80_FR_57733 80 FR 57548 - Protection of Human Subjects

80 FR 57548 - Protection of Human Subjects

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 80, Issue 185 (September 24, 2015)

Page Range57548-57549
FR Document2015-24247

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.

Federal Register, Volume 80 Issue 185 (Thursday, September 24, 2015) 
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Proposed Rules]
[Pages 57548-57549]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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: http://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

57548 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules and/or of essential functions, and possible the DOA, the approval must include the Rockville, MD 20852. Comments reduced control of the airplane. DOA-authorized signature. received, including any personal (f) Compliance (i) Related Information information, will be posted without Comply with this AD within the (1) Refer to Mandatory Continuing change to www.regulations.gov. compliance times specified, unless already Airworthiness Information (MCAI) European FOR FURTHER INFORMATION CONTACT: done. Aviation Safety Agency Airworthiness Hope E.J. Nesteruk, Human Factors Directive 2015–0006, dated January 15, 2015, Engineer, Division of Human Factors, (g) Modification for related information. This MCAI may be Directorate for Engineering Sciences, Within 24 months after the effective date found in the AD docket on the Internet at of this AD, modify the anti-collision light Consumer Product Safety Commission, http://www.regulations.gov by searching for bonding, in accordance with the and locating Docket No. FAA–2015–3629. 5 Research Place, Rockville, MD 20850; Accomplishment Instructions of the (2) For service information identified in telephone: 301–987–2579; email: applicable service information specified in this AD, contact Dassault Falcon Jet, P.O. Box hnesteruk@cpsc.gov. paragraphs (g)(1) through (g)(7) of this AD. 2000, South Hackensack, NJ 07606; SUPPLEMENTARY INFORMATION: (1) For Model MYSTERE–FALCON 50 telephone 201–440–6700; Internet http:// airplanes: Dassault Service Bulletin F50–481, www.dassaultfalcon.com. You may view this I. Background dated August 22, 2007. service information at the FAA, Transport (2) For Model MYSTERE–FALCON 900 On June 18, 1991, the Department of Airplane Directorate, 1601 Lind Avenue SW., Health and Human Services (‘‘HHS’’) airplanes with the WHELEN system installed Renton, WA. For information on the on the fin tip: Dassault Service Bulletin issued a rule setting forth the Common availability of this material at the FAA, call F900–372, dated August 22, 2007. 425–227–1221. Rule requirements for the protection of (3) For Model MYSTERE–FALCON 900 human subjects. (56 FR 28003). The airplanes with the WHELEN system installed Issued in Renton, Washington, on HHS regulations are codified at 45 CFR on the S-duct cowl: Dassault Service Bulletin September 2, 2015. part 46. At that time, 14 other agencies, F900–378, dated September 19, 2007. Michael Kaszycki, including the CPSC, joined HHS in (4) For Model FALCON 900EX airplanes Acting Manager, Transport Airplane with the WHELEN system installed on the fin adopting a uniform set of rules for the Directorate, Aircraft Certification Service. protection of human subjects identical tip: Dassault Service Bulletin F900EX–285, [FR Doc. 2015–22803 Filed 9–23–15; 8:45 am] to subpart A of 45 CFR part 46. The dated July 18, 2007. (5) For Model FALCON 900EX airplanes BILLING CODE 4910–13–P Common Rule is codified in the CPSC’s with the WHELEN system installed on the S- regulations at 16 CFR part 1028. The duct cowl: Dassault Service Bulletin basic provisions of the Common Rule F900EX–305, dated September 19, 2007. CONSUMER PRODUCT SAFETY include, among other things, (6) For Model FALCON 2000 airplanes: COMMISSION requirements related to the review of Dassault Service Bulletin F2000–337, dated July 25, 2007. human subjects research by an 16 CFR Part 1028 institutional review board, obtaining (7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX–108, and documenting informed consent of Protection of Human Subjects human subjects, and submitting a dated July 25, 2007. AGENCY: Consumer Product Safety written assurance of institutional (h) Other FAA AD Provisions Commission. compliance with the Common Rule. The following provisions also apply to this On September 8, 2015, (80 FR 53933), AD: ACTION: Proposed rule. HHS, on behalf of many of the same (1) Alternative Methods of Compliance SUMMARY: On September 8, 2015, the agencies that were signatories to the (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane federal departments and agencies that original Common Rule, proposed Directorate, FAA, has the authority to are subject to the Federal Policy for the revisions to modernize, strengthen, and approve AMOCs for this AD, if requested Protection of Human Subjects (referred make more effective the Federal Policy using the procedures found in 14 CFR 39.19. to as the ‘‘Common Rule’’) published a for the Protection of Human Subjects In accordance with 14 CFR 39.19, send your notice of proposed rulemaking (‘‘NPR’’) that was promulgated as a Common request to your principal inspector or local amending the Common Rule. Through Rule in 1991. The Common Rule NPR Flight Standards District Office, as this proposed rule, the Consumer seeks comment on proposals to better appropriate. If sending information directly Product Safety Commission (‘‘CPSC’’ or protect human subjects involved in to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, ‘‘Commission’’) proposes to adopt the research, while facilitating valuable International Branch, ANM–116, Transport Common Rule NPR and solicits public research and reducing burden, delay, Airplane Directorate, FAA, 1601 Lind comment on the proposal. and ambiguity for investigators. The Avenue SW., Renton, WA 98057–3356; DATES: Comments must be received no participating departments and agencies telephone 425–227–1137; fax 425–227–1139. later than 5 p.m. on December 7, 2015. proposed these revisions to the Information may be emailed to: 9-ANM-116- regulations because they believe these ADDRESSES: You may submit comments, AMOC-REQUESTS@faa.gov. Before using changes would strengthen protections any approved AMOC, notify your appropriate identified by docket ID number HHS– principal inspector, or lacking a principal OPHS–2015–0008, by one of the for research subjects while facilitating inspector, the manager of the local flight following methods: important research. standards district office/certificate holding • Federal eRulemaking Portal: http:// The full description of the proposed district office. The AMOC approval letter www.regulations.gov. Enter the above revisions to the Common Rule is must specifically reference this AD. docket ID number in the ‘‘Enter provided in the Common Rule NPR at (2) Contacting the Manufacturer: For any tkelley on DSK3SPTVN1PROD with PROPOSALS Keyword or ID’’ field and click on 80 FR 53933. Although the CPSC is a requirement in this AD to obtain corrective ‘‘Search.’’ On the next Web page, click signatory to the original Common Rule, actions from a manufacturer, the action must the CPSC’s procedural requirements be accomplished using a method approved on ‘‘Submit a Comment’’ action and by the Manager, International Branch, ANM– follow the instructions. require Commission deliberation and 116, Transport Airplane Directorate, FAA; or • Mail/Hand delivery/Courier [For vote on new rulemaking matters. Due to the European Aviation Safety Agency paper, disk, or CD–ROM submissions] HHS’s expedited schedule regarding (EASA); or Dassault Aviation’s EASA Design to: Jerry Menikoff, M.D., J.D., OHRP, publication of the Common Rule NPR in Organization Approval (DOA). If approved by 1101 Wootton Parkway, Suite 200, the Federal Register, the CPSC was not VerDate Sep<11>2014 16:29 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\24SEP1.SGM 24SEP1

Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Proposed Rules 57549 a signatory of the Common Rule NPR. DEPARTMENT OF ENERGY Commission, 888 First Street NE., However, through this proposed rule, Washington, DC 20426, (301) 665– the Commission proposes to adopt the Federal Energy Regulatory 1608, kenneth.hubona@ferc.gov. Common Rule NPR and solicits Commission Kevin Ryan (Legal Information), Office comment on the proposal. of the General Counsel, Federal 18 CFR Part 40 Energy Regulatory Commission, 888 II. CPSC’s Proposed Regulatory Text First Street NE., Washington, DC [Docket No. RM15–8–000] 20426, (202) 502–6840, kevin.ryan@ CPSC’s current regulations on the Relay Performance During Stable ferc.gov. protection of human subjects are the regulations promulgated by all of the Power Swings Reliability Standard SUPPLEMENTARY INFORMATION: departments and agencies subject to the AGENCY: Federal Energy Regulatory 1. Pursuant to section 215 of the Common Rule, as codified under the Commission. Federal Power Act (FPA),1 the CPSC’s regulations at 16 CFR part 1028. ACTION: Notice of proposed rulemaking. Commission proposes to approve For the reasons provided in the Reliability Standard PRC–026–1 (Relay Common Rule NPR (80 FR 53933), the SUMMARY: The Federal Energy Performance During Stable Power CPSC would adopt the amended Regulatory Commission proposes to Swings), submitted by the North regulatory text provided in the Common approve Reliability Standard PRC–026– American Electric Reliability Rule NPR. Because the CPSC follows the 1 (Relay Performance During Stable Corporation (NERC), the Commission- HHS regulations in 45 CFR part 46, Power Swings), submitted by the North approved Electric Reliability subpart A, the CPSC proposes to amend American Electric Reliability Organization (ERO). The proposed the Commission regulations at 16 CFR Corporation. The proposed Reliability Reliability Standard applies to planning part 1028 to cross-reference the HHS Standard is designed to ensure that coordinators, as well as generator applicable entities use protective relay owners and transmission owners that regulations in 45 CFR part 46, subpart systems that can differentiate between apply certain load-responsive protective A. faults and stable power swings. In relays in specific, identified List of Subjects in 16 CFR Part 1028 addition, the Commission requests circumstances, and is designed to comment regarding the potential burden ensure the use of protective relay Human research subjects, Reporting of modifying the applicability of systems that can differentiate between and recordkeeping requirements, proposed Reliability Standard PRC– faults and stable power swings. In Research. 026–1 to include relays with a time addition, the Commission proposes to For the reasons stated in the delay of 15 cycles or greater in instances approve NERC’s proposed where either (1) an element has been implementation plan, and the assigned preamble, the Consumer Product Safety identified by a Planning Coordinator as violation risk factors and violation Commission proposes to revise 16 CFR potentially susceptible to power swings severity levels. part 1028 to read as follows: or (2) an entity becomes aware of a bulk 2. Consistent with directives issued in PART 1028—PROTECTION OF HUMAN electric system element that tripped in Order No. 733,2 the Commission response to a stable or unstable power proposes to find that the proposed SUBJECTS swing due to the operation of its Reliability Standard addresses Sec. protective relay(s), even if the element undesirable relay operation due to 1028.101 Cross-Reference. was not previously identified by the power swings,3 and provides an equally planning coordinator. effective and efficient alternative to the Authority: 5 U.S.C. 301; 42 U.S.C. 300v– DATES: Comments are due November 23, Order No. 733 directive requiring the 1(b). 2015. use of protective relay systems that can PART 1028—PROTECTION OF HUMAN ADDRESSES: Comments, identified by differentiate between faults and stable SUBJECTS docket number, may be filed in the power swings and, when necessary, following ways: retirement of protective relay systems § 1028.101 Cross-Reference. • Electronic Filing through http:// that cannot meet this requirement.4 www.ferc.gov. Documents created Further, as discussed below, the The provisions set forth at 45 CFR Commission seeks comment regarding part 46, subpart A, concerning the electronically using word processing software should be filed in native the potential burden of modifying the protection of human research subjects, applicability of proposed Reliability apply to all research conducted, applications or print-to-PDF format and not in a scanned format. Standard PRC–026–1 to include relays supported, or otherwise subject to with a time delay of 15 cycles or greater • Mail/Hand Delivery: Those unable regulation by the CPSC. in instances where either (1) an element to file electronically may mail or hand- Dated: September 21, 2015. deliver comments to: Federal Energy has been identified by a Planning Todd A. Stevenson, Regulatory Commission, Secretary of the Coordinator as potentially susceptible to Commission, 888 First Street NE., power swings or (2) an entity becomes Secretary, Consumer Product Safety Washington, DC 20426. aware of a bulk electric system element Commission. Instructions: For detailed instructions that tripped in response to a stable or [FR Doc. 2015–24247 Filed 9–23–15; 8:45 am] on submitting comments and additional tkelley on DSK3SPTVN1PROD with PROPOSALS BILLING CODE 6355–01–P 1 16 U.S.C. 824o (2012). information on the rulemaking process, 2 Transmission Relay Loadability Reliability see the Comment Procedures Section of Standard, Order No. 733, 130 FERC ¶ 61,221 this document. (2010), order on reh’g and clarification, Order No. FOR FURTHER INFORMATION CONTACT: 733–A, 134 FERC ¶ 61,127, order on reh’g and clarification, Order No. 733–B, 136 FERC ¶ 61,185 Kenneth Hubona (Technical (2011). Information), Office of Electric 3 Order No. 733, 130 FERC ¶ 61,221 at P 153. Reliability, Federal Energy Regulatory 4 Id. P 150. VerDate Sep<11>2014 16:29 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\24SEP1.SGM 24SEP1


Document Created: 2018-02-26 10:18:22
Document Modified: 2018-02-26 10:18:22
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received no later than 5 p.m. on December 7, 2015.
ContactHope 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: [email protected]
FR Citation80 FR 57548 
CFR AssociatedHuman Research Subjects; Reporting and Recordkeeping Requirements and Research
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