[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50888-50894]
[FR Doc No: 2021-19690]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1307]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Examination of
Secondary Claim Disclosures and Biosimilar Disclosures in Prescription
Drug Promotional Materials

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 October 13, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Examination of Secondary Claim Disclosures
and Biosimilar Disclosures in Prescription Drug Promotional
Materials.'' Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Examination of Secondary Claim Disclosures and Biosimilar Disclosures
in Prescription Drug Promotional Materials

OMB Control Number 0910-New

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the aspects of prescription drug
promotion that are most central to our mission. Our research focuses in
particular on three main topic areas: Advertising features, including
content and format; target populations; and research quality. Through
the evaluation of advertising features, we assess how elements such as
graphics, format, and disease and product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first two areas: Advertising features and target
populations.
    Because we recognize that the strength of data and the confidence
in the robust nature of the findings is improved by utilizing the
results of multiple converging studies, we continue to develop evidence
to inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our homepage,
which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey on direct-to-
consumer (DTC) advertisements conducted in 1999.
    The purpose of this research is to build on prior FDA research on
the topic of disclosures by examining the impact of disclosures of two
different types of information, detailed later in this notice. The
literature on disclosures suggests their effectiveness is subject to
format, design, and audience factors, among other things (Ref. 1). For
example, research on consumer attitudes has found some people believe
that FDA evaluates certain dietary supplement claims despite the
presence and consumer awareness of language required by the Dietary
Supplement Health and Education Act, which clearly states that FDA has
not evaluated those claims (Refs. 2 and 3). In the context of
prescription drug promotion, there is initial evidence that--when
noticed--disclosures may effectively convey important information
(Refs. 4 to 6); however, what role disclosures may play in educating or
correcting misunderstanding warrants further investigation.
    In the new study proposed here, the first type of disclosed
information we will examine is clinical benefit information based on a
secondary endpoint reported in a product's approved labeling (a
secondary claim). In some cases, truthful and non-misleading
presentations about secondary endpoints in well-designed clinical
studies can provide reliable information about treatment effects that
may be distinct from the treatment effects described in the product's
indication statement. For example, a product may be indicated to treat
a specific type of cancer based on a primary endpoint of survival.
However, a secondary endpoint in the study of that product may provide
data about an additional distinct benefit, such as functional status.
    Phase 1 of the proposed research will examine the impact of adding
a disclosure about a secondary claim in DTC and healthcare provider
(HCP)-directed promotion in the context of a prescription drug website.
We will also examine the effect of the presence of a comparative claim
about the secondary claim. Our proposed main outcome measures are
perceptions of and attitudes toward the product, the secondary claim,
and the disclosure. The pretest and main studies for Phase 1 will have
the same design, will be conducted online, and will follow the same
procedure. We will examine four levels of secondary claim disclosure to
explore the effects of disclosing that the secondary benefit is not one
of the indicated uses of the product (e.g., not a treatment for [the
secondary benefit

claim], quantitative information about claim, not a treatment for
[claim] and quantitative information about claim, or no disclosure),
and two levels (presence or absence) of a comparative element regarding
the secondary claim, for a total of eight experimental conditions (see
table 1). Participants will be randomly assigned to one of these
conditions; they will view one version of a website. This 4 x 2 design
will be replicated across two target populations (HCPs and consumers).

                                                              Table 1--Phase 1 Study Design
                        [Phase 1: Secondary Claim Disclosure by Comparative Secondary Claim in Online Prescription Drug Websites]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Secondary claim disclosure
                                                                         -------------------------------------------------------------------------------
                                                                                ``Drug X is not a
                                                                                ``In a clinical      treatment for
                                                                                trial,        [claim]'' AND ``In
                       Comparative secondary claim                         ``Drug X is not a     participants      a clinical trial,  None (no secondary
                                                                             treatment for       [quantitative       participants      claim disclosure)
                                                                               [claim]''        information] on      [quantitative
                                                                                Drug X''         information] on
                                                                                Drug X''
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCPs:
    Present: Compared to [xx] on Drug Y.................................
    Absent..............................................................
Consumers:
    Present: Compared to [xx] on Drug Y.................................
    Absent..............................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The second, independent phase of the proposed research will examine
disclosures about a biosimilar product. In both consumer and HCP
audiences, we will assess the impact of a disclosure designating the
product as a biosimilar as well as varying basic factual statements
about biosimilars. Phase 2 will examine the impact of: (1) Adding a
disclosure designating the product as a biosimilar; (2) adding general
informational statements about biosimilars; and (3) naming a reference
product. This approach allows us to examine the effect of disclosing
biosimilar status; examines the additive effect of including one, two,
or three additional basic statements of information about biosimilars;
and measures the effect of naming the reference product. Our proposed
main outcome measures are perceptions of and attitudes toward the
biosimilar product and the disclosure.
    We propose to examine seven different disclosure conditions plus a
control with no disclosure for a total of eight test conditions. As a
baseline, each of the seven disclosure conditions will include a
statement that the drug is a biosimilar. Six of the seven disclosure
conditions will include this baseline statement and will vary the
amount of additional basic factual information about biosimilar
products in the following way: (1) Two of the six conditions have the
baseline + statement A; (2), two of the six conditions have the
baseline + statement A + statement B; and (3) two of the six conditions
have the baseline + statement A + statement B + statement C. Moreover,
three of the six disclosure conditions will name the specific reference
product while the other three will refer to a reference product
generally (for example, ``This biosimilar is a biological product that
is highly similar to and has no clinically meaningful differences from
an existing FDA-approved reference product''). The wording of the
disclosure will be tailored to the audience; for example, the
disclosures for the consumer audience will avoid technical terms. A
control condition will also be included in which no biosimilar
statement or additional information disclosure is presented.
    The pretest and main studies for Phase 2 will have the same design,
will be conducted online, and will follow the same procedure. Both
phases will be conducted concurrently. Sample sizes were determined on
the basis of power analysis that will allow us to detect medium effect
sizes.
    In the Federal Register of July 7, 2020 (85 FR 40659), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received eight submissions. Three
submissions (regulations.gov tracking numbers 1k4-9hoh-uskf, 1k4-9itu-
fj33, and 1k4-9its-ko9f) were outside the scope of the research and are
not addressed further. Within the remaining five submissions, FDA
received multiple comments that the Agency has addressed below. For
brevity, some public comments are paraphrased and therefore may not
reflect the exact language used by the commenter. We assure commenters
that the entirety of their comments was considered, even if not fully
captured by our paraphrasing in this document. The following acronyms
are used here: HCP = healthcare provider; FDA and ``The Agency'' = Food
and Drug Administration; DTC = direct-to-consumer; OPDP = FDA's Office
of Prescription Drug Promotion.
    (Comment 1) Two comments were supportive of the study, and one
comment was supportive of the study's inclusion of both HCP and
consumer samples.
    (Response 1) We thank the commenters for their support of the
research.
    (Comment 2) One comment asserted that FDA has not made the stimuli
available for public comment.
    (Response 2) Our full stimuli are under development during the PRA
process. We do not make draft stimuli public during this time because
of concerns that this may contaminate our participant pool and
compromise our research. In our research proposals, we describe the
purpose of the study, the design, the population of interest, and the
estimated burden.
    (Comment 3) Two comments recommended FDA ensure the wording of the
stimuli in both phases is appropriate to each audience (HCP and
consumer), and one comment suggested FDA partner with a health literacy
organization.
    (Response 3) We assessed understanding of both the consumer and
provider versions of statements through in-depth cognitive interviews
and will also do so in our survey. Findings from our cognitive
interviews suggest that most consumers understood the gist of this
information, although they were not always familiar with some
terminology.

The stimuli in both phases use language appropriate to each sample and,
where possible, use plain language in the consumer versions for greater
clarity. We crafted the statements about biosimilars using terminology
from FDA's Biosimilar Basics Patient Materials (https://www.fda.gov/drugs/biosimilars/patient-materials). However, when examining
perceptions around complex concepts, such as biosimilars, plain
language substitutes for certain terms are not always available.
    (Comment 4) One comment suggested we measure diabetes and obesity
comorbidities of the Phase 1 consumer sample. One comment suggested we
restrict the Phase 2 sample to consumers who have rheumatoid arthritis
(RA), half of whom are being treated with a biologic for that
condition, and one comment suggested we only sample rheumatologists.
    (Response 4) In Phase 1 we are measuring participants' self-
reported diagnosis of type 2 diabetes, knowledge about the disease and
treatments for type 2 diabetes and weight loss, and prior experience
with type 2 diabetes and weight loss treatment. These will be used as
covariates in the analyses, where appropriate.
    With respect to the suggestion to limit the sample to diagnosed
consumers and rheumatologists in Phase 2, there are several factors to
consider. Diagnosed sample participants are likely to be more motivated
to read the ad because it is relevant to their medical condition. On
the other hand, participants in that sample are also more likely to be
familiar with treatments for their condition and bring with them prior
knowledge that may influence their responses. As in Phase 1, we will
assess treatment familiarity and diagnosis amongst our general
population sample and control for those variables. While we understand
that the Phase 2 topic may be relevant for specialists, and we do often
include specialists in our research, we chose not to limit our HCP
sample. Recruiting from a wider HCP sample is more reflective of the
reality of the healthcare environment where patients interact with HCPs
across multiple specialties and expertise. Further, specialists make up
a small proportion of HCPs, which makes them harder to recruit. In
2020, for example, the proportion of specialists representing each
specialty area ranged from 3 percent (endocrinologists) to 17 percent
(emergency medicine specialists) (Ref. 7). These data demonstrate that
the pool of potentially eligible specialists is limited.
    (Comment 5) One comment suggested we focus the study on patients
rather than HCPs, as the knowledge levels of patients is low, or
perhaps conduct separate but parallel studies of both HCPs and
patients.
    (Response 5) The study will be conducted among two separate
populations, consumers from the general population and HCPs. As shown
in table 1, the study design incorporates parallel arms for consumers
and HCPs.
    (Comment 6) One comment suggested FDA ensure a sufficient sample
size to conduct rigorous statistical analysis.
    (Response 6) We conducted a power analyses to determine the sample
size per study arm and will have a sufficient sample to rigorously test
our research questions.
    (Comment 7) Two comments suggested studying comparative claims in a
separate study to reduce participant burden and confusion.
    (Response 7) Our proposed design examines the impact of adding
comparative and quantitative information to the disclosure of interest
(see table 1). Each participant will see only one claim. Because these
variables are fully crossed in the design, we will be able to examine
the impact of comparative information and quantitative information
separately.
    (Comment 8) One comment asked FDA to explain the added value and
appropriateness of including disclosures in biosimilar product
promotional materials. The comment cautioned that disclosures must not
be couched in cautionary or negative terms or include statements that
are ambiguous or of minimal relevance to patients.
    (Response 8) Currently, FDA neither requires nor prohibits
biosimilar-related disclosures in biosimilar product promotion, and
this research does not presuppose or reflect any established FDA
position on their value. FDA is using this research to gather
information to assess how certain biosimilar product disclosures, if
they are used in promotion, could impact perceptions. Our study seeks
to test several variations of biosimilar statements. We specifically
examined potential negative reactions during in-depth cognitive
interviews. Participants in our interviews expressed that the language
was neutrally worded, and participants did not perceive the statements
to be negative or cautionary.
    (Comment 9) One comment questioned whether there was a control
group in the Phase 2 questionnaire and suggested a control group that
will not identify the product as a biosimilar be included.
    (Response 9) The Phase 2 study includes a control condition where
the promotional material does not identify the product as biosimilar.
    (Comment 10) One comment noted that the prescribing information for
a biosimilar does not include a named reference product and questioned
why FDA is mandating inclusion of a named reference product in
biosimilar promotional materials.
    (Response 10) Sponsors may choose to disseminate promotion in which
a comparator product is named. These comparative promotions exist in
the marketplace. One purpose of Phase 2 is to examine the difference
between a disclosure statement that includes a named comparator and one
that refers to a comparator generally. The fact that FDA is conducting
research that includes specific disclosures does not create a
requirement that sponsors use any of those disclosures or any other
requirement.
    (Comment 11) Two comments suggested concepts that should be
conveyed in the biosimilar disclosures. One comment stressed the
importance of the tone of the disclosure statement about biosimilars.
The following key messages were proposed for inclusion in the study:
    1. Patients can expect that biosimilars will provide the same
safety and effectiveness as the reference product.
    2. FDA has a rigorous review and approval process, applying the
same high-quality standards to both biosimilars and reference products.
    3. Patients have been benefitting from the use of biosimilars for
many years.
    The second comment suggested the study should also include an
examination of the impact of adding additional information about the
list of extrapolated indications, and the rationale for extrapolation
of indications to a biosimilar product to assess impact on HCP
perceptions.
    (Response 11) This study seeks to test several variations on
potential biosimilar statements but does not attempt to test all
possible statements. We decline to expand this study to test additional
content like that suggested by the comments, but other content may be
considered in future research. With regard to the comment about tone,
for the disclosure variations that we will test, we examined potential
negative reactions during in-depth cognitive interviews. Participants
in our interviews expressed that the language was neutrally worded, and
participants did not perceive the statements to be negative or
cautionary. An examination of how HCPs perceive a biosimilar based on
extrapolated indications is beyond the scope of this research. It may
be considered in future research.

    (Comment 12) One comment suggested Phase 1 and Phase 2 be converted
to separate studies.
    (Response 12) Phase 1 and Phase 2 are intended to be two separate
studies that are being examined concurrently for efficiency. We will
make this distinction clear in any discussion of results.
    (Comment 13) One comment recommended FDA narrow the scope of the
research to questions within its jurisdiction and eliminate overlap
with other ongoing research.
    (Response 13) As explained earlier, the Public Health Service Act
authorizes FDA to conduct research relating to health information, and
the FD&C Act authorizes FDA to conduct research relating to drugs and
other FDA regulated products in carrying out the provisions of the FD&C
Act. The study is within FDA's authority, and it will help to inform
OPDP's work to help ensure that prescription drug information is
truthful, balanced, and accurately communicated, so that HCPs and
consumers can make informed decisions. While the comment did not
identify any specific ongoing research as overlapping, we note that in
general, OPDP may conduct concurrent or overlapping studies on similar
topics to serve these goals.
    (Comment 14) One comment suggested participants be permitted to
refer back to the stimuli while answering questions.
    (Response 14) For this study we will instruct participants to read
the material carefully and alert them that they will be answering
several questions about the content that they just saw. The goal of
this study is not to assess participants' comprehension of detailed,
verbatim information in the stimuli, for which repeated exposures to
study stimuli may be more appropriate. Rather, our study will determine
if experimental manipulation of the disclosure language influences
``gist'' understanding of the information, attitudes, and perceptions
(Ref. 8). Allowing for multiple exposures to the stimuli could
potentially influence these outcomes. A large body of literature
supports presence of a ``mere exposure effects'' in social science
research, where more exposure enhances processing and increases
positive affect towards stimuli (Refs. 9 and 10).
    (Comment 15) One comment stated the research lacks practical
utility because it treats the secondary benefit claim as not related to
the product's indicated uses, and the comment recommends that FDA
revise Phase 1 of the study to reflect that secondary endpoints are not
inherently unapproved uses and to focus instead on comprehension of
what is a primary versus secondary endpoint in the data supporting a
drug's approval.
    (Response 15) In this study, we are not making a generalization
about the approval status of secondary endpoints. We are examining the
specific case of a disclosure about a secondary endpoint that, while it
may be related to the product's primary indication, is not in itself an
indication for the product and was not evaluated in such a way to
support the drawing of conclusions about the product's effect on that
endpoint. In this scenario, a disclosure about the secondary claim may
help the audience interpret the secondary claim and provide context.
The purpose of this study is to evaluate such disclosures about this
specific type of secondary claim and measure the impact on perceptions
of and attitudes toward the product, the secondary claim, and the
disclosure. For instance, we will vary such elements as the presence of
quantitative information about the secondary claim and the presence of
comparative information (see table 1 for full design). We note that
there are examples of prescription drug ads currently in use that
contain language similar to what we are evaluating in order to qualify
secondary endpoints, thus highlighting the practical utility of this
research.
    (Comment 16) One comment suggested changes to the instructions for
Phase 2 to state that the study is intended to ``assess your
understanding of and reactions to biosimilar biologic drug
disclosures.''
    (Response 16) The control condition does not identify the product
as biosimilar. To maintain the internal validity of the study and avoid
potentially biasing participants' responses, we will keep the
instructions as they are.
    (Comment 17) One comment suggested changing the dosage route and
strength of the reference product to be consistent with currently
marketed biologics.
    (Response 17) We have made this change.
    (Comment 18) Two comments asked that the name of the reference
product be changed to one that is fictitious.
    (Response 18) We have made this change and will use a fictitious
reference product name.
    (Comment 19) One comment suggested stratifying the sample on
several variables. The comment suggested that obesity and diabetes
diagnosis be considered specifically for Phase 1, as well as variables
like disease severity, treatment history (e.g., patients who have never
received a biologic versus biologic-experienced patients), and
knowledge of the studied condition for both phases.
    (Response 19) Typically, stratified randomization is used if there
are prognostic variables that correlate with outcome measures and
researchers are concerned about such factors not being evenly
distributed across groups (Ref. 11). We have no reason to believe that
we will not achieve adequate balance of prognostic variables given the
large sample size proposed for this study (Ref. 11). Random assignment
will help to produce groups that are, on average, probabilistically
similar to each other. Because randomization eliminates most other
sources of systematic variation, we can be reasonably confident that
any effect that is found is the result of the intervention and not some
preexisting differences between the groups (Ref. 12). Our survey
includes several questions about health and medical demographics that
will enable us to assess their association with our outcomes and
statistically control for them if necessary.
    (Comment 20) One comment suggested using consistent scales
throughout the study and adding ``based on the ad you just saw'' to
many of the questions.
    (Response 20) As suggested, we have added statements in the
instructions for respondents to answer based on the promotion they
``just saw'' for clarification. Where possible, we have used validated
measures and have retained the scale endpoints of those measures. We do
not believe that these varied types of questions will pose difficulties
for respondents as we did not find evidence of difficulties in
cognitive testing.
    (Comment 21) One comment suggested deleting or revising Phase 1
Questions 4 to 7 to focus on whether the participant understands that
the secondary use is linked to the approved primary indication.
    (Response 21) Our collection of constructs and measures, grounded
in behavioral theory (Refs. 1 to 3), assesses perceptions, attitudes,
understanding, and intentions around prescription drug disclosures.
Based on cognitive testing, we have removed these questions.
    (Comment 22) One comment suggested deleting Phase 1 Questions 9,
15, and 16 because they deal with the practice of medicine.
    (Response 22) The intent of Question 9 is to assess understanding
of the secondary claim disclosure, which explains that even though the
drug is not indicated for weight loss, that it can help some people
lose weight. Based on

cognitive testing, we have revised the question to more specifically
assess potential misperceptions of the claim; ``[drug name] is for
weight loss'' Questions 15 and 16 are intended to assess perceptions
about the magnitude of the drug's benefit--with regard to both the
indication (reduction in A1C levels) and the secondary claim (weight
loss)--based on the information in the website. Based on cognitive
testing, we have revised these questions to read ``How much do you
think [drug name] would lower A1C levels for patients with type 2
diabetes?'' and ``How much do you think [drug name] would help with
weight loss for patients with type 2 diabetes?'' It is a proper subject
for FDA research to study whether particular framing of statements
contributes to an HCP's accurate understanding or to misunderstanding
about drugs to inform their prescribing decisions in the course of
their practice of medicine.
    (Comment 23) One comment suggested deleting or clarifying Phase 1
Question 11 to refer to ``type 1 or type 2 diabetes'' rather than
``other health conditions.'' This comment also suggested revising Phase
1 Questions 12 to 16 to indicate they are focused on diabetic patients.
    (Response 23) We have deleted Question 11 and have revised the
other items to refer specifically to type 2 diabetes to improve
question clarity.
    (Comment 24) One comment suggested deleting or revising Phase 1
Question 10 to read ``[Drug X] is approved for helping people without
diabetes lose weight.''
    (Response 24) We have deleted this question.
    (Comment 25) One comment recommended deleting Phase 1 Questions 17
to 23 and Questions 35 to 38 because responses could be influenced by
many reasons and it is unclear how these questions relate to the study
objectives.
    (Response 25) These items measure perceived efficacy and attitude
toward the drug. Attitude toward the drug and perceived efficacy can
influence other outcomes such as the intention to take the drug or
mention it to the doctor. Thus, we believe it is important to assess
these variables. Given that we are randomizing participants to
experimental conditions, we suspect that differences between
experimental conditions are due to the experimental manipulations
rather than participants' background and experiences. Additionally, we
also included several variables to measure participants' experience
with diabetes and weight loss, as well as medications for these
conditions. If these variables are related to perceived efficacy and
attitude toward the drug, we plan to include them as covariates in
analyses.
    (Comment 26) One comment suggested deleting Phase 1 Questions 32 to
34 because these questions ask about perceived risks and side effects
that are not within the stated study objectives.
    (Response 26) The goal of the study is to examine the impact of the
presence of the comparative claim and type of disclosures; it is
possible for participants to form different (and potentially distorted)
risk perceptions based on the presence or absence of the comparative
claim or type of disclosure. Assessing this outcome will allow us to
determine whether risk perceptions vary based on exposure to study
manipulations.
    (Comment 27) One comment suggested deleting or revising Phase 2
Questions 4 to 11 and Questions 14 to 18 because participants will not
be able to evaluate the safety and efficacy of, or make decisions
about, their intended course of action related to the fictitious drug.
    (Response 27) The promotional material will include information on
primary and secondary endpoints as well as an important safety
information section. We acknowledge that in a clinical setting patients
and HCPs may use additional information. However, the intent of these
items is to understand whether exposure to different types of
information related to the comparative claim and disclosure results in
different comprehension or behavioral intention. All participants will
have the same level of information regarding the fictitious drug with
the only difference being the manipulated content. So, we would expect
that all participants will be equally informed about the fictitious
drug and differences between conditions could be attributed to the
manipulations. Items 4 to 11 assess participant comprehension of
promotional material.
    (Comment 28) One comment suggested deleting all Phase 2 questions
about the advertising statement, questions assessing participants'
understanding of how prescription drugs and biologic products work,
familiarity with similar treatments, and attitudes about pharmaceutical
companies; in particular, Questions 3, 27 to 30, and 36.
    (Response 28) The answers to these questions may help contextualize
differences between the experimental conditions. There is some evidence
that prior attitudes toward prescription drugs and pharmaceutical
companies have an impact on attitudes and perceptions of particular
prescription drugs and DTC ads (Ref. 13). Question 3 assesses attitudes
toward the disclosure. For instance, it is possible that participants
exposed to a certain disclosure may have more favorable attitudes
towards the drug because they viewed the disclosure as trustworthy.
Questions 27 to 30 and 36 will also help us contextualize the findings
by understanding participants' prior beliefs about prescription drugs,
biosimilars, and pharmaceutical companies that may influence their
responses and how they process the disclosure, in which case we would
include them as controls in our analyses.
    (Comment 29) One comment suggested moving Phase 2 Questions 27 to
38 to the beginning of the questionnaire, before the participant views
the stimuli.
    (Response 29) These questions are included to contextualize the
findings and obtain an understanding of participants' prior beliefs and
perceptions about biosimilars and more broadly prescription drug
promotion. We ask these questions after the main study outcomes are
assessed so that we do not contaminate participants' thoughts and
perceptions of the promotional material. In addition, we do not want to
prime the participants in the control condition (who are not told the
drug is a biosimilar) to think the drug is a biosimilar, which would be
equivalent to one of the other study conditions.
    (Comment 30) One comment suggested adding a response option to
capture a neutral or ``no reaction'' response to questions.
    (Response 30) There are benefits and drawbacks to including a
neutral or ``no reaction'' response in survey research, and the
decision to use a neutral mid-point depends on the goal of the
measures. For items assessing comprehension of disclosure language, we
include a ``do not know'' option as this response would indicate some
level of uncertainty about the meaning of the disclosure, which is
meaningful and actionable information. However, when assessing
perceptions and attitudes towards disclosures, our objective is to
force a selection and have participants choose a leaning towards
agreement or disagreement with the statement. Inclusion of a neutral
response option in these instances could potentially encourage
``satisficing''--cuing participants to select a neutral response under
uncertainty because it is offered (Ref. 14).
    (Comment 31) One comment suggested clarifying Phase 2 Question 28
to make clear it refers to the

approved uses of biosimilars, not health conditions generally.
    (Response 31) We have removed this item from our survey.
    (Comment 32) One comment suggested revising Phase 2 Question 18 to
ask about safety and efficacy separately because they may introduce
bias if located in the same items.
    (Response 32) We acknowledge safety and efficacy are separate
issues, and we assess beliefs about safety and efficacy separately in
Questions 5 to 8. However, because biosimilars have no clinically
meaningful differences in safety, purity, or potency (safety and
effectiveness) from their reference product, we are also interested in
the impact of the disclosure statement on participants' perceptions of
safety and efficacy as a whole. Given this, we do not believe this
question will introduce bias.
    (Comment 33) One comment suggested either deleting or revising
questions about the biosimilar disclosure to make clear what ``same
types of sources'' means.
    (Response 33) The wording of the biosimilar disclosure statement
was crafted using terminology from FDA's Biosimilar Basics Patient
Materials (https://www.fda.gov/drugs/biosimilars/patient-materials),
and we tested its meaning during our in-depth cognitive interviews.
Both the consumer and provider groups sufficiently understood this
statement.
    (Comment 34) One comment suggested only asking Phase 2 Question 17
of participants who are currently receiving a biologic.
    (Response 34) The intent of the question is to understand whether
participants would ask their doctor to switch their medication after
viewing the ad. We provided a hypothetical scenario and asked
participants to answer this question as if they were taking the
reference medication or another prescription medication to treat RA.
This question would not be feasible among only those with RA who are
receiving a biologic, given the prevalence of RA in the population
(i.e., 0.6 percent) as we only expect to have a few individuals
diagnosed with RA, if any.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    No. of
                   Activity                         No. of       responses per   Total annual         Average  burden per  response         Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Pretest screener (HCPs)...............             278               1             278  0.08 (5 minutes)........................           22.24
Study 1 Pretest screener (consumers)..........             278               1             278  0.08 (5 minutes)........................           22.24
Study 1 Pretest completes (HCPs)..............             139               1             139  0.33 (20 minutes).......................           45.87
Study 1 Pretest completes (consumers).........             139               1             139  0.33 (20 minutes).......................           45.87
Study 2 Pretest screener (HCPs)...............             476               1             476  0.08 (5 minutes)........................           38.08
Study 2 Pretest screener (consumers)..........             476               1             476  0.08 (5 minutes)........................           38.08
Study 2 Pretest completes (HCPs)..............             238               1             238  0.33 (20 minutes).......................           78.54
Study 2 Pretest completes (consumers).........             238               1             238  0.33 (20 minutes).......................           78.54
Study 1 Main study screener (HCPs)............             990               1             990  0.08 (5 minutes)........................            79.2
Study 1 Main study screener (consumers).......             990               1             990  0.08 (5 minutes)........................            79.2
Study 1 Main study completes (HCPs)...........             495               1             495  0.33 (20 minutes).......................          163.35
Study 1 Main study completes (consumers)......             495               1             495  0.33 (20 minutes).......................          163.35
Study 2 Main study screener (HCPs)............             792               1             792  0.08 (5 minutes)........................           63.36
Study 2 Main study screener (consumers).......             792               1             792  0.08 (5 minutes)........................           63.36
Study 2 Main study completes (HCPs)...........             396               1             396  0.33 (20 minutes).......................          130.68
Study 2 Main study completes (consumers)......             396               1             396  0.33 (20 minutes).......................          130.68
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................           7,608  ..............           7,608  ........................................           1,243
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Note: With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached.
  Those participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in
  mind, we have included an additional 10 percent over our target number of valid completes to account for some overage.

II. References

    The following references marked with an asterisk (*) are on display
with the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500 and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; these also are available
electronically at https://www.regulations.gov. References without
asterisks are not on public display at https://www.regulations.gov
because they have copyright restriction. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

1. Andrews, J.C. (2011). ``Warnings and Disclosures.'' In:
Communicating Risks and Benefits: An Evidence-Based User's Guide.
Fischhoff, B., N.T. Brewer, and J.S. Downs, (Eds). FDA: Silver
Spring, MD. pp. 149-161.
2. Russo France, K. and P. Fitzgerald Bone (2005). ``Policy Makers'
Paradigms and Evidence from Consumer Interpretations of Dietary
Supplement Labels.'' Journal of Consumer Affairs, 39(1), 27-51.
3. Mason, M.J. and D.L. Scammon (2011). ``Unintended Consequences of
Health Supplement Information Regulations: The Importance of
Recognizing Consumer Motivations.'' Journal of Consumer Affairs,
45(2), 201-223.
4. Betts, K.R., K.J. Aikin, V. Boudewyns, et al. (2017). ``Physician
Response to Contextualized Price-Comparison Claims in Prescription
Drug Advertising.'' Journal of Communication in Healthcare, 10(3),
195-204.
5. Betts, K.R., V. Boudewyns, K.J. Aikin, et al. (2018). ``Serious
and Actionable Risks, Plus Disclosure: Investigating an Alternative
Approach for Presenting Risk Information in Prescription Drug
Television Advertisements.'' Research in Social and Administrative
Pharmacy, 14(10), 951-963.
6. Sullivan, H.W., A.C. O'Donoghue, K.T. David, et al. (2018).
``Disclosing Accelerated Approval on
Direct[hyphen]To[hyphen]Consumer Prescription Drug websites.''
Pharmacoepidemiology and Drug Safety, 27(11), 1277-1280.
7. *Kaiser Family Foundation. (2020). Professionally Active
Specialist

Physicians by Field. Retrieved from https://www.kff.org/other/state-indicator/physicians-by-specialty-area.
8. Corbin, J.C., V.F. Reyna, R.B. Weldon, et al. (2015). ``How
Reasoning, Judgment, and Decision Making Are Colored by Gist-Based
Intuition: A Fuzzy-Trace Theory Approach.'' Journal of Applied
Research in Memory and Cognition, 4(4), 344-355. https://doi.org/10.1016/j.jarmac.2015.09.001.
9. Bornstein, R.F. (1989). ``Exposure and Affect: Overview and Meta-
Analysis of Research, 1968-1987.'' Psychological Bulletin, 106(2),
265.
10. Bornstein, R.F. and P.R. D'Agostino (1994). ``The Attribution
and Discounting of Perceptual Fluency: Preliminary Tests of a
Perceptual Fluency/Attributional Model of the Mere Exposure
Effect.'' Social Cognition, 12(2), 103-128.
11. Friedman, L.M., Furberg, C.D., and D.L. DeMets, Fundamentals of
Clinical Trials. 1998. Spring Science-Business Media, LLC: New York,
NY.
12. Fisher, R.A. (1937). The Design of Experiments. Edinburgh,
United Kingdom: Oliver and Boyd.
13. Hausman, A. (2008). ``Direct-To-Consumer Advertising and Its
Effect on Prescription Requests.'' Journal of Advertising Research,
48(1), 42-56.
14. Krosnick, J.A. (2018). ``Questionnaire Design.'' In The Palgrave
Handbook of Survey Research (pp. 439-455). Palgrave Macmillan, Cham.

    Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19690 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 182 (Thursday, September 19, 2013)]
[Notices]
[Pages 57677-57679]
[FR Doc No: 2013-22775]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-8398; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-
2005-20027; FMCSA-2005-20560]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
5 individuals. FMCSA has statutory authority to exempt individuals from
the vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemption renewals
will provide a level of safety that is equivalent to or greater than
the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

DATES: This decision is effective August 30, 2013. Comments must be
received on or before October 21, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: Docket No. [Docket No. FMCSA-2000-
8398; FMCSA-2001-9258; FMCSA-2003-14504; FMCSA-2005-20027; FMCSA-2005-
20560], using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 5 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 5 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

Edmund J. Barron (PA)
Darryl D. Cassatt (IA)
Roger K. Cox (NJ)
Myron D. Dixon (TX)
Thomas E. Howard (IN)

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provides a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file and retains a copy of the certification on his/her
person while driving for presentation to a duly authorized Federal,
State, or local enforcement official. Each exemption will be valid for
two years unless rescinded earlier by FMCSA. The exemption will be
rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 5 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 78256; 66 FR 16311; 66 FR 17743; 66 FR 33990; 68 FR
13360; 68 FR 19598; 68 FR 33570; 68 FR 35772; 70 FR 2701; 70 FR 16887;
70 FR 17504; 70 FR 25878; 70 FR 30997; 70 FR 33937; 70 FR 37891; 72 FR
27624; 72 FR 32705; 72 FR 34062; 74 FR 26464; 74 FR 26471; 76 FR 34133;
76 FR 34135). Each of these 5 applicants has requested renewal of the
exemption and has submitted evidence showing that the vision in the
better eye continues to meet the requirement specified at 49 CFR
391.41(b)(10) and that the vision impairment is stable. In addition, a
review of each record of safety while driving with the respective
vision deficiencies over the past two years indicates each applicant
continues to meet the vision exemption requirements. These factors
provide an adequate basis for predicting each driver's ability to
continue to drive safely in interstate commerce. Therefore, FMCSA
concludes that extending the exemption for each renewal applicant for a
period of two years is likely to achieve a level of safety equal to
that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a

particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by October 21, 2013.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 5 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: September 9, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-22775 Filed 9-18-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27449-27450]
[FR Doc No: 2021-10612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0406]

Frequently Asked Questions--Statement of Investigator (Form FDA
1572) (Revision 1); Draft Information Sheet Guidance for Sponsors,
Clinical Investigators, and Institutional Review Boards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft information sheet guidance for
sponsors, clinical investigators, and institutional review boards
(IRBs) entitled ``Frequently Asked Questions--Statement of Investigator
(Form FDA 1572) (Revision 1).'' This draft guidance partially revises
the final information sheet guidance for sponsors, clinical
investigators, and IRBs entitled ``Frequently Asked Questions--
Statement of Investigator (Form FDA 1572)'' (May 2010) (the Form FDA
1572 FAQ Guidance) to explain FDA's current thinking regarding waivers
of the signature requirement for Form FDA 1572. This draft guidance
proposes to revise responses to frequently asked questions 10, 11, and
13 from the Form FDA 1572 FAQ Guidance by including information
regarding the waiver of the Form FDA 1572 signature requirement and
proposes a new section regarding signature waivers.

DATES: Submit either electronic or written comments on the draft
guidance by July 19, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2008-D-0406 for ``Frequently Asked Questions--Statement of
Investigator (Form FDA 1572) (Revision 1).'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft 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; or the
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. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Paul Gouge, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 51, Rm. 6328, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft information sheet
guidance for sponsors, clinical investigators, and IRBs entitled
``Frequently Asked Questions--Statement of Investigator (Form FDA 1572)
(Revision 1).'' The draft guidance proposes to revise responses to the
following questions from the Form FDA 1572 FAQ Guidance:
     Question 10: Must investigators who conduct studies
outside the United States sign a 1572?
     Question 11: If a foreign clinical study is being
conducted under an IND [investigational new drug application], what are
the investigator's responsibilities with respect to regional, national,
or local laws and regulations?
     Question 13: If a sponsor chooses to conduct a foreign
clinical study under an IND and the investigators at the non-U.S. sites
follow the recommendations in the [International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use] ICH E6 Good Clinical Practice Consolidated Guidance, would the
non-U.S. investigators also be in compliance with FDA's IND
requirements under 21 CFR part 312?
    The above questions now include reference to the Form FDA 1572
waiver process. Further, the draft guidance proposes the addition of a
new section describing the Agency's current thinking regarding the Form
FDA 1572 signature waiver process. The new section is entitled
``Section #9: Form FDA 1572 Signature Waiver.'' This new section
outlines the process for submitting requests to FDA for waivers from
the Form FDA 1572 signature requirements when investigators cannot or
will not sign the Form FDA 1572 for clinical studies conducted in
foreign countries, and the sponsor wishes to conduct the study at the
foreign sites under an IND. The new section also provides information
regarding the documentation that may be included in the 1572 signature
waiver request.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). Based on the comments
received to the docket, we intend to revise the Form FDA 1572 FAQ
Guidance to amend our responses to questions (such as general questions
10, 11, and 13) from that document and to include a new section (see
questions 39 through 46 of the draft guidance) about waivers of the
Form FDA 1572 signature requirement, the subjects addressed in this
draft guidance. This draft guidance is not intended to be finalized as
a separate guidance document but will be consolidated with the Form FDA
1572 Guidance and issued as one comprehensive guidance. When finalized,
the consolidated guidance will represent the current thinking of FDA on
``Frequently Asked Questions--Statement of Investigator (Form FDA 1572)
(Revision 1).'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10612 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71621-71622]
[FR Doc No: 2022-25598]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC21-77-001.
    Applicants: FirstEnergy Corp.
    Description: FirstEnergy Corp. submits Notice of Non-Material
Change in Fact.
    Filed Date: 11/16/22.
    Accession Number: 20221116-5167.
    Comment Date: 5 p.m. ET 12/7/22.

    Docket Numbers: EC23-28-000.
    Applicants: Michigan Electric Transmission Company, LLC, ITC
Interconnection LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Michigan Electric Transmission Company,
LLC, et al.
    Filed Date: 11/16/22.
    Accession Number: 20221116-5186.
    Comment Date: 5 p.m. ET 12/7/22.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-24-000.
    Applicants: Oak Solar, LLC.
    Description: Oak Solar, LLC submits Notice of Self-Certification of
Exempt Wholesale Generator Request.
    Filed Date: 11/16/22.
    Accession Number: 20221116-5183.
    Comment Date: 5 p.m. ET 12/7/22.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1355-012.
    Applicants: Southern California Edison Company.
    Description: Errata to October 31, 2022, Notice of Change in Status
of Southern California Edison Company.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5123.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER21-762-001.
    Applicants: Bishop Hill Energy II LLC.
    Description: Midcontinent Independent System Operator, Inc. submits
tariff filing per 35.19a(b): Refund Report_Bishop Hill Energy II LLC to
be effective N/A.
    Filed Date: 11/16/22.

    Accession Number: 20221116-5165.
    Comment Date: 5 p.m. ET 12/7/22.

    Docket Numbers: ER21-2722-001.
    Applicants: E. BarreCo Corp LLC.
    Description: Refund Report: Second Revised Refund report to 2 to be
effective N/A.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5000.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER21-2816-000; ER21-2816-002; ER21-2816-003; ER21-
2816-001.
    Applicants: Gratiot County Wind LLC.
    Description: Midcontinent Independent System Operator, Inc. submits
tariff filing per 35.19a(b): Refund Report_Gratiot County Wind LLC to
be effective N/A.
    Filed Date: 11/16/22.
    Accession Number: 20221116-5166.
    Comment Date: 5 p.m. ET 12/7/22.

    Docket Numbers: ER23-48-000.
    Applicants: West Line Solar, LLC.
    Description: Supplement to October 11, 2022, West Line Solar, LLC
Application for Order Accepting Market-Based Rate under ER23-48.
    Filed Date: 11/15/22.
    Accession Number: 20221115-5225.
    Comment Date: 5 p.m. ET 11/25/22.

    Docket Numbers: ER23-114-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Capital Budget Quarterly
Filing for Third Quarter of 2022.
    Filed Date: 10/14/22.
    Accession Number: 20221014-5249.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-449-000.
    Applicants: Shenandoah Hills Wind Project, LLC.
    Description: Request for Prospective Tariff Waiver, et al. of
Shenandoah Hills Wind Project, LLC.
    Filed Date: 11/10/22.
    Accession Number: 20221110-5282.
    Comment Date: 5 p.m. ET 12/1/22.

    Docket Numbers: ER23-450-000.
    Applicants: Mercuria Energy America, LLC.
    Description: Compliance filing: Compliance filing 2022 to be
effective N/A.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5002.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-451-000.
    Applicants: TN Solar 1, LLC.
    Description: Baseline eTariff Filing: TN Solar 1 MBR Application to
be effective 11/18/2022.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5087.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-452-000.
    Applicants: EEC Skyhawk Lessee LLC.
    Description: Baseline eTariff Filing: EEC Skyhawk Lessee MBR
Application to be effective 12/31/9998.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5089.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-453-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, SA No.
5869; Queue No. AE2-126 (amend) to be effective 12/3/2020.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5116.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-454-000.
    Applicants: San Diego Gas & Electric Company.
    Description: TO5 Formula Depreciation Rate Change for Common Plant
and Electric General Plant of San Diego Gas & Electric Company.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5125.
    Comment Date: 5 p.m. ET 12/8/22.

    Docket Numbers: ER23-455-000.
    Applicants: New York Independent System Operator, Inc., Power
Authority of the State of New York.
    Description: Sec.  205(d) Rate Filing: New York Independent System
Operator, Inc. submits tariff filing per 35.13(a)(2)(iii): NYISO-NYPA
Joint 205: LGIA NYISO, NYPA, North Side Solar SA2739--CEII to be
effective 11/3/2022.
    Filed Date: 11/17/22.
    Accession Number: 20221117-5133.
    Comment Date: 5 p.m. ET 12/8/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 17, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-25598 Filed 11-22-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72950-72951]
[FR Doc No: 2011-30449]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0799]

Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled
and Individual Samples From Donors of Whole Blood and Blood Components,
Including Source Plasma, to Reduce the Risk of Transmission of
Hepatitis B Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry: Use
of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from
Donors of Whole Blood and Blood Components (including Recovered Plasma,
Source Plasma and Source Leukocytes) to Adequately and Appropriately
Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and
Requalification of Donors Who Test HBV NAT Positive,'' dated November
2011. The draft guidance document provides recommendations on the use
of FDA-licensed nucleic acid tests (NAT) to screen blood donors for
hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations
for product testing and disposition, donor management, methods for
donor requalification, and product labeling. In addition, the draft
guidance provides notification that FDA considers the use of an FDA-
licensed HBV NAT to be necessary to reduce adequately and appropriately
the risk of transmission of HBV. The guidance is intended for blood
establishments that

collect Whole Blood and blood components for transfusion or for further
manufacture, including recovered plasma, Source Plasma and Source
Leukocytes. The draft guidance, when finalized, is intended to
supplement previous memoranda and guidance from FDA concerning the
testing of donations for hepatitis B surface antigen (HBsAg) and
antibody to hepatitis B core antigen (anti-HBc), and the management of
donors and units mentioned in those documents.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 27, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-(800) 835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Levine, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and
Individual Samples from Donors of Whole Blood and Blood Components
(including Recovered Plasma, Source Plasma and Source Leukocytes) to
Adequately and Appropriately Reduce the Risk of Transmission of
Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT
Positive,'' dated November 2011. FDA is providing blood establishments
that collect Whole Blood and blood components for transfusion or for
further manufacture, including recovered plasma, Source Plasma and
Source Leukocytes; with recommendations concerning the use of FDA-
licensed NAT to screen blood donors for HBV DNA. FDA is also providing
these blood establishments with recommendations for product testing and
disposition, donor management, methods for donor requalification, and
product labeling.
    In addition, FDA is notifying those blood establishments that FDA
considers the use of an FDA-licensed HBV NAT to be necessary to reduce
adequately and appropriately the risk of transmission of HBV. FDA-
licensed HBV NAT can detect evidence of infection at an earlier stage
than is possible using previously approved HBsAg and anti-HBc tests.
Therefore, FDA is recommending the use of an FDA-licensed HBV NAT, in
accordance with the requirements under 610.40(a) and (b) (21 CFR
610.40(a) and (b)).
    The draft guidance, when finalized, is intended to supplement
previous memoranda and guidance from FDA to blood establishments
concerning the testing of donations for HBsAg and anti-HBc, and the
management of donors and units mentioned in those documents. Note that
testing Whole Blood and blood components for transfusion and Source
Leukocytes for further manufacture for HBsAg and anti-HBc, and Source
Plasma for HBsAg should continue when a blood establishment implements
HBV NAT. FDA may consider advancements in technology for testing blood
donations, as well as data obtained following the implementation of HBV
NAT, to make future recommendations on adequate and appropriate testing
for HBV.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 606.121, 610.40 and 640.70 have been
approved under OMB Control Numbers 0910-0537, 0910-0116, and 0910-0338,
respectively.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES) either
electronic or written comments regarding this document. It is only
necessary to send one set of comments. It is no longer necessary to
send two copies of mailed comments. Identify comments with the docket
number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30449 Filed 11-25-11; 8:45 am]
BILLING CODE 4160-01-P