Sec. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY
624 words·~3 min read·
/statute-compilations/comps-16871/sec-305A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 305 DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY **[**[42 U.S.C. 282 note](/us/usc/t42/s282)**]** ###
(a)In general ####
(1)Request for proposals Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development. ####
(2)Determination on grants or contracts Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section. ###
(b)Application A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require. ###
(c)Use of Funds A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by— ####
(1)encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; ####
(2)mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing; ####
(3)connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology; ####
(4)assessing the scientific and medical merit of proposed pediatric device projects; ####
(5)providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and ####
(6)providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate. ###
(d)Coordination ####
(1)National institutes of health Each consortium that receives a grant or contract under this section shall— #####
(A)coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act, as added by section 304(a) of this Act; and #####
(B)provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest. ####
(2)Food and drug administration Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use. ####
(3)Effectiveness and outcomes Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium. ###
(e)Authorization of appropriations There are authorized to be appropriated to carry out this section $1,610,959 for the period beginning on October 1, 2022 and ending on December 23, 20221. 1Section 3104 of division FF of Public Law 117-328 attempts to amend subsection
(e)by striking “$1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022” and inserting “$7,000,000 for each of fiscal years 2023 through 2027”. This amendment does not execute due to a prior amendment made by section 304 of division C of Public Law 117-229. * * * * * * *
Connectionstraces to 3
Traces to 3 documents
Citation graph
cites case law
Sec. 305
DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY
Cites 3Cited by 0 across 0 sources