Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Content of Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling and Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, 24868-24871 [2021-09809]
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24868
Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA).
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the PRA (44
U.S.C. 3507). The OMB control number
and expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Applications for FDA Approval to Market a New Drug ...........................................................................................
Medical Devices; Humanitarian Use Devices .........................................................................................................
Medical Devices; Device Tracking ..........................................................................................................................
Dispute Resolution Procedures for Science Based Decision on Products Regulated by CVM .............................
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based
In Vitro Diagnostics ..............................................................................................................................................
Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion .........................................
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09811 Filed 5–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–N–0387]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recommended
Content of Medical Product
Communications That Are Consistent
With the Food and Drug
Administration-Required Labeling and
Recommendations for Drug and
Device Manufacturer Communications
With Payors, Formulary Committees,
and Similar Entities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
solicits comments on the information
collection associated with
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SUMMARY:
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recommended content of medical
product communications that are
consistent with the FDA-required
labeling and recommendations for drug
and device manufacturer
communications with payors, formulary
committees, and similar entities.
DATES: Submit either electronic or
written comments on the collection of
information by July 9, 2021.
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 July 9, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 9, 2021. 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
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Date approval
expires
0910–0001
0910–0332
0910–0442
0910–0566
3/31/2024
3/31/2024
3/31/2024
3/31/2024
0910–0850
0910–0895
3/31/2024
3/31/2024
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–
2021–N–0387 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recommended Content of Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling and Recommendations for
Drug and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities.’’ 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
E:\FR\FM\10MYN1.SGM
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
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-201509-18/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:
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, PRAStaff@
fda.hhs.gov.
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
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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.
I. Medical Product Communications
That Are Consistent With the FDARequired Labeling—Questions and
Answers
OMB Control Number 0910–0856—
Extension
This information collection supports
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and FDA’s
implementing regulations that govern
drug and device labeling and
prescription drug and restricted device
advertising. The FD&C Act specifies that
a drug or device shall be deemed to be
misbranded if its labeling is false or
misleading in any particular (section
502(a) (21 U.S.C. 352(a)) and that
labeling may be considered misleading
if it fails to reveal material facts about
the product being promoted, including
facts that are material in light of the
representations made in a promotional
piece (section 201(n) (21 U.S.C. 321(n))).
Similarly, under sections 201(n) and
502(n) of the FD&C Act and FDA’s
implementing regulations (21 CFR
202.1(e)(5)(i) and (iii)), an advertisement
for a prescription drug must not be false
or misleading with respect to side
effects, contraindications, or
effectiveness, or fail to reveal material
facts about the product being advertised,
including facts that are material in light
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24869
of the representations made in a
promotional piece. The FD&C Act also
specifies that restricted device
advertisements must not be false or
misleading (section 502(q)(1)) and must
reveal facts that are material about the
product being advertised (section
201(n)).
To assist respondents with the
requirements drug and device labeling
and prescription drug and restricted
device advertising, we developed the
guidance for industry entitled ‘‘Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling—Questions and Answers’’
(June 2018) (medical product
communications guidance), available at
https://www.fda.gov/media/133619/
download. This medical product
communications guidance includes
recommendations that firms consider
when developing ‘‘consistent with the
FDA-required labeling (CFL)’’
presentations in their labeling and
advertising materials to help ensure the
presentations are not false or misleading
in violation of the FD&C Act and FDA’s
implementing regulations. The guidance
also 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 that is different from the
use or uses for which the product is
legally marketed. Establishing a
product’s intended uses is an element in
establishing certain violations under the
FD&C Act and Public Health Service
Act. 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 help firms comply 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
medical product communications
guidance recommends that firms
accurately represent in the
communications any study results or
other data and information that are
relied upon to support a firm’s CFL
promotional communication. Other
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recommendations include the clear and
prominent disclosure of aspects of study
design and methodology that are
material for audiences to accurately
interpret the information being
presented (e.g., type of study, study
objectives, product dosage and use
regimens, control or controls used,
patient population studied), as well as
material limitations related to the study
design, methodology, and results. Also,
the guidance recommends that firms
accurately characterize and
contextualize the relevant information
about the product, including by
disclosing unfavorable or inconsistent
findings. In addition, the guidance
recommends that firms disclose material
contextual information from the FDArequired 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
CFL promotional communication.
The recommendations will help
ensure that health care professional and
consumer audiences receive truthful
information about the benefits and risks
of drugs and devices in firms’ CFL
promotional communications and that
material contextual information is
included in these communications so
that audiences are not misled. Accurate
information helps these audiences know
whether drugs or devices may be
appropriate for them or their patients
and know what they can expect to
experience when prescribing or using
these products.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Information collection activity
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.
Since our last request for OMB
approval, we have made no adjustments
to the currently approved burden
estimate.
II. Recommendations for Drug and
Device Manufacturer Communications
With Payors, Formulary Committees,
and Similar Entities
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OMB Control Number 0910–0857—
Extension
This information collection also
supports implementation of section
502(a) of the FD&C Act and applicable
Agency regulations. Section 502(a)(1) of
the FD&C Act provides that a drug or
device is deemed to be misbranded ‘‘[i]f
its labeling is false or misleading in any
particular.’’ Under longstanding FDA
practice and FDA’s statute and
regulations, and under case law,
labeling encompasses more than merely
the label of the drug, but extends to
other written, printed, or graphic matter
‘‘accompanying such article’’ (section
201(m) of the FD&C Act; see also 21 CFR
1.3(a)). Section 502(a) also includes a
provision about communication of
health care economic information
(HCEI) to payors through labeling or
advertising. To assist respondents in
this regard, we developed the guidance
for industry and review staff entitled
‘‘Drug and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities—Questions and Answers’’ (June
2018) (drug and device communications
guidance), available at https://
www.fda.gov/media/133620/download.
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This drug and device communications
guidance includes recommendations
regarding information firms should
include in HCEI for prescription drugs
if they choose to disseminate such
materials (HCEI materials) to payors, in
accordance with section 502(a) of the
FD&C Act. Specifically, if a
manufacturer communicates HCEI for
approved prescription drugs (including
biological products that also meet the
definition of drug under the FD&C Act
and approved or cleared medical
devices (collectively referred to as
medical products)) to payors, FDA
recommends that firms include in HCEI
materials disseminated to payors
information about: (1) Various aspects of
study design and methodology of an
economic analysis (i.e., type of analysis,
modeling technique, patient population,
perspective or viewpoint, treatment
comparator, time horizon, outcome
measures, cost estimates, and
assumptions); (2) factors that limit
generalizability of an economic analysis;
limitations to an economic analysis; and
(3) sensitivity analyses, if applicable, to
allow for informed decision making by
payors.
Furthermore, FDA recommends that
firms include other information when
disseminating HCEI materials, as
applicable, to provide a balanced and
complete presentation. Such
information includes a statement of the
FDA-approved indication of the drug
and a copy of the most current FDAapproved labeling. Under section 502(a)
of the FD&C Act, firms must also
include a conspicuous and prominent
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statement to describe any material
differences between the HCEI and the
FDA-approved labeling. HCEI materials
should also disclose whether certain
studies or data sources were omitted
from an economic analysis and how the
omission of those studies or data
sources may alter the conclusions
presented in the analysis. Moreover,
FDA recommends that HCEI materials
disclose important risk information
associated with the approved use of the
drug, and pursuant to section 502(a) of
the FD&C Act, HCEI materials must
disclose any additional risk information
related to assumptions that vary from
the approved labeling. In addition, HCEI
materials should disclose potential
financial or affiliation biases to the
extent reasonably known by firms at the
time of dissemination.
The drug and device communications
guidance provides similar
recommendations for HCEI materials
disseminated to payors about approved
or cleared devices.
If firms choose to make
communications to payors about
unapproved products or unapproved
uses of approved or cleared products,
FDA recommends that firms include a
clear statement with their
communications that the product or use
is not approved or cleared and that the
safety or effectiveness of the product or
use has not been established.
We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Information collection activity
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved prescription drugs .............................................
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved or cleared devices ............................................
Recommended information to be included when firms
choose to disseminate information about unapproved
products or unapproved uses of approved or cleared
products ............................................................................
Average
burden per
response
Total annual
responses
Total hours
430
10.465
4,500
20
90,000
236
10
2,360
20
47,200
717
2
1,434
0.5
(30 minutes)
717
Follow-up information to payors regarding previously communicated information about unapproved products or
unapproved uses of approved or cleared products .........
359
2
718
2
1,436
Total ..............................................................................
........................
........................
9,012
........................
139,353
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
collection associated with drug
establishment registration and product
listing requirements.
We have adjusted the estimate of
burden we associate with the
information collection
recommendations in the guidance to
reflect an increase of 2,000 hours and
100 responses annually.
Submit either electronic or
written comments on the collection of
information by July 9, 2021.
DATES:
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09809 Filed 5–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA, we, 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
solicits comments on the information
SUMMARY:
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19:05 May 07, 2021
Jkt 253001
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 July 9, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 9, 2021. 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.
ADDRESSES:
Electronic Submissions
HHS.
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Number of
responses per
respondent
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
PO 00000
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Fmt 4703
Sfmt 4703
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–
2011–N–0742 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution.’’ 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
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]]>Agencies
[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24868-24871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-N-0387]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Recommended Content of Medical Product Communications
That Are Consistent With the Food and Drug Administration-Required
Labeling and Recommendations for Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar Entities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 solicits comments on the information collection associated with
recommended content of medical product communications that are
consistent with the FDA-required labeling and recommendations for drug
and device manufacturer communications with payors, formulary
committees, and similar entities.
DATES: Submit either electronic or written comments on the collection
of information by July 9, 2021.
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 July 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 9, 2021. 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 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-2021-N-0387 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recommended Content of Medical
Product Communications That Are Consistent With the FDA-Required
Labeling and Recommendations for Drug and Device Manufacturer
Communications With Payors, Formulary Committees, and Similar
Entities.'' 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
[[Page 24869]]
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: 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,
[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.
I. Medical Product Communications That Are Consistent With the FDA-
Required Labeling--Questions and Answers
OMB Control Number 0910-0856--Extension
This information collection supports the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and FDA's implementing regulations that govern
drug and device labeling and prescription drug and restricted device
advertising. The FD&C Act specifies that a drug or device shall be
deemed to be misbranded if its labeling is false or misleading in any
particular (section 502(a) (21 U.S.C. 352(a)) and that labeling may be
considered misleading if it fails to reveal material facts about the
product being promoted, including facts that are material in light of
the representations made in a promotional piece (section 201(n) (21
U.S.C. 321(n))). Similarly, under sections 201(n) and 502(n) of the
FD&C Act and FDA's implementing regulations (21 CFR 202.1(e)(5)(i) and
(iii)), an advertisement for a prescription drug must not be false or
misleading with respect to side effects, contraindications, or
effectiveness, or fail to reveal material facts about the product being
advertised, including facts that are material in light of the
representations made in a promotional piece. The FD&C Act also
specifies that restricted device advertisements must not be false or
misleading (section 502(q)(1)) and must reveal facts that are material
about the product being advertised (section 201(n)).
To assist respondents with the requirements drug and device
labeling and prescription drug and restricted device advertising, we
developed the guidance for industry entitled ``Medical Product
Communications That Are Consistent With the FDA-Required Labeling--
Questions and Answers'' (June 2018) (medical product communications
guidance), available at https://www.fda.gov/media/133619/download. This
medical product communications guidance includes recommendations that
firms consider when developing ``consistent with the FDA-required
labeling (CFL)'' presentations in their labeling and advertising
materials to help ensure the presentations are not false or misleading
in violation of the FD&C Act and FDA's implementing regulations. The
guidance also 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 that is different from the use or uses for which the product is
legally marketed. Establishing a product's intended uses is an element
in establishing certain violations under the FD&C Act and Public Health
Service Act. 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 help firms comply
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 medical product
communications guidance recommends that firms accurately represent in
the communications any study results or other data and information that
are relied upon to support a firm's CFL promotional communication.
Other
[[Page 24870]]
recommendations include the clear and prominent disclosure of aspects
of study design and methodology that are material for audiences to
accurately interpret the information being presented (e.g., type of
study, study objectives, product dosage and use regimens, control or
controls used, patient population studied), as well as material
limitations related to the study design, methodology, and results.
Also, the guidance recommends that firms accurately characterize and
contextualize the relevant information about the product, including by
disclosing unfavorable or inconsistent findings. In addition, 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 CFL promotional
communication.
The recommendations will help ensure that health care professional
and consumer audiences receive truthful information about the benefits
and risks of drugs and devices in firms' CFL promotional communications
and that material contextual information is included in these
communications so that audiences are not misled. Accurate information
helps these audiences know whether drugs or devices may be appropriate
for them or their patients and know what they can expect to experience
when prescribing or using these products.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity 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.
Since our last request for OMB approval, we have made no
adjustments to the currently approved burden estimate.
II. Recommendations for Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities
OMB Control Number 0910-0857--Extension
This information collection also supports implementation of section
502(a) of the FD&C Act and applicable Agency regulations. Section
502(a)(1) of the FD&C Act provides that a drug or device is deemed to
be misbranded ``[i]f its labeling is false or misleading in any
particular.'' Under longstanding FDA practice and FDA's statute and
regulations, and under case law, labeling encompasses more than merely
the label of the drug, but extends to other written, printed, or
graphic matter ``accompanying such article'' (section 201(m) of the
FD&C Act; see also 21 CFR 1.3(a)). Section 502(a) also includes a
provision about communication of health care economic information
(HCEI) to payors through labeling or advertising. To assist respondents
in this regard, we developed the guidance for industry and review staff
entitled ``Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities--Questions and Answers''
(June 2018) (drug and device communications guidance), available at
https://www.fda.gov/media/133620/download.
This drug and device communications guidance includes
recommendations regarding information firms should include in HCEI for
prescription drugs if they choose to disseminate such materials (HCEI
materials) to payors, in accordance with section 502(a) of the FD&C
Act. Specifically, if a manufacturer communicates HCEI for approved
prescription drugs (including biological products that also meet the
definition of drug under the FD&C Act and approved or cleared medical
devices (collectively referred to as medical products)) to payors, FDA
recommends that firms include in HCEI materials disseminated to payors
information about: (1) Various aspects of study design and methodology
of an economic analysis (i.e., type of analysis, modeling technique,
patient population, perspective or viewpoint, treatment comparator,
time horizon, outcome measures, cost estimates, and assumptions); (2)
factors that limit generalizability of an economic analysis;
limitations to an economic analysis; and (3) sensitivity analyses, if
applicable, to allow for informed decision making by payors.
Furthermore, FDA recommends that firms include other information
when disseminating HCEI materials, as applicable, to provide a balanced
and complete presentation. Such information includes a statement of the
FDA-approved indication of the drug and a copy of the most current FDA-
approved labeling. Under section 502(a) of the FD&C Act, firms must
also include a conspicuous and prominent statement to describe any
material differences between the HCEI and the FDA-approved labeling.
HCEI materials should also disclose whether certain studies or data
sources were omitted from an economic analysis and how the omission of
those studies or data sources may alter the conclusions presented in
the analysis. Moreover, FDA recommends that HCEI materials disclose
important risk information associated with the approved use of the
drug, and pursuant to section 502(a) of the FD&C Act, HCEI materials
must disclose any additional risk information related to assumptions
that vary from the approved labeling. In addition, HCEI materials
should disclose potential financial or affiliation biases to the extent
reasonably known by firms at the time of dissemination.
The drug and device communications guidance provides similar
recommendations for HCEI materials disseminated to payors about
approved or cleared devices.
If firms choose to make communications to payors about unapproved
products or unapproved uses of approved or cleared products, FDA
recommends that firms include a clear statement with their
communications that the product or use is not approved or cleared and
that the safety or effectiveness of the product or use has not been
established.
We estimate the burden of this collection of information as
follows:
[[Page 24871]]
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Recommended information to be 430 10.465 4,500 20 90,000
included when firms choose to
disseminate HCEI materials to
payors about approved
prescription drugs.............
Recommended information to be 236 10 2,360 20 47,200
included when firms choose to
disseminate HCEI materials to
payors about approved or
cleared devices................
Recommended information to be 717 2 1,434 0.5 717
included when firms choose to (30 minutes)
disseminate information about
unapproved products or
unapproved uses of approved or
cleared products...............
Follow-up information to payors 359 2 718 2 1,436
regarding previously
communicated information about
unapproved products or
unapproved uses of approved or
cleared products...............
-------------------------------------------------------------------------------
Total....................... .............. .............. 9,012 .............. 139,353
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have adjusted the estimate of burden we associate with the
information collection recommendations in the guidance to reflect an
increase of 2,000 hours and 100 responses annually.
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09809 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P
