[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13686-13687]
[FR Doc No: 2013-04625]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0169]

Draft Guidance for Industry and Review Staff on Pediatric
Information Incorporated Into Human Prescription Drug and Biological
Products Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and review staff entitled
``Pediatric Information Incorporated into Human Prescription Drug and
Biological Products Labeling.'' This draft guidance is intended to
assist applicants and FDA review staff in making decisions about the
placement and content of pediatric information in human prescription
drug and biological products labeling in accordance with the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research
Equity Act (PREA), as amended by the Food and Drug Administration
Safety and Innovation Act (FDASIA), as well as FDA prescription drug
and biological product labeling regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 29, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach, and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
Matthew Bacho, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6420, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and review staff entitled ``Pediatric Information Incorporated into
Human Prescription Drug and Biological Products Labeling.'' In July
2012, FDASIA (Pub. L. 112-144) reauthorized and made permanent the BPCA
and PREA. The goal of both the BPCA and PREA is to provide pediatric
information in drug labeling to encourage the appropriate use of drugs
in treating pediatric patients.
    Data submitted in response to a pediatric Written Request under the
BPCA and assessments submitted in response to a PREA study requirement
must be described in labeling, whether the findings are positive,
negative, or inconclusive (sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a) and 21 U.S.C.
355(c)) as amended by

FDASIA). In addition, when pediatric studies under PREA are fully or
partially waived by FDA because there is evidence that a drug would be
ineffective or unsafe in a pediatric population or pediatric
subpopulation, the safety concern or lack of efficacy must be reflected
in the prescription drug labeling (section 505B(a)(4)(D) of the FD&C
Act). All useful information on the use of drugs and biological
products in the pediatric population should be consistently placed in
the proper sections within prescription labeling so that the
information is clear and accessible to health care providers.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
incorporating pediatric information into human prescription drug and
biological products labeling. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. The 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 201.56 and 201.57 have
been approved under OMB control number 0910-0572.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04625 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30226-30227]
[FR Doc No: 2022-10697]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0001]

Science Board to the Food and Drug Administration Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Board to
the Food and Drug Administration. The Science Board provides advice to
the Commissioner of Food and Drugs and other appropriate officials on
specific, complex scientific and technical issues important to FDA and
its mission, including emerging issues within the scientific community.
Additionally, the Science Board provides advice to the Agency on
keeping pace with technical and scientific developments, including in
regulatory science, input into the Agency's research agenda, and on
upgrading its scientific and research facilities and training
opportunities. It will also provide, where requested, expert review of
Agency-sponsored intramural and extramural scientific research
programs. The meeting will be open to the public.

DATES: The meeting will be held virtually on June 14, 2022, from 9 a.m.
to 4 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected], or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute

modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. The Science
Board to the Food and Drug Administration will consider challenges in
evaluating the safety of dietary supplement and food ingredients with
predicted pharmacological activity, utilizing cannabinoids as a case
study. The Science Board to the Food and Drug Administration will also
hear about the Agency's enhanced efforts to spur the development,
qualification, and adoption of new alternative methods for regulatory
use that can replace, reduce, and refine animal testing and have the
potential to provide both more timely and more predictive information
to accelerate product development and enhance emergency preparedness.
The Science Board to the Food and Drug Administration will also hear
about the Agency's enhanced efforts to ensure optimal organization,
infrastructure, and expertise for data science efforts in alignment
with its regulatory scope and evidence-based decision making, in
support of FDA's public health priorities.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
7, 2022. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before June 1, 2022. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by June 7, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Rakesh Raghuwanshi (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10697 Filed 5-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17597-17598]
[FR Doc No: 2021-06932]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R03-OAR-2021-0238; FRL-10022-18-Region 3]

Access to Confidential Business Information by Contractor
SafeGuard Document Destruction Inc.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of contractor access to confidential business
information.

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SUMMARY: The Environmental Protection Agency (EPA) has authorized
SafeGuard Document Destruction Inc. of Perrineville, NJ to access
information which has been submitted to EPA under the environmental
statutes administered by the Agency at its Region 3 offices. Some of
the information may be claimed or determined to be confidential
business information.

DATES: Comments must be received on or before April 26, 2021. Access to
the confidential data began on or about July 7, 2020.

ADDRESSES: You may submit your comments by one of the following
methods:
    1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2021-0238. EPA's policy is that all comments received will be included
in the public docket without change and may be available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov, or email. The federal website, https://www.regulations.gov, is an ``anonymous access'' system, which means EPA
will not know your identity or contact information unless you provide
it in the body of your comment. If you send an email comment directly
to EPA without going through https://www.regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment. If EPA cannot read your comment due to technical difficulties,
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. EPA encourages electronic submittals, but if you are unable to
submit electronically, please reach out to the EPA contact person
listed in the notice for assistance. If you need assistance in a
language other than English, or you are a person with disabilities who
needs a reasonable accommodation at no cost to you, please reach out to
the EPA contact person by email or telephone.

FOR FURTHER INFORMATION CONTACT: Kathy Schwartz,<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>address: EPA Region 3, Mission Support
Division (Mail Code 3MD20), 1650 Arch Street, Philadelphia, PA 19103.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the general public. This action may,
however, be of interest to anyone who submitted what may be determined
to be CBI to EPA Region 3. Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action.

B. How can I get copies of this document and other related information?

    All documents in the docket are listed in the https://www.regulations.gov index, under docket identification number EPA-R3-
OAR-2021-0238. Although listed in the index, some information might not
be publicly available, e.g., CBI or other information whose disclosure
is restricted by statute. Publicly available docket materials are
accessible electronically through https://www.regulations.gov.

II. What action is the agency taking?

    EPA Region 3 is shredding its records that are no longer required
to be retained or stored under the Federal Records Act or otherwise
required to be retained. EPA is performing this shredding using the
support of a contractor. Under EPA contract GS-

03F-065BA (the contract), SafeGuard Document Destruction Inc. (SDD) of
800 Rike Drive, Suite A, Perrineville, NJ 08535, is responsible for
providing locked bins and for shredding the hard copy records which the
agency has identified for disposal at two of its regional offices--
regional headquarters at 1650 Arch Street, Philadelphia, PA 19103 and
the Chesapeake Bay Program Office at 410 Severn Avenue, Suite 109,
Annapolis, MD 21403. Records that contain CBI may be included among
those being shredded.
    EPA will permit SDD personnel to have access to locked disposal
bins which contain information submitted to EPA under the statutes
administered by EPA Region 3. Some of the information may be claimed or
determined to be CBI. In accordance with 40 CFR 2.301(h)(2)(i) (Clean
Air Act (CAA)), and any provisions from 40 CFR 2.302 through 2.310
incorporating 40 CFR 2.301(h)(2)(i) (Clean Water Act (CWA), Safe
Drinking Water Act (SDWA), Resource Conservation and Recovery Act
(RCRA), Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA)), 40 CFR 2.306(j) (Toxic Substances Control Act
(TSCA)), 40 CFR 2.307(h)(3) (Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)), 40 CFR 2.308(i) (Federal Food, Drug and
Cosmetic Act (FDCA)), 40 CFR 350.23(b) (Emergency Planning and
Community Right-to-Know Act (EPCRA)), EPA has determined that SDD
requires access to locked disposal bins which may contain CBI submitted
to EPA, to perform successfully the duties required to carry out the
contract.
    Among the procedures established by EPA's confidentiality
regulations for granting access to CBI is prior notification to the
submitters of CBI that SDD may have access to this information. See 40
CFR 2.301(h)(2)(iii) for information submitted under the CAA,
corresponding provisions of 40 CFR 2.302 through 2.311 for information
submitted under the CWA, SDWA, RCRA, TSCA, FIFRA, FDCA, CERCLA, and 40
CFR 350.23 for EPCRA. This notification is intended to fulfill that
requirement. EPA Region 3 has permitted SDD personnel access to this
information prior to publishing this document. All potential access to
CBI under the contract has and will continue to occur at the two EPA
Region 3 offices located in Philadelphia and Annapolis. EPA Region 3 is
implementing the following procedures to ensure the security of the
files identified for disposal and the information therein. First, EPA
personnel deposit records that are ready for disposal into locked bins
located at either of the two EPA Region 3 offices. Next, during normal
business hours, SDD travels to the appropriate EPA Region 3 office
building with its shredding apparatus and is escorted into the building
by EPA personnel to retrieve the locked bins. Accompanied by EPA
personnel, SDD conducts onsite shredding of the contents of the bins
immediately after unlocking and emptying them into the shredding
apparatus. The contract prohibits SDD personnel from viewing,
inspecting, examining, or copying the materials identified for
shredding and requires SDD to safeguard such information. Additionally,
SDD is prohibited from transporting or shredding any records offsite.
    SDD's potential access to CBI under the contract began on or about
July 7, 2020 and will expire on October 31, 2021. If the contract is
further extended, this access will also continue for the duration of
the extension without further notice.

Catharine McManus,
Mission Support Division Director, Region 3.
[FR Doc. 2021-06932 Filed 4-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42721-42722]
[FR Doc No: 2022-15250]

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ENVIRONMENTAL PROTECTION AGENCY

[Docket EPA-R02-OW-2022-0598; FRL 9850-02-R2]

Availability of Clean Water Act List Decisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice and request for comments.

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SUMMARY: This notice announces EPA's addition of certain water quality
limited waters to the 2018 New York list of impaired waters, pursuant
to the Clean Water Act (CWA), and requests public comment. The CWA and
EPA's implementing regulations require States to submit, and EPA to
approve or disapprove, lists of waters for which technology-based and
other controls are not stringent enough to attain or maintain State
water quality standards and for which total maximum daily loads (TMDLs)
must be established. States are required to establish a priority
ranking for waters on the list and to identify waters targeted for TMDL
development over the next two years.

DATES: Comments must be submitted to EPA on or before September 16,
2022.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R02-

OW-2022-0598, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment.
    The written comment is considered the official comment and should
include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the internet, cloud, or other file
sharing system). For additional submission methods, the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Dr. Daniel Gurdak at telephone (212)
637-3634 or by mail at Environmental Protection Agency, Region 2, 290
Broadway, New York, New York 10007-1866.

SUPPLEMENTARY INFORMATION: New York submitted the 2018 New York CWA
Section 303(d) list (New York 2018 303(d) list) to EPA in
correspondence dated November 13th, 2020 (followed up by a correction
on December 7th, 2020, and a supplement on February 10th, 2022). On
March 10, 2022, EPA partially approved and partially disapproved the
New York 2018 303(d) list. Specifically, EPA approved the New York 2018
303(d) list with respect to the 835 waterbody/pollutant combinations
requiring TMDLs that New York included on the list and the State's
priority ranking for these waterbody/pollutant combinations.
    However, EPA disapproved the New York 2018 303(d) list because EPA
determined that it does not include twenty-two (22) waterbody/pollutant
combinations that meet CWA Section 303(d) listing requirements.
    For a detailed explanation of EPA's partial approval/partial
disapproval, please refer to EPA's Support Document (https://www.epa.gov/tmdl/new-yorkimpaired-waters-list). EPA is providing the
public the opportunity to review its decision to add these 22
waterbody/pollutant combinations to the New York 2018 303(d) list.
    EPA is disapproving the New York 2018 303(d) list because EPA has
determined that New York did not include twenty-two (22) waterbody/
pollutant combinations on the 2018 303(d) list that meet 303(d) listing
requirements, including:
     17 waterbody/pollutant combinations that New York
improperly delisted because data and information indicate that an
applicable water quality standard is not met, including:
    [cir] 4 waterbody/pollutant combinations where the applicable water
quality criterion for odors is not met
    [cir] 9 waterbody/pollutant combinations where data and/or
information indicate that the applicable water quality criterion/
criteria for floatables is/are not met.
    [cir] 2 waterbody/pollutant combinations where the applicable water
quality criterion for dissolved oxygen is not met
    [cir] 1 waterbody/pollutant combination where data and/or
information indicate the presence of harmful algal blooms (HABs), which
in turn, indicates that an applicable water quality standard is not
met.
    [cir] 1 waterbody/pollutant combination for an assessment unit
under 6.4 acres where data and/or information indicate that the
applicable water quality criterion for dissolved oxygen is not met.
     5 waterbody/pollutant combinations that New York did not
include on the State's 2016 and/or 2018 303(d) lists, including:
    [cir] 1 waterbody/pollutant combination that EPA listed on the New
York 2014 303(d) list where data and/or information indicate that the
applicable narrative water quality criterion for nutrients is not met.
    [cir] 3 waterbody/pollutant combinations where data and information
indicate the presence of HABs, which in turn, indicates that an
applicable water quality standard is not met. New York did not
demonstrate that no pollutant is causing the impairment of this water,
did not include this waterbody/pollutant combination on the 2018 303(d)
list and inappropriately categorized this waterbody/pollutant
combination.
    [cir] 1 waterbody/pollutant combination where data and/or
information indicate the presence of HABs, which in turn, indicates
that an applicable water quality standard is not met. New York did not
include this waterbody/pollutant combination on the 303(d) list or in
any other category.
    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

Javier Laureano,
Director, Water Division, Region II.
[FR Doc. 2022-15250 Filed 7-15-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Rules and Regulations]
[Pages 19928-19929]
[FR Doc No: 2012-7935]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1275; Airspace Docket No. 11-ANM-26]

Amendment of Class E Airspace; Hugo, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Hugo, CO.
Decommissioning of the Hugo Tactical Air Navigation System (TACAN) has
made this action necessary for the safety and management of Instrument
Flight Rules (IFR) operations in the vicinity of the Hugo VHF Omni-
Directional Radio Range/Distance Measuring Equipment (VOR/DME). This
action also makes a minor adjustment to the geographic coordinates of
the VOR/DME and makes a correction to the regulatory text. Also, the
legal description is better clarified at the request of the National
Aeronautical Navigation Services (NANS).

DATES: Effective date, 0901 UTC, May 31, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On December 19, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend

controlled airspace at Hugo, CO (76 FR 78576). Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
Subsequent to publication, it was discovered by NANS that the legal
description needed editing by removing the unneeded text ``* * *
excluding the airspace within Federal Airways''. This action makes
those edits.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9V dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace extending upward from 700 feet
above the surface in the vicinity of the Hugo VOR/DME, CO. The Hugo
TACAN has been decommissioned and replaced with a VOR/DME. The Federal
airway listed in the regulatory text as V-19 is edited to read V-83.
Also, the geographic coordinates of the VOR/DME are updated to coincide
with the FAA's aeronautical database. This action is necessary for the
safety and management of IFR operations.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (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 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 U.S.
Code. Subtitle 1, Section 106 discusses 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 in the vicinity of the Hugo VOR/DME, CO.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 14 CFR 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 the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM CO E5 Hugo, CO [Amended]

Hugo VOR/DME
    (Lat. 38[deg]49'03'' N., long. 103[deg]37'17'' W.)

    That airspace south and east of the Hugo VOR/DME extending
upward from 8,500 feet MSL, bounded on the west by V-83, on the
northwest by V-108 and V-169, on the north by V-4, on the northeast
by V-17, on the southeast by V-216, and on the south by V-210.

    Issued in Seattle, Washington, on March 23, 2012.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-7935 Filed 4-2-12; 8:45 am]
BILLING CODE 4910-13-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency s Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request 2. OMB control number b. X None EPA/ OAQPS/ ESD a.   2 0 6 0 3. Type of information collection ( check one) 4. Type of review requested ( check one)

a. X New collection a. X Regular b. Revision of a currently approved collection b. Emergency  Approval requested by: / /

c. Extension of a currently approved collection c. Delegated d. Reinstatement, without change, of a previously 5. Small entities approved collection for which approval has expired Will this information collection have a significant economic impact on a e. Reinstatement, with change, of a previously substantial number of small entities? Yes X No approved collection for which approval has expired f. Existing collection in use without OMB control 6. Requested expiration date number a. X Three years from approval date For b   f, note Item A2 of Supporting Statement Instructions b. Other Specify: /

7. Title NESHAP FOR Brick and Structural Clay Manufacturing ( 40 CFR part 63, subpart JJJJJ)

8. Agency form number( s) ( if applicable)

ICR no. 2022.02 9. Keywords Environmental protection, Air pollution control, Hazardous substances, Brick production, Structural Clay Products production, Recordkeeping and reporting requirements 10. Abstract Owners or operators of brick and structural clay products plants would comply with recordkeeping and reporting requirements of the NESHAP General Provisions ( 40 CFR part 63, subpart A) and maintain records of specific information needed by EPA to determine if compliance has been achieved.

11. Affected public 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms a. Voluntary b. P Business or other for profit e. X Federal Government b. Required to obtain or retain benefits c. Not for profit institutions f. X State, Local or Tribal c. P Mandatory Government 13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Number of respondents 77 a. Total annualized capital/ startup costs $ 115 b. Total annual responses 74 b. Total annual costs ( O& M) $ 5 1. Percentage of these responses c. Total annualized cost requested $ 120 collected electronically 10 % d. Current OMB inventory 0 c. Total annual hours requested 17,471 e. Difference $ 120 d. Current OMB inventory 0 f. Explanation of difference e. Difference 17,471 1. Program change $ 120 f. Explanation of difference 2. Adjustment $ 0 1. Program change 17,471 2. Adjustment 0 15. Purpose of information collection 16. Frequency of recordkeeping or reporting ( check all that apply)

( Mark primary with " P" and all others that apply with " X") a. X Recordkeeping b. Third party disclosure a. Application for benefits e. Program planning or c. X Reporting b. Program evaluation management 1. On occasion 2. Weekly c. General purpose statistics f. Research 3. Monthly 4. Quarterly d. Audit g. P Regulatory or compliance 5. X Semi annually 6. Annually 7. Biennially 8. X Other ( describe) Notifications 17. Statistical methods 18. Agency contact ( person who can best answer questions regarding the Does this information collection employ statistical methods? content of this submission)

Yes X No Name: Mary Johnson, EPA/ OAQPS/ ESD/ MICG Phone: ( 919) 541 5025 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Date Director, Regulatory Information Division OMB 83 I 10/ 95