Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 / Notices 65531 

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. 

NOTIFICATION PROCEDURE: 

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. 

[FR Doc. E6–18814 Filed 11–7–06; 8:45 am] 

BILLING CODE 4120–03–P 

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

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

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., 


cprice-sewell on PRODPC62 with NOTICES
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 

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. 

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 

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: http://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. 

SUPPLEMENTARY INFORMATION: 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 

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 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

FDA Form #3488 25 .08 2 0.41 .82 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


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