Fr Sr Part I General Rules.pdf ^NEW^
Fr Sr Part I General Rules.pdf ^NEW^
Fr Sr Part I General Rules.pdf
indirect costs are those costs incurred by non-federal entities in supporting the creation of goods, facilities, or services that are furnished to a federal agency. indirect costs consist of fixed and operating costs that are incurred by non-federal entities, such as interest, depreciation, repairs or maintenance, rent, taxes, utilities, and insurance, that cannot be readily traced to a particular direct cost that is incurred in producing the goods, facilities, or services.
fixed costs apply only to the costs of the system in place at the time of the cost. a change in the amounts of fixed costs to be incurred in the future (such as for purchase of equipment or stock of product) are not allowed as currently incurred costs because the future amounts are not known.
if a product clinical trial for fda-approved products is receiving no reimbursement from drug companies for the first year the trial is run, then the drug company will be reimbursed at the state’s usual rates for pharmaceutical services for the first year the trial is run.
a facility may not be constructed or purchased in advance of the indication for the facility being approved. the initial construction or acquisition of a facility for research for a drug being actively researched is not prohibited.
for example, a vendor normally purchases space in an underground vault with an estimated lifespan of 20 years. if that vendor purchases equipment for the testing of a new product, the vendor is allowed to recover its cost from the new product.
if a product is tested and manufactured without using reusable items, then the cost of reusable items is not allowed as an additional cost of the manufacturing process and is therefore not allowed as a direct cost of the product.
a nondiscrimination clause identifies the protection afforded by title vi of the civil rights act of 1964, and therefore by title vii of the civil rights act of 1964. in addition, the phrase “in a program or activity receiving federal financial assistance” is intended to be consistent with the definition of “federal financial assistance” under title vi, and the definition of “program or activity” under title vii. in order to receive a determination as to whether a particular program or activity is covered by title vii of the civil rights act of 1964, the entity would need to apply to a regional office or the civil rights office within the department of health & human services for a letter describing the entity’s position that it is not engaging in employment discrimination and the reasons supporting such position. the entity would be evaluated at the time the request is made. at that time, the entity would need to provide information sufficient to demonstrate that it is not engaging in employment discrimination.
this is intended to be an alphabetical list of grant awardees and grantees for which the centers for medicare & medicaid services (cms) is the primary departmental contact. if no contact information is available, contact information for the state may be found in the payment and provider compliance support system (pcss).
a non-federal entity must not coordinate the award, plan, or performance of federal funding through actual or apparent authority. a coordination, relationship, or joint action requires that one party has the authority to bind the other. a non-federal entity that engages in such a relationship cannot bill the government for such costs if an actual or apparent authority exists between the non-federal entity and a federal awarding or administering agency.
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