MEMORANDUM DATE: April 29, 2004 TO: Effluent Guidelines Planning Record FROM: M. Ahmar Siddiqui RE: Telephone discussion regarding PBSTs with Dave Basinger, EPA Region 9 As part of its study of the Petroleum Bulk Stations and Terminals ( PBST, SIC 5171) industry, EPA contacted permit writers and compliance officials to discuss permitting and other issues unique to PBSTs. On April 5, 2004, Mr. M. Ahmar Siddiqui contacted Mr. Dave Basinger of the Region 9 Office of Compliance to discuss these facilities. The telephone script, which served as a guide to the conversation, is part of another memorandum to the Effluent Guidelines Planning Record ( Summary of discussions with permit writers about PBST facilities, April 29, 2004).

Mr, Basinger identified contaminated stormwater, tank bottoms water, occasional ballast water ( if products arrive by barge) and groundwater seepage up into tanks as particular sources of polluted wastewaters at PBSTs. Depending on the volume of materials transferred, tank bottoms water may be very significant in volume and toxic ( in the event that received products have significant amounts of water in them). Mr. Basinger could not identify the quantities of polyaromatic hydrocarbons ( PAHs) or other pollutants in typical wastestreams, noting that this was largely a function of the products handled by the PBST.

To the question of the recycling of tank bottoms waters to recover petroleum products, Mr. Basinger stated that this practice often occurs at those facilities associated with oil refineries. He could not guess how widespread the practice is, though he noted that larger facilities were more likely to engage in it. Mr. Basinger went on to note that he didn't believe that refineries paid for tank bottoms waters: instead, those PBSTs that sent their tank bottoms waters to refineries, paid the refineries for ( effectively) treating their wastewaters.

Mr. Basinger stated that, for those PBSTs with treatment systems, oil/ water separation, by itself, is most commonly used. He went on to say that differences may exist based on size and other economic factors: those PBSTs that are co located with refineries will have local treatment ( oil/ water separation) in the event that the refineries tank farms were spread out. He also noted that treatment beyond oil/ water separation is rare and is largely due to local limits. In addition, he noted that biological treatment is not widely used due to the fact that PBSTs accept varying products: the variety of wastestreams that result cannot be easily treated this way due to damage to the treatment system's microorganisms, which are acclimated to specific pollutants profiles.

Mr. Basinger stated that, among the pollution prevention methods used by PBSTs, spill management and products recycle are fairly common. He also stated that current EPA rules, like the Spill Prevenetion, Control, and Countermeasures ( SPCC) rules and stormwater rules have lowered toxic discharges, though he was unable to guess the extent of reduction. As to the discharge status of the industry, Mr. Basinger was unable to verify the implication of the 2000 TRI database, which suggested that as much as two thirds of the industry practiced zerodischarge He did guess, however, that small, independent facilities were likely to be doing treatment.


[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Proposed Rules]
[Pages 53033-53036]
[FR Doc No: 2015-21567]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 91

[Docket No.: FAA-2015-3304; Notice No. 15-07]
RIN 2120-AK66

Temporary Flight Restrictions in the Proximity of Launch and
Reentry Operations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This proposed rulemaking would expand the temporary flight
restriction provisions for launch, reentry, and amateur rocket
operations and make such temporary flight restrictions applicable to
all aircraft--including non-U.S. registered aircraft. The FAA also
proposes revised language for consistency with other temporary flight
restriction provisions and commercial space regulations and
definitions. This proposed action would enhance safety in the affected
airspace and would improve the readability of temporary flight
restriction requirements.

DATES: Send comments on or before November 2, 2015.

ADDRESSES: Send comments identified by docket number FAA-2015-3304
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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
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: For technical questions concerning
this action, contact Paul Eure, Airspace Regulations Team, AJV-113,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    For legal questions concerning this action, contact Robert Frenzel,
Operations Law Branch, AGC-220, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone (202) 267-
3073; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on 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, Sovereignty and use of
airspace, and Subpart III, Section 44701, General requirements. Under
section 40103, the FAA is charged with prescribing regulations to
ensure the safety of aircraft and the efficient use of the navigable
airspace. Under section 44701, the FAA is charged with prescribing
regulations to ensure safety in air commerce.
    This proposed regulation is within the scope of sections 40103 and
44701 because restricting aircraft operations from the area in which
launch, reentry, and amateur rocket operations occur supports aviation
safety and the efficient use of navigable airspace.
    The Commercial Space Launch Act of 1984, as codified and amended at
51 U.S.C. Subtitle V--Commercial Space Transportation, Ch. 509,
Commercial Space Launch Activities, 51 U.S.C. 50901-50923 (Chapter
509), authorizes the Department of Transportation and thus the FAA,
through delegations, to oversee, license, and regulate commercial
launch and reentry activities, and the operation of launch and reentry
sites as carried out by U.S. citizens or within the United States. 51
U.S.C. 50904, 50905. Chapter 509 directs the FAA to exercise this
responsibility consistent with public health and safety, safety of
property, and the national security and foreign policy interests of the
United States. 51 U.S.C. 50905. The FAA is also responsible for
encouraging, facilitating, and promoting commercial space launches by
the private sector. 51 U.S.C. 50903.

I. Executive Summary

    14 CFR 91.143 authorizes the FAA to issue Notices to Airmen (NOTAM)
prohibiting a person from operating any aircraft of U.S. registry in
areas designated in the NOTAM for space flight operations. The FAA
proposes to amend this provision to apply to all aircraft.
    At the time of the promulgation of Sec.  91.143, recovery
operations were conducted outside of U.S. territorial boundaries, and
therefore, the FAA could only restrict U.S. registered aircraft or
aircraft flown by pilots using a FAA pilot certificate. This
regulation, clarified in 1984, included launches (and potential
emergency recovery operations) in support of the National Aeronautics
and Space Administration (NASA) Space Shuttle program.
    However, the initial applicability of this regulation does not
adequately address present day space launch and recovery operations
that are increasingly conducted within the boundaries of U.S.
territory. Therefore, the agency proposes to amend this rule to better
address present day operations to ensure that all aircraft--not only
U.S. registered aircraft or aircraft flown by pilots using a FAA pilot
certificate--are restricted from operating in airspace designated for
launch, reentry, or amateur rocket operations.
    Additionally, this amendment would allow the FAA to issue a NOTAM
to designate a temporary flight restriction (TFR) for launch, reentry,
or amateur rocket operations involving Class 2 or 3 amateur rockets
when it determines a TFR is necessary to maintain safety.
    Lastly, the FAA proposes other language changes that would align
the language used in Sec.  91.143 with the terminology used in Chapter
509 and the FAA space transportation regulations and definitions. For
example, the terms ``launch'' and ``reentry'' are defined in 14 CFR
401.5 and are normally used to broadly categorize these types of
operations. The FAA, therefore, proposes to replace ``space flight
operations'' with ``launch, reentry, or amateur rocket operation.''

    The FAA believes these revisions would strengthen the
understandability of these requirements while enhancing safety in the
affected airspace.

II. Background

    The language of ``flight limitations in the proximity of space
flight operations'' as utilized in 14 CFR 91.143 was first promulgated
in 1964 to support NASA's Gemini and Apollo space operations. By
restricting non-essential aircraft from the designated recovery area,
the FAA intended to ensure the safe recovery of spacecraft while
mitigating the risk of an aircraft collision. At the time this rule was
promulgated most of these recovery operations occurred outside of U.S.
territorial airspace and the FAA could restrict only U.S. registered
aircraft or aircraft piloted under an FAA-issued airman certificate.
These expanded regulations were clarified in 1984, to include launch
operations (and potential emergency recovery operations) in support of
NASA's space shuttle program.
    The FAA now issues TFRs only for the airspace over the territory of
the United States extending out to 12 nautical miles from the
coastline. Since rule promulgation in 1984, an increasing number of
rocket launches now occur over U.S. territorial airspace. The FAA
therefore believes it is necessary to update regulations to align them
with current practice.
    In recent years, because technological changes have resulted in an
increased growth of larger amateur rockets with greater power, the FAA
has issued NOTAMs under Sec.  91.143 to designate TFRs to segregate
Class 2 and 3 amateur rockets from all other users of the National
Airspace System (NAS). Class 2 and 3 amateur rockets operated under 14
CFR part 101 are capable of operating up to 93.2 miles with multiple
stages. Persons intending to operate a Class 2 or 3 rocket in a manner
that requires a waiver to 14 CFR part 101 subpart C, must submit a
proposal for waiver or authorization to the FAA. This includes
proposals to launch a Class 2 or 3 amateur rockets into controlled
airspace, which may require the FAA to implement a TFR to ensure
safety.
    The process for the development of a TFR is extensive. For example,
commercial space operators are required to file an application for a
permit or license in order to conduct commercial space operations. The
FAA reviews the application to determine ground and airborne hazard
areas. The FAA then analyzes these proposals for safety impact, and
then issues a permit or license for the operation. This license or
permit application includes a letter of agreement between the operator
and Air Traffic Control that may include special provisions that
determine the area covered by a TFR along with detailed operational
directives. Accordingly, in these circumstances, the FAA issues a NOTAM
to designate a TFR that encompasses the hazardous areas necessary to
avoid collisions with other NAS users.
    While TFRs may impose an inconvenience to NAS users, they are
necessary to provide the highest level of safety. From an efficiency
standpoint, the FAA strives to integrate all operations into the NAS.
The operations of most launch vehicles could result in scenarios that
are hazardous to other NAS users that may be in the vicinity of the
operation. The use of a TFR for the segregation of other NAS users from
commercial space operations and Class 2 and 3 amateur rockets is key to
ensuring safety--when it is determined that a TFR is required.
    Therefore, by expanding the applicability of the TFR provision to
amateur rocket operations, this proposed rulemaking would codify the
FAA's ability to establish a TFR for a Class 2 or 3 amateur rocket
operation, when it determines a TFR is necessary to maintain safety.

III. Discussion of the Proposal

A. Applicability

    The FAA has frequently used, without incident or accident, TFRs to
segregate hazardous launch, reentry, and amateur rocket operations from
all other NAS users (operating by visual and instrument flight rules).
While Sec.  91.143 was intended to support NASA and DOD space
operations outside U.S. airspace (over the ocean), in recent years
commercial space and amateur rocket operations have increased over U.S.
territorial airspace. The FAA issues TFRs only for the airspace over
the territory of the U.S. extending 12 nautical miles from the
coastline. Applying restrictions to all aircraft within this area is
within the FAA's statutory authority and is consistent with the purpose
of these restrictions (i.e., to mitigate the risk of aircraft collision
by segregating launch, reentry and amateur rocket operations from other
NAS users).
    Although current practice restricts all aircraft from areas
designated by TFRs for launch, reentry and amateur rocket operations,
this proposed change would ensure the applicability of the flight
restrictions to U.S. and non-U.S. registered aircraft from entering
into areas designated by TFR for launch, reentry, and amateur rocket
operations. Accordingly, the FAA proposes to expand the applicability
of Sec.  91.143 to all aircraft in order to mitigate the safety risk of
aircraft operations in proximity to launch, reentry, and Class 2 or 3
amateur rocket operations.

B. Title and Regulatory Change

    The FAA proposes revisions to the title and content of Sec.  91.143
for: (1) Consistency with other TFR provisions in 14 CFR part 91, (2)
consistency with the commercial space regulations in 14 CFR chapter
III, and (3) to include Class 2 and 3 amateur rockets.
    Specifically, the FAA proposes replacing the title of Sec.  91.143
``Flight limitation in the proximity of space flight operations'' with
``Temporary Flight Restrictions in the Proximity of Launch and Reentry
Operations,'' a title that more accurately reflects current practice
and includes the use of the terms ``temporary flight restrictions'' and
``launch and reentry operations.''
    The FAA also proposes replacing terms in the content of Sec.
91.143, such as ``space flight operations'' with ``launch, reentry, or
amateur rocket operations.'' ``Launch'' and ``reentry'' are defined in
14 CFR Sec.  401.5 and are normally used to describe launch or reentry
vehicles going to or returning from orbit or outer space, or operations
associated with orbital and suborbital flight. Current references to
``space operations'' encompass both launch and reentry.
    Finally, to align regulatory language with current practice, the
FAA proposes the inclusion of Class 2 and 3 amateur rockets for TFR
issuance when the FAA determines the proposed operation presents a
safety risk. A certificate of waiver or authorization for Class 2 or 3
amateur rocket launch would identify the designated hazard area used to
determine the area to be covered by the TFR.
    Although these revisions address commercial space and amateur
rocket operations, TFR provisions would continue to be used for DOD and
NASA space operations as originally intended.

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 and Executive Order 13563 direct
that each Federal agency shall propose or adopt a regulation only upon
a reasoned determination that the benefits of the intended regulation
justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub.
L. 96-354) requires agencies to analyze the economic impact of
regulatory changes on small

entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, the Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this proposed rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it to be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this proposed rule. The
reasoning for this determination follows.
    This proposed rule would expand the TFR provisions for launch,
reentry, and amateur rocket operations. This proposed rule would
formalize the current practice and apply the TFR to non-U.S. registered
aircraft. No actions are required for U.S. entities. Since this
proposed rule would merely amend language to improve the readability of
the TFR requirements, formalize that current practice, and apply these
restrictions to non-U.S. registered aircraft. The expected outcome
would be a minimal impact with positive net benefits, and a regulatory
evaluation was not prepared. The FAA requests comments with supporting
justification about the FAA determination of minimal impact.
    The FAA has therefore, determined that this proposed rule is not a
``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation.'' To achieve this principle, agencies are
required to solicit and consider flexible regulatory proposals and to
explain the rationale for their actions to assure that such proposals
are given serious consideration.'' The RFA covers a wide-range of small
entities, including small businesses, not-for-profit organizations, and
small governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    Since all U.S. entities are covered by current practice, this
proposed rule would expand the applicability of TFR provisions for
launch, reentry and amateur rocket operations to all aircraft,
including non-U.S. registered aircraft. The expected outcome would have
only a minimal impact on any small entity affected by this rulemaking
action. Therefore, as provided in section 605(b), the head of the FAA
certifies that this rulemaking will not result in a significant
economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this proposed rule and determined that
it would responds to a domestic safety objective and not considered an
unnecessary obstacle to trade.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $155 million in lieu of $100
million. This proposed rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there would be no new requirement for information collection associated
with this proposed rule.

F. International Compatibility and Cooperation

    (1) In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these proposed regulations.

G. Environmental Analysis

    FAA Order 1050.1F identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. The agency has
determined that this action would not have a substantial direct effect
on the States, or the relationship between the Federal Government and
the States, or on the distribution of power and responsibilities among
the various levels of government, and, therefore, would not have
Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
would not be a ``significant energy action'' under the executive order
and would not be likely to have a significant adverse effect on the
supply, distribution, or use of energy.

C. Executive Order 13609, Promoting International Regulatory
Cooperation

    Executive Order 13609, Promoting International Regulatory
Cooperation, promotes international regulatory cooperation to meet
shared challenges involving health, safety, labor, security,
environmental, and other issues and to reduce, eliminate, or prevent
unnecessary differences in regulatory requirements. The FAA has
analyzed this action under the policies and agency responsibilities of
Executive Order 13609, and has determined that this action would have
no effect on international regulatory cooperation.

VI. Additional Information

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The agency
also invites comments relating to the economic, environmental, energy,
or federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit only one time.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The agency may change this proposal in
light of the comments it receives.
    Proprietary or Confidential Business Information: Commenters should
not file proprietary or confidential business information in the
docket. Such information must be sent or delivered directly to the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this document, and marked as proprietary or confidential. If submitting
information on a disk or CD ROM, mark the outside of the disk or CD
ROM, and identify electronically within the disk or CD ROM the specific
information that is proprietary or confidential.
    Under 14 CFR 11.35(b), if the FAA is aware of proprietary
information filed with a comment, the agency does not place it in the
docket. It is held in a separate file to which the public does not have
access, and the FAA places a note in the docket that it has received
it. If the FAA receives a request to examine or copy this information,
it treats it as any other request under the Freedom of Information Act
(5 U.S.C. 552). The FAA processes such a request under Department of
Transportation procedures found in 49 CFR part 7.

B. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or notice number of this
rulemaking.
    All documents the FAA considered in developing this proposed rule,
including economic analyses and technical reports, may be accessed from
the Internet through the Federal eRulemaking Portal referenced in item
(1) above.

List of Subjects in 14 CFR Part 91

    Air traffic control, Aircraft, Airmen, Aviation safety.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend chapter I of title 14, Code of Federal
Regulations as follows:

PART 91--GENERAL OPERATING AND FLIGHT RULES

0
1. The authority citation for part 91 is revised to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105,
40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712,
44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507,
47122, 47508, 47528-47531, 47534, articles 12 and 29 of the
Convention on International Civil Aviation (61 Stat. 1180), (126
Stat. 11).

0
2. Revise Sec.  91.143 to read as follows:

Sec.  91.143  Temporary flight restrictions in the proximity of launch
and reentry operations.

    No person may operate an aircraft contrary to a Temporary Flight
Restriction established by the Administrator in a Notice to Airman
(NOTAM) within an area designated for a launch, reentry, or amateur
rocket operation, unless authorized by ATC.

    Issued under authority provided by 49 U.S.C. 106(f), 40103(b),
and 44701(a) in Washington, DC, on August 18, 2015.
Jodi S. McCarthy,
Director, Airspace Services.
[FR Doc. 2015-21567 Filed 9-1-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 29, 2007 (Volume 72, Number 60)]
[Notices]
[Page 14808-14810]
[DOCID:fr29mr07-89]

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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID No. EPA-HQ-ORD-2007-0241; FRL-8293-6]

Draft Toxicological Review of Nitrobenzene (CASRN 98-95-3): In
Support of the Summary Information in the Integrated Risk Information
System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of External Peer-Review Panel Meeting and Public Comment
Period.

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SUMMARY: EPA is announcing that the Oak Ridge Institute of Science and
Education (ORISE), under an agreement between the Department of Energy
and EPA, will convene an independent panel of experts and organize and
conduct an external peer-review workshop to review the external review
draft document titled, ``Toxicological Review of Nitrobenzene: In
Support of Summary Information in the Integrated Risk Information
System (IRIS).'' The EPA also is announcing a public comment period for
the external review draft document.
    The public comment period and the external peer-review workshop are
separate processes that provide opportunities for all interested
parties to comment on the document. In addition to consideration by
EPA, all public comments submitted in accordance with this notice will
also be forwarded to ORISE for consideration by the external peer-
review panel prior to the workshop.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. ORISE invites the public to register to attend
this workshop as observers. In addition, ORISE invites the public to
give brief oral comments at the workshop regarding the draft document
under review. The draft document and EPA's peer-review charge are
available via the Internet on the National Center for Environmental
Assessment's (NCEA's) home page under the Recent Additions and the
Publications menus at http://www.epa.gov/ncea. When finalizing the

draft document, EPA will consider ORISE's report of the comments and
recommendations from the external peer-review workshop and any public

comments that EPA receives in accordance with this notice.

DATES: The external peer-review panel workshop will begin on May 15,
2007, at 9:00 a.m. and end at 4:00 p.m. The public comment period
begins March 29, 2007 and ends April 30, 2007. Technical comments
should be in writing and must be received by EPA by April 30, 2007.
Comments received from the public by this date will be submitted to the
external peer-review panel prior to the workshop.

ADDRESSES: The external peer-review workshop will be held at the
American Geophysical Union, 2000 Florida Avenue, Washington, DC. ORISE
is organizing, convening, and conducting the peer-review workshop. To
attend the workshop and/or provide brief oral comments, you must
register by May 1, 2007, via the Internet at http://www.orau.gov/nitrobenzene.
 You may also register by calling ORISE at<PHONE_NUMBER>,

sending a facsimile to<PHONE_NUMBER>, or sending an e-mail to Margaret
Lyday at<EMAIL_ADDRESS>    The draft document, ``Toxicological Review of Nitrobenzene: In
Support of Summary Information in the Integrated Risk Information
System (IRIS)'' is available via the Internet on NCEA's home page under
the Recent Additions and the Publications menus at http://www.epa.gov/ncea.
 A limited number of paper copies are available from NCEA's

Technical Information Staff (telephone;<PHONE_NUMBER>, facsimile 202-
565-0050). If you are requesting a paper copy, please provide your
name, mailing address, and the document title. Copies are not available
from ORISE.
    Comments may be submitted electronically at http://

http://www.regulations.gov, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the peer-review
workshop, contact Margaret Lyday by mail: Oak Ridge Institute for
Science and Education, P.O. Box 117, Oak Ridge, TN 37831-0117; phone:
865-576-2922; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    For information on the public comment period, contact the Office of
Environmental Information Docket by phone:<PHONE_NUMBER>; facsimile:
202-566-1753; or e-mail<EMAIL_ADDRESS>    If you have questions about the document, contact Dr. Stedeford,
IRIS Staff, National Center for Environmental Assessment, by mail: U.S.
EPA (8601D), 1200 Pennsylvania Avenue, NW., Washington, DC 20460;
phone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Summary of Information About the Integrated Risk Information System
(IRIS)

    IRIS is a database that contains information regarding potential
adverse human health effects that may result from chronic (or lifetime)
exposure to specific chemical substances found in the environment. The
database (available on the Internet at http://www.epa.gov/iris)

contains qualitative and quantitative health effects information for
more than 540 chemical substances that may be used to support the first
two steps (hazard identification and dose-response evaluation) of a
risk assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. Workshop Information

    Members of the public may attend the workshop as observers, and
there will be a limited time for comments from the public. If you wish
to make oral comments during the review, you must pre-register at
http://www.orau.gov/nitrobenze by May 1, 2007. Space is limited and

reservations will be accepted on a first-come, first-served basis.

III. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-
0241 by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. The phone number is
202-566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue, NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the Docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. Consult EPA's Web site at
http://www.epa.gov/epahome/dockets.htm for current information on

docket operations, locations, and telephone numbers.
    If you provide comments by mail or hand delivery, please submit one
unbound original with pages numbered consecutively, and three copies of
the comments. For attachments, provide an index, number pages
consecutively with the comments, and submit an unbound original and
three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0241. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://www.regulations.gov
, including any personal information provided,

unless a 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 http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site 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 e-mail comment directly to EPA without going through http://www.regulations.gov
, your e-mail 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 and with any disk or CD-ROM you
submit. 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. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm    Docket: Documents in the docket are listed in the http://.

http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the

EPA Headquarters Docket Center.

    Dated: March 26, 2007.
David Bussard,
Acting Director, National Center for Environmental Assessment.
 [FR Doc. E7-5801 Filed 3-28-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 213 (Thursday, November 3, 2016)]
[Notices]
[Pages 76596-76598]
[FR Doc No: 2016-26528]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0403]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Protection of Human
Subjects: Informed Consent; Institutional Review Boards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by
December 5, 2016.

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 0910-0755.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852<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.

Protection of Human Subjects: Informed Consent; Institutional Review
Boards OMB Control Number 0910-0755--Extension

    Part 50 (21 CFR part 50) applies to all clinical investigations
regulated by FDA under sections 505(i) and 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i) and 360j(g),
respectively), as well as clinical investigations that support
applications for research or marketing permits for products regulated
by FDA, including foods and dietary supplements that bear a nutrient
content claim or a health claim, infant formulas, food and color
additives, drugs for human use, medical devices for human use,
biological products for human use, and electronic products. Compliance
with part 50 is intended to protect the rights and safety of subjects
involved in investigations filed with FDA under sections 403, 406, 409,
412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the
FD&C Act (21 U.S.C. 343, 346, 348, 350a, 350b, 352, 353, 355, 360,
360c-360f, 360h-360j, 379e, and 381, respectively) and sections 351 and
354-360F of the Public Health Service Act.
    With few exceptions, no investigator may involve a human being as a
subject in FDA-regulated research unless the investigator has obtained
the legally effective informed consent of the subject or the subject's
legally authorized representative (see Sec.  50.20). In seeking
informed consent, each subject must be provided with certain elements
of informed consent. Those elements are listed in Sec.  50.25. Informed
consent shall be documented in writing as described in Sec.  50.27.
    An institutional review board (IRB) may approve emergency research
without requiring the informed consent of all research subjects
provided the IRB finds and documents that certain criteria are met as
required in Sec.  50.24. We estimate that about eight times per year an
IRB is requested to review emergency research under Sec.  50.24. We
estimate, of the 8 yearly requests for IRB review under Sec.  50.24, a
particular IRB will take about an hour during each of three separate
fully convened IRB meetings to review the request under Sec.  50.24
(one meeting occurring after community consultation). The total annual
reporting burden for IRB review of emergency research under Sec.  50.24
is estimated at 24 hours (see table 1).
    The information requested in the regulations for exception from the
general requirements for informed consent for medical devices (21 CFR
812.47), and the information requested in the regulations for exception
from the general requirements of informed consent in Sec.  50.23,
paragraphs (a) through (c) and (e), is currently approved under OMB
control number 0910-0586. The information requested in the
investigational new drug (IND) regulations concerning exception from
informed consent for emergency research under Sec.  50.24 is currently
approved under OMB control number 0910-0014. In addition, the
information requested in the regulations for IND safety reporting
requirements for human drug and biological products and safety
reporting requirements for bioavailability and bioequivalence studies
in humans (21 CFR 320.31(d)

and 21 CFR 312.32(c)(1)(ii) and (iv)) is currently approved under OMB
control number 0910-0672.
    Some clinical investigations involving children, although otherwise
not approvable, may present an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children
(see Sec.  50.54). Certain clinical investigations involving children
may proceed if the IRB finds and documents that the clinical
investigation presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children and when the Commissioner
of Food and Drugs, after consultation with a panel of experts in
pertinent disciplines and following opportunity for public review and
comment, makes a determination that certain conditions are met (see
Sec.  50.54(b)).
    The information requested for clinical investigations in children
of FDA-regulated products is covered by the collections of information
in the IND regulations (part 312 (21 CFR part 312)), the
investigational device exemption (IDE) regulations (part 812 (21 CFR
part 812)), the IRB regulations (Sec.  56.115 (21 CFR 56.115)), the
food additive petition and nutrient content claim petition regulations
(21 CFR 101.69 and 101.70), and the infant formula regulations (parts
106 and 107 (21 CFR parts 106 and 107)), all of which are approved by
OMB. Specifically, the information collected under the IND regulations
is currently approved under OMB control number 0910-0014. The
information collected under the IDE regulations is currently approved
under OMB control number 0910-0078. The information collected under the
IRB regulations is currently approved under OMB control number 0910-
0130. The information collected in food additive and nutrient content
claim petitions is currently approved under OMB control number 0910-
0381 (general requirements) and 0910-0016 (Form FDA 3503). The
information collected under the infant formula regulations is currently
approved under OMB control number 0910-0256 (general requirements) and
0910-0188 (infant formula recalls).
    Part 56 (21 CFR part 56) contains the general standards for the
composition, operation, and responsibility of an IRB that reviews
clinical investigations regulated by FDA under sections 505(i) and
520(g) of the FD&C Act, as well as clinical investigations that support
applications for research or marketing permits for products regulated
by FDA, including foods and dietary supplements that bear a nutrient
content claim or a health claim, infant formulas, food and color
additives, drugs for human use, medical devices for human use,
biological products for human use, and electronic products. Compliance
with part 56 is intended to protect the rights and welfare of human
subjects involved in such investigations.
    The information collected under the IRB regulations ``Protection of
Human Subjects--Recordkeeping and Reporting Requirements for
Institutional Review Boards (part 56),'' including the information
collection activities in the provisions in Sec.  56.108(a)(1) and (b),
is currently approved under OMB control number 0910-0130. The
information collected under the regulations for the registration of
IRBs in Sec.  56.106 is currently approved under OMB control number
0990-0279. The information collected for IRB review and approval for
the IDE regulations (part 812) is currently approved under OMB control
number 0910-0078. The information collected for premarket approval of
medical devices (part 814 (21 CFR part 814)) is currently approved
under OMB control number 0910-0231. The information collected under the
regulations for IRB requirements for humanitarian use devices (part
814, subpart H) is currently approved under OMB control number 0910-
0332. The information collected under the regulations for IRB review
and approval of INDs (part 312) is currently approved under OMB control
number 0910-0014.
    This collection of information is limited to certain provisions in
part 50, subpart B (Informed Consent of Human Subjects), and part 56
(Institutional Review Boards), currently approved under OMB control
number 0910-0755.
    This proposed extension applies to the following collections of
information in part 50: Sec. Sec.  50.24 (Exception from informed
consent requirements for emergency research), 50.25 (Elements of
informed consent), and 50.27 (Documentation of informed consent).
    In part 56, this proposed extension applies to the following
collections of information: Sec.  56.109(d) (written statement about
research when documentation of informed consent is waived); Sec.
56.109(e) (IRB written notification to approve or disapprove research);
Sec.  56.109(f) (continuing review of research); Sec.  56.109(g) (IRB
written statements to the sponsor about required public disclosures
related to emergency research under Sec.  50.24); Sec.  56.113
(Suspension or termination of IRB approval of research); Sec.
56.120(a) (IRB response to lesser administrative actions for
noncompliance); and, Sec.  56.123 (Reinstatement of an IRB or an
institution).
    In Sec.  56.109(d), if an IRB has waived documentation of consent
for research that: (1) Presents no more than minimal risk of harm to
subjects and (2) involves no procedures for which consent is normally
required outside of the research context, the IRB may nevertheless
require the investigator to provide a written statement about the
research to the subjects. We estimate that each IRB will review about
two minimal risk FDA-regulated studies each year. Because the studies
are minimal risk, the review can be fairly straightforward, and the
written statement for the subjects would be brief. We estimate that IRB
review of each written statement could be completed in less than 30
minutes (0.5 hours).
    In Sec.  56.109(f), the amount of time an IRB spends on the
continuing review of a particular study will vary depending on the
nature and complexity of the research, the amount and type of new
information presented to the IRB, and whether the investigator is
seeking approval of substantive changes to the research protocol or
informed consent document. For many studies, continuing review can be
fairly straightforward, and the IRB should be able to complete its
deliberations and approve the research within a brief period of time.
    In Sec.  56.109(g), an IRB is required to provide the sponsor of a
study involving an exception from informed consent for emergency
research under Sec.  50.24 with a written statement of information that
has been publicly disclosed to the communities in which the
investigation will be conducted and from which the subjects will be
drawn. Public disclosure prior to initiation of the investigation would
include the plans for the investigation and its risks and expected
benefits. There must also be public disclosure of sufficient
information following completion of the clinical investigation to
apprise the community and researchers of the study, including the
demographic characteristics of the research population, and its
results. (See Sec.  50.24(a)(7)(ii) and (iii)). The purpose of the
IRB's written statements is to make the sponsor aware that public
disclosure has occurred, so that the sponsor can provide copies of the
information that has been disclosed to FDA, as required by Sec. Sec.
312.54(a) and 812.47(a).
    We estimate that about eight requests to review emergency research
under Sec.  50.24 are submitted each year, and the IRBs that review
those studies would prepare two public disclosure reports: One prior to
initiation of the research and one following the study's

completion. We estimate that it will take an IRB approximately 1 hour
to prepare a written statement to the study sponsor describing each
public disclosure, for a total of 2 hours per study. The total annual
third party disclosure burden for IRBs to fulfill this requirement
related to emergency research under Sec.  50.24 is estimated at 16
hours (see table 2).
    When an IRB or institution violates the regulations, FDA issues to
the IRB or institution a noncompliance letter (see Sec.  56.120(a)).
The IRB or institution must respond to the noncompliance letter
describing the corrective actions that will be taken by the IRB or
institution. FDA estimates about seven IRBs or institutions will be
issued a noncompliance letter annually. We estimate that the IRB's or
institution's response will take about 10 hours to prepare, with an
estimated total annual burden of 70 hours.
    In 2016, FDA disqualified one IRB under Sec.  56.121. To date, no
IRB or institution has been reinstated or applied for reinstatement
under Sec.  56.123. For this reason, we estimate the annual reporting
burden for one respondent only. We estimate a 5-hour burden per
response, with an estimated total annual burden of 5 hours.
    The regulatory provisions in parts 50 and 56 currently approved
under this collection of information, OMB control number 0910-0755, and
for which this extension is requested, are shown in table 1.
    In the Federal Register of July 19, 2016 (81 FR 46935), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
56.109(d) Written statement              2,520               2           5,040  .5 (30 minutes).           2,520
 about minimal risk research
 when documentation of
 informed consent is waived.
56.109(e) IRB written                    2,520              40         100,800  1...............         100,800
 notification to approve or
 disapprove research;
 56.109(f) Continuing review;
 50.25 Elements of informed
 consent; and 50.27
 Documentation of informed
 consent.
50.24 Exception from informed                8               3              24  1...............              24
 consent requirements for
 emergency research.
56.113 Suspension or                     2,520               1           2,520  .5 (30 minutes).           1,260
 termination of IRB approval
 of research.
56.120(a) IRB response to                    7               1               7  10..............              70
 lesser administrative actions
 for noncompliance.
56.123 Reinstatement of an IRB               1               1               1  5...............               5
 or an institution.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................         104,679
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
56.109(g) IRB written statement about public disclosures to sponsor               8                2               16                1               16
 of emergency research under 50.24.................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26528 Filed 11-2-16; 8:45 am]
 BILLING CODE 4164-01-P