[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Rules and Regulations]
[Pages 50758-50760]
[FR Doc No: 2015-20522]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31032; Amdt. No. 3656]

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 amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures 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 for the 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 August 21, 2015. 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 August 21, 2015.

ADDRESSES: Availability of matter 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 online 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: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Procedures
Division, 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, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but 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 contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and 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 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 and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    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 these
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 July 31, 2015.
John 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
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, 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(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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      AIRAC Date           State              City                 Airport          FDC No.      FDC Date                      Subject
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17-Sep-15............  KS             Syracuse............  Syracuse-Hamilton          5/0596     07/21/15  RNAV (GPS) RWY 36, Orig.
                                                             County Muni.
17-Sep-15............  NM             Albuquerque.........  Albuquerque Intl           5/0613     07/21/15  RNAV (RNP) Y RWY 21, Orig-A.
                                                             Sunport.
17-Sep-15............  TX             El Paso.............  El Paso Intl........       5/0614     07/21/15  RNAV (RNP) Y RWY 4, Orig-D.
17-Sep-15............  TX             El Paso.............  El Paso Intl........       5/0615     07/21/15  RNAV (RNP) Z RWY 4, Orig-C.
17-Sep-15............  GA             Atlanta.............  Dekalb-Peachtree....       5/1465     07/16/15  RNAV (GPS) Y RWY 21L, Amdt 1A.
17-Sep-15............  GA             Atlanta.............  Dekalb-Peachtree....       5/1466     07/16/15  ILS OR LOC RWY 21L, Amdt 8B.
17-Sep-15............  VA             Danville............  Danville Rgnl.......       5/2541     07/15/15  RNAV (GPS) RWY 31, Orig.
17-Sep-15............  VA             Brookneal...........  Brookneal/Campbell         5/3677     07/16/15  RNAV (GPS) RWY 6, Orig.
                                                             County.
17-Sep-15............  GA             Macon...............  Middle Georgia Rgnl.       5/4287     07/15/15  ILS OR LOC/DME RWY 5, Amdt 1A.
17-Sep-15............  GA             Macon...............  Middle Georgia Rgnl.       5/4288     07/15/15  RNAV (GPS) RWY 5, Amdt 1A.
17-Sep-15............  MS             Jackson.............  Jackson-Medgar Wiley       5/5477     07/16/15  VOR/DME OR TACAN RWY 16R, Orig.
                                                             Evers Intl.
17-Sep-15............  MS             Jackson.............  Jackson-Medgar Wiley       5/5478     07/16/15  VOR/DME OR TACAN RWY 16L, Orig.
                                                             Evers Intl.
17-Sep-15............  MS             Jackson.............  Jackson-Medgar Wiley       5/5479     07/16/15  VOR/DME OR TACAN RWY 34L, Orig.
                                                             Evers Intl.
17-Sep-15............  MS             Jackson.............  Jackson-Medgar Wiley       5/5486     07/16/15  VOR/DME OR TACAN RWY 34R, Orig-A.
                                                             Evers Intl.
17-Sep-15............  PA             Meadville...........  Port Meadville......       5/5667     07/16/15  LOC RWY 25, Amdt 6A.
17-Sep-15............  PA             Meadville...........  Port Meadville......       5/5669     07/16/15  RNAV (GPS) RWY 25, Amdt 1A.
17-Sep-15............  PA             Meadville...........  Port Meadville......       5/5671     07/16/15  RNAV (GPS) RWY 7, Amdt 1A.
17-Sep-15............  PA             Meadville...........  Port Meadville......       5/5672     07/16/15  VOR RWY 7, Amdt 8A.
17-Sep-15............  TX             Rockport............  Aransas Co..........       5/6318     07/21/15  VOR/DME OR TACAN-A, Amdt 9.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6319     07/21/15  LOC RWY 5, Amdt 1B.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6436     07/21/15  VOR/DME RWY 5, Amdt 3.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6437     07/21/15  RNAV (GPS) RWY 17, Amdt 1.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6438     07/21/15  RNAV (GPS) RWY 23, Amdt 1.

17-Sep-15............  NC             Washington..........  Warren Field........       5/6439     07/21/15  RNAV (GPS) RWY 35, Amdt 1.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6440     07/21/15  Takeoff Minimums and (Obstacle) DP, Amdt 1.
17-Sep-15............  NC             Washington..........  Warren Field........       5/6528     07/21/15  RNAV (GPS) RWY 5, Amdt 1A.
17-Sep-15............  NC             North Wilkesboro....  Wilkes County.......       5/8443     07/15/15  ILS OR LOC RWY 1, Orig-B.
17-Sep-15............  VT             Newport.............  Newport State.......       5/9046     07/15/15  RNAV (GPS) RWY 36, Orig-A.
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[FR Doc. 2015-20522 Filed 8-20-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Pages 30851-30852]
[FR Doc No: 2017-13951]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-15-000]

Dominion Cove Point LNG, LP; Notice of Availability of the
Environmental Assessment for the Proposed Eastern Market Access Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Eastern Market Access Project, proposed by Dominion Cove Point LNG, LP
(DCP) in the above-referenced docket. DCP requests authorization to
construct, install, modify, own, operate, and maintain natural gas
facilities in Virginia and Maryland to provide 294,000 dekatherms per
day of firm natural gas transportation service to Washington Gas Light
Company and Mattawoman Energy, LLC's Mattawoman Energy Center, a power
generation facility.
    The EA assesses the potential environmental effects of the
construction and operation of the Eastern Market Access Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major federal action significantly affecting the quality of the human
environment.
    The proposed Eastern Market Access Project includes the following
facilities:
     A new 24,370-horsepower (hp) natural gas compressor
station and ancillary facilities, and two new taps for customer
delivery at the existing Washington Gas Light Company Interconnect in
Charles County, Maryland;
     one new 7,000-hp electric reciprocating compressor unit
and discharge gas cooler, replacement of three gas coolers and
compression cylinders for three existing compressors, and an increase
to 30-inch-diameter discharge piping at the Loudoun Compressor Station
in Loudoun County, Virginia;
     one new meter building to enclose existing equipment at
the Loudoun Metering and Regulating Station in Loudoun County,
Virginia; and
     re-wheeling of the compressor on an existing 17,400-hp
electric unit and upgrading of two gas coolers at the Pleasant Valley
Compressor Station in Fairfax County, Virginia.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the project area. In addition,
the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before July 27,
2017.

    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket number (CP17-15-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \1\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP17-
15). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: June 27, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-13951 Filed 6-30-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 103 (Wednesday, May 29, 2019)]
[Notices]
[Pages 24798-24801]
[FR Doc No: 2019-11074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4131]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Adverse Event Reports; Electronic Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Fax written comments on the collection of information by June
28, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0645.
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_ADDRESS>
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. FDA Adverse Event Reports; Electronic
Submissions--21 CFR 310.305, 314.80, 314.98, 314.540, 329.100, 514.80,
600.80, 1271.350, and Part 803 OMB Control Number 0910-0645--Extension

I. Background

    The Safety Reporting Portal (SRP) and the Electronic Submission
Gateway (ESG) are the Agency's electronic systems for collecting,
submitting, and processing adverse event reports, product problem
reports, and other safety information for FDA-regulated products. To
ensure the safety and identify any risks, harms, or other

dangers to health for all FDA-regulated human and animal products, the
Agency needs to be informed whenever an adverse event, product quality
problem, or product use error occurs. This risk identification process
is the first necessary step that allows the Agency to gather the
information necessary to be able to evaluate the risk associated with
the product and take whatever action is necessary to mitigate or
eliminate the public's exposure to the risk.
    Some adverse event reports are required to be submitted to FDA
(mandatory reporting) and some adverse event reports are submitted
voluntarily (voluntary reporting). Requirements regarding mandatory
reporting of adverse events or product problems have been codified in
21 CFR parts 310, 314, 329, 514, 600, 803, and 1271, specifically
Sec. Sec.  [thinsp]310.305, 314.80, 314.98, 314.540, 329.100, 514.80,
600.80, 803.30, 803.40, 803.50, 803.53, 803.56, and 1271.350(a) (21 CFR
310.305, 314.80, 314.98, 314.540, 329.100, 514.80, 600.80, 803.30,
803.40, 803.50, 803.53, 803.56, and 1271.350(a)). While adverse event
reports submitted to FDA in paper format using Forms FDA 3500, 3500A,
1932, and 1932a are approved under OMB control numbers 0910-0284 and
0910-0291, this notice solicits comments on adverse event reports filed
electronically via the SRP and the ESG, and currently approved under
OMB control number 0910-0645.

II. The FDA Safety Reporting Portal Rational Questionnaires

    FDA currently has OMB approval to receive several types of adverse
event reports electronically via the SRP using rational questionnaires.
In this notice, FDA seeks comments on the extension of OMB approval for
the following rational questionnaires and the proposed revision of the
existing rational questionnaire for tobacco products.

A. Reportable Food Registry Reports

    The Food and Drug Administration Amendments Act of 2007 (Pub. L.
110-085) (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C
Act) by creating section 417 (21 U.S.C. 350f), Reportable Food Registry
(RFR). Section 417 of the FD&C Act defines ``reportable food'' as an
article of food (other than infant formula or dietary supplements) for
which there is a ``reasonable probability that the use of, or exposure
to, such article of food will cause serious adverse health consequences
or death to humans or animals.'' (See section 417(a)(2) of the FD&C
Act.) We designed the RFR report rational questionnaire to enable us to
quickly identify, track, and remove from commerce an article of food
(other than infant formula and dietary supplements) for which there is
a reasonable probability that the use of, or exposure to, such article
of food will cause serious adverse health consequences or death to
humans or animals. FDA's Center for Food Safety and Applied Nutrition
uses the information collected to help ensure that such products are
quickly and efficiently removed from the market to prevent foodborne
illnesses. The data elements for RFR reports remain unchanged in this
request for extension of OMB approval.

B. Reports Concerning Experience With Approved New Animal Drugs

    Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) and Sec.
[thinsp]514.80(b) of FDA's regulations (21 CFR 514.80(b)) require
applicants of approved new animal drug applications (NADAs) and
approved abbreviated new animal drug applications (ANADAs) to report
adverse drug experiences and product/manufacturing defects to the
Center for Veterinary Medicine (CVM). This continuous monitoring of
approved NADAs and ANADAs affords the primary means by which we obtain
information regarding potential problems with the safety and efficacy
of marketed approved new animal drugs as well as potential product/
manufacturing problems. Postapproval marketing surveillance is
important because data previously submitted to FDA may no longer be
adequate, as animal drug effects can change over time and less apparent
effects may take years to manifest.
    To report adverse drug experiences and product/manufacturing
defects using the Agency's paper forms, respondents are required to use
Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of
Effectiveness, Product Defect Report.'' Periodic drug experience
reports and special drug experience reports must be accompanied by a
completed Form FDA 2301, ``Transmittal of Periodic Reports and
Promotional Material for New Animal Drugs'' (see Sec.
[thinsp]514.80(d)). Form FDA 1932a, ``Veterinary Adverse Drug Reaction,
Lack of Effectiveness or Product Defect Report,'' allows for voluntary
reporting of adverse drug experiences or product/manufacturing defects
by veterinarians and the general public. Collection of information
using existing paper Forms FDA 2301, 1932, and 1932a is approved under
OMB control number 0910-0284.
    Alternatively, however, we encourage respondents to report adverse
drug experiences and product/manufacturing defects electronically. The
electronic submission data elements to report adverse drug experiences
and product/manufacturing defects electronically remain unchanged in
this request for extension of OMB approval.

C. Animal Food Adverse Event and Product Problem Reports

    Section 1002(b) of FDAAA directed the Secretary of Health and Human
Resources to establish an early warning and surveillance system to
identify adulteration of the pet food supply and outbreaks of illness
associated with pet food. We developed the Pet Food Early Warning
System rational questionnaire as a user-friendly data collection tool,
as well as a questionnaire for collecting voluntary adverse event
reports associated with livestock food. Information collected in these
voluntary adverse event reports contribute to CVM's ability to identify
adulteration of the livestock food supply and outbreaks of illness
associated with livestock food. We use the information collected to
help ensure that such products are quickly and efficiently removed from
the market to prevent foodborne illnesses. The electronic submission
data elements to report adverse events associated with animal food
remain unchanged since last OMB review.

D. Voluntary Tobacco Product Adverse Event and Product Problem Reports

    Section 909(a) of the FD&C Act (21 U.S.C. 387i(a)) authorizes FDA
to establish regulations with respect to mandatory adverse event
reports associated with the use of a tobacco product. We collect
voluntary adverse event reports associated with the use of tobacco
products from interested parties such as healthcare providers,
researchers, consumers, and other users of tobacco products.
Information collected in voluntary adverse event reports contributes to
FDA's Center for Tobacco Products (CTP's) ability to be informed of,
and assess the real consequences of, tobacco product use.
    The need for this collection of information derives from our
responsibility to obtain current, timely, and policy-relevant
information to carry out our statutory functions. CTP has been
receiving adverse event and product problem reports through the SRP
since January 2014. CTP has developed two voluntary rational
questionnaires on the SRP. The first is utilized by consumers and
concerned citizens to report tobacco product adverse event or product
problems. A second rational questionnaire is used by tobacco product
investigators in clinical

trials with investigational tobacco products. Both CTP voluntary
rational questionnaires capture tobacco-specific adverse event and
product problem information from reporting entities such as healthcare
providers, researchers, consumers, and other users of tobacco products.

E. Dietary Supplement Adverse Event Reports

    The Dietary Supplement and Nonprescription Drug Consumer Protection
Act (DSNDCPA) (Pub. L. 109-462, 120 Stat. 3469) amended the FD&C Act
with respect to serious adverse event reporting and recordkeeping for
dietary supplements and nonprescription drugs marketed without an
approved application.
    Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1))
requires the manufacturer, packer, or distributor whose name (under
section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) appears on the
label of a dietary supplement marketed in the United States to submit
to FDA all serious adverse event reports associated with the use of a
dietary supplement, accompanied by a copy of the product label. The
manufacturer, packer, or distributor of a dietary supplement is
required by the DSNDCPA to use the MedWatch form (Form FDA 3500A) when
submitting a serious adverse event report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the submitter of the serious adverse
event report (referred to in the statute as the ``responsible person'')
is required to submit to FDA a followup report of any related new
medical information the responsible person receives within 1 year of
the initial report.
    As required by section 3(d)(3) of the DSNDCPA, FDA issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. The guidance document entitled ``Guidance for
Industry: Questions and Answers Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act,''
discusses how, when, and where to submit serious adverse event reports
for dietary supplements and followup reports. The guidance also
provides FDA's recommendation on records maintenance and access for
serious and non-serious adverse event reports and related documents.
    Reporting of serious adverse events for dietary supplements to FDA
serves as an early warning sign of potential public health issues
associated with such products. Without notification of all serious
adverse events associated with dietary supplements, FDA would be unable
to investigate and followup promptly, which in turn could cause delays
in alerting the public when safety problems are found. In addition, the
information received provides a reliable mechanism to track patterns of
adulteration in food that supports efforts by FDA to target limited
inspection resources to protect the public health. FDA uses the
information collected to help ensure that such products are quickly and
efficiently removed from the market to prevent foodborne illnesses.
    Paper mandatory dietary supplement adverse event reports are
submitted to FDA on the MedWatch form, Form FDA 3500A, and paper
voluntary reports are submitted on Form FDA 3500. Forms FDA 3500 and
3500A are available as fillable pdf forms. Dietary supplement adverse
event reports may be electronically submitted to the Agency via the
SRP. This method of submission is voluntary. A manufacturer, packer, or
distributor of a dietary supplement who is unable to or chooses not to
submit reports using the electronic system will still be able to
provide their information by paper MedWatch form, Form FDA 3500A (by
mail or Fax). There is no change to the mandatory information
previously required on the MedWatch form. The electronic submission
data elements to report adverse events associated with dietary
supplement products remain unchanged in this request for extension of
OMB approval.

F. Food, Infant Formula, and Cosmetic Adverse Event Reports

    Rational questionnaires have also been developed for submitting
adverse event reports for food, infant formula, and cosmetics. The
electronic submission data elements to report adverse events associated
with food, infant formula, and cosmetics products remain unchanged in
this request for extension of OMB approval.
    In the Federal Register of November 30, 2018 (83 FR 61653), we
published a 60-day notice requesting public comment on the proposed
collection of information. One general comment was received suggesting
the associated forms could be improved but did not include specific
problems that might have been encountered. We are appreciative of this
comment and continually seek ways to improve the electronic reporting
of adverse events associated with FDA-regulated products.

III. Information Collection Burden Estimate

    Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
adverse event reports electronically to FDA via the ESG or the SRP
regarding FDA-regulated products.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Activity                             FDA Form        Number of     responses per   Total annual   Average burden    Total hours
                                                              number        respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Adverse Event Report via the SRP (Other than              3800           1,800               1           1,800             0.6           1,080
 RFR Reports)...........................................
Mandatory Adverse Event Report via the SRP (Other than              3800           3,360               1           3,360               1           3,360
 RFR Reports)...........................................
Mandatory Adverse Event Report via the ESG (Gateway-to-             3800       3,007,000               1       3,007,000             0.6       1,804,200
 Gateway transmission)..................................
Mandatory and Voluntary RFR Reports via the SRP.........            3800           1,260               1           1,260             0.6             756
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............       1,809,396
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 36 minutes.

    Our estimate of the number of respondents and the total annual
responses in table 1, Estimated Annual Reporting Burden, is based
primarily on mandatory and voluntary adverse event reports
electronically submitted to the Agency. The estimated total annual
responses are based on initial reports. Followup reports, if any, are
not counted as new reports. Based on our experience with adverse event
reporting, we assume it takes respondents 0.6 hour to submit a
voluntary adverse event report via the SRP, 1 hour to submit a
mandatory adverse event report via the SRP, and 0.6 hour to submit a
mandatory adverse event report via the ESG (gateway-to-gateway
transmission). Both mandatory and voluntary RFR reports must be
submitted via the SRP. We assume it takes respondents 0.6 hour to
submit an RFR report, whether the submission is mandatory or voluntary.
    The burden hours required to complete paper FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are reported under OMB control
numbers 0910-0284 and 0910-0291. While we do not charge for the use of
the ESG, we require respondents to obtain a public key infrastructure
certificate in order to set up the account. This can be obtained in-
house or outsourced by purchasing a public key certificate that is
valid for 1 year to 3 years. The certificate typically costs from $20
to $30.
    Our estimated burden for the information collection reflects an
overall increase of 688,547 hours and a corresponding increase of
1,145,763 responses. We attribute this adjustment to an increase in the
number of submissions we have received over the last few years.

    Dated: May 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11074 Filed 5-28-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Rules and Regulations]
[Page 9443-9445]
[DOCID:fr21fe08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-0310; Airspace Docket No. 07-AEA-21]

Amendment of Class E Airspace; Bradford, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule, request for comments.

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

SUMMARY: This action modifies Class E Airspace at Bradford, PA. The
existing controlled airspace from nearby Bradford Regional Airport does
not adequately support a new Area Navigation (RNAV) Global Positioning
System (GPS) Special Instrument Approach Procedure (IAP) that has been
developed for medical flight operations for the University of
Pittsburgh. This action will enhance the safety and management of
Instrument Flight Rule (IFR) operations by providing the required
controlled airspace to support this approach at Bradford, PA.

DATES: Effective 0901 UTC, June 05, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments. Comments for
inclusion in the Rules Docket must be received on or before April 7,
2008.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2007-0310; Airspace Docket No. 07-AEA-21, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5

p.m., Monday through Friday, except Federal Holidays. An informal
docket may also be examined during normal business hours at the office
of the Eastern Service Center, Federal Aviation Administration, Room
210, 1701 Columbia Avenue, College Park, Georgia 30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support Group,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; Telephone<PHONE_NUMBER>; Fax (404) 305-
5572.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. Unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period, the
regulation will become effective on the date specified above. After the
close of the comment period, the FAA will publish a document in the
Federal Register indicating that no adverse or negative comments were
received and confirming the effective date. If the FAA receives, within
the comment period, an adverse or negative comment, or written notice
of intent to submit such a comment, a document withdrawing the direct
final rule will be published in the Federal Register, and a notice of
proposed rulemaking may be published with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. An electronic copy of this document
may be downloaded from and comments may be submitted and reviewed via
http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov. or

the Federal Register's web page at http://www.gpoaccess.gov/fr/index.html.
 Communications should identify both docket numbers and be

submitted in triplicate to the address specified under the caption
ADDRESSES above or you may comment through the Web site. All
communications received on or before the closing date for comments will
be considered, and this rule may be amended or withdrawn in light of
the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Those
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed, stamped postcard on
which the following statement is made: ``Comments to Docket No. FAA-
2007-0310; Airspace Docket No. 07-AEA-21.'' The postcard will be date
stamped and returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E5 airspace at Bradford, PA, providing the
controlled airspace required to support the new Copter Area Navigation
(RNAV) Global Positioning System (GPS) 226 Point in Space (PinS)
approach developed to facilitate helicopter arrival and departures at
the University of Pittsburgh in Bradford. Although Class E airspace
exists near the area, it is insufficient for the protection for this
approach that will serve medical flights. Controlled airspace, known as
Class E5 airspace, extending upward from 700 feet Above Ground Level
(AGL) is required to encompass all Instrument Approach Procedures
(IAPs) to the extent practical and for general Instrument Flight Rule
(IFR) operations. The FAA is amending part 71 Title 14, Code of Federal
Regulations (14 CFR part 71) , by establishing a 6-mile radius Class E5
airspace area around the Point in Space Missed Approach Point (MAP),
HIVIT Waypoint, that serves the University of Pittsburgh in Bradford,
PA. Designations for Class E airspace areas extending upward from 700
feet or more above the surface of the Earth are published in FAA Order
7400.9R, signed August 15, 2007, effective September 15, 2007, which is
incorporated by reference in 14 CFR 71.1. The Class E designations
listed in this document will be published subsequently in the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Bradford, PA near the University of
Pittsburgh.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Bradford, PA [Amended]

Bradford Regional Airport, Bradford, PA
    (Lat. 41[deg]48'11'' N., long. 78[deg]38'24'' W.)
Bradford VORTAC
    (Lat. 41[deg]47'11'' N., long. 78[deg]37'10'' W.)
BRAFO LOM
    (Lat. 41[deg]45'18'' N., long. 78[deg]34'24'' W.)
HIVIT Waypoint
    (Lat. 41[deg]57'51'' N., long. 78[deg]39'15'' W.)

    That airspace extending upward from 700 feet above the surface
of the Earth within a 6.5-mile radius of the Bradford Regional
Airport and within 3.1 miles each side of the Bradford Regional
Airport southeast localizer course extending from the BRAFO LOM to
10 miles southeast of the LOM and within 4.4 miles each side of the
Bradford VORTAC 139[deg] radial extending from the VORTAC to 10
miles southeast of the VORTAC and within 4.4 miles each side of the
Bradford VORTAC 316[deg] radial extending from the VORTAC to 16.1
miles northwest of the VORTAC and that airspace within a 6-mile
radius of the HIVIT Waypoint serving the University of Pittsburgh.
* * * * *

    Issued in College Park, Georgia, on February 7, 2008.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center.
[FR Doc. 08-726 Filed 2-20-08; 8:45 am]

BILLING CODE 4910-13-M