Agency Information Collection Activities: Proposed Collection: Comment Request, 67656-67657 [2012-27563]
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Federal Register / Vol. 77, No. 219 / Tuesday, November 13, 2012 / Notices
the information that must be submitted
by a petitioner in order to establish the
safety of a food additive and to secure
the issuance of a regulation permitting
its use.
To implement the provisions of
section 409 of the FD&C Act, procedural
regulations have been issued under 21
CFR part 571. These procedural
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broader terms by the FD&C Act.
The regulations add no substantive
requirements to those indicated in the
FD&C Act, but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the petition. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in parts 501, 573, and 579.
The labeling regulations are considered
by FDA to be cross-referenced to
§ 571.1, which is the subject of this
same OMB clearance for food additive
petitions.
With regard to the investigational use
of food additives, section 409(j) of the
FD&C Act provides that any food
additive or any food bearing or
containing such an additive, may be
exempted from the requirements of this
section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive.
To implement the provisions of
section 409(j), regulations have been
issued under 21 CFR 570.17. These
regulations are designed to specify more
thoroughly the information that must be
submitted to meet the requirement set
down in broad terms by the FD&C Act.
Labeling requirements for
investigational food additives are also
set forth in various regulations
contained in part 501. The labeling
regulations are considered by FDA to be
cross referenced to § 570.17, which is
the subject of this same OMB clearance
for investigational food additive files.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FOOD ADDITIVE PETITIONS
Number of responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
571.1(c) Moderate Category ................................................
571.1(c) Complex Category .................................................
571.6 Amendment of Petition ..............................................
1
1
2
1
1
2
1
1
4
3,000
10,000
1,300
3,000
10,000
5,200
Total Hours ...................................................................
4
4
6
14,300
18,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
§ 571.1(c) Moderate Category: For a
food additive petition without complex
chemistry, manufacturing, efficacy, or
safety issues, the estimated time
requirement per petition is
approximately 3,000 hours. An average
of 1 petition of this type is received on
an annual basis, resulting in a burden of
3,000 hours.
§ 571.1(c) Complex Category: For a
food additive petition with complex
chemistry, manufacturing, efficacy, and/
or safety issues, the estimated time
requirement per petition is
approximately 10,000 hours. An average
of 1 petition of this type is received on
an annual basis, resulting in a burden of
10,000 hours.
§ 571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of 4 petitions of this type is received on
an annual basis, resulting in a burden of
5,200 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 INVESTIGATION FOOD ADDITIVE FILES
Number of responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
570.17 Moderate Category ..................................................
570.17 Complex Category ...................................................
9
4
1
1
9
4
1,500
5,000
13,500
20,000
Total Hours ...................................................................
13
2
13
6,500
33,500
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
§ 570.17 Moderate Category: For an
investigational food additive file
without complex chemistry,
manufacturing, efficacy, or safety issues,
the estimated time requirement per file
is approximately 1,500 hours. An
average of 9 files of this type are
received on an annual basis, resulting in
a burden of 13,500 hours.
§ 570.17 Complex Category: For an
investigational food additive file with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
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estimated time requirement per file is
approximately 5,000 hours. An average
of 4 files of this type are received on an
annual basis, resulting in a burden of
20,000 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: November 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Agency Information Collection
Activities: Proposed Collection:
Comment Request
[FR Doc. 2012–27485 Filed 11–9–12; 8:45 am]
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Health Resources and Services
Administration
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
SUMMARY:
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67657
Federal Register / Vol. 77, No. 219 / Tuesday, November 13, 2012 / Notices
comment on proposed data collection
projects (section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (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.
Information Collection Request Title:
The National Health Service Corps
(NHSC) Site Retention Assessment
Questionnaire (OMB No. 0915–xxxx)—
New
Abstract: The National Health Service
Corps (NHSC) provides health
professionals with loan repayment and
scholarships in return for their service
to underserved areas. The NHSC’s
mission is to improve access to primary
care, which is supported by clinicians
who remain in their sites well beyond
their contracted periods of service.
However, many sites are unaware of
their influence and impact on clinician
retention levels. The purpose of this
project is to gather survey information
from administrative officials at NHSCapproved sites that will guide NHSC
initiatives and assist sites in improving
their retention outcomes. The survey
will ask site administrators to rate how
difficult it is to retain clinicians, their
general attitudes about the feasibility of
good retention and awareness of its
principles, their practices’ current
approaches to promoting retention,
ratings on various aspects of their
practices’ organizational culture and
Number of
respondents
Form name
Number of
responses per
respondent
administrative style, and their sites’
interest in and preferred ways of
learning how to bolster retention.
Survey data will be gathered
anonymously and presented in
aggregate, to promote administrators’
participation and full disclosure.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and, to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
NHSC Site Retention Assessment Questionnaire ...............
7,000
1
7,000
0.507
3,549
Total ..............................................................................
7,000
1
7,000
0.507
3,549
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
ADDRESSES:
Dated: November 7, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–27563 Filed 11–9–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service (IHS) Sharing
What Works—Best Practice, Promising
Practice, and Local Effort (BPPPLE)
Form
Indian Health Service, HHS.
Notice.
AGENCY:
ACTION:
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
30 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
is publishing for comment a summary of
a proposed information collection to be
submitted to the Office of Management
and Budget (OMB) for review. This
proposed information collection project
was previously published in the Federal
Register (77 FR 52748) on August 30,
2012, and allowed 60 days for public
SUMMARY:
PO 00000
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comment. No public comment was
received in response to the notice. The
purpose of this notice is to allow 30
days for public comment to be
submitted directly to OMB.
Proposed Collection: Title: 0917–
0034, ‘‘Indian Health Service (IHS)
Sharing What Works—Best Practice,
Promising Practice, and Local Effort
(BPPPLE) Form.’’ Type of Information
Collection Request: Extension without
revision of the currently approved
information collection, 0917–0034, ‘‘IHS
Sharing What Works—Best Practice,
Promising Practice, and Local Effort
(BPPPLE) Form,’’ which was previously
approved under the title ‘‘Director’s 3
Initiative Best Practice, Promising
Practice, and Local Efforts Form.’’
Although the name of the form has
changed, the contents of the form
remain the same. Forms: 0917–0034,
‘‘IHS Sharing What Works—Best
Practice, Promising Practice, and Local
Effort (BPPPLE) Form.’’ Need and Use of
Information Collection: The IHS goal is
to raise the health status of the
American Indian and Alaska Native (AI/
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]]>Agencies
[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Notices]
[Pages 67656-67657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27563]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
[[Page 67657]]
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
HRSA especially requests comments on: (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.
Information Collection Request Title: The National Health Service Corps
(NHSC) Site Retention Assessment Questionnaire (OMB No. 0915-xxxx)--New
Abstract: The National Health Service Corps (NHSC) provides health
professionals with loan repayment and scholarships in return for their
service to underserved areas. The NHSC's mission is to improve access
to primary care, which is supported by clinicians who remain in their
sites well beyond their contracted periods of service. However, many
sites are unaware of their influence and impact on clinician retention
levels. The purpose of this project is to gather survey information
from administrative officials at NHSC-approved sites that will guide
NHSC initiatives and assist sites in improving their retention
outcomes. The survey will ask site administrators to rate how difficult
it is to retain clinicians, their general attitudes about the
feasibility of good retention and awareness of its principles, their
practices' current approaches to promoting retention, ratings on
various aspects of their practices' organizational culture and
administrative style, and their sites' interest in and preferred ways
of learning how to bolster retention. Survey data will be gathered
anonymously and presented in aggregate, to promote administrators'
participation and full disclosure.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and, to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
NHSC Site Retention Assessment 7,000 1 7,000 0.507 3,549
Questionnaire..................
-------------------------------------------------------------------------------
Total....................... 7,000 1 7,000 0.507 3,549
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: November 7, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-27563 Filed 11-9-12; 8:45 am]
BILLING CODE 4165-15-P
