[Code of Federal Regulations]
[Title 7, Volume 4]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 7CFR246.16a]

[Page 351-359]
 
                          TITLE 7--AGRICULTURE
 
    CHAPTER II--FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE
 
PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN--Table of Contents
 
                   Subpart E--State Agency Provisions
 
Sec. 246.16a  Infant formula cost containment.

    (a) Who must use cost containment procedures for infant formula? All 
State agencies must continuously operate a cost containment system for 
infant formula that is implemented in accordance with this section 
except:

[[Page 352]]

    (1) State agencies with home delivery or direct distribution food 
delivery systems;
    (2) Indian State agencies with 1,000 or fewer participants in April 
of any fiscal year, which are exempt for the following fiscal year;
    (3) State agencies granted a waiver under paragraph (e) of this 
section; and
    (4) State agencies granted a postponement under paragraph (f) of 
this section.
    (b) What cost containment procedures must be used? State agencies 
must use either a single-supplier competitive system as outlined in 
paragraph (c) of this section, or an alternative cost containment system 
as outlined in paragraph (d) of this section.
    (c) What is the single-supplier competitive system? Under the 
single-supplier competitive system, a State agency solicits sealed bids 
from infant formula manufacturers to supply and provide a rebate for 
infant formulas. The State agency must conduct the procurement in a 
manner that maximizes full and open competition consistent with the 
requirements of this section.
    (1) How must a State agency structure the bid solicitation? (i) 
Single solicitation. Under the single solicitation system, the State 
agency's bid solicitation must require the winning bidder to supply and 
provide a rebate on all infant formulas it produces that the State 
agency chooses to issue, except exempt infant formulas. Rebates must 
also be paid on any new infant formulas that are introduced after the 
contract is awarded. The solicitation must require bidders that do not 
produce a soy-based infant formula to subcontract with another 
manufacturer to supply a soy-based infant formula under the contract. In 
this case, the bid solicitation must require that the winning bidder pay 
the State agency a rebate on the soy-based infant formula supplied by 
the subcontractor that is issued by the State agency. The bid 
solicitation must require all rebates (including those for soy-based 
infant formula supplied by a subcontractor) to be calculated in 
accordance with paragraph (c)(5) of this section. All of these infant 
formulas are called contract brand infant formulas.
    (ii) Separate solicitations. Under the separate solicitation system, 
a State agency issues two bid solicitations. The first solicitation must 
require the winning bidder to supply and provide a rebate on all milk-
based infant formulas it produces that the State agency chooses to 
issue, except exempt infant formulas. Rebates must also be paid on any 
new milk-based infant formulas that are introduced by the manufacturer 
after the contract is awarded. These infant formulas are considered to 
be contract brand infant formulas. The second bid solicitation must 
require the winning bidder to supply and provide a rebate on all soy-
based infant formulas it produces that the State agency chooses to 
issue. Rebates must also be paid on any new soy-based infant formulas 
that are introduced by the manufacturer after the contract is awarded. 
These infant formulas are also considered to be contract brand infant 
formulas.
    (2) On what types and physical forms of infant formula must bids be 
solicited? The bid solicitation must require bidders to specify a rebate 
for each of the types and physical forms of infant formulas specified in 
the following chart. These rebates apply proportionally to other infant 
formulas produced by the winning bidder(s) (see paragraph (c)(5) of this 
section). For purposes of this section the infant formula on which bids 
are solicited is the primary contract brand infant formula.

------------------------------------------------------------------------
                                Physical forms of      Infant formula
    Type of infant formula        infant formula        requirements
------------------------------------------------------------------------
 (i) For a single solicitation, the solicitation must require bidders to
               specify a rebate amount for the following:
------------------------------------------------------------------------
A single milk-based infant      Concentrated       Meets requirements
 formula (primary contract       liquid,            under Sec.
 brand infant formula);          powdered, and      246.10(c)(1)(i) and
 bidders must specify the        ready-to-feed.     suitable for routine
 brand name of the milk-based                       issuance to the
 infant formula for which the                       majority of
 rebate is being specified.                         generally healthy,
                                                    full-term infants.
------------------------------------------------------------------------

[[Page 353]]


 (ii) For separate solicitations, the solicitation must require bidders
              to specify a rebate amount for the following:
------------------------------------------------------------------------
(A) A single milk-based infant  Concentrated       Meets requirements
 formula (primary milk-based     liquid,            under Sec.
 contract brand infant           powdered, and      246.10(c)(1)(i) and
 formula); bidders must          ready-to-feed.     suitable for routine
 specify the brand name of the                      issuance to the
 milk-based infant formula for                      majority of
 which the rebate is being                          generally healthy,
 specified.                                         full-term infants.
------------------------------------------------------------------------
(B) A single soy-based infant   Concentrated       Meets requirements
 formula (primary soy-based      liquid,            under Sec.
 contract brand infant           powdered, and      246.10(c)(1)(i).
 formula); bidders must          ready-to-feed.
 specify the brand name of the
 soy-based infant formula for
 which the rebate is being
 specified.
------------------------------------------------------------------------

    (3) How are contracts awarded? A State agency must award the 
contract(s) to the responsive and responsible bidder(s) offering the 
lowest total monthly net price for infant formula or the highest monthly 
rebate (subject to paragraph (c)(3)(ii) of this section) for a 
standardized number of units of infant formula. The State agency must 
calculate the lowest net price using the lowest national wholesale cost 
per unit for a full truckload of the infant formula on the date of the 
bid opening.
    (i) Calculating the standardized number of units of infant formula. 
The State agency must specify a standardized number of units (e.g., 
cans) of infant formula by physical form (e.g., concentrated liquid, 
powdered, and ready-to-feed) to be bid upon. The standardized number of 
units must contain the equivalent of the total number of ounces by 
physical form needed to give the maximum allowance to the average 
monthly number of infants using each form. The number of infants does 
not include infant participants who are exclusively breastfed and those 
who are issued exempt infant formula. The average monthly number of 
infant using each physical form must be based on at least 6 months of 
the most recent participation and issuance data. In order to calculate 
the standardized number of units of infant formula by form to be bid 
upon, the average monthly number of infants using each physical form is 
multiplied by the maximum monthly allowable number of ounces for each 
form (as allowed under Sec. 246.10(c)(1)(vi)), and divided by the 
corresponding unit size (i.e., number of ounces per unit being bid). In 
order to compare bids, total cost is calculated by multiplying this 
standardized number of units by the net price for each physical form. 
Alternative calculations that arrive at a mathematically equivalent 
result are acceptable.
    (ii) Determining the lowest total monthly net price or highest 
rebate. To determine the lowest total monthly net price a State agency 
must multiply the net price per unit by the established standardized 
amount of infant formula to be bid upon as calculated in paragraph 
(c)(3)(i) of this section. If the bid evaluation is based on highest 
rebate offered, the State agency must multiply the rebate offered by the 
established amount of infant formula to be bid upon as calculated in 
paragraph (c)(3)(i) of this section.
    (iii) Highest rebate limitation. Before issuing the bid 
solicitation, a State agency that elects to evaluate bids by highest 
rebate must demonstrate to FNS' satisfaction that the weighted average 
retail prices for different brands of infant formula in the State vary 
by 5 percent or less. The weighted average retail price must take into 
account the prices charged for each type and physical form of infant 
formula by authorized vendors or, if a State agency elects, it may 
include stores that do not participate in the WIC program in the State. 
The State agency must also base calculations on the proportion of each 
type and physical form of infant formula the State agency issues based 
on the data provided to bidders pursuant to paragraph (c)(4) of this 
section.
    (4) What data must be provided to bidders? The State agency must 
provide as part of the bid solicitation the participation and infant 
formula usage data and the standardized number of ounces

[[Page 354]]

by physical form of infant formula to be used in evaluating bids as 
described in paragraph (c)(3) of this section. The State agency must 
notify bidders that the participation and infant formula usage data does 
not necessarily reflect the actual issuance and redemption that will 
occur under the contract.
    (5) How is the rebate to be calculated on all other contract brand 
infant formulas? All bids must specify the rebates offered by each 
bidder for the primary contract brand infant formula(s). After the 
contract is awarded, the State agency must calculate the percentage 
discount for all other contract brand infant formulas (i.e., all other 
infant formulas produced by the bidder other than exempt infant 
formulas) approved for issuance by the State agency. The State agency 
must use the following method in calculating the rebates:
    (i) Calculation of percentage discounts. Rebates for contract brand 
infant formulas, other than the primary contract brand infant formula(s) 
for which bids were received, must be calculated by first determining 
the percentage discount for each physical form (e.g., concentrated 
liquid, powdered, and ready-to-feed) of the primary contract brand 
infant formula(s). The percentage discount must be calculated by 
dividing the rebate for the primary contract brand infant formula by the 
manufacturer's lowest national wholesale price per unit, as of the date 
of the bid opening, for a full truckload of the primary contract infant 
formula. The percentage discounts must be used to determine the rebate 
for all other contract brand infant formulas approved for issuance by 
the State agency.
    (ii) Calculation of rebate amount. The rebate for each type and form 
of all other contract brand infant formulas must be calculated by 
multiplying the percentage discount by the manufacturer's lowest 
national wholesale price per unit, as of the date of the bid opening, 
for a full truckload of the other contract brand infant formula. The 
percentage discount used for each of the other contract brand infant 
formulas depends on the physical form of the infant formula. For 
example, if the percentage discount provided for the primary contract 
brand powdered infant formula is 80 percent of its wholesale price, the 
same percentage discount must be applied to all other contract brand 
powdered infant formulas. The rebate for any types or forms of contract 
brand infant formulas that are introduced during the contract period 
must be calculated using the wholesale prices of these new contract 
brand infant formulas at the time the infant formulas are approved for 
issuance by the State agency.
    (iii) Calculation of rebates during contract term. The rebates 
resulting from the application of the percentage discount must remain 
the same throughout the contract period except for the inflation 
adjustments required in paragraph (c)(5)(iv) of this section.
    (iv) Inflation provisions. Bid solicitations must require the 
manufacturer to adjust for price changes subsequent to the bid opening. 
The inflation provision may require either a cent-for-cent increase in 
the rebate amounts whenever there is any change in the lowest national 
wholesale price for a full truckload of the particular infant formula, 
or may require another equally effective cost adjustment mechanism for 
inflation as established by the State agency in the bid solicitation.
    (6) Does a State agency have to approve the issuance of all contract 
brand infant formulas? No, the State agency may choose to approve for 
issuance, in addition to the primary contract brand infant formula(s), 
none, some, or all of the winning bidder's other infant formula(s). In 
addition, the State agency may require medical documentation before 
issuing any contract brand infant formula (see Sec. 246.10(c)(1)(i)) and 
must require medical documentation before issuing any WIC formula 
covered by Sec. 246.10(c)(1)(iii).
    (d) What is an alternative cost containment system? Under an 
alternative cost containment system, a State agency elects to implement 
an infant formula cost containment system of its choice. The State 
agency may only implement an alternative system if such a system 
provides a savings equal to or greater than a single-supplier 
competitive system. A State agency must conduct a cost comparison 
demonstrating such savings as described in paragraphs (d)(1) and (d)(2) 
of this section.

[[Page 355]]

    (1) How must the State agency structure the bid solicitation? The 
State agency must solicit bids simultaneously using the single-supplier 
competitive system described in paragraph (c) of this section and the 
alternative cost containment system(s) the State agency has selected. 
The State agency may prescribe standards of its choice for the 
alternative cost containment system(s), provided that conditions 
established for each system addressed in the bid solicitation include 
identical bid specifications for the contract period length and the 
types and forms of infant formula(s) to be included in the systems. In 
addition, the alternative cost containment system must cover the types 
and forms of infant formulas routinely issued to the majority of 
generally healthy, full-term infants. The State agency must use the 
procedure outlined in paragraph (d)(2) of this section in conducting a 
cost comparison to determine which system offers the greatest savings 
over the entire contract period specified in the bid solicitation.
    (2) How does the State agency conduct the cost comparison? (i) 
Establishing infant formula cost containment savings. (A) Savings under 
the single-supplier competitive system. The State agency must project 
food cost savings in the single-supplier competitive system based on the 
lowest monthly net price or highest monthly rebate, as described in 
paragraph (c)(3) of this section.
    (B) Savings under an alternative cost containment system. The State 
agency must project food cost savings under alternative cost containment 
systems based on the lowest monthly net cost or highest monthly rebate, 
as described in paragraph (c)(3) of this section. Food cost savings must 
be based on the standardized amount of infant formula expected to be 
issued as calculated for a single-supplier competitive system, prorated 
by the percentage of anticipated total infant formula purchases 
attributable to each manufacturer. The State agency must use the 
aggregate market share of the manufacturers submitting bids in 
calculating its cost savings estimate.
    (C) General. In establishing the potential food cost savings under 
each system, the State agency must take into consideration in its 
estimate of savings any inflation factors which would affect the amount 
of savings over the life of the contract. Further, the State agency must 
not subtract any loss of payments which would occur under the terms of a 
current contract as a result of any State agency action to be effective 
after expiration of the contract.
    (ii) Nutrition services and administration cost adjustment. The 
State agency must deduct from the food cost savings projected for each 
system under this paragraph (d) the nutrition services and 
administration costs associated with developing and implementing--but 
not operating--each cost containment system. This includes any 
anticipated costs for modifying its automated data processing system or 
components of its food delivery system(s), and of training participants, 
local agencies, vendors, and licensed health care professionals on the 
purpose and procedures of the new system. For contracts of two years or 
less, such costs must be proportionately distributed over at least a two 
year period. The State agency must not deduct any costs associated with 
procurement. The State agency must itemize and justify all nutrition 
services and administration cost adjustments as necessary and reasonable 
for the development and implementation of each system.
    (iii) Final cost comparison. The State agency must calculate the 
food costs savings and deduct the appropriate nutrition services and 
administration costs for each system for which bids were received. The 
State agency must implement the single-supplier competitive system, 
unless its comparative cost analysis shows that, over the length of the 
contract stipulated in the bid solicitation, an alternative cost 
containment system offers savings at least equal to, or greater than, 
those under the competitive single-supplier system. If the comparative 
cost analysis permits selection of the alternative cost containment 
system and the State agency wishes to implement that system, it must 
first submit a State Plan amendment with the calculations and supporting 
documentation for this cost analysis to FNS for approval. Only after the 
calculations are approved by FNS may the State agency award the contract 
or contracts

[[Page 356]]

under the alternative cost containment system.
    (e) How does a State agency request a waiver of the requirement for 
a single-supplier competitive system? A State agency which, after 
completing the cost comparison in paragraphs (d)(2)(i) through 
(d)(2)(iii) of this section, is required to implement the single-
supplier competitive cost containment system for infant formula 
procurement, may request a waiver from FNS to permit it to implement an 
alternative system. State agencies must support all waiver requests with 
documentation in the form of a State Plan amendment as required under 
Sec. 246.4(a)(14)(xi) and may submit such requests only in either of the 
following circumstances:
    (1) The difference between the single-supplier competitive system 
and the alternative cost containment system is less than 3 percent of 
the savings anticipated under the latter system and not more than 
$100,000 per annum.
    (2) The single-supplier competitive system would be inconsistent 
with the efficient or effective operation of the program. Examples of 
justifications FNS will not accept for a waiver, include, but are not 
limited to: preservation of participant preference for otherwise 
nutritionally equivalent infant formulas; maintenance of health care 
professionals' prerogatives to prescribe otherwise nutritionally 
equivalent infant formulas for non-medical reasons; potential loss of 
free or otherwise discounted materials to WIC clinics and other health 
care facilities; potential inability of a manufacturer selected in 
accordance with applicable State procurement procedures to supply 
contractually-specified amounts of infant formula; and the possibility 
of interrupted infant formula supplies to retail outlets as a 
consequence of entering into a contract with a single manufacturer.
    (f) How does a State agency request a postponement of the 
requirement for a continuously operated cost containment system for 
infant formula? A State agency may request a postponement of the 
requirement to continuously operate a cost containment system for infant 
formula that has been implemented in accordance with this section. 
However, a State agency may only request a postponement when it has 
taken timely and responsible action to implement a cost containment 
system before its current system expires but has been unable to do so 
due to procurement delays, disputes with FNS concerning cost containment 
issues during the State Plan approval process or other circumstances 
beyond its control. The written postponement request must be submitted 
to FNS before the expiration of the current system. The postponement 
period may be no longer than 120 days. If a postponement is granted, the 
State agency may extend, renew or otherwise continue an existing system 
during the period of the postponement.
    (g) May a State agency implement cost containment systems for other 
supplemental foods? Yes, when a State agency finds that it is 
practicable and feasible to implement a cost containment system for any 
WIC food other than infant formula, the State agency must fully 
implement that system in accordance with the time frames established by 
the State agency and notification must be given to FNS by means of the 
State agency's State Plan.
    (h) What are the implementation time frames for Indian State 
agencies that lose their exemption from the infant formula cost 
containment requirement? If an Indian State agency operating a retail 
food delivery system expands its program participation above 1000 and 
thereby loses its exemption from the requirements of paragraph (a) of 
this section regarding the method of cost containment for infant 
formula, then the Indian State agency must begin compliance with 
paragraph (a) of this section in accordance with time frames established 
by FNS.
    (i) What are the penalties for failure to comply with the cost 
containment requirements? Any State agency that FNS determines to be out 
of compliance with the cost containment requirements of this part must 
not draw down on or obligate any Program grant funds, nor will FNS make 
any further Program funds available to such State agency, until it is in 
compliance with these requirements.
    (j) What provisions are prohibited to be included in cost 
containment contracts? A

[[Page 357]]

State agency may not issue bid solicitations or enter into contracts 
which:
    (1) Prescribe conditions that would void, reduce the savings under 
or otherwise limit the original contract if the State agency solicited 
or secured bids for, or entered into, a subsequent cost containment 
contract to take effect after the expiration of the original contract;
    (2) Does not include the registration and certification requirements 
in Sec. 246.10(f); or
    (3) Require infant formula manufacturers to submit bids on more than 
one of the systems specified in the invitation for bids.
    (k) What are the requirements for the national cost containment bid 
solicitation and selection for infant formula? FNS will solicit and 
select bids for infant formula rebates on behalf of State agencies with 
retail food delivery systems based on the following guidelines:
    (1) FNS will solicit bids and select the winning bidder(s) for 
infant formula cost containment contracts only if two or more State 
agencies with retail food delivery systems request FNS to conduct bid 
solicitation and selection on their behalf. FNS will conduct the bid 
solicitation and selection process only and will not award or enter into 
any infant formula cost containment contract on behalf of the individual 
State agencies. Each State agency will individually award and enter into 
infant formula cost containment contract(s) with the winning bidder(s). 
State agencies must obtain the rebates directly from the infant formula 
manufacturer(s). FNS will conduct the bid solicitation in accordance 
with this paragraph (k) and the competitive bidding procurement 
procedures of the State agency with the highest infant participation in 
the bid group on whose behalf bids are being solicited. Any bid protests 
and contractual disputes are the responsibility of the individual State 
agencies to resolve.
    (2) FNS will make a written offer to all State agencies to conduct 
bid solicitation and selection on their behalf at least once every 12 
months. FNS will send State agencies a copy of the draft Request for 
Rebates when making the offer to State agencies. Only State agencies 
that provide the information required by this paragraph (k)(2) in 
writing, signed by a responsible State agency official, by certified 
mail, return receipt requested or by hand delivery with evidence of 
receipt within 15 days of receipt of the offer will be included in the 
national bid solicitation and selection process. Each interested State 
agency must provide:
    (i) A statement that the State agency requests FNS to conduct bid 
solicitation and selection on its behalf;
    (ii) A statement of the State agency's minimum procurement 
procedures applicable to competitive bidding (as defined in Sec. 246.2) 
for infant formula cost containment contracts and supporting 
documentation;
    (iii) A statement of any limitation on the duration of infant 
formula cost containment contracts and supporting documentation;
    (iv) A statement of any contractual provisions required to be 
included in infant formula cost containment contracts by the State 
agency;
    (v) The most recent available average monthly number of infant 
participants less those infant participants who are exclusively 
breastfed and those who are issued exempt infant formula. The average 
monthly participation level must be based on at least 6 months of 
participation data.
    (vi) Infant formula usage rates by type (e.g., milk-based or soy-
based), form (e.g., concentrated, powdered, ready-to-feed), container 
size, and supporting documentation;
    (vii) A statement of the termination date of the State agency's 
current infant formula cost containment contract; and
    (viii) Any other related information that FNS may request.
    (3) If FNS determines that the number of State agencies making the 
request provided for in paragraph (k)(2) of this section so warrants, 
FNS may, in consultation with such State agencies, divide such State 
agencies into more than one group and solicit bids for each group. These 
groups of State agencies are referred to as ``bid groups''. In 
determining the size and composition of the bid groups, FNS will, to the 
extent practicable, take into account the need to maximize the

[[Page 358]]

number of potential bidders so as to increase competition among infant 
formula manufacturers and the similarities in the State agencies' 
procurement and contract requirements (as provided by the State agencies 
in accordance with paragraphs (k)(2)(ii), (k)(2)(iii) and (k)(2)(iv) of 
this section). FNS reserves the right to exclude a State agency from the 
national bid solicitation and selection process if FNS determines that 
the State agency's procurement requirements or contractual requirements 
are so dissimilar from those of the other State agencies in any bid 
group that the State agency's inclusion in the bid group could adversely 
affect the bids.
    (4) For each bid group formed pursuant to paragraphs (k)(2) and 
(k)(3) of this section, FNS will use for soliciting bids the competitive 
bidding procurement procedures of the State agency in the group with the 
highest infant participation. To the extent not inconsistent with the 
requirements of this paragraph (k), FNS will use that set of procedures 
in soliciting the bids for that bid group of State agencies. FNS will 
notify each State agency in the bid group of the choice and provide them 
each a copy of the procurement procedures of the chosen State agency. 
Each State agency must provide FNS a written statement, signed by a 
responsible State agency official, by certified mail, return receipt 
requested or by hand delivery with evidence of receipt stating whether 
that State agency is legally authorized to award an infant formula cost 
containment contract pursuant to that set of procedures within 10 days 
of the receipt of the notification. If the State agency determines it is 
not legally authorized to award an infant formula cost containment 
contract pursuant to those procedures, that State agency may not 
continue in that round of the national bid solicitation and selection.
    (5) At a minimum, in soliciting bids FNS will address the following:
    (i) Unless FNS determines that doing so would not be in the best 
interest of the Program, bids will be solicited for either:
    (A) A single contract for each State agency under which the winning 
bidder will be required to supply and provide rebates on all infant 
formulas produced by that manufacturer (except exempt infant formulas) 
that are issued by the State agency. If that manufacturer does not 
produce a soy-based infant formula, the winning bidder will be required 
to subcontract with another manufacturer for a soy-based infant formula 
and the winning bidder will be required to pay a rebate on the soy-based 
infant formula; or
    (B) Two separate contracts for each State agency. Under the first 
contract, the winning bidder will supply and provide a rebate on all the 
milk-based infant formulas the winning bidder produces (except exempt 
infant formulas) that are issued by the State agency and under the 
second contract the winning bidder will supply and provide a rebate on 
all the soy-based infant formulas the winning bidder produces (except 
exempt infant formulas) that are issued by the State agency.
    (ii) The infant formula cost containment contract(s) to be entered 
into by the State agencies and infant formula manufacturers must provide 
for a constant net price for infant formula for the full term of the 
infant formula cost containment contract(s).
    (iii) The duration of the infant formula cost containment contracts 
for each bid group will be determined by FNS in consultation with the 
State agencies. The term will be for a period of not less than 2 years, 
unless the law applicable to a State agency regarding the duration of 
infant formula cost containment contracts is more restrictive than this 
paragraph (k)(5)(iii). In such cases, the term of the contract for only 
that State agency will be for one year, with the option provided to the 
State agency to extend the contract for a specified number of additional 
years (to be determined by FNS in consultation with the State agency). 
The date on which the individual State agencies' current infant formula 
cost containment contracts terminate may vary, so the infant formula 
cost containment contracts awarded by the State agencies within a bid 
group may begin on different dates.
    (iv) FNS will not prescribe conditions that are prohibited under 
paragraph (j) of this section.

[[Page 359]]

    (v) FNS will solicit bids for rebates only from infant formula 
manufacturers. FNS may limit advertising to contacting in writing each 
infant formula manufacturer which has registered with the Secretary of 
Health and Human Services under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321 et seq.).
    (6) FNS will select the winning bidder(s). The winning bidder(s) 
will be the responsive and responsible bidder(s) meeting the 
specifications and all bid terms and conditions which offers the lowest 
net price weighted to take into account infant formula usage rates and 
infant participation. In all instances the winning bidder(s) will be 
those which singly or in combination yield the greatest aggregate 
savings based on the net price weighted to take into account the infant 
formula usage rates. To break a tie between 2 equally low bids, FNS will 
select the bidder to be awarded the infant formula cost containment 
contract by a drawing by lot limited to the bidders which submitted 
those bids.
    (7) Once FNS has conducted bid selection, a State agency may decline 
to award the infant formula cost containment contract(s) only if the 
State agency determines that awarding the contract(s) would not be in 
the best interests of its Program, taking into account whether the 
national bid solicitation and selection would achieve a lower aggregate 
savings.
    (8) As soon as practicable after selecting the winning bid(s), FNS 
will notify the affected State agencies in writing of the bid results, 
including the name(s) of the winning bidder(s). If a State agency 
chooses to request approval to decline to award the infant formula cost 
containment contract(s) in accordance with paragraph (k)(7) of this 
section, it must notify FNS in writing, signed by a responsible State 
agency official, together with supporting documentation, by certified 
mail, return receipt requested or by hand delivery with evidence of 
receipt within 10 days of the State agency's receipt of this 
notification of bid results.
    (9) If FNS approves any State agency's request to decline to award 
the infant formula cost containment contract(s) in accordance with 
paragraphs (k)(7) and (k)(8) of this section, FNS will notify the 
bidders of the decision. If two or more State agencies remain in the 
group, FNS will require the bidders to indicate in writing whether they 
wish to withdraw or modify their bids within 5 days of receipt of this 
notification. FNS will again permit State agencies to decline to award 
the infant formula cost containment contract(s) in accordance with 
paragraphs (k)(7) and (k)(8) of this section. If FNS approves these 
additional State agency requests to decline contract awards, FNS may 
conduct a resolicitation of bids in accordance with this paragraph (k).

[65 FR 51224, Aug. 23, 2000]