This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

31299 

Vol. 80, No. 105 

Tuesday, June 2, 2015 

1Specifically, the SMDA deleted the then-last 

sentence of section 516(a). See Pub. L. 101–629, 

section 18(d)(2) (‘‘Section 516(a) (21 U.S.C. 360f(a)) 

is amended . . . by striking out the last sentence.’’); 

21 U.S.C. 360f(a) (1989) (stating, in the last 

sentence, ‘‘The Secretary shall afford all interested 

persons opportunity for an informal hearing on a 

regulation proposed under this subsection.’’). 

2Although the hearing provision was validly 

removed from § 895.21(d)(8) in 1992, the removed 

language erroneously reappeared in the Code of 

Federal Regulations starting in 1994. On March 5, 

2015 (80 FR 11865), the Office of the Federal 

Register published a correction document fixing 

this publication error. 

DEPARTMENT OF STATE 

2 CFR Part 600 

22 CFR Parts 135 and 145 

[Public Notice: 9160] 

RIN 1400–AD57 

Uniform Administrative Requirements, 

Cost Principles, and Audit 

Requirements for Federal Awards 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: The Department of State 

(‘‘Department’’) finalizes its portion of 

the uniform federal assistance rule 

published by the Office of Management 

and Budget. 

DATES: This rule is effective on June 2, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey D. Johnson, Director, Federal 

Assistance, 703–812–2526, johnsonjd4@

state.gov. 

SUPPLEMENTARY INFORMATION: On 

December 19, 2014, the Office of 

Management and Budget published an 

interim final rule that provided 

comprehensive modifications to the 

principles and requirements for federal 

awards. 79 FR 75871. The uniform rules 

were published as 2 CFR part 200. As 

part of that rulemaking, the Department 

of State adopted part 200, along with an 

agency-specific addendum in a new part 

600. In addition, the Department 

removed 22 CFR parts 135 and 145, as 

they became obsolete with the 

publication of the interim final rule. See 

79 FR at 76019. 

The Department received no relevant 

comments in response to the rule. 

Therefore, 2 CFR part 600, as described 

in the interim final rule, is adopted with 

no changes. 

Regulatory Findings 

For the regulatory findings regarding 

this rulemaking, please refer to the 

analysis prepared by OMB in the 

interim final rule, which is incorporated 

herein. 79 FR at 75876. 

List of Subjects in 2 CFR Part 600 and 

22 CFR Parts 135 and 145 

Accounting, Colleges and universities, 

Grant programs, Hospitals, Indians, 

Intergovernmental relations, Nonprofit 

organizations, Reporting and 

recordkeeping requirements. 

Accordingly, the interim rule adding 

2 CFR part 600 and amending 22 CFR 

parts 135 and 145, which was published 

at 79 FR 75871 on December 19, 2014, 

is adopted as a final rule without 

change. 

Dated: May 27, 2015. 

Jeffrey D. Johnson, 

Director, Federal Assistance, Department of 

State. 

[FR Doc. 2015–13437 Filed 6–1–15; 8:45 am] 

BILLING CODE 4710–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 895 

[Docket No. FDA–2015–N–0011] 

Banned Devices; General Provisions; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to clarify that the Agency 

will provide an opportunity for an 

informal hearing in connection with a 

proposed rule to ban a device with a 

special effective date. This action is 

being taken to align the regulations with 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). 

DATES: This rule is effective June 2, 

2015. 

FOR FURTHER INFORMATION CONTACT: Ian 

Ostermiller, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4432, Silver Spring, 

MD 20993–0002, 301–796–5678. 

SUPPLEMENTARY INFORMATION: FDA is 

correcting an error in the regulations 

that set forth the procedures for banning 

a medical device using a special 

effective date (§ 895.30 (21 CFR 

895.30)). Specifically, the Agency is 

restoring a phrase that was incorrectly 

deleted from § 895.30(c). The 

regulations are being amended to ensure 

clarity and consistency with the 

requirements of the FD&C Act (21 U.S.C. 

321 et seq.). 

In this case, the regulations became 

inconsistent after the Safe Medical 

Devices Act of 1990 (SMDA) (Pub. L. 

101–629) amended the FD&C Act. Prior 

to the SMDA, the FD&C Act required the 

Secretary of Health and Human Services 

to afford an opportunity for informal 

hearings about any proposed rule to ban 

a medical device, regardless of effective 

date. One of the SMDA’s provisions 

removed the requirement that FDA 

provide an opportunity for an informal 

hearing when FDA does not establish a 

special effective date for a proposed 

ban.1 However, the SMDA did not 

eliminate the informal hearing provision 

for a proposed ban issued with a special 

effective date. Thus, section 516(b) of 

the FD&C Act continues to require that 

FDA ‘‘provide reasonable opportunity 

for an informal hearing’’ on a proposed 

ban with a special effective date (21 

U.S.C. 360f(b)). 

On December 10, 1992 (57 FR 58400), 

FDA published a final rule 

implementing the SMDA. The final rule 

of 1992 correctly amended 21 CFR 

895.21(d), which covers the procedures 

for issuing a ban without a special 

effective date, by removing the 

requirement that FDA provide an 

opportunity for an informal hearing 

when there is no special effective date.2

However, the final rule incorrectly 

removed the same phrase from § 895.30, 


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