Agency Information Collection Activities; Proposed Collection; 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, 11989-11990 [2015-05024]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
For
additional information about the
information collection, contact Cathy
Williams at (202) 418–2918
Federal Communications Commission.
Marlene H. Dortch,
Secretary, Office of the Secretary, Office of
the Managing Director.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–05078 Filed 3–4–15; 8:45 am]
OMB Control Number: 3060–0264.
Title: Section 80.413, On-Board
Station Equipment Records.
Form Number: N/A.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit entities, not-for-profit institutions,
and state, local or tribal government.
Number of Respondents: 1,000
respondents; 1,000 responses.
Estimated Time per Response: 2
hours.
Frequency of Response:
Recordkeeping requirement.
Obligation to Respond: Required to
obtain or retain benefits. Statutory
authority for this information collection
is contained in 47 U.S.C. 154, 303,
307(e), 309 and 332 and 151–155 and
sections 301–609 of the
Communications Act of 1934, as
amended.
Total Annual Burden: 2,000 hours.
Total Annual Cost: No cost.
Privacy Impact Assessment: No
impact(s).
Nature and Extent of Confidentiality:
There is no need for confidentiality.
Needs and Uses: The Commission is
seeking an extension of this expiring
information collection in order to obtain
the full three year approval from OMB.
There is no change to the recordkeeping
requirement.
Section 80.413 requires the licensee of
an on-board station to keep equipment
records which show:
(1) The ship name and identification
of the on-board station;
(2) The number of and type of
repeater and mobile units used on-board
the vessel; and
(3) The date the type of equipment
which is added or removed from the onboard station.
The information is used by FCC
personnel during inspections and
investigations to determine what mobile
units and repeaters are associated with
on-board stations aboard a particular
vessel. If this information were not
maintained, no means would be
available to determine if this type of
radio equipment is authorized or who is
responsible for its operation.
Enforcement and frequency
management programs would be
negatively affected if the information
were not retained.
BILLING CODE 6712–01P
VerDate Sep<11>2014
19:28 Mar 04, 2015
Jkt 235001
FEDERAL COMMUNICATIONS
COMMISSION
Federal Advisory Committee Act;
Downloadable Security Technology
Advisory Committee
Federal Communications
Commission.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice advises interested persons that
the Federal Communications
Commission’s (FCC or Commission)
Downloadable Security Technology
Advisory Committee (DSTAC) will hold
a meeting on March 24, 2015. At the
meeting, the Current Commercial
Requirements Working Group and the
Technology and Preferred Architectures
Working Group will present their
findings, the Advisory Committee will
consider establishing more working
groups, and the committee will discuss
any other topics related to the DSTAC’s
work that may arise.
DATES: March 24, 2015.
ADDRESSES: Federal Communications
Commission, Room TW–C305
(Commission Meeting Room), 445 12th
Street SW., Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT: For
additional information on this
proceeding, contact Brendan Murray,
Brendan.Murray@fcc.gov, of the Media
Bureau, Policy Division, (202) 418–1573
or Nancy Murphy, Nancy.Murphy@
fcc.gov, of the Media Bureau, (202) 418–
1043.
SUPPLEMENTARY INFORMATION: The
meeting will be held on March 24, 2015,
from 10:00 a.m. to 4:00 p.m. in the
Commission Meeting Room of the
Federal Communications Commission,
Room TW–C305, 445 12th Street SW.,
Washington, DC 20554.
The DSTAC is a Federal Advisory
Committee that will ‘‘identify, report,
and recommend performance objectives,
technical capabilities, and technical
standards of a not unduly burdensome,
uniform, and technology- and platformneutral software-based downloadable
security system.’’
The meeting on March 24, 2015, will
be the second meeting of the DSTAC.
The FCC will attempt to accommodate
as many attendees as possible; however,
admittance will be limited to seating
SUMMARY:
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
11989
availability. The Commission will
provide audio and/or video coverage of
the meeting over the Internet from the
FCC’s Web page at https://www.fcc.gov/
live. The public may submit written
comments before the meeting to
Brendan Murray, DSTAC Designated
Federal Officer, by email to DSTAC@
fcc.gov or by U.S. Postal Service Mail to
445 12th Street SW., Room 4–A726,
Washington, DC 20554.
Open captioning will be provided for
this event. Other reasonable
accommodations for people with
disabilities are available upon request.
Requests for such accommodations
should be submitted via email to
fcc504@fcc.gov or by calling the
Consumer & Governmental Affairs
Bureau at (202) 418–0530 (voice), (202)
418–0432 (tty). Such requests should
include a detailed description of the
accommodation needed. In addition,
please include a way the FCC can
contact you if it needs more
information. Please allow at least five
days’ advance notice; last-minute
requests will be accepted, but may be
impossible to fill.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 2015–05077 Filed 3–4–15; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0147]
Agency Information Collection
Activities; Proposed Collection;
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.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
SUMMARY:
E:\FR\FM\05MRN1.SGM
05MRN1
11990
Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
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
the information collections in the
guidances for industry and FDA staff
entitled ‘‘Guidance for Industry and
Food and Drug Administration Staff on
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.’’
DATES: Submit either electronic or
written comments on the collection of
information by May 4, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: 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.
Guidance for Industry and Food and
Drug Administration Staff on 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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Full SE 905(j)(1)(A)(i) and 910(a) ........................................................
Product Quantity Change SE Report ..................................................
Same characteristics SE Report ..........................................................
75
125
100
1
1
1
75
125
100
300
87
47
22,500
10,875
4,700
Totals ............................................................................................
....................
........................
....................
....................
38,075
Activity
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:28 Mar 04, 2015
Jkt 235001
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
PO 00000
Frm 00015
Fmt 4703
Sfmt 9990
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: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05024 Filed 3–4–15; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 11989-11990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05024]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0147]
Agency Information Collection Activities; Proposed Collection;
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed
[[Page 11990]]
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 the information collections in the guidances for industry
and FDA staff entitled ``Guidance for Industry and Food and Drug
Administration Staff on 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.''
DATES: Submit either electronic or written comments on the collection
of information by May 4, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: 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.
Guidance for Industry and Food and Drug Administration Staff on 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
Activity Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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 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: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05024 Filed 3-4-15; 8:45 am]
BILLING CODE 4164-01-P
