Protection of Human Subjects, 57548-57549 [2015-24247]

Download as PDF 57548 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules and/or of essential functions, and possible reduced control of the airplane. the DOA, the approval must include the DOA-authorized signature. (f) Compliance Comply with this AD within the compliance times specified, unless already done. (i) Related Information (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency Airworthiness Directive 2015–0006, dated January 15, 2015, for related information. This MCAI may be found in the AD docket on the Internet at https://www.regulations.gov by searching for and locating Docket No. FAA–2015–3629. (2) For service information identified in this AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201–440–6700; Internet https:// www.dassaultfalcon.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425–227–1221. tkelley on DSK3SPTVN1PROD with PROPOSALS (g) Modification Within 24 months after the effective date of this AD, modify the anti-collision light bonding, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(7) of this AD. (1) For Model MYSTERE–FALCON 50 airplanes: Dassault Service Bulletin F50–481, dated August 22, 2007. (2) For Model MYSTERE–FALCON 900 airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900–372, dated August 22, 2007. (3) For Model MYSTERE–FALCON 900 airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900–378, dated September 19, 2007. (4) For Model FALCON 900EX airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900EX–285, dated July 18, 2007. (5) For Model FALCON 900EX airplanes with the WHELEN system installed on the Sduct cowl: Dassault Service Bulletin F900EX–305, dated September 19, 2007. (6) For Model FALCON 2000 airplanes: Dassault Service Bulletin F2000–337, dated July 25, 2007. (7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX–108, dated July 25, 2007. (h) Other FAA AD Provisions The following provisions also apply to this AD: (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057–3356; telephone 425–227–1137; fax 425–227–1139. Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD. (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM– 116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Dassault Aviation’s EASA Design Organization Approval (DOA). If approved by VerDate Sep<11>2014 16:29 Sep 23, 2015 Jkt 235001 Issued in Renton, Washington, on September 2, 2015. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. 2015–22803 Filed 9–23–15; 8:45 am] BILLING CODE 4910–13–P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1028 Protection of Human Subjects Consumer Product Safety Commission. ACTION: Proposed rule. AGENCY: On September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the ‘‘Common Rule’’) published a notice of proposed rulemaking (‘‘NPR’’) amending the Common Rule. Through this proposed rule, the Consumer Product Safety Commission (‘‘CPSC’’ or ‘‘Commission’’) proposes to adopt the Common Rule NPR and solicits public comment on the proposal. DATES: Comments must be received no later than 5 p.m. on December 7, 2015. ADDRESSES: You may submit comments, identified by docket ID number HHS– OPHS–2015–0008, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Enter the above docket ID number in the ‘‘Enter Keyword or ID’’ field and click on ‘‘Search.’’ On the next Web page, click on ‘‘Submit a Comment’’ action and follow the instructions. • Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, SUMMARY: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 Rockville, MD 20852. Comments received, including any personal information, will be posted without change to www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Hope E.J. Nesteruk, Human Factors Engineer, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301–987–2579; email: hnesteruk@cpsc.gov. SUPPLEMENTARY INFORMATION: I. Background On June 18, 1991, the Department of Health and Human Services (‘‘HHS’’) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 14 other agencies, including the CPSC, joined HHS in adopting a uniform set of rules for the protection of human subjects identical to subpart A of 45 CFR part 46. The Common Rule is codified in the CPSC’s regulations at 16 CFR part 1028. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an institutional review board, obtaining and documenting informed consent of human subjects, and submitting a written assurance of institutional compliance with the Common Rule. On September 8, 2015, (80 FR 53933), HHS, on behalf of many of the same agencies that were signatories to the original Common Rule, proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The Common Rule NPR seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The participating departments and agencies proposed these revisions to the regulations because they believe these changes would strengthen protections for research subjects while facilitating important research. The full description of the proposed revisions to the Common Rule is provided in the Common Rule NPR at 80 FR 53933. Although the CPSC is a signatory to the original Common Rule, the CPSC’s procedural requirements require Commission deliberation and vote on new rulemaking matters. Due to HHS’s expedited schedule regarding publication of the Common Rule NPR in the Federal Register, the CPSC was not E:\FR\FM\24SEP1.SGM 24SEP1 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules a signatory of the Common Rule NPR. However, through this proposed rule, the Commission proposes to adopt the Common Rule NPR and solicits comment on the proposal. II. CPSC’s Proposed Regulatory Text List of Subjects in 16 CFR Part 1028 Human research subjects, Reporting and recordkeeping requirements, Research. For the reasons stated in the preamble, the Consumer Product Safety Commission proposes to revise 16 CFR part 1028 to read as follows: PART 1028—PROTECTION OF HUMAN SUBJECTS Cross-Reference. Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 1(b). PART 1028—PROTECTION OF HUMAN SUBJECTS § 1028.101 Cross-Reference. The provisions set forth at 45 CFR part 46, subpart A, concerning the protection of human research subjects, apply to all research conducted, supported, or otherwise subject to regulation by the CPSC. Dated: September 21, 2015. Todd A. Stevenson, Secretary, Consumer Product Safety Commission. tkelley on DSK3SPTVN1PROD with PROPOSALS [FR Doc. 2015–24247 Filed 9–23–15; 8:45 am] BILLING CODE 6355–01–P VerDate Sep<11>2014 16:29 Sep 23, 2015 Jkt 235001 Federal Energy Regulatory Commission 18 CFR Part 40 [Docket No. RM15–8–000] CPSC’s current regulations on the protection of human subjects are the regulations promulgated by all of the departments and agencies subject to the Common Rule, as codified under the CPSC’s regulations at 16 CFR part 1028. For the reasons provided in the Common Rule NPR (80 FR 53933), the CPSC would adopt the amended regulatory text provided in the Common Rule NPR. Because the CPSC follows the HHS regulations in 45 CFR part 46, subpart A, the CPSC proposes to amend the Commission regulations at 16 CFR part 1028 to cross-reference the HHS regulations in 45 CFR part 46, subpart A. Sec. 1028.101 DEPARTMENT OF ENERGY Relay Performance During Stable Power Swings Reliability Standard Federal Energy Regulatory Commission. ACTION: Notice of proposed rulemaking. AGENCY: The Federal Energy Regulatory Commission proposes to approve Reliability Standard PRC–026– 1 (Relay Performance During Stable Power Swings), submitted by the North American Electric Reliability Corporation. The proposed Reliability Standard is designed to ensure that applicable entities use protective relay systems that can differentiate between faults and stable power swings. In addition, the Commission requests comment regarding the potential burden of modifying the applicability of proposed Reliability Standard PRC– 026–1 to include relays with a time delay of 15 cycles or greater in instances where either (1) an element has been identified by a Planning Coordinator as potentially susceptible to power swings or (2) an entity becomes aware of a bulk electric system element that tripped in response to a stable or unstable power swing due to the operation of its protective relay(s), even if the element was not previously identified by the planning coordinator. DATES: Comments are due November 23, 2015. ADDRESSES: Comments, identified by docket number, may be filed in the following ways: • Electronic Filing through https:// www.ferc.gov. Documents created electronically using word processing software should be filed in native applications or print-to-PDF format and not in a scanned format. • Mail/Hand Delivery: Those unable to file electronically may mail or handdeliver comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426. Instructions: For detailed instructions on submitting comments and additional information on the rulemaking process, see the Comment Procedures Section of this document. FOR FURTHER INFORMATION CONTACT: Kenneth Hubona (Technical Information), Office of Electric Reliability, Federal Energy Regulatory SUMMARY: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 57549 Commission, 888 First Street NE., Washington, DC 20426, (301) 665– 1608, kenneth.hubona@ferc.gov. Kevin Ryan (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502–6840, kevin.ryan@ ferc.gov. SUPPLEMENTARY INFORMATION: 1. Pursuant to section 215 of the Federal Power Act (FPA),1 the Commission proposes to approve Reliability Standard PRC–026–1 (Relay Performance During Stable Power Swings), submitted by the North American Electric Reliability Corporation (NERC), the Commissionapproved Electric Reliability Organization (ERO). The proposed Reliability Standard applies to planning coordinators, as well as generator owners and transmission owners that apply certain load-responsive protective relays in specific, identified circumstances, and is designed to ensure the use of protective relay systems that can differentiate between faults and stable power swings. In addition, the Commission proposes to approve NERC’s proposed implementation plan, and the assigned violation risk factors and violation severity levels. 2. Consistent with directives issued in Order No. 733,2 the Commission proposes to find that the proposed Reliability Standard addresses undesirable relay operation due to power swings,3 and provides an equally effective and efficient alternative to the Order No. 733 directive requiring the use of protective relay systems that can differentiate between faults and stable power swings and, when necessary, retirement of protective relay systems that cannot meet this requirement.4 Further, as discussed below, the Commission seeks comment regarding the potential burden of modifying the applicability of proposed Reliability Standard PRC–026–1 to include relays with a time delay of 15 cycles or greater in instances where either (1) an element has been identified by a Planning Coordinator as potentially susceptible to power swings or (2) an entity becomes aware of a bulk electric system element that tripped in response to a stable or 1 16 U.S.C. 824o (2012). Relay Loadability Reliability Standard, Order No. 733, 130 FERC ¶ 61,221 (2010), order on reh’g and clarification, Order No. 733–A, 134 FERC ¶ 61,127, order on reh’g and clarification, Order No. 733–B, 136 FERC ¶ 61,185 (2011). 3 Order No. 733, 130 FERC ¶ 61,221 at P 153. 4 Id. P 150. 2 Transmission E:\FR\FM\24SEP1.SGM 24SEP1

Agencies

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Proposed Rules]
[Pages 57548-57549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24247]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1028


Protection of Human Subjects

AGENCY: Consumer Product Safety Commission.

ACTION:  Proposed rule.

-----------------------------------------------------------------------

SUMMARY:  On September 8, 2015, the federal departments and agencies 
that are subject to the Federal Policy for the Protection of Human 
Subjects (referred to as the ``Common Rule'') published a notice of 
proposed rulemaking (``NPR'') amending the Common Rule. Through this 
proposed rule, the Consumer Product Safety Commission (``CPSC'' or 
``Commission'') proposes to adopt the Common Rule NPR and solicits 
public comment on the proposal.

DATES: Comments must be received no later than 5 p.m. on December 7, 
2015.

ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2015-0008, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Enter the above docket ID number in the ``Enter Keyword or ID'' field 
and click on ``Search.'' On the next Web page, click on ``Submit a 
Comment'' action and follow the instructions.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852. Comments received, including 
any personal information, will be posted without change to 
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Hope E.J. Nesteruk, Human Factors 
Engineer, Division of Human Factors, Directorate for Engineering 
Sciences, Consumer Product Safety Commission, 5 Research Place, 
Rockville, MD 20850; telephone: 301-987-2579; email: 
hnesteruk@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 18, 1991, the Department of Health and Human Services 
(``HHS'') issued a rule setting forth the Common Rule requirements for 
the protection of human subjects. (56 FR 28003). The HHS regulations 
are codified at 45 CFR part 46. At that time, 14 other agencies, 
including the CPSC, joined HHS in adopting a uniform set of rules for 
the protection of human subjects identical to subpart A of 45 CFR part 
46. The Common Rule is codified in the CPSC's regulations at 16 CFR 
part 1028. The basic provisions of the Common Rule include, among other 
things, requirements related to the review of human subjects research 
by an institutional review board, obtaining and documenting informed 
consent of human subjects, and submitting a written assurance of 
institutional compliance with the Common Rule.
    On September 8, 2015, (80 FR 53933), HHS, on behalf of many of the 
same agencies that were signatories to the original Common Rule, 
proposed revisions to modernize, strengthen, and make more effective 
the Federal Policy for the Protection of Human Subjects that was 
promulgated as a Common Rule in 1991. The Common Rule NPR seeks comment 
on proposals to better protect human subjects involved in research, 
while facilitating valuable research and reducing burden, delay, and 
ambiguity for investigators. The participating departments and agencies 
proposed these revisions to the regulations because they believe these 
changes would strengthen protections for research subjects while 
facilitating important research.
    The full description of the proposed revisions to the Common Rule 
is provided in the Common Rule NPR at 80 FR 53933. Although the CPSC is 
a signatory to the original Common Rule, the CPSC's procedural 
requirements require Commission deliberation and vote on new rulemaking 
matters. Due to HHS's expedited schedule regarding publication of the 
Common Rule NPR in the Federal Register, the CPSC was not

[[Page 57549]]

a signatory of the Common Rule NPR. However, through this proposed 
rule, the Commission proposes to adopt the Common Rule NPR and solicits 
comment on the proposal.

II. CPSC's Proposed Regulatory Text

    CPSC's current regulations on the protection of human subjects are 
the regulations promulgated by all of the departments and agencies 
subject to the Common Rule, as codified under the CPSC's regulations at 
16 CFR part 1028. For the reasons provided in the Common Rule NPR (80 
FR 53933), the CPSC would adopt the amended regulatory text provided in 
the Common Rule NPR. Because the CPSC follows the HHS regulations in 45 
CFR part 46, subpart A, the CPSC proposes to amend the Commission 
regulations at 16 CFR part 1028 to cross-reference the HHS regulations 
in 45 CFR part 46, subpart A.

List of Subjects in 16 CFR Part 1028

    Human research subjects, Reporting and recordkeeping requirements, 
Research.

    For the reasons stated in the preamble, the Consumer Product Safety 
Commission proposes to revise 16 CFR part 1028 to read as follows:

PART 1028--PROTECTION OF HUMAN SUBJECTS

Sec.
1028.101 Cross-Reference.

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

PART 1028--PROTECTION OF HUMAN SUBJECTS


Sec.  1028.101  Cross-Reference.

    The provisions set forth at 45 CFR part 46, subpart A, concerning 
the protection of human research subjects, apply to all research 
conducted, supported, or otherwise subject to regulation by the CPSC.

    Dated: September 21, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2015-24247 Filed 9-23-15; 8:45 am]
 BILLING CODE 6355-01-P
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