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Federal Register / Vol. 86, No. 236 / Monday, December 13, 2021 / Rules and Regulations information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120.
List of Subjects in 21 CFR Part 876
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:
PART 876GASTROENTEROLOGYUROLOGY DEVICES
1. The authority citation for part 876
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. Add 876.2100 to subpart C to read as follows:

876.2100
tool.

Pressure ulcer management
a Identification. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a users decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
b Classification. Class I general controls. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 876.9.
Dated: December 8, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126924 Filed 121021; 8:45 am BILLING CODE 416401P

DEPARTMENT OF STATE
22 CFR Part 42
Public Notice: 11460
RIN 1400AF20

Waiver of Personal Appearance and InPerson Oath Requirement for Certain Immigrant Visa Applicants Due to COVID19
Department of State.
Final rule and temporary final
AGENCY:
khammond on DSKJM1Z7X2PROD with RULES

ACTION:

rule.
This temporary final rule TFR provides flexibility for consular officers to waive the personal appearance of certain repeat immigrant visa applicants who were approved for an immigrant visa in the same
SUMMARY:

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classification and on the same basis as the current application on or after August 4, 2019. It also gives consular officers discretion to allow this subset of immigrant visa applicants to affirm the accuracy of the contents of their application without appearing in person before a consular officer. This TFR is effective immediately and expires after 24 months. The final rule portion of this document reinstates parts of the regulations with certain updates after the expiration of the TFR.
DATES: Amendments in instructions 2
and 3 in this temporary final rule are effective from December 13, 2021, through December 13, 2023. The amendment in instruction 4 is effective December 13, 2023.
FOR FURTHER INFORMATION CONTACT:
Andrea Lage, Acting Senior Regulatory Coordinator, Visa Services Directorate, Bureau of Consular Affairs, Department of State; telephone 202 4857586, VisaRegs@state.gov.
SUPPLEMENTARY INFORMATION:
I. What changes to 22 CFR 42.62 and 42.67 does this TFR make?
The Department is temporarily authorizing consular officers, for 24
months, to waive, on a discretionary basis, the requirements in 22 CFR 42.62
and 42.67 that an immigrant visa applicant appear in person before and be interviewed by a consular officer for certain repeat immigrant visa applicants. This TFR applies to immigrant visa applicants who were issued a U.S. immigrant visa on or after August 4, 2019, who meet the following additional criteria: Individuals who would be eligible for a discretionary waiver of personal appearance and interview pursuant to this TFR must be seeking an immigrant visa in the same classification or another classification as the result of automatic conversion due to the death or naturalization of the petitioner of the previously issued immigrant visa and pursuant to the same approved petition as their previously approved application, and they must continue to qualify for the immigrant visa sought.
Under this TFR, the personal appearance and interview of certain applicants for an immigrant visa may be waived in the discretion of the consular officer, provided that the applicant is willing to affirm under penalty of perjury to the information provided on the Online Immigrant Visa and Alien Registration Application, Form DS260
or Form DS230, Application for Immigrant Visa and Alien Registration if the consular officer authorizes the use of that form. The consular officer may
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communicate with the applicant by telephone or email, may request that the applicant provide additional information that the consular officer deems necessary, and may request the applicant to appear in person. If the applicant identifies the need to change responses to Form DS260, the consular officer or other authorized consular staff can reopen the DS260 for the applicant to make changes to that form and re-sign it under penalty of perjury.
This TFR will automatically expire 24
months after it takes effect. As the TFR
is designed to help address the problem of applicants who are unable to travel due to the COVID19 pandemic and who must meet specific time-limited criteria, this TFR will no longer be necessary as the pandemic becomes less acute and ordinary travel resumes. The Department believes that 24 months is sufficient to process the cases described.
Pursuant to section 222a of the Immigration and Nationality Act INA, 8 U.S.C. 1202a, every immigrant visa applicant must make an application in the form, manner, and place prescribed by regulation. Except as may otherwise be prescribed by regulations, every immigrant visa application must be signed by the applicant in the presence of the consular officer and verified by the oath of the applicant administered by the consular officer. INA 222e, 8
U.S.C. 1202e. Regulations further require immigrant visa applicants to be interviewed by a consular officer. 22
CFR 42.62b. This TFR provides an exception to these personal appearance and interview requirements pursuant to INA 222a and e, 8 U.S.C. 1202a and e.
II. Why is the Department promulgating this TFR?
A. The COVID19 Pandemic On January 31, 2020, the Secretary of Health and Human Services declared a public health emergency under section 319 of the Public Health Service Act 42
U.S.C. 247d in response to COVID19.1
On March 13, 2020, then-President Trump declared a National Emergency concerning the COVID19 outbreak to control the spread of the virus that causes COVID19 in the United States.2
That proclamation declared that the emergency began in the United States on March 1, 2020. In addition to the National Emergency, a variety of Presidential Proclamations have 1 HHS, Determination of Public Health Emergency, 85 FR 7316 Feb. 7, 2020.
2 Proclamation 9994 of March 13, 2020, Declaring a National Emergency Concerning the Coronavirus Disease COVID19 Outbreak, 85 FR 15337 Mar.
18, 2020.

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