Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007, 40107-40108 [2014-16252]
Download as PDF
<![CDATA[
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by August 11, 2014.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions:
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–5806
OR, Email: OIRA_submission@
omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice and Prior Quarter
Adjustment Statement; Use: Form CMS–
304 (Reconciliation of State Invoice) is
used by manufacturers to respond to the
state’s rebate invoice for current quarter
utilization. Form CMS–304a (Prior
Quarter Adjustment Statement) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Private
sector—Business or other for-profits;
Number of Respondents: 1,037; Total
Annual Responses: 4,148; Total Annual
Hours: 187,880. (For policy questions
regarding this collection contact Andrea
Wellington at 410–786–3490.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program Forms; Use: We develop
the rebate amount per drug unit from
information supplied by the drug
manufacturers and distributes these data
to the states. States then must report
quarterly to the drug manufacturers and
report to us the total number of units of
each dosage form/strength of their
covered outpatient drugs reimbursed
during a quarter and the rebate amount
to be refunded. This report is due
within 60 days of the end of each
calendar quarter. The information in the
report is based on claims paid by the
state Medicaid agency during a calendar
quarter. Form CMS–R–144 (Quarterly
Report Data) is required from states
quarterly to report utilization for any
drugs paid for during that quarter. Form
CMS–368 (Administrative Data) is
required only in those instances where
a change to the original data submittal
is necessary. Form Number: CMS–368
and –R–144 (OMB control number:
0938–0582); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 224; Total
Annual Hours: 12,101. (For policy
questions regarding this collection
contact Andrea Wellington at 410–786–
3490.)
3. Type of Information Collection
Request: New collection (Request for a
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
40107
new control number); Title of
Information Collection: The Predictive
Learning Analytics Tracking Outcome
(PLATOTM); Use: The Predictive
Learning Analytics Tracking Outcome
(PLATOTM) is a web-based application
tool that will serve as the centerpiece of
the advanced analytics initiative with
the Centers for Medicare & Medicaid
Services (CMS) and Health Integrity,
LLC, the National Benefit Integrity
Medicare Integrity Contractor (NBI
MEDIC). Developed by Health Integrity,
LLC and licensed for one of its
contracts—the NBI MEDIC—PLATOTM
utilizes a cutting-edge advanced
analytics fraud detection process in
conjunction with a state-of-the-art webbased user interface tool to present
fraud and abuse lead information
visually to Medicare Part D plan
sponsors. Summary data, based on
National Prescription Drug Event Data
and actions from all Part D plan
sponsors, is shared with law
enforcement, CMS, NBI MEDIC, and
Part D plan sponsors to review historic
actions taken against providers who are
enrolled in the Medicare Part D
program, which will assist in detecting
and preventing fraud, waste, and abuse.
Form Number: CMS–10517 (OMB
control number: 0938—New);
Frequency: Monthly; Affected Public:
Private sector—Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 1,550; Total
Annual Responses: 1,550; Total Annual
Hours: 18,600. (For policy questions
regarding this collection contact Delois
Newkirk at 410–786–1247.)
Dated: July 3, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–16083 Filed 7–10–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0125]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\11JYN1.SGM
Notice.
11JYN1
40108
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
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
(PRA).
DATES: Fax written comments on the
collection of information by August 11,
2014.
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-New and
title ‘‘Guidance for Industry on
Establishing That a Tobacco Product
Was Commercially Marketed in the
United States as of February 15, 2007.’’
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
SUMMARY:
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry on Establishing
That a Tobacco Product Was
Commercially Marketed in the United
States as of February 15, 2007—(OMB
Control Number 0910-New)
This guidance provides information
on how a manufacturer may establish
that a tobacco product was
commercially marketed in the United
States as of February 15, 2007.
Grandfathered tobacco products are not
considered new tobacco products and
thus are not subject to premarket
review. A grandfathered tobacco
product may also serve as the predicate
tobacco product in a Section 905(j)
Report: Demonstrating Substantial
Equivalence for Tobacco Products
(intended to be used toward
demonstrating substantial equivalence)
for a new tobacco product (section
905(j)(1)(A)(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
387e(j)(1)(A)(i))).
The guidance recommends that the
manufacturer submit information
adequate to demonstrate that the
tobacco product was commercially
marketed in the United States as of
February 15, 2007. Examples of such
information may include, but are not
limited to, the following: dated copies of
advertisements, dated catalog pages,
dated promotional material, and dated
bills of lading.
FDA’s estimate of the number of
respondents is based on the fact that
requesting an Agency determination of
the grandfathered status of a tobacco
product under the guidance is not
required and also on indications of
interest of making such request. The
number of hours to gather the evidence
is FDA’s estimate of how long it might
take one to review, gather, and submit
dated information if making a request
for Agency determination. After further
consideration of these estimates, FDA
has reduced the number of hours to
submit this information from 10 to 5
hours.
In the Federal Register of April 25,
2011 (76 FR 22903), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
submitted on FDA’s estimates of the
number of respondents or burden. FDA
received three comments that generally
addressed topics related to the
recommendations of the guidance,
including questions about the status of
tobacco products that were in test
markets in the United States as of
February 15, 2007, and how much
evidence should be submitted.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submit evidence of commercial marketing in the United
States as of February 15, 2007 .......................................
150
1
150
5
750
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the estimates on
information it received from
interactions with the industry that 3
large manufacturers might submit as
many as 25 packages of evidence
annually, and other manufacturers
might submit as many as 125 packages
of evidence indicating that their tobacco
product was commercially marketed in
the United States as of February 15,
2007, for a total of 150 responses
annually. FDA further estimates it
would take a manufacturer
approximately 5 hours to put together
this collection of evidence and to
submit the package to FDA for review.
This is a reduction from FDA’s original
estimate of 10 hours per response. FDA
estimates that it should take
approximately 750 hours annually (150
VerDate Mar<15>2010
20:23 Jul 10, 2014
Jkt 232001
responses times 5 hours for each
response) to respond to this collection
of information.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[Docket No. FDA–2012–E–0434]
[FR Doc. 2014–16252 Filed 7–10–14; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HORIZANT
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
HORIZANT and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
SUMMARY:
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40107-40108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16252]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0125]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Establishing That a Tobacco Product Was Commercially Marketed in the
United States as of February 15, 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 40108]]
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 (PRA).
DATES: Fax written comments on the collection of information by August
11, 2014.
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-New and
title ``Guidance for Industry on Establishing That a Tobacco Product
Was Commercially Marketed in the United States as of February 15,
2007.'' 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 on Establishing That a Tobacco Product Was
Commercially Marketed in the United States as of February 15, 2007--
(OMB Control Number 0910-New)
This guidance provides information on how a manufacturer may
establish that a tobacco product was commercially marketed in the
United States as of February 15, 2007. Grandfathered tobacco products
are not considered new tobacco products and thus are not subject to
premarket review. A grandfathered tobacco product may also serve as the
predicate tobacco product in a Section 905(j) Report: Demonstrating
Substantial Equivalence for Tobacco Products (intended to be used
toward demonstrating substantial equivalence) for a new tobacco product
(section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 387e(j)(1)(A)(i))).
The guidance recommends that the manufacturer submit information
adequate to demonstrate that the tobacco product was commercially
marketed in the United States as of February 15, 2007. Examples of such
information may include, but are not limited to, the following: dated
copies of advertisements, dated catalog pages, dated promotional
material, and dated bills of lading.
FDA's estimate of the number of respondents is based on the fact
that requesting an Agency determination of the grandfathered status of
a tobacco product under the guidance is not required and also on
indications of interest of making such request. The number of hours to
gather the evidence is FDA's estimate of how long it might take one to
review, gather, and submit dated information if making a request for
Agency determination. After further consideration of these estimates,
FDA has reduced the number of hours to submit this information from 10
to 5 hours.
In the Federal Register of April 25, 2011 (76 FR 22903), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were submitted on FDA's
estimates of the number of respondents or burden. FDA received three
comments that generally addressed topics related to the recommendations
of the guidance, including questions about the status of tobacco
products that were in test markets in the United States as of February
15, 2007, and how much evidence should be submitted.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submit evidence of commercial marketing in the United States as of 150 1 150 5 750
February 15, 2007.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the estimates on information it received from
interactions with the industry that 3 large manufacturers might submit
as many as 25 packages of evidence annually, and other manufacturers
might submit as many as 125 packages of evidence indicating that their
tobacco product was commercially marketed in the United States as of
February 15, 2007, for a total of 150 responses annually. FDA further
estimates it would take a manufacturer approximately 5 hours to put
together this collection of evidence and to submit the package to FDA
for review. This is a reduction from FDA's original estimate of 10
hours per response. FDA estimates that it should take approximately 750
hours annually (150 responses times 5 hours for each response) to
respond to this collection of information.
Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16252 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P
