[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Notices]
[Pages 64391-64393]
[FR Doc No: 2018-27084]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84775; File No. SR-NYSE-2018-57]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Certain of Its Listing Fees

December 10, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 29, 2018, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend certain of its listing fees. The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend certain of its listing fees set
forth in Chapter 9 of the Manual, in each case with effect from the
beginning of the calendar year commencing on January 1, 2019.
    The annual fee set forth in Section 902.03 of the Manual will
increase from $0.00108 per share to $0.0011 per share for each of the
following: A primary class of common shares (including Equity
Investment Tracking Stocks); each additional class of common shares
(including tracking stock), a primary class of preferred stock (if no
class of common shares is listed); each additional class of preferred
stock (whether the primary class is common or preferred stock); and
each class of warrants. In addition, the minimum annual fee will be
increased from $65,000 to $68,000 for each of (i) a primary class of
common shares (including Equity Investment Tracking Stocks) and (ii) a
primary class of preferred stock (if no class of common shares is
listed).
    The Exchange proposes to amend the annual fee schedule for
structured products set forth in Section 902.05 of the Manual and for
short term securities set forth in Section 902.06. In each case, the
annual fee per share will increase from $0.00108 to $0.0011 per share.
The minimum annual fee will increase from $25,000 to $35,000 for
securities listed under Sections 902.05 and 902.06 (except for warrants
to purchase equity securities, which will remain $5,000). In addition,
the Exchange proposes to amend the provision in Section 902.02 relating
to the $500,000 Total Maximum Fee by including annual fees paid for all
structured products in calculating the Total Maximum Fee. The Exchange
notes that retail debt securities are already included in the Total
Maximum Fee calculation. Historically many listed structured products
were financial products issued by banks and other financial
institutions so there was a reasonable basis for excluding them from
the benefits of the Total Maximum Fee provision. Today, however, most
structured products listed on the Exchange are issued by listed
companies for similar financing reasons to those for which they issue
retail debt, so it is reasonable to treat them the same for purposes of
the Total Maximum Fee calculation.
    The Exchange proposes to make an adjustment to the Investment
Management Entity Group Fee Discount set forth in Section 902.02 of the
Manual. The Investment Management Entity Group Fee Discount is
currently based on all annual and listing fees paid by the Investment
Management Entity and its Eligible Portfolio Companies in the
applicable calendar year. The Exchange proposes to amend the

discount by applying it only to annual fees incurred as of January 1 of
the applicable year.\4\ The current approach is logistically difficult
for Exchange staff and the benefitting companies, as the size and
proportionate share of the discount received by each company cannot be
calculated until year-end, as it must reflect the effect of
supplemental listing fees incurred for issuances of new shares during
the course of the year in addition to annual fees. A discount based on
annual fee bills incurred on January 1 will be more transparent and
predictable and will enable the Exchange to reduce the benefiting
companies' bills at the beginning of the year rather than charging them
in full and giving them a credit for the discount at year-end. In
connection with this modification, the Exchange also proposes to modify
the manner in which a company qualifies as an Eligible Portfolio
Company to reflect the fact that the benefits--and therefore Eligible
Portfolio Company Status--will be determined at the beginning of the
applicable year. As such, for calendar 2019 and subsequent years, a
company will be an Eligible Portfolio Company if it was listed on the
Exchange as of the first trading day of such calendar year. In order to
qualify for the Investment Management Entity Group Fee Discount in
calendar 2019 or any subsequent year, an issuer must submit
satisfactory proof to the Exchange no later than the first trading day
of such calendar year that it meets the ownership requirements
specified above.\5\
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    \4\ The Investment Management Entity Group Fee Discount is
limited to $500,000 per year for any Investment Management Entity
and its Eligible Portfolio Companies and, in the Exchange's
experience, each group of companies utilizing the discount has
benefited from the maximum $500,000 amount. The Exchange expects
that all groups of companies utilizing the discount will continue to
benefit from the maximum discount in the future based solely on
their annual fee obligations.
    \5\ Under the current rule, a company qualifies for the
Investment Management Entity Group Fee Discount in any calendar year
by submitting satisfactory proof to the Exchange no later than
December 31 that it has met the ownership requirements specified
above for the entire period between January 1 and September 30 of
that year.
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    As described below, the Exchange proposes to make the
aforementioned fee increases to better reflect the Exchange's costs
related to listing equity securities and the corresponding value of
such listing to issuers.
    The Exchange also proposes to remove a number of references in
Chapter 9 to fees that are no longer applicable as they were superseded
by new fee rates specified in the rule text or refer to fees that are
no longer applicable.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Section 6(b)(4) \7\ of the Act, in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges. The Exchange also believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\8\ in that
it is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
    \8\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that it is not unfairly discriminatory and
represents an equitable allocation of reasonable fees to amend Chapter
Nine of the Manual to increase the various listing fees as set forth
above because of the increased costs incurred by the Exchange since it
established the current rates. In that regard, the Exchange notes that
its general costs have increased since its most recent fee adjustments,
including due to price inflation. In addition, the Exchange continues
to improve and increase the services it provides to listed companies.
These improvements include the continued development and enhancement of
an interactive web-based platform designed to improve communication
between the Exchange and listed companies, the availability to listed
companies of the Exchange's new state-of-the-art conference facilities
at 11 Wall Street, and continued development of an investor relations
tool available to all listed companies which provides companies with
information enabling them to better understand the trading and
ownership of their securities and the cost of providing content for
inclusion in that tool.
    The inclusion of all structured products in the Total Maximum Fee
calculation is not unfairly discriminatory and represents an equitable
allocation of reasonable fees, as retail debt securities are already
included in the Total Maximum Fee calculation. Most listed structured
products are issued by listed companies for similar financing reasons
to those for which they issue retail debt, so it is reasonable,
equitable and not unfairly discriminatory to treat them the same for
purposes of the Total Maximum Fee calculation.
    The adjustments to the Investment Management Entity Group Fee
Discount are not unfairly discriminatory and represent an equitable
allocation of reasonable fees, because a discount based on annual fee
bills incurred on January 1 will be more transparent and predictable
and will enable the Exchange to reduce the benefitting companies' bills
at the beginning of the year rather than charging them in full and
giving them a credit for the discount at year-end. The proposed
amendment is not unfairly discriminatory because the eligible fees and
the test for receiving the benefits of the discount will be the same
for all listed companies.
    The above fee changes are not unfairly discriminatory because the
same fee schedule will apply to all listed issuers. Further, the
Exchange operates in a competitive environment and its fees are
constrained by competition in the marketplace. Other venues currently
list all of the categories of securities covered by the proposed fees
and if a company believes that the Exchange's fees are unreasonable it
can decide either not to list its securities or to list them on an
alternative venue.
    The proposed removal of text relating to fees that are no longer
applicable is ministerial in nature and has no substantive effect.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to ensure that the fees charged by the Exchange accurately
reflect the services provided and benefits realized by listed
companies. The market for listing services is extremely competitive.
Each listing exchange has a different fee schedule that applies to
issuers seeking to list securities on its exchange. Issuers have the
option to list their securities on these alternative venues based on
the fees charged and the value provided by each listing. Because
issuers have a choice to list their securities on a different national
securities exchange, the Exchange does not believe that the proposed
fee changes impose a burden on competition.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \9\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \10\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change 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. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \11\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \11\ 15 U.S.C. 78s(b)(2)(B).
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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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2018-57 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2018-57. This file
number should be included on the subject line if email 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 website (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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSE-2018-57 and should be submitted on
or before January 4, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2018-27084 Filed 12-13-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45889-45890]
[FR Doc No: 2020-16526]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0829]

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form
Drug Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Expiration
Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.''
The guidance describes the circumstances under which FDA generally does
not intend to take action regarding required stability studies for
unit-dose repackaged solid oral dosage form drug products and
appropriate expiration dates under those circumstances. This guidance
finalizes the revised draft guidance for industry issued in August
2017.

DATES: The announcement of the guidance is published in the Federal
Register on July 30, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-0829 for ``Expiration Dating of Unit-Dose Repackaged Solid
Oral Dosage Form Drug Products.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Bill Harvey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 4214, Silver Spring, MD 20993-0002, 240-
402-4180.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage
Form Drug Products.'' The last few decades have seen an increasing
demand in various health care settings for solid oral dosage form drug
products repackaged into unit-dose containers, which hold a quantity of
drug for administration as a single dose. The increase in unit-dose
repackaging has led to questions regarding stability studies and
appropriate expiration dates for these repackaged products. This
guidance describes the circumstances under which FDA generally does not
intend to take action regarding required stability studies for these
repackaged products and appropriate expiration dates under those
circumstances.
    This guidance finalizes the revised draft guidance of the same name
issued in August 2017 (82 FR 37229). FDA received a few comments on the
revised draft guidance and has modified this guidance by: (1)
Describing why liquid dosage forms are excluded, (2) indicating
approaches that may be used when conducting stability studies, and (3)
making editorial changes to update references and improve clarity.
Liquid dosage forms are substantially more susceptible to degradation
than solid dosage forms. Because of the inherent stability risks, FDA
does not intend to exercise enforcement discretion regarding the
stability and expiration dating requirements in 21 CFR 211.137 and
211.166 for repackaging liquid dosage forms.
    In conjunction with the publication of this guidance, FDA withdraws
Compliance Policy Guide 480.200, ``Expiration Dating of Unit-Dose
Repackaged Drugs,'' issued February 1, 1984, revised March 1995.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Expiration Dating of Unit-Dose Repackaged
Solid Oral Dosage Form Drug Products.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to previously approved collections of
information that are subject to review by the OMB under the PRA. The
collections of information in 21 CFR parts 210 and 211 have been
approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16526 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27518-27521]
[FR Doc No: 2023-09268]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1874]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Perceptions of
Prescription Drug Products With Medication Tracking Capabilities

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: Submit written comments (including recommendations) on the
collection of information by June 1, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Perceptions of Prescription Drug Products
with Medication Tracking Capabilities.'' Also include the FDA docket
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Perceptions of Prescription Drug Products With Medication Tracking
Capabilities

OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the 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 mission of the Office of Prescription Drug Promotion (OPDP) 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 health care 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 the characteristics of the disease and product 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. 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 the first topic area, advertising features.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings are 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 home page at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
    Patient non-adherence to medication regimens is a well-known
challenge in health care. The World Health Organization defines
adherence as the extent to which a person's behavior--taking
medication, following a diet, and/or executing lifestyle changes--
corresponds with agreed recommendations from a health care provider
(Ref. 1). It is estimated that only half of all patients with chronic
health conditions take their medications as prescribed (Ref. 2),
leading to as many as 100,000 preventable deaths and $100 billion in
additional medical costs every year (Ref. 3). Numerous solutions have
been tried to improve adherence, including resource-intensive
approaches such as directly observed therapy, which entails a trained
observer watching as the patient takes their medications (Ref. 4), and
technology-supported tools for patients (e.g., smartphone apps) (Ref.
5). As attention to the public health issue of medication adherence has
grown, OPDP has noted a corresponding increase in the number of claims
and presentations in prescription drug promotion that focus, either
directly or through implication, on a product's potential to improve
adherence to treatment regimens. Many of these presentations include
information about options and capabilities available to help patients
track their medication usage.
    One avenue that prescription drug sponsors have begun exploring to
track medication use includes the development of software that is
disseminated by or on behalf of the drug sponsor and accompanies one or
more of the sponsor's prescription drugs. This software is called
prescription drug use-related software.\1\ Studies exploring drug
products with prescription drug use-related software have been
conducted with medications to treat an array of chronic disorders,
including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes
(Ref. 7), end-stage renal disease requiring transplants (Ref. 8), and
opioid use among patients with acute fractures (Ref. 9).
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    \1\ In 2018, FDA established a public docket to solicit public
comment on a proposed framework for regulating software applications
disseminated by or on behalf of drug sponsors for use with one or
more of their prescription drug products. See https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments.
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    In recent years, new technologies that capture data on medication-
taking behavior and drug administration have been employed. The
SureClick 2.0 autoinjector for the prescription medication ENBREL, for
example, has Bluetooth built into the white cap that covers the needle.
The autoinjector records initial removal of the cap and can send this
data via Bluetooth to a paired smartphone using a mobile app (Ref. 10).
Technology can also now support the use of ingestible sensors embedded
in pills that will emit a weak signal to a receiver (patch or lanyard)
worn by the patient after the pill has been swallowed (Ref. 11). These
data can then be transmitted to a paired mobile device and viewed by
the patient through a smartphone app (Ref. 12). Whether these new
technologies will have an impact on adherence is currently unknown.
    Very little is known about patient and health care provider
perceptions of products that track medication use or that work in
tandem with software to track medication use, with most commentaries
having been largely theoretical (Refs. 13 and 14). The focus of the
present study is to explore patient and health care provider
perceptions of a fictitious prescription drug product that is
accompanied by software that is intended to track medication use.
    We have the following specific questions:

Research Questions

    1. When prescription drug promotional communications include claims
about a product's ability to track medication use, do these claims
influence perceptions about the product's risks and/or benefits
(including its effect on medication adherence)?
    2. If the promotional claims about the product's ability to track
medication use are accompanied by a disclosure that describes what is
known about the effect of medication tracking on medication adherence,
does this have an influence on perceptions of the product's risks and/
or benefits (including its effect on medication adherence)?
    To complete this research, we propose the design in table 1, which
varies based on:
     Whether the fictitious prescription drug product includes
technology that tracks medication use;
     Whether the prescription drug promotional communication
includes a disclosure describing what is known about the tracking
technology's effect on medication adherence; and
     What the disclosure communicates about the tracking
technology's effect on medication adherence (positive effect shown, no
effect shown, or unknown effect).

                              Table 1--Proposed One-Way, Five-Level Design (1 x 5)
----------------------------------------------------------------------------------------------------------------
                                          Claims about
                                          existence of          Disclosure about
       Experimental condition          medication tracking   technology's effect on     Content of disclosure
                                           technology               adherence
----------------------------------------------------------------------------------------------------------------
1. Drug............................  No....................  No....................
2. Drug + medication tracking        Yes...................  No....................
 technology.
3. Drug + medication tracking        Yes...................  Yes...................  No data are available on
 technology + no adherence data                                                       the technology's effect on
 collected.                                                                           adherence.
4. Drug + medication tracking        Yes...................  Yes...................  Data show the technology
 technology + data show no effect                                                     has no effect on
 on adherence.                                                                        adherence.

5. Drug + medication tracking        Yes...................  Yes...................  Data show the technology
 technology + data show a positive                                                    has a positive effect on
 effect on adherence.                                                                 adherence.
----------------------------------------------------------------------------------------------------------------
Note: Condition 5 is the only condition in which an adherence benefit has been demonstrated for the fictitious
  product. The evidence required to support a medication adherence claim is not the focus of this study, and the
  evidence will not be described in the disclosure.
Condition 2 is a control because the drug product does include medication tracking technology, but the
  promotional communication does not include a disclosure about the technology's effect on medication adherence.
  Condition 1 is a true control because the drug product does not include medication tracking technology.
  Comparisons between conditions 1 and 2 will show us the baseline of this issue, i.e., will indicate whether
  the fact that the drug product contains a tracking technology will alter perceptions of risks and benefits
  (including adherence).

    We will conduct pretests with 50 consumers who self-identify as
having been diagnosed with diabetes and 50 primary care physicians who
treat diabetes (both obtained from a web-based research vendor) to
ensure that the questionnaire programming works as expected. For the
main study, we will then recruit 350 consumers who self-identify as
having been diagnosed with diabetes and 350 primary care physicians who
treat diabetes. Each participant will see one of five versions of a
consumer web page for a fictitious prescription diabetes treatment, as
reflected in table 1. They will answer a questionnaire designed to take
no more than 20 minutes regarding their perception of the product's
benefits, risks, and effect on adherence.
    In the Federal Register of September 23, 2022 (87 FR 58103), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one submission that was not
PRA-related (regulations.gov tracking number lar-vv69-9wok).
    FDA estimates the burden of this collection of information as
follows:

                                 Table 2--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent      respondents     per response
----------------------------------------------------------------------------------------------------------------
Screener Consumers............             680               1             680  .08 (5 minutes).            54.4
Screener Primary Care                      680               1             680  .08 (5 minutes).            54.4
 Physicians.
Pretest Consumers.............              50               1              50  .33 (20 minutes)            16.5
Pretest Primary Care                        50               1              50  .33 (20 minutes)            16.5
 Physicians.
Main Study Consumers..........             350               1             350  .33 (20 minutes)           115.5
Main Study Primary Care                    350               1             350  .33 (20 minutes)           115.5
 Physicians.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           372.8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.

References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) 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. World Health Organization, ``Adherence to Long-Term Therapies:
Evidence for Action,'' p. 3, 2003, available at https://apps.who.int/iris/handle/10665/42682, accessed May 16, 2022.
2. Frias, J., N. Virdi, P. Raja, et al., ``Effectiveness of Digital
Medicines to Improve Clinical Outcomes in Patients with Uncontrolled
Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-
Randomized Pilot Clinical Trial,'' Journal of Medical internet
Research, Vol. 19, Issue 7, Article e246, 2017, doi:10.2196/
jmir.7833.
3. Kleinsinger, F., ``The Unmet Challenge of Medication
Nonadherence,'' The Permanente Journal, Vol. 22, Issue 3, Article
18-033, 2018, doi:10.7812/TPP/18-033.
4. Karumbi, J. and P. Garner, ``Directly Observed Therapy for
Treating Tuberculosis,'' Cochrane Database of Systematic Reviews,
Issue 5, Article CD003343, 2015, doi:10.1002/14651858.CD003343.pub4.
5. Dayer, L., S. Heldenbrand, P.O. Gubbins, et al., ``Smartphone
Medication Adherence Apps: Potential Benefits to Patients and
Providers,'' Journal of the American Pharmacy Association (2003),
Vol. 53, Issue 2, pp. 172-181, 2013, doi:10.1331/JAPhA.2013.12202.
* 6. FDA, ``FDA Approves Pill with Sensor That Digitally Tracks If
Patients Have Ingested Their Medication,'' FDA News Release,
November 13, 2017, available at https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication, accessed May 16, 2022.
7. Browne, S.H., Y. Behzadi, and G. Littlewort, ``Let Visuals Tell
the Story: Medication Adherence in Patients with Type II Diabetes
Captured by a Novel Ingestion Sensor Platform,'' JMIR Mhealth
Uhealth, Vol. 3, Issue 4, Article e108, 2015, doi:10.2196/
mhealth.4292.
8. Eisenberger, U., R.P. W[uuml]thrich, A. Bock, et al.,
``Medication Adherence Assessment: High Accuracy of the New
Ingestible Sensor System in Kidney Transplants,'' Transplantation,
Vol. 96, Issue 3, pp. 245-250, 2013, doi:10.1097/
TP.0b013e31829b7571.
9. Chai, P.R., S. Carreiro, B.J. Innes, et al., ``Oxycodone
Ingestion Patterns in Acute Fracture Pain with Digital Pills,''
Anesthesia and Analgesia, Vol. 125, Issue 6, pp. 2105-2112, 2017,
doi:10.1213/ANE.0000000000002574.

* 10. Amgen Inc., ``Enbrel (etanercept): Highlights of Prescribing
Information,'' revised April 2021, available at https://
www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/enbrel/
enbrel_pi.pdf, accessed May 16, 2022.
* 11. Reuter, E., ```Smart Pill' Startup EtectRx Strikes Partnership
with Pear Therapeutics,'' Med City News, January 14, 2021, available
at https://medcitynews.com/2021/01/smart-pill-startup-etectrx-strikes-partnership-with-pear-therapeutics, accessed May 16, 2022.
12. The Medical Futurist, ``The Present and Future of Digital
Pills,'' July 21, 2020, available at https://medicalfuturist.com/the-present-and-future-of-digital-pills, accessed May 16, 2022.
13. George, C.E., ``Should a Psychiatrist Prescribe a Nanodrug to
Help Parents Monitor a Teen's Adherence?,'' AMA Journal of Ethics,
Vol. 21, Issue 4, Article e317-323, 2019, doi:10.1001/
amajethics.2019.317.
* 14. Yang, M., ``A Psychiatrist's Perspective on the Digital
Pill,'' KevinMD.com, December 2, 2017, available at https://www.kevinmd.com/blog/2017/12/psychiatrists-perspective-digital-pill.html, accessed May 16, 2022.

    Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09268 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Proposed Rules]
[Pages 47787-47789]
[FR Doc No: 2012-19602]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2012-0628]
RIN 1625-AA09

Drawbridge Operation Regulation; Atlantic Intracoastal Waterway
(AIWW), Newport River, Morehead City, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to temporarily change the operating
schedule that governs the Carolina Coastal Railroad Bridge, at AIWW
mile 203.8, across Newport River in Morehead City, NC. This bridge is
presently maintained in the open position except when closure is
necessary for train crossings. This change would allow the bridge to
remain closed at night so that necessary repairs may be made with the
least possible impact to navigation.

DATES: Comments and related material must be received by the Coast
Guard on or before September 10, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0628 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>. To avoid duplication, please use only one of
these four methods. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section below for
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Terrance A. Knowles, Environmental Protection
Specialist, Fifth Coast Guard District, at<PHONE_NUMBER>,
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related material. All comments received will be posted,
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0628), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (http://www.regulations.gov), or by fax, mail or hand delivery,
but please use only one of these means. If you submit a comment online
via www.regulations.gov, it will be considered received by the Coast
Guard when you successfully transmit the comment. If you fax, hand
deliver, or mail your comment, it will be considered as having been
received by the Coast Guard when it is received at the Docket
Management Facility. We recommend that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rules'' and insert

``USCG-2012-0628'' in the ``Keyword'' box. Click ``Search'' then click
on the balloon shape in the ``Actions'' column. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit them by mail and would like to know that they
reached the Facility, please enclose a stamped, self-addressed postcard
or envelope. We will consider all comments and material received during
the comment period and may change the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2012-0628'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit either the Docket Management Facility in Room W12-
140 on the ground floor of the Department of Transportation West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why one would be beneficial. If we determine
that one would aid this rulemaking, we will hold one at a time and
place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    The current regulations, under the general requirements set out at
33 CFR 117.5, require that the Carolina Coastal Railroad Bridge, at
AIWW mile 203.8, across Newport River in Morehead City NC, shall open
promptly and fully for the passage of vessels when a request to open is
given. However, the drawbridge is currently maintained in the open to
navigation position at all times and closes for passing trains.
    In the closed position to vessels, this single-leaf bascule
drawbridge has a vertical clearance of 4 feet above mean high water.

C. Basis and Purpose

    The North Carolina Department of Transportation (NCDOT), who owns
and operates this bascule-type railroad bridge, has requested a
temporary change to the existing operating regulations to facilitate
repair of existing structural steel, strengthening of the main bascule
girders and upgrading the obsolete drive system.
    To facilitate the required repair work and to minimize the impact
on navigation, from October 1, 2012 to October 1, 2013 the drawbridge
would operate as follows: (1) From 5 a.m. to 8:30 p.m., shall be
maintained in the open position to vessels and would only be closed for
the passage of trains and to perform periodic maintenance; and in the
closed position to vessels, from 8:30 p.m. to 5 a.m., with one optional
opening provided at 12 a.m. (midnight) for vessels providing advance
notice before 4 p.m. on the afternoon before the requested opening.
    Vessel traffic along this part of the Atlantic Intracoastal
Waterway consists of commercial and pleasure craft including sail
boats, fishing boats, and tug and barge traffic, that transit mainly
during the daylight hours with the occasional tug and barge traffic at
night. The drawbridge is currently maintained in the open to navigation
position at all times and closes for passing trains. Consequently, the
number of mariners transiting through this section of the waterway is
not based on the amount of vessel openings but on the average number of
waterway users, which showed that there are fewer vessel openings at
night for mariners, making it a more suitable time to restrict the
operation of the drawbridge.

D. Discussion of Proposed Rule

    The Coast Guard would temporarily revise the operating regulations
at 33 CFR 117.821 by adding a new paragraph(c). Paragraph(c) would
state from October 1, 2012 to October 1, 2013, the draw of the Carolina
Coastal Railroad Bridge shall be maintained in the open position to
vessels, from 5 a.m. to 8:30 p.m., and would only be closed for the
passage of trains and to perform periodic maintenance; and at night
need not open from 8:30 p.m. to 5 a.m., except at 12 a.m. (midnight)
for vessels providing advance notice before 4 p.m. on the afternoon
before the requested opening.

E. 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 or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    The proposed temporary changes are expected to have minimal impact
on mariners due to the low number of vessels transiting this area at
night. Also, a midnight vessel opening would be available each night
for vessels requiring an opening provided that advance notice is given
by 4 p.m. on the afternoon before the requested opening.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. 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.
    This proposed rule will not have a significant economic impact on a
substantial number of small entities because the rule adds navigational
restrictions mainly to the movement of vessels during a time when there
is less traffic at night. Most commercial traffic will leave and return
during the day. The proposed rule would possibly affect small entities
such as owners/operators of vessels with limited drawbridge openings
from 8:30 p.m. to 5 a.m. To minimize delays, these vessels can plan
their transits in accordance with the proposed opening schedule.
    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.

3. Assistance for Small Entities

    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 so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Terrance Knowles, Environmental
Protection Specialist, Fifth Coast Guard District,<PHONE_NUMBER> or
<EMAIL_ADDRESS>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.

4. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    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 does not have implications for federalism.

6. Protest Activities

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

7. 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 will not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    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.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, and Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This rule is categorically
excluded under figure 2-1, paragraph (32)(e), of the Instruction, and
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

    1. The authority citation for part 117 continues to read as
follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

    2. In Sec.  117.821, add temporary paragraph (c) to read as
follows:

Sec.  117.821  Atlantic Intracoastal Waterway, Albemarle Sound to
Sunset Beach.

* * * * *
    (c) From October 1, 2012 to October 1, 2013, the draw of the
Carolina Coastal Railroad Bridge, at mile 203.8, (Newport River) at
Morehead City, shall operate as follows:
    (1) During the day from 5 a.m. to 8:30 p.m., shall be maintained in
the open position to vessels and would only be closed for the passage
of trains and to perform periodic maintenance.
    (2) At night need not open 8:30 p.m. to 5 a.m. except an opening
would be provided at 12 a.m. (midnight) if advance notice is given
before 4 p.m. on the afternoon before the requested opening.

    Dated: July 27, 2012.
Steven H. Ratti,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2012-19602 Filed 8-9-12; 8:45 am]
BILLING CODE 9110-04-P


Marjorie Jones/RTP/USEPA/US

06/25/2007 12:29 PM

To

"Schwab, Margo"<EMAIL_ADDRESS> cc

"Johansson, Robert"<EMAIL_ADDRESS>Bryan Hubbell/RTP/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Rebecca Daniels/RTP/USEPA/US@EPA

Subject

Fw: Revised section on unquantified impacts reflecting changes to UV-B section

Margo and Rob:  Please find attached below the language we discussed on the call this morning.

Thanks, Margie

Marjorie C. Jones

Office of Air Quality Planning & Standards

Air Benefit and Cost Group, Mail Code C439-02

Health and Environmental Impacts Division

RTP, NC 27711

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

Shipping/receiving: 4930 Old Page Rd.

Durham, NC 27709

----- Forwarded by Marjorie Jones/RTP/USEPA/US on 06/25/2007 12:21 PM -----

Bryan Hubbell/RTP/USEPA/US

06/25/2007 12:14 PM

To

Ron Evans@EPA, Marjorie Jones/RTP/USEPA/US@EPA

cc

Subject

Revised section on unquantified impacts reflecting changes to UV-B section

Please send to Margo S. for review

Dr. Bryan J. Hubbell

Senior Advisor for Science and Policy Analysis

Health and Environmental Impacts Division

U.S. EPA/OAQPS (C504-02)

RTP, NC 27711

(919) 541-0621


[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Page 5580]
[FR Doc No: 2011-2145]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13123-002]

Eagle Crest Energy Company; Notice of Applicant-Proposed Water
Pipeline Route for the Proposed Eagle Mountain Pumped Storage
Hydroelectric Project and Notice of Public Meetings

January 21, 2011.
    On June 22, 2009, Eagle Crest Energy Company (Eagle Crest or
applicant) filed an application for an original license with the
Federal Energy Regulatory Commission (Commission or FERC) for the
proposed Eagle Mountain Pumped Storage Hydroelectric Project (Eagle
Mountain Project). This notice describes the water supply pipeline
route proposed by the applicant and recommended by staff that is
identified in the Commission's draft environmental impact statement
(draft EIS). This notice and copies of the draft EIS are being sent to
landowners of property that would be crossed by the proposed water
supply pipeline. We are currently soliciting comments on the proposed
water supply pipeline and the draft EIS. Additionally, as discussed
below, we will be hosting two public meetings on February 3, 2011, to
discuss the proposed water supply pipeline as well as our other
recommendations in the draft EIS.
    The proposed Eagle Mountain Project would be located at the
inactive Eagle Mountain mine in Riverside County, California, near the
town of Desert Center and would consist of: (1) An upper and lower
reservoir with surface areas of 191 and 163 acres, respectively; (2) an
underground powerhouse with four reversible pump-turbine units each
rated at 325 megawatts (MW) for a total generating capacity of 1,300
MW; (3) a 13.5-mile-long transmission line; and (4) groundwater supply
facilities including an underground water supply pipeline.
    Eagle Crest's proposed water supply wells are about 3 miles
northeast of the town of Desert Center. The proposed feeder water lines
leading from the location of the wells to the main pipeline would cross
several privately owned parcels. The proposed main water supply
pipeline would then extend northwest within the right-of-way for the
existing 160-kilovolt Southern California Edison transmission line to
the intersection with Kaiser Road. After the intersection with Kaiser
Road, the proposed water supply pipeline would remain within the Kaiser
Road right-of-way to the proposed lower reservoir.
    Additional information about the proposed project is available on
the FERC Web site at http://www.ferc.gov, using the ``e-Library'' link.
Enter the docket number (P-13123) to access the public record. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    All comments must be filed by Monday, February 28, 2011, and should
reference Project No. 13123-002. Comments may be filed electronically
via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the ``eFiling'' link. For a simpler method of
submitting text-only comments, click on ``eComment'' under the
``Documents and Filings'' tab. For assistance, please contact FERC
Online Support. Although the Commission strongly encourages electronic
filing, documents may also be paper-filed. To paper-file, mail an
original and eight copies to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    In addition to or in lieu of sending written comments, you are
invited to attend a public meeting that will be held to receive
comments on the transmission line routes and the draft EIS. The time
and location of the meetings are as follows:
    Daytime Meeting:
    Date: February 3, 2011.
    Time: 1 p.m.
    Place: University of California at Riverside, Palm Desert Graduate
Center.
    Address: 75-080 Frank Sinatra Drive, Room B114/117, Palm Desert,
California 92211.
    Evening Meeting:
    Date: February 3, 2011.
    Time: 7 p.m.-10 p.m.
    Place: University of California at Riverside, Palm Desert Graduate
Center.
    Address: 75-080 Frank Sinatra Drive, Room B200, Palm Desert,
California 92211.
    At these meetings, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the draft EIS. The meetings will be
recorded by a court reporter, and all statements (verbal and written)
will become part of the Commission's public record for the project.
This meeting is posted on the Commission's calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx along with other related
information.
    For further information, please contact Kenneth Hogan at (202) 502-
8434 or at<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-2145 Filed 1-31-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36752-36756]
[FR Doc No: 2021-14768]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,

including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with medical device labeling regulations.

DATES: Submit either electronic or written comments on the collection
of information by September 13, 2021.

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 September 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 13, 2021. 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-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Labeling Regulations

OMB Control No. 0910-0485--Revision

    This information collection supports implementation of medical
device labeling requirements governed by section 502 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in
Agency regulations, and discussed in associated Agency guidance.
Medical device labeling requirements, among other things, provide for
the label or labeling content of a medical device so that it is not
misbranded and subject to regulatory action. Certain provisions under
section 502 of the FD&C Act require that

manufacturers, importers, and distributors of medical devices disclose
information about themselves or the devices on the labels or labeling
for the devices. Section 502 provides, in part, that a device shall be
misbranded if, among other things, its label or labeling fails to bear
certain required information concerning the device, is false or
misleading in any particular way, or fails to contain adequate
directions for use. Medical device labeling regulations in parts 800,
801, 809, and associated regulations in part 1040 (21 CFR parts 800,
801, 809, and 1040), prescribe the disclosure of specific information
by manufacturers, importers, and distributors of medical devices about
themselves and/or the devices, on the label or labeling for the
devices, to health professionals and consumers.
    In conjunction with provisions in part 800, part 801, subpart A
sets forth general labeling provisions applicable to all medical
devices, including content and format requirements pertaining to
intended uses, adequate directions for use, misleading statements, and
the prominence of required labeling. Information collection provisions
found in part 801, subpart B pertaining to labeling requirements for
Unique Device Identification are currently approved under OMB control
number 0910-0720 and not covered in this information collection
request. Information collection associated with labeling requirements
for Over-the-Counter (OTC) Devices are found in part 801, subpart C,
and cover principal display panel; statement of identity; declaration
of net quantity of contents; and certain warning statement elements.
Information collection associated with exemptions from adequate
directions for use and other exemptions are found in part 801, subparts
D and E, respectively. Information collection associated with special
labeling requirements applicable to specific devices are found in part
801, subpart H. We also include information collection associated with
labeling for in vitro diagnostic products for human use, as set forth
in part 809, subpart B. Finally, in addition to the labeling
requirements in part 801 and the certification and identification
requirements of 21 CFR 1010.2 and 1010.3, sunlamp products and
ultraviolet lamps are subject to specific labeling requirements as set
forth in part 1040.
    We have revised the information collection to include reference to
Agency guidance. The guidance documents were developed and issued
consistent with our Good Guidance Practice regulations in 21 CFR
10.115, which provide for public comment at any time.
    Section 502(b) of the FD&C Act requires that, for packaged devices,
the label must bear the name and place of business of the manufacturer,
packer, or distributor; and an accurate statement of the quantity of
the contents. Section 502(f) of the FD&C Act requires that the labeling
for a device must contain adequate directions for use. FDA may,
however, grant an exemption if the Agency determines that the adequate
directions for use labeling requirements are not necessary for the
particular case as it relates to protection of the public health.
Section 301 of the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250) amended section 502 of the FD&C Act to add
paragraph (u) to section 502 to require devices (both new and
reprocessed) to bear prominently and conspicuously the name of the
manufacturer, a generally recognized abbreviation of such name, or a
unique and generally recognized symbol identifying the manufacturer.
    Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (MDUFSA) amended section 502(u) of the FD&C Act by limiting the
provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended provision, if the
original SUD or an attachment to it prominently and conspicuously bears
the name of the manufacturer, then the reprocessor of the SUD is
required to identify itself by name, abbreviation, or symbol in a
prominent and conspicuous manner on the device or attachment to the
device. If the original SUD does not prominently and conspicuously bear
the name of the manufacturer, the manufacturer who reprocesses the SUD
for reuse may identify itself using a detachable label that is intended
to be affixed to the patient record. MDUFSA required that FDA issue
guidance identifying the circumstances in which the name, abbreviation,
or symbol of the manufacturer of an original device is not ``prominent
and conspicuous'' under section 502(u) of the FD&C Act. Accordingly, we
issued the guidance document entitled ``Compliance with Section 301 of
the Medical Device User Fee and Modernization Act of 2002, as amended--
Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices''
(May 2006), available at https://www.fda.gov/media/71187/download. The
guidance document is intended to identify circumstances in which the
name or symbol of the original SUD manufacturer is not prominent and
conspicuous, as used in section 502(u) of the FD&C Act. We believe the
information disclosures discussed in the guidance impose no burden
beyond that which we attribute already to complying with disclosure
provisions found in the applicable regulations; however, we include the
guidance document for respondents' instructional use and reference.
    We estimate 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   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary...................................................           3,000                1            3,000                1            3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our figures are based on data from the FDA Unified Registration and
Listing System and the OASIS shipment information. FDA allows the use
of stand-alone graphical representations of information, or symbols, in
the labeling for the medical devices, if the symbol has been
established in a Standards Development Organization developed standard,
provided that such symbol is explained in a symbols glossary that is
included in the labeling for the medical device and otherwise complies
with section 502 (misbranding) of the FD&C Act.

                               Table 2--Estimated Annual Recordkeeping Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average  burden
           Activity                Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Processing, labeling, or                 7,500             887       6,652,500  0.5 (30 minutes)       3,326,250
 repacking agreement; 801.150.
Impact resistant lenses;                 1,591          47,050      74,856,550  0.0008 (0.048             59,885
 invoices, shipping documents,                                                   minutes).
 and records of sale or
 distribution; 801.410(e) and
 (f).
Hearing aid records; 801.421..          10,000             160       1,600,000  0.25 (15                 400,000
                                                                                minutes).
Menstrual tampons, sampling                 33              11             363  80..............          29,040
 plan for measuring
 absorbency; 801.430(f).
Latex condoms; justification                51            3.65             186  1...............             186
 for the application of
 testing data to the variation
 of the tested product;
 801.435(g).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............      83,109,599  ................       3,815,361
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.

    As set forth in Sec.  801.150(a)(2) (21 CFR 801.150(a)(2)), device
manufacturers are required to retain a copy of the agreement containing
the specifications for the processing, labeling, or repacking of the
device for 2 years after the final shipment or delivery of the device.
Section 801.150(a)(2) requires that copies of this agreement be made
available for inspection at any reasonable hour upon request by any
officer or employee of the Department of Health and Human Services
(HHS). In Sec.  801.410(e) (21 CFR 801.410(e)) copies of invoices,
shipping documents, and records of sale or distribution of all impact
resistant lenses, including finished eyeglasses and sunglasses, are
required to be maintained for 3 years by the retailer and made
available upon request by any officer or employee of FDA or by any
other officer or employee acting on behalf of the Secretary of HHS.
Section 801.410(f) requires that the results of impact tests and
description of the test method and apparatus be retained for a period
of 3 years. Specific recordkeeping requirements applicable to hearing
aid dispensers, manufacturers of menstrual tampons, and manufacturers
of latex condoms are set forth in 21 CFR 801.421(d), 801.430(f), and
801.435(g), respectively.

                           Table 3--Estimated Annual Third-Party Disclosure Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                 Number of
          Activity               Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
----------------------------------------------------------------------------------------------------------------
           Parts 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
----------------------------------------------------------------------------------------------------------------
Contact lens cleaning                     47               8             376  1.................             376
 solution labeling;
 800.10(a)(3) and 800.12(c).
Liquid ophthalmic                         25               8             200  1.................             200
 preparation labeling;
 800.10(b)(2).
Manufacturer, packer, or              19,407               7         135,849  1.................         135,849
 distributor information;
 801.1.
Adequate directions for use;           8,526               6          51,156  22.35.............       1,143,337
 801.5.
Statement of identity;                 8,526               6          51,156  1.................          51,156
 801.61.
Declaration of net quantity            8,526               6          51,156  1.................          51,156
 of contents; 801.62.
Prescription device                    9,681               6          58,086  17.77.............       1,032,188
 labeling; 801.109.
Retail exemption for                  30,000             667      20,010,000  0.25..............       5,002,500
 prescription devices;
 801.110.
Processing, labeling, or                 453              34          15,402  4.................          61,608
 repacking; non-sterile
 devices; 801.150(e).
----------------------------------------------------------------------------------------------------------------
                         Part 801, subpart H: Special Requirements for Specific Devices
----------------------------------------------------------------------------------------------------------------
Labeling of articles                      35               1              35  4.................             140
 intended for lay use in the
 repairing and/or refitting
 of dentures; 801.405(b)(1).
Dentures; information                     35               1              35  4.................             140
 regarding temporary and
 emergency use; 801.405(c).
Hearing aids professional                136              12           1,632  80................         130,560
 and patient labeling;
 801.420.
Hearing aids, availability            10,000               5          50,000  0.17..............           8,500
 of User Instructional
 Brochure; 801.421.
User labeling for menstrual               16               8             128  2.................             256
 tampons; 801.430.
User labeling for latex                   52               6             312  100...............          31,200
 condoms; 801.437.
----------------------------------------------------------------------------------------------------------------
          Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
----------------------------------------------------------------------------------------------------------------
Format and content of                  1,700               6          10,200  80................         816,000
 labeling for IVDs; 809.10.
Advertising and promotional              300              25           7,500  1.................           7,500
 materials for ASRs;
 809.30(d).
Labeling of sunlamp                       30               1              30  10................             300
 products--1040.20(d).
----------------------------------------------------------------------------------------------------------------

                                           FD&C Action Section 502(u)
----------------------------------------------------------------------------------------------------------------
Establishments listing <10               161               2             322  0.1 (6 minutes)...              32
 SUDs.
Establishments listing >10                14              45             630  0.1 (6 minutes)...              63
 SUDs.
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............             952  ..................              95
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.

    Because many labeling provisions correspond to specific
recordkeeping requirements, we have accounted for burden attendant to
the provisions enumerated in table 3 as third-party disclosures. These
figures reflect what we believe to be the average burden incurred by
respondents to applicable information collection activities.
    Overall, the information collection reflects changes and
adjustments. For efficiency of operations, we have consolidated related
information collection currently approved under OMB control numbers
0910-0577 and 0910-0740 pertaining to recommendations found in Agency
guidance and discussed in this notice. This results in an increase to
the information collection by 30,482 burden hours annually. At the same
time, we have reduced our estimate of the total responses by 53,143,810
annually. Upon review, we believe we previously double-counted burden
ascribed to disclosures provisions having accounted for the same burden
as that associated with recordkeeping activities. We invite comment on
our estimates and these assumptions.

    Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14768 Filed 7-12-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 23, 2009 (Volume 74, Number 140)]
[Notices]
[Page 36541-36542]
[DOCID:fr23jy09-91]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form N-4, SEC File No. 270-282, OMB Control No. 3235-0318.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    The collection of information is entitled: ``Form N-4 (17 CFR
239.17b and 274.11c) under the Securities Act of 1933 (15 U.S.C. 77a et
seq.) under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et
seq.) registration statement of separate accounts organized as unit
investment trusts.'' Form N-4 is the form used by insurance company
separate accounts organized as unit investment trusts that offer
variable annuity contracts to register as investment companies under
the Investment Company Act of 1940 and/or to register their securities
under the Securities Act of 1933. The primary purpose of the
registration process is to provide disclosure of financial and other
information to investors and potential investors for the purpose of
evaluating an investment in a security. Form N-4 also permits separate
accounts organized as unit investment trusts that offer variable
annuity contracts to provide investors with a prospectus containing the
information required in a registration statement prior to the sale or
at the time of confirmation or delivery of the securities. The
estimated annual number of respondents filing on Form N-4 is 104 for
those filing initial registration statements and 1,360 for those filing
post-effective amendments. The proposed frequency of response is
annual. The estimate of the total annual reporting burden of the
collection of information is approximately 278.5 hours per initial
filing and 197.25 hours for a post-effective amendment, for a total of
297,224 hours ((104 initial registration statements x 278.5 hours) +
(1,360 post-effective amendments x 197.25 hour)). Providing the
information required by Form N-4 is mandatory. Responses will not be
kept confidential. Estimates of the burden hours are made solely for
the purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, VA 22312; or send an e-mail to: PRA_
<EMAIL_ADDRESS>

    Dated: July 17, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-17532 Filed 7-22-09; 8:45 am]

BILLING CODE 8010-01-P