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SUBCHAPTER A-GENERAL

PART 301-HHS ACQUISITION Sec.

301.670–2 Designation. REGULATION SYSTEM

301.670–3 Redelegation. Subpart 301.1-Purpose, Authority,

Subpart 301.7-Determinations and Issuance

Findings Sec.

301.703 Class determinations and findings. 301.101 Purpose.

301.704 Content. 301.102 Authority. 301.103 Applicability.

AUTHORITY: 5 U.S.C. 301; 40 U.S.C. 486(c). 301.104 Issuance. 301.104-1 Publication and code arrangement.

SOURCE: 49 FR 13961, Apr. 9, 1984, unless 301.104–2 Arrangement of regulations.

otherwise noted. 301.104-3 Copies. 301.105 OMB approval under the Paperwork Subpart 301.1-Purpose, Authority, Reduction Act.

Issuance
Subpart 301.2-Administration

301.101 Purpose.
301.201 Maintenance of the HHSAR.
301.270 Executive Committee for Acquisi-

(a) The Department of Health and tion.

Human Services Acquisition Regula301.271 Timing of HHSAR revisions.

tion (HHSAR) is issued to establish

uniform acquisition policies and proceSubpart 301.3–Agency Acquisition

dures for the Department of Health and Regulations

Human Services (HHS) which conform 301.301 Policy.

to the Federal Acquisition Regulation 301.302 Limitations.

(FAR) System. 301.303 Publication and codification.

(b) The HHSAR implements and sup301.304 Agency control and compliance pro

plements the FAR. (Implementing macedures.

terial expands upon or indicates the Subpart 301.4-Deviations From the FAR manner of compliance with related

FAR material. Supplementing material 301.403 Individual deviations.

is new material which has no counter301.404 Class deviations.

part in the FAR.) 301.470 Procedure.

(c) The HHSAR contains all formal Subpart 301.5-Agency and Public departmental policies and procedures Participation

that govern the acquisition process or

otherwise control contracting relation301.501 Solicitation of agency and public

ships between the Department's conviews. 301.501–2 Opportunity for public comments.

tracting offices and contractors. 301.501-3 Exceptions. 301.503 Public meetings.

301.102 Authority.

The HHSAR is prescribed by the AsSubpart 301.6-Contracting Authority and

sistant Secretary for Management and Responsibility

Budget under the authority of 5 U.S.C. 301.6023 Ratification of unauthorized com- 301 and Section 205(c) of the Federal mitments.

Property and Administrative Services 301.603 Selection, appointment, and termi

Act of 1949, as amended (40 U.S.C. nation of appointment. 301.603-1 General.

486(c)), as delegated by the Secretary. 301.6032 Selection.

The Assistant Secretary for Manage301.603 3 Appointment.

ment and Budget has redelegated the 301.6034 Termination.

authority to establish all departmental 301.603–70 Delegation of contracting officer

acquisition policy and publish all acresponsibilities.

quisition regulations to the Deputy As301.670 Head of the contracting activity. 301.670-1 Responsibility.

sistant Secretary for Management and

Acquisition. This authority is not redelegable. (49 FR 13961, Apr. 9, 1984, as amended at 54 FR 24342, June 7, 1989)

301.103 Applicability.

The FAR and HHSAR apply to all HHS acquisitions as stated in FAR 1.103. Unless specified otherwise, these regulations apply to acquisitions within and outside the United States.

numbers will always be two digits for agencies implementing the FAR). The remaining numbers are identical to and represent the same divisions as the FAR example.

(c) References and citations. (1) Unless otherwise stated, references, indicate parts, subparts, sections, subsections, etc, of this regulation, the HHSAR.

(2) This regulation shall be referred to as the Department of Health and Human Services Acquisition Regulation (HHSAR). Any reference may be cited as “HHSAR” followed by the ap propriate number. Within the HHSAR, the number alone will be used.

(3) Citations of authority shall be incorporated where necessary. All FAR reference numbers shall be preceded by FAR”.

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301.1043 Copies.

Copies of the HHSAR in FEDERAL REGISTER and CFR form may be purchased by the public from the Superintendent of Documents, Government Printing Office (GPO), Washington, DC 20402. Lose-leaf copies of the HHSAR may be obtained by departmental personnel having a need for the document by placing an order with a Directives Distribution Coordinator in accordance with General Administration Manual Chapter 1-00, HHS Staff Manual System.

same

or

301.105 OMB approval under the Pa

perwork Reduction Act. The following OMB control numbers apply to the information collection and recordkeeping requirements contained in this regulation:

cor

301.104–2 Arrangement of regulations.

(a) General. The HHSAR conforms to the FAR with respect to divisional arrangements; i.e., subchapters, parts, subparts, sections, subsections, and paragraphs.

(b) Numbering. The FAR System of numbering permits the keying of the

similar subject matter throughout Chapters 1 (FAR) and 3 (HHSAR). However, unlike the FAR numbering scheme, our scheme varies somewhat in the numbering to the left of the decimal point. Whereas the FAR only identifies the part number to the left of the decimal point, our responding reference identifies the chapter as well. For example, this corresponding paragraph in the FAR is numbered 1.104–2(b) where “1” is the part number (may be one or two digits and is followed by a decimal point), "1" (to the right of the decimal point) is the subpart number, “04" (always two digits) is the section number, “2” is the subsection number (always hyphenated), and “(b)” is the paragraph reference. The corresponding HHSAR reference is 301.104–2(b) where the “3” or first digit is the chapter number assigned to the particular department or agency (may be two digits) and the “01” represents the part number (part

HHSAR segment

OMB control

no.

315.4
324.70
332.406
342.7103
352.215-71
352.216-70
352.224-70
352.228–70
352.232-71
352.232-73
352.233–70
352.270–1
352.270-2
352.2703
352.270-5
370.1
370.2

0990-0139
0990-0136
0990-0134
0990-0131
0990_0139
0990-0138
0990_0136
0990-0135
0990-0134
0990-0134
0990-0133
0990-0129
0990_0129
0990-0129
0990-0130
0990-0129
0990_0129

The OMB control number"OMB No. 0990-0115" is to be included in the upper right corner of the first page of all solicitations, purchase orders, and contracts issued by departmental contracting activities. The number represents approval of the HHS acquisition process and covers recordkeeping and reporting requirements which are unique to individual acquisitions (e.g., requirements contained in specifications, statements of work, etc.). [49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 51 FR 44293, Dec. 9, 1986; 53 FR 15562, May 2, 1988)

Subpart 301.2-Administration

Human Development Services, Health Care Financing Administration, Social Security Administration, Public Health Service, and, collectively, the regional offices. The ECA is chaired by the Director, Office of Acquisition and Grants Management. All meetings will be held at the call of the Chairman, and all activities will be carried out under the direction of the Chairman.

(c) The ECA, to facilitate the planning, development, and coordination of government-wide and department-wide acquisition policies and procedures, is to:

(1) Advise and assist the Chairman concerning major acquisition policy matters;

(2) Review and appraise, at appropriate intervals, the overall effectiveness of existing policies and procedures; and

(3) Review and appraise the impact of new major acquisition policies, procedures, regulations, and developments on current acquisition policies and procedures.

(d) The Chairman will periodically issue a list of current members and alternates specifying the name, title, organization, address, and telephone number of each. The member organizations are responsible for apprising the Chairman whenever a new member or alternate is to be appointed to the ECA.

or

301.201 Maintenance of the HHSAR.

(a) The HHSAR is prepared and issued under the authority of the Deputy Assistant Secretary for Management and Acquisition. Acquisition policies and procedures which are necessary to implement, supplement, deviate from the FAR will be issued in the HHSAR by the Deputy Assistant Secretary for Management and Acquisition when necessary to accomplish Department-wide acquisition objectives.

(b) The HHSAR is maintained by the Office of Acquisition and Grants Management. The Director, Office of Acquisition and Grants Management is responsible for developing and preparing for issuance all acquisition regulatory material to be included in the HHSAR. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 54 FR 24342, June 7, 1989) 301.270 Executive Committee for Ac

quisition. (a) The Deputy Assistant Secretary for Management and Acquisition has established the Executive Committee for Acquisition (ECA) to assist and facilitate the planning and development of departmental acquisition policies and procedures and to assist in responding to other agencies and organizations concerning policies and procedures impacting the Federal acquisition process.

(b) The ECA consists of members and alternates from the Office of Acquisition and Grants Management, Division of Contract Operations-OS, Office of

[49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 54 FR 24342, June 7, 1989)

301.271 Timing of HHSAR revisions.

HHSAR revisions will be issued throughout the year as the need arises. HHSAR material shall become effective on the date cited in the FEDERAL REGISTER issuance or on the date of the transmittal notice which distributes it to HHSAR Staff Manual holders, unless otherwise indicated.

Subpart 301.3-Agency Acquisition Regulations

301.301 Policy.

(a)(1) The FAR and HHSAR are intended to provide all necessary regulatory guidance for the conduct of the acquisition process within the Department. However, there may be some rare instances where regulations are necessary to implement and/or supplement the FAR and/or HHSAR at the Operating Division (OPDIV) level or lower. The Department discourages the proliferation of OPDIV and lower level issuances, but will allow lower level issuances when deemed pertinent. [49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985)

301.302 Limitations.

The same limitations applicable to the FAR also apply to the HHSAR. 301.303 Publication and codification.

(a) The HHSAR shall be codified in Chapter 3 of Title 48, Code of Federal Regulations. Any OPDIV or lower implementation or supplementation of the HHSAR or FAR shall also be codified as part of Chapter 3. Implementing material is that which expands upon or indicates the manner of compliance with related higher level material. Supplementing material is that for which there is no counterpart. Where material in the FAR requires no implementation, there will be no corresponding number in the HHSAR. Thus, there are gaps in the HHSAR sequence of numbers where the FAR, as written, is deemed adequate. Supplementary material shall be numbered as specified in FAR 1.303. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985)

the request for incorporation into the organization's acquisition regulation. If the request is approved, the organization must prepare the proposed regulation in FEDERAL REGISTER format, obtain all necessary concurrences, including Office of General CounselBusiness and Administrative Law Division, and send it to the Director, Office of Acquisition and Grants Management for review and approval. The regulation must be prepared for signature by the Deputy Assistant Secretary for Management and Acquisition. All regulations will be required to be processed through the public rulemaking process in the FEDERAL REGISTER.

(b) Only the organizations listed in paragraph (d) are authorized to established acquisition regulations. As of the date of issuance of the HHSAR, no acquisition regulations below the HHSAR level exist, and the procedures detailed in paragraph (a) must be followed to initiate the establishment of an OPDIV or lower level regulation.

(c) Under no circumstances shall any organization's implementation supplementation of the FAR or HHSAR conflict with, supersede, or repeat, paraphrase, or otherwise restate policies or procedures prescribed by these regulatory issuances. OPDIV or lower level material shall follow the numbering system, format, and arrangement of the FAR and HHSAR and will be applicable only within the organization issuing it. One copy of all OPDIV or lower level material issued in looseleaf format shall be furnished the Director, Office of Acquisition and Grants Management at the times of issuance.

(d) Material issued by OPDIV or lower level organizations to implement and supplement the HHSAR and FAR shall be identified by prefixes to the digit 3 (indicating Chapter 3-HHSAR) as follows, and shall use the same numbering system as the HHSAR:

or

301.304 Agency control and compli

ance procedures. (a) Whenever an OPDIV or lower level organization determines a need for an acquisition regulation not covered by the FAR or HHSAR or wishes to implement or supplement the coverage in either, the organization shall prepare a memorandum that explains the need, background, justification, and significant aspects of the proposed regulation and send it, together with an outline, to the Director, Office of Acquisition and Grants Management. The Director will analyze the request to determine if it has applicability to the HHSAR or FAR; if not, the Director will either approve or disapprove

Organization

Prefix

Office of the Secretary

OS Health Care Financing Administration

HCFA Office of Human Development Services OHDS Public Health Service

PHS
Alcohol, Drug Abuse, and Mental Health ADAMHA

Administration,
Centers for Disease Control

CDC
Food and Drug Administration

FDA
Health Resources and Services Adminis- HRSA

tration,

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Each OPDIV or lower level acquisition regulation will be included in its entirety as a separate appendix to 48 CFR Chapter 3. The Director, Office of Acquisition and Grants Management will assign the appendix designation upon approval of the initial request to establish the OPDIV or lower level acquisition regulation. (49 FR 13961, Apr. 9, 1984, as amended at 49 FR 36110, Sept. 14, 1984; 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 53 FR 43206, Oct. 26, 1988, 54 FR 24342, June 7, 1989)

quired to confirm the request in writing as soon as possible.

(b) A deviation request shall clearly and precisely set forth the:

(1) Nature of the needed deviation;

(2) Identification of the FAR or HHSAR from which the deviation is needed;

(3) Circumstances under which the deviation would be used;

(4) Intended effect of the deviation; (5) Time-frame; and

(6) Reasons which will contribute to complete understanding and support of the requested deviation. A copy of pertinent background papers such as form or contractor's request should accompany the deviation request. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 54 FR 24342, June 7, 1989)

a

Subpart 301.4-Deviations From

the FAR

Subpart 301.5-Agency and

Public Participation

301.403 Individual deviations.

Requests for individual deviations to either the FAR or HHSAR shall be prepared in accordance with 301.470 and forwarded through administrative channels to the Director, Office of Acquisition and Grants Management for review and approval. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 54 FR 24342, June 7, 1989)

301.501 Solicitation of agency and

public views. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985)

301.404 Class deviations.

Requests for class deviations to either the FAR or HHSAR shall be prepared in accordance with 301.470 and forwarded through administrative channels to the Deputy Assistant Secretary for Management and Acquisition for review and approval. (49 FR 13961, Apr. 9, 1984, as amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985; 54 FR 24342, June 7, 1989)

301.501-2 Opportunity for public com

ments. (b) Public opportunity for comment on proposed changes or additions to the HHSAR or lower level acquisition regulations will be offered whenever the proposed regulation will have an impact on the public and/or contractors. This will be accomplished by publishing a notice of proposed rulemaking in the FEDERAL REGISTER which will include the proposed language and the background and rationale for the proposed regulation. Comments will not be solicited directly from professional or industry associations or other interested parties; they will be expected to respond based upon the FEDERAL REGISTER notification. Normally, the public will be given 45 days to comment. Proposed changes or additions to the HHSAR or FAR shall be staffed to the Executive Committee for Acquisition in accordance with 301.270. (49 FR 13961, Apr. 9, 1984. Redesignated and amended at 50 FR 23126, May 31, 1985; 50 FR 38004, Sept. 19, 1985)

301.470 Procedure.

(a) When a contracting activity or contracting office determines that a deviation is needed, it shall prepare a deviation request in memorandum form and forward it through administrative channels to the official designated as stated in 301.403 or 301.404. In an exigency situation, the contracting activity or contracting office may request a deviation verbally, but is re

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