[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23357-23358]
[FR Doc No: 2021-09255]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER19-2273-004.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Southwest Power Pool, Inc. Refund
Report to be effective N/A.
    Filed Date: 4/21/21.
    Accession Number: 20210421-5000.
    Comments Due: 5 p.m. ET 5/12/21.

    Docket Numbers: ER21-1707-001.
    Applicants: The Potomac Edison Company, PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Potomac submits Amendment to Pending
Filing of Service Agreement No. 4452 to be effective 6/16/2021.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5092.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: ER21-1719-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Tariff Cancellation: DEP--EPCOR USA NC-Southport SA
237 Termination to be effective 6/30/2021.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5078.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: ER21-1720-000.
    Applicants: Entergy Arkansas, LLC.
    Description: Sec.  205(d) Rate Filing: EAL-MSS-4 Replacement Tariff
to be effective 5/1/2021.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5142.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: ER21-1721-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3785 Tip Top Solar, SPS and
OG&E Shared Network Upgrade FCA to be effective 6/20/2021.
    Filed Date: 4/21/21.
    Accession Number: 20210421-5014.
    Comments Due: 5 p.m. ET 5/12/21.

    Take notice that the Commission received the following foreign
utility company status filings:

    Docket Numbers: FC21-3-000.
    Applicants: BLCP Power Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of BLCP Power Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5141.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-4-000.
    Applicants: Chaiyaphum Wind Farm Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Chaiyaphum Wind Farm Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5145.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-5-000.
    Applicants: EGCO Cogeneration Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of EGCO Cogeneration Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5149.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-6-000.
    Applicants: G-Power Source Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of G-Power Source Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5160.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-7-000.
    Applicants: Gulf Power Generation Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Gulf Power Generation Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5161.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-8-000.
    Applicants: Gulf Yala Green Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Gulf Yala Green Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5163.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-9-000.
    Applicants: Nam Theun 2 Power Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Nam Theun 2 Power Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5167.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-10-000.
    Applicants: Natural Energy Development Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Natural Energy Development Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5170.
    Comments Due: 5 p.m. ET 5/11/21.

    Docket Numbers: FC21-11-000.
    Applicants: Nong Khae Cogeneration Company Limited.
    Description: Notice of Self-Certification of Foreign Utility
Company Status of Nong Khae Cogeneration Company Limited.
    Filed Date: 4/20/21.
    Accession Number: 20210420-5172.
    Comments Due: 5 p.m. ET 5/11/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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 5:00 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: April 21, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-09255 Filed 4-30-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 176 (Wednesday, September 15, 2021)]
[Notices]
[Pages 51438-51439]
[FR Doc No: 2021-19914]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Final Agency Actions on Proposed Railroad Project in
California, on Behalf of the California High Speed Rail Authority

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

SUMMARY: FRA, on behalf of the California High-Speed Rail Authority
(Authority), is issuing this notice to announce actions taken by the
Authority that are final. By this notice, FRA is advising the public of
the time limit to file a claim seeking judicial review of the actions
related to a proposed railroad project, the California High-Speed Rail
(HSR) Authority's Bakersfield to Palmdale Project Section (Project).
These actions grant approvals for project implementation pursuant to
the National Environmental Policy Act (NEPA) and other laws,
regulations, and executive orders.

DATES: A claim seeking judicial review of the agency actions on the
Project will be barred unless the claim is filed on or before September
15, 2023. If the Federal law that authorizes judicial review of a claim
provides a time period of less than 2 years for filing such claim, then
that shorter time period applies.

FOR FURTHER INFORMATION CONTACT:
    For the Authority: Scott Rothenberg, NEPA Assignment Manager,
Environmental Services, California High-Speed Rail Authority,
telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    For FRA: Marlys Osterhues, Division Chief, Environment and Project
Engineering, RPD, telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Effective July 23, 2019, FRA assigned, and
the State of California acting through the Authority assumed,
environmental responsibilities for the California HSR System pursuant
to 23 U.S.C. 327. Notice is given that the Authority has taken final
agency actions subject to 23 U.S.C. 139(l)(1) and 49 U.S.C. 24201(a)(4)
by issuing approvals for the Project.
    The purpose of the California HSR System \1\ is to provide a
reliable, high-speed, electric-powered train system that links the
major metropolitan areas of California, delivering predictable and
consistent travel times. A further objective is to provide an interface
with commercial airports, mass transit, and the highway network, and to
relieve capacity constraints of the existing transportation system as
increases in intercity travel demand in California occur, in a manner
sensitive to and protective of California's unique natural resources.
The Authority has selected Alternative 2 with the Refined C[eacute]sar
E. Ch[aacute]vez National Monument Design Option, Avenue M Maintenance
Site and Maintenance-of-Way Facility, and the Palmdale Station
identified in the Final Environmental Impact Statement (Final EIS) for
the Project because the Selected Alternative (1) best satisfies the
Purpose, Need, and Objectives for the Project and (2) minimizes impacts
on the natural and human environment by utilizing an existing
transportation corridor where practicable and incorporating mitigation
measures. The actions by the Authority, and the laws under which such
actions were taken, are described in the Record of Decision (ROD) and
Final EIS on the Project, approved on September 3, 2021. The ROD, Final
EIS, and other documents are available online in PDF at the Authority's
website (www.hsr.ca.gov) and on CD-ROM by calling<PHONE_NUMBER>.
---------------------------------------------------------------------------

    \1\ The California HSR System would be implemented in two
phases. Phase 1 would connect San Francisco to Los Angeles and
Anaheim via the Pacheco Pass and the southern Central Valley. Phase
2 would extend the HSR system from the Central Valley (starting at
the Merced Station) to the state's capital in Sacramento and from
Los Angeles to San Diego.
---------------------------------------------------------------------------

    The notice applies to the ROD, Final EIS, and all other Federal
agency decisions with respect to the Project as of the issuance date of
this notice and

all laws under which such actions were taken, including but not limited
to:
    1. NEPA;
    2. Council on Environmental Quality regulations (1978); \2\
---------------------------------------------------------------------------

    \2\ The Council on Environmental Quality (CEQ) issued new
regulations on July 14, 2020, effective September 14, 2020, updating
the NEPA implementing procedures at 40 CFR parts 1500 through 1508.
However, this project initiated NEPA before the effective date and
relies on the CEQ regulations as they existed prior to September 14,
2020. All subsequent citations to the CEQ regulations in the ROD and
Final EIS refer to the 1978 regulations, consistent with 40 CFR
1506.13 (2020) and the preamble at 85 FR 43340.
---------------------------------------------------------------------------

    3. Fixing America's Surface Transportation Act (FAST Act);
    4. Department of Transportation Act of 1966, Section 4(f);
    5. Land and Water Conservation Fund (LWCF) Act of 1965, Section
6(f);
    6. Clean Air Act Amendments of 1990;
    7. Clean Water Act of 1977 and 1987;
    8. Endangered Species Act of 1973;
    9. Migratory Bird Treaty Act;
    10. National Historic Preservation Act of 1966, as amended;
    11. Executive Order 11990, Protection of Wetlands;
    12. Executive Order 11988, Floodplain Management;
    13. Executive Order 12898, Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations;
    14. Executive Order 13112, Invasive Species.

    Issued in Washington, DC.
Jamie P. Rennert,
Director, Office of Infrastructure Investment.
[FR Doc. 2021-19914 Filed 9-14-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Rules and Regulations]
[Pages 10173-10174]
[FR Doc No: 2021-03312]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2021-0040]

Special Local Regulations; Mark Hahn Memorial 300 PWC Endurance
Race, Lake Havasu City, AZ

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Mark Hahn Memorial 300 PWC
Endurance Race special local regulations on the waters of Lake Havasu,
Arizona from February 27 through February 28, 2021. These special local
regulations are necessary to provide for the safety of the
participants, crew, spectators, sponsor vessels, and general users of
the waterway. During the enforcement period, persons and vessels are
prohibited from anchoring, blocking, loitering, or impeding within this
regulated area unless authorized by the Captain of the Port, or his
designated representative.

DATES: The regulations in 33 CFR 100.1102 will be enforced from 7 a.m.
until 6 p.m., each day from February 27, 2021 through February 28, 2021
for Item 14 in Table 1 of Section 100.1102.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant John Santorum,
Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone
619-278-7656, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1102 for the Mark Hahn Memorial 300 PWC
Endurance Race on Lake Havasu, AZ in 33 CFR 100.1102, Table 1, Item 14
of that section from 7 a.m. to 6 p.m. daily, on February 27, 2021 and
February 28, 2021. This enforcement action is being taken to provide
for the safety of life on navigable waterways during the event. The
Coast Guard's regulation for annual marine events on the Colorado
River, between Davis Dam (Bullhead City, Arizona) and Headgate Dam
(Parker, Arizona) identifies the regulated entities and area for this
event. Under the provisions of 33 CFR 100.1102, persons and vessels are
prohibited from anchoring, blocking, loitering, or impeding within this
regulated area, unless authorized by the Captain of the Port, or his
designated representative. The Coast Guard may be assisted by other
Federal, State, or local law enforcement agencies in enforcing this
regulation.
    In addition to this document in the Federal Register, the Coast
Guard will provide the maritime community with advance notification of
this enforcement period via the Local Notice to Mariners and local
advertising by the event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
Broadcast Notice to Mariners or other communications coordinated with

the event sponsor to grant general permission to enter the regulated
area.

    Dated: February 11, 2021.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2021-03312 Filed 2-18-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Notices]
[Pages 27761-27762]
[FR Doc No: 2012-11372]

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

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: EC12-96-000.
    Applicants: Sierra Pacific Power Company.
    Description: Application of Sierra Pacific Power Company for Order
Authorizing Acquisition of Jurisdictional Facilities under FPA Section
203 and Request for Expedited Action.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5203.

    Comments Due: 5 p.m. ET 5/23/12.

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

    Docket Numbers: EG12-64-000.
    Applicants: High Plains Ranch II, LLC.
    Description: High Plains Ranch II, LLC--Notice of Self
Certification of Exempt Wholesale Generator Status.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5057.
    Comments Due: 5 p.m. ET 5/24/12.

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

    Docket Numbers: ER11-4105-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Order No. 745 Compliance to be effective 12/31/9998.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5189.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1151-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Compliance Refund Report for Marsh Landing E&P
Agreement to be effective N/A.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5003.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1471-001.
    Applicants: Canastota Windpower, LLC.
    Description: Canastota Windpower, LLC submits tariff filing per
35.17(b): Canastota Windpower, LLC Amendment to Electric Tariff to be
effective 5/4/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5097.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1613-001.
    Applicants: Hill Energy Resource & Services, LLC.
    Description: Amendments to Hill Energy Resource & Services, LLC
Electric Tariff to be effective 5/1/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5007.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1706-000.
    Applicants: NV Energy, Inc.
    Description: Service Agreement No. 12-00030 Mt Wheeler Power NITS
Agreement to be effective 6/1/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5000.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1707-000.
    Applicants: Liberty Power Wholesale Supply, LLC.
    Description: Market-Based Rate Application to be effective 5/3/
2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5006.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1708-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
ITC Midwest LLC.
    Description: ITCM-Northern Iowa Windpower IA to be effective 7/3/
2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5034.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1709-000.
    Applicants: New York Independent System Operator, Inc., Niagara
Mohawk Power Corporation.
    Description: Agreement No. 1488, Niagara Mohawk and Selkirk Cogen
Partners IA to be effective 4/1/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5042.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1710-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Submission of Notice of Cancellation--Service
Agreements 2021R1 and 2022R1 to be effective 4/1/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5050.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1711-000.
    Applicants: High Plains Ranch II, LLC.
    Description: High Plains Ranch II, LLC submits tariff filing per
35.12: Application for Market-Based Rate Authority to be effective 6/
25/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5056.
    Comments Due: 5 p.m. ET 5/24/12.

    Docket Numbers: ER12-1712-000.
    Applicants: ITC Midwest LLC.
    Description: ITC Midwest LLC submits tariff filing per
35.13(a)(2)(iii: Filing of Agreements with MidAmerican Energy Company
to be effective 7/3/2012.
    Filed Date: 5/3/12.
    Accession Number: 20120503-5084.
    Comments Due: 5 p.m. ET 5/24/12.

    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 5:00
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: May 03, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-11372 Filed 5-10-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 21, 2007 (Volume 72, Number 161)]
[Notices]
[Page 46627-46628]
[DOCID:fr21au07-62]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0861; FRL-8457-8]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Compliance Requirement for Child-
Resistant Packaging; EPA ICR No. 0616.09, OMB Control No. 2070-0052

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before September 20,
2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2006-0861, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: OPP Regulatory

Public Docket (7502P), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External
Affairs Division (7506-P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 21, 2007 (72 FR 13274), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received one comment during the
comment period, which is addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2006-0861, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the OPP Regulatory Public

Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. This docket facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
docket telephone number is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, CBI, or other information whose public disclosure is
restricted by statute. For further information about the electronic
docket, go to http://www.regulations.gov.

    Title: Compliance Requirement for Child-Resistant Packaging.
    ICR numbers: EPA ICR No. 0616.09, OMB Control No. 2070-0052.
    ICR Status: This ICR is scheduled to expire on August 31, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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 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 in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: This ICR is designed to provide the EPA with assurances
that the packaging of pesticide products sold and distributed to the
general public in the United States meets standards set forth by the
Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA). Unless a pesticide product qualifies for an exemption, if
the product meets certain

criteria regarding toxicity and use, it must be sold and distributed in
child-resistant packaging. Section 25(c)(3) of FIFRA authorizes EPA to
establish standards for packaging of pesticide products and pesticidal
devices to protect children and adults from serious illness or injury
resulting from accidental ingestion or contact. The law requires that
these standards are designed to be consistent with those under the
Poison Prevention Packaging Act, administered by the Consumer Product
Safety Commission (CPSC). Pesticide registrants must certify to the
Agency that the packaging or device meets these standards. EPA reviews
a registrant's child-resistant packaging (CRP) certification to
determine if there are human safety/health risk concerns. Exemption
requests are reviewed to ascertain if there is a health risk, and if
CRP is technically feasible, practicable, and appropriate.
    Responses to this collection of information are mandatory under
authority of 40 CFR 157.34. Although submission of confidential
information is not required as a part of this information collection,
there has been at least one instance where confidential data have been
submitted voluntarily as supporting material for an exemption request
from CRP compliance requirements. When any trade secret or Confidential
Business Information (CBI) is provided to EPA, such information is
protected from disclosure under section 10 of FIFRA. Data submitted to
EPA is handled strictly in accordance with the provisions of the FIFRA
Confidential Business Information Manual.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 4.9
hours per response. Burden means 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. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: All registrants of pesticide
products meeting the use criteria which trigger Child-Resistant
Packaging (CRP) requirements.
    Estimated Number of Respondents: 2,109.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 3,473.
    Estimated Total Annual Cost: $193,567.
    Changes in the Estimates: There is an increase of 1,364 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is an adjustment to the burden
estimate. Neither the number of responses nor the average burden
estimate for each response type has changed. However, the distribution
of those responses among the four response types has changed, with a
net shift from less-burdensome to more-burdensome type responses.

    Dated: August 14, 2007
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-16439 Filed 8-20-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]
[Page 53749-53750]
[DOCID:fr20oc09-65]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0487]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Informed Consent For In Vitro Diagnostic
Device Studies Using Leftover Human Specimens That Are Not Individually
Identifiable

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on guidance on informed consent
for in vitro diagnostic device studies using leftover human specimens
that are not individually identifiable.

DATES: Submit written or electronic comments on the collection of
information by December 21, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, including
each proposed extension of an existing 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.

Guidance on Informed Consent For In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That Are Not Individually Identifiable--
OMB Control Number 0910-0582--Extension

    FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and with ethical standards. Investigators
should have freedom to pursue the least burdensome means of
accomplishing this goal. However, to ensure that the balance is
maintained between product development and the protection of public
health, safety, and ethical standards, FDA has established human
subject protection regulations addressing requirements for informed
consent and institutional review board (IRB) review that apply to all
FDA-regulated clinical investigations involving human subjects. In
particular, informed consent requirements further both safety and
ethical considerations by allowing potential subjects to consider both
the physical and privacy risks they face if they agree to participate
in a trial.
    Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many
investigational device studies are exempt from most provisions of part
812 (21 CFR part 812), Investigational Device Exemptions, under Sec.
812.2(c)(3), but FDA's regulations for the protection of human subjects
(21 CFR parts 50 and 56) apply to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21 CFR 56.101, 21 U.S.C.
360j(g)(3)(A), and 21 U.S.C. 360j(g)(3)(D)).
    FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed

consent for research involving leftover or unidentifiable specimens.
    In a level one guidance document issued under the Good Guidances
Practices regulation, 21 CFR 10.115, FDA outlines the circumstances in
which it intends to exercise enforcement discretion as to the informed
consent regulations for clinical investigators, sponsors, and IRBs.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           No. of        Annual Frequency    Total Annual   Hours  per     Total    Total  Capital   Total Operating and
         FD&C  Act Section:            Recordkeepers     per Recordkeeping      Records       Record       Hours        Costs         Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g)                                            700                     1           700             4     2,800         $210,000              $420,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The recommendations of this guidance impose a minimal burden on
industry. FDA estimates that 700 studies will be affected annually.
Each study will result in one recordkeeping per year, estimated to take
4 hours to complete. This results in a total recordkeeping burden of
2,400 hours (700 x 4 = 2,800). FDA estimates that the cost of
developing standard operating procedures for each record keeper is $300
(6 hours of work at $50/hour (h)). This results in a total cost to
industry of $210,000 ($300 x 700 recordkeepers). FDA estimates that
operating costs for collecting this information is $300 per record
keeper (6 hours of work at $50/h). This results in a total operational
and maintenance cost to industry of $210,000 ($300 x 700
recordkeepers). The total cost of this recordkeeping, capital plus
operational and maintenance cost is estimated to be $420,000.

    Dated: October 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25178 Filed 10-19-09; 8:45 am]

BILLING CODE 4160-01-S