List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations; Correction, 36543 [2015-15558]

Download as PDF 36543 Federal Register / Vol. 80, No. 122 / Thursday, June 25, 2015 / Notices reporting on the overall performance of these grant programs. Data will be collected from all 60 Community-Centered Healthy Marriage, 54 Pathways to Responsible Fatherhood and 5 Community-Centered Responsible Fatherhood Ex-Prisoner Reentry grantees in the OFA programs. Grantees will report on program and participant outcomes in such areas as participants’ improvement in knowledge skills, attitudes, and behaviors related to healthy marriage and responsible fatherhood. Grantees will be asked to input data for selected outcomes for activities funded under the grants. Grantees will extract data from program records and will report the data twice yearly through an on-line data collection tool. Training and assistance will be provided to grantees to support this data collection process. Respondents: Office of Family Assistance Funded CommunityCentered Healthy Marriage, Pathways to Responsible Fatherhood and Community-Centered Responsible Fatherhood Ex-Prisoner Reentry Grantees. ANNUAL BURDEN ESTIMATES Performance measure reporting form (for private sector affected public) ........................................................................ Performance measure reporting form (for State, local, and tribal government affected public) ........................................ Estimated Total Annual Burden Hours: 190 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, Email: OIRA_SUBMISSION@ OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. asabaliauskas on DSK5VPTVN1PROD with NOTICES [FR Doc. 2015–15547 Filed 6–24–15; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 16:37 Jun 24, 2015 Jkt 235001 Number of responses per respondent Number of respondents Instrument Average burden hours per response Total annual burden hours 110 2 0.8 176 9 2 0.8 14 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration document, under Instructions, ‘‘Docket No. FDA–2013–N–1524’’ is corrected to read ‘‘Docket No. FDA–2015–N–1196’’. Dated: June 18, 2015. Leslie Kux, Associate Commissioner for Policy. [Docket No. FDA–2015–N–1196] List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Request for Nominations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Food and Drug Administration is correcting a notice entitled ‘‘List of Bulk Drug Substances That May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals; Request for Nominations’’ that appeared in the Federal Register of May 19, 2015 (80 FR 28622). The document announced the intention to develop a list of bulk drug substances that may be used by outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to compound animal drugs, in accordance with FDA’s draft guidance for industry #230, ‘‘Compounding Animal Drugs from Bulk Drug Substances.’’ The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, May 19, 2015, in FR Doc. 2015–11983, the following correction is made: 1. On page 28622, in the second column, in the ADDRESSES section of the SUMMARY: [FR Doc. 2015–15558 Filed 6–24–15; 8:45 am] [Docket No. FDA–2011–N–0915] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; 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: 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 July 27, 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_ SUMMARY: E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Page 36543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15558]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1196]


List of Bulk Drug Substances That May Be Used by an Outsourcing 
Facility To Compound Drugs for Use in Animals; Request for Nominations; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``List of Bulk Drug Substances That May Be Used by an 
Outsourcing Facility to Compound Drugs for Use in Animals; Request for 
Nominations'' that appeared in the Federal Register of May 19, 2015 (80 
FR 28622). The document announced the intention to develop a list of 
bulk drug substances that may be used by outsourcing facilities 
registered under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) to compound animal drugs, in accordance with FDA's draft guidance 
for industry #230, ``Compounding Animal Drugs from Bulk Drug 
Substances.'' The document was published with an incorrect docket 
number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, May 19, 
2015, in FR Doc. 2015-11983, the following correction is made:
    1. On page 28622, in the second column, in the ADDRESSES section of 
the document, under Instructions, ``Docket No. FDA-2013-N-1524'' is 
corrected to read ``Docket No. FDA-2015-N-1196''.

    Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15558 Filed 6-24-15; 8:45 am]
 BILLING CODE 4164-01-P
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