[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]


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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.

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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
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                                                                                         Number of
                          Type of activity                              Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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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.

    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