`[Federal Register Volume 70, Number 1 (Monday, January 3, 2005)]
[Rules and Regulations]
[Pages 38-41]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27697]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

48 CFR Chapter 3


Acquisition Regulation

AGENCY: Department of Health and Human Services (HHS).

ACTION: Direct final rule.

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

SUMMARY: The Department of Health and Human Services is amending its 
acquisition regulation (HHSAR) for the purpose of making administrative 
and editorial changes to reflect organizational title changes resulting 
from Office of the Secretary (OS) and Operating Division (OpDiv) 
reorganizations; updating and removing outdated references; providing 
procedural guidance for reporting violations of the Procurement 
Integrity Act; assigning unique document numbers for contracts and task 
orders, in accordance with an Office of Management and Budget 
Memorandum dated August 6, 2003; adding a new training requirement for 
HHS project officers; adding the terms ``veteran-owned'' and ``service-
disabled veteran-owned'' to describe small business categories 
consistent with the Federal Acquisition Regulation (FAR); permitting a 
total of basic and option periods of up to ten years for all service 
contracts not subject to the Service Contract Act or other statutory 
requirements; adding the Choice of Law (Overseas) clause in 
solicitations and contracts when contract performance will be outside 
the United States, its possessions, and Puerto Rico, except as 
otherwise provided in a government-to-government agreement; removing 
the reference to the Department's General Administration Manual with 
respect to major system acquisitions; deleting unconstitutional and 
unenforceable portions of the Confidentiality of Information clause 
resulting from the outcome of Board of Trustees of Leland Stanford 
Junior Univ. v. Sullivan, and providing current references with respect 
to assurances and regulations governing the protection of human 
subjects. HHS is issuing a direct final rule for this action because 
HHS expects there will be no significant adverse comments on the rule.

DATES: This direct final rule will become effective March 4, 2005, 
unless significant adverse comments are received by February 2, 2005. 
If adverse comment is received, HHS will publish a timely withdrawal of 
the rule in the Federal Register.

ADDRESSES: You may submit comments by either of the following methods: 
E-Mail: hhs.gov">Tracey.Mock@hhs.gov or by mail to: Tracey Mock, DHHS, OS, ASAM, 
Office of Acquisition Management and Policy, 200 Independence Ave., 
SW., Room 324E, Washington, DC 20201. Please state ``48 CFR 3'' on the 
subject line.

[[Page 39]]


FOR FURTHER INFORMATION CONTACT: Tracey Mock, Office of Acquisition 
Management and Policy, telephone (202) 205-4430, e-mail: hhs.gov">Tracey.Mock@hhs.gov.

SUPPLEMENTARY INFORMATION:

A. Background

    The Department emphasizes that it is not making significant 
amendments to the existing HHSAR. The amendments being made to the 
HHSAR concern internal procedural matters which are administrative in 
nature, and will not have a major effect on the general public or on 
contractors or offerors supporting the Department. The majority of the 
amendments concern HHS organizational title changes resulting from 
reorganizations, such as the Health Care Financing Administration 
(HCFA) being renamed the Centers for Medicare & Medicaid Services by 
the Secretary of Health and Human Services in June 2001.

B. Regulatory Flexibility Act

    The Department of Health and Human Service certifies this document 
will not have a significant economic effect on a substantial number of 
small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.) because it does not impose any new requirements. Therefore, no 
regulatory flexibility statement has been prepared. Since this rule 
conveys existing acquisition policies or procedures and does not 
promulgate any new policies or procedures which would impact the 
public, it has been determined that this rule will not have a 
significant economic effect on a substantial number of small entities, 
and, thus, a regulatory flexibility analysis was not performed.

C. Paperwork Reduction Act

    The Paperwork Reduction Act does not apply because the changes to 
the HHSAR do not impose any record keeping or information collection 
requirements that require approval by the Office of Management and 
Budget under 44 U.S.C. 3501, et seq. Existing approvals cited in 48 CFR 
301.106 remain in effect. The provisions of this regulation are issued 
under 5 U.S.C. 301; 40 U.S.C. 486 (c).

List of Subjects in 48 CFR, Parts 302, 303, 304, 306, 307, 317, 
324, 333, and 352

    Government procurement.

Ed Sontag,
Assistant Secretary for Administration and Management.

0
Accordingly, 48 CFR chapter 3, parts 302, 303, 304, 306, 307, 317, 324, 
333, 334, and 352 are amended as follows:
0
1. The authority citation for 48 CFR chapter 3, parts 302, 303, 304, 
306, 307, 317, 324, 333, 334, and 352 continues to read as follows:

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

CHAPTER 3--[AMENDED]

0
2. 48 CFR chapter 3 is amended by--
0
a. Removing ``Assistant Secretary for Management and Budget'' and 
adding ``Assistant Secretary for Administration and Management'' in its 
place each time it appears;
0
b. Removing ``Administration for Children and Families'' each time it 
appears;
0
c. Removing ``Health Care Financing Administration'' and adding 
``Centers for Medicare & Medicaid Services'' in its place each time it 
appears;
0
d. Removing ``Deputy Assistant Secretary for Grants and Acquisition 
Management'' and adding ``Director, Office of Acquisition Management 
and Policy'' in its place each time it appears;
0
e. Removing ``ACF'' each time it appears;
0
f. Removing ``HCFA'' and adding ``CMS'' in its place each time it 
appears;
0
g. Removing ``ASMB'' and adding ``ASAM'' in its place each time it 
appears.
0
h. Removing ``DASGAM'' and adding ``Director, OAMP'' in its place each 
time it appears.
0
i. Removing ``OAM'' and adding ``Division of Acquisition Policy (DAP)'' 
in its place each time it appears.

PART 302--DEFINITIONS OF WORDS AND TERMS


302.101  [Amended]

0
3. Amend section 302.101 in the definition of Head of the Contracting 
Agency (HCA) by removing ``FDA--Director, Policy, Evaluation and 
Support Staff, Office of Facilities, Acquisition and Central Services'' 
and adding ``FDA--Director, Office of Acquisitions & Grant Services'' 
in its place.

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

0
4. Add section 303.104-7 to read as follows:


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

    (a)(1) The contracting officer's determination that a reported 
violation or possible violation of the statutory prohibitions has no 
impact on the impending award or selection of a contractor must be 
submitted through appropriate channels, along with supporting 
documentation, to the Head of Contracting Activity (HCA) for review and 
approval of the determination awarding a contract.
    (2) The contracting officer's determination that a reported 
violation or possible violation of the statutory prohibitions has an 
impact on the pending award or selection of a contractor must be 
referred through channels, along with all related information 
available, to the HCA (if the HCA is an SES) or to another SES official 
designated by the OpDiv. That individual will--
    (i) Refer the matter immediately to the Office of Acquisition 
Management and Policy (OAMP), Assistant Secretary for Administration 
and Management, Office of the Secretary for review, which may consult 
with the Office of General Counsel (OGC) and the Office of Inspector 
General (OIG), as appropriate; and
    (ii) Determine the action to be taken on the procurement in 
accordance with FAR 3.104-7(c) and (d). The HCA shall obtain the 
approval or concurrence of the OAMP before proceeding with the action.
    (b) The individual in paragraph (a)(2) of this section acts as the 
agency head designee with respect to actions taken under the FAR clause 
52.203-10, Price or Fee Adjustment for Illegal or Improper Authority.

PART 304--ADMINISTRATIVE MATTERS

0
5. Revise paragraph (b) of Section 304.7001 to read as follows:


304.7001  Numbering acquisitions.

    (a) * * *
    (b) Numbering system for contracts. All contracts which require 
numbering (paragraphs (a)(1) through (3) of this section) shall be 
assigned a number consisting of the following:
    (1) The three digit identification code of the Department (HHS);
    (2) A one digit alphabetic identification code of the servicing 
agency:

O Office of the Secretary
P Program Support Center
M Centers for Medicare & Medicaid Services
F Food and Drug Administration

[[Page 40]]

D Centers for Disease Control and Prevention
I Indian Health Service
S Substance Abuse and Mental Health Administration
N National Institutes of Health
H Health Resources and Services Administration
A Agency for Health Care Research & Quality

    (3) The three digit numeric identification code assigned by the 
Office of Acquisition Management and Policy (OAMP) to the contracting 
office within the servicing agency;
    (4) A four digit fiscal year designation (e.g. 2005, 2006);
    (5) A five digit alphanumeric tracking number the content of which 
is determined by the contracting office within the servicing agency; 
and
    (6) A one digit code describing the type of contract action:

C New Definitive Contract
P Purchase Using Simplified Acquisition
I Indefinite Delivery Contract (IDIQ)
O Basic Ordering Agreement (BOA)
B Blanket Purchase Agreement (BPA)
F Facilities Contract
U Contracts placed with or through other Government departments, GSA 
contracts, or against mandatory source contracts such as the National 
Industries for the Blind (NIB), the National Industries for the 
Severely Handicapped (NISH), and the Federal Prison Industries (UNICOR)
L Lease Agreement
W Government-wide Acquisition Contract (GWAC)
E Letter Contract
G Federal Supply Schedule
M Micropurchase

    For example, the first contract for NIH, National Cancer Institute, 
for fiscal year 2005 may be numbered HHSN261200500001C.
    (c) Order numbers will be assigned to contracts with orders. The 
order number shall be a seventeen digit number consisting of the 
following:
    (1) The three digit identification code of the Department (HHS);
    (2) A one digit numeric identification code of the servicing 
agency:

O Office of the Secretary
P Program Support Center
M Centers for Medicare & Medicaid Services
F Food and Drug Administration
D Centers for Disease Control and Prevention
I Indian Health Service
S Substance Abuse and Mental Health Administration
N National Institutes of Health
H Health Resources and Services Administration
A Agency for Health Care Research and Quality;

    (3) The three digit numeric identification code assigned by the 
Office of Acquisition Management and Policy (OAMP) to the contracting 
office within the servicing agency;
    (4) A ten digit alphanumeric tracking number the content of which 
is determined by the contracting office within the servicing agency.

PART 306--COMPETITION REQUIREMENTS


306.501  [Amended]

0
6.-8. Amend section 306.501 by:
0
a. Removing ``FDA--Director, Office of Facilities, Acquisition, and 
Central Services'' and adding ``FDA--Chief, Office of Shared Services'' 
in its place;
0
b. By removing ``HCFA--Director, Office of Internal Customer Support'' 
and adding ``CMS--Chief Operating Officer--in its place;
0
c. By removing ``NIH--(R&D) Director, Office of Extramural Research 
(Other than R&D)--Director, Office of Intramural Research'' and adding 
``NIH--Senior Advisor for Policy, Office of Extramural Research (R&D) 
and Senior Advisor to the Deputy Director for Intramural Research 
(Other than R&D)'' in its place.

PART 307--ACQUISITION PLANNING

0
9. Redesignate paragraph (a)(3) as (a)(4) and add new paragraph (a)(3) 
to section 307.170-2 to read as follows:


307.170-2  Training course prerequisites.

    (a) * * *
    (3) Project Officers on HHS projects for which HHS or OMB requires 
an Exhibit 300 [under OMB Circular A-11, part 7] must successfully 
complete either HHS'' ``Early Warning Project Management System 
Workshop'' or an equivalent Earned Value Management course (see 
paragraph 307.170(c)).
* * * * *


307.7105  [Amended]

0
10.-11. In section 307.7105, revise the last sentence of paragraph 
(a)(6) to read as follows:


307.7105  Format and content.

* * * * *
    (a) * * *
    (6) * * * Efforts to identify set-aside possibilities, e.g., 8(a), 
HUBZone, veteran-owned, service-disabled veteran-owned, and small 
business, and efforts to identify sources such as small disadvantaged 
and women-owned small businesses must be documented.
* * * * *

PART 317--SPECIAL CONTRACTING METHODS

0
12. Add new section 317.204 to read as follows:


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 information technology 
contracts. However, statutes applicable to various classes of 
contracts, such as the Service Contract Act, may place additional 
restrictions on the length of contracts.

PART 324--PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

0
13. Redesignate section 324.100 as 324.000 and revise to read as 
follows:


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) (the Act) and 
OMB Circular A-130, Revised, November 30, 2000, to Government contracts 
and cites the Freedom of Information Act (5 U.S.C. 552, as amended).

PART 333--PROTESTS, DISPUTES, AND APPEALS

0
14.-15. Add new section 333.215-70 to read as follows:


333.215-70  Additional contract clause.

    Use the clause at 352.333-7001, Choice of Law (Overseas), in 
solicitations and contracts when contract performance will be outside 
the United States, its possessions, and Puerto Rico, except as 
otherwise provided for in a government-to-government agreement.

PART 334--MAJOR SYSTEM ACQUISITION

0
16. Amend section 334.003 by removing ``The Department's implementation 
of OMB Circular No. A-109 may be found in chapter 1-150 of the General 
Administration Manual'' and adding ``The Department's implementation of 
major system acquisitions should be conducted in accordance with OMB 
Circular A-109, Major System Acquisitions'' in its place.

[[Page 41]]

PART 352--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

Subpart 352.2--Texts of Provisions and Clauses


352.224-70  [Amended]

0
17. In section 352.224-70, remove paragraphs (b) and (f) and 
redesignate paragraph (c) as (b), paragraph (d) as (c), paragraph (e) 
as (d), paragraph (g) as (e), paragraph (h) as (f), and paragraph (i) 
as (g).


352.270-8  [Amended]

0
18.-20. Amend section 352.270-8 in paragraph (a) by removing ``Office 
for Protection from Research Risks (OPRR), National Institutes of 
Health,'' and adding ``Office for Human Research Protections (OHRP)'' 
in its place; amend the last sentence of paragraph (d) in section 
352.270-8 by removing ``National Institutes of Health'' and replacing 
with ``OpDiv''; and remove the last sentence of paragraph (e) in 
section 352.270-8 and add ``The contracting officer will direct the 
offeror/contractor to the OHRP IRB Registration and Assurance Filing 
website, found at http://www.hhs.gov/ohrp/ or to the physical address 
if the offeror/contractor cannot access the Internet. HHS regulations 
for the protection of human subjects may be found at: http://
www.access.gpo.gov/nara/cfr/waisidx--01/45cfr46--01.html'' in its 
place.


352.270-9  [Amended]

0
21.-22. Amend section 352.270-9 by removing the heading in paragraph 
(a) reading ``Notice to Offerors of Requirement for Adequate Assurance 
of Protection of Vertebrate Animal Subjects (Sep. 1985)'' and adding 
``Notice to Offerors of Requirement for Compliance with the Public 
Health Service Policy on Humane Care and Use of Laboratory Animals 
(Revised 1986, Reprinted 2000)'' in its place; and amend section 
352.270-9 by removing in the undesignated paragraph under the heading 
``Office for Protection from Research Risks (OPRR),'' and adding 
``Office of Laboratory Animal Welfare (OLAW)'' in its place.

0
23. Add new section 352.333-7001, to read as follows:


352.333-7001  Choice of Law (Overseas).

    As prescribed in 333.215-70, use the following clause:

Choice of Law (Overseas)

    This contract shall be construed and interpreted 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 United States Armed Services 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.

[FR Doc. 04-27697 Filed 12-30-04; 8:45 am]
BILLING CODE 4151-17-P`