Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products, 74194-74195 [2012-30057]
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74194
Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices
decompressed with data from the EdelKindwall Tables,(3) Information on
related control measures (e.g.,
engineering controls, work practices,
personal protective equipment) in use in
workplaces where decompression is
required, and (4) Information on
alternative tables and approaches being
used to protect tunneling workers from
higher pressures greater than 50 psi.
References
1. Hamilton RW, Bill Kay E. (2008) Boring
deep tunnels. Third conference on U.S.Japan panel on aerospace-diving
physiology & technology and hyperbaric
medicine.
2. Downs GJ, Kindwall EP. (1986) Aseptic
necrosis in caisson workers: A new set
of decompression tables. Aviat Space &
Environ Med 57:569–574.
Dated: December 4, 2012.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2012–30080 Filed 12–12–12; 8:45 am]
Dated: December 4, 2012.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2012–30081 Filed 12–12–12; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products
AGENCY:
ACTION:
BILLING CODE 4163–19–P
Food and Drug Administration,
HHS.
Notice.
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.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–238]
Issuance of Final Guidance Publication
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of issuance of final
guidance publication.
AGENCY:
srobinson on DSK4SPTVN1PROD with
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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 on Meetings With
Industry and Investigators on the
Research and Development of Tobacco
Products.’’ Also, include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
announces the availability of the
following publication: NIOSH Alert
entitled ‘‘Preventing Occupational
Respiratory Disease from Exposures
Caused by Dampness in Office
Buildings, Schools, and Other
Nonindustrial Buildings’’ [2013–102].
ADDRESSES: This document may be
obtained at the following link:
• Web site: https://www.cdc.gov/
niosh/docs/2013-102/.
FOR FURTHER INFORMATION CONTACT:
Michelle R. Martin, M.S., NIOSH/CDC,
1095 Willowdale Road, Morgantown,
WV 26505, telephone (304) 285–5734,
email mrmartin1@cdc.gov.
SUMMARY:
Fax written comments on the
collection of information by January 14,
2013.
DATES:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products—
(OMB Control Number 0910–NEW)
This guidance is intended to assist
tobacco manufacturers, importers,
researchers, and investigators, and their
representatives who seek meetings with
staff of FDA’s Center for Tobacco
Products (CTP) relating to their plans to
conduct research to inform the
regulation of tobacco products or
support the development or marketing
of tobacco products. This guidance does
not pertain to other types of meetings or
meeting requests with CTP staff. The
Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31) offers tobacco
product manufacturers several pathways
to obtain an order from FDA to
authorize the marketing of a tobacco
product before it may be introduced or
delivered into interstate commerce. To
provide assistance with these pathways
to market particular products, FDA will
meet with tobacco product
manufacturers, importers, researchers,
and investigators (or their
representatives) where appropriate. This
guidance is intended to assist persons
who seek guidance relating to their
research to inform the regulation of
tobacco products, or to support the
development or marketing of tobacco
products. In the guidance, the Agency
discusses, among other things:
• What information DA recommends
persons include in such a meeting
request;
• How and when to submit such a
request; and
• What information FDA
recommends persons submit prior to
such a meeting.
In the Federal Register of May 25,
2012 (77 FR 31368), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one response
containing PRA-related comments.. The
comment indicated that the guidance
should clarify that meeting request
times will vary depending on the type
of submission to be discussed and the
meeting information package
requirements should be tailored to the
submission type.
In response, the estimated burden
hours for both meeting requests and
meeting information package
requirements have been calculated by
FDA and are based on an average
number of hours for each type of
submission over a 3-year period. The
meeting information requirements are
also averaged together and are not
individually split into submission types
E:\FR\FM\13DEN1.SGM
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74195
Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices
for this collection. The commenter also
provided comments that were not PRA-
related and are beyond the scope of this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Meeting requests and information packages
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Meeting Requests
Combining and sending meeting request letters for manufacturers, importers, and researchers ..............................
67
1
67
10
670
Meeting Information Packages
Combining and submitting meeting information packages
for manufacturers, importers, and researchers. ...............
67
1
67
18
1,206
Collection Totals ...........................................................
........................
........................
........................
........................
1,876
srobinson on DSK4SPTVN1PROD with
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the number of
respondents for meeting requests in
table 1 of this document is based on the
number of meeting requests to be
received over the next three years. In
year 1 of this collection, FDA estimates
that 50 preapplication meetings will be
requested. In year 2, FDA estimates that
100 meetings will be requested,
especially as applications and reports
for substantial equivalence, etc., are
received and acted upon. Once the
public knows more about submitting
these applications in year 3 three, the
request for meetings is expected to drop
back to the year 1 one rate of 50 per
year. Thus, FDA estimates the number
of manufacturers, importers,
researchers, and investigators who are
expected to submit meeting requests in
table 1 of this document to be 67 (50
year 1 requests + 100 year 2 requests +
50 year 3 requests divided by 3). The
hours per response, which is the
estimated number of hours that a
respondent would spend preparing the
information recommended by the
guidance to be submitted with a meeting
request, is estimated to be
approximately 10 hours each, and the
total burden hours are 670 hours (10
hours preparation/mailing times 67
average respondents per year). Based on
FDA’s experience, the Agency expects it
will take respondents this amount of
time to prepare, gather, copy, and
submit brief statements about the
product and a description of the
purpose and details of the meeting.
FDA’s estimate of the number of
respondents for compiling meeting
information packages in table 1 of this
document is based on 67 respondents
each preparing copies of their
information package and submitting
them to FDA, for a total of 1,206 hours
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annually. The hours per response,
which is the estimated number of hours
that a respondent would spend
preparing the information package as
recommended by the guidance, is
estimated to be approximately 18 hours
per information package. Based on
FDA’s experience, the Agency expects
that it will take respondents 1,206 hours
of time (67 respondents times 18 hours)
to gather, copy, and submit brief
statements about the product, a
description of the details of the
anticipated meeting, and data and
information that generally would
already have been generated for the
planned research and/or product
development. The total number of
burden hours for this collection of
information is 1,876 hours (670 hours to
prepare and submit meeting requests
and 1,206 hours to prepare and submit
information packages).
Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30057 Filed 12–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1161]
Draft Guidance for Industry and Food
and Drug Administration Staff; Design
Considerations for Devices Intended
for Home Use; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00032
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Design Considerations for
Devices Intended for Home Use.’’ This
document is intended to assist
manufacturers in designing and
developing home use medical devices
that comply with applicable standards
of safety and effectiveness and other
regulatory requirements. Home use
devices are associated with unique risks
created by the interactions among the
user (often a layperson), the use
environment, and the device. This
document identifies several factors that
manufacturers should consider,
especially during device design and
development, and provides
recommendations for reducing or
minimizing these unique risks. This
draft guidance is not final nor is it in
effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 13,
2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Design
Considerations for Devices Intended for
Home Use’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 4613, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development (HFM–40), Center for
SUMMARY:
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]]>Agencies
[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Pages 74194-74195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Meetings
With Industry and Investigators on the Research and Development of
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 January
14, 2013.
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 on Meetings With Industry and Investigators on the
Research and Development of Tobacco Products.'' Also, include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@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 on Meetings With Industry and Investigators on the Research
and Development of Tobacco Products--(OMB Control Number 0910-NEW)
This guidance is intended to assist tobacco manufacturers,
importers, researchers, and investigators, and their representatives
who seek meetings with staff of FDA's Center for Tobacco Products (CTP)
relating to their plans to conduct research to inform the regulation of
tobacco products or support the development or marketing of tobacco
products. This guidance does not pertain to other types of meetings or
meeting requests with CTP staff. The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) offers
tobacco product manufacturers several pathways to obtain an order from
FDA to authorize the marketing of a tobacco product before it may be
introduced or delivered into interstate commerce. To provide assistance
with these pathways to market particular products, FDA will meet with
tobacco product manufacturers, importers, researchers, and
investigators (or their representatives) where appropriate. This
guidance is intended to assist persons who seek guidance relating to
their research to inform the regulation of tobacco products, or to
support the development or marketing of tobacco products. In the
guidance, the Agency discusses, among other things:
What information DA recommends persons include in such a
meeting request;
How and when to submit such a request; and
What information FDA recommends persons submit prior to
such a meeting.
In the Federal Register of May 25, 2012 (77 FR 31368), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one response containing PRA-
related comments.. The comment indicated that the guidance should
clarify that meeting request times will vary depending on the type of
submission to be discussed and the meeting information package
requirements should be tailored to the submission type.
In response, the estimated burden hours for both meeting requests
and meeting information package requirements have been calculated by
FDA and are based on an average number of hours for each type of
submission over a 3-year period. The meeting information requirements
are also averaged together and are not individually split into
submission types
[[Page 74195]]
for this collection. The commenter also provided comments that were not
PRA-related and are beyond the scope of this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Meeting requests and information Number of responses per Total annual per response Total hours
packages respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Meeting Requests
----------------------------------------------------------------------------------------------------------------
Combining and sending meeting 67 1 67 10 670
request letters for
manufacturers, importers, and
researchers....................
----------------------------------------------------------------------------------------------------------------
Meeting Information Packages
----------------------------------------------------------------------------------------------------------------
Combining and submitting meeting 67 1 67 18 1,206
information packages for
manufacturers, importers, and
researchers....................
-------------------------------------------------------------------------------
Collection Totals........... .............. .............. .............. .............. 1,876
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA's estimate of the number of respondents for meeting requests in
table 1 of this document is based on the number of meeting requests to
be received over the next three years. In year 1 of this collection,
FDA estimates that 50 preapplication meetings will be requested. In
year 2, FDA estimates that 100 meetings will be requested, especially
as applications and reports for substantial equivalence, etc., are
received and acted upon. Once the public knows more about submitting
these applications in year 3 three, the request for meetings is
expected to drop back to the year 1 one rate of 50 per year. Thus, FDA
estimates the number of manufacturers, importers, researchers, and
investigators who are expected to submit meeting requests in table 1 of
this document to be 67 (50 year 1 requests + 100 year 2 requests + 50
year 3 requests divided by 3). The hours per response, which is the
estimated number of hours that a respondent would spend preparing the
information recommended by the guidance to be submitted with a meeting
request, is estimated to be approximately 10 hours each, and the total
burden hours are 670 hours (10 hours preparation/mailing times 67
average respondents per year). Based on FDA's experience, the Agency
expects it will take respondents this amount of time to prepare,
gather, copy, and submit brief statements about the product and a
description of the purpose and details of the meeting.
FDA's estimate of the number of respondents for compiling meeting
information packages in table 1 of this document is based on 67
respondents each preparing copies of their information package and
submitting them to FDA, for a total of 1,206 hours annually. The hours
per response, which is the estimated number of hours that a respondent
would spend preparing the information package as recommended by the
guidance, is estimated to be approximately 18 hours per information
package. Based on FDA's experience, the Agency expects that it will
take respondents 1,206 hours of time (67 respondents times 18 hours) to
gather, copy, and submit brief statements about the product, a
description of the details of the anticipated meeting, and data and
information that generally would already have been generated for the
planned research and/or product development. The total number of burden
hours for this collection of information is 1,876 hours (670 hours to
prepare and submit meeting requests and 1,206 hours to prepare and
submit information packages).
Dated: December 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30057 Filed 12-12-12; 8:45 am]
BILLING CODE 4160-01-P
