[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8843-8845]
[FR Doc No: 2022-03368]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6644]

Fiscal Year 2022 Generic Drug Science and Research Initiatives
Workshop; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``FY 2022 Generic
Drug Science and Research Initiatives Workshop.'' The purpose of the
public workshop is to provide an overview of the status of science and
research initiatives for generic drugs and an opportunity for public
input on these initiatives. FDA is seeking this input from a variety of
stakeholders--industry, academia, patient advocates, professional
societies, and other interested parties--as it fulfills its commitment
under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to
develop an annual list of science and research initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its Fiscal Year (FY) 2023 Generic
Drug User Fee Amendments (GDUFA) science and research initiatives.

DATES: The public workshop will be held on May 9, 2022, and May 10,
2022, from 8:30 a.m. to 4:30 p.m. Eastern Time. Submit either
electronic or written comments on this public workshop by June 10,
2022. See the SUPPLEMENTARY INFORMATION section for registration date
and information.

ADDRESSES: The public workshop will be held virtually. Registrants will
have an opportunity to indicate their interest in attending the public
workshop in person. If applicable health guidelines for in-person
gatherings are permissive, interested registrants will be contacted no
later than March 9, 2022 with details for attending the public workshop
in person at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg.
31 Conference Center, the Great Room (Rm. 1503, sections B, and C),
Silver Spring, MD 20993-0002. If in-person attendance is determined to
be feasible, the registration form will also be updated so that people
registering for the public workshop from that point forward will be
able to indicate their interest in attending the workshop in person,
even if they are registering after March 9, 2022. Entrance for the
public workshop participants (non-FDA employees) is through Bldg. 1,
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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 June 10, 2022. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 10, 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-2017-N-6644 for ``FY 2022 Generic Drug Science and Research
Initiatives Workshop; Public Workshop; Request for Comments.'' 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,<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>.

FOR FURTHER INFORMATION CONTACT: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4706, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; or Robert Lionberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, Congress passed the Generic Drug User Fee Amendments
of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance
public access to safe, high-quality generic drugs and to modernize the
generic drug program. To support this goal, FDA agreed in the Generic
Drug User Fee Act Program Performance Goals and Procedures (GDUFA I
commitment letter) to work with industry and interested stakeholders on
identifying science and research initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
    In August 2017, GDUFA I was reauthorized until September 2022
through the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub.
L. 115-52). In the GDUFA Reauthorization Performance Goals and Program
Enhancements Fiscal Years 2018-2022 (GDUFA II commitment letter),\1\
FDA agreed to conduct annual public workshops ``to solicit input from
industry and stakeholders for inclusion in an annual list of GDUFA II
[r]egulatory [s]cience initiatives.'' The public workshop scheduled for
May 9, 2022, and May 10, 2022, seeks to fulfill this agreement.
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    \1\ The GDUFA II commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf.

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II. Topics for Discussion at the Public Workshop

    The purpose of the public workshop is to obtain input from industry
and other interested stakeholders on identifying generic drug science
and research initiatives for FY 2023. FDA is particularly interested in
receiving input about the next 5 years of the GDUFA science and
research program.
    Specific presentations and discussions at this workshop will be
announced at a later date and may differ from the topic above. However,
input about the topic above will help the Agency identify and expand
its scientific focus for the next fiscal year.
    FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2023 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found on the Science &
Research website at https://www.fda.gov/drugs/generic-drugs/science-research.

III. Participating in the Public Workshop

    Registration: Registration is free. Persons interested in attending
this public workshop must register online at https://fda.zoomgov.com/webinar/register/WN_kY1uqyD1RLqyRL2XU1KDTA. Registration may be
performed at any time before or during the workshop.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present your public comments. Public comment
presentation requests must be submitted by 11:59 p.m. Eastern Time at
the end of March 11, 2022. We will do our best to accommodate requests
to make public comments. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to participate in the workshop. Based upon
the public comment presentation requests received by March 11, 2022, at
11:59 p.m. Eastern Time, we will determine the amount of time allotted
to each presenter and the approximate time each oral presentation is to
begin; we will select and notify participants by March 28, 2022. All
public comment presentation requests must be received by March 11,
2022, at 11:59 p.m. Eastern Time. If selected for presentation, any
presentation materials must be emailed to
[email protected] no later than April 29, 2022, 11:59
p.m. Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
be webcast. Please register online (as described above) to attend the
workshop remotely. Registrants will receive a hyperlink that provides
access to the webcast on both days.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov or https://www.fda.gov/gdufaregscience. It may be
viewed at the Dockets Management Staff (see ADDRESSES).

    Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03368 Filed 2-15-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Page 88702]
[FR Doc No: 2023-28264]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2001-11213, Notice No. 28]

Drug and Alcohol Testing: Determination of Minimum Random Testing
Rates for 2024

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notification of determination.

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SUMMARY: This notification of determination announces FRA's minimum
annual random drug and minimum annual random alcohol testing rates for
covered service, maintenance-of-way (MOW), and mechanical (MECH)
employees for calendar year 2024.

DATES: This determination takes effect December 22, 2023.

FOR FURTHER INFORMATION CONTACT: Gerald Powers, FRA Drug and Alcohol
Program Manager, by email: [email protected] or by telephone: 202-
493-6313; or Melissa Van Dermeir, FRA Drug and Alcohol Program
Specialist, by email: [email protected] or by telephone: 312-
720-9491.

SUPPLEMENTARY INFORMATION: Each year, FRA sets its minimum annual
random testing rates after considering the last two complete calendar
years of railroad industry drug and alcohol program data submitted to
DOT's Management Information System (MIS) for DOT drug and alcohol
testing results. FRA, however, reserves the right to consider factors
in addition to MIS-reported data before deciding whether to lower
annual minimum random testing rates. See 85 FR 81265 (Dec. 15, 2020).
    To summarize, FRA is announcing that its minimum annual random drug
and alcohol testing rates for the period between January 1, 2024,
through December 31, 3024 (Calendar Year 2024) will continue to be as
follows:
    Covered service employees--25 percent for drugs and 10 percent for
alcohol.
    MOW employees--25 percent for drugs and 10 percent for alcohol.
    MECH employees--50 percent for drugs and 25 percent for alcohol.
    These rates are minimums, and railroads and railroad contractors
may conduct random testing at higher rates than those required by this
notification of determination.

Discussion

Random Testing Rates for Covered Service Employees

    The rail industry's random drug testing positive rate for covered
service employees remained below 1.0 percent for 2021 and 2022. The
Administrator has therefore determined the minimum annual random drug
testing rate for covered service employees will remain at 25 percent
for Calendar Year 2024. The industry-wide random alcohol testing
violation rate for covered service employees remained below .5 percent
for 2021 and 2022. The Administrator has therefore determined the
minimum random alcohol testing rate for covered service employees will
remain at 10 percent for Calendar Year 2024.

Random Testing Rates for MOW Employees

    The rail industry's random drug testing positive rate for MOW
employees remained below 1.0 percent for 2021 and 2022. The
Administrator has therefore determined the minimum annual random drug
testing rate for MOW employees will remain at 25 percent for calendar
year 2024. The industry-wide random alcohol testing violation rate for
MOW employees remained below 0.5 percent for 2021 and 2022. The
Administrator has therefore determined the minimum random alcohol
testing rate for MOW employees will remain at 10 percent for Calendar
Year 2024.

Random Testing Rates for MECH Employees

    FRA does not have the two full years of MIS data required to adjust
the random testing rates for MECH employees, because those employees
became subject to FRA random drug and alcohol testing in March 2022.
See 87 FR 5719, February 2, 2022. The Administrator has therefore
determined that the minimum random testing rates for MECH employees
will remain at 50 percent for drugs and 25 percent for alcohol for
Calendar Year 2024.

    Issued in Washington, DC.
Amitabha Bose,
Administrator.
[FR Doc. 2023-28264 Filed 12-21-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33083-33084]
[FR Doc No: 2019-14766]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2019-0014; OMB No. 1660-0098]

Agency Information Collection Activities: Proposed Collection;
Comment Request; FEMA Citizen Responder Programs Registration

AGENCY: Federal Emergency Management Agency, DHS.

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 to take this opportunity to comment on a revision of
a currently approved information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
FEMA's Citizen Responder programs registration. These programs include
Community Emergency Response Teams (CERTs) and Citizen Corps Councils.

DATES: Comments must be submitted on or before September 9, 2019.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2019-0014. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-
3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Andy Burrows, Citizen Responder Lead,
Individual and Community Preparedness Division, FEMA, 400 C Street SW,
Washington DC 20024,<PHONE_NUMBER><EMAIL_ADDRESS>You may
contact the Information Management Division for copies of the proposed
collection of information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Post Katrina Management Reform Act
(PKEMRA), codified within Title 6 of the U.S. Code, requires the FEMA
Administrator to provide Federal leadership necessary to prepare for,
protect against, respond to, recover from or mitigate against a natural
disaster, act of terrorism, or other man-made disaster. This
responsibility includes planning, training, and building the emergency
management profession by building a comprehensive incident management
system with State, local, Tribal and Territorial (SLTT) government
personnel, agencies and authorities, and helping the emergency response
providers to effectively respond. 6 U.S.C. 314. As part of this
responsibility to help and support emergency response providers, FEMA
supports efforts to train and assist in organizing citizen responder
programs. With Executive Order 13254, Citizen Corps was launched as a
Presidential Initiative, on January 29, 2002 with a mission to harness
the power of every individual through education, training, and
volunteer service to make communities safer, stronger, and better
prepared for the threats of terrorism, crime, public health issues, and
disasters of all kinds.
    Another FEMA Citizen Responder program, the Community Emergency
Response Team (CERT) was originally developed and implemented by the
Los Angeles City Fire Department in 1985. Since 1993 when this training
was made available nationally by FEMA, communities in 28 states and
Puerto Rico have conducted CERT training. FEMA supports CERT by
conducting or sponsoring Train-the-Trainer and Program Manager courses
for members of the fire, medical and emergency management community.
    To fulfill its mission, the Federal Emergency Management Agency
(FEMA) Individual and Community Preparedness Division (ICPD) will
collect information from Citizen Corps Councils and Community Emergency
Response Team Programs through the Citizen Responder online
registration form. The Citizen Responder registration form will allow
FEMA as well as SLTT personnel to evaluate whether prospective
Councils/Community Emergency Response Teams (CERTs) have the support of
the appropriate government officials in their area, ensure a dedicated
coordinator is assigned to the program, and provide an

efficient way to track the effectiveness of the nationwide network of
Councils and CERT programs.

Collection of Information

    Title: FEMA Citizen Responder Programs Registration.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0098.
    FEMA Forms: FEMA Form 008-0-25, FEMA Citizen Responder Programs
Registration.
    Abstract: The FEMA Citizen Responder registration form will allow
FEMA as well as SLTT personnel to evaluate whether prospective
Councils/Community Emergency Response Teams (CERTs) have the support of
the appropriate government officials in their area, ensure a dedicated
coordinator is assigned to the program, and provide an efficient way to
track the effectiveness of the nationwide network of Councils and CERT
programs.
    Affected Public: SLTT governments and FEMA affiliated citizen
responders throughout the US and its territories.
    Estimated Number of Respondents: 4,000.
    Estimated Number of Responses: 4,000.
    Estimated Total Annual Burden Hours: 2,000.
    Estimated Total Annual Respondent Cost: $54,750.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $10,475.
    Comments: Comments may be submitted as indicated in the ADDRESSES
caption above. 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.

William H. Holzerland,
Senior Director, Information Management Division, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2019-14766 Filed 7-10-19; 8:45 am]
 BILLING CODE 9111-46-P


[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3161-3162]
[FR Doc No: 2019-01916]

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ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-04-2018-3762; FRL-9989-20--Region 4]

Koppers Co., Inc. (Charleston Plant) Superfund Site Charleston,
South Carolina; Notice of Settlement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of settlement.

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SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation andLiability Act (CERCLA), the United States Environmental
Protection Agency (EPA) has entered into a settlement agreement with HR
Charleston VII, LLC (Prospective Purchaser) to perform work

at the Koppers Co., Inc. Superfund Site located in Charleston, South
Carolina. The work being performed will Support future residential land
use.

DATES: The Agency will consider public comments on the settlement until
March 13, 2019. The Agency will consider all comments received and may
modify or withdraw its consent to the proposed settlement if comments
received disclose facts or considerations which indicate that the
proposed settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Program Analyst, using the contact
information provided in this notice. Comments may also be submitted by
referencing the Site's name through one of the following methods:
    Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices.
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW, Atlanta,
Georgia 30303.
     Email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Paula V. Painter at 404/562-8887.

    Dated: December 10, 2018.
Maurice L. Horsey, IV,
Chief, Enforcement and Community Engagement Branch, Superfund Division.
[FR Doc. 2019-01916 Filed 2-8-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Proposed Rules]
[Pages 46007-46010]
[FR Doc No: 2017-21230]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0146]
RIN 1625-AA87

Security Zones; Port Canaveral Harbor, Cape Canaveral Air Force
Station, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to expand the geographical boundaries
of a permanent security zone at Port Canaveral Harbor. This action is
necessary to ensure the security of vessels, facilities, and the
surrounding areas within this zone. This rule is intended to prohibit
persons and vessels from entering, transiting through, anchoring in, or
remaining within the security zone unless authorized by the Captain of
the Port (COTP) Jacksonville or a designated representative. We invite
your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before November 3, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0146 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Allan Storm, Sector
Jacksonville, Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    On October 3, 1988, the Coast Guard published a final rule creating
a permanent security zone at Port Canaveral Harbor, Cape Canaveral,

Florida (53 FR 38718) to safeguard the waterfront and military assets
along the U.S. Navy's Poseidon Wharf inside the southeast portion of
Port Canaveral Harbor's Middle Basin. This waterfront area is located
on Cape Canaveral Air Force Station (CCAFS), a U.S. Air Force military
installation. Additionally, the northern and northeast portion of the
Middle Basin's waterfront is located almost entirely on CCAFS property,
and within this area are piers utilized by the U.S. Air Force and U.S.
Army. CCAFS routinely conducts operations critical to national
security.
    The U.S. Navy requested to amend the current regulation in 33 CFR
165.705(b) to expand the geographical boundaries to include the
northern and northeastern portion of the Middle Basin of Port Canaveral
Harbor in order to ensure the safety and security of military assets
and infrastructure along the entire CCAFS waterfront.
    The COTP Jacksonville has determined it is necessary to expand the
security zone to ensure the security of military assets and waterfront
facilities from destruction, loss, or injury from sabotage or other
subversive acts, accidents or other causes of a similar nature, while
still allowing for safe navigation within the Middle Basin of Port
Canaveral Harbor. The proposed expanded geographical boundaries would
encompass the entire CCAFS waterfront in the middle basin, with a
perpendicular boundary distance from the shore varying from
approximately 120 feet to 665 feet. The purpose of the proposed rule is
to ensure the security of vessels, facilities, and the surrounding
areas within the security zone. The Coast Guard proposes this
rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The Coast Guard proposes to expand the geographical boundaries of
the current regulated area in 33 CFR 165.705(b) to include the
navigable waters of the Port Canaveral Harbor's Middle Basin. The
proposed amendment would redesignate Sec.  165.705(b) to new Sec.
165.705(a)(2) and would read as follows: ``Security Zone B. Middle
Basin, Port Canaveral Harbor, at Cape Canaveral Air Force Station,
Brevard County, Florida. All waters within the following coordinates
inside the Middle Basin: starting at Point 1 in position
28[deg]24'54.49'' N., 80[deg]36'39.13'' W.; thence south to Point 2 in
position 28[deg]24'53.27'' N., 80[deg]36'39.15'' W.; thence east to
Point 3 in position 28[deg]24'53.25'' N., 80[deg]36'30.41'' W.; thence
south to Point 4 in position 28[deg]24'50.51'' N., 80[deg]36'30.41''
W.; thence southeast to Point 5 in position 28[deg]24'38.15'' N.,
80[deg]36'17.18'' W.; thence east to Point 6 in position
28[deg]24'38.16'' N., 80[deg]36' 14.92'' W.; thence northeast to Point
7 in position 28[deg]24'39.36'' N., 80[deg]36'13.37'' W.; thence
following the land based perimeter boundary to the point of origin.''
    The proposed rule would also make the following amendments: (1)
Change the title of the existing regulation in 33 CFR 165.705 from
``Port Canaveral Harbor, Cape Canaveral, Florida'' to ``Security Zones:
Port Canaveral Harbor, Cape Canaveral Air Force Station, FL''; (2) add
a new paragraph (c) and change the title to ``(c) Regulations''; (3)
redesignate existing paragraph (d) as new paragraph (c)(1) with minor
non-substantive changes; (4) redesignate existing paragraph (c) as new
paragraph (c)(2) with minor non-substantive changes; (5) and add a new
paragraph (c)(3), which states: ``Persons desiring to enter, transit
through, anchor in, or remain within the security zone may request
permission from the COTP Jacksonville by telephone at<PHONE_NUMBER>, or
a designated representative via VHF-FM radio on channel 16. If
authorization is granted, all persons and vessels receiving such
authorization must comply with the instructions of the COTP
Jacksonville or the designated representative.'' Lastly, we propose to
add a new paragraph (b), entitled ``Definitions'' and propose a new
definition for the term ``designated representative.''

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive Orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review) direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 13771 (Reducing Regulation and Controlling Regulatory
Costs) directs agencies to reduce regulation and control regulatory
costs and provides that ``for every one new regulation issued, at least
two prior regulations be identified for elimination, and that the cost
of planned regulations be prudently managed and controlled through a
budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, OMB has not reviewed it. As this rule is not
a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See the OMB Memorandum titled
``Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 titled `Reducing Regulation and Controlling Regulatory
Costs' '' (February 2, 2017).
    The economic impact of this proposed rule is not significant.
Although persons and vessels may not enter, transit through, anchor it,
or remain within the security zone without authorization from the COTP
Jacksonville or a designated representative, they may operate in the
navigable water adjacent to the proposed security zone and the Federal
channel.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
security zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on a substantial number of small entities.
    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.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business,

organization, or governmental jurisdiction and you have questions
concerning its provisions or options for compliance, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast
Guard will not retaliate against small entities that question or
complain about this proposed rule or any policy or action of the Coast
Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this proposed rule does not have tribal implications under
E.O. 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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 proposed rule would not
result in such an expenditure, the Coast Guard discusses the effects of
this rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. The proposed rule involves expanding
the geographical boundaries of a permanent security zone that will
prohibit entry within certain navigable waters of the Port Canaveral
Harbor's Middle Basin.
    Normally such actions are categorically excluded from further
review under paragraph 34(g) of Figure 2-1 of Commandant Instruction
M16475.lD. A preliminary Record of Environmental Consideration (REC)
supporting this determination is 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
proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    Public participation is essential to effective rulemaking, and the
Coast Guard will consider all comments and related materials received
during the comment period. Your comment can help shape the outcome of
this rulemaking. If you submit a comment, please include the docket
number for this rulemaking, indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

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 proposes
to amend 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; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Revise Sec.  165.705 to read as follows:

Sec.  165.705:  Security Zones: Port Canaveral Harbor, Cape Canaveral
Air Force Station, FL.

    (a) Regulated areas.
    (1) Security Zone A. East (Trident) Basin, Port Canaveral Harbor,
at Cape Canaveral Air Force Station, Brevard County, Florida. All
waters of the East Basin north of latitude 28[deg]24'36'' N.
    (2) Security Zone B. Middle Basin, Port Canaveral Harbor, at Cape
Canaveral Air Force Station, Brevard County, Florida. All waters within
the following coordinates inside the Middle Basin: Starting at Point 1
in position 28[deg]24'54.49'' N., 80[deg]36'39.13'' W.; thence south to
Point 2 in position 28[deg]24'53.27'' N., 80[deg]36'39.15'' W.; thence
east to Point 3 in position 28[deg]24'53.25'' N., 80[deg]36'30.41'' W.;
thence south to Point 4 in position 28[deg]24'50.51'' N.,
80[deg]36'30.41'' W.; thence southeast to Point 5 in position
28[deg]24'38.15'' N., 80[deg]36'17.18'' W.; thence east to Point 6 in
position 28[deg]24'38.16'' N., 80[deg]36'14.92'' W.; thence northeast
to Point 7 in position 28[deg]24'39.36'' N., 80[deg]36'13.37'' W.;
thence following the land based perimeter boundary to the point of
origin. These coordinates are based on North American Datum 1983.
    (b) Definitions. The term ``designated representative'' means
personnel

designated by or assisting the Captain of the Port (COTP) Jacksonville
in the enforcement of the security zone. This includes Coast Guard
Patrol Commanders, Coast Guard coxswains, petty officers, and other
officers operating Coast Guard vessels and federal, state, and local
law officers designated by or assisting the COTP Jacksonville in the
enforcement of regulated navigation areas and security zones.
    (c) Regulations.
    (1) The general regulations governing security zones found in 33
CFR 165.33 apply to the security zones described in paragraph (a) of
this section.
    (2) All persons and vessels are prohibited from entering,
transiting through, anchoring in, or remaining within the security zone
unless authorized by the COTP Jacksonville or a designated
representative.
    (3) Persons desiring to enter, transit through, anchor in, or
remain within the security zone may request permission from the COTP
Jacksonville by telephone at<PHONE_NUMBER>, or a designated
representative via VHF-FM radio on channel 16. If authorization is
granted, all persons and vessels receiving such authorization must
comply with the instructions of the COTP Jacksonville or the designated
representative.

    Dated: September 28, 2017.
T.C. Wiemers,
Captain, U.S. Coast Guard, Captain of the Port Jacksonville.
[FR Doc. 2017-21230 Filed 10-2-17; 8:45 am]
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[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60441-60442]
[FR Doc No: 2012-24213]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0284]

Pediatric Studies of Sodium Nitroprusside Conducted in Accordance
With Section 409I of the Public Health Service Act; Establishment of
Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a public docket to make available to the public a report of
the pediatric studies of sodium nitroprusside that were conducted in
accordance with the Public Health Service Act (the PHS Act) and
submitted to the Director of the National Institutes of Health (NIH)
and the Commissioner of Food and Drugs.

DATES: Submit either electronic or written comments by November 2,
2012.

ADDRESSES: You may submit comments, identified by FDA-2012-N-0284, by
any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Akilah Green, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6475, Silver Spring, MD 20993-0002,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under section 409I of the PHS Act (42 U.S.C.
284m), the Secretary of the Department of Health and Human Services
(the Secretary) acting through the Director of NIH, in consultation
with FDA and experts in pediatric research, must develop, prioritize,
and publish a list of priority needs in pediatric therapeutics,
including drugs, biological products, and indications that require
study.\1\ For drugs and biological products and indications on this
list, FDA, acting in consultation with NIH, is authorized to issue a
written request to holders of a new drug application (NDA) or
abbreviated new drug application (ANDA) for a drug, or holders of a
biologics license application (BLA) for a biological product, for which
pediatric studies are needed to provide safety and efficacy information
for pediatric labeling. If the sponsors receiving the written request
decline to conduct the studies or if FDA does not receive a response to
the written request within 30 days of the date the written request was
issued, the Secretary, acting through the Director of NIH and in
consultation with FDA, must publish a request for proposals to conduct
the pediatric studies described in the written request and award funds
to an entity with appropriate expertise for the conduct of the
pediatric studies described in the written request. Upon completion of
the pediatric studies, a study report that includes all data generated
in connection with the studies must be submitted to FDA and NIH and
placed in a public docket assigned by FDA.
---------------------------------------------------------------------------

    \1\ Prior to the 2007 reauthorization of the Best
Pharmaceuticals for Children Act (Pub. L. 107-109), the priority
list included specific drugs instead of therapeutic areas.
---------------------------------------------------------------------------

    Sodium nitroprusside, a hypotensive agent, is labeled for the
immediate reduction of blood pressure of patients in hypertensive
crises, for producing controlled hypotension in order to reduce
bleeding during surgery, and for the treatment of acute congestive
heart failure. Off-label use of sodium nitroprusside in pediatric
patients is significant, despite the lack of adequate pharmacokinetic,
dosing, tolerability, and safety data for this age group.
    On January 21, 2003, NIH published a Federal Register notice (68 FR
2789) announcing the addition of several drugs, including sodium
nitroprusside, to the priority list of drugs most in need of study for
use by children to ensure their safety and efficacy. A written request
for pediatric studies of sodium nitroprusside was issued on July 8,
2002, to Abbott Laboratories, the holder of the NDA for sodium
nitroprusside. FDA did not receive a response to the written request.
Accordingly, NIH issued a request for proposals to conduct the
pediatric studies described in the written request in July 2004, and
awarded funds to Duke University and Stanford University in September
2004, to complete the studies described in the written request. Upon
completion of the pediatric studies, a report of the pediatric studies
of sodium nitroprusside was submitted to NIH and FDA. As required under
section 409I of the PHS act, FDA opened a public docket and NIH placed
in the docket the report of pediatric studies of sodium nitroprusside
that was submitted to NIH and FDA. The report includes all data
generated in connection with the study, including the written request.
    We invite interested parties to review the report and submit
comments to the docket. The public docket is available

for public review in the Division of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24213 Filed 10-2-12; 8:45 am]
BILLING CODE 4160-01-P