contracting Officer shall coordinate immediately with 
the appropriate program office to determine whether the contract should 
be modified or terminated. If the Contracting Officer receives 
information from a source other than the contractor that a cost overrun 
is anticipated, the Contracting Officer shall verify the information 
with the contractor and remind the contractor of the notification 
requirements of the Limitation of Cost clause.


342.7101-2  Procedures.

    (a) Upon notification that a cost overrun is anticipated, the 
Contracting Officer shall inform the contractor to submit a request for 
additional funds, which shall include the following:
    (1) Name and address of contractor.
    (2) Contract number and expiration date.
    (3) Contract item(s) and amount(s) creating overrun.
    (4) The elements of cost which changed from the original estimate--
i.e., labor, material, travel, and overhead, to be furnished in the 
following format:
    (i) Original estimate.
    (ii) Costs incurred to date.
    (iii) Estimated cost to completion.
    (iv) Revised estimate.
    (v) Amount of adjustment.
    (5) The factors responsible for the increase (e.g., error in 
estimate, changed conditions).
    (6) The latest date by which funds must be available for commitment 
to avoid contract slippage, work stoppage, or other program impairment.
    (b) When the contractor submits a notice of a projected overrun, 
the Contracting Officer shall--
    (1) Immediately advise the appropriate program office and furnish 
the office a copy of the notice and any other data received;
    (2) Request audit or cost advisory services, and technical support, 
as necessary, for evaluation of information and data received; and
    (3) Maintain continuous communications with the program office to 
obtain: a timely written decision and justification to continue the 
contract with additional funds (including verification of funds 
availability); or a timely written decision and request to terminate 
the contract.
    (c) After receiving the decision by the program office, the 
Contracting Officer shall promptly notify the contractor in writing of 
the following:
    (1) The specified amount of additional funds allotted to the 
contract.
    (2) Work shall be discontinued when the allotted funds are 
exhausted, and any work performed after that date is at the 
contractor's risk.
    (3) The Government is considering whether to allot additional funds 
to the contract and will notify the contractor as soon as possible, but 
that any work performed after the currently allotted funds are 
exhausted is at the contractor's risk. (Timely, formal notification of 
the Government's intention is essential to preclude loss of contractual 
rights in the event of dispute, termination, or litigation.)
    (d) If the program office permits, the Contracting Officer shall 
refrain from issuing any contractual documents that require new work or 
an extension of time, pending resolution of the projected overrun.


342.7102  Contract modifications.

    (a) Modifications to contracts containing the Limitation of Cost 
clause shall include either--
    (1) A provision which: Increases the estimated or ceiling amount in 
the Limitation of Cost clause of the contract; and states that such 
clause will thereafter apply to the increased amount; or
    (2) A provision stating that the estimated or ceiling amount in the

[[Page 62453]]

Limitation of Cost clause is not changed by the modification.
    (b) The Contracting Officer shall not change a fixed-fee in a 
contract when funding a cost overrun. The Contracting Officer shall 
make changes in fixed-fee only to reflect changes in the SOW/PWS that 
justify an increase or decrease in fee.

SUBCHAPTER H--CLAUSES AND FORMS

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Subpart 352.1--Instructions for Using Provisions and Clauses
Sec.
352.100 Scope of subpart.
352.101-70 Application of provisions and clauses.
Subpart 352.2--Texts of Provisions and Clauses
352.201-70 Paperwork Reduction Act.
352.202-1 Definitions.
352.203-70 Anti-lobbying.
352.215-1 Instructions to offerors--competitive acquisition.
352.215-70 Late proposals and revisions.
352.216-70 Additional cost principles.
352.219-70 Mentor-prot[eacute]g[eacute] program.
352.219-71 Mentor-prot[eacute]g[eacute] program reporting 
requirements.
352.222-70 Contractor cooperation in equal employment opportunity 
investigations.
352.223-70 Safety and health.
352.224-70 Privacy Act.
352.227-70 Publications and publicity.
352.228-7 Insurance--liability to third persons.
352.231-70 Salary rate limitation.
352.231-71 Pricing of adjustments.
352.233-70 Choice of law (overseas).
352.233-71 Litigation and claims.
352.234-1 Notice of earned value management system--pre-award 
Integrated Baseline Review.
352.234-2 Notice of earned value management system--post-award 
Integrated Baseline Review.
352.234-3 Full earned value management system.
352.234-4 Partial earned value management system.
352.237-70 Pro-Children Act.
352.237-71 Crime Control Act--reporting of child abuse.
352.237-72 Crime Control Act--requirement for background checks.
352.239-70 Standard for security configurations.
352.239-71 Standard for encryption language.
352.239-72 Security requirements for Federal information technology 
resources.
352.239-73 Electronic information and technology accessibility.
352.242-70 Key personnel.
352.242-71 Tobacco-free facilities.
352.242-72 Native American Graves Protections and Repatriation Act.
352.242-73 Withholding of contract payments.
352.242-74 Final decisions on audit findings.
352.270-1 Accessibility of meetings, conferences, and seminars to 
persons with disabilities.
352.270-2 Indian preference.
352.270-3 Indian preference program.
352.270-4 Protection of human subjects.
352.270-5 Care of laboratory animals.
352.270-6 Restriction on use of human subjects.
352.270-7 Conference sponsorship request and conference materials 
disclaimer.
352.270-8 Prostitution and related activities.
352.270-9 Non-discrimination for conscience.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 352.1--Instructions for Using Provisions and Clauses


352.100  Scope of subpart.

    This subpart provides guidance for applying HHS provisions and 
clauses in solicitations, contracts, and orders.


352.101-70  Application of provisions and clauses.

    (a) Unless otherwise qualified (e.g., by the type of contract 
contemplated, the nature of the requirement, or dollar amount) in a 
prescription for a solicitation provision or contract clause specified 
in Part 352 or elsewhere in the HHSAR, the term ``contract'' means--
    (1) An award, including modifications thereunder, that exceeds the 
simplified acquisition threshold, including a task order or delivery 
order, whether placed under a GSA FSS contract, an IDIQ contract, a 
GWAC, or a BPA, and a purchase order placed under the authority of FAR 
subpart 13.5); and
    (2) A bilateral award--i.e., when both the Contracting Officer and 
the contractor sign the award document, that exceeds the micro-purchase 
threshold but which does not exceed the simplified acquisition 
threshold.
    (b) When the term ``order'' is specified in a prescription for a 
solicitation provision or order clause, it means an order that exceeds 
the micro-purchase threshold but which does not exceed the simplified 
acquisition threshold, except those bilateral awards specified in 
(a)(2) above.
    (c) If a clause is included in the master instrument (e.g., in an 
IDIQ contract or a BPA), it is not necessary to also include the clause 
in a task order or delivery order thereunder.
    (d) When a dollar amount or dollar threshold is specified (e.g., 
$25 million or simplified acquisition threshold), the dollar amount of 
the award (contract or order) includes any options thereunder.

Subpart 352.2--Texts of Provisions and Clauses


352.201-70  Paperwork Reduction Act.

    As prescribed in 301.106(b), the Contracting Officer shall insert 
the following clause:

Paperwork Reduction Act (January 2006)

    (a) This contract involves a requirement to collect or record 
information calling either for answers to identical questions from 
10 or more persons other than Federal employees, or information from 
Federal employees which is outside the scope of their employment, 
for use by the Federal government or disclosure to third parties; 
therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) shall apply to this contract. No plan, questionnaire, 
interview guide or other similar device for collecting information 
(whether repetitive or single time) may be used without the Office 
of Management and Budget (OMB) first providing clearance. 
Contractors and the Contracting Officer's Technical Representative 
shall be guided by the provisions of 5 CFR Part 1320, Controlling 
Paperwork Burdens on the Public, and seek the advice of the HHS 
operating division or Office of the Secretary Reports Clearance 
Officer to determine the procedures for acquiring OMB clearance.
    (b) The Contractor shall not expend any funds or begin any data 
collection until OMB Clearance is received. Once OMB Clearance is 
received from the Contracting Officer's Technical Representative, 
the Contracting Officer shall provide the Contractor with written 
notification authorizing the expenditure of funds and the collection 
of data. The Contractor shall allow at least 120 days for OMB 
clearance. The Contracting Officer will consider excessive delays 
caused by the Government which arise out of causes beyond the 
control and without the fault or negligence of the Contractor in 
accordance with the Excusable Delays or Default clause of this 
contract.
    (End of clause)


352.202-1  Definitions.

    As prescribed in FAR 2.201, the Contracting Officer shall insert 
the clause in FAR 52.202-1, Definitions, as revised by 302.201:

Definitions (January 2006)

    (a) In accordance with 52.202-1(a)(1), substitute the following as 
paragraph (a):

    ``(a) The term ``Secretary'' or ``Head of the Agency'' (also 
called ``Agency Head'') means the Secretary, Deputy Secretary, or 
any Assistant Secretary, Administrator or Commissioner of the 
Department of Health and Human Services; and the term ``his/her duly 
authorized representative'' means any person, persons, or board 
authorized to act for the Secretary.''

    (b) In accordance with 52.202-1(a)(1), add the following paragraph 
(h):

    ``(h) The term ``Contracting Officer's Technical 
Representative'' means the person

[[Page 62454]]

who monitors the technical aspects of contract performance. The 
Contracting Officer's Technical Representative is not authorized to 
issue any instructions or directions which cause any increase or 
decrease in the Statement of Work/Performance Work Statement/
Specifications which would result in the increase or decrease in the 
price of this contract, or changes in the delivery schedule or 
period of performance of this contract. If applicable, the 
Contracting Officer's Technical Representative is not authorized to 
receive or act upon any notification or revised cost estimate 
provided by the Contractor in accordance with the Limitation of Cost 
or Limitation of Funds clauses of this contract.''

352.203-70  Anti-lobbying.

    As prescribed in 303.808-70, the Contracting Officer shall insert 
the following clause:

Anti-Lobbying (January 2006)

    Pursuant to the current HHS annual appropriations act, except 
for normal and recognized executive-legislative relationships, the 
Contractor shall not use any HHS contract funds for (i) publicity or 
propaganda purposes; (ii) the preparation, distribution, or use of 
any kit, pamphlet, booklet, publication, radio, television or video 
presentation designed to support or defeat legislation pending 
before the Congress or any State legislature, except in presentation 
to the Congress or any State legislature itself; or (iii) payment of 
salary or expenses of the Contractor, or any agent acting for the 
Contractor, related to any activity designed to influence 
legislation or appropriations pending before the Congress or any 
State legislature.
    (End of clause)

352.215-1  Instructions to offerors--competitive acquisition.

    As prescribed in 315.209, the Contracting Officer shall insert the 
following paragraph (e) in the provision in FAR 52.215-1, Instructions 
to Offerors--Competitive Acquisition:

    (e) Restriction on disclosure and use of data.
    (1) The proposal submitted in response to this request may 
contain data (trade secrets; business data (e.g., commercial 
information, financial information, cost and pricing data); and 
technical data) which the offeror, including its prospective 
subcontractor(s), does not want used or disclosed for any purpose 
other than for evaluation of the proposal. The use and disclosure of 
any data may be so restricted; provided, that the Government 
determines that the data is not required to be disclosed under the 
Freedom of Information Act, 5 U.S.C. 552, as amended, and the 
offeror marks the cover sheet of the proposal with the following 
statements, specifying the particular portions of the proposal which 
are to be restricted:
    ``Unless disclosure is required by the Freedom of Information 
Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of 
Information (FOI) officials of the Department of Health and Human 
Services (HHS), data contained in the portions of this proposal 
which the offeror has specifically identified by page number, 
paragraph, etc. as containing restricted information shall not be 
used or disclosed except for evaluation purposes.
    The offeror acknowledges that HHS may not be able to withhold a 
record (e.g., data, document, etc.) nor deny access to a record 
requested pursuant to the Act and that the HHS' FOI officials must 
make that determination. The offeror hereby agrees that the 
Government is not liable for disclosure if HHS has determined that 
disclosure is required by the Act.
    If a contract is awarded to the offeror as a result of, or in 
connection with, the submission of this proposal, the Government 
shall have the right to use or disclose the data to the extent 
provided in the contract. Proposals not resulting in a contract 
remain subject to the Act.
    The offeror also agrees that the Government is not liable for 
disclosure or use of unmarked data and may use or disclose the data 
for any purpose, including the release of the information pursuant 
to requests under the Act. The data subject to this restriction are 
contained in pages (insert page numbers, paragraph designations, 
etc. or other identification).''
    (2) In addition, the offeror must mark each page of data it 
wishes to restrict with the following statement:
    ``Use or disclosure of data contained on this page is subject to 
the restriction on the cover sheet of this proposal or quotation.''
    (3) Offerors are cautioned that proposals submitted with 
restrictive statements or statements differing in substance from 
those cited above may not be considered for award. The Government 
reserves the right to reject any proposal submitted with 
nonconforming statement(s).


352.215-70  Late proposals and revisions.

    As prescribed in 315.208, the Contracting Officer shall insert the 
following provision:

Late Proposals and Revisions (January 2006)

    Notwithstanding the procedures contained in FAR 52.215-1(c)(3) 
of the provision of this solicitation entitled Instructions to 
Offerors--Competitive Acquisition, the Government may consider a 
proposal received after the date specified for receipt if it appears 
to offer the best value to the Government and it was received before 
proposals were distributed for evaluation, or within 5 calendar days 
after the exact time specified for receipt, whichever is earlier.
    (End of provision)


352.216-70  Additional cost principles.

    As prescribed in 316.307(j), the Contracting Officer shall insert 
the following clause:

Additional Cost Principles (January 2006)

    (a) Bid and proposal (B & P) costs.
    (1) B & P costs are the immediate costs of preparing bids, 
proposals, and applications for potential Federal and non-Federal 
contracts, grants, and agreements, including the development of 
scientific, cost, and other data needed to support the bids, 
proposals, and applications.
    (2) B & P costs of the current accounting period are allowable 
as indirect costs.
    (3) B & P costs of past accounting periods are unallowable in 
the current period. However, if the organization's established 
practice is to treat these costs by some other method, they may be 
accepted if they are found to be reasonable and equitable.
    (4) B & P costs do not include independent research and 
development (IR & D) costs covered by the following paragraph, or 
pre-award costs covered by paragraph 36 of Attachment B to OMB 
Circular A-122.
    (b) IR & D costs.
    (1) IR & D is research and development conducted by an 
organization which is not sponsored by Federal or non-Federal 
contracts, grants, or other agreements.
    (2) IR & D shall be allocated its proportionate share of 
indirect costs on the same basis as the allocation of indirect costs 
to sponsored research and development.
    (3) The cost of IR & D, including its proportionate share of 
indirect costs, is unallowable.
    (End of clause)


352.219-70  Mentor-prot[eacute]g[eacute] program.

    As prescribed in 319.270-1(a), the Contracting Officer shall insert 
the following provision:

Mentor-Prot[eacute]g[eacute] Program (October 2009)

    (a) Large business prime contractors serving as mentors in the 
HHS Mentor-Prot[eacute]g[eacute] program are eligible for HHS 
subcontracting plan credit, and shall submit a copy of their HHS 
Office of Small and Disadvantaged Business Utilization (OSDBU)-
approved mentor prot[eacute]g[eacute] agreements as part of their 
offers. The amount of credit provided by the Contracting Officer to 
a mentor firm for prot[eacute]g[eacute] firm developmental 
assistance costs shall be calculated on a dollar for dollar basis 
and reported by the mentor firm in the Summary Subcontract Report 
via the Electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov. The mentor firm and prot[eacute]g[eacute] firm shall 
submit to the Contracting Officer a signed joint statement agreeing 
on the dollar value of the developmental assistance the mentor firm 
provided. (For example, a mentor firm would report a $10,000 
subcontract awarded to a prot[eacute]g[eacute] firm and provision of 
$5,000 of developmental assistance as $15,000 of developmental 
assistance.) The mentor firm may use this additional credit towards 
attaining its subcontracting plan participation goal under this 
contract.
    (b) The program consists of--
    (1) Mentor firms--large businesses that: (i) demonstrate the 
interest, commitment, and capability to provide developmental 
assistance to small business prot[eacute]g[eacute] firms; and (ii) 
have a Mentor-Prot[eacute]g[eacute] agreement approved by HHS' 
OSDBU;
    (2) Prot[eacute]g[eacute] firms--firms that: (i) seek 
developmental assistance; (ii) qualify as small businesses, veteran-
owned small businesses, service-disabled veteran-owned small 
businesses, HUBZone small businesses,

[[Page 62455]]

small disadvantaged businesses, or woman-owned businesses; and (iii) 
have a Mentor-Prot[eacute]g[eacute] agreement approved by HHS' 
OSDBU; and
    (3) Mentor-Prot[eacute]g[eacute] agreements--joint agreements, 
approved by HHS' OSDBU, which detail the specific terms, conditions, 
and responsibilities of the mentor-prot[eacute]g[eacute] 
relationship.
    (End of provision)


352.219-71  Mentor-prot[eacute]g[eacute] program reporting 
requirements.

    As prescribed in 319.270-1(b), the Contracting Officer shall insert 
the following clause:

Mentor-Prot[eacute]g[eacute] Program Reporting Requirements (October 
2009)

    The Contractor shall comply with all reporting requirements 
specified in its Mentor-Prot[eacute]g[eacute] agreement approved by 
HHS' OSDBU.
    (End of clause)


352.222-70  Contractor cooperation in equal employment opportunity 
investigations.

    As prescribed in 322.810(h), the Contracting Officer shall insert 
the following clause:

Contractor Cooperation in Equal Employment Opportunity Investigations 
(October 2009)

    (a) In addition to complying with the clause in FAR 52.222-26, 
Equal Opportunity, the Contractor shall, in good faith, cooperate 
with the Department of Health and Human Services (Agency) in 
investigations of Equal Employment Opportunity (EEO) complaints 
processed pursuant to 29 CFR Part 1614. For purposes of this clause, 
the following definitions apply:
    (1) ``Complaint'' means a formal or informal complaint that has 
been lodged with Agency management, Agency EEO officials, the Equal 
Employment Opportunity Commission (EEOC), or a court of competent 
jurisdiction.
    (2) ``Contractor employee'' means all current Contractor 
employees who work or worked under this contract. The term also 
includes current employees of subcontractors who work or worked 
under this contract. In the case of Contractor and subcontractor 
employees, who worked under this contract, but who are no longer 
employed by the Contractor or subcontractor, or who have been 
assigned to another entity within the Contractor's or 
subcontractor's organization, the Contractor shall provide the 
Agency with that employee's last known mailing address, e-mail 
address, and telephone number, if that employee has been identified 
as a witness in an EEO complaint or investigation.
    (3) ``Good faith cooperation'' cited in paragraph (a) includes, 
but is not limited to, making Contractor employees available for: 
(i) Formal and informal interviews by EEO counselors or other Agency 
officials processing EEO complaints; (ii) formal or informal 
interviews by EEO investigators charged with investigating 
complaints of unlawful discrimination filed by Federal employees; 
(iii) reviewing and signing appropriate affidavits or declarations 
summarizing statements provided by such Contractor employees during 
the course of EEO investigations; (iv) producing documents requested 
by EEO counselors, EEO investigators, Agency employees, or the EEOC 
in connection with a pending EEO complaint; and (v) preparing for 
and providing testimony in hearings before the EEOC and U.S. 
District Court.
    (b) The Contractor shall include the provisions of this clause 
in all subcontract solicitations and subcontracts awarded at any 
tier under this contract.
    (c) Failure on the part of the Contractor or its subcontractors 
to comply with the terms of this clause may be grounds for the 
Contracting Officer to terminate this contract for default.
    (End of clause)


352.223-70  Safety and health.

    As prescribed in 323.7002, the Contracting Officer shall insert the 
following clause:

Safety and Health (January 2006)

    (a) To help ensure the protection of the life and health of all 
persons, and to help prevent damage to property, the Contractor 
shall comply with all Federal, State, and local laws and regulations 
applicable to the work being performed under this contract. These 
laws are implemented or enforced by the Environmental Protection 
Agency, Occupational Safety and Health Administration (OSHA) and 
other regulatory/enforcement agencies at the Federal, State, and 
local levels.
    (1) In addition, the Contractor shall comply with the following 
regulations when developing and implementing health and safety 
operating procedures and practices for both personnel and facilities 
involving the use or handling of hazardous materials and the conduct 
of research, development, or test projects:
    (i) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, 
Occupational exposure to hazardous chemicals in laboratories; and 
other applicable occupational health and safety standards issued by 
OSHA and included in 29 CFR Part 1910. These regulations are 
available at  http://www.osha.gov.
    (ii) Nuclear Regulatory Commission Standards and Regulations, 
pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et 
seq.). The Contractor may obtain copies from the U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001.
    (2) The following Government guidelines are recommended for 
developing and implementing health and safety operating procedures 
and practices for both personnel and facilities:
    (i) Biosafety in Microbiological and Biomedical Laboratories, 
CDC. This publication is available at http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4toc.htm.
    (ii) Prudent Practices for Safety in Laboratories (1995), 
National Research Council, National Academy Press, 500 Fifth Street, 
NW., Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This 
publication is available at http://www.nap.edu/catalog/4911.html.
    (b) Further, the Contractor shall take or cause to be taken 
additional safety measures as the Contracting Officer, in 
conjunction with the Contracting Officer's Technical Representative 
or other appropriate officials, determines to be reasonably 
necessary. If compliance with these additional safety measures 
results in an increase or decrease in the cost or time required for 
performance of any part of work under this contract, the Contracting 
Officer will make an equitable adjustment in accordance with the 
applicable ``Changes'' clause set forth in this contract.
    (c) The Contractor shall maintain an accurate record of, and 
promptly report to the Contracting Officer, all accidents or 
incidents resulting in the exposure of persons to toxic substances, 
hazardous materials or hazardous operations; the injury or death of 
any person; or damage to property incidental to work performed under 
the contract and all violations for which the Contractor has been 
cited by any Federal, State or local regulatory/enforcement agency. 
The report shall include a copy of the notice of violation and the 
findings of any inquiry or inspection, and an analysis addressing 
the impact these violations may have on the work remaining to be 
performed. The report shall also state the required action(s), if 
any, to be taken to correct any violation(s) noted by the Federal, 
State or local regulatory/enforcement agency and the time frame 
allowed by the agency to accomplish the necessary corrective action.
    (d) If the Contractor fails or refuses to comply with the 
Federal, State or local regulatory/enforcement agency's directive(s) 
regarding any violation(s) and prescribed corrective action(s), the 
Contracting Officer may issue an order stopping all or part of the 
work until satisfactory corrective action (as approved by the 
Federal, State or local regulatory/enforcement agencies) has been 
taken and documented to the Contracting Officer. No part of the time 
lost due to any stop work order shall be subject to a claim for 
extension of time or costs or damages by the Contractor.
    (e) The Contractor shall insert the substance of this clause in 
each subcontract involving toxic substances, hazardous materials, or 
hazardous operations. The Contractor is responsible for the 
compliance of its subcontractors with the provisions of this clause.
    (End of clause)


352.224-70  Privacy Act.

    As prescribed in 324.103(b)(2), the Contracting Officer shall 
insert the following clause:

Privacy Act (January 2006)

    This contract requires the Contractor to perform one or more of 
the following: (a) Design; (b) develop; or (c) operate a Federal 
agency system of records to accomplish an agency function in 
accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) 
and applicable agency regulations. The term ``system of records'' 
means a group of any records under the control of any agency from 
which information is retrieved by the name of the

[[Page 62456]]

individual or by some identifying number, symbol, or other 
identifying particular assigned to the individual. Violations of the 
Act by the Contractor and/or its employees may result in the 
imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor 
shall ensure that each of its employees knows the prescribed rules 
of conduct and that each employee is aware that he/she is subject to 
criminal penalties for violation of the Act to the same extent as 
Department of Health and Human Services employees. These provisions 
also apply to all subcontracts the Contractor awards under this 
contract which require the design, development or operation of the 
designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract 
work statement: (a) identifies the system(s) of records and the 
design, development, or operation work the Contractor is to perform; 
and (b) specifies the disposition to be made of such records upon 
completion of contract performance.
    (End of clause)


352.227-70  Publications and publicity.

    As prescribed in 327.404-70, the Contracting Officer shall insert 
the following clause:

Publications and Publicity (January 2006)

    (a) Unless otherwise specified in this contract, the Government 
encourages the Contractor to publish the results of its work under 
this contract. A copy of each article the Contractor submits for 
publication shall be promptly sent to the Contracting Officer's 
Technical Representative. The Contractor shall also inform the 
Contracting Officer's Technical Representative when the article or 
other publication is published, and furnish a copy of it as finally 
published.
    (b) Unless authorized by the Contracting Officer's Technical 
Representative, the Contractor shall not display the HHS logo on any 
publications.
    (End of clause)


352.228-7  Insurance--liability to third persons.

    As prescribed in 328.311-2, the Contracting Officer shall insert 
the following clause and either Alternate I or II, as appropriate:

Insurance--Liability to Third Persons (Dec. 1991)

    (a)(1) Except as provided in paragraph (a)(2) immediately 
following, or in paragraph (h) of this clause [if the clause has a 
paragraph (h)], the Contractor shall provide and maintain workers' 
compensation, employer's liability, comprehensive general liability 
(bodily injury), comprehensive automobile liability (bodily injury 
and property damage) insurance, and such other insurance as the 
Contracting Officer may require under this contract.
    (2) The Contractor may, with the approval of the Contracting 
Officer, maintain a self-insurance program; provided that, with 
respect to workers' compensation, the Contractor is qualified 
pursuant to statutory authority.
    (3) All insurance required by this paragraph shall be in form 
and amount and for those periods as the Contracting Officer may 
require or approve and with insurers approved by the Contracting 
Officer.
    (b) The Contractor agrees to submit for the Contracting 
Officer's approval, to the extent and in the manner required by the 
Contracting Officer, any other insurance that is maintained by the 
Contractor in connection with performance of this contract and for 
which the Contractor seeks reimbursement.
    (c) Except as provided in paragraph (h) of this clause [if the 
clause has a paragraph (h)], the Contractor shall be reimbursed--
    (1) For that portion of the reasonable cost of insurance 
allocable to this contract, and required or approved under this 
clause; and
    (2) For certain liabilities (and expenses incidental to such 
liabilities) to third persons not compensated by insurance or 
otherwise within the funds available under the Limitation of Cost or 
the Limitation of Funds clause of this contract. These liabilities 
must arise out of the performance of this contract, whether or not 
caused by the negligence of the Contractor or the Contractor's 
agents, servants, or employees, and must be represented by final 
judgments or settlements approved in writing by the Government. 
These liabilities are for--
    (i) Loss of or damage to property (other than property owned, 
occupied, or used by the Contractor, rented to the Contractor, or in 
the care, custody, or control of the Contractor); or
    (ii) Death or bodily injury.
    (d) The Government's liability under paragraph (c) of this 
clause is limited to the amounts reflected in final judgments, or 
settlements approved in writing by the Government, but in no event 
to exceed the funds available under the Limitation of Cost or 
Limitation of Funds clause of this contract. Nothing in this 
contract shall be construed as implying that, at a later date, the 
Government will request, or the Congress will appropriate, funds 
sufficient to meet any deficiencies.
    (e) The Government shall not reimburse the Contractor for 
liabilities (and expenses incidental to such liabilities)--
    (1) For which the Contractor is otherwise responsible under the 
express terms of any clause specified in the Schedule or elsewhere 
in the contract;
    (2) For which the Contractor has failed to insure or to maintain 
insurance as required by the Contracting Officer; or
    (3) That result from willful misconduct or lack of good faith on 
the part of the Contractor's directors, officers, managers, 
superintendents, or other representatives who have supervision or 
direction of --
    (i) All or substantially all of the Contractor's business;
    (ii) All or substantially all of the Contractor's operations at 
any one plant or separate location in which this contract is being 
performed; or
    (iii) A separate and complete major industrial operation in 
connection with the performance of this contract.
    (f) The provisions of paragraph (e) of this clause shall not 
restrict the right of the Contractor to be reimbursed for the cost 
of insurance maintained by the Contractor in connection with the 
performance of this contract, other than insurance required in 
accordance with this clause; provided, that such cost is allowable 
under the Allowable Cost and Payment clause of this contract.
    (g) If any suit or action is filed or any claim is made against 
the Contractor, the cost and expense of which may be reimbursable to 
the Contractor under this contract, and the risk of which is then 
uninsured or is insured for less than the amount claimed, the 
Contractor shall--
    (1) Immediately notify the Contracting Officer and promptly 
furnish copies of all pertinent papers received;
    (2) Authorize Government representatives to collaborate with 
counsel for the insurance carrier in settling or defending the claim 
when the amount of the liability claimed exceeds the amount of 
coverage; and
    (3) Authorize Government representatives to settle or defend the 
claim and to represent the Contractor in or to take charge of any 
litigation, if required by the Government, when the liability is not 
insured or covered by the bond. The Contractor may, at its own 
expense, be associated with the Government representatives in any 
such claim or litigation.
    (End of clause)

    Alternate I (APR 1984). If the successful offeror represents in its 
offer that it is partially immune from tort liability as a State 
agency, the Contracting Officer shall add the following paragraph (h) 
to the basic clause:

    (h) Notwithstanding paragraphs (a) and (c) of this clause--
    (1) The Government does not assume any liability to third 
persons, nor will the Government reimburse the Contractor for its 
liability to third persons, with respect to loss due to death, 
bodily injury, or damage to property resulting in any way from the 
performance of this contract or any subcontract under this contract; 
and
    (2) The Contractor need not provide or maintain insurance 
coverage as required by paragraph (a) of this clause; provided, that 
the Contractor may obtain any insurance coverage deemed necessary, 
subject to approval by the Contracting Officer as to form, amount, 
and duration. The Contractor shall be reimbursed for the cost of 
such insurance and, to the extent provided in paragraph (c) of this 
clause, for liabilities to third persons for which the Contractor 
has obtained insurance coverage as provided in this paragraph, but 
for which such coverage is insufficient in amount.
    (End of clause)

    Alternate II (APR 1984). If the successful offeror represents in 
its offer that it is totally immune from tort liability as a State 
agency, the Contracting Officer shall substitute the following 
paragraphs (a) and (b) for paragraphs (a) and (b) of the basic clause:

    (a) The Government does not assume any liability to third 
persons, nor will the Government reimburse the Contractor for its

[[Page 62457]]

liability to third persons, with respect to loss due to death, 
bodily injury, or damage to property resulting in any way from the 
performance of this contract or any subcontract under this contract.
    (b) If any suit or action is filed, or if any claim is made 
against the Contractor, the cost and expense of which may be 
reimbursable to the Contractor under this contract, the Contractor 
shall immediately notify the Contracting Officer and promptly 
furnish copies of all pertinent papers received by the Contractor. 
The Contractor shall, if Government requires, authorize Government 
representatives to settle or defend the claim and to represent the 
Contractor in or take charge of any litigation. The Contractor may, 
at its own expense, be associated with the Government 
representatives in any such claims or litigation.
    (End of clause)


352.231-70  Salary rate limitation.

    As prescribed in 331.101-70, the Contracting Officer shall insert 
the following clause:

Salary Rate Limitation (October 2009)

    (a) Pursuant to the current and applicable prior HHS 
appropriations acts, the Contractor shall not use contract funds to 
pay the direct salary of an individual at a rate in excess of the 
Federal Executive Schedule Level I in effect on the date an expense 
is incurred.
    (b) For purposes of the salary rate limitation, the terms 
``direct salary,'' ``salary,'' and ``institutional base salary'' 
have the same meaning and are collectively referred to as ``direct 
salary'' in this clause. An individual's direct salary is the annual 
compensation that the Contractor pays for an individual's direct 
effort (costs) under the contract. Direct salary excludes any income 
that an individual may be permitted to earn outside of duties to the 
Contractor. Direct salary also excludes fringe benefits, overhead, 
and general and administrative expenses (also referred to as 
indirect costs or facilities and administrative [F&A] costs).

    Note: The salary rate limitation does not restrict the salary 
that an organization may pay an individual working under an HHS 
contract or order; it merely limits the portion of that salary that 
may be paid with Federal funds.

    (c) The salary rate limitation also applies to individuals under 
subcontracts. If this is a multiple-year contract or order, it may 
be subject to unilateral modification by the Contracting Officer to 
ensure that an individual is not paid at a rate that exceeds the 
salary rate limitation provision established in the HHS 
appropriations act in effect when the expense is incurred regardless 
of the rate initially used to establish contract or order funding.
    (d) See the salaries and wages pay tables on the U.S. Office of 
Personnel Management Web site for Federal Executive Schedule salary 
levels that apply to the current and prior periods.
    (End of clause)


352.231-71  Pricing of adjustments.

    As prescribed in 331.102-70, the Contracting Officer shall insert 
the following clause:

Pricing of Adjustments (January 2001)

    When costs are a factor in determination of a contract price 
adjustment pursuant to the ``Changes'' clause or any provision of 
this contract, the applicable cost principles and procedures set 
forth below shall form the basis for determining such costs:

------------------------------------------------------------------------
               Principles                     Types of organizations
------------------------------------------------------------------------
(a) Subpart 31.2 of the Federal          Commercial.
 Acquisition Regulation.
(b) Subpart 31.3 of the Federal          Educational.
 Acquisition Regulation.
(c) Subpart 31.6 of the Federal          State, local, and Federally
 Acquisition Regulation.                  recognized
                                         Indian Tribal governments.
(d) 45 CFR Part 74 Appendix E..........  Hospitals (performing research
                                          and development contracts
                                          only).
(e) Subpart 31.7 of the Federal          Other nonprofit organizations.
 Acquisition Regulation.
------------------------------------------------------------------------

    (End of clause)


352.233-70  Choice of law (overseas).

    As prescribed in 333.215-70(a), the Contracting Officer shall 
insert the following clause:

Choice of Law (Overseas) (October 2009)

    This contract shall be construed in accordance with the 
substantive laws of the United States of America. By the execution 
of this contract, the Contractor expressly agrees to waive any 
rights to invoke the jurisdiction of local national courts where 
this contract is performed and agrees to accept the exclusive 
jurisdiction of the Civilian Board of Contract Appeals and the 
United States Court of Federal Claims for hearing and determination 
of any and all disputes that may arise under the Disputes clause of 
this contract.
    (End of clause)


352.233-71  Litigation and claims.

    As prescribed in 333.215-70(b), the Contracting Officer shall 
insert the following clause:

Litigation and Claims (January 2006)

    (a) The Contractor shall provide written notification 
immediately to the Contracting Officer of any action, including any 
proceeding before an administrative agency, filed against the 
Contractor arising out of the performance of this contract, 
including, but not limited to the performance of any subcontract 
hereunder; and any claim against the Contractor the cost and expense 
of which is allowable under the clause entitled ``Allowable Cost and 
Payment.''
    (b) Except as otherwise directed by the Contracting Officer, the 
Contractor shall furnish immediately to the Contracting Officer 
copies of all pertinent papers received by the Contractor with 
respect to such action or claim. To the extent not in conflict with 
any applicable policy of insurance, the Contractor may, with the 
Contracting Officer's approval, settle any such action or claim. If 
required by the Contracting Officer, the Contractor shall effect an 
assignment and subrogation in favor of the Government of all the 
Contractor's rights and claims (except those against the Government) 
arising out of any such action or claim against the Contractor; and 
authorize representatives of the Government to settle or defend any 
such action or claim and to represent the Contractor in, or to take 
charge of, any action.
    (c) If the Government undertakes a settlement or defense of an 
action or claim, the Contractor shall furnish all reasonable 
assistance in effecting a settlement or asserting a defense. Where 
an action against the Contractor is not covered by a policy of 
insurance, the Contractor shall, with the approval of the 
Contracting Officer, proceed with the defense of the action in good 
faith. The Government shall not be liable for the expense of 
defending any action or for any costs resulting from the loss 
thereof to the extent that the Contractor would have been 
compensated by insurance which was required by law or regulation or 
by written direction of the Contracting Officer, but which the 
Contractor failed to secure through its own fault or negligence. In 
any event, unless otherwise expressly provided in this contract, the 
Government shall not reimburse or indemnify the Contractor for any 
liability loss, cost, or expense, which the Contractor may incur or 
be subject to by reason of any loss, injury or damage, to the person 
or to real or personal property of any third parties as may accrue 
during, or arise from, the performance of this contract.
    (End of clause)


352.234-1  Notice of earned value management system--pre-award 
Integrated Baseline Review.

    As prescribed in 334.203-70(a), the Contracting Officer shall 
insert the following provision:

Notice of Earned Value Management System--Pre-Award Integrated Baseline 
Review (October 2008)

    The offeror shall provide documentation that its proposed Earned 
Value Management System (EVMS) complies with the EVMS guidelines in 
ANSI/EIA Standard-748 (current version at time of solicitation).

[[Page 62458]]

    (a) If the offeror proposes to use a system that currently does 
not meet the requirements of paragraph (a) of this provision, the 
offeror shall submit a comprehensive plan for compliance with the 
guidelines.
    (1) The plan shall--
    (i) Describe the EVMS the offeror intends to use in performance 
of the contract;
    (ii) Distinguish between the offeror's existing management 
system and modifications proposed to meet the guidelines;
    (iii) Describe the management system and its application in 
terms of the EVMS guidelines;
    (iv) Describe the proposed procedure for application of the EVMS 
requirements to subcontractors;
    (v) Provide documentation describing the process and results, 
including Government participation if applicable, of any third-party 
evaluation or self-evaluation of the system's compliance with the 
EVMS guidelines; and
    (vi) Provide a schedule of events leading up to formal 
validation and Government acceptance of the offeror's EVMS, if the 
value of the offeror's proposal, including options, is $25 million 
or more.
    (2) The offeror shall provide information and assistance, as 
required by the Contracting Officer, to support review of the plan.
    (3) The Contracting Officer will review the offeror's EVMS 
implementation plan prior to contract award.
    (4) The offeror's EVMS plan must provide milestones indicating 
when the offeror anticipates that the EVMS will be compliant with 
the ANSI/EIS Standard-748 guidelines.
    (b) The offeror shall identify in its offer the subcontractors, 
or subcontracted effort if subcontractors have not been identified, 
to which the requirements of EVMS will be applied. Prior to contract 
award, the offeror and HHS shall agree on the subcontractors, or 
subcontracted effort, subject to the EVMS requirement.
    (c) HHS will conduct an Integrated Baseline Review (IBR) prior 
to contract award. The offeror shall be compensated as set forth 
elsewhere in this solicitation for its preparation for and 
participation in the IBR.
    (End of provision)


352.234-2  Notice of earned value management system--post-award 
Integrated Baseline Review.

    As prescribed in 334.203-70(b), the Contracting Officer shall 
insert the following provision:

Notice of Earned Value Management System--Post-Award Integrated 
Baseline Review (October 2008)

    (a) The offeror shall provide documentation that its proposed 
Earned Value Management System (EVMS) complies with the EVMS 
guidelines in ANSI/EIA Standard-748 (current version in effect at 
time of solicitation).
    (b) If the offeror proposes to use a system that currently does 
not meet the requirements of paragraph (a) of this provision, the 
offeror shall submit a comprehensive plan for compliance with the 
guidelines.
    (1) The plan shall--
    (i) Describe the EVMS the offeror intends to use in performance 
of the contract;
    (ii) Distinguish between the offeror's existing management 
system and modifications proposed to meet the guidelines;
    (iii) Describe the management system and its application in 
terms of the EVMS guidelines;
    (iv) Describe the proposed procedure for application of the EVMS 
requirements to subcontractors;
    (v) Provide documentation describing the process and results, 
including Government participation if applicable, of any third-party 
evaluation or self-evaluation of the system's compliance with the 
EVMS guidelines; and
    (vi) Provide a schedule of events leading up to formal 
validation and Government acceptance of the offeror's EVMS, if the 
value of the offeror's proposal, including options, is $25 million 
or more.
    (2) The offeror shall provide information and assistance, as 
required by the Contracting Officer, to support review of the plan.
    (3) The Contracting Officer will review the offeror's EVMS 
implementation plan prior to contract award.
    (4) The offeror's EVMS plan must provide milestones indicating 
when the offeror anticipates that the EVM system will be compliant 
with the ANSI/EIA Standard-748 guidelines.
    (c) The offeror shall identify in its offer the subcontractors, 
or subcontracted effort if subcontractors have not been identified, 
to which the requirements of EVMS will be applied. Prior to contract 
award, the offeror and HHS shall agree on the subcontractors, or 
subcontracted effort, subject to the EVMS requirement.
    (d) HHS will conduct an Integrated Baseline Review after 
contract award.
    (End of provision)


352.234-3  Full earned value management system.

    As prescribed in 334.203-70(c), the Contracting Officer shall 
insert the following clause:

Full Earned Value Management System (October 2008)

    (a) The Contractor shall use an Earned Value Management System 
(EVMS) that has been validated and accepted by the Cognizant Federal 
Agency (CFA) as being compliant with the guidelines in ANSI/EIA 
Standard-748 (current version at the time of award) to manage this 
contract. If the Contractor's current EVMS has not been validated 
and accepted by the CFA at the time of award, see paragraph (b) of 
this clause. The Contractor shall submit EVM reports in accordance 
with the requirements of this contract.
    (b) If, at the time of award, the Contractor's EVM system has 
not been validated and accepted by the CFA as complying with EVMS 
guidelines in ANSI/EIA Standard-748 (current version at time of 
award), the Contractor shall--
    (1) Apply the current system to the contract; and
    (2) Take necessary and timely actions to meet the milestones in 
the Contractor's EVMS plan approved by the Contracting Officer.
    (c) HHS requires the Contractor to obtain validation and 
acceptance of its EVM system by the CFA during the base period of 
performance of this contract. The Contracting Officer or designee 
will conduct a Compliance Review to assess the Contractor's 
compliance with its approved plan. If the Contractor does not follow 
the approved implementation schedule or correct all resulting system 
deficiencies noted during the Compliance Review within a reasonable 
time, the Contracting Officer may take remedial action, which may 
include, but is not limited to, suspension of or reduction in 
progress payments, or a reduction in fee.
    (d) HHS will conduct an Integrated Baseline Review (IBR). If a 
pre-award IBR has not been conducted, a post-award IBR will be 
conducted by HHS as early as practicable, but no later than 90 days 
after contract award. The Contracting Officer may also require an 
IBR as part of the exercise of an option or the incorporation of a 
major modification.
    (e) Unless a waiver is granted by the CFA, Contractor-proposed 
EVMS changes require approval of the CFA prior to implementation. 
The CFA will advise the Contractor of the acceptability of such 
changes within 30 calendar days after receipt of the notice of 
proposed changes from the Contractor. If the advance approval 
requirements are waived by the CFA, the Contractor shall disclose 
EVMS changes to the CFA at least 14 calendar days prior to the 
effective date of implementation.
    (f) The Contractor shall provide access to all pertinent records 
and data requested by the Contracting Officer or a duly authorized 
representative as necessary to permit Government surveillance to 
ensure that the EVMS conforms, and continues to conform, with the 
requirements referenced in paragraph (a) of this clause.
    (g) The Contractor shall require the subcontractors specified 
below to comply with the requirements of the clause: (Insert list of 
applicable subcontractors.)
-----------------------------------------------------------------------
-----------------------------------------------------------------------
-----------------------------------------------------------------------
    (End of clause)

(Alternate I) (October 2008)

    As prescribed in 334.203-70(c), the Contracting Officer shall 
substitute the following paragraphs (a), (b), and (c) for paragraphs 
(a), (b), and (c) of the basic clause and delete paragraph (e) of the 
basic clause:

    (a) The Contractor shall use an Earned Value Management System 
(EVMS) that is compliant with the guidelines in ANSI/EIA Standard-
748 (current version at the time of award) to manage this contract. 
If the Contractor's current EVMS is not compliant at the time of 
award, see paragraph (b) of this clause. The Contractor shall submit 
EVM reports in accordance with the requirements of this contract.
    (b) If, at the time of award, the Contractor's EVM system is not 
in compliance with the EVMS guidelines in ANSI/EIA Standard-748 
(current version at time of award), the Contractor shall--

[[Page 62459]]

    (1) Apply the current system to the contract; and
    (2) Take necessary and timely actions to meet the milestones in 
the Contractor's EVMS plan approved by the Contracting Officer.
    (c) HHS will not formally validate or accept the Contractor's 
EVMS with respect to this contract. The use of the Contractor's EVMS 
for this contract does not imply HHS acceptance of the Contractor's 
EVMS for application to future contracts. The Contracting Officer or 
designee will conduct a Compliance Review to assess the Contractor's 
compliance with its approved plan. If the Contractor does not follow 
the approved implementation schedule or correct all resulting system 
deficiencies noted during the Compliance Review within a reasonable 
time, the Contracting Officer may take remedial action that may 
include, but is not limited to, suspension of or reduction in 
progress payments, or a reduction in fee.


352.234-4  Partial earned value management system.

    As prescribed in 334.203-70(d), the Contracting Officer shall 
insert the following clause:

Partial Earned Value Management System (October 2008)

    (a) The Contractor shall use an Earned Value Management System 
(EVMS) that has been validated and accepted by the Cognizant Federal 
Agency (CFA) as being compliant with the schedule-related guidelines 
in ANSI/EIA Standard-748 (current version at the time of award) to 
manage this contract. If the Contractor's current EVMS has not been 
validated and accepted by the CFA at the time of award, see 
paragraph (b) of this clause. The Contractor shall submit EVM 
reports in accordance with the requirements of this contract.
    (b) If, at the time of award, the Contractor's EVM system has 
not been validated and accepted by the CFA as complying with the 
schedule-related EVMS guidelines in ANSI/EIA Standard-748 (current 
version at time of award), the Contractor shall--
    (1) Apply the current system to the contract; and
    (2) Take necessary and timely actions to meet the milestones in 
the Contractor's EVMS plan approved by the Contracting Officer.
    (c) HHS requires the Contractor to obtain validation and 
acceptance of the schedule-related portions of its EVM system by the 
CFA during the base period of performance of this contract. The 
Contracting Officer or designee will conduct a Compliance Review to 
assess the Contractor's compliance with its approved plan. If the 
Contractor does not follow the approved implementation schedule or 
correct all resulting system deficiencies noted during the 
Compliance Review within a reasonable time, the Contracting Officer 
may take remedial action, which may include, but is not limited to, 
suspension of or reduction in progress payments, or a reduction in 
fee.
    (d) HHS will conduct an Integrated Baseline Review (IBR). If a 
pre-award IBR has not been conducted, a post-award IBR will be 
conducted by HHS as early as practicable, but no later than 90 days 
after contract award. The Contracting Officer may also require an 
IBR as part of the exercise of an option or the incorporation of a 
major modification.
    (e) Unless a waiver is granted by the CFA, Contractor-proposed 
EVMS changes require approval of the CFA prior to implementation. 
The CFA will advise the Contractor of the acceptability of such 
changes within 30 calendar days after receipt of the notice of 
proposed changes from the Contractor. If the advance approval 
requirements are waived by the CFA, the Contractor shall disclose 
EVMS changes to the CFA at least 14 calendar days prior to the 
effective date of implementation.
    (f) The Contractor shall provide access to all pertinent records 
and data requested by the Contracting Officer or a duly authorized 
representative as necessary to permit Government surveillance to 
ensure that the EVMS conforms, and continues to conform, with the 
requirements referenced in paragraph (a) of this clause.
    (g) The Contractor shall require the subcontractors specified 
below to comply with the requirements of the clause: (Insert list of 
applicable subcontractors.)
-----------------------------------------------------------------------
-----------------------------------------------------------------------
-----------------------------------------------------------------------
    (End of clause)

(Alternate I) (October 2008)

    As prescribed in 334.203-70(d), the Contracting Officer shall 
substitute the following paragraphs (a), (b), and (c) for paragraphs 
(a), (b), and (c) of the basic clause and delete paragraph (e) of the 
basic clause:

    (a) The Contractor shall use an Earned Value Management System 
(EVMS) that is compliant with the schedule-related guidelines in 
ANSI/EIA Standard-748 (current version at the time of award) to 
manage this contract. If the Contractor's current EVMS is not 
compliant at the time of award, see paragraph (b) of this clause. 
The Contractor shall submit EVM reports in accordance with the 
requirements of this contract.
    (b) If, at the time of award, the Contractor's schedule-related 
EVM system is not in compliance with the schedule-related EVMS 
guidelines in ANSI/EIA Standard-748 (current version at time of 
award), or the Contractor does not have an existing schedule control 
system that is compliant with such guidelines, the Contractor 
shall--
    (1) Apply the current system to the contract; and
    (2) Take necessary and timely actions to meet the milestones in 
the Contractor's EVMS plan approved by the Contracting Officer.
    (c) HHS will not formally validate or accept the Contractor's 
schedule-related EVMS with respect to this contract. The use of the 
Contractor's EVMS for this contract does not imply HHS acceptance of 
the Contractor's EVMS for application to future contracts. The 
Contracting Officer or designee will conduct a Compliance Review to 
assess the Contractor's compliance with its approved plan. If the 
Contractor does not follow the approved implementation schedule or 
correct all resulting system deficiencies noted during the 
Compliance Review within a reasonable time, the Contracting Officer 
may take remedial action that may include, but is not limited to, 
suspension of or reduction in progress payments, or a reduction in 
fee.


352.237-70  Pro-Children Act.

    As prescribed in 337.103-70(a), the Contracting Officer shall 
insert the following clause:

Pro-Children Act (January 2006)

    (a) Public Law 103-227, Title X, Part C, also known as the Pro-
Children Act of 1994 (Act), 20 U.S.C. 7183, imposes restrictions on 
smoking in facilities where certain Federally funded children's 
services are provided. The Act prohibits smoking within any indoor 
facility (or portion thereof), whether owned, leased, or contracted 
for, that is used for the routine or regular provision of (i) 
kindergarten, elementary, or secondary education or library services 
or (ii) health or day care services that are provided to children 
under the age of 18. The statutory prohibition also applies to 
indoor facilities that are constructed, operated, or maintained with 
Federal funds.
    (b) By acceptance of this contract or order, the Contractor 
agrees to comply with the requirements of the Act. The Act also 
applies to all subcontracts awarded under this contract for the 
specified children's services. Accordingly, the Contractor shall 
ensure that each of its employees, and any subcontractor staff, is 
made aware of, understand, and comply with the provisions of the 
Act. Failure to comply with the Act may result in the imposition of 
a civil monetary penalty in an amount not to exceed $1,000 for each 
violation and/or the imposition of an administrative compliance 
order on the responsible entity. Each day a violation continues 
constitutes a separate violation.
    (End of clause)


352.237-71  Crime Control Act--reporting of child abuse.

    As prescribed in 337.103-70(b), the Contracting Officer shall 
insert the following clause:

Crime Control Act of 1990--Reporting of Child Abuse (January 2006)

    (a) Public Law 101-647, also known as the Crime Control Act of 
1990 (Act), imposes responsibilities on certain individuals who, 
while engaged in a professional capacity or activity, as defined in 
the Act, on Federal land or in a Federally-operated (or contracted) 
facility, learn of facts that give the individual reason to suspect 
that a child has suffered an incident of child abuse.
    (b) The Act designates ``covered professionals'' as those 
persons engaged in professions and activities in eight different 
categories including, but not limited to, physicians, dentists, 
medical residents or interns, hospital personnel and administrators, 
nurses, health care practitioners, chiropractors, osteopaths,

[[Page 62460]]

pharmacists, optometrists, podiatrists, emergency medical 
technicians, ambulance drivers, alcohol or drug treatment personnel, 
psychologists, psychiatrists, mental health professionals, child 
care workers and administrators, and commercial film and photo 
processors. The Act defines the term ``child abuse'' as the physical 
or mental injury, sexual abuse or exploitation, or negligent 
treatment of a child.
    (c) Accordingly, any person engaged in a covered profession or 
activity under an HHS contract or subcontract, regardless of the 
purpose of the contract or subcontract, shall immediately report a 
suspected child abuse incident in accordance with the provisions of 
the Act. If a child is suspected of being harmed, the appropriate 
State Child Abuse Hotline, local child protective services (CPS), or 
law enforcement agency shall be contacted. For more information 
about where and how to file a report, the Childhelp USA, National 
Child Abuse Hotline (1-800-4-A-CHILD) shall be called. Any covered 
professional failing to make a timely report of such incident shall 
be guilty of a Class B misdemeanor.
    (d) By acceptance of this contract or order, the Contractor 
agrees to comply with the requirements of the Act. The Act also 
applies to all applicable subcontracts awarded under this contract. 
Accordingly, the Contractor shall ensure that each of its employees, 
and any subcontractor staff, is made aware of, understand, and 
comply with the provisions of the Act.
    (End of clause)


352.237-72  Crime Control Act--requirement for background checks.

    As prescribed in 337.103-70(c), the Contracting Officer shall 
insert the following clause:

Crime Control Act of 1990--Requirement for Background Checks (January 
2006)

    (a) Public Law 101-647, also known as the Crime Control Act of 
1990 (Act), requires that all individuals involved with the 
provision of child care services to children under the age of 18 
undergo a criminal background check. ``Child care services'' 
include, but are not limited to, social services, health and mental 
health care, child (day) care, education (whether or not directly 
involved in teaching), and rehabilitative programs. Any conviction 
for a sex crime, an offense involving a child victim, or a drug 
felony, may be grounds for denying employment or for dismissal of an 
employee providing any of the services listed above.
    (b) The Contracting Officer will provide the necessary 
information to the Contractor regarding the process for obtaining 
the background check. The Contractor may hire a staff person 
provisionally prior to the completion of a background check, if at 
all times prior to the receipt of the background check during which 
children are in the care of the newly-hired person, the person is 
within the sight and under the supervision of a previously 
investigated staff person.
    (c) By acceptance of this contract or order, the Contractor 
agrees to comply with the requirements of the Act. The Act also 
applies to all applicable subcontracts awarded under this contract. 
Accordingly, the Contractor shall ensure that each of its employees, 
and any subcontractor staff, is made aware of, understand, and 
comply with the provisions of the Act.
    (End of clause)


352.239-70  Standard for security configurations.

    As prescribed in 339.101(d)(1), the Contracting Officer shall 
insert the following clause:

Standard for Security Configurations (October 2009)

    (a) The Contractor shall configure its computers that contain 
HHS data with the applicable Federal Desktop Core Configuration 
(FDCC) (see http://nvd.nist.gov/fdcc/index.cfm) and ensure that its 
computers have and maintain the latest operating system patch level 
and anti-virus software level.

    Note: FDCC is applicable to all computing systems using Windows 
XPTM and Windows VistaTM, including desktops 
and laptops--regardless of function--but not including servers.

    (b) The Contractor shall apply approved security configurations 
to information technology (IT) that is used to process information 
on behalf of HHS. The following security configuration requirements 
apply:
-----------------------------------------------------------------------
-----------------------------------------------------------------------
-----------------------------------------------------------------------

    Note: The Contracting Officer shall specify applicable security 
configuration requirements in solicitations and contracts based on 
information provided by the Project Officer, who shall consult with 
the OPDIV/STAFFDIV Chief Information Security Officer.

    (c) The Contractor shall ensure IT applications operated on 
behalf of HHS are fully functional and operate correctly on systems 
configured in accordance with the above configuration requirements. 
The Contractor shall use Security Content Automation Protocol 
(SCAP)-validated tools with FDCC Scanner capability to ensure its 
products operate correctly with FDCC configurations and do not alter 
FDCC settings--see http://nvd.nist.gov/validation.cfm. The 
Contractor shall test applicable product versions with all relevant 
and current updates and patches installed. The Contractor shall 
ensure currently supported versions of information technology 
products meet the latest FDCC major version and subsequent major 
versions.
    (d) The Contractor shall ensure IT applications designed for end 
users run in the standard user context without requiring elevated 
administrative privileges.
    (e) The Contractor shall ensure hardware and software 
installation, operation, maintenance, update, and patching will not 
alter the configuration settings or requirements specified above.
    (f) The Contractor shall (1) include Federal Information 
Processing Standard (FIPS) 201-compliant (see http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security 
Presidential Directive 12 (HSPD-12) card readers with the purchase 
of servers, desktops, and laptops; and (2) comply with FAR Subpart 
4.13, Personal Identity Verification.
    (g) The Contractor shall ensure that its subcontractors (at all 
tiers) which perform work under this contract comply with the 
requirements contained in this clause.
    (End of clause)


352.239-71  Standard for encryption language.

    As prescribed in 339.101(d)(2), the Contracting Officer shall 
insert the following clause:

Standard for Encryption Language (October 2009)

    (a) The Contractor shall use Federal Information Processing 
Standard (FIPS) 140-2-compliant encryption (Security Requirements 
for Cryptographic Module, as amended) to protect all instances of 
HHS sensitive information during storage and transmission. (Note: 
The Government has determined that HHS information under this 
contract is considered ``sensitive'' in accordance with FIPS 199, 
Standards for Security Categorization of Federal Information and 
Information Systems, dated February 2004.)
    (b) The Contractor shall verify that the selected encryption 
product has been validated under the Cryptographic Module Validation 
Program (see http://csrc.nist.gov/cryptval/) to confirm compliance 
with FIPS 140-2 (as amended). The Contractor shall provide a written 
copy of the validation documentation to the Contracting Officer and 
the Contracting Officer's Technical Representative.
    (c) The Contractor shall use the Key Management Key (see FIPS 
201, Chapter 4, as amended) on the HHS personal identification 
verification (PIV) card; or alternatively, the Contractor shall 
establish and use a key recovery mechanism to ensure the ability for 
authorized personnel to decrypt and recover all encrypted 
information (see http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf). The Contractor shall notify the 
Contracting Officer and the Contracting Officer's Technical 
Representative of personnel authorized to decrypt and recover all 
encrypted information.
    (d) The Contractor shall securely generate and manage encryption 
keys to prevent unauthorized decryption of information in accordance 
with FIPS 140-2 (as amended).
    (e) The Contractor shall ensure that this standard is 
incorporated into the Contractor's property management/control 
system or establish a separate procedure to account for all laptop 
computers, desktop computers, and other mobile devices and portable 
media that store or process sensitive HHS information.
    (f) The Contractor shall ensure that its subcontractors (at all 
tiers) which perform work under this contract comply with the 
requirements contained in this clause.
    (End of clause)

[[Page 62461]]

352.239-72  Security requirements for Federal information technology 
resources.

    As prescribed in 339.7103, the Contracting Officer shall insert the 
following clause:

Security Requirements for Federal Information Technology Resources 
(October 2009)

    (a) Applicability. This clause applies whether the entire 
contract or order (hereafter ``contract''), or portion thereof, 
includes information technology resources or services in which the 
Contractor has physical or logical (electronic) access to, or 
operates a Department of Health and Human Services (HHS) system 
containing, information that directly supports HHS' mission. The 
term ``information technology (IT)'', as used in this clause, 
includes computers, ancillary equipment (including imaging 
peripherals, input, output, and storage devices necessary for 
security and surveillance), peripheral equipment designed to be 
controlled by the central processing unit of a computer, software, 
firmware and similar procedures, services (including support 
services) and related resources. This clause does not apply to 
national security systems as defined in FISMA.
    (b) Contractor responsibilities. The Contractor is responsible 
for the following:
    (1) Protecting Federal information and Federal information 
systems in order to ensure their--
    (i) Integrity, which means guarding against improper information 
modification or destruction, and includes ensuring information non-
repudiation and authenticity;
    (ii) Confidentiality, which means preserving authorized 
restrictions on access and disclosure, including means for 
protecting personal privacy and proprietary information; and.
    (iii) Availability, which means ensuring timely and reliable 
access to and use of information.
    (2) Providing security of any Contractor systems, and 
information contained therein, connected to an HHS network or 
operated by the Contractor, regardless of location, on behalf of 
HHS.
    (3) Adopting, and implementing, at a minimum, the policies, 
procedures, controls, and standards of the HHS Information Security 
Program to ensure the integrity, confidentiality, and availability 
of Federal information and Federal information systems for which the 
Contractor is responsible under this contract or to which it may 
otherwise have access under this contract. The HHS Information 
Security Program is outlined in the HHS Information Security Program 
Policy, which is available on the HHS Office of the Chief 
Information Officer's (OCIO) Web site.
    (c) Contractor security deliverables. In accordance with the 
timeframes specified, the Contractor shall prepare and submit the 
following security documents to the Contracting Officer for review, 
comment, and acceptance:
    (1) IT Security Plan (IT-SP)--due within 30 days after contract 
award. The IT-SP shall be consistent with, and further detail the 
approach to, IT security contained in the Contractor's bid or 
proposal that resulted in the award of this contract. The IT-SP 
shall describe the processes and procedures that the Contractor will 
follow to ensure appropriate security of IT resources that are 
developed, processed, or used under this contract. If the IT-SP only 
applies to a portion of the contract, the Contractor shall specify 
those parts of the contract to which the IT-SP applies.
    (i) The Contractor's IT-SP shall comply with applicable Federal 
laws that include, but are not limited to, the Federal Information 
Security Management Act (FISMA) of 2002 (Title III of the E-
Government Act of 2002, Public Law 107-347), and the following 
Federal and HHS policies and procedures:
    (A) Office of Management and Budget (OMB) Circular A-130, 
Management of Federal Information Resources, Appendix III, Security 
of Federal Automated Information Resources.
    (B) National Institute of Standards and Technology (NIST) 
Special Publication (SP) 800-18, Guide for Developing Security Plans 
for Federal Information Systems, in form and content, and with any 
pertinent contract Statement of Work/Performance Work Statement 
(SOW/PWS) requirements. The IT-SP shall identify and document 
appropriate IT security controls consistent with the sensitivity of 
the information and the requirements of Federal Information 
Processing Standard (FIPS) 200, Recommended Security Controls for 
Federal Information Systems. The Contractor shall review and update 
the IT-SP in accordance with NIST SP 800-26, Security Self-
Assessment Guide for Information Technology Systems and FIPS 200, on 
an annual basis.
    (C) HHS-OCIO Information Systems Security and Privacy Policy.
    (ii) After resolution of any comments provided by the Government 
on the draft IT-SP, the Contracting Officer shall accept the IT-SP 
and incorporate the Contractor's final version into the contract for 
Contractor implementation and maintenance. On an annual basis, the 
Contractor shall provide to the Contracting Officer verification 
that the IT-SP remains valid.
    (2) IT Risk Assessment (IT-RA)--due within 30 days after 
contract award. The IT-RA shall be consistent, in form and content, 
with NIST SP 800-30, Risk Management Guide for Information 
Technology Systems, and any additions or augmentations described in 
the HHS-OCIO Information Systems Security and Privacy Policy. After 
resolution of any comments provided by the Government on the draft 
IT-RA, the Contracting Officer shall accept the IT-RA and 
incorporate the Contractor's final version into the contract for 
Contractor implementation and maintenance. The Contractor shall 
update the IT-RA on an annual basis.
    (3) FIPS 199 Standards for Security Categorization of Federal 
Information and Information Systems Assessment (FIPS 199 
Assessment)--due within 30 days after contract award. The FIPS 199 
Assessment shall be consistent with the cited NIST standard. After 
resolution of any comments by the Government on the draft FIPS 199 
Assessment, the Contracting Officer shall accept the FIPS 199 
Assessment and incorporate the Contractor's final version into the 
contract.
    (4) IT Security Certification and Accreditation (IT-SC&A)--due 
within 3 months after contract award. The Contractor shall submit 
written proof to the Contracting Officer that an IT-SC&A was 
performed for applicable information systems--see paragraph (a) of 
this clause. The Contractor shall perform the IT-SC&A in accordance 
with the HHS Chief Information Security Officer's Certification and 
Accreditation Checklist; NIST SP 800-37, Guide for the Security 
Certification and Accreditation of Federal Information Systems; and 
NIST SP 800-53, Recommended Security Controls for Federal 
Information Systems. An authorized senior management official shall 
sign the draft IT-SC&A and provide it to the Contracting Officer for 
review, comment, and acceptance.
    (i) After resolution of any comments provided by the Government 
on the draft IT-SC&A, the Contracting Officer shall accept the IT-
SC&A and incorporate the Contractor's final version into the 
contract as a compliance requirement.
    (ii) The Contractor shall also perform an annual security 
control assessment and provide to the Contracting Officer 
verification that the IT-SC&A remains valid. Evidence of a valid 
system accreditation includes written results of:
    (A) Annual testing of the system contingency plan; and
    (B) The performance of security control testing and evaluation.
    (d) Personal identity verification. The Contractor shall 
identify its employees with access to systems operated by the 
Contractor for HHS or connected to HHS systems and networks. The 
Contracting Officer's Technical Representative (COTR) shall 
identify, for those identified employees, position sensitivity 
levels that are commensurate with the responsibilities and risks 
associated with their assigned positions. The Contractor shall 
comply with the HSPD-12 requirements contained in ``HHS-Controlled 
Facilities and Information Systems Security'' requirements specified 
in the SOW/PWS of this contract.
    (e) Contractor and subcontractor employee training. The 
Contractor shall ensure that its employees, and those of its 
subcontractors, performing under this contract complete HHS-
furnished initial and refresher security and privacy education and 
awareness training before being granted access to systems operated 
by the Contractor on behalf of HHS or access to HHS systems and 
networks. The Contractor shall provide documentation to the COTR 
evidencing that Contractor employees have completed the required 
training.
    (f) Government access for IT inspection. The Contractor shall 
afford the Government access to the Contractor's and subcontractors' 
facilities, installations, operations, documentation, databases, and 
personnel used in performance of this contract to the extent 
required to carry out a program of IT

[[Page 62462]]

inspection (to include vulnerability testing), investigation, and 
audit to safeguard against threats and hazards to the integrity, 
confidentiality, and availability, of HHS data or to the protection 
of information systems operated on behalf of HHS.
    (g) Subcontracts. The Contractor shall incorporate the substance 
of this clause in all subcontracts that require protection of 
Federal information and Federal information systems as described in 
paragraph (a) of this clause, including those subcontracts that--
    (1) Have physical or electronic access to HHS' computer systems, 
networks, or IT infrastructure; or
    (2) Use information systems to generate, store, process, or 
exchange data with HHS or on behalf of HHS, regardless of whether 
the data resides on a HHS or the Contractor's information system.
    (h) Contractor employment notice. The Contractor shall 
immediately notify the Contracting Officer when an employee either 
begins or terminates employment (or is no longer assigned to the HHS 
project under this contract), if that employee has, or had, access 
to HHS information systems or data.
    (i) Document information. The Contractor shall contact the 
Contracting Officer for any documents, information, or forms 
necessary to comply with the requirements of this clause.
    (j) Contractor responsibilities upon physical completion of the 
contract. The Contractor shall return all HHS information and IT 
resources provided to the Contractor during contract performance and 
certify that all HHS information has been purged from Contractor-
owned systems used in contract performance.
    (k) Failure to comply. Failure on the part of the Contractor or 
its subcontractors to comply with the terms of this clause shall be 
grounds for the Contracting Officer to terminate this contract.
    (End of clause)


352.239-73  Electronic information and technology accessibility.

    (a) As prescribed in 339.201-70(a), the Contracting Officer shall 
insert the following provision:

Electronic and Information Technology Accessibility (October 2009)

    (a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 
794d), as amended by the Workforce Investment Act of 1998, and the 
Architectural and Transportation Barriers Compliance Board 
Electronic and Information (EIT) Accessibility Standards (36 CFR 
Part 1194), require that, unless an exception applies, all EIT 
products and services developed, acquired, maintained, or used by 
any Federal department or agency permit--
    (1) Federal employees with disabilities to have access to and 
use information and data that is comparable to the access and use of 
information and data by Federal employees who are not individuals 
with disabilities; and
    (2) Members of the public with disabilities seeking information 
or services from a Federal agency to have access to and use of 
information and data that is comparable to the access and use of 
information and data by members of the public who are not 
individuals with disabilities.
    (b) Accordingly, any vendor submitting a proposal/quotation/bid 
in response to this solicitation must demonstrate compliance with 
the established EIT accessibility standards. Information about 
Section 508 is available at http://www.section508.gov/. The complete 
text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm.
    (c) The Section 508 accessibility standards applicable to this 
solicitation are identified in the Statement of Work/Specification/
Performance Work Statement. In order to facilitate the Government's 
evaluation to determine whether EIT products and services proposed 
meet applicable Section 508 accessibility standards, offerors must 
prepare an HHS Section 508 Product Assessment Template, in 
accordance with its completion instructions, and provide a binding 
statement of conformance. The purpose of the template is to assist 
HHS acquisition and program officials in determining that EIT 
products and services proposed support applicable Section 508 
accessibility standards. The template allows vendors or developers 
to self-evaluate their products or services and document in detail 
how they do or do not conform to a specific Section 508 
accessibility standard. Instructions for preparing the HHS Section 
508 Evaluation Template may be found under Section 508 policy on the 
HHS Office on Disability Web site (http://www.hhs.gov/od).
    (d) Respondents to this solicitation must also provide any 
additional detailed information necessary for determining applicable 
Section 508 accessibility standards conformance, as well as for 
documenting EIT products or services that are incidental to the 
project, which would constitute an exception to Section 508 
requirements. If a vendor claims its products or services, including 
EIT deliverables such as electronic documents and reports, meet 
applicable Section 508 accessibility standards in its completed HHS 
Section 508 Product Assessment Template, and it is later determined 
by the Government--i.e., after award of a contract/order, that 
products or services delivered do not conform to the described 
accessibility standards in the Product Assessment Template, 
remediation of the products or services to the level of conformance 
specified in the vendor's Product Assessment Template will be the 
responsibility of the Contractor and at its expense.
    (End of provision)

    (b) As prescribed in 339.201-70(b), the Contracting Officer shall 
insert the following clause:

Electronic and Information Technology Accessibility (October 2009)

    (a) Pursuant to Section 508 of the Rehabilitation Act of 1973 
(29 U.S.C. 794d), as amended by the Workforce Investment Act of 
1998, all electronic and information technology (EIT) products and 
services developed, acquired, maintained, or used under this 
contract/order must comply with the ``Electronic and Information 
Technology Accessibility Provisions'' set forth by the Architectural 
and Transportation Barriers Compliance Board (also referred to as 
the ``Access Board'') in 36 CFR part 1194. Information about Section 
508 is available at http://www.section508.gov/. The complete text of 
Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm.
    (b) The Section 508 accessibility standards applicable to this 
contract/order are identified in the Statement of Work/
Specification/Performance Work Statement. The Contractor must 
provide a written Section 508 conformance certification due at the 
end of each contract/order exceeding $100,000 when the contract/
order duration is one year or less. If it is determined by the 
Government that EIT products and services provided by the Contractor 
do not conform to the described accessibility standards in the 
Product Assessment Template, remediation of the products or services 
to the level of conformance specified in the Contractor's Product 
Assessment Template will be the responsibility of the Contractor at 
its own expense.
    (c) In the event of a modification(s) to this contract/order, 
which adds new EIT products or services or revises the type of, or 
specifications for, products or services the Contractor is to 
provide, including EIT deliverables such as electronic documents and 
reports, the Contracting Officer may require that the contractor 
submit a completed HHS Section 508 Product Assessment Template to 
assist the Government in determining that the EIT products or 
services support Section 508 accessibility standards. Instructions 
for documenting accessibility via the HHS Section 508 Product 
Assessment Template may be found under Section 508 policy on the HHS 
Office on Disability Web site (http://www.hhs.gov/od).

    (c) As prescribed in 339.201-70(c), the Contracting Officer shall 
add the following paragraph to the end of clause 352.239-73(b):

    Prior to the Contracting Officer exercising an option for a 
subsequent performance period/additional quantity or adding funding 
for a subsequent performance period under this contract, as 
applicable, the Contractor must provide a Section 508 Annual Report 
to the Contracting Officer and Project Officer. Unless otherwise 
directed by the Contracting Officer in writing, the Contractor shall 
provide the cited report in accordance with the following schedule. 
Instructions for completing the report are available in the Section 
508 policy on the HHS Office on Disability Web site under the 
heading Vendor Information and Documents. The Contractor's failure 
to submit a timely and properly completed report may jeopardize the 
Contracting Officer's exercising an option or adding funding, as 
applicable.

Schedule for Contractor Submission of Section 508 Annual Report

    (To be completed by the Contracting Officer at time of contract/
order award.)

[[Page 62463]]

352.242-70  Key personnel.

    As prescribed in 342.302(c)(2), the Contracting Officer shall 
insert the following clause:

Key Personnel (January 2006)

    The key personnel specified in this contract are considered to 
be essential to work performance. At least 30 days prior to 
diverting any of the specified individuals to other programs or 
contracts (or as soon as possible, if an individual must be 
replaced, for example, as a result of leaving the employ of the 
Contractor), the Contractor shall notify the Contracting Officer and 
shall submit comprehensive justification for the diversion or 
replacement request (including proposed substitutions for key 
personnel) to permit evaluation by the Government of the impact on 
performance under this contract. The Contractor shall not divert or 
otherwise replace any key personnel without the written consent of 
the Contracting Officer. The Government may modify the contract to 
add or delete key personnel at the request of the contractor or 
Government.
    (End of clause)


352.242-71  Tobacco-free facilities.

    As prescribed in 342.302(c)(3), the Contracting Officer shall 
insert the following clause:

Tobacco-free Facilities (January 2006)

    In accordance with Department of Health and Human Services (HHS) 
policy, the Contractor and its staff are prohibited from using 
tobacco products of any kind (e.g., cigarettes, cigars, pipes, and 
smokeless tobacco) while on any HHS property, including use in 
personal or company vehicles operated by Contractor employees while 
on an HHS property. This policy also applies to all subcontracts 
awarded under the contract or order. The term ``HHS properties'' 
includes all properties owned, controlled and/or leased by HHS when 
totally occupied by HHS, including all indoor and outdoor areas of 
such properties. Where HHS only partially occupies such properties, 
it includes all HHS-occupied interior space. Where HHS leases space 
in a multi-occupant building or complex, the tobacco-free HHS policy 
will apply to the maximum area permitted by both law and current 
lease agreements. The Contractor shall ensure that each of its 
employees, and any subcontractor staff, is made aware of, 
understand, and comply with this policy.
    (End of clause)


352.242-72  Native American Graves Protection and Repatriation Act.

    As prescribed in 342.302(c)(4), the Contracting Officer shall 
insert the following clause:

Native American Graves Protection and Repatriation Act (January 2006)

    (a) Public Law 101-601, dated November 16, 1990, also known as 
the Native American Graves Protection and Repatriation Act (Act), 
imposes certain responsibilities on individuals and organizations 
when they discover Native American cultural items (including human 
remains) on Federal or Tribal lands.
    (b) In the event the Contractor discovers Native American 
cultural items (including human remains, associated funerary 
objects, unassociated funerary objects, sacred objects and cultural 
patrimony), as defined in the Act during contract performance, the 
Contractor shall--
    (i) Immediately cease activity in the area of the discovery;
    (ii) Notify the Contracting Officer of the discovery; and
    (iii) Make a reasonable effort to protect the items discovered 
before resuming such activity. Upon receipt of the Contractor's 
discovery notice, the Contracting Officer will notify the 
appropriate authorities as required by the Act.
    (c) Unless otherwise specified by the Contracting Officer, the 
Contractor may resume activity in the area on the 31st calendar day 
following the date that the appropriate authorities certify receipt 
of the discovery notice. The Contracting Officer shall provide to 
the Contractor the date that the appropriate authorities certify 
receipt of the discovery notice and the date on which the Contractor 
may resume activities.
    (End of clause)


352.242-73  Withholding of contract payments.

    As prescribed in 342.7003-1(a), the Contracting Officer shall 
insert the following clause:

Withholding of Contract Payments (January 2006)

    Notwithstanding any other payment provisions of this contract, 
failure of the Contractor to submit required reports when due or 
failure to perform or deliver required work, supplies, or services, 
may result in the withholding of payments under this contract unless 
such failure arises out of causes beyond the control, and without 
the fault or negligence of the Contractor as defined by the clause 
entitled ``Excusable Delays'' or ``Default,'' as applicable. The 
Government will immediately notify the Contractor of its intention 
to withhold payment of any invoice or voucher submitted.
    (End of clause)


352.242-74  Final decisions on audit findings.

    As prescribed in 342.7003-1(b), the Contracting Officer shall 
insert the following clause:

Final Decisions on Audit Findings (April 1984)

    For the purpose of issuing final decisions under the Disputes 
clause of this contract concerning monetary audit findings, the 
Contracting Officer is the individual authorized to make such 
decisions.
    (End of clause)


352.270-1  Accessibility of meetings, conferences, and seminars to 
persons with disabilities.

    As prescribed in 370.102, the Contracting Officer shall insert the 
following clause:

Accessibility of Meetings, Conferences, and Seminars to Persons With 
Disabilities (January 2001)

    The Contractor agrees as follows:
    (a) Planning. The Contractor shall develop a plan to assure that 
any meeting, conference, or seminar held pursuant to this contract 
will meet or exceed the minimum accessibility standards set forth in 
28 CFR 36.101-36.500 and Appendix A: ADA Accessibility Guidelines 
(ADAAG). The Contractor shall submit the plan to the Contracting 
Officer's Technical Representative for approval prior to initiating 
action. (The Contractor may submit a consolidated or master plan for 
contracts requiring numerous meetings, conferences, or seminars in 
lieu of separate plans.)
    (b) Facilities. Any facility the Contractor intends to utilize 
for meetings, conferences, or seminars in performance of this 
contract shall be in compliance with 28 CFR 36.101-36.500 and 
Appendix A. The Contractor shall determine, by an on-site 
inspection, that the facility meets these requirements. (1) Parking. 
Parking shall be in compliance with 228 CFR 36.101-36.500 and 
Appendix A.
    (2) Entrances. Entrances shall be in compliance with 28 CFR 
36.101-36.500 and Appendix A.
    (3) Meeting Rooms. Meeting rooms, including seating 
arrangements, shall be in compliance with 28 CFR 36.101-36.500 and 
Appendix A. In addition, stages, speaker platforms, etc. which are 
to be used by persons in wheelchairs must be accessible by ramps or 
lifts. When used, the ramp may not necessarily be independently 
negotiable if space does not permit. However, the Contracting 
Officer's Technical Representative must approve any slope over 1:12, 
and the Contractor must provide assistance to negotiate access to 
the stage or platform.
    (4) Restrooms. Restrooms shall be in compliance with 28 CFR 
36.101-36.500 and Appendix A.
    (5) Eating Facilities. Eating facilities in the meeting facility 
must also comply with 28 CFR 36.101-36.500 and Appendix A.
    (6) Overnight Facilities. If overnight accommodations are 
required, the facility providing the overnight accommodations shall 
also comply with 28 CFR 36.101-36.500 and Appendix A.
    (7) Water Fountains. Water fountains shall comply with 28 CFR 
36.101-36.500 and Appendix A.
    (8) Telephones. Public telephones shall comply with 28 CFR 
36.101-36.500 and Appendix A.
    (c) Provisions of Services for Attendees with Sensory 
Impairments.
    (1) The Contractor, in planning the meeting, conference, or 
seminar, shall include in all announcements and other materials 
pertaining to the meeting, conference, or seminar a notice 
indicating that services will be made available to persons with 
sensory impairments attending the meeting, if requested within five 
(5) days of the date of the meeting, conference, or seminar. The 
announcement(s) and other material(s) shall indicate that persons 
with sensory impairments may contact a specific person(s), at a 
specific address and phone

[[Page 62464]]

number(s), to make their service requirements known. The phone 
number(s) shall include a telecommunication device for the deaf 
(TDD).
    (2) The Contractor shall provide, at no additional cost to the 
individual, those services required by persons with sensory 
impairments to ensure their complete participation in the meeting, 
conference, or seminar.
    (3) At a minimum, when requested in advance, the Contractor 
shall provide the following services:
    (i) For persons with hearing impairments, qualified 
interpreters. Also, the meeting rooms shall be adequately 
illuminated so signing by interpreters can be easily seen.
    (ii) For persons with vision impairments, readers and/or 
cassette materials, as necessary, to enable full participation. 
Also, meeting rooms shall be adequately illuminated.
    (iii) Agenda and other conference material(s) shall be 
translated into a usable form for persons with sensory impairments. 
Readers, Braille translations, large print text, and/or tape 
recordings are all acceptable. These materials shall be available to 
individuals with sensory impairments upon their arrival.
    (4) The Contractor shall make a reasonable effort to ascertain 
the number of individuals with sensory impairments who plan to 
attend the meeting, conference, or seminar. However, if the 
Contractor can determine that there will be no person with sensory 
impairment in attendance, the provision of those services under 
paragraph (c) of this clause for the non-represented group, or 
groups, is not required.
    (End of clause)


352.270-2  Indian preference.

    As prescribed in 370.202(a), the Contracting Officer shall insert 
the following clause:

Indian Preference (April 1984)

    (a) The Contractor agrees to give preference in employment 
opportunities under this contract to Indians who can perform 
required work, regardless of age (subject to existing laws and 
regulations), sex, religion, or Tribal affiliation. To the extent 
feasible and consistent with the efficient performance of this 
contract, the Contractor further agrees to give preference in 
employment and training opportunities under this contract to Indians 
who are not fully qualified to perform regardless of age (subject to 
existing laws and regulations), sex, religion, or Tribal 
affiliation. The Contractor also agrees to give preference to Indian 
organizations and Indian-owned economic enterprises in the awarding 
of any subcontracts to the extent feasible and consistent with the 
efficient performance of this contract. The Contractor shall 
maintain statistical records as are necessary to indicate compliance 
with this paragraph.
    (b) In connection with the Indian employment preference 
requirements of this clause, the Contractor shall provide 
opportunities for training incident to such employment. Such 
training shall include on-the-job, classroom or apprenticeship 
training which is designed to increase the vocational effectiveness 
of an Indian employee.
    (c) If the Contractor is unable to fill its employment and 
training opportunities after giving full consideration to Indians as 
required by this clause, the Contractor may satisfy those needs by 
selecting persons other than Indians in accordance with the clause 
of this contract entitled ``Equal Opportunity.''
    (d) If no Indian organizations or Indian-owned economic 
enterprises are available under reasonable terms and conditions, 
including price, for awarding of subcontracts in connection with the 
work performed under this contract, the Contractor agrees to comply 
with the provisions of this contract involving utilization of small 
businesses; HUBZone small businesses; service-disabled, veteran-
owned small businesses; 8(a) small businesses; veteran-owned small 
businesses; women-owned small businesses; or small disadvantaged 
businesses.
    (e) As used in this clause,
    (1) ``Indian'' means a person who is a member of an Indian 
Tribe. If the Contractor has reason to doubt that a person seeking 
employment preference is an Indian, the Contractor shall grant the 
preference but shall require the individual to provide evidence 
within 30 days from the Tribe concerned that the person is a member 
of the Tribe.
    (2) ``Indian Tribe'' means an Indian Tribe, pueblo, band, 
nation, or other organized group or community, including Alaska 
Native village or regional or village corporation as defined in or 
established pursuant to the Alaska Native Claims Settlement Act (85 
Stat. 688; 43 U.S.C. 1601) which is recognized as eligible for the 
special programs and services provided by the United States to 
Indians because of their status as Indians.
    (3) ``Indian organization'' means the governing body of any 
Indian Tribe or entity established or recognized by such governing 
body in accordance with the Indian Financing Act of 1974 (88 Stat. 
77; 25 U.S.C. 1451).
    (4) ``Indian-owned economic enterprise'' means any Indian-owned 
commercial, industrial, or business activity established or 
organized for the purpose of profit, provided that such Indian 
ownership shall constitute not less than 51 percent of the 
enterprise, and that ownership shall encompass active operation and 
control of the enterprise.
    (f) The Contractor agrees to include the provisions of this 
clause, including this paragraph (f) of this clause, in each 
subcontract awarded at any tier under this contract.
    (g) In the event of noncompliance with this clause, the 
Contracting Officer may terminate the contract in whole or in part 
or may impose any other sanctions authorized by law or by other 
provisions of the contract.
    (End of clause)


352.270-3  Indian preference program.

    As prescribed in 370.202(b), the Contracting Officer shall insert 
the following clause:

Indian Preference Program (January 2006)

    (a) In addition to the requirements of the clause of this 
contract entitled ``Indian Preference,'' the Contractor agrees to 
establish and conduct an Indian preference program which will expand 
opportunities for Indians to receive preference for employment and 
training in connection with the work to be performed under this 
contract, and which will expand the opportunities for Indian 
organizations and Indian-owned economic enterprises to receive a 
preference in the awarding of subcontracts. In this connection, the 
Contractor shall perform the following:
    (1) Designate a liaison officer who will maintain liaison with 
the Government and the Tribe(s) on Indian preference matters; 
supervise compliance with the provisions of this clause; and 
administer the Contractor's Indian preference program.
    (2) Advise its recruitment sources in writing and include a 
statement in all advertisements for employment that Indian 
applicants will be given preference in employment and training 
incident to such employment.
    (3) Not more than 20 calendar days after award of the contract, 
post a written notice in the Tribal office of any reservations on 
which or near where the work under this contract is to be performed 
that sets forth the Contractor's employment needs and related 
training opportunities. The notice shall include the approximate 
numbers and types of employees needed; the approximate dates of 
employment; the experience or special skills required for 
employment, if any; training opportunities available; and other 
pertinent information necessary to advise prospective employees of 
any other employment requirements. The Contractor shall also request 
the Tribe(s) on or near whose reservation(s) the work is to be 
performed to provide assistance to the Contractor in filling its 
employment needs and training opportunities. The Contracting Officer 
will advise the Contractor of the name, location, and phone number 
of the Tribal officials to contact in regard to the posting of 
notices and requests for Tribal assistance.
    (4) Establish and conduct a subcontracting program which gives 
preference to Indian organizations and Indian-owned economic 
enterprises as subcontractors and suppliers under this contract. The 
Contractor shall give public notice of existing subcontracting 
opportunities and, to the extent feasible and consistent with the 
efficient performance of this contract, shall solicit bids or 
proposals only from Indian organizations or Indian-owned economic 
enterprises. The Contractor shall request assistance and information 
on Indian firms qualified as suppliers or subcontractors from the 
Tribe(s) on or near whose reservation(s) the work under the contract 
is to be performed. The Contracting Officer will advise the 
Contractor of the name, location, and phone number of the Tribal 
officials to be contacted in regard to the request for assistance 
and information. Public notices and solicitations for existing 
subcontracting opportunities shall provide an equitable opportunity 
for Indian firms to submit bids or proposals by including--
    (i) A clear description of the supplies or services required, 
including quantities, specifications, and delivery schedules which 
facilitate the participation of Indian firms;

[[Page 62465]]

    (ii) A statement indicating that preference will be given to 
Indian organizations and Indian-owned economic enterprises in 
accordance with section 7(b) of Public Law 93-638 [88 Stat. 2205; 25 
U.S.C. 450e(b)];
    (iii) Definitions for the terms ``Indian organization'' and 
``Indian-owned economic enterprise'' as prescribed under the 
``Indian Preference'' clause of this contract;
    (iv) A statement to be completed by the bidder or offeror that 
it is an Indian organization or Indian-owned economic enterprise; 
and
    (v) A closing date for receipt of bids or proposals which 
provides sufficient time for preparation and submission of a bid or 
proposal. If after soliciting bids or proposals from Indian 
organizations and Indian-owned economic enterprises, no responsive 
bid or acceptable proposal is received, the Contractor shall comply 
with the requirements of paragraph (d) of the ``Indian Preference'' 
clause of this contract. If one or more responsible bids or 
acceptable proposals are received, award shall be made to the low 
responsible bidder or acceptable offeror if the price is determined 
to be reasonable. If the low responsive bid or acceptable proposal 
is determined to be unreasonable as to price, the Contractor shall 
attempt to negotiate a reasonable price and award a subcontract. If 
a reasonable price cannot be agreed upon, the Contractor shall 
comply with the requirements of paragraph (d) of the ``Indian 
Preference'' clause of this contract.
    (5) Maintain written records under this contract which 
indicate--
    (i) The numbers of Indians seeking employment for each 
employment position available under this contract;
    (ii) The number and types of positions filled by Indians and 
non-Indians;
    (iii) The total number of Indians employed under this contract;
    (iv) For those positions where there are both Indian and non-
Indian applicants, and a non-Indian is selected for employment, the 
reason(s) why the Indian applicant was not selected;
    (v) Actions taken to give preference to Indian organizations and 
Indian-owned economic enterprises for subcontracting opportunities 
which exist under this contract;
    (vi) Reasons why preference was not given to Indian firms as 
subcontractors or suppliers for each requirement where it was 
determined by the Contractor that such preference would not be 
consistent with the efficient performance of the contract; and
    (vii) The number of Indian organizations and Indian-owned 
economic enterprises contacted, and the number receiving subcontract 
awards under this contract.
    (6) Submit to the Contracting Officer for approval a quarterly 
report which summarizes the Contractor's Indian preference program 
and indicates the number and types of available positions filled by 
Indians and non-Indians, and the dollar amounts of all subcontracts 
awarded to Indian organizations and Indian-owned economic 
enterprises, and to all other firms.
    (7) Maintain records pursuant to this clause and keep them 
available for review by the Government for one year after final 
payment under this contract, or for such longer period as may be 
required by any other clause of this contract or by applicable law 
or regulation.
    (b) For purposes of this clause, the following definitions of 
terms shall apply:
    (1) The terms ``Indian,'' ``Indian Tribe,'' ``Indian 
Organization,'' and ``Indian-owned economic enterprise'' are defined 
in the clause of this contract entitled ``Indian Preference.''
    (2) ``Indian reservation'' includes Indian reservations, public 
domain Indian Allotments, former Indian reservations in Oklahoma, 
and land held by incorporated Native groups, regional corporations, 
and village corporations under the provisions of the Alaska Native 
Claims Settlement Act (85 Stat. 688; 43 U.S.C. 1601 et seq.)
    (3) ``On or near an Indian Reservation'' means on a reservation 
or reservations or within that area surrounding an Indian 
reservation(s) where a person seeking employment could reasonably be 
expected to commute to and from in the course of a work day.
    (c) Nothing in the requirements of this clause shall be 
interpreted to preclude Indian Tribes from independently developing 
and enforcing their own Indian preference requirements. Such 
requirements must not conflict with any Federal statutory or 
regulatory requirement dealing with the award and administration of 
contracts.
    (d) The Contractor agrees to include the provisions of this 
clause, including this paragraph (d), in each subcontract awarded at 
any tier under this contract and to notify the Contracting Officer 
of such subcontracts.
    (e) In the event of noncompliance with this clause, the 
Contracting Officer may terminate the contract in whole or in part 
or may impose any other sanctions authorized by law or by other 
provisions of the contract.
    (End of clause)


352.270-4   Protection of human subjects.

    (a) As prescribed in 370.303(a), the Contracting Officer shall 
insert the following provision:

Notice to Offerors of Requirements of 45 CFR Part 46, Protection of 
Human Subjects (January 2006)

    (a) Copies of the Department of Health and Human Services (HHS) 
regulations for the protection of human subjects, 45 CFR Part 46, 
are available from the Office for Human Research Protections (OHRP), 
Bethesda, Maryland 20892. The regulations provide a systematic 
means, based on established ethical principles, to safeguard the 
rights and welfare of individuals who participate as subjects in 
research activities supported or conducted by HHS.
    (b) The regulations define a human subject as a living 
individual about whom an investigator (whether professional or 
student) conducting research obtains data through intervention or 
interaction with the individual, or identifiable private 
information. The regulations extend to the use of human organs, 
tissue, and body fluids from individually identifiable human 
subjects as well as to graphic, written, or recorded information 
derived from individually identifiable human subjects. The use of 
autopsy materials is governed by applicable State and local law and 
is not directly regulated by 45 CFR Part 46.
    (c) Activities in which the only involvement of human subjects 
will be in one or more of the categories set forth in 45 CFR 
46.101(b)(1-6) are exempt from coverage.
    (d) Inappropriate designations of the noninvolvement of human 
subjects or of exempt categories of research in a project may result 
in delays in the review of a proposal. The Government's Project 
Officer will make a final determination of whether the proposed 
activities are covered by the regulations or are in an exempt 
category, based on the information provided in the proposal. In 
doubtful cases, the Project Officer will consult with OHRP.
    (e) In accordance with 45 CFR Part 46, offerors being considered 
for award shall file with OHRP an acceptable Assurance of Compliance 
with the regulations, specifying review procedures and assigning 
responsibilities for the protection of human subjects. The initial 
and continuing review of a research project by an institutional 
review board shall ensure that: the rights and welfare of the human 
subjects involved are adequately protected; the risks to the 
subjects are reasonable in relation to both the potential benefits, 
if any, to the subjects and the importance of the knowledge to be 
gained; and informed consent will be obtained by methods that are 
adequate and appropriate. HHS regulations for the protection of 
human subjects (45 CFR Part 46), information regarding OHRP 
registration and assurance requirements/processes, and OHRP contact 
information can be accessed at the OHRP Web site (at  http://www.hhs.gov/ohrp/).
    (f) Offerors may consult with OHRP for advice or guidance 
concerning either regulatory requirements or ethical issues 
pertaining to research involving human subjects.
    (End of provision)

    (b) As prescribed in 370.304(a), the Contracting Officer shall 
insert the following clause:

Protection of Human Subjects (January 2006)

    (a) The Contractor agrees that the rights and welfare of human 
subjects involved in research under this contract shall be protected 
in accordance with 45 CFR Part 46 and with the Contractor's current 
Assurance of Compliance on file with the Office for Human Research 
Protections (OHRP), Department of Health and Human Services. The 
Contractor further agrees to provide certification at least annually 
that the Institutional Review Board has reviewed and approved the 
procedures, which involve human subjects in accordance with 45 CFR 
Part 46 and the Assurance of Compliance.
    (b) The Contractor shall bear full responsibility for the 
performance of all work and services involving the use of human 
subjects under this contract and shall ensure that work is conducted 
in a proper manner and as safely as is feasible. The parties hereto 
agree that the Contractor retains the right to control and direct 
the performance of all

[[Page 62466]]

work under this contract. The Contractor shall not deem anything in 
this contract to constitute the Contractor or any subcontractor, 
agent or employee of the Contractor, or any other person, 
organization, institution, or group of any kind whatsoever, as the 
agent or employee of the Government. The Contractor agrees that it 
has entered into this contract and will discharge its obligations, 
duties, and undertakings and the work pursuant thereto, whether 
requiring professional judgment or otherwise, as an independent 
contractor without imputing liability on the part of the Government 
for the acts of the Contractor or its employees.
    (c) If at any time during the performance of this contract, the 
Contracting Officer determines, in consultation with OHRP that the 
Contractor is not in compliance with any of the requirements and/or 
standards stated in paragraphs (a) and (b) above, the Contracting 
Officer may immediately suspend, in whole or in part, work and 
further payments under this contract until the Contractor corrects 
the noncompliance. The Contracting Officer may communicate the 
notice of suspension by telephone with confirmation in writing. If 
the Contractor fails to complete corrective action within the period 
of time designated in the Contracting Officer's written notice of 
suspension, the Contracting Officer may, after consultation with 
OHRP, terminate this contract in whole or in part, and the 
Contractor's name may be removed from the list of those contractors 
with approved Human Subject Assurances.
    (End of clause)


352.270-5   Care of laboratory animals.

    (a) As prescribed in 370.403(a), the Contracting Officer shall 
insert the following provision:

Notice to Offerors of Requirement for Compliance With the Public Health 
Service Policy on Humane Care and Use of Laboratory Animals (January 
2006)

    The Public Health Service (PHS) Policy on Humane Care and Use of 
Laboratory Animals (PHS Policy) establishes a number of requirements 
for research activities involving animals. Before award may be made 
to an applicant organization, the organization shall file, with the 
Office of Laboratory Animal Welfare (OLAW), National Institutes of 
Health (NIH), a written Animal Welfare Assurance (Assurance) which 
commits the organization to comply with the provisions of the PHS 
Policy, the Animal Welfare Act, and the Guide for the Care and Use 
of Laboratory Animals (National Academy Press, Washington, DC). In 
accordance with the PHS Policy, applicant organizations must 
establish an Institutional Animal Care & Use Committee (IACUC), 
qualified through the experience and expertise of its members, to 
oversee the institution's animal program, facilities and procedures. 
Applicant organizations are required to provide verification of 
IACUC approval prior to release of an award involving live 
vertebrate animals. No award involving the use of animals shall be 
made unless OLAW approves the Assurance and verification of IACUC 
approval for the proposed animal activities has been provided to the 
Contracting Officer. Prior to award, the Contracting Officer will 
notify Contractor(s) selected for projects that involve live 
vertebrate animals that an Assurance and verification of IACUC 
approval are required. The Contracting Officer will request that 
OLAW negotiate an acceptable Assurance with those Contractor(s) and 
request verification of IACUC approval. For further information, 
contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 
Bethesda, Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301-
496-7163).
    (End of provision)

    (b) As prescribed in 370.404, the Contracting Officer shall insert 
the following clause:

Care of Live Vertebrate Animals (October 2009)

    (a) Before undertaking performance of any contract involving 
animal-related activities where the species is regulated by USDA, 
the Contractor shall register with the Secretary of Agriculture of 
the United States in accordance with 7 U.S.C. 2136 and 9 CFR 
sections 2.25 through 2.28. The Contractor shall furnish evidence of 
the registration to the Contracting Officer.
    (b) The Contractor shall acquire vertebrate animals used in 
research from a dealer licensed by the Secretary of Agriculture 
under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source 
that is exempt from licensing under those sections.
    (c) The Contractor agrees that the care, use and intended use of 
any live vertebrate animals in the performance of this contract 
shall conform with the Public Health Service (PHS) Policy on Humane 
Care of Use of Laboratory Animals (PHS Policy), the current Animal 
Welfare Assurance (Assurance), the Guide for the Care and Use of 
Laboratory Animals (National Academy Press, Washington, DC) and the 
pertinent laws and regulations of the United States Department of 
Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 
1-4). In case of conflict between standards, the more stringent 
standard shall govern.
    (d) If at any time during performance of this contract, the 
Contracting Officer determines, in consultation with the Office of 
Laboratory Animal Welfare (OLAW), National Institutes of Health 
(NIH), that the Contractor is not in compliance with any of the 
requirements and standards stated in paragraphs (a) through (c) 
above, the Contracting Officer may immediately suspend, in whole or 
in part, work and further payments under this contract until the 
Contractor corrects the noncompliance. Notice of the suspension may 
be communicated by telephone and confirmed in writing. If the 
Contractor fails to complete corrective action within the period of 
time designated in the Contracting Officer's written notice of 
suspension, the Contracting Officer may, in consultation with OLAW, 
NIH, terminate this contract in whole or in part, and the 
Contractor's name may be removed from the list of those contractors 
with approved Assurances.

    Note: The Contractor may request registration of its facility 
and a current listing of licensed dealers from the Regional Office 
of the Animal and Plant Health Inspection Service (APHIS), USDA, for 
the region in which its research facility is located. The location 
of the appropriate APHIS Regional Office, as well as information 
concerning this program may be obtained by contacting the Animal 
Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 
(E-mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal_welfare).

    (End of clause)


352.270-6   Restriction on use of human subjects.

    As prescribed in 370-304(b), the Contracting Officer shall insert 
the following clause:

Restriction on Use of Human Subjects (January 2006)

    Pursuant to 45 CFR part 46, Protection of Human Research 
Subjects, the Contractor shall not expend funds under this award for 
research involving human subjects or engage in any human subjects 
research activity prior to the Contracting Officer's receipt of a 
certification that the research has been reviewed and approved by 
the Institutional Review Board (IRB) designated under the 
Contractor's Federal-wide assurance of compliance. This restriction 
applies to all collaborating sites, whether domestic or foreign, and 
subcontractors. The Contractor must ensure compliance by 
collaborators and subcontractors.
    (End of clause)


352.270-7   Conference sponsorship request and conference materials 
disclaimer.

    As prescribed in 370.602, the Contracting Officer shall insert the 
following clause:

Conference Sponsorship Request and Conference Materials Disclaimer 
(October 2009)

    (a) If HHS is not the sole provider of funding under this 
conference contract, then prior to the Contractor claiming HHS 
conference sponsorship, the Contractor shall submit a written 
request (including rationale) to the Contracting Officer for 
permission to claim such HHS sponsorship.
    (b) Whether or not HHS is the conference sponsor, the Contractor 
shall include the following statement on conference materials, 
including promotional materials, agendas, and Web sites:
    ``This conference was funded, in whole or in part, through a 
contract (insert contract number) with the Department of Health and 
Human Services (HHS) (insert name of OPDIV/STAFFDIV). The views 
expressed in written conference materials and by speakers and 
moderators at this conference, do not necessarily reflect the 
official policies of HHS, nor does mention of trade names, 
commercial practices, or organizations imply endorsement by the U.S. 
Government.''
    (c) Unless authorized by the Contracting Officer's Technical 
Representative, the Contractor shall not display the HHS logo on any 
conference materials.
    (End of clause)

[[Page 62467]]

352.270-8   Prostitution and related activities.

    As prescribed in 370.701, the Contracting Officer shall insert the 
following clause:

Prostitution and Related Activities (October 2009)

    (a) The U.S. Government is opposed to prostitution and related 
activities, which are inherently harmful and dehumanizing and 
contribute to the phenomenon of trafficking in persons.
    (b) Neither the Contractor nor any subcontractor(s) shall use 
Government funds provided under this contract to promote or advocate 
the legalization or practice of prostitution or sex trafficking. 
(Note: The term ``contract'' includes ``order'' wherever it appears 
in this clause.) The Contractor shall not construe anything in the 
preceding sentence to preclude providing individuals with palliative 
care, treatment, or post-exposure pharmaceutical prophylaxis, and 
necessary pharmaceuticals and commodities, including test kits, 
condoms, and, when proven effective, microbicides.
    (c) The Government does not require the Contractor to endorse or 
utilize a multisectoral approach to combating HIV/AIDS, or endorse, 
utilize, or participate in a prevention method or treatment program 
to which it has a religious or moral objection. Any information the 
Contractor provides about the use of condoms as part of projects or 
activities that are funded in connection with this contract shall be 
medically accurate and shall include the public health benefits and 
failure rates of such use.
    (d) In addition, the Contractor shall have a policy explicitly 
opposing prostitution and sex trafficking. The preceding sentence 
shall not apply to any ``exempt organizations'' (i.e., the Global 
Fund to Fight AIDS, Tuberculosis and Malaria; the World Health 
Organization; the International AIDS Vaccine Initiative; and any 
United Nations agency), or to any contractors that are awarded 
``specified types of commercial contracts'' as set forth below.
    (e) The following definitions apply for purposes of this clause:
    (1) ``Commercial sex act'' means any sex act on account of which 
anything of value is given to or received by any person.
    (2) ``Prostitution'' means procuring or providing any commercial 
sex act.
    (3) ``Sex trafficking'' means the recruitment, harboring, 
transportation, provision, or obtaining of a person for the purpose 
of a commercial sex act [22 U.S.C. 7102(9)].
    (4) ``Specified types of commercial contracts'' means contracts 
awarded for commercial items and services as defined in Federal 
Acquisition Regulation (FAR) 2.101, such as pharmaceuticals, medical 
supplies, logistics support, data management, and freight 
forwarding. Notwithstanding the preceding definition of ``specified 
types of commercial contracts,'' contracts for the purposes 
specified in paragraphs (e)(4)(i) through (iii) of this clause, that 
are awarded to implement HIV/AIDS programs, require that the 
Contractor have a policy explicitly opposing prostitution and sex 
trafficking--
    (i) Supplies or services provided directly to the final 
populations receiving such supplies or services in host countries;
    (ii) Technical assistance and training furnished directly to 
host country individuals or entities for the provision of supplies 
or services to the final populations receiving such supplies and 
services; or
    (iii) The types of services listed in FAR 37.203(b)(1)-(6) that 
involve giving advice about substantive policies of a recipient, 
giving advice regarding the activities referenced in paragraphs 
(e)(4)(i) and (ii) of this clause, or making decisions or 
functioning in a recipient's chain of command (e.g., providing 
managerial or supervisory services; approving financial 
transactions, personnel actions, etc.).
    (f) The Contractor must have and maintain ``objective integrity 
and independence'' from any organization that engages in activities 
inconsistent with a policy opposing prostitution and sex 
trafficking. HHS will consider the Contractor to have objective 
integrity and independence from such an organization if the--
    (1) Organization is a legally separate entity;
    (2) Organization receives no transfer of Leadership Act funds, 
and Leadership Act funds do not subsidize activities inconsistent 
with a policy opposing prostitution and sex trafficking; and
    (3) Contractor is physically and financially separate from the 
organization. Mere bookkeeping separation of Leadership Act funds 
from other funds is not sufficient. HHS will determine, on a case-
by-case basis, and based on the totality of the facts, whether 
sufficient physical and financial separation exists. The presence or 
absence of any one factor below will not be determinative. Factors 
relevant to this determination shall include, but not be limited to, 
the following:
    (i) The existence of separate personnel, management, and 
governance.
    (ii) The existence of separate accounts, accounting records, and 
timekeeping records.
    (iii) The degree of separation from facilities, equipment, and 
supplies used by the organization to conduct activities inconsistent 
with a policy opposing prostitution and sex trafficking, and the 
extent of such activities by the organization.
    (iv) The extent to which--
    (A) Signs and other forms of identification that distinguish the 
Contractor from the organization are present, and
    (B) Signs and materials that could be associated with the 
organization or activities inconsistent with a policy opposing 
prostitution and sex trafficking are absent.
    (v) The extent to which the U.S. Government, HHS, and the 
project name are protected from public association with an 
organization and its activities that are inconsistent with a policy 
opposing prostitution and sex trafficking in materials, such as 
publications, conferences, and press or public statements.
    (g) The Contractor shall include, as express terms and 
conditions, the applicable provisions of this clause in all 
subcontract solicitations and subcontracts awarded under this 
contract. The Contractor agrees that HHS may, at any reasonable 
time, inspect the documents and materials the Contractor maintains 
or prepares in the usual course of its operations that relate to the 
Contractor's compliance with this clause.
    (h) As a prerequisite to award and payment of any Government 
funds under this contract, the Contractor shall certify compliance 
with this clause for the performance period funded by the contract. 
The Contractor shall provide the three following compliance 
certifications in a written statement addressed to the Contracting 
Officer:
    (1) Organizational Integrity Certification:
    ``I certify that (insert Contractor's name), which will be the 
recipient of Government funds made available through this contract, 
has objective integrity and independence from any organization that 
engages in activities inconsistent with a policy opposing 
prostitution and sex trafficking.''
    (2) Subcontractor Compliance Certification:
    ``I certify that (insert Contractor's name) will include the 
Organizational Integrity certification in any subcontract awarded 
under this contract and will require such subcontractor to provide 
the same certification that the Contractor provided.''
    (3) Acknowledgment Certification:
    ``I certify that (insert Contractor's name) acknowledges that 
these certifications are a prerequisite to receipt of Government 
funds in connection with this contract, and that any violation of 
these certifications by the Contractor or subcontractor(s) at any 
level shall be grounds for termination of the contract by HHS in 
accordance with the Federal Acquisition Regulation, Part 49, as well 
as any other remedies provided by law.''

    Note: In the case of existing contracts, the Contracting Officer 
shall add the certification requirements whenever the contract is 
modified to extend the period of performance or add funds, including 
any options that may be exercised. In so doing, the Contracting 
Officer shall delete in paragraph (h) the language ``As a 
prerequisite to award and payment of any Government funds under this 
contract,'' and replace it with: ``As a prerequisite to continuation 
of this contract and payment of any Government funds under it,''.

    (i) A person(s) authorized to bind the Contractor and any 
subcontractor(s) shall execute the certifications. The Contractor 
shall provide its certifications to the Contracting Officer. A 
subcontractor(s) shall provide its certifications to the Contractor. 
The Contracting Officer may request that the Contractor provide any 
subcontractor certifications. In addition, the Contractor and any 
subcontractors shall provide renewed certifications for any 
modification that extends the contract period of performance or adds 
funds to the contract, including any options that may be exercised.
    (j) This clause does not affect the applicability of the FAR 
clause at 52.222-50 entitled, ``Combating Trafficking in Persons.''
    (End of clause)


352.270-9  Non-discrimination for conscience.

    As prescribed in 370.702, the Contracting Officer shall insert the 
following provision:

[[Page 62468]]

Non-discrimination for Conscience (October 2009)

    (a) Section 301(d) of the United States Leadership Against HIV/
AIDS, Tuberculosis, and Malaria Act, as amended, provides that an 
organization, including a faith-based organization, that is 
otherwise eligible to receive assistance under section 104A of the 
Foreign Assistance Act of 1961, under the United States Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003, under the 
Tom Lantos and Henry J. Hyde United States Global Leadership Against 
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, or 
under any amendment to the foregoing Acts for HIV/AIDS prevention, 
treatment, or care--
    (1) Shall not be required, as a condition of receiving such 
assistance, to--
    (i) Endorse or utilize a multisectoral or comprehensive approach 
to combating HIV/AIDS; or
    (ii) Endorse, utilize, make a referral to, become integrated 
with, or otherwise participate in any program or activity to which 
the organization has a religious or moral objection.
    (2) Shall not be discriminated against under the provisions of 
law in subparagraph (a) for refusing to meet any requirement 
described in paragraph (a)(1) in this solicitation.
    (b) Accordingly, an offeror who believes this solicitation 
contains work requirements that would require it to endorse or 
utilize a multisectoral or comprehensive approach to combating HIV/
AIDS, or to endorse, utilize, make referral to, become integrated 
with, or otherwise participate in a program or activity to which it 
has a religious or moral objection, shall identify those work 
requirements it has excluded in its technical proposal.
    (c) The Government acknowledges that an offeror has specific 
rights, as cited in paragraph (b) of this provision, to exclude 
certain work requirements in this solicitation from its proposal. 
However, the Government reserves the right to not make an award to 
an offeror whose proposal does not comply with the salient work 
requirements of the solicitation. Any exercise of that Government 
right will be made by the Head of the Contracting Activity.
    (End of provision)

PART 353--FORMS

Subpart 353.3--Illustrations of Forms
Sec.
353.370-674 Form HHS 674, Structured Approach Profit/Fee Objective.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 353.3--Illustrations of Forms


353.370-674  Form HHS 674, Structured Approach Profit/Fee Objective.

    This form is available from local cost advisory personnel or PSC.

    Authority:  5 U.S.C. 301; 40 U.S.C. 486(c).

SUBCHAPTERS I THROUGH L [RESERVED]

PARTS 354 THROUGH 369 [RESERVED]

SUBCHAPTER M--HHS SUPPLEMENTATIONS

PART 370--SPECIAL PROGRAMS AFFECTING ACQUISITION

Subpart 370.1--Accessibility of Meetings, Conferences, and Seminars to 
Persons With Disabilities
Sec.
370.101 Policy.
370.102 Responsibilities.
Subpart 370.2--Indian Preference in Employment, Training, and 
Subcontracting Opportunities
370.201 Statutory requirements.
370.202 Applicability.
370.203 Definitions.
370.204 Compliance enforcement.
370.205 Tribal preference requirements.
Subpart 370.3--Acquisitions Involving Human Subjects
370.300 Scope of subpart.
370.301 Policy.
370.302 Types of assurances.
370.303 Notice to offerors.
370.304 Contract clauses.
Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals
370.400 Scope of subpart.
370.401 Policy.
370.402 Assurances.
370.403 Notice to offerors.
370.404 Contract clause.
Subpart 370.5--Acquisitions Under the Buy Indian Act
370.500 Scope of subpart.
370.501 Policy.
370.502 Definitions.
370.503 Requirements.
370.504 Competition.
370.505 Responsibility determinations.
Subpart 370.6--Conference Funding and Sponsorship
370.600 Policy.
370.601 Funding and sponsorship.
370.602 Contract clause.
Subpart 370.7--Acquisitions under the Leadership Act
370.700 Scope of subpart.
370.701 Contract clause.
370.702 Solicitation provision.

    Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).

Subpart 370.1--Accessibility of Meetings, Conferences, and Seminars 
to Persons With Disabilities


370.101  Policy.

    (a) It is HHS policy that all meetings, conferences, and seminars 
be accessible to persons with disabilities. For the purpose of this 
policy, accessibility is defined as both physical access to meeting, 
conference, and seminar sites, and aids and services to enable 
individuals with sensory disabilities to fully participate in meetings, 
conferences, and seminars.
    (b) In regard to acquisition, the policy is applicable to all 
contracts where the SOW/PWS requires the contractor to conduct 
meetings, conferences, or seminars that are open to the public or 
involve HHS personnel, but not to ad hoc meetings that may be necessary 
or incidental to contract performance.


370.102  Responsibilities.

    (a) The Contracting Officer shall insert the clause in 352.270-1, 
Accessibility of Meetings, Conferences, and Seminars to Persons with 
Disabilities, in solicitations, contracts, and orders when the SOW/PWS 
requires the contractor to conduct meetings, conferences, or seminars 
in accordance with 370.101(b).
    (b) The COTR shall obtain, review, and approve the contractor's 
plan, which is to be submitted in response to paragraph (a) of the 
contract clause in 352.270-1. A consolidated or master plan for 
contracts requiring numerous meetings, conferences, or seminars is 
acceptable. The COTR, prior to approving the plan, shall consult with 
the OPDIV or other designated organization responsible for monitoring 
compliance with the Architectural Barriers Act of 1968 and the 
Americans with Disabilities Act of 1990, to ensure that the 
contractor's plan meets the accessibility requirements of the contract 
clause. The COTR shall request the responsible organization to review, 
and determine the adequacy of, the contractor's plan, and respond to 
the COTR, in writing, within 10 working days of receiving the request 
from the COTR.

Subpart 370.2--Indian Preference in Employment, Training, and 
Subcontracting Opportunities


370.201  Statutory requirements.

    Section 7(b) of the Indian Self-Determination and Education 
Assistance Act, Public Law 93-638, 88 Stat. 2205, 25 U.S.C. 450e(b), 
requires:
    ``Any contract, subcontract, grant, or subgrant pursuant to this 
Act, the Act of April 16, 1934 (48 Stat. 596), as amended, or any other 
Act authorizing Federal contracts with or grants to Indian 
organizations or for the benefit of Indians, shall require that to the 
greatest extent feasible:
    (1) Preferences and opportunities for training and employment in 
connection with the administration of such

[[Page 62469]]

contracts or grants shall be given to Indians; and
    (2) Preference in the award of subcontracts and subgrants in 
connection with the administration of such contracts or grants shall be 
given to Indian organizations and to Indian-owned economic enterprises 
as defined in section 3 of the Indian Financing Act of 1974 (88 Stat. 
77).''


370.202  Applicability.

    The Indian Preference clause set forth in 352.270-2 and the Indian 
Preference Program clause set forth in 352.270-3 implement section 7(b) 
of Public Law 93-638 for all HHS activities. Contracting activities 
shall use the clauses as follows, except that solicitations issued and 
contracts awarded pursuant to Title I of Public Law 93-638 (25 U.S.C. 
450 et seq.) are exempted:
    (a) The Contracting Officer shall insert the clause in 352.270-2, 
Indian Preference, in solicitations, contracts, and orders when--
    (1) The award is (or will be) made pursuant to an act specifically 
authorizing such awards with Indian organizations; or
    (2) The work to be performed is specifically for the benefit of 
Indians and is in addition to any incidental benefits which might 
otherwise accrue to the general public.
    (b) The Contracting Officer shall insert the clause in 352.270-3, 
Indian Preference Program, in solicitations, contracts, and orders 
when--
    (1) The dollar amount of the acquisition is expected to equal or 
exceed $50,000 for nonconstruction work or $100,000 for construction 
work;
    (2) The Indian Preference clause is included in the solicitation, 
contract, or order; and
    (3) The Contracting Officer makes the determination, prior to 
solicitation, that performance will take place in whole or in 
substantial part on or near an Indian reservation(s). In addition, the 
Contracting Officer may insert the Indian Preference Program clause in 
solicitations, contracts, and orders below the $50,000 or $100,000 
level for nonconstruction or construction contracts, respectively, but 
which meet the requirements of paragraphs (b)(2) and (3) of this 
section 370.202, and, in the opinion of the Contracting Officer, offer 
substantial opportunities for Indian employment, training, and 
subcontracting.


370.203  Definitions.

    For purposes of this Subpart 370.2, the following definitions shall 
apply:
    (a) Indian means a person who is a member of an Indian Tribe. If 
the contractor has reason to doubt that a person seeking employment 
preference is an Indian, the contractor shall grant the preference but 
shall require the individual to provide evidence within 30 days from 
the Tribe concerned that the person is a member of the Tribe.
    (b) Indian Tribe means an Indian Tribe, pueblo, band, nation, or 
other organized group or community, including any Alaska Native Village 
or regional or village corporation as defined in or established 
pursuant to the Alaska Native Claims Settlement Act (85 Stat. 688, 43 
U.S.C. 1601), which is recognized as eligible for the special programs 
and services provided by the United States to Indians because of their 
status as Indians.
    (c) Indian organization means the governing body of any Indian 
Tribe, or entity established or recognized by such governing body, in 
accordance with the Indian Financing Act of 1974 (88 Stat. 77, 25 
U.S.C. 1451).
    (d) Indian-owned economic enterprise means any Indian-owned 
commercial, industrial, or business activity established or organized 
for the purpose of profit, provided that such Indian ownership shall 
constitute not less than 51 percent of the enterprise, and the 
ownership shall encompass active operation and control of the 
enterprise.
    (e) Indian reservation includes Indian reservations, public domain 
Indian allotments, former Indian reservations in Oklahoma, and land 
held by incorporated Native groups, regional corporations, and village 
corporations under the provisions of the Alaska Native Claims 
Settlement Act (85 Stat. 688, 43 U.S.C. 1601 et seq.)
    (f) On or near an Indian Reservation means on a reservation or 
reservations or within that area surrounding an Indian reservation(s) 
where a person seeking employment could reasonably be expected to 
commute to and from in the course of a work day.


370.204  Compliance enforcement.

    (a) The contracting activity shall conduct periodic reviews to 
ensure contractor compliance with the requirements of the clauses in 
352.270-2 and 352.270-3. The Indian Tribe(s) concerned may assist in 
the conduct of these reviews.
    (b) The Contracting Officer shall promptly investigate and resolve 
complaints of noncompliance with the requirements of the clauses in 
352.270-2 and 352.270-3 that are filed in writing with the contracting 
activity.


370.205  Tribal preference requirements.

    (a) When the contractor will perform work under a contract on an 
Indian reservation, the Contracting Officer may supplement the clause 
in 352.270-3 by adding specific Indian preference requirements of the 
Tribe on whose reservation the work is to be performed. The contracting 
activity and the Tribe shall jointly develop supplemental requirements 
for the contract. Supplemental preference requirements shall represent 
a further implementation of the requirements of section 7(b) of Public 
Law 93-638 and require the approval of the affected program director 
and OGC-GLD, or a regional attorney, before the Contracting Officer 
adds them to a solicitation and resultant contract. Any supplemental 
preference requirements the Contracting Officer adds to the clause in 
352.270-3 shall also be part of the solicitation and clearly 
identified, to ensure uniform understanding of the additional 
requirements by all prospective bidders or offerors.
    (b) Nothing in this part shall preclude tribes from independently 
developing and enforcing their own Tribal preference requirements. Such 
independently developed Tribal preference requirements shall not, 
except as provided in paragraph (a) of this section, become a 
requirement in contracts covered under this 370.2, and shall not 
conflict with any Federal statutory or regulatory requirement 
concerning the award and administration of contracts.

Subpart 370.3--Acquisitions Involving Human Subjects


370.300  Scope of subpart.

    This subpart applies to all R & D activities involving human 
subjects conducted under contract--see 45 CFR 46.102(d) and (f).


370.301  Policy.

    It is HHS policy that the Contracting Officer shall not award a 
contract involving human subjects until a prospective contractor has 
provided acceptable assurance that the activity will be subject to 
initial and continuing review by an appropriate Institutional Review 
Board (IRB) as described in HHS regulations at 45 CFR 46.103. The 
Contracting Officer shall require an applicable Federal-wide assurance 
(FWA), approved by the HHS Office for Human Research Protections 
(OHRP), of each contractor, subcontractor, or cooperating institution 
having responsibility for human subjects involved in performance of a 
contract. OHRP is responsible for negotiating assurances covering all 
HHS-supported or HHS-conducted activities involving human subjects. 
OHRP shall provide

[[Page 62470]]

guidance to Contracting Officers regarding non-award or termination of 
a contract due to inadequate assurance or breach of assurance for 
protection of human subjects.


370.302  Types of assurances.

    (a) If an institution does not currently hold an FWA, it should 
submit one. An FWA listed in OHRP's current ``List of Registered 
Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) 
and Approved Assurances'' is acceptable for the purposes of this 
policy.
    (b) The OHRP Web site includes links to instructions and the forms 
for submitting both a domestic and international FWA at: http://www.hhs.gov/ohrp/assurances/assurances_index.html. To expedite 
approval of a FWA, as well as any update/renewal, the institution shall 
use the OHRP Electronic Submission System. Once the institution 
``submits'' an electronic file to OHRP, the institution must fax or 
mail (but not both) a copy of the signature page to initiate the review 
process. The institution shall mail the FWA to the OHRP, U.S. 
Department of Health and Human Services, 1101 Wootton Parkway, Suite 
200, Rockville, Maryland 20852, or fax it to OHRP at 240-453-8202 (but 
not both).


370.303  Notice to offerors.

    (a) The Contracting Officer shall insert the provision in 352.270-
4(a), Notice to Offerors of Requirements of 45 CFR Part 46, Protection 
of Human Subjects, in solicitations that involve human subjects.
    (b) Institutions having an OHRP-approved FWA shall certify IRB 
approval of submitted proposals in the manner required by instructions 
for completion of the contract proposal; by completion of an OMB Form 
No. 0990-0263, ``Protection of Human Subjects Assurance Identification/
IRB Certification/Declaration of Exemption (Common Rule); or by letter 
indicating the institution's OHRP-assigned FWA number, the date of IRB 
review and approval, and the type of review (convened or expedited). 
The date of IRB approval must not be more than 12 months prior to the 
deadline for proposal submission.
    (c) The Contracting Officer generally will not request FWAs for 
contractors, subcontractors, or cooperating institutions prior to 
determination that a contract proposal has been selected for 
negotiation. When a contractor submits an FWA, it provides 
certification for the initial contract period. No additional 
documentation is required. If the contract provides for additional 
years to complete the project, the contractor shall certify the 
noncompetitive renewal proposal in the manner described in the 
preceding paragraph.


370.304  Contract clauses.

    (a) The Contracting Officer shall insert the clause in 352.270-
4(b), Protection of Human Subjects, in solicitations, contracts, and 
orders that involve human subjects.
    (b) The Contracting Officer shall insert the clause in 352.270-6, 
Restriction on Use of Human Subjects, in contracts and orders if the 
contractor has an approved Federal-wide assurance of compliance in 
place, but cannot certify prior to award that the research has been 
reviewed and approved by the IRB designated under the contractor's 
Federal-wide assurance of compliance, because definite plans for 
involvement of human subjects are not set forth in the proposal (e.g., 
projects in which human subjects' involvement will depend upon 
completion of instruments, prior animal studies, or purification of 
compounds). Under these conditions, the Contracting Officer may make 
the award without the requisite certification, as long as the 
Contracting Officer includes appropriate conditions in the contract or 
order.

Subpart 370.4--Acquisitions Involving the Use of Laboratory Animals


370.400  Scope of subpart.

    This subpart applies to all R & D, research training, and 
biological testing activities involving live vertebrate animals 
conducted under contract (see Public Health Service Policy on Humane 
Care and Use of Laboratory Animals (PHS Policy), Rev. 1986, Repr. 
1996).


370.401  Policy.

    (a) It is HHS policy that contracting activities shall not award a 
contract involving live vertebrate animals until the contractor has 
given acceptable assurance that the work under the contract will be 
subject to initial and continuing review by an appropriate 
Institutional Animal Care and Use Committee (IACUC) as described in the 
PHS Policy at IV.B.6. and 7. The Contracting Officer shall require an 
applicable Full Animal Welfare Assurance or Inter-institutional 
Agreement/Assurance, approved by the Office of Laboratory Animal 
Welfare (OLAW), NIH, of each contractor, subcontractor, or cooperating 
institution having responsibility for animal care and use involved in 
performance of the contract--see PHS Policy II., IV.A., and V.B.
    (b) The OLAW, NIH, is responsible for negotiating assurances 
covering all HHS/PHS-supported or HHS/PHS-conducted activities 
involving the care and use of live vertebrate animals. OLAW shall 
provide guidance to Contracting Officers regarding adequate animal 
care, and use, approval, disapproval, restriction, or withdrawal of 
approval of assurances--see PHS Policy V.A.


370.402  Assurances.

    (a) Assurances may be one of two following types:
    (1) Full Animal Welfare Assurance (AWA). An AWA describes the 
institution's complete program for the care and use of animals, 
including but not limited to the facilities, occupational health, 
training, veterinary care, IACUC procedures and lines of authority and 
responsibility. An AWA listed in OLAW's list of institutions which have 
an approved full AWA is acceptable for purposes of this policy.
    (2) Inter-institutional Agreement/Assurance (IAA). An IAA describes 
the arrangements between an offeror and usually a subcontractor where 
animal activities will occur. An IAA is limited to the specific award 
or single project.
    (b) The Contracting Officer shall forward copies of proposals 
selected for negotiation and requiring an assurance to the Assurance 
Branch, Office of Laboratory Animal Welfare, NIH MSC 7507, 6100 
Executive Blvd., Room 3B01, Rockville, Maryland 20892, as early as 
possible to secure the necessary assurances.
    (c) A contractor providing animal care services at an assured 
entity, such as a Government-owned, contractor-operated (GOCO) site, 
does not need a separate assurance. GOCO site assurances normally cover 
such contractor services.


370.403  Notice to offerors.

    (a) The Contracting Officer shall insert the provision in 352.270-
5(a), Notice to Offerors of Requirement for Compliance with the Public 
Health Service Policy on Humane Care and Use of Laboratory Animals, in 
solicitations that involve vertebrate animals.
    (b) Offerors having a full AWA on file with OLAW shall submit IACUC 
approval of the use of animals in the manner required by instructions 
for completion of the contract proposal, but prior to the technical 
review of the proposal. The date of IACUC approval must not be more 
than 36 months prior to the deadline for proposal submission.
    (c) It is not necessary for non-assured offerors to submit 
assurances or IACUC approval with proposals. OLAW shall contact 
contractors, subcontractors and

[[Page 62471]]

cooperating institutions to negotiate necessary assurances and verify 
IACUC approvals when requested by the Contracting Officer.


370.404  Contract clause.

    The Contracting Officer shall insert the clause in 352.270-5(b), 
Care of Live Vertebrate Animals, in solicitations, contracts, and 
orders that involve vertebrate animals.

Subpart 370.5--Acquisitions Under the Buy Indian Act


370.500  Scope of subpart.

    This subpart sets forth the policy on preferential acquisition from 
Indians under the negotiation authority of the Buy Indian Act. This 
subpart applies only to acquisitions made by or on behalf of IHS.


370.501  Policy.

    (a) The IHS shall utilize the negotiation authority of the Buy 
Indian Act to give preference to Indians whenever the use of that 
authority is authorized and is practicable. The Buy Indian Act, 25 
U.S.C. 47, prescribes the application of the advertising requirements 
of section 3709 of the Revised Statutes to the acquisition of Indian 
supplies. As specified in 25 U.S.C. 47, the Buy Indian Act provides 
that, so far as may be practicable, Indian labor shall be employed, and 
purchases of the products (including, but not limited to printing, 
notwithstanding any other law) of Indian industry may be made in open 
market in the discretion of the Secretary of the Interior.
    (b) Due to the transfer of authority from the Department of the 
Interior to HHS, the Secretary of HHS is authorized to use the Buy 
Indian Act in the acquisition of products of Indian industry, in 
connection with the maintenance and operation of hospital and health 
facilities for Indians, and for the conservation of the health of 
Indians. This authority has been delegated exclusively to IHS and is 
not available for use by any other HHS component (unless that component 
is making an acquisition on behalf of IHS). However, the Buy Indian Act 
itself does not exempt IHS from meeting the statutorily mandated small 
business goals.
    (c) Subsequent legislation, particularly Public Law 94-437 and 
Public Law 96-537, have emphasized the use of the Buy Indian Act 
negotiation authority.


370.502  Definitions.

    (a) Buy Indian contract means any contract involving activities 
covered by the Buy Indian Act that is negotiated under the provisions 
of 41 U.S.C. 252(c) and 25 U.S.C. 47 between an Indian firm and a 
Contracting Officer representing IHS.
    (b) Indian means a member of any Tribe, pueblo, band, group, 
village or community that is recognized by the Secretary of the 
Interior as being Indian or any individual or group of individuals that 
is recognized by the Secretary of the Interior or the Secretary of HHS. 
The Secretary of HHS in making determinations may take into account the 
determination of the Tribe with which affiliation is claimed.
    (c) Indian firm means a sole enterprise, partnership, corporation, 
or other type of business organization owned, controlled, and operated 
by one or more Indians (including, for the purpose of sections 301 and 
302 of Public Law 94-437, former or currently Federally recognized 
Indian tribes in the State of New York) or by an Indian firm; or a 
nonprofit firm organized for the benefit of Indians and controlled by 
Indians (see 370.503(a)).
    (d) Product of Indian industry means anything produced by Indians 
through either physical labor or intellectual effort involving the use 
and application of their skills.


370.503  Requirements.

    (a) Indian ownership. The degree of Indian ownership of an Indian 
firm shall be at least 51 percent during the period covered by a Buy 
Indian contract.
    (b) Joint ventures. An Indian firm may enter into a joint venture 
with other entities for specific projects as long as the Indian firm is 
the managing partner. However, the Contracting Officer shall approve 
the joint venture prior to the award of a contract under the Buy Indian 
Act.
    (c) Bonds. In the case of contracts for the construction, 
alteration, or repair of public buildings or public works, the Miller 
Act (40 U.S.C. 270a-270f) and FAR part 28 require performance and 
payment bonds. Bonds are not required in the case of contracts with 
Indian tribes or public nonprofit organizations serving as governmental 
instrumentalities of an Indian Tribe. However, bonds are required when 
dealing with private business entities that are owned by an Indian 
Tribe or members of an Indian Tribe. The Contracting Officer may 
require bonds of private business entities that are joint ventures 
with, or subcontractors of, an Indian Tribe or a public nonprofit 
organization serving as a governmental instrumentality of an Indian 
Tribe. A bid guarantee or bid bond is required only when a performance 
or payment bond is required.
    (d) Indian preference in employment, training and subcontracting. 
Contracts awarded under the Buy Indian Act are subject to the 
requirements of section 7(b) of the Indian Self-Determination and 
Education Assistance Act 25 U.S.C. 450e, which requires that preference 
be given to Indians in employment, training, and subcontracting. The 
Contracting Officer shall include the Indian Preference clause 
specified in 352.270-2 in all Buy Indian solicitations and resultant 
contracts. The Contracting Officer shall use the Indian Preference 
Program clause specified in 352.270-3 as prescribed in 370.202(b). The 
Contracting Officer shall follow all requirements specified in subpart 
370.2 which are applicable to a Buy Indian acquisition (e.g., sections 
370.204 and 370.205).
    (e) Subcontracting. A contractor shall not subcontract to other 
than Indian firms more than 50 percent of the work under a prime 
contract awarded pursuant to the Buy Indian Act. For this purpose, work 
to be performed does not include the provision of materials, supplies, 
or equipment.
    (f) Wage rates. The Contracting Officer shall include a 
determination of the minimum wage rates by the Secretary of Labor as 
required by the Davis-Bacon Act (40 U.S.C. 276a) in all contracts 
awarded under the Buy Indian Act for over $2,000 for construction, 
alteration, or repair, including painting and decorating, of public 
buildings and public works, except contracts with Indian tribes or 
public nonprofit organizations serving as governmental 
instrumentalities of an Indian Tribe. The Contracting Officer shall 
include the wage rate determination in contracts with private business 
entities, even if they are owned by an Indian Tribe or a member of an 
Indian Tribe and in connection with joint ventures with, or 
subcontractors of, an Indian Tribe or a public nonprofit organization 
serving as a governmental instrumentality of an Indian Tribe.


370.504  Competition.

    (a) Contracts awarded under the Buy Indian Act are subject to 
competition among Indians or Indian concerns to the maximum extent 
practicable. When the Contracting Officer determines that competition 
is not practicable, a JOFOC is required in accordance with 306.303.
    (b) The Contracting Officer shall: synopsize and publicize 
solicitations in FedBizOpps and provide copies of the synopses to the 
Tribal office of the Indian Tribal government directly concerned with 
the proposed

[[Page 62472]]

acquisition as well as to Indian concerns and others having a 
legitimate interest. The synopses shall state that the acquisitions are 
restricted to Indian firms under the Buy Indian Act.


370.505  Responsibility determinations.

    (a) The Contracting Officer may award a contract under the Buy 
Indian Act only if the Contracting Officer determines that the project 
or function to be contracted is likely to be: satisfactorily performed 
under that contract; and properly completed or maintained under that 
contract.
    (b) The Contracting Officer shall make the determination specified 
in paragraph (a) of this section in writing prior to the award of a 
contract. The determination shall reflect an analysis of the standards 
set forth in FAR 9.104-1.

Subpart 370.6--Conference Funding and Sponsorship


370.600  Policy.

    It is HHS policy that the conferences it funds or sponsors shall: 
be consistent with HHS missions, objectives, and policies; represent an 
efficient and effective use of taxpayer funds; and be able to withstand 
public scrutiny.


370.601  Funding and sponsorship.

    Funding a conference through an HHS contract does not automatically 
imply HHS (OPDIV/STAFFDIV) conference sponsorship, unless the 
conference is funded entirely by HHS. Also, HHS staff attendance or 
participation at a conference does not imply HHS conference 
sponsorship. Accordingly, for other than conference contracts funded 
entirely by HHS, prior to a contractor claiming HHS conference 
sponsorship, the contractor must provide to the Contracting Officer a 
written request for permission to claim HHS as the conference sponsor--
see 370.602. The OPDIV/STAFFDIV head, or designee, shall approve such 
requests.


370.602  Contract clause.

    To ensure that a contractor:
    (a) Properly requests approval to claim HHS as the conference 
sponsor, where HHS is not the sole provider of conference funding; and
    (b) Includes an appropriate Federal funding disclosure and content 
disclaimer statement on conference materials, the Contracting Officer 
shall include the clause in 352.270-7, Conference Sponsorship Request 
and Conference Materials Disclaimer, in solicitations, contracts, and 
orders that provide funding, in whole or in part, to support a 
conference.

Subpart 370.7--Acquisitions Under the Leadership Act


370.700  Scope of subpart.

    This subpart sets forth the acquisition requirements regarding 
implementation of HIV/AIDS programs under the President's Emergency 
Plan for AIDS Relief under the Leadership Act of 2003, and under the 
Tom Lantos and Henry J. Hyde United States Global Leadership Against 
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 
(Emergency Plan reauthorization legislation), which was signed by the 
President on July 30, 2008.


370.701  Contract clause.

    The Contracting Officer shall insert the clause in 352.270-8, 
Prostitution and Related Activities, in solicitations, contracts, and 
orders, and in existing contracts and orders (whenever they are 
modified to extend the period of performance or add funds, including 
any options that may be exercised): in connection with the 
implementation of HIV/AIDS programs under the President's Emergency 
Plan for AIDS Relief; or where the contractor will receive funding 
under the United States Leadership Against HIV/AIDS, Tuberculosis and 
Malaria Act of 2003. (Note: See 370.702 and 352.270-9 for the ``Non-
discrimination for Conscience'' provision that must also be included in 
applicable solicitations.) In resolving any issues/complaints that 
offerors/contractors may raise about meeting the requirements specified 
in the clause, the Contracting Officer shall consult with the Office of 
Global Health Affairs, Office of the General Counsel, the Project 
Officer, and other HHS officials, as appropriate.


370.702  Solicitation provision.

    The Contracting Officer shall insert the provision in 352.270-9, 
Non-discrimination for Conscience, in solicitations valued at more than 
the micro-purchase threshold: in connection with the implementation of 
HIV/AIDS programs under the President's Emergency Plan for AIDS Relief; 
or where the contractor will receive funding under the United States 
Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003. 
(Note: See 370.701 and 352.270-8 for the ``Prostitution and Related 
Activities'' clause that must also be included in applicable 
solicitations, contracts, and orders.) In resolving any issues/
complaints that offerors may raise about meeting the requirements 
specified in the provision, the Contracting Officer shall consult with 
the Office of Global Health Affairs, Office of the General Counsel, the 
Project Officer, and other HHS officials, as appropriate.

    Dated: September 28, 2009.
E.J. Holland, Jr.
Assistant Secretary for Administration and Management, Office of the 
Secretary, U.S. Department of Health and Human Services.
[FR Doc. E9-26948 Filed 11-25-09; 8:45 am]
BILLING CODE 4151-17-P