82 FR 18293 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 73 (April 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 73 (April 18, 2017)
| Page Range | 18293-18294 | |
| FR Document | 2017-07769 |
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)] [Notices] [Pages 18293-18294] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07769] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0736] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet 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 May 18, 2017. 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 [email protected]. 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: JonnaLynn Cappezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. 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. Tracking Network for PETNet, LivestockNet, and SampleNet OMB Control Number 0910-0680--Revision The Center for Veterinary Medicine and the Partnership for Food Protection developed a Web-based tracking network (the tracking network) to allow Federal, State, and Territorial regulatory and public health Agencies to share safety information about animal food. Information is submitted to the tracking network by regulatory and public health Agency employees with membership rights. The efficient exchange of safety information is necessary because it improves early identification and evaluation of a risk associated with an animal food product. We use the information to assist regulatory Agencies to quickly identify and evaluate a risk and take whatever action is necessary to mitigate or eliminate exposure to the risk. Earlier identification and communication with respect to emerging safety information may also mitigate the potential adverse economic impact for the impacted parties associated with such safety issues. The tracking network was developed under the requirements set forth under section 1002(b) of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-085). Section 1002(b) of FDAAA required FDA, in relevant part, to establish a pet food early warning alert system. Currently we receive two types of reports via the tracking network: (1) Reports of pet food-related illness and product defects associated with dog food, cat food, and food for other pets, which are submitted via the Pet Event Tracking Network (PETNet); and (2) reports of animal food-related illness and product defects associated with animal food for livestock animals, aquaculture species, and horses, which are submitted via LivestockNet. We are revising the collection to include a third type of report that would be submitted via ``SampleNet.'' SampleNet will collect reports about animal food laboratory samples considered adulterated by State or FDA regulators. SampleNet will allow Federal, State, and Territorial regulatory and public health Agencies to share laboratory data related to adulterated samples for [[Page 18294]] purposes of surveillance, mitigation, work planning, and supporting the animal food standard requirements. PETNet and LivestockNet reports share the following common data elements, the majority of which are drop down menu choices: Product details (product name, 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 report, additional data elements specific to livestock animals will be captured: Product details (indication of whether the product is a medicated feed under 21 CFR 558.3(b)(8), product packaging, and intended purpose of the product), class of the animal species affected, and production loss. For PETNet reports, the only additional data field is the animal life stage. The proposed SampleNet reports will have the following data elements, many of which are drop down menu choices: Product information (product name, lot code, guarantor information, date and location of sample collection, and product description); laboratory information (sample identification number, the reason for testing, whether the food was reported to the Reportable Food Registry, who performed the analysis); and results information (analyte, test method, analytical results, whether the results contradict a label claim or guarantee, and whether action was taken as a result of the sample analysis). Description of Respondents: Respondents to the collection of information are Federal, State, and Territorial regulatory and public health Agency employees with membership access to the Animal Feed Network. In the Federal Register of March 15, 2016 (81 FR 13794), 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\ ---------------------------------------------------------------------------------------------------------------- Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- PETNet.......................... 20 5 100 * 0.25 25 LivestockNet.................... 20 5 100 * 0.25 25 SampleNet....................... 20 5 100 * 0.25 25 ------------------------------------------------------------------------------- Total....................... 75 .............. .............. .............. .............. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. * 15 minutes. Our estimate is based on our experience with the tracking network over the past 3 years. We estimate that we will receive an average of 5 submissions from 20 respondents for each type of report, and that it will take 15 minutes (0.25 hour) per response. Dated: April 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-07769 Filed 4-17-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices 18293
general public; academia; and public B. Josephson Revocable Trust, Omaha, Administration, Three White Flint
health organizations. Nebraska; the Lawrence B. Josephson North, 10A63, 11601 Landsdown St.,
Revocable Trust; Melissa Josephson, North Bethesda, MD 20852, 301–796–
III. How can I request to participate in
Omaha, Nebraska; Eric Leibsohn, 3794.
this meeting?
Paradise Valley, Arizona; Steven SUPPLEMENTARY INFORMATION: In
PPDC meetings are free, open to the Leibsohn, Scottsdale, Arizona; Matthew compliance with 44 U.S.C. 3507, FDA
public, and no advance registration is Rose, Phoenix, Arizona; Thomas J. Rose, has submitted the following proposed
required. Public comments may be as trustee of The Rose Family Trust collection of information to OMB for
made during the public comment under the Anne D. Rose Revocable review and clearance.
session of each meeting or in writing to Trust, Phoenix, Arizona; and The Rose
the person listed under FOR FURTHER Family Trust under the Anne D. Rose Tracking Network for PETNet,
INFORMATION CONTACT. Revocable Trust, to retain voting shares LivestockNet, and SampleNet OMB
Authority: 7 U.S.C. 136 et seq. of Guaranty Bankshares, Ltd and Control Number 0910–0680—Revision
thereby indirectly retain voting shares of The Center for Veterinary Medicine
Dated: March 28, 2017.
Guaranty Bank and Trust Company, and the Partnership for Food Protection
Richard P. Keigwin, Jr.,
both of Cedar Rapids, Iowa. developed a Web-based tracking
Acting Director, Office of Pesticide Programs.
Board of Governors of the Federal Reserve network (the tracking network) to allow
[FR Doc. 2017–07817 Filed 4–17–17; 8:45 am]
System, April 12, 2017. Federal, State, and Territorial regulatory
BILLING CODE 6560–50–P
Ann E. Misback, and public health Agencies to share
Secretary of the Board. safety information about animal food.
[FR Doc. 2017–07737 Filed 4–17–17; 8:45 am] Information is submitted to the tracking
FEDERAL RESERVE SYSTEM network by regulatory and public health
BILLING CODE 6210–01–P
Agency employees with membership
Change in Bank Control Notices;
rights. The efficient exchange of safety
Acquisitions of Shares of a Bank or
information is necessary because it
Bank Holding Company DEPARTMENT OF HEALTH AND
improves early identification and
HUMAN SERVICES
The notificants listed below have evaluation of a risk associated with an
applied under the Change in Bank Food and Drug Administration animal food product. We use the
Control Act (12 U.S.C. 1817(j)) and information to assist regulatory
225.41 of the Board’s Regulation Y (12 [Docket No. FDA–2016–N–0736] Agencies to quickly identify and
CFR 225.41) to acquire shares of a bank evaluate a risk and take whatever action
Agency Information Collection
or bank holding company. The factors is necessary to mitigate or eliminate
Activities; Submission for Office of
that are considered in acting on the exposure to the risk. Earlier
Management and Budget Review;
notices are set forth in paragraph 7 of identification and communication with
Comment Request; Tracking Network
the Act (12 U.S.C. 1817(j)(7)). respect to emerging safety information
for PETNet, LivestockNet, and
The notices are available for may also mitigate the potential adverse
SampleNet
immediate inspection at the Federal economic impact for the impacted
Reserve Bank indicated. The notices AGENCY: Food and Drug Administration, parties associated with such safety
also will be available for inspection at HHS. issues. The tracking network was
the offices of the Board of Governors. ACTION: Notice. developed under the requirements set
Interested persons may express their forth under section 1002(b) of the Food
views in writing to the Reserve Bank SUMMARY: The Food and Drug and Drug Administration Amendments
indicated for that notice or to the offices Administration (FDA) is announcing Act of 2007 (FDAAA) (Pub. L. 110–085).
of the Board of Governors. Comments that a proposed collection of Section 1002(b) of FDAAA required
must be received not later than May 3, information has been submitted to the FDA, in relevant part, to establish a pet
2017. Office of Management and Budget food early warning alert system.
A. Federal Reserve Bank of Chicago (OMB) for review and clearance under Currently we receive two types of
(Colette A. Fried, Assistant Vice the Paperwork Reduction Act of 1995. reports via the tracking network: (1)
President) 230 South LaSalle Street, DATES: Fax written comments on the Reports of pet food-related illness and
Chicago, Illinois 60690–1414: collection of information by May 18, product defects associated with dog
1. Robert David Becker, Cedar Rapids, 2017. food, cat food, and food for other pets,
Iowa, individually and as a member of which are submitted via the Pet Event
a group acting in concert consisting of: ADDRESSES: To ensure that comments on Tracking Network (PETNet); and (2)
Dianne Becker, Cedar Rapids, Iowa; the information collection are received, reports of animal food-related illness
Maya Becker, Cedar Rapids, Iowa; OMB recommends that written and product defects associated with
Robert David Becker, in his individual comments be faxed to the Office of animal food for livestock animals,
capacity and as trustee for The Harold Information and Regulatory Affairs, aquaculture species, and horses, which
M. Becker Irrevocable Children’s Trust, OMB, Attn: FDA Desk Officer, FAX: are submitted via LivestockNet. We are
Cedar Rapids, Iowa; The Harold M. 202–395–7285, or emailed to oira_ revising the collection to include a third
Becker Irrevocable Children’s Trust; submission@omb.eop.gov. All type of report that would be submitted
Sherri A. Becker, Kansas City, Missouri; comments should be identified with the via ‘‘SampleNet.’’ SampleNet will
sradovich on DSK3GMQ082PROD with NOTICES
Linda Deaktor, Chatsworth, California; OMB control number 0910–0680. Also collect reports about animal food
Alan Josephson, Omaha, Nebraska; include the FDA docket number found laboratory samples considered
Deborah B. Josephson, as trustee for the in brackets in the heading of this adulterated by State or FDA regulators.
Deborah B. Josephson Revocable Trust, document. SampleNet will allow Federal, State,
Omaha, Nebraska; the Deborah B. FOR FURTHER INFORMATION CONTACT: and Territorial regulatory and public
Josephson Revocable Trust; Lawrence B. JonnaLynn Cappezzuto, Office of health Agencies to share laboratory data
Josephson, as trustee for the Lawrence Operations, Food and Drug related to adulterated samples for
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![18294 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
purposes of surveillance, mitigation, member logs in to the system). For the to the Reportable Food Registry, who
work planning, and supporting the LivestockNet report, additional data performed the analysis); and results
animal food standard requirements. elements specific to livestock animals information (analyte, test method,
PETNet and LivestockNet reports will be captured: Product details analytical results, whether the results
share the following common data (indication of whether the product is a contradict a label claim or guarantee,
elements, the majority of which are drop medicated feed under 21 CFR and whether action was taken as a result
down menu choices: Product details 558.3(b)(8), product packaging, and of the sample analysis).
(product name, lot code, product form, intended purpose of the product), class Description of Respondents:
and the manufacturer or distributor/ of the animal species affected, and Respondents to the collection of
packer (if known)), the species affected, production loss. For PETNet reports, the information are Federal, State, and
number of animals exposed to the only additional data field is the animal Territorial regulatory and public health
product, number of animals affected, life stage. The proposed SampleNet Agency employees with membership
body systems affected, product reports will have the following data access to the Animal Feed Network.
problem/defect, date of onset or the date elements, many of which are drop down In the Federal Register of March 15,
product problem was detected, the State menu choices: Product information 2016 (81 FR 13794), FDA published a
where the incident occurred, the origin (product name, lot code, guarantor 60-day notice requesting public
of the information, whether there are information, date and location of sample comment on the proposed collection of
supporting laboratory results, and collection, and product description); information. No comments were
contact information for the reporting laboratory information (sample received.
member (i.e., name, telephone number identification number, the reason for FDA estimates the burden of this
will be captured automatically when testing, whether the food was reported collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
PETNet ................................................................................. 20 5 100 * 0.25 25
LivestockNet ......................................................................... 20 5 100 * 0.25 25
SampleNet ........................................................................... 20 5 100 * 0.25 25
Total .............................................................................. 75 ........................ ........................ ........................ ........................
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 15 minutes.
Our estimate is based on our announcing an opportunity for public comment will be made public, you are
experience with the tracking network comment on the proposed collection of solely responsible for ensuring that your
over the past 3 years. We estimate that certain information by the Agency. comment does not include any
we will receive an average of 5 Under the Paperwork Reduction Act of confidential information that you or a
submissions from 20 respondents for 1995 (PRA), Federal Agencies are third party may not wish to be posted,
each type of report, and that it will take required to publish notice in the such as medical information, your or
15 minutes (0.25 hour) per response. Federal Register concerning each anyone else’s Social Security number, or
Dated: April 11, 2017. proposed collection of information, confidential business information, such
Anna K. Abram, including each proposed extension of an as a manufacturing process. Please note
Deputy Commissioner for Policy, Planning,
existing collection of information, and that if you include your name, contact
Legislation, and Analysis. to allow 60 days for public comment in information, or other information that
[FR Doc. 2017–07769 Filed 4–17–17; 8:45 am]
response to the notice. This notice identifies you in the body of your
solicits comments on the information comments, that information will be
BILLING CODE 4164–01–P
collection regarding exception from the posted on https://www.regulations.gov.
general requirements for informed • If you want to submit a comment
DEPARTMENT OF HEALTH AND consent. with confidential information that you
HUMAN SERVICES do not wish to be made available to the
DATES: Submit either electronic or
public, submit the comment as a
written comments on the collection of
Food and Drug Administration written/paper submission and in the
information by June 19, 2017.
manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2010–N–0062] ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
as follows:
Agency Information Collection Written/Paper Submissions
Activities; Proposed Collection; Electronic Submissions
Submit written/paper submissions as
Comment Request; Medical Devices; Submit electronic comments in the follows:
Exception From General Requirements following way: • Mail/Hand delivery/Courier (for
sradovich on DSK3GMQ082PROD with NOTICES
for Informed Consent • Federal eRulemaking Portal: written/paper submissions): Division of
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the Dockets Management (HFA–305), Food
HHS. instructions for submitting comments. and Drug Administration, 5630 Fishers
ACTION: Notice. Comments submitted electronically, Lane, Rm. 1061, Rockville, MD 20852.
including attachments, to https:// • For written/paper comments
SUMMARY: The Food and Drug www.regulations.gov will be posted to submitted to the Division of Dockets
Administration (FDA or Agency) is the docket unchanged. Because your Management, FDA will post your
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Document Created: 2017-04-18 00:00:24
Document Modified: 2017-04-18 00:00:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 18, 2017. | |
| Contact | JonnaLynn Cappezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794. | |
| FR Citation | 82 FR 18293 |
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