Submission for OMB Review, Comment Request, 65531-65532 [06-9111]
Download as PDF
65531
Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices
security requirements. Employees who
maintain records in this system are
instructed not to release data until the
intended recipient agrees to implement
appropriate management, operational
and technical safeguards sufficient to
protect the confidentiality, integrity and
availability of the information and
information systems and to prevent
unauthorized access.
This system will conform to all
applicable Federal laws and regulations
and Federal, HHS, and CMS policies
and standards as they relate to
information security and data privacy.
These laws and regulations may apply
but are not limited to: the Privacy Act
of 1974; the Federal Information
Security Management Act of 2002; the
Computer Fraud and Abuse Act of 1986;
the Health Insurance Portability and
Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare
Modernization Act of 2003, and the
corresponding implementing
regulations. OMB Circular A–130,
Management of Federal Resources,
Appendix III, Security of Federal
Automated Information Resources also
applies. Federal, HHS, and CMS
policies and standards include but are
not limited to: All pertinent National
Institute of Standards and Technology
publications; the HHS Information
Systems Program Handbook and the
CMS Information Security Handbook.
RETENTION AND DISPOSAL:
CMS will retain identifiable MSIS
data for a total period not to exceed 10
years after the final determination of the
case is completed. All claims-related
records are encompassed by the
document preservation order and will
be retained until notification is received
from DOJ.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Informational
Analysis and Technical Assistance,
Finance, Systems & Budget Group,
Center for Medicaid and State
Operations, CMS, Mail Stop S3–18–15,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
NOTIFICATION PROCEDURE:
Submission for OMB Review,
Comment Request
For purpose of access, the subject
individual should write to the system
manager who will require the system
name, HICN, address, date of birth, and
gender, and for verification purposes,
the subject individual’s name (woman’s
maiden name, if applicable), and SSN.
Furnishing the SSN is voluntary, but it
may make searching for a record easier
and prevent delay.
RECORD ACCESS PROCEDURE:
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also specify the record contents being
sought. (These procedures are in
accordance with department regulation
45 CFR 5b.5(a)(2).)
CONTESTING RECORDS PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the records and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
Procedures are in accordance with
Department regulation 45 CFR 5b.7.)
RECORDS SOURCE CATEGORIES:
CMS obtains the identifying
information contained in this system
from state Medicaid agencies, or
Medicaid Management Information
Systems maintained by the individual
states, and information contained on
CMS Form 2082.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
None.
Administration for Children and
Families
Title: Evaluation of the Head Start
Region III I am Moving, I am Learning
(IM/IL) Program.
OMB No.: New Collection.
Description: The purpose of this
evaluation is to examine the
implementation of the Head Start
project I am Moving, I am Learning (IM/
IL) as a preventive intervention targeting
obesity in children. IM/IL was designed
to fit within the Head Start Performance
Standards and the Head Start Child
Outcomes Framework through
enhancements to current teaching and
family support practices by providing
more focused guidance on quality
movement, gross and fine motor
development, and child nutrition.
This data collection will be conducted
among programs implementing IM/IL in
Region III, and will gain information
about each site’s program context and
service components, including level of
adoption of IM/IL enhancements,
intensity of implementation, and
sustainability of enhancements. Progress
toward achieving outcomes and goals of
the IM/IL program that can be measured
will also be assessed.
Respondents: Head Start directors,
management teams, teachers, and staff
in Region III that received spring 2006
IM/IL training; parents or guardians of
children who attend Head Start
programs where IM/IL is being
implemented.
[FR Doc. E6–18814 Filed 11–7–06; 8:45 am]
BILLING CODE 4120–03–P
ANNUAL BURDEN ESTIMATES
Number of respondents
cprice-sewell on PRODPC62 with NOTICES
Instrument
Number of responses per
respondent
Average burden hours per
response
65
30
60
16
48
80
160
1
1
1
1
1
1
1
0.84
1.5
0.5
2.0
1.5
1.5
1.5
Director/Manager Questionnaire ......................................................................
Director/Manager Telephone Interview ............................................................
Teacher/Home Visitor Telephone Interview ....................................................
Director Interview .............................................................................................
Key Management Staff Interview ....................................................................
Teacher/Home Visitor Focus Group ................................................................
Parent Focus Group ........................................................................................
Estimated Total Annual Burden
Hours: 593.6.
VerDate Aug<31>2005
15:11 Nov 07, 2006
Jkt 211001
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
Total burden
hours
54.6
45.0
30.0
32.0
72.0
120.0
240.0
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
E:\FR\FM\08NON1.SGM
08NON1
65532
Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503, Attn: Desk
Officer for ACF, E-mail address:
Karen_T._Matsuoka@omb.epo.gov.
Dated: November 3, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–9111 Filed 11–7–06; 8:45am]
BILLING CODE 4184–01–M
reporting requirements for the
information collection activity entitled
‘‘How to Use E-mail to Submit a Notice
of Intent to Slaughter For Human Food
Purposes.’’
DATES: Submit written or electronic
comments on the collection of
information by January 8, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
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
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0435]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on How to Use E-Mail to
Submit a Notice of Intent to Slaughter
for Human Food Purposes
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
cprice-sewell on PRODPC62 with NOTICES
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
extending OMB approval on the existing
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.
Guidance for Industry on ‘‘How to Use
E-mail to Submit a Notice of Intent to
Slaughter for Human Food Purposes,’’
Section 512j, Federal Food, Drug, and
Cosmetic Act; (OMB Control Number
0910–0450)—Extension
Section 512(j) of the Federal Food,
Drug, and Cosmetic Act (the act), gives
FDA the authority to set conditions
under which animals treated with
investigational new animal drugs may
be marketed for food use. Under this
authority, the Center for Veterinary
Medicine (CVM), issues to a new animal
drug sponsor (sponsors) a slaughter
authorization letter that sets the terms
under which investigational animals
may be slaughtered. The United States
Department of Agriculture (USDA), also
monitors the slaughter of animals
treated with investigational new animal
drugs under the authority of the Meat
Inspection Act (21 U.S.C. 601–95).
Sponsors must submit slaughter notices
each time investigational animals are
presented for slaughter, unless this
requirement is waived by an
authorization letter ((21 CFR
511.1(b)(5)), (9 CFR 309.17)). These
notifications assist CVM and USDA in
monitoring the safety of the food
supply. Slaughter notices were
previously submitted to CVM and
USDA on paper. (OMB No. 0910–0450).
CVM’s guidance on ‘‘How to Use E-Mail
to Submit a Notice of Intent to Slaughter
for Human Food Purposes’’ provides
sponsors with the option to submit a
slaughter notice as an e-mail attachment
to CVM and USDA by the internet.
The electronic submission of
slaughter notices is part of CVM’s
ongoing initiative to provide a method
for paperless submissions.
The likely respondents are new
animal drug sponsors.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Form No.
No. of
Respondents
FDA Form #3488
1There
Annual Frequency
per Response
25
.08
Total Annual
Responses2
Hours per
Response
2
0.41
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
15:11 Nov 07, 2006
Jkt 211001
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
E:\FR\FM\08NON1.SGM
Total Hours
08NON1
.82
Agencies
[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Notices]
[Pages 65531-65532]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9111]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review, Comment Request
Title: Evaluation of the Head Start Region III I am Moving, I am
Learning (IM/IL) Program.
OMB No.: New Collection.
Description: The purpose of this evaluation is to examine the
implementation of the Head Start project I am Moving, I am Learning
(IM/IL) as a preventive intervention targeting obesity in children. IM/
IL was designed to fit within the Head Start Performance Standards and
the Head Start Child Outcomes Framework through enhancements to current
teaching and family support practices by providing more focused
guidance on quality movement, gross and fine motor development, and
child nutrition.
This data collection will be conducted among programs implementing
IM/IL in Region III, and will gain information about each site's
program context and service components, including level of adoption of
IM/IL enhancements, intensity of implementation, and sustainability of
enhancements. Progress toward achieving outcomes and goals of the IM/IL
program that can be measured will also be assessed.
Respondents: Head Start directors, management teams, teachers, and
staff in Region III that received spring 2006 IM/IL training; parents
or guardians of children who attend Head Start programs where IM/IL is
being implemented.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Director/Manager Questionnaire.................. 65 1 0.84 54.6
Director/Manager Telephone Interview............ 30 1 1.5 45.0
Teacher/Home Visitor Telephone Interview........ 60 1 0.5 30.0
Director Interview.............................. 16 1 2.0 32.0
Key Management Staff Interview.................. 48 1 1.5 72.0
Teacher/Home Visitor Focus Group................ 80 1 1.5 120.0
Parent Focus Group.............................. 160 1 1.5 240.0
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 593.6.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Administration, Office of Information Services, 370 L'Enfant
Promenade, SW.,
[[Page 65532]]
Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, 725 17th Street,
NW., Washington, DC 20503, Attn: Desk Officer for ACF, E-mail address:
Karen--T.--Matsuoka@omb.epo.gov.
Dated: November 3, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06-9111 Filed 11-7-06; 8:45am]
BILLING CODE 4184-01-M