[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48870-48878]
[FR Doc No: 2023-15919]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2965]

Medical Device User Fee Rates for Fiscal Year 2024

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) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the Medical Device User Fee Amendments of 2022 (MDUFA V),
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 2024, which apply from October 1, 2023, through September
30, 2024, and provides information on how the fees for FY 2024 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: Olufunmilayo Ariyo, Office
of Financial Management, Food and Drug Administration, 4041 Powder Mill
Rd., Beltsville, MD 20705-4304,<PHONE_NUMBER>; or the User Fee Support
Staff at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The FD&C Act, as amended by MDUFA V, 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. 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 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 2023 through FY 2027; the
base fee for a premarket application received by FDA during FY 2024 is
$435,000. From this starting point, this document establishes FY 2024
fee rates for certain types of submissions, and for periodic reporting,
by applying criteria specified in the FD&C Act. 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)). For
more information on fee waivers, please see Section IX. Small Business
Fee Reductions and Fee Waivers.
    The FD&C Act specifies the base fee for establishment registration
for each year from FY 2023 through FY 2027; the base fee for an
establishment registration in FY 2024 is $6,875. 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. Total Revenue Amount for FY 2024

    The total revenue amount for FY 2024 is $335,750,000, as set forth
in the statute prior to the inflation adjustment (see 21 U.S.C.
379j(b)(3)). MDUFA V 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 2024 are described in this document.

Inflation Adjustment

    MDUFA specifies that the $335,750,000 is to be adjusted for
inflation increases for FY 2024 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 2024 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, provides the percent change from the previous fiscal year, and
provides the average percent change over the first 3 of the 4 fiscal
years preceding FY 2024. The 3-year average is 3.9280 percent
(rounded).

                                 Table 1--FDA PC&Bs Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                               FY 2020           FY 2021           FY 2022       3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..............................    $2,875,592,000    $3,039,513,000    $3,165,477,000  ................
Total FTE...............................           $17,535           $18,501           $18,474  ................
PC&B per FTE............................          $163,922          $164,289          $171,348  ................
Percent change from previous year.......           7.3063%           0.1811%           4.2967%           3.9280%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 3.9280 percent multiplied by 60 percent,
or 2.3568 percent. The statute specifies that the component of the
inflation adjustment for non-payroll costs for FY 2024 is the average
annual percent change that occurred in the Consumer Price Index (CPI)
for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-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)).
    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
----------------------------------------------------------------------------------------------------------------
                                                2020              2021              2022         3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI..............................           267.157           277.728           296.117  ................
Annual Percent Change...................           0.8989%           3.9568%           6.6212%  ................
3-Year Average Percent Change in CPI....  ................  ................  ................           3.8256%
----------------------------------------------------------------------------------------------------------------

    The non-payroll adjustment is 3.8256 percent multiplied by 40
percent, or 1.5302 percent. Next, the payroll adjustment (2.3568
percent or 0.023568) is added to the non-payroll adjustment (1.5302
percent or .015302), for a total of 3.8870 percent (or 0.038870). To
complete the inflation adjustment, 1 (100 percent or 1.0) is added for
a total base inflation adjustment of 1.03887 for FY 2024.
    MDUFA V provides for this inflation adjustment to be compounded for
FY 2023 and each subsequent fiscal year (see 21 U.S.C.
379j(c)(2)(B)(ii)). To complete the compounded inflation adjustment for
FY 2024, the FY 2023 compounded adjustment (1.038870) is multiplied by
the FY 2024 base inflation adjustment (1.038935) to reach the
applicable inflation adjustment of 1.079318 (rounded) for FY 2024. We
then multiply the total revenue amount for FY 2024 ($335,750,000) by
1.079318, yielding an inflation adjusted total revenue amount of
$362,381,000 (rounded to the nearest thousand dollars).

III. Adjustments to Base Fee Amounts for FY 2024

    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 $435,000 (premarket
application) and $6,875 (establishment registration) are to be adjusted
for FY 2024 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
1.079318 yields inflation adjusted base fees of $469,503 (premarket
application) and $7,420 (establishment registration).

B. Further Adjustments To Generate the Inflation-Adjusted Total Revenue
Amount

    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)). After this adjustment, if necessary, 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. MDUFA V Adjustments Solely to Registration Fees

    MDUFA V has three new potential adjustments that will not change
the total revenue amount but may impact collections by increasing or
decreasing establishment registration base fees only. These adjustments
are the performance improvement adjustment, the hiring adjustment, and
the operating reserve adjustment. Only the operating reserve adjustment
is potentially applicable in FY 2024.
1. Performance Improvement Adjustment
    For FY 2024, there is no performance improvement adjustment.
Beginning with FY 2025, this adjustment allows FDA to collect fees in
addition to the total revenue amount in FYs 2025, 2026, and 2027, if
the Agency meets certain performance goals in FYs 2023, 2024, and 2025.
If applicable, this provision further increases base establishment
registration fee amounts to achieve an increase in total fee
collections equal to the applicable performance improvement adjustment,
which is set forth in the statute (see 21 U.S.C. 379j(c)(4)).
2. Hiring Adjustment
    For FY 2024, there is no hiring adjustment. Beginning with FY 2025,
this adjustment provides for the reduction of base establishment
registration fees in FYs 2025, 2026, and 2027, if specified hiring
goals for FYs 2023, 2024, and 2025 are not met by a certain threshold.
The hiring adjustment would serve to decrease the base establishment
registration fee amounts as necessary to achieve a reduction in total
fee collections equal to the hiring adjustment amount, which is set
forth in the statute (see 21 U.S.C. 379j(c)(5)).
3. Operating Reserve Adjustment
    For FYs 2023 to 2027, the operating reserve adjustment requires FDA
to decrease base establishment registration fees if the amount of
operating reserves of carryover user fees exceeds the ``designated
amount'' and such reduction is necessary to provide for not more than
such designated amount of operating reserves of carryover user fees
(see 21 U.S.C. 379j(c)(6)). In making this calculation for FYs 2023 to
2026, a certain amount is excluded from the designated amount and is
not subject to the decrease (see 21 U.S.C. 379j(c)(6)(C)). For FY 2024,
this excluded amount is $100,600,981.
    The designated amount is equal to the sum of 13 weeks of operating
reserves of carryover user fees plus 1 month of operating reserves
described in 21 U.S.C. 379j(c)(8) (see 21 U.S.C. 379j(c)(6)(B)).
    To determine the 13-week operating reserves of carryover user fees
amount, the FY 2024 inflation-adjusted total revenue amount,
$362,381,000 is divided by 52, and then multiplied by 13. The 13-week
operating reserve amount for FY 2024 is $90,595,250.
    To determine the 1 month of operating reserves described in 21
U.S.C. 379j(c)(8), the FY 2024 inflation-adjusted total revenue amount
of $362,381,000 is divided by 12. The 1 month of operating reserves for
FY 2024 is $30,198,417.
    For FY 2024, the designated amount is equal to the 13-week
operating reserve of $90,595,250 plus the 1 month of operating reserves
of $30,198,417, totaling $120,793,667.
    To determine the FY 2023 end-of-year operating reserves of
carryover user fees amount, FDA combined the actual collections and
obligations at the end of the third quarter (June 2023) and added the
forecasted collections and obligations for the fourth quarter of FY
2023 to generate a full year estimate for FY 2023. The estimated end-
of-year FY 2023 operating reserves of carryover user fees is
$30,019,132. (Note, this amount includes the 1-month reserve.)
    Note that under MDUFA V, for the purposes of calculating the
operating reserve adjustment, this amount does not include user fee
funds considered unappropriated ($26,680,243) or unearned revenue
($65,418,275). In addition, as noted above, for purposes of the
operating reserve adjustment, operating reserves of carryover user fees
do not include the estimated $100,600,981 remaining to spend at the end
of FY 2023 from the total of $118,000,000 intended to support the Total
Product Life Cycle Advisory Program Pilot and Third-Party Review
programs.
    Because the estimated end-of-year FY 2023 MDUFA operating reserves
of carryover user fees amount totaling $30,019,132 does not exceed the
FY 2024 designated amount of $120,793,667 FDA will not decrease the
base establishment registration fee amounts for FY 2024 to provide for
not more than such designated amount.

IV. Calculation of Fee Rates

    As noted in section II, the total revenue amount after the
applicable inflation adjustment is $362,381,000 (rounded to the nearest
thousand dollar). As noted in section III, there is no MDUFA V
adjustment solely to registration fees for FY 2024.
    Table 3A provides fee-paying submission counts excluding
establishment registration for the last 3 years and the 3-year average.
Table 3B provides establishment registration fee-paying submission
counts for the last 5 years and the 5-year average. Historically, FDA
has estimated the total number of fee-paying submission counts it
expects to receive during the next fiscal year by averaging the number
of fee-paying submission counts received in the 3 most recently
completed fiscal years; for FY 2024 fee-setting, this would be an
average of FY 2020 through FY 2022. FDA received an abnormally high
volume of fee paying establishment registrations due to the COVID-19
pandemic in FY 2020 and FY 2021. The surge in fee-paying establishment
registrations has been declining starting in FY 2022, trending back
toward pre-pandemic levels. In an effort to normalize the projected
volume of establishment registration submissions for the FY 2024 fee-
setting calculation and more accurately project the associated
establishment registration revenue, FDA decided to average the number
of establishment registrations from FY 2018 through FY 2022. FDA
believes a 5-year average to estimate establishment registration volume
will

minimize the impact of the surge in fee paying establishment
registration volume in FY 2020 and FY 2021.

          Table 3A--Three-Year Average of Fee-Paying Submissions (Excluding Establishment Registration)
----------------------------------------------------------------------------------------------------------------
               Application type                 FY 2020 actual  FY 2021 actual  FY 2022 actual   3-Year average
----------------------------------------------------------------------------------------------------------------
Full Fee applications.........................              29              25              18                24
    Small Business............................               7               5               3                 5
Panel-Track Supplements.......................              23              31              21                25
    Small Business............................               6               6               1                 4
De Novo Classifications.......................              20              16              23                20
    Small Business............................              47              42              53                47
180-Day Supplements...........................             124              98              93               105
    Small Business............................              20              34              31                28
Real-Time Supplements.........................             175             150             140               155
    Small Business............................              28              20              12                20
510(k)s.......................................           2,048           2,133           2,012             2,064
    Small Business............................           1,667           1,846           1,757             1,757
30-Day Notice (Note also includes counts for               870             843             782               832
 135 Day Supplements).........................
    Small Business............................             104              77              67                83
513(g)(21 U.S.C. 360c(g)) Request for                       96              83              93                91
 Classification Information...................
    Small Business............................              57              53              58                56
Annual Fee for Periodic Reporting.............             622             613             620               618
    Small Business............................              95              84              87                89
----------------------------------------------------------------------------------------------------------------

                Table 3B--Five-Year Average of Fee-Paying Establishment Registration Submissions
----------------------------------------------------------------------------------------------------------------
      Application type          FY 2018      FY 2019      FY 2020      FY 2021      FY 2022      5-Year average
----------------------------------------------------------------------------------------------------------------
Establishment Registrations.      27,544       27,728       41,942       33,812       31,748             32,555
----------------------------------------------------------------------------------------------------------------

    The information in tables 3A and 3B is necessary to estimate the
amount of revenue that will be collected based on the fee amounts.
Tables 4A and B display the FY 2024 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, the 3-year
average of fee-paying submissions (excluding establishment
registration), and the 5-year average of fee-paying establishment
registration submissions, collections are projected to total
$351,531,781 which is $10,849,219 lower than the inflation adjusted
total revenue amount (in section II). Accordingly, the next step in the
fee setting process is to increase the base fee amounts on a uniform
proportionate basis to generate the inflation adjusted total revenue
amounts (see 21 U.S.C. 379j(c)(2)(D)(ii) and table 4A, column three).
    Applying these further adjusted fee rates to the 3-year average of
fee paying submissions, and the 5-year average of fee-paying
establishment registration submissions results in estimated total fee
collections of $362,040,886, which is still $340,114 lower than the
inflation adjusted total revenue amount (in Section II). The next step
in the fee setting process, after the adjustment in (2)(D) is done, is
to increase the base establishment registration fee amount as necessary
for total fee collections to generate the inflation adjusted total
revenue amount, as adjusted under paragraph (2) (see 21 U.S.C.
379j(c)(3)). Accordingly, the base establishment registration fee was
increased by $11 for an establishment registration fee rate of $7,653
(see 21 U.S.C. 379j(c)(3)). The fees in column three in tables 4A and
4B are those we are establishing for FY 2024, which are the standard
fees.

                           Table 4A--Fees Needed To Achieve New FY 2024 Revenue Target
----------------------------------------------------------------------------------------------------------------
                                                   FY 2024
                                                  inflation     Adjusted FY 2024
                                  FY 2024         adjusted        fees to meet    3-Year average      FY 2024
      Application type        statutory fees   statutory base    revenue target    of fee-paying   revenue from
                                (base fees)    fees (standard    (standard fees)    submissions    adjusted fees
                                                    fees)
----------------------------------------------------------------------------------------------------------------
Full Fee Applications.......        $435,000          $469,503          $483,560              24     $11,605,440
    Small Business..........         108,750           117,376           120,890               5         604,450
Panel-Track Supplement......         348,000           375,603           386,848              25       9,671,200
    Small Business..........          87,000            93,901            96,712               4         386,848
De Novo Classification               130,500           140,851           145,068              20       2,901,360
 Request....................
    Small Business..........          32,625            35,213            36,267              47       1,704,549
180-Day Supplements.........          65,250            70,425            72,534             105       7,616,070
    Small Business..........          16,313            17,606            18,134              28         507,752
Real-Time Supplements.......          30,450            32,865            33,849             155       5,246,595
    Small Business..........           7,613             8,216             8,462              20         169,240
510(k)s.....................          19,575            21,128            21,760           2,064      44,912,640
    Small Business..........           4,894             5,282             5,440           1,757       9,558,080
30-Day Notice...............           6,960             7,512             7,737             832       6,437,184

    Small Business..........           3,480             3,756             3,869              83         321,127
513(g) Request for                     5,873             6,338             6,528              91         594,048
 Classification Information.
    Small Business..........           2,937             3,169             3,264              56         182,784
Annual Fee for Periodic               15,225            16,433            16,925             618      10,459,650
 Reporting..................
    Small Business..........           3,806             4,108             4,231              89         376,559
                             -----------------------------------------------------------------------------------
        Total...............  ..............  ................  ................  ..............     113,255,576
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                                               Table 4B--Fees Needed To Achieve New FY 2024 Revenue Target
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                FY 2024 inflation
                                                                     FY 2024           adjusted       Adjusted FY 2024   5-Year average  FY 2024 revenue
                        Application type                          statutory fees    statutory base      fees to meet     of fee-paying    from adjusted
                                                                   (base fees)      fees (standard     revenue target     submissions          fees
                                                                                fees)         (standard fees)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishment Registrations....................................          $6,875             $7,420             $7,653           32,555     $249,143,415
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The standard fee (adjusted base amount) for a premarket
application, including a BLA, and for a premarket report and a BLA
efficacy supplement, is $483,560 for FY 2024. The fees set by reference
to the standard fee for a premarket application are:
     For a panel-track supplement, 80 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, 4.5 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 adjustments,
is set at $7,653 for FY 2024. For FY 2024, there is no small business
waiver for the annual establishment registration fee; all
establishments pay the same fee.
    For more information on reduced fees and waivers for small
businesses, please see Section IX. Small Business Fee Reductions and
Fee Waivers.
    Table 5 summarizes the FY 2024 rates for all medical device fees.

                                    Table 5--Medical Device Fees for FY 2024
----------------------------------------------------------------------------------------------------------------
                                             Standard fee (as a percent of the
          Application fee type                 standard fee for a premarket           FY 2024      FY 2024 small
                                                       application)                standard fee    business fee
----------------------------------------------------------------------------------------------------------------
Premarket application (a PMA submitted    Base fee specified in statute.........        $483,560        $120,890
 under section 515(c)(1) of the FD&C Act
 (21 U.S.C. 360e(c)(1)), a 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         100...................................         483,560         120,890
 section 515(c)(2) of the FD&C Act).
Efficacy supplement (to an approved BLA   100...................................         483,560         120,890
 under section 351 of the PHS Act).
Panel-track supplement..................  80....................................         386,848          96,712
De novo classification request..........  30....................................         145,068          36,267
180-day supplement......................  15....................................          72,534          18,134
Real-time supplement....................  7.....................................          33,849           8,462
510(k) premarket notification submission  4.5...................................          21,760           5,440
30-day notice...........................  1.60..................................           7,737           3,869
513(g) request for classification         1.35..................................           6,528           3,264
 information.
Annual Fee Type.........................  ......................................  ..............  ..............
Annual fee for periodic reporting on a    3.50..................................          16,925           4,231
 class III device.
Annual establishment registration fee     Base fee specified in statute.........           7,653           7,653
 (to be paid by the establishment
 engaged in the manufacture,
 preparation, propagation, compounding,
 or processing of a device, as defined
 by 21 U.S.C. 379i(14)).
----------------------------------------------------------------------------------------------------------------

V. 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 must submit the materials showing
you qualify as a small business at least 60 days before you send your
submission to FDA. For more information on fee waivers or reductions,
please see Section IX. Small Business Fee Reductions and Fee Waivers.
    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 2024, you should not submit a Small Business Certification
Request. 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 2023, your
status as a small business will expire at the close of business on
September 30, 2023. You must re-qualify for FY 2024 in order to pay
small business fees during FY 2024.

A. Domestic (U.S.) Businesses

    If you are a domestic (U.S.) business and wish to qualify as a
small business for FY 2024, submit the following to FDA:
    1. A completed MDUFA Small Business Certification Request for a
Business Headquartered in the United States (Form FDA 3602). Form FDA
3602 is provided in the FDA Forms database: https://www.fda.gov/media/128050/download.
    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 2023, except:
     If you submit your MDUFA Small Business Certification
Request for FY 2024 before April 15, 2024, and you have not yet filed
your return for 2023, you may use tax year 2022.
     If you submit your MDUFA Small Business Certification
Request for FY 2024 on or after April 15, 2024, and have not yet filed
your 2023 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, if extant, 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 your affiliate is headquartered in a country without a
National Taxing Authority, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].
    4. Once you have completed your Form FDA 3602, print and sign the
form. Mail the completed form and your supporting documentation (copies
of the Federal (U.S.) income tax returns) to Medical Device User Fee
Small Business Certification Request mailing address, which is
available at the following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.
    If you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

B. Foreign Businesses

    If you are a foreign business, and wish to qualify as a small
business for FY 2024, 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/media/128059/download.
    2. A National Taxing Authority Certification, completed by, and
bearing the official seal of, the National Taxing Authority, if extant,
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.
    If your firm is headquartered in a country without a National
Taxing Authority, please contact the Division of Industry and Consumer
Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at [email protected].
    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 (2022 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, if extant, 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.
     If your affiliate is headquartered in a country without a
National Taxing Authority, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].
    4. Once you have completed your Form FDA 3602A, print and sign the
form. Mail the completed form and your supporting documentation,
including the following, to CDRH's Medical Device User Fee Small
Business Certification Request address, which is available at the
following website: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm577696.htm.

     A copy of the most recent Federal (U.S.) income tax return
for each of your affiliates headquartered in the U.S. and
     A copy of an MDUFA Foreign Small Business Certification
Request for each of your foreign affiliates.
    If you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

VI. 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, 2023, and September 30,
2024, you must pay the fee in effect for FY 2024. To avoid delay in the
review of your application, you should pay the application fee at the
time you submit your application to FDA. 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 2023 or FY 2024 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, 2023. One choice is for
applications and fees that will be received on or before September 30,
2023, which are subject to FY 2023 fee rates. A second choice is for
applications and fees received on or after October 1, 2024, which are
subject to FY 2024 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.

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.

VII. 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 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.

VIII. 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 2024 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 username and password, log into the
Establishment Registration User Fee FY 2024 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 2024, or To Register a New Establishment for
FY 2024

    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 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 2023. Manufacturers of
licensed biologics should register in the electronic Blood
Establishment Registration (eBER) 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 protected] 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 eBER 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.

IX. Small Business Fee Reductions and Fee Waivers

    To qualify for reduced fees for small businesses or a small
business fee waiver, please see the requirements for qualification
provided in Section V. How To Qualify as a Small Business for Purposes
of Medical Device Fees. The applicant should submit a Small Business
Certification Request and the supporting 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 you need assistance, please contact the Division of Industry and
Consumer Education at<PHONE_NUMBER> or<PHONE_NUMBER> or email at
[email protected].

A. Premarket Approval Fee Reduction or Waiver

    A small business applicant may request to pay a reduced rate for
premarket approval fees. An applicant may also request a fee waiver for
their first premarket application or premarket report (see 21 U.S.C.
379j(d)).

B. Premarket Notification Submission Fee Reduction

    A small business applicant may request to pay a reduced rate for a
premarket notification submission.

C. Annual Establishment Registration Fee

    There is no small business waiver for the annual establishment
registration fee; all establishments pay the same fee.

X. Refunds

    To qualify for consideration for a refund, a person shall submit to
FDA a written request for a refund not later than 180 days after such
fee is due. FDA has discretion to refund a fee or a portion of the fee.
A determination by FDA concerning a refund shall not be reviewable. For
more information on qualifying and submitting a refund, see 21 U.S.C.
379j(a)(2)(D).

    Dated: July 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15919 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P


Using the SEAMAP Ichthyoplankton Databases

	The following document is intended to serve as a basic guideline for
working with SEAMAP ichthyoplankton data.  The goal of which is to
familiarize users with the primary data structures and variables, as
well as give users insight into how the data may be used for analysis.
The document will assume that users of these database files are familiar
with basic database manipulations such as merges, sorts and the creation
and/or deletion or variables (fields).  Concepts for working to achieve
specific goals will be outlined in broad concepts.  This will allow
users to utilize their own preferred methods for database manipulation
and analysis.  The document is broken up into three sections.  Section
I, is a listing of database structures, variable definitions and
listings of codes specific to each variable.  Section II, describes the
relationships within and among the databases. Section III, addresses
concepts on how to utilize the databases to quantitatively summarize
data on fish eggs and larvae with comments on issues regarding specific
variables necessary for quantification.

SECTION I

Data Structures

	The 3 primary databases necessary to summarize data on fish eggs and
larvae are the STATCARD, ICHSTRWK and ICHSARWK.  The STATCARD contains
information on where and when sampling operations (stations) have taken
places.  The ICHSTRWK contains information on the plankton samples taken
at each station.  While the ICHSARWK contains information on the
individual taxa collected in each sample.  Each of the database
structures and its variables are outlined below:

STATCARD Database File Structure

	Field Name = database variable name

	Type = character, numeric or date variable

	Wid = width/format

	Dec = number of decimal places in field if applicable

	Range/Table = valid range of values or code table listing

	Req = Minimum required fields

	Units = Units recorded in

      Field Name  Type  Wid Dec  Range/Table     Req  Units

   1  CRUISE_NO   Char
3                        *

   2  VESSEL      Char   2
VESSELS          *

   3  P_STA_NO    Char
5                        *

   4  TIME_ZN     Char   1       TIMEZONE
*

   5  MIL_TIME    Char   4       0000 - 2359      *
hrs, min

   6  S_LATD      Num    2       0 <= x <= 90
*  degrees

   7  S_LATM      Num    5   2   0 <= x <
60         minutes

   8  S_LATH      Char   1       N or X

   9  S_LOND      Num    3       0 <= x <= 180
*  degrees

  10  S_LONM      Num    5   2   0 <= x <
60         minutes

  11  S_LONH      Char   1       W or X

  12  ST_DEPTH    Num    6   1   x > 0
*  fathoms

  13  S_STA_NO    Char   5

  14  MO_DAY_YR   Date
8                        *  mm/dd/yy

  15  END_TIME    Char   4       0000 -
2359         hrs, min

  16  E_LATD      Num    2       0 <= x <=
90        degrees

  17  E_LATM      Num    5   2   0 <= x <
60         minutes

  18  E_LATH      Char   1       N or X

  19  E_LOND      Num    3       0 <= x <=
180       degrees

  20  E_LONM      Num    5   2   0 <= x <
60         minutes

  21  E_LONH      Char   1       W or X

  22  EDEPTH      Num    6   1   x >
0               fathoms

  23  GEARS       Char  14       GEARTYPE

  24  SURF_TEMP   Num    5   2   -1.1 <= x <= 34     deg
(C)

  25  BOT_TEMP    Num    5   2   -1.1 <= x <= 32     deg
(C)

  26  AIR_TEMP    Num    4   1   x >
-10             deg (C)

  27  B_PRSSR     Num    6   1   880 <= x <= 1032
millibars

or x = 0

  28  WIND_SPD    Num    2       0 <= x <=
50        knots

  29  WIND_DIR    Num    3       0 <= x <= 360
compass deg

  30  WAVE_HT     Num    4   1   0 <= x <= 10
meters

  31  SEA_COND    Char   1       0 -
9               Beaufort Scale

  32  DATA_CODE   Char   2       DATACODE         *

  33  VESSEL_SPD  Num    4   1   0 < x <= 60
knots

  34  STAT_ZONE   Num    5   1   x > 0

  35  TOW_NO      Char   1       1 - 9

  36  NET_NO      Char   1       1 - 3

  37  COMMENT     Char 111

Explanation Of STATCARD Variables

CRUISE_NO

	3-character cruise code.

VESSEL

	2-character vessel code.  Valid Values are:

	01     OREGON

	02     SILVER BAY

	03     GEORGE M. BOWERS

	04     OREGON II

	05     COMBAT

	06     PELICAN

	07     FRIGATA

	08     KINGFISHER

	09     HERNAN CORTEZ

	10     GERONIMO

	11     UNDAUNTED

	12     ANTILLAS

	13     CALAMAR

	14     ALCYON

	15     GULF RANGER

	16     WESTERN GULF

	17     TOMMY MUNRO

	18     TANYA & JOE

	19     ONJUKO

	20     JEFF & TINA

	21     DELAWARE II

	22     OSV ANTELOPE

	23     ALABAMA INSHORE VESSELS

	24     FLORENCE MAY

	25     LOUISIANA INSHORE VESSELS

	26     SUNCOASTER

	27     MISSISSIPPI INSHORE VESSE

	28     CHAPMAN

	29     NISSHING MARU #201

	30     R/V BELLOWS

	31     R.J.KEMP

	32     MATAGORDA BAY

	33     LAGUNA MADRE

	34     GALVESTON BAY

	35     LUMCON PELICAN

	36     HERNAN CORTEZ II

	37     OLD COLONY

	38     SEAWOLF

	39     ATLANTIC HARVESTER

	40     SABINE

	41     PERSISTANCE

	42     CAPTAIN GRUMPY

	43     GULF STREAM

	44     KELCY ANN

	45     MR.JUG

	46     CALANUS

	47     A.NEEDLER

	48     B.I.P.

	49     ALBATROSS IV

	50     MOLLY M.

	51     LADY LISA

	52     MISS CARRIE

	53     CSS HUDSON

	54     CORAL SEA

	55     CARETTA

	56     R/V ABREU

	57     R/V GUAYANILLA

	58     SEAHORSE

	59     LINDSAY

	60     TEDDY'S SCOW

	61     RELENTLESS

	62     RATFIELD VESSELS

	63     GORDON GUNTER

	64     FERREL

	65     TRINITY BAY

	66     ALABAMA 38ft BERTRAM

	67     NUECES BAY

	68     MCARTHUR

	69     SAN JACINTO

	70     R/V SARINNA

	71     HARVESTING SYSTEM TECH

	99     OTHER VESSELS

P_STA_NO

	5-character code designating the Pascagoula station number.

TIME_ZN

	1-character time zone code.  Valid values are:

               1    Eastern Standard
Time

               2    Eastern Daylight Savings
Time

               3    Central Standard
Time

               4    Central Daylight Savings
Time

               8    Greenwich Mean
Time

               9    Other - Explain in Comments
Section

               5    Atlantic Standard
Time

               6    Atlantic Daylight Savings
Time

MIL_TIME

	Starting time (HHMM) in 24 hour military time.

S_LATD

	Degree of latitude for the position occupied at the start time of 	a
station.

S_LATM

	Decimal minutes of latitude for the position occupied at the 	start
time of a station.

S_LATH

	Hemi-sphere of latitude for the position occupied at the start

	time of a station.

S_LOND

	Degree of longitude for the position occupied at the start time 	of a
station.

S_LONM

	Decimal minutes of longitude for the position occupied at the 	start
time of a station.

S_LONH

	Hemi-sphere of longitude for the position occupied at the start

	time of a station.

ST_DEPTH

	Station depth in fathoms for the position occupied at the start

	time of a station.

MO_DAY_YR

	Date station was taken in MM/DD/YY format.

S_STA_NO

	5-character SEAMAP or alternate station number.

END_TIME

	Ending time (HHMM) in 24 hour military time.

E_LATD

	Degree of latitude for the position occupied at the end time of 	a
station.

E_LATM

	Decimal minutes of latitude for the position occupied at the 	end time
of a station.

E_LATH

	Hemi-sphere of latitude for the position occupied at the end

	time of a station.

E_LOND

	Degree of longitude for the position occupied at the end time 	of a
station.

E_LONM

	Decimal minutes of longitude for the position occupied at the 	end time
of a station.

E_LONH

	Hemi-sphere of longitude for the position occupied at the end

	time of a station.

EDEPTH

	Station depth in fathoms for the position occupied at the end

	time of a station.

GEARS

	Up to seven 2-character gear codes.  Valid values are:

               A    ASSORTED

               C    BIOSONICS ACOUSTIC SYSTEM

               BG   BATHYTHERMOGRAPH(CTD,STD)

               BC   BOTTLE
CAST

               GR   BOTTOM GRAB OR CORE SAMPLER

               MC
CAMERA,MOVIE

               SC
CAMERA,STILL

               VC
CAMERA,VIDEO

               CS   CONTINUOUS FLOW SYSTEM

               CM   CURRENT
DOPPLER

               DL   DEEP
LINE

               DV
DIVING

               CD
DREDGE,CLAM

               QD
DREDGE,QUAHOG

               SD
DREDGE,SCALLOP

               TD
DREDGE,TUMBLER

               XB   EXPENDABLE BATHYTHERMOGRAPH(XB

               FP   FISH
PUMP

               GN   GILLNET

               BL
LONGLINE,BOTTOM

               KP   LONGLINE,KALI
POLE

               OB
LONGLINE,OFF-BOTTOM

               LL
LONGLINE,SURFACE

               MQ
MARQUESETTE

               MN
MICROPEKTON

               ML
MISCELLANEOUS

               NS
NETSONDE

               LT   NIGHT
LIGHT

               OD
ODOMETER

               OF
OVERFLIGHT

               OX
OXYGEN,SENSOR,CTD

               OY
OXYGEN,SENSOR,YSI

               OH   OXYGEN,TITRATION,HACHKIT

               OW   OXYGEN,TITRATION,WINKLER

               OR   OYSTER
RAKE

               PN   PLANKTON,GENERAL(BONGO,ETC.)

               MO
PLANKTON,MOCNESS

               NN   PLANKTON,SINGLE NEUSTON OR NEK

               DN   PLANKTON,DOUBLE NEUSTON OR NEK

               RG   PLANKTON,RING
NET

               TU   PLANKTON,TUCKER
TRAWL

               RF   RECORDING
FATHOMETER

               RV   REMOTELY OPERATED VEHICLE(ROV)

               RT
ROTENONE

               RN   ROUND
NET

               SA
SALINITY,AUTOSAL

               SB   SALINITY,BECKMAN
RS5

               SF   SALINITY,CONTINUOUS FLOW SYSTE

               SX
SALINITY,CTD

               RE   SALINITY,REFRACTOMETER

               BS
SEINE,BEACH

               LP
SEINE,LAMPARA

               PS
SEINE,PURSE

               TS   SEINE,PURSE,TURTLE

               SO
SONAR

               SJ   SQUID
JIG

               DR   SURFACE
DRIFTER

               RL   TAG
RELEASE

               TA   TEMPERATURE,CONTINUOUS FLOW SY

               TC
TEMPERATURE,CTD

               TB   TEMPERATURE,BECKMAN RS5

               TM
TEMPERATURE,BUCKET

               TF
TEMPERATURE,FLUKE

               TY
TEMPERATURE,YSI

               CT
TRAP,CRAB

               TR
TRAP,FISH

               LR
TRAP,LOBSTER,REED

               LW
TRAP,LOBSTER,WIRE

               WT
TRAP,LOBSTER,WOOD

               TV   TRAP
VIDEO

               BT
TRAWL,BEAM

               BB
TRAWL,BIB

               FT
TRAWL,FISH

               EF   TRAWL,FISH,EXPERIMENTAL

               FD   TRAWL,FISH
DEFLECTOR

               FE   TRAWL,FISH
EXCLUDER

               HO   TRAWL,HIGH OPENING BOTTOM

               MT
TRAWL,MIDWATER

               PT
TRAWL,SCALLOP

               SN
TRAWL,SEPARATOR

               SH
TRAWL,SHUMAN

               ST
TRAWL,SHRIMP

               ES   TRAWL,SHRIMP,EXPERIMENTAL

               SM   TRAWL,STANDARD MONGOOSE

               *T
TRAWL,STAR

               TN
TRAWL,TRYNET

               TE   TRAWL,TURTLE
EXCLUDER

               TT
TRAWL,TWIN

               KT
TRAWL,WING

               TG   TROLLING
GEAR

               VD   VERTICAL
DRIFTLINE

               CC   CAMERA,CLOSED CIRCUIT TELEVISI

               01
COMBINATION--SS+CC

               02
COMBINATION--SS+PR

               03
COMBINATION--CC+PR

               04
COMBINATION--SS+CC+PR

               05
COMBINATION--FM+SS

               06
COMBINATION--FM+SS+PR

               07
COMBINATION--FM+PR

               FM
FATHOMETER

               FL   FLUORESCENCE,CONTINUOUS FLOW S

               FX
FLUORESCENCE,CTD

               PR   PROFILER,3.5 KHZ SUB-BOTTOM

               SS   SONAR,SIDE
SCAN

               IT   TRAP,ICHTHYOPLANKTON,ILLUMINAT

SURF_TEMP

	Surface temperature in degrees (C).

BOT_TEMP

	Bottom temperature in degrees (C).

AIR_TEMP

	Air temperature in degrees (C).

B_PRSSR

	Barometric pressure in millibars.

WIND_SPD

	Wind speed in knots.

WIND_DIR

	Wind direction in compass degrees.

WAVE_HT

	Wave height in meters.

SEA_COND

	Sea surface condition according to Beaufort Scale.

DATA_CODE

	2-character data collection code designating collection agency.  	Valid
values are:

               AL   Alabama

               FL   Florida

               GA
Georgia

               LA
Louisiana

               MS
Mississippi

               NC   North
Carolina

               SC   South
Carolina

               TX
Texas

               US   Federal
Vessel

               99
Other

               PR   Puerto
Rico

               VI   Virgin Islands

VESSEL_SPD

	Vessel speed in knots.

STAT_ZONE

	Code for SEAMAP shrimp statistical zone.  Valid values are 01 to 	22.

TOW_NO

	Consecutive tow withing a SEAMAP (S_STA_NO). Valid values are 1 	to 9.

NET_NO

	Code designating tow position of trawl.  Valid values are

			1 = Port

			2 = Starboard

			3 = Stern Trawl

COMMENT

	Short comment regarding station operations and any issues with

	sampling.

ICHSTRWK Database File Structure

      Field Name  Type  Wid Dec  Range/Table     Req  Units

   1  CRUISE_NO   Char
3                        *

   2  VESSEL      Char   2
VESSELS          *

   3  P_STA_NO    Char
5                        *

   4  SAMPLE_NO   Char
5                        *

   5  SIPC_CODE   Char   1       SIPC

   6  DATA_CODE   Char   2       DATACODE         *

   7  CR_STDATE   Date
8                            mm/dd/yy

   8  CRENDDATE   Date
8                            mm/dd/yy

   9  AREA_PROJ   Char   2       AREA_PRO

  10  PI_CODE     Char   2       PI_CODE

  11  TIME_ZONE   Char   1       TIMEZONE         *

  12  TIME        Char   4       0000 - 2359
*   hrs, min

  13  GEAR_CODE   Char   2       GEAR_ICH

  14  MESH_CODE   Char   2       MESH_ICH

  15  START_TIME  Char   6       000000 - 235959
hrs,min,sec

  16  END_TIME    Char   6       000000 - 235959
hrs,min,sec

  17  START_FLOW  Num    6       x >=
0               meter reading

  18  END_FLOW    Num    6       x >=
0               meter reading

  19  MIN_DEPTH   Num    4       x >=
0               meters

  20  MAX_DEPTH   Num    4       x >=
0               meters

  21  VOL_FILT    Num
3                            cu. meters

  22  ROTOR       Num    5       x >= 0

  23  NO_EGGS     Num    6       x >= 0

  24  EGGS_ALIQU  Char   4       ALIQUOT

Explanation of ICHSTRWK Variables

CRUISE_NO

	3-character cruise code.

VESSEL

	2-character vessel code.  See explanantion of STATCARD variables

	for valid values.

P_STA_NO

	5-character code designating the Pascagoula station number.

SAMPLE_NO

	5-characer code designating the SEAMAP plankton sample number.  	This
is a unique identifier for each sample.

SIPC_CODE

	Sample initial preservative code.  Valid values are:

               0    Unknown

               1    5% Formalin

               2    10% Formalin

               3    95% Ethanol

               4    70% Ethanol

               5    0T0FIX

DATA_CODE

	Equivalent to DATA_CODE in the STATCARD database file.

CR_STDATE

	Date the cruise began in MM/DD/YY format.

CRENDDATE

	Date the cruise ended in MM/DD/YY format.

AREA_PROJ

	Code for area and project. Valid Values are:

               01   GOM/SEAMAP

               02   NOT SEAMAP

               03   CAN/RICHARDS

               04   W.J.RICHARDS

               05   SA/SEAMAP

PI_CODE

	Principle Investigator Code.  Valid Values are:

               01   NMFS

               02   GCRL

               03   TOPW

               04   FL.DNR

               05   LDWF

               06   STATE OF AL

               07   UNIV. MIA.

               08   CANADA

               09   MEXICO

               10   FL. INST. OCEAN

               11   TEXAS

               12   SOUTH CAROLINA

TIME_ZONE

	Equivalent in structure and valid values to TIME_ZN in the

 	STATCARD structures.  May be different values and times than the

	STATCARD values.

TIME

	Approximate time (HHMM) plankton sampling operations began.

GEAR_CODE

	Plankton gear code.  Valid values are:

               01   60 cm Bongo         0.61

               02   1m Ring             1.00

               03   1X2m Neuston

               04   1/2m Ring           0.50

               05   20 cm Bongo         0.20

               07   1m**2 Tucker Trawl

               08   Double 1X2m Neuston

               09   1m**2 Mocness

               10   4m**2 Mocness

               11   60 cm o/c Bongo     0.60

               12   20 cm o/c Bongo     0.20

               13   60 cm BNF1          0.61

               14   70 cm Bongo         0.70

               06   Other/Unknown

MESH_CODE

	Plankton net mesh size code.  Valid values are:

               01   .303m

               02   .999m

               03   .333m

               04   .253m

               05   .505m

               06   UNKNOWN

               09   .946m

               10   .363m

               11   .153m

               12   .202m

               13   .760m

               14   .064m

               15   .100m

START_TIME

	Time in hrs,min,sec (HHMMSS) that the plankton gear began fishing.

END_TIME

	Time in hrs,min,sec (HHMMSS) that the plankton gear stopped 	fishing.

START_FLOW

	Starting flow meter reading.

END_FLOW

	Ending flow meter reading.

MIN_DEPTH

	Minimum tow depth in meters.

MAX_DEPTH

	Maximum tow depth in meters.

VOL_FILT

	Volume of water in cubic meters filtered through the plankton net.

ROTOR

	Constant valued from the flow meter manufacture used to convert

	flow meter counts to distance.

NO_EGGS

	Number of fish eggs removed from the sample.

EGGS_ALIQU

	Size of sample aliquot eggs were removed from.  Valid Values are:

               1/1

               1/2

               1/4

               1/8

ICHSARWK Database File Structure

      Field Name  Type  Wid Dec  Range/Table     Req  Units

   1  CRUISE_NO   Char
3                        *

   2  VESSEL      Char   2
VESSELS          *

   3  P_STA_NO    Char
5                        *

   4  SAMPLE_NO   Char
5                        *

   5  SAMP_STAT   Char   1       SMPLSTAT

   6  DATA_CODE   Char   2       DATACODE         *

   7  CATALOG_NO  Char  13

   8  TAXONOMIC   Char  13       BIOCODE          *

   9  BIOCODE     Num    9
BIOCODE          *

  10  LIFE_STAGE  Char   1       LIFESTA

  11  MEAS        Num    4       x >=
0           *

  12  NOT_MEAS    Num    4       x >= 0

  13  SAMP_DATE   Date
8                        *  mm/dd/yy

  14  VOL_DISP    Num    3       x >=
0              milliliters

  15  ALIQUOT     Char   3       1/1,1/2,1/4,1/8

  16  STATUS      Char   2       STATUS

  17  COMMENT     Char  75

  18  SASBIOCODE  Char  12

  19  SASTAXON    Char  50

  20  TIMES       Char   2

  21  UP_YEAR     Char   4

  22  UP_DATE     Char  10

  23  UP_ACTION   Char   1

  24  UP_ID       Char   3

  25  UP_TYPE     Char  15

  26  UP_PREDATE  Char   1

Explanation of ICHSARWK Variables

CRUISE_NO

	3-character cruise code.

VESSEL

	2-character vessel code.  See explanantion of STATCARD variables

	for valid values.

P_STA_NO

	5-character code designating the Pascagoula station number.

SAMPLE_NO

	5-characer code designating the SEAMAP plankton sample number.  	This
is a unique identifier for each sample.

SAMP_STAT

	Sample status sorting code.  Valid values are:

	0
Unknown

      1    Sorted with fish
caught

      2    Sorted with no fish caught

      3    Sample lost or
broken

      4    Sample sorted for only selected taxa

	5    Sample sent to Gulf Coast Research Lab

	6    Sample sent to Miami Laboratory

	7    Sample sent to Panama City Laboratory

	8    Sample used for student thesis

	9    Sample number assigned no sample taken

	A    Bongo/Neuston paired status

	*	Non-Quantitative

DATA_CODE

	Equivalent to DATA_CODE in the STATCARD database file.

CATALOG_NO

	13-character field containing the SEAMAP archive serial number.

TAXONOMIC

	13-character field containg the abbreviated SEAMAP taxonomic

	code.  At the species level the 1st 7 character refer to the genus

	and the last 6 characters refer to the species.  At taxonomic 	levels
greater than species the whole field is used to identify a

	taxon.

BIOCODE

	9-digit numeric code for a taxon.

LIFE_STAGE

	Life stage of a taxon. Currently not used for fish larvae.  Valid

	values are:

			1    ZOEAE

               	2    MEGALOPAE

               	3    POSTLARVAE

               	4    JUVENILE

MEAS

	Number of fish larvae measured for a specific CATALOG_NO.

NOT_MEAS

	Number of fish larvae not measured for a specific CATALOG_NO.

SAMP_DATE

	Date sample (SAMPLE_NO) was taken in MM/DD/YY format.

VOL_DISP

	Wet displacement volume in milliliter/cubic centimeters of entire

	plankton sample.

ALIQUOT

	Size of sample aliquot from which fish larvae were sorted.  Valid

	values are:

               1/1

               1/2

               1/4

               1/8

STATUS

	Taxonomic identification status code.  Valid values are:

		   00   Normal condition.  No examination of or

                    changes in sample have been made.

               01   Specimen(s) lost.

               02   Specimen(s)
destroyed.

               03   Specimen(s) cleared and
stained.

               04   Specimen(s) dessicated, but not
destroyed.

               05   Specimen(s)
sectioned.

               06   ID change.  Orig ID incorrect; new
ID

                    positive to genus level.

               07   ID change.  Orig ID incorrect; new
ID

                    positive to species
level.

               08   ID change.  Orig ID incorrect; new
ID

uncertain.

               09   ID change.  Orig ID incorrect; see
DCOMM(yr).

               10   ID change.  Orig ID incorrect;
disagreement

                    on correct ID among loan users;
see

                    DCOMM(yr).

               11   Orig ID
confirmed.

               12   ID change.  Orig ID incorrect; new
ID

                    positive to family
level.

               13   ID change.  Orig ID incorrect; new
ID

                    positive to order
level.

            14   Specimen(s) on permanent or long term
loan.

COMMENT

	Short comment documenting issues at the CATALOG_NO level.

SASBIOCODE, SASTAXON, TIMES, UP_YEAR, UP_DATE, UP_ACTION, UP_ID,
UP_TYPE, UP_PREDATE

	Variables added to the structure to allow for tracking updates to 	the
SEAMAP ichthyoplankton databases by the data management team.  	They are
not documented for the original SEAMAP system.

SECTION II

Within Table Relationships

STATCARD

	The STATCARD database contains individual records for each station at
which sampling occurred, including stations at which gear other than
plankton gears were used.  Each unique record in the database is defined
by the combination of the VESSEL + CRUISE_NO + P_STA_NO variables.  Only
the combination of all three variables will define a unique station.

ICHSTRWK

	The ICHSTRWK database contains individual records for each plankton
sample number (SAMPLE_NO) taken at a station.  The database therefore
contains 1 record for each sample number.  However, there may be
multiple samples (SAMPLE_NO) for each combination of VESSEL + CRUISE_NO
+ P_STA_NO.

ICHSARWK

	The ICHSARWK database contains at least one record for each sample
number (SAMPLE_NO) in the ICHSTRWK.  Within the ICHSARWK database the
combination of the VESSEL + CRUISE_NO + P_STA_NO + SAMPEL_NO +
CATALOG_NO define a unique record.  Samples with a sample status
(SAMP_STAT) equal to 0, 2, 3, 5, 6, 7, 8, and 9 contain a single record.
 These records are place holders that indicate the disposition of
samples taken under the SEAMAP umbrella.  Samples with a sample status
equal to 1, 4 or * may have multiple records associated with a sample
number.  Only, records with a sample status of 1, 4, and * will have
information pertaining to specific taxon.  Records with a sample status
of 1 or 2 are the only samples that should be used for quantitative
analysis and summaries.  A sample status of 1 indicates the sample was
shorted for all fish larvae, and a status of 2 indicates a valid sample
with no fish larvae.  The taxonomic (TAXONOMIC) and/or biocode (BIOCODE)
variables do not define a unique record, and multiple entries for a
specific taxon may be valid for multiple catalog numbers under a single
sample number.

Among Table Relationships

	The STATCARD, ICHSTRWK and ICHSARWK databases are relational, and
information in them follows a hierarchical progression.   In regards to
ichthyoplankton data, the statcard with its location information is at
the station level, the ICHSTRWK is at the level individual samples
collected at a station, while the ICHSTRWK contains information on the
individual fish larvae taken in the samples.  In order to link to
information contain in each of the separate databases the following
relationships can be used.

	Information between the STATCARD and ICHSTRWK can be linked (merged) by
setting a relationship between the unique combination of the VESSEL +
CRUISE_NO + P_STA_NO variables.

	Information between the ICHSTRWK and ICHSARWK can be linked (merged) by
setting a relationship between the unique combination of VESSEL +
CRUISE_NO + P_STA_NO + SAMPLE_NO variables.

	Information may also be linked by setting relationships between any of
the variables common among the 3 databases.  Suggestions for how to link
(merge) the databases for quantitative analysis can be found in the next
section.

SECTION III

Suggestions for Quantitative Analysis

	This section is written for user wishing to use the SEAMAP
ichthyoplankton databases to develop quantitative analyses and
summaries.  The focus will be on utilizing the standard SEAMAP bongo and
neuston collections to determine abundance estimates for eggs,
displacement volume, total fish larvae and larvae of specific taxon.  It
assumes that users will wish to select data from specific geographic
areas.

	Ichthyoplankton samples have been collected during fishery-independent,
resource surveys in the Gulf of Mexico (GOM) since 1982 under the
Southeast Area Monitoring and Assessment Program (SEAMAP).  Surveys are
conducted by the National Marine Fisheries Service in cooperation with
the states of Florida, Alabama, Mississippi, and Louisiana.  The SEAMAP
samples compose a majority of the data in the ICHSTRWK and ICHSARWK
databases.

Most but not all SEAMAP, standard plankton stations (bnumbers) are
located at 30 mile or ½ degree (~56 km) intervals in a fixed,
systematic grid across the GOM (Figure 1), although, only every other
N-S transect of stations is sampled during spring surveys and during
fall plankton surveys in 1988-1991. Summer and Fall SEAMAP sampling is
conducted at bnumbers over the continental shelf, and Spring sampling in
the open waters of the Gulf of Mexico.  Occasionally during surveys,
samples are taken at nonstandard locations or stations are moved to
avoid navigational hazards. Samples are taken upon arrival on station
regardless of time of day. At each station either a bongo and/or neuston
tow are made depending on the specific survey.

Standard SEAMAP survey plankton sampling is conducted with 61 cm bongo
nets and/or single or double 1x2 meter neuston net.  The 61 cm bongo net
is fitted with 0.333 (0.335) micron mesh nets.  Bongo nets are fished in
an oblique tow path from the surface to a maximum

depth of 200 m or to 2-5 m off the bottom at depths less than 200 m.  A
mechanical flowmeter is mounted off-center in the mouth of each bongo
net to record the volume of water filtered. Volume filtered ranges from
~20 to 600 m3 but is typically 30 to 40 m3 at the shallowest stations
and 300 to 400 m3 at the deepest stations.  Typically, abundance for
eggs, displacement volume and fish larvae are expresses as the number or
volume under 10 m2 of sea surface.  Alternately, abundance may be
expresses as the number or volume per volume of seawater filtered
through the net.  However, per volume of seawater estimates are
integrated over the entire depth range.  Neuston nets are fitted with
0.947 (0.950) 1 mm mesh net.  The neuston gear is towed at the

surface with its frame half-submerged for 10 minutes.  Data are only
available for fish larvae.  Abundance estimates of fish larvae are
expressed as the number per 10 minute tow.  Non-standard gear and mesh
sizes have been used to collect plankton samples and are coded as such
in the database.

In order arrive at these abundance estimates it will be necessary to
utilize data from all of the STATCARD, ICHSTRWK and ICHSARWK databases.
This is necessary since the databases are optimized for efficient
storage not data analysis and summary.  For instance, examining the
basic database structures outlined above we can see position information
is located in the STATCARD; information of the gear used and effort are
located in the ICHSTRWK; and variables necessary to enumerate larvae of
individual taxon and sample status are located in the ICHSARWK.
Therefore, in order to determine abundance estimates of fish larvae for
a specific gear and mesh combination within a given geographic area
requires the building of a dataset that contains all the necessary
variables from all three databases.  The rest of this document will deal
with the specifics of arriving at these estimates for the standard
SEAMAP samples.  Each section covers a different topic.

Putting all the variables needed to do quantitative analysis into a
singe dataset.

Since most personal computers have the storage and memory requirement to
handle large amounts of data, start by merging the three separate
databases into a single database/dataset that can be further
manipulated.  The following steps outline suggested concepts necessary
to do this:

Add a new numeric variable to the STATCARD database called STAREC
(statcard record) and set it equal to 1 for all records.

Add a new numeric variable to the ICHSTRWK database called ISTREC
(ichstrwk record) and set it equal to 1 for all records.

Add a new numeric variable to the ICHSARWK file called ISAREC (ichsarwk
record) and set it equal to 1 for all records.

Sort/index the STATCARD file on VESSEL + CRUISE_NO + P_STA_NO

Sort/index the ICHSTRWK file on VESSEL + CRUISE_NO + P_STA_NO

6.  Sort/index the ICHSARWK file on VESSEL + CRUISE_NO + P_STA_NO

    + SAMPLE_NO.

Merge/combine the STATCARD and ICHSTRWK files by setting a
relationship/link between the STATCARD and ICHSTRWK databases on VESSEL
+ CRUISE_NO + P_STA_NO.

Sort/index the combined STATCARD/ICHSTRWK file on VESSEL + CRUISE_NO +
P_STA_NO + SAMPLE_NO.

9. Next, merge/combine the newly combined STATCARD/ICHSTRWK

   database/dataset with the ICHSARWK database by setting a

   relationship/link between the combined STATCARD/ICHSTRWK and

   the ICHSARWK database on VESSEL + CRUISE_NO + P_STA_NO +

   SAMPLE_NO.

Keep only the records in the final database/dataset where

The variables STAREC = 1 and ISTREC = 1 and ISAREC = 1.  The final
database/dataset should have as many records as were found in the
original ICHSARWK database.  The final dataset should now contain the
STATCARD and ICHSTRWK information for each record in the ICHSARWK
database.

Filtering data by geographic area.

The SEAMAP BNumbers (Figure 1) represent the systematic sampling grid
design of the SEAMAP surveys.  The bnumbers when recorded are found in
the SEAMAP Station Number Field (S_STA_NO).  Unfortunately, the bnumbers
are not consistently recorded for all cruises, nor are they recorded in
a consistent manner in the S_STA_NO variable.  For example, bnumber B001
may appear in the database as B1, B01, B001, B-001 etc..  Therefore,
filtering data by geographic area is best done by longitude and
latitude.  Figure 1 can be used to find the approximate area a bnumber
represents.  It is easiest to work in decimals degree.  Using the
combined database created earlier or with the STATCARD database, decimal
longitude and latitude can be calculated as follows (make sure to
include parentheses in the formula):

Decimal Longitude:

( ( S_LOND + ( S_LONM / 60 ) ) * -1 )

Decimal Lattitude:

( S_LATD + ( S_LATM /60 ) )

Filtering Data by Gear and Sampling Status

The beginning of this section outlines the SEAMAP sampling design and
the standard bongo and neuston net sampling gears.  The primary
difference between the two gears is that the bongo gear can give
estimates of abundance for eggs, displacement volume, total fish larvae
and individual taxonomic categories, while the neuston gear only
provides data on fish larvae and individual taxonomic categories.
However, egg and displacement volume may not be available for all bongo
samples.  Bongo net samples as noted above are towed in an oblique
pattern from the surface to near bottom and then back to the surface.
Therefore abundance estimates based on volume or surface area, for a
sample are intergraded over the water column.  Nueston net samples are
only collected from the surface half meter of the water column and are
effort bases on time.

Valid quantitative SEAMAP samples can be filter out of the combined
STATCARD/ICHSTRWK/ICHSARWK data set by selecting only records where:

For Standard SEAMAP Bongo Net Tows:

(GEAR_CODE = “01” and MESH_CODE = “03”) and

(SAMP_STAT = “1” or SAMP_STAT = “2”)

I.E, give me only samples where gear = 61 cm bongo with a mesh size of
.333 with a sorting status of sorted with fish larvae found or sorted
with no larvae.

For Standard SEAMAP Neuston Net Tows:

( ( (GEAR_CODE = “03” or GEAR_CODE = “08”) and MESH_CODE =
‘09’ ) and (SAMP_STAT = ‘1’ or SAMP_STAT = ‘2’)

I.E, give me only samples collected where gear = a single or double
neuston net sample with a mesh size of .947 with a sorting status of
sorted with fish larvae found or sorted with no larvae.

Figure 1.  Gulfwide distribution of SEAMAP BNumbers.

A merged dataset is necessary since the GEAR_CODE and MESH_CODE
variables are taken from the ICHSTRWK database and the SAMP_STAT
variable from the ICHSARWK database.

The majority of the database has only a data for only a single bongo or
neuston sample taken at each station.  In some cases both samples from a
paired gear (bongo or double neuston) may have data from both samples
taken at a station.  These samples can be considered as replicates.  In
addition, some stations may have multiple bongo or nueston tows at the
same station.  Currently, the database does not code for paired samples
or multiple samples taken at a station.

Estimating Abundance of Fish Larvae from Bongo Net Samples.

	As noted above, abundance estimates of fish larvae can be volume or
surface area based.  Additionally, estimates of fish larvae can be based
on all fish larvae in a sample (total fish larvae), or based on
individual taxonomic categories.  This section will outline the
necessary calculation and concepts necessary to properly enumerate total
fish larvae and fish larvae by taxonomic category.

	At this point, we will assume that our combined dataset created at the
beginning of this section has been pre-filtered by geographic area and
contains only records for valid (SAMP_STAT = 1 or 2) bongo (GEAR_CODE =
‘01’ and MESH_CODE = ‘03’) samples.  The dataset should contain
a single record for each unique combination of VESSEL + CRUISE_NO +
P_STA_NO + SAMPLE_NO + CATALOG_NO.  Unique combinations of VESSEL +
CRUISE_NO + P_STA_NO + SAMPLE_NO + CATALOG_NO for samples with a
SAMP_STAT = 2 in the dataset will have a empty CATALOG_NO variable, and
will have only a single record in the dataset.  As the only record, the
blank CATALOG_NO field is unique for that SAMPLE_NO.  Unique
combinations of VESSEL + CRUISE_NO + P_STA_NO + SAMPLE_NO + CATALOG_NO
with a SAMP_STAT = 1 will have a unique CATALOG_NO for each record, and
will have one record for each unique CATALOG_NO for a unique SAMPLE_NO.
Therefore, there are 1 or more records for SAMPLE_NOs with a SAMP_STAT =
1.  However, there may be several unique CATALOG_NOs in a sample with
the same TAXONOMIC category.  Figure 2 shows a hypothetical minimum
dataset for 3 unique SAMPLE_NOs for 2 samples with a SAMP_STAT = 2 and
single SAMPLE_NO with a SAMP_STAT = 1.

	The minimum variable set necessary to calculate the number of larvae
under 10 m2 for each unique combination of VESSEL + CRUISE_NO + P_STA_NO
+ SAMPLE_NO + CATALOG_NO is MEAS, NOT_MEAS, ALIQUOT, VOL_FILT and
MAX_DEPTH.  The minimum variable set necessary to calculate the number
of larvae per m3 is MEAS, NOT_MEAS, ALIQUOT, VOL_FILT.  However, several
changes to the dataset are needed prior to calculating these values due
to the way the data is stored in the original databases:

	1.  In some instances the numeric MEAS and NOT_MEAS fields are blank
(null) or may contain -9 (also considered a null value). In these cases,
the blanks and -9 must be set to a value of 0 (zero).  For example, if
MEAS = -9 then MEAS = 0 or if MEAS = NULL (database dependent) then MEAS
= 0, and likewise for NOT_MEAS.

	2.  ALIQUOT in the database is a character variable with valid values
of ALIQUOT = “1/1”, “1/2”, “1/4” or “1/8”.  SAMPLE_NOs
with a SAMP_STAT = ‘1’ will have one of the valid values.
SAMPLE_NOs with a SAMP_STAT = ‘2’ may have a valid value or be left
blank.  In order to properly calculate the larvae/10 m2 or larvae/10 m3
values, a numeric variable to be used as an ALIQUOT multiplier will be
necessary.  The multiplier is the reciprocal of the fraction represented
in the ALIQUOT variable, i.e. “1/2” = 2.  This step is necessary in
order to account for sub-sampling by aliquoting.  For SAMPLE_NOs with a
SAMP_STAT = ‘2’  the aliquot multiplier is 1.  The new variable can
be created with the following logic:

	If ALIQUOT = “1/1” then MULTIPLIER = 1

	If ALIQUOT = “1/2” then MULTIPLIER = 2

	If ALIQUOT = “1/4” then MULTIPLIER = 4

	If ALIQUOT = “1/8” then MULTIPLIER = 8

	If SAMP_STAT = ‘2’ then MULTIPLIER = 1

Figure 3 shows the modifications to the pertinent variables for the
sample numbers in our hypothetical dataset from Figure 2.

	Once these modifications have taken place it is possible to calculate
larvae/10 m2 or larvae/10 m3 for each unique combination of VESSEL +
CRUISE_NO + P_STA_NO + SAMPLE_NO + CATALOG_NO (Figure 4).  The formula
for larvae/10 m2 is:

((MEAS + NOT_MEAS) * MULTIPLIER) * ((MAX_DEPTH/VOL_FILT) * 10)

where:

	((MEAS + NOT_MEAS) * MULTIPLIER) = Extrapolated total number of
    fish larvae for unique    							     combination of VESSEL +
	     CRUISE_NO + P_STA_NO + 								     SAMPLE_NO + CATALOG_NO

	((MAX_DEPTH/VOL_FILT) * 10)      = The standard haul factor for a

						     unique combination of VESSEL +

                                         CRUISE_NO + P_STA_NO +

                                         SAMPLE_NO

      Note:  The 10 in the standard haul factor can be changed to any

             multiplier.  For example, 100 which will result in

     	       larvae/100 m2.

The formula for larvae/ m3 is:

((MEAS + NOT_MEAS) * MULTIPLIER) / (VOL_FILT)

where:

	((MEAS + NOT_MEAS) * MULTIPLIER) = Extrapolated total number of
    fish larvae for a unique    							     combination of VESSEL +
			     CRUISE_NO + P_STA_NO + 								     SAMPLE_NO + CATALOG_NO

Figure 2.  Hypothetical minimum dataset showing data for three unique
sample numbers from a cruise.

VESSEL	CRUISE_NO	P_STA_NO	SAMPLE_NO	SAMP_STAT	VOL_FILT	MAX_DEPTH
CATALOG_NO	TAXONOMIC	MEAS	NOT_MEAS	ALIQUOT

	4	145	41077	3115	2	100	100

4	145	41078	3116	2	200	200

	-9	-9	1/1

	4	145	41079	3117	1	100	50	SML20218-000	BOTHIDAE	2	-9	1/2

4	145	41079	3117	1	100	50	SML20603-001	DECAPTEPUNCTA	2	-9	1/2

4	145	41079	3117	1	100	50	SML21163-000	GOBIIDAE	2	13	1/2

4	145	41079	3117	1	100	50	SML21892-001	SCOMBERCAVALL	1	-9	1/2

4	145	41079	3117	1	100	50	SML20329-000	SYACIUM	2	7	1/2

4	145	41079	3117	1	100	50	SML20867-000	LUTJANUCAMPEC	10	0	1/2

4	145	41079	3117	1	100	50	SML22236-000	LUTJANUCAMPEC	5	0	1/2

Figure 3.  Modifications to the pertinent variables for the sample
numbers in our hypothetical dataset from Figure 2.  VESSEL CRUISE and
P_STA_NO not shown.

SAMPLE_NO	SAMP_STAT	VOL_FILT	MAX_DEPTH	CATALOG_NO	TAXONOMIC	MEAS
NOT_MEAS	ALIQUOT	MULTIPLIER

	3115	2	100	100

	0	0

1

	3116	2	200	200

	0	0	1/1	1

	3117	1	100	50	SML20218-000	BOTHIDAE	2	0	1/2	2

3117	1	100	50	SML20603-001	DECAPTEPUNCTA	2	0	1/2	2

3117	1	100	50	SML21163-000	GOBIIDAE	2	13	1/2	2

3117	1	100	50	SML21892-001	SCOMBERCAVALL	1	0	1/2	2

3117	1	100	50	SML20329-000	SYACIUM	2	7	1/2	2

3117	1	100	50	SML20867-000	LUTJANUCAMPEC	10	0	1/2	2

3117	1	100	50	SML22236-000	LUTJANUCAMPEC	5	0	1/2	2

Figure 4.  Calculated larvae/10 m2 and larvae / m3 for each unique
VESSEL + CRUISE_NO + P_STA_NO + SAMPLE_NO + CATALOG_NO for our
hypothetical dataset from Figure 3.

SAMPLE_NO	SAMP_STAT	VOL_FILT	MAX_DEPTH	CATALOG_NO	TAXONOMIC	MEAS
NOT_MEAS	ALIQUOT	MULTIPLIER	TOTAL FISH	SHF	LARVAE	LARVAE

LARVAE

10 SQR METER	CUBIC METER

	3115	2	100	100

	0	0

1	0	10	0	0

	3116	2	200	200

	0	0	1/1	1	0	10	0	0

	3117	1	100	50	SML20218-000	BOTHIDAE	2	0	1/2	2	4	5	20	0.04

3117	1	100	50	SML20603-001	DECAPTEPUNCTA	2	0	1/2	2	4	5	20	0.04

3117	1	100	50	SML21163-000	GOBIIDAE	2	13	1/2	2	30	5	150	0.3

3117	1	100	50	SML21892-001	SCOMBERCAVALL	1	0	1/2	2	2	5	10	0.02

3117	1	100	50	SML20329-000	SYACIUM	2	7	1/2	2	18	5	90	0.18

3117	1	100	50	SML20867-000	LUTJANUCAMPEC	10	0	1/2	2	20	5	100	0.2

3117	1	100	50	SML22236-000	LUTJANUCAMPEC	5	0	1/2	2	10	5	50	0.1

 VOL_FILT                         = Volume of water filtered for a

                                         unique combination of VESSEL +

                                         CRUISE_NO + P_STA_NO +

                                         SAMPLE_NO in cubic meters

Sorry this is an ongoing process and I have been redirected to another
project.  Please contact me as below for further details.

David S. Hanisko

Research Fisheries Biologist

National Marine Fisheries Service

Pascagoula Laboratory

3209 Frederic St.

Pascagoula MS, 39568

Voice:<PHONE_NUMBER> x204

Fax:<PHONE_NUMBER>

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
or

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>