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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by August 8, 2013.


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FAX: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-NEW and title “Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information.”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.

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Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-Start Printed Page 41065400B, Rockville, MD 20850, 301-796-7726,

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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Draft Guidance for Industry on and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information—(OMB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This draft guidance provides recommendations on when to use a Dear Health Care Provider (DHCP) Letter, the types of information to include in a DHCP letter, how to organize that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 The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products.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

Number of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
Annual Average251.20301003,000
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.

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Dated: July 2, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-16445 Filed 7-8-13; 8:45 am]