Government Contracting - FAR Supplements - HHS - Health and Human Services

FAR SUPPLEMENTS
------------------------
COMPLIMENTARY
WEBINAR SERIES
2022

FAR SUPPLEMENTS - COMPLIMENTARY WEBINAR SERIES – 2022
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❖ Market Analysis to Proposal Writing & Contract Administration
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202-365-0598

About The FAR SUPPLEMENTS Webinar Series - 2022
❖ Complimentary
❖ Recorded (YouTube & JS Website)
❖ Wednesdays 12pm eastern
❖ Federal Acquisition Regulations covering Department procurement rules
❖ Speakers are SME and Govt Contracts Attorneys
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WEBINAR WEDNESDAY - Schedule At A Glance
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1/12/22 – FAR
1/19/22 – FAR CAS
1/26/22 – DOD
2/2/22 – DPGI
2/9/22 – ARMY
2/16/22 – AIR FORCE
2/23/22 – DISA
3/2/22 – DLA
3/9/22 – USMC
3/16/22 - SPECIAL OPS
3/23/22 -TRANS COMMAND
3/30/22 – AGRICULTURE
4/6/22 – AIDAR
4/13/22 – DOC
4/20/22 – DOE
4/27/22 – DOI
5/4/22 – DOL
5/11/22 – DOS
5/18/22 – DOT (Treasury)
5/25/22 – DOEd
6/1/22 – EPA
6/8/22 – FEHB
6/15/22 – GSA
6/22/22 – HHS
6/29/22 – DHS
7/6/22 – HUD
7/13/22 – BBG
7/20/22 – DOJ
7/27/22 – OPM
8/3/22 – NASA
8/10/22 – NRC
8/17/22 – DOT (Transportation)
8/24/22 – VA

FRIDAY PLAYBOOKS - Schedule At A Glance
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1/12/22 – N/A
1/19/22 – N/A
1/28/22 – DOD
2/2/22 – N/A
2/11/22 – ARMY
2/18/22 – AIR FORCE
2/25/22 – DISA
3/4/22 – DLA
3/11/22 – USMC-NAVY
3/18/22 - SPECIAL OPS
3/25/22 -TRANS COMMAND
4/1/22 – AGRICULTURE
4/8/22 – AIDAR
4/15/22 – DOC
4/22/22 – DOE
4/29/22 – DOI
5/6/22 – DOL
5/13/22 – DOS
5/20/22 – DOT (Treasury)
5/27/22 – DOEd
6/3/22 – EPA
6/10/22 – FEHB
6/17/22 – GSA
6/24/22 – HHS
7/1/22 – DHS
7/8/22 – HUD
7/15/22 – BBG
7/22/22 – DOJ
7/29/22 – OPM
8/5/22 – NASA
8/12/22 – NRC
8/19/22 – DOT (Transportation)
8/26/22 – VA

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2022 – FAR SUPPLEMENT – HHSAR
HEALTH AND HUMAN SERVICES
Date: Wednesday, June 22, 2022
202-365-0598

DEPARTMENT OF HEALTH AND HUMAN SERVICES
202-365-0598

SPEAKER
INSERT YOUR
LOGO HERE
2022 – FAR SUPPLEMENT – HHSAR – HEALTH & HUMAN SERVICES
202-365-0598
SPEAKER
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HERE
MEET OUR SPEAKER
Janae Aune
Stinson LLP
janae.aune@stinson.com
(612) 335-1745

U.S. Department of Health and Human Services (HHS)
• Agencies within HHS (to name a few):
• Office for Civil Rights
• National Institutes of Health
• Health Resources and Services Administration
• Centers for Medicare and Medicaid Services
• Center for Disease Control and Prevention
• Agency for Toxic Substances and Disease Registry
• Substance Abuse and Mental Health Services Administration
The HHS Acquisition Regulation (HHSAR) is found in 48 CFR part 3
• Last amended to be current with FAR requirements effective December 18, 2015
• HHSAR establishes policies and procedures “that implement and supplement the FAR”
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HHSAR 302.101 Definitions to Note
• Head of the Contracting Activity (“HCA”) – an official having overall responsibility for managing a contracting
activity.
• Can be Operations Division (“OPDIV”) or Staff Division (“STAFFDIV”) or another HHS organization which has
been delegated broad authority regarding the conduct of acquisitions functions.
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HHSAR 303 – Improper Business Practices and Personal Conflicts of Interest
• Conflicts of interest are of great importance in HHS contracts because HHS deals with Research and Development
(R&D), including human and animal subject research, so often
• Elements giving rise to conflict of interest problems include, but are not limited to: impaired objectivity and significant
financial interests at odds or in conflict with contract
• Additional conflict of interest rules, specifically focusing on financial interests, for human subject research
• Guidance from HHS suggests considering the following (non-exhaustive):
• Establish independence of the institutional responsibility for research from the management responsibility
• Establish conflict of interest committees, policies, and procedures to monitor
• Utilize independent organizations to hold or administer institution’s financial interests
• Link to full HHS Guidance for Financial Conflicts of Interest in Human Subject Research
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HHSAR 303.101 – Standards of Conduct
303.104-7 – Violations or Possible Violations of the Procurement Integrity Act (“PIA”):
• CO to submit to HCA the determination and supporting documentation that a reported violation or possible violation of the
PIA has no impact on the pending award or selection of a contractor for award
• If CO has determination that reported violation or possible violation does have an impact on pending award or selection of
contract, CO should refer that HCA and HCA shall
• Refer matter to Associate Deputy Assistance Secretary – Acquisition for review AND
• Determine the necessary action in accordance with FAR.3.104-7(c) and (d)
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HHSAR 304.72 Administrative Matters – Affordable Care Act Prevention and Public Health Fund (“PPHR”) Reporting
Requirements
• 304.7200 Reporting Requirement: semi-annual reporting on use of funds from PPHF including, but not limited to: (a) dollar
amount of contract invoices; (b) supplies delivered and services performed; and (c) other information identified in 352.204-70.
• Applies to: all contracts, grants, etc. receiving PPHF funds
• More information required for those contracts with value of $25,000 or more
• CO shall structure contract awards to allow for separately tracking PPHS funds (awarding dedicated separate contracts
or establishing contract line item for PPHF items)
• Contractor has 30 days from end of reporting period to submit responses
• Failure to submit will allow CO to exercise contractual remedies and become part of contractor’s performance
information
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HHSAR 305.70 – Affordable Care Act Prevention and Public Health Fund (“PPHR”) Publication Requirements
305.7003 and 3.05.7004– Publicizing Contract Actions for PPHF Awards:
• Pre-award: must be posted within one day of issuance of the solicitation or other proposal or quotation document
• Post-award: notice of contract actions exceeding $25,000, funded in whole or in part by PPHF, must be posted on HHS’ PPHF
website within 5 days after contract action occurs
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HHSAR 307.71 – Acquisition Plan
• 307.7101 Policy: Acquisition Plan (AP) required for all acquisitions expected to exceed $500,000 (including options),
with the exceptions, including, but not limited to: (1) letter contract; (2) unsolicited proposals; (3) regulated utility
services available from only one source; and (4) proposals under the Small Business Innovative Research (SBIR) and
Small Business Technology Transfer (STTR) Programs
• HHS has a template for the AP on their website, but at minimum, an AP must consist of the following seven
parts:
• Transmittal and Approval Form
• Summary Sheet
• Project Considerations and Information
• Clearance/Approval Checklist
• Acquisition Milestone Schedule
• Independent Government Cost Estimate
• Attachments
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HHSAR 315.208 – Contracting by Negotiation – Submission, Modification, Revision, and Withdrawal of Proposals
• This is an authorized FAR deviation
• If HCA determines that biomedical or behavioral research and development (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, the provisions at 352.215-70, Late Proposals and Revisions
• “…the Government may consider a proposal received after the date specified for receipt if it appears to offer
significant cost or technical advantage 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.”
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HHSAR 315 – Contracting by Negotiation – Unsolicited Proposals
• 315.605 – Content of Unsolicited Proposals: Must include the following specific warranty in that proposal and have
the warranty signed by the responsible management official of the proposing organization:
“This is to warrant 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;
(c) Any contact with 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.”
• 315.606-1 Consideration of Unsolicited Proposals: HCA may consider an unsolicited proposal even though an
organization initially submitted it as a grant application.
• However, HCA shall not award contracts based on unsolicited proposals that have been rejected for grant
awards due to lack of scientific merit.
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HHSAR 317 – Special Contract Methods
• 317.107 Options – When included as part of a multi-year contract, use of options shall not extend the performance of
the original requirement beyond 5 years.
• Options may serve as a means to acquire related services (severable or non-severable) and, upon their exercise,
shall receive funding from the then-current fiscal year’s appropriation
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HHSAR 324 – Protection of Privacy and Freedom of Information
• 324.7001 – HHS is a “covered entity” that is a “hybrid entity” under HIPAA
• As such, only the portions of HHS that the Secretary has designated as “health care components” are subject to
HIPAA
• HCCs may utilize persons or entities known as “business associates” which can be a contractor, third-party
vendor, or other entity when those other others;
• (a) Create, receive, maintain, or transmit protected health information on behalf of an HHS HCC to carry
out HHS HIPAA “covered functions” OR
• (b) provide certain services to an HHS HCC that involve protected health information
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HHSAR 333 – Protests, Disputes, and Appeals
• 333.102 – Generally
• Office of General Counsel – Law Division is liaison for protests lodged with GAO and is designated office
responsible for all agency protests within HHS
• Civilian Board of Contract Appeals (CBCA) is the authorized Board to hear non-protest, contractual disputes
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HHSAR 334.201 – Major System Acquisition – Earned Value Management System
• Cost or Incentive Contracts Value at $50 million
• Earned value management system will be determined by the cognizant Federal agency to be in compliance with
the guidelines in ANSI/EIA-748
• Cost or Incentive Contracts Value at $20-50 million
• Earned value management system must comply with the guidelines in the ANSI/EIA-748
• Cost or Incentive Contracts Value at under $20 million
• Earned value management is option at the discretion of the program/project manager and is a risk-based decision
that must be supported and the decision to apply an earned value management documented in the contract file
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HHSAR 370 – Special Programs Affecting Acquisition – Research Activities Conducted Under Contracts Involving Human
Subjects
• 370.301 – CO requires a federal-wide assurance (“FWA”) approved by the HHS Office for Human Research
Protections (OHRP) of each contractor, subcontractor, or institution engaged in human subject research in
performance of a contract
• 307.302 – FWA
• Usually, contractor/subcontractor/institution must provide approval of an FWA before the contract is awarded
• If a contractor/sub/institution does not have an approved FWA, it must submit an explanation with its proposal
and an FWA application prior to submitting a proposal
• CO can award on a case by case basis
202-365-0598

SPEAKER
INSERT YOUR
LOGO HERE
202-365-0598
SPEAKER
IMAGE
HERE
THANK YOU TO OUR SPEAKER
Janae Aune
Stinson LLP
janae.aune@stinson.com
(612) 335-1745

THANK YOU FOR ATTENDING!
FAR SUPPLEMENTS
FEDERAL ACQUISITION
REGULATIONS
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