Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile, 39736 [2013-15796]

Download as PDF 39736 Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices The burden estimate for this reporting requirement was derived in our Office of Minor Use and Minor Species Animal Drug Development by extrapolating the current investigational new animal drug/new animal drug application reporting requirements for similar actions by this same segment of the regulated industry and from previous interactions with the minor use/minor species community. Dated: June 25, 2013. Leslie Kux, Assistant Commissioner for Policy. Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15794 Filed 7–1–13; 8:45 am] Food and Drug Administration BILLING CODE 4160–01–P [Docket No. FDA–2013–D–0576] DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft Guidance for Industry: Considerations for the Design of EarlyPhase Clinical Trials of Cellular and Gene Therapy Products; Availability Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: [Docket No. FDA–2013–N–0032] HHS. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Food Labeling; Notification Procedures for Statements on Dietary Supplements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 27, 2013, the Agency submitted a proposed collection of information entitled ‘‘Food Labeling; Notification Procedures for Statements on Dietary Supplements’’ 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 0910–0331. The approval expires on May 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/ Processors With Interest in Exporting to Chile BILLING CODE 4160–01–P VerDate Mar<15>2010 16:48 Jul 01, 2013 Jkt 229001 ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/ Processors With Interest in Exporting to Chile’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5733, domini.bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 25, 2013, the Agency submitted a proposed collection of information entitled, ‘‘Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile’’ 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 0910–0509. The approval expires on May 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUMMARY: Dated: June 26, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–15796 Filed 7–1–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. [Docket No. FDA–2012–N–1106] [FR Doc. 2013–15792 Filed 7–1–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ‘‘Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products’’ dated July 2013. The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 22, 2013. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUMMARY: E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Page 39736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1106]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Establishing and Maintaining a List 
of U.S. Dairy Product Manufacturers/Processors With Interest in 
Exporting to Chile

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 ``Establishing and Maintaining a 
List of U.S. Dairy Product Manufacturers/Processors With Interest in 
Exporting to Chile'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On March 25, 2013, the Agency submitted a 
proposed collection of information entitled, ``Establishing and 
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With 
Interest in Exporting to Chile'' 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 0910-0509. 
The approval expires on May 31, 2016. 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 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15796 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P
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