[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Rules and Regulations]
[Pages 74289-74291]
[FR Doc No: 2016-25784]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31098; Amdt. No. 3715]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or because of changes occurring in the
National Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective October 26, 2016. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of October 26, 2016.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS.
The complete regulatory description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part Sec.  97.20. The
applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A,
and 8260-15B when required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers of
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAPs, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPS as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as Amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an

effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC, on September 23, 2016.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 10 November 2016

Barter Island, AK, Barter Island, Takeoff Minimums and Obstacle DP,
Orig
Barter Island, AK, Barter Island, Takeoff Minimums and Obstacle DP,
Orig, CANCELED
Bettles, AK, Bettles, VOR RWY 1, Amdt 1B
Kodiak, AK, Kodiak, ILS Y OR LOC Y RWY 26, Amdt 3A
Platinum, AK, Platinum, Takeoff Minimums and Obstacle DP, Amdt 1A
Scammon Bay, AK, Scammon Bay, Takeoff Minimums and Obstacle DP, Amdt
2
El Dorado, AR, South Arkansas Rgnl At Goodwin Field, ILS OR LOC RWY
22, Amdt 2D
El Dorado, AR, South Arkansas Rgnl At Goodwin Field, RNAV (GPS) RWY
4, Orig-B
El Dorado, AR, South Arkansas Rgnl At Goodwin Field, RNAV (GPS) RWY
22, Orig-B
El Dorado, AR, South Arkansas Rgnl At Goodwin Field, VOR/DME RWY 4,
Amdt 10B
Jackson, CA, Westover Field Amador County, Takeoff Minimums and
Obstacle DP, Amdt 1
Long Beach, CA, Long Beach/Daugherty Field/, ILS OR LOC RWY 30, Amdt
33
Long Beach, CA, Long Beach/Daugherty Field/, RNAV (GPS) Z RWY 30,
Amdt 3
Long Beach, CA, Long Beach/Daugherty Field/, RNAV (RNP) RWY 12, Amdt
2
Long Beach, CA, Long Beach/Daugherty Field/, RNAV (RNP) RWY 25R,
Amdt 1
Long Beach, CA, Long Beach/Daugherty Field/, RNAV (RNP) Y RWY 30,
Amdt 2
Palm Springs, CA, Palm Springs Intl, RNAV (RNP) Y RWY 13R, Amdt 1B,
CANCELED
Palm Springs, CA, Palm Springs Intl, RNAV (RNP) Z RWY 13R, Amdt 1
San Andreas, CA, Calaveras Co-Maury Rasmussen Field, Takeoff
Minimums and Obstacle DP, Amdt 1
San Diego, CA, San Diego Intl, Takeoff Minimums and Obstacle DP,
Amdt 9
Santa Ana, CA, John Wayne Airport-Orange County, LOC BC RWY 2L, Amdt
13
Santa Ana, CA, John Wayne Airport-Orange County, RNAV (GPS) Y RWY
2L, Amdt 2
Santa Ana, CA, John Wayne Airport-Orange County, RNAV (RNP) Z RWY
2L, Orig
Santa Ana, CA, John Wayne Airport-Orange County, RNAV (RNP) Z RWY
20R, Amdt 2
Santa Barbara, CA, Santa Barbara Muni, Takeoff Minimums and Obstacle
DP, Amdt 8
Georgetown, DE, Delaware Coastal, Takeoff Minimums and Obstacle DP,
Amdt 4B
Hilo, HI, Hilo Intl, RNAV (GPS) RWY 21, Orig-B
Hilo, HI, Hilo Intl, RNAV (GPS) RWY 26, Orig-D
Hilo, HI, Hilo Intl, VOR-B, Orig-C
Hilo, HI, Hilo Intl, VOR/DME OR TACAN RWY 26, Amdt 5D
Hilo, HI, Hilo Intl, VOR/DME OR TACAN-A, Amdt 7C
Forest City, IA, Forest City Muni, NDB RWY 33, Amdt 2B
Forest City, IA, Forest City Muni, RNAV (GPS) RWY 33, Orig-A
Forest City, IA, Forest City Muni, VOR/DME-A, Amdt 3A
Hampton, IA, Hampton Muni, VOR/DME RWY 35, Amdt 1E
Keokuk, IA, Keokuk Muni, NDB RWY 14, Amdt 12B
Keokuk, IA, Keokuk Muni, NDB RWY 26, Amdt 1B
Mount Pleasant, IA, Mount Pleasant Muni, NDB RWY 33, Amdt 6B
Driggs, ID, Driggs-Reed Memorial, LAMON TWO GRAPHIC DP
Grangeville, ID, Idaho County, MELLR ONE GRAPHIC DP
Grangeville, ID, Idaho County, MELLR TWO GRAPHIC DP, CANCELED
Grangeville, ID, Idaho County, RNAV (GPS) RWY 7, Amdt 1A, CANCELED
Grangeville, ID, Idaho County, RNAV (GPS) RWY 8, Orig
Grangeville, ID, Idaho County, RNAV (GPS) RWY 25, Amdt 1A, CANCELED
Grangeville, ID, Idaho County, RNAV (GPS) RWY 26, Orig
Grangeville, ID, Idaho County, Takeoff Minimums and Obstacle DP,
Orig
Grangeville, ID, Idaho County, Takeoff Minimums and Obstacle DP,
Amdt 1, CANCELED
Canton, IL, Ingersoll, RNAV (GPS) RWY 36, Amdt 1B
Macomb, IL, Macomb Muni, LOC RWY 27, Amdt 3B
Macomb, IL, Macomb Muni, RNAV (GPS) RWY 9, Amdt 1B
Greensburg, IN, Greensburg Municipal, VOR-A, Amdt 2D
Indianapolis, IN, Greenwood Muni, VOR-A, Amdt 5A
Winchester, IN, Randolph County, RNAV (GPS) RWY 8, Amdt 1A
St Francis, KS, Cheyenne County Muni, NDB-A, Orig
St Francis, KS, Cheyenne County Muni, NDB OR GPS RWY 32, Amdt 1A,
CANCELED
St Francis, KS, Cheyenne County Muni, RNAV (GPS) RWY 32, Orig
St Francis, KS, Cheyenne County Muni, Takeoff Minimums and Obstacle
DP, Orig
Albert Lea, MN, Albert Lea Muni, VOR/DME RWY 35, Amdt 1B
Austin, MN, Austin Muni, RNAV (GPS) RWY 17, Amdt 1B
Austin, MN, Austin Muni, RNAV (GPS) RWY 35, Amdt 1B
Monroe, NC, Charlotte-Monroe Executive, ILS OR LOC RWY 5, Amdt 2
Monroe, NC, Charlotte-Monroe Executive, RNAV (GPS) RWY 5, Amdt 2
Monroe, NC, Charlotte-Monroe Executive, RNAV (GPS) RWY 23, Amdt 1
Eugene, OR, Mahlon Sweet Field, ILS OR LOC RWY 16L, Amdt 1A
Eugene, OR, Mahlon Sweet Field, ILS OR LOC RWY 16R, ILS RWY 16R (SA
CAT I), ILS RWY 16R (CAT II), ILS RWY 16R (CAT III), Amdt 37
Eugene, OR, Mahlon Sweet Field, VOR-A, Amdt 7A
Eugene, OR, Mahlon Sweet Field, VOR OR TACAN RWY 16R, Amdt 5B
Eugene, OR, Mahlon Sweet Field, VOR OR TACAN RWY 34L, Amdt 5A

Greenwood, SC, Greenwood County, NDB RWY 27, Amdt 2
Greenwood, SC, Greenwood County, RNAV (GPS) RWY 9, Orig
Greenwood, SC, Greenwood County, RNAV (GPS) RWY 27, Orig
Greenwood, SC, Greenwood County, Takeoff Minimums and Obstacle DP,
Amdt 1
Greenwood, SC, Greenwood County, VOR RWY 9, Amdt 14
College Station, TX, Easterwood Field, VOR/DME RWY 28, Amdt 13A
Houston, TX, David Wayne Hooks Memorial, LOC RWY 17R, Amdt 3C
Midland, TX, Midland Intl Air & Space Port, RADAR-1, Amdt 7
Ellensburg, WA, Bowers Field, Takeoff Minimums and Obstacle DP, Amdt
2B
Wenatchee, WA, Pangborn Memorial, ILS X RWY 12, Orig-A, CANCELED
Wenatchee, WA, Pangborn Memorial, ILS Y RWY 12, Amdt 1
Wenatchee, WA, Pangborn Memorial, ILS Z RWY 12, Orig
Wenatchee, WA, Pangborn Memorial, RNAV (RNP) RWY 12, Amdt 1
Wenatchee, WA, Pangborn Memorial, RNAV (RNP) Z RWY 30, Amdt 1
Wenatchee, WA, Pangborn Memorial, VOR-A, Amdt 9
Wenatchee, WA, Pangborn Memorial, VOR-B, Orig
Wenatchee, WA, Pangborn Memorial, VOR/DME-C, Amdt 4A, CANCELED

[FR Doc. 2016-25784 Filed 10-25-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32878-32880]
[FR Doc No: 2018-15092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2515]

Hypertension: Conducting Studies of Drugs To Treat Patients on a
Background of Multiple Antihypertensive Drugs; 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
``Hypertension: Conducting Studies of Drugs to Treat Patients on a
Background of Multiple Antihypertensive Drugs.'' This draft guidance is
intended to clarify the recommended approach for sponsors developing
drugs to treat hypertension for patients who are on a background of
multiple antihypertensive drugs.

DATES: Submit either electronic or written comments on the draft
guidance by September 14, 2018 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-2018-D-2515 for ``Hypertension: Conducting Studies of Drugs to
Treat Patients on a Background of Multiple Antihypertensive Drugs;
Draft Guidance for Industry; Availability.'' 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.
     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.
    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: Stephen Grant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4160, Silver Spring, MD 20903, 301-796-
2240.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Hypertension: Conducting Studies of Drugs to Treat Patients
on a Background of Multiple Antihypertensive Drugs.'' This draft
guidance is intended to clarify the recommended approach for sponsors
developing drugs to treat hypertension for patients who are on a
background of multiple antihypertensive drugs. Sponsors have approached
FDA to discuss development programs for drugs intended to treat
resistant hypertension, which sponsors have defined as hypertension not
adequately controlled by maximally tolerated doses of three or more
antihypertensive drugs with different mechanisms of action. FDA
encourages development of additional classes of drugs for hypertension,
particularly classes of drugs that demonstrate effects when added to
currently available therapies.
    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 conducting
studies of drugs to treat hypertension in patients on a background of
multiple antihypertensive drugs. 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. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 312 have been
approved under OMB control number 0910-0014. The collection of
information in the guidance for industry entitled ``Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims''
(available at<EMAIL_ADDRESS>has been approved under OMB
control number 0910-0670.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15092 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Proposed Rules]
[Pages 37772-37773]
[FR Doc No: 2022-13410]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 /
Proposed Rules

SECURITIES AND EXCHANGE COMMISSION

17 CFR Chapter II

[Release Nos. 33-11073; 34-95122; IC-34619; File No. S7-19-22]

List of Rules To Be Reviewed Pursuant to the Regulatory
Flexibility Act

AGENCY: Securities and Exchange Commission.

ACTION: Publication of list of rules scheduled for review.

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SUMMARY: The Securities and Exchange Commission is publishing a list of
rules to be reviewed pursuant to Section 610 of the Regulatory
Flexibility Act. The list is published to provide the public with
notice that these rules are scheduled for review by the agency and to
invite public comment on whether the rules should be continued without
change, or should be amended or rescinded to minimize any significant
economic impact of the rules upon a substantial number of small
entities.

DATES: Comments should be submitted by August 23, 2022.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/submitcomments.htm); or
     Send an email to [email protected]. Please include
File Number S7-19-22 on the subject line.

Paper Comments

     Send paper comments to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File Number S7-19-22. This file number
should be included on the subject line if email is used. To help the
Commission process and review your comments more efficiently, please
use only one method of submission. The Commission will post all
comments on the Commission's website (https://www.sec.gov/rules/other.shtml). Comments are also available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Operating conditions may limit access to the
Commission's Public Reference Room.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Leila Bham, Senior Special Counsel,
Office of the General Counsel,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Regulatory Flexibility Act (``RFA''),
codified at 5 U.S.C. 601-612, requires an agency to review its rules
that have a significant economic impact upon a substantial number of
small entities within ten years of the publication of such rules as
final rules. 5 U.S.C. 610(a). The purpose of the review is ``to
determine whether such rules should be continued without change, or
should be amended or rescinded . . . to minimize any significant
economic impact of the rules upon a substantial number of such small
entities.'' 5 U.S.C. 610(a). The RFA sets forth specific considerations
that must be addressed in the review of each rule:
     the continued need for the rule;
     the nature of complaints or comments received concerning
the rule from the public;
     the complexity of the rule;
     the extent to which the rule overlaps, duplicates or
conflicts with other federal rules, and, to the extent feasible, with
state and local governmental rules; and
     the length of time since the rule has been evaluated or
the degree to which technology, economic conditions, or other factors
have changed in the area affected by the rule. 5 U.S.C. 610(b).
    The list below includes rules adopted in 2012 that may have a
significant economic impact on a substantial number of small entities
(but excludes rules that have been substantially changed since
adoption, rules that are minor amendments to previously adopted rules,
and rules that are ministerial, procedural, or technical in nature).
Where the Commission has previously made a determination of a rule's
impact on small businesses, the determination is noted on the list.
    The Commission particularly solicits public comment on whether the
rules listed below affect small businesses in new or different ways
than when they were first adopted. The rules and forms listed below are
scheduled for review by staff of the Commission.

    Title: Purchase of Certain Debt Securities by Business and
Industrial Development Companies Relying on an Investment Company Act
Exemption.
    Citation: 17 CFR 270.6a-5.
    Authority: 15 U.S.C. 80a-6(a)(5)(A)(iv)(I) and 15 U.S.C. 80a-37(a).
    Description: The Commission adopted a new rule to establish a
standard of credit-worthiness in place of a statutory reference to
credit ratings that the Dodd-Frank Wall Street Reform and Consumer
Protection Act (``Dodd-Frank Act'') removed. The rule established the
standard of credit quality that must be met by certain debt securities
purchased by business and industrial development companies that rely on
an exemption from the Investment Company Act of 1940.
    Prior RFA Analysis: When the Commission adopted this rule on
November 19, 2012, it published a Final Regulatory Flexibility Analysis
in the adopting release, Release No. IC-30268, available at: https://www.federalregister.gov/documents/2012/11/23/2012-28456/purchase-of-certain-debt-securities-by-business-and-industrial-development-companies-relying-on-an. The Commission received no comments on its
Initial Regulatory Flexibility Analysis published in the proposing
release, Release No. IC-29592 (March 3, 2011), available at: https://www.federalregister.gov/documents/2011/03/09/2011-5184/references-to-credit-ratings-in-certain-investment-company-act-rules-and-forms.
* * * * *
    Title: Conflict Minerals.
    Citation: 17 CFR 240.13p-1 and 17 CFR 249b.400.
    Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee,
77ggg, 77jjj, 77kkk, 77nnn, 77sss, 77ttt, 78a et seq. 78c, 78d, 78e,
78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78 l, 78m, 78n, 78n-

1, 78o, 78o-4, 78o-8, 78p, 78q, 78s, 78u-5, 78w, 78x, 78dd(b), 78dd(c),
78 ll, 78mm, 80a-20, 80a-23, 80a-29, 80a-37, 80b-3, 80b-4, 80b-11, 7201
et seq., and 8302; 18 U.S.C. 1350; 12 U.S.C. 5221(e)(3), and Pub. L.
111-203, Sec. 1502, 124 Stat. 1376.
    Description: The Commission adopted a new form and rule pursuant to
Section 1502 of the Dodd-Frank Act relating to the use of conflict
minerals. Section 1502 added Section 13(p) to the Securities Exchange
Act of 1934 (``Exchange Act''), which required the Commission to
promulgate rules requiring issuers with conflict minerals that are
necessary to the functionality or production of a product manufactured
by such person to disclose annually whether any of those minerals
originated in the Democratic Republic of the Congo or an adjoining
country. If an issuer's conflict minerals originated in those
countries, Section 13(p) required the issuer to submit a report to the
Commission that includes a description of the measures it took to
exercise due diligence on the conflict minerals' source and chain of
custody. The measures taken to exercise due diligence must include an
independent private sector audit of the report that is conducted in
accordance with standards established by the Comptroller General of the
United States. Section 13(p) also required the issuer submitting the
report to identify the auditor and to certify the audit. In addition,
Section 13(p) required the report to include a description of the
products manufactured or contracted to be manufactured that are not
``DRC conflict free,'' the facilities used to process the conflict
minerals, the country of origin of the conflict minerals, and the
efforts to determine the mine or location of origin. Section 13(p)
required the information disclosed by the issuer to be available to the
public on its internet website.\1\
---------------------------------------------------------------------------

    \1\ In April 2014, the U.S. Court of Appeals for the District of
Columbia Circuit rejected challenges to the bulk of the SEC conflict
minerals rule but held that Section 1502 of the Dodd-Frank Act and
the rule violate the First Amendment to the extent that they require
regulated entities to report to the SEC and to state on their
website that any of their products ``have not been found to be DRC
conflict free.'' Nat'l Ass'n of Mfrs. v. SEC, 748 F.3d 359 (D.C.
Cir. Apr. 14, 2014). In April 2017, the U.S. District Court for the
District of Columbia remanded the case to the Commission. Nat'l
Ass'n of Mfrs. v. SEC, No. 13-635 (D.D.C. Apr. 3, 2017) (Doc. No.
47) (Final Judgment).
---------------------------------------------------------------------------

    Prior RFA Analysis: When the Commission adopted the new form and
rule on August 22, 2012, it published a Final Regulatory Flexibility
Analysis in the adopting release, Release No. 34-67716, available at:
https://www.federalregister.gov/documents/2012/09/12/2012-21153/conflict-minerals. The Commission solicited comment on the Initial
Regulatory Flexibility Analysis included in the proposing release,
Release No. 34-63547 (Dec. 15, 2010), available at https://www.federalregister.gov/documents/2010/12/23/2010-31940/conflict-minerals, and considered comments received at that time.
* * * * *
    Title: Listing Standards for Compensation Committees.
    Citation: 17 CFR 229.407 and 17 CFR 240.10C-1.
    Authority: 15 U.S.C. 77c, 77d, 77e, 77f, 77g, 77h, 77j, 77k, 77s,
77z-2, 77z-3, 77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77iii,
77jjj, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1,
78j-3, 78k, 78k-1,78l, 78m, 78n, 78n-1, 78o, 78o-4, 78p, 78q, 78s, 78u-
5, 78w, 78x, 78ll, 78mm, 80a-8, 80a-9, 80a-20, 80a-23, 80a-29, 80a-30,
80a-31(c), 80a-37, 80a-38(a), 80a-39, 80b-3, 80b-4, 80b-11, and 7201 et
seq.; and 18 U.S.C. 1350, and 12 U.S.C. 5221(e)(3), unless otherwise
noted.
    Description: The Commission adopted a new rule and amendments to
its proxy disclosure rules to implement Section 952 of the Dodd-Frank
Act, which added Section 10C to the Exchange Act. Section 10C required
the Commission to adopt rules directing the national securities
exchanges and national securities associations to prohibit the listing
of any equity security of an issuer that is not in compliance with
Section 10C's compensation committee and compensation adviser
requirements. In accordance with the statute, 17 CFR 240.10C-1 (Rule
10C-1) directs the national securities exchanges to establish listing
standards that, among other things, require each member of a listed
issuer's compensation committee to be a member of the board of
directors and to be ``independent,'' as defined in the listing
standards of the national securities exchanges adopted in accordance
with the final rule. In addition, pursuant to Section 10C(c)(2), the
Commission adopted amendments to its proxy disclosure rules concerning
issuers' use of compensation consultants and related conflicts of
interest.
    Prior RFA Analysis: When the Commission adopted the new rule and
amendments on June 20. 2012, it published a Final Regulatory
Flexibility Analysis in the adopting release, Release No. 33-9330,
available at: https://www.federalregister.gov/documents/2012/06/27/2012-15408/listing-standards-for-compensation-committees. The
Commission received no comments on its Initial Regulatory Flexibility
Analysis published in the proposing release, Release No. 33-9199 (Mar.
30, 2011), available at https://www.federalregister.gov/documents/2011/04/06/2011-7948/listing-standards-for-compensation-committees. However,
other comments received that addressed aspects of the proposed rule
that could potentially affect small entities were considered at that
time.
* * * * *

    By the Commission.

    Dated: June 17, 2022.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2022-13410 Filed 6-23-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67463-67464]
[FR Doc No: 2013-26945]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0114]

National Emergency Medical Services Advisory Council (NEMSAC) and
Federal Interagency Committee on Emergency Medical Services (FICEMS);
Notice of Federal Advisory Committee Meeting

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Meeting Notice--National Emergency Medical Services Advisory
Council and Federal Interagency Committee on Emergency Medical
Services.

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SUMMARY: The NHTSA announces meetings of NEMSAC and FICEMS to be held
consecutively in the Metropolitan Washington, DC, area. This notice
announces the date, time, and location of the meetings, which will be
open to the public, as well as opportunities for public input to the
NEMSAC and FICEMS. The purpose of NEMSAC, a nationally recognized
council of emergency medical services representatives and consumers, is
to advise and consult with DOT and the FICEMS on matters relating to
emergency medical services (EMS). The purpose of FICEMS is to ensure
coordination among Federal agencies supporting EMS and 9-1-1 systems.

DATES: The NEMSAC meeting will be held on December 5, 2013, from 8 a.m.
to 5:00 p.m. EST, and on December 6, 2013, from 8 a.m. to 12 p.m. EST.
A public comment period will take place on December 5, 2013, between 2
p.m. and 2:30 p.m. EST and December 6, 2013, between 10 a.m. and 10:15
a.m. EST. Written comments for the NEMSAC from the public must be
received no later than December 2, 2013.
    The FICEMS meeting will be held on December 6, 2013, from 1 p.m. to
4 p.m.

EST. A public comment period will take place on December 6, 2013,
between approximately 3:30 p.m. and 3:45 p.m. EST. Written comments for
FICEMS from the public must be received no later than December 2, 2013.

ADDRESSES: The meetings will both be held at the Performance Institute
on the third floor of 901 New York Avenue NW., Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT: Drew Dawson, Director, U.S. Department
of Transportation, Office of Emergency Medical Services, 1200 New
Jersey Avenue SE., NTI-140, Washington, DC 20590, telephone 202-366-
9966; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C.
App.). The NEMSAC is authorized under Section 31108 of the Moving Ahead
with Progress in the 21st Century Act of 2012. The FICEMS is authorized
under Section 10202 of the Safe, Accountable, Flexible, Efficient
Transportation Equity Act: A Legacy for Users (SAFETEA-LU).

Tentative Agenda of the National EMS Advisory Council Meeting

    The tentative NEMSAC agenda includes the following:

Thursday, December 5, 2013 (8 a.m. to 5 p.m. EST)

(1) Opening Remarks
(2) Disclosure of Conflicts of Interests by Members
(3) Reports and Updates From the Departments of Transportation,
Homeland Security, and Health & Human Services
(4) Presentation, Discussion and Possible Adoption of Reports and
Recommendations From the following NEMSAC Workgroups:
    a. Patient Protection and Affordable Care Act
    b. Revision of the EMS Education Agenda for the Future
    c. EMS Agenda for the Future
    d. Safety
(5) Other Business of the Council
(6) Public Comment Period (2 p.m. to 2:30 p.m. EST)
(7) Workgroup Breakout Sessions (2:30 p.m. to 5 p.m. EST)

Friday, December 6, 2013 (8 a.m. to 12 p.m. EST)

(1) Unfinished Business/Continued Discussion From Previous Day
(2) Public Comment Period (10 a.m. to 10:15 a.m. EST)
(3) Next Steps and Adjourn
    On Thursday, December 5, 2013, From 2:30 p.m. to 5 p.m. EST, the
NEMSAC workgroups will meet in breakout sessions at the same location.
These sessions are open for public attendance, but their agendas do not
accommodate public comment.

Tentative Agenda of the Federal Interagency Committee on EMS Meeting

Friday, December 6, 2013 (1 p.m. to 4 p.m. EST)

(1) Welcome, Introductions, Opening Remarks
(2) Review and Approval of Executive Summary of July 8, 2013 Meeting
(3) National EMS Advisory Council (NEMSAC) Report
(4) The NIH Office of Emergency Care Research--An Overview
(5) Presentation and Discussion of the Final Draft FICEMS Strategic
Plan
(6) Technical Working Group (TWG) Committee Reports
(7) Updates on Progress Responding to National Transportation Safety
Board Recommendations
(8) Election of Chair and Vice-Chair for Calendar Year 2014
(9) Other FICEMS Business
(10) Public Comment Period (approximately 3:30 p.m. to 3:45 p.m. EST)
(11) Next Steps and Adjourn
    Registration Information: These meetings will be open to the
public; however, pre-registration is requested. Individuals wishing to
attend must register online at http://tinyurl.com/NEMSAC-FICEMS-2013 no
later than December 2, 2013. For assistance with registration, please
contact Noah Smith at<EMAIL_ADDRESS>or<PHONE_NUMBER>. There will
not be a teleconference option for these meetings.
    Public Comment: Members of the public are encouraged to comment
directly to the NEMSAC and FICEMS during designated public comment
periods. In order to allow as many people as possible to speak,
speakers are requested to limit their remarks to 5 minutes. Written
comments from members of the public will be distributed to NEMSAC or
FICEMS members at the meeting and should reach the NHTSA Office of EMS
no later than December 2, 2013. Written comments may be submitted by
either one of the following methods: (1) You may submit comments by
email<EMAIL_ADDRESS>or<EMAIL_ADDRESS>or (2) you may submit comments
by fax:<PHONE_NUMBER>.
    A final agenda as well as meeting materials will be available to
the public online through www.EMS.gov on or before November 29, 2013.

    Issued on: November 6, 2013.
Jeffrey P. Michael,
Associate Administrator for Research and Program Development.
[FR Doc. 2013-26945 Filed 11-8-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57576-57577]
[DOCID:fr03oc05-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-383-067]

Dominion Transmission, Inc.; Notice of Service Agreement

September 27, 2005.
    Take notice that on September 19, 2005, Dominion Transmission, Inc.
(DTI) tendered for filing as part of its FERC Gas Tariff, Third Revised
Volume No. 1, Fourteenth Revised Sheet No. 1300, to become effective
October 1, 2005.
    DTI states the purpose of this filing is to disclose three non-
conforming service agreements that materially deviate from DTI's form
of service agreements. DTI further states that the service agreements
are with Hope Gas, Inc. dba Dominion Hope.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests 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 to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible online 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 October 4, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5394 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Page 38763]
[FR Doc No: 2018-16825]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2018-64]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, this aspect of the FAA's regulatory activities.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before August 27, 2018.

ADDRESSES: Send comments identified by docket number FAA-2018-0267
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Forseth, AIR-673, Federal
Aviation Administration, 2200 S. 216th St., WA 98198-6547, email
[email protected], phone<PHONE_NUMBER>; or Alphonso Pendergrass,
ARM-200, Office of Rulemaking, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591, email
[email protected], phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington, on July 31, 2018.
Suzanne Masterson,
Acting Manager, Transport Standards Branch.

Petition for Exemption

    Docket No.: FAA-2018-0267.
    Petitioner: The Boeing Company.
    Section of 14 CFR Affected: Sec.  25.795(b)(1).
    Description of Relief Sought:
    Provide relief from the requirements of flightdeck smoke
protection for Boeing Model 737-7, 737-8, and 737-8200 airplanes.

[FR Doc. 2018-16825 Filed 8-6-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29663-29664]
[FR Doc No: 2012-12038]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities: Proposed Collection;
Comment Request; User Fee Cover Sheet; Form FDA 3397

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 Form FDA 3397, User Fee Cover
Sheet, which must be submitted along with certain drug and biologic
product applications and supplements.

DATES: Submit either electronic or written comments on the collection
of information by July 17, 2012.

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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
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 comment 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.

User Fee Cover Sheet; Form FDA 3397--(OMB Control Number 0910-0297)--
Extension

    Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379g and 379h), as amended, FDA has the authority to
assess and collect user fees for certain drug and biologics license
applications and supplements. Under this authority, pharmaceutical
companies pay a fee for certain new human drug applications, biologics
license applications, or supplements submitted to the Agency for
review. Because the submission of user fees concurrently with
applications and supplements is required, review of an application by
FDA cannot begin until the fee is submitted. Form FDA 3397, the user
fee cover sheet, is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference of
the fee submitted for an application by using a unique number tracking
system. The information collected is used by FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) to initiate the administrative screening of new drug
applications, biologics license applications, and supplemental
applications.
    Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2011, there are an estimated 260 manufacturers of products subject
to the Prescription Drug User Fee Act (Public Law 105-115). The total
number of annual responses is based on the number of submissions
received by FDA in FY 2011. CDER received 3,363 annual responses that
include the following submissions: 114 new drug applications; 4
biologics license applications; 1,900 manufacturing supplements; 1,209
labeling supplements; and 136 efficacy supplements. CBER received 768
annual responses that include the following submissions: 6 biologics
license applications; 698 manufacturing supplements; 44 labeling
supplements; and 20 efficacy supplements. The estimated hours per
response are based on past FDA experience with the various submissions.
    FDA is revising Form FDA 3397 in the following ways: (1) By
updating the applicable Web sites; (2) adding a Privacy Act Notice
pursuant to the Privacy Act of 1974, 5 U.S.C. 552a(3)j; (3) by adding
351(k) applications to the CDER and CBER lists of applications and
supplements for which Form FDA 3397 need not be submitted; (4) by
adding ``or proper name'' to instruction number 3; and (5) by making
minor editorial changes.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                            FDA Form No.                                Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3397......................................................             260            15.89            4,131          \2\ 0.5          2,065.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ 30 minutes.

    Dated: May 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12038 Filed 5-17-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Notices]
[Page 68948-68949]
[DOCID:fr06de07-119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Airport Noise Compatibility Planning

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. The respondents are those airport operators
voluntarily submitting noise exposure maps and noise compatibility
programs to the FAA for review and approval.

DATES: Please submit comments by February 4, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Airport Noise Compatibility Planning.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0517.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 15 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 3,360 hours
per response.
    Estimated Annual Burden Hours: An estimated 50,400 hours annually.
    Abstract: The respondents are those airport operators voluntarily
submitting noise exposure maps and noise compatibility programs to the
FAA for review and approval.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information

collection; ways to enhance the quality, utility and clarity of the
information to be collected; and ways to minimize the burden of the
collection of information on respondents, including the use of
automated collection techniques or other forms of information
technology.

    Issued in Washington, DC, on November 29, 2007.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 07-5959 Filed 12-5-07; 8:45 am]

BILLING CODE 4910-13-M