83 FR 52490 - Agency Information Collection Activities; Proposed Collection; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 201 (October 17, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 201 (October 17, 2018)
| Page Range | 52490-52494 | |
| FR Document | 2018-22569 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Notices] [Pages 52490-52494] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22569] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3163] Agency Information Collection Activities; Proposed Collection; Comment Request; Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces 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 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of [[Page 52491]] information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces.'' This study will examine important public health issues in professionally directed prescription drug print promotion. DATES: Submit either electronic or written comments on the collection of information by December 17, 2018. 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 December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 17, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-3163 for ``Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces.'' 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: https://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, 10:00 a.m.-12:00 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. For copies of the questionnaire contact: Office of Prescription Drug Promotion (OPDP) Research Team, [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. Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional Pieces OMB Control Number 0910-NEW I. Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes [[Page 52492]] 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 FD&C Act section 201(n) and 502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR 202.1). The proposed collection of information will investigate how physician perception of prescription drug information is influenced by variations in information context (presence of graphical elements and information delivery vehicle--medical journal abstract or sales aid), methodologic rigor of the underlying clinical study (high or low), and time pressure (present versus absent). This will contribute to the body of knowledge on perceptual influences, including information summarized below. A. Ways in Which Information Context and Study Quality May Influence Perceptions Physicians gain knowledge about medical product uses from a variety of information vehicles including peer-reviewed journal articles, compendia, continuing medical education, and physician-directed promotion by or on behalf of manufacturers. Peer-reviewed scientific publications may report the results of a variety of studies, employing a wide range of methodologies with varying levels of quality. As a result, information of varying quality is disseminated to the field. Physician detailing sometimes includes information derived from peer- reviewed research that, in this context, serves a dual purpose: To both inform and market a particular product (Ref. 1). Prior research has examined some impacts of study quality and funding source on physician perception. For example, research by Kesselheim et al. (Ref. 2) on study abstracts examined how methodologic rigor (high, medium, low) and information about the source of funding (industry, National Institutes of Health, none) affected physician perceptions of study quality, prescribing intentions, and interest in reading the full article. Results indicated physician participants were able to distinguish between levels of methodologic rigor. Physicians also used information about the funding source to distinguish materials: They reported less willingness to prescribe the drugs or read the full study from trials funded by industry, regardless of study quality. Thus, funding source was a contextual factor that impacted physicians' perceptions of the information. Research has also shown that physician prescribing behavior can be influenced by the context in which the information is delivered. Spurling et al (Ref. 3) examined the way in which information from a pharmaceutical company was delivered (using conventional promotional techniques such as sales rep visits, journal advertisements, or attendance at pharmaceutical-sponsored meetings versus not using conventional promotional techniques such as participation in company sponsored trials and representatives' visits for nonpromotional purposes) and prescribing outcome across 58 studies. They found conventional promotional techniques were associated with an increase in prescribing and a decrease in prescribing quality. We are proposing to test a different type of contextual factor in this study: Whether the drug information appears in a medical journal abstract or a sales aid. B. Ways in Which Graphics May Influence Perceptions Promotional materials about prescription drugs that are directed toward physicians often include a variety of visual elements beyond simple text. In a study of professionally directed prescription drug brochures left for physicians by pharmaceutical representatives, researchers found 95 percent contained a visual graphic (including bar charts, line graphs, pie charts, arrows) accompanying the presentation of data (Ref. 4). An analysis of professionally directed prescription drug print advertisement in medical journals found 80 percent of the ads contained some type of image and 21 percent contained graphics. A group of two physicians and one pharmacist judged these ads. This group found that of those ads that contained images, 58 percent contained images that minimized the risks of the product and 24 percent of the images in the ads misled about product efficacy (Ref. 5). C. Ways in Which Time Pressure May Influence Perceptions We are also interested in how time pressure may impact physician perceptions. Time pressure can impact processing of information (e.g., accuracy and speed) as well as decision making. Physicians are often under pressure to split their work time between myriad duties that may include clinical care, research, mentoring, teaching, and administrative duties (Ref. 6). Individuals under time pressure tend to rely on previously formed attitudes for decision making and have less cognitive capacity to process information (Refs. 7 and 8). This results in different decisions depending on the amount of time available (Ref. 9). Research suggests that in situations with high time pressure or increased ambiguity, experts use intuitive decision making strategies rather than structured approaches (Refs. 10 and 11). Physicians may therefore tend to rely on intuitive processes rather than evidence- based information under time pressure. Research has also found that under time pressure, physician adherence to clinical practice guidelines concerning history taking and advice giving can be compromised (Ref. 12). Moreover, one study that assessed the reading habits of physicians found that given the limited time available for critical reading, these practitioners relied heavily on abstracts and prescreening of articles by editors to ensure they received rigorous and useful information (Ref. 13). Thus, time pressure is an element of physicians' practice environment that can impact decision making and, consequently, quality of healthcare delivered. II. Proposed Study We propose to investigate how physician perception of professional prescription drug communications is influenced by variations in information context, methodologic rigor of the underlying clinical study, and time pressure. We propose to test three different contextual presentations of drug information (medical journal abstract, sales aid without graphic design elements, sales aid with graphic design elements), and two types of study methodological rigor used by Kesselheim et al. (classified as high or low; Ref. 2). We have chosen to test a mock sales aid presentation and a medical journal abstract to examine the potential differences in perception that may arise by presenting the same information in different vehicles. Mirroring the time constraints of practicing physicians, we will examine the role of time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials. Table 1 describes the study design. [[Page 52493]] Table 1--Study Design ---------------------------------------------------------------------------------------------------------------- Information context -------------------------------------------------- Sales aid Sales aid with Medical journal without graphic graphic design abstract design elements elements \2\ ---------------------------------------------------------------------------------------------------------------- Limited Time to Read.......... Methodological High Rigor \1\. ................. Low Unlimited Time to Read........ ................. High ................. Low ---------------------------------------------------------------------------------------------------------------- \1\ As defined by Kesselheim et al. (Ref. 2). \2\ For example, colors and background images. For this proposed study, voluntary participants will be board- certified internists. To examine differences between experimental conditions, we will conduct inferential statistical tests, such as analysis of variance. With the sample size described in this document, we will have sufficient power to detect small-to-medium sized effects in the main study. We plan to conduct one pretest with 158 voluntary participants and one main study with 566 voluntary participants. The studies will be conducted online. The pretest and main studies will have the same design and will follow the same procedure. Participants will be randomly assigned to 1 of 12 test conditions (see table 1). Following exposure to the stimuli, they will be asked to complete a questionnaire that assesses comprehension, perceptions, prescribing intentions, and demographics. We anticipate analyzing the data as a full factorial design (main effects and interactions) with two primary comparisons for the information context independent variable: Journal abstract versus sales aid without graphics, and sales aid without graphics versus sales aid with graphics. We will also do an exploratory comparison of journal abstract versus sales aid with graphics. In the pretest, participants will also answer questions about the study design and questionnaire. This study will be conducted as part of the research program of FDA's Office of Prescription Drug Promotion (OPDP). OPDP's mission is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated, so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program supports this mission by providing scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study falls under the topic of both target populations and advertising features. Because we recognize the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website includes links to the latest Federal Register documents and peer- reviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a direct-to- consumer survey conducted in 1999. FDA estimates the burden of this collection of information as follows: Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of Responses per Total annual Average burden Total hours respondents Respondent responses per response ---------------------------------------------------------------------------------------------------------------- Pretest screener.............. 197 1 197 0.03 (2 minutes) 6 Main Study screener........... 700 1 700 0.03 (2 minutes) 21 Completes, Pretest............ 158 1 158 0.33 (20 53 minutes). Completes, Main Study......... 566 1 566 0.33 (20 187 minutes). --------------------------------------------------------------------------------- Total..................... 1,621 .............. 1,621 ................ 267 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 52494]] III. References The following references are on display with 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; these are not available electronically at https://www.regulations.gov, as these references are copyright protected. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Yi, J.C., G. Anandalingam, and L.A. Sorrell, ``An Expert System to Physician-Detailing Planning,'' Expert Systems with Applications, 25:533-544, 2003. 2. Kesselheim, A.S., C.T. Robertson, J.A. Myers, et al., ``A Randomized Study of How Physicians Interpret Research Funding Disclosures,'' New England Journal of Medicine, 367:1119-1127, 2012. 3. Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al., ``Information from Pharmaceutical Companies and the Quality, Quantity, and Cost of Physicians' Prescribing: A Systematic Review,'' PLoS Medicine, 7:e1000352, 2010. 4. Cardarelli, R., J.C. Licciardone, and L.G. Taylor, ``A Cross- Sectional Evidence-Based Review of Pharmaceutical Promotional Marketing Brochures and Their Underlying Studies: Is What They Tell Us Important and True?'' BMC Family Practice, 7:13, 2006. 5. Wilkes, M.S., B.H. Doblin, and M.F. Shapiro, ``Pharmaceutical Advertisements in Leading Medical Journals: Experts' Assessments,'' Annals of Internal Medicine, 116:912-919, 1992. 6. Fassiotto, M., C. Simard, C. Sandborg, et al., ``An Integrated Career Coaching and Time-Banking System Promoting Flexibility, Wellness, and Success: A Pilot Program at Stanford University School of Medicine,'' Academic Medicine, 93:881-887, 2018. 7. Alison, L., B. Doran, M.L. Long, et al., ``The Effects of Subjective Time Pressure and Individual Differences on Hypotheses Generation and Action Prioritization in Police Investigations,'' Journal of Experimental Psychology. Applied, 19:83-93, 2013. 8. Ratneshwar, S. and S. Chaiken, ``Comprehension's Role in Persuasion: The Case of Its Moderating Effect on the Persuasive Impact of Source Cues,'' Journal of Consumer Research, 18:52-62, 1991. 9. Moore, D.L., D. Hausknecht, and K. Thamodaran, ``Time Compression, Response Opportunity, and Persuasion,'' Journal of Consumer Research, 13:85-99, 1986. 10. Dror, I.E., J.R. Busemeyer, and B. Basola, ``Decision Making Under Time Pressure: An Independent Test of Sequential Sampling Models,'' Memory & Cognition, 27:713-725, 1999. 11. Croskerry, P., ``The Cognitive Imperative: Thinking About How We Think,'' Academic Emergency Medicine, 7:1223-1231, 2000. 12. Tsiga, E., E. Panagopoulou, N. Sevdalis, et al., ``The Influence of Time Pressure on Adherence to Guidelines in Primary Care: An Experimental Study,'' BMJ Open, 3:e002700, 2013. 13. Saint, S., D.A. Christakis, S. Saha, et al., ``Journal Reading Habits of Internists,'' Journal of General Internal Medicine, 15:881-884, 2000. Dated: October 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22569 Filed 10-16-18; 8:45 am] BILLING CODE 4164-01-P
![52490 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
The Tobacco Control Act amended the any other additive or ingredient) of a Grandfathered tobacco products are not
Federal Food, Drug, and Cosmetic Act tobacco product where the modified considered new tobacco products and
(FD&C Act) by adding, among other product was commercially marketed in are not subject to the premarket
things, a chapter granting FDA authority the United States after February 15, requirements of section 910 of the FD&C
to regulate the manufacture, marketing, 2007 (section 910(a)(1) of the FD&C Act. The guidance document provides
and distribution of tobacco products to Act). information on how a manufacturer may
protect the public health generally and The Tobacco Control Act also gave establish that a tobacco product was
to reduce tobacco use by minors. FDA the authority to issue a regulation commercially marketed in the United
Section 201(rr) of the FD&C Act (21 deeming all other products that meet the States as of February 15, 2007. A
U.S.C.321(rr)), as amended, defines a statutory definition of a tobacco product grandfathered tobacco product may also
tobacco product as any product made or to be subject to chapter IX of the FD&C serve as the predicate tobacco product
derived from tobacco that is intended Act (section 901(b) (21 U.S.C. 387a(b)) in a section 905(j) report (intended to be
for human consumption, including any of the FD&C Act). On May 10, 2016, used toward demonstrating substantial
component, part, or accessory of a FDA issued that rule, extending FDA’s equivalence) for a new tobacco product
tobacco product (except for raw tobacco product authority to all (section 905(j)(1)A)(i) of the FD&C Act
materials other than tobacco used in products that meet the definition of (21 U.S.C. 387e(j)(1)(A)(i))).
manufacturing a component, part, or tobacco product in the law (except for
accessory of a tobacco product). Section accessories of newly regulated tobacco The guidance recommends that the
910 of the FD&C Act (21 U.S.C. 387j) products), including electronic nicotine manufacturer submit information
sets out premarket requirements for new delivery systems, cigars, hookah, pipe adequate to demonstrate that the
tobacco products. The term new tobacco tobacco, nicotine gels, dissolvables that tobacco product was commercially
product is defined as any tobacco were not already subject to the FD&C marketed in the United States as of
product (including those products in Act, and other tobacco products that February 15, 2007. Examples of such
test markets) that was not commercially may be developed in the future (81 FR information may include, but are not
marketed in the United States as of 28974 at 28976). limited to, the following: Dated copies
February 15, 2007, or any modification FDA refers to tobacco products that of advertisements, dated catalog pages,
(including a change in design, any were commercially marketed (other than dated promotional material, and dated
component, any part, or any constituent, exclusively in test markets) in the bills of lading.
including a smoke constituent, or in the United States as of February 15, 2007, FDA estimates the burden of this
content, delivery, or form of nicotine, or as grandfathered tobacco products. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
Number of Total
Number of burden per
FD&C Act sections or action responses per annual Total hours
respondents response
respondent responses (in hours)
Submit evidence of commercial marketing in the United
States as of February 15, 2007 ....................................... 1,000 1 1,000 5 5,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of take one to review, gather, and submit DEPARTMENT OF HEALTH AND
respondents is based on the fact that dated information if making a request HUMAN SERVICES
requesting an Agency determination of for Agency determination.
the grandfathered status of a tobacco Food and Drug Administration
FDA further estimates it would take a
product under the guidance is not manufacturer approximately 5 hours to [Docket No. FDA–2018–N–3163]
required and also on the number of put together this collection of evidence
grandfathered submissions received and to submit the package to FDA for Agency Information Collection
from 2011 to June 2018. We estimate review. FDA estimates that it should Activities; Proposed Collection;
submissions have increased due to the Comment Request; Physician
take approximately 5,000 hours
effective date of the deeming rule. FDA Interpretation of Information About
annually to respond to this collection of
has stated that, for deemed combustible Prescription Drugs in Scientific
information.
products that were on the market as of Publications Versus Promotional
August 8, 2016, it does not intend to Our estimated burden for the Pieces
initiate enforcement for failure to have information collection reflects an
overall increase of 4,235 hours. We AGENCY: Food and Drug Administration,
premarket authorization until August 8, HHS.
2021. FDA has also stated that, for attribute this adjustment to an updated
number of submissions received ACTION: Notice.
deemed noncombustible products that
were on the market as of August 2, 2016, through this approval and the number of SUMMARY: The Food and Drug
it does not intend to initiate submissions expected in the next 3 Administration (FDA) is announcing an
daltland on DSKBBV9HB2PROD with NOTICES
enforcement for failure to have years. opportunity for public comment on the
premarket authorization until August 8, Dated: October 11, 2018. proposed collection of certain
2022. When these compliance periods Leslie Kux, information by the Agency. Under the
end, FDA expects a drop in the number Paperwork Reduction Act of 1995
Associate Commissioner for Policy.
of grandfathered submissions. The (PRA), Federal Agencies are required to
[FR Doc. 2018–22578 Filed 10–16–18; 8:45 am]
number of hours to gather the evidence publish notice in the Federal Register
is FDA’s estimate of how long it might BILLING CODE 4164–01–P concerning each proposed collection of
VerDate Sep<11>2014 19:46 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00115 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/83_FR_52691/page/1.svg)
![52494 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
III. References Thinking About How We Think,’’ Scientific Review, 6701 Rockledge Drive,
Academic Emergency Medicine, 7:1223– Bethesda, MD 20892, 301–402–4179,
The following references are on 1231, 2000. thomas.cho@nih.gov.
display with the Dockets Management 12. Tsiga, E., E. Panagopoulou, N. Sevdalis, Name of Committee: Center for Scientific
Staff (see ADDRESSES) and are available et al., ‘‘The Influence of Time Pressure Review Special Emphasis Panel; Conflicts in
for viewing by interested persons on Adherence to Guidelines in Primary Gastrointestinal Immunology and Diseases.
between 9 a.m. and 4 p.m., Monday Care: An Experimental Study,’’ BMJ Date: November 6, 2018.
through Friday; these are not available Open, 3:e002700, 2013.
Time: 1:00 p.m. to 5:00 p.m.
13. Saint, S., D.A. Christakis, S. Saha, et al.,
electronically at https:// Agenda: To review and evaluate grant
‘‘Journal Reading Habits of Internists,’’
www.regulations.gov, as these references Journal of General Internal Medicine, applications.
are copyright protected. FDA has 15:881–884, 2000. Place: National Institutes of Health, 6701
verified the website addresses, as of the Rockledge Drive, Bethesda, MD 20892,
Dated: October 11, 2018. (Telephone Conference Call).
date this document publishes in the
Federal Register, but websites are Leslie Kux, Contact Person: Jonathan K Ivins, Ph.D.,
Associate Commissioner for Policy. Scientific Review Officer, Center for
subject to change over time. Scientific Review, National Institutes of
[FR Doc. 2018–22569 Filed 10–16–18; 8:45 am]
1. Yi, J.C., G. Anandalingam, and L.A. Health, 6701 Rockledge Drive, Room 2190,
Sorrell, ‘‘An Expert System to Physician- BILLING CODE 4164–01–P
MSC 7850, Bethesda, MD 20892, (301) 594–
Detailing Planning,’’ Expert Systems with 1245, ivinsj@csr.nih.gov.
Applications, 25:533–544, 2003. Name of Committee: Center for Scientific
2. Kesselheim, A.S., C.T. Robertson, J.A. DEPARTMENT OF HEALTH AND
Review Special Emphasis Panel; Conflicts in
Myers, et al., ‘‘A Randomized Study of HUMAN SERVICES Integrative Gastroenterology.
How Physicians Interpret Research Date: November 7, 2018.
Funding Disclosures,’’ New England National Institutes of Health Time: 1:00 p.m. to 4:00 p.m.
Journal of Medicine, 367:1119–1127,
Agenda: To review and evaluate grant
2012. Center for Scientific Review; Notice of
applications.
3. Spurling, G.K., P.R. Mansfield, B.D. Closed Meetings Place: National Institutes of Health, 6701
Montgomery, et al., ‘‘Information from
Pursuant to section 10(d) of the Rockledge Drive, Bethesda, MD 20892,
Pharmaceutical Companies and the
Federal Advisory Committee Act, as (Telephone Conference Call).
Quality, Quantity, and Cost of
Contact Person: Jonathan K Ivins, Ph.D.,
Physicians’ Prescribing: A Systematic amended, notice is hereby given of the
Review,’’ PLoS Medicine, 7:e1000352, Scientific Review Officer, Center for
following meetings. Scientific Review, National Institutes of
2010. The meetings will be closed to the
4. Cardarelli, R., J.C. Licciardone, and L.G. Health, 6701 Rockledge Drive, Room 2190,
public in accordance with the MSC 7850, Bethesda, MD 20892, (301) 594–
Taylor, ‘‘A Cross-Sectional Evidence- provisions set forth in sections
Based Review of Pharmaceutical 1245, ivinsj@csr.nih.gov.
Promotional Marketing Brochures and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: Center for Scientific
Their Underlying Studies: Is What They as amended. The grant applications and Review Special Emphasis Panel; Member
Tell Us Important and True?’’ BMC the discussions could disclose Conflict: Cell Biology.
Family Practice, 7:13, 2006. confidential trade secrets or commercial Date: November 8, 2018.
5. Wilkes, M.S., B.H. Doblin, and M.F. property such as patentable material, Time: 9:00 a.m. to 12:00 p.m.
Shapiro, ‘‘Pharmaceutical and personal information concerning Agenda: To review and evaluate grant
Advertisements in Leading Medical individuals associated with the grant applications.
Journals: Experts’ Assessments,’’ Annals applications, the disclosure of which Place: National Institutes of Health, 6701
of Internal Medicine, 116:912–919, 1992. Rockledge Drive, Bethesda, MD 20892,
6. Fassiotto, M., C. Simard, C. Sandborg, et would constitute a clearly unwarranted
(Telephone Conference Call).
al., ‘‘An Integrated Career Coaching and invasion of personal privacy. Contact Person: Jessica Smith, Ph.D.,
Time-Banking System Promoting Name of Committee: Center for Scientific Scientific Review Officer, Center for
Flexibility, Wellness, and Success: A Review Special Emphasis Panel; Member Scientific Review, National Institutes of
Pilot Program at Stanford University Conflict: Immune System, Brain, and the Health, 6701 Rockledge Drive, Bethesda, MD
School of Medicine,’’ Academic Visual System. 20892, jessica.smith6@nih.gov.
Medicine, 93:881–887, 2018. Date: November 2, 2018. Name of Committee: Center for Scientific
7. Alison, L., B. Doran, M.L. Long, et al., Time: 9:00 a.m. to 2:00 p.m. Review Special Emphasis Panel; Shared
‘‘The Effects of Subjective Time Pressure Agenda: To review and evaluate grant
Instrumentation for Genomics Research.
and Individual Differences on applications.
Hypotheses Generation and Action Date: November 8, 2018.
Place: National Institutes of Health, 6701
Prioritization in Police Investigations,’’ Rockledge Drive, Bethesda, MD 20892, Time: 11:00 a.m. to 3:00 p.m.
Journal of Experimental Psychology. (Telephone Conference Call). Agenda: To review and evaluate grant
Applied, 19:83–93, 2013. Contact Person: Alessandra C Rovescalli, applications.
8. Ratneshwar, S. and S. Chaiken, Ph.D., Scientific Review Officer, National Place: National Institutes of Health, 6701
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The Case of Its Moderating Effect on the Review, 6701 Rockledge Drive, Rm 5205 (Telephone Conference Call).
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Response Opportunity, and Persuasion,’’ Date: November 5, 2018. methode.bacanamwo@nih.gov.
daltland on DSKBBV9HB2PROD with NOTICES
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Sampling Models,’’ Memory & Cognition, (Telephone Conference Call). Time: 10:00 a.m. to 4:00 p.m.
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