[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76203-76204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27012]


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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 Healthcare 
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, 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: Submit written comments (including recommendations) on the 
collection of information by January 12, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 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, 
[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.

Improving Communication of Important Safety Information--21 CFR Part 
200

OMB Control Number 0910-0754--Extension

    This information collection supports Agency regulations and 
recommendations found in associated Agency guidance, as discussed 
below. Under section 705 of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health 
and Human Services (the Secretary) may require dissemination of 
information for drugs in situations that involve, in the Secretary's 
opinion, ``imminent danger to health, or gross deception of the 
consumer.'' Implementing regulations are found in Sec.  200.5 (21 CFR 
200.5) and outline the general provisions for ``Dear Healthcare 
Provider'' (DHCP) letters that manufacturers and distributors 
disseminate about important drug warnings, important prescribing 
information, and important correction of drug information. The 
regulations also prescribe certain format and content instructions 
regarding the dissemination of covered information. Manufacturers or 
distributors send DHCP letters to physicians and other healthcare 
providers to communicate an important drug warning, a change in 
prescribing information, or a correction of misinformation in 
prescription drug promotional labeling or advertising. We developed the 
guidance document entitled ``Dear Healthcare Provider Letters: 
Improving Communication of Important Safety Information'' (January 
2014), available at https://www.fda.gov/media/79793/download, to 
provide instructions and recommendations to respondents on implementing 
the applicable requirements. All Agency guidance documents are issued 
consistent with our good guidance practice regulations at 21 CFR 
10.115.
    In addition to the content and format recommendations for each type 
of DHCP letter, the guidance also includes recommendations on 
consulting with FDA on: (1) how to develop a DHCP letter; (2) when to 
send a letter; (3) what type of letter to send; and (4) how to assess 
the letter's impact.
    In the Federal Register of June 24, 2022 (87 FR 37871), we 
published a 60-day notice requesting public comment

[[Page 76204]]

on the proposed collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of                        Average time
                      Activity; 21 CFR section                          Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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Preparation of DHCP letters; Sec.   200.5..........................               6              1.3                8              100              800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have identified 24 DHCP letters that 18 distinct sponsors 
submitted to FDA during the 3-year period (2019 to 2021). Based on our 
Document Archiving, Reporting, and Regulatory Tracking System, we 
estimate eight DHCP letters will be submitted annually from six 
application holders. Based on our experience, we assume that each 
letter will require 100 hours to prepare and disseminate as recommended 
in the guidance. Our estimate reflects a downward adjustment by five 
responses and 500 hours annually. We attribute this decrease to the 
effectiveness of the guidance and the decreased number of DHCP letters 
submitted for FDA review.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27012 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P


