80 FR 18407 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 65 (April 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 65 (April 6, 2015)
| Page Range | 18407-18410 | |
| FR Document | 2015-07818 |
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)] [Notices] [Pages 18407-18410] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07818] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0554] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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: Fax written comments on the collection of information by May 6, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-New and title, ``Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements--(0910-NEW) Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the 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. By their very nature, medical and health decisions are comparative (e.g., treat versus not treat). For consumers, these decisions may include the use of prescription drug products versus over the counter products versus herbal supplements, as well as one prescription brand versus another prescription brand. Similarly, advertising is often comparative. In prescription drug advertising, sponsors are permitted to include truthful, non-misleading information about the price of their products in promotion. This may extend to price comparison information, wherein sponsors may include information about the price of a competing product in order to make advantageous claims. Currently, when price comparisons are made, the advertisement (ad) should also include context that the two drugs may not be comparable in terms of efficacy and safety and that the acquisition costs presented do not necessarily reflect the actual prices paid by consumers, pharmacies, or third party payers. Despite the inclusion of this additional information, there is concern that adding contextual information about efficacy or safety is not sufficient to correct the impression that the products are interchangeable and that price is the main factor to consider. The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of price comparison information and additional contextual information on prescription drug product perceptions. This will be investigated in direct-to-consumer (DTC) and healthcare-directed professional advertising for prescription drugs. Design Overview and Procedure The design consists of two pretests and a main study. We will conduct two sequential pretest waves prior to main data collection. The purpose the pretests are to: (1) Ensure the stimuli are understandable and viewable; (2) identify and address any challenges to embedding the stimuli within the online survey; and (3) ensure the study questions are appropriate and meet the study's goals. Participants in the pretests will be randomly assigned to one of two versions of an ad. One version will present information about the price of the product relative to a competitor for the same indication (Price Comparison). Another version will present this information with additional contextual information that the two drugs may not be comparable in [[Page 18408]] terms of efficacy and safety and that the acquisition costs do not necessarily reflect actual prices paid (Price Comparison + Additional Context). Participants in Pretest 1 will be consumers (n=400) who self- identify as having been diagnosed with diabetes. Pretest 2 will be conducted with physicians (n=1,000) who are General Practitioners (e.g., Family Practice, General Practice, Internal Medicine) and Specialists (e.g., Endocrinology, Pain Management). Pretest 2 has a two-fold purpose. In addition to the measurement and stimuli verification issues identified above, we will also conduct an experiment to evaluate the impact of incentive level (level 1 vs. level 2) and study sponsorship (FDA vs. Public Health Agency) disclosure on physician response rates (see Exhibit 1). Pretest 2 will therefore provide a comparison of recruitment approaches, identify ways to optimize response rates, and provide a ``dry run'' of experimental study recruitment procedures. Exhibit 1--Pretest 2 Design, Incentive Level by Study Sponsorship by Type of Ad -------------------------------------------------------------------------------------------------------------------------------------------------------- Type of ad ---------------------------------------------------------------- Price comparison Price comparison + additional Study sponsor -------------------------------- context Total -------------------------------- FDA Public Health Public Health Agency FDA Agency -------------------------------------------------------------------------------------------------------------------------------------------------------- Incentive Level.......................... Level 1...................... 125 125 125 125 500 Level 2...................... 125 125 125 125 500 ------------------------------------------------------------------------------- Total................................ ............................. 250 250 250 250 1,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- In the main study phase, physician (n=1440) and consumer (n=1,500) participants will be randomly assigned to view one of three possible versions of a DTC or professional ad for a fictitious prescription drug for diabetic neuropathy and will be asked to complete an online survey to assess their perceptions and understanding of product safety and efficacy, perceptions and understanding of the additional contextual information, perceptions of comparative safety and efficacy, perceptions of the comparator product, and intention to seek more information about the product (see Exhibit 2). This sample size will provide us with sufficient power to detect small-to-medium sized effects. In addition to the Price Comparison and Price Comparison + Additional Context ads used in pretesting, a third ad version will have a claim about the price of the product but will not present information about the price relative to a competitor, and will act as a control. Exhibit 2--Main Study Design ---------------------------------------------------------------------------------------------------------------- Type of price comparison ----------------------------------------------------------------------------------------------------------------- Price Price information Sample Price comparison + only (no Total comparison additional comparison/ context control) ---------------------------------------------------------------------------------------------------------------- Consumers (DTC ad).............................. 500 500 500 1,500 Physicians (Professional ad).................... 480 480 480 1,440 --------------------------------------------------------------- Total....................................... 980 980 980 2,940 ---------------------------------------------------------------------------------------------------------------- Participants will be consumers who self-identify as having been diagnosed with diabetes and physicians who are General Practitioners (e.g., Family Practice, General Practice, Internal Medicine) and Specialists (e.g., Endocrinology, Pain Management). All participants will be 18 years of age or older. We will exclude individuals from the consumer sample who work in healthcare, pharmaceutical, or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Recruitment and administration of the study will take place over the Internet. Participation is estimated to take approximately 30 minutes. In the Federal Register of May 7, 2014 (79 FR 26255), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two submissions were received; one from Ms. Lenisse Lippert of Quality Matrix Solutions, and one from AbbVie biopharmaceutical company, which contained multiple comments. We summarize and respond to these comments below. (Comment 1 from Lenisse Lippert, Quality Matrix Solutions) ``I would like to participate in the industry feedback on a proposed study to better understand direct-to-consumer advertisements that compare drug pricing, and how that information affects a consumer's perception of a drug's overall safety and efficacy versus the comparator product.'' (Response) We thank Ms. Lippert for her comment. (Comment 2 from AbbVie) To prevent fatigue, online market research surveys do not generally exceed 20 minutes. Given that FDA is trying to make the most of their survey opportunity by asking many questions, it would be wise to place the meatier pricing related questions earlier in the survey when respondents are still engaged. (Response) We take the survey length very seriously. We are sensitive to issues regarding respondent fatigue and its impact upon completion rates and thus have placed items that are most likely to be influenced by respondent fatigue (open-ended questions) at the beginning of the survey. We have employed similar online surveys on [[Page 18409]] several previous studies, and we have obtained high completion rates, typically 90 percent or higher. For example, on a recent study (Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising [OMB control number 0910-0737]), we had a pool of 1,071 eligible respondents, and only 14 of those respondents failed to complete the survey. We anticipate that the completion rate for this study will be similar. (Comment 3 from AbbVie) In both surveys, respondents are asked many questions about product X that appear positively stated. Therefore, there is a risk of a bias by asking the critical pricing and language questions after the respondent has already been exposed to many product X questions and supposed attributes. To avoid bias, the most critical questions should appear as up front in the surveys as possible. (Response) Of greatest interest to FDA is the question of whether presence or absence of price comparison information and contextual information influences outcomes such as perceptions of comparative safety and efficacy, perceptions of the comparator product, and intentions to seek more information about the advertised product. Placing pricing related questions near the beginning of the survey would likely bias participants to think about pricing information more than they would under natural conditions, which may influence their responses to the aforementioned critical dependent variables. Although current question ordering may bias responses to pricing related questions, we believe this outcome is less consequential than the reverse, as suggested in this comment. Consequently, we intend to retain the current order of questions in the survey. (Comment 4 from AbbVie) It is unclear if the drug examples (X and Y) are real world medicines that could be taken by the patient respondents. If so, do respondents need to be aware of each product? If they need not be aware, you will need to balance the samples for any differences between cells. In addition, the cells will also need to be balanced for current drug usage to prevent additional bias. (Response) We have constructed a fictional product for use in this study to control for effects that might result as a consequence of having taken the product in the past. The comparator is a real product. We will measure participants' experience with medication for this condition, prior exposure to advertising for the comparator, and prior experience taking the comparator. Responses to these questions can be used as covariates in analysis. (Comment 5 from AbbVie) The questions on the physician survey should be at a higher level language versus the general population. We note the questions in the patient questionnaire seem to vary in reading level required to comprehend them. We recommend that FDA review the questions for consistency so as not [to] introduce a reading bias. (Response) We appreciate this comment. We have conducted cognitive interviews (OMB control number 0910-0695) to refine and improve the survey questions. We will also be conducting two rounds of pretesting which will provide an additional opportunity to identify and remove questions that do not function as intended, further refining the questionnaire prior to the main study. These activities include consideration of language level and whether it is appropriate for the participants being surveyed. (Comment 6 from AbbVie) We recommend this ad explicitly present contextual information that the two drugs may not be comparable in terms of efficacy and safety (i.e., the products are not interchangeable) notwithstanding price comparisons. This would permit FDA to assess whether it has provided enough contextual information so that the audience understands that the products are not interchangeable. Consequently, there would be a response choice in the questionnaire that allows a respondent to acknowledge the products are not interchangeable. AbbVie suggests that an option be added that reads, ``The brochure left the impression that Drug X's efficacy (and safety) should not be compared to Drug Y's; the products are not interchangeable.'' (Response) The context language is based on feedback from the cognitive interviews. We appreciate the comment and have added a question to assess participants' attitudes about the context with regard to interchangeability of the products being compared. (Comment 7 from AbbVie) It is not clear what type of cost information is being presented in these ads. We suggest that the advertisement should make clear what costs are being presented, for what doses, and over what time frames so that readers are comparing `apples to apples' when viewing the ads. If study budget allows, it would be ideal to test a variety of cost information. (Response) The price comparison is for the same indication on a yearly basis. We agree that it would be informative to expand the study to test a variety of cost information but do not have the resources to do so. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent respondents -------------------------------------------------------------------------------------------------------------------------------------------------------- Sample outgo (pretests and main survey)........ 41,110 .............. .............. ....................................... .............. Screener completes............................. 7,400 1 7,400 0.03 (2 minutes)....................... 222 Eligible....................................... 4,933 .............. .............. ....................................... .............. Completes, Pretests Phase 1.................... 400 1 400 0.5 (30 minutes)....................... 200 Completes, Pretest Phase 2..................... 1,000 1 1,000 0.5 (30 minutes)....................... 500 Completes, Main Study.......................... 2,940 1 2,940 0.5 (30 minutes)....................... 1,470 -------------------------------------------------------------------------------------------------------- Total...................................... .............. .............. .............. ....................................... 2,392 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 18410]] Dated: March 31, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07818 Filed 4-3-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18407
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND relating to drugs and other FDA
HUMAN SERVICES HUMAN SERVICES regulated products in carrying out the
provisions of the FD&C Act.
National Institutes of Health Food and Drug Administration By their very nature, medical and
health decisions are comparative (e.g.,
National Institute of Dental & [Docket No. FDA–2014–N–0554]
treat versus not treat). For consumers,
Craniofacial Research; Notice of these decisions may include the use of
Agency Information Collection
Closed Meeting prescription drug products versus over
Activities; Submission for Office of
Pursuant to section 10(d) of the Management and Budget Review; the counter products versus herbal
Federal Advisory Committee Act, as Comment Request; Comparative Price supplements, as well as one
amended (5 U.S.C. App.), notice is Information in Direct-to-Consumer and prescription brand versus another
hereby given of a meeting of the Board Professional Prescription Drug prescription brand. Similarly,
of Scientific Counselors, National Advertisements advertising is often comparative. In
Institute of Dental and Craniofacial prescription drug advertising, sponsors
AGENCY: Food and Drug Administration, are permitted to include truthful, non-
Research.
The meeting will be closed to the HHS. misleading information about the price
public as indicated below in accordance ACTION: Notice. of their products in promotion. This
with the provisions set forth in section may extend to price comparison
SUMMARY: The Food and Drug information, wherein sponsors may
552b(c)(6), title 5 U.S.C., as amended for Administration (FDA) is announcing
the review, discussion, and evaluation include information about the price of a
that a proposed collection of competing product in order to make
of individual intramural programs and information has been submitted to the
projects conducted by the National advantageous claims. Currently, when
Office of Management and Budget price comparisons are made, the
Institute of Dental & Craniofacial (OMB) for review and clearance under
Research, including consideration of advertisement (ad) should also include
the Paperwork Reduction Act of 1995. context that the two drugs may not be
personnel qualifications and
DATES: Fax written comments on the comparable in terms of efficacy and
performance, and the competence of
collection of information by May 6, safety and that the acquisition costs
individual investigators, the disclosure
2015. presented do not necessarily reflect the
of which would constitute a clearly
unwarranted invasion of personal ADDRESSES: To ensure that comments on actual prices paid by consumers,
privacy. the information collection are received, pharmacies, or third party payers.
OMB recommends that written Despite the inclusion of this additional
Name of Committee: Board of Scientific information, there is concern that
Counselors, National Institute of Dental and comments be faxed to the Office of
Information and Regulatory Affairs, adding contextual information about
Craniofacial Research.
Date: May 28–29, 2015. OMB, Attn: FDA Desk Officer, FAX: efficacy or safety is not sufficient to
Time: May 28, 2015, 12:00 p.m. to 5:40 202–395–7285, or emailed to oira_ correct the impression that the products
p.m. submission@omb.eop.gov. All are interchangeable and that price is the
Agenda: To review and evaluate personal comments should be identified with the main factor to consider. The Office of
qualifications and performance, and OMB control number 0910-New and Prescription Drug Promotion plans to
competence of individual investigators. investigate, through empirical research,
Place: National Institutes of Health, title, ‘‘Comparative Price Information in
Direct-to-Consumer and Professional the impact of price comparison
Building 30, Room 117, NIH Campus, information and additional contextual
Bethesda, MD 20892. Prescription Drug Advertisements.’’
Also include the FDA docket number information on prescription drug
Time: May 29, 2015, 8:00 a.m. to product perceptions. This will be
Adjournment. found in brackets in the heading of this
Agenda: To review and evaluate personal document. investigated in direct-to-consumer
qualifications and performance, and (DTC) and healthcare-directed
FOR FURTHER INFORMATION CONTACT: FDA
competence of individual investigators. professional advertising for prescription
PRA Staff, Office of Operations, Food drugs.
Place: National Institutes of Health,
Building 30, Room 117, NIH Campus, and Drug Administration, 8455
Bethesda, MD 20892 Colesville Rd., COLE–14526, Silver Design Overview and Procedure
Contact Person: Alicia J. Dombroski, Ph.D., Spring, MD 20993–0002, PRAStaff@ The design consists of two pretests
Director, Division of Extramural Activities, fda.hhs.gov. and a main study. We will conduct two
Natl Inst of Dental and Craniofacial Research, sequential pretest waves prior to main
SUPPLEMENTARY INFORMATION: In
National Institutes of Health, Bethesda, MD
20892, (301) 594–4805. compliance with 44 U.S.C. 3507, FDA data collection. The purpose the pretests
Information is also available on the has submitted the following proposed are to: (1) Ensure the stimuli are
Institute’s/Center’s home page: http:// collection of information to OMB for understandable and viewable; (2)
www.nidcr.nih.gov/about/ review and clearance. identify and address any challenges to
CouncilCommittees.asp, where an agenda embedding the stimuli within the online
and any additional information for the Comparative Price Information in survey; and (3) ensure the study
meeting will be posted when available. Direct-to-Consumer and Professional questions are appropriate and meet the
(Catalogue of Federal Domestic Assistance Prescription Drug Advertisements— study’s goals. Participants in the
Program Nos. 93.121, Oral Diseases and (0910–NEW) pretests will be randomly assigned to
Disorders Research, National Institutes of Section 1701(a)(4) of the Public one of two versions of an ad. One
Health, HHS)
tkelley on DSK4VPTVN1PROD with NOTICES
Health Service Act (42 U.S.C. version will present information about
Dated: March 31, 2015. 300u(a)(4)) authorizes the FDA to the price of the product relative to a
David Clary, conduct research relating to health competitor for the same indication
Program Analyst, Office of Federal Advisory information. Section 1003(d)(2)(C) of the (Price Comparison). Another version
Committee Policy. Federal Food, Drug, and Cosmetic Act will present this information with
[FR Doc. 2015–07738 Filed 4–3–15; 8:45 am] (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) additional contextual information that
BILLING CODE 4140–01–P authorizes FDA to conduct research the two drugs may not be comparable in
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![Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18409
several previous studies, and we have (Comment 4 from AbbVie) It is (Comment 6 from AbbVie) We
obtained high completion rates, unclear if the drug examples (X and Y) recommend this ad explicitly present
typically 90 percent or higher. For are real world medicines that could be contextual information that the two
example, on a recent study taken by the patient respondents. If so, drugs may not be comparable in terms
(Experimental Study: Examination of do respondents need to be aware of each of efficacy and safety (i.e., the products
Corrective Direct-to-Consumer product? If they need not be aware, you are not interchangeable)
Television Advertising [OMB control will need to balance the samples for any notwithstanding price comparisons.
number 0910–0737]), we had a pool of differences between cells. In addition, This would permit FDA to assess
1,071 eligible respondents, and only 14 the cells will also need to be balanced whether it has provided enough
of those respondents failed to complete for current drug usage to prevent contextual information so that the
the survey. We anticipate that the additional bias. audience understands that the products
completion rate for this study will be (Response) We have constructed a are not interchangeable. Consequently,
similar. fictional product for use in this study to there would be a response choice in the
(Comment 3 from AbbVie) In both control for effects that might result as a questionnaire that allows a respondent
surveys, respondents are asked many consequence of having taken the to acknowledge the products are not
questions about product X that appear product in the past. The comparator is interchangeable. AbbVie suggests that
positively stated. Therefore, there is a a real product. We will measure an option be added that reads, ‘‘The
risk of a bias by asking the critical participants’ experience with brochure left the impression that Drug
pricing and language questions after the medication for this condition, prior X’s efficacy (and safety) should not be
respondent has already been exposed to exposure to advertising for the compared to Drug Y’s; the products are
many product X questions and comparator, and prior experience taking not interchangeable.’’
supposed attributes. To avoid bias, the the comparator. Responses to these
most critical questions should appear as questions can be used as covariates in (Response) The context language is
up front in the surveys as possible. analysis. based on feedback from the cognitive
(Response) Of greatest interest to FDA (Comment 5 from AbbVie) The interviews. We appreciate the comment
is the question of whether presence or questions on the physician survey and have added a question to assess
absence of price comparison should be at a higher level language participants’ attitudes about the context
information and contextual information versus the general population. We note with regard to interchangeability of the
influences outcomes such as the questions in the patient products being compared.
perceptions of comparative safety and questionnaire seem to vary in reading (Comment 7 from AbbVie) It is not
efficacy, perceptions of the comparator level required to comprehend them. We clear what type of cost information is
product, and intentions to seek more recommend that FDA review the being presented in these ads. We suggest
information about the advertised questions for consistency so as not [to] that the advertisement should make
product. Placing pricing related introduce a reading bias. clear what costs are being presented, for
questions near the beginning of the (Response) We appreciate this what doses, and over what time frames
survey would likely bias participants to comment. We have conducted cognitive so that readers are comparing ‘apples to
think about pricing information more interviews (OMB control number 0910– apples’ when viewing the ads. If study
than they would under natural 0695) to refine and improve the survey budget allows, it would be ideal to test
conditions, which may influence their questions. We will also be conducting a variety of cost information.
responses to the aforementioned critical two rounds of pretesting which will
dependent variables. Although current provide an additional opportunity to (Response) The price comparison is
question ordering may bias responses to identify and remove questions that do for the same indication on a yearly
pricing related questions, we believe not function as intended, further basis. We agree that it would be
this outcome is less consequential than refining the questionnaire prior to the informative to expand the study to test
the reverse, as suggested in this main study. These activities include a variety of cost information but do not
comment. Consequently, we intend to consideration of language level and have the resources to do so.
retain the current order of questions in whether it is appropriate for the FDA estimates the burden of this
the survey. participants being surveyed. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents respondents per response
respondent
Sample outgo (pretests and main survey) ...................... 41,110 ........................ ........................ ............................ ........................
Screener completes ........................................................ 7,400 1 7,400 0.03 (2 minutes) 222
Eligible ............................................................................. 4,933 ........................ ........................ ............................ ........................
Completes, Pretests Phase 1 ......................................... 400 1 400 0.5 (30 minutes) 200
Completes, Pretest Phase 2 ........................................... 1,000 1 1,000 0.5 (30 minutes) 500
Completes, Main Study ................................................... 2,940 1 2,940 0.5 (30 minutes) 1,470
Total ......................................................................... ........................ ........................ ........................ ............................ 2,392
tkelley on DSK4VPTVN1PROD with NOTICES
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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![18410 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
Dated: March 31, 2015. and format of the same labeling that labeling. They will not be interacting
Leslie Kux, FDA researchers will develop using the with the device and this will be a
Associate Commissioner for Policy. existing labeling as their source of the usability test; they will be responding to
[FR Doc. 2015–07818 Filed 4–3–15; 8:45 am] information. scenarios to search for information.
BILLING CODE 4164–01–P
Building upon the research (Comment 3) One comment stated
methodology and success of the that FDA should ask the question,
approach FDA used to evaluate drug particularly to physicians, whether the
DEPARTMENT OF HEALTH AND labeling, we propose to measure the standard of care requires them to read
HUMAN SERVICES usability and usefulness of a draft the user instructions and understand the
standard content and format of device product’s warning.
Food and Drug Administration labeling against existing manufacturer (Response) This study is the third part
labeling of the same device. This will of a three-part study. FDA performed
[Docket No. FDA–2014–N–1219] focus groups of health care practitioners
support our research that has already
Agency Information Collection been done to assess whether health care asking them what they want in labeling,
practitioners (HCPs) find the format and where do they find labeling, what are
Activities; Submission for Office of
content of device labeling to be clear, the most important sections of labeling,
Management and Budget Review;
understandable, useful, and user and whether they even look at labeling.
Comment Request; Survey of Health
friendly (OMB control number 0910– Their responses indicated that they do
Care Practitioners for Device Labeling
0715). Findings will provide evidence to not look at labeling because it is
Format and Content
inform FDA’s planned regulatory complicated and they typically cannot
AGENCY: Food and Drug Administration, approach to standardizing medical find the information they want in one
HHS. device labeling across the United States. section. They stated they would like an
ACTION: Notice. In the Federal Register of September abbreviated version of labeling in order
12, 2014 (79 FR 54727), FDA published to find use information more easily,
SUMMARY: The Food and Drug a 60-day notice requesting public they would like a standard content of
Administration (FDA) is announcing comment on the proposed collection of labeling, and they also would like to
that a proposed collection of information. FDA used comments from find it electronically and in one place if
information has been submitted to the the medical device industry, health care possible.
Office of Management and Budget professionals, caregivers, and patients to FDA does not regulate the practice of
(OMB) for review and clearance under help formulate the objectives and define medicine; we do, however, regulate
the Paperwork Reduction Act of 1995. the scope of this study. The received labeling that accompanies a device.
DATES: Fax written comments on the comments are followed by FDA’s Based on the previous phases of the
collection of information by May 6, responses as follows: studies already done, we now want to
2015. (Comment 1) One comment stated test a standard content of labeling
that FDA should coordinate with the against an existing piece of the same
ADDRESSES: To ensure that comments on
American Society for Testing and labeling to see if health care
the information collection are received,
Materials (ASTM) as they already have practitioners can find what they need in
OMB recommends that written
published a consensus standard (F2943) a consistent and easy way. This is a
comments be faxed to the Office of
on this topic. This standard resulted cognitive testing of a standard content of
Information and Regulatory Affairs,
from the work of a multi-stakeholder labeling and does not include questions
OMB, Attn: FDA Desk Officer, FAX:
working group. regarding whether or not someone is
202–395–7285, or emailed to oira_ (Response) FDA reviewed the required to read the labeling before
submission@omb.eop.gov. All consensus standard (F2943) when we using the device.
comments should be identified with the drafted the outline for this study. We We will be using outside experts to
title Survey of Health Care Practitioners consulted with a member of the ASTM develop the protocol, develop the
for Device Labeling Format and Content. committee. We also requested a member scenarios, develop the draft
Also include the FDA docket number of the committee to be on our strategic standardized labeling, perform the
found in brackets in the heading of this planning committee for this study. testing, and provide a summary of the
document. (Comment 2) A comment stated that study. This is being done through the
FOR FURTHER INFORMATION CONTACT: FDA FDA does not follow the guidance on Entrepreneurs in Residence program
PRA Staff, Office of Operations, Food formative human factors and usability that is funded by the White House to
and Drug Administration, 8455 studies. The guidance provides good use outside experts and their special
Colesville Rd., COLE–14526, Silver direction on appropriately choosing knowledge and skills to work on an
Spring, MD 20993–0002, PRAStaff@ representative end users, replicating the innovative idea that helps the
fda.hhs.gov. intended user environment, and government when faced with a unique
SUPPLEMENTARY INFORMATION: In evaluating the user-product interface problem. Dr. Daryle Gardner-Bonneau is
compliance with 44 U.S.C. 3507, FDA (see FDA draft guidance ‘‘Applying a renowned social scientist and human
has submitted the following proposed Human Factors and Usability factors specialist who has worked with
collection of information to OMB for Engineering to Optimize Medical Device the device industry, standards
review and clearance. Design’’ issued on June 22, 2011). organizations, and the National
(Response) FDA had designed the Research Council on issues with
Survey of Health Care Practitioners for protocol for this study with a human medical device labeling. Patricia
Device Labeling Format and Content—
tkelley on DSK4VPTVN1PROD with NOTICES
factors expert and a social scientist. In Kingsley is a former FDA employee who
21 CFR Part 801 (OMB Control Number this particular study, we will be doing worked on medical device labeling
0910–NEW) a cognitive test of the health care issues. Nancy Ostrove is a former FDA
The purpose of this study is to practitioners. They will be asked to find employee who worked on surveys and
compare existing device labeling from a piece of information in the draft studies with drug community when the
approximately six different types of outline of standard content of labeling, Center for Drug Evaluation and Research
medical devices with a standard content or in the manufacturer’s existing was developing standardized labeling
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Document Created: 2015-12-18 11:18:04
Document Modified: 2015-12-18 11:18:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 6, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 18407 |
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