Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer's Certificate, 17170-17171 [2019-08174]
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17170
Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices
Authority: 42 U.S.C. 5106.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–08247 Filed 4–23–19; 8:45 am]
BILLING CODE 4184–01–P
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.
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 oira_
submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.
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.
SUMMARY:
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:
jbell on DSK30RV082PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA form No.
Submission of Interstate Shellfish
Dealer’s Certificate.
VerDate Sep<11>2014
17:20 Apr 23, 2019
Jkt 247001
Number of
respondents
3038
PO 00000
Number of
responses per
respondent
40
Frm 00037
Fmt 4703
57
Sfmt 4703
Total
annual
responses
2,280
E:\FR\FM\24APN1.SGM
Average burden per
response
0.10 (6 minutes) ........
24APN1
Total hours
228
Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices
17171
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
FDA form No.
Number of
responses per
respondent
Total
annual
responses
Average burden per
response
Total hours
Submission of NSSP Compliance
Documentation.
N/A
13
1
13
0.25 (15 minutes) ......
3.25
Total ......................................
........................
........................
........................
........................
....................................
231.25
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 × 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 × 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3458]
Food Handler Antiseptic Drug
Products for Over-the-Counter Human
Use; Request for Data and Information;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for data and
information; reopening of the comment
period.
ACTION:
jbell on DSK30RV082PROD with NOTICES
Number of
respondents
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period provided
in the notice entitled ‘‘Food Handler
Antiseptic Drug Products for Over-theCounter Human Use; Request for Data
and Information’’ that appeared in the
SUMMARY:
VerDate Sep<11>2014
17:20 Apr 23, 2019
Jkt 247001
Federal Register of December 7, 2018.
That notice announced the
establishment of a docket to obtain data,
information, and comments that will
assist the Agency in assessing the safety
and effectiveness of food handler
antiseptic drug products (i.e., antiseptic
hand washes or rubs intended for use in
food handling settings) for over-thecounter human use. The Agency is
taking this action to allow interested
persons additional time to submit
comments, data, or information.
DATES: FDA is reopening the comment
period on the notice published on
December 7, 2018 (83 FR 63168).
Submit either electronic or written
comments by July 23, 2019.
ADDRESSES: You may submit comments,
data, or information as follows. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before July 23, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 23, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3458 for ‘‘Food Handler
Antiseptic Drug Products for Over-theCounter Human Use; Request for Data
and Information; Reopening of
Comment Period.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
E:\FR\FM\24APN1.SGM
24APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
-------------------------------------------------------------------------------------------------------------------
Total........................... .............. .............. .............. .............. .................................. 231.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
