[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.

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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: 
[email protected].

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