Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions, 57935 [2014-22981]

Download as PDF 57935 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices amount for judicial review changes to $1,464.80 based on the 46.480 percent increase over the initial threshold amount of $1,000. This amount was rounded to the nearest multiple of $10, resulting in the CY 2015 AIC threshold amount of $1,460.00 for judicial review. CY 2011 ALJ Hearing ............................................................................................. Judicial Review ........................................................................................ III. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). Dated: September 11, 2014. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. BILLING CODE 4120–01–P $130 1,300 $130 1,350 clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0540. The approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. [FR Doc. 2014–22981 Filed 9–25–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2007–N–0037] Food and Drug Administration Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions [Docket No. FDA–2011–N–0075] AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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. On July 08, 2014, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions’’ to OMB for review and SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:14 Sep 25, 2014 Food and Drug Administration, HHS. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies AGENCY: Notice. Jkt 232001 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 (PRA). DATES: Fax written comments on the collection of information by October 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 SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 In the following table we list the CYs 2011 through 2015 threshold amounts. CY 2012 Dated: September 23, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22625 Filed 9–25–14; 8:45 am] C. Summary Table of Adjustments in the AIC Threshold Amounts CY 2013 $140 1,400 CY 2014 $140 1,430 CY 2015 $150 1,460 OMB control number 0910–0119. 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 Rd., 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. Good Laboratory Practice Regulations for Nonclinical Studies—21 CFR Part 58 (OMB Control Number 0910–0119)— Extension Sections 409, 505, 512, and 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348, 355, 360b, 360e) and related statutes require manufacturers of food additives, human drugs and biological products, animal drugs, and medical devices to demonstrate the safety and utility of their product by submitting applications to FDA for research or marketing permits. Such applications contain, among other important items, full reports of all studies done to demonstrate product safety in man and/or other animals. In order to ensure adequate quality control for these studies and to provide an adequate degree of consumer protection, the Agency issued good laboratory practice (GLP) regulations for nonclinical laboratory studies in part 58 (21 CFR part 58). The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification. Part 58 requires testing facilities engaged in conducting toxicological studies to retain, and make available to regulatory officials, records regarding compliance with GLPs. Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. The GLP regulations E:\FR\FM\26SEN1.SGM 26SEN1

Agencies

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Page 57935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0037]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry: Animal Drug 
User Fees and Fee Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry: Animal Drug 
User Fees and Fee Waivers and Reductions'' has been approved by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
of 1995.

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: On July 08, 2014, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry: 
Animal Drug User Fees and Fee Waivers and Reductions'' to OMB for 
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0540. The approval expires on August 31, 2017. A 
copy of the supporting statement for this information collection is 
available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22981 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P

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