80 FR 40071 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products and Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 133 (July 13, 2015)

Page Range		40071-40072
FR Document		2015-16952

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 133 (Monday, July 13, 2015)

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40071-40072]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-16952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0147]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
and Food and Drug Administration Staff; Section 905(j) Reports:
Demonstrating Substantial Equivalence for Tobacco Products and
Demonstrating the Substantial Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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
12, 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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0673.
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, PRAStaff@fda.hhs.gov.

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.

Guidance for Industry and Food and Drug Administration Staff; Section
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco
Products OMB Control Number 0910-0673--Extension

On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (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) by adding a new chapter granting
FDA 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(j) of the FD&C Act (21 U.S.C.
387e(j)) authorizes FDA to establish the manner and form for the
submission of information related to substantial equivalence (SE). In
guidance documents issued under the Good Guidances Practices regulation
(21 CFR 10.115), FDA provides recommendations intended to assist
persons submitting reports under section 905(j) of the FD&C Act and
explains, among other things, FDA's interpretation of the statutory
sections related to substantial equivalence.
In the Federal Register of March 5, 2015 (80 FR 11989), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. The commenter
expressed a concern that small manufacturers have the burden of
conducting testing without a definitive guide on what will constitute
substantial equivalence. FDA has carefully considered the burden
associated with the submission of an SE report. The information needed
to demonstrate substantial equivalence is dependent on the new product
and the predicate product that the manufacturer identifies.
Nevertheless, to assist manufacturers in preparing SE reports, FDA has
issued guidance documents and participated in outreach such as webinars
to provide manufacturers with information. Moreover, manufacturers
seeking to demonstrate substantial equivalence may also contact FDA to
seek the Agency's input on the specific types of information that the
Agency believes will be necessary to support the manufacturer's section
905(j) report. The commenter also supported FDA's development of more
streamlined SE Reports but challenged ``new requirements on label
changes,'' and requested that FDA promulgate a rule on categorical
exclusions (environmental assessments). Although these comments are
outside of the scope of this PRA collection, FDA intends to consider
them as part of the Agency's other regulatory efforts as appropriate.
FDA estimates the burden of this collection of information as
follows:

[[Page 40072]]

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Full SE 905(j)(1)(A)(i) and 75 1 75 300 22,500
910(a).........................
Product Quantity Change SE 125 1 125 87 10,875
Report.........................
Same Characteristics SE Report.. 100 1 100 47 4,700
Totals...................... .............. .............. .............. .............. 38,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

FDA has based these estimates on information it now has available
from interactions with the industry, information related to other
regulated products, and FDA's expectations regarding the tobacco
industry's use of the section 905(j) pathway to market their products.
Table 1 describes the annual reporting burden as a result of the
implementation of the SE requirements of sections 905(j) and 910(a) of
the FDC Act (21 U.S.C. 387j(a)). Based on current information, FDA now
estimates that it will receive 300 section 905(j) reports each year. Of
these 300 reports, FDA estimates that 75 of these reports will be
``full'' SE reports that take a manufacturer approximately 300 hours to
prepare. Under the newly issued guidance entitled, ``Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions,'' FDA is recommending that certain
modifications might be addressed in either a ``Same Characteristics SE
Report'' or ``Product Quantity Change Report.'' FDA estimates that it
will receive 100 Same Characteristics SE Reports and that it will take
a manufacturer approximately 47 hours to prepare this report. FDA
estimates that it will receive 125 Product Quantity Change SE Reports
and that it will take a manufacturer approximately 87 hours to prepare
this report. Therefore, FDA estimates the burden for submission of SE
information will be 38,075 hours.

Dated: July 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16952 Filed 7-10-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices 40071

arguments they wish to present, the DEPARTMENT OF HEALTH AND and Tobacco Control Act (the Tobacco
names and addresses of proposed HUMAN SERVICES Control Act) (Pub. L. 111–31) into law.
participants, and an indication of the The Tobacco Control Act amended the
approximate time requested to make Food and Drug Administration Federal Food, Drug, and Cosmetic Act
their presentation on or before July 14, [Docket No. FDA–2011–D–0147] (the FD&C Act) by adding a new chapter
2015. Time allotted for each granting FDA authority to regulate the
presentation may be limited. If the Agency Information Collection manufacture, marketing, and
number of registrants requesting to Activities; Submission for Office of distribution of tobacco products to
speak is greater than can be reasonably Management and Budget Review; protect the public health generally and
accommodated during the scheduled Comment Request; Guidance for to reduce tobacco use by minors.
open public hearing session, FDA may Industry and Food and Drug Section 905(j) of the FD&C Act (21
conduct a lottery to determine the Administration Staff; Section 905(j) U.S.C. 387e(j)) authorizes FDA to
Reports: Demonstrating Substantial establish the manner and form for the
speakers for the scheduled open public
Equivalence for Tobacco Products and submission of information related to
hearing session. The contact person will
Demonstrating the Substantial substantial equivalence (SE). In
notify interested persons regarding their Equivalence of a New Tobacco guidance documents issued under the
request to speak by July 15, 2015. Product: Responses to Frequently Good Guidances Practices regulation (21
Persons attending FDA’s advisory Asked Questions CFR 10.115), FDA provides
committee meetings are advised that the recommendations intended to assist
AGENCY: Food and Drug Administration,
Agency is not responsible for providing persons submitting reports under
HHS.
access to electrical outlets. section 905(j) of the FD&C Act and
ACTION: Notice. explains, among other things, FDA’s
FDA welcomes the attendance of the
public at its advisory committee SUMMARY: The Food and Drug interpretation of the statutory sections
meetings and will make every effort to Administration (FDA) is announcing related to substantial equivalence.
accommodate persons with physical that a proposed collection of In the Federal Register of March 5,
disabilities or special needs. If you information has been submitted to the 2015 (80 FR 11989), FDA published a
require special accommodations due to Office of Management and Budget 60-day notice requesting public
a disability, please contact Mr. Rakesh (OMB) for review and clearance under comment on the proposed collection of
the Paperwork Reduction Act of 1995. information. FDA received one
Raghuwanshi at least 7 days in advance
DATES: Fax written comments on the comment. The commenter expressed a
of the meeting.
collection of information by August 12, concern that small manufacturers have
FDA is committed to the orderly 2015. the burden of conducting testing
conduct of its advisory committee ADDRESSES: To ensure that comments on without a definitive guide on what will
meetings. Please visit our Web site at the information collection are received, constitute substantial equivalence. FDA
http://www.fda.gov/ OMB recommends that written has carefully considered the burden
AdvisoryCommittees/ comments be faxed to the Office of associated with the submission of an SE
AboutAdvisoryCommittees/ Information and Regulatory Affairs, report. The information needed to
ucm111462.htm for procedures on OMB, Attn: FDA Desk Officer, FAX: demonstrate substantial equivalence is
public conduct during advisory 202–395–7285, or emailed to oira_ dependent on the new product and the
committee meetings. submission@omb.eop.gov. All predicate product that the manufacturer
Notice of this meeting is given under comments should be identified with the identifies. Nevertheless, to assist
the Federal Advisory Committee Act (5 OMB control number 0910–0673. Also manufacturers in preparing SE reports,
U.S.C. app. 2). include the FDA docket number found FDA has issued guidance documents
in brackets in the heading of this and participated in outreach such as
Dated: July 7, 2015. document. webinars to provide manufacturers with
Leslie Kux, FOR FURTHER INFORMATION CONTACT: FDA information. Moreover, manufacturers
Associate Commissioner for Policy. PRA Staff, Office of Operations, Food seeking to demonstrate substantial
[FR Doc. 2015–16957 Filed 7–10–15; 8:45 am] and Drug Administration, 8455 equivalence may also contact FDA to
BILLING CODE 4164–01–P Colesville Rd., COLE–14526, Silver seek the Agency’s input on the specific
Spring, MD 20993–0002, PRAStaff@ types of information that the Agency
fda.hhs.gov. believes will be necessary to support the
manufacturer’s section 905(j) report.
SUPPLEMENTARY INFORMATION: In
The commenter also supported FDA’s
compliance with 44 U.S.C. 3507, FDA
development of more streamlined SE
has submitted the following proposed
Reports but challenged ‘‘new
collection of information to OMB for
requirements on label changes,’’ and
review and clearance.
requested that FDA promulgate a rule
Guidance for Industry and Food and on categorical exclusions
Drug Administration Staff; Section (environmental assessments). Although
asabaliauskas on DSK5VPTVN1PROD with NOTICES

905(j) Reports: Demonstrating these comments are outside of the scope
Substantial Equivalence for Tobacco of this PRA collection, FDA intends to
Products OMB Control Number 0910– consider them as part of the Agency’s
0673—Extension other regulatory efforts as appropriate.
On June 22, 2009, the President FDA estimates the burden of this
signed the Family Smoking Prevention collection of information as follows:

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40072 Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of re- Average bur-
No. of re- Total annual
Activity sponses per den per re- Total hours
spondents responses
respondent sponse

Full SE 905(j)(1)(A)(i) and 910(a) ........................................ 75 1 75 300 22,500
Product Quantity Change SE Report .................................. 125 1 125 87 10,875
Same Characteristics SE Report ......................................... 100 1 100 47 4,700
Totals ............................................................................ ........................ ........................ ........................ ........................ 38,075
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on DEPARTMENT OF HEALTH AND will be posted on the phe.gov Web site:
information it now has available from HUMAN SERVICES http://www.phe.gov/Preparedness/
interactions with the industry, planning/science/Documents/
information related to other regulated Extension of Comment Period for the AccessPlan.pdf.
products, and FDA’s expectations Office of the Assistant Secretary for Procedures for Providing Public Input:
regarding the tobacco industry’s use of Preparedness and Response Public All comments must be received by July
the section 905(j) pathway to market Access Plan to Federally Funded 13, 2015. Please submit comments to
Research: Publications and Data Harvey Ball via email harvey.ball@
their products. Table 1 describes the
annual reporting burden as a result of AGENCY: Department of Health and hhs.gov.
the implementation of the SE Human Services. Dated: July 2, 2015.
requirements of sections 905(j) and ACTION: Notice of extension of public Nicole Lurie,
910(a) of the FDC Act (21 U.S.C. comment period until July 13. Assistant Secretary for Preparedness and
387j(a)). Based on current information, Response.
FDA now estimates that it will receive SUMMARY: The Department of Health and
[FR Doc. 2015–16969 Filed 7–10–15; 8:45 am]
Human Services (HHS) is extending the
300 section 905(j) reports each year. Of BILLING CODE P
comment period on the Assistant
these 300 reports, FDA estimates that 75 Secretary for Preparedness and
of these reports will be ‘‘full’’ SE reports Response (ASPR) Public Access Plan for
that take a manufacturer approximately DEPARTMENT OF HEALTH AND
Federally Funded Research: HUMAN SERVICES
300 hours to prepare. Under the newly Publications and Data. The document is
issued guidance entitled, available to the public via http:// Indian Health Service
‘‘Demonstrating the Substantial www.phe.gov/Preparedness/planning/
Equivalence of a New Tobacco Product: science/Pages/AccessPlan.aspx. The Office of Direct Service and
Responses to Frequently Asked comment period was previously Contracting Tribes; National Indian
Questions,’’ FDA is recommending that scheduled to end June 25, 2015. The Health Outreach and Education—
certain modifications might be public comment period is extended Health Reform Cooperative
addressed in either a ‘‘Same until July 13, 2015. Agreement; Correction
Characteristics SE Report’’ or ‘‘Product FOR FURTHER INFORMATION CONTACT:
Quantity Change Report.’’ FDA Please submit comments via email to AGENCY: Indian Health Service, HHS.
estimates that it will receive 100 Same Harvey.ball@hhs.gov ACTION: Notice; correction.
Characteristics SE Reports and that it SUPPLEMENTARY INFORMATION: Pursuant
to Section 103 of the America SUMMARY: The Indian Health Service
will take a manufacturer approximately
COMPETES Reauthorization Act of 2010 published a document in the Federal
47 hours to prepare this report. FDA
(Pub. L. 111–358), the Executive Office Register on June 19, 2015, for the FY
estimates that it will receive 125
of the President, Office of Science and 2015 National Indian Health Outreach
Product Quantity Change SE Reports and Education, Health Reform
and that it will take a manufacturer Technology Policy (OSTP) issued a
memorandum on February 22, 2013 to Cooperative Agreement Program. The
approximately 87 hours to prepare this notice contained two incorrect dates.
report. Therefore, FDA estimates the the heads of federal agencies directing
them to develop plans to enhance access FOR FURTHER INFORMATION CONTACT: Mr.
burden for submission of SE
to the results of federally-funded Paul Gettys, Grant Systems Coordinator,
information will be 38,075 hours.
scientific research. ASPR is voluntarily Division of Grants Management (DGM),
Dated: July 7, 2015. developing a public access plan in order Indian Health Service, 801 Thompson
Leslie Kux, to maximize availability of digitally- Avenue, Suite TMP 360, Rockville, MD
Associate Commissioner for Policy. formatted scientific data resulting from 20852, Telephone direct (301) 443–
[FR Doc. 2015–16952 Filed 7–10–15; 8:45 am] research supported wholly or in part by 2114, or the DGM main number (301)
federal funding that will improve the 443–5204. (This is not a toll-free
BILLING CODE 4164–01–P
public’s ability to locate and access this number.)
asabaliauskas on DSK5VPTVN1PROD with NOTICES

data. Corrections
Background: This plan considers the
interests and needs of various In the Federal Register of June 19,
stakeholders, including, but not limited 2015, in FR Doc. 2015–15157, on page
to, federally funded researchers, 35373, in the third column, under the
universities, libraries, publishers, data heading Key Dates, the correct
users and civil society groups. Application Deadline Date and Proof of
Availability of Materials: The draft Non-Profit Status Due Date should read
copy of the ASPR Public Access Plan as follows:

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Document Created: 2018-02-23 09:18:06
Document Modified: 2018-02-23 09:18:06

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 12, 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 40071

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 133 (July 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration