Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0554]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards

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 review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by April 2, 2010.

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: 202-395-7285, or e-mailed to

oira_submission@omb.eop.gov

. All comments should be identified with the OMB control number 0910-0601. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156,

Daniel.Gittleson@fda.hhs.gov

.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Manufactured Food Regulatory Program Standards—(OMB Control Number 0910-0601)—Extension

I. Background

In the

Federal Register

of July 20, 2006 (71 FR 41221), FDA announced the availability of a draft document entitled “Manufactured Food Regulatory Program Standards.” These draft program standards are the framework that States should use to design and manage its manufactured food program. The implementation of the program standards will be negotiated as an option for payment under the State food contract. States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards. In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if they meet the elements of each standard. The State program should use the worksheets and forms contained herein; however it can use alternate forms that are equivalent. The State program maintains the documents and verifying records required for each standard. The information contained in the documents must be current and fit-for-use. If the State program fails to meet all program elements and documentation requirements of a standard, it develops a strategic plan to fully implement the program standards in 5 years. The strategic plan includes the following: (1) The individual element or documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, and (3) projected completion dates for each task.

II. Electronic Access

Persons with access to the Internet may obtain the draft program standards at

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125448.pdf.

In the

Federal Register

of December 2, 2009 (74 FR 63154), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden

1

No. of Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours

per Response

Total Hours

44

1

44

40

1,760

1

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

Table 2.—Estimated First-Year Baseline Self-Assessment Burden

1

No. of Respondents

Five-Year Frequency

per Response

Total First-Year

Responses

Hours

per Response

Total Hours

17

1

17

200

3,400

1

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

Dated: February 25, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-4340 Filed 3-2-10; 8:45 am]

BILLING CODE 4160-01-S