Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals, 3607-3608 [2015-01113]

Download as PDF 3607 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices Desk Officer for the Administration for Children and Families. Percentage’’ for the District of Columbia from ‘‘14.17’’ to ‘‘30.00.’’ Robert Sargis, Reports Clearance Officer. Melody Wayland, Senior Grants Policy Specialist, Office of Administration. [FR Doc. 2015–01122 Filed 1–22–15; 8:45 am] [FR Doc. 2015–01106 Filed 1–22–15; 8:45 am] BILLING CODE 4184–01–P BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Food and Drug Administration [CFDA Number 93.645] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals [Docket No. FDA–2008–N–0312] Correction to the Notice of Allotment Percentages to States for Child Welfare Services State Grants Administration on Children, Youth and Families, Administration for Children and Families, Department of Health and Human Services. AGENCY: ACTION: Notice; correction. The Administration on Children, Youth and Families, Administration on Children and Families published a document in the Federal Register of November 28, 2014, concerning the biennial publication of allotment percentages for States under Title IV–B subpart 1, Child Welfare Services State Grants Program. The document contained an incorrect allotment percentage for the District of Columbia. SUMMARY: FOR FURTHER INFORMATION CONTACT: Deborah Bell, Grants Fiscal Management Specialist, Office of Grants Management, Office of Administration, Administration for Children and Families, telephone (202) 401–4611. Correction: In the Federal Register of November 28, 2014, in FR. Doc. 2014– 28135, on page 70873, in the second column, correct the ‘‘Allotment 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. DATES: Fax written comments on the collection of information by February 23, 2015. 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 0910–0325. 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, 8455 Colesville Road; COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: 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 in Animals—21 CFR 530 (OMB Control Number—0910– 0325)—(Extension) The Animal Medicinal Drug Use Clarification Act of 1994 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 present a 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. 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, or Federal and/or State Agencies, academia, or individuals. In the Federal Register of November 4, 2014 (79 FR 65408), 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 respondents Number of responses per respondent Total annual responses Average burden per response Total hours 530.22(b) .............................................................................. tkelley on DSK3SPTVN1PROD with NOTICES 21 CFR Section 2 1 2 4,160 8,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:05 Jan 22, 2015 Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1 3608 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices Dated: January 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–01113 Filed 1–22–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0915] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application AGENCY: Food and Drug Administration, HHS. ACTION: Submit either electronic or written comments on the collection of information by March 24, 2015. ADDRESSES: Submit electronic comments on the collection of information to https:// 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY 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 DATES: Notice. 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 FDA guidance for industry on ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.’’ This guidance document provides recommendations on postmarketing serious adverse event reporting for nonprescription (over-thecounter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. SUMMARY: 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. Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (OMB Control Number 0910–0636)—Extension Respondents to this collection of information are manufacturers, packers, and distributors whose name (under section 502(b)(1) (21 U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)) appears on the label of a nonprescription drug marketed in the United States. FDA is requesting public comment on estimates of annual submissions from these respondents, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109–462) and described in the guidance. The guidance document discusses what should be included in a serious adverse drug event report submitted under section 760(b)(1) (21 U.S.C. 379aa(b)(1)) of the FD&C Act, including follow-up reports under 760(c)(2) (21 U.S.C. 379aa(c)(2)) of the FD&C Act, and how to submit these reports. The estimates for the annual reporting and recordkeeping burdens are based on FDA data on the number of adverse drug experience reports submitted for nonprescription drug products marketed without an approved application, including FDA’s knowledge about the time needed to prepare the reports and to maintain records. Based on FDA data, we estimate between 10,000 and 15,000 (i.e., approximately 12,500) total annual responses from approximately 50 respondents for nonprescription drugs marketed without an approved application, and we also estimate that each submission will take approximately 2 hours to prepare and submit. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 tkelley on DSK3SPTVN1PROD with NOTICES Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Reports of serious adverse drug events (21 U.S.C. 379aa((b) and (c)) ............................................................ 50 250 12,500 2 25,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 18:05 Jan 22, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3607-3608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01113]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Extralabel Drug Use 
in Animals

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 
February 23, 2015.

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 0910-0325. 
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, 8455 Colesville Road; COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Extralabel Drug Use in Animals--21 CFR 530 (OMB Control Number--0910-
0325)--(Extension)

    The Animal Medicinal Drug Use Clarification Act of 1994 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 present a 
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. 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, or Federal and/or State 
Agencies, academia, or individuals.
    In the Federal Register of November 4, 2014 (79 FR 65408), 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
                           21 CFR Section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
530.22(b)..........................................................               2                1                2            4,160            8,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 3608]]

    Dated: January 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01113 Filed 1-22-15; 8:45 am]
BILLING CODE 4164-01-P
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