82 FR 27268 - Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 113 (June 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 113 (June 14, 2017)
| Page Range | 27268-27271 | |
| FR Document | 2017-12329 |
[Federal Register Volume 82, Number 113 (Wednesday, June 14, 2017)] [Notices] [Pages 27268-27271] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12329] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0558] Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Disclosures in Professional and Consumer Prescription Drug Promotion.'' DATES: Submit either electronic or written comments on the collection of information by August 14, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 14, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2017-N-0558 for ``Disclosures in Professional and Consumer Prescription Drug Promotion.'' 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 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 [[Page 27269]] redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jonnalynn Capezzuto, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE- 14526, Silver Spring, MD 20993-0002, 301-796-3794, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Disclosures in Professional and Consumer Prescription Drug Promotion-- OMB Control Number 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(b)(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. FDA regulates prescription drug promotion directed to healthcare professionals (HCPs) and consumers (section 502(n) of the FD&C Act (21 U.S.C. 352(n)). In the course of promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. In an effort to present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. Additionally, sponsors may not always present limitations to the claim in the main body of the text or display. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. There is little or no published research on disclosures in prescription drug promotion, either directed to consumers or to HCPs. Previous research on the effectiveness of disclosures has been conducted primarily in the dietary supplement arena (Refs. 1-4). Thus, the proposed research will examine the effectiveness of clear and conspicuous disclosures in prescription drug promotion directed to both of these populations. The purpose of our study is to determine how useful disclosures regarding prescription drug information are when presented prominently and adjacent to claims.\1\ Specifically, are HCPs and consumers able to use disclosures to effectively frame information in efficacy claims in prescription drug promotion? --------------------------------------------------------------------------- \1\ The Federal Trade Commission (FTC), which regulates the advertising of non-prescription drug products as well as other non- FDA regulated products (e.g., package goods, cars, etc.), issued a specific position on disclosures (Ref. 5) for the advertising it regulates. Specifically, FTC explains that disclosures must be ``clear and conspicuous''; in other words, in understandable language, located near the claim to be further clarified, and not hidden or minimized by small font or other distractions. --------------------------------------------------------------------------- To address this research question, we have designed a set of studies that cover both consumers and HCPs, as well as three different types of claims: Scope of treatment, ease of use, and statistical significance (see table 1). The scope of treatment claim can be thought of as a disease-awareness claim; that is, a broader discussion of a medical condition that may include disease characteristics beyond what the promoted drug has been shown to treat, followed by a disclosure of this nature. The ease of use claim is a simple claim of easy drug administration that omits specific important details that contribute to a more difficult drug administration than suggested. Finally, the statistical significance claim will be [[Page 27270]] one in which the disclosure reveals that the presented analyses were not statistically significant, and thus must be viewed with considerable caution. Table 1--Identical Study Designs for Samples of HCPs and Consumers ---------------------------------------------------------------------------------------------------------------- Level of disclosure Type of claim -------------------------------------------------------------------------- Weak Strong Control ---------------------------------------------------------------------------------------------------------------- Study A: HCPs ---------------------------------------------------------------------------------------------------------------- Scope of Treatment................... Evidence Only........... Evidence + Conclusion... None. Ease of Use.......................... Evidence Only........... Evidence + Conclusion... None. Statistical Significance............. Evidence Only........... Evidence + Conclusion... None. ---------------------------------------------------------------------------------------------------------------- Study B: Consumers ---------------------------------------------------------------------------------------------------------------- Scope of Treatment................... Evidence Only........... Evidence + Conclusion... None. Ease of Use.......................... Evidence Only........... Evidence + Conclusion... None. Statistical Significance............. Evidence Only........... Evidence + Conclusion... None. ---------------------------------------------------------------------------------------------------------------- Each participant will view three different mock promotional print pieces for different prescription drug products. For each of the three promotional pieces, they will be randomized to see an ad with a weak disclosure, a strong disclosure, or no disclosure. We will manipulate the strength of disclosure by including additional concluding information (strong) or not (weak) in the disclosure statement. In all cases, disclosures will be adjacent to claims and written in font clear enough to be detected. Technically speaking, these designs can be viewed as 3 within- subjects 1 x 3 designs with level of disclosure as a between subject factor. In other words, we will analyze the results of the scope of treatment disclosures independently of the ease of use disclosures and statistical significance disclosures, even though each participant will see one of each. The claims and disclosures are different enough that practice effects should be moderated, but we will counterbalance the order of ads shown to minimize potential bias. Because promotional pieces intended for HCPs and consumers have different levels of complexity and medical depth, and because the amount of knowledge expected between the two groups differs, the studies will use separate mock promotional pieces and ask slightly different comprehension questions of each group. We will maintain as much similarity across groups as possible for descriptive comparisons. Both consumers and HCPs will be recruited from Internet panels. Because promotional pieces will represent three different medical conditions, we will obtain a general population sample of consumers and a HCP sample of primary care physicians. Eligible participants who agree to participate will view mock promotional pieces and answer questions about their comprehension of the main messages in the promotion, perceptions of the product, attention to disclosures and intention to ask a HCP about it (consumers) or to prescribe the product (HCPs). Questionnaires are available upon request. Pretests will be conducted before conducting the main studies in order to ensure the mock promotional pieces are realistic and that the questionnaire flows well and questions are reasonable. We will supplement the findings of the pretests with two small eye-tracking studies. Researchers use eye-tracking technology to capture viewing behavior that is independent of self-report. The technology measures where and for how long participants glanced at or examined particular parts of a display. It has been used in studies of consumer print advertising (Refs. 6-8) and Internet promotion (Refs. 9-10). To our knowledge, there is little or no published research using eye-tracking technology with HCPs. We will use these small eye-tracking studies to determine what parts of each promotional piece consumers and HCPs actually viewed. Specifically, we will be able to determine whether they looked at the disclosure statement at all, and we can obtain a rough idea of how long they looked at it. This data will complement the self-reported items on the questionnaire. Moreover, we will use this data, as well as the pretest data, to improve the main studies. For this part of the study, 20 consumers and 20 HCPs will view the promotional pieces. FDA estimates the burden of this collection of information as follows: Table 2--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity \1\ Number of responses per Total annual Average burden per response Total hours respondents respondent responses \2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Consumers -------------------------------------------------------------------------------------------------------------------------------------------------------- Pretest Screener............................ 833 1 833 .03 (2 min.).............................. 25 Pretest..................................... 500 1 500 0.33 (20 min.)............................ 165 Eye-Tracking Screener....................... 80 1 80 .08 (5 min.).............................. 7 Eye-Tracking Study.......................... 20 1 20 1......................................... 20 Main Study Screener......................... 2,500 1 2,500 .03 (2 min.).............................. 75 Main Study.................................. 1,500 1 1,500 0.33 (20 min.)............................ 495 -------------------------------------------------------------------------------------------------------------------------------------------------------- HCPs -------------------------------------------------------------------------------------------------------------------------------------------------------- Pretest Screener............................ 735 1 735 .03 (2 min.).............................. 22 [[Page 27271]] Pretest..................................... 500 1 500 0.33 (20 min.)............................ 165 Eye-Tracking Screener....................... 80 1 80 .08 (5 min.).............................. 7 Eye-Tracking Study.......................... 20 1 20 1......................................... 20 Main Study Screener......................... 2,206 1 2,206 .03 (2 min.).............................. 67 Main Study.................................. 1,500 1 1,500 0.33 (20 min.)............................ 495 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 1,563 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Rounded to the next full hour. References 1. Dodge, T. and A. Kaufman. ``What Makes Consumers Think Dietary Supplements Are Safe and Effective? The Role of Disclaimers and FDA Approval.'' Health Psychology, 26(4), 513-517. (2007). 2. Dodge, T., D. Litt, and A. Kaufman. ``Influence of the Dietary Supplement Health and Education Act on Consumer Beliefs About the Safety and Effectiveness of Dietary Supplements.'' Journal of Health Communication: International Perspectives. 16(3), 230-244. (2011). 3. Mason, M.J., D.L. Scammon, and X. Feng. ``The Impact of Warnings, Disclaimers and Product Experience on Consumers' Perceptions of Dietary Supplements.'' Journal of Consumer Affairs, 41(1), 74-99. (2007). 4. France, K.R. and P.F. Bone. ``Policy Makers' Paradigms and Evidence from Consumer Interpretations of Dietary Supplement Labels.'' Journal of Consumer Affairs, 39(1), 27-51. (2005). 5. FTC. ``Full Disclosure.'' Accessed at: https://www.ftc.gov/news-events/blogs/business-blog/2014/09/full-disclosure (September 23, 2014). 6. Higgins, E., M. Leinenger, and K. Rayner. ``Eye Movements When Viewing Advertisements.'' Frontiers in Psychology, 5, 210. (2014). 7. Pieters, R., M. Wedel, and R. Batra. ``The Stopping Power of Advertising: Measures and Effects of Visual Complexity.'' Journal of Marketing, 74(5), 48-60. (2010). 8. Thomsen, S. and K. Fulton. ``Adolescents' Attention to Responsibility Messages in Magazine Alcohol Advertisements: An Eye- Tracking Approach.'' Journal of Adolescent Health, 41, 27-34. (2007). 9. Simola, J., J. Kuisma, A. [Ouml][ouml]rni, L. Uusitalo, et al. ``The Impact of Salient Advertisements on Reading and Attention on Web pages.'' Journal of Experimental Psychology: Applied, 17(2), 174-190. (2011). 10. Wedel, M. and R. Pieters. ``A Review of Eye-Tracking Research in Marketing.'' In Review of Marketing Research, Vol. 4 (pp. 123-147), N.K. Malhotra (Ed.). Armonk, New York: M.E. Sharpe. (2008). Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12329 Filed 6-13-17; 8:45 am] BILLING CODE 4164-01-P
![27268 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices
II. Determination of Regulatory Review 305), Food and Drug Administration, including attachments, to https://
Period 5630 Fishers Lane, Rm. 1061, Rockville, www.regulations.gov will be posted to
FDA has determined that the MD 20852. the docket unchanged. Because your
applicable regulatory review period for Dated: June 9, 2017. comment will be made public, you are
NEUROPACE RNS SYSTEM is 3,796 Anna K. Abram,
solely responsible for ensuring that your
days. Of this time, 2,694 days occurred comment does not include any
Deputy Commissioner for Policy, Planning,
during the testing phase of the confidential information that you or a
Legislation, and Analysis.
third party may not wish to be posted,
regulatory review period, while 1102 [FR Doc. 2017–12322 Filed 6–13–17; 8:45 am]
such as medical information, your or
days occurred during the approval BILLING CODE 4164–01–P
anyone else’s Social Security number, or
phase. These periods of time were
confidential business information, such
derived from the following dates:
as a manufacturing process. Please note
1. The date an exemption under DEPARTMENT OF HEALTH AND that if you include your name, contact
section 520(g) of the Federal Food, Drug, HUMAN SERVICES information, or other information that
and Cosmetic Act (the FD&C Act) (21
Food and Drug Administration identifies you in the body of your
U.S.C. 360j(g)) involving this device
comments, that information will be
became effective: June 26, 2003. FDA [Docket No. FDA–2017–N–0558] posted on https://www.regulations.gov.
has verified the applicant’s claim that • If you want to submit a comment
the date the investigational device Agency Information Collection with confidential information that you
exemption (IDE) required under section Activities; Proposed Collection; do not wish to be made available to the
520(g) of the FD&C Act for human tests Comment Request; Disclosures in public, submit the comment as a
to begin became effective was June 26, Professional and Consumer written/paper submission and in the
2003. Prescription Drug Promotion manner detailed (see ‘‘Written/Paper
2. The date an application was Submissions’’ and ‘‘Instructions’’).
initially submitted with respect to the AGENCY: Food and Drug Administration,
device under section 515 of the FD&C HHS. Written/Paper Submissions
Act (21 U.S.C. 360e): November 9, 2010. ACTION: Notice. Submit written/paper submissions as
FDA has verified the applicant’s claim follows:
SUMMARY: The Food and Drug
that the premarket approval application • Mail/Hand delivery/Courier (for
(PMA) for NEUROPACE RNS SYSTEM Administration (FDA) is announcing an
written/paper submissions): Division of
(PMA P100026) was initially submitted opportunity for public comment on the
Dockets Management (HFA–305), Food
November 9, 2010. proposed collection of certain
and Drug Administration, 5630 Fishers
3. The date the application was information by the Agency. Under the
Lane, Rm. 1061, Rockville, MD 20852.
approved: November 14, 2013. FDA has Paperwork Reduction Act of 1995 (the • For written/paper comments
verified the applicant’s claim that PMA PRA), Federal Agencies are required to submitted to the Division of Dockets
P100026 was approved on November publish notice in the Federal Register Management, FDA will post your
14, 2013. concerning each proposed collection of comment, as well as any attachments,
This determination of the regulatory information and to allow 60 days for except for information submitted,
review period establishes the maximum public comment in response to the marked and identified, as confidential,
potential length of a patent extension. notice. This notice solicits comments on if submitted as detailed in
However, the USPTO applies several research entitled, ‘‘Disclosures in ‘‘Instructions.’’
statutory limitations in its calculations Professional and Consumer Prescription Instructions: All submissions received
of the actual period for patent extension. Drug Promotion.’’ must include the Docket No. FDA–
In its applications for patent extension, DATES: Submit either electronic or 2017–N–0558 for ‘‘Disclosures in
the applicant seeks 5 years of patent written comments on the collection of Professional and Consumer Prescription
term extension. information by August 14, 2017. Drug Promotion.’’ Received comments
ADDRESSES: You may submit comments will be placed in the docket and, except
III. Petitions
as follows. Please note that late, for those submitted as ‘‘Confidential
Anyone with knowledge that any of untimely filed comments will not be Submissions,’’ publicly viewable at
the dates as published are incorrect may considered. Electronic comments must https://www.regulations.gov or at the
submit either electronic or written be submitted on or before August 14, Division of Dockets Management
comments and ask for a redetermination 2017. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday
(see DATES). Furthermore, any interested electronic filing system will accept through Friday.
person may petition FDA for a comments until midnight Eastern Time • Confidential Submissions—To
determination regarding whether the at the end of August 14, 2017. submit a comment with confidential
applicant for extension acted with due Comments received by mail/hand information that you do not wish to be
diligence during the regulatory review delivery/courier (for written/paper made publicly available, submit your
period. To meet its burden, the petition submissions) will be considered timely comments only as a written/paper
must be timely (see DATES and if they are postmarked or the delivery submission. You should submit two
ADDRESSES) and contain sufficient facts service acceptance receipt is on or copies total. One copy will include the
to merit an FDA investigation. (See H. before that date. information you claim to be confidential
Rept. 857, part 1, 98th Cong., 2d sess., with a heading or cover note that states
mstockstill on DSK30JT082PROD with NOTICES
pp. 41–42, 1984.) Petitions should be in Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
the format specified in 21 CFR 10.30. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Submit petitions electronically to following way: Agency will review this copy, including
https://www.regulations.gov at Docket • Federal eRulemaking Portal: the claimed confidential information, in
No. FDA–2013–S–0610. Submit written https://www.regulations.gov. Follow the its consideration of comments. The
petitions (two copies are required) to the instructions for submitting comments. second copy, which will have the
Division of Dockets Management (HFA– Comments submitted electronically, claimed confidential information
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![Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Notices 27271
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden per
Activity 1 responses per Total hours 2
respondents responses response
respondent
Pretest ....................................................................... 500 1 500 0.33 (20 min.) ........... 165
Eye-Tracking Screener ............................................. 80 1 80 .08 (5 min.) ............... 7
Eye-Tracking Study .................................................. 20 1 20 1 ................................ 20
Main Study Screener ................................................ 2,206 1 2,206 .03 (2 min.) ............... 67
Main Study ................................................................ 1,500 1 1,500 0.33 (20 min.) ........... 495
Total ................................................................... ........................ ........................ ........................ ................................... 1,563
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the next full hour.
References Dated: June 9, 2017. assist in the workshop discussion, FDA
Anna K. Abram, is making available an issues paper that
1. Dodge, T. and A. Kaufman. ‘‘What Makes
Deputy Commissioner for Policy, Planning, provides a brief overview of the
Consumers Think Dietary Supplements
Are Safe and Effective? The Role of
Legislation, and Analysis. currently available data resources used
Disclaimers and FDA Approval.’’ Health [FR Doc. 2017–12329 Filed 6–13–17; 8:45 am] for evaluating the impact of opioid
Psychology, 26(4), 513–517. (2007). BILLING CODE 4164–01–P formulations with properties designed
2. Dodge, T., D. Litt, and A. Kaufman. to deter abuse; summarizes some of the
‘‘Influence of the Dietary Supplement key methodological issues in this area;
Health and Education Act on Consumer DEPARTMENT OF HEALTH AND and outlines the issues that we would
Beliefs About the Safety and HUMAN SERVICES like to discuss during the upcoming
Effectiveness of Dietary Supplements.’’ workshop, including enhancing existing
Journal of Health Communication: Food and Drug Administration resources, applying new methodology,
International Perspectives. 16(3), 230– [Docket No. FDA–2017–N–2903] and creating new resources.
244. (2011). DATES: The public workshop will be
3. Mason, M.J., D.L. Scammon, and X. Feng. Data and Methods for Evaluating the held on July 10 and 11, 2017, from 8:30
‘‘The Impact of Warnings, Disclaimers Impact of Opioid Formulations With a.m. to 5 p.m. Submit either electronic
and Product Experience on Consumers’ Properties Designed To Deter Abuse in or written comments on this public
Perceptions of Dietary Supplements.’’ the Postmarket Setting: A Scientific workshop by September 11, 2017. Late,
Journal of Consumer Affairs, 41(1), 74– Discussion of Present and Future untimely filed comments will not be
99. (2007). Capabilities; Public Workshop; Issues considered. Electronic comments must
4. France, K.R. and P.F. Bone. ‘‘Policy Paper; Request for Comments be submitted on or before September 11,
Makers’ Paradigms and Evidence from 2017. The https://www.regulations.gov
Consumer Interpretations of Dietary AGENCY: Food and Drug Administration, electronic filing system will accept
Supplement Labels.’’ Journal of HHS. comments until midnight Eastern Time
Consumer Affairs, 39(1), 27–51. (2005). ACTION: Notice of public workshop; at the end of September 11, 2017.
5. FTC. ‘‘Full Disclosure.’’ Accessed at: request for comments. Comments received by mail/hand
https://www.ftc.gov/news-events/blogs/ delivery/courier (for written/paper
business-blog/2014/09/full-disclosure SUMMARY: The Food and Drug submissions) will be considered timely
(September 23, 2014). Administration (FDA, the Agency, or if they are postmarked or the delivery
6. Higgins, E., M. Leinenger, and K. Rayner. we) is announcing a public workshop service acceptance receipt is on or
‘‘Eye Movements When Viewing entitled ‘‘Data and Methods for before that date. See the SUPPLEMENTARY
Advertisements.’’ Frontiers in Evaluating the Impact of Opioid INFORMATION section for registration date
Psychology, 5, 210. (2014). Formulations with Properties Designed and information.
7. Pieters, R., M. Wedel, and R. Batra. ‘‘The to Deter Abuse in the Postmarket
Stopping Power of Advertising: ADDRESSES: The public workshop will
Setting: A Scientific Discussion of be held at the Sheraton Silver Spring
Measures and Effects of Visual Present and Future Capabilities.’’ The
Complexity.’’ Journal of Marketing, Hotel, 8777 Georgia Ave., Silver Spring,
purpose of the public workshop is to MD 20910. The hotel’s phone number is
74(5), 48–60. (2010). host a scientific discussion with expert
8. Thomsen, S. and K. Fulton. ‘‘Adolescents’ 301–589–0800.
panel members and interested You may submit comments as
Attention to Responsibility Messages in
stakeholders about the challenges in follows:
Magazine Alcohol Advertisements: An
using the currently available data and
Eye-Tracking Approach.’’ Journal of Electronic Submissions
Adolescent Health, 41, 27–34. (2007).
methods for assessing the impact of
9. Simola, J., J. Kuisma, A. Öörni, L. Uusitalo, opioid formulations with properties Submit electronic comments in the
et al. ‘‘The Impact of Salient designed to deter abuse on opioid following way:
Advertisements on Reading and misuse, abuse, addiction, overdose, and • Federal eRulemaking Portal:
death in the postmarket setting. The https://www.regulations.gov. Follow the
mstockstill on DSK30JT082PROD with NOTICES
Attention on Web pages.’’ Journal of
Experimental Psychology: Applied, goal of this meeting is to discuss ways instructions for submitting comments.
17(2), 174–190. (2011). to improve the analysis and Comments submitted electronically,
10. Wedel, M. and R. Pieters. ‘‘A Review of interpretation of existing data, as well as including attachments, to https://
Eye-Tracking Research in Marketing.’’ In to discuss opportunities and challenges www.regulations.gov will be posted to
Review of Marketing Research, Vol. 4 for collecting and/or linking additional the docket unchanged. Because your
(pp. 123–147), N.K. Malhotra (Ed.). data to improve national surveillance comment will be made public, you are
Armonk, New York: M.E. Sharpe. (2008). and research capabilities in this area. To solely responsible for ensuring that your
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Document Created: 2017-06-14 01:23:55
Document Modified: 2017-06-14 01:23:55
| 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 | Submit either electronic or written comments on the collection of information by August 14, 2017. | |
| Contact | Jonnalynn Capezzuto, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE- 14526, Silver Spring, MD 20993-0002, 301-796-3794, [email protected] | |
| FR Citation | 82 FR 27268 |
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