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The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2020]
[CITE: 21CFR314.125]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

Subpart D - FDA Action on Applications and Abbreviated Applications

Sec. 314.125 Refusal to approve an NDA.

(a) The Food and Drug Administration will refuse to approve the NDA and for a new drug give the applicant written notice of an opportunity for a hearing under § 314.200 on the question of whether there are grounds for denying approval of the NDA under section 505(d) of the Federal Food, Drug, and Cosmetic Act, if:

(1) FDA sends the applicant a complete response letter under § 314.110;

(2) The applicant requests an opportunity for hearing for a new drug on the question of whether the NDA is approvable; and

(3) FDA finds that any of the reasons given in paragraph (b) of this section apply.

(b) FDA may refuse to approve an NDA for any of the following reasons, unless the requirement has been waived under § 314.90:

(1) The methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product are inadequate to preserve its identity, strength, quality, purity, stability, and bioavailability.

(2) The investigations required under section 505(b) of the Federal Food, Drug, and Cosmetic Act do not include adequate tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.

(3) The results of the tests show that the drug is unsafe for use under the conditions prescribed, recommended, or suggested in its proposed labeling or the results do not show that the drug product is safe for use under those conditions.

(4) There is insufficient information about the drug to determine whether the product is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.

(5) There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling.

(6) The proposed labeling is false or misleading in any particular.

(7) The NDA contains an untrue statement of a material fact.

(8) The drug product's proposed labeling does not comply with the requirements for labels and labeling in part 201.

(9) The NDA does not contain bioavailability or bioequivalence data required under part 320 of this chapter.

(10) A reason given in a letter refusing to file the NDA under § 314.101(d), if the deficiency is not corrected.

(11) The drug will be manufactured in whole or in part in an establishment that is not registered and not exempt from registration under section 510 of the Federal Food, Drug, and Cosmetic Act and part 207.

(12) The applicant does not permit a properly authorized officer or employee of the Department of Health and Human Services an adequate opportunity to inspect the facilities, controls, and any records relevant to the NDA.

(13) The methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product do not comply with the current good manufacturing practice regulations in parts 210 and 211.

(14) The NDA does not contain an explanation of the omission of a report of any investigation of the drug product sponsored by the applicant, or an explanation of the omission of other information about the drug pertinent to an evaluation of the NDA that is received or otherwise obtained by the applicant from any source.

(15) A nonclinical laboratory study that is described in the NDA and that is essential to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling was not conducted in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study.

(16) Any clinical investigation involving human subjects described in the NDA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.

(17) The applicant or contract research organization that conducted a bioavailability or bioequivalence study described in § 320.38 or § 320.63 of this chapter that is contained in the NDA refuses to permit an inspection of facilities or records relevant to the study by a properly authorized officer or employee of the Department of Health and Human Services or refuses to submit reserve samples of the drug products used in the study when requested by FDA.

(18) For a new drug, the NDA failed to contain the patent information required by section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act.

(19) The 505(b)(2) application failed to contain a patent certification or statement with respect to each listed patent for a drug product approved in an NDA that:

(i) Is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted; and

(ii) Was approved before the original 505(b)(2) application was submitted.

Ltt speed test internet. (c) For drugs intended to treat life-threatening or severely-debilitating illnesses that are developed in accordance with §§ 312.80 through 312.88 of this chapter, the criteria contained in paragraphs (b) (3), (4), and (5) of this section shall be applied according to the considerations contained in § 312.84 of this chapter.

[50 FR 7493, Feb. 22, 1985, as amended at 53 FR 41524, Oct. 21, 1988; 57 FR 17991, Apr. 28, 1992; 58 FR 25926, Apr. 28, 1993; 64 FR 402, Jan. 5, 1999; 73 FR 39610, July 10, 2008; 74 FR 9766, Mar. 6, 2009; 81 FR 60221, Aug. 31, 2016; 81 FR 69658, Oct. 6, 2016]

Item #: SCP-314

Object Class: Euclid

Special Containment Procedures: SCP-314 is contained at the location of its original discovery at Site 47 which has been built around the anomaly. Local personnel publicly operate under the guise of the US Forest Service.

Although SCP-314 is highly mobile, it has never moved beyond a 50 (fifty)-meter radius of its origin point; the area delineated by this radius is known as the 'red zone'. SCP-314 has created an equally large depression in the earth below its origin point. All attempts to remove or restrain the object have thus far failed, but containment has been achieved by the construction of Site 47 itself, which is also used for various physics experiments regarding anomalous objects.

Any experiments involving SCP-314 must be cleared by Dr. Williams; see form HM-120.

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With the exception of approved experimentation, all personnel are to keep clear of the red zone. SCP-314 is highly reactive to all motion within approximately 50 52 meters of its origin point.

Addendum: After incident 314-oe, researchers are reminded that the object's 'kill radius' is approximately 50 meters from point of origin, and for purposes of safety should be assumed to actually be 51 meters. Although safe interaction is possible at the outer edge of the red zone, and the object may even exhibit what the late Dr. Stratham described as 'playful behavior' at that range, all action within the kill radius has always been met with violent reaction.

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Description: SCP-314 is a 0.97 m long, 0.21 m thick obelisk which is highly reflective and metallic in appearance, with tapered edges that are apparently sharpened to a molecular level. No material has ever been recovered from SCP-314.

The object is capable of levitation and extremely swift motion, although it lacks any visible means of locomotion. Although research does not indicate any true intelligence, the object is most certainly sentient of its surroundings and extremely reactive to any motions or vibrations within an approximately 50 52-meter radius.

Analysis of rubble recovered from the ground below SCP-314's origin point indicates that the object arrived at this location some time between 1975 and 1979, which is supported by pre-containment reports from civilians.

The object emits no unusual radiation save for a very faint sound which appears to be an anomalous broadcast of █████ FM, a local classic rock station. Comparisons between SCP-314's vibrations and the actual broadcast of █████ FM are identical approximately 85% of the time, although recordings from SCP-314 often include extra audio in the form of guttural sounds, snarling and occasional commentary from the late DJ ██████ ███████, who passed away in 1998 and was not employed with █████ FM after 1983.

Research Summary: SCP-314 reacts to all motion within its kill radius by impacting with the source of movement, although it ignores particulate matter smaller than 125 micrometers. SCP-314 will continue to react in this manner until the triggering object no longer moves, has exited the kill radius, or has been reduced to pieces small enough to be ignored. It displays unerring accuracy; no limit to its speed has yet been established.

Current experimentation revolves around introducing multiple targets into SCP-314's kill radius at a time to quantify its method of identifying, prioritizing and reacting to multiple targets.

Multiple slow-moving targets are often struck down in order of their introduction to the kill zone, notably in a method which suggests that SCP-314 is anticipating further objects to be introduced. In experiment 314-113, several tennis balls were tossed into the kill radius by researchers standing outside the red zone. SCP-314 bisected each ball neatly in such a manner that their remaining momentum took them out of the kill radius, while putting itself into position to strike balls not yet thrown.

SCP-314 has correctly predicted when a researcher will only pretend to throw an object, as well as when a researcher will fail to throw an object into the kill radius despite intent.

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Multiple fast-moving targets, such as bullets fired into the kill radius, can produce speeds from SCP-314 that exceed the sound barrier, or even create the appearance of SCP-314 existing in more than one location simultaneously.

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Experiment 314-230 flooded the containment room within Site 47. SCP-314 was able to strike at the encroaching liquid with such speed and consistency that it created an irregularly shaped dry sphere within its kill radius. The ground below SCP-314 remained dry at all times. In previous tests (and accidents) SCP-314 has allowed liquid to fall upon the ground within its kill zone.

When SCP-314 detects motion close to the edge of the kill radius it moves in erratic patterns that observers have variously interpreted as 'threatening', 'graceful', or 'playful'. These motions sometimes correspond to the individuals that provoke them, suggesting that SCP-314 may have some means of recognizing or remembering individuals to whom it has previously been exposed.

Containment Breach 7/12/20██At approximately 3:23 PM local time, SCP-314 exited its previously-defined area of operation and cut through the walls of Site 47 before returning to its place of origin. No personnel were harmed during this event. This time corresponded with an offsite review on whether or not SCP-314 should be reclassified as Safe. Whether this is coincidence or not is yet to be determined, but it clearly demonstrates that we do not know everything about this object or its motivations, or if it is capable of having any. Classification remains Euclid.

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-Dr. Williams.