will be effective on the date of the transmittal notice by which distributed unless otherwise indicated in the respective transmittal notice. (c) All HEWPR material deemed necessary for the general public to understand basic and significant HEW procurement policies and procedures will be published in the FEDERAL REGISTER and codified as Chapter 3 of Title 41, Code of Federal Regulations. The FEDERAL REGISTER and Title 41 of the Code of Federal Regulations may be purchased from the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402. [36 FR 22980, Dec. 2, 1971, as amended at 38 FR 4667, Feb. 20, 1973] § 3-1.107 Arrangement. § 3-1.107-1 General plan. (a) The HEWPR conform with the Federal Procurement Regulations System with respect to divisional arrangements into parts, subparts, sections, subsections, and further subdivisions as necessary. (b) As the FPR System pertains to the Department, it consists of (1) regulations published by the Administrator of General Services in Chapter 1-Federal Procurement Regulations, and (2) complementary Departmental regulations published in Chapter 3. In keeping with the DHEW Staff Manual System, such regulations will be published as integral parts of the HEW Procurement Regulations. (a) The FPR System of numbering permits the keying of similar subject matter throughout Chapters 1 and 3. Each section number is a combination showing to the left of the decimal point the chapter and part numbers, separated by a dash. To the right of the decimal point the subpart, section, and subsection numbers are indicated in that order. Thus, the Department, to complement the cost-plus-a-fixed-fee contract provisions contained in Chapter 1, Part 1-3, Subpart 1-3.4, Section 04, Subsection 3 of the Federal Procurement Regulations (§ 1-3.404-3), would assign the section number "3-3.404-3" to the complementary provisions. (b) The first 49 parts of Chapter 3 are reserved for regulations implementing Chapter 1. Part 50 and succeeding parts are reserved for Departmental and agency regulations that are not included in Chapter 1 or elsewhere in Chapter 3. (c) Where material in the FPR requires no implementation or deviation, there is no corresponding number in the HEWPR. Thus, there are gaps in the HEWPR sequence of numbers where the FPR, as written, are applicable to HEW procurement. § 3-1.107-3 Citation. The HEWPR will be cited in the same manner as the FPR are cited. Thus, this section, in referring to divisions of the FPR system, should be cited 8.5 "§ 3-1.107-3 of Chapter 3." When the official Code of Federal Regulations citation is used, this section should be cited as "41 CFR 3-1.107-3." Any section of the HEWPR may be identified informally, for purposes of brevity, as "HEWPR" followed by the section number, such as "HEWPR 3-1.107-3." § 3-1.108 Implementation. (a) Procurement policies and procedures which are necessary to implement, supplement, or deviate from the FPR will be issued in the HEWPR by the Director of Procurement and Materiel Management, OS-OASAM, when necessary to accomplish Departmentwide ment objectives. procure (b) Policies and procedures which are necessary to implement and supplement the FPR and the HEWPR at the operating agency level will be issued by the heads of procuring activity (see § 3-75.101) or their designees. § 3-1.109 Deviation. § 3-1.109-1 Description. As used in the HEWPR, the term "deviation" pertains to actions set forth in § 1-1.009-1 of this title. § 3-1.109-2 Procedure. In the interest of establishing and maintaining uniformity to the greatest extent feasible, deviations from either the FPR or HEWPR shall be kept to a minimum and controlled as follows: (a) When a change is considered necessary to a prescribed contract clause, request for approval shall be submitted in the manner set forth in § 3-16.5003. (b) With the exception of paragraph (a) of this section, the head of each procuring activity or the official he has designated to act for him in authorizing a deviation from procurement regulations shall authorize a deviation from the FPR or HEWPR only after he obtains approval resulting from the submission of a request to the Director of Procurement and Materiel Management, OASAM, prepared in accordance with paragraphs (c) and (d) of this section. (c) When an agency or staff office determines that a deviation is needed, it shall normally request the deviation in writing as far as possible in advance of need. In an exigency, an agency or staff office may request a deviation verbally, to be confirmed in writing as soon as circumstances permit. (d) A deviation request shall set forth clearly and precisely: (1) Nature of the needed deviation; (2) Identification of the FPR or HEWPR 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. Copies of pertinent background papers such as forms, or contractor's request, should accompany the deviation request. (e) Where deviations from the FPR in classes of cases are considered necessary, requests for authority to deviate shall be submitted through administrative channels to the Director of Procurement and Materiel Management, OASAM, who will consider the submission jointly with the General Services Administration (GSA). Where compelling circumstances preclude the obtaining of prior concurrence of GSA, the Director of Procurement and Materiel Management, OASAM, may authorize a deviation and shall inform GSA of the deviation including the circumstances under which it was required. § 3-1.150 Revision. When an operating agency deems it essential that a regulation set forth in HEWPR be changed in the interest of program effectiveness, a proposed revision of the regulation may be submitted to the Director of Procurement and Materiel Management, OASAM, for review and consideration. A detailed statement of justification shall be attached to each proposed revision submitted for review. Subpart 3-1.3-General Policies § 3-1.302 Procurement sources. [36 F.R. 22981, Dec. 2, 1971] 7 [36 F.R. 22981, Dec. 2, 1971] § 3-1.313 Records of contract actions. § 3-1.313-50 General. (a) All procuring activities within HEW shall maintain an official contract file for each contract issued. Files for small purchase transactions shall be established and maintained in accordance with Subparts 1-3.6 and 3-3.6. (b) Operating agencies shall ensure that each contract file constitutes an independent record, documented to provide a complete chronology of all actions related to the contracting aspects of a procurement. Each contract file shall contain documents or other data sufficient to explain and support the rationale, judgments, and authorities upon which all decisions and actions were predicated. 134 F.R. 5159, Mar. 13, 1969. Redesignated, 36 F.R. 22981, Dec. 2, 1971] § 3-1.318 Contracting officer's decision under a disputes clause. A copy of each contracting officer's decision shall be furnished to the contractor by certified mail, return receipt requested, or in person, obtaining a receipt therefor. 137 FR 12797, June 29, 1972] § 3-1.318-50 Decision preparation, processing, and modification or withdrawal. (a) Where a dispute arises under a contract, the contracting officer will prepare a final decision pursuant to the Disputes Clause of the contract. This single document in the format set forth in paragraph (b) of this section should contain a simple and concise statement of: (1) The claim, (2) the decision, (3) the findings of fact which support the decision, and (4) the reference to the Disputes Clause. (b) The following format is suggested for use by contracting officers in prepar ing decisions under the disputes clause, if the contractor's claim is disallowed: (Date of findings and decision) Subject: Decision disallowing request of (Name of contractor) Under contract No. Date To: (Name and address of contractor) 1. In accordance with the provisions of the above-numbered contract, I have considered your request for (insert factual description of the request to identify clearly its nature and scope). 2. Your request as set forth above is disallowed (in whole or in part, according to the fact) for the following reasons: (Insert the findings of fact upon which the disallowance or allowance is based.) 3. The disputes "Clause" of the contract provides that within 30 days from the date of receipt hereof the contractor may appeal from this decision by mailing or otherwise furnishing to the contracting officer a written appeal addressed to the Secretary of the Department of Health, Education, and Welfare. Two copies should accompany the original notice of appeal. The notice of appeal should identify the contract (by number), the decision from which the appeal is taken, and be signed by appellant or an officer of appellant organization, or by a duly authorized representative or attorney. 4. The Armed Services Board of Contract Appeals (ASBCA) is the authorized representative of the Secretary for hearing and determining such disputes. (c) Contracting officers shall refer all proposed final decisions to the Office of General Counsel (GBA), OS, or the Regional Attorney in the HEW Regional Office for the region in which the procuring activity is located, for advice as to legal sufficiency and format before forwarding them to contractors. Contracting officers shall submit a copy of the complete contract file with each proposed final decision. (d) At any time within the period of appeal, the contracting officer may modify or withdraw his final decision. If an appeal from the final decision has been taken to the ASBCA, the contracting offilcer will forward his recommended action to the Office of General Counsel (GBA) together with the file required by § 3-1.318-50(c), as supplemented to support the recommended correction or amendment. [37 FR 12797, June 29, 1972] § 3-1.318-51 Disputes appeals. (a) The Secretary has designated the ASBCA to hear, consider, and determine fully and finally appeals by contractors from decisions of contracting officers or their authorized representatives pursuant to the provisions of contracts requiring his decisions. (b) Appeals will be governed by the rules set forth in 32 CFR 30.1, Appendix A (Rules of the Armed Services Board of Contract Appeals) and by the implementation of ASBCA rules 3 and 4 as set forth in § 3-1.318-52 (a) and (b). [40 FR 16319, Apr. 11, 1975] § 3-1.318-52 Preparation and processing of appeal files. (a) Forwarding appeals. When a notice of appeal in any form has been received by the contracting officer, he shall endorse thereon the date of mailing (or date of receipt, if otherwise conveyed) and within 10 days shall forward said notice of appeal to the ASBCA with a copy to the Division of Business and Administrative Law, Office of General Counsel or cognizant Regional Attorney as appropriate. Following receipt by the Board of the original notice of an appeal (whether through contracting officer or otherwise), the contractor, the contracting officer, and the Office of General Counsel, will be promptly advised of its receipt, and the contractor will be furnished a copy of the rules of the ASBCA. (b) Duties of the contracting officer. Within 30 days of receipt of an appeal, or advice that an appeal has been filed, the contracting officer shall assemble and transmit to the Board, with a copy to the DHEW Government trial attorney, an appeal file consisting of all documents pertinent to the appeal, including: (1) The decision and findings of fact from which the appeal is taken. (2) The contract, including specifications and pertinent amendments, 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 witnesses on the matter in dispute made prior to the filing of the notice of appeal with the Board. (5) Any additional information considered pertinent. Within 30 days of receipt of an appeal or advice that an appeal has been filed, the contracting officer shall furnish the appellant with a copy of each document transmitted to the Board, except those enumerated in paragraph (b) (2) of this section, for which a list of the contractual documents submitted will suffice. Documents in the appeal file may be originals or legible facsimiles or authenticated copies thereof, and shall be arranged in chronological order, where practicable, numbered sequentially, tabbed and indexed to identify the contents of the file. A copy of any material submitted to the ASBCA should be submitted to the Division of Business and Administrative Law, Office of General Counsel or cognizant Regional Attorney as appropriate. (c) Formats. (1) The following format is suggested for transmitting appeal files to the ASBCA: Your reference: (Docket No.) Mr. GEORGE L. HAWKES, DEAR MR. HAWKES: Transmitted herewith are documents relative to appeal under contract No. with the (name of contractor) in accordance with the procedures under Rule 4. The Government Trial Attorney for this case is: (Insert Division of Business and Administrative Law, Office of General Counsel, Department of Health, Education and Welfare, 330 Independence Avenue, S.W., Washington, D.C. 20201, telephone number 245-7752, or Regional Attorney and office address as appropriate). The request for payment of charges resulting from the processing of this appeal should be addressed to: (Insert name and address of cognizant (d) The Office of General Counsel is designated as the Government Trial Attorney to represent the Government in the defense of appeals before the ASBCA. Decisions of the ASBCA will be transmitted by the Government Trial Attorney to appropriate contracting officers for action according to ASBCA's decision. (e) At all times after the filing of an appeal, the contracting officer will render all assistance requested by the Office of General Counsel. Whenever an appeal is set for hearing, the contracting officer concerned, acting under the guidance of the Office of General Counsel, will be responsible for arranging for the pres ence of Government witnesses and specified physical and documentary evidence at both the pre-hearing conference and the hearing. (f) Whenever the contractor, subsequent to filing an appeal with the ASBCA, elects nevertheless to accept fully the decision from which appeal was taken or any modification thereof, and gives written notification of such acceptance to the Office of General Counsel or the contracting officer concerned, the Office of General Counsel will notify the ASBCA of the disposition of the dispute in accordance with Rule 27 of the ASBCA. [40 FR 16319, Apr. 11, 1975, as amended at 41 FR 19634, May 13, 1976] § 3-1.350 mailing. Procurement involving bulk (a) Use of official mailing indicia. Envelopes or labels may be furnished to contractors for use in accordance with contract terms. However, they must bear the printed return address of the Department over the words "Official Business." The name and return address of a private person or firm must never be used on an envelope or label bearing official mailing indicia. This includes envelopes mailed by the contractor as well as envelopes used in reply to a contractor's inquiries. (b) Use of Zip Code presort. All contracts and all solicitation documents for proposed procurements to be entered into with private mailers, or other contracts when bulk mailing is incident to contract performance, shall include the stipulation that mailings will be prepared in compliance with current Zip Code Presort requirements, and be deposited in the post office no later than 4:00 p.m. [35 F.R. 19751. Dec. 30, 1970] § 3-1.352 Drug products-effectiveness. [36 F.R. 19586, Oct. 8, 1971] § 3-1.352-1 General. (a) The National Academy of Sciences/National Research Council, after a review of the clinical data of drug products for which New Drug Applications had been approved by the Food and Drug Administration between 1938 and 1962, has submitted reports to the Food and Drug Administration containing recommendations for the effectiveness classification for each indication of each drug product. Notices of the Food and Drug Administration judgments on the effectiveness of these drug products are published in the FEDERAL REGISTER. (b) In arriving at its decision in determining the effectiveness of a drug product, the judgments of the NAS-NRC Panel are based on the following criteria: (1) Factual information that is freely available in the scientific literature; (2) Factual information that is available from the FDA, from the manufacturer or other sources; or (3) On the experience and informed judgment of the members of the Panels. [36 F.R. 19586, Oct. 8, 1971] § 3-1.352-2 Definitions. The indications referred to in these definitions corresponds with the reference that is made in the law to "the effect the drug purports or is represented to have under the conditions of use prescribed, recommended or suggested in the proposed labeling." This is to say that the indications are the claims that are cited in the labeling of a given drug. (a) Category A-Effective. For the presented indication, the drug is effective on the basis of the criteria stated in § 3-1.352-1(b). (b) Category B-Probably effective. For the indication presented effectiveness of the drug is probable on the basis of the criteria stated in § 3-1.352-1(b), but additional evidence in required before it can be assigned to Category A. (c) Category C-Possibly effective. In relation to the indication in question, there is little evidence of effectiveness under any of the criteria stated in § 31.352-1(b). The possibility that additional supporting evidence might be developed should not be ruled out, however. (d) Category D-Ineffective. In relation to the indication in question, there is no acceptable evidence under any of the criteria stated in § 3-352-1(b) to support a claim of effectiveness. [36 F.R. 19586, Oct. 8, 1971] § 3-1.352-3 Policy. (a) It is the policy of the Department that Federal funds will not be expended for purchasing drug products classified "ineffective" or "possibly effective" for use in its direct care programs (refer to § 103-25.358 of this title) and its contract care programs under the direct care programs with the following two exceptions: (1) Federal funds may be expended to purchase "ineffective" and "possibly effective" drug products for use in the pursuit of approved clinical research projects. (2) Federal funds may be expended to purchase a "possibly effective" drug product when no alternate means of therapy with drug products in the "probably effective" or "effective" classification are available. (b) This policy also applies to similar drug products marketed by the same or other firms. (c) Drug products listed as "ineffective" have been classified as "ineffective" for all indications or an unfavorable benefit to risk ratio exists. Drug products listed as "possibly effective" have been classified as either "ineffective" or "possibly effective" for each indication. [36 F.R. 19586, Oct. 8, 1971] § 3-1.352-4 Distribution of information. (a) The Chief Pharmacy Officer, Office of the Surgeon General, Public Health Service has responsibility for distributing information on the effectiveness of drug products to the head of the procuring activity or his designee. The head of the procuring activity or his designee will be advised by telephone of drug products classified as "ineffective" or "possibly effective" prior to publication in the FEDERAL REGISTER, and will be provided a list of such drug products monthly following publication in the FEDERAL REGISTER. (b) The head of the procuring activity shall establish a procedure for the distribution of information on the effectiveness of drug products and implement such other controls as may be necessary to assure compliance with the policy set forth in § 3-1.352-3. [36 F.R. 19586, Oct. 8, 1971] § 3-1.352-5 Procedure. (a) Prior to taking purchase action on any request for drug products, the contracting officer shall ensure that the items are screened against current lists of products identified by the Chief Pharmacy Officer, and notation that such action has been taken, bearing the initials of the individual actually doing the screening, entered on the request. (b) In those instances when purchase is requested of an item which is allowable due to either of the two exceptions set forth in § 3-1.352-3 (a), appropriate justification, signed by the responsible program official, shall be provided and made a part of the purchase file. |