[Federal Register Volume 78, Number 180 (Tuesday, September 17, 2013)]
[Notices]
[Pages 57164-57166]
[FR Doc No: 2013-22540]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0662]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Applications for Food
and Drug Administration Approval To Market a New Drug: Patent
Submission and Listing Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by October
17, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0513.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Applications for FDA Approval To Market a New Drug: Patent Submission
and Listing Requirements and Application of 30-Month Stays on Approval
of Abbreviated New Drug Applications Certifying That a Patent Claiming
a Drug Is Invalid or Will Not Be Infringed--(OMB Control Number 0910-
0513)--Extension

    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(b)(1)) requires all new drug application (NDA)
applicants to file, as part of the NDA, ``the patent number and the
expiration date of any patent which claims the drug for which the
applicant submitted the application or which claims a method of using
such drug and with respect to which a claim of patent infringement
could reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug.'' Section
505(c)(2) of the FD&C Act (21 U.S.C. 355(c)(2)) imposes a similar
patent submission obligation on holders of approved NDAs when the NDA
holder could not have submitted the patent information with its
application. Under section 505(b)(1) of the FD&C Act, we publish patent
information after approval of an NDA in the list entitled ``Approved
Drug Products With Therapeutic Equivalence Evaluations'' (the Orange
Book). If patent information is submitted after NDA approval, section
505(c)(2) of the FD&C Act directs us to publish the information upon
its submission.
    FDA regulations at Sec. Sec.  314.50(h) (21 CFR 314.50(h)) and
314.53 (21 CFR 314.53) clarify the types of patent information that
must and must not be submitted to FDA as part of an NDA, an amendment,
or a supplement, and require persons submitting an NDA, an amendment,
or a supplement, or submitting information on a patent after NDA
approval, to make a detailed patent declaration using Forms FDA 3542
and 3542a.
    The reporting burden for submitting an NDA, an amendment, or a
supplement in accordance with Sec.  314.50 (a) through (f) and (k) has
been estimated by FDA and the collection of information has been
approved by OMB under OMB control number 0910-0001. We are not
reestimating these approved burdens in this document. Only the
reporting burdens associated with patent submission and listing, as
explained in the following paragraphs, are estimated in this document.
    The information collection reporting requirements are as follows:
    Section 314.50(h) requires that an NDA, an amendment, or a
supplement

contain patent information described under Sec.  314.53.
    Section 314.53 requires that an applicant submitting an NDA, an
amendment, or a supplement, except as provided in Sec.  314.53(d)(2),
submit on Forms FDA 3542 and 3542a, the required patent information
described in this section.
    Compliance with the information collection burdens under Sec. Sec.
314.50(h) and 314.53 consists of submitting with an NDA, an amendment,
or a supplement (collectively referred to as ``application'') the
required patent declaration(s) on Form FDA 3542a for each ``patent that
claims the drug or a method of using the drug that is the subject of
the new drug application or amendment or supplement to it and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner of the patent engaged in
the manufacture, use, or sale of the drug product'' (Sec.  314.53(b)).
Such patents claim the drug substance (active ingredient), drug product
(formulation and composition), or method of use. If a patent is issued
after the application is filed with FDA, but before the application is
approved, the applicant must submit the required patent information on
Form FDA 3542a as an amendment to the application, within 30 days of
the date of issuance of the patent.
    Within 30 days after the date of approval of an application, the
applicant must submit Form FDA 3542 for each patent that claims the
drug substance (active ingredient), drug product (formulation and
composition), or approved method of use for listing in the Orange Book.
In addition, for patents issued after the date of approval of an
application, Form FDA 3542 must be submitted within 30 days of the date
of issuance of the patent.
    In the Federal Register of June 17, 2013 (78 FR 36193), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment from a private
citizen. The comment stated, generally, that ``it would be appropriate
to require, along with the submission of any patents on the original
drug and its formulation, any associated patents or claimed patent
submission on metabolites or secondary products of the original
drugs.''
    (FDA Response) FDA disagrees with the comment. FDA's regulations at
Sec.  314.53(b) prohibit submission of drug substance (active
ingredient) patents claiming metabolites when the metabolite is not the
active ingredient described in the NDA. Section 314.53(b) states, in
relevant part: ``For patents that claim the drug substance, the
applicant shall submit information only on those patents that claim the
drug substance that is the subject of the pending or approved
application or that claim a drug substance that is the same as the
active ingredient that is the subject of the approved or pending
application. . . . Process patents, patents claiming packaging, patents
claiming metabolites, and patents claiming intermediates are not
covered by this section, and information on these patents must not be
submitted to FDA.'' FDA clarified the criteria for listing patent
information in the Orange Book in response to a request by the Federal
Trade Commission (FTC) in its July 2002 report on ``Generic Drug Entry
Prior to Patent Expiration: An FTC Study'' (see 68 FR 36676; June 18,
2003, and http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf). FDA
determined that a patent claiming a metabolite does not claim an
approved drug and thus does not meet the statutory requirements for
listing in the Orange Book (see 67 FR 65448 at 65451; October 24,
2002). However, if a patent claims an approved method of using an
approved drug to administer a metabolite, the submission of the patent
would be permissible as long as all of the conditions for submitting
``method-of-use'' patents are met (see 68 FR 36676 at 36680; June 18,
2003). Section 314.53(c)(2)(i)(M)(4) and 314.53(c)(2)(ii)(N)(4) require
that an applicant submit on Forms FDA 3542a or 3542, as appropriate,
information on whether a drug substance patent claims only a metabolite
of the active ingredient that is described in the application or
supplement, so that FDA can determine whether the patent is eligible
for listing in the Orange Book (see section 2.5 of Forms FDA 3542a and
3542).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   21 CFR 314.50  (citing Sec.       Number of     responses per   Total  annual    burden per      Total hours
             314.53)                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Form FDA 3542...................             183             2.8             512               5           2,560
Form FDA 3542a..................             201             2.8             563              20          11,260
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          13,820
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The numbers of patents submitted to FDA for listing in the Orange
Book in 2010, 2011, and 2012 were 351, 329, and 458, respectively, for
an annual average of 379 (351 patents + 329 patents + 458 patents)/3
years = 379 patents/year). Because many of these individual patents are
included in multiple NDA submissions, there could be multiple
declarations for a single patent. From our previous review of
submissions, we believe that approximately 14 percent of the patents
submitted are included in multiple NDA submissions, and thus require
multiple patent declarations. Therefore, we estimate that 53 (379
patents x 14 percent) patents will be multiple listings, and there will
be a total of 432 patents (379 patents + 53 patents = 432 patents)
declared on Form FDA 3542. We approved 84, 93, and 86 NDAs in 2010,
2011, and 2012, respectively, of which approximately 71 percent
submitted patent information for listing in the Orange Book. The
remaining NDAs submitted Form FDA 3542 as required and declared that
there were no relevant patents. We also approved approximately 101, 83,
and 101 NDA supplements in 2010, 2011, and 2012, respectively, for
which submission of a patent declaration would be required. We estimate
there will be 183 instances (based on an average of 88 NDA approvals
and 95 supplement approvals per year) where an NDA holder would be
affected by the patent declaration requirements, and that each of these
NDA holders would, on average, submit 2.8 declarations (432 patent
declarations + 76 no relevant patent declarations)/183 instances = 2.8
declarations per instance) on Form FDA 3542. We filed 96, 91, and 112
NDAs in 2010, 2011,

and 2012, respectively, and 100, 91, and 112 NDA supplements in 2010,
2011, and 2012, respectively, for which submission of a patent
declaration would be required. We estimate there will be 201 instances
(based on an average of 100 NDAs filed and 101 NDA supplements filed
per year) where an NDA holder would be affected by the patent
declaration requirements. We estimate, based on a proportional increase
from the number of declarations for approved NDAs, that there will be
an annual total of 563 declarations (201 instances x 2.8 declarations
per instance = 563 declarations) on Form FDA 3542a submitted with these
applications. Based upon information provided by regulated entities and
other information, we previously estimated that the information
collection burden associated with Sec.  314.50(h) (citing Sec.  314.53)
and FDA Forms 3542 and 3542a will be approximately 5 hours and 20 hours
per response, respectively.

    Dated: September 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22540 Filed 9-16-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Notices]
[Page 24797]
[FR Doc No: 2018-11577]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9978-54-OW]

Extension of the Application Deadline Date for Credit Assistance
Under the Water Infrastructure Finance and Innovation Act (WIFIA)
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) extends the deadline
to submit a letter of interest (LOI) from prospective borrowers seeking
credit assistance from EPA. EPA takes this action to allow more time
for the preparation and submission of LOIs by prospective borrowers.

DATES: Deadline for Submittal of Letter of Interest: 12:00 p.m. (noon)
EDT on July 31, 2018.

ADDRESSES: Prospective borrowers should submit all LOIs electronically
via email at: [email protected] or via EPA's SharePoint site. To be granted
access to the SharePoint site, prospective borrowers should contact
[email protected] and request a link to the SharePoint site, where they can
securely upload their LOIs. Requests to upload documents should be made
no later than 12:00 p.m. (noon) EDT on July 27, 2018.
    EPA will notify prospective borrowers that their letter of interest
has been received via a confirmation email.
    Prospective borrowers can access additional information, including
the WIFIA program handbook and application materials, on the WIFIA
website: https://www.epa.gov/wifia/.

SUPPLEMENTARY INFORMATION: On April 12, 2018 EPA published in the
Federal Register (83 FR 15828) a Notice of Funding Availability (NOFA)
to solicit letters of interest (LOIs) from prospective borrowers
seeking credit assistance from EPA. The deadline in the NOFA for
submitting a LOI was July 6, 2018. EPA is extending this deadline to
provide additional time for the preparation and submission of LOIs by
prospective borrowers.
    All information in the NOFA published on April 12, 2018 (83 FR
15828), remains the same, except for the deadline date, which has been
changed to 12:00 p.m. (noon) EDT on July 31, 2018, and the deadline to
request a link to EPA's SharePoint site to upload documents, which has
been changed to 12:00 p.m. (noon) EDT on July 27, 2018.
    EPA will host a question and answer webinar about submitting a LOI
on May 30, 2018 at 2:00 p.m. EDT. EPA will also host a webinar
providing an overview of the WIFIA program and the current LOI
submittal round on June 4, 2018 at 2:00 p.m. EDT. Registration
directions can be found on the WIFIA program website: www.epa.gov/wifia.
    Prospective borrowers with questions about the program or interest
in meeting with WIFIA program staff may send a request to
[email protected]. EPA will meet with all prospective borrowers interested
in discussing the program, but only prior to submission of a LOI.

    Authority: 33 U.S.C. 3901-3914; 40 CFR part 35.

    Dated: May 15, 2018.
Andrew D. Sawyers,
Director, Office of Wastewater Management.
[FR Doc. 2018-11577 Filed 5-29-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27392-27395]
[FR Doc No: 2019-12332]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2019-0053]

Saleen Automotive Inc.; Receipt of Petition for a Temporary
Exemption From all Requirements of FMVSS No. 126 and the Air Bag
Requirements of FMVSS No. 208

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of receipt of a petition for a temporary exemption,
request for comment.

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SUMMARY: Saleen Automotive Inc. has petitioned NHTSA for a temporary
exemption from all requirements of Federal Motor Vehicle Safety
Standard (FMVSS) No. 126, ``Electronic stability control for light
vehicles,'' and from the air bag requirements of FMVSS No. 208,
``Occupant crash protection,'' for its newly-designed S1 model. Saleen
is seeking a one-year exemption from these standards, asserting that
compliance with these standards would cause substantial economic
hardship, and that it has tried in good faith to comply with the
standards. NHTSA is publishing this notice of receipt of the
application in accordance with its exemption regulations, and has not
made any judgment on the merits of the application.

DATES: If you would like to comment on the petition, you should submit
your comments not later than July 12, 2019.

FOR FURTHER INFORMATION CONTACT: For electronic stability control:
David Jasinski. For air bags: Daniel Koblenz. Both of these officials
can be reached at: Office of Chief Counsel, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590.
Telephone:<PHONE_NUMBER>; Facsimile:<PHONE_NUMBER>.

ADDRESSES: You may submit your comment, identified by the docket number
in the heading of this document, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, Room W12-140, 1200 New Jersey Avenue SE, Washington,
DC 20590.
     Hand Delivery: 1200 New Jersey Avenue SE, West Building
Ground Floor, Room W12-140, Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
    Instructions: All submissions must include the agency name and
docket number.
    Note that all comments received will be posted without change to
http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act discussion below. NHTSA will
consider all comments received before the close of business on the
comment closing date indicated above. To the extent possible, NHTSA
will also consider comments filed after the closing date.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov at any time or to
1200 New Jersey Avenue, SE, West Building Ground Floor, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m. Monday through Friday,
except Federal Holidays. Telephone:<PHONE_NUMBER>.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, to www.regulations.gov, as
described in the system of records notice, DOT/ALL-14 FDMS, accessible
through www.dot.gov/privacy. In order to facilitate comment tracking
and response, the agency encourages commenters to provide their name,
or the name of their organization; however, submission of names is
completely

optional. Whether or not commenters identify themselves, all timely
comments will be fully considered. If you wish to provide comments
containing proprietary or confidential information, please see below.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit a copy, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. When you send a comment containing information
claimed to be confidential business information, you should include a
cover letter setting forth the information specified in our
confidential business information regulation (49 CFR part 512).

SUPPLEMENTARY INFORMATION:

I. Statutory Authority for Temporary Exemptions

    The National Traffic and Motor Vehicle Safety Act (Safety Act),
codified as 49 U.S.C. Chapter 301, provides the Secretary of
Transportation authority to exempt, on a temporary basis and under
specified circumstances, motor vehicles from a motor vehicle safety
standard or bumper standard. This authority is set forth at 49 U.S.C.
30113. The Secretary has delegated the authority for implementing this
section to NHTSA.
    A manufacturer may request an exemption under one of four
enumerated statutory bases, one of which is ``economic hardship.'' To
grant an economic hardship exemption, NHTSA must find that an exemption
is consistent with the public interest and the Safety Act, and that
``compliance with the standard would cause substantial economic
hardship to a manufacturer that has tried to comply with the standard
in good faith.'' If NHTSA is able to make the requisite findings to
grant an economic hardship exemption, NHTSA is authorized to grant a
manufacturer an exemption to produce for sale or otherwise deploy in
interstate commerce not more than 10,000 motor vehicles annually, on
such terms NHTSA deems appropriate.
    NHTSA established Part 555, Temporary Exemption from Motor Vehicle
Safety and Bumper Standards, to implement the statutory provisions
concerning temporary exemptions. Under Part 555, a petitioner must
provide specified information in submitting a petition for exemption.
These requirements are specified in 49 CFR 555.5, and include a number
of items. Foremost among them are that the petitioner must set forth
the basis of the application under Sec.  555.6, and the reasons why the
exemption would be in the public interest and consistent with the
objectives of 49 U.S.C. chapter 301.
    A manufacturer is only eligible to apply for a hardship exemption
if its total motor vehicle production in its most recent year of
production did not exceed 10,000 vehicles (49 U.S.C. 30113).
    While 49 U.S.C. 30113(b) states that exemptions from a Safety Act
standard are to be granted on a ``temporary basis,'' \1\ this refers to
the period of production, and not the period during which exempted
vehicles may be operated. The statute also expressly provides for
renewal of an exemption on reapplication.
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    \1\ 49 U.S.C. 30113(b)(1).
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II. Background on Electronic Stability Control Requirements

    In April 2007, NHTSA published a final rule establishing FMVSS No.
126, to require vehicles with a gross vehicle weight rating of 4,536
kilograms (kg) (10,000 pounds) or less be equipped with electronic
stability control (ESC) systems. ESC systems use automatic computer-
controlled braking of individual wheels to address critical situations
in which a driver may lose control of the vehicle.
    Preventing single-vehicle loss-of-control crashes is the most
effective way to reduce deaths resulting from rollover crashes. This is
because most loss-of-control crashes culminate in the vehicle leaving
the roadway, which dramatically increases the probability of a
rollover. NHTSA's crash data study of existing vehicles equipped with
ESC demonstrated that these systems reduce fatal single-vehicle crashes
of passenger cars by 55 percent and fatal single-vehicle crashes of
light trucks and vans (LTVs) by 50 percent.\2\ NHTSA estimates that ESC
has the potential to prevent 56 percent of the fatal passenger car
rollovers and 74 percent of the fatal LTV first-event rollovers that
would otherwise occur in single-vehicle crashes.\3\
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    \2\ Sivinski, R., Crash Prevention Effectiveness of Light-
Vehicle Electronic Stability Control: An Update of the 2007 NHTSA
Evaluation; DOT HS 811 486 (June 2011).
    \3\ Id.
---------------------------------------------------------------------------

    The ESC requirement became effective for substantially all light
vehicles on September 1, 2011. Since then, NHTSA has received two
exemption requests from the ESC requirement under the ``economic
hardship'' basis, one of which was withdrawn and the other of which the
agency granted.\4\
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    \4\ See Terrafugia, Inc.; Grant of Application for Temporary
Exemption From Certain Requirements of FMVSS No. 110, Tire Selection
and Rims for Motor Vehicles, FMVSS No. 126, Electronic Stability
Control Systems, FMVSS No. 205, Glazing Materials, and FMVSS No.
208, Occupant Crash Protection, 76 FR 38270 (June 1, 2012).
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III. Background on Air Bag Requirements

    In 2000, NHTSA upgraded the requirements in FMVSS No. 208 for air
bags in passenger cars and light trucks, to require what are commonly
known as ``advanced air bags.'' This upgrade was intended to meet the
twin goals of improving protection for occupants of all sizes, belted
and unbelted, in moderate-to-high- speed crashes, and of minimizing the
risks posed by air bags to infants, children, and other occupants,
especially in low-speed crashes. The ``advanced air bag'' rule was the
culmination of a comprehensive plan that the agency announced in 1996
to address the adverse effects of air bags, especially with regard to
out-of-position children. The rule accomplished this primarily by
establishing new test requirements and injury criteria and specifying
the use of an entire family of test dummies: The then-existing dummy
representing 50th percentile adult males, and new dummies representing
5th percentile adult females, 6-year-old children, 3-year-old children,
and 1-year-old infants. The new requirements were phased in, beginning
with the 2004 model year. Small volume manufacturers were not subject
to the advanced air bag requirements until the end of the phase in
period, i.e., September 1, 2006.
    In the years immediately following NHTSA's publication of the 2000
advanced air bag rule, NHTSA received and granted a number of
``economic hardship'' exemptions to permit the manufacture and sale of
vehicles without any air bags.\5\ NHTSA granted these exemptions due to
the relative newness of the technology at the time, and the high costs
associated with developing any kind of air bag system for limited-run
vehicles. However, by the time the advanced air bag requirements became
effective in 2006, air bag technology had matured to the point that
most low-volume manufacturers were seeking a hardship exemption from
only the advanced air bag requirements in FMVSS No. 208.

Those manufacturers were providing standard (non-advanced) air bags,
even when they found that advanced air bags were still not economically
feasible.\6\ Given the increased availability of non-advanced air bags
to low-volume manufacturers, NHTSA announced in 2007 that ``it is
generally not in the public interest or consistent with the Safety Act
to grant new economic hardship exemptions to permit light vehicles to
be sold without air bags.'' \7\ As advanced air bag systems have become
increasingly feasible for small manufacturers to provide, NHTSA has
become increasingly skeptical of granting exemptions from advanced air
bag requirements, noting in 2011 that ``the expense of advanced air bag
technology is not now sufficient, in and of itself, to justify the
grant of a petition for a hardship exemption from the advanced air bag
requirements.'' \8\ Since announcing this change in policy, NHTSA has
received two very limited requests for an exemption from advanced air
bag requirements based on economic hardship, both of which the agency
granted.\9\
---------------------------------------------------------------------------

    \5\ E.g., Panoz Auto Development Company; Grant of Application
for Temporary Exemption From Federal Motor Vehicle Safety Standard
No. 208, 66 FR 6757 (Jan. 22, 2001).
    \6\ E.g., Ferrari S.p.A and Ferrari North America, Inc. Grant of
Application for a Temporary Exemption From S14.2 of Federal Motor
Vehicle Safety Standard No. 208, 71 FR 166 (May 22, 2006).
    \7\ SS II of America, Inc.; Denial of Application for a
Temporary Exemption From the Air Bag Requirements of FMVSS No. 208,
72 FR 30426 (May 31, 2007).
    \8\ See Pagani Automobili SpA; Denial of Application for
Temporary Exemption From Advanced Air Bag Requirements of FMVSS No.
208, 76 FR 47641 (August 5, 2011).
    \9\ See, e.g., Group Lotus plc; Grant of Petition for a
Temporary Exemption From an Advanced Air Bag Requirement of FMVSS
No. 208, 78 FR 15114 (March 8, 2013) (exemption from only the 35 MPH
belted test requirement using 5th percentile adult female dummies);
Tesla Motors, Inc. Grant of Petition for Renewal of a Temporary
Exemption From the Advanced Air Bag Requirements of FMVSS No. 208,
76 FR 60118 (Sept. 28, 2011) (exemption limited to 40 days to
accommodate the end of production of Roadster model).
---------------------------------------------------------------------------

IV. Overview of Petitions

    On March 14, 2019, Saleen Automotive Inc. (Saleen) submitted a
petition for a temporary exemption from the electronic stability
control requirements of FMVSS No. 126. On the same date, Saleen
separately sought an exemption from the air bag requirements of FMVSS
No. 208.\10\ Both petitions request an exemption on the basis that
compliance would cause the petitioner substantial economic hardship and
that the petitioner has tried in good faith to comply with the
standard. To view non-confidential versions of the petitions, go to
http://www.regulations.gov and enter the docket number set forth in the
heading of this document. For administrative purposes, NHTSA is
addressing both petitions in this notice. NHTSA will evaluate the
merits of granting each exemption request separately. However, as part
of the assessment of the merits of each petition, NHTSA will also
consider the cumulative effect of granting multiple exemptions to the
same manufacturer for the same vehicle.
---------------------------------------------------------------------------

    \10\ NHTA has previously granted Saleen exemptions from the air
bag requirements of FMVSS No. 208. In 2001, NHTSA granted Saleen a
three-year exemption from the standard air bag requirements of FMVSS
No. 208 on the basis of economic hardship, which NHTSA renewed for
another three years in 2004. In 2006, when the advanced air bag
requirements were being phased in, Saleen again requested NHTSA to
renew its exemption from the standard air bag requirements for three
years, and also requested a new three-year exemption from the
advanced air bag requirements. Although NHTSA granted Saleen's
request for a three-year exemption from the advanced air bag
requirements in full, the agency renewed Saleen's exemption from the
standard air bag requirements for only one year. NHTSA explained
that this was because granting a renewal for three years would not
be in the public interest considering the safety benefits that air
bags provide. See Saleen, Inc.; Response to Application for
Temporary Exemption From Certain Provisions of Federal Motor Vehicle
Safety Standard No. 208, 71 FR 52869 (September 7, 2006).
    It is important to note that Saleen requested these earlier
exemptions in order to modify vehicles manufactured by other
companies. By contrast, today's petition concerns a line of vehicles
that Saleen intends to manufacture itself.
---------------------------------------------------------------------------

    Saleen is a U.S. company incorporated under the laws of the State
of Nevada. Saleen's headquarters is in Corona, California. Saleen has
not manufactured any vehicles in the 12 months prior to filing its
exemption requests.
    Saleen seeks an exemption to permit the manufacture and sale of its
S1 model, which is a new passenger car model. Saleen provides various
vehicle and engine specifications for the S1 in its petitions. Saleen
seeks a one-year exemption from June 15, 2019 to June 15, 2020. Saleen
states that it plans to produce no more than 3,500 units under the
exemption in the United States. Saleen states that it expects to fully
comply with both FMVSS Nos. 126 and 208 at the end of the one-year
exemption period.

Electronic Stability Control (ESC)

    It appears from the petition that exempted vehicles will not be
equipped with an electronic stability control (ESC) system. Saleen
asserts that it will need to expend approximately 2,000 man-hours to
complete ESC certification.\11\ Saleen states that the expenditures on
the system would be the same whether it receives an exemption or not.
However, Saleen states that it will take approximately 15 months to
develop and validate an ESC system and that sales from an exempt
vehicle can be used to finance that development. Without an exemption,
Saleen states that it may not be able to sustain the development of the
vehicle, which would cause financial hardship to the company.
---------------------------------------------------------------------------

    \11\ Saleen does not specify what activities these man-hours
will be spent on.
---------------------------------------------------------------------------

    Saleen states that, as an alternative to having an ESC system
developed specifically for the S1, it sought to use an available ESC
system from another vehicle in the automotive market. However, Saleen
found that all ESC systems are designed to the specific geometry,
deployment, occupant arrangement, and styling features of a vehicle.

Air Bags

    It appears from the petition that exempted vehicles will not be
equipped with frontal air bags of any type (neither standard nor
advanced). Saleen asserts that it will need to expend 3,300 man-hours
to develop air bags that comply with FMVSS No. 208.\12\ Saleen states
that the expenditures toward a compliant occupant crash protection
system would be the same whether it receives an exemption or not.
However, Saleen states that it will take approximately 18 months to
develop and validate an occupant crash protection
system,13 14 and that sales from an exempt vehicle can be
used to finance that development. Without an exemption, Saleen states
that it may not be able to sustain the development of the vehicle,
which would cause financial hardship to the company.
---------------------------------------------------------------------------

    \12\ Saleen does not specify what activities these man-hours
will be spent on.
    \13\ Saleen's FMVSS No. 208 petition contained a discrepancy
regarding the development time for a compliant air bag system. On
page 6, the petition stated that the development time would be 15
months, but on page 8, the petition stated the development time
would be 18 months. NHTSA reached out to Saleen by email to clarify
this discrepancy, to which Saleen replied that the development time
would be 18 months. A copy of this email exchange has been placed in
the docket indicated in the header of this notice.
    \14\ We note that the 18-month time period to develop a
compliant air bag system indicated by Saleen could extend past the
end date of Saleen's requested 1-year exemption period.
---------------------------------------------------------------------------

    Saleen states that it tried three separate avenues to achieve
compliance with FMVSS No. 208. First, Saleen investigated using
available air bag systems currently used in other vehicles on the
market. However, Saleen found this was not a viable option because the
air bags are designed to fit the specific geometry of a vehicle, and
the S1 is a new vehicle with a different design geometry. Second,
Saleen investigated equipping the S1 with a single-stage

(i.e., non-advanced) air bag, such as those used in non-US markets.
Saleen found that, in addition to these single-stage systems not being
FMVSS No. 208-compliant, adapting these single-stage air bag systems so
that they can be installed in the S1 would take a similar amount of
time as developing a compliant advanced air bag system, and thus would
not meet Saleen's start-of-production deadline. Third, Saleen
investigated providing a computer simulation analysis to show that the
S1 would ``comply structurally'' with several crashworthiness
standards, including FMVSS No. 208.\15\ However, Saleen states that
this simulation testing was not scheduled to begin until the first
quarter of 2019.
---------------------------------------------------------------------------

    \15\ The petition does not explain what is meant by ``comply
structurally.''
---------------------------------------------------------------------------

Public Interest

    Saleen states in both petitions that an exemption would be in the
public interest and consistent with the objective of the Safety Act
because the development of the S1 provides direct employment to
approximately 30 employees and indirect employment to over 100
employees. Saleen further projects that, once production of the S1
starts, the S1 would support numerous additional jobs relating to the
distribution and sale of the vehicle.

V. Comment Period

    NHTSA seeks comment from the public on the merits of Saleen's
application for a temporary exemption from FMVSS No. 126 and the air
bag requirements of FMVSS No. 208. After considering public comments
and other available information, NHTSA will publish a notice of final
action on the application in the Federal Register.

(Authority: 49 U.S.C. 30113; delegation of authority at 49 CFR
1.95.)

    Issued under authority delegated in 49 CFR 1.95 and 501.5.
Heidi Renate King,
Deputy Administrator.
[FR Doc. 2019-12332 Filed 6-11-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Page 70310]
[FR Doc No: 2010-29075]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on November 19, 2010
at 10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
    1. The Commission will consider whether to propose new rules and
rule amendments under the Investment Advisers Act of 1940 to implement
provisions of the Dodd-Frank Wall Street Reform and Consumer Protection
Act. These rules and rule amendments are designed to give effect to
provisions of Title IV of the Dodd-Frank Act that, among other things,
increase the statutory threshold for registration by investment
advisers with the Commission, require advisers to hedge funds and other
private funds to register with the Commission, and address reporting by
certain investment advisers that are exempt from registration.
    2. The Commission will consider whether to propose rules that would
implement new exemptions from the registration requirements of the
Investment Advisers Act of 1940 for advisers to venture capital funds
and advisers with less than $150 million in private fund assets under
management in the United States. These exemptions were enacted as part
of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The
proposed rules also would clarify the meaning of certain terms included
in a new exemption for foreign private advisers.
    3. The Commission will consider whether to propose new rules under
Section 763(i) of the Dodd-Frank Wall Street Reform and Consumer
Protection Act governing the security-based swap data repository
registration process, the duties of such repositories, and the core
principles applicable to such repositories.
    4. The Commission will consider whether to propose Regulation SBSR
under Title VII of the Dodd-Frank Wall Street Reform and Consumer
Protection Act to provide for the reporting of security-based swap
information to registered security-based swap data repositories or the
Commission and the public dissemination of security-based swap
transaction, volume, and pricing information.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: November 12, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-29075 Filed 11-15-10; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Rules and Regulations]
[Pages 13634-13636]
[FR Doc No: 2022-05028]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2021-0945; FRL-9487-02-R1]

Air Plan Approval; New Hampshire; Conformity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of New
Hampshire. This submission revises previously approved transportation
conformity criteria and procedures

related to interagency consultation and enforceability of certain
transportation-related control measures and mitigation measures. In
addition, the revision continues to rely on the Federal rule for
General Conformity. The intended effect of this action is to approve
State criteria and procedures to govern conformity determinations. This
action is being taken in accordance with the Clean Air Act.

DATES: This rule is effective April 11, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2021-0945. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available at https://www.regulations.gov or at the U.S.
Environmental Protection Agency, EPA Region 1 Regional Office, Air and
Radiation Division, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that, if at all possible, you contact the contact listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays and
facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Eric Rackauskas, Air Quality Branch,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel. (617)
918-1628, email [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On January 28, 2022 (87 FR 4535), EPA published a notice of
proposed rulemaking (NPRM) for the State of New Hampshire.
    The NPRM proposed approval of amendments to New Hampshire's Env-A
1500, Conformity. This revision consists of minor administrative
language changes, updated definitions and references to Federal rules,
and clarifications to roles and responsibilities for Federal, state,
and municipal partners. The formal SIP revision was submitted by the
New Hampshire Air Resources Division (ARD) on September 21, 2021.
    Other specific requirements of the New Hampshire Conformity SIP
revision and the rationale for EPA's proposed action are explained in
the NPRM and will not be restated here. No public comments were
received on the NPRM.

II. Final Action

    EPA is approving New Hampshire's Env-A 1500 Conformity into the New
Hampshire SIP. This revision and approval are consistent with the Clean
Air Act.

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the New
Hampshire Air Resources Division described in the amendments to 40 CFR
part 52 set forth below. The EPA has made, and will continue to make,
these documents generally available through https://www.regulations.gov
and at the EPA Region 1 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the State implementation plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of EPA's approval, and will be incorporated by reference in
the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other

required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 9, 2022. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: March 4, 2022.
David Cash,
Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart EE--New Hampshire

0
2. In Sec.  52.1520(c), amend the table by revising the entry ``Env-A
1500'' to read as follows:

Sec.  52.1520   Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved New Hampshire Regulations
----------------------------------------------------------------------------------------------------------------
                                                             State       EPA approval date
          State citation              Title/subject     effective date          \1\              Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Env-A 1500.......................  Conformity.........       1/18/2020  3/10/2022 [Insert    Env-A 1500 revision
                                                                         Federal Register     approved entirely.
                                                                         citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
[FR Doc. 2022-05028 Filed 3-9-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Rules and Regulations]
[Page 19135]
[FR Doc No: E9-9637]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2009-0223

Drawbridge Operation Regulations; Gowanus Canal, Brooklyn, NY,
Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Hamilton Avenue Bridge across the Gowanus Canal, mile 1.2, at Brooklyn,
New York. Under this temporary deviation the bridge shall require a
four-hour advance notice for bridge openings for three months and a
three day bridge closure to facilitate bridge maintenance. Vessels that
can pass under the draw without a bridge opening may do so at all
times.

DATES: This deviation is effective from 6 a.m. on April 21, 2009
through 11:59 p.m. on July 31, 2009.

ADDRESSES: and are available online at www.regulations.gov, selecting
the Advanced Docket Search Option on the right side of the screen,
inserting USCG-2009-0223 in the Docket ID box, pressing Enter, and then
clicking on the item in the Docket ID column. 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 rule,
call Judy Leung-Yee, Project Officer, First Coast Guard District,
telephone<PHONE_NUMBER>. If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: The Hamilton Avenue Bridge, across the
Gowanus Canal, mile 1.2, at Brooklyn, New York, has a vertical
clearance in the closed position of 19 feet at mean high water and 23
feet at mean low water. The Drawbridge Operation Regulations are listed
at 33 CFR 117.5. The waterway has seasonal recreational vessels, and
commercial vessels of various sizes. The owner of the bridge, New York
City Department of Transportation, requested a temporary deviation to
facilitate the training of bridge personnel, mechanical and electrical
testing at the bridge.
    Under this temporary deviation the Hamilton Avenue Bridge shall
require at least a four-hour advance notice for bridge openings from
April 24, 2009 through July 31, 2009. In addition a three day bridge
closure will be necessary from 6 a.m. on April 21, 2009 through 8 p.m.
on April 23, 2009, to facilitate bridge railing installation.
    Vessels that can pass under the bridge without a bridge opening may
do so at all times. Notice may be provided by calling<PHONE_NUMBER>.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 10, 2009.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E9-9637 Filed 4-27-09; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Proposed Rules]
[Pages 916-919]
[FR Doc No: 2021-28537]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0661]
RIN 1625-AA11

Regulated Navigation Area; Offshore, Cape Canaveral, Florida

AGENCY: Coast Guard, DHS.

ACTION: Supplemental notice of proposed rulemaking.

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

SUMMARY: On September 17, 2021, the Coast Guard published a notice of
proposed rulemaking (NPRM) proposing to replace the existing safety
zone in Captain of the Port (COTP) zone Jacksonville, Offshore Cape
Canaveral, Florida with a regulated navigation area (RNA). Changes in
the type and size of launch vehicles, rocket component recovery
methods, and the increased frequency of launches now pose variable
risks to marine traffic and require a more flexible regulatory tool.
After considering comments received from the public, the Coast Guard is
making modifications to the regulated area in the proposed rule. This
supplemental notice requests comments on the revised proposal.

DATES: Comments and related material must be received by the Coast
Guard on or before February 7, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0661 using the Federal Decision Making Portal at https://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 Junior Grade Stephanie
Miranda, Seventh District, Waterways Management Branch (Dpw), U.S.
Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Coast Guard proposes to replace the existing safety zone in 33
CFR 165.775 titled, ``Safety Zone; Captain of the Port Zone
Jacksonville; Offshore Cape Canaveral, Florida'' with a regulated
navigation area (RNA). The existing safety zone established in 2009 is
composed of four large regulated areas and was established in 2009 with
the intent of protecting marine traffic from the hazards associated
with the launching of space vehicles, to expedite notification to the
public, and to reduce the administrative workload of the Coast Guard.
However, since the establishment of the safety zone in Sec.  165.775,
changes in the type and size of launch vehicles, rocket component
recovery methods, and the increased frequency of launches pose variable
risks to marine traffic and require a more flexible regulatory tool.
    On September 17, 2021, the Coast Guard published a notice of
proposed rulemaking entitled, ``Regulated Navigation Area; Offshore,
Cape Canaveral, Florida in the Federal Register (86 FR 51845) in order
to replace the existing safety zone in Sec.  165.775 with a RNA. During
the comment period that ended on October 18, 2021, we received three
comments and those comments are addressed in Section III of this SNPRM.
    The Coast Guard is proposing this SNPRM under authority in 46
U.S.C. 70034. The purpose of this SNPRM is to revise the regulatory
text as proposed in the NPRM to expand the zone to include additional
missions which are expected to be conducted (including the Transport 2
mission conducted by the U.S Space Launch Delta 45 (SLD 45) and
operations by the Blue Origin, LLC), and to include the Captain of the
Port's (COTP) consideration of analysis from (SLD 45) when activating a
zone. The revised regulatory text we are proposing in this SNPRM
appears at the end of this document. It differs from the text proposed
in the NPRM, primarily in that it expands the zone westward to include
areas of operation by the SLD 45 and the Blue Origin, LLC.

III. Discusion of Comments on the NPRM and Change to the Proposed Rule

    In response to the NPRM, the Coast Guard received three public
comments. Unless we receive recommendations for changes during the
SNPRM comment period, we plan to adopt the regulations proposed in the
NPRM with revisions to the regulatory text as reflected in this SNPRM.
The SNPRM provides an additional comment period to shape the final
regulatory action. Concerns received on this SNPRM will be addressed in
the final rule.
    The Coast Guard received a comment addressing the growing effect of
commercial space travel in terms of potential for pollution and hazards
to land and sea vehicles in the path of flight. The commenter felt the
proposed change was valid and important. No changes were made based on
this comment.
    Another comment addressed the growth of the aerospace industry in
the region and associated increase in launch activity observed since
2009. The commenter felt that an evaluation of the 2009 rulemaking and
the associated changes proposed in the NPRM were warranted and in the
interest of preserving the safety of marine interests in the area. No
changes were made based on this comment.
    The Coast Guard received a comment from the Blue Origin Florida,
LLC and included a request for an adjustment to the dimensions of the
RNA to provide a launch hazard area suitable for potential future
launches to Polar Orbits. The change was evaluated and implemented. In
response to this comment, the Coast Guard made changes to the
regulatory text in this SNPRM by making an adjustment to the southeast
launch hazard area to encompass dimensions aligned to a Polar Orbit-
mission specific launch exclusion area as provided by the SLD 45.

IV. Discussion of Proposed Rule

    The proposed rule would establish a RNA in the following revised
area based on comments received during the NPRM comment period: All
waters offshore Cape Canaveral from surface to bottom, encompassed by a
line connecting the following points beginning with Point 1 at
28[deg]48'54'' N, 80[deg]28'40'' W; thence southwest to Point 2 at
28[deg]43'20'' N, 80[deg]41'00'' W; thence south along the shoreline to
Point 3 at 28[deg]25'18'' N, 80[deg]34'43'' W; thence continuing south
offshore to Point 4 at 28[deg]11'00'' N,

80[deg]29'00'' W; thence east to Point 5 at 28[deg]10'00'' N,
80[deg]21'13'' W; thence north along the 12 nautical mile line back to
Point 1. Coordinates are in WGS 1984. These coordinates are based on
the furthest north and south trajectories of typical rocket launch
vehicles originating from Cape Canaveral. In addition, there are five
launch hazard areas in which the majority of rocket launches will fall
and are meant to alert mariners to the general areas in which launches
will occur. We list the coordinates and locations of the five launch
hazard areas in the regulatory text of this SNPRM.
    When the RNA is deemed activated, the COTP or a designated
representative would be able to restrict vessel movement including but
not limited to transiting, anchoring, or mooring within this RNA to
protect vessels from hazards associated with rocket launches. Active
restrictions are based on mission specific launch exclusion areas
provided by the SLD 45, are temporary in nature, and would only be
enacted and enforced prior to and just after a launch. The COTP would
be able to activate any single area, a combination of areas, or
establish areas within the RNA boundary area as warranted by specific
risks posed by individual launches. The determination of risk would be
at the discretion of the COTP and informed by the mission specific
launch exclusion areas provided by SLD-45.
    The COTP would inform the public of the activation or status of the
RNA and specific exclusion areas, by Broadcast Notice to Mariners on
VHF-FM channel 16, Public Notice of Enforcement, on-scene presence, and
by the display of a yellow ball from a 90-foot pole near the shoreline.

V. 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 and 13563 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. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    The RNA will operate in a similar way to the existing safety zone,
but will reduce the size of exclusionary areas for each specific rocket
launch. We expect the economic impact of this rule to be so minimal
that a full regulatory evaluation is unnecessary. The RNA will only be
activated a reasonable time before a launch and deactivated once the
area is no longer hazardous.

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.
    The total time of the RNA activation and thus restriction to the
public is expected to be approximately one hour per launch. Vessels
would be able to transit around the activated RNA locations during
these launches. We do not anticipate any significant economic impact
resulting from activation of the RNA.
    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 call or email 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 Executive Order 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 Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 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 call or email 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, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01 and Commandant Instruction M16475.1D 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. This proposed rule involves the activation of a RNAwith
exclusionary zones smaller than the existing safety zones. The
activation of the RNA is expected to be an hour total per occurrence.
Normally such actions

are categorically excluded from further review under paragraph L60(a)
of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. 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 call or email 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.

VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material 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.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2021-0661 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

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:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Revise Sec.  165.775 to read as follows:

Sec.  165.775   Regulated Navigation Area; Launch Area Offshore Cape
Canaveral, FL.

    (a) Location.
    (1) The following area is a regulated navigation area (RNA): All
waters offshore Cape Canaveral from surface to bottom, encompassed by a
line connecting the following points beginning with Point 1 at
28[deg]48'54'' N, 80[deg]28'40'' W; thence southwest to Point 2 at
28[deg]43'20'' N, 80[deg]41'00'' W; thence south along the shoreline to
Point 3 at 28[deg]25'18'' N, 80[deg]34'43'' W; thence continuing south
offshore to Point 4 at 28[deg]11'00'' N, 80[deg]29'00'' W; thence east
to Point 5 at 28[deg]10'00'' N, 80[deg]21'13'' W; thence north along
the 12 nautical mile line back to Point 1. Coordinates are in WGS 1984.
These coordinates are based on the furthest north and south
trajectories of typical rocket launch vehicles originating from Cape
Canaveral.
    (2) Restrictions may be enforced anywhere within the boundaries of
the RNA. Restrictions will be based on the risk assessment of the
Captain of the Port Jacksonville and informed by the mission specific
launch exclusion areas provided by U.S Space Launch Delta 45 (SLD 45).
There are five launch hazard areas that cover rocket launches. Launch
hazard areas include all navigable waters within the following
coordinates, encompassed by a line starting at Point 1 connecting the
following points:
    (i) Northeast Launch Hazard Area:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]47'47'' N    080[deg]27'48'' W
Point 2.......................  28[deg]42'18'' N    080[deg]34'55'' W
Point 3.......................  28[deg]39'13'' N    080[deg]37'49'' W
Point 4.......................  28[deg]32'29'' N    080[deg]33'53'' W
Point 5.......................  28[deg]34'00'' N    080[deg]29'00'' W
Point 6.......................  28[deg]39'43'' N    080[deg]21'57'' W
------------------------------------------------------------------------

    (ii) East Northeast Launch Hazard Area:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]43'53'' N    080[deg]24'50'' W
Point 2.......................  28[deg]36'10'' N    080[deg]35'20'' W
Point 3.......................  28[deg]31'46'' N    080[deg]33'40'' W
Point 4.......................  28[deg]34'42'' N    080[deg]28'40'' W
Point 5.......................  28[deg]40'45'' N    080[deg]22'28'' W
------------------------------------------------------------------------

    (iii) Large East Launch Hazard Area:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]40'32'' N    080[deg]22'21'' W
Point 2.......................  28[deg]39'14'' N    080[deg]37'48'' W
Point 3.......................  28[deg]27'00'' N    080[deg]31'55'' W
Point 4.......................  28[deg]27'35'' N    080[deg]18'27'' W
------------------------------------------------------------------------

    (iv) Small East Launch Hazard Area:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]39'42'' N    080[deg]21'56'' W
Point 2.......................  28[deg]39'00'' N    080[deg]31'00'' W
Point 3.......................  28[deg]38'00'' N    080[deg]36'58'' W
Point 4.......................  28[deg]32'00'' N    080[deg]33'45'' W
Point 5.......................  28[deg]31'51'' N    080[deg]20'41'' W
------------------------------------------------------------------------

    (v) Southeast Launch Hazard Area:

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

------------------------------------------------------------------------
Point 1.......................  28[deg]37'00'' N    080[deg]29'00'' W
Point 2.......................  28[deg]35'48'' N    080[deg]34'59'' W
Point 3.......................  28[deg]25'18'' N    080[deg]34'43'' W
Point 4.......................  28[deg]11'00'' N    080[deg]29'00'' W
Point 5.......................  28[deg]10'00'' N    080[deg]21'13'' W
Point 6.......................  28[deg]19'36'' N    080[deg]23'10'' W
Point 7.......................  28[deg]22'11'' N    080[deg]20'17'' W
------------------------------------------------------------------------

    (b) Definitions. The following definitions apply to this section:
Designated representative means Coast Guard Patrol Commanders including
Coast Guard coxswains, petty officers and other officers operating
Coast Guard vessels, and federal, state, and local officers designated
by or assisting the Captain of the Port (COTP) Jacksonville in the
enforcement of RNAs, safety zones, and security zones.
    (c) Regulations. (1) The COTP Jacksonville or a designated
represented may restrict vessel movement including but not limited to
transiting, anchoring, or mooring within this RNA to protect vessels
from hazards associated with rocket launches. These restrictions are
temporary in nature and will only be enacted and enforced prior to and
just after a launch.
    (2) The COTP Jacksonville may activate restrictions within any
single area, a combination of areas, or establish ad hoc areas within
the RNA boundary area. Activation of prescribed or ad hoc Launch Hazard
Areas will be based on the risk assessment of the Captain of the Port
Jacksonville and informed by the mission specific launch exclusion
areas

provided by SLD 45 to account for the specific risks posed by
individual launches.
    (d) Notice of activation of RNA. The COTP Jacksonville will inform
the public of the activation or status of the RNA and specific
exclusion areas, by Broadcast Notice to Mariners on VHF-FM channel 16,
Public Notice of Enforcement, on-scene presence, and by the display of
a yellow ball from a 90-foot pole near the shoreline at approximately
28[deg]35'00'' N, 080[deg]34'36'' W and from a 90-foot pole near the
shoreline at approximately 28[deg]55'18'' N, 080[deg]35'00'' W. Coast
Guard assets or other Federal, State, or local law enforcement assets
will be clearly identified by lights, markings, or with agency
insignia.
    (e) Contact information. The COTP Jacksonville may be reached by
telephone at<PHONE_NUMBER>. Any on-scene Coast Guard or designated
representative assets may be reached on VHF-FM channel 16.

    Dated: December 22, 2021.
Brendan C. McPherson,
Rear Admiral, Commander, Seventh Coast Guard District.
[FR Doc. 2021-28537 Filed 1-6-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54147-54148]
[FR Doc No: 2018-23423]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2017-0004]

Maritime Advisory Committee for Occupational Safety and Health
(MACOSH): Request for Nominations

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for nominations.

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

SUMMARY: OSHA invites interested persons to submit nominations for
membership on the Maritime Advisory Committee for Occupational Safety
and Health.

DATES: You must submit nominations for MACOSH membership (postmarked,
sent, transmitted, or received) by December 10, 2018.

ADDRESSES: You may submit nominations and supporting materials by one
of the following methods:
    Electronically: You may submit nominations, including attachments,
electronically at: http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for submitting nominations.
    Facsimile: If your nomination and supporting materials, including
attachments, do not exceed 10 pages, you may fax them to the OSHA
Docket Office at<PHONE_NUMBER>.
    Regular mail, express mail, hand delivery, and messenger or courier
service: You may submit nominations and supporting materials to the
OSHA Docket Office, Docket No. OSHA-2015-0014, Occupational Safety and
Health Administration, U.S. Department of Labor, Room N-3653, 200
Constitution Avenue NW, Washington, DC 20210. Deliveries (express mail,
hand (courier) delivery, and messenger service) are accepted during the
Docket Office's normal business hours, 10:00 a.m. to 3:00 p.m., ET.
    Instructions: All submissions must include the agency name and
docket number for this Federal Register notice (Docket No. OSHA-2017-
0004). Because of security-related procedures, submissions by regular
mail may result in a significant delay in receipt. Please contact the
OSHA Docket Office for information about security procedures for making
submissions by express mail, hand (courier) delivery, and messenger
service.
    OSHA will post submissions in response to this Federal Register
notice, including personal information provided, without change at
http://www.regulations.gov. Therefore, OSHA cautions interested parties
about submitting personal information such as Social Security numbers
and birthdates.
    Docket: To read or download submissions in response to this Federal
Register notice, go to Docket No. OSHA-2017-0004 at http://www.regulations.gov. All documents in the docket are available in the
http://www.regulations.gov index; however, some documents (e.g.,
copyrighted material) are not publicly available to read or download
through that web page. All submissions, including copyrighted material,
are available for inspection and copying at the OSHA Docket Office.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    For general information about MACOSH: Ms. Amy Wangdahl, Director,
Office of Maritime and Agriculture, OSHA, U.S. Department of Labor;
telephone:<PHONE_NUMBER>; email [email protected].
    For copies of this Federal Register notice: Electronic copies of
this Federal Register notice are available at http://www.regulations.gov. This notice, as well as news releases and other
relevant information, are also available at OSHA's web page at:
www.osha.gov.

SUPPLEMENTARY INFORMATION: The Secretary of Labor invites interested
persons to submit nominations for membership on MACOSH.

I. Background

    The Secretary of Labor renewed the MACOSH charter for two years on
January 23, 2017. MACOSH is a Federal Advisory Committee established
under the authority of the Occupational Safety and Health Act (OSH Act)
(29 U.S.C. 651 et seq.), the Federal Advisory Committee Act (FACA) 5
U.S.C. App. 2, and regulations issued pursuant to those statutes (29
CFR part 1912, 41 CFR part 102-3). The Committee advises the Secretary
of Labor on matters relating to occupational safety and health
programs, enforcement, new initiatives, and standards for the maritime
industries of the United States, which include longshoring, marine
terminals, commercial fishing, and shipyard employment. OSHA invites
persons interested in serving on MACOSH to submit their names for
consideration for Committee membership.
    MACOSH reports to the Secretary of Labor through OSHA, and
functions solely as an advisory body. MACOSH provides recommendations
and advice to the Department of Labor and OSHA on various policy issues
pertaining to safe and healthful employment in the maritime industries.
The Secretary of Labor consults with MACOSH on various subjects,
including: Ways to increase the effectiveness of safety and health
standards that apply to the maritime industries, injury and illness
prevention, the use of stakeholder partnerships to improve training and
outreach initiatives, and ways to increase the national dialogue on
occupational safety and health. In addition, MACOSH provides advice on
enforcement initiatives that will improve the working conditions and
the safety and health of workers in the maritime industries. The
Committee meets approximately two times per year. Committee members
serve without compensation, but OSHA provides travel and per diem
expenses. Members serve a two-year term, which begins from the date of
appointment by the Secretary of Labor. The term of the most recent
MACOSH membership expired on January 20, 2018.

II. MACOSH Membership

    MACOSH consists of not more than 15 members appointed by the
Secretary of Labor. The Agency seeks committed members who have a
strong interest in the safety and health of workers in the maritime
industries. The U.S. Department of Labor is committed to equal
opportunity in the workplace. The Secretary of Labor will appoint
members to create a broad-based, balanced, and diverse committee
reflecting the shipyard, longshoring, and commercial fishing
industries, and representing affected interests such as employers,
employees, safety and health professional organizations, government
organizations with interests or activities related to the maritime
industry, academia, and the public.
    Nominations of new members, or resubmissions of former members,
will be accepted in all categories of membership. Interested persons
may nominate themselves or submit the name of another person whom they
believe to be interested in and qualified to serve on MACOSH.
Nominations may also be submitted by organizations from one of the
categories listed above (e.g., employer, employee, public, safety and
health professional organization, state safety and health agency,
academia).

III. Submission Requirements

    Nominations must include the following information:
    (1) Nominee's contact information and current employment or
position;
    (2) Nominee's resume or curriculum vitae, including prior
membership on MACOSH and other relevant organizations and associations;
    (3) Maritime industry interest (e.g., employer, employee, public,
safety and health professional organization, state safety and health
agency, academia) that the nominee is qualified to represent;
    (4) A summary of the background, experience, and qualifications
that addresses the nominee's suitability for membership; and
    (5) A statement that the nominee is aware of the nomination, is
willing to regularly attend and participate in MACOSH meetings, and has
no conflicts of interest that would preclude membership on MACOSH.
    OSHA will conduct a basic background check of candidates before
their appointment to MACOSH. The background check will involve
accessing publicly available, internet-based sources.

IV. Member Selection

    The Secretary of Labor will select MACOSH members based on their
experience, knowledge, and competence in the field of occupational
safety and health, particularly in the maritime industries. Information
received through this nomination process, and other relevant sources of
information, will assist the Secretary of Labor in appointing members
to MACOSH. In selecting MACOSH members, the Secretary of Labor will
consider individuals nominated in response to this Federal Register
notice, as well as other qualified individuals. OSHA will publish a
list of MACOSH members in the Federal Register.

Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice under the
authority granted by 29 U.S.C. 655(b)(1) and 656(b), 5 U.S.C. App. 2,
Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR part
1912.

    Signed at Washington, DC, on October 19, 2018.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2018-23423 Filed 10-25-18; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13008-13009]
[FR Doc No: 2015-05513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

2015 Parenteral Drug Association/Food and Drug Administration
Joint Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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

    The Food and Drug Administration (FDA), is announcing a public
conference, to be held in co-sponsorship with the Parenteral Drug
Association (PDA), entitled ``Mission Possible: Patient-Focused
Manufacturing, Quality, and Regulatory Solutions.'' The conference will
cover current issues affecting the industry as well as explore
strategies to facilitate the development and continuous improvement of
safe and effective medical products. The conference establishes a
unique forum to discuss the foundations, emerging technologies, and
innovations in regulatory science, as well as the current quality and
compliance areas of concerns. Meeting participants will hear from FDA
and industry speakers about the requirements and best practices to
consider while implementing robust quality systems in order to deliver
the best quality product.
    Date and Time: The public conference will be held on September 28,
2015, from 7 a.m. to 7:30 p.m.; September 29, 2015, from 7 a.m. to 9:30
p.m.; and September 30, 2015, from 7 a.m. to 12:30 p.m.
    Location: The public conference will be held at the Renaissance
Washington Hotel, 999 Ninth Street NW., Washington, DC 20001, 202-898-
9000, FAX:<PHONE_NUMBER>.
    Contact: Wanda Neal, Parenteral Drug Association, PDA Global
Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 150,
Bethesda, MD 20814,<PHONE_NUMBER>, ext. 111, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Ken Nolan, Office of Communications, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-8629, email<EMAIL_ADDRESS>    Accommodations: Attendees are responsible for their own
accommodations. To make reservations, contact the Renaissance
Washington Hotel (see Location) and reference ``the 2015 PDA/FDA Joint
Regulatory Conference'' to receive the PDA group rate. Room rates are:
Single: $305 plus 14.5 percent State and local taxes. Requests will be
processed on a first-come, first-served basis.
    Registration: Attendees are encouraged to register at their
earliest convenience. The PDA registration fees cover the cost of
facilities, materials, and refreshments. Seats are limited; please
submit your registration as soon as possible. Conference space will be
filled in order of receipt of registration. Those accepted for the
conference will receive confirmation. Registration will close after the
conference is filled. Onsite registration will be available on a space
available basis beginning at 1 p.m. on September 27, 2015, and at 7
a.m. from September 28 through 30, 2015. The cost of registration is as
follows:

                          Cost of Registration
------------------------------------------------------------------------
                                                  July 19-      After
           Affiliation             Before July   August 18,   August 18,
                                     19, 2015       2015         2015
------------------------------------------------------------------------
     Premier Package (Includes Conference and Workshop Registration)
------------------------------------------------------------------------
Member...........................       $3,240       $3,490       $3,740
Nonmember........................        3,599        3,849        4,099
------------------------------------------------------------------------
                             Conference Only
------------------------------------------------------------------------
Member...........................        1,895        2,095        2,295
Nonmember........................        2,154        2,354        2,554
Government/Health Authority                700          700          700
 Member..........................
Government/Health Authority                800          800          800
 Nonmember *.....................
Academic Member..................          700          700          700
Academic Nonmember *.............          800          800          800

Student Member...................          280          280          280
Student Nonmember *..............          310          310          310
------------------------------------------------------------------------
* For this member type, online registration is not available and must be
  faxed in.

    Please visit PDA's Web site: www.pda.org/pdafda2015 to confirm the
prevailing registration fees. (FDA has verified the Web site address,
but FDA is not responsible for any subsequent changes to the Web site
after this document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please
contact Wanda Neal (see Contact), at least 7 days in advance of the
conference.
    Registration Instructions: To register, please submit your name,
affiliation, mailing address, telephone, fax number, and email address,
along with a check or money order payable to ``PDA.'' Mail to: PDA,
Global Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 150,
Bethesda, MD 20814. To register via the Internet, go to PDA's Web site:
www.pda.org/pdafda2015.
    The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting,
or for questions on registration, contact PDA (see Contact).
    Transcripts: As soon as a transcript is available, it can be
obtained in either hardcopy or on CD-ROM, after submission of a Freedom
of Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The PDA/FDA Joint Regulatory Conference
offers the unique opportunity for participants to join FDA
representatives and industry experts in face-to-face dialogues. Each
year, FDA speakers provide updates on current efforts affecting the
development of global regulatory strategies, while industry
professionals from pharmaceutical companies present case studies on how
they employ global strategies in their daily processes.
    Through a series of sessions and meetings, the conference will
provide participants with the opportunity to hear directly from FDA
experts and representatives of global regulatory authorities on best
practices, including:
     Product Quality
     Data Integrity
     Breakthrough Therapies
     Regulatory Challenges and Opportunities
     Lifecycle Management
     Clinically Relevant Specifications
     Food and Drug Administration Safety and Innovation Act
     Quality Metrics/Quality Culture
     Manufacturing of the Future With Submissions
     Continuous Verification and Validation
     Continuous Manufacturing
     ``Fishbowl'' Role Play
     Quality Systems
     Contract Manufacturing Organizations
     Maturity of Quality Systems
     Investigations
     Case Studies for Quality
     Quality Submissions
     Prescription Drug User Fee Act
     Risk-Based Control Strategies
     Supply Chain
     Quality Risk Management Systems
     Drug Shortages
     Customer Complaint Reviews and Trending
     Human Factors
     Office of Pharmaceutical Quality and Program Alignment
Group
     Patient Perspective
     Compliance Update
     Center Initiatives--Regulatory Submission Update
    To help ensure the quality of FDA-regulated products, the workshop
helps to achieve objectives set forth in section 406 of the FDA
Modernization Act of 1997 (21 U.S.C. 393), which includes working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. The workshop also is
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Pub. L. 104-121), as outreach activities by government
agencies to small businesses.

    Dated: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05513 Filed 3-11-15; 8:45 am]
 BILLING CODE 4164-01-P