80 FR 30077 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 100 (May 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 100 (May 26, 2015)
| Page Range | 30077-30080 | |
| FR Document | 2015-12582 |
[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)] [Notices] [Pages 30077-30080] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12582] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1819] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 25, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title ``Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer (DTC) Prescription Drug Advertisements''. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Spousal Influence on Consumer Understanding of and Response to Direct- to-Consumer Prescription Drug Advertisements--(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. Consumers are often thought of as individual targets for prescription drug advertisements (ads), as if they are always exposed to DTC ads individually and subsequently make judgments about advertised products on their own. However, judgments about prescription drugs portrayed in DTC television ads are likely made in social contexts much of the time. For example, a potential consumer and his or her spouse (e.g., marital or domestic partner) may view an ad together and discuss drug benefits, side effects, and risks. These social interactions may result in unique reactions relative to consumers who view DTC prescription drug television ads alone. For example, spouses may influence their partner by expressing concern about risks and side effects that might occur, or pressuring their partner to consider the drug despite its risks and side effects. These outcomes have important public health implications. The Office of Prescription Drug Promotion plans to examine differences between consumers viewing prescription drug ads with a spouse versus alone through empirical research. The main study will be preceded by pretesting designed to delineate the procedures and measures used in the main study. Pretest and main study participants will be couples who are married or in a marital-like living arrangement in which one member (consumer) has asthma and the other does not (spouse). All participants will be 18 years of age or older and married or cohabiting for 6 months or longer. We will exclude individuals who work in [[Page 30078]] healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Data collection will take place in person. Participants will be randomly assigned to one of four experimental conditions in a 2 x 2 design, as depicted in Table 1. We will compare one version of an ad that depicts a low benefit and low risk drug with a second version that depicts a high benefit and high risk drug. Participants will be randomly assigned to view the ad alone or together with their spouse. Participants in both viewing conditions will individually complete a prequestionnaire. In the ``together'' condition, participants will view the ad with their spouse and then engage in a brief discussion together about the ad. In the ``alone'' condition, participants will view the ad without their spouse, take a short break, and then respond to a postquestionnaire consisting of questions about information in the ad. The short break in the ``alone'' condition will facilitate reflection about the ad to mirror discussion engaged in by those in the ``together'' condition. The consumer in the ``together'' condition will complete the same postquestionnaire administered to those in the ``alone'' condition, and the spouse will complete a slightly different questionnaire that assesses key measures that relate to consumer reactions. These procedures are depicted in Table 2. Participation is estimated to take approximately 60 minutes. Measures are designed to assess memory and understanding of risk and benefit information as well as other ad content, intention to seek more information about the product, and variables pertaining to the consumer-spouse relationship such as relationship closeness and communication style. The questionnaire is available upon request. Table 1--Experimental Study Design ------------------------------------------------------------------------ Risk/benefit condition --------------------------------------- Viewing condition Low risk/low High risk/high benefit benefit ------------------------------------------------------------------------ Alone........................... Condition A....... Condition B Together........................ Condition C....... Condition D ------------------------------------------------------------------------ Table 2--Overview of Data Collection Process for Alone and Together Conditions ------------------------------------------------------------------------ Viewing condition Steps ------------------------------------------- Alone Together ------------------------------------------------------------------------ 1........................... Consumer completes Consumer and spouse prequestionnaire. complete prequestionnaire separately (spouse completes selected measures). 2........................... Consumer views Consumer and spouse advertising stimuli view advertising alone. stimuli together. 3........................... 5 minute break...... Couples engage in a 5 minute semi- structured conversation related to the advertising stimuli. 4........................... Consumer completes Consumer and spouse postquestionnaire. complete postquestionnaire separately (spouse completes selected measures). ------------------------------------------------------------------------ In the Federal Register of November 14, 2014 (79 FR 68278), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received comments from two organizations in response to our Federal Register notice. In the following section, we outline the observations and suggestions raised in the comments and provide our responses. (Comment from Abbvie) It is difficult to ascertain how the Agency will utilize the results of this study should it demonstrate that the perception of ads differs when viewed alone or with someone else. Regulating companion versus solitary viewing practices would present insurmountable legal and practical hurdles. Rather than conduct this study, we suggest that FDA resources and tax payer dollars would be better directed to research that enhances the quality of how we communicate benefit and risk information to consumers regardless of the setting in which the ad is viewed. (Response) Much research in the social sciences demonstrates the strong influence of environmental and social conditions under which humans think and act. In regard to prescription drug advertising, it may be that when a risk is perceived as particularly negative, viewing with a partner reinforces this perception. Conversely, it may be that partners downplay risks or emphasize benefits, leading to alternate perceptions and intentions. These potential outcomes have implications for public health. Thus, it is important to generate insight about not only the message portrayed in DTC TV ads but also the conditions under which these messages are received and processed. Pending findings from this research, organizations involved in developing DTC drug communications may be encouraged to remain aware of the social context in which DTC ads are often viewed and the influence of this context on consumer perceptions, judgments, and decisions. Consideration of this broader context may facilitate the development of better DTC drug communications that remain accurate and balanced regardless of setting. (Comment from Eli Lilly) Compelling a discussion between the consumer and spouse about the advertisement is likely to generate data that may or may not be applicable in a real-world setting. Consider removing the prescribed interaction and allow a discussion to occur if the couple so chooses. (Response) Allowing a discussion to occur if the couple chooses could confound the research design and undermine our ability to make conclusive statements. Implementing the procedures systematically across the sample is a stronger study design (Ref. 1). There is a long tradition in the social and behavioral sciences of studying marital communication as proposed (Ref. 2). This research tradition continues because this method is more objective than participant self-reports (Ref. 3). Also, measures taken from these spousal communications are linked with important real world outcomes including health behavior and well-being (Ref. 4, Ref. 5), divorce, and marital satisfaction (Ref. 6, Ref. 2). This research method compels a discussion between partners as a way to understand the content and style of their communication. Thus, our proposed study is in keeping with the methods in this research area. (Comment from Eli Lilly) We are challenged to understand how this research yields any useful, actionable information when it is impractical to [[Page 30079]] influence who is watching TV advertisements at any given time. (Response) As stated in response to a previous comment, it is important to generate insight about not only the message portrayed in DTC TV ads but also the conditions under which these messages are received and processed. Such insight may facilitate the development of better DTC drug communications regardless of setting. (Comment from Eli Lilly) Include a ``General Population'' control group. (Response) Researching each medical condition, or general population sample, requires significant resources. We are interested in response to the ads among consumers for whom the ad is personally relevant (i.e., they or their partner have been diagnosed with asthma). We are committed to conducting this research using our available resources while ensuring the integrity of the research by collecting data on a high prevalence condition for which participants might be thought of as sufficiently representative of the average consumer, thus allowing us to draw conclusions about broad perceptual and cognitive processing outcomes. (Comment from Eli Lilly) Q12 invites speculation from respondents who may be unable to evaluate what is or is not a ``serious'' side effect. Consider eliminating this question or re-phrasing to: ``Please rate the seriousness of the side effects for [Drug X] that you remember from the ad.'' (Response) We have conducted cognitive interviews to refine and improve the survey questions. Through this process, we found that a number of participants had difficulty reading and/or answering Q12 in its original form. We also tested an alternative version of this question that conforms to the reviewer's re-phrasing, ``In your opinion, how serious are the side effects of [Drug X]?'' Many cognitive interview participants preferred this alternative version, and we will adopt it for the final questionnaire. (Comment from Eli Lilly) Response options in Q16 may be interpreted qualitatively (i.e., on the whole, the risks outweigh the benefits) or literally (i.e., how many more risks were stated than benefits). Rephrasing to reflect true intent is recommended. (Response) We appreciate this comment. This item was tested in a rigorous cognitive interview protocol and there was no indication that participants had difficulty interpreting the response options. However, we will also be conducting pretesting which will provide an additional opportunity to identify and remove questions that do not function as intended, further refining the questionnaire prior to the main study. (Comment from Eli Lilly) Q19b is ambiguous and unclear. Rephrasing or deletion is recommended. (Response) We tested this item as part of our cognitive interview protocol. The majority of participants understood this question, and their answers suggest that the question did a good job of distinguishing between those who focused on the arguments and facts presented in the ad versus those who paid more attention to peripheral cues, such as the visual narrative. Because the item functioned as intended, we intend to retain Q19b. (Comment from Eli Lilly) Q20 is ambiguous and unclear. Rephrasing or deletion is recommended. (Response) In our cognitive interviews, some participants had difficulty understanding the meaning of the introductory phrase ``In these thoughts''. Due to the ambiguity of Q20 as a whole, we will remove this item from the questionnaire. (Comment from Eli Lilly) Q21 instructions could bias respondents to evaluate each statement as risk-related. Consider rephrasing to, ``The following statements describe how people deal with various situations.'' (Response) The Q21 battery is a validated scale specifically designed to measure attitudes toward risk (Ref. 7). Respondents are meant to evaluate the statements as though they are risk-related. Therefore, we will retain the Q21 battery. (Comment from Eli Lilly) The scale for Q25 should be made consistent with other scales to ensure internal consistency. A scale with a midpoint is recommended. (Response) When developing the questionnaires, we included a number of questions from existing multi-items scales. The number and format of response options differed from scale to scale (e.g., 6-points vs. 10- points, fully labelled vs. anchors-only, etc.). We will revise the Likert-type response scales so that the number of levels and labeling formats across questions is consistent. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described in Table 3, we will have sufficient power to detect small-to-medium sized effects in the main study. FDA estimates the burden of this collection of information as follows: Table 3--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average burden per Activity respondents per annual response Total hours respondent responses ---------------------------------------------------------------------------------------------------------------- Pretesting ---------------------------------------------------------------------------------------------------------------- Number to Complete the Screener..... 700 1 700 0.08 (5 minutes)...... 56 Number of Completes................. 120 1 120 1..................... 120 ---------------------------------------------------------------------------------------------------------------- Main Study ---------------------------------------------------------------------------------------------------------------- Number to Complete the Screener..... 4,060 1 4,060 0.08 (5 minutes)...... 325 Number of Completes................. 792 1 792 1..................... 792 --------------------------------------------------------------------------- Total........................... ........... ........... ........... ...................... 1,293 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any [[Page 30080]] subsequent changes to the Web sites after this document publishes in the Federal Register.) Reis, H., and C. Judd, Handbook of Research Methods in Social and Personality Psychology, 2nd Ed. New York: Cambridge University Press (2014). Kerig, P.K., and D.H. Baucom, (Eds.). Couple Observational Coding Systems, Mahwah, NJ: Erlbaum (2004). Bakeman, R., Behavioral Observation and Coding, In H.T. Reis & C.M. Judd (Eds.) Handbook of Research Methods in Social and Personality Psychology,pp. 138-159. New York: Cambridge University Press (2000). Ewart, C.K., C.B. Taylor, H.C. Kraemer, and W.S. Agras. ``High Blood Pressure and Marital Discord: Not Being Nasty Matters More Than Being Nice,'' Health Psychology, 10, pp. 155-163 (1991). Spitzberg, B.H., and W.R. Cupach, Handbook of Interpersonal Competence Research, NY: Springer-Verlag (1989). Gottman, J.M., What Predicts Divorce? The Relationship Between Marital Processes and Marital Outcomes. Hillsdale, NJ: Erlbaum (1994). Rohrmann, B., ``Risk Attitude Scales: Concepts, Questionnaires, Utilizations [Project Report],'' University of Melbourne, Australia. Retrieved from http://www.rohrmannresearch.net/pdfs/rohrmann-racreport.pdf (2005). Dated: May 18, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-12582 Filed 5-22-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices 30077
policies to assist victims of human Respondents: Individual participants
trafficking. in TVAP projects.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Request for Information ................................................................................... 1250 1 .25 312.5
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Spousal Influence on Consumer
Hours: 312.5. HUMAN SERVICES Understanding of and Response to
In compliance with the requirements Direct-to-Consumer Prescription Drug
Food and Drug Administration Advertisements—(OMB Control
of Section 506(c)(2)(A) of the Paperwork
Number 0910–NEW)
Reduction Act of 1995, the
Administration for Children and [Docket No. FDA–2014–N–1819] Section 1701(a)(4) of the Public
Families is soliciting public comment Health Service Act (42 U.S.C.
Agency Information Collection 300u(a)(4)) authorizes FDA to conduct
on the specific aspects of the Activities; Submission for Office of
information collection described above. research relating to health information.
Management and Budget Review; Section 1003(d)(2)(C) of the Federal
Copies of the proposed collection of Comment Request; Spousal Influence
information can be obtained and Food, Drug, and Cosmetic Act (the
on Consumer Understanding of and FD&C Act) (21 U.S.C. 393(d)(2)(C))
comments may be forwarded by writing Response to Direct-to-Consumer authorizes FDA to conduct research
to the Administration for Children and Prescription Drug Advertisements relating to drugs and other FDA
Families, Office of Planning, Research regulated products in carrying out the
and Evaluation, 370 L’Enfant AGENCY: Food and Drug Administration,
HHS. provisions of the FD&C Act.
Promenade SW., Washington, DC 20447, Consumers are often thought of as
Attn: ACF Reports Clearance Officer. ACTION: Notice. individual targets for prescription drug
Email address: infocollection@ advertisements (ads), as if they are
acf.hhs.gov. All requests should be SUMMARY: The Food and Drug
always exposed to DTC ads individually
Administration (FDA) is announcing
identified by the title of the information and subsequently make judgments about
that a proposed collection of
collection. advertised products on their own.
information has been submitted to the
The Department specifically requests However, judgments about prescription
Office of Management and Budget
comments on: (a) Whether the proposed drugs portrayed in DTC television ads
(OMB) for review and clearance under
are likely made in social contexts much
collection of information is necessary the Paperwork Reduction Act of 1995.
of the time. For example, a potential
for the proper performance of the DATES: Fax written comments on the consumer and his or her spouse (e.g.,
functions of the agency, including collection of information by June 25, marital or domestic partner) may view
whether the information shall have 2015. an ad together and discuss drug
practical utility; (b) the accuracy of the benefits, side effects, and risks. These
ADDRESSES: To ensure that comments on
agency’s estimate of the burden of the social interactions may result in unique
the information collection are received,
proposed collection of information; (c) reactions relative to consumers who
OMB recommends that written
the quality, utility, and clarity of the view DTC prescription drug television
comments be faxed to the Office of
information to be collected; and (d) Information and Regulatory Affairs, ads alone. For example, spouses may
ways to minimize the burden of the OMB, Attn: FDA Desk Officer, FAX: influence their partner by expressing
collection of information on 202–395–7285, or emailed to oira_ concern about risks and side effects that
respondents, including through the use submission@omb.eop.gov. All might occur, or pressuring their partner
of automated collection techniques or comments should be identified with the to consider the drug despite its risks and
other forms of information technology. OMB control number 0910–NEW and side effects. These outcomes have
Consideration will be given to title ‘‘Spousal Influence on Consumer important public health implications.
comments and suggestions submitted Understanding of and Response to The Office of Prescription Drug
within 60 days of this publication. Direct-to-Consumer (DTC) Prescription Promotion plans to examine differences
Drug Advertisements’’. Also include the between consumers viewing
Robert Sargis, prescription drug ads with a spouse
FDA docket number found in brackets
Reports Clearance Officer. in the heading of this document. versus alone through empirical research.
[FR Doc. 2015–12591 Filed 5–22–15; 8:45 am] The main study will be preceded by
FOR FURTHER INFORMATION CONTACT: FDA
BILLING CODE 4184–01–P pretesting designed to delineate the
PRA Staff, Office of Operations, Food procedures and measures used in the
and Drug Administration, 8455 main study. Pretest and main study
Colesville Rd., COLE–14526, Silver
mstockstill on DSK4VPTVN1PROD with NOTICES
participants will be couples who are
Spring, MD 20993–0002, PRAStaff@ married or in a marital-like living
fda.hhs.gov. arrangement in which one member
SUPPLEMENTARY INFORMATION: In (consumer) has asthma and the other
compliance with 44 U.S.C. 3507, FDA does not (spouse). All participants will
has submitted the following proposed be 18 years of age or older and married
collection of information to OMB for or cohabiting for 6 months or longer. We
review and clearance. will exclude individuals who work in
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![Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices 30079
influence who is watching TV We also tested an alternative version of (Response) In our cognitive
advertisements at any given time. this question that conforms to the interviews, some participants had
(Response) As stated in response to a reviewer’s re-phrasing, ‘‘In your difficulty understanding the meaning of
previous comment, it is important to opinion, how serious are the side effects the introductory phrase ‘‘In these
generate insight about not only the of [Drug X]?’’ Many cognitive interview thoughts’’. Due to the ambiguity of Q20
message portrayed in DTC TV ads but participants preferred this alternative as a whole, we will remove this item
also the conditions under which these version, and we will adopt it for the from the questionnaire.
messages are received and processed. final questionnaire. (Comment from Eli Lilly) Q21
Such insight may facilitate the (Comment from Eli Lilly) Response instructions could bias respondents to
development of better DTC drug options in Q16 may be interpreted evaluate each statement as risk-related.
communications regardless of setting. qualitatively (i.e., on the whole, the Consider rephrasing to, ‘‘The following
(Comment from Eli Lilly) Include a risks outweigh the benefits) or literally statements describe how people deal
‘‘General Population’’ control group. (i.e., how many more risks were stated with various situations.’’
(Response) Researching each medical than benefits). Rephrasing to reflect true (Response) The Q21 battery is a
condition, or general population intent is recommended. validated scale specifically designed to
sample, requires significant resources. (Response) We appreciate this measure attitudes toward risk (Ref. 7).
We are interested in response to the ads comment. This item was tested in a Respondents are meant to evaluate the
among consumers for whom the ad is rigorous cognitive interview protocol statements as though they are risk-
personally relevant (i.e., they or their and there was no indication that related. Therefore, we will retain the
partner have been diagnosed with participants had difficulty interpreting Q21 battery.
asthma). We are committed to the response options. However, we will
(Comment from Eli Lilly) The scale
conducting this research using our also be conducting pretesting which
for Q25 should be made consistent with
available resources while ensuring the will provide an additional opportunity
other scales to ensure internal
integrity of the research by collecting to identify and remove questions that do
consistency. A scale with a midpoint is
data on a high prevalence condition for not function as intended, further
recommended.
which participants might be thought of refining the questionnaire prior to the
as sufficiently representative of the main study. (Response) When developing the
average consumer, thus allowing us to (Comment from Eli Lilly) Q19b is questionnaires, we included a number
draw conclusions about broad ambiguous and unclear. Rephrasing or of questions from existing multi-items
perceptual and cognitive processing deletion is recommended. scales. The number and format of
outcomes. (Response) We tested this item as part response options differed from scale to
(Comment from Eli Lilly) Q12 invites of our cognitive interview protocol. The scale (e.g., 6-points vs. 10-points, fully
speculation from respondents who may majority of participants understood this labelled vs. anchors-only, etc.). We will
be unable to evaluate what is or is not question, and their answers suggest that revise the Likert-type response scales so
a ‘‘serious’’ side effect. Consider the question did a good job of that the number of levels and labeling
eliminating this question or re-phrasing distinguishing between those who formats across questions is consistent.
to: ‘‘Please rate the seriousness of the focused on the arguments and facts To examine differences between
side effects for [Drug X] that you presented in the ad versus those who experimental conditions, we will
remember from the ad.’’ paid more attention to peripheral cues, conduct inferential statistical tests such
(Response) We have conducted such as the visual narrative. Because the as analysis of variance. With the sample
cognitive interviews to refine and item functioned as intended, we intend size described in Table 3, we will have
improve the survey questions. Through to retain Q19b. sufficient power to detect small-to-
this process, we found that a number of (Comment from Eli Lilly) Q20 is medium sized effects in the main study.
participants had difficulty reading and/ ambiguous and unclear. Rephrasing or FDA estimates the burden of this
or answering Q12 in its original form. deletion is recommended. collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of responses Total annual Average burden
Activity Total hours
respondents per responses per response
respondent
Pretesting
Number to Complete the Screener ................................................. 700 1 700 0.08 (5 minutes) 56
Number of Completes ..................................................................... 120 1 120 1 ......................... 120
Main Study
Number to Complete the Screener ................................................. 4,060 1 4,060 0.08 (5 minutes) 325
Number of Completes ..................................................................... 792 1 792 1 ......................... 792
mstockstill on DSK4VPTVN1PROD with NOTICES
Total .......................................................................................... .................... .................... .................... ............................ 1,293
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
References Management (see ADDRESSES) and may be www.regulations.gov. (FDA has verified all
The following references have been placed seen by interested persons between 9 a.m. the Web site addresses in this reference
and 4 p.m., Monday through Friday, and are section, but we are not responsible for any
on display in the Division of Dockets
available electronically at http://
VerDate Sep<11>2014 17:50 May 22, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\26MYN1.SGM 26MYN1](https://thefederalregister.org/doc/80_FR_30177/page/3.svg)
![30080 Federal Register / Vol. 80, No. 100 / Tuesday, May 26, 2015 / Notices
subsequent changes to the Web sites after this examination. Based on an annual individuals associated with the grant
document publishes in the Federal Register.) objective review of the qualifications applications, the disclosure of which
Reis, H., and C. Judd, Handbook of Research and content of the examination, the would constitute a clearly unwarranted
Methods in Social and Personality Secretary shall annually publish a list in invasion of personal privacy.
Psychology, 2nd Ed. New York: the Federal Register of those entities
Cambridge University Press (2014). Name of Committee: National Institute of
Kerig, P.K., and D.H. Baucom, (Eds.). Couple
and boards that have been approved.’’ General Medical Sciences Initial Review
Observational Coding Systems, Mahwah, HHS has completed its review of Group; Training and Workforce Development
NJ: Erlbaum (2004). entities that certify MROs, in Subcommittee—C.
Bakeman, R., Behavioral Observation and accordance with requests submitted by Date: June 8, 2015.
Coding, In H.T. Reis & C.M. Judd (Eds.) such entities to HHS. Time: 8:30 a.m. to 5:00 p.m.
Handbook of Research Methods in Social The HHS Secretary approves the Agenda: To review and evaluate grant
and Personality Psychology,pp. 138–159. following MRO certifying entities that applications.
New York: Cambridge University Press Place: Hotel Monaco Alexandria, 480 King
offer MRO certification through Street, Alexandria, VA 22314.
(2000).
examination: Contact Person: Mona R. Trempe, Ph.D.,
Ewart, C.K., C.B. Taylor, H.C. Kraemer, and
W.S. Agras. ‘‘High Blood Pressure and American Association of Medical Scientific Review Officer, Office of Scientific
Marital Discord: Not Being Nasty Matters Review Officers (AAMRO), P.O. Box Review, National Institute of General Medical
More Than Being Nice,’’ Health 12873, Research Triangle Park, NC Sciences, National Institutes of Health, 45
Psychology, 10, pp. 155–163 (1991). 27709; Phone: (800) 489–1839; Fax: Center Drive, Room 3An.12A, Bethesda, MD
Spitzberg, B.H., and W.R. Cupach, Handbook (919) 490–1010; Email: cferrell@ 20892–4874, 301–594–3998, trempemo@
of Interpersonal Competence Research, mail.nih.gov.
aamro.com; Web site: http://
NY: Springer-Verlag (1989). This notice is being published less than 15
Gottman, J.M., What Predicts Divorce? The
www.aamro.com/. days prior to the meeting due to the timing
Relationship Between Marital Processes Medical Review Officer Certification limitations imposed by the review and
and Marital Outcomes. Hillsdale, NJ: Council (MROCC), 836 Arlington funding cycle.
Erlbaum (1994). Heights Road, #327, Elk Grove
(Catalogue of Federal Domestic Assistance
Rohrmann, B., ‘‘Risk Attitude Scales: Village, IL 60007; Phone: (847) 631– Program Nos. 93.375, Minority Biomedical
Concepts, Questionnaires, Utilizations 0599; Fax: (847) 483–1282; Email: Research Support; 93.821, Cell Biology and
[Project Report],’’ University of mrocc@mrocc.org; Web site: http:// Biophysics Research; 93.859, Pharmacology,
Melbourne, Australia. Retrieved from www.mrocc.org/. Physiology, and Biological Chemistry
http://www.rohrmannresearch.net/pdfs/ Research; 93.862, Genetics and
rohrmann-racreport.pdf (2005). DATES: HHS approval is effective May
26, 2015. Developmental Biology Research; 93.88,
Dated: May 18, 2015. Minority Access to Research Careers; 93.96,
FOR FURTHER INFORMATION CONTACT: Special Minority Initiatives, National
Leslie Kux,
Jennifer Fan, Pharm.D., J.D., Division of Institutes of Health, HHS)
Associate Commissioner for Policy. Workplace Programs (DWP), Center for
[FR Doc. 2015–12582 Filed 5–22–15; 8:45 am] Dated: May 19, 2015.
Substance Abuse Prevention (CSAP),
BILLING CODE 4164–01–P Substance Abuse and Mental Health Melanie J. Gray,
Services Administration (SAMHSA), 1 Program Analyst, Office of Federal Advisory
Choke Cherry Road, Room 7–1038, Committee Policy.
DEPARTMENT OF HEALTH AND Rockville, MD 20857; Telephone: (240) [FR Doc. 2015–12543 Filed 5–22–15; 8:45 am]
HUMAN SERVICES 276–1759; Email: jennifer.fan@ BILLING CODE 4140–01–P
samhsa.hhs.gov
Mandatory Guidelines for Federal
Workplace Drug Testing Programs Dated: May 15, 2015. DEPARTMENT OF HEALTH AND
Sylvia M. Burwell, HUMAN SERVICES
AGENCY: Substance Abuse and Mental
Secretary.
Health Services Administration National Institutes of Health
[FR Doc. 2015–12559 Filed 5–22–15; 8:45 am]
(SAMHSA), Department of Health and
BILLING CODE 4160–20–P
Human Services. Prospective Grant of Exclusive
ACTION: HHS Approval of Entities That License: Development of Autologous
Certify Medical Review Officers (MRO). DEPARTMENT OF HEALTH AND Tumor Infiltrating Lymphocyte
HUMAN SERVICES Adoptive Cells for the Treatment of
SUMMARY: The current version of the Lung, Breast, Bladder, and HPV-
Department of Health and Human Positive Cancers
National Institutes of Health
Services (HHS) Mandatory Guidelines
for Federal Workplace Drug Testing National Institute of General Medical AGENCY: National Institutes of Health,
Programs (Mandatory Guidelines), Sciences; Notice of Closed Meeting HHS.
effective on October 1, 2010, addresses ACTION: Notice.
the role and qualifications of Medical Pursuant to section 10(d) of the
Review Officers (MROs) and HHS Federal Advisory Committee Act, as SUMMARY: This is notice, in accordance
approval of entities that certify MROs. amended (5 U.S.C. App.), notice is with 35 U.S.C. 209 and 37 CFR 404, that
Subpart M—Medical Review Officer hereby given of the following meeting. the National Institutes of Health,
(MRO), Section 13.1(b) of the Mandatory The meeting will be closed to the Department of Health and Human
mstockstill on DSK4VPTVN1PROD with NOTICES
Guidelines, ‘‘Who may serve as an public in accordance with the Services, is contemplating the grant of
MRO?’’ states as follows: ‘‘Nationally provisions set forth in sections an exclusive patent license to the
recognized entities that certify MROs or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., current licensee, Lion Biotechnologies,
subspecialty boards for physicians as amended. The grant applications and Inc., which is located in Woodland
performing a review of Federal the discussions could disclose Hills, California to practice the
employee drug test results that seek confidential trade secrets or commercial inventions embodied in the following
approval by the Secretary must submit property such as patentable material, patent applications and applications
their qualifications and a sample and personal information concerning claiming priority to these applications:
VerDate Sep<11>2014 17:50 May 22, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\26MYN1.SGM 26MYN1](https://thefederalregister.org/doc/80_FR_30177/page/4.svg)
Document Created: 2018-02-21 10:31:12
Document Modified: 2018-02-21 10:31:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by June 25, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 30077 |
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