[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17170-17171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0232]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Interstate Shellfish 
Dealer's Certificate

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by May 24, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0021. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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

Interstate Shellfish Dealer's Certificate OMB Control Number 0910-
0021--Revision

    Under section 243 of the Public Health Service Act (42 U.S.C. 243) 
FDA is required to cooperate with and aid State and local authorities 
in the enforcement of their health regulations, and is authorized to 
assist States in the prevention and suppression of communicable 
diseases. Under this authority, we participate with State regulatory 
agencies, some foreign nations, and the molluscan shellfish industry in 
the National Shellfish Sanitation Program (NSSP). NSSP is a voluntary, 
cooperative program to promote the safety of molluscan shellfish by 
providing for the classification and patrol of shellfish growing waters 
and for the inspection and certification of shellfish processors.
    Each NSSP-participating State and foreign nation monitors its 
molluscan shellfish processors and for purposes of interstate or 
international commerce issues certificates for those that meet the 
State or foreign shellfish control authority's criteria. Each 
participating State and nation provides a certificate of its certified 
shellfish processors to FDA on Form FDA 3038, ``Interstate Shellfish 
Dealer's Certificate.'' We use this information to publish the 
``Interstate Certified Shellfish Shippers List,'' a monthly 
comprehensive listing of all molluscan shellfish processors certified 
under the cooperative program. If we did not collect the information 
necessary to compile this list, participating States would not be able 
to identify and keep out shellfish processed by uncertified processors 
in other States and foreign nations. Consequently, NSSP would not be 
able to control the distribution of uncertified and possibly unsafe 
shellfish in interstate and international commerce, and its 
effectiveness would be nullified.
    In the Federal Register of March 9, 2018 (83 FR 10487), we 
published a notice seeking comment on a proposed determination that the 
European Union's (EU's) system of food safety control measures for raw 
bivalve molluscan shellfish intended for export into the United States, 
as adopted and implemented in Spain and the Netherlands, provides at 
least the same level of sanitary protection as the United States 
equivalent. If finalized, such a determination would permit the 
importation of shellfish harvested from certain European production 
areas and processed by European establishments that have been listed by 
FDA on the Interstate Certified Shellfish Shippers List.
    The March 9, 2018, notice also described the European Commission's 
(EC's) determination that the United States' system is equivalent to 
its own, and as a result of that determination, its stated intent to 
accept shellfish from certain growing areas in the United States. On 
November 6, 2018, the EC published Commission Implementing Decision 
(EU) 2018/1668 which added the United States (MA and WA only) to the 
list of Third Countries from which molluscan shellfish imports are 
permitted. Shellfish harvested from growing areas with an Approved 
classification in those states are eligible for export to the EU.
    As part of the equivalence determination, the EC identified the 
need for FDA to provide documentation collected from NSSP-participating 
shellfish control authorities seeking recognition under the EC's 
equivalence determination. This documentation includes:
     A list of growing areas with an Approved classification,
     The most recent sanitary survey for each growing area with 
an Approved classification, and
     The most recent inspection report for each firm seeking to 
export shellfish to the EU.
    For NSSP-Participants that do not produce live/raw shellfish 
required documentation is limited to the most recent Plant and Shipping 
Element Program Evaluation Report and the most recent inspection report 
for each shellfish processing firm to be listed for export to the EU.
    In the Federal Register of June 8, 2018 (83 FR 26699), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                         Number of
              Activity                 FDA form No.      Number of     responses per   Total annual       Average burden per response       Total hours
                                                        respondents     respondent       responses
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Submission of Interstate Shellfish              3038              40              57           2,280  0.10 (6 minutes)..................             228
 Dealer's Certificate.

[[Page 17171]]

 
Submission of NSSP Compliance                    N/A              13               1              13  0.25 (15 minutes).................            3.25
 Documentation.
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    Total...........................  ..............  ..............  ..............  ..............  ..................................          231.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate that 40 respondents will submit 2,280 Interstate 
Shellfish Dealer's Certificates (Form FDA 3038) annually, or an average 
of 57 responses per respondent. We estimate that it takes a respondent 
an average of 6 minutes or 0.1 hour to complete each form for a total 
burden of 228 hours (2,280 submissions x 0.10 hours). This estimate is 
based on our experience with this information collection and the number 
of certificates received in the past 3 years, which has remained 
constant.
    In order to gain equivalence recognition by the EC, we estimate 
that respondents will make a one-time submission of documents 
demonstrating NSSP compliance. We estimate that 13 respondents will 
each submit 1 response, for a total of 13 responses. We estimate that 
each response will take 15 minutes, or 0.25 hour, for an annual total 
of 3.25 hours (13 responses x 0.25 hour).

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08174 Filed 4-23-19; 8:45 am]
BILLING CODE 4164-01-P