81 FR 12734 - Agency Information Collection Activities; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 47 (March 10, 2016)

Page Range		12734-12735
FR Document		2016-05301

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 solicits comments on the information collection associated with the guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' This guidance offers specific recommendations to industry 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. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.

Federal Register, Volume 81 Issue 47 (Thursday, March 10, 2016)

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12734-12735]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


Agency Information Collection Activities; Comment Request; 
Guidance for Industry and Food and Drug Administration Staff on Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 solicits comments on the information collection 
associated with the guidance for industry and FDA staff entitled ``Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information.'' This guidance offers specific recommendations to 
industry 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. This guidance 
provides recommendations on when to use a DHCP letter, the types of 
information to include in the DHCP letter, how to organize the 
information so that it is communicated effectively to health care 
providers, and formatting techniques to make the information more 
accessible.

DATES: Submit either electronic or written comments on the collection 
of information by May 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as 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 the Docket No. 
FDA-2010-D-0319 for Guidance for Industry and Food and Drug 
Administration Staff on Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information. Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets

[[Page 12735]]

Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Guidance for Industry and Food and Drug Administration Staff on Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information OMB Control Number 0910-0754--Extension

    This final Guidance for Industry and FDA staff entitled ``Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information'' offers specific guidance 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.
    This guidance gives specific instruction on what should and should 
not be included in DHCP letters. To date, 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 advice on consulting with FDA 
to develop a DHCP letter, when to send a letter, what type of letter to 
send, and conducting an assessment of the letter's impact.
    Based on a review of FDA's Document Archiving, Reporting, and 
Regulatory Tracking System for 2012-2015, we identified DHCP letters 
that were sent and the identity of each sponsor sending out a DHCP 
letter for each year. We estimate that we will receive approximately 25 
DHCP Letters annually from approximately 18 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.
    FDA estimates the annual reporting burden of this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Annual Average................              18             1.4              25  100 hours.......           2,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05301 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12735

Management, 5630 Fishers Lane, Rm. utility; (2) the accuracy of FDA’s material, or otherwise have not met the
1061, Rockville, MD 20852. estimate of the burden of the proposed goals set forth in the applicable
FOR FURTHER INFORMATION CONTACT: FDA collection of information, including the regulation (21 CFR 200.5). In some
PRA Staff, Office of Operations, Food validity of the methodology and cases, health care providers have not
and Drug Administration, 8455 assumptions used; (3) ways to enhance been aware of important new
Colesville Rd., COLE–14526, Silver the quality, utility, and clarity of the information, and have been unable to
Spring, MD 20993–0002, PRAStaff@ information to be collected; and (4) communicate it to patients, because the
fda.hhs.gov. ways to minimize the burden of the letters’ content and length have made it
SUPPLEMENTARY INFORMATION: Under the
collection of information on difficult to find the relevant
PRA (44 U.S.C. 3501–3520), Federal respondents, including through the use information. In addition, letters have
Agencies must obtain approval from the of automated collection techniques, sometimes been sent for the wrong
Office of Management and Budget when appropriate, and other forms of reasons.
(OMB) for each collection of information technology. In addition to content and format
information they conduct or sponsor. Guidance for Industry and Food and recommendations for each type of DHCP
‘‘Collection of information’’ is defined Drug Administration Staff on Dear letter, the guidance also includes advice
in 44 U.S.C. 3502(3) and 5 CFR Health Care Provider Letters: on consulting with FDA to develop a
1320.3(c) and includes Agency requests Improving Communication of DHCP letter, when to send a letter, what
or requirements that members of the Important Safety Information OMB type of letter to send, and conducting an
public submit reports, keep records, or Control Number 0910–0754—Extension assessment of the letter’s impact.
provide information to a third party.
This final Guidance for Industry and Based on a review of FDA’s Document
Section 3506(c)(2)(A) of the PRA (44
FDA staff entitled ‘‘Dear Health Care Archiving, Reporting, and Regulatory
U.S.C. 3506(c)(2)(A)) requires Federal
Provider Letters: Improving Tracking System for 2012–2015, we
Agencies to provide a 60-day notice in
Communication of Important Safety identified DHCP letters that were sent
the Federal Register concerning each
Information’’ offers specific guidance to and the identity of each sponsor sending
proposed collection of information,
industry and FDA staff on the content out a DHCP letter for each year. We
including each proposed extension of an
and format of Dear Health Care Provider estimate that we will receive
existing collection of information,
(DHCP) letters. These letters are sent by approximately 25 DHCP Letters
before submitting the collection to OMB
for approval. To comply with this manufacturers or distributors to health annually from approximately 18
requirement, FDA is publishing notice care providers to communicate an application holders. FDA professionals
of the proposed collection of important drug warning, a change in familiar with DHCP letters and with the
information set forth in this document. prescribing information, or a correction recommendations in the guidance
With respect to the following of misinformation in prescription drug estimate that it should take an
collection of information, FDA invites promotional labeling or advertising. application holder approximately 100
comments on these topics: (1) Whether This guidance gives specific hours to prepare and send DHCP letters
the proposed collection of information instruction on what should and should in accordance with the guidance.
is necessary for the proper performance not be included in DHCP letters. To FDA estimates the annual reporting
of FDA’s functions, including whether date, some DHCP letters have been too burden of this collection of information
the information will have practical long, have contained promotional as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent

Annual Average .................................................... 18 1.4 25 100 hours ..................... 2,500
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 3, 2016. DEPARTMENT OF HEALTH AND that a proposed collection of
Leslie Kux, HUMAN SERVICES information has been submitted to the
Associate Commissioner for Policy. Office of Management and Budget
Food and Drug Administration (OMB) for review and clearance under
[FR Doc. 2016–05301 Filed 3–9–16; 8:45 am]
the Paperwork Reduction Act of 1995.
BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0477]
DATES: Fax written comments on the
Agency Information Collection collection of information by April 11,
Activities; Submission for Office of 2016.
Management and Budget Review;
ADDRESSES: To ensure that comments on
Comment Request; Investigational
the information collection are received,
Device Exemptions Reports and
mstockstill on DSK4VPTVN1PROD with NOTICES

OMB recommends that written
Records
comments be faxed to the Office of
AGENCY: Food and Drug Administration, Information and Regulatory Affairs,
HHS. OMB, Attn: FDA Desk Officer, FAX:
ACTION: Notice. 202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
SUMMARY: The Food and Drug comments should be identified with the
Administration (FDA) is announcing OMB control number 0910–0078. Also

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Document Created: 2018-02-02 15:11:49
Document Modified: 2018-02-02 15:11:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 9, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 12734

81 FR 12734 - Agency Information Collection Activities; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 47 (March 10, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration