Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet, 17583-17584 [2020-06537]

Download as PDF 17583 Federal Register / Vol. 85, No. 61 / Monday, March 30, 2020 / Notices ANNUAL BURDEN ESTIMATES Total/annual number of respondents Instrument Survey of NSCAW Adopted Youth, Young Adults, and Adults ....................... Survey of NSCAW Adoptive Parents .............................................................. Estimated Total Annual Burden Hours: 571 Comments: 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. Authority: Child Abuse Prevention and Treatment and Adoption Reform Act of 1978. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–06491 Filed 3–27–20; 8:45 am] BILLING CODE 4184–25–P 588 554 meeting was announced in the Federal Register on February 24, 2020. FOR FURTHER INFORMATION CONTACT: Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307, Silver Spring, MD 20993–0002, 301– 796–7864, kathleen.hayes@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting, which was announced in the Federal Register of February 24, 2020, 85 FR 10451. Dated: March 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06513 Filed 3–27–20; 8:45 am] Allergenic Products Advisory Committee; Cancellation of Meeting AGENCY: HHS. ACTION: Notice. The meeting of the Allergenic Products Advisory Committee scheduled for May 15, 2020, is canceled. The Allergenic Products Advisory Committee meeting scheduled for May 15, 2020, to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A, has been canceled to allow time for the FDA to review outstanding issues. The Agency intends to continue evaluating the product and will schedule an Advisory Committee meeting in the future, as needed. The lotter on DSKBCFDHB2PROD with NOTICES VerDate Sep<11>2014 18:05 Mar 27, 2020 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. DATES: Fax written comments on the collection of information by April 29, 2020. SUMMARY: SUMMARY: Jkt 250001 294 277 395–7285, 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: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. 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: Tracking Network for PETNet, LivestockNet, and SampleNet 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 the FDAAA required FDA, in relevant part, to establish a pet food early warning alert system. AGENCY: Food and Drug Administration, .5 .5 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet [Docket No. FDA–2020–N–0008] Annual burden hours OMB Control Number 0910–0680— Extension [Docket No. FDA–2016–N–0736] Food and Drug Administration 1 1 Average burden hours per response BILLING CODE 4164–01–P Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Number of responses per respondent 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– ADDRESSES: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\30MRN1.SGM 30MRN1 17584 Federal Register / Vol. 85, No. 61 / Monday, March 30, 2020 / Notices The tracking network collects: (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); (2) reports of animal food-related illness and product defects associated with animal food for livestock animals, aquaculture species, and horses (LivestockNet); and (3) reports about animal food laboratory samples considered adulterated by State or FDA regulators (SampleNet). 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 are captured: product details (indication of whether the product is a medicated product, 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 SampleNet reports 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: Voluntary respondents to this 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 November 22, 2019 (84 FR 64533), we published a 60-day notice requesting public comment on the proposed collection of information. One comment was received offering general support for the information collection, but did not suggest a change to our burden estimate. At the same time, upon our own reevaluation we have reduced the number of respondents to the collection, which results in an overall reduction of 225 responses and 57 hours annually. We made this adjustment to better reflect current use of the tracking networks. We, therefore, estimate the burden of the information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Total annual responses Average burden per response Total hours PETNet ............................................................. LivestockNet ..................................................... SampleNet ........................................................ 5 5 5 5 5 5 25 25 25 0.25 (15 minutes) ....... 0.25 (15 minutes) ....... 0.25 (15 minutes) ....... 6.25 6.25 6.25 Total ........................................................... ........................ .............................. 75 ..................................... 18.75 Dated: March 20, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–06537 Filed 3–27–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053 AGENCY: Food and Drug Administration, HHS. lotter on DSKBCFDHB2PROD with NOTICES Number of responses per respondent Number of respondents Activity ACTION: Electronic Submissions Notice. The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for SUMMARY: VerDate Sep<11>2014 18:05 Mar 27, 2020 use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 053’’ (Recognition List Number: 053), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments on the notice at any time. These modifications to the list of recognized standards are applicable March 30, 2020. ADDRESSES: You may submit comments on the current list of FDA Recognized Consensus Standards at any time as follows: Jkt 250001 Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 including attachments, to https:// 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 https://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: E:\FR\FM\30MRN1.SGM 30MRN1

Agencies

[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17583-17584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06537]


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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 April 
29, 2020.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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--Extension

    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 the FDAAA required FDA, 
in relevant part, to establish a pet food early warning alert system.

[[Page 17584]]

    The tracking network collects: (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); (2) reports of animal food-related illness and 
product defects associated with animal food for livestock animals, 
aquaculture species, and horses (LivestockNet); and (3) reports about 
animal food laboratory samples considered adulterated by State or FDA 
regulators (SampleNet).
    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 are captured: product details (indication of 
whether the product is a medicated product, 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 SampleNet reports 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: Voluntary respondents to this 
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 November 22, 2019 (84 FR 64533), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received offering general 
support for the information collection, but did not suggest a change to 
our burden estimate. At the same time, upon our own reevaluation we 
have reduced the number of respondents to the collection, which results 
in an overall reduction of 225 responses and 57 hours annually. We made 
this adjustment to better reflect current use of the tracking networks. 
We, therefore, estimate the burden of the information collection as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                  Number of
          Activity               Number of      responses per     Total annual    Average burden    Total hours
                                respondents       respondent        responses      per response
----------------------------------------------------------------------------------------------------------------
PETNet......................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
LivestockNet................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
SampleNet...................               5                  5              25  0.25 (15                   6.25
                                                                                  minutes).
                             -----------------------------------------------------------------------------------
    Total...................  ..............  .................              75  ...............           18.75
----------------------------------------------------------------------------------------------------------------


    Dated: March 20, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06537 Filed 3-27-20; 8:45 am]
 BILLING CODE 4164-01-P