Notice of Public Meeting and Availability for Public Comment, 70598-70599 [E7-24047]
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70598
Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
based survey which will be conduced
over one year.
Respondents and Burden Estimates for
the Training Ph.D.S Survey
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
Type of respondent
Faculty Survey Instrument .............
Faculty who advise a PhD
candidate.
Mary Oliver-Anderson,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E7–24055 Filed 12–11–07; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–115]
Notice of Public Meeting and
Availability for Public Comment
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 public meeting and
availability for public comment.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the following meeting and
request for public comment on the draft
Current Intelligence Bulletin (CIB)
entitled ‘‘Interim Guidance on Medical
Screening of Workers Potentially
Exposed to Engineered Nanoparticles.’’
The document and instructions for
submitting comments can be found at
https://www.cdc.gov/niosh/review/
public/115/. Comments may be
provided to the NIOSH docket, as well
as given orally at the following meeting.
Public Comment Period: December 14,
2007 through February 15, 2008.
Public Meeting Time and Date: 9
a.m.–4 p.m., January 30, 2008.
Place: Robert A. Taft Laboratories,
Taft Auditorium, NIOSH, CDC, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
Purpose of Meeting: To discuss and
obtain comments on the draft CIB
‘‘Interim Guidance on Medical
Screening of Workers Potentially
Exposed to Engineered Nanoparticles.’’
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15:54 Dec 11, 2007
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4,620
Special emphasis will be placed on
discussion of the following:
(1) Do the data support the
conclusions of the document?
(2) Are the conclusions appropriate in
light of the current understanding of
toxicological data?
(3) Is medical surveillance
appropriate at this time for workers with
potential exposure to engineered
nanoparticles; if so, what form(s) of
medical surveillance are specific for
such workers?
(4) What are the potential benefits,
adverse impacts, and limitations of
medical screening of workers
potentially exposed to engineered
nanoparticles?
(5) What are the potential benefits,
adverse impacts, and limitations of
establishing an exposure registry for
workers exposed to engineered
nanoparticles?
Status: The forum will include
scientists and representatives from
various government agencies, industry,
labor, and other stakeholders, and is
open to the public, limited only by the
space available. The meeting room
accommodates 80 people. Due to
limited space and security clearance
requirements, notification of intent to
attend the meeting must be made to the
NIOSH Docket Office no later than
Friday, January 18, 2008. Persons
wanting to provide oral comments at the
meeting are requested to notify the
NIOSH Docket Office no later than
January 11, 2008 at 513/533–8611 or by
e-mail at nioshdocket@cdc.gov. Priority
for attendance will be given to those
providing oral comments. Other
requests to attend the meeting will then
be accommodated on a first-come basis.
Unreserved walk-in attendees will not
be admitted due to security clearance
requirements.
Persons wanting to provide oral
comments will be permitted up to 20
minutes. If additional time becomes
available, presenters will be notified.
Oral comments given at the meeting will
be recorded and included in the docket.
Written comments will also be accepted
at the meeting. Written comments may
also be submitted to the NIOSH Docket
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Average burden
hours per
response
(in hours)
Number of responses per
respondent
Number of
respondents
1
20/60
Total burden
hours
1,540
Office, Robert A. Taft Laboratories, 4676
Columbia Parkway, MS C–34,
Cincinnati, Ohio 45226, telephone 513/
533–8611. All material submitted to the
Agency should reference docket number
NIOSH–115 and must be submitted by
February 15, 2008 (public review
closing date) to be considered by the
Agency. All electronic comments
should be formatted as Microsoft Word.
Please make reference to docket number
NIOSH–115.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, Room 111, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
Background: Concerns have been
raised about whether workers exposed
to engineered nanoparticles will be at
increased risk of adverse health effects
and whether medical screening or some
other type of occupational health
surveillance is appropriate for these
workers. Although increasing evidence
indicates that exposure to some
engineered nanoparticles can cause
adverse health effects in laboratory
animals, insufficient medical evidence
exists to recommend the medical
screening of workers potentially
exposed to engineered nanoparticles.
However, NIOSH will continue to assess
the scientific evidence and periodically
update the guidance on medical
screening. Because occupational
exposure to engineered nanoparticles is
likely to become more common in the
future, NIOSH has recommended that
employers identify the presence of
engineered nanoparticles in their
workplace and implement effective
efforts to minimize worker exposure to
these materials [NIOSH 2006]. This
guidance document does not have the
force and effect of the law.
Contact Persons for Technical
Information: Dr. Paul A. Schulte, M/S
C–14, Robert A. Taft Laboratories, 4676
Columbia Parkway, Cincinnati, Ohio
45226, telephone 513/533–8302, or
Ralph Zumwalde, M/S C–32, Robert A.
Taft Laboratories, 4676 Columbia
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 72, No. 238 / Wednesday, December 12, 2007 / Notices
Parkway, Cincinnati, Ohio 45226,
telephone 513/533–8320.
Reference:
NIOSH [2006]. Approaches to safe
nanotechnology: an information
exchange with NIOSH. Cincinnati, OH:
Department of Health and Human
Services, Centers for Disease Control
and Prevention, National Institute for
Occupational Safety and Health, July
2006. Web address for this document:
https://www.cdc.gov/niosh/topics/
nanotech/safenano/.
Dated: December 5, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–24047 Filed 12–11–07; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0472]
Agency Emergency Processing Under
the Office of Management and Budget
Review; Certification to Accompany
Drug, Biological Product, and Device
Applications or Submissions
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 emergency processing under
the Paperwork Reduction Act of 1995
(the PRA). The proposed collection of
information concerns the certification to
accompany human drug, biological
product, and device applications or
submissions.
Fax written comments on the
collection of information by December
17, 2007.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–NEW and title,
‘‘Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
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DATES:
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. 301–827–
4659.
FDA has
requested emergency processing of this
proposed collection of information
under section 3507(j) of the PRA (44
U.S.C. 3507(j) and 5 CFR 1320.13). The
emergency processing was requested in
order to comply with the provisions of
Title VIII of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Public Law 110–85),
which require this certification to be
submitted to FDA beginning no later
than December 26, 2007. This
information will be needed immediately
to implement these provisions of
FDAAA, and it is essential to the
agency’s mission of protecting and
promoting the public health. Since the
statutory deadline for collecting the
information is December 26, 2007, the
lack of a form would result in confusion
for the sponsors/applicants as the
information necessary for FDA to carry
out its future statutory responsibilities
would not be obvious without the form.
While some sponsors/applicants may
submit information, it most likely
would neither be complete nor provided
in a systematic fashion so that it can be
more easily retrieved.
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.
SUPPLEMENTARY INFORMATION:
Certification to Accompany Drug,
Biological Product, and Device
Applications or Submissions
The information required under
section 402(j)(5)(B) of the Public Health
Service Act (PHS Act) (42 U.S.C.
282(j)(5)(B)), will be submitted in the
form of a certification with applications
and submissions currently submitted to
FDA under part 312 (21 CFR part 312)
and 21 CFR part 314 (human drugs)
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70599
approved under OMB control numbers
0910–0014 (expires May 31, 2009) and
0910–0001 (expires May 31, 2008),
respectively, part 312 and 21 CFR part
601 (biological products) approved
under OMB control numbers 0910–0014
and 0910–0338 (expires June 30, 2010)
and 21 CFR parts 807 and 814 (devices)
approved under OMB control numbers
0910–0120 (expires August 31, 2010)
and 0910–0231 (expires November 30,
2010), respectively.
Title VIII of FDAAA amended the
PHS Act by adding section 402(j) (42
U.S.C. 282(j)). The new provisions
require additional information to be
submitted to the clinical trials data bank
(ClinicalTrials.gov) previously
established by the National Institutes of
Health/National Library of Medicine,
including expanded information on
clinical trials and information on the
results of clinical trials. The provisions
include new responsibilities for FDA as
well as several amendments to the
Federal Food, Drug, and Cosmetic Act
(FD&C Act).
One new provision, section
402(j)(5)(B) of the PHS Act, requires that
a certification accompany human drug,
biological, and device product
submissions made to FDA. Specifically,
at the time of submission of an
application under sections 505, 515, or
520(m) of the FD&C Act (21 U.S.C. 354,
360e, or 360j(m)), or under section 351
of the PHS Act (21 U.S.C. 262), or
submission of a report under section
510(k) of the FD&C Act (21 U.S.C.
360(k)), such application or submission
must be accompanied by a certification
that all applicable requirements of
section 402(j) of the PHS Act have been
met. Where available, such certification
must include the appropriate National
Clinical Trial (NCT) numbers.
The proposed collection of
information is necessary to satisfy the
above statutory requirement.
The importance of obtaining these
data relates to adherence to the legal
requirements for submissions to the
clinical trials registry and results data
bank and ensuring that individuals and
organizations submitting applications or
reports to FDA under the listed
provisions of the FD&C Act or the PHS
Act adhere to the appropriate legal and
regulatory requirements for certifying to
having complied with those
requirements. The failure to submit the
certification required by section
402(j)(5)(B) of the PHS Act, and the
knowing submission of a false
certification are both prohibited acts
under section 301 of the FD&C Act (21
U.S.C. 331). Violations are subject to
civil money penalties.
E:\FR\FM\12DEN1.SGM
12DEN1
]]>Agencies
[Federal Register Volume 72, Number 238 (Wednesday, December 12, 2007)]
[Notices]
[Pages 70598-70599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24047]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number NIOSH-115]
Notice of Public Meeting and Availability for Public Comment
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 public meeting and availability for public comment.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC)
announces the following meeting and request for public comment on the
draft Current Intelligence Bulletin (CIB) entitled ``Interim Guidance
on Medical Screening of Workers Potentially Exposed to Engineered
Nanoparticles.'' The document and instructions for submitting comments
can be found at https://www.cdc.gov/niosh/review/public/115/. Comments
may be provided to the NIOSH docket, as well as given orally at the
following meeting.
Public Comment Period: December 14, 2007 through February 15, 2008.
Public Meeting Time and Date: 9 a.m.-4 p.m., January 30, 2008.
Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC,
4676 Columbia Parkway, Cincinnati, Ohio 45226.
Purpose of Meeting: To discuss and obtain comments on the draft CIB
``Interim Guidance on Medical Screening of Workers Potentially Exposed
to Engineered Nanoparticles.'' Special emphasis will be placed on
discussion of the following:
(1) Do the data support the conclusions of the document?
(2) Are the conclusions appropriate in light of the current
understanding of toxicological data?
(3) Is medical surveillance appropriate at this time for workers
with potential exposure to engineered nanoparticles; if so, what
form(s) of medical surveillance are specific for such workers?
(4) What are the potential benefits, adverse impacts, and
limitations of medical screening of workers potentially exposed to
engineered nanoparticles?
(5) What are the potential benefits, adverse impacts, and
limitations of establishing an exposure registry for workers exposed to
engineered nanoparticles?
Status: The forum will include scientists and representatives from
various government agencies, industry, labor, and other stakeholders,
and is open to the public, limited only by the space available. The
meeting room accommodates 80 people. Due to limited space and security
clearance requirements, notification of intent to attend the meeting
must be made to the NIOSH Docket Office no later than Friday, January
18, 2008. Persons wanting to provide oral comments at the meeting are
requested to notify the NIOSH Docket Office no later than January 11,
2008 at 513/533-8611 or by e-mail at nioshdocket@cdc.gov. Priority for
attendance will be given to those providing oral comments. Other
requests to attend the meeting will then be accommodated on a first-
come basis. Unreserved walk-in attendees will not be admitted due to
security clearance requirements.
Persons wanting to provide oral comments will be permitted up to 20
minutes. If additional time becomes available, presenters will be
notified. Oral comments given at the meeting will be recorded and
included in the docket. Written comments will also be accepted at the
meeting. Written comments may also be submitted to the NIOSH Docket
Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34,
Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted
to the Agency should reference docket number NIOSH-115 and must be
submitted by February 15, 2008 (public review closing date) to be
considered by the Agency. All electronic comments should be formatted
as Microsoft Word. Please make reference to docket number NIOSH-115.
All information received in response to this notice will be
available for public examination and copying at the NIOSH Docket
Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226.
Background: Concerns have been raised about whether workers exposed
to engineered nanoparticles will be at increased risk of adverse health
effects and whether medical screening or some other type of
occupational health surveillance is appropriate for these workers.
Although increasing evidence indicates that exposure to some engineered
nanoparticles can cause adverse health effects in laboratory animals,
insufficient medical evidence exists to recommend the medical screening
of workers potentially exposed to engineered nanoparticles. However,
NIOSH will continue to assess the scientific evidence and periodically
update the guidance on medical screening. Because occupational exposure
to engineered nanoparticles is likely to become more common in the
future, NIOSH has recommended that employers identify the presence of
engineered nanoparticles in their workplace and implement effective
efforts to minimize worker exposure to these materials [NIOSH 2006].
This guidance document does not have the force and effect of the law.
Contact Persons for Technical Information: Dr. Paul A. Schulte, M/S
C-14, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati,
Ohio 45226, telephone 513/533-8302, or Ralph Zumwalde, M/S C-32, Robert
A. Taft Laboratories, 4676 Columbia
[[Page 70599]]
Parkway, Cincinnati, Ohio 45226, telephone 513/533-8320.
Reference:
NIOSH [2006]. Approaches to safe nanotechnology: an information
exchange with NIOSH. Cincinnati, OH: Department of Health and Human
Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, July 2006. Web address
for this document: https://www.cdc.gov/niosh/topics/nanotech/safenano/.
Dated: December 5, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-24047 Filed 12-11-07; 8:45 am]
BILLING CODE 4163-19-P
