80_FR_8060 80 FR 8030 - Clinical Trials Registration and Results Submission

80 FR 8030 - Clinical Trials Registration and Results Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 30 (February 13, 2015)

Page Range8030-8031
FR Document2015-02990

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.

Federal Register, Volume 80 Issue 30 (Friday, February 13, 2015) 
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Proposed Rules]
[Pages 8030-8031]
From the Federal Register Online  [www.thefederalregister.org]
[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:
     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]]

     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 jm40z@nih.gov.
    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 
sheehanjr@nlm.nih.gov.

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

8030 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Proposed Rules and the burners performed as expected. volume under all conditions. We would of their own AMELs. As noted in This discussion, titled ‘‘Process control expect owners or operators to calculate section II.B above, we also solicit system overview-multipoint ground NHVcz and LFLcz in a manner similar to comment and data on other pressure- flare system,’’ is in the docket for this those in the currently proposed assisted flare burner types. Commenters action. At this time, we are not requirements of 79 FR 36980–40 CFR should include data or specific considering any requirements for 63.670(l)–(m). examples in support of their comments. additional process control or ignition 2. The flare system must be operated Dated: February 3, 2015. testing. However, we believe it would be with a flame present at all times when Janet G. McCabe, important to require that cameras are in use. Each row of flare burners must have at least one pilot with a constant Acting Assistant Administrator. installed and operated such that operators have a visual indication of pilot flame. The pilot flame(s) must be [FR Doc. 2015–03064 Filed 2–12–15; 8:45 am] flames from the flare at all times that the continuously monitored by a BILLING CODE 6560–50–P MPGF is operating and that this footage thermocouple. The time, date and be available for inspection by the duration of any loss of pilot flame must permitting agency, along with be recorded. Each monitoring device DEPARTMENT OF HEALTH AND operational records of the waste gas must be maintained or replaced at a HUMAN SERVICES flowrate, pressure in header and stages, frequency in accordance with the pilot and waste gas composition. manufacturer’s specifications. National Institutes of Health Because these flares are located at 3. The flare system must be operated ground level, it is possible that ambient with no visible emissions except for 42 CFR Part 11 concentrations of pollutants could be periods not to exceed a total of 5 [Docket Number NIH–2011–0003] higher than they would be under an minutes during any 2 consecutive alternative scenario where waste gases hours. A video camera can be used in RIN 0925–AA52 would be flared in an elevated flare, order to conduct visible emission enabling greater dispersion and observations since operating personnel Clinical Trials Registration and Results potentially lessening the impact to cannot enter the fenced area while the Submission neighboring communities. To that end, MPGF is operating. AGENCY: National Institutes of Health, we are soliciting comment on whether 4. The operator must install and Department of Health and Human additional ambient monitoring is operate an on-line vent gas flow meter Services. warranted to provide for immediate and an on-line gas chromatograph to ACTION: Proposed rule; extension of notification to emergency planning measure the flow and composition of the vent gas to each flare. We would comment period; request for comments. officials and the community during significant events and malfunctions of expect the operator to comply with SUMMARY: The Department of Health and the system. similar monitoring and testing Human Services (HHS) is extending the requirements and recordkeeping and public comment period for the Notice of III. AMEL for Pressure-Assisted MPGF reporting requirements for these Proposed Rulemaking (NPRM) on Considering the above requests from monitoring systems as currently Clinical Trials Registration and Results both Dow and ExxonMobil, we are proposed in 79 FR 36980–40 CFR Submission. The proposed rule was seeking the public’s input on the 63.670(i)–(j) and (l)–(m). published on November 21, 2014 (79 FR operating requirements for the proposed 5. The operator should install and 69566) with a deadline for public pressure-assisted MPGFs that would be operate pressure and/or flow monitors comments of February 19, 2015. The used by both companies which would on each stage of the flare. We would comment period is being extended to establish an AMEL that will achieve a expect the operator to comply with provide additional time for commenters reduction in emissions at least similar applicable monitoring and to prepare their responses. The equivalent to the reduction in emissions testing requirements and recordkeeping comment period will close at 5 p.m. being controlled by a steam-assisted, air- and reporting requirements for these Eastern Standard Time (EST) on March assisted or non-assisted flare complying monitoring systems as currently 23, 2015. with the requirements of either 40 CFR proposed in 79 FR 36980–40 CFR 63.11(b) or 40 CFR 60.18(b). Information DATES: Comments on the NPRM must be 63.670(i). provided in the AMEL requests and the received before 5 p.m. EST on March 23, available emissions test data from the IV. Request for Comments 2015 in order to ensure we will be able test reports described above indicate We solicit comments on all aspects of to consider the comments when that the following list of operating these requests for an AMEL. We preparing the final rule and policy. requirements for pressure-assisted specifically seek comment regarding ADDRESSES: Individuals and MPGF result in destruction efficiencies whether or not the potential alternative organizations interested in submitting at least equivalent to destruction operating requirements listed in section comments on the NPRM, identified by efficiencies expected from complying III above would be adequate for RIN 0925–AA52 and Docket Number with the requirements of 40 CFR ensuring that the MPGF will achieve NIH–2011–0003, may do so by any of 63.11(b) and 40 CFR 60.18(b) for the good combustion at all times and enable the following methods: pressure-assisted MPGF being proposed the facilities to meet their applicable • Electronic Submissions: Use wreier-aviles on DSK5TPTVN1PROD with PROPOSALS for use by both Dow and ExxonMobil: emission standards. Additionally, Federal eRulemaking Portal: http:// 1. The flare system must be designed several other entities have indicated to www.regulations.gov. Follow the and operated such that the net heating us that they intend to make similar instructions for submitting comments. value of the combustion zone gas requests for the ability to operate NIH is no longer accepting comments (NHVcz) for the pressure assisted flare pressure-assisted MPGFs. We are also submitted directly by email. The NIH burners meets a minimum heating value soliciting comment on whether the encourages you to continue to submit of 800 BTU/scf or a lower flammability requirements listed above, if followed electronic comments by using the limit of the combustion zone gas (LFLcz) by these other entities, could enable Federal eRulemaking Portal: http:// of less than or equal to 6.5 percent by these other facilities to receive approval www.regulations.gov. VerDate Sep<11>2014 13:53 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4702 Sfmt 4702 E:\FR\FM\13FEP1.SGM 13FEP1

Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Proposed Rules 8031 • Written Submissions: You may notice-files/NOT-OD-15-019.html. The SUMMARY: In this document, the submit written submissions by Fax at draft NIH Policy aims to promote broad Commission proposes to expand to 301–402–0169, or by Mail/Hand and responsible dissemination of cable operators, satellite TV providers, Delivery/Courier (For paper, disk, or information on clinical trials funded by broadcast radio licensees, and satellite CD–ROM submissions) to: Jerry Moore, the NIH through registration and radio licensees the requirement that NIH Regulations Officer, Office of submission of summary results public inspection files be posted to the Management Assessment, 6011 information to ClinicalTrials.gov. The FCC’s online database. In 2012, the Executive Boulevard, Suite 601, MSC original deadline for written comments Commission adopted online public file 7669, Rockville, MD 20852–7669. on the draft NIH Policy was February rules for broadcast television stations FOR FURTHER INFORMATION CONTACT: 19, 2015, but the deadline is also being that required them to post public file Regulatory Process: Jerry Moore, NIH extended until 5 p.m. EST on March 23, documents to a central, FCC-hosted Regulations Officer, Office of 2015. online database rather than maintaining Management Assessment, Telephone Instructions for Submitting the files locally at their main studios. (301–496–4607) (not a toll-free number), Comments: We welcome comments Now that television broadcasters have Fax (301–402–0169), or by email at from the public on all issues set forth in completed their transition to the online jm40z@nih.gov. the proposed rule, and on specific file, the Commission believes it is Technical Information: Jerry Sheehan, issues identified in the document. All appropriate to commence the process of Assistant Director for Policy submissions received must include the expanding the online file to other media Development, National Library of agency name, the Docket No., and entities to extend the benefits of Medicine, National Institutes of Health, Regulatory Information Number (RIN) improved public access to public Department of Health and Human for this rulemaking. All comments inspection files and, ultimately, reduce Services, Telephone (301–496–6221) received at http://www.regulations.gov the burden of maintaining these files. (not a toll-free number), Fax (301–402– may be posted without change, DATES: Comments may be filed on or 2586), or by email at sheehanjr@ including any personal information before March 16, 2015, and reply nlm.nih.gov. provided. The http:// comments may be filed April 14, 2015. SUPPLEMENTARY INFORMATION: HHS www.regulations.gov Web site is an Written comments on the proposed published a Notice of Proposed ‘‘anonymous access’’ system, which information collection requirements, Rulemaking (NPRM) on Clinical Trials means NIH will not know your identity subject to the Paperwork Reduction Act Registration and Results Submission in or contact information unless you (PRA) of 1995, Pub. L. 104–13, should the Federal Register on November 21, provide it in the body of your comment. be submitted on or before April 14, 2014 (79 FR 69566). The NPRM You can assist us in considering your 2015. proposes requirements for submitting comment by referencing the number ADDRESSES: You may submit comments, registration and summary results assigned to each key issue discussed in identified by MB Docket No. 14–127, by information, including adverse event section III.C of the preamble or the any of the following methods: information, for specified clinical trials number of the section of this proposed • Federal eRulemaking Portal: http:// of drugs (including biological products) rule to which your comment relates. For www.regulations.gov. Follow the and devices and for pediatric access to background documents or instructions for submitting comments. postmarket surveillances of a device to comments received, go to http:// • Federal Communications ClinicalTrials.gov, the clinical trial www.regulations.gov and insert the Commission’s Web site: http:// registry and results data bank operated docket number found in the brackets in fjallfoss.fcc.gov/ecfs2/. Follow the by the National Library of Medicine. the heading of this document into the instructions for submitting comments. The proposed rule provides for the ‘‘Search’’ box and follow the prompts. • Mail: Filings can be sent by hand or expanded registry and results data bank Dated: January 16, 2015. messenger delivery, by commercial specified in Title VIII of the Food and Francis S. Collins, overnight courier, or by first-class or Drug Administration Amendments Act Director, National Institutes of Health. overnight U.S. Postal Service mail. All of 2007 (FDAAA) to enhance patient Approved: February 5, 2015. filings must be addressed to the enrollment, provide a mechanism to Sylvia Mathews Burwell Commission’s Secretary, Office of the track subsequent progress of clinical Secretary, Federal Communications Secretary, HHS. trials, provide more complete results Commission. information, and enhance patient access [FR Doc. 2015–02990 Filed 2–12–15; 8:45 am] • People with Disabilities: Contact the to and understanding of the results of BILLING CODE 4140–01–P FCC to request reasonable clinical trials. The deadline for written accommodations (accessible format comments was originally established as documents, sign language interpreters, February 19, 2015. Since the NPRM was FEDERAL COMMUNICATIONS CART, etc.) by email: FCC504@fcc.gov published, the Department has received COMMISSION or phone: (202) 418–0530 or TTY: (202) requests to extend the period for the 418–0432. public submission of comments. 47 CFR Parts 25, 73, and 76 In addition to filing comments with Effective with this notice, we are the Secretary, a copy of any comments extending the comment period with a [MB Docket No. 14–127; FCC 14–209] on the Paperwork Reduction Act wreier-aviles on DSK5TPTVN1PROD with PROPOSALS deadline of 5 p.m. EST on March 23, proposed information collection 2015. Expansion of Online Public File requirements contained herein should NIH published a related request for Obligations to Cable and Satellite TV be submitted to the Federal public comments on a draft NIH Policy Operators and Broadcast and Satellite Communications Commission via email on Dissemination of NIH-Funded Radio Licensees to PRA@fcc.gov and to Cathy.Williams@ Clinical Trial Information in the NIH AGENCY: Federal Communications fcc.gov and also to Nicholas A. Fraser, Guide for Contracts and Grants (NOT– Commission. Office of Management and Budget, via OD–15–019) on November 19, 2014. See email to Nicholas-A.-Fraser@ ACTION: Proposed rule. http://grants.nih.gov/grants/guide/ omb.eop.gov. For detailed instructions VerDate Sep<11>2014 13:53 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4702 Sfmt 4702 E:\FR\FM\13FEP1.SGM 13FEP1


Document Created: 2015-12-18 13:17:41
Document Modified: 2015-12-18 13:17:41
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; extension of comment period; request for comments.
DatesComments 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.
ContactRegulatory 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 [email protected]
FR Citation80 FR 8030 
RIN Number0925-AA52
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