This PDF is the current document as it appeared on Public Inspection on 08/23/2013 at 08:45 am.
Food and Drug Administration, HHS.
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 the paperwork burden to the public of the Animal Feed Network, which includes the Pet Event Tracking Network (PETNet) and LivestockNET, for reporting of pet food or animal feed related instances, respectively.
Submit either electronic or written comments on the collection of information by October 25, 2013.
Submit electronic comments on the collection of information to http://www.regulations.gov. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville, MD 20850, 301-796-5733, email@example.com.End Further Info End Preamble Start Supplemental 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.
Pet Event Tracking Network—State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases—and Livestock.NET—21 U.S.C. 342, 21 U.S.C. 343, Section 1002(b) of the FDA Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823) (2007)—OMB Control Number 0910-0680
On August 1, 2011, the Pet Event Tracking Network (PETNet) was launched by FDA and its partners in the Start Printed Page 52775Partnership for Food Protection (PFP). PETNet is a secure, Web-based network that allows information to be exchanged more freely and efficiently between FDA and other Federal and State regulatory agencies. PETNet allows the exchange of information about pet food related incidents, such as illness associated with the consumption of pet food or pet food product defects. PETNet is only accessible by government employees with membership rights, and each member has equal access to the data in the system. At its launch, the system had over 200 members representing 4 Federal agencies, all 50 states, and 3 U.S. territories. Using the shared information, State and Federal agencies can work together to quickly determine if regulatory actions are needed to prevent or quickly limit adverse effects associated with pet food products.
Since its launch, PETNet has seen increased usage among members. Two years following the launch of the system, there have been reports entered by two Federal agencies and multiple states. Approximately 60 percent of the entries are from Federal agency members and 40 percent by State agency members. The majority of entries in PETNet are associated with dog food products, followed by cat food products, products affecting species “other” than those available in the drop down menu choices, and small mammal products. As familiarity with PETNet has increased, there has been increased usage and entries from members.
PETNet was originally developed for pet animals only, but after its initial launch in 2011, there have been ongoing requests to expand the system to include livestock animals, aquaculture species, and horses. Such an early alert system does not currently exist to share information related to illness associated with consumption of adulterated food or product defects for these species. LivestockNET has been developed to serve as a similar early alert system for feed-related illness and product defects associated with feed for livestock animals, aquaculture species, and horses.
LivestockNET and PETNet will be Web-based portals with the same functionality, but the questions asked for each portal will be specific for each. Users of the individual portals are expected to be the same officials from Federal, State, and Territorial agencies. Because of the similarity of the portals and the intended audience for both, the two individual portals will be housed in an overall system titled the Animal Feed Network. PETNet and LivestockNET will be able to be accessed individually in the Animal Feed Network, once the user logs in to the system.
Use of the Animal Feed Network, including the reporting of incidents by non-FDA members, will continue to be voluntary. The Animal Feed Network is a Web-based system, based in a proprietary system using CORESHIELD technology, and will be accessible only to members via password. PETNet and LivestockNET will make use of standardized electronic forms that have been custom developed for the individual portals. The two forms share the following common data elements, the majority of which are drop down menu choices: Product details (name of feed, lot code, product form, and the manufacturer or distributor/packer (if known)), the species affected, number of animals exposed to the product, number of animals affected, body systems affected, product problem/defect, date of onset or the date product problem was detected, the State where the incident occurred, the origin of the information, whether there are supporting laboratory results, and contact information for the reporting member (i.e., name, telephone number will be captured automatically when member logs in to the system). For the LivestockNET form, additional data elements specific to livestock animals will be captured: Product details (indication of whether the feed is a medicated feed, product packaging, and intended purpose of the feed), class of the animal species affected, and production loss. For PETNet, the only additional data field is the animal life stage. The form would be filled out and submitted by a member in the specified portal of the Animal Feed Network. Once the entry is submitted, it will be available to other members. Thus, the information will be entered and received by Animal Feed Network members in as close to real time as possible. FDA and the PFP have designed the form itself to contain only the essential information necessary to alert Animal Feed Network members about animal feed and pet food related incidents.
FDA estimates the burden of this collection of information as follows:
|21 U.S.C. section||Number of respondents||Number of responses per respondent||Total annual responses||Average burden per response||Total hours|
|21 U.S.C. 342, 21 U.S.C. 343, Section 1002(b) of the FDA Amendments Act of 2007/PETNet||20||5||100||0.25 (15 minutes)||25|
|Ibid./LivestockNET portal||20||5||100||0.25 (15 minutes)||25|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
FDA estimates that each State will report to the Animal Feed Network (i.e., fill out the PETNet or LivestockNET form to alert other members about a pet food or animal food related incident, respectively) approximately 5 times per year for each portal. This estimate represents the maximum number of reports that FDA expects a State to submit in a year, and in many cases the number of reports submitted by a State will probably be far less. FDA believes that, given the PETNet form has 15 items and the LivestockNET form has 19 items, with most being drop down fields and not all fields being required for submission, 15 minutes is a sufficient amount of time to complete the form. State regulatory officials responsible for animal feed and pet food already possess computer systems and have the Internet access necessary to participate in the Animal Feed Network, and thus there are no capital expenditures associated with the reporting.
Regarding recordkeeping, State regulatory officials who report in the Animal Feed Network receive the reportable information from consumers in their States in the course of their customary and regular duties. Further, these individuals already maintain records of such consumer complaints in the course of their duties, which are Start Printed Page 52776sufficient for the purposes of reporting in the PETNet and LivestockNET portals of the Animal Feed Network. Therefore, FDA believes that the proposed collection of information does not have additional recordkeeping requirements.Start Signature
Dated: August 20, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-20710 Filed 8-23-13; 8:45 am]
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