Notice2022-13536
Agency Information Collection Activities; Proposed Collection; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information
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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
June 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice requests comments on information collection associated with the communication of important safety information to medical practitioners.
Full Text
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<title>Federal Register, Volume 87 Issue 121 (Friday, June 24, 2022)</title>
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[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37871-37873]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13536]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0319]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice requests comments on information collection associated with the
communication of important safety information to medical practitioners.
DATES: Submit either electronic or written comments on the collection
of information by August 23, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 23, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 23, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as
[[Page 37872]]
well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include Docket No. FDA-
2010-D-0319 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Dear Healthcare Provider Letters:
Improving Communication of Important Safety Information.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="1f4f4d5e4c6b7e79795f797b7e3177776c31787069">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
We estimate the burden of the information collection as follows:
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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: June 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13536 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P
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