Notice2022-27012
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 238 (Tuesday, December 13, 2022)</title>
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[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76203-76204]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#550507140621343333153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="045456455770656262446260652a6c6c772a636b72">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/79793/download">https://www.fda.gov/media/79793/download</a>, 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
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