83 FR 6190 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 30 (February 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 30 (February 13, 2018)
| Page Range | 6190-6192 | |
| FR Document | 2018-02852 |
[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)] [Notices] [Pages 6190-6192] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02852] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0180] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.'' DATES: Submit either electronic or written comments on the collection of information by April 16, 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 April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-0180 for ``Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.'' 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 [[Page 6191]] 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov. 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 including each proposed extension of an existing 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. Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications OMB Control Number 0910-0810--Extension In order to conduct educational and public information programs relating to tobacco use as authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's Center for Tobacco Products will create and use a variety of media to inform and educate the public, tobacco retailers, and health professionals about the risks of tobacco use, how to quit using tobacco products, and FDA's role in regulating tobacco. To ensure that these health communication messages have the highest potential to be received, understood, and accepted by those for whom they are intended, the Center for Tobacco Products will conduct research and studies relating to the control and prevention of disease. In conducting such research, FDA will employ formative pretests. Formative pretests are conducted on a small scale, and their focus is on developing and assessing the likely effectiveness of communications with specific target audiences. This type of research involves: (1) Assessing audience knowledge, attitudes, behaviors, and other characteristics for the purpose of determining the need for and developing health messages, communication strategies, and public information programs and (2) pretesting these health messages, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. Formative pretesting is a staple of best practices in communications research. Obtaining voluntary feedback from intended audiences during the development of messages and materials is crucial for the success of every communication program. The purpose of obtaining information from formative pretesting is that it allows FDA to improve materials and strategies while revisions are still affordable and possible. Formative pretesting can also avoid potentially expensive and dangerous unintended outcomes caused by audiences' interpreting messages in a way that was not intended by the drafters. By maximizing the effectiveness of messages and strategies for reaching targeted audiences, the frequency with which tobacco communication messages need to be modified should be greatly reduced. The voluntary information collected will serve the primary purpose of providing FDA information about the perceived effectiveness of messages, advertisements, and materials in reaching and successfully communicating with their intended audiences. Quantitative testing messages and other materials with a sample of the target audience will allow FDA to refine messages, advertisements, and materials, including questionnaires or images, directed at consumers while the materials are still in the developmental stage. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Screener.................................... 130,500 1 130,500 0.083 (5 minutes)......................... 10,831 Self-Administered Surveys................... 27,000 1 27,000 0.33 (20 minutes)......................... 8,910 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 19,741 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 6192]] The number of respondents to be included in each new survey will vary, depending on the nature of the material or message being tested and the target audience. The burden for this information collection extension is proposed to increase by 12,613 hours since the last OMB approval. The burden increase is due to an increase in the number of respondents and the categories of respondents. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02852 Filed 2-12-18; 8:45 am] BILLING CODE 4164-01-P
![6190 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
Devices News & Events—Workshops & Dated: February 8, 2018. www.regulations.gov will be posted to
Conferences calendar at http:// Leslie Kux, the docket unchanged. Because your
www.fda.gov/MedicalDevices/ Associate Commissioner for Policy. comment will be made public, you are
NewsEvents/WorkshopsConferences/ [FR Doc. 2018–02923 Filed 2–12–18; 8:45 am] solely responsible for ensuring that your
default.htm. (Select this public BILLING CODE 4164–01–P comment does not include any
workshop from the posted events list.) confidential information that you or a
Please provide complete contact third party may not wish to be posted,
information for each attendee, including DEPARTMENT OF HEALTH AND such as medical information, your or
name, title, affiliation, address, email, HUMAN SERVICES anyone else’s Social Security number, or
and telephone. confidential business information, such
Registration is free and based on Food and Drug Administration as a manufacturing process. Please note
space availability, with priority given to [Docket No. FDA–2018–N–0180] that if you include your name, contact
early registrants. Persons interested in information, or other information that
attending this public workshop must Agency Information Collection identifies you in the body of your
register by April 20, 2018, by 4 p.m. Activities; Proposed Collection; comments, that information will be
Eastern Time. Early registration is Comment Request; Generic Clearance posted on https://www.regulations.gov.
recommended because seating is for the Collection of Quantitative Data • If you want to submit a comment
limited; therefore, FDA may limit the on Tobacco Products and with confidential information that you
number of participants from each Communications do not wish to be made available to the
organization. Registrants will receive public, submit the comment as a
confirmation when they have been AGENCY: Food and Drug Administration, written/paper submission and in the
accepted. If time and space permit, HHS. manner detailed (see ‘‘Written/Paper
onsite registration on the day of the ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
public workshop will be provided
SUMMARY: The Food and Drug Written/Paper Submissions
beginning at 7:30 a.m. We will let
registrants know if registration closes Administration (FDA or Agency) is Submit written/paper submissions as
before the day of the public workshop. announcing an opportunity for public follows:
If you need special accommodations comment on the proposed collection of • Mail/Hand delivery/Courier (for
due to a disability, please contact Susan certain information by the Agency. written/paper submissions): Dockets
Monahan, Center for Devices and Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
Radiological Health, Food and Drug 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
Administration, 10903 New Hampshire required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
Ave., Bldg. 32, Rm. 5231, Silver Spring, Federal Register concerning each • For written/paper comments
MD 20993–0002, 301–796–5661, email: proposed collection of information, submitted to the Dockets Management
Susan.Monahan@fda.hhs.gov, no later including each proposed extension of an Staff, FDA will post your comment, as
than April 16, 2018. existing collection of information, and well as any attachments, except for
Streaming Webcast of the Public to allow 60 days for public comment in information submitted, marked and
Workshop: This public workshop will response to the notice. This notice identified, as confidential, if submitted
also be webcast. The webcast link will solicits comments on ‘‘Generic as detailed in ‘‘Instructions.’’
be available on the registration web page Clearance for the Collection of Instructions: All submissions received
after April 20, 2018. Organizations are Quantitative Data on Tobacco Products must include the Docket No. FDA–
requested to register all participants, but and Communications.’’ 2018–N–0180 for ‘‘Generic Clearance for
to view using one connection per DATES: Submit either electronic or the Collection of Quantitative Data on
location. written comments on the collection of Tobacco Products and
If you have never attended a Connect information by April 16, 2018. Communications.’’ Received comments,
Pro event before, test your connection at ADDRESSES: You may submit comments those filed in a timely manner (see
https://collaboration.fda.gov/common/ as follows. Please note that late, ADDRESSES), will be placed in the docket
help/en/support/meeting_test.htm. To untimely filed comments will not be and, except for those submitted as
get a quick overview of the Connect Pro considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
program, visit https://www.adobe.com/ be submitted on or before April 16, viewable at https://www.regulations.gov
go/connectpro_overview. FDA has 2018. The https://www.regulations.gov or at the Dockets Management Staff
verified the website addresses in this electronic filing system will accept between 9 a.m. and 4 p.m., Monday
document, as of the date this document comments until midnight Eastern Time through Friday.
publishes in the Federal Register, but at the end of April 16, 2018. Comments • Confidential Submissions—To
websites are subject to change over time. received by mail/hand delivery/courier submit a comment with confidential
Transcripts: Please be advised that as (for written/paper submissions) will be information that you do not wish to be
soon as a transcript of the public considered timely if they are made publicly available, submit your
workshop is available, it will be postmarked or the delivery service comments only as a written/paper
accessible at https:// acceptance receipt is on or before that submission. You should submit two
www.regulations.gov. It may be viewed date. copies total. One copy will include the
at the Dockets Management Staff (see information you claim to be confidential
ADDRESSES). A link to the transcript will Electronic Submissions with a heading or cover note that states
sradovich on DSK3GMQ082PROD with NOTICES
also be available approximately 45 days Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
after the public workshop on the following way: CONFIDENTIAL INFORMATION.’’ The
internet at http://www.fda.gov/Medical • Federal eRulemaking Portal: Agency will review this copy, including
Devices/NewsEvents/Workshops https://www.regulations.gov. Follow the the claimed confidential information, in
Conferences/default.htm. (Select this instructions for submitting comments. its consideration of comments. The
public workshop from the posted events Comments submitted electronically, second copy, which will have the
list). including attachments, to https:// claimed confidential information
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![6192 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
The number of respondents to be time. Indeed, Mallinkrodt stated in its redetermination by April 16, 2018.
included in each new survey will vary, May 15, 2013, request for withdrawal of Furthermore, any interested person may
depending on the nature of the material approval of ANDA 075726 that it had petition FDA for a determination
or message being tested and the target never manufactured or distributed its regarding whether the applicant for
audience. The burden for this product after it received approval of its extension acted with due diligence
information collection extension is application. during the regulatory review period by
proposed to increase by 12,613 hours In the Federal Register of October 4, August 13, 2018. See ‘‘Petitions’’ in the
since the last OMB approval. The 2016 (81 FR 68427), FDA erroneously SUPPLEMENTARY INFORMATION section for
burden increase is due to an increase in included ANDA 075726 in a list of drug more information.
the number of respondents and the applications for which approval was ADDRESSES: You may submit comments
categories of respondents. being withdrawn under § 314.150(c) (21 as follows. Please note that late,
Dated: February 7, 2018. CFR 314.150(c)). In a separate notice untimely filed comments will not be
Leslie Kux, published in this issue of the Federal considered. Electronic comments must
Associate Commissioner for Policy.
Register, FDA corrects that notice to be submitted on or before April 16,
remove ANDA 075726 from the list of 2018. The https://www.regulations.gov
[FR Doc. 2018–02852 Filed 2–12–18; 8:45 am]
applications whose approval was electronic filing system will accept
BILLING CODE 4164–01–P
withdrawn under § 314.150(c). In comments until midnight Eastern Time
addition, for the reasons discussed at the end of April 16, 2018. Comments
DEPARTMENT OF HEALTH AND above, and pursuant to Mallinkrodt’s received by mail/hand delivery/courier
HUMAN SERVICES request, FDA is withdrawing approval (for written/paper submissions) will be
of ANDA 075726, and all amendments considered timely if they are
Food and Drug Administration and supplements thereto, under postmarked or the delivery service
§ 314.150(d). Distribution of PEMOLINE acceptance receipt is on or before that
[Docket No. FDA–2018–N–0409] Tablets, 18.75 mg, 37.5 mg, and 75 mg, date.
Mallinkrodt Pharmaceuticals LLC; in interstate commerce without an
Electronic Submissions
Withdrawal of Approval of an approved application is illegal and
subject to regulatory action (see sections Submit electronic comments in the
Abbreviated New Drug Application for following way:
PEMOLINE Tablets, 18.75 Milligrams, 505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)). • Federal eRulemaking Portal:
37.5 Milligrams, and 75 Milligrams https://www.regulations.gov. Follow the
Dated: February 8, 2018. instructions for submitting comments.
AGENCY: Food and Drug Administration, Leslie Kux,
HHS. Comments submitted electronically,
Associate Commissioner for Policy. including attachments, to https://
ACTION: Notice.
[FR Doc. 2018–02925 Filed 2–12–18; 8:45 am] www.regulations.gov will be posted to
SUMMARY: The Food and Drug BILLING CODE 4164–01–P the docket unchanged. Because your
Administration (FDA) is withdrawing comment will be made public, you are
the approval of abbreviated new drug solely responsible for ensuring that your
application (ANDA) 075726 for DEPARTMENT OF HEALTH AND comment does not include any
PEMOLINE Tablets, 18.75 milligrams HUMAN SERVICES confidential information that you or a
(mg), 37.5 mg, and 75 mg, held by third party may not wish to be posted,
Mallinkrodt Pharmaceuticals, LLC Food and Drug Administration such as medical information, your or
(Mallinkrodt). Mallinkrodt requested [Docket No. FDA–2013–E–0780] anyone else’s Social Security number, or
withdrawal of this application and has confidential business information, such
waived its opportunity for a hearing. Determination of Regulatory Review as a manufacturing process. Please note
DATES: Approval is withdrawn as of Period for Purposes of Patent that if you include your name, contact
February 13, 2018. Extension; VASCEPA information, or other information that
FOR FURTHER INFORMATION CONTACT: AGENCY: Food and Drug Administration, identifies you in the body of your
Kristiana Brugger, Center for Drug HHS. comments, that information will be
Evaluation and Research, Food and posted on https://www.regulations.gov.
ACTION: Notice. • If you want to submit a comment
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6262, SUMMARY: The Food and Drug with confidential information that you
Silver Spring, MD 20993, 301–796– Administration (FDA or the Agency) has do not wish to be made available to the
3600. determined the regulatory review period public, submit the comment as a
for VASCEPA and is publishing this written/paper submission and in the
SUPPLEMENTARY INFORMATION: FDA manner detailed (see ‘‘Written/Paper
approved ANDA 075726 for PEMOLINE notice of that determination as required
by law. FDA has made the Submissions’’ and ‘‘Instructions’’).
Tablets, 18.75 mg, 37.5 mg, and 75 mg,
on March 30, 2001, for the conditions of determination because of the Written/Paper Submissions
use in the labeling of new drug submission of an application to the
Submit written/paper submissions as
application (NDA) 016832, the reference Director of the U.S. Patent and
follows:
listed drug on which it relied. However, Trademark Office (USPTO), Department • Mail/Hand delivery/Courier (for
on October 24, 2005, FDA announced its of Commerce, for the extension of a
sradovich on DSK3GMQ082PROD with NOTICES
written/paper submissions): Dockets
concern that the overall liver toxicity patent which claims that human drug Management Staff (HFA–305), Food and
risk of CYLERT (NDA 016832) and product. Drug Administration, 5630 Fishers
generic pemoline products outweighed DATES: Anyone with knowledge that any Lane, Rm. 1061, Rockville, MD 20852.
the benefits of these products. of the dates as published (in the • For written/paper comments
Mallinkrodt and other holders of SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management
approved applications for PEMOLINE incorrect may submit either electronic Staff, FDA will post your comment, as
products ceased marketing them at that or written comments and ask for a well as any attachments, except for
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Document Created: 2018-02-13 02:32:19
Document Modified: 2018-02-13 02:32:19
| 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 April 16, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 6190 |
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