[Federal Register: November 23, 2007 (Volume 72, Number 225)]
[Notices]
[Page 65730-65731]
[DOCID:fr23no07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12901-000]

BPUS Generation Development, LLC; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

November 16, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12901-000.
    c. Date Filed: July 30, 2007.
    d. Applicant: BPUS Generation Development, LLC.
    e. Name of Project: Allegheny Lock & Dam No. 7 Hydroelectric
Project.
    f. Location: Allegheny River in Armstrong County, Pennsylvania. It
would use the U.S. Army Corps of Engineers' Allegheny Lock & Dam No. 7.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Jeffrey M. Auser, P.E., BPUS Generation
Development, LLC, 225 Greenfield Parkway, Suite 201, Liverpool, NY
13088,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for Filing Comments, Protests, and Motions to
Intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12901-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army

Corps of Engineers' Allegheny Lock & Dam No. 7 and operated in a run-
of-river mode would consist of: (1) A new 125-foot long, 160-foot wide,
60-foot high concrete powerhouse; (2) a new intake channel and tailrace
channel on the eastern side of the river; (3) three turbine/generator
units with a combined installed capacity of 16.5 megawatts; (4) a new
12,000-foot long above ground transmission line extending from the
switchyard near the powerhouse to a connection at a substation located
south of the powerhouse on the Kittanning side of the river; and (5)
appurtenant facilities. The proposed Allegheny Lock & Dam No. 7 Project
would have an average annual generation of 89 gigawatt-hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.
    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

 Kimberly D. Bose,
 Secretary.
 [FR Doc. E7-22838 Filed 11-21-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4558-4559]
[FR Doc No: 2012-1899]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC12-55-000.
    Applicants: ConocoPhillips Company.
    Description: Amendment to Section 203 Application of ConocoPhillips
Company.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5259.
    Comments Due: 5 p.m. ET 1/30/12.

    Docket Numbers: EC12-62-000.
    Applicants: La Paloma Generating Company, LLC, Merrill Lynch Credit
Products, LLC.
    Description: Application for Order Authorizing Disposition of
Jurisdictional Facilities under section 203 of The Federal Power Act
and Request for Waivers and Expedited Action of Merrill Lynch Credit
Products, LLC and La Paloma Generating Company, LLC.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5257.
    Comments Due: 5 p.m. ET 2/10/12.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG12-25-000.
    Applicants: Tenaska Washington Partners, LP.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Tenaska Washington Partners, LP.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5173.
    Comments Due: 5 p.m. ET 2/10/12.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2026-000.
    Applicants: Pacific Gas and Electric Company.
    Description: TO13 Compliance Electric Refund Report to be effective
N/A.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5160.
    Comments Due: 5 p.m. ET 2/10/12.

    Docket Numbers: ER10-3286-003; ER10-3299-002.
    Applicants: Millennium Power Partners, LP, New Athens Generating
Company, LLC.
    Description: Additional Supplement to Updated Market Power Analysis
of Millennium Power Partners, LP, et al.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5258.
    Comments Due: 5 p.m. ET 2/10/12.

    Docket Numbers: ER12-551-001.
    Applicants: Westar Energy, Inc.
    Description: Amendment to Compliance Filing, Schedule 3A, Generator
Regulation & Frequency to be effective 12/25/2011.
    Filed Date: 1/18/12.
    Accession Number: 20120118-5131.
    Comments Due: 5 p.m. ET 2/8/12.

    Docket Numbers: ER12-855-000.
    Applicants: Nevada Power Company.
    Description: Rate Schedule No. 95 Amended & Restated Navajo Project
Co-Tenancy Agreement to be effective 3/20/2012.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5179.
    Comments Due: 5 p.m. ET 2/10/12.

    Docket Numbers: ER12-856-000.
    Applicants: Nevada Power Company.
    Description: Rate Schedule No. 96 Navajo Project Western
Transmission System Operating Agreement to be effective 3/20/2012.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5185.
    Comments Due: 5 p.m. ET 2/10/12.

    Docket Numbers: ER12-857-000.
    Applicants: Pacific Gas and Electric Company.
    Description: PWRPA 3rd Amendment to Appendix B to IA and WDT
Service Agreement to be effective 12/31/9998.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5192.
    Comments Due: 5 p.m. ET 2/10/12.

    Docket Numbers: ER12-858-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits tariff filing
per 35.13(a)(2)(iii: Modifications to Joint Agreements, Rate Schedules
No. 211, 212, 242, and 243 to be effective 3/21/2012.
    Filed Date: 1/20/12.
    Accession Number: 20120120-5239.
    Comments Due: 5 p.m. ET 2/10/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings

can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: January 23, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-1899 Filed 1-27-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 10, 2008 (Volume 73, Number 7)]
[Notices]
[Page 1873]
[DOCID:fr10ja08-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-203-000]

Primary Energy of North Carolina, LLC; Notice of Issuance of
Order

January 3, 2008.
    Primary Energy of North Carolina, LLC (Primary Energy) filed an
application for market-based rate authority, with an accompanying rate
schedule. The proposed market-based rate schedule provides for the sale
of energy, capacity and ancillary services at market-based rates.
Primary Energy also requested waivers of various Commission
regulations. In particular, Primary Energy requested that the
Commission grant blanket approval under 18 CFR Part 34 of all future
issuances of securities and assumptions of liability by Primary Energy.
    On January 2, 2008, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Primary Energy, should file a protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2007).
    Notice is hereby given that the deadline for filing protests is
February 1, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Primary Energy is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Primary Energy, compatible with
the public interest, and is reasonably necessary or appropriate for
such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Primary Energy's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-226 Filed 1-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Pages 55043-55044]
[FR Doc No: 2021-21587]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-318, OMB Control No. 3235-0361]

Proposed Collection; Comment Request

    Upon Written Request Copies Available From: U.S. Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE,
Washington, DC 20549-2736

Extension:
    Form ADV-E

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form ADV-E (17 CFR 279.8) is the cover sheet for certificates of
accounting filed pursuant to rule 206(4)-2 under the Investment
Advisers Act of 1940 (17 CFR 275.206(4)-2). The rule further requires
that the public accountant file with the Commission a Form ADV-E and
accompanying statement within four business days of the resignation,
dismissal, removal or other termination of its engagement.
    The Commission has estimated that compliance with the requirement
to complete Form ADV-E imposes a total burden of approximately 0.05
hours (3 minutes) per respondent. Based on current information from
advisers

registered with the Commission, the Commission staff estimates that
1,743 filings will be submitted with respect to surprise examinations
and 33 filings will be submitted with respect to termination of
accountants. Based on these estimates, the total estimated annual
burden would be 88.80 hours ((1,743 filings x .05 hours) + (33 filings
x .05 hours)).
    Written comments are invited on: (a) 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; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication. An agency may not conduct or sponsor a
collection of information unless it displays a currently valid OMB
control number. No person shall be subject to any penalty for failing
to comply with a collection of information subject to the PRA that does
not display a valid OMB control number.
    Please direct your written comments to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549; or send an email to:
<EMAIL_ADDRESS>
    Dated: September 29, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-21587 Filed 10-4-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Rules and Regulations]
[Pages 63450-63453]
[FR Doc No: 2020-19761]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0338; FRL-10013-94]

Kasugamycin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of kasugamycin in or on almonds. This action is in response to
EPA's granting of an emergency exemption under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide
on almond trees. This regulation establishes maximum permissible levels
for residues of kasugamycin in or on this commodity. The time-limited
tolerances expire on December 31, 2023.

DATES: This regulation is effective October 8, 2020. Objections and
requests for hearings must be received on or before December 7, 2020,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0338, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2020-0338 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing and must be
received by the Hearing Clerk on or before December 7, 2020. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified

by docket ID number EPA-HQ-OPP-2020-0338, 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 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for residues of kasugamycin, (3-O-[2-amino-4-
[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-arabino-
hexopyranosyl]-D-chiro-inositol), in or on Almond at 0.04 parts per
million (ppm); and Almond, hulls at 0.4 ppm. These time-limited
tolerances expire on December 31, 2023.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Kasugamycin on Almond Trees

    According to the California Department of Pesticide Regulation
(CDPR), the California almond industry has been experiencing frequent
frost events with concurrent wetness and temperatures below 0 [deg]C in
the last several years, specifically from 2013 to 2019. In recent
seasons (2017, 2018, and 2019), early-spring cold spells have resulted
in a high incidence of bacterial blast in almond buds and blossoms in
several almond production areas in California. CDPR claims that these
freeze events caused direct crop losses in the form of blasted flowers,
dropped fruit, and shoot dieback affecting future fruiting wood on the
tree. CDPR claims that frost injury has been described as one of the
main limiting factors to crop production in many locations in
California. Some plants' frost injuries have been shown to involve an
interaction of certain leaf surface bacteria and low temperature
stress. Some epiphytic bacteria such as P. syringae cause frost-
sensitive plants to become more susceptible to freeze damage by
initiating the formation of ice that results in frost injury. Many
pathovars of P. syringae are active in ice nucleation and are the most
common ice nucleation active bacteria found on plants in the United
States.
    After having reviewed the submission, EPA determined that an
emergency condition exists for this State, and that the criteria for
approval of an emergency exemption were met. EPA has authorized a
specific exemption under FIFRA section 18 for the use of kasugamycin on
almond trees for control of bacterial blast in almonds in California.
    As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of kasugamycin
in or on almonds. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in FFDCA section 408(l)(6). Although
these time-limited tolerances expire on December 31, 2023, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on almond after that
date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
kasugamycin meets FIFRA's registration requirements for use on almonds
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of kasugamycin by
a State for special local needs under FIFRA section 24(c). Nor does
this tolerance by itself serve as the authority for persons in any
State other than California to use this pesticide on the applicable
crops under FIFRA section 18 absent the issuance of an emergency
exemption applicable within that State. For additional information
regarding the emergency exemption for kasugamycin, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    On March 6, 2018, EPA published in the Federal Register a final
rule establishing tolerances for residues of

kasugamycin in or on cherry subgroup 12-12A and walnut based on the
Agency's conclusion that aggregate exposure to kasugamycin is safe for
the general population, including infants and children. See (83 FR
9442) (FRL-9972-96). EPA is including the following portions of that
document by reference here, as they have not changed in the Agency's
current assessment of kasugamycin tolerances: The toxicological
profile, assumptions for exposure assessment, and the Agency's
determination regarding the children's safety factor, which have not
changed. The Agency is also incorporating the toxicological points of
departure that are referenced in that document and published in Federal
Register published on August 29, 2014 (79 FR 51492) (FRL-9911-57),
which have not changed.
    EPA's exposure assessments have been updated to include the
additional exposure from use of kasugamycin from use on almonds,
assuming both tolerance-level residues and 100 percent crop treated.
    An acute dietary endpoint was not identified for kasugamycin, as a
result, acute dietary risk is not of concern and a separate acute
dietary exposure analysis was not performed. Chronic dietary risk
estimates for kasugamycin are below the Agency's level of concern of
100% of the chronic population adjusted dose (cPAD) for all population
subgroups. The most highly exposed population subgroup, children 1-2
years old, had a risk estimate of 4.5% of the cPAD, while the general
US population had a risk estimate of 1.3% of the cPAD. There are no
dietary risk estimates of concern associated with the section 18 use of
kasugamycin on almonds in California, when considered along with
existing uses of the fungicide.
    Since there are no residential uses of kasugamycin and no
commercial uses that could result in residential exposure, aggregate
risk estimates are equivalent to dietary risk estimates, which are not
of concern.
    Occupational handler exposures to kasugamycin were estimated
assuming the maximum application rate, and label-recommended equipment
and methods, and standard assumptions with respect to the area treated.
In the absence of chemical-specific data to assess handler's exposure
and risk, EPA relied on surrogate unit exposure data to estimate
exposure and risk. The Agency assumed a single layer of clothing
(baseline), without additional personal protective equipment (PPE). The
resulting handler risk estimates, or margins of exposures, are all
above 100, and are not of concern.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children from
aggregate exposure to kasugamycin residues. More detailed information
on the Agency's analysis to establish a time-limited tolerance in or
almonds can be found at http://www.regulations.gov in the document
titled ``Kasugamycin. Human Health Risk Assessment for the Proposed
Section 3 Registration of New Uses of the Antibiotic Fungicide on
Cherry Subgroup 12-12A and Walnuts'' dated September 27, 2017, in
docket ID EPA-HQ-OPP-2016-0519 and the document titled, ``Kasugamycin.
20CA01. Human Health Risk Assessment for the Proposed Section 18
Specific Exemption for Use on Almonds'' dated April 15, 2020, in docket
ID number EPA-HQ-OPP-2020-0338.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (a reverse-phase, ion pairing
HPLC/UV method (Morse Laboratories Method #Meth-146, Revision #4)) is
available for collecting data and enforcing tolerances for kasugamycin
in plant commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established MRLs for kasugamycin.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol), in or on
Almond at 0.04 ppm and Almond, hulls at 0.4 ppm. These tolerances
expire on December 31, 2023.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(l)(6) in
response to an emergency exemption application submitted to the Agency.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993). Because this
action has been exempted from review under Executive Order 12866, this
action is not subject to Executive Order 13211, entitled ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled ``Protection of Children from Environmental Health
Risks and Safety Risks'' (62 FR 19885, April 23, 1997), nor is it
considered a regulatory action under Executive Order 13771, entitled
``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339,
February 3, 2017). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in support of
a FIFRA section 18 emergency exemption do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, but does not directly regulate states or
tribes, nor does this action alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). As such, the Agency has
determined that this action will not have a substantial direct effect
on States or

tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 25, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.614 add paragraph (b) to read as follows:

Sec.  180.614  Kasugamycin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of
kasugamycin, including metabolites and degradates, in or on the
specified agricultural commodities, resulting from use of the pesticide
pursuant to FIFRA section 18 emergency exemptions. Compliance with the
tolerance levels specified is to be determined by measuring only
kasugamycin (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol) in or on
the commodity. The tolerances expire on the date specified in the
table.

------------------------------------------------------------------------
                                      Parts per
              Commodity                million       Expiration date
------------------------------------------------------------------------
Almond..............................       0.04  December 31, 2023.
Almond, hulls.......................        0.4  December 31, 2023.
------------------------------------------------------------------------

* * * * *

[FR Doc. 2020-19761 Filed 10-7-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7802-7803]
[FR Doc No: 2016-02965]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practices; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Educational Conference Co-
Sponsored With the Society of Clinical Research Associates (SOCRA).''
The public workshop on FDA's clinical trial requirements is designed to
aid the Clinical Research Professional's understanding of the mission,
responsibilities, and authority of FDA and to facilitate interaction
with FDA representatives. The program will focus on the relationships
among FDA, clinical trial staff, investigators, and institutional
review boards (IRBs). Individual FDA representatives will discuss the
informed consent process and informed consent documents; regulations
relating to drugs, devices, and biologics; as well as inspections of
clinical investigators, of IRBs, and of research sponsors.

DATES: The public workshop will be held on March 9 and 10, 2016, from 8
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the Holiday Inn San
Diego Bayside, 4875 North Harbor Dr., San Diego, CA 92106, 619-224-
3621.

FOR FURTHER INFORMATION CONTACT: Jane Kreis, Food and Drug
Administration, 1301 Clay St., Suite 1180N, Oakland, CA 94612, 510-287-
2708, FAX:<PHONE_NUMBER>, or Society of Clinical Research Associates
(SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914,
telephone:<PHONE_NUMBER> or<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>Web site: www.socra.org. (FDA has verified the Web
site addresses throughout this document, but we are not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.)

SUPPLEMENTARY INFORMATION:

I. Background

    The public workshop helps fulfill the Department of Health and
Human Services' and FDA's important mission to protect the public
health. The workshop will provide those engaged in FDA-regulated
(human) clinical trials with information on a number of topics
concerning FDA requirements related to informed consent, clinical
investigation requirements, IRB inspections, electronic record
requirements, and investigator initiated research.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The workshop helps to achieve objectives set forth
in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393),
which include working closely with stakeholders and maximizing the
availability and clarity of information to stakeholders and the public.
The workshop also is consistent with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach
activities by Government Agencies to small businesses.

II. Topics for Discussion at the Public Workshop

    Topics for discussion include the following: (1) The Role of the
FDA District Office Relative to the Bioresearch Monitoring Program
(BIMO); (2) Modernizing FDA's Clinical Trials/BIMO; (3) What FDA
Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects
of Clinical Research; (5) Adverse Event Reporting--Science, Regulation,
Error, and Safety; (6) Working With FDA's Center for Biologics
Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8)
Keeping Informed and Working Together; (9) FDA Conduct of Clinical
Investigator Inspections; (10) Investigator Initiated Research; (11)
Meetings With FDA--Why, When, and How; (12) Part 11 Compliance--
Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14)
Informed Consent Regulations; (15) The Inspection is Over--What Happens
Next? Possible FDA Compliance Actions; and (16) Question and Answer
Session/Panel Discussion.
    Registration: The registration fee will cover actual expenses
including refreshments, lunch, materials, and speaker expenses. Seats
are limited; please submit your registration as soon as possible.
Workshop space will be filled in order of receipt of registration.
Those accepted into the workshop will receive confirmation. The cost of
the registration is as follows: SOCRA member--$575, SOCRA nonmember
(includes membership)--$650, Federal Government member--$450, Federal

Government nonmember--$525, and FDA Employee--(free) Fee Waived.
    Attendees are responsible for their own accommodations. Please
mention SOCRA to receive the hotel room rate of $142 plus applicable
taxes (available until the SOCRA room block is filled).
    If you need special accommodations due to a disability, please
contact SOCRA (see FOR FURTHER INFORMATION CONTACT) at least 21 days in
advance.
    Extended periods of question and answer and discussion have been
included in the program schedule. SOCRA designates this education
activity for a maximum of 13.3 Continuing Education (CE) Credits for
SOCRA CE and Nurse CNE; SOCRA designates this live activity for a
maximum of 13.3 AMA PRA Category 1 Credit(s)TM. Physicians
should claim only the credit commensurate with the extent of their
participation. CME for Physicians: SOCRA is accredited by the
Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians. CNE for Nurses: Society of
Clinical Research Associates is accredited as a provider of continuing
nursing education by the American Nurses Credentialing Center's
Commission on Accreditation.
    Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address,
telephone, fax number, and email, along with a check or money order
payable to ``SOCRA.'' Mail to: SOCRA (see FOR FURTHER INFORMATION
CONTACT). To register via the Internet, go to http://www.socra.org/html/FDAConference.htm. Payment by major credit card is accepted (Visa/
MasterCard/AMEX only). For more information on the meeting
registration, or for questions on the workshop, contact SOCRA (see FOR
FURTHER INFORMATION CONTACT).

    Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02965 Filed 2-12-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3392-3394]
[FR Doc No: 2020-00823]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5666]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Empirical Study of Promotional Implications of
Proprietary Prescription Drug Names

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Empirical Study of
Promotional Implications of Proprietary Prescription Drug Names.''

DATES: Submit either electronic or written comments on the collection
of information by March 23, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 23, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.

Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your comment will be made public, you are solely responsible for
ensuring that your comment does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-5666 for ``Empirical Study of Promotional Implications of
Proprietary Prescription Drug Names.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Empirical Study of Promotional Implications of Proprietary Prescription
Drug Names

OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotional material is truthful, balanced, and accurately
communicated, so that patients and healthcare providers (HCPs) can make
informed decisions about treatment options. OPDP's research program
provides scientific evidence to help ensure that our policies related
to prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: Advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits; focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience; and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues. This

study will inform the first two topic areas.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a direct-to-consumer (DTC)
survey conducted in 1999.
    During the prescription drug approval process, sponsors propose
proprietary names for their products. These names undergo a proprietary
name review that involves the Office of Drug Safety, the relevant
medical office, and the OPDP. OPDP reviews names to assess for
alignment with the FD&C Act, which provides that labeling or
advertising can misbrand a product if misleading representations are
made (see 21 U.S.C. 321(n)). A proprietary name, which appears in
labeling, could result in such misbranding if it is false or
misleading. OPDP focuses its misbranding review on identifying names
that overstate the efficacy or safety of the drug, expand drug
indications, suggest superiority without substantiation, or are of a
fanciful nature that misleadingly implies unique effectiveness or
composition. While there are several ways proprietary names can be
misleading, this research will primarily focus on overstatement of the
efficacy of the drug product.
    The proposed study is designed to provide systematic, empirical
evidence to answer two research questions:
     Primary research question: How, if at all, do names that
suggest the drug's indication affect consumers' and/or healthcare
providers' perceptions of the prescription drug?
     Secondary research question: How, if at all, do names that
suggest an overstatement of the efficacy of the drug affect consumers'
and/or healthcare providers' perceptions of prescription drugs?
    The ideas generated in the Prescription Drug User Fee Amendments
pilot project proprietary name review concept paper of 2008 \1\
provided a starting point for the study. Based on ideas from that
document, a review of the linguistics and social sciences literature,
and an environmental scan, FDA developed and pretested an extreme,
explicitly suggestive name (e.g., CureAll) and a neutral name for two
indications, high cholesterol and gastroesophageal reflux disease (OMB
control number 0910-0695). In the proposed main study, approximately
500 consumers from the general population and 500 HCPs (including
physicians, nurse practitioners, and physician assistants) will see
these pretested extreme and neutral names plus five target (to be
tested) names per indication and answer questions about the names,
before and after they have been told what each drug's indication is.
Target names will vary such that some efficacy implications are more
apparent than others and some will more clearly imply indication or
benefits than others. Dependent variables will include indication
identification, efficacy, and perceptions.
---------------------------------------------------------------------------

    \1\ https://www.regulations.gov/docket?D=FDA-2008-N-0281.
_____________________________________-

    To our knowledge, this study is the first to provide a systemic
investigation of a variety of proprietary prescription drug names.
    The questionnaire is available upon request from
<EMAIL_ADDRESS>    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual        Average burden per response \2\         Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consumer Screener............................           1,233               1           1,233  0.08 (5 minutes).........................              99
HCP Screener.................................           1,233               1           1,233  0.08 (5 minutes).........................              99
Consumer Study...............................             493               1             493  0.33 (20 minutes)........................             163
HCP Study....................................             493               1             493  0.33 (20 minutes)........................             163
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             524
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

    Dated: January 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00823 Filed 1-17-20; 8:45 am]
 BILLING CODE 4164-01-P