[Federal Register Volume 86, Number 186 (Wednesday, September 29, 2021)]
[Notices]
[Pages 53967-53968]
[FR Doc No: 2021-21115]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0544]

Nontuberculous Mycobacterial Pulmonary Disease Caused by
Mycobacterium avium Complex: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Nontuberculous Mycobacterial Pulmonary Disease Caused by
Mycobacterium avium Complex: Developing Drugs for Treatment.'' The
purpose of this draft guidance is to assist sponsors in the clinical
development of drugs for the treatment of nontuberculous mycobacterial
pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).

DATES: Submit either electronic or written comments on the draft
guidance by November 29, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2021-D-0544 for ``Nontuberculous Mycobacterial Pulmonary Disease
Caused by Mycobacterium avium Complex: Developing Drugs for
Treatment.'' Received comments 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Mukil Natarajan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6393, Silver Spring, MD 20993, 240-402-
4626.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Nontuberculous Mycobacterial Pulmonary Disease Caused by
Mycobacterium avium Complex: Developing Drugs for Treatment.''

    The purpose of this draft guidance is to assist sponsors in the
clinical development of drugs for the treatment of NTM-PD caused by
MAC. Specifically, this guidance addresses FDA's current thinking
regarding clinical trial design issues, choice of study population, and
endpoints for the treatment of na[iuml]ve and refractory NTM-PD caused
by MAC.
    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 current thinking of FDA on
``Nontuberculous Mycobacterial Pulmonary Disease Caused by
Mycobacterium avium Complex: Developing Drugs for Treatment.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for submissions of investigational new drug
applications, new drug applications and biologic license applications
in 21 CFR part 312, part 314 and part 601 have been approved under OMB
control numbers 0910-0014, 0910-0001, and 0910-0338, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21115 Filed 9-28-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 60 (Tuesday, March 29, 2022)]
[Notices]
[Pages 18012-18013]
[FR Doc No: 2022-06510]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2444-040]

Northern States Power Company; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.

    a. Type of Application: Request for a temporary amendment of
reservoir elevation requirement.
    b. Project No.: 2444-040.
    c. Date Filed: March 9, 2022.
    d. Applicant: Northern States Power Company.
    e. Name of Project: White River Hydroelectric Project.
    f. Location: The project is located on the White River in Ashland
County, Wisconsin.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Mr. Matthew Miller, 1414 West Hamilton
Avenue, P.O. Box 8, Eau Claire, WI 54702,<PHONE_NUMBER>.
    i. FERC Contact: Mr. Steven Sachs,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance of this notice by the Commission. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/doc-sfiling/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-2444-040.
    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 on 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 Request: The applicant requests a temporary
amendment of its minimum reservoir elevation requirement to allow for
gate inspections and repairs. The applicant states it would draw down
the reservoir to approximately 8 feet below the normal elevation to
allow for work on its spillway gates. The applicant expects the
drawdown to last 4 to 6 weeks, but requests the Commission allow it to

perform the drawdown anytime between July 1 and October 31, 2022 to
allow for weather and other contingences.
    l. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://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, contact FERC at [email protected] or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a motion to intervene, or a protest 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, motions to
intervene, or protests must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``MOTION TO
INTERVENE'', or ``PROTEST'' as applicable; (2) set forth in the heading
the name of the applicant and the project number(s) of the application
to which the filing responds; (3) furnish the name, address, and
telephone number of the person intervening or protesting; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. A copy of all other filings in reference
to this application must be accompanied by proof of service on all
persons listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.

    Dated: March 22, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-06510 Filed 3-28-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 5, 2006 (Volume 71, Number 87)]
[Notices]
[Page 26485-26486]
[DOCID:fr05my06-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER05-1232-001]

J.P. Morgan Ventures Energy Corporation; Notice of Filing

April 27, 2006.
    Take notice that on October 13, 2005, J.P. Morgan Ventures Energy
Corporation filed revisions to its market-based Rate Schedule No. 1 in
compliance with the Commission's September 20, 2005 order.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the

appropriate action to be taken, but will not serve to make protestants
parties to the proceeding. Any person wishing to become a party must
file a notice of intervention or motion to intervene, as appropriate.
Such notices, motions, or protests must be filed on or before the
comment date. Anyone filing a motion to intervene or protest must serve
a copy of that document on the Applicant and all the parties in this
proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on May 4, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6824 Filed 5-4-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Notices]
[Page 17950-17951]
[DOCID:fr02ap08-27]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

Proposed Information Collection; Comment Request; Competitive
Enhancement Needs Assessment Survey Program

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Notice.

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SUMMARY: The Department of Commerce, as part of its continuing effort
to reduce paperwork and respondent burden, invites the general public
and other Federal agencies to take this opportunity to comment on
proposed and/or continuing information collections, as required by the
Paperwork Reduction Act of 1995.

DATES: Written comments must be submitted on or before June 2, 2008.

ADDRESSES: Direct all written comments to Diana Hynek, Departmental
Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th
and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet
at dHynek@doc.gov).

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection instrument and instructions should
be directed to Larry Hall, BIS ICB Liaison,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Abstract

    The Defense Production Act of 1950, as amended, and Executive Order
12919, authorizes the Secretary of Commerce to assess the capabilities
of the defense industrial base to support the national defense. They
also develop policy alternatives to improve the international
competitiveness of specific domestic industries and their abilities to
meet defense program needs. The information collected from voluntary
surveys will be used to assist small- and medium-sized firms in defense
transition and in gaining access to advanced technologies and
manufacturing processes available from Federal Laboratories. The goal
is to improve regions of the country adversely affected by cutbacks in
defense spending and military base closures.

II. Method of Collection

    Surveys will be electronically submitted.

III. Data

    OMB Control Number: 0694-0083.
    Form Number(s): None.
    Type of Review: Business or other for-profit organizations.
    Estimated Number of Respondents: 3,000.
    Estimated Time Per Response: 30 minutes.
    Estimated Total Annual Burden Hours: 1,500.
    Estimated Total Annual Cost to Public: $0.

IV. Request for Comments

    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 shall have practical
utility; (b) the accuracy of the agency's estimate of the burden
(including hours and cost) of the proposed collection of information;
(c) ways to enhance the quality, utility, and clarity of the
information to be 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.
    Comments submitted in response to this notice will be summarized
and/or

included in the request for OMB approval of this information
collection; they also will become a matter of public record.

    Dated: March 27, 2008.
Gwellnar Banks,
Management Analyst, Office of the Chief Information Officer.
 [FR Doc. E8-6685 Filed 4-1-08; 8:45 am]

BILLING CODE 3510-33-P