[Federal Register Volume 76, Number 162 (Monday, August 22, 2011)]
[Rules and Regulations]
[Pages 52266-52268]
[FR Doc No: 2011-21331]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0754]
RIN 1625-AA00

Safety Zone; Coast Guard Exercise, Detroit River, Ambassador
Bridge to the Western Tip of Belle Isle

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
Captain of the Port Detroit Zone on the Detroit River, from the
Ambassador Bridge to the western tip of Belle Isle. This safety zone is
intended to restrict vessels from portions of the Detroit River during
the Coast Guard Exercise. This safety zone is necessary to protect the
public from the hazards associated with this Coast Guard exercise.

DATES: This rule is effective and will be enforced from 8 a.m. to 3
p.m. on August 23, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0754 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0754 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 Adrian Palomeque, Prevention
Department, Sector Detroit, 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<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 doing so would be impracticable and
contrary to the public interest. Notice was not received in sufficient
time for the Coast Guard to solicit public comments before the start of
the event. Thus, waiting for a notice and comment period to run would
be impracticable and contrary to the public interest because it would
inhibit the Coast Guard's ability to protect the public from the
hazards

associated with this Coast Guard exercise.
    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 the 30 day notice period to run
rule would be impracticable and contrary to the public interest of
ensuring the safety of spectators and vessels during this event and
immediate action is necessary to prevent possible loss of life or
property.

Background and Purpose

    On August 23, 2011, an exercise will be conducted by the Coast
Guard along with local facilities and response organizations.

Discussion of Rule

    This safety zone is necessary to ensure the safety of the public
from the hazards associated with the Coast Guard Exercise. The exercise
will occur between 8 a.m. and 3 p.m. on August 23, 2011. This rule will
be in effect and the safety zone will be enforced from 8 a.m. to 3 p.m.
on August 23, 2011.
    The safety zone will begin at Ambassador Bridge to the western tip
of Belle Isle and encompass all U.S. waters of the Detroit River
starting at position 42[deg]18'45'' N, 083[deg]04'28'' W; to position
42[deg]19'59'' N, 083[deg]00'18'' W. All geographic coordinates are
North American Datum of 1983 [NAD 83].
    All persons and vessels shall comply with the instructions of the
Captain of the Port Detroit or his designated on scene representative.
Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Detroit or his
designated on scene representative. The Captain of the Port Detroit or
his designated on scene representative may be contacted via VHF Channel
21.

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.
    We expect the economic impact of this rule to be so minimal that a
full Regulatory Evaluation under the regulatory policies and procedures
of DHS is unnecessary. This determination is based on the short time
that vessels will be restricted from the area of water impacted by the
safety zone. Under certain conditions, moreover, vessels may still
transit through the safety zone when permitted by the Captain of the
Port. 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 during the short time this zone will be in effect, 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 or legal policy issue.

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 or anchor in a portion of the Detroit River between Ambassador
bridge and the western tip of Belle Isle, between 8 a.m. and 3 p.m. on
August 23, 2011.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will only be in effect and enforced for seven hours on one day.
Vessels may also request permission from the Captain of the Port
Detroit to transit through the safety zone. The Coast Guard will give
notice to the public via a Broadcast Notice to Mariners that the
regulation is in effect, allowing vessel owners and operators to plan
accordingly.

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 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.

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
which will only be effective temporarily and is therefore categorically
excluded under paragraph 34(g) of the Instruction.
    A final 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 record
keeping 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. 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.T09-0754 to read as follows:

Sec.  165.T09-0754  Safety Zone; Coast Guard Exercise, Detroit River,
Ambassador Bridge to the western tip of Belle Isle.

    (a) Location. The safety zone will begin at Ambassador Bridge to
the western tip of Belle Isle, and encompass all U.S. waters of the
Detroit River, starting at position 42[deg]18'45'' N, 083[deg]04'28''
W; to position 42[deg]19'59'' N, 083[deg]00'18'' W. (DATUM: NAD 83).
    (b) Effective Period. This regulation is effective and will be
enforced from 8 a.m. until 3 p.m. on August 23, 2011.
    (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 Detroit, 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 Detroit or his designated 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. The Captain of the Port or
his designated on scene representative may be contacted via VHF Channel
21.
    (4) Vessel operators desiring to enter or operate within the safety
zone should contact the Captain of the Port Detroit or his on-scene
representative to obtain permission to do so. 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 or his on-scene
representative.

    Dated: August 8, 2011.
E. J. Marohn,
Commander, U. S. Coast Guard, Acting Captain of the Port Detroit.
[FR Doc. 2011-21331 Filed 8-19-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72983-72985]
[FR Doc No: 2021-27889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4206]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Small Business Qualification
and Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 Form FDA 3602 and Form FDA 3602A, on which
domestic and foreign applicants certify that they qualify as a small
business and pay certain medical device user fees at reduced rates.

DATES: Submit either electronic or written comments on the collection
of information by February 22, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 22, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-N-4206 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device User Fee Small
Business Qualification and Certification.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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, 240-
402-7500.
     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>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Medical Device User Fee Small Business Qualification and Certification

OMB Control Number 0910-0508--Extension

    Medical device user fees were first established in 2002 by the
Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-
250). User fees were renewed in 2007, with the Medical Device User Fee
Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the
Medical Device User Fee Amendments to the FDA Safety and Innovation Act
(MDUFA III), and in 2017 with the Medical Device User Fee Amendments to
the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from
October 1, 2017, until September 30, 2022.
    A ``small business'' is eligible for reduced or waived fees. If an
applicant does not provide information to FDA demonstrating to FDA's
satisfaction that the applicant is a small business, the applicant must
pay the standard (full) fee for any application it submits.
    Section 738(d)(2)(A) and (e)(2)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a ``small
business'' as an entity that reported $100 million or less of gross
receipts or sales in its most recent Federal income tax return,
including such returns of its affiliates, partners, and parent firms.
If a firm's gross receipts or sales are no more than $30 million
(including all affiliates, partners, and parent firms), they will also
qualify for a waiver of the fee for their first (ever) premarket
application, product development protocol, biological licensing
application, or premarket report.
    Forms FDA 3602 (``MDUFA Small Business Certification Request for a
Business Headquartered in the United States'') and FDA 3602A (``MDUFA
Foreign Small Business Certification Request for a Business
Headquartered Outside the United States'') are submitted to FDA to
demonstrate that an applicant qualifies as a MDUFA small business. The
guidance ``Medical Device User Fee Small Business Qualification and
Certification; Guidance for Industry, Food and Drug Administration
Staff and Foreign Governments'' \1\ describes the process by which a
business may request certification as a small business and the criteria
FDA will use to decide whether an entity qualifies as a MDUFA small
business and is eligible for a reduction in user fees.
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    \1\ The guidance ``Medical Device User Fee Small Business
Qualification and Certification Guidance for Industry, Food and Drug
Administration Staff and Foreign Governments'' is available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
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    This estimated burden is based on the number of applications
received in the last few years and includes time required to collect
the required information. Based on our experience with Forms FDA 3602
and FDA 3602A, FDA believes it will take respondents 1 hour to complete
either form.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          FDA form No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
FDA 3602--MDUFA Small Business             2,500               1           2,500               1           2,500
 Certification Request For a
 Business Headquartered in the
 United States..................
FDA 3602A--MDUFA Foreign Small             2,000               1           2,000               1           2,000
 Business Certification Request
 For a Business Headquartered
 Outside the United States......
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............           4,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated ``No. of Respondents'' has been updated to better
reflect the recent submission volume. This adjustment has resulted in a
2,500-hour decrease in the estimated ``Total Hours'' burden.

    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27889 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P