[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69449-69451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Food and Drug Administration 
Staff on Dear Health Care Provider Letters: Improving Communication of 
Important Safety Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Dear Health Care Provider Letters: Improving Communication of 
Important Safety Information.'' Dear Health Care Provider (DHCP) 
Letters are correspondence--usually in the form of a mass mailing from 
the manufacturer or distributor of a human drug or biologic, or from 
FDA--intended to alert physicians and other health care providers to 
important new information about a marketed drug or biological product. 
This draft guidance provides recommendations on when to use a DHCP 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 The draft guidance is intended to improve 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.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 11, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or 
the Office of Communication, Outreach, and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one

[[Page 69450]]

self-addressed adhesive label to assist those offices in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandy Benton, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4206, Silver Spring, MD 20993-0002, 301-
796-2270; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information.'' Important new 
information about prescription drug and biological products emerges 
throughout a product's lifecycle. For marketed products, there may be 
occasions when it is important to communicate new information promptly 
to health care practitioners involved in prescribing or dispensing a 
drug, or in caring for patients who receive a drug. The DHCP letter is 
an important mechanism (one of a number of different mechanisms) used 
to communicate important new information to health care professionals 
about a marketed product.
    Formal and informal evaluations of DHCP letters have shown that the 
communication quality of DHCP letters--the extent to which the 
information is accessible and can be understood--varies widely. A study 
reported in 2005 evaluated the quality of a group of DHCP letters sent 
during 2000 and 2001 that were intended to communicate important new 
drug safety information.\1\ The study found that there is a correlation 
between the quality or perceived quality of a DHCP letter and the 
extent to which physicians perceive the new information as important. 
Letters that were evaluated as clearer, more concise, better organized 
and formatted, and focused on the most important aspects of the new 
safety information were considered to be more effective in 
communicating the new information.
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    \1\ Mazor K, S. Andrade, J. Auger, et al., ``Communicating 
Safety Information to Physicians: An Examination of Dear Doctor 
Letters,'' Pharmacoepidemiol Drug Safety, 14:869-875, 2005.
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    FDA believes guidance concerning the format and content of the DHCP 
letter would be beneficial in improving the effectiveness of DHCP 
letters in communicating drug information. Accordingly, this draft 
guidance contains recommendations on when to use a DHCP letter, what 
types of information to include in a DHCP letter, how to organize that 
information, and formatting techniques to make the information in the 
letter more accessible.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the format 
and content of DHCP letters. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 that 
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 for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    FDA estimates the burden of this collection of information as 
follows:
    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         Hours per      Total hours
                                    respondents     respondent       responses       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 information collection.


[[Page 69451]]

    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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28440 Filed 11-10-10; 8:45 am]
BILLING CODE 4160-01-P