[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Notices]
[Pages 53151-53152]
[FR Doc No: 2013-20916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0918]

The Applicability of Good Laboratory Practice in Premarket Device
Submissions: Questions and Answers; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``The Applicability of Good
Laboratory Practice in Premarket Device Submissions: Questions &
Answers.'' This draft guidance answers commonly asked questions about
the applicability of good laboratory practice (GLP) to nonclinical
laboratory studies conducted in support of research and marketing
applications for medical devices. This draft guidance is not final nor
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Applicability of Good Laboratory
Practice in Premarket Device Submissions: Questions & Answers'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration (CDRH), 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or Office of Communication, Outreach, and
Development (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
CDRH at<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Victoria Hampshire, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1218, Silver Spring, MD 20993-0002, 301-
796-6375; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the GLP regulations in response to public concerns that
several important studies supporting the safety of FDA-regulated
products were seriously flawed due to poor research practices and
laboratory misconduct. The GLP regulations apply to nonclinical
laboratory studies supporting the safety of FDA-regulated products (21
CFR 58.1). The draft guidance provides clarification on GLP
terminology, the types of medical device research or marketing
applications that are subject to the GLP regulation, and, if
applicable, the types of information related to GLP that should be
provided to FDA.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on good
laboratory practices. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``The
Applicability of Good Laboratory Practice in Premarket Device
Submissions: Questions & Answers,'' you may either send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1779 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; and the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20916 Filed 8-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7443-7444]
[FR Doc No: 2015-02632]

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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
rate filings:

    Docket Numbers: ER10-2964-006.
    Applicants: Selkirk Cogen Partners, L.P.
    Description: Notice of Non-Material Change in Status of Selkirk
Cogen Partners, L.P.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5386.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER10-3203-003; ER10-3050-002; ER10-3052-002; ER10-
3053-002.
    Applicants: J. Aron & Company, Cabazon Wind Partners, LLC, Rock
River I, LLC, Whitewater Hill Wind Partners, LLC.
    Description: Notice of Non-Material Change in Status of J. Aron &
Company, et al.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5453.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER13-342-006.
    Applicants: CPV Shore, LLC.
    Description: Notice of Change in Status of CPV Shore, LLC.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5391.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER14-1317-003; ER11-2041-006; ER11-2042-006; ER10-
3193-006; ER10-2964-007; ER10-2924-006; ER10-2480-005; ER10-2959-006;
ER10-2961-005; ER10-2934-005; ER12-281-007; ER10-3099-011; ER13-821-
007; ER10-2950-005; ER14-2500-001; ER14-2498-001; ER10-2615-005; ER11-
2335-006; ER10-2538-003.
    Applicants: Sunshine Gas Producers, LLC, Innovative Energy Systems,
LLC, Seneca Energy II, LLC, Brooklyn Navy Yard Cogeneration Partners,
L.P., Selkirk Cogen Partners, L.P., Kleen Energy Systems, LLC,
Berkshire Power Company, LLC, Chambers Cogeneration, Limited
Partnership, Edgecombe Genco, LLC, Logan Generating Company, L.P.,
Northampton Generating Company, L.P., RC Cape May Holdings, LLC,
Scrubgrass Generating Company, L.P., Spruance Genco, LLC, Newark Energy
Center, LLC, EIF Newark, LLC, Plum Point Energy Associates, LLC, Plum
Point Services Company, LLC, Panoche Energy Center, LLC
    Description: Notice of Non-Material Change in Status of Sunshine
Gas Producers, LLC, et al.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5454.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER14-2553-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing per 35: Compliance Filing--ER14-
2553--Implement Long Term Congestion Rights to be effective 2/1/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5296.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-142-002.
    Applicants: Midcontinent Independent System Operator, Inc., Van
Ness Feldman LLP.
    Description: Compliance filing per 35: 2015-01-30_MMU Attachment O
Compliance Filing to be effective 1/1/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5302.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-947-000.
    Applicants: The Connecticut Light and Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Interconnection Agreement Between CL&P and Energy Stream, LLC. to be
effective 3/31/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5297.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-948-000.
    Applicants: Illinois Power Marketing Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): System
Support Resources Agreement and Request for Consolidation to be
effective 1/1/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5300.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-949-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 1-30-
15_SPS CP Filing to be effective 2/1/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5301.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-950-000.
    Applicants: PJM Interconnection, L.L.C., Baltimore Gas and Electric
Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): BGE
submits revisions to Att H-2A re Stated Depreciation Rates to be
effective 3/30/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5303.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-951-000.
    Applicants: Alabama Power Company.

    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Attachment S (MPCo) Filing to be effective 1/1/2015.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5305.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-952-000.
    Applicants: New Jersey Energy Associates, a Limited Partnership.
    Description: Petition of New Jersey Energy Associates, a Limited
Partnership for Waiver of PJM Tariff and Operating Agreement.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5390.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-953-000.
    Applicants: Arkansas Electric Cooperative Corporation.
    Description: Application of Arkansas Electric Cooperative
Corporation for approval of revenue requirements for reactive supply in
MISO.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5399.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-954-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Notice of Termination of Generator Interconnection
Agreement for Service Agreement No. 2317 for Project G667 of
Midcontinent Independent System Operator, Inc.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5402.
    Comments Due: 5 p.m. ET 2/20/15.

    Docket Numbers: ER15-955-000.
    Applicants: Robinson Power Company, LLC.
    Description: Petition for Waiver of Competitive Entry Exemption
Deadline of Robinson Power Company, LLC.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5435.
    Comments Due: 5 p.m. ET 2/9/15.

    Docket Numbers: ER15-956-000.
    Applicants: Portland General Electric Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): GTA
Agreement PGE and BPA Exhibit D Update to be effective 2/3/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5250.
    Comments Due: 5 p.m. ET 2/23/15.

    Docket Numbers: ER15-957-000.
    Applicants: AltaGas Ripon Energy Inc.
    Description: Baseline eTariff Filing per 35.1: AltaGas Ripon Energy
Inc. MBR Tariff to be effective 2/5/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5256.
    Comments Due: 5 p.m. ET 2/23/15.

    Docket Numbers: ER15-958-000.
    Applicants: Transource Kansas, LLC.
    Description: Baseline eTariff Filing per 35.1: Transource Kansas,
LLC Sec.  205 Filing to Establish an Incentive Formula Rate to be
effective 4/3/2015.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5266.
    Comments Due: 5 p.m. ET 2/23/15.

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

    Docket Numbers: ES15-11-000.
    Applicants: Entergy Services, Inc.
    Description: Application of Entergy Services, Inc. on behalf of
Entergy Louisiana Power, LLC, for Section 204 authorizations.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5410.
    Comments Due: 5 p.m. ET 2/20/15.

    Take notice that the Commission received the following land
acquisition reports:

    Docket Numbers: LA14-4-000.
    Applicants: All Dams Generation, LLC, Arlington Valley Solar Energy
II, LLC, Bluegrass Generation Company, L.L.C., Calhoun Power Company,
LLC, Carville Energy LLC, Centinela Solar Energy, LLC, Cherokee County
Cogeneration Partners, LLC, Columbia Energy LLC, Decatur Energy Center,
LLC, DeSoto County Generating Company, LLC, Doswell Limited
Partnership, Lake Lynn Generation, LLC, Las Vegas Power Company, LLC,
LS Power Marketing, LLC, LSP University Park, LLC, Mobile Energy LLC,
Oneta Power, LLC, PE Hydro Generation, LLC, Renaissance Power, L.L.C.,
Riverside Generating Company, LLC, Rocky Road Power, LLC, Santa Rosa
Energy Center, LLC, Seneca Generation, LLC, Tilton Energy LLC,
University Park Energy, LLC, Wallingford Energy LLC, West Deptford
Energy, LLC.
    Description: Quarterly Land Acquisition Report of the LS Power
Development, LLC subsidiaries.
    Filed Date: 1/30/15.
    Accession Number: 20150130-5432.
    Comments Due: 5 p.m. ET 2/20/15.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH15-8-000.
    Applicants: Enbridge Inc.
    Description: Enbridge Inc. submits FERC 65-B Waiver Notification
and Notice of Material Change in Facts.
    Filed Date: 2/2/15.
    Accession Number: 20150202-5214.
    Comments Due: 5 p.m. ET 2/23/15.

    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: February 2, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-02632 Filed 2-9-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Notices]
[Pages 7473-7474]
[FR Doc No: 2022-02689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3404]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Drug User Fee
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by March 11, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0727. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD

20852,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Drug User Fee Program

OMB Control Number 0910-0727--Revision

    This information collection supports implementation of FDA's
Generic Drug User Fee program. The Generic Drug User Fee Amendments
(GDUFA) (Pub. L. 112-144, Title 111) were enacted to speed the delivery
of safe and effective generic drugs to the public and reduce costs to
industry. GDUFA authorizes FDA to assess user fees to fund critical and
measurable enhancements to the performance of FDA's generic drugs
program, bringing greater predictability and timeliness to the review
of generic drug applications. GDUFA is currently authorized through
September 30, 2022, with reauthorization activities currently underway.
For more information regarding GDUFA and ongoing implementation, we
invite you to visit our website at https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.
    GDUFA is based on an agreement negotiated by FDA and
representatives of the generic drug industry intended to address
continuing regulatory challenges. GDUFA reflects input received during
an open process that includes regular public meetings, posting of
meeting minutes, and consideration of comments from a public docket. We
are revising the information collection to include the current GDUFA
agreement, or ``goals letter,'' as reflected in the document ``GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2018-2022,'' available for download from our website at https://www.fda.gov/media/101052/download. The performance goals and program
enhancements specified in the goals letter apply to aspects of the
generic drug review program that are important for facilitating timely
access to quality, affordable generic medicines. FDA is committed to
meeting the performance goals specified in the goals letter and to
continuous improvement of its performance.
    Included among the performance goals is the issuance of topic-
specific guidance documents. We maintain a searchable guidance database
on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. In publishing the respective notices of
availability for each guidance document, we include an analysis under
the PRA and invite public comment on the associated information
collection recommendations. In addition, all Agency guidance documents
are issued in accordance with our Good Guidance Practice regulations in
21 CFR 10.115, which provide for public comment at any time.
    We have developed Form FDA 3794, the Generic Drug User Fee Cover
Sheet, available at https://www.fda.gov/industry/fda-user-fee-programs
which requests the minimum necessary information from generic drug
applicants to account for and track user fees and to determine the
amount of the fee required. Applicants complete and submit the cover
sheets to accompany payments. While applicants may submit payment
through multiple means, all cover sheets are prepared using FDA's web-
based electronic User Fee System. Upon submitting the completed cover
sheet, the User Fee System generates a user fee identification number,
which is provided to applicants at the bottom of the cover sheet. It
also notes the correct fiscal year user fee assessment that is due for
the submission or program. FDA requests that applicants submit a copy
of this completed cover sheet along with the abbreviated new drug
application, as well as other additional GDUFA fees, so FDA can verify
that the applicant has paid the correct user fee and their account is
current.
    Respondents to the information collection are potential or actual
generic drug application holders or related active pharmaceutical
ingredient and finished dosage form manufacturers. Companies with
multiple user fee obligations may submit a cover sheet for each user
fee obligation.
    In the Federal Register of November 19, 2021 (86 FR 64945), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                                  Number of
                Form FDA 3794                     Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generic Drug User Fee Cover Sheet............             500           7.616           3,808  0.5(30 minutes)..........................           1,904
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we have retained
the currently approved burden estimate.

    Dated: February 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02689 Filed 2-8-22; 8:45 am]
BILLING CODE 4164-01-P