§ 3-1.352-1 Genera!....

(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 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 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 car

rying 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, the Government cannot 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 consider it, in which case the offeror should be So advised, see § 31.353(f)(2).

(d) Policy for solicited proposals. (1) HEW recognizes that requests for proposals may require the offeror, including his subcontractor(s), if any, to submit technical data which the offeror or his subcontractor(s) does not want used or disclosed for any purpose other than for evaluation of the proposal. Each proposal containing technical data which the offeror or his proposed subcontractor(s) desires to restrict shall be marked on the cover sheet by the offeror with the legend set forth in paragraph (d)(2) of this section. 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. The Government assumes no liability for disclosure or use of unmarked technical data in solicited proposals 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).

(2) The following provision shall be inserted in the RFP:

The proposal submitted in response to this request may contain technical data which the offeror or his subcontractor(s) does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any such technical data may be so restricted: Prorided, The offeror marks the cover sheet of

the proposal with the following legend, specifying the pages of the proposal which are 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.

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).

Proposals submitted with restrictive legends or statements differing from the above legend will be treated under the terms of the above legend.

(e) HEW notice for handling proposals. In order that both solicited and unsolicited proposals are handled in accordance with the policies set forth in paragraphs (c) and (d) of this section, the following notice shall be affixed to each solicited and unsolicited proposal which is to be disclosed outside the Government for evaluation purposes in accordance with the policies and procedures set forth in paragraph (f) of this section. Application of the following notice in no way alters any obligation of the Government or diminishes any rights to use or disclose technical data or business information.

HEW NOTICE FOR HANDLING PROPOSALS

This proposal shall be used or duplicated only for evaluation purposes and this notice shall be applied to any reproduction or abstract thereof.

Disclosure of this proposal outside the Government for evaluation purposes shall not be made unless the policy and procedures prescribed by HEW Procurement Regulation § 3-1.353(f)(2), including the requirements for approval and for an arrangement with the outside evaluator prior to disclosure, are followed.

The restrictions contained in this notice do not apply to technical data or business

information obtained from another source without restriction.

(f) Disclosure of solicited and unsolicited proposals outside the Government (1) Policy. It is the policy of HEW to have proposals evaluated by the most competent technical and management sources available in the Government. However, in processing a proposal for evaluation, HEW may find in some instances that it is necessary to disclose a proposal outside the Government to meet its evaluation needs. Such outside evaluation may be made provided the requirements in paragraphs (f) (2) and (3) of this section are met.

(2) Approval. Decisions to disclose proposals outside the Government for evaluation purposes shall be made by the chief official of the requiring organization having programmatic responsibility for the procurement, after consultation with the contracting officer for the procuring activity, and in accordance with agency procedures. (Copies of any agency implementing procedures shall be sent to the Director, Office of Procurement and Materiel Management (OASAM).) The decision to disclose either a solicited or unsolicited proposal outside the Government for the purpose of obtaining an evaluation shall take into consideration avoidance of organizational conflicts of interest and the competitive relationship between the originator of the proposal and the prospective evaluator.

(3) Evaluation of unsolicited proposals. Should an unsolicited proposal under consideration contain a restrictive use statement or legend other than the legend prescribed in paragraph (c) of this section, the legend or statement should be reviewed to assure that it does not preclude HEW from disclosing the proposal outside the Government for purposes of obtaining an evaluation. In the event HEW is so precluded and an outside evaluation is nevertheless desired, the offeror should be advised that HEW may be unable to consider the proposal unless the offeror consents in writing to having the proposal evaluated outside the Government.

(4) Conditions of outside evaluation. Where it is determined to disclose a proposal outside the Government pursuant to paragraph (f)(2) of this section, the following conditions, or similar appropriate conditions for the treatment of the proposal, shall be included in the agreement with the evaluator prior to such disclosure. Also, review should be made to assure that the notice required by paragraph (e) of this section is affixed to the proposal before it is disclosed to the evaluator.

CONDITIONS FOR EVALUATING PROPOSALS

The evaluator agrees to use the technical data and business information contained in the proposal only for evaluation purposes.

This requirement does not apply to technical data or business information obtained from another source without restriction.

Any notice or legend placed on the proposal by either HEW or the originator of the proposal shall be applied to any reproduction or abstract thereof. Upon completion of the evaluation, the evaluator shall return all copies of the proposal and abstracts, if any, to the HEW office which initially furnished the proposal for evaluation.

Unless authorized by the HEW initiating office, the evaluator shall not contact the originator of the proposal concerning any aspects of its contents.

The evaluator will be obligated to obtain commitments from its employees in order to affect the purposes of these conditions.

(g) Evaluation and testing of equipment and material. Should evaluation of a proposal include the evaluation and testing of equipment or material submitted with the proposal, neither the Government nor any person acting on behalf of the Government assumes any liability to the submitter of the proposal, or any person acting on his behalf, in connection with any damage, loss, injury, or destruction resulting from such evaluation, and testing.

[37 FR 16397, Aug. 12, 1972]

upon the availability of funds. In these cases, the supplies or services shall not be accepted until the funds are available to the contracting officer for the procurement and until the contracting officer has given notice, confirmed in writing, to the contractor of the availability of funds. Appropriate records shall be maintained to insure adequate control of funds.

(b) Limitations. Contracts conditioned upon the availability of funds shall be used only for operation, maintenance and continuing services (e.g., janitorial services, garbage removal, utilities, rentals) which are necessary for normal operation and for which the Congress consistently appropriates funds.

(c) Contract clause. The following clause shall be inserted in all solicitations and resultant contracts:

AVAILABILITY OF FUNDS

Funds are not presently available for this procurement. The Government's obligation hereunder is contingent upon the availability of appropriated funds from which payment for the contract can be made.

No legal liability on the part of the Government for payment of any money shall arise unless and until funds are made available to the Contracting Officer for this procurement and notice of such availability, to be confirmed in writing by the Contracting Officer, is given to the Contractor.

[38 FR 1392, Jan. 12, 1973]

§ 3-1.355 Federal Reports Act of 1942.

(a) General. The Federal Reports Act of 1942 (44 U.S.C. 3501 et seq.), prohibits the conducting or sponsoring of the collection of information, upon identical items, from 10 or more persons (other than Federal employees considered as such), unless the approval of the Director, Office of Management and Budget, is obtained in advance of the adoption or revision of any plans or forms for such collection.

(b) Approvals. Whenever possible, data requirements shall be defined, cleared within HEW, and approval obtained from OMB prior to the issuance of the solicitation. The advice of the cognizant reports clearance officer shall be sought on all questions pertaining to required clearances. (See part 10 of the General Administration

Manual for a detailed discussion of Federal Reports Act requirements and related directives.)

(c) Required clauses. Solicitations and resulting contracts which provide for the collection of information as described in (a) of this § 3-1.355, shall contain the clause set forth in §37.5010 of this chapter and the appropriate clause set forth in § 3-7.5011 of this chapter.

[38 FR 13647, May 24, 1973]

Subpart 3-1.4-Procurement Responsibility and Authority

SOURCE: 36 FR 22981, Dec. 2, 1971, unless otherwise noted.

§ 3-1.401 Responsibility of the head of the procuring activity.

The head of the procuring activity (see §3-75.101) is responsible for the conduct of an effective and efficient procurement program. Adequate controls shall be established to assure compliance with applicable laws, regulations, procedures, and the dictates of good management practices. Periodic reviews shall be conducted and evaluated by qualified personnel, preferably assigned to positions other than in the procurement activity being reviewed, to determine the extent of adherence to prescribed policies and regulations, and to detect a need for guidance and/ or training. The Procurement and Materiel Checklist, Form HEW 552, available through normal distribution channels, shall be used to assist in conducting such reviews.

§ 3-1.403 Requirements to be met before entering into contracts.

(a) No contract shall be entered into, modified, or terminated unless all required reviews, clearances, or approvals have been obtained and all applicable requirements of law, the FPR, the HEWPR, and other applicable regulations have been met.

(b) In addition to the requirements specified in paragraph (a) of this section, no negotiated contract shall be entered into until the determinations and findings required by Parts 1-3 and 3-3 of this title with respect to the circumstances justifying negotiation and