Clinical Trials Registration and Results Submission, 8030-8031 [2015-02990]

Download as PDF 8030 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Proposed Rules wreier-aviles on DSK5TPTVN1PROD with PROPOSALS and the burners performed as expected. This discussion, titled ‘‘Process control system overview-multipoint ground flare system,’’ is in the docket for this action. At this time, we are not considering any requirements for additional process control or ignition testing. However, we believe it would be important to require that cameras are installed and operated such that operators have a visual indication of flames from the flare at all times that the MPGF is operating and that this footage be available for inspection by the permitting agency, along with operational records of the waste gas flowrate, pressure in header and stages, pilot and waste gas composition. Because these flares are located at ground level, it is possible that ambient concentrations of pollutants could be higher than they would be under an alternative scenario where waste gases would be flared in an elevated flare, enabling greater dispersion and potentially lessening the impact to neighboring communities. To that end, we are soliciting comment on whether additional ambient monitoring is warranted to provide for immediate notification to emergency planning officials and the community during significant events and malfunctions of the system. III. AMEL for Pressure-Assisted MPGF Considering the above requests from both Dow and ExxonMobil, we are seeking the public’s input on the operating requirements for the proposed pressure-assisted MPGFs that would be used by both companies which would establish an AMEL that will achieve a reduction in emissions at least equivalent to the reduction in emissions being controlled by a steam-assisted, airassisted or non-assisted flare complying with the requirements of either 40 CFR 63.11(b) or 40 CFR 60.18(b). Information provided in the AMEL requests and the available emissions test data from the test reports described above indicate that the following list of operating requirements for pressure-assisted MPGF result in destruction efficiencies at least equivalent to destruction efficiencies expected from complying with the requirements of 40 CFR 63.11(b) and 40 CFR 60.18(b) for the pressure-assisted MPGF being proposed for use by both Dow and ExxonMobil: 1. The flare system must be designed and operated such that the net heating value of the combustion zone gas (NHVcz) for the pressure assisted flare burners meets a minimum heating value of 800 BTU/scf or a lower flammability limit of the combustion zone gas (LFLcz) of less than or equal to 6.5 percent by VerDate Sep<11>2014 13:53 Feb 12, 2015 Jkt 235001 volume under all conditions. We would expect owners or operators to calculate NHVcz and LFLcz in a manner similar to those in the currently proposed requirements of 79 FR 36980–40 CFR 63.670(l)–(m). 2. The flare system must be operated with a flame present at all times when in use. Each row of flare burners must have at least one pilot with a constant pilot flame. The pilot flame(s) must be continuously monitored by a thermocouple. The time, date and duration of any loss of pilot flame must be recorded. Each monitoring device must be maintained or replaced at a frequency in accordance with the manufacturer’s specifications. 3. The flare system must be operated with no visible emissions except for periods not to exceed a total of 5 minutes during any 2 consecutive hours. A video camera can be used in order to conduct visible emission observations since operating personnel cannot enter the fenced area while the MPGF is operating. 4. The operator must install and operate an on-line vent gas flow meter and an on-line gas chromatograph to measure the flow and composition of the vent gas to each flare. We would expect the operator to comply with similar monitoring and testing requirements and recordkeeping and reporting requirements for these monitoring systems as currently proposed in 79 FR 36980–40 CFR 63.670(i)–(j) and (l)–(m). 5. The operator should install and operate pressure and/or flow monitors on each stage of the flare. We would expect the operator to comply with similar applicable monitoring and testing requirements and recordkeeping and reporting requirements for these monitoring systems as currently proposed in 79 FR 36980–40 CFR 63.670(i). IV. Request for Comments We solicit comments on all aspects of these requests for an AMEL. We specifically seek comment regarding whether or not the potential alternative operating requirements listed in section III above would be adequate for ensuring that the MPGF will achieve good combustion at all times and enable the facilities to meet their applicable emission standards. Additionally, several other entities have indicated to us that they intend to make similar requests for the ability to operate pressure-assisted MPGFs. We are also soliciting comment on whether the requirements listed above, if followed by these other entities, could enable these other facilities to receive approval PO 00000 Frm 00051 Fmt 4702 Sfmt 4702 of their own AMELs. As noted in section II.B above, we also solicit comment and data on other pressureassisted flare burner types. Commenters should include data or specific examples in support of their comments. Dated: February 3, 2015. Janet G. McCabe, Acting Assistant Administrator. [FR Doc. 2015–03064 Filed 2–12–15; 8:45 am] BILLING CODE 6560–50–P 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 National Institutes of Health, Department of Health and Human Services. ACTION: Proposed rule; extension of comment period; request for comments. AGENCY: 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: https:// 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: https:// www.regulations.gov. SUMMARY: E:\FR\FM\13FEP1.SGM 13FEP1 wreier-aviles on DSK5TPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Proposed Rules • 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 https://grants.nih.gov/grants/guide/ VerDate Sep<11>2014 13:53 Feb 12, 2015 Jkt 235001 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 https://www.regulations.gov may be posted without change, including any personal information provided. The https:// 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 https:// 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 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 25, 73, and 76 [MB Docket No. 14–127; FCC 14–209] Expansion of Online Public File Obligations to Cable and Satellite TV Operators and Broadcast and Satellite Radio Licensees Federal Communications Commission. ACTION: Proposed rule. AGENCY: PO 00000 Frm 00052 Fmt 4702 Sfmt 4702 8031 In this document, the Commission proposes to expand to cable operators, satellite TV providers, broadcast radio licensees, and satellite radio licensees the requirement that public inspection files be posted to the FCC’s online database. In 2012, the Commission adopted online public file rules for broadcast television stations that required them to post public file documents to a central, FCC-hosted online database rather than maintaining the files locally at their main studios. Now that television broadcasters have completed their transition to the online file, the Commission believes it is appropriate to commence the process of expanding the online file to other media entities to extend the benefits of improved public access to public inspection files and, ultimately, reduce the burden of maintaining these files. DATES: Comments may be filed on or before March 16, 2015, and reply comments may be filed April 14, 2015. Written comments on the proposed information collection requirements, subject to the Paperwork Reduction Act (PRA) of 1995, Pub. L. 104–13, should be submitted on or before April 14, 2015. ADDRESSES: You may submit comments, identified by MB Docket No. 14–127, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Federal Communications Commission’s Web site: https:// fjallfoss.fcc.gov/ecfs2/. Follow the instructions for submitting comments. • Mail: Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission’s Secretary, Office of the Secretary, Federal Communications Commission. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: FCC504@fcc.gov or phone: (202) 418–0530 or TTY: (202) 418–0432. In addition to filing comments with the Secretary, a copy of any comments on the Paperwork Reduction Act proposed information collection requirements contained herein should be submitted to the Federal Communications Commission via email to PRA@fcc.gov and to Cathy.Williams@ fcc.gov and also to Nicholas A. Fraser, Office of Management and Budget, via email to Nicholas-A.-Fraser@ omb.eop.gov. For detailed instructions SUMMARY: E:\FR\FM\13FEP1.SGM 13FEP1

Agencies

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Proposed Rules]
[Pages 8030-8031]
From the Federal Register Online via the Government Printing 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.

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

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: 
https://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: https://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 https://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 https://www.regulations.gov may be posted without change, including any 
personal information provided. The https://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 https://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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