Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Network (Pet Event Tracking Network and LivestockNet)-State, Federal Cooperation To Prevent Spread of Pet Food and Animal Feed Related Diseases, 10529-10530 [2014-04012]

Download as PDF 10529 Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Request for Assistance for Child Victims of Human Trafficking ..................... 80 1 1 80 Estimated Total Annual Burden Hours: 80. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2014–04001 Filed 2–24–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0973] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Network (Pet Event Tracking Network and LivestockNet)—State, Federal Cooperation To Prevent Spread of Pet Food and Animal Feed Related Diseases AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: Fax written comments on the collection of information by March 27, 2014. DATES: 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 emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0680. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. emcdonald on DSK67QTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:58 Feb 24, 2014 Jkt 232001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Pet Event Tracking Network—State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases—and Livestock.Net; OMB Control Number 0910–0680—Revision On August 1, 2011, the Pet Event Tracking Network (PETNet) was launched by FDA and its partners in the Partnership 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 dropdown 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 E:\FR\FM\25FEN1.SGM 25FEN1 10530 Federal Register / Vol. 79, No. 37 / Tuesday, February 25, 2014 / Notices 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. In the Federal Register of August 26, 2013 (78 FR 52774), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although four comments were received, none were responsive to the four collection of information topics solicited and therefore will not be discussed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED REPORTING BURDEN 1 Number of respondents 21 U.S.C. Section 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. Ibid./LivestockNet portal ................................................ 20 5 100 0.25 (15 minutes) 25 20 5 100 0.25 (15 minutes) 25 Total Hours ............................................................. ........................ ........................ ........................ .............................. 50 emcdonald on DSK67QTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that each member 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 five times per year for each portal. This estimate represents the maximum number of reports that FDA expects will be submitted in a year, and in many cases the number of reports submitted by a member 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. VerDate Mar<15>2010 17:58 Feb 24, 2014 Jkt 232001 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 sufficient 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. Dated: February 20, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04012 Filed 2–24–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1619] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10529-10530]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04012]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0973]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Feed Network 
(Pet Event Tracking Network and LivestockNet)--State, Federal 
Cooperation To Prevent Spread of Pet Food and Animal Feed Related 
Diseases

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 March 
27, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0680. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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.

Pet Event Tracking Network--State, Federal Cooperation To Prevent 
Spread of Pet Food Related Diseases--and Livestock.Net; OMB Control 
Number 0910-0680--Revision

    On August 1, 2011, the Pet Event Tracking Network (PETNet) was 
launched by FDA and its partners in the Partnership 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

[[Page 10530]]

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.
    In the Federal Register of August 26, 2013 (78 FR 52774), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although four comments were received, none 
were responsive to the four collection of information topics solicited 
and therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
               21 U.S.C. Section                   Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C. 342, 21 U.S.C. 343, Section 1002(b)               20               5             100  0.25 (15 minutes).......................              25
 of the FDA Amendments Act of 2007/PETNet.
Ibid./LivestockNet portal.....................              20               5             100  0.25 (15 minutes).......................              25
                                               ---------------------------------------------------------------------------------------------------------
    Total Hours...............................  ..............  ..............  ..............  ........................................              50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that each member 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 five times per year for each portal. This estimate 
represents the maximum number of reports that FDA expects will be 
submitted in a year, and in many cases the number of reports submitted 
by a member 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 sufficient 
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.

    Dated: February 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04012 Filed 2-24-14; 8:45 am]
BILLING CODE 4160-01-P
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