[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72808-72809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25481]


-----------------------------------------------------------------------

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; 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 or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by 
November 21, 2016.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0754. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

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.

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

[[Page 72809]]

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 to 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.
    In the Federal Register of March 10, 2016 (81 FR 12734), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    FDA estimates the annual reporting burden of this collection of 
information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses         (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual average.....................................................              18              1.4               25              100            2,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25481 Filed 10-20-16; 8:45 am]
 BILLING CODE 4164-01-P