Public Health Service Act Section 361

The authority for carrying out these functions on a daily basis has been delegated to the centers for disease control and prevention cdc.

Public health service act section 361. The agency cited section 361 of the public health service act as authorizing the moratorium. Secretary of health and human services is authorized to take measures to prevent the entry and spread of communicable diseases from foreign countries into the united states and between states. 264 and 42 cfr 70 6 71 32 a and 71 33.

Currently these provisions only apply to applicants outside the united states who have to be examined by panel physicians. Code 264 the u s. Hct p s regulated under 21 cfr 1271 3 d 1 and section 361 of the phs act.

Components of the department of health and human services hhs together with state and local public health partners will arrange for. Code 264 the u s. Communicable diseases that may make a person subject to quarantine as listed in a presidential executive order as provided under section 361 b of the public health service act.

Deviation reporting for human cells tissues and cellular and tissue based products regulated solely under section 361 of the public health service act and 21 cfr part 1271. Secretary of health and human services is authorized to take measures to prevent the entry and spread of communicable diseases from foreign countries into the united states and between states. Quarantine is authorized by section 361 of the public health service act 42 u s c.

As discussed below these two pathways differ markedly in terms of the time effort and expense required to bring these products to market in the u s. Sections 351 and 361 of the public health service act phsa provides the authority for fda to establish regulatory requirements for marketing traditional biologics and human cells tissues and cellular and tissue based products hct ps. These products are called 361 products because they are regulated under section 361 of the public health service phs act.

107 188 142 a 1 2 b 1 and c which directed certain amendments to section 361 of the public health act was executed by making the amendments to this section which is section 361 of the public health service act to reflect the probable intent of congress. These hct p s are regulated solely as 361 products when they meet all of the criteria in 21 cfr 1271 10 a. Under section 361 of the public health service act 42 u s.