Proposed Information Collection Activity; Comment Request, 69487-69488 [2012-28061]
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69487
Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Notices
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to the
CDC. NIOSH implements this responsibility
for CDC. The charter was issued on August
3, 2001, renewed at appropriate intervals,
and will expire on August 3, 2013.
Purpose: This Advisory Board is charged
with (a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class.
Matters To Be Discussed: The agenda for
the Advisory Board meeting includes: NIOSH
Program Update; Department of Labor
Program Update; Department of Energy
Program Update; Update on 10-Year Review
Implementation; SEC petitions for: Hanford
(1987–1989; petition #155), Battelle
Laboratories—King Avenue (Columbus, OH),
Savannah River Site, General Steel Industries
(Granite City, IL), Baker Brothers (Toledo,
OH), and Joslyn Manufacturing and Supply
Co. (Fort Wayne, IN); SEC Petitions Status
Update; and Board Work Sessions.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot attend,
written comments may be submitted in
accordance with the redaction policy
provided below. Any written comments
received will be provided at the meeting and
should be submitted to the contact person
below well in advance of the meeting.
Policy on Redaction of Board Meeting
Transcripts (Public Comment): (1) If a person
making a comment gives his or her name, no
attempt will be made to redact that name. (2)
NIOSH will take reasonable steps to ensure
that individuals making public comment are
aware of the fact that their comments
(including their name, if provided) will
appear in a transcript of the meeting posted
on a public Web site. Such reasonable steps
include: (a) A statement read at the start of
each public comment period stating that
transcripts will be posted and names of
speakers will not be redacted; (b) A printed
copy of the statement mentioned in (a) above
will be displayed on the table where
individuals sign up to make public
comments; (c) A statement such as outlined
in (a) above will also appear with the agenda
for a Board Meeting when it is posted on the
NIOSH Web site; (d) A statement such as in
(a) above will appear in the Federal Register
Notice that announces Board and
Subcommittee meetings. (3) If an individual
in making a statement reveals personal
information (e.g., medical information) about
themselves that information will not usually
be redacted. The NIOSH FOIA coordinator
will, however, review such revelations in
accordance with the Freedom of Information
Act and the Federal Advisory Committee Act
and if deemed appropriate, will redact such
information. (4) All disclosures of
information concerning third parties will be
redacted. (5) If it comes to the attention of the
DFO that an individual wishes to share
information with the Board but objects to
doing so in a public forum, the DFO will
work with that individual, in accordance
with the Federal Advisory Committee Act, to
find a way that the Board can hear such
comments.
Contact Person for More Information:
Theodore Katz, Executive Secretary, NIOSH,
CDC, 1600 Clifton Road, MS
E–20, Atlanta GA 30333, telephone: (513)
533–6800, toll free: 1–800–CDC–INFO, email:
dcas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: November 9, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–28023 Filed 11–16–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects:
Title: Child Care and Development
Fund Annual Financial Report (ACF–
696T) for Tribes.
OMB No.: 0970–0195.
Description: Tribes use the Financial
Report Form ACF–696T to report Child
Care and Development Fund (CCDF)
expenditures. Authority to collect and
report this information is found in
Section 658G of the Child Care and
Development Block Grant Act of 1990,
as revised. In addition to the Program
Reporting Requirements set forth in 45
CFR Part 98, Subpart H, the regulations
at 45 CFR 98.65(g) and 98.67(c)(1)
authorize the Secretary to require
financial reports as necessary.
Tribal grantees submit the ACF–696T
report on an annual basis on behalf of
the Tribal Lead Agency administering
the Child Care and Development Fund
(CCDF).
The collection will not duplicate
other information.
Respondents: Tribes and Tribal
Organizations that are CCDF grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden
hours
ACF–696T CCDF Financial Reporting Form for Tribes ..................................
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Instrument
272
1
6
1,632
Estimated Total Annual Burden
Hours: 1,632.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
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Jkt 229001
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@acf.hhs.
gov. All requests should be identified by
the title of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
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functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
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69488
Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Notices
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012–28061 Filed 11–16–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1045]
Medical Devices; Custom Devices;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration Safety and Innovation
Act (FDASIA), which was signed into
law on July 9, 2012, amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act). The Food and Drug
Administration (FDA) is in the process
of developing an implementation
strategy and policy for the custom
device exemption criteria in the FD&C
Act amended by FDASIA. FDA is
seeking information on appropriate uses
of the custom device exemption.
DATES: Submit either electronic or
written comments by January 18, 2013.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville MD 20852.
FOR FURTHER INFORMATION CONTACT:
Bryan Benesch, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3424, Silver Spring,
MD 20993–0002, 301–796–5506.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Section 520(b) of the FD&C Act (21
U.S.C. 360j(b), as amended by section
617 of FDASIA (Pub. L. 112–144), sets
forth the requirements that must be met
in order for a device to qualify for a
custom device exemption (Ref. 1).
Section 520(b) of the FD&C Act exempts
‘‘custom devices’’ from performance
standard or premarket approval
requirements under sections 514 and
515 of the FD&C Act (21 U.S.C. 360d
and 360e), if these devices meet the
enumerated statutory requirements,
including, among others, the following
for each device: (1) Is ‘‘created or
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modified in order to comply with the
order of an individual physician or
dentist (or any other specially qualified
person designated under regulations
promulgated by the Secretary after an
opportunity for an oral hearing)’’; (2)
must not be ‘‘generally available in the
United States in finished form through
labeling or advertising by the
manufacturer, importer, or distributor
for commercial distribution’’; (3) must
be for the purpose of treating a ‘‘unique
pathology or physiological condition
that no other device is domestically
available to treat’’; and (4) must be
manufactured for the ‘‘special needs of
such physician or dentist (or other
specially qualified person so
designated) in the course of the
professional practice of the physician or
dentist (or other specially qualified
person so designated)’’ or by an
individual patient named in such order.
In addition to these new requirements
for establishing a custom device,
manufacturers will have limitations for
use of a custom device only for the
purpose of treating a ‘‘sufficiently rare
condition, such that conducting clinical
investigations on such device would be
impracticable’’ and production of the
device must be limited to no more than
five units per year of a particular device
type. Lastly, manufacturers will be
required to submit an annual report
explaining their use of the custom
device exemption under section 617 of
FDASIA.
FDA is seeking information on and
examples of appropriate uses of the
custom device exemption identified in
section 520(b) of the FD&C Act. FDA
encourages all stakeholders, including
patients, physicians, dentists, and
manufacturers, to submit comments on
the appropriate use of this statutory
provision.
FDA is particularly interested in
receiving information relating to:
1. Input from patients, manufacturers,
dentists, or physicians on where use of
the custom device exemption is
appropriate.
2. Specific instances where
manufacturers, dentists, or physicians
have used, would have liked to use, or
plan to use the custom device
exemption for treatment of a sufficiently
rare condition.
3. Product areas other than orthopedic
and dental devices where the custom
device exemption may be useful.
4. The type of information
manufacturers intend to require a
physician, dentist, or other qualified
person to submit to them when ordering
a custom device.
5. How often a custom device is
ordered due to unusual anatomical
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features of the individual physician/
dentist, or due to a unique need in the
physician’s/dentist’s practice not shared
by health professionals of the same
specialty (i.e., a special need of a
physician or dentist).
This notice provides the first
opportunity for the public to comment
on these issues. The public will have a
second opportunity to provide input
when the Agency announces the
availability of a draft guidance
document and a draft regulation for
implementing section 520(b) of the
FD&C Act.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. The Food and Drug Administration
Safety and Innovation Act, available at
https://www.fda.gov/
RegulatoryInformation/Legislation/
FederalFoodDrug
andCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/ucm20027187.htm.
Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–28042 Filed 11–16–12; 8:45 am]
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[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Pages 69487-69488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28061]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: Child Care and Development Fund Annual Financial Report
(ACF-696T) for Tribes.
OMB No.: 0970-0195.
Description: Tribes use the Financial Report Form ACF-696T to
report Child Care and Development Fund (CCDF) expenditures. Authority
to collect and report this information is found in Section 658G of the
Child Care and Development Block Grant Act of 1990, as revised. In
addition to the Program Reporting Requirements set forth in 45 CFR Part
98, Subpart H, the regulations at 45 CFR 98.65(g) and 98.67(c)(1)
authorize the Secretary to require financial reports as necessary.
Tribal grantees submit the ACF-696T report on an annual basis on
behalf of the Tribal Lead Agency administering the Child Care and
Development Fund (CCDF).
The collection will not duplicate other information.
Respondents: Tribes and Tribal Organizations that are CCDF
grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-696T CCDF Financial Reporting Form for 272 1 6 1,632
Tribes.....................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,632.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
[[Page 69488]]
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2012-28061 Filed 11-16-12; 8:45 am]
BILLING CODE 4184-01-P
