[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37871-37873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 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.
    We estimate the burden of the information collection as follows:

[[Page 37873]]



                                                     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


