Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles, 33521-33522 [2015-14436]

Download as PDF 33521 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 3090–0221, Civilian Board of Contract Appeals Rules of Procedure, in all correspondence. Dated: June 4, 2015. David A. Shive, Chief Information Officer. [FR Doc. 2015–14446 Filed 6–11–15; 8:45 am] BILLING CODE 6820–AL–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB) Title: Immediate Disaster Case Management Intake Assessment. OMB No.: 0970–New. Description Section 426 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), as amended, 42 U.S.C. 5189d authorizes the Federal Emergency Management Agency (FEMA) and the U.S. Department of Health Services’ Administration for Children and Families (ACF) to provide Immediate Disaster Case Management (IDCM) services under the federal Disaster Case Management Program (DCMP). The use of the Electronic Case Management Record System (ECMRS) is aligned with Executive Order of the President 13589 and the memorandum to the Heads of Executive Departments and Agencies M–12–12 from the Office of Management and Budget to ‘‘Promote Efficient Spending to Support Agency Operations.’’ The primary purpose of the information collection pertains to ACF/ OHSEPR’s initiative to improve the intake process and delivery of case management services to individuals and households impacted by a disaster. Further, the information collection will be used to support ACF/OHSEPR’s goal to quickly identify critical gaps, resources, needs, and services to support State, local and non-profit capacity for disaster case management and to augment and build capacity where none exists. There are two versions of this Paper Reduction Act request: (1) paper intake assessment that will be used until ECMRS is implemented and operational and (2) Electronic Case Record platform. The ECMRS will greatly reduce respondent burden through built-in algorithms that will streamline response options and patterns. All information gathered will be exclusively used to inform the delivery of disaster case management services and programmatic strategies and improvements. Respondents: Individuals impacted by a major disaster. ANNUAL BURDEN ESTIMATES Number of respondents Instrument IDCM Intake Assessment ............................................ Number of responses per respondent 3,500 1 Average burden hours per response 40 minutes ....................... Total burden hours 140,000 minutes Estimated Total Annual Burden Hours: 140,000 minutes. mstockstill on DSK4VPTVN1PROD with NOTICES Additional Information ACF is requesting that OMB grant a 180 day approval for this information collection under procedures for emergency processing by June 19, 2015. A copy of this information collection, with applicable supporting documentation, may be obtained by calling the Administration for Children and Families, Reports Clearance Officer, Robert Sargis at (202) 690–7275. Comments and questions about the information collection described above should be directed to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ACF, Office of Management and Budget, Paperwork Reduction Project, 725 17th Street NW., Washington, DC 20503; FAX: (202) 395– 7285; email:oira_submission@ omb.eop.gov. [FR Doc. 2015–14400 Filed 6–11–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0543] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles Food and Drug Administration, HHS. 19:05 Jun 11, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles’’ 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. SUMMARY: Robert Sargis, Reports Clearance Officer. AGENCY: VerDate Sep<11>2014 ACTION: On April 24, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated SUPPLEMENTARY INFORMATION: E:\FR\FM\12JNN1.SGM 12JNN1 33522 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices Articles’’ 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 0910–0575. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: June 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14436 Filed 6–11–15; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0634] Cell-Based Products for Animal Use; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #218 (GFI #218) entitled ‘‘Cell-Based Products for Animal Use.’’ FDA is aware that many potential veterinary therapies may be produced using cell-based products. GFI #218 describes FDA’s Center for Veterinary Medicine’s current thinking on cell-based products for animal use that meet the definition of a new animal drug. This guidance is for persons developing, manufacturing, or marketing cell-based products, including ‘‘animal stem cell-based products’’. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:05 Jun 11, 2015 Jkt 235001 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary Medicine (HFV–114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0611, lynne.boxer@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 1, 2014 (79 FR 44803), FDA published the notice of availability for a draft guidance for industry #218 entitled ‘‘Cell-Based Products for Animal Use’’ giving interested persons until September 30, 2014, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated August 1, 2014. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Cell-Based Products for Animal Use. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 514 and 21 CFR 511.1 have been approved under OMB control numbers 0910–0032 and 0910–0117, respectively. IV. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 V. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: June 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14360 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1030] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Allergen Labeling and Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Allergen Labeling and Reporting’’ 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. SUMMARY: On March 30, 2015, the Agency submitted a proposed collection of information entitled ‘‘Food Allergen Labeling and Reporting’’ 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 0910–0792. The approval expires on May 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: June 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14437 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33521-33522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0543]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Waivers of Invivo Demonstration of
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and
Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled, ``Waivers of Invivo Demonstration
of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
and Type A Medicated Articles'' 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 April 24, 2015, the Agency submitted a
proposed collection of information entitled, ``Waivers of Invivo
Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral
Dosage Form and Type A Medicated

[[Page 33522]]

Articles'' 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 0910-0575. The approval
expires on May 31, 2018. A copy of the supporting statement for this
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

Dated: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14436 Filed 6-11-15; 8:45 am]
BILLING CODE P

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