Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 26698-26699 [2018-12338]
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26698
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
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 July 16, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 16, 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.
ADDRESSES:
amozie on DSK3GDR082PROD with NOTICES1
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–
2018–N–0529 for ‘‘Draft Concept Paper:
Illicit Trade in Tobacco Products after
Implementation of a Food and Drug
Administration Product Standard.’’
VerDate Sep<11>2014
16:53 Jun 07, 2018
Jkt 241001
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
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:
Christopher Griffiths or Nate Mease,
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 1–877–287–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 16, 2018,
FDA published an NOA with a 90-day
comment period to request public
comment on the draft concept paper
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
regarding the potential for illicit trade
markets to develop in response to a
tobacco product standard. The Agency
received a request for a 90-day
extension of the comment period for the
NOA. The request conveyed concern
that the current 90-day comment period
does not allow sufficient time to
develop a meaningful or thoughtful
response to the NOA.
FDA has considered the request and
is extending the comment period for the
NOA for 30 days, until July 16, 2018.
The Agency believes that a 30-day
extension allows adequate time for
interested persons to submit comments
without creating significant delay.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12370 Filed 6–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–N–0231; FDA–
2014–N–0996; FDA–2010–N–0161; FDA–
2017–N–5624; FDA–2011–N–0085; FDA–
2013–D–0575; and FDA–2016–N–3710]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
SUPPLEMENTARY INFORMATION:
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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:
VerDate Sep<11>2014
16:53 Jun 07, 2018
Jkt 241001
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
Frm 00059
Fmt 4703
Sfmt 4703
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
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]]>Agencies
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26698-26699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12338]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-N-0231; FDA-2014-N-0996; FDA-2010-N-0161; FDA-
2017-N-5624; FDA-2011-N-0085; FDA-2013-D-0575; and FDA-2016-N-3710]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required
[[Page 26699]]
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 Date approval
Title of collection No. expires
------------------------------------------------------------------------
Biological Products--General Records and 0910-0308 4/30/2021
Postmarket Adverse Experience Reporting
Guidance for Industry: Fast Track, Drug 0910-0389 4/30/2021
Development Programs--Designation,
Development, and Application Review....
Export Certificates for FDA Regulated 0910-0498 4/30/2021
Products under U.S.C. Sections 801(e)
and 802................................
Content and Format of Labeling for Human 0910-0624 4/30/2021
Prescription Drugs and Biologics;
Requirements for Pregnancy and
Lactation Labeling.....................
Guidance for Industry: Cooperative 0910-0629 4/30/2021
Manufacturing Arrangements for Licensed
Biologics..............................
Guidance of Industry: Expedited Programs 0910-0765 4/30/2021
for Serious Conditions--Drugs and
Biologics..............................
Evaluation of the Food and Drug 0910-0851 4/30/2021
Administration's Point-of-Sale Campaign
------------------------------------------------------------------------
Dated: June 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12338 Filed 6-7-18; 8:45 am]
BILLING CODE 4164-01-P
