[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64541-64542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25333]


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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; 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, the Agency, 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.

DATES: Fax written comments on the collection of information by 
December 23, 2019.

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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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.

[[Page 64542]]

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 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. The guidance is available from our 
website at: https://www.fda.gov/media/79793/download.
    The guidance document 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 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.
    In the Federal Register of August 19, 2019 (84 FR 42929), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received expressing the 
importance of communicating safety information, for which we are 
appreciative. No other comments were received.
    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: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25333 Filed 11-21-19; 8:45 am]
 BILLING CODE 4164-01-P


