Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates, 2674 [C1-2020-28064]

Download as PDF 2674 Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices 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: Extralabel Drug Use for Animals—21 CFR 530 OMB Control Number 0910–0325— Extension The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 103– 396) allows a veterinarian to prescribe the extralabel use of approved new animal drugs. Also, it permits FDA, if it finds that there is a reasonable probability that the extralabel use of an animal drug may prevent the risk to the public health, to establish a safe level for a residue from the extralabel use of the drug and to require the development of an analytical method for the detection of residues above that established safe level (21 CFR 530.22(b)). Although to date, we have not established a safe level for a residue from the extralabel use of any new animal drug and, therefore, have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are, therefore, estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs; State, Federal, and/or State Agencies; academia; or individuals. In the Federal Register of August 6, 2020 (85 FR 47794), we published a 60day notice requesting public comment on the proposed collection of information. One comment was received but was not responsive to topics solicited regarding the information collection. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR part Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 530.22(b); Submission(s) of Analytical Method ................... 2 1 2 4,160 8,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: January 5, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [Docket No. FDA–2014–N–0913] [FR Doc. 2021–00475 Filed 1–12–21; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: [Docket No. FDA–2010–N–0161] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates Correction In notice document 2020–28064 appearing on pages 83091–83092 in the issue of Monday, December 21, 2020, make the following correction: On page 83091, in the second column, in the DATES section, change ‘‘January 20, 2021’’ to read ‘‘January 21, 2021.’’ [FR Doc. C1–2020–28064 Filed 1–12–21; 8:45 am] VerDate Sep<11>2014 18:08 Jan 12, 2021 Jkt 253001 The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 information collection burden estimate for requests for a written statement from FDA regarding the classification and regulatory requirements that may be applicable to a particular device (513(g) requests). DATES: Submit either electronic or written comments on the collection of information by March 15, 2021. SUMMARY: Food and Drug Administration BILLING CODE 1301–00–D Notice. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 15, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 15, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, 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 E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Page 2674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2020-28064]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export of Food and 
Drug Administration-Regulated Products: Export Certificates

Correction

    In notice document 2020-28064 appearing on pages 83091-83092 in the 
issue of Monday, December 21, 2020, make the following correction:
    On page 83091, in the second column, in the DATES section, change 
``January 20, 2021'' to read ``January 21, 2021.''

[FR Doc. C1-2020-28064 Filed 1-12-21; 8:45 am]
BILLING CODE 1301-00-D