83 FR 42664 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 164 (August 23, 2018)

Page Range		42664-42666
FR Document		2018-18212
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 Tobacco Health Document Submissions.
Federal Register, Volume 83 Issue 164 (Thursday, August 23, 2018)
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42664-42666]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18212]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0377]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Health Document Submission

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 Tobacco Health Document Submissions.

DATES: Submit either electronic or written comments on the collection 
of information by October 22, 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 October 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 22, 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-2013-N-0377 for ``Tobacco Health Document Submission.'' 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: 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].

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

[[Page 42665]]

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.

Tobacco Health Document Submission

OMB Control Number 0910-0654--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) by adding, among other things, a new 
chapter granting FDA important authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect the public 
health generally and to reduce tobacco use by minors. Additionally, 
section 101 of the Tobacco Control Act amended the FD&C Act by adding, 
among other things, new section 904(a)(4) (21 U.S.C. 387d(a)(4)).
    Section 904(a)(4) of the FD&C Act requires each tobacco product 
manufacturer or importer, or agent thereof, to submit all documents 
developed after June 22, 2009, ``that relate to health, toxicological, 
behavioral, or physiologic effects of current or future tobacco 
products, their constituents (including smoke constituents), 
ingredients, components, and additives'' (herein referred to as 
``tobacco health documents'').
    FDA announced the availability of a guidance on this collection in 
the Federal Register of April 4, 2010 (75 FR 20606) (revised December 
5, 2016 (81 FR 87565) and August 10, 2017 (82 FR 37459) (extending 
compliance dates)), and requested health documents that were created 
during the period of June 23, 2009, through December 31, 2009 based on 
the statutory requirements. The guidance stated that information 
required under section 904(a)(4) of the FD&C Act must be submitted to 
FDA beginning December 22, 2009. However, FDA also explained that it 
did not intend to enforce the December 22, 2009, deadline provided that 
the documents were submitted by April 30, 2010, for all health 
documents developed between June 23, 2009 and December 31, 2009. 
Further, FDA stated it would publish a revised guidance specifying the 
timing of subsequent reporting.
    FDA has been collecting the information submitted pursuant to 
section 904(a)(4) of the FD&C Act through a facilitative electronic 
form and through a paper form (Form FDA 3743) for those individuals who 
choose not to use the electronic method. On both forms, FDA is 
requesting the following information from firms that have not already 
reported or still have documents to report:

 Submitter identification
 Submitter type, company name, address, country, company 
headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned 
Facility Establishment Identifier (FEI) number
 Submitter point of contact
 Contact name, title, position title, email, telephone, and fax
 Submission format and contents (as applicable)
 Electronic documents: Media type, media quantity, size of 
submission, quantity of documents, file type, and file software
 Paper documents: Quantity of documents, quantity of volumes, 
and quantity of boxes
 Whether or not a submission is being provided
 Confirmation statement
 Identification and signature of submitter including name, 
company name, address, position title, email, telephone, and fax
 Document categorization (as applicable): Relationship of the 
document or set of documents to the following:
[cir] Health, behavioral, toxicological, or physiological effects
[cir] Uniquely identified current or future tobacco product(s)
[cir] Category of current or future tobacco product(s)
[cir] Specific ingredient(s), constituent(s), component(s), or 
additive(s)
[cir] Class of ingredient(s), constituent(s), component(s), or 
additive(s)
     Document readability and accessibility: Keywords; glossary 
or explanation of any abbreviations, jargon, or internal (e.g., code) 
names; special instructions for loading or compiling submission.
     Document metadata: Date document was created, document 
author(s), document recipient(s), document custodian, document title or 
identification number, beginning and ending Bates numbers, Bates number 
ranges for documents attached to a submitted email, document type, and 
whether the document is present in the University of California San 
Francisco's Truth Tobacco Documents database.
    In addition to the electronic and paper forms, FDA issued guidance 
documents intended to assist persons making tobacco health document 
submissions (draft guidance: December 28, 2009 (74 FR 68629); final 
guidance: April 20, 2010 (75 FR 20606); revised December 5, 2016 (81 FR 
87565) and August 10, 2017 (82 FR 37459) (extending compliance dates)). 
For further assistance, FDA is providing a technical guide, embedded 
hints, and a web tutorial on the electronic portal.
    FDA issued a final rule to deem products meeting the statutory 
definition of ``tobacco product'' to be subject to the FD&C Act on May 
10, 2016 (81 FR 28973), which became effective on August 8, 2016. The 
FD&C Act provides FDA authority to regulate cigarettes, cigarette 
tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other 
tobacco products that the Agency by regulation deems to be subject to 
the law. This final rule extends the Agency's ``tobacco product'' 
authorities to all other categories of products that meet the statutory 
definition of ``tobacco product'' in the FD&C Act, except accessories 
of such deemed tobacco products.
    For tobacco products subject to the deeming rule, FDA understands 
``current or future tobacco products'' to refer to products 
commercially distributed on or after August 8, 2016, or products in any 
stage of research or development at any time after August 8, 2016, 
including experimental products and developmental products intended for 
introduction into the market for consumer use. For cigarettes, 
cigarette tobacco, RYO, and smokeless tobacco, FDA understands 
``current or future tobacco products'' to refer to products 
commercially distributed on or after

[[Page 42666]]

June 23, 2009, or products in any stage of research or development at 
any time after June 23, 2009, including experimental products and 
developmental products intended for introduction into the market for 
consumer use.
    All manufacturers and importers of tobacco products are now subject 
to the FD&C Act and are required to comply with section 904(a)(4), 
which requires immediate and ongoing submission of health documents 
developed after June 22, 2009 (the date of enactment of the Tobacco 
Control Act). However, FDA generally does not intend to enforce the 
requirement at this time with respect to all such health documents 
relating to the deemed tobacco products, so long as a specified set of 
documents, those developed between June 23, 2009, and December 31, 
2009, were submitted by February 8, 2017, or in the case of small-scale 
deemed tobacco product manufacturers (small-scale manufacturers), by 
November 8, 2017 (81 FR 28974 at 29008-09). Additionally, FDA extended 
the compliance deadlines by an additional 6 months for small-scale 
manufacturers in the areas impacted by recent natural disasters to May 
8, 2018. Thereafter, FDA's compliance plan requests deemed 
manufacturers provide tobacco health document submissions from the 
specified period, at least 90 days prior to the delivery for 
introduction into interstate commerce of tobacco products to which the 
health documents relate. Manufacturers or importers of cigarettes, 
cigarette tobacco, RYO, or smokeless tobacco products must provide all 
health documents developed between June 23, 2009, and December 31, 
2009, at least 90 days prior to the delivery for introduction of 
tobacco products into interstate commerce. 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    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Health Document Submissions and Form FDA 3743..............              10              3.2               32               50            1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of documents received each year since the original 
collection period has fallen to less than 5 percent of what was 
received in the original collection period. FDA expects this is because 
documents created within the specified period should have already been 
submitted. The Agency bases this estimate on the total number of 
tobacco firms it is aware of and its experience with document 
production and the number of additional documents that have been 
reported each year since the original estimate of the reporting burden.
    FDA estimates that a tobacco health document submission for cigars, 
pipe and waterpipe tobacco, electronic nicotine delivery systems 
(ENDS), and other tobacco products as required by section 904(a)(4) of 
the FD&C Act, will take approximately 50 hours per submission based on 
the existing collection that applies to tobacco products currently 
subject to the FD&C Act and FDA experience. To derive the number of 
respondents for this provision, FDA assumes that very few manufacturers 
or importers of deemed tobacco products, or agents thereof, would have 
health documents to submit. In addition to the existing 4 respondents, 
the Agency estimates that approximately 6 submissions (2 for cigar 
manufacturers, 1 for pipe and waterpipe tobacco manufacturers, 1 for 
other tobacco product manufacturers, 1 for tobacco importers, and 1 for 
importers of ENDS who are considered manufacturers) will be submitted 
on an annual basis for a total of 10 respondents. FDA estimates the 
total annual reporting burden to be 1,600 hours.
    Based on a review of the information collection of our current OMB 
approval, we have made no adjustments to our burden estimate.

    Dated: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18212 Filed 8-22-18; 8:45 am]
BILLING CODE 4164-01-P
42666 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices

June 23, 2009, or products in any stage all such health documents relating to deemed manufacturers provide tobacco
of research or development at any time the deemed tobacco products, so long as health document submissions from the
after June 23, 2009, including a specified set of documents, those specified period, at least 90 days prior
experimental products and developed between June 23, 2009, and to the delivery for introduction into
developmental products intended for December 31, 2009, were submitted by interstate commerce of tobacco products
introduction into the market for February 8, 2017, or in the case of small- to which the health documents relate.
consumer use. scale deemed tobacco product Manufacturers or importers of cigarettes,
All manufacturers and importers of manufacturers (small-scale cigarette tobacco, RYO, or smokeless
tobacco products are now subject to the
manufacturers), by November 8, 2017 tobacco products must provide all
FD&C Act and are required to comply
(81 FR 28974 at 29008–09). health documents developed between
with section 904(a)(4), which requires
immediate and ongoing submission of Additionally, FDA extended the June 23, 2009, and December 31, 2009,
health documents developed after June compliance deadlines by an additional at least 90 days prior to the delivery for
22, 2009 (the date of enactment of the 6 months for small-scale manufacturers introduction of tobacco products into
Tobacco Control Act). However, FDA in the areas impacted by recent natural interstate commerce. FDA estimates the
generally does not intend to enforce the disasters to May 8, 2018. Thereafter, burden of this collection of information
requirement at this time with respect to FDA’s compliance plan requests as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Tobacco Health Document Submissions and Form FDA
3743 .................................................................................. 10 3.2 32 50 1,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of documents received annual basis for a total of 10 on this subject and to publish a report
each year since the original collection respondents. FDA estimates the total summarizing the topics discussed
period has fallen to less than 5 percent annual reporting burden to be 1,600 within 90 days of the public workshop.
of what was received in the original hours. This summary report fulfills FDA’s
collection period. FDA expects this is Based on a review of the information mandate under FDARA.
because documents created within the collection of our current OMB approval, ADDRESSES: For persons without
specified period should have already we have made no adjustments to our internet access, copies of the summary
been submitted. The Agency bases this burden estimate. report can be requested from the
estimate on the total number of tobacco Dated: August 17, 2018. Division of Drug Information, Food and
firms it is aware of and its experience Leslie Kux, Drug Administration, by mail: 10001
with document production and the New Hampshire Ave, Silver Spring, MD
Associate Commissioner for Policy.
number of additional documents that 20993–0002, or toll free telephone: 855–
[FR Doc. 2018–18212 Filed 8–22–18; 8:45 am]
have been reported each year since the 543–3784.
original estimate of the reporting BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
burden. Dianne Paraoan, Center for Drug
FDA estimates that a tobacco health DEPARTMENT OF HEALTH AND Evaluation and Research, Food and
document submission for cigars, pipe HUMAN SERVICES Drug Administration, 10903 New
and waterpipe tobacco, electronic Hampshire Ave., Bldg 51, Rm. 3326,
nicotine delivery systems (ENDS), and Food and Drug Administration Silver Spring, MD 20993, 301–796–
other tobacco products as required by 2500, Dianne.Paraoan@fda.hhs.gov.
section 904(a)(4) of the FD&C Act, will [Docket No. FDA–2018–D–2776]
SUPPLEMENTARY INFORMATION:
take approximately 50 hours per
Evaluating Inclusion and Exclusion I. Background
submission based on the existing
Criteria in Clinical Trials; Workshop
collection that applies to tobacco Section 610 of FDARA requires that
Report; Availability
products currently subject to the FD&C FDA convene a public workshop to
Act and FDA experience. To derive the AGENCY: Food and Drug Administration, discuss clinical trial eligibility criteria
number of respondents for this HHS. to inform a guidance on this subject and
provision, FDA assumes that very few ACTION: Notice of availability. to publish a report summarizing the
manufacturers or importers of deemed topics discussed within 90 days of the
tobacco products, or agents thereof, SUMMARY: The Food and Drug public workshop (Pub. L. 115–52). On
would have health documents to Administration (FDA or the Agency is April 16, 2018, FDA convened the
submit. In addition to the existing 4 announcing the availability of a public workshop required by FDARA
respondents, the Agency estimates that summary report of a public workshop entitled ‘‘Evaluating Inclusion and
daltland on DSKBBV9HB2PROD with NOTICES

approximately 6 submissions (2 for cigar that was held on April 16, 2018, entitled Exclusion Criteria in Clinical Trials.’’
manufacturers, 1 for pipe and waterpipe ‘‘Evaluating Inclusion and Exclusion This notice announces the availability
tobacco manufacturers, 1 for other Criteria in Clinical Trials.’’ The FDA of the report required by FDARA that
tobacco product manufacturers, 1 for Reauthorization Act of 2017 (FDARA) summarizes the major points explored
tobacco importers, and 1 for importers requires that the Agency convene a with stakeholders during the public
of ENDS who are considered public workshop to discuss clinical trial workshop. The report is intended only
manufacturers) will be submitted on an eligibility criteria to inform a guidance as a summary of the workshop

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Document Created: 2018-08-23 00:32:38
Document Modified: 2018-08-23 00:32:38
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 October 22, 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 42664
83 FR 42664 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 164 (August 23, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
