81 FR 2871 - Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 11 (January 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 11 (January 19, 2016)
| Page Range | 2871-2872 | |
| FR Document | 2016-00836 |
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)] [Notices] [Pages 2871-2872] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00836] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0073] Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may be adapted for or extrapolated to tobacco products. FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. The purpose of this request for information (RFI) is to gather additional information that could help identify and evaluate predictors of consumer initiation, uptake, and use of tobacco products. FDA has already searched the publicly available scientific literature and is now seeking to supplement that with information that is not included in the published scientific literature. DATES: Submit either electronic or written comments or information by March 4, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food [[Page 2872]] and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-N-0073 for ``Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Shireen Ahmad, Office of Science, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4462, Silver Spring, MD 20993-0002, 1- 877-287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) into law. The Tobacco Control Act grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. FDA is conducting a systematic review and meta-analysis of the scientific literature in an effort to identify the best psychosocial predictors that longitudinally predict initiation of tobacco product use, uptake of specific types of tobacco products, and uptake of specific individual tobacco products. This information may be used by FDA in future rulemaking and review of industry submissions. II. Request for Information FDA seeks information related to psychosocial predictors of uptake of tobacco and other products. FDA has searched the publicly available scientific literature and is now looking to supplement that search with information from other sources, specifically unpublished data or other information. For the purpose of this RFI, FDA considers ``psychosocial predictors'' to include constructs that can be measured at the level of the individual, such as beliefs, attitudes, perceptions, intentions, willingness/openness, curiosity, or other measures that have been used in longitudinal research and demonstrated to be associated with product uptake or initiation. In addition to studies reporting on tobacco products, FDA also would accept information on uptake and use of other products from which predictors may be adapted for or extrapolated to tobacco products. If such information is submitted, it should include an explanation of why the predictor and product could be extrapolated to tobacco products. For this RFI, FDA is requesting unpublished data (summarized); unpublished or prepublication copies of manuscripts, conference presentations, and/or posters; dissertations and/or theses; and white papers or other unpublished reports. FDA is requesting both data that show associations as well as data that fail to show an association (i.e., null findings). Specifically, FDA is requesting unpublished data from studies on human subjects (including youth, young adults, and older adults) that include: A longitudinal design (observational or experimental) in which there is at least one month between assessments and data are reported for at least two time points; At least one psychosocial predictor; and A quantifiable (continuous or categorical) outcome measure of actual product use (not intentions to use) related to initiation or uptake. Outcomes may include: Initiation; Continued use; Progression to more frequent use; Choice of a specific product; or Other similar outcomes. Data may come from studies outside of the United States; however, we prefer that reports be submitted in English. For this RFI, FDA is seeking only quantitative scientific data presented in report or manuscript format, and not data from qualitative studies (e.g., interviews, focus groups), anecdotes, or testimonials. FDA is requesting data and information from all interested parties, including, but not limited to, academic and government researchers, industry, and any other sources. When submitting information, please include details about how the data were collected, including the sample composition, year(s) of data collection, and a detailed summary of the methods and measures used. For data summaries, please include both point estimates and measures of variance, as well as effect sizes (if available). Please also note that when submitting information and data to the docket, certain compressed file formats (e.g., zip files) are not allowed. Acceptable file formats include: .doc, .docx, .pdf, .ppt, .pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb, and .wpd. Dated: January 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00836 Filed 1-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices 2871
announced advisory committee meeting making formal oral presentations should Tobacco Products (CTP), is opening a
cannot always be published quickly notify the contact person and submit a docket to obtain data and information
enough to provide timely notice. brief statement of the general nature of related to psychosocial predictors of
Therefore, you should always check the the evidence or arguments they wish to uptake and continued use of tobacco
Agency’s Web site at http:// present, the names and addresses of products, including specific categories
www.fda.gov/AdvisoryCommittees/ proposed participants, and an of tobacco products and specific
default.htm and scroll down to the indication of the approximate time individual tobacco products, as well as
appropriate advisory committee meeting requested to make their presentation on other products from which predictors
link, or call the advisory committee or before February 22, 2016. Time may be adapted for or extrapolated to
information line to learn about possible allotted for each presentation may be tobacco products. FDA is seeking data
modifications before coming to the limited. If the number of registrants and information in the form of reports
meeting. requesting to speak is greater than can and manuscripts that are unpublished
Agenda: On March 15, 2016, the be reasonably accommodated during the or not available through indexed
committee will discuss, make scheduled open public hearing session, bibliographic databases. The purpose of
recommendations, and vote on FDA may conduct a lottery to determine this request for information (RFI) is to
information related to the premarket the speakers for the scheduled open gather additional information that could
approval application for the Absorb GT1 public hearing session. The contact help identify and evaluate predictors of
Bioresorbable Vascular Scaffold (BVS) person will notify interested persons consumer initiation, uptake, and use of
System sponsored by Abbott Vascular. regarding their request to speak by tobacco products. FDA has already
The Absorb GT1 BVS System is a February 24, 2016. searched the publicly available
temporary scaffold that will fully resorb Persons attending FDA’s advisory scientific literature and is now seeking
over time and is indicated for improving committee meetings are advised that the to supplement that with information
coronary luminal diameter in patients Agency is not responsible for providing that is not included in the published
with ischemic heart disease due to de access to electrical outlets. scientific literature.
novo native coronary artery lesions FDA welcomes the attendance of the DATES: Submit either electronic or
(length ≤ 24 millimeters (mm)) with a public at its advisory committee written comments or information by
reference vessel diameter of ≥ 2.5 mm meetings and will make every effort to March 4, 2016.
and ≤ 3.75 mm. accommodate persons with disabilities.
On March 16, 2016, the committee If you require accommodations due to a ADDRESSES: You may submit comments
will discuss, make recommendations, disability, please contact Artair Mallett as follows:
and vote on information related to the at artair.mallett@fda.hhs.gov, 301–796– Electronic Submissions
premarket approval application for the 9638, at least 7 days in advance of the
AngelMed Guardian System sponsored Submit electronic comments in the
meeting.
by Angel Medical Systems, Inc. The FDA is committed to the orderly following way:
AngelMed Guardian System is an conduct of its advisory committee • Federal eRulemaking Portal: http://
implantable cardiac monitor intended to meetings. Please visit our Web site at www.regulations.gov. Follow the
alert patients to ST segment shifts http://www.fda.gov/ instructions for submitting comments.
indicating coronary ischemia. The AdvisoryCommittees/ Comments submitted electronically,
AngelMed Guardian System is intended AboutAdvisoryCommittees/ including attachments, to http://
for use in patients with prior acute ucm111462.htm for procedures on www.regulations.gov will be posted to
coronary syndrome events, and at risk public conduct during advisory the docket unchanged. Because your
for recurrent events, to ST segment committee meetings. comment will be made public, you are
changes indicating cardiac ischemia. Notice of this meeting is given under solely responsible for ensuring that your
FDA intends to make background the Federal Advisory Committee Act (5 comment does not include any
material available to the public no later U.S.C. app. 2). confidential information that you or a
than 2 business days before the meeting. third party may not wish to be posted,
Dated: January 11, 2016.
If FDA is unable to post the background such as medical information, your or
material on its Web site prior to the Jill Hartzler Warner, anyone else’s Social Security number, or
meeting, the background material will Associate Commissioner for Special Medical confidential business information, such
be made publicly available at the Programs. as a manufacturing process. Please note
location of the advisory committee [FR Doc. 2016–00824 Filed 1–15–16; 8:45 am] that if you include your name, contact
meeting, and the background material BILLING CODE 4164–01–P information, or other information that
will be posted on FDA’s Web site after identifies you in the body of your
the meeting. Background material is comments, that information will be
available at http://www.fda.gov/ DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov.
AdvisoryCommittees/Calendar/ HUMAN SERVICES • If you want to submit a comment
default.htm. Scroll down to the Food and Drug Administration with confidential information that you
appropriate advisory committee meeting do not wish to be made available to the
link. [Docket No. FDA–2016–N–0073] public, submit the comment as a
Procedure: Interested persons may written/paper submission and in the
present data, information, or views, Request for Information on
asabaliauskas on DSK5VPTVN1PROD with NOTICES
manner detailed (see ‘‘Written/Paper
orally or in writing, on issues pending Psychosocial Predictors of Uptake of Submissions’’ and ‘‘Instructions’’).
before the committee. Written Tobacco and Other Products
submissions may be made to the contact Written/Paper Submissions
AGENCY: Food and Drug Administration,
person on or before March 1, 2016. Oral HHS. Submit written/paper submissions as
presentations from the public will be ACTION: Notice; request for information. follows:
scheduled on March 15 and 16, 2016, • Mail/Hand delivery/Courier (for
between approximately 1 p.m. and 2 SUMMARY: The Food and Drug written/paper submissions): Division of
p.m. Those individuals interested in Administration (FDA), Center for Dockets Management (HFA–305), Food
VerDate Sep<11>2014 17:50 Jan 15, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/81_FR_2882/page/1.svg)
![2872 Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, rm. theses; and white papers or other
Lane, rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. unpublished reports. FDA is requesting
• For written/paper comments FOR FURTHER INFORMATION CONTACT: both data that show associations as well
submitted to the Division of Dockets Shireen Ahmad, Office of Science, as data that fail to show an association
Management, FDA will post your Center for Tobacco Products, Food and (i.e., null findings). Specifically, FDA is
comment, as well as any attachments, Drug Administration, 10903 New requesting unpublished data from
except for information submitted, Hampshire Ave., Bldg. 75, rm. 4462, studies on human subjects (including
marked and identified, as confidential, Silver Spring, MD 20993–0002, 1–877– youth, young adults, and older adults)
if submitted as detailed in 287–1373, email: CTPRegulations@ that include:
‘‘Instructions.’’ fda.hhs.gov.
Instructions: All submissions received • A longitudinal design
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: (observational or experimental) in
2016–N–0073 for ‘‘Request for I. Background which there is at least one month
Information on Psychosocial Predictors between assessments and data are
of Uptake of Tobacco and Other On June 22, 2009, the President reported for at least two time points;
Products.’’ Received comments will be signed the Family Smoking Prevention
and Tobacco Control Act (Pub. L. 111– • At least one psychosocial predictor;
placed in the docket and, except for
31) (Tobacco Control Act) into law. The and
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at Tobacco Control Act grants FDA • A quantifiable (continuous or
http://www.regulations.gov or at the authority to regulate the manufacture, categorical) outcome measure of actual
Division of Dockets Management marketing, and distribution of tobacco product use (not intentions to use)
between 9 a.m. and 4 p.m., Monday products to protect public health related to initiation or uptake.
through Friday. generally and to reduce tobacco use by
Outcomes may include:
• Confidential Submissions—To minors. FDA is conducting a systematic
submit a comment with confidential review and meta-analysis of the • Initiation;
information that you do not wish to be scientific literature in an effort to • Continued use;
made publicly available, submit your identify the best psychosocial predictors
• Progression to more frequent use;
comments only as a written/paper that longitudinally predict initiation of
submission. You should submit two tobacco product use, uptake of specific • Choice of a specific product; or
copies total. One copy will include the types of tobacco products, and uptake of • Other similar outcomes.
information you claim to be confidential specific individual tobacco products.
Data may come from studies outside
with a heading or cover note that states This information may be used by FDA
of the United States; however, we prefer
‘‘THIS DOCUMENT CONTAINS in future rulemaking and review of
that reports be submitted in English.
CONFIDENTIAL INFORMATION.’’ The industry submissions.
Agency will review this copy, including For this RFI, FDA is seeking only
II. Request for Information quantitative scientific data presented in
the claimed confidential information, in
its consideration of comments. The FDA seeks information related to report or manuscript format, and not
second copy, which will have the psychosocial predictors of uptake of data from qualitative studies (e.g.,
claimed confidential information tobacco and other products. FDA has interviews, focus groups), anecdotes, or
redacted/blacked out, will be available searched the publicly available testimonials. FDA is requesting data and
for public viewing and posted on scientific literature and is now looking information from all interested parties,
http://www.regulations.gov. Submit to supplement that search with including, but not limited to, academic
both copies to the Division of Dockets information from other sources, and government researchers, industry,
Management. If you do not wish your specifically unpublished data or other and any other sources.
name and contact information to be information. For the purpose of this RFI,
made publicly available, you can FDA considers ‘‘psychosocial When submitting information, please
provide this information on the cover predictors’’ to include constructs that include details about how the data were
sheet and not in the body of your can be measured at the level of the collected, including the sample
comments and you must identify this individual, such as beliefs, attitudes, composition, year(s) of data collection,
information as ‘‘confidential.’’ Any perceptions, intentions, willingness/ and a detailed summary of the methods
information marked as ‘‘confidential’’ openness, curiosity, or other measures and measures used. For data summaries,
will not be disclosed except in that have been used in longitudinal please include both point estimates and
accordance with 21 CFR 10.20 and other research and demonstrated to be measures of variance, as well as effect
applicable disclosure law. For more associated with product uptake or sizes (if available).
information about FDA’s posting of initiation. In addition to studies Please also note that when submitting
comments to public dockets, see 80 FR reporting on tobacco products, FDA also information and data to the docket,
56469, September 18, 2015, or access would accept information on uptake certain compressed file formats (e.g., zip
the information at: http://www.fda.gov/ and use of other products from which
files) are not allowed. Acceptable file
regulatoryinformation/dockets/ predictors may be adapted for or
formats include: .doc, .docx, .pdf, .ppt,
default.htm. extrapolated to tobacco products. If such
Docket: For access to the docket to .pptx, .rtf, .txt, .xls, .xlsx, .xlsm, .xlsb,
information is submitted, it should
asabaliauskas on DSK5VPTVN1PROD with NOTICES
read background documents or the include an explanation of why the and .wpd.
electronic and written/paper comments predictor and product could be Dated: January 12, 2016.
received, go to http:// extrapolated to tobacco products. Leslie Kux,
www.regulations.gov and insert the For this RFI, FDA is requesting Associate Commissioner for Policy.
docket number, found in brackets in the unpublished data (summarized); [FR Doc. 2016–00836 Filed 1–15–16; 8:45 am]
heading of this document, into the unpublished or prepublication copies of
BILLING CODE 4164–01–P
‘‘Search’’ box and follow the prompts manuscripts, conference presentations,
and/or go to the Division of Dockets and/or posters; dissertations and/or
VerDate Sep<11>2014 17:50 Jan 15, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/81_FR_2882/page/2.svg)
Document Created: 2016-01-16 01:11:20
Document Modified: 2016-01-16 01:11:20
| 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; request for information. | |
| Dates | Submit either electronic or written comments or information by March 4, 2016. | |
| Contact | Shireen Ahmad, Office of Science, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 4462, Silver Spring, MD 20993-0002, 1- 877-287-1373, email: [email protected] | |
| FR Citation | 81 FR 2871 |
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