80 FR 11865 - Banned Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

Page Range		11865-11865
FR Document		2015-05028

Federal Register, Volume 80 Issue 43 (Thursday, March 5, 2015)

[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Rules and Regulations]
[Page 11865]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 895


Banned Devices

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, 
revised as of April 1, 2014, on page 594, in Sec.  895.21, remove the 
undesignated paragraph following paragraph (d)(8).

[FR Doc. 2015-05028 Filed 3-4-15; 08:45 am]
 BILLING CODE 1505-01D

Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Rules and Regulations 11865

Dated: February 27, 2015. and Health Administration (OSHA), revised regulations are designed to be
Kevin J. Wolf, investigations by OSHA, appeals of consistent with the procedures applied
Assistant Secretary for Export OSHA determinations to an to claims under other whistleblower
Administration. administrative law judge (ALJ) for a statutes administered by OSHA,
[FR Doc. 2015–05085 Filed 3–4–15; 8:45 am] hearing de novo, hearings by ALJs, including the Surface Transportation
BILLING CODE 3510–33–P review of ALJ decisions by the Assistance Act of 1982 (STAA), 29 CFR
Administrative Review Board (ARB) part 1978; the National Transit Systems
(acting on behalf of the Secretary of Security Act (NTSSA) and the Federal
DEPARTMENT OF HEALTH AND Labor), and judicial review of the Railroad Safety Act (FRSA), 29 CFR part
HUMAN SERVICES Secretary of Labor’s final decision. It 1982; the Consumer Product Safety
also sets forth the Secretary of Labor’s Improvement Act of 2008 (CPSIA), 29
Food and Drug Administration interpretations of the Sarbanes-Oxley CFR part 1983; the Employee Protection
whistleblower provision on certain Provisions of Six Environmental
21 CFR Part 895 matters. Statutes and Section 211 of the Energy
DATES: This final rule is effective on
Reorganization Act of 1974, as
Banned Devices March 5, 2015. amended, 29 CFR part 24; the
Affordable Care Act (ACA), 29 CFR part
CFR Correction FOR FURTHER INFORMATION CONTACT:
1984; the Consumer Financial
Brian Broecker, Directorate of
In Title 21 of the Code of Federal Protection Act (CFPA), 29 CFR part
Whistleblower Protection Programs, 1985; the Seaman’s Protection Act
Regulations, Parts 800 to 1299, revised
Occupational Safety and Health (SPA), 29 CFR part 1986; and the FDA
as of April 1, 2014, on page 594, in
Administration, U.S. Department of Food Safety Modernization Act (FSMA),
§ 895.21, remove the undesignated
Labor, Room N–4624, 200 Constitution 29 CFR part 1987.
paragraph following paragraph (d)(8).
Avenue NW., Washington, DC 20210;
[FR Doc. 2015–05028 Filed 3–4–15; 08:45 am] telephone (202) 693–2199; email: II. Summary of Statutory Procedures
BILLING CODE 1505–01D OSHA.DWPP@dol.gov. This is not a toll- and Statutory Changes to the Sarbanes-
free number. This Federal Register Oxley Whistleblower Provision
publication is available in alternative Sarbanes-Oxley’s whistleblower
DEPARTMENT OF LABOR formats. The alternative formats provision, as amended by Dodd-Frank,
available are large print, electronic file includes procedures that allow a
Occupational Safety and Health on computer disk (Word Perfect, ASCII, covered employee to file a complaint
Administration Mates with Duxbury Braille System) and with the Secretary of Labor (Secretary) 1
audiotape. not later than 180 days after the alleged
29 CFR Part 1980 SUPPLEMENTARY INFORMATION: retaliation or after the employee learns
[Docket Number: OSHA–2011–0126] of the alleged retaliation. Sarbanes-
I. Background
RIN 1218–AC53
Oxley further provides that the rules
Sarbanes-Oxley was first enacted on and procedures set forth in the Wendell
July 30, 2002. Title VIII is designated as H. Ford Aviation Investment and
Procedures for the Handling of
the Corporate and Criminal Fraud Reform Act for the 21st Century
Retaliation Complaints Under Section
Accountability Act of 2002. Section 806, (AIR21), 49 U.S.C. 42121(b), govern in
806 of the Sarbanes-Oxley Act of 2002,
codified at 18 U.S.C. 1514A, is the Sarbanes-Oxley actions. 18 U.S.C.
as Amended
‘‘whistleblower provision,’’ which 1514A(b)(2)(A). Accordingly, upon
AGENCY: Occupational Safety and Health provides protection to employees receipt of the complaint, the Secretary
Administration, Labor. against retaliation by certain persons must provide written notice to the
ACTION: Final rule. covered under the Act for engaging in person or persons named in the
specified protected activity. The Act complaint alleged to have violated the
SUMMARY: This document provides the generally was designed to protect Act (respondent) of the filing of the
final text of regulations governing investors by ensuring corporate complaint, the allegations contained in
employee protection (retaliation or responsibility, enhancing public the complaint, the substance of the
whistleblower) claims under section 806 disclosure, and improving the quality evidence supporting the complaint, and
of the Corporate and Criminal Fraud and transparency of financial reporting the rights afforded the respondent
Accountability Act of 2002, Title VIII of and auditing. The whistleblower throughout the investigation. The
the Sarbanes-Oxley Act of 2002 provision is intended to protect Secretary must then, within 60 days of
(Sarbanes-Oxley or Act), which was employees who report fraudulent receipt of the complaint, afford the
amended by sections 922 and 929A of activity and violations of Securities respondent an opportunity to submit a
the Dodd-Frank Wall Street Reform and Exchange Commission (SEC) rules and
Consumer Protection Act of 2010 (Dodd- regulations that can harm innocent 1 The regulatory provisions in this part have been

Frank), enacted on July 21, 2010. An investors in publicly traded companies. written and organized to be consistent with other
whistleblower regulations promulgated by OSHA to
interim final rule (IFR) governing these Dodd-Frank amended the Sarbanes- the extent possible within the bounds of the
provisions and request for comment was Oxley whistleblower provision, 18 statutory language of Sarbanes-Oxley.
published in the Federal Register on U.S.C. 1514A. The regulatory revisions Responsibility for receiving and investigating
November 3, 2011. Five comments were described herein reflect these statutory complaints under Sarbanes-Oxley has been
mstockstill on DSK4VPTVN1PROD with RULES

delegated to the Assistant Secretary for
received. This rule responds to those amendments and also seek to clarify and Occupational Safety and Health. Secretary of
comments and establishes the final improve OSHA’s procedures for Labor’s Order No. 01–2012 (Jan. 18, 2012), 77 FR
procedures and time frames for the handling Sarbanes-Oxley whistleblower 3912 (Jan. 25, 2012). Hearings on determinations by
handling of retaliation complaints under claims, as well as to set forth OSHA’s the Assistant Secretary are conducted by the Office
of Administrative Law Judges, and appeals from
Sarbanes-Oxley, including procedures interpretations of the Act. To the extent decisions by administrative law judges are decided
and time frames for employee possible within the bounds of by the ARB. Secretary of Labor’s Order 2–2012 (Oct.
complaints to the Occupational Safety applicable statutory language, these 19, 2012), 77 FR 69378 (Nov. 16, 2012).

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Document Created: 2015-12-18 12:08:54
Document Modified: 2015-12-18 12:08:54

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
FR Citation		80 FR 11865

80 FR 11865 - Banned Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration