83 FR 52472 - Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television
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 | 52472-52477 | |
| FR Document | 2018-22567 |
[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)] [Notices] [Pages 52472-52477] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22567] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3516] Agency Information Collection Activities; Proposed Collection; Comment Request; Disease Awareness and Prescription Drug Promotion on Television 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 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Disease Awareness and Prescription Drug Promotion on Television.'' 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 [[Page 52473]] 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-3516 for ``Disease Awareness and Prescription Drug Promotion on Television.'' 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. Disease Awareness and Prescription Drug Promotion on Television (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 (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. The FDA's Center for Drug Evaluation and Research (CDER), Office of Prescription Drug Promotion (OPDP) is responsible for ensuring that prescription drug promotional materials are truthful, balanced, and accurately communicated. This project is being proposed as part of the research program of OPDP. 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 in particular 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 is 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 [[Page 52474]] 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 notices and peer-reviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a DTC survey conducted in 1999. The present research concerns disease awareness and prescription drug promotion communications on television. When pharmaceutical companies market a new drug, they often also release disease awareness communications about the medical condition the new drug is intended to treat (Ref. 1; Ref. 2). FDA is interested in whether and to what extent this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion. Prior research has documented that in both print (Ref. 3) and online (Ref. 4) contexts, consumers tend to conflate the information presented in prescription drug promotional materials with information presented in disease awareness communications. Specifically, the results of these studies suggest consumers incorrectly ascribe benefits to a prescription drug as a result of being exposed to information in a disease awareness communication that broadly describes the symptoms and negative consequences of the disease. There are ways in which this effect can be attenuated. For example, prior research has indicated that greater visual distinctiveness between the two ad types can ameliorate such confusion (Ref. 3). The present research seeks to extend previous studies of print and online promotion to the context of television promotion, and broadly examine how perceptual similarity between the two communication types, as well as their temporal proximity and exposure frequency, may impact the nature and extent of viewer confusion. Fors Marsh Group (FMG) is conducting this research under the guidance and supervision of FDA to determine how the similarity, temporal positioning, and frequency of exposure to disease awareness communications and prescription drug television promotion impact consumer perception and understanding of the benefits and risks of a prescription drug product. These objectives will be achieved using two experimental studies. The first study will explore the impact on consumer perception and comprehension of different levels of temporal separation between the disease awareness communication and prescription drug promotion within a single period of television programming, as well as the level of similarity versus distinctiveness between these communication types. Temporal separation is defined as the spacing or proximity between the disease awareness communication and prescription drug promotion in the hour-long programming, for example, if they are shown back-to-back or if they are separated by other ads or television programming. Similarity/distinctiveness is defined by variations between the disease awareness communication and prescription drug promotion, including visual and presentation elements such as the setting, actors, and colors. The second study will experimentally examine the impact of disease awareness communication temporal separation and exposure frequency on consumer perception and comprehension. Temporal separation in this second study again refers to the spacing or proximity between the disease awareness communication and prescription drug promotion but is operationally defined as either one day or one week. Exposure frequency is defined as the number of times that participants will view the disease awareness communication, either one, three, or six times. The results of this latter study will examine the practice of ``seeding the market,'' in which pharmaceutical companies release disease awareness communications before releasing product promotion communications. Similarity versus distinctiveness will also be examined in this study. We propose the following hypotheses for this research: Study 1: H1: Increased perceptual similarity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H2: Increased temporal proximity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. Study 2: H1: Increased frequency of exposure to a disease awareness communication before exposure to a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H2: Increased temporal proximity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. H3: Increased perceptual similarity between a disease awareness communication and a prescription drug promotion will result in significantly more conflation of the information presented in both pieces. In each instance, conflation is operationalized as the extent to which an individual remembers and attributes benefits to a product that is based on information presented in a disease awareness communication and not in the drug promotion. To address these hypotheses, Study 1 will employ a 3x4 factorial design in which participants are randomly assigned to one disease awareness communication condition, plus one control condition where participants will not view a disease awareness communication. The extent to which the disease awareness communication is perceptually similar to the product promotion communication will vary, as will the temporal separation of the disease awareness communication and product promotion communication. Table 1 depicts our design visually. Table 1--Study 1 Experimental Design -------------------------------------------------------------------------------------------------------------------------------------------------------- Disease awareness and product ad temporal separation Perceptual similarity -------------------------------------------------------------------------------------------- Disease awareness ad to product ad Within same In neighboring In non-neighboring Back to back commercial pod \1\ commercial pods commercial pods -------------------------------------------------------------------------------------------------------------------------------------------------------- Yes................................ Similar............... Semi-similar.......... Distinct.............. [[Page 52475]] No................................. N/A................... -------------------------------------------------------------------------------------------------------------------------------------------------------- [GRAPHIC] [TIFF OMITTED] TN17OC18.023 Study 2 will employ a 2x2x3 factorial design in which participants are randomly assigned to one disease awareness communication condition. The varying factors in Study 2 are the temporal separation between the disease awareness and product promotion communication, the number of exposures to the disease awareness communication, and the perceptual similarity of the disease awareness communication to the product promotion communication. Table 3 visually depicts our design. Of note, to reduce the overall number of experimental conditions for Study 2, no semi-similar experimental condition is used. --------------------------------------------------------------------------- \1\ A commercial pod refers to a group of ads into which the test ad is inserted, designed to simulate an advertising break during a television program. As depicted in Table 2, by neighboring commercial pods, we mean commercial pods separated only by television programming and no other commercial pods. By non- neighboring commercial pods, we mean commercial pods separated by both television programming and one or more (one, as studied here) other commercial pods. Table 3--Study 2 Experimental Design ---------------------------------------------------------------------------------------------------------------- Exposures to disease awareness ad Time delay until product ad Perceptual ----------------------------------------------------------- exposure (temporal separation) similarity of ads One exposure Three exposures Six exposures ---------------------------------------------------------------------------------------------------------------- One Day......................... Similar........... Distinct.......... One Week........................ Similar........... Distinct.......... ---------------------------------------------------------------------------------------------------------------- [GRAPHIC] [TIFF OMITTED] TN17OC18.024 Study 1 and 2 Sample. The targeted voluntary sample for both studies will comprise adults who self-report a current asthma diagnosis, a lifetime incidence of asthma, or experience a large number of asthma symptoms. These groups are believed to be very likely to be targeted by disease awareness and product promotion [[Page 52476]] communications for asthma. The combined incidence rate of these groups is 22.2% (Ref. 5; Ref. 6). In addition, several exclusion criteria are specified. These include: (1) Training or employment as a healthcare professional, (2) employment with a pharmaceutical company, an advertising agency, a market research company, or the Department of Health and Human Services (HHS), and (3) participation in market research within the past three months on the topic of prescription drugs. Pretest participants will also be ineligible for the main study. Pretesting. Pretesting will take place before the main studies to evaluate the procedures used in the main studies. Each of the two pretests will have the same design as its respective main study (pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both pretests will be to: (1) Ensure that the mock stimuli are understandable, viewable, and delivering intended messages; (2) identify and eliminate any challenges to embedding the mock stimuli within the online survey; (3) ensure that survey questions are appropriate and meet the analytical goals of the research; and (4) pilot test the methods, including examining response rates and timing of survey. The two pretests will be conducted simultaneously.\2\ Based on pretest findings, we will refine the mock stimuli, survey questions, and data collection process, as necessary, to optimize the full-scale study conditions. --------------------------------------------------------------------------- \2\ Pretesting will be preceded by cognitive interviewing, not described here. Cognitive interviews are used to probe a small sample of participants on how and why they responded to various questions as they did, resulting in strong measurement instruments. --------------------------------------------------------------------------- Measurement. Our planned analyses are designed to address the key hypotheses. For both Study 1 and Study 2, we anticipate that the primary analysis will be analysis of variance (ANOVA) to compare the main and interaction effects of the experimental factors. The focal dependent variable will be conflation--a measure of memory and perceptions regarding the promoted drug relative to the information presented in the disease awareness communication. Conflation will be measured by using the number of benefits that are incorrectly attributed to the prescription drug product based on responses to a number of both open-ended and closed-ended items. Other key dependent variables will reflect perceptions and attitudes toward the product ad. These include measures of: 1. Perception of product promotion effectiveness; 2. Behavioral intentions toward the drug; 3. Perceived efficacy of the drug; and 4. Perceived risks of the drug. In addition to the primary variables of interest, we have also identified potential covariates that will be included in the analyses: 1. Knowledge about asthma; 2. Health literacy; and 3. Perceived ad effectiveness. We expect that knowledge about asthma and increased health literacy may moderate any conflation that results from ad similarity, temporal proximity, and frequency of exposure. Perceptions of promotion effectiveness, on the other hand, can be examined both as an outcome/ dependent variable but also as a covariate that examines involvement with the product promotion. Greater involvement may attenuate conflation in that it directs more in-depth processing of both the disease awareness communication and product promotion, and therefore more correct understanding of the claims in each (Ref. 7; Ref. 8; Ref. 9). FDA estimates the burden of this collection of information as follows: Table 5--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Study 1 Pretest screener........ 385 1 385 0.08 (~5 min.) 31 Study 2 Pretest screener........ 329 1 329 0.08 (~5 min.) 26 Study 1 screener................ 3,007 1 3,007 0.08 (~5 min.) 241 Study 2 screener................ 2,643 1 2,643 0.08 (~5 min.) 211 Study 1 Pretest................. 270 1 270 1.33 (~1 hr 20 360 min.) Study 2 Pretest................. 158 1 158 0.53 (~32 84 min.) Study 1......................... 2,105 1 2,105 1.33 (~1 hr 20 2,800 min.) Study 2......................... 1,269 1 1,269 0.53 (32 min.) 673 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 4,426 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. 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 website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. https://www.fiercepharma.com/marketing/unbranded-pharma-ad-what-are-they-good-for-actually-quite-a-bit-marketer-panelists-say?mkt_tok=eyJpIjoiWkRnelpUSmlORFpoWkdNMSIsInQiOiJPaENIUERpT0tnUmt6Y1BPMk9LTnpreUI3bUtPOVRzRnh1RzNuWUtYQmp0cWJhcW05UFhlcllwTzI3V0RJSndjVkZLR3NGUHBLamJOZmJSK2FZeWtIVXczeFRFcmtEV0NFaVdCSjArUmx4dUlRVHZpUzFFOWlVY0dNb1RzOU9XayJ9&mrkid=20932234. 2. https://www.fiercepharma.com/marketing/avanir-launches-nuedexta-brand-campaign-retires-danny-glover-pba-disease-awareness-ad. 3. Aikin, K. J., Sullivan, H. W., & Betts, K. R. (2016). Disease information in direct-to-consumer prescription drug print ads. Journal of Health Communication, 21, 228-239. 4. Sullivan, H. W., O'Donoghue, A. C., Rupert, D. J., Willoughby, J. F., Amoozegar, J. B., & Aikin, K. J. (2016). Are disease awareness links on prescription drug websites misleading? [[Page 52477]] A randomized study. Journal of Health Communication, 21, 1198-1207. 5. Centers for Disease Control and Prevention. (2018a, May 18). 2016 National Health Interview Survey (NHIS) data. Retrieved from https://www.cdc.gov/asthma/nhis/2016/table2-1.htm. 6. Centers for Disease Control and Prevention. (2018b, May 15). Most recent asthma data. Retrieved from https://www.cdc.gov/asthma/most_recent_data.htm. 7. Petty, R. E., & Cacioppo, J. T. (1979). Issue involvement can increase or decrease persuasion by enhancing message-relevant cognitive responses. Journal of Personality and Social Psychology, 37, 1915-1926. doi: 10.1037/0022-3514.37.10.1915. 8. Petty, R. E., & Cacioppo, J. T. (1986). The elaboration likelihood model of persuasion. Advances in Experimental Social Psychology, 19, 123-205. doi: 10.1016/S0065-2601(08)60214-2. 9. Petty, R. E., Cacioppo, J. T., & Goldman, R. (1981). Personal involvement as a determinant of argument-based persuasion. Journal of Personality and Social Psychology, 41, 847-855. doi: 10.1037/ 0022-3514.41.5.847. Dated: October 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-22567 Filed 10-16-18; 8:45 am] BILLING CODE 4164-01-P
![52472 Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices
A regulatory review period consists of which was 30 days after FDA receipt of DEPARTMENT OF HEALTH AND
two periods of time: A testing phase and the IND. HUMAN SERVICES
an approval phase. For human 2. The date the application was
biological products, the testing phase Food and Drug Administration
initially submitted with respect to the
begins when the exemption to permit [Docket No. FDA–2018–N–3516]
human biological product under section
the clinical investigations of the
351 of the Public Health Service Act (42
biological product becomes effective Agency Information Collection
and runs until the approval phase U.S.C. 262): November 16, 2016. FDA
Activities; Proposed Collection;
begins. The approval phase starts with has verified the applicant’s claim that
Comment Request; Disease
the initial submission of an application the biologics license application (BLA)
Awareness and Prescription Drug
to market the human biological product for TREMFYA (BLA 761061) was Promotion on Television
and continues until FDA grants initially submitted on November 16,
permission to market the biological 2016. AGENCY: Food and Drug Administration,
product. Although only a portion of a 3. The date the application was HHS.
regulatory review period may count approved: July 13, 2017. FDA has ACTION: Notice.
toward the actual amount of extension verified the applicant’s claim that BLA SUMMARY: The Food and Drug
that the Director of USPTO may award 761061 was approved on July 13, 2017. Administration (FDA or Agency) is
(for example, half the testing phase must
This determination of the regulatory announcing an opportunity for public
be subtracted as well as any time that
review period establishes the maximum comment on the proposed collection of
may have occurred before the patent
potential length of a patent extension. certain information by the Agency.
was issued), FDA’s determination of the
However, the USPTO applies several Under the Paperwork Reduction Act of
length of a regulatory review period for
statutory limitations in its calculations 1995 (the PRA), Federal Agencies are
a human biological product will include
of the actual period for patent extension. required to publish notice in the
all of the testing phase and approval
In its applications for patent extension, Federal Register concerning each
phase as specified in 35 U.S.C.
this applicant seeks 1,252 days or 1,203 proposed collection of information and
156(g)(1)(B).
FDA has approved for marketing the days of patent term extension. to allow 60 days for public comment in
human biologic product TREMFYA response to the notice. This notice
(guselkumab). TREMFYA is indicated III. Petitions solicits comments on research entitled,
for the treatment of adult patients with ‘‘Disease Awareness and Prescription
Anyone with knowledge that any of Drug Promotion on Television.’’
moderate-to-severe plaque psoriasis the dates as published are incorrect may
who are candidates for systemic therapy DATES: Submit either electronic or
submit either electronic or written written comments on the collection of
or phototherapy. Subsequent to this comments and, under 21 CFR 60.24, ask
approval, the USPTO received patent information by December 17, 2018.
for a redetermination (see DATES). ADDRESSES: You may submit comments
term restoration applications for
Furthermore, as specified in § 60.30 (21 as follows. Please note that late,
TREMFYA (U.S. Patent Nos.7,935,344
and 7,993,645) from Janssen Biotech, CFR 60.30), any interested person may untimely filed comments will not be
Inc., and the USPTO requested FDA’s petition FDA for a determination considered. Electronic comments must
assistance in determining the patents’ regarding whether the applicant for be submitted on or before December 17,
eligibility for patent term restoration. In extension acted with due diligence 2018. The https://www.regulations.gov
a letter dated January 9, 2018, FDA during the regulatory review period. To electronic filing system will accept
advised the USPTO that this human meet its burden, the petition must comments until midnight Eastern Time
biological product had undergone a comply with all the requirements of at the end of December 17, 2018.
regulatory review period and that the § 60.30, including but not limited to: Comments received by mail/hand
approval of TREMFYA represented the Must be timely (see DATES), must be delivery/courier (for written/paper
first permitted commercial marketing or filed in accordance with § 10.20, must submissions) will be considered timely
use of the product. Thereafter, the contain sufficient facts to merit an FDA if they are postmarked or the delivery
USPTO requested that FDA determine investigation, and must certify that a service acceptance receipt is on or
the product’s regulatory review period. true and complete copy of the petition before that date.
II. Determination of Regulatory Review has been served upon the patent Electronic Submissions
Period applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.) Submit electronic comments in the
FDA has determined that the Petitions should be in the format following way:
applicable regulatory review period for specified in 21 CFR 10.30. • Federal eRulemaking Portal:
TREMFYA is 2,968 days. Of this time, https://www.regulations.gov. Follow the
2,728 days occurred during the testing Submit petitions electronically to instructions for submitting comments.
phase of the regulatory review period, https://www.regulations.gov at Docket Comments submitted electronically,
while 240 days occurred during the No. FDA–2013–S–0610. Submit written including attachments, to https://
approval phase. These periods of time petitions (two copies are required) to the www.regulations.gov will be posted to
were derived from the following dates: Dockets Management Staff (HFA–305), the docket unchanged. Because your
1. The date an exemption under Food and Drug Administration, 5630 comment will be made public, you are
section 505(i) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD solely responsible for ensuring that your
daltland on DSKBBV9HB2PROD with NOTICES
and Cosmetic Act (21 U.S.C. 355(i)) 20852. comment does not include any
became effective: May 30, 2009. The Dated: October 11, 2018. confidential information that you or a
applicant claims April 30, 2009, as the third party may not wish to be posted,
Leslie Kux,
date the investigational new drug such as medical information, your or
application (IND) became effective. Associate Commissioner for Policy. anyone else’s Social Security number, or
However, FDA records indicate that the [FR Doc. 2018–22571 Filed 10–16–18; 8:45 am] confidential business information, such
IND effective date was May 30, 2009, BILLING CODE 4164–01–P as a manufacturing process. Please note
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![Federal Register / Vol. 83, No. 201 / Wednesday, October 17, 2018 / Notices 52477
A randomized study. Journal of Health potential relevance to the growth or Written/Paper Submissions
Communication, 21, 1198–1207. progression of one or more pediatric
5. Centers for Disease Control and Submit written/paper submissions as
cancers. The latter list details those follows:
Prevention. (2018a, May 18). 2016
National Health Interview Survey (NHIS)
targets that are unlikely to be associated • Mail/Hand delivery/Courier (for
data. Retrieved from https:// with the growth or progression of written/paper submissions): Dockets
www.cdc.gov/asthma/nhis/2016/table2- pediatric cancers such that statutory Management Staff (HFA–305), Food and
1.htm. requirements for early pediatric Drug Administration, 5630 Fishers
6. Centers for Disease Control and evaluation would be waived. These lists Lane, Rm. 1061, Rockville, MD 20852.
Prevention. (2018b, May 15). Most recent fulfill one of FDA’s obligations under
asthma data. Retrieved from https://
• For written/paper comments
the FDA Reauthorization Act of 2017 submitted to the Dockets Management
www.cdc.gov/asthma/most_recent_
(FDARA) and provide information to Staff, FDA will post your comment, as
data.htm.
7. Petty, R. E., & Cacioppo, J. T. (1979). Issue industry in planning for initial pediatric well as any attachments, except for
involvement can increase or decrease study plan submissions for certain information submitted, marked and
persuasion by enhancing message- oncology drugs or biological products in identified, as confidential, if submitted
relevant cognitive responses. Journal of accordance with the amended as detailed in ‘‘Instructions.’’
Personality and Social Psychology, 37, provisions of the Federal Food, Drug, Instructions: All submissions received
1915–1926. doi: 10.1037/0022- and Cosmetic Act (FD&C Act). FDA is
3514.37.10.1915. must include the Docket No. FDA–
establishing this docket for public 2018–N–3633 for ‘‘Oncology Center of
8. Petty, R. E., & Cacioppo, J. T. (1986). The
elaboration likelihood model of
comment on possible additions to or Excellence: Pediatric Oncology Program;
persuasion. Advances in Experimental deletions from the list on the lists Establishment of a Public Docket;
Social Psychology, 19, 123–205. doi: described above. Request for Comments.’’ Received
10.1016/S0065-2601(08)60214-2. The lists can be found on the comments will be placed in the docket
9. Petty, R. E., Cacioppo, J. T., & Goldman, Oncology Center of Excellence: and, except for those submitted as
R. (1981). Personal involvement as a ‘‘Confidential Submissions,’’ publicly
determinant of argument-based
Pediatric Oncology website at the
persuasion. Journal of Personality and following link: https://www.fda.gov/ viewable at https://www.regulations.gov
Social Psychology, 41, 847–855. doi: AboutFDA/CentersOffices/ or at the Dockets Management Staff
10.1037/0022-3514.41.5.847. OfficeofMedicalProductsandTobacco/ between 9 a.m. and 4 p.m., Monday
Dated: October 11, 2018. OCE/ucm544641.htm. through Friday.
• Confidential Submissions—To
Leslie Kux, DATES: Submit either electronic or submit a comment with confidential
Associate Commissioner for Policy. written comments. This docket will information that you do not wish to be
[FR Doc. 2018–22567 Filed 10–16–18; 8:45 am] remain open indefinitely. made publicly available, submit your
BILLING CODE 4164–01–P ADDRESSES: You may submit comments comments only as a written/paper
as follows: submission. You should submit two
copies total. One copy will include the
DEPARTMENT OF HEALTH AND Electronic Submissions information you claim to be confidential
HUMAN SERVICES with a heading or cover note that states
Submit electronic comments in the
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration
CONFIDENTIAL INFORMATION.’’ FDA
[Docket No. FDA–2018–N–3633] • Federal eRulemaking Portal: will review this copy, including the
https://www.regulations.gov. Follow the claimed confidential information, in its
Oncology Center of Excellence: instructions for submitting comments. consideration of comments. The second
Pediatric Oncology Program; Comments submitted electronically, copy, which will have the claimed
Establishment of a Public Docket; including attachments, to https:// confidential information redacted/
Request for Comments www.regulations.gov will be posted to blacked out, will be available for public
the docket unchanged. Because your viewing and posted on https://
AGENCY: Food and Drug Administration, comment will be made public, you are
HHS. www.regulations.gov. Submit both
solely responsible for ensuring that your copies to the Dockets Management Staff.
ACTION: Notice; establishment of a comment does not include any
public docket; request for comments. If you do not wish your name and
confidential information that you or a contact information be made publicly
SUMMARY: The Oncology Center of third party may not wish to be posted, available, you can provide this
Excellence (OCE) Pediatric Oncology such as medical information, your or information on the cover sheet and not
Program of the Food and Drug anyone else’s Social Security number, or in the body of your comments and you
Administration (FDA or the Agency) confidential business information, such must identify the information as
announces the creation of a list of as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
molecular targets that have been that if you include your name, contact as ‘‘confidential’’ will not be disclosed
determined to be substantially relevant information, or other information that except in accordance with 21 CFR 10.20
to the growth or progression of a identifies you in the body of your and other applicable disclosure law. For
pediatric cancer (Candidate Pediatric comments, that information will be more information about FDA’s posting
Molecular Target List) and a list of posted on https://www.regulations.gov. of comments to public dockets, see 80
molecular targets of new cancer drugs • If you want to submit a comment FR 56469, September 18, 2015, or access
daltland on DSKBBV9HB2PROD with NOTICES
and biological products in development with confidential information that you the information at: https://www.gpo.gov/
for which requirements for studies in do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
pediatric cancers would be public, submit the comment as a 23389.pdf.
automatically waived. The former list written/paper submission and in the Docket: For access to the docket to
includes molecular targets for which manner detailed below (see ‘‘Written/ read background documents or the
prevailing evidence and/or a scientific Paper Submissions’’ and electronic and written/paper comments
rationale exists to determine their ‘‘Instructions’’). received, go to https://
VerDate Sep<11>2014 19:46 Oct 16, 2018 Jkt 247001 PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 E:\FR\FM\17OCN1.SGM 17OCN1](https://thefederalregister.org/doc/83_FR_52673/page/6.svg)
Document Created: 2018-10-17 01:48:03
Document Modified: 2018-10-17 01:48:03
| 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 December 17, 2018. | |
| 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] | |
| FR Citation | 83 FR 52472 |
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