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Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Rules and Regulations determine the arithmetic mean, unless the employer provides an acceptable survey. The NPC shall determine the wage in accordance with secs. 212n and 212t of the INA. If an acceptable employer-provided wage survey provides a median and does not provide an arithmetic mean, the median shall be the prevailing wage applicable to the employers job opportunity. In making a PWD, the Chicago NPC will follow 20
CFR 656.40 and other administrative guidelines or regulations issued by ETA.
The Chicago NPC shall specify the validity period of the PWD, which in no event shall be for less than 90 days or more than 1 year from the date of the determination.

2 If the employer is unable to wait for the NPC to produce the requested prevailing wage for the occupation in question, or for the CO and/or the BALCA to issue a decision, the employer may rely on other legitimate sources of available wage information as set forth in paragraphs a2iiB and C of this section. If the employer later discovers, upon receipt of the PWD from the NPC, that the information relied upon produced a wage below the final PWD and the employer was paying the NPC-determined wage, no wage violation will be found if the employer retroactively compensates the H2B
nonimmigrants for the difference between the wage paid and the prevailing wage, within 30 days of the employers receipt of the PWD.

PART 656LABOR CERTIFICATION
PROCESS FOR PERMANENT
EMPLOYMENT OF ALIENS IN THE
UNITED STATES

Angela Hanks, Acting Assistant Secretary for Employment and Training, Labor.
FR Doc. 202126660 Filed 121021; 8:45 am
3. The authority citation for part 656
is revised to read as follows:

BILLING CODE 4510FPP

Authority: 8 U.S.C. 1182a5A, 1182p1; sec.122, Public Law 101649, 109
Stat. 4978; and Title IV, Public Law 105277, 112 Stat. 2681.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

4. Amend 656.40 by revising paragraphs a and b2 and 3 to read as follows:

Food and Drug Administration
656.40 Determination of prevailing wage for labor certification purposes.

Docket No. FDA2021N0575

khammond on DSKJM1Z7X2PROD with RULES

2010, the NPC shall receive and process prevailing wage determination requests in accordance with these regulations and with Department guidance. The NPC will provide the employer with an appropriate prevailing wage rate. The NPC shall determine the wage in accordance with sec. 212t of the INA.
Unless the employer chooses to appeal the centers PWD under 656.41a of this part, it files the Application for Permanent Employment Certification either electronically or by mail with the processing center of jurisdiction and maintains the PWD in its files. The determination shall be submitted to the CO, if requested.
b
2 If the job opportunity is not covered by a CBA, the prevailing wage for labor certification purposes shall be the arithmetic mean, except as provided in paragraph b3 of this section, of the wages of workers similarly employed in the area of intended employment. The wage component of the DOL
Occupational Employment Statistics Survey shall be used to determine the arithmetic mean, unless the employer provides an acceptable survey under paragraph g of this section.
3 If the employer provides a survey acceptable under paragraph g of this section that provides a median and does not provide an arithmetic mean, the prevailing wage applicable to the employers job opportunity shall be the median of the wages of workers similarly employed in the area of intended employment.

a Application process. The employer must request a PWD from the NPC, on a form or in a manner prescribed by OFLC. Prior to January 1, 2010, the SWA having jurisdiction over the area of intended employment shall continue to receive and process prevailing wage determination requests in accordance with the regulatory provisions and Department guidance in effect prior to January 1, 2009. On or after January 1,
VerDate Sep<11>2014

15:56 Dec 10, 2021

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21 CFR Part 882

Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final amendment; final order.

The Food and Drug Administration FDA or we is classifying the temporary coil
SUMMARY:

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embolization assist device into class II
special controls. The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary coil embolization assist devices classification. We are taking this action because we have determined that classifying the device into class II
special controls will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients access to beneficial innovative devices.
DATES: This order is effective December 13, 2021. The classification was applicable on April 24, 2019.
FOR FURTHER INFORMATION CONTACT:
Xiaolin Zheng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4224, Silver Spring, MD 209930002, 3017962823, Xiaolin.Zheng@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background Upon request, FDA has classified the temporary coil embolization assist device as class II special controls, which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device.
Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device see 21 U.S.C. 360cf1. We refer to these devices as postamendments devices because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act FD&C Act.
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513i of the FD&C Act to a predicate device that does not require premarket approval see 21 U.S.C.
360ci. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section
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