§ 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. [37 FR 12797, June 29, 1972] § 3-1.318-50 Decision preparation, processing, and modification or withdraw. al. (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 preparing 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. (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 wriiten 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 officer 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 Law, and Administrative 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 documen. 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 (Insert name and address of cognizant finance office.) (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 presence of Government witnesses and specified pnysical 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, (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 FR 19751, Dec. 30, 1970] § 3-1.352 Drug products-effectiveness. [36 FR 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 NASNRC 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 FR 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 § 3-1.3521(b), but additional evidence is 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 §3-3521(b) to support a claim of effective ness. [36 FR 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 prod ucts 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 FR 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 FR 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. (c) When the demand for a restricted product cannot be resolved by the substitution of a satisfactory item, the request shall be processed in the same manner as a deviation (see § 3-1.108). [36 FR 19586, Oct. 8, 1971] § 3-1.353 Treatment of technical data in contract proposals. (a) General. Technical data (such as plans, designs, suggestions, improvements or concepts) acquired by HEW may have been obtained under conditions which restrict HEW's right to use the data. Therefore, care must be taken when considering the use of technical data to assure that HEW has sufficient rights to use the data in the manner desired. One of the principal ways in which HEW receives technical data is by means of proposals. HEW has a continuing interest in receiving and evaluating proposals which are pertinent to its potential needs in carrying out its objectives and goals. Some proposals are offered and received under conditions which may prevent HEW from using the technical data contained therein other than for evaluation purposes. Proposals received by HEW are of two types-solicited and unsolicited. The policies and procedures for handling unsolicited proposals are set forth in Subpart 34.52. (b) Definitions-(1) Unsolicited proposal. Essentially, an unsolicited proposal is a written offer to perform work which does not result from a formal written request for proposals or quotations. See Subpart 3-4.5201 for a definitive definition. (2) Solicited proposal. A solicited proposal is a written offer to perform work which results from a formal written request for proposals or quotations. (c) Policy for unsolicited proposals. It is the policy of HEW to use technical data included in unsolicited proposals for evaluation purposes only. However, due to the administrative problems involved in handling the large number of unsolicited proposals received, cannot the Government assume liability for disclosure or use of such technical data unless it is marked by the offeror in accordance with the legend set forth below. The Government assumes no liability for disclosure or use of unmarked technical data and may use or disclose the data for any purpose and may consider that the proposal was not submitted in confidence and therefore releasable under the Freedom of Information Act (5 U.S.C. 552). Each proposal containing technical data, which the offeror intends to be used by HEW for evaluation purposes only, should be marked on the cover sheet with the following legend and shall specify the pages of the proposal to be restricted in accordance with the conditions of the legend: Technical data contained in pages of this proposal shall not be used or disclosed, except for evaluation purposes: Provided, That if a contract is awarded to this offeror as a result of or in connection with the submission of this proposal, the Government shall have the right to use or disclose this technical data to the extent provided in the contract. This restriction does not limit the Government's right to use or disclose technical data obtained from another source without restriction. Contracting officers and other Government personnel shall not refuse to consider any proposal merely because the proposal is restrictively marked. Proposals, or portions thereof, so marked shall be used only for evaluation and shall not otherwise be used or disclosed without the written permission of the offeror except under the conditions provided in the legend. In the event an unsolicited proposal is submitted with more restrictive conditions than those provided in the legend above, HEW may be unable to |