What is considered a NSR?
An NSR device investigation is one that does not meet the definition for a significant risk study.
What is NSR in government?
California Air Resources Board New Source Review (NSR) is a title applied to programs regulating the new construction of, and/or modifications to, industrial sources which emit, or will emit, air pollutants. New Source Review. Federal New Source Review.
What are NSR pollutants?
31. Regulated NSR pollutant, for purposes of this Ruling, means the following: (i) Nitrogen oxides or any volatile organic compounds; (ii) Any pollutant for which a national ambient air quality standard has been promulgated.
What must an IRB review in NSR?
Unless FDA has already made a risk determination for the study, the IRB must review the sponsor’s SR or NSR determination for every investigational medical device study reviewed and modify the determination if the IRB disagrees with the sponsor.
What does ECG NSR mean?
The term normal sinus rhythm (NSR) is sometimes used to denote a specific type of sinus rhythm where all other measurements on the ECG also fall within designated normal limits, giving rise to the characteristic appearance of the ECG when the electrical conduction system of the heart is functioning normally.
When was NSR created?
1977
Congress established the New Source Review (NSR) Permitting program as part of the 1977 Clean Air Act Amendments.
What is NSPS EPA?
New Source Performance Standards (NSPS) are pollution control standards issued by the United States Environmental Protection Agency (EPA).
What is 510k approval?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
What is an IND study?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
How do you determine whether NSR applies?
For the purpose of determining whether NSR applies, this rule directs facilities and permitting authorities to combine, or aggregate, emissions from plant modifications when those projects are related. Thus, total emissions for the related projects must be considered when permitting authorities determine whether NSR applies.
What is the NSR permitting program?
Congress established the New Source Review (NSR) Permitting program as part of the 1977 Clean Air Act Amendments. What are permits? Who issues permits?
When did the NSR improvement rule come into effect?
These provisions were part of EPAs NSR improvement rule issued on December 31, 2002. On June 24, 2005, the United States Court of Appeals for the District of Columbia Circuit vacated the portions of the 2002 and 1992 NSR rules that pertained to CU and PCP.
What are the benefits of NSR registration?
NSR registration provides the registered persons with an industry preferred profile on a central system. All leading companies participate in this initiative and would request reference to such profile. Registration also provides with a secure identity and credible profile. NSR provides control over access to the profile to the registered person.