Notice2021-15653
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
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Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is 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.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39035-39038]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15653]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0387]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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.
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SUMMARY: The Food and Drug Administration (FDA) is 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: Submit written comments (including recommendations) on the
collection of information by August 23, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control numbers for
the collections of information are 0910-0856 and 0910-0857. Also
include the FDA docket number found in brackets in the heading of this
document.
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,
<a href="/cdn-cgi/l/email-protection#b3e3e1f2e0c7d2d5d5f3d5d7d29ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="643436253710050202240200054a0c0c174a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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. Section 502(a) of the FD&C Act (21 U.S.C. 352(a))
specifies that a drug or device shall be deemed to be misbranded if its
labeling is false or
[[Page 39036]]
misleading in any particular, 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) of the FD&C
Act (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 drug and device labeling requirements
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 <a href="https://www.fda.gov/media/133619/download">https://www.fda.gov/media/133619/download</a>. 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 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.
In the Federal Register of May 10, 2021 (86 FR 24868), we published
a 60-day notice requesting public comment on the proposed collection of
information. Two comments were received; one appearing to question the
effectiveness of the information collection and the other offering its
support. Neither comment suggested FDA revise its estimate of the
attendant information collection.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Information collection activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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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.................................................
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\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,
[[Page 39037]]
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) of the FD&C Act 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 <a href="https://www.fda.gov/media/133620/download">https://www.fda.gov/media/133620/download</a>.
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.
In the Federal Register of May 10, 2021, we published a 60-day
notice requesting public comment on the proposed collection of
information. Two comments were received; one appearing to question the
effectiveness of the information collection and the other offering its
support. Neither comment suggested FDA revise its estimate of the
attendant information collection.
We estimate the burden of this collection of information as
follows:
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Information collection activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Recommended information to be included when 430 10.465 4,500 20....................................... 90,000
firms choose to disseminate HCEI materials
to payors about approved prescription drugs.
Recommended information to be included when 236 10 2,360 20....................................... 47,200
firms choose to disseminate HCEI materials
to payors about approved or cleared devices.
Recommended information to be included when 717 2 1,434 0.5 (30 minutes)......................... 717
firms choose to disseminate information
about unapproved products or unapproved uses
of approved or cleared products.
Followup information to payors regarding 359 2 718 2........................................ 1,436
previously communicated information about
unapproved products or unapproved uses of
approved or cleared products.
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Total.................................... .............. .............. 9,012 ......................................... 139,353
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 39038]]
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: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15653 Filed 7-22-21; 8:45 am]
BILLING CODE 4161-01-P
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