82 FR 27845 - Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 116 (June 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 116 (June 19, 2017)
| Page Range | 27845-27848 | |
| FR Document | 2017-12599 |
[Federal Register Volume 82, Number 116 (Monday, June 19, 2017)] [Notices] [Pages 27845-27848] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12599] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1779] Agency Information Collection Activities; Proposed Collection; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion.'' DATES: Submit either electronic or written comments on the collection of information by August 18, 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 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 18, 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): 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 [[Page 27846]] identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-1779 for ``Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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: http://www.thefederalregister.org/fdsys/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. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: I. Background 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 of Descriptive Presentations in Professional Oncology 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 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. Under the FD&C Act and implementing regulations, promotional labeling and advertising about prescription drugs are generally required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted (see sections 502(a) and (n), and 201(n) of the FD&C Act (21 U.S.C. 352(a) and (n), and 321(n)); see also 21 CFR 202.1). As a part of the ongoing evaluation of FDA's regulations in this area, FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decisionmaking, and may affect how and what treatment they prescribe for their patients. Pharmaceutical companies market directly to physicians through publishing advertisements in medical journals, exhibit booths at physician meetings or events, sending unsolicited promotional materials to doctors' offices, or presentations (``detailing'') by pharmaceutical representatives (Ref. 1). Detail aids may contain carefully extracted data from clinical studies that, taken out of context, can exaggerate the benefits of a drug (Ref. 2) or contribute to physicians prescribing the drug for an inappropriate patient population. Promotional labeling and advertising for cancer drugs deserve specific attention. Oncology drugs represented 26 percent of the 649 compounds under clinical trial investigation from 2006 to 2011 (Ref. 3). The past decade has seen a dramatic rise in the number of oncology drugs brought to market. In the past 18 months, FDA has approved 27 cancer drugs (Ref. 4). Although overall survival remains the gold standard for demonstrating clinical benefit of a drug, several additional endpoints are accepted as surrogates illustrating clinical benefit with regard to cancer and many drugs are granted expedited approval on their basis. These include disease-free survival, objective response rate, complete response rate, progression-free survival, and time to progression (Ref. 5). For clinicians who are not specifically trained in clinical trial design, interpreting these endpoints may be challenging. Pharmaceutical companies invest heavily in the development and distribution of promotional materials to educate oncologists about favorable clinical trial results. When communicating scientific and clinical data, a disclosure (a specific statement that modifies or qualifies a claim) could be used to convey the limitations of the data and practical [[Page 27847]] utility of the information for treatment. Much of the prior research on disclosures in this topic area has been limited to the dietary supplement arena with consumers (Refs. 6-9). Disclosures in professional pieces could influence prescriber comprehension as well as subsequent decisionmaking; however, no published data exist regarding how prescribers use and understand scientific claims in conjunction with qualifying disclosures. Different aspects of disclosures may influence their effectiveness. For example, despite the advanced education of health care providers, in a busy practice they may not be willing or able to process the disclosures thoroughly. Thus, the level of technicality in the disclosure may play a role in their use of the disclosure to contextualize the data display. Additionally, the addition of a general summary statement to frame the disclosure may help or hinder the processing of the disclosure and therefore the entire data display. Finally, it is possible that the impact of disclosure statements on prescriber comprehension, perceptions, and intentions to prescribe the promoted product will vary based on the level of clinical training. Although oncologists and primary care physicians (PCPs) will have more experience with clinical data, mid-level practitioners have reported having significantly more formal training on pharmaceutical marketing tactics than specialists and PCPs (Ref. 10). Therefore, it is unclear whether any one group would be more or less affected by both the claims made in promotional materials or by the disclosures that accompany those claims. The proposed study seeks to address the following research questions: 1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion? 2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure? 3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures? 4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data? 5. Which disclosures do physicians prefer? To address these questions, FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncological product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (oncologists, PCPs, mid-level practitioners). Each phase will have the following design: ---------------------------------------------------------------------------------------------------------------- Specific disclosure Sample General statement ---------------------------------------------------------- Technical Non-technical No disclosure ---------------------------------------------------------------------------------------------------------------- Oncologists..................... Present............ Control. Absent............. PCPs............................ Present............ Control. Absent............. Mid-Level Practitioners......... Present............ Control. Absent............. ---------------------------------------------------------------------------------------------------------------- Specific disclosures will include material information specifically related to the particular data display in question. As such, each specific disclosure may include clinical or statistical information related to the trial design, the statistical analysis plan of the trial, or any other material statistical or clinical information necessary for evaluation or interpretation of the data. The team developing the disclosures includes social science analysts, pharmacists, oncological medical officers, and an oncology nurse. An example of the general statement is ``This presentation includes exploratory information of uncertain clinical utility and should be interpreted cautiously when used to make treatment decisions.'' Outcome variables will focus on the assessment of the data display as a whole as well as attention to the disclosure, if present. Specifically, we will examine recognition of the clinical endpoint in the data display, comprehension of the data display, perceptions of the exploratory nature of the data, and the perceived credibility of the promotional piece. We will also look at attention to the specific disclosure and the general statement, prescriber decisions, and prescriber preferences. This latter outcome variable will be determined by a secondary task at the end of the questionnaire that shows each participant all disclosure options and asks them to choose their preferred version. Oncologists, PCPs, and non-oncology mid-level practitioners will be recruited to participate via the Internet, and the study is expected to take approximately 20 minutes. Participants will view professionally developed promotional pieces that mimic currently available promotion and answer questions. The questionnaire is available upon request. 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 responses \2\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Pretest Screener............................ 134 1 134 0.03 (2 minutes).......................... 5 Pretest..................................... 90 1 90 0.33 (20 minutes)......................... 30 Main Study Screener......................... 3,134 1 3,134 0.03 (2 minutes).......................... 105 Main Study.................................. 2,115 1 2,115 0.33 (20 minutes)......................... 705 ----------------------------------------------------------------------------------------------------------- [[Page 27848]] Total................................... .............. .............. .............. .......................................... 845 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Rounded to the next full hour. II. References The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Johar, K., ``An Insider's Perspective: Defense of the Pharmaceutical Industry's Marketing Practices,'' Albany Law Review, 76:299-334, 2012-2013. 2. Wick, C., M. Egger, S. Trelle, et al., ``The Characteristics of Unsolicited Clinical Oncology Literature Provided by Pharmaceutical Industry,'' Annals of Oncology, 18:1580-1582, 2007. 3. Fisher, J.A., M.D. Cottingham, and C.A. Kalbaugh, ``Peering Into the Pharmaceutical `Pipeline': Investigational Drugs, Clinical Trials, and Industry Priorities,'' Social Science & Medicine, 131:322-330, 2015. 4. Centerwatch, ``FDA Approved Drugs for Oncology,'' https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology (accessed on March 2, 2017). 5. Pazdur, R., ``Endpoints for Assessing Drug Activity in Clinical Trials,'' The Oncologist, 13:19-21, 2008. 6. Dodge, T. and A. Kaufman, ``What Makes Consumers Think Dietary Supplements Are Safe and Effective? The Role of Disclaimers and FDA Approval,'' Health Psychology, 26:513-517, 2007. 7. 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, 16:230-244, 2011. 8. Mason, M.J., D.L. Scammon, and X. Fang, ``The Impact of Warnings, Disclaimers, and Product Experience on Consumers' Perceptions of Dietary Supplements,'' The Journal of Consumer Affairs, 41:74-99, 2007. 9. France, K.R. and P.F. Bone, ``Policy Makers' Paradigms and Evidence From Consumer Interpretations of Dietary Supplement Labels,'' The Journal of Consumer Affairs, 39:27-51, 2005. 10. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al., ``Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings,'' Journal of Health Communication, 20:1330-1336, 2015. Dated: June 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-12599 Filed 6-16-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices 27845
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Activity responses per Total hours
respondents responses per response
respondent
Pilot screener ............................................................ 120 1 120 0.03 (2 minutes) ....... 4
Study 1 screener ...................................................... 600 1 600 0.03 (2 minutes) ....... 18
Study 2 screener ...................................................... 600 1 600 0.03 (2 minutes) ....... 18
Completes, Pilot ........................................................ 40 1 40 1 ................................ 40
Completes, Study 1 .................................................. 200 1 200 1 ................................ 200
Completes, Study 2 .................................................. 200 1 200 1 ................................ 200
Total ................................................................... ........................ ........................ ........................ ................................... 480
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References Dated: June 13, 2017. Comments received by mail/hand
Anna K. Abram, delivery/courier (for written/paper
The following references are on Deputy Commissioner for Policy, Planning, submissions) will be considered timely
display in the Dockets Management Legislation, and Analysis. if they are postmarked or the delivery
Staff (see ADDRESSES) and are available [FR Doc. 2017–12600 Filed 6–16–17; 8:45 am] service acceptance receipt is on or
for viewing by interested persons BILLING CODE 4164–01–P before that date.
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available Electronic Submissions
electronically at https:// DEPARTMENT OF HEALTH AND Submit electronic comments in the
www.regulations.gov. FDA has verified HUMAN SERVICES following way:
the Web site addresses, as of the date • Federal eRulemaking Portal:
this document publishes in the Federal Food and Drug Administration https://www.regulations.gov. Follow the
Register, but Web sites are subject to [Docket No. FDA–2017–N–1779] instructions for submitting comments.
change over time. Comments submitted electronically,
Agency Information Collection including attachments, to https://
1. McGuire, L.C., ‘‘Remembering What the Activities; Proposed Collection;
Doctor Said: Organization and Older
www.regulations.gov will be posted to
Comment Request; Disclosures of the docket unchanged. Because your
Adults’ Memory for Medical
Descriptive Presentations in comment will be made public, you are
Information.’’ Experimental Aging
Professional Oncology Prescription solely responsible for ensuring that your
Research, 22, 403–428 (1996).
Drug Promotion comment does not include any
2. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and AGENCY: Food and Drug Administration, confidential information that you or a
Behaviors Associated with DTC HHS. third party may not wish to be posted,
Promotion of Prescription Drugs: ACTION: Notice. such as medical information, your or
Summary of FDA Survey Research anyone else’s Social Security number, or
Results’’ (2004). Available at http:// SUMMARY: The Food and Drug confidential business information, such
www.fda.gov/downloads/Drugs/ Administration (FDA or Agency) is as a manufacturing process. Please note
ScienceResearch/ResearchAreas/ announcing an opportunity for public that if you include your name, contact
DrugMarketingAdvertisingand comment on the proposed collection of information, or other information that
CommunicationsResearch/ certain information by the Agency. identifies you in the body of your
UCM152860.pdf. Under the Paperwork Reduction Act of comments, that information will be
3. Warnings and Risk Communication (2005). 1995 (PRA), Federal Agencies are posted on https://www.regulations.gov.
Wogalter, M.S., D. DeJoy, and K.R. required to publish notice in the • If you want to submit a comment
Laughery (Eds.). Philadelphia: Taylor & Federal Register concerning each with confidential information that you
Francis, Inc. proposed collection of information and do not wish to be made available to the
4. Conzola, V.C., and M.S. Wogalter, ‘‘A to allow 60 days for public comment in public, submit the comment as a
Communication-Human Information response to the notice. This notice written/paper submission and in the
Processing (C–HIP) Approach to Warning solicits comments on research entitled manner detailed (see ‘‘Written/Paper
Effectiveness in the Workplace.’’ Journal ‘‘Disclosures of Descriptive Submissions’’ and ‘‘Instructions’’).
of Risk Research, 4(4), 309–322; (2001). Presentations in Professional Oncology
5. Wogalter, M.S., and K.R Laughery, Written/Paper Submissions
Prescription Drug Promotion.’’
‘‘Warning! Sign and Label DATES: Submit either electronic or Submit written/paper submissions as
Effectiveness.’’ Current Directions in written comments on the collection of follows:
Psychological Science, 5(2), 33–37; information by August 18, 2017. • Mail/Hand delivery/Courier (for
(1996). written/paper submissions): Dockets
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ADDRESSES: You may submit comments
6. Wogalter, M.S., T.L. Smith-Jackson, B.J. Management Staff (HFA–305), Food and
as follows. Please note that late,
Mills, and C.S. Paine, ‘‘The Effects of Drug Administration, 5630 Fishers
untimely filed comments will not be
Print Format in Direct-to-Consumer
considered. Electronic comments must Lane, Rm. 1061, Rockville, MD 20852.
Prescription Drug Advertisements on
Risk Knowledge and Preference.’’ Drug
be submitted on or before August 18, • For written/paper comments
Information Journal, 36(3), 693–705,
2017. The https://www.regulations.gov submitted to the Dockets Management
2002.
electronic filing system will accept Staff, FDA will post your comment, as
comments until midnight Eastern Time well as any attachments, except for
at the end of August 18, 2017. information submitted, marked and
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![27848 Federal Register / Vol. 82, No. 116 / Monday, June 19, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Activity responses per Total hours 2
respondents responses per response
respondent
Total ................................................................... ........................ ........................ ........................ ................................... 845
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the next full hour.
II. References Drug Administration’s Bad Ad Program Name of Committee: AIDS and Related
and Education Regarding Pharmaceutical Research Integrated Review Group; AIDS
The following references are on Advertising: A National Survey of Molecular and Cellular Biology Study
display in the Dockets Management Prescribers in Ambulatory Care Section.
Staff (see ADDRESSES) and are available Settings,’’ Journal of Health Date: July 10, 2017.
for viewing by interested persons Communication, 20:1330–1336, 2015. Time: 8:00 a.m. to 6:00 p.m.
between 9 a.m. and 4 p.m., Monday Dated: June 13, 2017. Agenda: To review and evaluate grant
through Friday; they are also available applications.
Anna K. Abram, Place: Residence Inn Bethesda, 7335
electronically at https:// Deputy Commissioner for Policy, Planning, Wisconsin Avenue, Bethesda, MD 20814.
www.regulations.gov. FDA has verified Legislation, and Analysis. Contact Person: Kenneth A. Roebuck,
the Web site addresses, as of the date [FR Doc. 2017–12599 Filed 6–16–17; 8:45 am] Ph.D., Scientific Review Officer, Center for
this document publishes in the Federal Scientific Review, National Institutes of
BILLING CODE 4164–01–P
Register, but Web sites are subject to Health, 6701 Rockledge Drive, Room 5214,
change over time. MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
1. Johar, K., ‘‘An Insider’s Perspective: DEPARTMENT OF HEALTH AND
Defense of the Pharmaceutical Industry’s HUMAN SERVICES Name of Committee: Center for Scientific
Marketing Practices,’’ Albany Law Review Special Emphasis Panel; AIDS and
Review, 76:299–334, 2012–2013. National Institutes of Health Related Research Member Conflict.
2. Wick, C., M. Egger, S. Trelle, et al., ‘‘The Date: July 10, 2017.
Characteristics of Unsolicited Clinical Center for Scientific Review; Notice of Time: 10:00 a.m. to 5:00 p.m.
Oncology Literature Provided by Agenda: To review and evaluate grant
Closed Meetings applications.
Pharmaceutical Industry,’’ Annals of
Oncology, 18:1580–1582, 2007. Pursuant to section 10(d) of the Place: National Institutes of Health, 6701
3. Fisher, J.A., M.D. Cottingham, and C.A. Federal Advisory Committee Act, as Rockledge Drive, Bethesda, MD 20892
Kalbaugh, ‘‘Peering Into the (Virtual Meeting).
amended (5 U.S.C. App.), notice is
Pharmaceutical ‘Pipeline’: Contact Person: Shalanda A. Bynum,
hereby given of the following meetings. Ph.D., MPH, Scientific Review Officer, Center
Investigational Drugs, Clinical Trials, The meetings will be closed to the
and Industry Priorities,’’ Social Science for Scientific Review, National Institutes of
public in accordance with the Health, 6701 Rockledge Drive, Room 3206,
& Medicine, 131:322–330, 2015.
provisions set forth in sections Bethesda, MD 20892, 301–755–4355,
4. Centerwatch, ‘‘FDA Approved Drugs for
Oncology,’’ https:// 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., bynumsa@csr.nih.gov.
www.centerwatch.com/drug- as amended. The grant applications and Name of Committee: Center for Scientific
information/fda-approved-drugs/ the discussions could disclose Review Special Emphasis Panel; PAR 16–
therapeutic-area/12/oncology (accessed confidential trade secrets or commercial 257: Predicting Behavioral Responses to
on March 2, 2017). property such as patentable material, Population Level Cancer Control Strategies
5. Pazdur, R., ‘‘Endpoints for Assessing Drug and personal information concerning (R21).
Activity in Clinical Trials,’’ The Date: July 11, 2017.
individuals associated with the grant
Oncologist, 13:19–21, 2008. Time: 11:00 a.m. to 2:00 p.m.
applications, the disclosure of which Agenda: To review and evaluate grant
6. Dodge, T. and A. Kaufman, ‘‘What Makes
would constitute a clearly unwarranted applications.
Consumers Think Dietary Supplements
Are Safe and Effective? The Role of invasion of personal privacy. Place: National Institutes of Health, 6701
Disclaimers and FDA Approval,’’ Health Name of Committee: Center for Scientific Rockledge Drive, Bethesda, MD 20892
Psychology, 26:513–517, 2007. Review Special Emphasis Panel; RFA Panel: (Telephone Conference Call).
7. Dodge, T., D. Litt, and A. Kaufman, Revision Applications for U.S.-South Africa Contact Person: Karin F. Helmers, Ph.D.,
‘‘Influence of the Dietary Supplement Program for Collaborative Biomedical Scientific Review Officer, Center for
Health and Education Act on Consumer Research. Scientific Review, National Institutes of
Beliefs About the Safety and Date: June 29, 2017. Health, 6701 Rockledge Drive, Room 3148,
Effectiveness of Dietary Supplements,’’ Time: 2:00 p.m. to 5:00 p.m. MSC 7770, Bethesda, MD 20892, (301) 254–
Journal of Health Communication, Agenda: To review and evaluate grant 9975, helmersk@csr.nih.gov.
16:230–244, 2011. applications. Name of Committee: Center for Scientific
8. Mason, M.J., D.L. Scammon, and X. Fang, Place: National Institutes of Health, 6701 Review Special Emphasis Panel; PAR 15–
‘‘The Impact of Warnings, Disclaimers, Rockledge Drive, Bethesda, MD 20892 287: Opportunities for Collaborative Research
and Product Experience on Consumers’ (Telephone Conference Call). at the NIH Clinical Center.
Contact Person: Robert Freund, Ph.D., Date: July 11, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Perceptions of Dietary Supplements,’’
The Journal of Consumer Affairs, 41:74– Scientific Review Officer, Center for Time: 1:30 p.m. to 5:00 p.m.
99, 2007. Scientific Review, National Institutes of Agenda: To review and evaluate grant
9. France, K.R. and P.F. Bone, ‘‘Policy Health, 6701 Rockledge Drive, Room 5216, applications.
Makers’ Paradigms and Evidence From MSC 7852, Bethesda, MD 20892, 301–435– Place: National Institutes of Health, 6701
Consumer Interpretations of Dietary 1050, freundr@csr.nih.gov. Rockledge Drive, Bethesda, MD 20892
Supplement Labels,’’ The Journal of This notice is being published less than 15 (Virtual Meeting).
Consumer Affairs, 39:27–51, 2005. days prior to the meeting due to the timing Contact Person: Fungai Chanetsa, MPH,
10. O’Donoghue, A.C., V. Boudewyns, K.J. limitations imposed by the review and Ph.D., Scientific Review Officer, Center for
Aikin, et al., ‘‘Awareness of the Food and funding cycle. Scientific Review, National Institutes of
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Document Created: 2017-06-17 01:48:11
Document Modified: 2017-06-17 01:48:11
| 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 18, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 27845 |
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