Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 3191-3192 [2019-01812]
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Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
796–5003, Fax: 301–847–8443,
Graham.Thompson@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
This public workshop is intended to
meet one of the performance goals
included in PDUFA VI. This PDUFA
reauthorization is part of the FDA
Reauthorization Act of 2017 signed by
the President on August 18, 2017. The
complete set of performance goals and
procedures documented in the PDUFA
Reauthorization Performance Goals And
Procedures Fiscal Years 2018 Through
2022 (Goals Letter) is available at
https://www.fda.gov/downloads/
ForIndustry/UserFees/PrescriptionDrug
UserFee/UCM511438.pdf. These goals
were developed in consultation with
patient and consumer advocates, health
care professionals, and other public
stakeholders, as part of negotiations
with regulated industry. Section I.J.1 of
the Goals Letter, ‘‘Enhancing the
Incorporation of the Patient’s Voice in
Drug Development and DecisionMaking,’’ outlines the requirement for
FDA to conduct a public workshop.
II. Topics for Discussion at the Public
Workshop
This workshop will provide FDA the
opportunity to better understand
patients’ perspectives on current
barriers to participating in clinical trials
and will discuss best practices and key
considerations for enhancing the
incorporation of patient perspectives
into clinical trial development. At the
workshop, patients (including patients
with experience in participating in
clinical trials and patients who have not
participated in clinical trials but who
are interested in doing so), caregivers,
and other patient representatives will
provide perspectives on several key
topics related to clinical trials. These
topics will include challenges and
barriers patients face with access to
trials, trial design, trial conduct, and
trial followup. The meeting will also
gather input from patients, caregivers,
industry experts, academic researchers,
and other external stakeholders on
approaches and best practices to address
these challenges and barriers. For more
information on meeting topics and
discussion questions, visit https://
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events.r20.constantcontact.com/register/
event?llr=w8jl4kkab&oeidk=a07efu
k61xm39d90653. FDA will also post the
agenda and other workshop materials to
this site approximately 5 business days
before the workshop.
The format of the meeting will consist
of a series of presentations, panel
discussions, and audience Q&A. In
addition to input generated through this
public workshop, FDA is interested in
receiving input through written
comments, which can be submitted to
the public docket (see ADDRESSES).
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website https://
events.r20.constantcontact.com/register/
eventReg?oeidk=a07efuk61xm39
d90653&oseq=&c=&ch. Please register
by March 11, 2019. Persons without
access to the internet can call 919–668–
5938 to register. If you are unable to
attend the workshop in person, you can
register to view a live webcast of the
workshop. You will be asked to indicate
in your registration if you plan to attend
in person or via the webcast. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by March 11, 2019, 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation once they have been
accepted. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public workshop.
If you need special accommodations
due to a disability, please contact
Graham Thompson (see FOR FURTHER
INFORMATION CONTACT) no later than
March 11, 2019, 11:59 p.m. Eastern
Time.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast. Please register for the
webcast by visiting https://
events.r20.constantcontact.com/register/
eventReg?oeidk=a07efuk61xm39
d90653&oseq=&c=&ch=.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
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3191
Federal Register, but websites are
subject to change over time.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It also may be
viewed at the Dockets Management Staff
(see ADDRESSES).
Dated: January 24, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–01826 Filed 2–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–N–0438; FDA–
2018–D–1592; FDA–2014–D–2138; FDA–
2018–N–0180; FDA–2014–N–1960; FDA–
2015–N–1837; and FDA–2016–D–4308]
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
to respond to, a collection of
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 84, No. 28 / Monday, February 11, 2019 / Notices
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
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use ..........................................................................................................................
Guidance for Industry on Controlled Correspondence Related to Generic Drug Development .............................
Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act .....................................................................................................................
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications ..............
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based) .......................................
Electronic User Fee Payment Form Requests ........................................................................................................
Labeling of Red Blood Cell Units with Historical Antigen Typing Results ..............................................................
Postmarketing Adverse Drug Experience Reporting ...............................................................................................
Dated: February 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 12,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 12, 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.
[FR Doc. 2019–01812 Filed 2–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0429]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act
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 certain labeling
statements for nonprescription human
drug products marketed without an
approved application.
DATES: Submit either electronic or
written comments on the collection of
information by April 12, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
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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:
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Date
approval
expires
0910–0583
0910–0797
10/31/2021
10/31/2021
0910–0800
0910–0810
0910–0291
0910–0805
0910–0862
0910–0230
10/31/2021
10/31/2021
11/30/2021
11/30/2021
11/30/2021
12/31/2021
• 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–
2007–D–0429 for ‘‘Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.’’ 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
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[Federal Register Volume 84, Number 28 (Monday, February 11, 2019)]
[Notices]
[Pages 3191-3192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01812]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-N-0438; FDA-2018-D-1592; FDA-2014-D-2138; FDA-
2018-N-0180; FDA-2014-N-1960; FDA-2015-N-1837; and FDA-2016-D-4308]
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,
PRAStaff@fda.hhs.gov.
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 to respond to, a collection of
[[Page 3192]]
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
------------------------------------------------------------------------
Recommendations for Early Food Safety 0910-0583 10/31/2021
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use........
Guidance for Industry on Controlled 0910-0797 10/31/2021
Correspondence Related to Generic Drug
Development............................
Guidance for Industry on Adverse Event 0910-0800 10/31/2021
Reporting for Outsourcing Facilities
Under Section 503B of the Federal Food,
Drug, and Cosmetic Act.................
Generic Clearance for the Collection of 0910-0810 10/31/2021
Quantitative Data on Tobacco Products
and Communications.....................
MedWatch: Adverse Event and Product 0910-0291 11/30/2021
Experience Reporting System (Paper-
Based).................................
Electronic User Fee Payment Form 0910-0805 11/30/2021
Requests...............................
Labeling of Red Blood Cell Units with 0910-0862 11/30/2021
Historical Antigen Typing Results......
Postmarketing Adverse Drug Experience 0910-0230 12/31/2021
Reporting..............................
------------------------------------------------------------------------
Dated: February 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01812 Filed 2-8-19; 8:45 am]
BILLING CODE 4164-01-P
