Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers; Guidance for Industry; Availability, 27602-27605 [2018-12631]
Download as PDF
<![CDATA[
27602
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
New York City, Washington DC, 5 U.S.
territories (American Samoa, the
Commonwealth of Northern Mariana
Islands, Guam, Puerto Rico, and the U.S.
Virgin Islands), and 3 freely associated
states (Federated States of Micronesia,
the Republic of the Marshall Islands,
and the Republic of Palau). This
information is shared across
jurisdictional boundaries and both
surveillance and prevention and control
activities are coordinated at regional
and national levels.
Approximately 90% of case
notifications are encrypted and
submitted to NNDSS electronically from
already existing databases by automated
electronic messages. When automated
transmission is not possible, case
notifications are faxed, emailed,
uploaded to a secure network or entered
into a secure website. All case
notifications that are faxed, emailed,
and uploaded are done so in the form
of an aggregate weekly or annual report,
not individual cases. These different
mechanisms used to send case
notifications to CDC vary by the
jurisdiction and the disease or
condition. Private personally
identifiable information (PII) is
collected from automated electronic
messages and information can be
retrieved by PII. In addition, some
combinations of submitted data
elements could potentially be used to
identify individuals. Private information
is not be disclosed unless otherwise
compelled by law. All data are treated
in a secure manner consistent with the
technical, administrative, and
operational controls required by the
Federal Information Security
Management Act of 2002 (FISMA) and
the 2010 National Institute of Standards
and Technology (NIST) Recommended
Security Controls for Federal
Information Systems and Organizations.
Weekly tables of nationally notifiable
diseases are available through CDC
WONDER and data.cdc.gov. Annual
summaries of finalized nationally
notifiable disease data are published on
CDC WONDER and data.cdc.gov and
disease-specific data are published by
individual CDC programs.
The burden estimates include the
number of hours that the public health
department uses to process and send
case notification data from their
jurisdiction to CDC. Specifically, the
burden estimates include separate
burden hours incurred for automated
and non-automated transmissions,
separate weekly burden hours incurred
for modernizing surveillance systems as
part of NNDSS Modernization Initiative
(NMI) implementation, separate burden
hours incurred for annual data
reconciliation and submission, and
separate one-time burden hours
incurred for the addition of new
diseases and data elements. The burden
estimates also include the one-time
burden for reporting jurisdictions for the
addition of case notification data for
CP–CRE and C. auris and diseasespecific data elements for CP–CRE. The
estimated annual burden for the 233
respondents is 18,619 hours. The cost of
the information collection is $787,846.
The total burden hours increased from
18,529 to 18,619 since the last revision
because of the addition of diseases and
disease-specific data elements.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
States
States
States
States
States
................................................
................................................
................................................
................................................
................................................
Territories
Territories
Territories
Territories
Territories
..........................................
..........................................
..........................................
..........................................
..........................................
Freely Associated States ..................
Freely Associated States ..................
Number of
responses per
respondent
Number of
respondents
Form name
Weekly (Automated) .........................
Weekly (Non-Automated) .................
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly (Automated) .........................
Weekly, Quarterly (Non-Automated)
Weekly (NMI Implementation) ..........
Annual ..............................................
One-time Addition of Diseases and
Data Elements.
Weekly, Quarterly (Non-Automated)
Annual ..............................................
52
52
52
1
1
20/60
2
4
75
10
867
1,040
10,400
3,750
485
1
5
5
5
1
52
56
52
1
1
20/60
20/60
4
5
10/60
17
93
1,040
25
1
3
3
56
1
20/60
5
56
15
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–12637 Filed 6–12–18; 8:45 am]
Medical Product Communications That
Are Consistent With the Food and
Drug Administration-Required
Labeling—Questions and Answers;
Guidance for Industry; Availability
amozie on DSK3GDR082PROD with NOTICES1
Food and Drug Administration
[Docket No. FDA–2016–D–2285]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Total
burden
(in hours)
50
10
50
50
50
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
BILLING CODE 4163–18–P
Average
burden per
response
(in hours)
announcing the availability of a
guidance for industry entitled ‘‘Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling—Questions and Answers.’’
This guidance provides information for
manufacturers, packers, and distributors
and their representatives (collectively
‘‘firms’’) of drugs and medical devices
for humans, including those that are
licensed as biological products, and
animal drugs (collectively ‘‘medical
products’’), about how FDA evaluates
their medical product communications
that present information that is not
contained in the FDA-required labeling
for the product but that may be
E:\FR\FM\13JNN1.SGM
13JNN1
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
consistent with the FDA-required
labeling for the product. The Agency is
issuing this guidance to explain FDA’s
current thinking on commonly asked
questions regarding such
communications to provide clarity for
firms. FDA is also 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: The announcement of the
guidance is published in the Federal
Register on June 13, 2018. Submit
written comments on the collection of
information by July 13, 2018.
ADDRESSES: To ensure comments on the
information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Recommended Content of Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling—Questions and Answers;
Guidance for Industry.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
You may submit either electronic or
written comments on Agency guidances
at any time as follows:
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
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
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–
2016–D–2285 for ‘‘Medical Product
Communications That Are Consistent
With the FDA-Required Labeling—
Questions and Answers; Guidance for
Industry; Availability.’’ Received
comments 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
27603
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002;
Division of Small Manufacturers,
International and Consumer Assistance,
Office of Communication, Education
and Radiation Programs, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993–0002; or to
Policy and Regulations Staff (HFV–6),
Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Kristin Davis,
Office of Policy, Office of the
Commissioner, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4252, Silver Spring,
MD 20993–0002, 301–796–0418; or
Elizabeth Pepinsky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3248,
Silver Spring, MD 20993–0002, 301–
796–1200; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911; or Ana Loloei Marsal,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5452, Silver Spring, MD 20993–
0002, 301–796–8774; or Thomas
Moskal, Center for Veterinary Medicine,
Food and Drug Administration, 7519
E:\FR\FM\13JNN1.SGM
13JNN1
27604
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
Standish Pl. (HFV–216), Rockville, MD
20855, 240–402–6251.
Regarding the information collection:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 11601 Landsdown
St., 10A–12M, North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
amozie on DSK3GDR082PROD with NOTICES1
FDA is announcing the availability of
a guidance for industry entitled
‘‘Medical Product Communications That
Are Consistent With the FDA-Required
Labeling—Questions and Answers.’’
This guidance provides information for
firms about how FDA evaluates their
medical product communications (that
fall within the scope of FDA’s regulatory
authority) that present information that
is not contained in the FDA-required
labeling 1 for the product but that may
be consistent with the FDA-required
labeling for the product.
FDA determines whether a medical
product is safe and effective for use
under the conditions prescribed,
recommended, or suggested in the
proposed labeling submitted with the
product’s marketing application or
submission (and for devices, also during
the classification process). In making
this determination, FDA evaluates
whether the conditions of use in the
proposed labeling are supported by the
required levels and types of evidence of
safety and effectiveness and whether the
benefits of using the product under
those specific conditions of use
outweigh the risks of the product. After
FDA approves, clears, or licenses a
medical product, the FDA-required
labeling sets forth the conditions of use
under which the product has been
shown to meet the relevant standard for
marketing, and it provides directions
and information on how to use the
product safely and effectively under
those conditions.
Medical product firms have told FDA
that they are interested in
communicating, including in their
promotional materials, data and
information about the approved/
cleared/licensed uses of their products
that are not contained in their products’
1 As used in the guidance, the term FDA-required
labeling includes the labeling reviewed and
approved by FDA as part of the medical product
marketing application review process. For products
not subject to premarket approval, but instead
subject to premarket notification (510(k))
requirements or exempt from premarket review, the
term FDA-required labeling includes the labeling
that provides adequate directions for use and other
information required to appear on the label or in
labeling.
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
FDA-required labeling. We are aware
that firms have questions about how
FDA determines whether such
communications are consistent with the
FDA-required labeling.
The guidance describes FDA’s
thinking when examining the
consistency of a firm’s product
communications with that product’s
own FDA-required labeling. As
explained in the guidance, if a firm
communicates information that is not
contained in its product’s FDA-required
labeling but that is determined to be
consistent with the FDA-required
labeling, FDA does not intend to rely on
that communication to establish a new
intended use, different from the use(s)
for which the product is legally
marketed. Establishing a product’s
intended uses is an element in
establishing certain violations under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and Public Health Service
Act. However, firms’ communications
about their products that are consistent
with the products’ FDA-required
labeling but that are false or misleading
may subject a firm to enforcement
action under the FD&C Act. Thus, the
guidance not only describes FDA’s
thinking on communications that are
consistent with the FDA-required
labeling, but also provides general
recommendations intended to aid firms
in complying with requirements in the
FD&C Act and FDA’s implementing
regulations for conveying information
that is consistent with the FDA-required
labeling in a truthful and nonmisleading way. The general
recommendations provided in the
guidance for conveying information in a
truthful and non-misleading way are
applicable only to drug and device
labeling and prescription drug and
restricted device advertising that are
consistent with the FDA-required
labeling. Communication of information
that is not consistent with the FDArequired labeling is outside the scope of
these recommendations.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on firms’
communications for their medical
products that may be consistent with
the FDA-required labeling. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
II. Paperwork Reduction Act of 1995
In compliance with 44 U.S.C. 3507,
FDA has submitted the following
proposed collection for OMB review
and clearance.
Title: Recommended Content of
Medical Product Communications That
Are Consistent With the FDA-Required
Labeling; OMB Control No. 0910—NEW.
The guidance includes third-party
disclosure recommendations regarding
information that firms should include in
communications that contain
information not found in the FDArequired labeling for their medical
products but that are consistent with the
FDA-required labeling (as explained in
the guidance) if they choose to publicly
disseminate such materials. The
guidance recommends that various
aspects of study design and
methodology for studies relied on in
such communications be disclosed to
provide material contextual information
(e.g., type of study, study objectives,
product dosage/use regimens, control(s)
used, patient population studied), and
that material limitations related to the
study design, methodology, and results
also be disclosed in a clear and
prominent manner to help ensure that
the communications are not false or
misleading. Additionally, the guidance
recommends that firms accurately
characterize and contextualize the
relevant information about the product,
including by disclosing unfavorable or
inconsistent findings. Finally, the
guidance recommends that firms
disclose material contextual information
from the FDA-required labeling in these
communications, such as data and
information from studies in the FDArequired labeling that are relevant to the
data or information presented in the
communication (e.g., if a
communication provides post-market
information about the types and rates of
occurrence of adverse events that have
been observed in practice, the
communication should also include
information from the FDA-required
labeling about the types and rates of
occurrence of adverse reactions
observed in clinical trials to provide
context).
In the Federal Register of January 19,
2017 (82 FR 6575), we published a
notice announcing the availability of the
draft guidance document and included
an analysis under the PRA of the
information collection burden
associated with our recommendations.
No comments were received in response
to the four information collection topics
solicited in the notice.
According to FDA data,
approximately 162,000 FDA-regulated
E:\FR\FM\13JNN1.SGM
13JNN1
27605
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
promotional materials are prepared by
approximately 500 firms annually. Of
these materials, we estimate
approximately 5 percent contain unique
presentations of information consistent
with FDA-required labeling, as
described in the guidance, submitted by
approximately 64 percent (or 324) of the
firms. Anticipating that the number of
these FDA-regulated promotional
materials will soon increase to 6
percent, we estimate the 324 firms will
prepare and disseminate annually 9,720
FDA-regulated promotional materials
that contain unique presentations of
information that is consistent with the
FDA-required labeling, as described in
the guidance, and that therefore are
recommended to include the proposed
third party disclosures. Based on our
experience reviewing FDA-regulated
promotional materials for medical
products, we estimate it will take
respondents approximately 4 hours per
unique presentation to prepare and
incorporate the disclosures
recommended in the guidance, if they
choose to disseminate this information.
We therefore estimate the burden of
the information collection as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of information
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours
Recommended information to be included when firms
choose to disseminate communications that are consistent with the FDA-required labeling .............................
324
30
9,720
4
38,880
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA is issuing this final guidance
subject to OMB approval of the
collection of information. Before
implementing the information
collection provisions of the guidance,
FDA will publish a notice in the Federal
Register announcing OMB’s decision to
approve, modify, or disapprove the
collection of information, including
OMB control number(s) for newly
approved collections.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Electronic Access
AGENCY:
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
https://www.regulations.gov.
ACTION:
[FR Doc. 2018–12631 Filed 6–12–18; 8:45 am]
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
18:01 Jun 12, 2018
[Docket No. FDA–2016–D–1307]
Drug and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities—Questions and Answers;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
VerDate Sep<11>2014
Food and Drug Administration
Jkt 244001
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Drug
and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities—Questions and Answers.’’ This
guidance provides answers to common
questions regarding the communication
of health care economic information (d)
about approved prescription drugs and
approved or cleared medical devices by
medical product manufacturers,
packers, distributers, and their
representatives (firms) to payors,
formulary committees, or other similar
entities with knowledge and expertise
in the area of health care economic
analysis (collectively referred to as
payors). This guidance also provides
answers to common questions about
both firms’ dissemination of information
to payors about medical products that
are not yet approved or cleared for any
use and firms’ dissemination of
information to payors about unapproved
uses of approved or cleared medical
products. The Agency is issuing this
guidance to explain FDA’s current
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
thinking on frequently asked questions
regarding these topics in order to
provide clarity for firms and payors.
FDA is also 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: The announcement of the
guidance is published in the Federal
Register on June 13, 2018. Submit
written comments on the collection of
information by July 13, 2018.
ADDRESSES: To ensure comments on the
information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-New and
title ‘‘Recommendations for Drug and
Device Manufacturer Communications
With Payors, Formulary Committees,
and Similar Entities.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
You may submit either electronic or
written comments on Agency guidances
at any time as follows:
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
E:\FR\FM\13JNN1.SGM
13JNN1
]]>Agencies
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27602-27605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12631]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2285]
Medical Product Communications That Are Consistent With the Food
and Drug Administration-Required Labeling--Questions and Answers;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Medical Product
Communications That Are Consistent With the FDA-Required Labeling--
Questions and Answers.'' This guidance provides information for
manufacturers, packers, and distributors and their representatives
(collectively ``firms'') of drugs and medical devices for humans,
including those that are licensed as biological products, and animal
drugs (collectively ``medical products''), about how FDA evaluates
their medical product communications that present information that is
not contained in the FDA-required labeling for the product but that may
be
[[Page 27603]]
consistent with the FDA-required labeling for the product. The Agency
is issuing this guidance to explain FDA's current thinking on commonly
asked questions regarding such communications to provide clarity for
firms. FDA is also 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: The announcement of the guidance is published in the Federal
Register on June 13, 2018. Submit written comments on the collection of
information by July 13, 2018.
ADDRESSES: To ensure comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Recommended Content of Medical Product Communications That Are
Consistent With the FDA-Required Labeling--Questions and Answers;
Guidance for Industry.'' Also include the FDA docket number found in
brackets in the heading of this document.
You may submit either electronic or written comments on Agency
guidances at any time as follows:
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 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-2016-D-2285 for ``Medical Product Communications That Are
Consistent With the FDA-Required Labeling--Questions and Answers;
Guidance for Industry; Availability.'' Received comments 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.
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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
Division of Small Manufacturers, International and Consumer Assistance,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002;
or to Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Kristin Davis, Office of Policy, Office of
the Commissioner, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver
Spring, MD 20993-0002, 301-796-0418; or Elizabeth Pepinsky, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301-
796-1200; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; or Ana Loloei
Marsal, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver
Spring, MD 20993-0002, 301-796-8774; or Thomas Moskal, Center for
Veterinary Medicine, Food and Drug Administration, 7519
[[Page 27604]]
Standish Pl. (HFV-216), Rockville, MD 20855, 240-402-6251.
Regarding the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North,
11601 Landsdown St., 10A-12M, North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Medical Product Communications That Are Consistent With the
FDA-Required Labeling--Questions and Answers.'' This guidance provides
information for firms about how FDA evaluates their medical product
communications (that fall within the scope of FDA's regulatory
authority) that present information that is not contained in the FDA-
required labeling \1\ for the product but that may be consistent with
the FDA-required labeling for the product.
---------------------------------------------------------------------------
\1\ As used in the guidance, the term FDA-required labeling
includes the labeling reviewed and approved by FDA as part of the
medical product marketing application review process. For products
not subject to premarket approval, but instead subject to premarket
notification (510(k)) requirements or exempt from premarket review,
the term FDA-required labeling includes the labeling that provides
adequate directions for use and other information required to appear
on the label or in labeling.
---------------------------------------------------------------------------
FDA determines whether a medical product is safe and effective for
use under the conditions prescribed, recommended, or suggested in the
proposed labeling submitted with the product's marketing application or
submission (and for devices, also during the classification process).
In making this determination, FDA evaluates whether the conditions of
use in the proposed labeling are supported by the required levels and
types of evidence of safety and effectiveness and whether the benefits
of using the product under those specific conditions of use outweigh
the risks of the product. After FDA approves, clears, or licenses a
medical product, the FDA-required labeling sets forth the conditions of
use under which the product has been shown to meet the relevant
standard for marketing, and it provides directions and information on
how to use the product safely and effectively under those conditions.
Medical product firms have told FDA that they are interested in
communicating, including in their promotional materials, data and
information about the approved/cleared/licensed uses of their products
that are not contained in their products' FDA-required labeling. We are
aware that firms have questions about how FDA determines whether such
communications are consistent with the FDA-required labeling.
The guidance describes FDA's thinking when examining the
consistency of a firm's product communications with that product's own
FDA-required labeling. As explained in the guidance, if a firm
communicates information that is not contained in its product's FDA-
required labeling but that is determined to be consistent with the FDA-
required labeling, FDA does not intend to rely on that communication to
establish a new intended use, different from the use(s) for which the
product is legally marketed. Establishing a product's intended uses is
an element in establishing certain violations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and Public Health Service Act.
However, firms' communications about their products that are consistent
with the products' FDA-required labeling but that are false or
misleading may subject a firm to enforcement action under the FD&C Act.
Thus, the guidance not only describes FDA's thinking on communications
that are consistent with the FDA-required labeling, but also provides
general recommendations intended to aid firms in complying with
requirements in the FD&C Act and FDA's implementing regulations for
conveying information that is consistent with the FDA-required labeling
in a truthful and non-misleading way. The general recommendations
provided in the guidance for conveying information in a truthful and
non-misleading way are applicable only to drug and device labeling and
prescription drug and restricted device advertising that are consistent
with the FDA-required labeling. Communication of information that is
not consistent with the FDA-required labeling is outside the scope of
these recommendations.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on firms' communications for their medical
products that may be consistent with the FDA-required labeling. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
In compliance with 44 U.S.C. 3507, FDA has submitted the following
proposed collection for OMB review and clearance.
Title: Recommended Content of Medical Product Communications That
Are Consistent With the FDA-Required Labeling; OMB Control No. 0910--
NEW.
The guidance includes third-party disclosure recommendations
regarding information that firms should include in communications that
contain information not found in the FDA-required labeling for their
medical products but that are consistent with the FDA-required labeling
(as explained in the guidance) if they choose to publicly disseminate
such materials. The guidance recommends that various aspects of study
design and methodology for studies relied on in such communications be
disclosed to provide material contextual information (e.g., type of
study, study objectives, product dosage/use regimens, control(s) used,
patient population studied), and that material limitations related to
the study design, methodology, and results also be disclosed in a clear
and prominent manner to help ensure that the communications are not
false or misleading. Additionally, the guidance recommends that firms
accurately characterize and contextualize the relevant information
about the product, including by disclosing unfavorable or inconsistent
findings. Finally, the guidance recommends that firms disclose material
contextual information from the FDA-required labeling in these
communications, such as data and information from studies in the FDA-
required labeling that are relevant to the data or information
presented in the communication (e.g., if a communication provides post-
market information about the types and rates of occurrence of adverse
events that have been observed in practice, the communication should
also include information from the FDA-required labeling about the types
and rates of occurrence of adverse reactions observed in clinical
trials to provide context).
In the Federal Register of January 19, 2017 (82 FR 6575), we
published a notice announcing the availability of the draft guidance
document and included an analysis under the PRA of the information
collection burden associated with our recommendations. No comments were
received in response to the four information collection topics
solicited in the notice.
According to FDA data, approximately 162,000 FDA-regulated
[[Page 27605]]
promotional materials are prepared by approximately 500 firms annually.
Of these materials, we estimate approximately 5 percent contain unique
presentations of information consistent with FDA-required labeling, as
described in the guidance, submitted by approximately 64 percent (or
324) of the firms. Anticipating that the number of these FDA-regulated
promotional materials will soon increase to 6 percent, we estimate the
324 firms will prepare and disseminate annually 9,720 FDA-regulated
promotional materials that contain unique presentations of information
that is consistent with the FDA-required labeling, as described in the
guidance, and that therefore are recommended to include the proposed
third party disclosures. Based on our experience reviewing FDA-
regulated promotional materials for medical products, we estimate it
will take respondents approximately 4 hours per unique presentation to
prepare and incorporate the disclosures recommended in the guidance, if
they choose to disseminate this information.
We therefore estimate the burden of the information collection as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of information Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms choose to 324 30 9,720 4 38,880
disseminate communications that are consistent with the FDA-
required labeling.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA is issuing this final guidance subject to OMB approval of the
collection of information. Before implementing the information
collection provisions of the guidance, FDA will publish a notice in the
Federal Register announcing OMB's decision to approve, modify, or
disapprove the collection of information, including OMB control
number(s) for newly approved collections.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12631 Filed 6-12-18; 8:45 am]
BILLING CODE 4164-01-P
