Food and Drug Administration Science Forum 2019; Public Workshop, 42930-42931 [2019-17703]
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information
OMB Control Number 0910–0754—
Extension
This information collection supports
recommendations found in the Agency
guidance document entitled, ‘‘Dear
Health Care Provider Letters: Improving
Communication of Important Safety
Information.’’ The guidance provides
instruction to industry and FDA staff on
the content and format of DHCP letters.
These letters are sent by manufacturers
or distributors to health care providers
to communicate an important drug
warning, a change in prescribing
information, or a correction of
misinformation in prescription drug
promotional labeling or advertising.
This guidance gives specific
instruction on what should and should
not be included in DHCP letters. Some
DHCP letters have been too long, have
contained promotional material, or
otherwise have not met the goals set
forth in the applicable regulation (21
CFR 200.5). In some cases, health care
providers have not been aware of
important new information, and have
been unable to communicate it to
patients, because the letters’ content and
length have made it difficult to find the
relevant information. In addition, letters
have sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes
recommendations on consulting with
FDA on how to develop a DHCP letter,
when to send a letter, what type of letter
to send, and how to assess the letter’s
impact. Based on a review of FDA’s
Document Archiving, Reporting, and
Regulatory Tracking System for 2016–
2018, we identified 38 DHCP letters that
were sent out by 24 distinct sponsors
during the 3-year timeframe. We
estimate that we will receive
approximately 13 DHCP letters annually
from approximately 8 application
holders. FDA professionals familiar
with DHCP letters and with the
recommendations in the guidance
estimate that it should take an
application holder approximately 100
hours to prepare and send DHCP letters
in accordance with the guidance.
We estimate the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Dear Health Care Provider Letters ......................................
8
1.625
13
100
1,300
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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, we have reduced our burden
estimate by 17 respondents with a
corresponding decrease in annual hours
by 1,200. We attribute the decrease to
the effectiveness of the guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Food and Drug Administration Science
Forum 2019; Public Workshop
[FR Doc. 2019–17708 Filed 8–16–19; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
AGENCY:
Food and Drug Administration,
Notice of public workshop.
The Food and Drug
Administration (FDA or the Agency) is
announcing the following public
workshop entitled ‘‘FDA Science Forum
2019.’’ The purpose of the public
workshop is to share with the public the
unique scientific research and
16:29 Aug 16, 2019
Jkt 247001
The public workshop will be
held on September 11, 2019, from 8:30
a.m. to 4:40 p.m., and September 12,
2019, from 9 a.m. to 4 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
DATES:
SUMMARY:
VerDate Sep<11>2014
collaborative efforts of FDA’s 11,000
scientists and researchers, who use
novel science and technologies to
inform FDA’s regulatory decisionmaking—and drive innovation.
PO 00000
Frm 00043
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The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
ADDRESSES:
E:\FR\FM\19AUN1.SGM
19AUN1
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
security check procedures will be
performed. For parking and security
information, please refer to
www.fda.gov/publicmeetinginfo.
FOR FURTHER INFORMATION CONTACT:
Rokhsareh Shahidzadeh, Office of
Scientific Professional Development,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2383, Silver Spring,
MD 20993, 301–796–8740,
FDASciProDev@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Science Forum is held
biennially to share with the public the
unique scientific research and
collaborative efforts of our 11,000
scientists and researchers. These
scientists and researchers use novel
science and technologies to inform
FDA’s regulatory decision-making—and
drive innovation. FDA scientific experts
and nationally renowned scientists will
speak on the eight topics of the
upcoming FDA Science Forum,
Transforming Health: Innovation in
FDA Science. FDA’s Science Forum
welcomes the public, industry,
academia, patient advocates, sister
Agencies, and current and potential
collaborators, to learn about the
Agency’s regulatory science—the type of
science that is rarely undertaken by
industry or academia, but that makes
critical contributions to product quality
and safety.
jspears on DSK3GMQ082PROD with NOTICES
II. Topics for Discussion at the Public
Workshop
Sessions in the two-day forum will
highlight such areas as FDA research
into new predictive tools for developing
and evaluating therapeutics, advancing
artificial intelligence, evaluating digital
health devices, and novel methods of
tackling critical public health challenges
such as addiction.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://www.fda.gov/
scienceforum.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by September 6, 2019, at 5 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 when they have been
accepted.
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
If you need special accommodations
due to a disability, please contact
Rokhsareh Shahidzadeh (see FOR
FURTHER INFORMATION CONTACT) no later
than September 4, 2019, by 5 p.m.
Eastern Time.
Streaming Webcast of the public
workshop: This public workshop will
also be webcast. To register, please visit
the following website: https://
www.fda.gov/scienceforum. Participants
interested in viewing via webcast must
register by September 6, 2019, at 5 p.m.
Eastern 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. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Dated: August 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17703 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0134]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mammography
Quality Standards Act Requirements
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 September
18, 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 0910–0309. Also
SUMMARY:
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include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Mammography Quality Standards Act
Requirements—21 CFR Part 900
OMB Control Number 0910–0309—
Extension
The Mammography Quality Standards
Act (Pub. L. 102–539) requires the
establishment of a Federal certification
and inspection program for
mammography facilities; regulations
and standards for accreditation and
certification bodies for mammography
facilities; and standards for
mammography equipment, personnel,
and practices, including quality
assurance. The intent of these
regulations is to assure safe, reliable,
and accurate mammography on a
nationwide level. Under the regulations,
as a first step in becoming certified,
mammography facilities must become
accredited by an FDA-approved
accreditation body (AB). This requires
undergoing a review of their clinical
images and providing the AB with
information showing that they meet the
equipment, personnel, quality
assurance, and quality control
standards, and have a medical reporting
and recordkeeping program, a medical
outcomes audit program, and a
consumer complaint mechanism. On the
basis of this accreditation, facilities are
then certified by FDA or an FDAapproved State certification agency and
must prominently display their
certificate. These actions are taken to
ensure safe, accurate, and reliable
mammography on a nationwide basis.
The following sections of Title 21 of
the Code of Federal Regulations (CFR)
are not included in the burden tables
because they are considered usual and
customary practice and were part of the
standard of care prior to the
implementation of the regulations;
therefore, they resulted in no additional
burden: 21 CFR 900.12(c)(1) and (3) and
900.3(f)(1). 21 CFR 900.24(c) was also
not included in the burden tables
because if a certifying State had its
approval withdrawn, FDA would take
E:\FR\FM\19AUN1.SGM
19AUN1
Agencies
[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42930-42931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17703]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0001]
Food and Drug Administration Science Forum 2019; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the following public workshop entitled ``FDA Science Forum
2019.'' The purpose of the public workshop is to share with the public
the unique scientific research and collaborative efforts of FDA's
11,000 scientists and researchers, who use novel science and
technologies to inform FDA's regulatory decision-making--and drive
innovation.
DATES: The public workshop will be held on September 11, 2019, from
8:30 a.m. to 4:40 p.m., and September 12, 2019, from 9 a.m. to 4 p.m.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
[[Page 42931]]
security check procedures will be performed. For parking and security
information, please refer to www.fda.gov/publicmeetinginfo.
FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of
Scientific Professional Development, Office of the Chief Scientist,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301-796-
8740, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Science Forum is held biennially to share with the public
the unique scientific research and collaborative efforts of our 11,000
scientists and researchers. These scientists and researchers use novel
science and technologies to inform FDA's regulatory decision-making--
and drive innovation. FDA scientific experts and nationally renowned
scientists will speak on the eight topics of the upcoming FDA Science
Forum, Transforming Health: Innovation in FDA Science. FDA's Science
Forum welcomes the public, industry, academia, patient advocates,
sister Agencies, and current and potential collaborators, to learn
about the Agency's regulatory science--the type of science that is
rarely undertaken by industry or academia, but that makes critical
contributions to product quality and safety.
II. Topics for Discussion at the Public Workshop
Sessions in the two-day forum will highlight such areas as FDA
research into new predictive tools for developing and evaluating
therapeutics, advancing artificial intelligence, evaluating digital
health devices, and novel methods of tackling critical public health
challenges such as addiction.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://www.fda.gov/scienceforum.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by September 6, 2019, at 5 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 when they have been
accepted.
If you need special accommodations due to a disability, please
contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no
later than September 4, 2019, by 5 p.m. Eastern Time.
Streaming Webcast of the public workshop: This public workshop will
also be webcast. To register, please visit the following website:
https://www.fda.gov/scienceforum. Participants interested in viewing
via webcast must register by September 6, 2019, at 5 p.m. Eastern 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. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Dated: August 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17703 Filed 8-16-19; 8:45 am]
BILLING CODE 4164-01-P