43246 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Rules and Regulations 

that include subcutaneous ports must 

include the following: 

(A) Labeling must include the 

recommended type of needle for access 

as well as detailed instructions for care 

and maintenance of the port, 

subcutaneous pocket, and skin 

overlying the port. 

(B) Performance testing must include 

results on repeated use of the ports that 

simulates use over the intended life of 

the device. 

(C) Clinical performance testing must 

demonstrate safe and effective use and 

capture any adverse events observed 

during clinical use. 

(vii) In addition to Special Controls in 

paragraphs (b)(1)(i) through (v) of this 

section, implanted blood access devices 

with coatings or additives must include 

the following: 

(A) A description and material 

characterization of the coating or 

additive material, the purpose of the 

coating or additive, duration of 

effectiveness, and how and where the 

coating is applied. 

(B) An identification in the labeling of 

any coatings or additives and a 

summary of the results of performance 

testing for any coating or material with 

special characteristics, such as 

decreased thrombus formation or 

antimicrobial properties. 

(C) A Warning Statement in the 

labeling for potential allergic reactions 

including anaphylaxis if the coating or 

additive contains known allergens. 

(D) Performance data must 

demonstrate efficacy of the coating or 

additive and the duration of 

effectiveness. 

(viii) The following must be included 

for A–V shunt cannulae (with vessel 

tips): 

(A) The device must comply with 

Special Controls in paragraphs (b)(1)(i) 

through (v) of this section with the 

exception of paragraphs (b)(1)(ii)(B), 

(b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), 

which do not apply. 

(B) Labeling must include Warning 

Statements to address the potential for 

vascular access steal syndrome, arterial 

stenosis, arterial thrombosis, and 

hemorrhage including exsanguination 

given that the device accesses the 

arterial circulation. 

(C) Clinical performance testing must 

demonstrate safe and effective use and 

capture any adverse events observed 

during clinical use. 

(2) Class II (performance standards) 

for the nonimplanted blood access 

device. 

(3) Class II (performance standards) 

for accessories for both the implanted 

and the nonimplanted blood access 

devices not listed in paragraph (b)(4) of 

this section. 

(4) Class I for the cannula clamp, 

disconnect forceps, crimp plier, tube 

plier, crimp ring, and joint ring, 

accessories for both the implanted and 

nonimplanted blood access device. The 

devices subject to this paragraph (b)(4) 

are exempt from the premarket 

notification procedures in subpart E of 

part 807 of this chapter subject to the 

limitations in § 876.9. 

Dated: July 18, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–17477 Filed 7–24–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 13 

[Public Notice: 8808] 

RIN 1400–AD61 

Personnel; Changes in Statutory 

Authority; Technical Corrections; 

Liability for Neglect of Duty or for 

Malfeasance Generally; Repeal of 

Regulation 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State is 

repealing the regulation that provides 

for personal liability for Consular 

Officers in cases of malfeasance, and 

provides updates to citations of 

authorities. The deleted regulation, 

which was promulgated in 1957 and last 

amended in 1984, is no longer 

authorized by statute. 

DATES: This rule is effective July 25, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Klimow, Office of Legal Affairs, 

Overseas Citizen Services, U.S. 

Department of State, 2201 C Street NW., 

SA–17, Washington, DC 20520, (202) 

485–6224, klimowda1@state.gov. 

SUPPLEMENTARY INFORMATION: This rule 

removes 22 CFR 13.3 from the Code of 

Federal Regulations. 22 CFR 13.3 

provides that consular officers who 

willfully neglect or fail to perform any 

duty imposed on them by law shall be 

found liable to all persons injured by 

any such neglect, or omission, 

malfeasance, abuse, or corrupt conduct. 

22 CFR 13.3 also provides for criminal 

penalties for consular officers found 

guilty for malfeasance and corrupt 

conduct in office. The Department is 

removing 22 CFR 13.3 because the rule’s 

authorizing statute has been repealed. 

22 CFR 13.3 implemented 22 U.S.C. 

1199, which explicitly provided for civil 

and criminal liability against consular 

officers for willful neglect or omission 

in the performance of their assigned 

duties. Section 1199 was repealed in 

1977, and the legislative history for the 

repeal of Section 1199 reflected a desire 

by Congress to treat consular officers the 

same as other federal employees with 

respect to personal liability for acts 

taken within the scope of their official 

duties. Foreign Relations Authorization 

Act, Fiscal Year 1978, Public Law 95– 

105, title I, section 111, 91 Stat. 848 

(1977); H.R. Rep. No. 95–231, at 17, 21 

(1977); H.R. Rep. No. 95–537 at 33 

(1977) (Conf. Rep.). 

22 CFR 13.3 was also promulgated 

under the authority of 22 U.S.C. 2658 

and 22 U.S.C. 3926. However, 22 U.S.C. 

2658 was repealed in 1994. 22 U.S.C. 

3926 is still in effect and is a general 

authorization for the Secretary of State 

to prescribe such regulations as are 

necessary to administer the foreign 

service in conformity with federal law; 

however, it does not grant the Secretary 

specific authority to provide for the civil 

and criminal liability of consular 

officers in 22 CFR 13.3. 

Finally, this rule updates all of the 

statutory authorities cited in Part 13, 

and updates one regulatory reference 

(from Section 22.4 to Section 22.6). 

Regulatory Analysis and Notices 

Administrative Procedure Act 

This action is being taken as a final 

rule pursuant to the ‘‘good cause’’ 

provision of 5 U.S.C. 553(b). It is the 

position of the Department that notice 

and comment are not necessary in light 

of the fact that 22 CFR 13.3 implements 

a repealed statute; thus, it is no longer 

authorized. In addition, there were only 

technical edits to the remaining three 

sections of Part 13. This rulemaking is 

effective immediately in accordance 

with 5 U.S.C. 553(d)(3). Finally, this 

rulemaking is exempt from the notice 

and comment pursuant to 5 U.S.C. 

553(a)(2), as it is a matter relating to 

agency management of personnel. 

Regulatory Flexibility Act 

The Department hereby certifies that 

this rulemaking will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act, 5 

U.S.C. 605(b). 

Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995, 2 U.S.C. 

1532, generally requires agencies to 

prepare a statement before proposing 


rmajette on DSK2TPTVN1PROD with RULES
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Rules and Regulations 43247 

any rule that may result in an annual 

expenditure of $100 million or more by 

State, local, or tribal governments, or by 

the private sector. This rulemaking will 

not result in any such expenditure, nor 

will it significantly or uniquely affect 

small governments. 

Executive Orders 12866 and 13563 

The Department of State has reviewed 

this rule to ensure its consistency with 

the regulatory philosophy and 

principles set forth in Executive Order 

12866 and has determined that the 

benefits of this rule seeking repeal of 22 

CFR 13.3 and updates to Part 13 justify 

its costs. The Department does not 

consider this rule to be a significant rule 

as defined by E.O. 12866. The 

Department has considered this rule in 

light of Executive Order 13563, and 

affirms that this regulation is consistent 

with the guidance therein. 

Federalism 

This rule will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. Nor will the rule 

have federalism implications warranting 

the application of Executive Orders 

12372 and 13132. 

Civil Justice Reform 

The Department has reviewed this 

rulemaking in light of sections 3(a) and 

3(b)(2) of Executive Order 12988 to 

eliminate ambiguity, minimize 

litigation, establish clear legal 

standards, and reduce burden. 

Consultations With Tribal Governments 

The Department has determined that 

this rulemaking will not have Tribal 

implications, will not impose 

substantial direct compliance costs on 

Indian Tribal governments, and will not 

pre-empt Tribal law. Accordingly, the 

requirements of Executive Order 13175 

do not apply to this rulemaking. 

Paperwork Reduction Act 

This rule does not impose information 

collection requirements under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. Chapter 35. 

List of Subjects in 22 CFR Part 13 

Consular services, Crime, Government 

employees. 

Accordingly, 22 CFR part 13 is 

amended as follows: 

PART 13—PERSONNEL 

■ 1. The authority citation for Part 13 is 

revised to read as follows: 

Authority: 22 U.S.C. 2651a; 22 U.S.C. 

4198–4199, 4209, and 4217–4218. 

§ 13.1 [Amended] 

■ 2. Section 13.1 is amended by 

removing ‘‘(22 U.S.C. 1189)’’ and adding 

‘‘(22 U.S.C. 4209)’’ in its place, by 

removing ‘‘§ 22.4’’ and adding ‘‘§ 22.6’’ 

in its place in the Note, and by 

removing the sectional authority 

citation. 

§ 13.2 [Amended] 

■ 3. Section 13.2 is amended by 

removing ‘‘(22 U.S.C. 1198)’’ and adding 

‘‘(22 U.S.C. 4217’’) in its place, and by 

removing ‘‘(22 U.S.C. 1178 and 1179)’’ 

adding ‘‘(22 U.S.C. 4198 and 4199)’’ in 

its place, and by removing the sectional 

authority citation. 

§ 13.3 [Removed and Reserved] 

■ 4. Section 13.3 is removed and 

reserved. 

§ 13.4 [Amended] 

■ 5. Section 13.4 is amended by 

removing ‘‘(22 U.S.C. 1200)’’ and adding 

‘‘(22 U.S.C. 4218)’’ in its place, and by 

removing the sectional authority 

citation. 

Dated: July 18, 2014. 

Michele T. Bond, 

Acting Assistant Secretary, Bureau of 

Consular Affairs, U.S. Department of State. 

[FR Doc. 2014–17428 Filed 7–24–14; 8:45 am] 

BILLING CODE 4710–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2014–M–0966] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

Implantable Transprostatic Tissue 

Retractor System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final Order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

implantable transprostatic tissue 

retractor system into class II (special 

controls). The special controls that will 

apply to the device are identified in this 

order and will be part of the codified 

language. The Agency is classifying the 

device into class II (special controls) in 

order to provide a reasonable assurance 

of safety and effectiveness of the device. 

DATES: This order is effective August 25, 

2014. The classification was applicable 

beginning September 13, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Mark Kreitz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G270, Silver Spring, 

MD 20993–0002, 301–796–7019. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

section 513(a)(1). Under the first 

procedure, the person submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified and, 

within 30 days of receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

the person requests a classification 

under section 513(f)(2). Under the 

second procedure, rather than first 

submitting a premarket notification 

under section 510(k) of the FD&C Act 

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 


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