Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction, 51280 [2015-20832]

Download as PDF 51280 Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices In row 1 of table 1 we estimate the total annual hourly burden necessary to comply with the requirement under section 403(y) of the FD&C Act to be 1,112 hours. Using historical A.C. Nielson Sales Scanner Data, we estimate the number of dietary supplement stock keeping units for which product sales are greater than zero to be 55,600. Assuming that the flow of new products is 10 percent per year, then each year approximately 5,560 new dietary supplement products are projected to enter the market. Estimating that there are 1,700 dietary supplement manufacturers, re-packagers, re-labelers, and holders of dietary supplements subject to the information collection requirement (using the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR 34752), on the ‘‘Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,’’ and factoring for a 2 percent annual growth rate), we calculate an annual disclosure burden of 3.27 disclosures (labels) per firm. Last, we expect that firms prepare the required labeling for their products in a manner that takes into account at one time all information required to be disclosed and therefore believe that less than 0.2 hours (12 minutes) per product label would be expended to fulfill this requirement. In row 2 of table 1 we estimate the total burden associated with the recommendation to include an explanatory statement on dietary supplement product labels letting consumers know the purpose of the domestic address or telephone number to be 1,112 hours. Based upon our knowledge of food and dietary supplement labeling, we estimate it would require less than 0.2 hours (12 minutes) per product label to include such a statement. Notice; correction. DEPARTMENT OF HEALTH AND HUMAN SERVICES The Food and Drug Administration (FDA) is correcting a notice that appeared in theFederal Register of Monday, August 3, 2015 (80 FR 45999). The document announced a public workshop entitled ‘‘Surrogate Endpoints for Clinical Trials in Kidney Transplantation.’’ The document was published without the email address and fax number in the Contact Person section and without the option for email or phone registration in the Registration section. This document corrects those errors. SUMMARY: FOR FURTHER INFORMATION CONTACT: Ramou Pratt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993–0002, 301–796–3928 or 301– 796–1600, FAX: 301–595–7993, endpoints@fda.hhs.gov. In FR Doc. 2015–18911, appearing on page 45999 in the Federal Register of Monday, August 3, 2015, the following corrections are made: 1. On page 45999, in the first column, the Contact Person section is corrected to read: ‘‘Contact Person: Ramou Pratt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993–0002, 301–796–3928 or 301– 796–1600, FAX: 301–595–7993, endpoints@fda.hhs.gov.’’ SUPPLEMENTARY INFORMATION: [Docket No. FDA–2015–N–0001] 2. On page 45999, in the second column, the Registration section is corrected to read: ‘‘Registration: Email, fax, or phone your registration information (including name, title, firm name, address, telephone and fax numbers) to Ramou Pratt (see Contact Person) by September 25, 2015. Registration is free for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space-available basis beginning at 8 a.m. If you need special accommodations because of a disability, please contact Ramou Pratt (see Contact Person) at least 7 days in advance.’’ Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Notice of Public Workshop; Correction Dated: August 19, 2015. Leslie Kux, Associate Commissioner for Policy. Dated: August 17, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–20760 Filed 8–21–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration tkelley on DSK3SPTVN1PROD with NOTICES ACTION: [FR Doc. 2015–20832 Filed 8–21–15; 8:45 am] AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 BILLING CODE 4164–01–P PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 [Document Identifier: OS–0990–0302–60D] Agency Information Collection Request. 60-Day Public Comment Request AGENCY: Office of the Secretary, HHS. Agency Information Collection Request. 60-Day Public Comment Request In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, email your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on (202) 690–6162. Written comments and recommendations for the proposed information collections must be directed to the OS Paperwork Clearance Officer at the above email address within 60days. Proposed Project: Medical Reserve Corps Unit Profile and Reports (Revision)—OMB No. 0990–0302— Office of the Secretary/Office of the Assistant Secretary for Health/Office of the Surgeon General/Division of Civilian Volunteer Medical Reserve Corps (OS/OASH/OSG/DCVMRC) is changed to Office of the Secretary/Office of the Assistant Secretary for Preparedness and Response/Office of Emergency Management/Division of the Civilian Volunteer Medical Reserve Corps this reorganization was effective as of 26 November 2014 as published in the Federal Register [FR Doc. 2014– 28030 Filed 11–25–14; 8:45am]. Abstract: Medical Reserve Corps units are currently located in almost 1,000 communities across the United States, E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Page 51280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Surrogate Endpoints for Clinical Trials in Kidney 
Transplantation; Notice of Public Workshop; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in theFederal Register of Monday, August 3, 2015 (80 FR 
45999). The document announced a public workshop entitled ``Surrogate 
Endpoints for Clinical Trials in Kidney Transplantation.'' The document 
was published without the email address and fax number in the Contact 
Person section and without the option for email or phone registration 
in the Registration section. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Ramou Pratt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993-0002, 301-
796-3928 or 301-796-1600, FAX: 301-595-7993, endpoints@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2015-18911, appearing on page 
45999 in the Federal Register of Monday, August 3, 2015, the following 
corrections are made:
    1. On page 45999, in the first column, the Contact Person section 
is corrected to read: ``Contact Person: Ramou Pratt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6193, Silver Spring, MD 20993-0002, 301-
796-3928 or 301-796-1600, FAX: 301-595-7993, endpoints@fda.hhs.gov.''

    2. On page 45999, in the second column, the Registration section is 
corrected to read: ``Registration: Email, fax, or phone your 
registration information (including name, title, firm name, address, 
telephone and fax numbers) to Ramou Pratt (see Contact Person) by 
September 25, 2015. Registration is free for the public workshop. Early 
registration is recommended because seating is limited. Registration on 
the day of the public workshop will be provided on a space-available 
basis beginning at 8 a.m.
    If you need special accommodations because of a disability, please 
contact Ramou Pratt (see Contact Person) at least 7 days in advance.''

    Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20832 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P