[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]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice 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, 
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 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\
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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, 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\
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                                                     Number of
 Information collection activity     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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...............
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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.

    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


