Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate, 26699-26700 [2018-12340]
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26699
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Biological Products—General Records and Postmarket Adverse Experience Reporting ......................................
Guidance for Industry: Fast Track, Drug Development Programs—Designation, Development, and Application
Review ..................................................................................................................................................................
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802 .....................................
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy
and Lactation Labeling .........................................................................................................................................
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics ....................................
Guidance of Industry: Expedited Programs for Serious Conditions—Drugs and Biologics ...................................
Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign ..........................................................
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
at the end of August 7, 2018. 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.
[FR Doc. 2018–12338 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2009–N–0232]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Interstate Shellfish
Dealer’s Certificate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the Interstate
Shellfish Dealer’s Certificate.
DATES: Submit either electronic or
written comments on the collection of
information by August 7, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 7,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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16:53 Jun 07, 2018
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
PO 00000
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Date
approval
expires
0910–0308
4/30/2021
0910–0389
0910–0498
4/30/2021
4/30/2021
0910–0624
0910–0629
0910–0765
0910–0851
4/30/2021
4/30/2021
4/30/2021
4/30/2021
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–
2009–N–0232 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Interstate
Shellfish Dealer’s Certificate.’’ 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
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
E:\FR\FM\08JNN1.SGM
08JNN1
26700
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
SUPPLEMENTARY INFORMATION:
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Interstate Shellfish Dealer’s Certificate
OMB Control Number 0910–0021—
Extension
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 are authorized to assist States in the
prevention and suppression of
communicable diseases. Under this
authority, FDA participates 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 participating State and foreign
nation monitors its molluscan shellfish
processors and 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.’’ FDA uses 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 FDA 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 commerce, and its
effectiveness would be nullified.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Submission of Interstate Shellfish Dealer’s Certificate.
amozie on DSK3GDR082PROD with NOTICES1
1 There
Number of
respondents
FDA Form No.
3038
Number of
responses per
respondent
40
Total
annual
responses
57
Average burden
per response
2,280
0.10 (6 minutes) .............
Total hours
228
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
estimate that 40 respondents will
submit 2,280 Interstate Shellfish
Dealer’s Certificates annually, for a total
burden of 228 hours (2,280 submissions
× 0.10 hours = 228 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.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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16:53 Jun 07, 2018
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National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
[FR Doc. 2018–12340 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
PO 00000
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]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26699-26700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12340]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0232]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Interstate Shellfish Dealer's Certificate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the Interstate Shellfish Dealer's Certificate.
DATES: Submit either electronic or written comments on the collection
of information by August 7, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 7, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2009-N-0232 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Interstate Shellfish Dealer's
Certificate.'' 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 for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For
[[Page 26700]]
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Interstate Shellfish Dealer's Certificate
OMB Control Number 0910-0021--Extension
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 are authorized to
assist States in the prevention and suppression of communicable
diseases. Under this authority, FDA participates 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 participating State and foreign nation
monitors its molluscan shellfish processors and 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.'' FDA uses 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 FDA 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 commerce, and
its effectiveness would be nullified.
FDA estimates 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. We estimate that 40 respondents will submit 2,280 Interstate
Shellfish Dealer's Certificates annually, for a total burden of 228
hours (2,280 submissions x 0.10 hours = 228 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.
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12340 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
