Issuance of Final Guidance Publication, 74194 [2012-30081]
Download as PDF
<![CDATA[
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
VerDate Mar<15>2010
16:21 Dec 12, 2012
Jkt 229001
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
13DEN1
]]>Agencies
[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Page 74194]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30081]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number NIOSH-238]
Issuance of Final Guidance Publication
AGENCY: 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.
-----------------------------------------------------------------------
SUMMARY: 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.
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
