Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 42929-42930 [2019-17708]
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: August 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17721 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–2010–D–0319]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information
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 associated with Agency
guidance entitled ‘‘Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information.’’ The guidance offers
specific recommendations to industry
on the content and format of Dear
Health Care Provider (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 provides
recommendations on when to use a
DHCP letter, the types of information to
include in the DHCP letter, how to
organize the information so that it is
communicated effectively to health care
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
providers, and formatting techniques to
make the information more accessible.
DATES: Submit either electronic or
written comments on the collection of
information by October 18, 2019.
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 October 18,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 18, 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.
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.’’
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
42929
Instructions: All submissions received
must include the Docket No. FDA–
2010–D–0319 for ‘‘Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information.’’ 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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
E:\FR\FM\19AUN1.SGM
19AUN1
42930
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
jspears on DSK3GMQ082PROD with NOTICES
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
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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
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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
Agencies
[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42929-42930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0319]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Dear Health Care Provider
Letters: Improving Communication of Important Safety Information
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 associated with
Agency guidance entitled ``Dear Health Care Provider Letters: Improving
Communication of Important Safety Information.'' The guidance offers
specific recommendations to industry on the content and format of Dear
Health Care Provider (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 provides recommendations on when to use a
DHCP letter, the types of information to include in the DHCP letter,
how to organize the information so that it is communicated effectively
to health care providers, and formatting techniques to make the
information more accessible.
DATES: Submit either electronic or written comments on the collection
of information by October 18, 2019.
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 October 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 18, 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.
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-2010-D-0319 for ``Guidance for Industry on Dear Health Care
Provider Letters: Improving Communication of Important Safety
Information.'' 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/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 42930]]
20852, 301-796-5733, [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.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dear Health Care Provider Letters.................................. 8 1.625 13 100 1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17708 Filed 8-16-19; 8:45 am]
BILLING CODE 4164-01-P