[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20235-20236]
[FR Doc No: 2015-08613]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1083]

Innovations in Medical Evidence Development and Surveillance-
Methods Research Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of Center for Drug
Evaluation and Research (CDER). The goal of the CDER is to support the
development of appropriate methodologies to conduct medical product
safety surveillance in large electronic databases. Innovations in
Medical Evidence Development and Surveillance (IMEDS)-Methods is a
program within the Reagan-Udall Foundation that supports FDA's
scientific mission of serving public health needs by initiating and
facilitating research into the methods of safety evaluation in large
databases.

DATES: 1. The application due date is June 15, 2015.
    2. The anticipated start date is July 15, 2015.
    3. The opening date is April 13, 2015.
    4. The expiration date is June 16, 2015.

ADDRESSES: Submit the electronic application to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Patrick Archdeacon, Food and Drug
Administration, Bldg. 51 Rm.6314, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Vieda Hubbard, Division of
Acquisition Support and Grants (HFA-500), Food and Drug Administration,
5630 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.
    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at: http://www.grants.gov/.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-15-010 93.103

A. Background

    Section 905 of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85) mandates FDA to develop an enhanced ability to
monitor the safety of drugs after these products reach the market. In
response to this mandate, FDA launched its Sentinel Initiative, a long-
term program designed to build and implement an electronic system for
monitoring the safety of medical products in the post market setting.
FDA has already created significant infrastructure on which to operate
such a system: Through its Mini-Sentinel pilot, a distributed database
with access to more than 150 million patient records has been created
(the Sentinel Distributed Database). In order to optimally leverage
these data, however, new analytic methodologies will be required.
IMEDS-Methods is a program within the Reagan-Udall Foundation that
supports FDA's scientific mission of serving public health needs by
initiating and facilitating research into the methods of safety
evaluation in large databases. IMEDS-Methods aims to improve the tools
for conducting post-marketing safety surveillance using automated
healthcare data and to foster their adoption.

B. Research Objectives

    IMEDS plans to conduct methods research in five core areas: (1)
Addressing bias in estimates from observational studies; (2) better
understanding uses and limitations of the data; (3) applying lessons
learned from earlier IMEDS projects to FDA surveillance activities; (4)
expanding the surveillance question to continuous risk/benefit
assessment; and (5) continuing to support qualified investigators in
industry, government, and academic settings by providing access to de-
identified electronic healthcare data and computing resources through
the IMEDS Research Laboratory.

C. Eligibility Information

    Eligibility is limited to the Reagan-Udall Foundation. The Reagan-
Udall Foundation has established the IMEDS-Methods program, which is
uniquely positioned to develop the new methodologies required for FDA
to conduct effective active post market safety surveillance of medical
products using large electronic health care data. The IMEDS
organization has developed a network of statisticians, epidemiologists,
data scientists, and clinicians who have experience operating in both
the IMEDS research laboratory and also familiarity with the Sentinel
Distributed Database. In addition, through the Reagan-Udall Foundation
public-private partnership, the IMEDS-Methods program has a unique
ability to convene FDA, patients, academics, government, and industry
so that the findings and tools developed through its research agenda
will be promulgated and adopted.

II. Award Information/Funds Available

A. Award Amount

    FDA/CDER intends to fund up to $1,000,000 in fiscal year 2015 in
support of this program project. It is anticipated that only one award
will be made, not to exceed $1,000,000 (direct plus indirect) for total
costs.

B. Length of Support

    There is a one year period of performance beginning on June 15,
2015 or the date of award.

III. Electronic Application, Registration, and Submission

    Only one electronic application will be accepted. To submit an
electronic application in response to this FOA, the applicant should
first review the full announcement located at http://www.grants.gov/.
(FDA has verified the Web site addresses throughout this document, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
    For the electronically submitted application, the following steps
are required.
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With System for Award Management (SAM)
     Step 3: Obtain Username & Password

     Step 4: Authorized Organization Representative (AOR)
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit the electronic application to: http://www.grants.gov.

    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08613 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19172-19173]
[FR Doc No: 2016-07490]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0108; FRL-9943-77]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection (EPA ICR No. 0278.12); Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: ``Notice of Supplemental Distribution of a
Registered Pesticide Product,'' and identified by EPA ICR No. 0278.12
and OMB Control No. 2070-0044, represents the renewal of an existing
ICR that is scheduled to expire on November 30, 2016. Before submitting
the ICR to OMB for review and approval, EPA is soliciting comments on
specific aspects of the proposed information collection that are
summarized in this document. The ICR and accompanying material are
available in the docket for public review and comment.

DATES: Comments must be received on or before June 3, 2016.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2016-0108, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jeffrey Bryan, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Notice of Supplemental Distribution of a Registered
Pesticide Product.
    ICR number: EPA ICR No. 0278.12.
    OMB control number: OMB Control No. 2070-0044.
    ICR status: This ICR is currently scheduled to expire on November
30, 2016. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by

publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers for certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This information collection activity provides the EPA
with notification of supplemental registration of distributors of
pesticide products. EPA is responsible for the regulation of pesticides
as mandated by the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA), as amended. Section 3(e) of FIFRA (see 7 U.S.C. 136a (e),
allows pesticide registrants to distribute or sell a registered
pesticide product under a different name instead of or in addition to
the name under the original registration. Such distribution and sale is
termed ``supplemental distribution'' and the product is termed a
``distributor product.'' EPA requires the pesticide registrant to
submit a supplemental statement (EPA Form 8570-5, Notice of
Supplemental Distribution of a Registered Pesticide Product) when the
registrant has entered into an agreement with a second company that
will distribute the registrant's product under the second company's
name and product name.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.32
hours per response. The ICR, a copy of which is available in the
docket, provides a detailed explanation of this estimate, which is only
briefly summarized here:
    Estimated total number of potential respondents: 1,885.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 603 hours.
    Estimated total annual costs: $54,463. This includes an estimated
burden cost of $ 54,463 and an estimated cost of $ 0 for non-burden
hour paperwork costs, e.g., investment or maintenance and operational
costs.
    Changes in the estimates from the last approval: The renewal of
this ICR will result in an overall increase of 216 hours in the total
estimated respondent burden identified in the currently approved ICR.
This increase reflects the increase in the number of applications the
Agency expects to receive in the next 3 years. EPA had expected to
receive about 1,451 notice submissions annually over the past three
years. Based on the number of submissions received annually over that
period, the Agency now expects to receive about 1,885 notice
submissions annually over the next 3 years. This change is an
adjustment.

III. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICRs as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of this ICR to OMB and the opportunity for the public to
submit additional comments for OMB consideration. If you have any
questions about this ICR or the approval process in general, please
contact the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: March 25, 2016.
 James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2016-07490 Filed 4-1-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 56 (Friday, March 22, 2019)]
[Notices]
[Pages 10820-10821]
[FR Doc No: 2019-05494]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-18-000]

Commission Information Collection Activities (Ferc-740); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-740 (Availability of E-Tag Information to
Commission Staff).

DATES: Comments on the collection of information are due by May 21,
2019.

ADDRESSES: You may submit comments (identified by Docket No. IC19-18-
000) by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-740, Availability of E-Tag Information to Commission
Staff.
    OMB Control No.: 1902-0254.
    Type of Request: Three-year extension of the FERC-740 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: In Order 771,\1\ the FERC-740 information collection
(providing Commission staff access to e-Tag data) was implemented to
provide the Commission, Market Monitoring Units, Regional Transmission
Organizations, and Independent System Operators with information that
allows them to perform market surveillance and analysis more
effectively. The e-Tag information is necessary to understand the use
of the interconnected electricity grid, particularly transactions
occurring at interchanges. Due to the nature of the electric grid, an
individual transaction's impact on an interchange cannot be assessed
adequately in all cases without information from all connected systems,
which is included in the e-Tags. The details of the physical path of a
transaction included in the e-Tags helps the Commission to monitor, in
particular, interchange transactions more effectively, detect and
prevent price manipulation over interchanges, and improve the efficient
and orderly use of the transmission grid. For example, the e-Tag data
allows the Commission to identify transmission reservations as they go
from one market to another and link the market participants involved in
that transaction.
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    \1\ Order 771 was issued in Docket No. RM11-12 (77 FR 76367, 12/
28/2012).
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    Order No. 771 provided the Commission access to e-Tags by requiring
that Purchasing-Selling Entities \2\ (PSEs) and Balancing Authorities
(BAs), list the Commission on the ``CC'' list of e-Tags so that the
Commission can receive a copy of the e-Tags (the ``'CC' list
requirement''). The Commission accesses the e-Tags by contracting with
a commercial vendor, OATI.
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    \2\ A Purchasing-Selling Entity is the entity that purchases or
sells, and takes title to, energy, capacity, and Interconnected
Operations Services. Purchasing-Selling Entities may be affiliated
or unaffiliated merchants and may or may not own generating
facilities. Purchasing-Selling Entities are typically E-Tag Authors.
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    In early 2014, the North American Energy Standards Board (NAESB)
incorporated the ``CC'' list requirement on e-Tags as part of the
tagging process.\3\ Even before NAESB added the FERC requirement to the
tagging standards, the ``CC'' list requirement had already been
programmed into the industry standard tagging software so as to make
the inclusion of FERC in the ``CC'' list automatic, where appropriate.
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    \3\ NAESB Electronic Tagging Functional Specifications, Version
1.8.2.
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    The Commission expects that PSEs and BAs will continue to use
existing, automated procedures to create and validate the e-Tags in a
way that provides the Commission with access to them. In the rare event
that a new BA would need to alert e-Tag administrators that certain
tags it generates qualify for exemption under the Commission's
regulations (e.g., transmissions from a new non-U.S. BA into another
non-U.S. BA using a path that does not go through a U.S. BA), this
administrative function would be expected to require less than an hour
of effort total from both the BA and an e-Tag administrator to include
the BA on the exemption list. New exempt BAs occur less frequently than
every year, but for the purpose of estimation we will conservatively
assume one appears each year creating an additional burden and cost
associated with the Commission's FERC-740 of one hour and $65.68.\4\
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    \4\ The estimated hourly cost (wages plus benefits) provided in
this section is based on the figures for May 2017 posted by the
Bureau of Labor Statistics for the Utilities sector (available at
https://www.bls.gov/oes/current/naics2_22.htm), assuming:
     15 minutes legal (code 23-0000), at $143.68/hour
     45 minutes information and record clerk (code 43-4199), at
$39.68/hour.
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    Type of Respondents: Purchasing-Selling Entities and Balancing
Authorities.
    Estimate of Annual Burden: \5\ The Commission estimates the burden
and cost for FERC-740 as follows based on the distinct e-Tags submitted
to the Commission in 2017 (the most recent full year available).
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    \5\ ``Burden'' is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to Title 5 Code of Federal Regulations Part 1320.

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                                                                                Average burden    Total annual burden
            FERC-740                 Number of        Annual number of       Total number     hours & cost per      hours & total          Cost per
                                    respondents   responses per respondent   of responses         response           annual cost        respondent ($)
                                             (1)  (2).....................     (1) * (2) =  (4)................  (3) * (4) = (5)....  (5) / (1)
                                                                                (3)
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Purchasing-Selling Entities (e-              355  4,482 (rounded).........       1,591,208  Automatic, so 0      Automatic, so 0      Automatic, so 0
 Tag Authors).                                                                               burden and cost.     burden and cost.     burden and cost.
Balancing Authorities...........              81  19,645 (rounded)........       1,591,208  Automatic, so 0      Automatic, so 0      Automatic, so 0
                                                                                burden and cost.     burden and cost.     burden and cost.
New Balancing Authority [as                    1  1.......................               1  1 hr.; $65.68......  1 hr.; $65.68......  $65.68.
 noted above].
                                 -----------------------------------------------------------------------------------------------------------------------
    Total.......................  ..............  ........................  ..............  ...................  1 hr.; $65.68......  $65.68.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: March 18, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-05494 Filed 3-21-19; 8:45 am]
 BILLING CODE 6717-01-P