CFR 30 day notice 2018

Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
entitled ‘‘Evaluating the Pressor Effects
of Drugs.’’ This public workshop is
convened by the Duke-Robert J.
Margolis, MD, Center for Health Policy
at Duke University and supported by a
cooperative agreement with FDA. The
purpose of this public workshop is to
bring the stakeholder community
together to discuss the premarketing
assessment of a drug’s effect on blood
pressure. Elevated blood pressure is
known to increase the risk of stroke,
heart attack, and death. The effect of a
drug on blood pressure may therefore be
an important consideration in benefitrisk assessment. Agency staff will
present findings related to the use of
ambulatory blood pressure monitoring
to assess treatment effects.

SUMMARY:

The public workshop will be
held on Monday, February 4, 2019 from
8:30 a.m. to 5 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
DATES:

The public workshop will
be held at 1777 F Street NW,
Washington, DC 20006. For additional
travel and hotel information, please
refer to the following website: https://
healthpolicy.duke.edu/events/
evaluating-pressor-effects-drugsambulatory-blood-pressure-monitoringstudies.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Norman Stockbridge, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4166,
Silver Spring, MD 20903, 301–796–
2240, email: Norman.Stockbridge@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

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I. Background
FDA is announcing a public
workshop regarding FDA’s assessment
of the pressor effects of drugs. Elevated
blood pressure is known to increase the
risk of stroke, heart attack, and death.
The effect of a drug on blood pressure
may therefore be an important
consideration in benefit-risk assessment.
Following FDA’s announcement in the
Federal Register of the availability of a
draft guidance for industry entitled
‘‘Assessment of Pressor Effects of
Drugs’’ (May 31, 2018, 83 FR 25013),
FDA is convening this public meeting in
collaboration with the Duke-Margolis
Center for Health Policy to discuss the
Agency’s current thinking with expert
stakeholders and to consider public
comments.

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II. Topics for Discussion at the Public
Workshop
Topics for discussion during this
meeting include:
• Risk associated with blood pressure
change
• Aspects and FDA analyses related
to ambulatory blood pressure
monitoring
• Evaluating a drug’s effect on blood
pressure and understanding the optimal
regulatory approach to assigning risk

evaluating-pressor-effects-drugsambulatory-blood-pressure-monitoringstudies.
Dated: November 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24961 Filed 11–14–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOMELAND
SECURITY

III. Participating in the Public
Workshop

[Docket No.: DHS–2018–0063]

Registration: To register for the public
workshop, please visit the following
website: https://healthpolicy.duke.edu/
events/evaluating-pressor-effects-drugsambulatory-blood-pressure-monitoringstudies. 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 Thursday, January 31, 2019,
midnight Eastern Time. There will be no
onsite registration. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If you are unable to attend the
meeting in person, you can register to
view a live webcast of the meeting.
Duke-Margolis will post on its website
if registration closes before the day of
the public meeting.
If you need special accommodations
due to a disability, please contact Sarah
Supsiri at the Duke-Margolis Center for
Health Policy (202–791–9561, email:
[email protected]) no later than
November 29, 2018.
Streaming webcast of the public
workshop: This public workshop will be
webcast live. Persons interested in
viewing the live webcast may register
ahead of the event by visiting https://
healthpolicy.duke.edu/events/
evaluating-pressor-effects-drugsambulatory-blood-pressure-monitoringstudies. The live webcast will also be
available at the website above on the
day of the event without preregistration.
Archived video footage will be available
at the Duke-Margolis website following
the workshop.
All event materials will be provided
to registered attendees via email prior to
the workshop and will be publicly
available at the Duke-Margolis Center
for Health Policy website https://
healthpolicy.duke.edu/events/

First Responders Community of
Practice (FRCoP)

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Science and Technology
Directorate, Department of Homeland
Security.
ACTION: 30-Day Notice of Information
Collection; request for comment. (Reinstatement of a Currently Approved
Collection, 1640–0016).
AGENCY:

The Department of Homeland
Security (DHS), Science and Technology
(S&T) is proposing to reinstate OMB
1640–0016, an information collection,
by inviting the public to comment on
the collection: First Responders
Community of Practice (FRCoP) User
Registration Page (DHS Form 10059 (9/
09)). The FRCoP web based tool collects
profile information from first responders
and select authorized non-first
responder users to facilitate networking
and formation of online communities.
All users are required to authenticate
prior to entering the site. In addition,
the tool provides members the
capability to create wikis, discussion
threads, blogs, documents, etc., allowing
them to enter and upload content in
accordance with the site’s Rules of
Behavior. Members are able to
participate in threaded discussions and
comment on other members’ content.
The FRCoP program is responsible for
providing a collaborative environment
for the first responder community to
share information, best practices, and
lessons learned. The Homeland Security
Act of 2002 established this
requirement. Interested persons may
receive a copy of the collection by
contacting the DHS S&T Paperwork
Reduction Act (PRA) Coordinator.
DATES: Comments are encouraged and
accepted until December 17, 2018.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2018–0063, at:
• Federal eRulemaking Portal: http://
www.regulations.gov. Please follow the
instructions for submitting comments.
• Mail and hand delivery or
commercial delivery: Science and
SUMMARY:

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57492

Federal Register / Vol. 83, No. 221 / Thursday, November 15, 2018 / Notices

Technology Directorate, ATTN: Chief
Information Office—Mary Cantey, 245
Murray Drive, Mail Stop 0202,
Washington, DC 20528.
Instructions: All submissions received
must include the agency name and
docket number DHS–2018–0063. All
comments received will be posted
without change to http://
www.regulations.gov, including any
personal information provided. Please
note that comments submitted by fax or
email and those submitted after the
comment period will not be accepted.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov.

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DHS/S&T/FRG System Owner: Marc
Caplan, [email protected],
(202) 254–6134 (Not a toll free number).
SUPPLEMENTARY INFORMATION: DHS, in
accordance with the PRA (6 U.S.C. 193),
provides the general public and Federal
agencies with an opportunity to
comment on proposed, revised, and
continuing collection of information.
This helps the Department assess the
impact of its information collection
requirements and minimize the public’s
reporting burden. It also helps the
public understand the Department’s
information collection requirements and
provides the requested data in the
desired format. DHS is soliciting
comments on the proposed information
collection request (ICR) that is described
below. The Department of Homeland
Security is especially interested in
public comment addressing the
following issues: (1) Is this collection
necessary to the proper functions of the
Department; (2) will this information be
processed and used in a timely manner;
(3) is the estimate of burden accurate;
(4) how might the Department enhance
the quality, utility, and clarity of the
information to be collected; and (5) how
might the Department minimize the
burden of this collection on the
respondents, including through the use
of information technology. Please note
that written comments received in
response to this notice will be
considered public records.
Title of Collection: First Responders
Community of Practice User
Registration Page (DHS Form 10059 (9/
09)).
Prior OMB Control Number: 1640–
0016.
Prior Federal Register Document:
2018–0035, August 2, 2018.
Type of Review: An extension of an
information collection.
Respondents/Affected Public: Federal,
State, Local, and Tribal Governments.

16:53 Nov 14, 2018

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Gregg Piermarini,
Deputy Chief Information Officer, Science
and Technology Directorate.
[FR Doc. 2018–24907 Filed 11–14–18; 8:45 am]
BILLING CODE 9110–9F–P

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2018–0038]

FOR FURTHER INFORMATION CONTACT:

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Frequency of Collection: Once per
respondent.
Average Burden per Response: 30
minutes.
Total Estimated Number of Annual
Responses: 2,000.
Total Estimated Number of Annual
Burden Hours: 1,000.

Science and Technology Collection of
Qualitative Feedback
Science and Technology
Directorate (S&T), Department of
Homeland Security (DHS).
ACTION: 60-Day notice of information
collection; new request for comment.
AGENCY:

S&T will submit the following
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB) for review and clearance in
accordance with the Paperwork
Reduction Act of 1995. The information
collection activity will garner
qualitative customer and stakeholder
feedback in an efficient, timely manner,
in accordance with the Administration’s
commitment to improving service
delivery.
DATES: Comments are encouraged and
accepted until January 14, 2019.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2018–0038, at:
• Federal eRulemaking Portal: http://
www.regulations.gov. Please follow the
instructions for submitting comments.
• Mail and hand delivery or
commercial delivery: Science and
Technology Directorate, ATTN: Chief
Information Office—Mary Cantey, 245
Murray Drive, Mail Stop 0202,
Washington, DC 20528.
Instructions: All submissions received
must include the agency name and
docket number DHS–2018–0038. All
comments received will be posted
without change to http://
www.regulations.gov, including any
personal information provided. Please
note that comments submitted by fax or
email and those submitted after the
comment period will not be accepted.
Docket: For access to the docket to
read background documents or
comments received, go to http://
www.regulations.gov.
SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

DHS/S&T/OCIO Program Manager: Mary
Cantey, [email protected] or
202–254–5367 (Not a toll free number).
SUPPLEMENTARY INFORMATION: The
information collection activity will
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
S&T’s commitment to improving service
delivery. By qualitative feedback we
mean information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between
S&T and its customers and stakeholders.
It will also allow feedback to contribute
directly to the improvement of S&T’s
program management. Feedback
collected under this generic clearance
will provide useful information, but it
will not yield data that can be
generalized to the overall population.
This type of generic clearance for
qualitative information will not be used
for quantitative information collections
that are designed to yield reliably
actionable results, such as monitoring
trends over time or documenting
program performance. Such data uses
require more rigorous designs that
address: The target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential
nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results. DHS, in accordance
with the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., provides
the general public and Federal agencies
with an opportunity to comment on
proposed, revised, and continuing
collections of information. DHS is
soliciting comments on the proposed
Information Collection Request (ICR)
that is described below. DHS is

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