Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 52197 

These devices also do not include any 

device intended for use to select patient 

therapy, predict patient response to 

therapy, or to screen for disease as well 

as any device with a claim for a 

particular diagnosis, prognosis, 

monitoring, or risk assessment. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must also include the 

following information: 

(i) A detailed description of all probes 

included in the kit; 

(ii) Purpose of each probe; 

(iii) Probe molecular specificity; 

(iv) Probe specificity; 

(v) Probe limits; 

(vi) Probe sensitivity; 

(vii) Specification of required 

ancillary reagents, instrumentation, and 

equipment; 

(viii) Specification of the specimen 

collection, processing, storage and slide 

preparation methods; 

(ix) Specification of the assay 

procedure; 

(x) Specification of control elements 

that are incorporated into the 

recommended testing procedures; 

(xi) Specification of risk mitigation 

elements: Description of all additional 

procedures, methods, and practices 

incorporated into the directions for use 

that mitigate risks associated with 

testing; 

(xii) Specification of the criteria for 

test result interpretation and reporting; 

(xiii) Device analytical sensitivity 

data; 

(xiv) Device analytical specificity 

data; 

(xv) Device reference limit data; 

(xvi) Device precision/reproducibility 

data; 

(xvii) Device stability data to include: 

(A) Real-time stability, 

(B) Freeze-thaw stability, 

(C) Transport and temperature 

stability, 

(D) Post-hybridization signal stability, 

(E) Photostability of probe, and 

(xviii) Documentation that 

demonstrates the clinical validity of the 

device. The documentation must 

include data from clinical studies, a 

minimum of two peer-reviewed 

published literature references using the 

specific device seeking marketing 

clearance, or both. Documentation for 

the clinical studies and peer-reviewed 

published literature references cited 

must include the following elements: 

(A) Documentation that the sponsor’s 

probe was used in the literature 

reference, 

(B) Number and type of specimens, 

(C) Target population studied, 

(D) Upper reference limit, and 

(E) Range of positive probe results. 

(2) Your § 809.10(b)(12) of this 

chapter compliant labeling must include 

a statement summarizing the data 

identified in paragraphs (b)(1)(xiii) 

through (xviii) of this section and a 

description of the studies supporting the 

information, including the pre-specified 

acceptance criteria for these 

performance studies, justification for the 

pre-specified acceptance criteria, and 

whether the pre-specified acceptance 

criteria were met. 

(3) Your § 809.10 of this chapter 

compliant labeling must include: 

(i) A warning that reads ‘‘The assay 

results are intended to be interpreted 

only by a qualified pathologist or 

cytogeneticist.’’ 

(ii) A warning that reads ‘‘This device 

is not for high-risk uses such as 

selecting therapy, predicting therapeutic 

response or disease screening.’’ 

(iii) A warning that reads ‘‘The use of 

this device for diagnosis, monitoring or 

risk assessment has not been 

established.’’ 

Dated: August 27, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–20882 Filed 9–2–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 22 

[Public Notice: 8858] 

RIN 1400–AD47 

Schedule of Fees for Consular 

Services, Department of State and 

Overseas Embassies and 

Consulates—Visa and Citizenship 

Services Fee Changes; Correction 

AGENCY: Department of State. 

ACTION: Interim final rule; correction. 

SUMMARY: The Department of State 

published a Federal Register document 

on August 28, 2014, in Volume 79, No. 

167, page 51247, amending the 

Schedule of Fees for Consular Services 

(Schedule) for certain nonimmigrant 

visa application processing fees, certain 

immigrant visa application processing 

and special visa services fees, and 

certain citizenship services fees. The 

document contained an incorrect 

effective date. This document corrects 

the document by changing the effective 

date that the new fees will go into effect 

from September 6, 2014 to September 

12, 2014 and the date that comments 

must be received by from October 21, 

2014 to October 26, 2014. 

DATES: The interim rule published on 

August 28, 2014 (79 FR 51247), becomes 

effective September 12, 2104. Written 

comments must be received on or before 

October 26, 2014. 

ADDRESSES: Interested parties may 

submit comments to the Department by 

any of the following methods: 

• Visit the Regulations.gov Web site 

at: http://www.regulations.gov and 

search the RIN 1400–AD47 or docket 

number DOS–2014–0016. 

• Mail (paper, disk, or CD–ROM): U.S. 

Department of State, Office of the 

Comptroller, Bureau of Consular Affairs 

(CA/C), SA–17 8th Floor, Washington, 

DC 20522–1707. 

• E-Mail: fees@state.gov. You must 

include the RIN (1400–AD47) in the 

subject line of your message. 

• All comments should include the 

commenter’s name, the organization the 

commenter represents, if applicable, 

and the commenter’s address. If the 

Department is unable to read your 

comment for any reason, and cannot 

contact you for clarification, the 

Department may not be able to consider 

your comment. After the conclusion of 

the comment period, the Department 

will publish a Final Rule (in which it 

will address relevant comments) as 

expeditiously as possible. 

FOR FURTHER INFORMATION CONTACT: 

Celeste Scott, Special Assistant, Office 

of the Comptroller, Bureau of Consular 

Affairs, Department of State; phone: 

202–485–6681, telefax: 202–485–6826; 

Email: fees@state.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 28, 2014, in 

Volume 79, No. 167, page 51247, in the 

DATES section of the document it states 

the dates the new fees become effective 

is September 6, 2014, and written 

comments must be received on or before 

October 21, 2014. The correct date new 

fees become effective is September 12, 

2014, and written comments must be 

received on or before October 26, 2014. 

Correction 

In FR Doc 2014–20516, appearing on 

page 51247 in the Federal Register of 

August 28, 2014 (79 FR 51247), in the 

third column, the effective date and 

comment period end date are corrected 

in the DATES section of this document. 

Dated: August 28, 2014. 

Patrick Kennedy, 

Under Secretary of State for Management, 

Department of State. 

[FR Doc. 2014–21045 Filed 9–2–14; 8:45 am] 

BILLING CODE 4710–06–P 


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