[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Rules and Regulations]
[Pages 33309-33312]
[FR Doc No: 2012-13685]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0347]
RIN 1625-AA00

Safety Zone; Race on the Lake, Onondaga Lake, Syracuse, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Onondaga Lake, Syracuse, NY. This safety zone is intended to restrict
vessels from a portion of Onondaga Lake during the Race on the Lake
powerboat races. This temporary safety zone is necessary to protect
participants, spectators, and vessels from the hazards associated with
hydroplane and powerboat races.

DATES: This rule is effective between 8:30 a.m. and 6:30 p.m. on June
15-17, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2012-0347 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0347 in the
``Keyword'' box, and then clicking ``Search.'' This material is 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 email LT Christopher Mercurio, Chief of
Waterway Management, U.S. Coast Guard Sector Buffalo; telephone 716-
843-9343, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. 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 doing so would be impracticable and
contrary to the public interest. The final details for this event were
not known to the Coast Guard until there was insufficient time
remaining before the event to publish an NPRM. Thus, delaying the
effective date of this rule to wait for a comment period to run would
be both impracticable and contrary to the public

interest because it would inhibit the Coast Guard's ability to protect
spectators and vessels from the hazards associated with a power boat
race, which are discussed further below.
    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. For the same reasons discussed in
the preceding paragraph, waiting for 30 day notice period run would
also be impracticable and contrary to the public interest.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 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; Public Law 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to protect the public and vessels from
the hazards associated with power boat races. Between 9:00 a.m. and
6:00 p.m. on June 15-17, 2012 a series of hydroplane and powerboat
races will take place on Onondaga Lake near Syracuse, NY. The Captain
of the Port Buffalo has determined that hydroplane and powerboat races
create a significant risk of collisions between participants and the
boating public.

C. Discussion of the Final Rule

    With the aforementioned risks in mind, the Captain of the Port
Buffalo has determined that this temporary safety zone is necessary to
ensure the safety of participants and the boating public during the
Race on the Lake.
    The safety zone will be effective and enforced from 8:30 a.m. until
6:30 p.m. on June 15-17, 2012.
    The safety zone will encompass all waters of Onondaga Lake,
Syracuse, NY starting from position 43[deg]6'49.63'' N and
76[deg]14'8.82'' W then South East to 43[deg]6'9.79'' N and
76[deg]13'5.07'' W then West to 43[deg]5'57.22'' N and
76[deg]13'33.64'' W then North to 43[deg]6'44.01'' N and
76[deg]14'28.24'' W then returning to the point of origin to form a
square (NAD 83).
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the designated on scene patrol
personnel. Entry into, transiting, or anchoring within the safety zone
is prohibited unless authorized by the Captain of the Port Buffalo or
his designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

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. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). We conclude that this rule is not a significant
regulatory action because we anticipate that it will have minimal
impact on the economy, will not interfere with other agencies, will not
adversely alter the budget of any grant or loan recipients, and will
not raise any novel legal or policy issues. The safety zone created by
this rule will be relatively small and enforced for relatively short
time. Also, the safety zone is designed to minimize its impact on
navigable waters. Furthermore, the safety zone has been designed to
allow vessels to transit around it. Thus, restrictions on vessel
movement within that particular area are expected to be minimal. Under
certain conditions, moreover, vessels may still transit through the
safety zone when permitted by the Captain of the Port.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule will 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.
    This temporary final rule may affect the following entities, some
of which might be small entities: the owners or operators of vessels
intending to transit or anchor in a portion of Onondaga Lake, Syracuse,
NY between 8:30 a.m. and 6:30 p.m. on June 15-17, 2012.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: this
rule will be in effect for approximately ten hours each day in an area
with low commercial vessel traffic. Also, in the event that this
temporary safety zone affects shipping, commercial vessels may request
permission from the Captain of the Port Buffalo to transit through the
safety zone. Additionally, the Coast Guard will give advanced notice to
the public via a local Broadcast Notice to Mariners that the regulation
is in effect. Moreover, the COTP will suspend enforcement of the safety
zone if the event for which the zone is established ends earlier than
the expected time.
    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 this 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.
    If this rule will affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact LT Christopher
Mercurio, Chief of Waterway Management, U.S. Coast Guard Sector
Buffalo; email<EMAIL_ADDRESS>telephone 716-843-
9343. 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.

Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INTFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

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 (adjusted for
inflation) 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 will not create an
environmental risk to health or risk to safety that might
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 will 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 that 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. Because it involves the establishment of a safety
zone, a final environmental analysis checklist and a preliminary
categorical exclusion determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 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. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0347 to read as follows:

Sec.  165.T09-0347  Safety Zone; Race on the Lake, Onondaga Lake,
Syracuse, NY.

    (a) Location. The safety zone will encompass all waters of Onondaga
Lake, Syracuse, NY starting from position 43[deg]6'49.63'' N and
76[deg]14'8.82'' W then South East to 43[deg]6'9.79'' N and
76[deg]13'5.07'' W then West to 43[deg]5'57.22'' N and 76[deg]
13'33.64'' W then North to 43[deg]6'44.01'' N and 76[deg]14'28.24'' W
then returning to the point of origin to form a square. (NAD 83)
    (b) Effective and Enforcement Period. This regulation is effective
and will be enforced from 8:30 a.m. to 6:30 p.m. on June 15-17, 2012.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Buffalo or
his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the

Port Buffalo or his on-scene representative may be contacted via VHF
Channel 16. Vessel operators given permission to enter or operate in
the safety zone must comply with all directions given to them by the
Captain of the Port Buffalo, or his on-scene representative.

    Dated: May 16, 2012.
S.M. Wischmann,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2012-13685 Filed 6-5-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57306-57307]
[DOCID:fr30se05-110]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

Agency Information Collection Activities: Proposed Collection;
Comment Request

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on proposed continuing information collections. In
accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3506(c)(2)(A)), this notice seeks comments concerning the U.S. Fire
Administration's National Fire Academy Long-term Course Evaluation
Forms.

SUPPLEMENTARY INFORMATION: The data collection from the long-term
evaluation forms--one for students and one for the student's
supervisor--will obtain course specific feedback regarding the impact
of course content on job performance. This data is needed to improve
instructional delivery and curriculum design. Demographic data are
needed to identify differentials in course impact. The information
collection also supports the Government Performance and Results Act and
the Agency's Programming, Planning and Budgeting reporting
requirements. In an effort to help minimize the burden of the
collection of information on those who are to respond, the paper-based
forms will be converted to an automated/electronic format that will
allow for the electronic submission of responses. As such the
respondent universe will increase due to the on-line availability of
the forms and linkage to the current end-of-course evaluation form. By
using an automated process, it is expected that the estimated cost
associated with the processing of the forms will decrease.

Collection of Information

    Title: National Fire Academy Long-term Evaluation Forms (Students
and Supervisors).
    Type of Information Collection: Extension of a currently approved
collection.
    OMB Number: 1660-0039.
    Form Numbers: FF 95-58 and FF 95-59.
    Abstract: The National Fire Academy's long-term evaluation forms--
one for students and one for the student's supervisor--will obtain
course specific feedback regarding impact of course content on job
performance. The information is needed to improve instruction and
content. Demographic data are needed to identify differentials in
course impact.
    Affected Public: Individuals participating in NFA resident training
courses; State, local or tribal government.
    Estimated Total Annual Burden Hours: 3,300.

----------------------------------------------------------------------------------------------------------------
                                                     Number of
                   FEMA forms                       respondents    Frequency of      Hours per     Annual burden
                                                        (A)        response  (B)   response  (C)  hours  (AxBxC)
----------------------------------------------------------------------------------------------------------------
FF 95-58 (Student)..............................           5,000               1             .33           1,650
FF 95-59 (Supervisor)...........................           5,000               1             .17           1,650
                                                 -----------------
    Total.......................................          10,000               1             .50           3,300
----------------------------------------------------------------------------------------------------------------

    Frequency of Response: Once at the conclusion of National Fire
Academy resident training courses.
    Estimated Cost: $75,000.
    Comments: Written comments are solicited to (a) evaluate whether
the proposed data collection is necessary for the proper performance of
the agency, including whether the information shall

have practical utility; (b) evaluate the accuracy of the agency's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (c)
enhance the quality, utility, and clarity of the information to be
collected; and (d) minimize the burden of the collection of information
on those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses. Comments should be received within
60 days of the date of this notice.

ADDRESSES: Interested persons should submit written comments to: Chief,
Records Management Section, Information Resources Management Branch,
Information Technology Services Division, Federal Emergency Management
Agency, Emergency Preparedness and Response Directorate, Department of
Homeland Security, 500 C Street, SW., Room 316, Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: Ms. Terry Gladhill, Program Analyst,
National Fire Academy,<PHONE_NUMBER> for additional information. You
may contact the Records Management Section at<PHONE_NUMBER> or e-mail
address<EMAIL_ADDRESS>
    Dated: September 26, 2005.
Darcy Bingham,
Branch Chief, Information Resources Management Branch, Information
Technology Services Division.
[FR Doc. 05-19579 Filed 9-29-05; 8:45 am]

BILLING CODE 9110-17-P


[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Rules and Regulations]
[Pages 42608-42610]
[FR Doc No: 2010-17854]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0652]
RIN 1625-AA00

Safety Zone; Lyme Community Days, Chaumont Bay, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
Lyme Community Days Fireworks on Chaumont Bay, Lyme, New York. All
vessels are prohibited from transiting the zone except as specifically
authorized by the Captain of the Port or a designated representative.
This action is necessary and intended to ensure safety of life on
navigable waters immediately prior to, during, and immediately after
the fireworks event.

DATES: This rule is effective from 9:30 p.m. to 10 p.m. on July 24,
2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0652 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0652 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 MST2 Jessica Seguin, The Marine Events
Coordinator, Coast Guard; telephone:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

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.'' 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 the permit application associate with this
event was not received in time and given the risks to the public
created by fireworks displays, delaying the publication of this rule
would be contrary to the public interest.
    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. The permit application associated
with this event was not received in time to provide for a 30 day period
before making the rule effective and delaying the effective date would
be contrary to the public interest because of the hazards to the public
created by fireworks displays.

Basis and Purpose

    This temporary safety zone is necessary to ensure the safety of
vessels and spectators from hazards associated with a fireworks
display. Based on the explosive hazards of fireworks, the Captain of
the Port Buffalo has determined that fireworks launches proximate to
watercraft pose a significant risk to public safety and property. The
likely combination of large numbers of recreation vessels, congested
waterways, darkness punctuated by bright flashes of light, alcohol use,
and debris falling into the water could easily result in serious
injuries or fatalities. Establishing a safety zone to control vessel
movement around the location of the launch platform will help ensure
the safety of persons and property at these events and help minimize
the associated risks.

Discussion of Rule

    A temporary safety zone is necessary to ensure the safety of
spectators and vessels during the setup, loading, and launching of a
fireworks display in conjunction with the Lyme Community Days
Fireworks. The fireworks display will occur from 9:30 p.m. to 10 p.m.
on July 24, 2010. The safety zone will encompass all waters of Chaumont
Bay, Lyme, New York in a 210 ft radius from position 44[deg]4'6.03'' N
and 76[deg]8'54.61'' W (DATUM: NAD 83). Entry into, transiting, or
anchoring within the safety zone is prohibited unless authorized by the
Captain of the Port Buffalo or his on-scene representative. The Captain
of the Port or his on-scene representative may be contacted via VHF
Channel 16.

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.
    This determination is based on the minimal time that the area will
be restricted. The Coast Guard expects this area will have an
insignificant adverse impact to mariners from the zones activation.

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. This rule will affect the following entities, some of which
may be small entities: The owners and operators of vessels intending to
transit the specified portion of Chaumont Bay, New York from 9:30 p.m.
until 10 p.m. on July 24, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will be enforced for only 30 minutes in a low vessel traffic area.
Vessel traffic can pass safely around the zone. Before the effective
period, we will issue maritime advisories, which include a Local Notice
to Mariners and a Broadcast Notice to Mariners.

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 (adjusted for
inflation) 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 cause 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. Nevertheless, Indian
Tribes that have questions concerning the provisions of this Proposed
Rule or options for compliance are encourage to contact the point of
contact listed under FOR FURTHER INFORMATION CONTACT.

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 that 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 the establishment of a safety zone.
An environmental analysis checklist and a categorical exclusion
determination are 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, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 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. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T09-0652 to read as follows:

Sec.  165.T09-0652  Safety Zone; Lyme Community Days, Chaumont Bay, NY.

    (a) Location. The following area is a temporary safety zone: all
U.S. waters of Chaumont Bay, Lyme, NY in a 210 ft radius from position
44[deg]4'6.03'' N and 076[deg]8'54.61'' W. (DATUM: NAD 83).
    (b) Enforcement period. This zone will be enforced from 9:30 p.m.
to 10 p.m. on July 3, 2010.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Buffalo, or his on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his on-scene
representative.

    (3) The ``on-scene representative'' of the Captain of the Port is
any Coast Guard commissioned, warrant or petty officer who has been
designated by the Captain of the Port to act on his behalf. The on-
scene representative of the Captain of the Port will be aboard either a
Coast Guard or Coast Guard Auxiliary vessel.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
or his on-scene representative may be contacted via VHF Channel 16.
    (5) Vessel operators given permission to enter or operate in the
safety zone must comply with all directions given to them by the
Captain of the Port Buffalo or his on-scene representative.

    Dated: July 2, 2010.
R.S. Burchell,
Captain, U. S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2010-17854 Filed 7-21-10; 8:45 am]
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[Federal Register: March 31, 2009 (Volume 74, Number 60)]
[Rules and Regulations]
[Page 14474-14475]
[DOCID:fr31mr09-8]

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DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30659; Amdt. No. 3315]

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

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final Rule.

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

DATES: This rule is effective March 31, 2009. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of March 31, 2009.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1.FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2.The FAA Regional Office of the region in which the affected
airport is located.

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

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and

safety in air commerce, I find that notice and public procedure before
adopting these SIAPs are impracticable and contrary to the public
interest and, where applicable, that good cause exists for making these
SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

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

John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

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

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

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

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

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs.

--------------------------------------------------------------------------------------------------------------------------------------------------------
        FDC date               State                 City                   Airport           FDC No.                        Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
02/20/09...............  SC                 NEWBERRY..............  NEWBERRY COUNTY.......       9/6480  NDB RWY 22, AMDT 6
02/23/09...............  MD                 FREDERICK.............  FREDERICK MUNI........       9/6582  ILS OR LOC RWY 23, AMDT 5B
02/27/09...............  NY                 BATAVIA...............  GENESEE COUNTY........       9/7308  ILS OR LOC RWY 28, AMDT 6
03/03/09...............  ID                 CALDWELL..............  CALDWELL INDUSTRIAL...       9/7641  NDB RWY 30, AMDT 1
03/03/09...............  ID                 CALDWELL..............  CALDWELL INDUSTRIAL...       9/7642  RNAV (GPS) RWY 30, AMDT 1
03/03/09...............  ID                 CALDWELL..............  CALDWELL INDUSTRIAL...       9/7643  RNAV (GPS) RWY 12, AMDT 1
03/03/09...............  CA                 MODESTO...............  MODESTO CITY-CO-HARRY        9/7694  ILS OR LOC/DME RWY 28R, AMDT 14
                                                                     SHAM FLD.
03/03/09...............  KS                 WICHITA...............  BEECH FACTORY.........       9/7696  VOR/DME RNAV RWY 36, ORIG
03/03/09...............  KS                 WICHITA...............  BEECH FACTORY.........       9/7697  VOR/DME RNAV RWY 18, ORIG
--------------------------------------------------------------------------------------------------------------------------------------------------------

 [FR Doc. E9-7039 Filed 3-30-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 172 (Thursday, September 3, 2020)]
[Notices]
[Pages 55017-55019]
[FR Doc No: 2020-19519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1530]

Control of Nitrosamine Impurities in Human Drugs; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a final guidance for industry, entitled
``Control of Nitrosamine Impurities in Human Drugs.'' This guidance
recommends steps manufacturers of active pharmaceutical ingredients and
drug products should take to detect and prevent objectionable levels of
nitrosamine impurities in pharmaceutical products. The guidance also
describes conditions that may introduce nitrosamine impurities. The
recent unexpected finding of nitrosamine impurities, which are probable
human carcinogens, in drugs such as angiotensin II receptor blockers,
ranitidine, nizatidine, and metformin, has made clear the need for a
risk assessment strategy to identify and minimize nitrosamines in any
pharmaceutical product at risk for their presence.

DATES: The announcement of the guidance is published in the Federal
Register on September 3, 2020.

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-2020-D-1530 for ``Control of Nitrosamine Impurities in Human
Drugs.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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 guidance to the
Office of Communications, Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-
0002. Send two self-addressed adhesive labels to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dongmei Lu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6649, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Control of Nitrosamine Impurities in Human Drugs.'' We are
issuing this guidance consistent with our good guidance practices (GGP)
regulation (Sec.  10.115 (21 CFR 10.115)). We are implementing this
guidance without prior public comment because we have determined that
prior public participation is not feasible or appropriate (Sec.
10.115(g)(2)). We made this determination because of the importance of
providing timely information to manufacturers regarding risk
assessments, testing, and other appropriate actions they should take to
reduce and mitigate nitrosamine impurities in active pharmaceutical
ingredients (APIs) and drug products. Although this guidance document
is immediately in effect, it remains subject to comment in accordance
with FDA's GGP regulation (Sec.  10.115(g)(3)(D)).
    Nitrosamines have been classified as probably carcinogenic to
humans by the World Health Organization. This guidance recommends steps
manufacturers of APIs and drug products should take to detect and
prevent objectionable levels of nitrosamine impurities in
pharmaceutical products. The guidance also describes conditions that
may introduce nitrosamine impurities.
    The recent discovery of nitrosamine impurities in some types of
drug products, including angiotensin II receptor blockers, ranitidine,
nizatidine, and metformin, led FDA and other international regulators
to conduct a detailed analysis of these impurities in affected APIs and
drug products. Recently, preliminary results from FDA stability testing
raised concerns that N-Nitrosodimethylamine (NDMA) levels in some
ranitidine products stored at room temperature can increase with time
to unacceptable levels. Results from other tests FDA conducted suggest
that the NDMA levels increase with storage time. On April 1, 2020, FDA
requested that all ranitidine products be withdrawn from the U.S.
market.
    Based on the testing results and the Agency's current understanding
of the chemistry, FDA has developed this guidance to provide API and
drug product manufacturers information on the potential root causes of
nitrosamine formation. It recommends ways API and drug product
manufacturers can conduct risk assessments of their products, whether
approved, marketed, or with pending applications. The guidance also
suggests actions they should take to reduce or prevent the presence of
nitrosamines in APIs and drug products.
    API and drug product manufacturers should assess the risk of
nitrosamine contamination or formation in their drugs. These risk
assessments should be conducted in a timely manner. Manufacturers do
not need to submit risk assessment documents to the Agency, but they
should retain them so that they are available if requested. FDA may
request an expedited risk assessment, confirmatory testing, or other
regulatory action based on information available to the Agency.
    For products at the pre-submission stage, FDA recommends that
applicants conduct a risk assessment for nitrosamine impurities in APIs
and proposed drug products and conduct confirmatory testing as needed
prior to submission of an original application. However, the risk
assessment and submission of any confirmatory testing or changes to the
drug master file or application may be submitted in an amendment if
they are not available at the time of the original submission filing.
For applications that are pending with the Agency, applicants should
conduct the risk assessment expeditiously and inform FDA if
confirmatory testing finds nitrosamine levels above the recommended
acceptable daily intake (ADI) limit. If a nitrosamine impurity is
detected above the limit of quantitation but is within the ADI limit,
the applicant should amend the application as appropriate. The Agency
will work with the applicant to resolve issues during the review cycle
or immediately after approval, and before distribution, if determined
to be necessary by the Agency.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115). The guidance represents the
current thinking of FDA on the ``Control of Nitrosamine Impurities in
Human Drugs.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR parts 210 and 211 have been approved under OMB control number 0910-
0139; the collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014; the collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338; the collections
of information for the permanent discontinuation or interruption in
manufacturing of certain drug and biological products have been
approved under OMB control number 0910-0759; the collections of
information pertaining to the guidance for industry entitled
``Controlled Correspondence Related to Generic Drug Development'' have
been approved under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: August 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19519 Filed 9-2-20; 8:45 am]
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