[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12734-12735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0319]
Agency Information Collection Activities; Comment Request;
Guidance for Industry and Food and Drug Administration Staff 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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 the guidance for industry and FDA staff entitled ``Dear
Health Care Provider Letters: Improving Communication of Important
Safety Information.'' This 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 May 9, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 and Food and Drug
Administration Staff on Dear Health Care Provider Letters: Improving
Communication of Important Safety Information. Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets
[[Page 12735]]
Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, [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.
Guidance for Industry and Food and Drug Administration Staff on Dear
Health Care Provider Letters: Improving Communication of Important
Safety Information OMB Control Number 0910-0754--Extension
This final Guidance for Industry and FDA staff entitled ``Dear
Health Care Provider Letters: Improving Communication of Important
Safety Information'' offers specific guidance to industry and FDA staff
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 gives specific instruction on what should and should
not be included in DHCP letters. To date, 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 advice on consulting with FDA
to develop a DHCP letter, when to send a letter, what type of letter to
send, and conducting an assessment of the letter's impact.
Based on a review of FDA's Document Archiving, Reporting, and
Regulatory Tracking System for 2012-2015, we identified DHCP letters
that were sent and the identity of each sponsor sending out a DHCP
letter for each year. We estimate that we will receive approximately 25
DHCP Letters annually from approximately 18 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.
FDA estimates the annual reporting burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Annual Average................ 18 1.4 25 100 hours....... 2,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05301 Filed 3-9-16; 8:45 am]
BILLING CODE 4164-01-P