[Federal Register Volume 86, Number 46 (Thursday, March 11, 2021)]
[Proposed Rules]
[Pages 13830-13833]
[FR Doc No: 2021-05086]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1171; Product Identifier 2017-SW-124-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Deutschland GmbH Model MBB-BK 117 C-2 and
Model MBB-BK 117 D-2 helicopters. This proposed AD was prompted by a
determination that a life limit for the adapter forward (FWD) of the
outboard load system, repetitive inspections of other components of
that system, and for certain helicopters, a modification of the
outboard load system, are necessary to address the unsafe condition.
This proposed AD would require a modification of the outboard load
system for certain helicopters, repetitive inspections of the outboard
load system and its components for any defect (including cracking,
damage, corrosion, and incorrect installation) and applicable
corrective actions, and implementation of a new life limit for the FWD
adapter, as specified in a European Aviation Safety Agency (EASA) AD,
which is proposed for incorporation by reference (IBR). The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by April 26,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that is proposed for IBR in this AD, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999
000;

email<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find
this material on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-1171.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1171; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aviation Safety
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2020-1171; Product Identifier
2017-SW-124-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Kathleen Arrigotti, Aviation Safety Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Any commentary that the FAA receives that
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Discussion

    The EASA (now European Union Aviation Safety Agency), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2017-0177, dated September 14, 2017 (EASA AD 2017-0177) (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), to correct an unsafe condition for all Airbus Helicopters
Deutschland GmbH Model MBB-BK 117 C-2 helicopters, except the Model C-
2e variant, and all Model MBB-BK 117 D-2 helicopters.
    Airbus Helicopters Deutschland GmbH MBB-BK 117 C-2e variant
helicopters are not a unique model on the U.S. type certificate but are
considered a configuration of the Model MBB-BK117 C-2. The U.S. type
certificate data sheet explains that the FAA determined that the type
design changes involved did not rise to the level that required an FAA
amended type certificate. However, the FAA does recognize that
helicopters with these type design changes exist, therefore the
designation Model MBB-BK117 C-2(e) is used, starting from Serial Number
9601. The Model MBB-BK117 C-2(e) is a visual flight rules only
configuration of the Model MBB-BK117 C-2 utilizing a Garmin 500H flight
display system.
    This proposed AD was prompted by a determination that a life limit
for the adapter FWD of the outboard load system, repetitive inspections
of other components of that system, and for certain helicopters, a
modification of the outboard load system, are necessary to address the
unsafe condition. The FAA is proposing this AD to address detachment of
an external load or person from the helicopter hoist, resulting in
personal injury, or injury to persons on the ground. See the MCAI for
additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2017-0177 describes procedures for modification of the
outboard load system for certain Model MBB-BK 117 C-2 helicopters,
repetitive inspections of the outboard load system and its components
for any defect (including cracking, damage, corrosion, and incorrect
installation) and corrective actions, and implementation of a new life
limit for the FWD adapter (i.e., repetitive replacements). The
corrective actions include replacement of any defective component with
a serviceable part.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD after evaluating all the
relevant information and determining the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2017-0177, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to

use this process. As a result, EASA AD 2017-0177 will be incorporated
by reference in the FAA final rule. This proposed AD would, therefore,
require compliance with EASA AD 2017-0177 in its entirety, through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this proposed AD. Using common terms that are
the same as the heading of a particular section in the EASA AD does not
mean that operators need comply only with that section. For example,
where the AD requirement refers to ``all required actions and
compliance times,'' compliance with this AD requirement is not limited
to the section titled ``Required Action(s) and Compliance Time(s)'' in
the EASA AD. Service information specified in EASA AD 2017-0177 that is
required for compliance with EASA AD 2017-0177 will be available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-1171 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 175 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................          $1,306           $1,476         $258,300
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable providing cost estimates for the modification
  specified in this proposed AD.

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition actions:

                Estimated Costs of On-Condition Action *
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                                                             Cost per
              Labor cost                   Parts cost        product
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2 work-hours x $85 per hour = $170....           $ (*)         $170 (*)
------------------------------------------------------------------------
* The FAA has not received any definitive data regarding the parts cost,
  therefore this table does not include estimated costs for parts.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2020-1171;
Product Identifier 2017-SW-124-AD.

(a) Comments Due Date

    The FAA must receive comments by April 26, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 C-2 and Model MBB-BK 117 D-2 helicopters, certificated in
any category, all manufacturer serial numbers, except the Model MBB-
BK117 C-2(e) configuration.

    Note 1 to paragraph (c):  Model MBB-BK117 C-2 helicopters
utilizing a Garmin 500H flight display system are designated by EASA
as Model MBB-BK117 C-2e variants of the Model BK 117 C-2
helicopters, and by the FAA as a Model MBB-BK117 C-2(e)
configuration.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2500, Cabin
Equipment/Furnishings.

(e) Reason

    This AD was prompted by a determination that a life limit for
the adapter forward (FWD) of the outboard load system, repetitive
inspections of other components of that system, and for certain
helicopters, a modification of the outboard load system are
necessary to address the unsafe condition. The FAA is issuing this
AD to address detachment of an external load or person from the
helicopter hoist, which could result in personal injury, or injury
to persons on the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2017-0177, dated September 14,
2017 (EASA AD 2017-0177).

(h) Exceptions to EASA AD 2017-0177

    (1) Where EASA AD 2017-0177 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2017-0177 does not apply
to this AD.
    (3) Where the service information referenced in EASA AD 2017-
0177 specifies contacting the applicable manufacturer of the
dedicated equipment for a definition of a cycle and recalculation to
hoist cycles, this AD does not require contacting the manufacturer
for a definition of a cycle and recalculation to hoist cycles.
    (4) Where paragraph (3) of EASA AD 2017-0177 specifies to do
``applicable corrective actions,'' for this AD, if there are any
defective components, replace all defective components with
serviceable components in accordance with FAA-approved procedures.
For the purposes of this AD, a defect may be indicated by cracking,
damage, corrosion, or incorrect installation.
    (5) Although the service information referenced in EASA AD 2017-
0177 specifies to discard certain parts, this AD requires removing
those parts from service instead.
    (6) Where the service information referenced in EASA AD 2017-
0177 refers to flight hours (FH), this AD requires using hours time-
in-service.
    (7) Paragraph (9) of EASA AD 2017-0177 does not apply to this
AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Manager of the Strategic Policy Rotorcraft Section,
send it to: Manager, Strategic Policy Rotorcraft Section, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local Flight Standards District Office/Certificate Holding
District Office.

(j) Related Information

    (1) For EASA AD 2017-0177, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-1171.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aviation Safety Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
    Issued on January 5, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-05086 Filed 3-10-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 215 (Wednesday, November 6, 2019)]
[Notices]
[Pages 59833-59836]
[FR Doc No: 2019-24229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4763]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Assessment of Terms and Phrases Commonly Used in
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on research entitled ``Assessment of Terms and
Phrases Commonly Used in Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection
of information by January 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 6, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-4763 for ``Assessment of Terms and Phrases Commonly Used in
Prescription Drug Promotion.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For copies of the questionnaire, contact: Office
of Prescription Drug Promotion (OPDP) Research Team,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes Agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
Federal Agencies to provide a 60-day notice in

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

Assessment of Terms and Phrases Commonly Used in Prescription Drug
Promotion

OMB Control Number 0910-New

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotional material is truthful, balanced, and accurately
communicated, so that patients and healthcare providers can make
informed decisions about treatment options. OPDP's research program
provides scientific evidence to help ensure that our policies related
to prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: Advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits; focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience; and our focus on research quality aims at maximizing the
quality of research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
all three topic areas.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a direct-to-consumer
survey conducted in 1999.
    The present research involves assessment of how consumers and
primary care physicians (PCPs) interpret terms and phrases commonly
used in prescription drug promotion. This includes both what these
terms and phrases mean to each population (e.g., definitions) and what
these terms and phrases imply (e.g., about efficacy and safety). Some
examples of interest include: ``natural'' or ``naturally-occurring,''
and ``targeted'' or ``targeted therapy.'' The full list for assessment
will include approximately 30 terms and phrases for each population. To
accommodate such a large number, presented terms and phrases will be
accompanied by only limited context (terms within sentences and phrases
within paragraphs, as opposed to full promotional materials).
Understanding the most prevalent interpretations of these terms and
phrases can help OPDP determine the impact of specific language in
prescription drug promotion. For example, certain terms and phrases,
when used without additional contextual information, might overstate
the efficacy or minimize the risk of a product. Additionally, from a
health literacy perspective, it is helpful to ascertain general
understanding of such terms and phrases as this may aid in the
development of best practices around communicating these concepts.
    We plan to conduct this research in two phases. First, we will
conduct formative semi-structured interviews with 30 members of each
population (general population consumers and PCPs). Second, we will
conduct nationally representative, probability-based surveys of more
than 1,000 members of each population on the same topic.
    Phase 1: Semi-Structured Interviews. In Phase 1 of the research,
semi-structured interviews will be conducted by web conferencing using
the itracks platform, an online and mobile market research service
provider. This approach allows for the participant and interviewer to
see each other and includes a whiteboard feature that can be used to
show the terms, statements, or passages for participants to read and
follow along as the interviewer reads them aloud. This may be helpful
in cases where the statements or passages are long, which may make them
difficult to understand when read aloud. In addition, the written
information may be helpful as a reference as the discussion progresses.
    Participation is estimated to take 1 hour. Participants will be
recruited by email through itracks and its partner panels. All
participants will be 18 years of age or older and must not have
participated in a focus group or interview during the previous 3
months. Additionally, for the consumer sample, we will exclude
individuals who work in healthcare or marketing settings because their
knowledge and experiences may not reflect those of the average
consumer. For the PCP sample, we will exclude individuals who spend
less than 50 percent of their time on patient care. Department of
Health and Human Services employees will be excluded from both
respondent groups. We will start data collection with a soft launch of
three interviews per segment (10 percent) to ensure that all processes
are working well. Although we do not intend on making major changes to
the interview guides as a result of these soft launch interviews, they
will provide an opportunity to make minor changes (e.g., adding
interviewer notes). Measurement for this phase will consist of a
thematic analysis using a matrix approach to identify themes and mental
models common across participants.
    Phase 2: Nationally Representative Surveys. In Phase 2 of the
research, primarily closed-ended survey questions will be administered
to each population. The closed-ended survey

format will allow the team to quantify the frequency or prevalence of
certain interpretations or meanings among a nationally representative
sample of the general U.S. consumer and physician populations. Final
questions and response options will be informed by key interpretations
discovered during the Phase 1 interviews. For the consumer survey, we
will use a probability sample selected from an address-based sampling
frame and conduct the survey using a web-based platform. For the PCP
survey, we will obtain a probability sample from the American Medical
Association Masterfile and will conduct the survey via mail. For each
population, we chose the sampling frame and survey mode that has been
shown to produce the highest quality results for that population with
respect to coverage, response rates, and nonresponse bias. The same
exclusion criteria as specified for Phase 1 will be maintained for
Phase 2. Participation is estimated at 20 minutes.
    We also plan to embed an experiment in the PCP mail survey.
Research has shown that including a pen in the survey package can help
to increase response rates and time to response, even potentially
reducing the number of reminders required (Refs. 1 and 2). However, the
shipping of pens can be costly and often pens are damaged in the mail
(e.g., ink can leak, etc.). To determine whether another token
incentive might be as effective at increasing response rates, we will
randomize half of the sample to receive a pen and half to receive a
packet of sticky notes or other token incentive. We will compare
response rates between the two groups to help inform methods for future
studies.
    We set our sample requirements to a 95 percent confidence interval
and a 3 percent margin of error assuming an underlying proportion of
0.50 in the population (which is the most conservative estimate and
overestimates the sample size relative to alternate proportions). These
parameters are commonly used in quantitative survey research (Refs. 3
to 6) and offer balance between precision and cost. Thus, assuming a
total U.S. population of roughly 250 million adults aged 18 or older
(Ref. 7), we estimate the number of completed surveys to be 1,067 for
the general population survey. Assuming a total population of 209,000
PCPs (Ref. 8), with the same 95 percent confidence interval and 3 percent margin of error, we estimate the number of completes
for the provider survey to be 1,062. These sample sizes would also
allow us to detect a mean difference between 0.15 and 0.30
points (Ref. 6).
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of
             Activity                 Number of     responses per       Total annual respondents               Hours per response           Total hours
                                     respondents     respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   General Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes                    85               1  85................................  0.08 (5 minutes).................               7
 (assumes 35% eligible).
Phase 1: Number of completes.....              30               1  30................................  1................................              30
Phase 2: Screener completes                 1,185               1  1,185.............................  0.08 (5 minutes).................              95
 (assumes 90% eligible).
Phase 2: Number of completes.....           1,067               1  1,067 + 10% \2\ = 1,174...........  0.34 (20 minutes)................             399
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     PCP Population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase 1: Screener completes                   104               1  104...............................  0.08 (5 minutes).................               8
 (assumes 30% eligible).
Phase 1: Number of completes.....              30               1  30................................  1................................              30
Phase 2: Screener completes                 1,180               1  1,180.............................  0.08 (5 minutes).................              94
 (assumes 90% eligible).
Phase 2: Number of completes.....           1,062               1  1,062 + 10% \2\ = 1,168...........  0.34 (20 minutes)................             397
                                  ----------------------------------------------------------------------------------------------------------------------
    Total........................  ..............  ..............  ..................................  .................................           1,060
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target
  number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated
  approximately 10 percent overage for both samples in the study.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Bell, K., L. Clark, C. Fairhurst, et al, ``Enclosing A Pen
Reduced Time to Response to Questionnaire Mailings.'' Journal of
Clinical Epidemiology, 74:144-150, 2016.
2. Sharp, L., C. Cochran, S.C. Cotton, et al., ``Enclosing a Pen
with a Postal Questionnaire Can Significantly Increase the Response
Rate.'' Journal of Clinical Epidemiology, 59:747-754, 2006.
3. Bartlett, J.E., J.W. Kotrlik, and C.C. Higgins, ``Organizational
Research: Determining Appropriate Sample Size in Survey Research.''
Information Technology, Learning, and Performance Journal, 19:43-50,
2001.
4. Cochran, W.G. (1997) Sampling Techniques (3rd ed.). New York:
John Wiley & Sons.
5. Dillman, D.A., J.D. Smyth, and L.M. Christian. (2014) internet,
Phone, Mail, and Mixed-mode Surveys: The Tailored Design Method (4th
Ed.). Hoboken, NJ: John Wiley & Sons, Inc.
6. Krejcie, R.V. and D.W. Morgan, ``Determining Sample Size for
Research Activities.'' Educational and Psychological Measurement,
30: 607-610, 1970.
7. *U.S. Census Bureau. (2017) ``National Population by
Characteristics: 2010-2017.'' (Available at: https://www.census.gov.)
8. *Agency for Healthcare Research and Quality. (2011) ``The Number
of Practicing Primary Care Physicians in the United States.''
Retrieved from http://www.ahrq.gov/research/findings/

factsheets/primary/pcwork1/index.html.

    Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24229 Filed 11-5-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 8, 2010 (Volume 75, Number 130)]
[Notices]
[Page 39314-39315]
[DOCID:fr08jy10-139]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62421; File No. SR-OCC-2010-08]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Additional Underlying Interests for Commodity Futures and
Commodity Options Available to ELX Futures, L.P. for Clearing and
Settlement Services

June 30, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of
1934,\1\ notice is hereby given that on June 16, 2010, the Options
Clearing Corporation (``OCC'') filed with the Securities and Exchange
Commission the proposed rule change as described in Items I, II, and
III below, which Items have been prepared primarily by OCC. OCC filed
the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the
Act \2\ and Rule 19b-4(f)(4) thereunder \3\ so that the proposal was
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \3\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The proposed rule change consists of adding Schedule C-1 to the
Agreement for Clearing and Settlement Services (``Agreement'') dated
December 5, 2008, between the Options Clearing Corporation (``OCC'')
and ELX Futures L.P. (``ELX'').

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. OCC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    OCC and ELX are parties to a clearing and settlement agreement
pursuant to which OCC provides clearing services for U.S. treasury
futures traded on ELX. The Agreement further provides, among other
things, that ELX may select additional underlying interests for
commodity futures and commodity options by completing and executing a
Schedule C, which is subject to the agreement of OCC. (ELX may trade
futures options on futures contracts traded on ELX and cleared by OCC
without executing a Schedule C.) When completed and duly executed, a
Schedule C is incorporated into the Agreement and becomes a part
thereof.
    ELX has selected Eurodollar Time Deposits having a principal value
of USD $1,000,000 with a 3-month maturity as an underlying interest for
futures contracts (``Eurodollar Futures'') and OCC has agreed to clear
Eurodollar Futures on behalf of ELX. OCC and ELX have now executed
Schedule C-1 to codify that Eurodollar Futures will be incorporated and
become a part of the Agreement between the parties. Schedule C-1 is
attached as Exhibit 5A to OCC's filing with the Commission.\4\
---------------------------------------------------------------------------

    \4\ The filing, including Schedule C-1, can be seen at http://
www.theocc.com/about/publications/bylaws.jsp.
---------------------------------------------------------------------------

    OCC states that the proposed change is consistent with Section 17A
of the Act \5\ because it makes explicit that OCC will clear pursuant
to the Agreement the Eurodollar futures contracts proposed for trading
by ELX. OCC also states that the proposed rule change is not
inconsistent with the existing rules of OCC including any other rules
proposed to be amended.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose any
burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    OCC has not solicited or received written comments relating to the
proposed rule change. OCC will notify the Commission of any written
comments it receives.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) of the Act \6\ and Rule 19b-4(f)(4) \7\ thereunder
because it effects a change in an existing service of a registered
clearing agency that does not adversely affect the safeguarding of
securities or funds in the custody or control of the clearing agency or
for which it is responsible and does not significantly affect the
respective rights or obligations of the clearing agency or persons
using the service. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \7\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-OCC-2010-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-OCC-2010-08. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at OCC's principal office and on OCC's Web site
at http://www.theocc.com/about/publications/bylaws.jsp. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File No. SR-OCC-2010-08 and should be
submitted on or before July 29, 2010.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-16667 Filed 7-7-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 13 (Friday, January 22, 2021)]
[Notices]
[Pages 6642-6643]
[FR Doc No: 2021-01347]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-23-000]

Columbia Gas Transmission, LLC.; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on January 5, 2021, Columbia Gas Transmission,
LLC, 700 Louisiana Street, Suite 700, Houston, TX 77002-2700 filed in
the above referenced docket a prior notice pursuant to Section 157.205
and 157.216 of the Federal Energy Regulatory Commission's regulations
under the Natural Gas Act, requesting authorization to abandon five
injection/withdrawal wells and associated pipelines and appurtenances,
located in its Coco B and Coco C Storage Fields in Kanawha County, West
Virginia (2021 Coco B and Coco C Wells Abandonment Project or Project).
Columbia proposes to abandon these facilities under authorities granted
by its blanket certificate issued in Docket No. CP83-76-000.\1\ The
proposed abandonments will have no impact on Columbia's existing
customers or affect Columbia's existing storage operations. The
estimated cost for the Project is approximately $2.8 million, all as
more fully set forth in the request which is on file with the
Commission and open to public inspection.
---------------------------------------------------------------------------

    \1\ Columbia Gas Transmission Corporation (predecessor to
Columbia Gas Transmission, LLC), 22 FERC 62,029 (1983).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Dave Hammel, Director, Commercial & Regulatory Law,<PHONE_NUMBER>,
exception occurred on : 2021-01347.htm
exception occurred on : 2021-01347.htm
[email protected]">dave_[email protected], Columbia Gas Transmission, LLC, 700 Louisiana
Street, Suite 700, Houston, TX 77002-2700.

Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on March 15, 2021.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is March 15, 2021. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is March 15, 2021. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before March 15, 2021. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP21-23-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
---------------------------------------------------------------------------

    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below.\8\ Your submission must reference the Project docket
number CP21-23-000.
---------------------------------------------------------------------------

    \8\ Hand-delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
---------------------------------------------------------------------------

    Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
exception occurred on : 2021-01347.htm
exception occurred on : 2021-01347.htm
either by mail or email (with a link to the document) at: [email protected]">dave_[email protected], 700 Louisiana Street, Suite 700, Houston, TX
77002-2700. Any subsequent submissions by an intervenor must be served
on the applicant and all other parties to the proceeding. Contact
information for parties can be downloaded from the service list at the
eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: January 14, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-01347 Filed 1-21-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Pages 5592-5593]
[FR Doc No: 2015-01898]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9713; 34-74158, File No. 265-27]

Advisory Committee on Small and Emerging Companies

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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

SUMMARY: The Securities and Exchange Commission Advisory Committee on
Small and Emerging Companies is providing notice that it will hold an
open, public telephone meeting on Tuesday, February 17, 2015, beginning
at 2:00 p.m. EST. Members of the public may attend the meeting by
listening to the webcast accessible on the Commission's Web site at
www.sec.gov. Persons needing special accommodations to access the
meeting because of a disability should notify the contact person listed
below. The agenda for the meeting includes consideration of
recommendations to the Commission regarding the definition of
``accredited

investor.'' The public is invited to submit written statements for the
meeting, including any comments.

DATES: The public meeting will be held on Tuesday, February 17, 2015.
Written statements should be received on or before Friday, February 13,
2015.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

     Use the Commission's Internet submission form (http://www.sec.gov/info/smallbus/acsec.shtml); or
     Send an email message to<EMAIL_ADDRESS>Please
include File Number 265-27 on the subject line; or

Paper Statements

    Send paper statements in triplicate to Brent J. Fields, Federal
Advisory Committee Management Officer, Securities and Exchange
Commission, 100 F Street, NE., Washington, DC 20549-1090. All
submissions should refer to File No. 265-27. This file number should be
included on the subject line if email is used. To help us process and
review your statement more efficiently, please use only one method. The
Commission will post all statements on the Advisory Committee's Web
site at http://www.sec.gov./info/smallbus/acsec.shtml.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Julie Z. Davis, Senior Special
Counsel, at<PHONE_NUMBER>, Office of Small Business Policy, Division
of Corporation Finance, Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: In accordance with Section 10(a) of the
Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations
thereunder, Keith F. Higgins, Designated Federal Officer of the
Committee, has ordered publication of this notice.

    Dated: January 28, 2015.
Brent J. Fields,
Committee Management Officer.
[FR Doc. 2015-01898 Filed 1-30-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 22, 2006 (Volume 71, Number 98)]
[Notices]
[Page 29327]
[DOCID:fr22my06-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-356-000]

Transcontinental Gas Pipe Line Corporation; Notice of Proposed
Changes in FERC Gas Tariff

May 12, 2006.
    Take notice that on May 9, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Eighth Revised Sheet No. 30, Sixth
Revised Sheet No. 437, and First Revised Sheet No. 438, to become
effective June 9, 2006.
    Transco states that the purpose of this filing is to revise
Transco's Form of Service Agreement under Seller's Rate Schedule FT to
insert alternative language in Article IV, Term of Agreement, to be
used for firm transportation service under newly constructed expansion
projects whose in-service date is unknown at the time of the service
agreement's execution.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7704 Filed 5-19-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Pages 57814-57816]
[FR Doc No: 2017-26425]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0073; Notice 1]

FCA US LLC, Receipt of Petition for Decision of Inconsequential
Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: FCA US LLC (FCA US), (f/k/a Chrysler Group LLC) has determined
that certain Mopar Service seat belt assemblies sold to FCA dealers as
replacement equipment in certain model year (MY) 1992-2018 FCA US motor
vehicles do not fully comply with Federal Motor Vehicle Safety Standard
(FMVSS) No. 209, Seat Belt Assemblies. FCA US filed a noncompliance
report dated July 25, 2017. FCA US also petitioned NHTSA on August 17,
2017, for a decision that the subject noncompliance is inconsequential
as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is January 8,
2018.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the Internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:

    I. Overview: FCA US LLC (FCA US), (f/k/a Chrysler Group LLC) has
determined that certain Mopar Service seat belt assemblies sold to FCA
dealers as replacement equipment in certain model year (MY) 1992-2018
FCA US motor vehicles do not fully comply with paragraphs S4.1(k) and
S4.1(l) of Federal Motor Vehicle Safety Standard (FMVSS) No. 209, Seat
Belt Assemblies. FCA US filed a noncompliance report dated July 25,
2017, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. FCA US also petitioned NHTSA on August 17,
2017, pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556,
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety.
    This notice of receipt of FCA US petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Equipment and Vehicles Involved: Approximately 728,100 Mopar
Service seat belt assemblies sold to FCA dealers as replacement
equipment for use in the following FCA motor vehicles are potentially
involved:

 2010-2017 Ram 3500 Cab Chassis (``DD'')
 2016-2017 Ram 3500 Cab Chassis (``DF'')
 2010-2017 Ram 2500 (``DJ'')
 2010-2017 Ram 4500/5500 Cab Chassis (``DP'')
 2009-2017 Ram 1500 (``DS'')
 2010-2017 Ram 3500 (``D2'')
 2012-2017 Fiat 500 (``FF'')
 2009-2017 Dodge Journey (``JC'')
 2007-2017 Jeep Wrangler (``JK'')
 2014-2017 Jeep Cherokee (``KL'')
 2015-2017 Dodge Challenger (``LA'')
 2012-2017 Chrysler 300 (``LX'')
 2012-2017 Dodge Charger (``LD'')
 2008-2017 Jeep Compass (``MK'')
 2008-2017 Jeep Patriot (``MK'')
 2012-2017 Dodge Dart (``PF'')
 2015-2017 Chrysler 200 (``UF'')
 2008-2017 Chrysler Town & Country (``RT'')
 2008-2017 Dodge Grand Caravan (``RT'')
 2017 Chrysler Pacifica (``RU'')
 2011-2017 Dodge Durango (``WD'')
 2011-2017 Jeep Grand Cherokee (``WK'')
 2013-2017 Dodge SRT Viper (``ZD'')
 2002-2008 Dodge Ram 1500 (``DR'')
 2004-2010 Dodge Durango (``HB'')
 2007-2010 Chrysler Aspen (``HG'')
 2005-2012 Dodge Dakota (``ND'')
 1994-2002 Dodge Ram 1500 (``BR'')
 1993-2004 Dodge Intrepid (``LH'')
 1993-2004 Chrysler Concorde (``LH'')
 1993-2004 Chrysler 300M (``LH'')
 1995-2005 Dodge Neon (``PL'')
 2006-2012 Dodge Caliber (``PM'')
 1997-2000 Plymouth Prowler (``PR'')
 2001-2002 Chrysler Prowler (``PR'')
 2001-2010 Chrysler PT Cruiser (``PT'')
 1992-2002 Dodge Viper (``SR'')
 2003-2010 Dodge Viper (``ZB'')
 1993-1998 Jeep Grand Cherokee (``ZJ'')
 2014-2018 Ram ProMaster (``VF'')
 2015-2018 Ram ProMaster City (``VM'')
 2015-2018 Jeep Renegade (``BU'')
 2015-2017 Fiat 500x (``FB'')
 2014-2017 Fiat 500L (``BF'')
 2016-2017 Alfa Romeo Giulia (``GA'')
 2015-2017 Alfa Romeo 4C (``4C'')
 2017 Fiat 124 Spider (``BA'')

    III. Noncompliance: FCA US explains that the noncompliance is that
the Mopar Service Seat Belt assemblies sold to FCA US dealerships for
use or for subsequent resale to dealership customers for the subject
vehicles, were sold without the proper inclusion of the ``I-Sheets''
(i.e., ``Installation instructions'' and ``Usage and maintenance
instructions''), and therefore, do not meet all applicable requirements
specified in paragraphs S4.1(k) and 4.1(l) of FMVSS No. 209.
    IV. Rule Text: Paragraph S4.1(k) and S4.1(l) of FMVSS No. 209
states, in pertinent part:

    S4 Requirements.
    S4.1 . . .
    (k) Installation instructions. A seat belt assembly, other than
a seat belt assembly installed in a motor vehicle by an automobile
manufacturer, shall be accompanied by an instruction sheet providing
sufficient information for installing the assembly in a motor
vehicle. The installation instructions shall state whether the
assembly is for universal installation or for installation only in
specifically stated motor vehicles, and shall include at least those
items specified in SAE Recommended Practice J800c (1973)
(incorporated by reference, see Sec.  571.5). If the assembly is for
use only in specifically stated motor vehicles, the assembly shall
either be permanently and legibly marked or labeled with the
following statement, or the instruction sheet shall include the
following statement:
    This seat belt assembly is for use only in [insert specific
seating position(s), e.g., ``front right''] in [insert specific
vehicle make(s) and model(s)].
    (l) Usage and maintenance instructions. A seat belt assembly or
retractor shall be accompanied by written instructions for the
proper use of the assembly, stressing particularly the importance of
wearing the assembly snugly and properly located on the body, and on
the maintenance of the assembly and periodic inspection of all
components. The instructions shall show the proper manner of
threading webbing in the hardware of seat belt assemblies in which
the webbing is not permanently fastened. Instructions for a
nonlocking retractor shall include a caution that the webbing must
be fully extended from the retractor during use of the seat belt
assembly unless the retractor is attached to the free end of webbing
which is not subjected to any tension during restraint of an
occupant by the assembly. Instructions for Type 2a shoulder belt
shall include a warning that the shoulder belt is not to be used
without a lap belt.

    V. Summary of FCA US's Petition: As background, FCA US stated that
the packaging for the Mopar Service Seat Belts should have been
accompanied by the I-Sheets, but there was insufficient information to
confirm that the I-Sheets, in fact, accompanied the affected products
that were sent to FCA US dealers.
    FCA US described the subject noncompliance and stated its belief
that the noncompliance is inconsequential as it relates to motor
vehicle safety.
    In support of its petition, FCA US submitted the following
reasoning:
    FCA US understands that S4.1 concerns, among other things, the
threading of webbing and location and drilling of anchorage holes.
Moreover, S4.l(k) is specifically aimed at preventing the mismatch of a
seat belt assembly in the wrong model vehicle or the wrong seating
position and preventing improper installation of a seat belt at the
correct position. These provisions were once correctly aimed at
addressing the concern of aftermarket, universal seatbelt assemblies
being added into vehicles that were not originally equipped with
seatbelt assemblies. It has been many decades since vehicles without
seatbelt assemblies have been sold in the United States.
    As NHTSA has noted many times, the end-user's reliance on packaging
literature for proper part selection, part installation and seatbelt
use is now highly unlikely. This is particularly true for the subject
seat belt assemblies, for the following reasons:
     Mopar Service Seat Belt assemblies are only sold in FCA US
authorized dealerships and used for service within the dealership and
for sale to dealer customers. These assemblies are not sold to
aftermarket auto parts distributors or retail outlets.
     The Mopar Service Seat Belt assemblies are clearly
identified in the FCA US part system for very specific make, model and
model year vehicles and specific seating positions through
DealerCONNECT, the web-based parts ordering system used between FCA US
and its dealers. In order to purchase these parts, the buyer would need
to supply either the part assembly number or make, model and model year
and seating position of vehicle. In either case, only the proper
assembly will be sold to the end user.
     The proper installation of all Mopar Service Seat Belt
assemblies are clearly described in FCA US service manuals, which are
also available on-line through DealerCONNECT and sold to the public
through Mopar and FCA US brand Web sites. Installation of the seatbelt

assembly is a complex process in the modern motor vehicle, unlike the
vehicles in the past that the S4.1 provisions were intended to address.
     All Mopar Service Seat Belt assemblies are properly
labeled with the correct service part number so that the correct parts
are shipped to FCA US dealerships for use on specific make, model and
model year vehicles and specific seating positions.
     The owner's manual for the FCA US vehicles at issue have
always provided instruction about proper usage and maintenance
information for seatbelts to the vehicle owner and operator. Therefore,
incorrect usage and maintenance by the vehicle owner is highly
unlikely. The seatbelt usage requirement language S4.1(l) is far
exceeded in any of the vehicle owner's manuals implicated by the
recall.
     In over 25 years and hundreds of thousands of parts sales,
FCA US is not aware of a single field incident or consumer complaint
arising from the absence of an I-Sheet during the sale of any Mopar
Service Seat Belt assemblies.
    There have been many instances of similar documentation omissions
where the agency has granted inconsequential treatment. NHTSA has
granted similar petitions for noncompliance with seat belt assembly
installation and usage instruction standards. See Mitsubishi Motors
North America, Inc. (77 FR 24762, April 25, 2012); Bentley Motors, Inc.
(75 FR 35877, September 20, 2011); Hyundai Motor Company (73 FR 49238,
March 2, 2009); Ford Motor Company (73 FR 11462, March 3, 2008); Mazda
North America Operations (73 FR 11464, March 3, 2008); Ford Motor
Company (73 FR 63051, October 22, 2008); and TRW, Inc. (58 FR 7171,
February 4, 1993).
    The most notable grant of inconsequential treatment, and one which
is substantially similar to equipment recall T49 (NHTSA 17E-039), is
Subaru of America, Inc. (65 FR 67471, November 9, 2000), where the
agency made the following succinct observations:

    There seems to be little need for the installation instructions
with replacements for original equipment seat belts. The SAE J800c
Recommended Practice incorporated in FMVSS No. 209 appears to have
been written as a guide on how to install a seat belt where one does
not exist. The Recommended Practice discusses such things as how to
determine the correct location for anchorages, how to create
adequate anchorages and how to properly attach webbing to the newly
installed anchorages. These instructions do not apply to today's
replacement market. Additionally, vehicle manufacturers provide
service manuals on how seat belts should be replaced. NHTSA does not
believe the ``how to'' instructions are necessary in this case.
Next, we note that the subject seat belt assemblies were distributed
without the required `usage and maintenance instructions' specified
in FMVSS No. 209, S4.1(l), which requires that seat belt assemblies
sold as replacement equipment have owner instructions on how to wear
the seat belt and how to properly thread the webbing on seat belts
where the webbing is not permanently attached. NHTSA believes that
the proper usage is adequately described in the vehicle owner's
manual. NHTSA does not believe that instructions about the proper
threading of webbing is applicable to modern original equipment
automobile seat belt systems. This second instruction sheet is
either duplicated in the owner's manual or not applicable.

    FCS US understands that while FMVSS No. 209 S4.1(k) and S4.1(l) may
be somewhat antiquated, it is nevertheless required to fully comply
with this safety standard. In this regard FCA US has made process
changes to ensure that hard copies of the I-Sheets will be included
with all Mopar Service Seat Belt assemblies shipped to its dealers.
Moreover, FCA US has implemented changes in its part ordering process
to ensure that all I-Sheets for Mopar Service Seat Belt assemblies
affected by recall T49 (NHTSA 17E-039) have been uploaded to on-line
resources (StarPartsTM and DealerCONNECT) and directly
linked to the specific Mopar Service Seat Belt part numbers. Going
forward, this hard copy and on-line mating of the service parts and
S4.1(k) and S4.1(l) instructions will ensure that the documentation
requirement of FMVSS No. 209 will be met.
    FCA US concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that FCA US no
longer controlled at the time it determined that the noncompliance
existed. However, any decision on this petition does not relieve
vehicle distributors and dealers of the prohibitions on the sale, offer
for sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after FCA US
notified them that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Associate Administrator for Enforcement.
[FR Doc. 2017-26425 Filed 12-6-17; 8:45 am]
 BILLING CODE 4910-59-P


DuPont Chemical Solutions Enterprise

Chambers Works

Deepwater, NJ  08023

CERTIFIED MAIL – Return Receipt Requested

June 5, 2008

Document Control Office

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 6428

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Re: 	EPA – HQ – OPPT – 2003 - 0012

	DuPont Chambers Works NJPDES Permit No. NJ0005100

	PFOA Data Submittal – Outfall DSN662 Weekly Grab Samples

	March 2008 Sample Data

Dear Document Control Office:

As per Part IV, Section G.5.a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during March 2008. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at (856) 540-3015.

Sincerely,

Karen L. Pinder

SET Environmental Coordinator

DuPont Chambers Works

Enclosures

Copies to:

Director, Chemical Control Division

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 4146

1201 Constitution Avenue, NW

Washington, DC 20004

Ms. Susan Rosenwinkel (cover letter only)

Principal Environmental Engineer

NJDEP Division of Water Quality

Bureau of Point Source Permitting – Region 2

401 E. State Street

P.O. Box 029

Trenton, NJ 08625-0029


[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78368-78369]
[FR Doc No: 2013-30799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Allergenic Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Allergenic Products Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 28, 2014,
between approximately 8:30 a.m. and 3:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    For those unable to attend in person, the meeting will also be Web
cast. The link for the Web cast is available at: https://collaboration.fda.gov/apac.
    Contact Person: Gail Dapolito or Joanne Lipkind, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852,<PHONE_NUMBER>,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On January 28, 2014, the committee will meet in open
session to discuss and make recommendations on the safety and efficacy
of RAGWITEK, a short ragweed pollen allergen extract tablet for
sublingual use, manufactured by Merck, indicated for immunotherapy for
diagnosed ragweed pollen induced allergic rhinitis, with or without
conjunctivitis.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
January 21, 2014. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. and 12:30 p.m. on January 28, 2014.
Those individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
January 13, 2014. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by January 14,
2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to

accommodate persons with physical disabilities or special needs. If you
require special accommodations due to a disability, please contact Gail
Dapolito or Joanne Lipkind at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30799 Filed 12-24-13; 8:45 am]
BILLING CODE 4160-01-P