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                    the following: the agency or agencies that issued and signed a document
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                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
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                      the Unified Agenda of Federal Regulatory and Deregulatory
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                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2013-N-0115]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is announcing an 
                        ( print page 7545)
                        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 “Manufactured Food Regulatory Program Standard.”
 DATES: Submit either electronic or written comments on the collection of information by April 12, 2016.
 ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal:*http://www.regulations.gov.*
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    *http://www.regulations.gov*
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    *http://www.regulations.gov.*
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” *Instructions:*
                     All submissions received must include the Docket No. FDA-2013-N-0115 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    *http://www.regulations.gov*
                     or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on*http://www.regulations.gov.*
                     Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    *http://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.* *Docket:*
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    *http://www.regulations.gov*
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
 FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
                        *PRAStaff@fda.hhs.gov.*


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. Manufactured Food Regulatory Program Standards—OMB Control Number 0910-0601—Extension 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 (MFRPS).” These program standards are the framework that States should use to design and manage their manufactured food programs. There are 42 State programs enrolled, which may receive up to $300,000 each year for a period of 5 years provided there is significant conformance with the 10 standards. In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if it meets the elements of each standard. The State program should use the worksheets and forms contained in the draft program standards; however, it can use alternate 
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                    forms that are equivalent. The State program maintains the documents and verifies 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 which includes the following: (1) The individual element of 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. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
Respondent
Number of 
                             respondents
Number of 
                             responses  
                             per  
                             respondent
Total annual 
                             responses
Average 
                             burden per  
                             response
Total hoursState Departments of Agriculture or Health
42
1
42
750
31,5001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The burden has been calculated as 750 hours per respondent. This burden was determined by capturing the average amount of time for each respondent to assess the current state of the program and work toward implementation of each of the 10 standards contained in MFRPS. The hours per respondent will change as accounted for in the continuing improvement and self-sufficiency of the program. Dated: February 8, 2016. Leslie Kux, Associate Commissioner for Policy.


[FR Doc. 2016-02888 Filed 2-11-16; 8:45 am] BILLING CODE 4164-01-P