			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 1, 2006

NOTICE OF ACTION TAKEN -- DOCKETS OST-2004-19214  OST-2003-14397

				 OST-2005-20145

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Application of DELTA AIR LINES, INC. (DELTA) and KLM CITYHOPPER
B.V. (CITYHOPPER) filed 4/11/06 for:

OST-2004-19214

XX  Statement of authorization for blanket code-share authority for
Cityhopper under CFR Part 212 to:

Permit Cityhopper to display the“DL” code of Delta on flights
operated by Cityhopper between

(1) any points in the Netherlands; (2) any point or points in the
Netherlands and any point or points in any third country; and (3) any
points in third countries.

The applicants request that the Delta and Cityhopper codesharing
authority be administered with the existing Delta and KLM statement of
authorization in the instant docket, and that previous and future notice
given for points served by KLM be deemed notice given for points to be
served by Cityhopper, and vice versa, via all authorized gateways.

OST-2003-14397

XX  Amended exemption for Cityhopper under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of persons, property, and mail by
displaying Delta’s designator code on flights operated by Cityhopper
between (1) any points in the Netherlands;

(2) any point or points in the Netherlands and any point or points in
any third country; and

(3) any points in third countries.  The applicants request that the
exemption authority be granted for a period co-extensive with its
exemption granted previously in the instant docket (through

February 15, 2007).

OST-2005-20145

XX  Amended exemption for Delta under 49 U.S.C. 40109 to include
Cityhopper as an additional authorized foreign code-share partner and
permit Delta to display its designator code on flights operated by
Cityhopper on the following services:

Scheduled foreign air transportation of persons, property, and mail
between the United States and points worldwide on a third-country
code-share basis pursuant to the blanket code-sharing statement of
authorization with Cityhopper.  The applicants request that the
exemption authority be granted for a period co-extensive with its
exemption granted previously in the instant docket (through February 6,
2008).

Applicant reps: Robert E. Cohn<PHONE_NUMBER> (Delta) DOT Analyst: Thuy
H. Cooper<PHONE_NUMBER> 	            Charles F. Donley<PHONE_NUMBER>
(Cityhopper)

DISPOSITION

XX  Granted amended exemption authority to Delta and Cityhopper (subject
to conditions, see   below)

XX  Granted statement of authorization to Cityhopper (subject to
conditions, see below)

XX  Denied in part (see remarks below)

The above action granting amended exemption authority to Delta was
effective when taken: May 1, 2006, through February 6, 2008.

The above action granting amended exemption authority to Cityhopper was
effective when taken:

May 1, 2006, through February 15, 2007.

The above action granting a statement of authorization to Cityhopper was
effective when taken:

May 1, 2006, and will remain in effect indefinitely, subject to the
conditions below.

Action taken by:  Paul L. Gretch, Director

                              Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and the Netherlands.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	   XX Delta’s certificates of public convenience and necessity

	   XX Standard Exemption Conditions (attached as Appendix B)

	   XX Foreign Carrier Exemption Conditions (attached as Appendix C)

	   XX Statement of authorization approving Delta/KLM code-share
   	          	          operations and applicable conditions

________________________________________________________________________
_____________

Conditions:  The statement of authorization granted is subject to the
following conditions:

(a) The statement of authorization will remain in effect only as long as
(i) Delta and Cityhopper continue to hold the necessary underlying
authority to operate the code-share services at issue, and (ii) the
code-share agreement providing for the code-share operations remains in
effect.

(b) Delta and Cityhopper must promptly notify the Department (Office of
International Aviation) if the code-share agreement providing for the
code-share operations is no longer effective or if the carriers decide
to cease operating all or a portion of the approved code-share services.
 Such notices should be filed in Docket OST-2005-19214.

(c) Delta and/or Cityhopper must notify the Department no later than 30
days before they begin any new code-share service under the code-share
services authorized here.  Such notice shall identify the market(s) to
be served and the date on which the service will begin.  Such notices
should be filed in Docket OST-2004-19214.

(d) The code-sharing operations conducted under this authority must
comply with 14 CFR 257 and with any amendments to the Department’s
regulations concerning code-share arrangements that may be adopted.
Notwithstanding any provisions in the contract between the carriers, our
approval here is expressly conditioned upon the requirements that the
subject foreign air transportation be sold in the name of the carrier
holding out such service in the computer reservation systems and
elsewhere; that the carrier selling such transportation (i.e., the
carrier shown on the ticket) accept responsibility for the entirety of
the code-share journey for all obligations established in its contract
of carriage with the passenger; that the passenger liability of the
operating carrier be unaffected; and that the operating carrier shall
not permit the code of its U.S. code-sharing partner to be carried on
any flight that enters, departs, or transits the airspace of any area
for whose airspace the Federal Aviation Administration has issued a
flight prohibition.

(e) Any service provided shall be consistent with all applicable
agreements between the United States and the Netherlands, and all
applicable agreements with other foreign countries involved.
Furthermore, (i) nothing in the award of this blanket statement of
authorization should be construed as conferring upon Delta rights
(including code-share, fifth-freedom intermediate and/or beyond rights)
to serve markets where U.S. carrier rights are limited unless Delta
notifies us of its intent to serve such market and unless and until the
Department has completed any necessary carrier selection procedures to
determine which carrier(s) should be authorized to exercise such rights;
and (ii) should there be a request by any carrier to use the
limited-entry route rights that are included in Delta’s authority by
virtue of the blanket statement of authorization granted here, but that
are not being used by Delta, the holding of such authority will not be
considered as providing any preference for Delta in a carrier selection
proceeding to determine which carrier(s) should be entitled to use the
authority at issue.

(f) The authority granted here is specifically conditioned so that
neither Delta nor Cityhopper shall give any force or effect to any
contractual provisions between themselves that are contrary to these
conditions.

(g) We may amend, modify, or revoke the authority granted at any time
without hearing at our 		      discretion.

Remarks: With regards to the codesharing authority, we grant, on a
prospective basis only, the joint applicants’ request that the
Delta-Cityhopper codesharing authority be administered jointly with the
existing Delta-KLM statement of authorization in Docket OST-2004-19214.
However, we deny the applicants’ request to deem the code share
services already provided under the KLM-Delta statement of authorization
to be covered by the statement of authorization granted here.  The
applicants must comply with the 30-day notice requirement (condition
(c), above) before beginning any new code share service under the
statement of authorization granted here, including markets currently
served under the KLM-Delta statement of authorization.

We note that Delta has conducted a safety audit of Cityhopper under the
Department’s Code-Share Safety Audit Program, and the FAA has advised
that it has reviewed the relevant audit and found it to be acceptable.

The exemption authority granted here is for operations with the foreign
code-share partner named above.  Should Delta and any new code-share
partner be granted a statement of authorization, Delta will need to
apply for exemption authority to the extent necessary to permit Delta to
display its code on flights operated by the new code-share partner.

________________________________________________________________________
____________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicants qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the exemption authority was consistent with the
public interest; and (3) grant of the authority would not constitute a
major federal action under the Energy Policy and Conservation Act of
1975.  To the extent not granted, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Appendix A

CODE-SHARE ROUTES

Amsterdam-Hamburg

Amsterdam-Oslo

Amsterdam-Hanover

Amsterdam-Nuremburg

Amsterdam-Newcastle

Amsterdam-Bremen

Amsterdam-Luxembourg

Amsterdam-Riga

APPENDIX B

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  05/2004

APPENDIX C

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

5/04

 The code-share partners provided a listing of specific code-share
markets that they intend initially to serve under this arrangement.  We
have reproduced it as Appendix A of this Notice.

 By Notice of Action Taken dated March 1, 2005 in the instant docket,
the Department granted Delta’s request for exemption authority to
display its designator code on flights operated by its then existing
open-skies foreign code-share partners and subsidiaries and affiliates.
In the same Notice (page 2, Remarks), we also informed Delta that it
would need to apply for exemption authority to permit Delta to display
its code on flights operated by new code-share partners.

 See Order 2006-2-1, issued February 6, 2006, in Docket OST-2004-19214.

 We expect this notification to be received within 10 days of such
non-effectiveness or of such decision.

 This notice covers operations conducted by KLM and/or Cityhopper.

 The notice referenced in condition (c) above may be used for this
notification.

 Delta will need to have conducted code-share safety audits of its
foreign partners prior to receipt of authority for such code-share
services.

 PAGE

 PAGE   2


[Federal Register Volume 76, Number 104 (Tuesday, May 31, 2011)]
[Rules and Regulations]
[Pages 31235-31237]
[FR Doc No: 2011-13329]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0391]
RIN 1625-AA00

Safety Zone; Ocean City Air Show, Atlantic Ocean, Ocean City, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary Final rule.

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

SUMMARY: The Coast Guard will establish a temporary safety zone on the
Atlantic Ocean in the vicinity of Ocean City, MD to support the Ocean
City Air Show. This action is necessary to provide for the safety of
life on navigable waters during the Ocean City Air Show. This action is
intended to restrict vessel traffic movement on the Atlantic Ocean to
protect mariners from the hazards associated with air show events.

DATES: This rule is effective from 10 a.m. on June 10, 2011, until 4
p.m. on June 12, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0391 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0391 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LT Michael DiPace, Waterways Management
Division Chief, Sector Hampton Roads, Coast Guard; telephone 757-668-
5581, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because any delay encountered in this
regulation's effective date by publishing a NPRM would be contrary to
public interest since immediate action is needed to provide for the
safety of life and property on navigable waters.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to the public interest since immediate action is needed to
ensure the safety of the event participants, spectator craft, and other
vessels transiting the event area.

Background and Purpose

    Coast Guard Sector Hampton Roads has been notified that on June 10,
11, and 12, 2011, Ocean City, MD will host an air show event above the
Atlantic Ocean between Talbot Street and 33rd Street in Ocean City, MD.
In recent years, there have been unfortunate instances of jet and plane
crashes during performances at air shows. Typical of jet or plane
crashes, there is also a wide area of scattered debris that damages
property and could cause significant injury or death. Due to the need
to protect mariners and the public transiting the Atlantic Ocean
immediately below the air show from hazards associated with the air
show, the Coast Guard is establishing a temporary safety zone bound by
the following coordinates: 38[deg]21'38'' N/075[deg]04'04'' W,
38[deg]21'27'' N/075[deg]03'29'' W, 38[deg]19'35'' N/075[deg]04'19'' W,
38[deg]19'45'' N/075[deg]04'54'' W (NAD 1983). Access to this area will
be temporarily restricted for public safety purposes.

Discussion of Rule

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Atlantic Ocean bound by the following
coordinates: 38[deg]21'38'' N/075[deg]04'04'' W, 38[deg]21'27'' N/
075[deg]03'29'' W, 38[deg]19'35'' N/075[deg]04'19'' W, 38[deg]19'45''
N/075[deg]04'54'' W (NAD 1983), in the vicinity of Talbot Street and
33rd Street in Ocean City, MD.
    This safety zone is in the interest of public safety during the
Ocean City Air Show and will be enforced from 10 a.m. until 4 p.m. on
June 10, 2011, from 10 a.m. until 4 p.m. on June 11, 2011, and from 10
a.m. until 4 p.m. on June 12, 2011. Access to the safety zone will be
restricted during the specified dates and times. Except for vessels
authorized by the Captain of the Port or his Representative, no person
or vessel may enter or remain in the safety zone.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this regulation restricts access
to the safety zone, the effect of this rule will not be significant
because: (i) The safety zone will be in effect for a limited duration;
(ii) the zone is of

limited size; (iii) mariners may transit the waters in and around this
safety zone at the discretion of the Captain of the Port or designated
representative; and (iv), the Coast Guard will make notifications via
maritime advisories so mariners can adjust their plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    The rule would affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor on the Atlantic Ocean in the vicinity of Ocean City,
MD from 10 a.m. until 4 p.m. on June 10, 2011, from 10 a.m. until 4
p.m. on June 11, 2011, and from 10 a.m. until 4 p.m. on June 12, 2011.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (i) The
safety zone will only be in place for a limited duration and limited
size. (ii) Before the enforcement period of June 10, 2011 to June 12,
2011, maritime advisories will be issued allowing mariners to adjust
their plans accordingly.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a

category of actions which do not individually or cumulatively have a
significant effect on the human environment. This rule is categorically
excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This
rule involves establishing a temporary safety zone. An environmental
analysis checklist and a categorical exclusion determination will be
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 subpart C as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701; 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Temporary Sec.  165.T05-0391, to read as follows:

Sec.  165.T05-0391  Safety Zone; Ocean City Air Show, Atlantic Ocean,
Ocean City, MD

    (a) Regulated area. The following area is a safety zone: Specified
waters of the Atlantic Ocean bound by the following coordinates:
38[deg]21'38'' N/075[deg]04'04'' W, 38[deg]21'27'' N/075[deg]03'29'' W,
38[deg]19'35'' N/075[deg]04'19'' W, 38[deg]19'45'' N/075[deg]04'54'' W
(NAD 1983), in the vicinity of Ocean City, Maryland.
    (b) Definition: For purposes of enforcement of this section,
Captain of the Port Representative means any U.S. Coast Guard
commissioned, warrant or petty officer who has been authorized by the
Captain of the Port, Hampton Roads, Virginia to act on his behalf.
    (c) Regulation. (1) In accordance with the general regulations in
165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port, Hampton Roads or his designated
representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on board a vessel displaying a
U.S. Coast Guard Ensign; and
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a U.S. Coast Guard Ensign.
    (3) The Captain of the Port, Hampton Roads, Virginia can be
contacted at telephone number<PHONE_NUMBER>.
    (4) U.S. Coast Guard vessels enforcing the safety zone can be
contacted on VHF-FM marine band radio, channel 13 (156.65 MHz) and
channel 16 (156.8 MHz).
    (d) Enforcement period. This rule will be enforced from 10 a.m.
until 4 p.m. on June 10, 2011, from 10 a.m. until 4 p.m. on June 11,
2011, and from 10 a.m. until 4 p.m. on June 12, 2011.

    Dated: May 16, 2011.
Mark S. Ogle,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2011-13329 Filed 5-27-11; 8:45 am]
BILLING CODE 9110-04-P


Comment Info: =================

General Comment: Dear Mr. Zeller:

I Shaun Bianchi am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I currently work for an electronic cigarette store and I speek to atleast 100 people a week who know these devices are safe and are a life saving because they use them. Please do not fear this technology. This is an article from the local paper in which I express my feelings on the flavoring "issue" http://m.nhregister.com/nhregister/db_/contentdetail.htm?contentguid=2ZHZ5qB1 I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61649-61655]
[FR Doc No: 2022-22126]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2022-0099]

Privacy Act of 1974; System of Records

AGENCY: Office of the Departmental Chief Information Officer, Office of
the Secretary of Transportation, DOT.

ACTION: Notice of a modified system of records.

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

SUMMARY: In accordance with the Privacy Act of 1974, the Department of
Transportation (DOT) intends to rename, modify and re-issue a DOT
Federal Aviation Administration (FAA) system of records notice titled,
``DOT/FAA 845 Administrators Correspondence Control and Hotline
Information System, ACCIS, Administrator's Hotline Information System,
AHIS, and Consumer Hotline Information System, CHIS.'' The name of this
SORN will be changed to ``DOT/FAA 845 Complaint Intake System.'' The
modification of the system of records notice (hereafter referred to as
``Notice'') will include the intake records for additional types of
allegations that need to be identified in the Notice for purposes of
transparency and accountability by FAA. These expanded reports are of
actual or perceived aviation safety hazards and potential violations of
criminal, civil and administrative laws and regulations, and aviation
safety related orders under the regulatory oversight of the FAA. The
Suspected Unapproved Program (SUP) complaint intake records covered by
the former DOT/FAA 852 SUP Program SORN will be subsumed

by this Notice. The records of the complaint investigations and
resolutions will be covered by the updated DOT/FAA 852 Complaint
Investigations System (formerly SUP Program) SORN, while the complaint
intake will be covered by this Notice.

DATES: Written comments should be submitted on or before November 14,
2022. The Department may publish an amended SORN in light of any
comments received. This new system will be effective November 14, 2022.

ADDRESSES: You may submit comments, identified by docket number 2022-
0099 by any of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Ave. SE, between 9 a.m. and 5 p.m. ET, Monday
through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
     Instructions: You must include the agency name and docket
number DOT-OST-2022-0099. All comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
comments received in any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.).
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to the street
address listed above. Follow the online instructions for accessing the
docket.

FOR FURTHER INFORMATION CONTACT: For questions, please contact Karyn
Gorman, Acting Departmental Chief Privacy Officer, Privacy Office,
Department of Transportation, Washington, DC 20590; [email protected]; or
202-366-3140.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the
Department of Transportation (DOT) proposes to rename, modify and re-
issue a DOT system of records notice to be titled, ``Department of
Transportation, Federal Aviation Administration, DOT/FAA 845 Complaint
Intake System.''
    The Notice currently covers FAA Administrator correspondence and
hotline records which includes those who write, call, or are referred
to the Administrator, the Deputy Administrator, and their immediate
offices; those who write, call, or are referred to the Secretary, the
Deputy Secretary, and their immediate offices, and the correspondence
which has been referred to the FAA; individuals who are the subject of
an action requiring approval or action by one of the forenamed, such as
appeals, actions, grievances, and applications for waivers from the
FAA. These FAA correspondence control records will be subsumed under
the DOT/Office of the Secretary (OST)-041 Correspondence Control Mail
(CCM) SORN.\1\ This Notice will cover the intake and processing of
administrator hotlines along with additional reports of actual or
perceived aviation safety hazards as well as allegations of violations
of criminal, civil and administrative laws and regulations, and
aviation safety related orders under the regulatory oversight of the
FAA. These records, hereafter referred to as ``complaints or complaint
records,'' originate from members of the public as well as FAA
employees and contractors. While the information technology (IT)
systems referenced in the previous Notice, ACCIS, AHIS and CHIS, are
decommissioned, their records have been subsumed into different IT
systems and continue to be covered by this updated Notice with the
exception of the correspondence control files. Records pertaining to
the SUP program, whistleblower complaints and other aviation safety-
related issues, such as aircraft noise concerns, and allegations by
FAA's Office of Aviation Safety (AVS) employees about individuals and
external entities, are being added to this system of records in order
to consolidate maintenance of complaint records by the FAA. AVS
employees utilize an internal system to report their issues whereas
others, including remaining FAA personnel and members of the public,
use external facing websites to submit their SUP, whistleblower and
other aviation safety-related complaints. The records of all complaint
investigations and resolutions are currently covered by the updated
DOT/FAA 852 Complaint Investigations System (formerly SUP Program),
while the complaint intake records are to be covered by this Notice.
Complaint records may include, but are not limited to, certain personal
information such as name, address, phone number, email address,
aircraft registration number, and certificate number of the reporting
individual or subject of alleged violations.
---------------------------------------------------------------------------

    \1\ DOT is in the process of updating the DOT/OST-041 CCM SORN.
Please check the DOT Privacy Act System of Records Notices page
(Privacy Act System of Records Notices [verbar] US Department of
Transportation) for the current status of the update.
---------------------------------------------------------------------------

    The following substantive changes have been made to the Notice:
    1. System Name: This Notice updates the system name to ``DOT/FAA
845 Complaint Intake System'' to better reflect the expanded scope of
the system of records created as part of the complaint intake process
under this Notice.
    2. System Location: This Notice updates the system location to
include the multiple system locations for the various complaint records
added to this Notice. The additional system locations include the
William J. Hughes Technical Center (WJHTC) in Atlantic City, New
Jersey, and the facility at 3701 MacIntosh Drive, Warrenton, Virginia.
The complaints submitted by AVS employees prior to April 2021 are
located at the Mike Monroney Aeronautical Center (MMAC) in Oklahoma
City, Oklahoma, and the subsequent records are located at the MITRE
offices at 7525 Colshire Drive, McLean, Virginia. The previous
reference to the Administrator offices at the FAA headquarters
locations will be removed from this Notice given correspondence control
records will be covered by the DOT/OST-041 SORN, however, the FAA
headquarters location will remain with updated office information.
    3. System Manager: This Notice updates the system manager
information to reflect the inclusion of records maintained at the WJHTC
in Atlantic City, New Jersey, the facility at Warrenton, Virginia, the
MMAC in Oklahoma City, Oklahoma (pre-April 2021) and the MITRE offices
in McLean, Virginia (April 2021 onward). Additionally, contact
information for each system manager is included in this update. The
reference in the previous Notice to the Administrator offices at the
FAA headquarters locations will be removed from this Notice given
correspondence control records will be covered by the DOT/OST-041 SORN,
however, the FAA headquarters location will remain with updated office
and contact information.
    4. Authority: This Notice updates the authorities to include: 49
United States Code (U.S.C.) 42121 which applies to discrimination
against airline employees reporting safety concerns/violations, as well
as reporting of other safety issues covered by 49 U.S.C. 40101 section
341, section 510, section 1210 Federal Aviation Reauthorization Act of
1996, and section 180 FAA

Reauthorization Act of 2018, and 49 U.S.C. 106(t). 49 U.S.C. 44701,
from DOT/FAA 852, covering the SUP program, including discussion on
safety and minimum safety standards, will be added given that SUP
complaint intake records are subsumed into this Notice. This statute
also applies to AVS personnel complaints and other hotline records. The
previously referenced authority of 44 U.S.C. 3101 as it pertains to
records containing adequate and proper documentation of the
organization, functions, policies, decisions, procedures, and essential
transactions of the agency that are maintained by heads of agencies,
such as the Administrator and Noise Ombudsman, will remain in this
Notice.
    5. Purpose: This Notice updates the purpose of this System as
covering the records pertaining to the complaint reports of unsafe or
unauthorized aviation activities concerning the perceived or actual
violations of FAA regulation, order, or other provision of Federal law
related to aviation safety or practices, including SUP, whistleblower
and noise complaints. The previous purpose to provide documentation of
hotline calls will remain with expanded language, and information
related to correspondence records will be removed in this Notice.
    6. Categories of Individuals: This Notice updates the categories of
individuals to include complainants, such as members of the public, FAA
employees and contractors, and other individuals alleged to have been
involved in the reported alleged violations or other aviation safety
concerns. These individuals add clarification to the previously
referenced individuals who write, call in or are referred to senior
agency heads, as well as correspondence and subjects of actions
requiring approval by these agency heads.
    7. Categories of Records: This Notice updates the categories of
records with files specific to reports of alleged violations. The list
of personal information contained in these complaint records could
include names of complainants and other individuals involved with the
alleged violations, contact information (phone number, address, email
address), certificate number, aircraft registration number, aircraft
tail number, and report/case tracking number (to include, but not
limited to, reference number, case number, record number, and control
number). The previously referenced records, such as specific
correspondence files involving senior agency heads, will be removed
from this Notice.
    8. Records Source Categories: The Notice updates the records source
categories to clarify that records related to complaints of alleged
violations are received from complainants, including members of the
public, FAA employees and contractors, and other federal agencies. The
previously referenced correspondence by members of the public to senior
agency heads will be removed from this Notice.
    9. Routine Uses: This Notice updates the routine uses to include
the Department of Transportation's general routine uses applicable to
this Notice as they were previously only incorporated by reference. OMB
Memoranda A-108 recommends that agencies include all routine uses in
one notice rather than incorporating general routine uses by reference.
Therefore, the Department is replacing the statement in DOT/FAA 845
that referenced the ``Statement of General Routine Uses'' with all of
the general routine uses that apply to this system of records. The
routine use referenced in the previous Notice is superseded by the
departmental routine uses and will be removed in this update. This
Notice adds new system-specific routine uses that are compatible with
the purpose of the system of records. The routine uses include:
    a. To the Federal Bureau of Investigation, U.S. Customs Service,
and the Department of Defense, the initial SUP complaints received by
FAA, for their use in any civil/criminal investigations when an FAA
suspected unapproved parts case is initiated. FAA waits for the go-
ahead from these external entities before proceeding with any
investigation of their own;
    b. Routine use (2)(a) and 2(b) apply only to records pertaining to
noise complaints, and do not apply to information contained in related
hotline or whistleblower protection complaint files. Pursuant to
routine use 2(a) and 2(b), the FAA may disclose:
    i. To airport sponsors, federal agencies and departments when
necessary to resolve noise complaints of their manned and unmanned
aircraft, and other operators of aerial landing and takeoff sites,
records relating to noise complaints stemming from their flight
operations and to ensure consistency between the FAA and these entities
on noise complaints;
    ii. To manned and unmanned aircraft operators when necessary to
resolve a complaint pertaining to the operator, or when necessary to
ensure consistency between the FAA and the operator in responding to
noise complaints. Records disclosed pursuant to this routine use are
limited to the following information: geolocation only to the extent
necessary to identify the general location of the noise complaint; time
and date of complaint; and description of the complaint or inquiry.
Complainant names and contact information will not be disclosed
pursuant to this routine use; and
    c. To officials of labor organizations recognized under 5 U.S.C.
chapter 71, when relevant and necessary to their duties of exclusive
representation concerning AVS's Voluntary Safety Reporting Program. The
FAA analysts work in conjunction with the labor organizations in
conducting the investigations of actual or alleged violations reported
by AVS employees.
    10. Records Retrieval: This Notice updates records retrieval to
include all records that can be retrieved by report/case tracking
number (to include, but not limited to, reference number, case number,
and record number). Additionally, FAA complaint records can be
retrieved by individual's name (including complainant name and subject
of complaint) while noise complaint records can be retrieved by
individual's name, email address and address (street/city/state). This
language supersedes that in the previous Notice.
    11. Records Retention and Disposal: This Notice updates the records
retention and disposal to reflect records retention timeframes for the
new type of complaints covered by this System. FAA complaints and
whistleblower records are to be maintained in accordance with DAA-0237-
2019-0012 with cut off after cases are closed and destruction 3 years
after cut off, and the SUP records maintained in accordance with DAA-
0237-2019-0010 with cut off at the end of the calendar year in which
cases are closed and destruction 8 years after cut off. The FAA is
adding a new section to DAA-0237-2019-0012 to request destruction of
noise complaint records to be 10 years after cut off. These records
will be treated as permanent records until the temporary record is
approved by the National Archives and Records Administration (NARA).
Finally, records on AVS employee reporting on aviation safety matters
are maintained in accordance with DAA-0237-2019-0012 with destruction 3
years after cut off (pre-April 2021) with subsequent records collected
to be treated as permanent records until NARA approves the new records
retention request, DAA-0237-2020-0028, for 15 years. This language
supersedes that in the previous Notice.
    12. Records Access: This Notice updates the record access
procedures to reflect that signatures on signed requests for records
must either be notarized or accompanied by a statement made

under penalty of perjury in compliance with 28 U.S.C. 1746.
    The following non-substantive changes to Records storage,
administrative, technical and physical safeguards, contesting records
procedures, and notification procedures, have been made to improve the
transparency and readability of the Notice:
    13. Records Storage: This Notice updates records storage procedures
to generalize the language.
    14. Administrative, Technical and Physical Safeguards: This Notice
updates the administrative, technical and physical safeguards to
generalize the language.
    15. Contesting Records: This Notice updates the procedures for
contesting records to refer the individual to the record access
procedures section.
    16. Notifications: This Notice updates the notification procedures
to refer the individual to the record access procedures section.

II. Privacy Act

    The Privacy Act (5 U.S.C. 552a) governs the means by which the
Federal Government collects, maintains, and uses personally
identifiable information (PII) in a System of Records. A ``System of
Records'' is a group of any records under the control of a Federal
agency from which information about individuals is retrieved by name or
other personal identifier. The Privacy Act requires each agency to
publish in the Federal Register a System of Records Notice (SORN)
identifying and describing each System of Records the agency maintains,
including the purposes for which the agency uses PII in the system, the
routine uses for which the agency discloses such information outside
the agency, and how individuals to whom a Privacy Act record pertains
can exercise their rights under the Privacy Act (e.g., to determine if
the system contains information about them and to contest inaccurate
information). In accordance with 5 U.S.C. 552a(r), DOT has provided a
report of this system of records to the Office of Management and Budget
and to Congress.

SYSTEM NAME AND NUMBER:
    Department of Transportation (DOT)/Federal Aviation Administration
(FAA) 845 Complaint Intake and Correspondence Records System.

SECURITY CLASSIFICATION:
    Unclassified, sensitive.

SYSTEM LOCATION:
    The system locations are as follow:
    1. Hotline complaints, including SUP and whistleblower records:
Office of Audit and Evaluation, Reporting and Data Analysis Branch,
AAE-300, Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591; and, AIT Infrastructure and Operations, Data
Center Services, AIF-300, Federal Aviation Administration, William J.
Hughes Technical Center, Atlantic City, New Jersey 08405.
    2. AVS employee reporting: Operations Services Division AIF-300,
Federal Aviation Administration, Mike Monroney Aeronautical Center
(MMAC), 6500 South Macarthur Boulevard, Oklahoma City, Oklahoma 73169
(pre-April 2021); and MITRE Corporation, 7525 Colshire Drive, McLean,
Virginia 22102 (April 2021 onward).
    3. Noise specific complaints: ATO System Operations, NAS Data
Integration and Services, AJR-G2, Federal Aviation Administration, 3701
MacIntosh Dr., Warrenton, Virginia 20187.

SYSTEM MANAGER(S):
    The system managers are as follows:
    1. Hotline complaints, including SUP and whistleblower records:
Director, Office of Audit and Evaluation (AAE-1), Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591,
https://www.faa.gov/about/office_org/headquarters_offices/aae/.
    2. AVS employee reporting: Manager, Flight Standards Service,
Quality Control and Investigations Branch (AFB-440A), Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591 (pre-
April 2021); and Executive Director, Office of Quality, Integration and
Executive Services (AQS-1), Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591, [email protected] (April
2021 onward); and
    3. Noise specific complaints: IT Program Manager, System Data and
Infrastructure (AJR-G2), Federal Aviation Administration, 3701
MacIntosh Dr., Warrenton, Virginia 20187, https://noise.faa.gov.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    44 U.S.C. 3101; 49 U.S.C. Section 106(t); 49 U.S.C. 40101 section
341, section 510, section 1210 Federal Aviation Reauthorization Act of
1996, and section 180 FAA Reauthorization Act of 2018; 49 U.S.C. 42121;
and 49 U.S.C. 44701.

PURPOSE(S) OF THE SYSTEM:
    The purpose of this system of records is to cover reports of unsafe
or unauthorized aviation activities concerning the perceived or actual
violations of FAA regulation, order, or other provision of Federal law
related to aviation safety or practices, including whistleblower, SUP
and noise complaints.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals covered by this system of records consist of
complainants, including members of the public and FAA employees and
contractors, and individuals who are the subject of such violations;
and members of Congress and the public who call in or correspond with
the FAA personnel.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Records maintained in this system include files specific to reports
of alleged violations. Individual records may include names of
complainants, contact information (phone number, address, email
address), geolocation of noise, aircraft registration number,
certificate number, aircraft tail number, and report/case tracking
number (to include, but not limited to, reference number, case number,
record number, and control number).

RECORD SOURCE CATEGORIES:
    Reports of alleged violations and other aviation related concerns
and safety-related issues, such as noise complaints, are received from
complainants, including members of the public, FAA employees and
contractors, and other federal agencies.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to other disclosures, generally permitted under 5
U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or
information contained in this system may be disclosed outside DOT as a
routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
System Specific Routine Uses:
    1. To the Federal Bureau of Investigation, U.S. Customs Service,
and the Department of Defense, the initial SUP complaints received by
FAA, for their use in any civil/criminal investigations when an FAA
suspected unapproved parts case is initiated.
    2. Routine use (2)(a) and (b) apply only to records pertaining to
noise complaints, and do not apply to information contained in related
hotline or whistleblower protection complaint files. Pursuant to
routine use (2), the FAA may disclose:

    a. To airport sponsors, federal agencies and departments operating
manned and unmanned aircraft outside FAA's regulatory jurisdiction, and
other operators of aerial landing and takeoff sites, records relating
to noise complaints stemming from their operations to ensure
consistency between the FAA and these entities on noise complaints;
    b. To man and unmanned aircraft operators when necessary to resolve
a complaint pertaining to the operator, or when necessary to ensure
consistency between the FAA and the operator in responding to noise
complaints. Records disclosed pursuant to this routine use are limited
to the following information: geolocation only to the extent necessary
to identify the general location of the noise complaint; time and date
of complaint; and description of the complaint or inquiry. Complainant
names and contact information will not be disclosed pursuant to this
routine use; and
    3. To officials of labor organizations recognized under 5 U.S.C.
chapter 71, access to all information when relevant and necessary to
their duties of exclusive representation concerning AVS's Voluntary
Safety Reporting Program.
Department General Routine Uses:
    4. In the event that a system of records maintained by DOT to carry
out its functions indicates a violation or potential violation of law,
whether civil, criminal or regulatory in nature, and whether arising by
general statute or particular program pursuant thereto, the relevant
records in the system of records may be referred, as a routine use, to
the appropriate agency, whether Federal, State, local or foreign,
charged with the responsibility of investigating or prosecuting such
violation or charged with enforcing or implementing the statute, or
rule, regulation, or order issued pursuant thereto.
    5. A record from this system of records may be disclosed, as a
routine use, to a Federal, State, or local agency maintaining civil,
criminal, or other relevant enforcement information or other pertinent
information, such as current licenses, if necessary to obtain
information relevant to a DOT decision concerning the hiring or
retention of an employee, the issuance of a security clearance, the
letting of a contract, or the issuance of a license, grant or other
benefit.
    6. A record from this system of records may be disclosed, as a
routine use, to a Federal agency, in response to its request, in
connection with the hiring or retention of an employee, the issuance of
a security clearance, the reporting of an investigation of an employee,
the letting of a contract, or the issuance of a license, grant, or
other benefit by the requesting agency, to the extent that the
information is relevant and necessary to the requesting agency's
decision on the matter.
    7a. Routine Use for Disclosure for Use in Litigation. It shall be a
routine use of the records in this system of records to disclose them
to the Department of Justice or other Federal agency conducting
litigation when (a) DOT, or any agency thereof, or (b) Any employee of
DOT or any agency thereof, in his/her official capacity, or (c) Any
employee of DOT or any agency thereof, in his/her individual capacity,
where the Department of Justice has agreed to represent the employee,
or (d) The United States or any agency thereof, where DOT determines
that litigation is likely to affect the United States, is a party to
litigation or has an interest in such litigation, and the use of such
records by the Department of Justice or other Federal agency conducting
the litigation is deemed by DOT to be relevant and necessary in the
litigation, provided, however, that in each case, DOT determines that
disclosure of the records in the litigation is a use of the information
contained in the records that is compatible with the purpose for which
the records were collected.
    7b. Routine Use for Agency Disclosure in Other Proceedings. It
shall be a routine use of records in this system to disclose them in
proceedings before any court or adjudicative or administrative body
before which DOT or any agency thereof, appears, when (a) DOT, or any
agency thereof, or (b) Any employee of DOT or any agency thereof in
his/her official capacity, or (c) Any employee of DOT or any agency
thereof in his/her individual capacity where DOT has agreed to
represent the employee, or (d) The United States or any agency thereof,
where DOT determines that the proceeding is likely to affect the United
States, is a party to the proceeding or has an interest in such
proceeding, and DOT determines that use of such records is relevant and
necessary in the proceeding, provided, however, that in each case, DOT
determines that disclosure of the records in the proceeding is a use of
the information contained in the records that is compatible with the
purpose for which the records were collected.
    8. The information contained in this system of records will be
disclosed to the Office of Management and Budget, OMB in connection
with the review of private relief legislation as set forth in OMB
Circular No. A-19 at any stage of the legislative coordination and
clearance process as set forth in that Circular.
    9. Disclosure may be made to a Congressional office from the record
of an individual in response to an inquiry from the Congressional
office made at the request of that individual. In such cases, however,
the Congressional office does not have greater rights to records than
the individual. Thus, the disclosure may be withheld from delivery to
the individual where the file contains investigative or actual
information or other materials which are being used, or are expected to
be used, to support prosecution or fines against the individual for
alleged violations of a statute, or of regulations of the Department
based on statutory authority. No such limitations apply to records
requested for Congressional oversight or legislative purposes; release
is authorized under 49 CFR 10.35(9).
    10. One or more records from a system of records may be disclosed
routinely to the National Archives and Records Administration in
records management inspections being conducted under the authority of
44 U.S.C. 2904 and 2906.
    11. Routine Use for disclosure to the Coast Guard and to
Transportation Security Administration. A record from this system of
records may be disclosed as a routine use to the Coast Guard and to the
Transportation Security Administration if information from this system
was shared with either agency when that agency was a component of the
Department of Transportation before its transfer to the Department of
Homeland Security and such disclosure is necessary to accomplish a DOT,
TSA or Coast Guard function related to this system of records.
    12. DOT may make available to another agency or instrumentality of
any government jurisdiction, including State and local governments,
listings of names from any system of records in DOT for use in law
enforcement activities, either civil or criminal, or to expose
fraudulent claims, regardless of the stated purpose for the collection
of the information in the system of records. These enforcement
activities are generally referred to as matching programs because two
lists of names are checked for match using automated assistance. This
routine use is advisory in nature and does not offer unrestricted
access to systems of records for such law enforcement and related
antifraud activities. Each request will be considered on the basis of
its purpose, merits, cost effectiveness and alternatives using
Instructions on reporting computer matching programs

to the Office of Management and Budget, OMB, Congress, and the public,
published by the Director, OMB, dated September 20, 1989.
    13. It shall be a routine use of the information in any DOT system
of records to provide to the Attorney General of the United States, or
his/her designee, information indicating that a person meets any of the
disqualifications for receipt, possession, shipment, or transport of a
firearm under the Brady Handgun Violence Prevention Act. In case of a
dispute concerning the validity of the information provided by DOT to
the Attorney General, or his/her designee, it shall be a routine use of
the information in any DOT system of records to make any disclosures of
such information to the National Background Information Check System,
established by the Brady Handgun Violence Prevention Act, as may be
necessary to resolve such dispute.
    14a. To appropriate agencies, entities, and persons when (1) DOT
suspects or has confirmed that there has been a breach of the system of
records; (2) DOT has determined that as a result of the suspected or
confirmed breach there is a risk of harm to individuals, DOT (including
its information systems, programs, and operations), the Federal
Government, or national security; and (3) the disclosure made to such
agencies, entities, and persons is reasonably necessary to assist in
connection with DOT's efforts to respond to the suspected or confirmed
breach or to prevent, minimize, or remedy such harm.
    14b. To another Federal agency or Federal entity, when DOT
determines that information from this system of records is reasonably
necessary to assist the recipient agency or entity in (1) responding to
a suspected or confirmed breach or (2) preventing, minimizing, or
remedying the risk of harm to individuals, the recipient agency or
entity (including its information systems, programs, and operations),
the Federal Government, or national security, resulting from a
suspected or confirmed breach.
    15. DOT may disclose records from this system, as a routine use, to
the Office of Government Information Services for the purpose of (a)
resolving disputes between FOIA requesters and Federal agencies and (b)
reviewing agencies' policies, procedures, and compliance in order to
recommend policy changes to Congress and the President.
    16. DOT may disclose records from this system, as a routine use, to
contractors and their agents, experts, consultants, and others
performing or working on a contract, service, cooperative agreement, or
other assignment for DOT, when necessary to accomplish an agency
function related to this system of records.
    17. DOT may disclose records from this system, as a routine use, to
an agency, organization, or individual for the purpose of performing
audit or oversight operations related to this system of records, but
only such records as are necessary and relevant to the audit or
oversight activity. This routine use does not apply to intra-agency
sharing authorized under Section (b)(1) of the Privacy Act.
    18. DOT may disclose from this system, as a routine use, records
consisting of, or relating to, terrorism information (6 U.S.C.
485(a)(5)), homeland security information (6 U.S.C. 482(f)(1)), or Law
enforcement information (Guideline 2 Report attached to White House
Memorandum, ``Information Sharing Environment, November 22, 2006) to a
Federal, State, local, tribal, territorial, foreign government and/or
multinational agency, either in response to its request or upon the
initiative of the Component, for purposes of sharing such information
as is necessary and relevant for the agencies to detect, prevent,
disrupt, preempt, and mitigate the effects of terrorist activities
against the territory, people, and interests of the United States of
America, as contemplated by the Intelligence Reform and Terrorism
Prevention Act of 2004 (Pub. L. 108-458) and Executive Order 13388
(October 25, 2005).

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    Records are stored in electronic databases and/or hard copy files.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
    All complaint records can be retrieved by report/case tracking
number (to include, but not limited to, reference number, case number,
record number, and control number). FAA Hotline complaint records,
including whistleblower records, can be retrieved by individual's name,
and noise complaint records can be retrieved by individual's name,
email address and address (street/city/state).

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    FAA will maintain hotline complaint records, including
whistleblower records, in accordance with DAA-0237-2019-0012 with cut
off after cases are closed and destruction 3 years after cut off, SUP
records in accordance with DAA-0237-2019-0010 with cut off at the end
of the calendar year in which cases are closed and destruction 8 years
after cut off, and AVS employee safety reporting records in accordance
with DAA-0237-2019-0012 with destruction 3 years after cut off (pre-
April 2021). The new retention schedule, DAA-0237-2020-0028, for the
AVS employee safety reporting records (April 2021 onward) is still
pending at NARA, so the FAA will treat these records as permanent
records until it receives an approval of record disposition authority
for the 15-year retention request. Additionally, the FAA is adding a
new section to DAA-0237-2019-0012 to request destruction of noise
complaint records to be 10 years after cut off with records to be
treated as permanent records until approval of the new schedule by
NARA.

ADMINISTRATIVE, TECHNICAL AND PHYSICAL SAFEGUARDS:
    Records in this system are safeguarded in accordance with
applicable rules and policies, including all applicable DOT automated
systems security and access policies. Strict controls have been imposed
to minimize the risk of compromising the information that is being
stored. Access to records in this system is limited to those
individuals who have a need to know the information for the performance
of their official duties and who have appropriate clearances or
permissions.

RECORD ACCESS PROCEDURES:
    Individuals seeking notification of whether this system of records
contains information about them may contact the System Manager at the
address provided in the section ``System Manager''. When seeking
records about yourself from this system of records or any other
Departmental system of records your request must conform to the Privacy
Act regulations set forth in 49 CFR part 10. You must sign your request
and your signature must either be notarized or submitted under 28
U.S.C. 1746, a law that permits statements to be made under penalty of
perjury as a substitute for notarization. If your request is seeking
records pertaining to another living individual, you must include a
statement from that individual certifying his/her agreement for you to
access his/her records.

CONTESTING RECORDS PROCEDURES:
    See ``Redress Access Procedure'' above.

NOTIFICATION PROCEDURES:
    See ``Redress Access Procedure'' above.

EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    A full notice of this system of records, DOT/FAA 845, was published
in the Federal Register on April 11, 2000 (65 FR 19526).

    Issued in Washington, DC.
Karyn Gorman,
Acting Departmental Chief Privacy Officer.
[FR Doc. 2022-22126 Filed 10-11-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]
[Page 18209-18210]
[DOCID:fr09ap10-90]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0181]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Threshold of Regulation for Substances Used in Food-
Contact Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requests for exemption from
the food additive listing regulation requirements that are submitted
under part 170 (21 CFR part 170).

DATES: Submit written or electronic comments on the collection of
information by June 8, 2010.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Threshold of Regulation for Substances Used in Food-Contact Articles--
21 CFR 170.39 (OMB Control Number 0910-0298)--Extension

    Under section 409(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 348(a)), the use of a food additive is deemed
unsafe unless one of the following is applicable: (1) It conforms to an
exemption for investigational use under section 409(j) of the act, (2)
it conforms to the terms of a regulation prescribing its use, or (3) in
the case of a food additive which meets the definition of a food-
contact substance in section 409(h)(6) of the act, there is either a
regulation authorizing its use in accordance with section 409(a)(3)(A)
or an effective notification in accordance with section 409(a)(3)(B).
    The regulations in Sec.  170.39 (21 CFR 170.39) established a
process that provides the manufacturer with an opportunity to
demonstrate that the likelihood or extent of migration to food of a
substance used in a food-contact article is so trivial that the use
need not be the subject of a food additive listing regulation or an
effective notification. The agency has established two thresholds for
the regulation of substances used in food-contact articles. The first
exempts those substances used in food-contact articles where the
resulting dietary concentration would be at or below 0.5 part per
billion (ppb). The second exempts regulated direct food additives for
use in food-contact articles where the resulting dietary exposure is 1
percent or less of the acceptable daily intake for these substances.
    In order to determine whether the intended use of a substance in a
food-contact article meets the threshold criteria, certain information
specified in Sec.  170.39(c) must be submitted to FDA. This information
includes the following components: (1) The chemical composition of the
substance for which the request is made, (2) detailed information on
the conditions of use of the substance, (3) a clear statement of the
basis for the request for exemption from regulation as a food additive,
(4) data that will enable FDA to estimate the daily dietary
concentration resulting from the proposed use of the substance, (5)
results of a literature search for toxicological data on the substance
and its impurities, and (6) information on the environmental impact
that would result from the proposed use.
    FDA uses this information to determine whether the food-contact
article meets the threshold criteria. Respondents to this information
collection are individual manufacturers and suppliers of substances
used in food-contact articles (i.e., food packaging and food processing
equipment) or of the articles themselves.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours Per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
170.39                             7                  1                  7                 48                336
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In compiling these estimates, FDA consulted its records of the
number of regulation exemption requests received in the past three
years. The annual hours per response reporting estimate of 48 hours is
based on information received from representatives of the food
packaging and processing industries and agency records.
    FDA estimates that approximately 7 requests per year will be
submitted under the threshold of regulation exemption process of Sec.
170.39, for a total of 336 hours. The threshold of regulation process
offers one advantage over the premarket notification process for food-
contact substances established by section 409(h) of the act (OMB
control number 0910-0495) in that the use of a substance exempted by
the agency is not limited to only the manufacturer or supplier who
submitted the request for an exemption. Other manufacturers or
suppliers may use exempted substances in food-contact articles as long
as the conditions of use (e.g., use levels, temperature, type of food
contacted, etc.) are those for which the exemption was issued. As a
result, the overall burden on both the agency and the regulated
industry would be significantly less in that other manufacturers and
suppliers would not have to prepare, and FDA would not have to review,
similar submissions for identical components of food-contact articles
used under identical conditions. Manufacturers and other interested
persons can easily access an up-to-date list of exempted substances
which is on display at FDA's Division of Dockets Management and on the
Internet at http://www.cfsan.fda.gov. Having the list of exempted
substances publicly available decreases the likelihood that a company
would submit a food additive petition or a notification for the same
type of food-contact application of a substance for which the agency
has previously granted an exemption from the food additive listing
regulation requirement.

    Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8050 Filed 4-8-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Notices]
[Pages 37652-37653]
[FR Doc No: 2019-16423]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1562]

Uncomplicated Urinary Tract Infections: Developing Drugs for
Treatment; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Uncomplicated Urinary Tract Infections: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in the
development of new drugs for the treatment of uncomplicated urinary
tract infections. This guidance finalizes the draft guidance of the
same name issued May 10, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on August 1, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1562 for ``Uncomplicated Urinary Tract Infections:
Developing Drugs for Treatment''. Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed

except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in the
development of new drugs for the treatment of uncomplicated urinary
tract infections.
    This guidance finalizes the draft guidance of the same name issued
May 10, 2018 (83 FR 21784). There were no comments regarding the draft
guidance submitted to the public docket. We made some editorial changes
made in the final guidance primarily for clarification.
    Issuance of this guidance fulfills a portion of the requirements of
Title VIII, section 804, of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as
appropriate, revise not fewer than three guidance documents per year
for the conduct of clinical trials with respect to antibacterial and
antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Uncomplicated Urinary Tract Infections:
Developing Drugs for Treatment.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312, 314, and 601
have been approved under OMB control numbers 0910-0014, 0910-0001, and
0910-0338, respectively.

III. Electronic Access

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

    Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16423 Filed 7-31-19; 8:45 am]
BILLING CODE 4164-01-P