[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41064-41065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 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.

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SUMMARY: 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 August 
8, 2013.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Draft Guidance for Industry and Food and Drug Administration 
Staff on Dear Health Care Provider Letters: Improving Communication of 
Important Safety Information.'' Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-

[[Page 41065]]

400B, Rockville, MD 20850, 301-796-7726, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Draft Guidance for Industry on and Food and Drug Administration Staff 
on Dear Health Care Provider Letters: Improving Communication of 
Important Safety Information--(OMB Control Number 0910-New)

    This draft guidance provides recommendations on when to use a Dear 
Health Care Provider (DHCP) Letter, the types of information to include 
in a DHCP letter, how to organize that information, and formatting 
techniques to make the information more accessible. The draft guidance 
is intended to improve the quality of DHCP letters to make them more 
effective communication tools for new information about marketed 
products.
    In the Federal Register of November 12, 2010 (75 FR 69449), FDA 
published a 60-day notice requesting public comment on the draft 
version of this guidance. Eleven public comments were received during 
the comment period and in nine of the letters the following two issues 
were raised. However, the other two comments did not address the 
information collection.
    (Comment 1) Section V of the draft guidance states that the target 
audience should be all health care providers who could not only 
prescribe the drug, but who could also dispense or administer the 
drugs. The comments call this an expansion of the target audience, 
which would require manufacturers to send DHCP letters to physicians, 
nurses, pharmacists, and other prescribing and non-prescribing 
providers. Manufacturers would also need to seek out lists of such non-
prescribing health care providers proactively and disseminate the 
letters more broadly than to just physicians. A recommendation was made 
to limit the letters to prescribers only.
    (Response) The regulation requires manufacturers and distributors 
to mail important information to ``physicians and others responsible 
for patient care''. (See 21 CFR 200.5) To the extent this includes non-
prescribing health care professionals responsible for patient care, the 
manufacturers should send letters to relevant personnel. This is not an 
expansion of the scope of the letters, merely a clarification of the 
regulation and a reflection of the health care system today, which has 
a variety of practitioners involved in patient care.
    (Comment 2) In Section VI of the draft guidance, FDA recommends 
that companies conduct an evaluation of the extent to which the target 
audience received the DHCP letter and is aware of the information that 
was communicated in the letter. It also asked manufacturers to assess 
the impact of DHCP letters and their impact on patient behavior. 
Comments found this overly burdensome, beyond the Agency's statutory 
authority, and an unnecessary increase in correspondence, thereby 
potentially diluting the impact of the DHCP letters.
    (Response) We agree with the comments. The final guidance has been 
modified to suggest that manufacturers conduct an evaluation, for their 
own use, of the utility of the letters and their success in reaching 
the target audiences.
    Based on a review of MedWatch Safety Alerts for 2008 and 2009, we 
identified each Dear Health Care Provider Letter sent and the identity 
of each sponsor sending out a Dear Health Care Provider Letter for each 
year. We estimate that we will receive approximately 30 Dear Health 
Care Provider Letters annually from approximately 25 application 
holders. FDA professionals familiar with Dear Health Care Provider 
Letters and with the recommendations in the draft guidance estimate 
that it should take an application holder approximately 100 hours to 
prepare and send Dear Health Care Provider Letters in accordance with 
the draft guidance. Therefore we estimate the annual reporting burden 
as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                                                                        Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Annual Average.....................................................              25             1.20               30              100            3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the draft guidance, we refer to an earlier guidance for industry 
entitled ``Using Electronic Means to Distribute Certain Product 
Information'' (71 FR 26102; May 3, 2006). That guidance referred to 
previously approved collections of information found in FDA regulations 
that are subject to review by OMB. The collections of information in 
that guidance have been approved under OMB control number 0910-0249.

    Dated: July 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16445 Filed 7-8-13; 8:45 am]
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