[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34276-34277]
[FR Doc No: 2018-15380]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Regulation AC; SEC File No. 270-517, OMB Control No. 3235-0575

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in
Regulation Analyst Certification (``Regulation AC'') (17 CFR 242.500-
505), under the Securities Exchange Act of 1934 (15 U.S.C. 78a et
seq.).
    Regulation AC requires that research reports published, circulated,
or provided by a broker or dealer or covered person contain a statement
attesting that the views expressed in each research report accurately
reflect

the analyst's personal views and whether or not the research analyst
received or will receive any compensation in connection with the views
or recommendations expressed in the research report. Regulation AC also
requires broker-dealers to, on a quarterly basis, make, keep, and
maintain records of research analyst statements regarding whether the
views expressed in public appearances accurately reflected the
analyst's personal views, and whether any part of the analyst's
compensation is related to the specific recommendations or views
expressed in the public appearance. Regulation AC also requires that
research prepared by foreign persons be presented to U.S. persons
pursuant to Securities Exchange Act Rule 15a-6 and that broker-dealers
notify associated persons if they would be covered by the regulation.
Regulation AC excludes the news media from its coverage.
    The collections of information under Regulation AC are necessary to
provide investors with information with which to determine the value of
the research available to them. It is important for an investor to know
whether an analyst may be biased with respect to securities or issuers
that are the subject of a research report. Further, in evaluating a
research report, it is reasonable for an investor to want to know about
an analyst's compensation. Without the information collection, the
purposes of Regulation AC could not be met. This regulation does not
involve the collection of confidential information.
    The Commission estimates that Regulation AC imposes an aggregate
annual time burden of approximately 25,844 hours on 5,186 respondents,
or approximately 5 hours per respondent. The Commission estimates that
the total annual internal cost of compliance for the 25,844 hours is
approximately $12,452,349, or approximately $2,401 per respondent,
annually.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
[email protected]; and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Candace
Kenner, 100 F Street NE, Washington, DC 20549, or by sending an email
to: [email protected]. Comments must be submitted to OMB within 30
days of this notice.

    Dated: July 13, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-15380 Filed 7-18-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9422-9423]
[FR Doc No: 2010-4260]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration

(FDA). The meeting will be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 23, 2010, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C
and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Tracy Phillips, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), code<PHONE_NUMBER>. Please call the Information
Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On March 23, 2010, the committee will discuss and make
recommendations on issues relevant to FDA's reevaluation of the ReGen
Collagen Scaffold (CS) device (marketed as the Menaflex[reg]), which
FDA cleared in K082079 on December 18, 2008, sponsored by ReGen
Biologics, Inc. The indications for use statement for this device
states that the device is intended for use in surgical procedures for
the reinforcement and repair of soft tissue injuries of the medial
meniscus. In repairing and reinforcing medial meniscal defects, the
patient must have an intact meniscal rim and anterior and posterior
horns for attachment of the mesh. In addition, the surgically prepared
site for the CS must extend at least into the red/white zone of the
meniscus to provide sufficient vascularization. The CS reinforces soft
tissue and provides a resorbable scaffold that is replaced by the
patient's own soft tissue. The CS is not a prosthetic device and is not
intended to replace normal body structure.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present views, orally or in
writing, on issues pending before the committee. These views may be
submitted in writing to the contact person on or before March 16, 2010.
Oral presentations from the public will be scheduled at approximately 1
p.m., immediately following lunch. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the arguments they wish to present,
the names and addresses of proposed participants, and an indication of
the approximate time requested to make their presentation on or before
March 8, 2010. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by March 9, 2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
at<PHONE_NUMBER>, at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 24, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-4260 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Notices]
[Page 52103-52104]
[DOCID:fr12se07-77]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2323-172]

TransCanada Hydro Northeast, Inc.; Notice of Application for
Amendment of License and Soliciting Comments, Motions to Intervene, and
Protests

September 6, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters.
    b. Project No: 2323-172.
    c. Date Filed: August 13, 2007.
    d. Applicant: Mount Snow Ski Resort.
    e. Name of Project: Deerfield River Hydroelectric Project.
    f. Location: The project, consisting of eight developments, is
located on the Deerfield River, in Windham and Bennington Counties,
Vermont, and Franklin and Berkshire Counties, Massachusetts.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kelly Pawlak, General Manager, Mount Snow Ski
Resort, 12 Pisgah Road, West Dover, VT 05356;<PHONE_NUMBER>.
    i. FERC Contact: Andrea Claros, Telephone<PHONE_NUMBER>, and e-
mail<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protest:
October 9, 2007.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: Mount Snow seeks authorization to
construct a 18,000 foot pipeline from Somerset Reservoir, located on
the East Branch of the Deerfield River, to Mount Snow Ski Resort,
allowing up to 484 million

gallons of water per season (October-March) to be pumped into Mount
Snow's snowmaking system. Somerset Reservoir is one development of the
Deerfield River Hydroelectric Project, owned by TransCanada Hydro
Northeast, Inc. Two pump houses, one at Somerset Reservoir and one at
the base of Mount Snow North Face would be built. The current in-stream
impoundment used for snowmaking, Snow Lake on the North Branch
Deerfield River, would be taken off-stream, and the stream channel
would be restored. Carinthia Pond, also currently used for snowmaking,
would serve as a short-term water transfer station. Implementation of
the proposed project would not affect TransCanada's water flows or
water level requirements.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to

be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number (P-2323) of the particular application to which
the filing refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-17963 Filed 9-11-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Page 61674]
[FR Doc No: 2016-21420]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14329-002]

Columbia Basin Hydropower; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14329-002.
    c. Date Filed: June 27, 2016.
    d. Submitted By: Columbia Basin Hydropower.
    e. Name of Project: Banks Lake Pumped Storage Project.
    f. Location: On Banks Lake and Franklin D. Roosevelt Lake, in Grant
and Douglas Counties, Washington. The project occupies about 65 acres
of United States lands administered by Bureau of Reclamation.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Tim Culbertson, Columbia Basin
Hydropower, P.O. Box 219, Ephrata, WA 98823;<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    i. FERC Contact: Karen Sughrue at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Columbia Basin Hydropower filed its request to use the
Traditional Licensing Process on June 27, 2016. Columbia Basin
Hydropower provided public notice of its request on August 4, 2016. In
a letter dated August 31, 2016, the Director of the Division of
Hydropower Licensing approved Columbia Basin Hydropower's request to
use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Washington State Historic Preservation Officer,
as required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Columbia Basin Hydropower
as the Commission's non-federal representative for carrying out
informal consultation pursuant to section 7 of the Endangered Species
Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. Columbia Basin Hydropower filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: August 31, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-21420 Filed 9-6-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46673-46679]
[FR Doc No: 2020-16793]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3505]

Medical Device User Fee Rates for Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for medical device user fees for fiscal
year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV),
authorizes FDA to collect user fees for certain medical device
submissions and annual fees both for certain periodic reports and for
establishments subject to registration. This notice establishes the fee
rates for FY 2021, which apply from October 1, 2020, through September
30, 2021. To avoid delay in the review of your application, you should
pay the application fee before or at the time you submit your
application to FDA. The fee you must pay is the fee that is in effect
on the later of the date that your application is received by FDA or
the date your fee payment is recognized by the U.S. Treasury. If you
want to pay a reduced small business fee, you must qualify as a small
business before making your submission to FDA; if you do not qualify as
a small business before making your submission to FDA, you will have to
pay the higher standard fee. Please note that the establishment
registration fee is not eligible for a

reduced small business fee. As a result, if the establishment
registration fee is the only medical device user fee that you will pay
in FY 2021, you should not submit a Small Business Certification
Request. This document provides information on how the fees for FY 2021
were determined, the payment procedures you should follow, and how you
may qualify for reduced small business fees.

FOR FURTHER INFORMATION CONTACT: For information on Medical Device User
Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
    For questions relating to the MDUFA Small Business Program, please
visit the Center for Devices and Radiological Health's website: https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program.
    For questions relating to this notice: David Haas, Office of
Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Rm. 62041A, Beltsville, MD 20705,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for
certain medical device applications, submissions, supplements, notices,
and requests (for simplicity, this document refers to these
collectively as ``submissions'' or ``applications''); for periodic
reporting on class III devices; and for the registration of certain
establishments. Under statutorily defined conditions, a qualified
applicant may receive a fee waiver or may pay a lower small business
fee (see 21 U.S.C. 379j(d) and (e)).
    Under the FD&C Act, the fee rate for each type of submission is set
at a specified percentage of the standard fee for a premarket
application (a premarket application is a premarket approval
application (PMA), a product development protocol (PDP), or a biologics
license application (BLA)). The FD&C Act specifies the base fee for a
premarket application for each year from FY 2018 through FY 2022; the
base fee for a premarket application received by FDA during FY 2021 is
$328,000. From this starting point, this document establishes FY 2021
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2018 through FY 2022; the base fee for an
establishment registration in FY 2021 is $4,975. There is no reduction
in the registration fee for small businesses. Each establishment that
is registered (or is required to register) with the Secretary of Health
and Human Services under section 510 of the FD&C Act (21 U.S.C. 360)
because such establishment is engaged in the manufacture, preparation,
propagation, compounding, or processing of a device is required to pay
the annual fee for establishment registration.

II. Revenue Amount for FY 2021

    The total revenue amount for FY 2021 is $211,748,789, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA directs FDA to use the yearly total revenue amount
as a starting point to set the standard fee rates for each fee type.
The fee calculations for FY 2021 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $211,748,789 is to be adjusted for
inflation increases for FY 2021 using two separate adjustments--one for
payroll costs and one for non-payroll costs (see 21 U.S.C. 379j(c)(2)).
The base inflation adjustment for FY 2021 is the sum of one plus the
two separate adjustments and is compounded as specified in the statute
(see 21 U.S.C. 379j(c)(2)(C) and 379j(c)(2)(B)).
    The component of the inflation adjustment for payroll costs is the
average annual percent change in the cost of all personnel compensation
and benefits (PC&B) paid per full-time equivalent position (FTE) at FDA
for the first 3 of the 4 preceding FYs, multiplied by 0.60, or 60
percent (see 21 U.S.C. 379j(c)(2)(C)).
    Table 1 summarizes the actual cost and FTE data for the specified
FYs, and provides the percent change from the previous FY and the
average percent change over the first 3 of the 4 FYs preceding FY 2021.
The 3-year average is 1.2644 percent (rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
             Fiscal year                     2017               2018               2019          3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..........................     $2,581,551,000     $2,690,678,000     $2,620,052,000  .................
Total FTE...........................             17,022             17,023             17,144  .................
PC&B per FTE........................           $151,660           $158,061           $152,826  .................
Percent change from previous year...             2.8845             4.2206            -3.3120             1.2644
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 1.2644 percent multiplied by 60 percent,
or 0.7586 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2021 is the average
annual percent change that occurred in the Consumer Price Index (CPI)
for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally
Adjusted; All Items; Annual Index) for the first 3 of the preceding 4
years of available data multiplied by 0.40, or 40 percent (see 21
U.S.C. 379j(c)(2)(C)). As a result of a geographical revision made by
the Bureau of Labor and Statistics in January 2018,\1\ the
``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and that provides the most current
data available, the Washington-Arlington-Alexandria index will be used
in calculating the relevant adjustment factors for FY 2021 and
subsequent years.
---------------------------------------------------------------------------

    \1\ The Bureau of Labor Statistics' Announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
---------------------------------------------------------------------------

    Table 2 provides the summary data and the 3-year average percent
change in the specified CPI for the Washington-Arlington-Alexandria
area. These data are published by the Bureau of Labor Statistics and
can be found on their website under series Id CUURS35ASA0 at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

          Table 2--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI
----------------------------------------------------------------------------------------------------------------
                   Fiscal year                         2017            2018            2019       3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         256.221         261.445         264.777  ..............
Annual Percent Change...........................          1.1045          2.0389          1.2745  ..............
3-Year Average Percent Change in CPI............  ..............  ..............  ..............          1.4726
----------------------------------------------------------------------------------------------------------------

    The non-payroll adjustment is 1.4726 percent multiplied by 40
percent, or 0.5890 percent. Next, the payroll adjustment (0.7586
percent or 0.007586) is added to the non-payroll adjustment (0.5890
percent or .005890), for a total of 1.3476 percent (or 0.013476). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.013476 for FY 2021.
    MDUFA IV provides for this inflation adjustment to be compounded
for FY 2021 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2021, the FY 2020 compounded adjustment (1.099985) is multiplied by
the FY 2021 base inflation adjustment (1.013476) to reach the
applicable inflation adjustment of 1.114808 (rounded) for FY 2021. We
then multiply the total revenue amount for FY 2021 ($211,748,789) by
1.114808, yielding an inflation adjusted total revenue amount of
$236,059,000 (rounded to the nearest thousand dollars).

III. Fees for FY 2021

    Under the FD&C Act, all submission fees and the periodic reporting
fee are set as a percent of the standard (full) fee for a premarket
application (see 21 U.S.C. 379j(a)(2)(A)).

A. Inflation Adjustment

    MDUFA specifies that the base fees of $328,000 (premarket
application) and $4,975 (establishment registration) are to be adjusted
for FY 2021 using the same methodology as that for the total revenue
inflation adjustment in section II (see 21 U.S.C. 379j(c)(2)(D)(i)).
Multiplying the base fees by the compounded inflation adjustment of
1.114808 yields inflation adjusted base fees of $365,657 (premarket
application) and $5,546 (establishment registration).

B. Further Adjustments

    After the applicable inflation adjustment to fees is done, FDA may
increase, if necessary to achieve the inflation adjusted total revenue
amount, the base fee amounts on a uniform proportionate basis (see 21
U.S.C. 379j(c)(2)(D)(ii)). If necessary after this adjustment, FDA may
further increase the base establishment registration fees to generate
the inflation adjusted total revenue amount (see 21 U.S.C. 379j(c)(3)).

C. Calculation of Fee Rates

    Table 3 provides the last 3 years of fee-paying submission counts
and the 3-year average. These numbers are used to project the fee-
paying submission counts that FDA will receive in FY 2021.

                              Table 3--Three-Year Average of Fee-Paying Submissions
----------------------------------------------------------------------------------------------------------------
                                                      FY 2017         FY 2018         FY 2019         3-Year
                Application type                      actual          actual          actual          average
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...........................              37              38              32              36
    Small Business..............................               6               7               8               7
Panel-Track Supplement..........................              22              23              14              20
    Small Business..............................               2               5               4               4
De Novo Classification Request \1\..............  ..............              27              12              20
    Small Business \1\..........................  ..............              29              37              33
180-Day Supplements.............................             167             133             124             141
    Small Business..............................              33              27              23              28
Real-Time Supplements...........................             187             169             213             190
    Small Business..............................              19              34              43              32
510(k)s.........................................           2,969           2,122           2,069           2,387
    Small Business..............................           1,072           1,385           1,558           1,338
30-Day Notice...................................             998           1,058             925             994
    Small Business..............................              78              98             111              96
513(g) (21 U.S.C. 360c(g)) Request for                        93              84              75              84
 Classification Information.....................
    Small Business..............................              41              33              54              43
Annual Fee for Periodic Reporting \2\...........             618             624             629             624
    Small Business \2\..........................              57              74              96              76
Establishment Registration......................          27,115          27,544          27,734          27,464
----------------------------------------------------------------------------------------------------------------
\1\ Two-year average for De Novo is based on actuals from available data.
\2\ Includes collection of quarter 4 billing for FY 2019 during FY 2020.

    The information in table 3 is necessary to estimate the amount of
revenue that will be collected based on the fee amounts. Table 4
displays the FY 2021 base fees set in statute (column one) and the
inflation adjusted base fees (per calculations in section III.A.)
(column two). Using the inflation adjusted fees and the 3-year averages
of fee-paying submissions, collections are projected to total
$236,842,961, which is $783,961 higher than the inflation adjusted
total revenue amount (in section II). The fees in column two are those
we are establishing in FY 2021, which are the standard fees.

                           Table 4--Fees Needed To Achieve New FY 2021 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                         FY 2021 inflation
                                                              adjusted      3-Year average of   FY 2021 revenue
          Application type            FY 2021 statutory    statutory base       fee-paying       from adjusted
                                       fees (base fees)    fees (standard      submissions            fees
                                                               fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications...............           $328,000           $365,657                 36        $13,163,652
    Small Business..................             82,000             91,414                  7            639,898
Panel-Track Supplement..............            246,000            274,243                 20          5,484,860
    Small Business..................             61,500             68,561                  4            274,244
De Novo Classification Request......             98,400            109,697                 20          2,193,940
    Small Business..................             24,600             27,424                 33            904,992
180-Day Supplements.................             49,200             54,849                141          7,733,709
    Small Business..................             12,300             13,712                 28            383,936
Real-Time Supplements...............             22,960             25,596                190          4,863,240
    Small Business..................              5,740              6,399                 32            204,768
510(k)s.............................             11,152             12,432              2,387         29,675,184
    Small Business..................              2,788              3,108              1,338          4,158,504
30-Day Notice.......................              5,248              5,851                994          5,815,894
    Small Business..................              2,624              2,926                 96            280,896
513(g) Request for Classification                 4,428              4,936                 84            414,624
 Information........................
    Small Business..................              2,214              2,468                 43            106,124
Annual Fee for Periodic Reporting...             11,480             12,798                624          7,985,952
    Small Business..................              2,870              3,200                 76            243,200
Establishment Registration..........              4,975              5,546             27,464        152,315,344
                                     ---------------------------------------------------------------------------
        Total.......................  .................  .................  .................        236,842,961
----------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $365,657 for FY 2021. The fees set by reference
to the standard fee for a premarket application are:
     For a panel-track supplement, 75 percent of the standard
fee;
     For a de novo classification request, 30 percent of the
standard fee;
     For a 180-day supplement, 15 percent of the standard fee;
     For a real-time supplement, 7 percent of the standard fee;
     For an annual fee for periodic reporting concerning a
class III device, 3.5 percent of the standard fee;
     For a 510(k) premarket notification, 3.4 percent of the
standard fee;
     For a 30-day notice, 1.6 percent of the standard fee; and
     For a 513(g) request for classification information, 1.35
percent of the standard fee.
    For all submissions other than a 30-day notice and a 513(g) request
for classification information, the small business fee is 25 percent of
the standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)
and (e)(2)(C)). For a 30-day notice and a 513(g) request for
classification information, the small business fee is 50 percent of the
standard (full) fee for the submission (see 21 U.S.C. 379j(d)(2)(C)).
    The annual fee for establishment registration, after adjustment, is
set at $5,546 for FY 2021. There is no small business rate for the
annual establishment registration fee; all establishments pay the same
fee.
    Table 5 summarizes the FY 2021 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2021
----------------------------------------------------------------------------------------------------------------
                                                      Standard fee (as a percent
                Application fee type                   of the standard fee for a      FY 2021      FY 2021 small
                                                        premarket  application)    standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted under section  Base fee specified in             $365,657         $91,414
 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a   statute.
 PDP submitted under section 515(f) of the FD&C Act,
 or a BLA submitted under section 351 of the Public
 Health Service Act (the PHS Act) (42 U.S.C. 262)).
Premarket report (submitted under section 515(c)(2)   100.......................         365,657          91,414
 of the FD&C Act).
Efficacy supplement (to an approved BLA under         100.......................         365,657          91,414
 section 351 of the PHS Act).
Panel-track supplement..............................  75........................         274,243          68,561
De novo classification request......................  30........................         109,697          27,424
180-day supplement..................................  15........................          54,849          13,712
Real-time supplement................................  7.........................          25,596           6,399
510(k) premarket notification submission............  3.40......................          12,432           3,108
30-day notice.......................................  1.60......................           5,851           2,926
513(g) request for classification information.......  1.35......................           4,936           2,468
Annual Fee Type.....................................  ..........................  ..............  ..............
Annual fee for periodic reporting on a class III      3.50......................          12,798           3,200
 device.
Annual establishment registration fee (to be paid by  Base fee specified in                5,546           5,546
 the establishment engaged in the manufacture,         statute.
 preparation, propagation, compounding, or
 processing of a device, as defined by 21 U.S.C.
 379i(14)).
----------------------------------------------------------------------------------------------------------------

IV. How To Qualify as a Small Business for Purposes of Medical Device
Fees

    If your business, including your affiliates, has gross receipts or
sales of no more than $100 million for the most recent tax year, you
may qualify for reduced small business fees. If your business,
including your affiliates, has gross sales or receipts of no more than
$30 million, you may also qualify for a waiver of the fee for your
first premarket application (i.e. PMA, PDP, or BLA) or premarket
report. If you want to pay the small business fee rate for a submission
or you want to receive a waiver of the fee for your first premarket
application or premarket report, you should submit the materials
showing you qualify as a small business at least 60 days before you
send your submission to FDA. FDA will review your information and
determine whether you qualify as a small business eligible for the
reduced fee and/or fee waiver. If you make a submission before FDA
finds that you qualify as a small business, you must pay the standard
(full) fee for that submission.
    If your business qualified as a small business for FY 2020, your
status as a small business will expire at the close of business on
September 30, 2020. You must re-qualify for FY 2021 in order to pay
small business fees during FY 2021.
    If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2021, submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request For a
Business Headquartered in the U.S. (Form FDA 3602). Form FDA 3602 is
provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573420.pdf.
    2. A signed copy of your Federal (U.S.) Income Tax Return for the
most recent tax year. The most recent tax year will be 2020, except:
    If you submit your MDUFA Small Business Certification Request for
FY 2021 before April 15, 2021, and you have not yet filed your return
for 2020, you may use tax year 2019.
    If you submit your MDUFA Small Business Certification Request for
FY 2021 on or after April 15, 2021, and have not yet filed your 2020
return because you obtained an extension, you may submit your most
recent return filed prior to the extension.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year, or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates of
the gross receipts or sales collected. The business must also submit a
statement signed by the head of the business's firm or by its chief
financial officer that the business has submitted certifications for
all of its affiliates, identifying the name of each affiliate, or that
the business has no affiliates.
    If you are a foreign business, and wish to qualify as a small
business for FY 2021, submit the following:
    1. A completed MDUFA Foreign Small Business Certification Request
For a Business Headquartered Outside the United States (Form FDA
3602A). Form FDA 3602A is provided in the FDA Forms database: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM573423.pdf.
    2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority of the
country in which the firm is headquartered. This certification must
show the amount of gross receipts or sales for the most recent tax
year, in both U.S. dollars and the local currency of the country, the
exchange rate used in converting the local currency to U.S. dollars,
and the dates of the gross receipts or sales collected.
    3. For each of your affiliates, either:
     If the affiliate is a domestic (U.S.) business, a signed
copy of the affiliate's Federal (U.S.) Income Tax Return for the most
recent tax year (2020 or later), or
     If the affiliate is a foreign business and cannot submit a
Federal (U.S.) Income Tax Return, a National Taxing Authority
Certification completed by, and bearing the official seal of, the
National Taxing Authority of the country in which the firm is
headquartered. The National Taxing Authority is the foreign equivalent
of the U.S. Internal Revenue Service. This certification must show the
amount of gross receipts or sales for the most recent tax year, in both
U.S. dollars and the local currency of the country, the exchange rate
used in converting the local currency to U.S. dollars, and the dates
for the gross receipts or sales collected. The business must also
submit a statement signed by the head of the business's firm or by its
chief financial officer that the applicant has submitted certifications
for all of its affiliates, identifying the name of each affiliate, or
that the business has no affiliates.

V. Procedures for Paying Application Fees

    If your application or submission is subject to a fee and your
payment is received by FDA between October 1, 2020, and September 30,
2021, you must pay the fee in effect for FY 2021. The later of the date
that the application is received in the reviewing center's document
room or the date the U.S. Treasury recognizes the payment determines
whether the fee rates for FY 2020 or FY 2021 apply. FDA must receive
the correct fee at the time that an application is submitted, or the
application will not be accepted for filing or review.
    FDA requests that you follow the steps below before submitting a
medical device application subject to a fee to ensure that FDA links
the fee with the correct application. (Note: Do not send your user fee
check to FDA with the application.)

A. Secure a Payment Identification Number (PIN) and Medical Device User
Fee Cover Sheet From FDA Before Submitting Either the Application or
the Payment

    Log into the User Fee System at: https://userfees.fda.gov/OA_HTML/mdufmaCAcdLogin.jsp. Complete the Medical Device User Fee cover sheet.
Be sure you choose the correct application submission date range. (Two
choices will be offered until October 1, 2020. One choice is for
applications and fees that will be received on or before September 30,
2020, which are subject to FY 2020 fee rates. A second choice is for
applications and fees received on or after October 1, 2020, which are
subject to FY 2021 fee rates.) After completing data entry, print a
copy of the Medical Device User Fee cover sheet and note the unique PIN
located in the upper right-hand corner of the printed cover sheet.

B. Electronically Transmit a Copy of the Printed Cover Sheet With the
PIN

    When you are satisfied that the data on the cover sheet is
accurate, electronically transmit that data to FDA according to
instructions on the screen. Applicants are required to set up a user
account and password to assure data security in the creation and
electronic submission of cover sheets.

C. Submit Payment for the Completed Medical Device User Fee Cover Sheet

    1. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to utilize Pay.gov, a web-based
payment system, for online electronic payment. You may make a payment
via electronic check or credit card after submitting your cover sheet.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay. Note: Only full payments are
accepted. No partial payments can be made online. Once you search for
your invoice, select ``Pay Now'' to be redirected to Pay.gov.
Electronic payment options are based on the balance due. Payment by
credit card is available for balances that are less than $25,000. If
the balance exceeds this amount, only the ACH option is available.
Payments must be made using U.S. bank accounts as well as U.S. credit
cards.
    2. If paying with a paper check:
     All paper checks must be in U.S. currency from a U.S. bank
and made payable to the Food and Drug Administration. If needed, FDA's
tax identification number is 53-0196965.
     Please write your application's unique PIN (from the upper
right-hand corner of your completed Medical Device User Fee cover
sheet) on your check.
     Mail the paper check and a copy of the completed cover
sheet to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO
63197-9000. (Please note that this address is for payments of
application and annual report fees only and is not to be used for
payment of annual establishment registration fees.)
    If you prefer to send a check by a courier, the courier may deliver
the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is
for courier delivery only. If you have any questions concerning courier
delivery contact U.S. Bank at<PHONE_NUMBER>. This telephone number is
only for questions about courier delivery).
    3. If paying with a wire transfer:
     Please include your application's unique PIN (from the
upper right-hand corner of your completed Medical Device User Fee cover
sheet) in your wire transfer. Without the PIN, your payment may not be
applied to your cover sheet and review of your application may be
delayed.
     The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee
it is required that you add that amount to the payment to ensure that
the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.
    FDA records the official application receipt date as the later of
the following: (1) The date the application was received by the FDA
Document Control Center for the reviewing Center or (2) the date the
U.S. Treasury recognizes the payment. It is helpful if the fee arrives
at the bank at least 1 day before the application arrives at FDA.

D. Submit Your Application to FDA With a Copy of the Completed Medical
Device User Fee Cover Sheet

    Please submit your application and a copy of the completed Medical
Device User Fee cover sheet to the address located at https://www.fda.gov/cdrhsubmissionaddress.

VI. Procedures for Paying the Annual Fee for Periodic Reporting

    You will be invoiced at the end of the quarter in which your PMA
Periodic Report is due. Invoices will be sent based on the details
included on your PMA file. You are responsible for ensuring that FDA
has your current billing information, and you may update your contact
information for the PMA by submitting an amendment to the pending PMA
or a supplement to the approved PMA.
    1. The preferred payment method is online using electronic check
(ACH also known as eCheck) or credit card (Discover, VISA, MasterCard,
American Express). Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay (Note:
Only full payments are accepted. No partial payments can be made
online). Once you search for your invoice, select ``Pay Now'' to be
redirected to Pay.gov. Note that electronic payment options are based
on the balance due. Payment by credit card is available for balances
that are less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be made using U.S. bank
accounts as well as U.S. credit cards.
    2. If paying with a paper check:
    The check must be in U.S. currency from a U.S. bank and made
payable to the Food and Drug Administration. If needed, FDA's tax
identification number is 53-0196965.
     Please write your invoice number on the check.
     Mail the paper check and a copy of the invoice to: Food
and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000.
(Please note that this address is for payments of application and
annual report fees only and is not to be used for payment of annual
establishment registration fees.)
    To send a check by a courier, the courier must deliver the check
and printed copy of the cover sheet to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery only. If you have any
questions concerning courier delivery, contact U.S. Bank at 314-418-
4013. This telephone number is only for questions about courier
delivery).
    3. When paying by a wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. If the payment amount is not applied, the invoice amount would
be referred to collections. The originating financial institution may
charge a wire transfer fee. If the financial institution charges a wire
transfer fee, it is required that you add that amount to the payment to
ensure that the invoice is paid in full.
    Use the following account information when sending a wire transfer:
U.S. Department of the Treasury, TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33.

VII. Procedures for Paying Annual Establishment Registration Fees

    To pay the annual establishment registration fee, firms must access
the Device Facility User Fee (DFUF) website at https://userfees.fda.gov/OA_HTML/furls.jsp. (FDA has verified the website
address, but FDA is not responsible for any subsequent changes to the
website address after this document publishes in the Federal Register.)
Create a DFUF order and you will be issued a PIN when you place your
order. After payment has been processed, you will be issued a payment
confirmation number (PCN). You will not be able to register your
establishment if you do not have a PIN and a PCN. An establishment
required to pay an annual establishment registration fee is not legally
registered in FY 2021 until it has completed the steps below to
register and pay any applicable fee (see 21 U.S.C. 379j(f)(2)).
    Companies that do not manufacture any product other than a licensed

biologic are required to register in the Blood Establishment
Registration (BER) system. FDA's Center for Biologics Evaluation and
Research (CBER) will send establishment registration fee invoices
annually to these companies.

A. Submit a DFUF Order With a PIN From FDA Before Registering or
Submitting Payment

    To submit a DFUF Order, you must create or have previously created
a user account and password for the user fee website listed previously
in this section. After creating a user name and password, log into the
Establishment Registration User Fee FY 2021 store. Complete the DFUF
order by entering the number of establishments you are registering that
require payment. When you are satisfied that the information in the
order is accurate, electronically transmit that data to FDA according
to instructions on the screen. Print a copy of the final DFUF order and
note the unique PIN located in the upper right-hand corner of the
printed order.

B. Pay For Your DFUF Order

    Unless paying by U.S. credit card, all payments must be in U.S.
currency and drawn on a U.S. bank.
    1. If paying by credit card or electronic check (ACH or eCheck):
    The DFUF order will include payment information, including details
on how you can pay online using a credit card or electronic check.
Follow the instructions provided to make an electronic payment.
    2. If paying with a paper check:
    The check must be in U.S. currency and drawn on a U.S. bank, and
mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO
63197-9000. (Note: This address is different from the address for
payments of application and annual report fees and is to be used only
for payment of annual establishment registration fees.)
    If a check is sent by a courier that requests a street address, the
courier can deliver the check to: U.S. Bank, Attn: Government Lockbox
979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S.
Bank address is for courier delivery only. If you have any questions
concerning courier delivery, contact U.S. Bank at<PHONE_NUMBER>. This
telephone number is only for questions about courier delivery.)
    Please make sure that both of the following are written on your
check: (1) The FDA post office box number (P.O. Box 979108) and (2) the
PIN that is printed on your order. Include a copy of your printed order
when you mail your check.
    3. If paying with a wire transfer:
    Wire transfers may also be used to pay annual establishment
registration fees. To send a wire transfer, please read and comply with
the following information:
    Include your order's unique PIN (in the upper right-hand corner of
your completed DFUF order) in your wire transfer. Without the PIN, your
payment may not be applied to your facility and your registration may
be delayed.
    The originating financial institution may charge a wire transfer
fee. If the financial institution charges a wire transfer fee, it is
required that you add that amount to the payment to ensure that the
invoice is paid in full. Use the following account information when
sending a wire transfer: U.S. Dept. of the Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No.
021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number
is 53-0196965.

C. Complete the Information Online to Update Your Establishment's
Annual Registration for FY 2021, or To Register a New Establishment for
FY 2021

    Go to the Center for Devices and Radiological Health's website at
https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing and click the ``Access Electronic
Registration'' link on the left side of the page. This opens up a new
page with important information about the FDA Unified Registration and
Listing System (FURLS). After reading this information, click on the
``Access Electronic Registration'' link in the middle of the page. This
link takes you to an FDA Industry Systems page with tutorials that
demonstrate how to create a new FURLS user account, if your
establishment did not create an account in FY 2020. Manufacturers of
licensed biologics should register in the Biologics Establishment
Registration (BER) system at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-establishment-registration.
    Enter your existing account ID and password to log into FURLS. From
the FURLS/FDA Industry Systems menu, click on the Device Registration
and Listing Module (DRLM) of FURLS button. New establishments will need
to register and existing establishments will update their annual
registration using choices on the DRLM menu. When you choose to
register or update your annual registration, the system will prompt you
through the entry of information about your establishment and your
devices. If you have any problems with this process, email:
<EMAIL_ADDRESS>or call<PHONE_NUMBER> for assistance. (Note: This
email address and this telephone number are for assistance with
establishment registration only; they are not to be used for questions
related to other aspects of medical device user fees.) Problems with
the BER system should be directed to https://www.accessdata.fda.gov/scripts/email/cber/bldregcontact.cfm or call<PHONE_NUMBER>.

D. Enter Your DFUF Order PIN and PCN

    After completing your annual or initial registration and device
listing, you will be prompted to enter your DFUF order PIN and PCN,
when applicable. This process does not apply to establishments engaged
only in the manufacture, preparation, propagation, compounding, or
processing of licensed biologic devices. CBER will send invoices for
payment of the establishment registration fee to such establishments.

    Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16793 Filed 7-29-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68689-68690]
[FR Doc No: 2022-24924]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2022-0869; FRL-10393-01-OW]

Proposed Information Collection Request; Comment Request; Chrome
Finishing Industry Data Collection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``U.S. Environmental
Protection Agency Chrome Finishing Industry Data Collection'' (EPA ICR
No. 2723.01, OMB Control No. 2040-NEW) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (PRA). Before doing so, EPA is soliciting public comments
on specific aspects of the proposed information collection as described
below. This is a request for approval of a new collection. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before January 17, 2023.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2022-0869, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Dr. Phillip Flanders, Engineering and
Analysis Division, Office of Science and Technology, (4303T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA (44 U.S.C. 3501 et
seq), EPA is soliciting comments and information to enable it to: (i)
evaluate 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; (ii) evaluate the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (iii) enhance the quality, utility, and clarity
of the information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: Under the Clean Water Act (CWA), EPA develops effluent
limitations guidelines (ELGs) to limit pollutants discharged from
industrial point source categories. EPA initially promulgated the Metal
Finishing ELGs in 1983 and amended the regulations in 1984 and 1986.
The current regulation covers wastewater discharges from facilities
performing various metal finishing operations. Metal finishing is the
process of changing the surface of an object, for the purpose of
improving its appearance and/or durability. Metal finishing is related
to electroplating, which is the production of a thin surface coating of
a metal upon another by electrodeposition. EPA first promulgated the
Electroplating ELGs in 1974, with amendments in 1977, 1979, 1981, and
1983. Together, the Metal Finishing and Electroplating ELGs apply to
thousands of facilities which perform one or more of the following
operations and discharge process wastewater directly to surface waters
or indirectly to surface waters through publicly owned treatment works
(POTWs): electroplating, electroless plating, anodizing, coating
(including phosphating, chromating, and coloring), chemical etching and
milling, and printed circuit board manufacture.
    As announced in the Preliminary Effluent Guidelines Program Plan
15, published in September 2021, EPA plans to conduct a rulemaking to
address Per- and Polyfluoroalkyl Substances (PFAS) discharges from a

subset of facilities in the Metal Finishing and Electroplating point
source categories. Based on information and data collected during the
Multi-Industry PFAS Study, EPA determined PFAS are used by some metal
finishing and electroplating facilities to control hexavalent chromium
emissions, a known human carcinogen and inhalation hazard. EPA
determined facilities performing certain chromium operations (hereafter
referred to as ``chrome finishing facilities''), including chromium
plating, chromium anodizing, chromic acid etching, and chromate
conversion coating operations, are the predominant sources of PFAS
discharges by the Metal Finishing and Electroplating point source
categories.
    Publicly available data on metal finishing and electroplating
facilities, including whether they perform chromium finishing
operations and potential use and discharge of PFAS, are limited. EPA
reviewed information on metal finishing and electroplating facilities
that potentially conduct one or more chromium finishing operations
available in national EPA data sets, including the Chromium
Electroplating and Anodizing National Emissions Standards for Hazardous
Air Pollutants (NESHAP) codified at 40 CFR part 63 subpart N, 2017
National Emissions Inventory (NEI), Compliance and Emissions Data
Reporting Interface (CEDRI), Environmental Compliance History Online
(ECHO), and Integrated Compliance Information System (ICIS), as well as
data collected from several state environmental agencies. However, none
of these data sources define a complete population of chromium
finishing facilities in the United States nor do they provide detailed
information on specific facility operations (including use of
hexavalent chromium or PFAS), generation and management of wastewater,
or wastewater characteristics--factors essential to EPA's review and
development of ELGs to address PFAS discharges. Therefore, a
questionnaire and wastewater sampling program for the Metal Finishing
and Electroplating point source categories are essential portions of
the rulemaking process, necessary for EPA to determine if the current
regulations remain appropriate and, if warranted, develop new
regulations. If new regulations are deemed to be warranted, the
questionnaire and sampling activities are essential for EPA to complete
the detailed technical and economic analysis for the entire industry
necessary for the rulemaking process. EPA has identified and compiled
mailing addresses for approximately 1,815 potential chromium finishing
facilities in the United States. All active metal finishing and
electroplating facilities that conduct or have conducted one or more of
the specified chromium finishing operations will be required to
complete the questionnaire. The objectives of the questionnaire will be
to confirm the population of facilities that engage or have engaged in
chromium finishing operations, as well as gather facility-specific
information and data relevant to generation and discharge of PFAS-
containing wastewater by the industry.
    Confidential Business Information (CBI) may be collected. In
accordance with 40 CFR, part 2, subpart B, section 2.203, the survey
informs respondents of their right to claim information as
confidential. Each survey provides instructions for claiming
confidentiality and informs respondents of the terms and rules
governing the protection of CBI under the Clean Water Act and 40 CFR
2.203(B). Survey respondents are able to and are requested to mark any
claimed confidential responses as CBI. EPA and its contractors will
follow EAD's existing procedures to protect data labeled as CBI.
    Form Numbers: None.
    Respondents/affected entities: All chrome finishing facilities in
the U.S. facilities will receive the questionnaire (1,815 facilities)
and no more than 20 facilities will be asked to conduct specific
wastewater sampling.
    Respondent's obligation to respond: Mandatory (Clean Water Act
section 308) (citing authority).
    Estimated number of respondents: 1,815 (total).
    Frequency of response: One-time data collection.
    Total estimated respondent burden: 35,858 hours. Burden is defined
at 5 CFR 1320.03(b).
    Total estimated respondent cost: $1,696,682.83 one-time cost.
    Changes in Estimates: This is a new data collection request and is
a one-time temporary increase to the agency's burden.

Deborah Nagle,
Director, Office of Science and Technology, Office of Water.
[FR Doc. 2022-24924 Filed 11-15-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Rules and Regulations]
[Pages 78304-78305]
[FR Doc No: 2014-30494]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0952]

Drawbridge Operation Regulation; Victoria Barge Canal,
Bloomington, Texas

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
method of operation for the Victoria Barge Canal Railroad Bridge across
the Victoria Barge Canal, mile 29.4 at Bloomington, Victoria County,
Texas. The bridge will continue to open on signal. The bridge owner,
the Victoria County Navigation District, in conjunction with the Union
Pacific Railroad (UPRR), the operator of the bridge, requested
permission to remotely operate the bridge. This deviation tests a
remote operating system as the method for opening the bridge under the
existing operating schedule to determine whether a permanent change to
remote operations can be approved.

DATES: This deviation is effective from midnight on December 30, 2014
through midnight on June 29, 2015.
    Comments and related material must be received by the Coast Guard
on March 2, 2015.

ADDRESSES: You may submit comments identified by docket number USCG-
2014-0952 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this test
deviation, call or email the Coast Guard; Mr. David M. Frank, telephone
504-671-2128, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Cheryl Collins,
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 materials. 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-2014-0952), 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 http://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, type the docket number [USCG-2014-
0952] in the ``SEARCH'' box and click ``SEARCH.'' Click on ``Submit a
Comment'' on the line associated with this rulemaking. 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, type the docket number (USCG-2014-0952) in
the ``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on
the line associated with this rulemaking. You may also visit 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.

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 three 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. Basis and Purpose

    The bridge owner, the Victoria County Navigation District, in
conjunction with the UPRR requested permission to remotely operate the
Victoria Barge Canal Railroad Bridge across the Victoria Barge Canal,
mile 29.4 at Bloomington, Victoria County, Texas. Traffic on the
waterway consists of primarily commercial traffic, vessels and tows
providing services to the Port of Victoria. The vertical lift bridge
has a vertical clearance of 22 feet above high water in the closed-to-
navigation position and 50 feet above high water in the open-to-
navigation position.
    Presently, the bridge is required to open on signal for the passage
of vessels in accordance with 33 CFR 117.5. However, due to the passing
trains, when a request signal to open the bridge is received and before
opening the bridge for vessel traffic, the tender is required by his
company to contact the railroad dispatcher so that railroad traffic can
be stopped, if necessary. The bridge will continue to open on signal
for the passage of vessels, but the method of opening the bridge will
be accomplished through remote operation by the railroad dispatcher.
    The bridge operator, UPRR, determined that by remotely operating
the bridge, vessel transit through the bridge will become more
efficient. This new remote method of operation provides for the signal
to open to be received directly by the railroad dispatcher and will
allow the railroad dispatcher to then open the bridge from the remote
location.
    Vessel traffic on the waterway will be monitored by the railroad
dispatcher through the use of Automatic Identification System (AIS).
The Victoria County Navigation District recommends that all vessels
wishing to transit on the Victoria Barge Canal up to the Port of
Victoria have an operating AIS transponder onboard. This AIS tracking
system allows the Port of Victoria and the railroad dispatcher to
determine where vessels are located on the waterway in relationship to
the bridge. Movements of vessels with AIS onboard within two miles of
the bridge will trigger notification to the railroad dispatcher that a
vessel is approaching the bridge and needs the bridge to be opened. Any
vessel that has passed the two-mile signage may also choose to contact
the railroad dispatcher via telephone. Upon receipt of this initial
notification, the railroad dispatcher must contact the vessel via
radiotelephone (marine radio) on VHF-FM channel 13 to coordinate the
safe passage of the vessel through the bridge. The railroad dispatcher
must provide information to include, but not limited to, the
availability to continue the vessel transit as the bridge is open for
navigation or that the vessel will have to wait as a train is in the
block. If a vessel is required to wait, the railroad dispatcher must
indicate to the vessel the amount of time the vessel will have to wait
so that the train can be cleared from the block.
    In preparation for this test deviation, the bridge owner has posted
signage regarding the operation of the bridge at two miles, at one
mile, and at one-half mile from the bridge in each direction. To
facilitate the continued smooth operation of the bridge, mariners
should exchange opening requests using the following method:

    1. When a vessel with AIS equipment onboard approaches the two-
mile post, the vessel may continue to transit the waterway but must
tune their radiotelephone to VHF-FM channel 13 and receive passing
instructions from the railroad dispatcher. The dispatcher must
contact the vessel promptly to provide passing instruction to insure
the continued safe transit of the vessel. Vessels without AIS
equipment or vessels with AIS who would prefer to call via
telephone, may call the railroad dispatcher at<PHONE_NUMBER> to
arrange passing instructions.
    2. When any vessel approaches the one-mile post, the railroad
dispatcher should have either cleared the vessel through the bridge
or given an indication that a train is in the block and the vessel
will be cleared as soon as practicable. If the vessel has not yet
spoken with the railroad dispatcher, the vessel should immediately
call the railroad dispatcher via telephone at<PHONE_NUMBER>.
    3. When any vessel reaches the one-half mile post and has not
communicated with the railroad dispatcher nor been cleared to
proceed, the vessel should stop and contact either the railroad
dispatcher at<PHONE_NUMBER> or the Port of Victoria emergency contact
at<PHONE_NUMBER>.

    During the test deviation phase, the bridge will be operated from
Spring, TX, but the bridge operator will be required to have a signal
maintainer on call to respond to bridge operation issues should one
occur.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedules immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: December 4, 2014.
David M. Frank,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2014-30494 Filed 12-29-14; 8:45 am]
BILLING CODE 9110-04-P