80 FR 44971 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 144 (July 28, 2015)

Page Range		44971-44973
FR Document		2015-18410

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 144 (Tuesday, July 28, 2015)

[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44971-44973]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18410]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0386]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Registration and 
Product Listing for Owners and Operators of Domestic Tobacco Product 
Establishments and Listing of Ingredients in Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
27, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0650. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Registration and Product Listing for Owners and Operators of Domestic 
Tobacco Product Establishments and Listing of Ingredients in Tobacco 
Products--OMB Control Number 0910-0650--Extension

    On June 22, 2009, the President signed the Tobacco Control Act 
(Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) by, 
among other things, adding a 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.
    Section 905(b) of the FD&C Act (21 U.S.C. 387e(b)), as amended by 
the Tobacco Control Act, requires that ``every person who owns or 
operates any establishment in any State engaged in the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products . . .'' register with FDA the name, places of business, and 
all establishments owned or operated by that person. Every person must 
register by December 31 of each year. Section 905(c) of the FD&C Act 
requires that first-time persons ``engaging in the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products shall register with the Secretary the name, places of 
business, and all such establishments of that person.'' Section 905(d) 
states that persons required to register under section 905(b) or (c) 
shall register any additional establishment that they own or operate in 
any State which begins the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products. Section 905(h)

[[Page 44972]]

addresses foreign establishment registration requirements, which will 
go into effect when regulations are issued by the Secretary. Section 
905(i)(1) of the FD&C Act, as amended by the Tobacco Control Act, 
requires that all registrants ``shall, at the time of registration 
under any such subsection, file with [FDA] a list of all tobacco 
products which are being manufactured, prepared, compounded, or 
processed by that person for commercial distribution,'' along with 
certain accompanying consumer information, such as all labeling and a 
representative sampling of advertisements. Section 904(a)(1) of the 
FD&C Act (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, 
requires each tobacco product manufacturer or importer, or agent 
thereof, to submit ``a listing of all ingredients, including tobacco, 
substances, compounds, and additives that are * * * added by the 
manufacturer to the tobacco, paper, filter, or other part of each 
tobacco product by brand or by quantity in each brand and subbrand.'' 
Since the Tobacco Control Act was enacted on June 22, 2009, the 
information required under section 904(a)(1) must be submitted to FDA 
by December 22, 2009, and include the ingredients added as of the date 
of submission. Section 904(c) of the FD&C Act also requires submission 
of information whenever additives, or the quantities of additives, are 
changed.
    FDA issued guidance documents on both: (1) Registration and Product 
Listing for Owners and Operators of Domestic Tobacco Product 
Establishments and (2) listing of Ingredients in Tobacco Products to 
assist persons making such submissions to FDA under the Tobacco Control 
Act. While electronic submission of registration and product listing 
information and ingredient listing information are not required, FDA is 
strongly encouraging electronic submission to facilitate efficiency and 
timeliness of data management and collection. To that end, FDA designed 
electronic submission applications to streamline the data entry process 
for registration and product listing and for ingredient listing. These 
tools allow for importation of large quantities of structured data, 
attachment of files (e.g., in portable document format (PDFs) and 
certain media files), and automatic acknowledgement of FDA's receipt of 
submissions.
    FDA also developed paper forms (Form FDA 3741--Registration and 
Listing for Owners and Operators of Domestic Tobacco Product 
Establishments, and Form FDA 3742--Listing of Ingredients in Tobacco 
Products) as an alternative submission tool. Both the electronic 
submission application and the paper forms can be accessed at http://www.fda.gov/tobacco.
    In the Federal Register of April 21, 2015 (80 FR 22202), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                   Number of       Number of     Total annual                                     Total    operating and
         FDA Form/activity/TCA section            respondents    responses per     responses          Hours per  response         hours     maintenance
                                                                  respondent                                                                   costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tobacco Product Establishment Initial                      135               1             135  2..............................      270           $0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Establishment Renewal                      135               1             135  0.20 (12 minutes)..............       27            0.66
 Registration and Listing; Form FDA 3741
 Registration and Product Listing for Owners
 and Operators of Domestic Establishments
 (Electronic and Paper submissions); Section
 905(b), (c), (d), (h), or (i).
Tobacco Product Initial Ingredient Listing;                135               1             135  2..............................      270            0.66
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Tobacco Product Renewal Ingredient Listing;                135               2             270  0.40 (24 minutes)..............      108            1.32
 Form FDA 3742 Listing of Ingredients
 (Electronic and Paper submissions); Section
 904(a)(1) or (c).
Obtaining a Dun and Bradstreet D-U-N-S Number.               8               1               8  0.5............................        4  ..............
Tobacco Product Ingredient Listing Electronic              135               1             135  3..............................      405            0.66
 and Paper submission.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ...............................    1,084            3.96
--------------------------------------------------------------------------------------------------------------------------------------------------------

    On April 21, 2015, the FDA published a 60-day notice (80 FR 22202) 
requesting public comments in the Federal Register. In this notice, the 
total amount of burden hours for this collection was incorrectly listed 
as 1,354 hours. After an internal review of burden for this collection, 
FDA realized that the burden in the 60-day Federal Register notice did 
not take into account new information from another Federal Agency 
(which revised the number of respondents slightly upward), and the use 
of a new electronic registration and product listing submission system. 
To correct this oversight, FDA is revising the number of respondents 
upward, from 125 to 135 respondents. FDA also has incorporated the use 
of a new electronic system into this collection, so the total hours 
were revised from 1,354 hours to 1,084 hours in table 1.
    The burden estimates have been updated to fully incorporate the use 
of FDA's new electronic system known as FURLS for submitting 
registration and product listing information to FDA. This system allows 
companies to enter information quickly and easily. For example, product 
label pictures can be uploaded directly into the system and FDA 
anticipates that most, if not all companies already have electronic 
versions of their labels for printing, sales, or marketing purposes. 
FDA anticipates that the initial entry registration and initial product 
listing will each take 2 hours per entity.
    Under section 905, once information is entered into FURLS, the 
twice yearly conformation or updates to product lists are expected to 
be simplified as all information previously entered is maintained and 
visible in the system. Therefore, FDA expects that ongoing maintenance 
of the product listing information will take 30 minutes twice a year, 
or a total of 1 hour annually. This is broken down into 12 minutes for 
recurring Registration and Listing each year, and 24 minutes twice a 
year for recurring Product Ingredient Listings, or a total of 48 
minutes annually.

[[Page 44973]]

    Based on data shared by another Federal Agency, FDA estimates that 
135 establishments will initially submit one report, and then will 
submit confirmation or update reports on a semiannual basis.
    FDA estimates that the confirmation or updating of registration 
information as required by section 905 will take 12 minutes annually 
per confirmation or update per establishment.
    FDA estimates that the submission of product listings required by 
section 905 for each establishment will take 2 hours initially. FDA 
also estimates that the confirmation or updating of product listing 
information required by section 905 will take 48 minutes annually for 
two confirmations or updates per establishment.
    FDA estimates that obtaining an optional Dun and Bradstreet D-U-N-S 
number will take 0.5 hours, and that 8 respondents (1 percent x 135 = 
1.35 of establishments required to register under section 905, and 5 
percent x 135 = 6.75 of submitters required to list ingredients under 
section 904) will not already have a Dun and Bradstreet D-U-N-S number.
    FDA estimates that the submission of ingredient listing information 
as required by section 904 of the act will take 3 hours per tobacco 
product.

    Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18410 Filed 7-27-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices 44971

FOR FURTHER INFORMATION CONTACT: The purpose of the planning calls will Information and Regulatory Affairs,
Lillian A. Sparks Robinson, be to identify individuals who will OMB, Attn: FDA Desk Officer, FAX:
Commissioner, Administration for provide oral testimony to ACF, solicit 202–395–7285, or emailed to oira_
Native Americans, at 202–401–5590, by for tribal moderators and identify submission@omb.eop.gov. All
email at Lillian.sparks@acf.hhs.gov, or specific topics of interest so we can comments should be identified with the
by mail at 370 L’Enfant Promenade SW., ensure that all appropriate individuals OMB control number 0910–0650. Also
2 West, Washington, DC 20447. are present. include the FDA docket number found
SUPPLEMENTARY INFORMATION: On Testimonies are to be submitted no in brackets in the heading of this
November 5, 2009, President Obama later than September 8, 2015, to: Lillian document.
signed the ‘‘Memorandum for the Heads Sparks Robinson, Commissioner, FOR FURTHER INFORMATION CONTACT: FDA
of Executive Departments and Agencies Administration for Native Americans, PRA Staff, Office of Operations, Food
on Tribal Consultation.’’ The President 370 L’Enfant Promenade SW., and Drug Administration, 8455
stated that his Administration is Washington, DC 20447, Colesville Rd., COLE–14526, Silver
committed to regular and meaningful anacommissioner@acf.hhs.gov. Spring, MD 20993–0002, PRAStaff@
consultation and collaboration with To facilitate the security process fda.hhs.gov.
tribal officials in policy decisions that when entering our building, we would
SUPPLEMENTARY INFORMATION: In
have tribal implications, including, as appreciate if participants register for the
session by sending an email to compliance with 44 U.S.C. 3507, FDA
an initial step, through complete and has submitted the following proposed
consistent implementation of Executive anacommissoner@acf.hhs.gov with the
collection of information to OMB for
Order 13175. names of attendees, titles, and tribe/
review and clearance.
The United States has a unique legal organization name. If you plan to
and political relationship with Indian provide testimony, please include the Registration and Product Listing for
tribal governments, established through name of the office(s) you wish to Owners and Operators of Domestic
and confirmed by the Constitution of address. We are also interested in Tobacco Product Establishments and
the United States, treaties, statutes, collecting the same information from Listing of Ingredients in Tobacco
executive orders, and judicial decisions. anyone who will be attending by Products—OMB Control Number 0910–
In recognition of that special webinar. 0650—Extension
relationship, pursuant to Executive Dated: July 21, 2015. On June 22, 2009, the President
Order 13175 of November 6, 2000, Mark H. Greenberg, signed the Tobacco Control Act (Pub. L.
executive departments and agencies are Acting Assistant Secretary for Children and 111–31) into law. The Tobacco Control
charged with engaging in regular and Families. Act amended the Federal Food, Drug,
meaningful consultation and [FR Doc. 2015–18430 Filed 7–27–15; 8:45 am] and Cosmetic Act (the FD&C Act) (21
collaboration with tribal officials in the BILLING CODE 4184–34–P U.S.C. 301 et seq.) by, among other
development of federal policies that things, adding a chapter granting FDA
have tribal implications and are important authority to regulate the
responsible for strengthening the DEPARTMENT OF HEALTH AND manufacture, marketing, and
government-to-government relationship HUMAN SERVICES distribution of tobacco products to
between the United States and Indian protect the public health generally and
tribes. Food and Drug Administration to reduce tobacco use by minors.
HHS has taken its responsibility to [Docket No. FDA–2012–N–0386]
Section 905(b) of the FD&C Act (21
comply with Executive Order 13175 U.S.C. 387e(b)), as amended by the
very seriously over the past decade; Agency Information Collection Tobacco Control Act, requires that
including the initial implementation of Activities; Submission for Office of ‘‘every person who owns or operates
a Department-wide policy on tribal Management and Budget Review; any establishment in any State engaged
consultation and coordination in 1997, Comment Request; Registration and in the manufacture, preparation,
and through multiple evaluations and Product Listing for Owners and compounding, or processing of a
revisions of that policy, most recently in Operators of Domestic Tobacco tobacco product or tobacco products
2010. ACF has developed its own Product Establishments and Listing of . . .’’ register with FDA the name,
agency-specific consultation policy that Ingredients in Tobacco Products places of business, and all
complements the Department-wide establishments owned or operated by
AGENCY: Food and Drug Administration, that person. Every person must register
efforts.
HHS. by December 31 of each year. Section
The ACF Tribal Consultation Session
will begin on the morning of September ACTION: Notice. 905(c) of the FD&C Act requires that
14, 2015, and continue throughout the first-time persons ‘‘engaging in the
SUMMARY: The Food and Drug manufacture, preparation,
day until all discussions have been Administration (FDA) is announcing
completed. To help both tribal officials compounding, or processing of a
that a proposed collection of tobacco product or tobacco products
and the ACF Principals prepare for this information has been submitted to the
consultation, planning teleconference shall register with the Secretary the
Office of Management and Budget name, places of business, and all such
calls will be held on: (OMB) for review and clearance under establishments of that person.’’ Section
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Wednesday, August 19, 2015, 3 p.m.– the Paperwork Reduction Act of 1995. 905(d) states that persons required to
3:30 p.m. Eastern Time DATES: Fax written comments on the register under section 905(b) or (c) shall
Wednesday, August 26, 2015, 3 p.m.– collection of information by August 27, register any additional establishment
3:30 p.m. Eastern Time 2015. that they own or operate in any State
Wednesday, September 2, 2015, 3 p.m.– ADDRESSES: To ensure that comments on which begins the manufacture,
3:30 p.m. Eastern Time the information collection are received, preparation, compounding, or
The call-in number is: 866–769–9393. OMB recommends that written processing of a tobacco product or
The passcode is: 4449449#. comments be faxed to the Office of tobacco products. Section 905(h)

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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices 44973

Based on data shared by another intended to gain stakeholders’ performed. For parking and security
Federal Agency, FDA estimates that 135 perspectives on various aspects of the information, please refer to http://
establishments will initially submit one development and planned www.fda.gov/AboutFDA/
report, and then will submit implementation of a quality metrics WorkingatFDA/BuildingsandFacilities/
confirmation or update reports on a program launched under the authority WhiteOakCampusInformation/
semiannual basis. of the Food, Drug, and Cosmetic Act ucm241740.htm.
FDA estimates that the confirmation (the FD&C Act). The guidance includes Submit written requests for single
or updating of registration information an explanation of how FDA intends to copies of the draft guidance to the
as required by section 905 will take 12 use quality metrics data to further Division of Drug Information, Center for
minutes annually per confirmation or develop the FDA’s risk-based inspection Drug Evaluation and Research, Food
update per establishment. scheduling, to identify situations in and Drug Administration, 10001 New
FDA estimates that the submission of which there may be a risk for drug Hampshire Ave., Hillandale Building,
product listings required by section 905 supply disruption, to improve the 4th Floor, Silver Spring, MD 20993–
for each establishment will take 2 hours efficiency and effectiveness of 0002, or Center for Biologics Evaluation
initially. FDA also estimates that the establishment inspections, and to and Research, Food and Drug
confirmation or updating of product improve FDA’s evaluation of drug Administration, 10903 New Hampshire
listing information required by section manufacturing and control operations. Ave., Bldg. 71, Rm. 7301, Silver Spring,
905 will take 48 minutes annually for FDA expects that the initial use of the MD 20993–0002, 240–402–7911. Send
two confirmations or updates per metrics will be to consider a decreased one self-addressed adhesive label to
establishment. surveillance inspection frequency for assist that office in processing your
FDA estimates that obtaining an certain establishments. For example, requests. See the SUPPLEMENTARY
optional Dun and Bradstreet D–U–N–S establishments that have highly INFORMATION section for electronic
number will take 0.5 hours, and that 8 controlled manufacturing processes access to the draft guidance document.
respondents (1 percent × 135 = 1.35 of have the potential to be inspected less The draft guidance may also be obtained
establishments required to register often (as a lower priority for inspection) by mail by calling CBER at 1–800–835–
under section 905, and 5 percent × 135 than similar establishments that 4709 or 240–402–7800.
= 6.75 of submitters required to list demonstrate uncontrolled processes (as Submit electronic comments on the
ingredients under section 904) will not a higher priority for inspection). In draft guidance to http://
already have a Dun and Bradstreet D–U– addition, FDA intends to consider www.regulations.gov. Submit written
N–S number. whether these metrics may provide a comments to the Division of Dockets
FDA estimates that the submission of basis for FDA to use improved risk- Management (HFA–305), Food and Drug
ingredient listing information as based principles to determine the Administration, 5630 Fishers Lane, Rm.
required by section 904 of the act will appropriate reporting category for 1061, Rockville, MD 20852. All
take 3 hours per tobacco product. postapproval manufacturing changes. comments should be identified with the
FDA intends to consider the input from docket number found in brackets in the
Dated: July 22, 2015.
this public meeting as we finalize this heading of this document.
Leslie Kux,
guidance and the planned FOR FURTHER INFORMATION CONTACT:
Associate Commissioner for Policy.
implementation of this program, Althea Cuff, Food and Drug
[FR Doc. 2015–18410 Filed 7–27–15; 8:45 am]
including FDA’s initial set of requests Administration, 10903 New Hampshire
BILLING CODE 4164–01–P for quality metrics data. Ave., Silver Spring, MD 20993–0002,
DATES: The meeting will be held on 301–796–4061, email: Althea.Cuff@
August 24, 2015, from 8:30 a.m. to 5 fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES p.m. The meeting may be extended or SUPPLEMENTARY INFORMATION:
end early depending on the level of
public participation. Register to attend I. Background
Food and Drug Administration
or present at the meeting by August 7, More than a decade ago, FDA
[Docket No. FDA–2014–D–2537] 2015, (see section V.C. for information launched an initiative to encourage the
on how to register or make a implementation of a modern, risk-based
Request for Quality Metrics; Notice of
presentation at the meeting). If you pharmaceutical quality assessment
Draft Guidance Availability and Public
cannot attend in person, information system. As part of this initiative, and in
Meeting; Request for Comments
about how you can access a live Web recognition of the increasing complexity
AGENCY: Food and Drug Administration, cast will be located at http:// of pharmaceutical manufacturing, FDA
HHS. www.fda.gov/Drugs/NewsEvents/ developed a 21st century vision for
ACTION: Notice of meeting; notice of ucm451529.htm. manufacturing and quality with input
draft guidance availability, request for Submit either electronic or written from academia and industry. The
comments. comments concerning the draft desired state was described as follows:
guidance and collection of information ‘‘A maximally efficient, agile, flexible
SUMMARY: The Food and Drug proposed in the draft guidance by pharmaceutical manufacturing sector
Administration (FDA), Center for Drug September 28, 2015. that reliably produces high-quality drug
Evaluation and Research (CDER) and ADDRESSES: The meeting will be held at products without extensive regulatory
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Center for Biologics Evaluation and FDA White Oak Campus, 10903 New oversight.’’ 1
Research (CBER), is announcing the Hampshire Ave., Bldg. 31 Conference There has been significant progress
availability of a draft guidance for Center, the Great Room (Rm. 1503 toward this vision in the intervening
industry entitled ‘‘Request for Quality Section B/C), Silver Spring, MD 20993–
1 See ‘‘FDA Pharmaceutical Quality Oversight:
Metrics’’ and a public meeting regarding 0002. Entrance for the public meeting
One Quality Voice’’ at http://www.fda.gov/
the Agency’s plans associated with a participants (non-FDA employees) is downloads/AboutFDA/CentersOffices/
quality metrics reporting program. The through Building 1, where routine OfficeofMedicalProductsandTobacco/CDER/
draft guidance and public meeting are security check procedures will be UCM442666.pdf.

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Document Created: 2018-02-23 09:28:42
Document Modified: 2018-02-23 09:28:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 27, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 44971

80 FR 44971 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 144 (July 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration