[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Proposed Rules]
[Pages 8030-8031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 11

[Docket Number NIH-2011-0003]
RIN 0925-AA52


Clinical Trials Registration and Results Submission

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Proposed rule; extension of comment period; request for 
comments.

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SUMMARY: The Department of Health and Human Services (HHS) is extending 
the public comment period for the Notice of Proposed Rulemaking (NPRM) 
on Clinical Trials Registration and Results Submission. The proposed 
rule was published on November 21, 2014 (79 FR 69566) with a deadline 
for public comments of February 19, 2015. The comment period is being 
extended to provide additional time for commenters to prepare their 
responses. The comment period will close at 5 p.m. Eastern Standard 
Time (EST) on March 23, 2015.

DATES: Comments on the NPRM must be received before 5 p.m. EST on March 
23, 2015 in order to ensure we will be able to consider the comments 
when preparing the final rule and policy.

ADDRESSES: Individuals and organizations interested in submitting 
comments on the NPRM, identified by RIN 0925-AA52 and Docket Number 
NIH-2011-0003, may do so by any of the following methods:
    <bullet> Electronic Submissions: Use Federal eRulemaking Portal: 
http://www.regulations.gov. Follow the instructions for submitting 
comments. NIH is no longer accepting comments submitted directly by 
email. The NIH encourages you to continue to submit electronic comments 
by using the Federal eRulemaking Portal: http://www.regulations.gov.

[[Page 8031]]

    <bullet> Written Submissions: You may submit written submissions by 
Fax at 301-402-0169, or by Mail/Hand Delivery/Courier (For paper, disk, 
or CD-ROM submissions) to: Jerry Moore, NIH Regulations Officer, Office 
of Management Assessment, 6011 Executive Boulevard, Suite 601, MSC 
7669, Rockville, MD 20852-7669.

FOR FURTHER INFORMATION CONTACT: 
    Regulatory Process: Jerry Moore, NIH Regulations Officer, Office of 
Management Assessment, Telephone (301-496-4607) (not a toll-free 
number), Fax (301-402-0169), or by email at <a href="/cdn-cgi/l/email-protection#cea4a3fafeb48ea0a7a6e0a9a1b8"><span class="__cf_email__" data-cfemail="543e3960642e143a3d3c7a333b22">[email protected]</span></a>.
    Technical Information: Jerry Sheehan, Assistant Director for Policy 
Development, National Library of Medicine, National Institutes of 
Health, Department of Health and Human Services, Telephone (301-496-
6221) (not a toll-free number), Fax (301-402-2586), or by email at 
<a href="/cdn-cgi/l/email-protection#85f6ede0e0ede4ebeff7c5ebe9e8abebecedabe2eaf3"><span class="__cf_email__" data-cfemail="a1d2c9c4c4c9c0cfcbd3e1cfcdcc8fcfc8c98fc6ced7">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: HHS published a Notice of Proposed 
Rulemaking (NPRM) on Clinical Trials Registration and Results 
Submission in the Federal Register on November 21, 2014 (79 FR 69566). 
The NPRM proposes requirements for submitting registration and summary 
results information, including adverse event information, for specified 
clinical trials of drugs (including biological products) and devices 
and for pediatric postmarket surveillances of a device to 
ClinicalTrials.gov, the clinical trial registry and results data bank 
operated by the National Library of Medicine. The proposed rule 
provides for the expanded registry and results data bank specified in 
Title VIII of the Food and Drug Administration Amendments Act of 2007 
(FDAAA) to enhance patient enrollment, provide a mechanism to track 
subsequent progress of clinical trials, provide more complete results 
information, and enhance patient access to and understanding of the 
results of clinical trials. The deadline for written comments was 
originally established as February 19, 2015. Since the NPRM was 
published, the Department has received requests to extend the period 
for the public submission of comments. Effective with this notice, we 
are extending the comment period with a deadline of 5 p.m. EST on March 
23, 2015.
    NIH published a related request for public comments on a draft NIH 
Policy on Dissemination of NIH-Funded Clinical Trial Information in the 
NIH Guide for Contracts and Grants (NOT-OD-15-019) on November 19, 
2014. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html. The draft NIH Policy aims to promote broad and responsible 
dissemination of information on clinical trials funded by the NIH 
through registration and submission of summary results information to 
ClinicalTrials.gov. The original deadline for written comments on the 
draft NIH Policy was February 19, 2015, but the deadline is also being 
extended until 5 p.m. EST on March 23, 2015.
    Instructions for Submitting Comments: We welcome comments from the 
public on all issues set forth in the proposed rule, and on specific 
issues identified in the document. All submissions received must 
include the agency name, the Docket No., and Regulatory Information 
Number (RIN) for this rulemaking. All comments received at http://www.regulations.gov may be posted without change, including any 
personal information provided. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means NIH will not know your 
identity or contact information unless you provide it in the body of 
your comment. You can assist us in considering your comment by 
referencing the number assigned to each key issue discussed in section 
III.C of the preamble or the number of the section of this proposed 
rule to which your comment relates. For access to background documents 
or comments received, go to http://www.regulations.gov and insert the 
docket number found in the brackets in the heading of this document 
into the ``Search'' box and follow the prompts.

    Dated: January 16, 2015.
Francis S. Collins,
Director, National Institutes of Health.
    Approved: February 5, 2015.
Sylvia Mathews Burwell
Secretary, HHS.
[FR Doc. 2015-02990 Filed 2-12-15; 8:45 am]
BILLING CODE 4140-01-P


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